NextCure (NASDAQ: NXTC) narrows loss but warns on going-concern and funding needs
NextCure, Inc. reported a net loss of $9.8 million for the quarter ended March 31, 2026, modestly improved from $11.0 million a year earlier, as both research and development and general and administrative expenses declined.
Operating expenses fell to $10.1 million, driven by lower spending on deprioritized programs and reduced stock-based compensation, partly offset by new costs for SIM0505, an antibody-drug conjugate licensed in 2025. Other income decreased as interest earnings declined with a smaller cash balance.
Cash, cash equivalents and marketable securities totaled $29.7 million, and operating activities used $13.4 million of cash in the quarter. The company disclosed that this cash is not sufficient to fund operations for 12 months after issuance of the financial statements, raising substantial doubt about its ability to continue as a going concern unless additional capital is secured. NextCure continues Phase 1 trials for SIM0505 and LNCB74 and raised about $1.2 million through at-the-market stock sales during the quarter.
Positive
- None.
Negative
- Going-concern uncertainty: Management states that existing cash, cash equivalents and marketable securities of $29.7 million are insufficient to fund operations for one year after issuance of the financial statements, raising substantial doubt about the company’s ability to continue as a going concern without new capital.
Insights
Improving cost control but going-concern risk and funding gap dominate.
NextCure narrowed its quarterly net loss to $9.8 million as R&D fell to $6.8 million and G&A to $3.3 million. Spending shifted toward lead ADC programs SIM0505 and LNCB74 while deprioritized assets such as NC410 and NC525 consumed less.
Liquidity is the key issue. Cash, cash equivalents and marketable securities of $29.7 million and quarterly operating cash use of $13.4 million led management to state that resources are insufficient for 12 months after issuance, triggering substantial doubt about going concern. A modest $1.2 million raised via an at-the-market facility does little to alter that picture.
The company indicates it must raise additional capital to advance SIM0505 and LNCB74 beyond the first half of 2027, or it may need further cost cuts, including slower trial enrollment, pausing a program, or workforce reductions. Actual impact will depend on access to equity, partnerships, or other financing disclosed in future filings.
Key Figures
Key Terms
antibody-drug conjugate medical
going concern financial
pre-funded warrants financial
at-the-market offering agreement financial
Fast Track Designation medical
Phase 1 clinical trial medical
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the quarterly period ended
or
Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the transition period from to .
Commission File Number:
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
| |
(Address of principal executive offices) | (Zip Code) |
(
(Registrant’s telephone number, including area code)
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered: |
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ | Accelerated filer ☐ |
Smaller reporting company | |
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
As of May 1, 2026, the registrant had
Table of Contents
NextCure, Inc.
Form 10-Q
For the Quarter Ended March 31, 2026
TABLE OF CONTENTS
| | |
| | Page |
PART I. FINANCIAL INFORMATION | ||
Item 1. | Financial Statements | 1 |
| Condensed Balance Sheets as of March 31, 2026 (unaudited) and December 31, 2025 | 1 |
| Unaudited Condensed Statements of Operations and Comprehensive Loss for the Three Months Ended March 31, 2026 and 2025 | 2 |
| Unaudited Condensed Statements of Stockholders’ Equity for the Three Months Ended March 31, 2026 and 2025 | 3 |
| Unaudited Condensed Statements of Cash Flows for the Three Months Ended March 31, 2026 and 2025 | 4 |
| Notes to Unaudited Condensed Financial Statements | 5 |
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 16 |
Item 3. | Quantitative and Qualitative Disclosures about Market Risk | 25 |
Item 4. | Controls and Procedures | 25 |
Part II. OTHER INFORMATION | ||
Item 1. | Legal Proceedings | 25 |
Item 1A. | Risk Factors | 25 |
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 25 |
Item 3. | Defaults Upon Senior Securities | 26 |
Item 4. | Mine Safety Disclosures | 26 |
Item 5. | Other Information | 26 |
Item 6. | Exhibits | 27 |
SIGNATURES | 28 | |
i
Table of Contents
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
NEXTCURE, INC.
CONDENSED BALANCE SHEETS
(in thousands, except share and per share amounts)
| | | | | | |
| | March 31, 2026 | | December 31, | ||
| | (unaudited) | | 2025 | ||
Assets |
| | | | | |
Current assets: |
| | | | | |
Cash and cash equivalents | | $ | | | $ | |
Marketable securities | | | | | | |
Prepaid expenses and other current assets | |
| | |
| |
Total current assets | |
| | |
| |
Property and equipment, net | |
| | |
| |
Right of use assets | | | | | | |
Other assets | |
| | |
| |
Total assets | | $ | | | $ | |
Liabilities and Stockholders’ Equity | |
| | |
| |
Current liabilities: | |
| | |
| |
Accounts payable | | $ | | | $ | |
Accrued liabilities and other liabilities | |
| | |
| |
Total current liabilities | |
| | |
| |
Lease liabilities, long term | | | | | | |
Other long-term liabilities | |
| | |
| |
Total liabilities | |
| | |
| |
Stockholders’ equity: | |
| | |
| |
Preferred stock, par value of $ | | | — | | | — |
Common stock, par value of $ | |
| | |
| |
Additional paid-in capital | |
| | |
| |
Accumulated other comprehensive (loss) income | | | ( | | | |
Accumulated deficit | |
| ( | |
| ( |
Total stockholders’ equity | |
| | |
| |
Total liabilities and stockholders’ equity | | $ | | | $ | |
The accompanying notes are an integral part of these unaudited condensed financial statements.
1
Table of Contents
NEXTCURE, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited, in thousands, except share and per share amounts)
| | | | | | |
| Three Months Ended | | ||||
| March 31, | | ||||
| 2026 | | 2025 | | ||
Operating expenses: | | | | | | |
Research and development | $ | | | $ | | |
General and administrative | | | | | | |
Total operating expenses |
| | |
| | |
Loss from operations |
| ( | |
| ( | |
Other income, net |
| | |
| | |
Net loss | $ | ( | | $ | ( | |
Net loss per common share - basic and diluted | $ | ( | | $ | ( | |
Weighted-average shares outstanding - basic and diluted | | | | | | |
Comprehensive loss: | | | | | | |
Net loss | $ | ( | | $ | ( | |
Unrealized loss on marketable securities | | ( | | | ( | |
Total comprehensive loss | $ | ( | | $ | ( | |
The accompanying notes are an integral part of these unaudited condensed financial statements.
2
Table of Contents
NEXTCURE, INC.
CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY
(unaudited, in thousands, except share data)
| | | | | | | | | | | | | | | | | |
| | Three Months Ended March 31, 2026 | |||||||||||||||
| | | | | | | | | | | | | | | | | |
| | Stockholders’ Equity | |||||||||||||||
| | | | | | | Additional | | Accumulated Other | | | | | |
| ||
| | Common Stock | | Paid-in | | Comprehensive | | Accumulated | | Stockholders’ | |||||||
| | Shares | | Amount | | Capital | | (Loss) Income | | Deficit | | Equity | |||||
Balance as of December 31, 2025 |
| | | $ | | | $ | | | $ | | | $ | ( | | $ | |
Stock-based compensation | | — | | | — | | | | | | — | | | — | | | |
Exercise of stock options | | | | | — | | | | | | — | | | — | | | |
Issuance of shares from at-the-market sales, net of expenses | | | | | — | | | | | | — | | | — | | | |
Unrealized loss on marketable securities, net of tax | | — | | | — | | | — | | | ( | | | — | | | ( |
Net loss | | — | | | — | | | — | | | — | | | ( | | | ( |
Balance as of March 31, 2026 | | | | $ | | | $ | | | $ | ( | | $ | ( | | $ | |
| | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | |
| | Three Months Ended March 31, 2025 | |||||||||||||||
| | | | | | | | | | | | | | | | | |
| | Stockholders’ Equity | |||||||||||||||
| | | | | | | Additional | | Accumulated Other | | | | | |
| ||
| | Common Stock | | Paid-in | | Comprehensive | | Accumulated | | Stockholders’ | |||||||
| | Shares | | Amount | | Capital | | (Loss) Income | | Deficit | | Equity | |||||
Balance as of December 31, 2024 |
| | | $ | | | $ | | | $ | | | $ | ( | | $ | |
Stock-based compensation | | — | | | — | | | | | | — | | | — | | | |
Unrealized loss on marketable securities, net of tax | | — | | | — | | | — | | | ( | | | — | | | ( |
Net loss |
| — | | | — | | | — | | | — | | | ( | | | ( |
Balance as of March 31, 2025 | | | | $ | | | $ | | | $ | — | | $ | ( | | $ | |
The accompanying notes are an integral part of these unaudited condensed financial statements.
3
Table of Contents
NEXTCURE, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(unaudited, in thousands)
| | | | | | |
| | Three Months Ended | ||||
| | March 31, | ||||
| | 2026 | | 2025 | ||
Cash flows from operating activities: |
| | | | | |
Net loss | | $ | ( | | $ | ( |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | | |
Depreciation and amortization | |
| | | | |
Amortization of premiums and discounts on marketable securities | | | ( | | | ( |
Stock-based compensation | |
| | | | |
Noncash operating lease expense | | | | | | |
Changes in operating assets and liabilities: | |
| | | | |
Prepaid expenses and other assets | |
| ( | | | |
Accounts payable | |
| | | | ( |
Accrued liabilities and other liabilities | |
| ( | | | ( |
Lease liabilities | | | ( | | | ( |
Other long-term liabilities | | | ( | | | ( |
Net cash used in operating activities | |
| ( | | | ( |
Cash flows from investing activities: | |
| | | | |
Sales and maturities of marketable securities | |
| | | | |
Purchases of marketable securities | | | — | | | ( |
Net cash provided by investing activities | |
| | | | |
Cash flows from financing activities: | |
| | | | |
Net proceeds from at-the-market sales | | | | | | — |
Proceeds from exercise of stock options | | | | | | — |
Net cash provided by financing activities | |
| | | | — |
Net increase (decrease) in cash and cash equivalents | |
| ( | | | ( |
Cash and cash equivalents – beginning of period | |
| | | | |
Cash and cash equivalents – end of period | | $ | | | $ | |
Supplemental disclosures of cash flow information: | |
| | | | |
Cash paid for interest | | $ | | | $ | |
| | | | | | |
| | | | | | |
The accompanying notes are an integral part of these unaudited condensed financial statements.
4
Table of Contents
1. Nature of the Business
Organization
NextCure, Inc. (“NextCure” the “Company,” “we,” “us,” or “our”) was incorporated in Delaware in September 2015 and is headquartered in Beltsville, Maryland. The Company is a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or that have disease progression on, current therapies, through the use of targeted therapies including antibody-drug conjugates. The Company focuses 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. Since inception, the Company has devoted substantially all of its efforts and financial resources to discovery, research and development activities for the Company’s product candidates, identifying business development opportunities, raising capital and securing intellectual property rights related to the Company’s product candidates.
Reverse Stock Split
On July 14, 2025, the Company effectuated a one-for-twelve (1:12) reverse stock split of its outstanding shares of common stock (the “Reverse Stock Split”). In connection with the Reverse Stock Split, every twelve shares of the Company’s common stock issued and outstanding as of July 14, 2025 were automatically converted into one share of the Company’s common stock.
Liquidity
The Company has not generated any revenue to date from product sales and does not expect to generate any revenues from product sales in the foreseeable future. Through March 31, 2026, the Company has funded its operations primarily with proceeds from public offerings of its common stock and private placements of its common and preferred stock. The Company expects to incur additional operating losses and negative operating cash flows for the foreseeable future.
As of March 31, 2026, the Company had cash, cash equivalents and marketable securities of $
2. Summary of Significant Accounting Policies
There have been no material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 (the “Annual Report”).
Basis of Presentation
The unaudited condensed financial statements include the accounts of the Company and have been prepared by the Company in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. Accordingly, these condensed financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto in the Annual Report.
5
Table of Contents
Unaudited Financial Information
In the opinion of management, the information furnished reflects certain adjustments, all which are of a normal and recurring nature and are necessary for a fair presentation of the Company’s financial position as of the reported balance sheet date and of the Company’s results for the reported interim periods. The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The results of operations for interim periods are not necessarily indicative of results to be expected for the full year or any other interim period.
Liquidity and Going Concern
The Company has incurred net losses and negative cash flows from operations since its inception, has an accumulated deficit of $
As a result, the Company will be required to raise additional capital by partnering, selling equity, or other means and has implemented cost-reduction measures. There can be no assurance as to whether partnering efforts will be successful or whether additional financing will be available on terms acceptable to the Company, if at all. If sufficient funds on acceptable terms are not available when needed, it would have a negative impact on the Company’s financial condition and could force the Company to delay, limit, reduce, or terminate product development or future commercialization efforts or grant rights to develop and market product candidates that the Company would otherwise plan to develop and market itself.
