NextCure, Inc.: Form 10-Q for the period ended Sep 30, 2025

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited condensed financial statements and the notes thereto included in this Quarterly Report and the audited financial information and related notes, as well as Management’s Discussion and Analysis of Financial Condition and Results of Operations and other disclosures, included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, or our “2024 Annual Report.” Some of the statements contained in this discussion and analysis or set forth elsewhere in this Quarterly Report are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “continue,” “could,” “due,” “estimate,” “expect,” “intend,” “may,”

“objective,” “plan,” “predict,” “project,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language. Forward-looking statements include, but are not limited to, statements about:

• our expectations regarding the timing, progress and results of preclinical studies and clinical trials for SIM0505, LNCB74 and any other product candidates we develop, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;
• our estimates regarding our expenses, future revenues, capital requirements, needs for or ability to obtain additional financing and the period over which we expect our current cash, cash equivalents and marketable securities to be sufficient to fund our operations;
• the timing or likelihood of regulatory filings for SIM0505, LCNB74 and any other product candidates we develop and our ability to obtain and maintain regulatory approvals for such product candidates for any indication;
• the identification, analysis and use of biomarkers and biomarker data;
• our drug product sourcing and manufacturing strategy, including the scalability of our methods and processes;
• our expectations regarding the potential benefits, activity, effectiveness and safety of SIM0505, LNCB74 and any other product candidates we develop;
• our intentions and ability to successfully commercialize, including through partnering, our product candidates;
• our expectations regarding the nature of the biological pathways we are targeting;
• our expectations regarding our ability to discover and advance product candidates using our technologies;
• the potential benefits of and our ability to maintain our relationship with LigaChem Biosciences, Inc., (formerly known as LegoChem Bioscienses, Inc. or hereinafter “LigaChem”), Hainan Simcere Zaiming Pharmaceutical, Ltd. (“Zaiming”), Yale University (“Yale”), and other third parties;
• our ability to retain key personnel;
• our intended reliance on and the performance of third parties, including collaborators, contract research organizations and third-party manufacturers;
• changes in trade tariffs and international relations between the U.S. and China;
• our ability to protect and enforce our intellectual property protection and the scope and duration of such protection;
• our ability to maintain listing of our common stock on the Nasdaq Global Select Market;
• developments and projections relating to our competitors and our industry, including competing therapies; and
• the impact of current and future laws and regulations.

Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: the potential that positive results in preclinical studies may not be predictive of the results of clinical trials; our limited operating history and lack of any products approved for commercial sale; our history of significant losses; our need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; the unproven approach to the discovery and development of product candidates based on our technologies; risks related to our restructuring and reduction in force; and our dependence on key personnel. More detailed information on these and additional factors that could affect our actual results are described under the heading “Risk Factors” in our 2024 Annual Report and in our other filings with the Securities and Exchange Commission (the “SEC”). You should not place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of this report, and we assume no obligation to update any forward-looking statements, even if expectations change.

We are a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or that have disease progression on, current therapies, through the use of targeted therapies, including antibody-drug conjugates (“ADCs”), antibodies and proteins. An ADC consists of a monoclonal antibody conjugated to a cytotoxic drug via a chemical linker. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response.

Our product candidate SIM0505 is a novel ADC candidate developed by Zaiming, to which we acquired the global rights (excluding China, Hong Kong, Macau and Taiwan) to develop, manufacture, and commercialize under the

License Agreement, dated June 13, 2025, between the Company and Zaiming. It is directed to CDH6 (cadherin-6 or K-cadherin), a promising anti-tumor target, using a unique binding epitope designed to have increased tumor binding compared to competing candidates. It also features Zaiming’s proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity while offering fast systemic clearance to enlarge the therapeutic window. Preclinical studies have demonstrated robust anti-tumor activity across multiple solid tumor models and a promising safety profile in toxicology models.

Zaiming is currently in Phase 1 dose escalation studies in China with SIM0505 for the treatment of solid tumors, including ovarian, endometrial, non-small cell lung and renal. In December 2024, Zaiming received clearance from the U.S. Food and Drug Administration for its Investigational New Drug (“IND”) for a Phase 1 clinical trial for treating multiple cancers. We received notification by the FDA in June 2025 of the assignment of the IND to NextCure. In October 2025, we announced dosing our first patient and expect to provide proof of concept data readout in the first half of 2026.

