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NextCure, Inc.: Form 10-Q for the period ended Jun 30, 2026

Filed with the SEC on Aug 6, 2026 and accepted by EDGAR at Aug 6, 2026, 16:25 ET.

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Management's discussion and analysis

As filed, 49,826 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.

We are a clinical-stage biopharmaceutical company that has historically focused on advancing innovative medicines for the treatment of cancer 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 have focused 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. Following the announcement of our proposed merger with Avere Therapeutics, Inc. (“Avere Therapeutics”) in July 2026, we are evaluating strategic alternatives for our legacy development programs and assets while continuing to support existing obligations related to those programs.

The following discussion and analysis of our financial condition and results of operations should be read together with “Recent Developments” and Note 15, Subsequent Events, which describe the proposed merger with Avere Therapeutics and related restructuring actions announced on July 14, 2026, in conjunction with the unaudited condensed financial statements and the notes thereto included in this Quarterly Report on Form 10-Q 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 on Form 10-Q 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 NextCure, Avere Therapeutics, the proposed merger and other matters, including with respect to the structure, timing and completion of the proposed merger; the combined company’s listing on Nasdaq after closing of the proposed merger; expectations regarding the ownership structure of the combined company; expectations regarding the contingent value rights; the future operations of the combined company; the nature, strategy and focus of the combined company; as well as funding for our operations, our expected cash runway, objectives and expectations for our business, operations and financial performance and condition, and expectations regarding including the progress and results of clinical trials, development plans and upcoming milestones regarding our therapies.

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: risks associated with the possible failure to satisfy the conditions to the closing or consummation of the merger, including NextCure’s failure to obtain stockholder approval for the merger; risks associated with the uncertainty as to the timing of the consummation of the merger and the ability of each of NextCure and Avere Therapeutics to consummate the transactions contemplated by the merger; risks associated with NextCure’s continued listing on Nasdaq until closing of the merger; the failure or delay in obtaining required approvals from any governmental or quasi-governmental entity necessary to consummate the merger; the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the merger prior to the closing or consummation of the merger; risks associated with the possible failure to realize certain anticipated benefits of the merger, including with respect to future financial and operating results; the effect of the completion of the merger on the combined company’s business relationships, operating results and business generally; risks associated with the combined company’s ability to manage expenses and unanticipated spending and costs that could reduce the combined company’s cash resources; risks related to the combined company’s ability to correctly estimate its operating expenses and other events; changes in capital resource requirements; risks related to the inability of the combined company to obtain sufficient additional capital to continue to advance its product candidates or its preclinical programs; the outcome of any legal proceedings that may be instituted against the combined company or any of its directors or officers related to the merger or the transactions contemplated thereby; the ability of the combined company to obtain, maintain and protect its intellectual property rights, in particular those related to its product candidates; the combined company’s ability to advance the development of its product candidates or preclinical activities under the timelines it anticipates in planned and future clinical trials; the combined company’s ability to replicate in later clinical trials positive results found in preclinical studies and clinical trials of its product candidates; the combined company’s ability to realize the anticipated benefits of its research and development programs, strategic partnerships, licensing programs or other collaborations; regulatory requirements or developments and the combined company’s ability to obtain necessary approvals from the U.S. Food and Drug Administration or other regulatory authorities; changes to clinical trial designs and regulatory pathways; competitive responses to the merger and changes in expected or existing competition; unexpected costs, charges or expenses resulting from the merger; potential adverse reactions or changes to business relationships resulting from the completion of the merger; legislative, regulatory, political and economic developments; risks regarding the timing, progress and results of preclinical studies and clinical trials for any of our developmental or clinical stage drug product candidates; our expenses, future revenues, capital requirements, needs for or ability to obtain additional financing and the period over which our current cash, cash equivalents and marketable securities to be sufficient to fund our operations; market and other conditions; the timing or likelihood of regulatory filings for drug product candidates and our ability to obtain and maintain regulatory approvals for such product candidates for any indication; the potential benefits of and our ability to maintain our relationship with

LigaChem Biosciences, Inc., Simcere Zaiming Pharmaceutical Co, Ltd., and other third-party vendors and collaborators; 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 international relations, tariffs, and other trade regulations between the U.S. and China; developments and projections relating to our competitors and our industry, including competing therapies; and the impact of current and future laws and regulations.

More detailed information on these and additional factors that could affect our actual results are described under the heading “Risk Factors” in our 2025 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.

