NextCure, Inc.
For the period ended Sep 30, 2025. Filed Nov 5, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 5, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0001558370-25-010782
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-05.
0001104659-25-107036
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 74 previous paragraphs and 77 current paragraphs.
46 unchanged; 27 reworded; 1 added; 0 removed; 1 previous and 3 current paragraphs rearranged.
Tables are not compared: 42 previous and 42 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (1)
Current report
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
Reworded paragraphs (27)
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,” “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:
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, 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,”
Previous wording
We announced in June 2025 a license agreement and began a strategic partnership to develop SIM0505, a novel ADC candidate developed by 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 high 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
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, and renal. In December 2024, Zaiming received clearance from the FDA for its IND for a Phase 1 clinical trial for treating multiple cancers. We received notification by the FDA in June 2025 of the assignment
Current 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.
Previous wording
In December 2024, we announced that the U.S. Food and Drug Administration (the “FDA”) accepted an Investigational New Drug (“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. Since announcing in January 2025 that the first patient in our Phase 1 trial of LNCB74 had been dosed, we cleared cohort 3 in June 2025 and are currently within cohort 4 of the dose escalation portion of the Phase 1 trial. We plan to initiate backfill cohorts in the second half of 2025, provide a program update by the fourth quarter of 2025, and provide proof of concept data readout in the first half of 2026.
Current 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.
Previous wording
In March 2024, we announced a prioritization and restructuring of our operations to align with our focused pipeline (the “2024 Restructuring”). We paused our internal manufacturing operations and reduced our workforce. In part because of these actions, we expect to be able to fund our operations into mid-2026 with our existing cash position of approximately $35.3 million as of June 30, 2025.
Current wording
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.
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 June 30, 2025, we raised approximately $423 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 June 30, 2025 and 2024, was $26.8 million and $15.4 million, respectively. Our net loss for the six months ended June 30, 2025 and 2024, was $37.8 million and $32.5 million, respectively. As of June 30, 2025, we had an accumulated deficit of $417.9 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 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.
Previous wording
As of June 30, 2025, we had cash, cash equivalents and marketable securities of $35.3 million. We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operations into mid-2026. However, we have concluded that there is substantial doubt about our ability to continue as a going concern within one year after the issuance of the condensed financial statements.
Current wording
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
Previous wording
We expect to incur substantial expenditures in the foreseeable future as we advance 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 LNCB74, SIM0505 and other research and development activities.
Current wording
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.
Previous wording
We cannot determine with certainty the duration and costs of future clinical trials of LNCB74, SIM0505 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 LNCB74, SIM0505 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 will depend on a variety of factors, including:
Previous wording
Comparison of the Three and Six Months Ended June 30, 2025 and 2024
Current wording
Comparison of the Three and Nine Months Ended September 30, 2025 and 2024
Previous wording
Research and development expenses for thethree months ended June 30, 2025 increased by $11.7 million compared to the three months ended June 30, 2024 due to $17.0 million of fees associated with the Licensing Agreement dated June 13, 2025 with Zaiming. These higher costs were partially offset by lower costs on other programs. Internal costs decreased largely due tolower personnel-related costs, primarily stock compensation costs.
Current 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.
Previous wording
Research and development expenses for the six months ended June 30, 2025 increased by $8.2 million compared to the six months ended June 30, 2024 due to $17.0 million of fees associated with the Licensing Agreement signed in June 2025. These higher costs were largely offset by 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 also decreased, largely due tolower personnel-related costs.
Current wording
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 tolower personnel-related costs.
Previous wording
General and administrative expenses for thethree months ended June 30, 2025 decreased by $0.9 million compared to the three months ended June 30, 2024. The decrease was driven primarily by $0.8 million lower personnel-related costs, primarily stock compensation costs.
Current 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.
Previous wording
General and administrative expenses for the six months ended June 30, 2025 decreased by $1.5 million compared to the six months ended June 30, 2024. The decrease was driven primarily by $1.1 million lower personnel-related costs, primarily stock compensation costs and lower insurance costs.
Current wording
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.
Previous wording
There were no restructuring and asset impairment charges for the three and six months ended June 30, 2025. Restructuring and asset impairment charges were $0 and $2.5 million for the three and six months ended June 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.
Current wording
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.
Previous wording
Other income, net for the six months ended June 30, 2025 decreased by $1.2 million compared to the six months ended June 30, 2024, due to lower interest income as a result of lower investable cash.
Current wording
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.
Previous wording
Since inception through June 30, 2025, we have raised approximately $423 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 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.
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 may 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 will depend on a variety of factors to be 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 June 30, 2025.
Current 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.
Previous wording
As of June 30, 2025, we had cash, cash equivalents and marketable securities of $35.3 million. We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operations into mid-2026. However, we have concluded that there is substantial doubt about our ability to continue as a going concern within one year after the issuance of the condensed financial statements.
Current 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.
Previous wording
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:
Current wording
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
Previous wording
Net cash used in operating activities was $35.7 million for the six months ended June 30, 2025, which was primarily the result of our net loss of $37.8 million, and $1.1 million used by net changes in operating assets and liabilities. partially offset by non-cash charges for depreciation of $1.3 million and stock-based compensation of $2.0 million. Net cash used in operating activities was $22.4 million for the six months ended June 30, 2024, which was primarily the result of our net loss of $32.5 million, partially offset by non-cash charges for depreciation of $1.5 million, stock-based compensation of $3.3 million and impairment charges of $1.8 million, and $3.9 million provided by net changes in operating assets and liabilities.
Current 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.
Previous wording
Net cash provided by investing activities for the six months ended June 30, 2025 was $10.9 million, which was entirely due to net proceeds from sales and maturities of marketable securities. Net cash provided by investing activities for the six months ended June 30, 2024 was $30.0 million, which was primarily due to net proceeds from sales and maturities of marketable securities of $30.4 million.
Current 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.
Previous wording
Net cash provided by financing activities was $2.0 million for the six months ended June 30, 2025 representing sales of stock issued in connection with the Subscription Agreement, dated as of June 13, 2025, between the Company and Hainan Simcere Zaiming Pharmaceutical Co., Ltd. (see Note 7, Mezzanine Equity). Net cash provided by financing activities was $0.1 million for the six months ended June 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.
Current wording
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.
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 $97,002 as of June 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 $111,175 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.
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
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
Previous wording
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 June 30, 2025, as compared to those disclosed in our 2024 Annual Report.
Current wording
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.
Previous wording
During the six months ended June 30, 2025, there were no material changes to our critical accounting policies as reported in our 2024 Annual Report.
Current 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.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
“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:
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
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:
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
of the IND to NextCure. We anticipate dosing our first patient in the third quarter of 2025, provide a program update by the fourth quarter of 2025, and expect to provide proof of concept data readout in the first half of 2026.