Our product candidate LNCB74 is designed as a state-of-the-art B7-H4 targeted ADC to kill tumors. B7-H4, a clinically validated target, is a cell surface protein expressed on multiple tumor types including breast, ovarian, and endometrial cancers. LNCB74 will be positioned with both potential improved safety and efficacy compared to other ADCs targeting B7-H4. Preclinical studies demonstrated potent tumor killing in disease models and a favorable safety profile. LNCB74 is being advanced under a November 2022 Research Collaboration and Co-Development Agreement with LigaChem.

In December 2024, we announced that the FDA accepted an IND application for initiation of a Phase 1 clinical trial to evaluate LNCB74 for treating multiple cancers known to have high B7-H4 expression, including breast, ovarian, and endometrial cancers. In January 2025, the first patient in our Phase 1 trial of LNCB74 was dosed. In November 2025, we announced that the FDA had cleared a protocol amendment giving us the ability to add higher dose escalation cohorts. We plan to provide proof of concept data readout in the first half of 2026.

In addition, we are seeking to partner our other clinical programs NC410 and NC525 and to pursue a partner or third-party financing to advance our preclinical non-oncology programs NC605 and NC181.

In March 2024, we announced a prioritization and restructuring of our operations to align with our focused pipeline (the “2024 Restructuring”) (see Note 10, Restructuring and Asset Impairment). We paused our internal manufacturing operations and reduced our workforce.

Financial Overview

Since commencing operations in 2015, we have devoted substantially all of our efforts and financial resources to organizing and staffing our company, identifying business development opportunities, raising capital, securing intellectual property rights related to our product candidates, building and optimizing our manufacturing capabilities and conducting discovery, research and development activities for our product candidates.

To date, we have not generated any revenue from product sales and have financed our operations primarily through proceeds from public offerings of our common stock, with private placements of our preferred stock and with upfront fees received under our former research and development collaboration agreement. Since inception through September 30, 2025, we raised approximately $425 million in gross proceeds from the sale of equity instruments and had received a $25 million upfront payment from our former collaboration partner. We have never been profitable and have incurred net losses since the commencement of our operations. Our net loss for the three months ended September 30, 2025 and 2024, was $8.6 million and $11.5 million, respectively. Our net loss for the nine months ended September 30, 2025 and 2024, was $46.4 million and $44.1 million, respectively. As of September 30, 2025, we had an accumulated deficit of $426.5 million, primarily as a result of research and development and general and administrative expenses. We do not expect to generate product revenue unless and until we obtain marketing approval for and commercialize a product candidate, and we cannot make assurances that we will ever generate significant revenue or profits.

As of September 30, 2025, we had cash, cash equivalents and marketable securities of $29.1 million. We believe that our existing cash, cash equivalents and marketable securities will not be sufficient to fund our planned operations for a period of one year after the issuance of the accompanying unaudited financial statements. Thus, we have concluded that there is substantial doubt about our ability to continue as a going concern.

We expect to incur substantial expenditures in the foreseeable future as we advance SIM0505 and LNCB74 through clinical development, the regulatory approval process and, if approved, commercialization. Specifically, in the near term, we expect to incur expenses relating to clinical development activities with respect to SIM0505 and LNCB74.

We will need substantial additional funding to support our continuing operations and to pursue our development strategy. Until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our operations through a combination of public and private equity offerings, debt financings, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may be required to delay, limit, reduce or terminate preclinical studies, clinical trials, or other research and development activities or one or more of our development programs.

Components of Our Results of Operations

Operating Expenses

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for our clinical trials, discovery efforts, research activities, and development and testing of our product candidates and include:

• the costs of acquired in-process research and development;
• expenses incurred under agreements with third parties, including agreements with third parties that conduct research, preclinical activities or clinical trials on our behalf;
• the costs of outside consultants, including their fees, stock-based compensation and related travel expenses;
• the costs of laboratory supplies and acquiring, developing and manufacturing preclinical study and clinical trial materials;
• salaries, benefits and other related costs, including stock-based compensation, for personnel engaged in research and development functions; and
• facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs.

We expense research and development costs as incurred. Our expenses related to clinical trials are based on actual costs incurred and estimates of other incurred costs. These estimated costs are based on several factors, including patient enrollment and related expenses at clinical investigator sites, contract services received, consulting agreement costs and efforts expended under contracts with research institutions and third-party contract research organizations that conduct and manage clinical trials on our behalf. We generally accrue estimated costs related to clinical trials based on contracted amounts applied to the level of patient enrollment and other activity according to the protocol. If future timelines or contracts are modified based on changes in the clinical trial protocol or scope of work to be performed, we would modify our estimates of accrued expenses accordingly on a prospective basis. Historically, any such modifications have not been material.