The accompanying condensed financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The accompanying financial statements do not reflect any adjustments relating to the recoverability and reclassifications of assets and liabilities that might be necessary if the Company is unable to continue as a going concern.
The Company intends to raise additional capital to continue the advancement of its programs. In the near term, the Company's primary uses of cash will be to fund the completion of key milestones for clinical programs and to fund its operations, including research and development activities and employee salaries. This includes significant costs relating to clinical trials of the Company's product candidates. The Company's planned uses of cash in the long term will be similar as the Company advances its research and development activities and pays employee salaries. Most pharmaceutical products require larger clinical trials as development progresses, and the Company expects its funding requirements to grow with the advancement of its programs. The Company's long-term funding requirements will depend on many factors, which are uncertain but include its portfolio prioritization decisions and the success of its collaborations. In turn, the Company's ability to raise additional capital through equity or partnering, or other avenues, will depend on the general economic environment in which it operates and its ability to achieve key milestones.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of assets and liabilities as of the date of the condensed financial statements, and the reported amounts of revenues and expenses during the reporting periods. Although actual results could differ from those estimates, management does not believe that such differences would be material.
Recently Issued Accounting Pronouncements
The Company considers the applicability and impact of all Accounting Standards Updates (“ASUs”) issued by the Financial Accounting Standards Board (“FASB”). All other ASUs issued subsequent to the filing of the Company’s
6
Table of Contents
Annual Report were assessed and determined to be either inapplicable or not expected to have a material impact on the Company’s financial position or results of operations.
3. License Agreement
On June 13, 2025, the Company entered into a License Agreement (the “License Agreement”) with Simcere Zaiming Pharmaceutical Co., Ltd. (formerly known as Hainan Simcere Zaiming Pharmaceutical Co., Ltd. or hereinafter “Zaiming”), a biopharmaceutical company based in China. Pursuant to the License Agreement, the Company obtained (1) an exclusive, worldwide (excluding the Zaiming Territory, as identified below) license to develop, manufacture, and commercialize Zaiming’s clinical-stage antibody drug conjugate (“ADC”) candidate, SIM0505 (also known as SCR-9359), and related compounds (the “Zaiming Products”), and (2) a non-exclusive, worldwide (excluding the Zaiming Territory) license to use Zaiming’s ADC platform technology to develop ADCs based on the Company’s proprietary antibodies for an additional novel target (the “NextCure Products”). Zaiming retained exclusive rights to develop and commercialize the Zaiming Products and any NextCure Products in China, Hong Kong, Macau, and Taiwan (the “Zaiming Territory”).
Under the License Agreement: (i) the Company agreed to pay $
The rights acquired under the License agreement are considered in-process research and development (IPRD) under Accounting Standards Codification (“ASC”) 730, Research and Development. Specifically, ASC 730-10-25-(c) states intangible assets used in research and development activities acquired in an asset acquisition should be expensed at the acquisition date if there is no alternative future use in other research and development projects. Since the acquired asset is the right to a specific compound, the Company does not believe there is an alternative future use and expensed both the upfront $
4. Collaboration Agreement
In November 2022, the Company entered into a Research and Collaboration and Co-Development Agreement (“the LigaChem Agreement”) with LigaChem Biosciences, Inc., formerly known as LegoChem Biosciences, Inc., (“LigaChem”), to develop up to
7
Table of Contents
are no implied licenses or other rights created under the LigaChem Agreement after designation of a co-development product.
Effective April 1, 2023, the parties designated LNCB74 as the first co-development product under the LigaChem Agreement. As such, cost sharing on a
Given the involvement by both parties under the LigaChem Agreement, management assessed the criteria under ASC 808, Collaborative Arrangements (“ASC 808”), to determine if such agreement is within the scope of ASC 808. Based on the terms of the LigaChem Agreement, the Company concluded that the LigaChem Agreement meets the requirements of a collaboration within the guidance of ASC 808. The Company and LigaChem are active participants in the activities associated with the LigaChem Agreement and are exposed to significant risks and rewards dependent on the commercial success of the activity. The LigaChem Agreement is not reflective of a vendor-customer relationship and therefore not within the scope of ASC 606, Revenue from Contracts with Customers. Accordingly, the net costs associated with the co-development are expensed as incurred and recognized within research and development expenses on the statement of operations.
As of March 31, 2026, LNCB74 was the lone co-development product and was in the early stages of development. During the three months ended March 31, 2026, the Company incurred more costs than LigaChem under the LigaChem Agreement and recorded a corresponding reduction of $
5. Marketable Securities
Marketable securities consist of the following:
| | | | | | | | | | | | |
| | March 31, 2026 | ||||||||||
| | | | | Gross | | Gross | | | | ||
| | Amortized | | Unrealized | | Unrealized | | Estimated | ||||
(in thousands) | | Cost | | Gain | | Loss | | Fair Value | ||||
Corporate bonds | | $ | | | $ | | | $ | ( | | $ | |
Total | | $ | | | $ | | | $ | ( | | $ | |
| | | | | | | | | | | | |
| | December 31, 2025 | ||||||||||
| | | | | Gross | | Gross | | | | ||
| | Amortized | | Unrealized | | Unrealized | | Estimated | ||||
(in thousands) | | Cost | | Gain | | Loss | | Fair Value | ||||
Corporate bonds | | $ | | | $ | | | $ | ( | | $ | |
Total | | $ | | | $ | | | $ | ( | | $ | |
The Company uses the specific identification method when calculating realized gains and losses. The Company realized a gain of $
The Company reviewed all investments which were in a loss position at the respective balance sheet dates, as well as the remainder of the portfolio. As of March 31, 2026, the Company had investments with a total fair market value of $
8
Table of Contents
terms. Furthermore, the Company does not believe that these securities expose the Company to undue market risk or counterparty credit risk.
The following table summarizes maturities of the Company’s investments available-for-sale as of
March 31, 2026:
| | | | | | |
| | March 31, 2026 | ||||
| | | | | Fair | |
(in thousands) | | Cost | | Value | ||
Maturities: | | | | | | |
Within 1 year | | $ | | | $ | |
Total investments available-for-sale | | $ | | | $ | |
The Company has elected to report interest receivable from its marketable securities with prepaid expenses and other current assets on its balance sheet. Interest receivable included in prepaid expenses and other current assets totaled $
6. Fair Value Measurements
The Company has certain financial assets recorded at fair value, which have been classified as Level 1, 2 or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements.
Level 1—Quoted market prices in active markets for identical assets or liabilities.