Recent Developments

On July 14, 2026, NextCure, Inc., (“NextCure” or “Parent”), Neptune Merger Sub Corp., a Delaware corporation and a wholly owned subsidiary of NextCure (“First Merger Sub”), Neptune Second Merger Sub, LLC, a Delaware limited liability company and a wholly owned subsidiary of NextCure (“Second Merger Sub” and, together with First Merger Sub, the “Merger Subs”), and Avere Therapeutics, entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”), pursuant to which, among other matters, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, (i) First Merger Sub will merge with and into Avere Therapeutics, with Avere Therapeutics continuing as a wholly owned subsidiary of NextCure and the surviving corporation of the merger (the “First Merger”), and (ii) immediately following the First Merger and as part of the same overall transaction as the First Merger, Avere Therapeutics will merge with and into Second Merger Sub, with Second Merger Sub continuing as the surviving entity and a wholly owned subsidiary of NextCure (the “Second Merger” and, together with the First Merger, the “Merger”). The Merger is intended to qualify for federal income tax purposes as a tax-free reorganization under the provisions of Section 368(a) of the Internal Revenue Code of 1986, as amended.

Legacy Development Programs

Our product candidate SIM0505 is a novel ADC candidate developed by Simcere Zaiming Pharmaceutical Co, Ltd. (“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 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 (the “FDA”) 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. 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. On June 1, 2026 we presented interim Phase 1 dose escalation data from the ongoing global study for SIM0505 at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The data, which included 59 heavily pre-treated patients with advanced solid tumors enrolled in the United States and China, demonstrated an objective response rate of 55% in evaluable gynecologic cancer patients treated within the therapeutic dose range of 4.8 mg/kg to 8.0 mg/kg, including objective response rates of 52.9% in ovarian cancer and 66.7% in uterine serous carcinoma patients, with a generally manageable safety profile.

On July 14, 2026, NextCure announced it had informed all U.S. clinical trial sites to stop screening, consenting, enrolling, and delivering first doses to new patients in the SIM0505 study. NextCure also announced that it no longer intended to expand the clinical site footprint for SIM0505 into Europe and Canada.

NextCure is working with clinical trial sites and principal investigators to develop and implement plans to cease treatment of patients currently on study and to transition such patients, as appropriate, to alternative therapies in accordance with applicable requirements. This program-specific decision is not based on any negative safety or efficacy finding or any dispute with Zaiming. Any strategic alternatives with respect to SIM0505 would be pursued in accordance with the terms of the parties’ existing license agreement.

NextCure expects to seek opportunities to partner, license or otherwise monetize its rights to SIM0505, including in connection with the contingent value right arrangement described above, although there can be no assurance that any such transaction will be entered into or consummated or that any proceeds will become payable to holders of the contingent value rights.

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. 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.

On July 14, 2026, we announced that we had informed LigaChem that we have opted-out of continued cost-sharing for LNCB74. Our specific decision with respect to LNCB74 is not based on any negative safety or efficacy finding or any dispute with LigaChem. On August 6, 2026, the Company and LigaChem entered into a Transition and Continuation Agreement, pursuant to which, effective July 1, 2026, the Company ceased co-funding the LNCB74 program and LigaChem assumed responsibility for 100% of program costs. The Company agreed to provide certain transition support, including support for the ongoing clinical trial and transfer of program-related materials, regulatory documentation, vendor agreements, inventory and related records, for which LigaChem will reimburse the Company for certain full-time equivalent support costs. As per the terms of the LigaChem Agreement, LigaChem as Sole Developing Party will pay the Company certain developmental, regulatory and commercial milestones and single-digit royalties on future net sales of LNCB74. The parties also agreed to resolve amounts owed under the prior 50-50 cost-sharing arrangement for costs incurred through June 30, 2026.

In addition, we continue to evaluate strategic alternatives for our legacy development programs and assets. We are seeking opportunities to partner, license, divest, monetize or otherwise realize value from our clinical and pre-clinical stage programs. We may pursue such opportunities through partnering arrangements, licensing transactions, asset sales, third-party financings or other strategic transactions. In connection with the proposed merger with Avere Therapeutics, certain of our legacy assets are expected to be included within the contingent value right structure established for the benefit of pre-merger NextCure stockholders. There can be no assurance that any such transaction will be completed or that any resulting proceeds will be realized.