Research and development activities are central to our business model. We expect that our research and development expenses will increase substantially in the future as we advance our product candidates through development.

We cannot determine with certainty the duration and costs of future clinical trials of SIM0505, LNCB74 or any other product candidate we may develop or if, when or to what extent we will generate revenue from the commercialization and sale of any product candidate for which we may obtain marketing approval. We may never succeed in obtaining marketing approval for any product candidate. The duration, costs and timing of clinical trials and development of SIM0505, LNCB74 and any other product candidate we may develop will depend on a variety of factors, including:

• the scope, progress, results and costs of clinical trials of SIM0505, LNCB74 as well as of any future clinical trials of other product candidates and other research and development activities that we may conduct;
• our ability to obtain partnerships for our other programs;
• uncertainties in selection of indications, clinical trial design and patient enrollment rates;
• the probability of success for our product candidates, including safety and efficacy, early clinical data, competition, ease and ability of manufacturing and commercial viability;
• significant and changing government regulation and regulatory guidance;
• the timing and receipt of any development or marketing approvals; and
• the expense of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.

A change in the outcome of any of these variables with respect to the development of a product candidate could lead to a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development of a product candidate, or if we experience significant delays in our clinical trials due to patient enrollment or other reasons, we would be required to expend significant additional financial resources and time to complete clinical development for any such product candidate.

General and Administrative Expenses

General and administrative expenses consist primarily of personnel-related costs, including payroll and stock-based compensation, for personnel in executive, finance, human resources, business and corporate development and other administrative functions, professional fees for legal, intellectual property, consulting and accounting services, rent and other facility-related costs, depreciation and other general operating expenses not otherwise classified as research and development expenses. General and administrative expenses also include all patent-related costs incurred in connection with filing and prosecuting patent applications, which are expensed as incurred.

Restructuring and Asset Impairment Charges

Restructuring and asset impairment charges consist of severance charges associated with a reduction in force, and include salary continuation, payroll taxes and company funded benefits. Asset impairment charges reflect the write-down of long-lived assets that are considered impaired under ASC 360.

Other Income, Net

Other income, net consists primarily of interest income earned on marketable securities.

Results of Operations

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

The following table summarizes our results of operations for the periods indicated (in thousands):

Research and Development Expenses

The following table summarizes our research and development expenses by product candidate for the periods indicated (in thousands):

(in thousands)

We do not allocate personnel-related costs, including stock-based compensation costs, or other indirect costs to specific programs, as they are deployed across multiple projects under development and discovery and, as such, are separately classified as internal research and development expenses in the table above.

Research and development expenses for the three months ended September 30, 2025 decreased by $2.6 million compared to the three months ended September 30, 2024 due to lower costs on other programs, largely costs for NC410 and NC525 as the Company previously deprioritized these programs and focused on finding a partner to further develop these programs. Internal costs decreased largely due to lower personnel-related costs, primarily stock compensation costs.

Research and development expenses for the nine months ended September 30, 2025 increased by $5.5 million compared to the nine months ended September 30, 2024 due to $17.0 million of fees associated with the License Agreement signed in June 2025. These higher costs were largely offset by lower costs on other programs, largely costs associated with NC410 and NC525 as the Company previously deprioritized these programs and focused on finding a partner to further develop these programs. Internal costs also decreased, largely due to lower personnel-related costs.

General and Administrative Expenses

General and administrative expenses for the three months ended September 30, 2025 decreased by $0.9 million compared to the three months ended September 30, 2024. The decrease was driven primarily by $0.6 million lower personnel-related costs, primarily stock compensation costs.

General and administrative expenses for the nine months ended September 30, 2025 decreased by $2.4 million compared to the nine months ended September 30, 2024. The decrease was driven primarily by $1.8 million lower personnel-related costs, primarily stock compensation costs and $0.3 million lower insurance costs.

Restructuring and Asset Impairment Charges

There were no restructuring and asset impairment charges for the three and nine months ended September 30, 2025. Restructuring and asset impairment charges were $0 and $2.5 million for the three and nine months ended September 30, 2024, consisting of $0.7 million of severance charges as a result of a reduction in force and $1.8 million of asset impairment charges associated with the write-down of certain manufacturing equipment, right of use assets and related improvements, each in connection with the 2024 Restructuring.

Other Income, Net

Other income, net for the three months ended September 30, 2025 decreased by $0.6 million compared to the three months ended September 30, 2024, due to lower interest income as a result of lower investable cash.

Other income, net for the nine months ended September 30, 2025 decreased by $1.8 million compared to the nine months ended September 30, 2024, due to lower interest income as a result of lower investable cash.