Level 2—Inputs other than Level 1 inputs that are either directly or indirectly observable, such as quoted market prices, interest rates and yield curves.
Level 3—Unobservable inputs developed using estimates of assumptions developed by the Company, which reflect those that a market participant would use.
To the extent the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair values requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized as Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
9
Table of Contents
The following tables set forth the fair value of the Company’s financial assets by level within the fair value hierarchy as of March 31, 2026 and December 31, 2025:
To the extent the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair values requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized as Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.e following tables set forth the fair value of the Company’s financial assets by level within the fair value hierarchy as of March 31, 2026 and December 31, 2025: | | | | | | | | | | | | |
| | March 31, 2026 | ||||||||||
| | | | | | | | Significant | | | | |
| | | | | Quoted Prices in | | Other | | | | ||
| | | | | Active Markets or | | Observable | | Significant | |||
| | | | | Identical Assets | | Inputs | | Unobservable | |||
(in thousands) | | Total | | (Level 1) | | (Level 2) | | (Level 3) | ||||
Cash equivalents: | | | | | | | | | | | | |
Money market funds | | $ | | | $ | | | $ | — | | $ | — |
Marketable securities: | | | | | | | | | | | | |
Corporate bonds | | | | | | — | | | | | | — |
Total | | $ | | | $ | | | $ | | | $ | — |
| | | | | | | | | | | | |
| | December 31, 2025 | ||||||||||
| | | | | | | | Significant | | | | |
| | | | | Quoted Prices in | | Other | | | | ||
| | | | | Active Markets or | | Observable | | Significant | |||
| | | | | Identical Assets | | Inputs | | Unobservable | |||
(in thousands) | | Total | | (Level 1) | | (Level 2) | | (Level 3) | ||||
Cash equivalents: | | | | | | | | | | | | |
Money market funds | | $ | | | $ | | | $ | — | | $ | — |
Marketable securities: | | | | | | | | | | | | |
Corporate bonds | | | | | | — | | | | | | — |
Total | | $ | | | $ | | | $ | | | $ | — |
The Company did
10
Table of Contents
7. Leases
The Company's lease portfolio consists of office space and laboratory facilities. All of the Company's leases are classified as operating leases. The terms of the Company's lease agreements currently extend through March 2030 and provide the Company with an
The leases do not provide an implicit rate; therefore, the Company uses its incremental borrowing rate as the discount rate when measuring operating lease liabilities. The incremental borrowing rate represents an estimate of the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of the lease.
Operating lease expense was $
As of March 31, 2026, the maturities of the Company’s operating lease liabilities were as follows (in thousands), which are included in Accrued liabilities and other liabilities and Lease liabilities, long term in the accompanying balance sheet:
| | | | | | |
| | | | | | |
| | | | |
| |
| 2026 | | $ | | | |
| 2027 | |
| | | |
| 2028 | |
| | | |
| 2029 | |
| | | |
| 2030 | | | | | |
| Total future minimum payments | | $ | | | |
| Less: present value discount | | | ( | | |
| Present value of lease liabilities | | $ | | | |
| | | | | | |
8. Stock-Based Compensation
Employee Equity Plans
The NextCure, Inc. 2015 Omnibus Incentive Plan (the “2015 Plan”) was adopted in December 2015 and provides for the grant of awards of stock options, restricted stock awards, unrestricted stock awards and restricted stock units to employees, consultants, and directors of the Company.
The NextCure, Inc. 2019 Omnibus Incentive Plan (the “2019 Plan”) became effective on May 8, 2019, the date on which the Company’s Registration Statement on Form S-1 filed in connection with the Company’s initial public offering was declared effective (the “Effective Date”). The Company’s board of directors (the “Board”) determined not to make additional awards under the 2015 Plan following the effectiveness of the 2019 Plan. The 2019 Plan provides for the grant of awards of stock options, stock appreciation rights, restricted stock, restricted stock units, deferred stock units, unrestricted stock, dividend equivalent rights, other equity-based awards and cash bonus awards to the Company’s officers, employees and non-employee directors as well as other key persons (including consultants).
11
Table of Contents
The number of shares of common stock reserved for issuance under the 2019 Plan is
As of March 31, 2026,
| | | | | | | | | | |
| | Options Outstanding and Exercisable | ||||||||
| | | | | | | Weighted | | | |
| | | | Weighted | | Average | | Aggregate | ||
| | | | Average | | Remaining | | Intrinsic | ||
| | Number of | | Exercise | | Contractual | | Value(1) | ||
| | Shares | | Price | | Life (Years) | | (in thousands) | ||
Outstanding as of December 31, 2025 |
| | | $ | |
| | $ | — | |
Granted | | | | $ | | | — | | | — |
Exercised | | ( | | $ | | | — | | | — |
Forfeitures | | ( | | $ | | | — | | | — |
Outstanding as of March 31, 2026 | | | | $ | | | | | | |
Exercisable as of March 31, 2026 |
| | | $ | |
| | $ | | |
| (1) | The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the estimated fair value of the common stock for the options that were in the money at December 31, 2025 and March 31, 2026. |
The weighted average grant date fair value of stock options granted to employees for the three months ended March 31, 2026 was $
The aggregate grant date fair value of stock options vested during the three months ended March 31, 2026 and 2025 was approximately $
Stock-based compensation expense was classified on the statements of operations as follows for the three months ended March 31, 2026 and 2025:
| | | | | | | |
| | Three Months Ended | | ||||
| | March 31, | | ||||
(in thousands) | | 2026 | | 2025 | | ||
Research and development | | $ | | | $ | | |
General and administrative | |
| | |
| | |
Total stock-based compensation expense | | $ | | | $ | | |
12
Table of Contents
The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model using the assumptions in the following table for options issued during the period indicated:
| | | | | | | |
| | Three Months Ended | | ||||
| | March 31, | | ||||
| | 2026 | | 2025 | | ||
Expected term |
| years | | | years | | |
Expected volatility |
| | % | | | % | |
Risk free interest rate |
| | % | | | % | |
Expected dividend yield |
| | % | | | % | |
Employee Stock Purchase Plan
The NextCure, Inc. 2019 Employee Stock Purchase Plan (the “ESPP”) was approved in May 2019 and provides for eligible employees of the Company to purchase shares of Company stock at a discounted price. As of March 31, 2026,
9. Common Stock
Securities Purchase Agreement
On November 12, 2025, the Company 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)
Pre-Funded Warrants
The rights and privileges of the pre-funded warrants issued under the offering are set forth in the warrant agreement between the Company and each of the respective warrant holders. The pre-funded warrants are exercisable at the option of the warrant holder at any time and do not expire. Pre-funded warrants do not provide any of the rights or privileges provided by the Company's common stock, including any voting rights, until the pre-funded warrants are exercised and settled in underlying shares of common stock.