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 common and preferred stock and with upfront fees received under our former research and development collaboration agreement. Since inception through June 30, 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 loss for the three months ended June 30, 2026 and 2025, was $14. 9 million and $26.8 million, respectively. Our net loss for the six months ended June 30, 2026 and 2025, was $24.7 million and $37.8 million, respectively. As of June 30, 2026, we had an accumulated deficit of $461 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 June 30, 2026, we had cash, cash equivalents and marketable securities of $20.1 million. Prior to entering into the Merger Agreement with Avere Therapeutics, Inc. on July 14, 2026, our expectation to incur additional operating losses and negative operating cash flows in the future and our need for additional funding to support planned operations raised substantial doubt regarding our ability to continue as a going concern for a period of one year after the date these unaudited financial statements were issued. Subsequent to June 30, 2026, we entered into the Merger Agreement with Avere Therapeutics pursuant to which Avere concurrently entered into a securities purchase agreement for a private financing expected to provide significant capital to the combined company upon closing, subject to the satisfaction of customary closing conditions. Accordingly, our future liquidity strategy and capital requirements are expected to be substantially impacted by the outcome of the proposed merger transaction.

On July 14, 2026, we entered into a definitive merger agreement with Avere Therapeutics, a privately held biotechnology company. If completed, the transaction is expected to result in a reverse merger in which Avere equity holders will own the substantial majority of the combined company, while existing NextCure stockholders will retain a minority ownership interest and will receive contingent value rights tied to the potential monetization of certain legacy NextCure assets. The proposed transaction represents a significant strategic shift and is expected to redefine the operations, development priorities and financial profile of the combined company.

Concurrently, Avere Therapeutics entered into a securities purchase agreement providing for a private financing expected to generate approximately $320 million in gross proceeds immediately prior to closing of the merger, subject to customary closing conditions.

Prior to signing the Merger Agreement, we expected to require substantial additional capital to continue development of our clinical programs, including SIM0505 and LNCB74. In connection with the proposed merger, we have initiated activities to wind down certain of our legacy operations and are evaluating strategic alternatives for our existing assets. We currently expect our cash, cash equivalents and marketable securities of $20.1 million to last into the fourth quarter of 2026. See Note 2, Summary of Significant Accounting Policies, to our unaudited condensed financial statements included elsewhere in this Quarterly Report on form 10-Q for a further assessment of liquidity.

In connection with the proposed merger with Avere Therapeutics, we approved a restructuring plan intended to significantly reduce operating expenses and align our organization with the anticipated strategy of the combined company. The restructuring includes a substantial reduction of our workforce and the wind-down of certain activities related to our legacy oncology development programs. We expect to incur restructuring and severance costs associated with these actions, substantially all of which are expected to be recognized during 2026.

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 have historically been central to our business model. On July 14, 2026, we entered into a definitive merger agreement with Avere Therapeutics and announced a restructuring plan that includes the wind-down of certain of our legacy oncology development activities. As a result, we expect research and development expenses associated with our legacy programs to decline significantly as restructuring activities are implemented, although we may continue to incur limited expenses related to the maintenance, transition, disposition or potential partnering of our legacy assets pending completion of the proposed merger.

Prior to entering into the Merger Agreement, our future operating plans were focused on advancing SIM0505 and LNCB74 through clinical development. In connection with the proposed merger and related restructuring, we are reassessing the ongoing development activities associated with our legacy programs. Accordingly, estimates regarding future development timelines, clinical trial costs and commercialization activities for SIM0505 and other legacy product candidates are subject to significant uncertainty and may be materially affected by the outcome of the proposed merger, strategic decisions regarding our legacy assets and the implementation of restructuring activities.

Following execution of the Transition and Continuation Agreement with LigaChem on July 31, 2026, the Company no longer funds development of the LNCB74 program. Accordingly, future research and development expenses associated with the program are expected to decline significantly and may consist primarily of temporary transition support activities reimbursable by LigaChem.

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:

  • our ability to obtain partnerships for our other programs;
  • 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.

In connection with the proposed merger with Avere Therapeutics and related restructuring activities, we expect to incur additional general and administrative expenses, including professional fees associated with the proposed transaction, severance costs, retention payments, legal and accounting expenses and other costs associated with the wind-down of certain legacy operations. These expenses may fluctuate significantly until the proposed merger is completed or otherwise terminated.