Liquidity and Capital Resources

Since inception through September 30, 2025, we have raised approximately $425 million in gross proceeds from the sale of equity instruments and had received a $25 million upfront payment from our former collaboration partner.

On August 4, 2023, the Company entered into a sales agreement (the “Sales Agreement”) with Leerink Partners LLC (the “Agent”), pursuant to which the Company was entitled to sell, from time to time, up to an aggregate sales price of $75 million of its common stock through the Agent in negotiated transactions that are deemed to be an “at the market offering.” The Agent will be entitled to compensation equal to 3.0% of the gross proceeds from the sale of all shares of common stock sold through it as the Agent under the Sales Agreement. Actual sales depended on a variety of factors determined by the Company from time to time, including, among other things, market conditions, the trading price of the common stock, capital needs and determinations by the Company of the appropriate sources of funding for the Company. No shares of common stock were sold in the three months ended September 30, 2025. The Sales Agreement was terminated by the Company effective as of October 8, 2025.

Under the Company's current plan, management believes its cash and cash equivalents and marketable securities of $29.1 million as of September 30, 2025 will not be sufficient to fund the Company's operations for a period of one year after the issuance of the accompanying unaudited financial statements. Thus, we have concluded that there is substantial doubt about our ability to continue as a going concern. The Company will need to raise additional capital in order to extend its runway and enable it to continue advancing its current clinical programs, SIM0505 and LNCB74, beyond mid-2026. While the Company intends to use any additional funding to continue development of both its lead programs, if the Company does not raise sufficient funds in one or more financings by year-end or obtain other financial support for program development, the Company will need to implement additional cost cutting measures to extend its runway, which may include delaying enrollment in, or pausing, one of its clinical programs and a further reduction in workforce.

See Note 2, Summary of Significant Accounting Policies, to our condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on our assessment. We will continue to require additional capital to develop our product candidates and fund operations for the foreseeable future. We may seek to raise capital through sale of equity, debt financings, strategic alliances and licensing arrangements. Adequate additional funding may not be available to us on acceptable terms or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development of our product candidates. Our need to raise additional capital will depend on many factors, including:

• the scope, progress, results and costs of researching and developing SIM0505, LNCB74 and our other programs, and of conducting preclinical studies and clinical trials;
• the timing of, and the costs involved in, obtaining marketing approvals for SIM0505, LNCB74 and any future product candidates we develop, if clinical trials are successful;
• the costs of manufacturing SIM0505, LNCB74 and any future product candidates we develop for preclinical studies and clinical trials in preparation for marketing approval and commercialization;
• the costs of commercialization activities, including marketing, sales and distribution costs, for SIM0505, LNCB74 and any future product candidates we develop, whether alone or with a collaborator, if any such product candidates are approved for sale, including marketing, sales and distribution costs;
• our ability to establish and maintain additional collaborations, licenses or other arrangements on favorable terms, if at all;
• the costs involved in preparing, filing, prosecuting, maintaining, expanding, defending and enforcing patent claims, including litigation costs and the outcome of any such litigation;
• our current collaboration and license agreements remaining in effect and our achievement of milestones and the timing and amount of milestone payments we are required to make, or that we may be eligible to receive, under those agreements;
• the timing, receipt and amount of sales of, or royalties on, our future products, if any; and
• the emergence of competing therapies and other developments in the oncology market.

Adequate additional financing may not be available to us on acceptable terms, or at all. If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing into which we enter may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments and engage in certain merger, consolidation or asset sale transactions. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. If we raise additional funds through government or private grants, collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our future revenue streams, product candidates or research programs or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, reduce or terminate some or all of our development programs and clinical trials. We may also be required to sell or license to others rights to our product candidates in certain territories or indications that we would prefer to retain for ourselves. See the section entitled “Risk Factors” for additional risks associated with our substantial capital requirements.

Cash Flows

The following table sets forth the primary sources and uses of cash and cash equivalents for each of the periods presented below (in thousands):

Net Cash Used in Operating Activities

Net cash used in operating activities was $42.0 million for the nine months ended September 30, 2025, which was primarily the result of our net loss of $46.4 million, partially offset by non-cash charges for depreciation of $1.8 million and stock-based compensation of $2.6 million. Net cash used in operating activities was $33.8 million for the nine months ended September 30, 2024, which was primarily the result of our net loss of $44.1 million, partially offset by non-cash charges for depreciation of $2.2 million, stock-based compensation of $4.8 million and impairment charges of $1.8 million, and $1.9 million provided by net changes in operating assets and liabilities.