The Company evaluated the pre-funded warrants issued under the offering and concluded the warrants are indexed to the Company's common stock, meet the criteria to be classified as equity and are not subject to remeasurement. The proceeds received from the issuance of the pre-funded warrants were recorded as additional paid-in capital. The Company issued
At-The-Market Offering Agreement
On December 19, 2025, the Company entered into an at-the-market offering agreement (the “Wainwright ATM Agreement”) with H.C. Wainwright & Co., LLC (the “Agent”), pursuant to which the Company may sell, from time to time, up to an aggregate sales price of $
13
Table of Contents
funding for the Company. During the three months ended March 31, 2026,
10. Segment Information
We operate our business in
The accounting policies of the life sciences segment are the same as those described in Note 2, Summary of Significant Accounting Policies. The CODM assesses performance for the life science segment based on net loss, which is reported on the statements of operations and comprehensive net loss as net loss. The measure of segment assets is reported on the balance sheet as total assets.
To date, the Company has not generated any product revenue. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through all stages of development and clinical trials and, ultimately, seek regulatory approval.
As such, the CODM uses cash forecast models in deciding how to invest into the life sciences segment. Such cash forecast models are reviewed to assess the entity-wide operating results and performance. Net loss is used to monitor budget versus actual results. Monitoring budgeted versus actual results is used in assessing performance of the segment and in establishing management’s compensation, along with cash forecast models.
The tables below summarize the significant expense categories regularly reviewed by the CODM for the three months ended March 31, 2026 and 2025:
| | | | | | |
| | Three Months Ended | ||||
(in thousands) | | March 31, | ||||
| | 2026 | | | 2025 | |
Research and development expenses | | | | | | |
Employee costs | | $ | | | $ | |
Clinical product candidates | | | | | | |
Nonclinical product candidates | | | | | | |
Depreciation and amortization | | | | | | |
Other R&D (1) | | | | | | |
Total R&D | | $ | | | $ | |
| | | | | | |
| | | | | | |
General and administrative expenses | | | | | | |
Employee costs | | $ | | | $ | |
Professional services | | | | | | |
Insurance | | | | | | |
Other G&A (2) | | | | | | |
Total G&A | | $ | | | $ | |
| (1) | Other R&D consists of facilities related expenses and office expenses. |
| (2) | Other G&A consists of facilities related expenses, depreciation, office expenses and taxes and fees. |
14
Table of Contents
11. Net Loss Per Share Attributable to Common Stockholders
Basic net loss per share is calculated by dividing net loss applicable to common stockholders by the weighted-average common shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted-average common shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method. For purposes of computing both basic and diluted net loss per share, pre-funded warrants are considered outstanding shares upon issuance because the underlying shares may be issued for nominal consideration and are exercisable immediately after the original issuance date. For the three months ended March 31, 2026, pre-funded warrants to purchase up to
The computation for basic and diluted loss per share were as follows (in thousands, except share and per share data):
| | | | | | | |
| | Three Months Ended | | ||||
| | March 31, | | ||||
| | 2026 | | 2025 | | ||
Net loss (Numerator): |
| | | | | |
|
Net loss - basic and diluted | | $ | ( | | $ | ( | |
Shares (Denominator): | |
| | |
| | |
Weighted-average shares outstanding - basic and diluted | |
| | |
| | |
Loss per share - basic and diluted | | $ | ( | | $ | ( | |
The Company excluded the following potential common shares, presented based on amounts outstanding at period end, from the computation of diluted net loss per share attributable to common stockholders because including them would have had an anti-dilutive effect:
| | | |
| | March 31, | |
| | 2026 | 2025 |
Outstanding options to purchase common stock |
| | |
Total |
| | |
12. Income Taxes
The Company did
The Company has evaluated the positive and negative evidence involving its ability to realize its deferred tax assets. Management has considered the Company’s history of cumulative net losses incurred since inception and its lack of any commercially ready products. The Company has concluded that it is more likely than not that the Company will not realize the benefits of the deferred tax assets. Management reevaluates the positive and negative evidence involving its ability to realize its deferred tax assets at each reporting period.
Under the provisions of Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the “IRC”), certain substantial changes in the Company’s ownership may have limited, or may limit in the future, the amount of net operating loss and research and development credit carryforwards that can be used to reduce future income taxes. We have not performed a detailed analysis to determine whether an ownership change under Section 382 of the IRC occurred. The effect of an ownership change would be the imposition of an annual limitation on the use of losses and credits attributable to periods before the change and could result in a reduction in the total losses and credits available.
15
Table of Contents
On July 4, 2025, the One Big Beautiful Bill Act (the “Act”) was enacted into law. Given the Company’s history of operating losses and full valuation allowances against its deferred tax assets, the Act did not have a significant impact on the Company’s financial statements and is not expected to have have a significant impact on the Company’s future financial statements.