Asset Impairment Charges

Asset impairment charges reflect the write-down of long-lived assets, including right-of-use 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 Six Months Ended June 30, 2026 and 2025

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

​ ​ ​ ​ Operating expenses: ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended June 30, 2026 ​ ​ ​ ​ ​ ​ ​ ​ 2025 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Change ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Six Months Ended June 30, 2026 ​ ​ ​ ​ ​ ​ ​ ​ 2025 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Change ​ ​ ​ ​ ​ ​
Research and development ​ $7,425 ​ $24,091 ​ $(16,666) ​ $14,259 ​ $31,987 ​ $(17,728) ​
General and administrative ​ 2,592 ​ 3,201 ​ (609) ​ 5,863 ​ 6,927 ​ (1,064) ​
Asset impairment ​ ​ 5,077 ​ ​ — ​ ​ 5,077 ​ ​ 5,077 ​ ​ — ​ ​ 5,077 ​
Loss from operations ​ (15,094) ​ (27,292) ​ 12,198 ​ (25,199) ​ (38,914) ​ 13,715 ​
Other income, net ​ 202 ​ 484 ​ (282) ​ 511 ​ 1,130 ​ (619) ​
Net loss ​ $(14,892) ​ $(26,808) ​ $11,916 ​ $(24,688) ​ $(37,784) ​ $13,096 ​

Research and Development Expenses

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

(in thousands)

​ ​ ​ External research and development expenses: ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended June 30, 2026 ​ ​ ​ ​ ​ ​ ​ ​ ​ 2025 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Change ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Six Months Ended June 30, 2026 ​ ​ ​ ​ ​ ​ ​ ​ ​ 2025 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Change ​ ​
LNCB74, net of cost sharing ​ ​ 698 ​ ​ 1,363 ​ ​ (665) ​ ​ 1,137 ​ ​ 2,016 ​ ​ (879)
SIM0505 ​ ​ 3,552 ​ ​ 17,000 ​ ​ (13,448) ​ ​ 6,154 ​ ​ 17,000 ​ ​ (10,846)
Other programs and preclinical development ​ ​ 746 ​ ​ 2,179 ​ ​ (1,433) ​ ​ 1,603 ​ ​ 5,396 ​ ​ (3,793)
Total external research and development expenses ​ ​ 4,996 ​ ​ 20,542 ​ ​ (15,546) ​ ​ 8,894 ​ ​ 24,412 ​ ​ (15,518)
Total internal research and development expenses ​ ​ 2,429 ​ ​ 3,549 ​ ​ (1,120) ​ ​ 5,365 ​ ​ 7,575 ​ ​ (2,210)
Total research and development expenses $7,425 ​ $24,091 ​ $(16,666) ​ $14,259 ​ $31,987 ​ $(17,728)

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 June 30, 2026 decreased by $16.7 million compared to the three months ended June 30, 2025 as the Company incurred a $17.0 million license fee (see Note 3, License Agreement) in the three months ended June 30, 2025. Lower costs on other programs and lower internal costs for the three months ended June 30, 2026 offset higher costs on the clinical trial for SIM0505.

Research and development expenses for the six months ended June 30, 2026 decreased by $17.7 million compared to the six months ended June 30, 2025 as the Company incurred a $17.0 million license fee (see Note 3, License Agreement) in the six months ended June 30, 2025. Lower costs on other programs and lower internal costs for the six months ended June 30, 2026 offset higher costs on the clinical trial for SIM0505.

Subsequent to June 30, 2026, in connection with the anticipated Merger, the Company approved a restructuring plan intended to significantly reduce operating expenses and wind down certain legacy oncology development activities. As a result, research and development expenses are expected to decline significantly following implementation of the restructuring plan.

General and Administrative Expenses

General and administrative expenses for the three months ended June 30, 2026 decreased by $0.6 million compared to the three months ended June 30, 2025. The decrease was driven primarily by $0.5 million lower personnel related costs.

General and administrative expenses for the six months ended June 30, 2026 decreased by $1.1 million compared to the six months ended June 30, 2025. The decrease was driven primarily by $1.1 million lower personnel related costs.

General and administrative expenses in future periods may increase as a result of transaction-related costs associated with the proposed merger, including legal, accounting, advisory, severance and other restructuring-related expenses.

Asset Impairment Charges

Asset impairment charges were $5.1 million for the three and six months ended June 30, 2026, reflecting the write-down of property and equipment, right-of-use assets and related improvements in connection with our restructuring initiatives. There were no asset impairment charges in the three and six months ended June 30, 2025.

Other Income, Net

Other income, net for the three months ended June 30, 2026 decreased by $0.3 million compared to the three months ended June 30, 2025, due to lower interest income as a result of lower investable cash.