Net Cash Provided by Investing Activities

Net cash provided by investing activities for the nine months ended September 30, 2025 was $19.6 million, which was entirely due to net proceeds from sales and maturities of marketable securities. Net cash provided by investing activities for the nine months ended September 30, 2024 was $48.3 million, which was primarily due to net proceeds from sales and maturities of marketable securities of $48.9 million.

Net Cash Provided by Financing Activities

Net cash provided by financing activities was $2.0 million for the nine months ended September 30, 2025 representing sales of stock issued in connection with the Subscription Agreement, dated as of June 13, 2025, between the Company and Zaiming (see Note 7, Mezzanine Equity). Net cash provided by financing activities was $0.1 million for the nine months ended September 30, 2024 representing the exercise of stock options, sales of stock under the ESPP and the sale of 17,151 shares of common stock under the Sales Agreement.

Contractual Obligations and Commitments

Operating Leases

We are party to several non-cancelable lease agreements for office and laboratory space that expire in March 2030. The monthly base rent for these leases totals $111,175 as of September 30, 2025 per month plus our prorated share of operating expenses. The monthly base rent is subject to annual 3% increases through the lease term.

We also have potential contingent payment obligations upon the achievement by us of clinical, regulatory, and commercial events, as applicable, or royalty payments that we may be required to make under license agreements we have entered into with various entities pursuant to which we have in-licensed intellectual property, including our license agreement with Yale. The timing and amount (if any) of any such payments cannot be reasonably estimated at this time.

We enter into contracts in the normal course of business with third-party contract organizations for clinical trials, non-clinical studies and testing, manufacturing and other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice, and therefore we believe that our non-cancelable obligations under these agreements are not material. There have been no material changes to our contractual obligations during the three months ended September 30, 2025, as compared to those disclosed in our 2024 Annual Report.

Critical Accounting Policies, Significant Judgments and Use of Estimates

Our condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or “GAAP”. The preparation of our 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 financial statements, as well as the reported expenses incurred during the reporting periods. The most significant assumptions used in the financial statements are the underlying assumptions used in valuing share-based compensation, including the fair value of our common stock in periods before our initial public offering. Our estimates are based on our historical experience and on 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 that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Actual results may differ from these estimates under different assumptions or conditions.

During the nine months ended September 30, 2025, there were no material changes to our critical accounting policies as reported in our 2024 Annual Report.

Off-Balance Sheet Arrangements

Since our inception, we have not engaged in any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

Recent Accounting Pronouncements

See Note 2, Summary of Significant Accounting Policies, to our unaudited condensed financial statements included elsewhere in this Quarterly Report for a discussion of recent accounting pronouncements that may impact our financial position and results of operations.

As a “smaller reporting company” as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), we are not required to provide the information requested by this Item.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act as of September 30, 2025. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of September 30, 2025, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, that occurred during the quarter ended September 30, 2025, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

There have been no material updates to the risk factors set forth in our 2024 Annual Report other than as set forth below:

There is substantial doubt as to our ability to continue as a going concern, which may affect our ability to obtain future financing and may require us to curtail or cease our operations. We will require substantial additional funding in the immediate term to continue operations as planned.

The Company has incurred net losses and negative cash flows from operations since its inception, has an accumulated deficit of $426.5 million as of September 30, 2025 and anticipates continuing to incur net losses for the foreseeable future. Under the Company's current plan, management believes its cash and cash equivalents and marketable securities of $29.1 million as of September 30, 2025 will not be sufficient to fund the Company's operations for a period of one year after the issuance of the accompanying unaudited financial statements. Thus, we have concluded that there is substantial doubt about our ability to continue as a going concern.

As a result, the Company will be required to raise additional capital by partnering, selling equity, or other means and has implemented cost-reduction measures. There can be no assurance as to whether partnering efforts will be successful or whether additional financing will be available on terms acceptable to the Company, if at all, or in amounts sufficient to fund our operations. If sufficient funds on acceptable terms are not available when needed, it would have a negative impact on the Company’s financial condition and could force the Company to implement additional cost cutting measures, delay, limit, reduce, or terminate product development or future commercialization efforts or grant rights to develop and market product candidates that the Company would otherwise plan to develop and market itself.

If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our audited financial statements, and it is likely that investors will lose all or part of their investment. If we seek additional financing to fund our business activities as a result of the substantial doubt as to our ability to continue as a going concern, investors or other financing sources may be unwilling to provide additional funding to us on commercially reasonable terms or at all.