13. Commitments and Contingencies
Legal Proceedings
From time to time, the Company is a party to litigation or legal proceedings arising in the ordinary course of business. The Company is not currently a party to any litigation or legal proceeding, nor is management aware of any pending or threatened litigation that, in the opinion of the Company’s management, is likely to materially affect the Company’s business or financial results. At each reporting date, the Company evaluates whether a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses the costs related to its legal proceedings as incurred.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited condensed financial statements and the notes thereto included in this Quarterly Report and the audited financial information and related notes, as well as Management’s Discussion and Analysis of Financial Condition and Results of Operations and other disclosures, included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, or our “2025 Annual Report.” Some of the statements contained in this discussion and analysis or set forth elsewhere in this Quarterly Report are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “continue,” “could,” “due,” “estimate,” “expect,” “intend,” “may,” “objective,” “plan,” “predict,” “project,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or similar language. Forward-looking statements include, but are not limited to, statements about:
| ● | our expectations regarding the timing, progress and results of preclinical studies and clinical trials for SIM0505, LNCB74 and any other product candidates we develop, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; |
| ● | our estimates regarding our expenses, future revenues, capital requirements, needs for or ability to obtain additional financing and the period over which we expect our current cash, cash equivalents and marketable securities to be sufficient to fund our operations; |
| ● | the timing or likelihood of regulatory filings for SIM0505, LNCB74 and any other product candidates we develop and our ability to obtain and maintain regulatory approvals for such product candidates for any indication; |
| ● | the identification, analysis and use of biomarkers and biomarker data; |
| ● | our drug product sourcing and manufacturing strategy, including the scalability of our methods and processes; |
| ● | our expectations regarding the potential benefits, activity, effectiveness and safety of SIM0505, LNCB74 and any other product candidates we develop; |
| ● | our intentions and ability to successfully commercialize, including through partnering, our product candidates; |
| ● | our expectations regarding the nature of the biological pathways we are targeting; |
| ● | our expectations regarding our ability to discover and advance product candidates using our technologies; |
| ● | the potential benefits of and our ability to maintain our relationship with LigaChem Biosciences, Inc. (formerly known as LegoChem Biosciences, Inc. or hereinafter “LigaChem”), Simcere Zaiming Pharmaceutical Co, Ltd. (formerly known as Hainan Simcere Zaiming Pharmaceutical, Ltd. or hereinafter “Zaiming”), and other third-party vendors and collaborators; |
| ● | our ability to retain key personnel; |
16
Table of Contents
| ● | 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; |
| ● | our ability to protect and enforce our intellectual property protection and the scope and duration of such protection; |
| ● | developments and projections relating to our competitors and our industry, including competing therapies; and |
| ● | the impact of current and future laws and regulations. |
Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those projected in any forward-looking statement. Such risks and uncertainties include, among others: the potential that positive results in preclinical studies may not be predictive of the results of clinical trials; our limited operating history and lack of any products approved for commercial sale; our history of significant losses; our need and ability to obtain additional financing on acceptable terms or at all; risks related to clinical development, marketing approval and commercialization; the unproven approach to the discovery and development of product candidates based on our technologies; risks related to our restructuring and reduction in force; and our dependence on key personnel. More detailed information on these and additional factors that could affect our actual results are described under the heading “Risk Factors” in our 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.
We are a clinical-stage biopharmaceutical company that is focused on advancing innovative medicines that treat cancer patients that do not respond to, or that have disease progression on, current therapies, through the use of targeted therapies, including antibody-drug conjugates (“ADCs”). An ADC consists of a monoclonal antibody conjugated to a cytotoxic drug via a chemical linker. We focus on advancing therapies that leverage our core strengths in understanding biological pathways and biomarkers, the interactions of cells, including in the tumor microenvironment, and the role each interaction plays in a biologic response.
Our product candidate SIM0505 is a novel ADC candidate developed by Zaiming, to which we acquired the global rights (excluding China, Hong Kong, Macau and Taiwan) to develop, manufacture, and commercialize under the License Agreement, dated June 13, 2025, between the Company and Zaiming. It is directed to CDH6 (cadherin-6 or K-cadherin), a promising anti-tumor target, using a unique binding epitope designed to have increased tumor binding compared to competing candidates. It also features Zaiming’s proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity while offering fast systemic clearance to enlarge the therapeutic window. Preclinical studies have demonstrated robust anti-tumor activity across multiple solid tumor models and a promising safety profile in toxicology models.
Zaiming is currently investigating SIM0505 in China for the treatment of solid tumors, including ovarian, endometrial, non-small cell lung and renal. In December 2024, Zaiming received clearance from the U.S. Food and Drug Administration for its Investigational New Drug (“IND”) for a Phase 1 clinical trial for treating multiple cancers. Following the FDA's assignment of the IND to NextCure in June 2025, the Company successfully dosed the first U.S. patient in its ongoing Phase 1 trial of SIM0505 in October 2025. In April 2026, the FDA granted Fast Track Designation to SIM0505 for the treatment of patients with platinum-resistant ovarian cancer. We also announced that initial Phase 1 clinical data for this program will be presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. In May 2026, we announced the initiation of the dose optimization phase for SIM0505, targeting gynecologic cancers through the treatment of patients with platinum-resistant ovarian cancer.
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,
17
Table of Contents
and endometrial cancers. In January 2025, the first patient in our Phase 1 trial of LNCB74 was dosed. In November 2025, we announced that the FDA had cleared a protocol amendment giving us the ability to add higher dose escalation cohorts. In January 2026, we announced that implementation of the amended protocol, including expanded dosing and enrollment, prioritization of patients with high B7-H4 expression in breast and gynecological cancers, and the addition of adenoid cystic carcinoma type 1, would delay the reporting of proof-of-concept data, previously anticipated in the first half of 2026. We are backfilling patients to investigate particular dose levels and schedules in the expected therapeutic window, and plan to provide a trial progress update in the second half of 2026.
In addition, we continue to seek to partner our other clinical programs NC410 and NC525 and to pursue a partner or third-party financing to advance our preclinical non-oncology programs NC605 and NC181.
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 March 31, 2026, we raised approximately $446 million in gross proceeds from the sale of equity instruments and had received a $25 million upfront payment from our former collaboration partner. We have never been profitable and have incurred net losses since the commencement of our operations. Our net losses for the three months ended March 31, 2026 and 2025, was $9.8 million and $11.0 million, respectively. As of March 31, 2026, we had an accumulated deficit of $445.8 million, primarily as a result of research and development and general and administrative expenses. We do not expect to generate product revenue unless and until we obtain marketing approval for and commercialize a product candidate, and we cannot make assurances that we will ever generate significant revenue or profits.
As of March 31, 2026, we had cash, cash equivalents and marketable securities of $29.7 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.
We will need to raise additional capital in order to extend our runway and enable us to continue advancing our current clinical programs, SIM0505 and LNCB74, beyond the first half of 2027. While we intend to use any additional funding to continue development of both of our lead programs, if we do not raise sufficient funds in one or more financings or obtain other financial support for program development, we will need to implement additional cost cutting measures to extend our runway, which may include delaying enrollment in, or pausing, one of our clinical programs and a reduction in workforce. See Note 2, Summary of Significant Accounting Policies, to our unaudited condensed financial statements included elsewhere in this Quarterly Report for a further assessment of liquidity.
We expect to incur substantial expenditures in the foreseeable future as we advance SIM0505 and LNCB74 through clinical development, the regulatory approval process and, if approved, commercialization. Specifically, in the near term, we expect to incur expenses relating to clinical development activities with respect to SIM0505 and LNCB74.
We will need substantial additional funding to support our continuing operations and to pursue our development strategy. Until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our operations through a combination of public and private equity offerings, debt financings, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may be required to delay, limit, reduce or terminate preclinical studies, clinical trials, or other research and development activities or one or more of our development programs.