Other income, net for the six months ended June 30, 2026 decreased by $0.6 million compared to the six months ended June 30, 2025, due to lower interest income as a result of lower investable cash.

Liquidity and Capital Resources

Since inception through June 30, 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.

On June 13, 2025, we entered into a License Agreement with Zaiming, a biopharmaceutical company based in China (see Note 3, License Agreement, to our unaudited condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q, for more information). In connection with the License Agreement, the Company also entered into a Subscription Agreement (the “Subscription Agreement”) pursuant to which the Company issued and sold to Simcere Zaiming, Inc., a Delaware corporation and an affiliate of Zaiming, in a private placement, an aggregate of 338,636 shares (the “Shares”) of our common stock, at a price of approximately $5.904 per share for an aggregate purchase price of $2.0 million.

On November 12, 2025, we entered into a securities purchase agreement (the “Purchase Agreement”) with certain institutional and accredited investors (each, a “Purchaser” and collectively, the “Purchasers”) for a private placement of an aggregate of (i) 708,428 shares (the “Shares”) of the Company’s common stock at a purchase price of $8.52 per share, and (ii) pre-funded warrants to purchase up to an aggregate of 1,815,049 shares of common stock at a purchase price of $8.519 per pre-funded warrant, which represents the per share purchase price of the Shares less the $0.001 per share exercise price for each pre-funded warrant. The pre-funded warrants are exercisable at any time after the date of issuance and will not expire. The offering closed on November 14, 2025. Proceeds from the offering, net of placement agent’s fees and other offering expenses, were $20.3 million. The Company issued 117,371 shares of common stock upon the exercise of pre-funded warrants during the year ended December 31, 2025 and 456,855 shares of common stock upon the exercise of pre-funded warrants during the three months ended June 30, 2026. As of June 30, 2026, pre-funded warrants to purchase up to an aggregate of 1,240,823 shares of common stock remained outstanding.

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 six months ended June 30, 2026, 99,446 shares of common stock were sold under the Wainwright ATM Agreement for net proceeds of approximately $1.2 million.

As of June 30, 2026 we had cash, cash equivalents and marketable securities of $20.1 million. Our expectation to incur additional operating losses and negative operating cash flows in the future and the need for additional funding to support our planned operations raise substantial doubt regarding our ability to continue as a going concern for a period of one year after the date that these unaudited financial statements are issued.

Prior to entering into the Merger Agreement, we expected to require additional capital to continue development of SIM0505 and LNCB74 beyond the first half of 2027. In connection with the proposed merger with Avere Therapeutics and related restructuring activities, we are winding down certain legacy operations. Accordingly, our future capital requirements and operating plans are expected to differ materially from those contemplated prior to the announcement of the proposed transaction. The proposed merger is expected to be accompanied by a concurrent private financing for the benefit of the combined company; however, completion of the merger and related financing remains subject to stockholder approval and other customary closing conditions. See Note 2, Summary of Significant Accounting Policies, to our unaudited condensed financial statements included elsewhere in this Quarterly Report on Form 10-Q for a further assessment of liquidity.

We expect to incur expenditures in the foreseeable future primarily associated with supporting our remaining obligations related to legacy programs, implementing restructuring activities, pursuing strategic alternatives for legacy assets and completing the proposed merger transaction. The nature and magnitude of future expenditures will depend significantly on whether and when the proposed merger is completed.

Depending on whether and when the proposed merger is completed, 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. Our need to raise additional capital will depend on many factors, including:

  • the timing and completion of the proposed merger with Avere Therapeutics;
  • satisfaction of the closing conditions associated with the merger and related financing transactions;
  • costs associated with restructuring activities, including workforce reductions and facility obligations;
  • costs associated with maintaining, monetizing or otherwise disposing of our legacy assets;
  • transaction-related legal, accounting, consulting and advisory expenses;
  • potential proceeds from the sale, licensing or other strategic transactions involving legacy assets;
  • obligations arising under existing license, collaboration and lease agreements; and
  • the operating requirements of the combined company following consummation of the merger

The Company's future liquidity requirements and capital resources are expected to be significantly affected by the proposed merger with Avere Therapeutics and the related restructuring activities announced on July 14, 2026. Completion of the proposed merger remains subject to stockholder approval and other customary closing conditions and there can be no assurance that the merger or the related financing transactions will be completed. If the proposed merger is not completed, the Company will be required to seek additional financing, pursue strategic alternatives for its legacy assets, further reduce operating expenses, or take other actions to preserve liquidity. Any such financing or strategic transaction may not be available on acceptable terms, or at all, and could result in significant dilution to existing stockholders, restrictions on operations, or the disposition of assets on terms that may not be favorable to the Company.

