NextCure, Inc.

Previous wording

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,”

Current wording

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, 2025, or our “2025 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:

Previous wording

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.

Current wording

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”). 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.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

Zaiming is currently investigating SIM0505 in China 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. Following the FDA's assignment of the IND to NextCure in June 2025, the Company successfully dosed the first U.S. patient in its ongoing Phase 1 trial of SIM0505 in October 2025. In April 2026, the FDA granted Fast Track Designation to SIM0505 for the treatment of patients with platinum-resistant ovarian cancer. We also announced that initial Phase 1 clinical data for this program will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. In May 2026, we announced the initiation of the dose optimization phase for SIM0505, targeting gynecologic cancers through the treatment of patients with platinum-resistant ovarian cancer.

Previous wording

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.

Current wording

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. In January 2026, we announced that implementation of the amended protocol, including expanded dosing and enrollment, prioritization of patients with high B7-H4 expression in breast and gynecological cancers, and the addition of adenoid cystic carcinoma type 1, would delay the reporting of proof-of-concept data, previously anticipated in the first half of 2026. We are backfilling patients to investigate particular dose levels and schedules in the expected therapeutic window, and plan to provide a trial progress update in the second half of 2026.

Previous wording

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.

Current wording

In addition, we continue to seek 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.

Previous wording

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.

Current wording

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 common and preferred stock and with upfront fees received under our former research and development collaboration agreement. Since inception through March 31, 2026, we raised approximately $446 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 losses for the three months ended March 31, 2026 and 2025, was $9.8 million and $11.0 million, respectively. As of March 31, 2026, we had an accumulated deficit of $445.8 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.

Previous wording

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.

Current wording

We will need to raise additional capital in order to extend our runway and enable us to continue advancing our current clinical programs, SIM0505 and LNCB74, beyond the first half of 2027. While we intend to use any additional funding to continue development of both of our lead programs, if we do not raise sufficient funds in one or more financings or obtain other financial support for program development, we will need to implement additional cost cutting measures to extend our runway, which may include delaying enrollment in, or pausing, one of our clinical programs and a reduction in workforce. See Note 2, Summary of Significant Accounting Policies, to our unaudited condensed financial statements included elsewhere in this Quarterly Report for a further assessment of liquidity.

Previous wording

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:

Current wording

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 depends on a variety of factors, including:

Previous wording

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

Current wording

Comparison of the Three Months Ended March 31, 2026 and 2025

Previous wording

Research and development expenses for thethree 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 tolower personnel-related costs, primarily stock compensation costs.

Current wording

Research and development expenses for thethree months ended March 31, 2026 decreased by $1.1 million compared to the three months ended March 31, 2025 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. These lower costs were largely offset by cost related to SIM0505, which was acquired in the second quarter of 2025. Internal costs decreased largely due tolower personnel-related costs, primarily stock compensation costs, and lower depreciation.

Previous wording

General and administrative expenses for thethree 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.

Current wording

General and administrative expenses for thethree months ended March 31, 2026 decreased by $0.5 million compared to the three months ended March 31, 2025. The decrease was driven primarily by $0.6 million lower non-cash stock compensation costs.

Previous wording

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.

Current wording

Other income, net for the three months ended March 31, 2026 decreased by $0.3 million compared to the three months ended March 31, 2025, due to lower interest income as a result of lower investable cash.

Previous wording

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.

Current wording

Since inception through March 31, 2026, we have raised approximately $446 million in gross proceeds from the sale of equity instruments and had received a $25 million upfront payment from our former collaboration partner.

Previous wording

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.

Current wording

On December 19, 2025, we entered into an at-the-market offering agreement (the “Wainwright ATM Agreement”) with H.C. Wainwright & Co., LLC (the “Agent”), pursuant to which we may sell, from time to time, up to an aggregate sales price of $14.5 million of its common stock, through the Agent. Actual sales will depend on a variety of factors to be determined by us from time to time, including, among other things, market conditions, the trading price of the common stock, capital needs and determinations by us of the appropriate sources of funding for the Company. During the three months ended March 31, 2026, 99,446 shares of common stock were sold under the Wainwright ATM Agreement for net proceeds of approximately $1.2 million.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

Net cash used in operating activities was $13.4 million for the three months ended March 31, 2026, which was primarily the result of our net loss of $9.8 million and $4.3 million used by net changes in operating assets and liabilities, partially offset by non-cash charges for depreciation of $0.3 million and stock-based compensation of $0.3 million. Net cash used in operating activities was $13.0 million for the three months ended March 31, 2025, which was primarily the result of our net loss of $11.0 million, and $3.9 million used by net changes in operating assets and liabilities, partially offset by non-cash charges for depreciation of $0.7 million and stock-based compensation of $1.4 million.

Previous wording

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.

Current wording

Net cash provided by investing activities for the three months ended March 31, 2026 was $1.3 million, which was entirely due to net proceeds from sales and maturities of marketable securities. Net cash provided by investing activities for the three months ended March 31, 2025 was $7.1 million, which was entirely due to net proceeds from sales and maturities of marketable securities.

Previous wording

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.

Current wording

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 $111.4 thousand as of March 31, 2026 per month plus our prorated share of operating expenses. The monthly base rent is subject to annual 3% increases through the lease term.

Previous wording

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.

Current wording

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 Zaiming. The timing and amount (if any) of any such payments cannot be reasonably estimated at this time.

Previous wording

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

Current wording

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 March 31, 2026, as compared to those disclosed in our 2025 Annual Report.

Previous wording

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.

Current wording

During the three months ended March 31, 2026, there were no material changes to our critical accounting policies as reported in our 2025 Annual Report.