18
Table of Contents
Components of Our Results of Operations
Operating Expenses
Research and Development Expenses
Research and development expenses consist primarily of costs incurred for our clinical trials, discovery efforts, research activities, and development and testing of our product candidates and include:
| ● | the costs of acquired in-process research and development; |
| ● | expenses incurred under agreements with third parties, including agreements with third parties that conduct research, preclinical activities or clinical trials on our behalf; |
| ● | the costs of outside consultants, including their fees, stock-based compensation and related travel expenses; |
| ● | the costs of laboratory supplies and acquiring, developing and manufacturing preclinical study and clinical trial materials; |
| ● | salaries, benefits and other related costs, including stock-based compensation, for personnel engaged in research and development functions; and |
| ● | facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs. |
We expense research and development costs as incurred. Our expenses related to clinical trials are based on actual costs incurred and estimates of other incurred costs. These estimated costs are based on several factors, including patient enrollment and related expenses at clinical investigator sites, contract services received, consulting agreement costs and efforts expended under contracts with research institutions and third-party contract research organizations that conduct and manage clinical trials on our behalf. We generally accrue estimated costs related to clinical trials based on contracted amounts applied to the level of patient enrollment and other activity according to the protocol. If future timelines or contracts are modified based on changes in the clinical trial protocol or scope of work to be performed, we would modify our estimates of accrued expenses accordingly on a prospective basis. Historically, any such modifications have not been material.
Research and development activities are central to our business model. We expect that our research and development expenses will increase substantially in the future as we advance our product candidates through development.
We cannot determine with certainty the duration and costs of future clinical trials of SIM0505, LNCB74 or any other product candidate we may develop or if, when or to what extent we will generate revenue from the commercialization and sale of any product candidate for which we may obtain marketing approval. We may never succeed in obtaining marketing approval for any product candidate. The duration, costs and timing of clinical trials and development of SIM0505, LNCB74 and any other product candidate we may develop depends on a variety of factors, including:
| ● | the scope, progress, results and costs of clinical trials of SIM0505, LNCB74 as well as of any future clinical trials of other product candidates and other research and development activities that we may conduct; |
| ● | our ability to obtain partnerships for our other programs; |
| ● | uncertainties in selection of indications, clinical trial design and patient enrollment rates; |
| ● | the probability of success for our product candidates, including safety and efficacy, early clinical data, competition, ease and ability of manufacturing and commercial viability; |
19
Table of Contents
| ● | 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.
Other Income, Net
Other income, net consists primarily of interest income earned on marketable securities.
Results of Operations
Comparison of the Three Months Ended March 31, 2026 and 2025
The following table summarizes our results of operations for the periods indicated (in thousands):
| | | | | | | | | | |
| | Three Months Ended | | | | | ||||
| | March 31, | | | | | ||||
| | 2026 | | 2025 | | Change | | |||
Operating expenses: |
| | |
| | |
| | |
|
Research and development | | $ | 6,834 | | $ | 7,896 | | $ | (1,062) | |
General and administrative | |
| 3,271 | |
| 3,726 | |
| (455) | |
Loss from operations | |
| (10,105) | |
| (11,622) | |
| (1,517) | |
Other income, net | |
| 309 | |
| 646 | |
| (337) | |
Net loss | | $ | (9,796) | | $ | (10,976) | | $ | 1,180 | |
20
Table of Contents
Research and Development Expenses
The following table summarizes our research and development expenses by product candidate for the periods indicated (in thousands):
| | | | | | | | | |
| | Three Months Ended | | | | ||||
| | March 31, | | | | ||||
(in thousands) | | 2026 | | 2025 | | Change | |||
External research and development expenses: | | | | | | | | | |
LNCB74, net of cost sharing | | | 499 | | | 592 | | | (93) |
SIM0505 | | | 2,602 | | | — | | | 2,602 |
Other programs and preclinical development | | | 858 | | | 3,337 | | | (2,479) |
Total external research and development expenses | | | 3,959 | | | 3,929 | | | 30 |
Total internal research and development expenses | | | 2,875 | | | 3,967 | | | (1,092) |
Total research and development expenses |
| $ | 6,834 | | $ | 7,896 | | $ | (1,062) |
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 March 31, 2026 decreased by $1.1 million compared to the three months ended March 31, 2025 due to lower costs on other programs, largely costs for NC410 and NC525, as the Company previously deprioritized these programs and focused on finding a partner to further develop these programs. These lower costs were largely offset by cost related to SIM0505, which was acquired in the second quarter of 2025. Internal costs decreased largely due to lower personnel-related costs, primarily stock compensation costs, and lower depreciation.
General and Administrative Expenses
General and administrative expenses for the three months ended March 31, 2026 decreased by $0.5 million compared to the three months ended March 31, 2025. The decrease was driven primarily by $0.6 million lower non-cash stock compensation costs.
Other Income, Net
Other income, net for the three months ended March 31, 2026 decreased by $0.3 million compared to the three months ended March 31, 2025, due to lower interest income as a result of lower investable cash.
Liquidity and Capital Resources
Since inception through March 31, 2026, we have raised approximately $446 million in gross proceeds from the sale of equity instruments and had received a $25 million upfront payment from our former collaboration partner.
On June 13, 2025, we entered into a License Agreement (the “License Agreement”) with Simcere Zaiming Pharmaceutical Co., Ltd. (formerly known as Hainan Simcere Zaiming Pharmaceutical, Ltd. or hereinafter “Zaiming”), a biopharmaceutical company based in China (see Note 3, License Agreement, to our unaudited condensed financial statements included elsewhere in this Quarterly Report, 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. (“Simcere Zaiming”), 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
21
Table of Contents
an aggregate of (i) 708,428 shares (the “Shares”) of the Company’s common stockat 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. On December 15, 2025, 117,371 of the pre-funded warrants were exercised.
On December 19, 2025, we entered into an at-the-market offering agreement (the “Wainwright ATM Agreement”) with H.C. Wainwright & Co., LLC (the “Agent”), pursuant to which we may sell, from time to time, up to an aggregate sales price of $14.5 million of its common stock, through the Agent. Actual sales will depend on a variety of factors to be determined by us from time to time, including, among other things, market conditions, the trading price of the common stock, capital needs and determinations by us of the appropriate sources of funding for the Company. During the three months ended March 31, 2026, 99,446 shares of common stock were sold under the Wainwright ATM Agreement for net proceeds of approximately $1.2 million.
As of March 31, 2026 we had cash, cash equivalents and marketable securities of $29.7 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.