The Company's ability to continue operations and satisfy its obligations will depend on its ability to successfully execute its strategic plans and obtain additional sources of capital if needed

Proposed Merger and Restructuring

On July 14, 2026, in connection with the proposed merger with Avere Therapeutics the Company approved a restructuring plan designed to reduce operating expenses and wind down certain legacy operations. The restructuring includes a substantial workforce reduction and related severance obligations. The Company currently estimates restructuring charges of approximately $2.4 million, consisting primarily of employee severance and related costs. Additional transaction-related costs are expected to be incurred in connection with the proposed merger. As a result, future cash flows may differ materially from historical trends presented below.

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) provided by: ​ ​ ​ ​ ​ ​ ​ ​ Six Months Ended June 30, 2026 ​ ​ ​ ​ ​ ​ ​ ​ 2025 ​ ​
Operating activities ​ $(23,078) ​ $(35,707)
Investing activities ​ 11,086 ​ 10,853
Financing activities ​ 1,270 ​ 2,019
Net increase (decrease) in cash and cash equivalents ​ $(10,722) ​ $(22,835)

Net Cash Used in Operating Activities

Net cash used in operating activities was $23.1 million for the six months ended June 30, 2026, which was primarily the result of our net loss of $24.7 million and $4.9 million used by net changes in operating assets and liabilities, partially offset by non-cash charges for asset impairment of $5.1 million, depreciation of $0.6 million and stock-based compensation of $0.6 million. 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 Provided by Investing Activities

Net cash provided by investing activities for the six months ended June 30, 2026 was $11.1 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, 2025 was $10.9 million, which was entirely due to net proceeds from sales and maturities of marketable securities

Net Cash Provided by Financing Activities

Net cash provided by financing activities was $1.3 million for the six months ended June 30, 2026 primarily representing the sale of 99,446 shares of stock under the Wainwright ATM Agreement. 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 Zaiming.

Contractual Obligations and Commitments

Operating Leases

We are party to several non-cancelable lease agreements for office, manufacturing and laboratory space that expire in March 2030. The monthly base rent for these leases totals $112.8 thousand as of June 30, 2026 per month plus our prorated share of operating expenses. The monthly base rent is subject to annual 3% increases through the lease term.

On July 27, 2026 and August 3, 2026, respectively, we entered into a seventh amendment and eighth amendment to our lease agreement with ARE-8000/9000/1000 Virginia Manor, LLC (such amendments, the “Amendments”) pursuant to which, subject to certain conditions, including the landlord entering into replacement lease arrangements for the surrendered space, we agreed to terminate approximately 39,432 rentable square feet of leased premises consisting of Suite 180 at 8000 Virginia Manor Road and Suites 200 and 201 at 9000 Virginia Manor Road. Upon effectiveness of the Amendments, our leased premises will be reduced from approximately 69,296 rentable square feet to approximately 29,864 rentable square feet. In connection with the Amendments, we are required to pay a one-time fee of $0.8 million for such reduction and satisfy certain surrender, restoration and decommissioning obligations.

The Amendments align with our restructuring efforts and anticipated reduction in operational requirements. The Company is evaluating alternatives with respect to its remaining lease obligations in connection with the restructuring plan. However, as of the date of this Quarterly Report on Form 10-Q, the remaining lease agreements remain in effect and the Company continues to be obligated under their existing terms.

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

The Company is also evaluating strategic alternatives for certain legacy assets and intellectual property. Any future sale, license or other disposition of such assets could affect the timing and nature of contingent obligations associated with existing license agreements.

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.

Other than the proposed merger with Avere Therapeutics, the related restructuring plan and the Amendments entered into in July and August 2026 that provides for the potential early termination of certain leased premises, there have been no material changes to our contractual obligations during the three months ended June 30, 2026, as compared to those disclosed in our 2025 Annual Report and subsequent Quarterly Report on Form 10-Q for the quarter ended March 31, 2026.

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 three months ended June 30, 2026, there were no material changes to our critical accounting policies as reported in our 2025 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 on Form 10-Q, for a discussion of recent accounting pronouncements that may impact our financial position and results of operations.

Market risk

As filed, 201 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.

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.

Controls and procedures

As filed, 1,241 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.

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 June 30, 2026. 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 June 30, 2026, 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 June 30, 2026, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

Risk factors

As filed, 8,239 characters, with its headings, lists and tables. Extracted from the main document; charts and exhibits are in the original on sec.gov.

There have been no material updates to the risk factors set forth in our 2025 Annual Report other than as set forth below.

The Merger may not be completed on the currently contemplated terms or within the expected timeframe, or at all, which could adversely affect our business, financial condition and results of operations.

The Merger is subject to a number of conditions, including the effectiveness of a registration statement on Form S-4 and approval by the stockholders of NextCure and Avere Therapeutics. We have incurred, and expect to continue to incur, significant costs in connection with the Merger, including legal, accounting, financial advisor, and other professional fees, and these costs may be higher than we currently anticipate. The Merger process has diverted, and may continue to, divert management’s attention and resources from ongoing operations, and could make it more difficult to retain employees, enter into contracts on favorable terms, or maintain relationships with our licensors, collaborators and other business partners. If the Merger is not completed, we will be required to pursue other strategic alternatives, which could include raising additional capital on unfavorable terms, further reducing or discontinuing our operations, or pursuing a voluntary dissolution and liquidation. There can be no assurance that any alternative transaction or strategy will be available on acceptable terms, or at all.

If the Merger is not completed, we may decide to pursue a liquidation and dissolution of NextCure. In such an event and in light of our current capital resource constraints, it is unlikely that substantial resources would be available for distribution to our stockholders.

Although we have entered into the Merger Agreement, the closing may be delayed or may not occur at all. If for any reason the Merger is not completed, we may elect to, among other things, attempt to complete another strategic transaction, attempt to sell or otherwise dispose of various assets. Any of these alternatives would be costly and time-consuming and would likely require that we obtain additional near-term funding. We expect that it would be difficult to secure such funding in a timely manner, on favorable terms or at all. If the Merger is not completed, we may decide that it is in the best interests of our stockholders to dissolve the Company and liquidate its assets. In that event, the amount of cash, if any, available for distribution to our stockholders would depend on the timing of such decision and the timing of such liquidation since the amount of cash available for distribution continues to decrease as we fund our operations and incur fees and expenses related to the Merger. In addition, if our board of directors were to approve and recommend, and our stockholders were to approve, a dissolution of NextCure, we would be required under Delaware law to pay our outstanding obligations, as well as to make reasonable provision for contingent and unknown obligations, prior to making any distributions in liquidation to our stockholders. As a result of this requirement, a portion of our assets may need to be reserved pending the resolution of such obligations. In addition, we may be subject to litigation or other claims related to a liquidation and dissolution of the Company. If a liquidation and dissolution were pursued, our board of directors, in consultation with its advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve. Accordingly, in such a circumstance and in light of our current capital resources, it is highly unlikely that substantial resources, if any, would be available for distributions to our stockholders. Our stockholders would likely lose all or a significant portion of their investment.

The private placement financing to be completed concurrently with the Merger may not be completed on the currently contemplated terms or at all, and, even if completed, may result in significant dilution and other adverse effects.

Concurrently with the execution of the Merger Agreement, certain institutional and accredited investors entered into a securities purchase agreement with Avere Therapeutics pursuant to which they agreed, subject to the terms and conditions thereof, to purchase shares of Avere Therapeutics capital stock and pre-funded warrants (including through the contribution of certain notes) for an aggregate purchase price of approximately $320 million immediately prior to the closing of the Merger (the “Private Placement”). It is a condition to the closing of the Merger that the securities purchase agreement remain in full force and effect and that proceeds of not less than $150.0 million be received, or be received substantially concurrently with the closing.

The Private Placement is subject to a number of conditions and may be impacted by market, industry, regulatory and other factors outside of our control. If the Private Placement is not completed, the Merger may be delayed or may not be completed, and we may need to seek alternative financing or strategic alternatives, which may not be available on acceptable terms, if at all. In addition, the securities issued in the Private Placement (and the shares of our common stock and pre-funded warrants into which they convert in the Merger), together with the related registration rights, will result in substantial dilution to our existing stockholders and could adversely affect the market price of our common stock.

Even if the Merger is completed, the combined company may incur losses for the foreseeable future and might never achieve or sustain profitability.

Even if the Merger is completed, the combined company may never become profitable, even if the combined company is able to complete clinical development for one or more product candidates and eventually commercialize such product candidates. The combined company will need to successfully complete significant research, development, testing and regulatory compliance activities that, together with projected general and administrative expenses, are expected to result in substantial increased operating losses for at least the next several years. Even if the combined company does achieve profitability, it may not be able to sustain or increase profitability on a quarterly or annual basis.

Our stockholders may not receive any payment on the CVRs, and the CVRs may expire valueless.

At or prior to the closing of the Merger, NextCure will enter into a Contingent Value Rights Agreement (the “CVR Agreement”) pursuant to which each of our pre-Merger stockholders will receive one contingent value right (each, a “CVR”) for each outstanding share of our common stock and preferred stock held as of the applicable record date, including shares issued in respect of restricted stock awards accelerated in connection with the Merger. Each CVR represents the contractual right to receive 90% of the gross proceeds, if any, derived from any consideration paid to NextCure during a specified period as a result of the license, sale, assignment, transfer or other disposition of certain of our pre-Merger legacy assets identified in the CVR Agreement, less permitted deductions.

There can be no assurance that any payments will be made with respect to the CVRs. The right to receive any payment on the CVRs is contingent solely upon our receipt of qualifying proceeds from a disposition of the specified legacy assets within the time periods and on the terms specified in the CVR Agreement, and we may be unable to enter into any such disposition on favorable terms, or at all. The CVRs will not be transferable except in limited circumstances specified in the CVR Agreement, will not be evidenced by any certificate or other instrument, will not be registered with the SEC, will not have any voting or dividend rights, will not represent any equity or ownership interest in NextCure or the combined company, and will not accrue interest. Accordingly, if no qualifying proceeds are received for any reason within the time periods specified in the CVR Agreement, no payments will be made under the CVRs and the CVRs will expire valueless.

Figures reported in this filing

Standardized line items from the XBRL in this filing, for the period ended 2026-06-30. Comparative periods it repeats are left out.

Figures reported in this filing
Line itemPeriodValueXBRL concept
Research and development3 months2026-04-01 to 2026-06-30$7.4mus-gaap:ResearchAndDevelopmentExpense
Research and development6 months2026-01-01 to 2026-06-30$14.3mus-gaap:ResearchAndDevelopmentExpense
Operating income3 months2026-04-01 to 2026-06-30−$15.1mus-gaap:OperatingIncomeLoss
Operating income6 months2026-01-01 to 2026-06-30−$25.2mus-gaap:OperatingIncomeLoss
Income tax3 months2026-04-01 to 2026-06-30$0us-gaap:IncomeTaxExpenseBenefit
Income tax6 months2026-01-01 to 2026-06-30$0us-gaap:IncomeTaxExpenseBenefit
Net income3 months2026-04-01 to 2026-06-30−$14.9mus-gaap:NetIncomeLoss
Net income6 months2026-01-01 to 2026-06-30−$24.7mus-gaap:NetIncomeLoss
Diluted EPS3 months2026-04-01 to 2026-06-30−$2.80us-gaap:EarningsPerShareDiluted
Diluted EPS6 months2026-01-01 to 2026-06-30−$4.68us-gaap:EarningsPerShareDiluted
Basic EPS3 months2026-04-01 to 2026-06-30−$2.80us-gaap:EarningsPerShareBasic
Basic EPS6 months2026-01-01 to 2026-06-30−$4.68us-gaap:EarningsPerShareBasic
Diluted shares (weighted)3 months2026-04-01 to 2026-06-305,309,724 sharesus-gaap:WeightedAverageNumberOfDilutedSharesOutstanding
Diluted shares (weighted)6 months2026-01-01 to 2026-06-305,274,630 sharesus-gaap:WeightedAverageNumberOfDilutedSharesOutstanding
Operating cash flow6 months2026-01-01 to 2026-06-30−$23.1mus-gaap:NetCashProvidedByUsedInOperatingActivities
Cash and equivalentsAt period end2026-06-30$15.3mus-gaap:CashAndCashEquivalentsAtCarryingValue
Current assetsAt period end2026-06-30$22.3mus-gaap:AssetsCurrent
Total assetsAt period end2026-06-30$22.6mus-gaap:Assets
Current liabilitiesAt period end2026-06-30$6.4mus-gaap:LiabilitiesCurrent
Total liabilitiesAt period end2026-06-30$10.5mus-gaap:Liabilities
Shareholders' equityAt period end2026-06-30$12.1mus-gaap:StockholdersEquity

Source: SEC EDGAR, the filing index for accession 0001104659-26-092050. Last ingested by Listed: Oct 30, 2026, 08:01 ET. Listed shows no prices and gives no investment advice.