We will need to raise additional capital in order to extend our runway and enable us to continue advancing our current clinical programs, SIM0505 and LNCB74, beyond the first half of 2027. While we intend to use any additional funding to continue development of both of our lead programs, if we do not raise sufficient funds in one or more financings or obtain other financial support for program development, we will need to implement additional cost cutting measures to extend our runway, which may include delaying enrollment in, or pausing, one of our clinical programs and a reduction in workforce. See Note 2, Summary of Significant Accounting Policies, to our unaudited condensed financial statements included elsewhere in this Quarterly Report for a further assessment of liquidity.
We expect to incur substantial expenditures in the foreseeable future as we advance SIM0505 and LNCB74 through clinical development, the regulatory approval process and, if approved, commercialization. Specifically, in the near term, we expect to incur expenses relating to clinical development activities with respect to SIM0505 and LNCB74.
We will need substantial additional funding to support our continuing operations and to pursue our development strategy. Until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our operations through a combination of public and private equity offerings, debt financings, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements. Adequate funding may not be available to us on acceptable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may be required to delay, limit, reduce or terminate preclinical studies, clinical trials, or other research and development activities or one or more of our development programs. Our need to raise additional capital will depend on many factors, including:
| ● | the scope, progress, results and costs of researching and developing SIM0505, LNCB74 and our other programs, and of conducting preclinical studies and clinical trials; |
| ● | the timing of, and the costs involved in, obtaining marketing approvals for SIM0505, LNCB74 and any future product candidates we develop, if clinical trials are successful; |
| ● | the costs of manufacturing SIM0505, LNCB74 and any future product candidates we develop for preclinical studies and clinical trials in preparation for marketing approval and commercialization; |
22
Table of Contents
| ● | the costs of commercialization activities, including marketing, sales and distribution costs, for SIM0505, LNCB74 and any future product candidates we develop, whether alone or with a collaborator, if any such product candidates are approved for sale, including marketing, sales and distribution costs; |
| ● | our ability to establish and maintain additional collaborations, licenses or other arrangements on favorable terms, if at all; |
| ● | the costs involved in preparing, filing, prosecuting, maintaining, expanding, defending and enforcing patent claims, including litigation costs and the outcome of any such litigation; |
| ● | our current collaboration and license agreements remaining in effect and our achievement of milestones and the timing and amount of milestone payments we are required to make, or that we may be eligible to receive, under those agreements; |
| ● | the timing, receipt and amount of sales of, or royalties on, our future products, if any; and |
| ● | the emergence of competing therapies and other developments in the oncology market. |
Adequate additional financing may not be available to us on acceptable terms, or at all. If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing into which we enter may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments and engage in certain merger, consolidation or asset sale transactions. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. If we raise additional funds through government or private grants, collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our future revenue streams, product candidates or research programs or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, reduce or terminate some or all of our development programs and clinical trials. We may also be required to sell or license to others rights to our product candidates in certain territories or indications that we would prefer to retain for ourselves.
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):
| | | | | | |
| | Three Months Ended | ||||
| | March 31, | ||||
| | 2026 | | 2025 | ||
Net cash (used in) provided by: |
| | |
| | |
Operating activities | | $ | (13,363) | | $ | (12,994) |
Investing activities | |
| 1,300 | |
| 7,094 |
Financing activities | |
| 1,248 | |
| — |
Net increase (decrease) in cash and cash equivalents | | $ | (10,815) | | $ | (5,900) |
Net Cash Used in Operating Activities
Net cash used in operating activities was $13.4 million for the three months ended March 31, 2026, which was primarily the result of our net loss of $9.8 million and $4.3 million used by net changes in operating assets and liabilities, partially offset by non-cash charges for depreciation of $0.3 million and stock-based compensation of $0.3 million. Net cash used in operating activities was $13.0 million for the three months ended March 31, 2025, which was primarily the result of our net loss of $11.0 million, and $3.9 million used by net changes in operating assets and liabilities, partially offset by non-cash charges for depreciation of $0.7 million and stock-based compensation of $1.4 million.
23
Table of Contents
Net Cash Provided by Investing Activities
Net cash provided by investing activities for the three months ended March 31, 2026 was $1.3 million, which was entirely due to net proceeds from sales and maturities of marketable securities. Net cash provided by investing activities for the three months ended March 31, 2025 was $7.1 million, which was entirely due to net proceeds from sales and maturities of marketable securities.
Net Cash Provided by Financing Activities
Net cash provided by financing activities was $1.2 million for the three months ended March 31, 2026 representing the sale of 99,446 shares of stock under the Wainwright ATM Agreement. There was no cash provided by financing activities for the three months ended March 31, 2025.
Contractual Obligations and Commitments
Operating Leases
We are party to several non-cancelable lease agreements for office and laboratory space that expire in March 2030. The monthly base rent for these leases totals $111.4 thousand as of March 31, 2026 per month plus our prorated share of operating expenses. The monthly base rent is subject to annual 3% increases through the lease term.
We also have potential contingent payment obligations upon the achievement by us of clinical, regulatory, and commercial events, as applicable, or royalty payments that we may be required to make under license agreements we have entered into with various entities pursuant to which we have in-licensed intellectual property, including our license agreement with Zaiming. The timing and amount (if any) of any such payments cannot be reasonably estimated at this time.
We enter into contracts in the normal course of business with third-party contract organizations for clinical trials, non-clinical studies and testing, manufacturing and other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice, and therefore we believe that our non-cancelable obligations under these agreements are not material. There have been no material changes to our contractual obligations during the three months ended March 31, 2026, as compared to those disclosed in our 2025 Annual Report.
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 March 31, 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.
24
Table of Contents
Recent Accounting Pronouncements
See Note 2, Summary of Significant Accounting Policies, to our unaudited condensed financial statements included elsewhere in this Quarterly Report, for a discussion of recent accounting pronouncements that may impact our financial position and results of operations.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
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.
Item 4. Controls and Procedures.
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 March 31, 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 March 31, 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 March 31, 2026, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
The information set forth under the heading “Legal Proceedings” in Note 13, Commitments and Contingencies, to our unaudited condensed financial statements included elsewhere in this Quarterly Report, is incorporated herein by reference. In addition, from time to time, we are involved in litigation or other legal proceedings as part of our ordinary course of business. In the opinion of our management, the ultimate disposition of these legal proceedings in the ordinary course of business is not likely to have a material adverse effect on our business.
Item 1A. Risk Factors.
There have been no material updates to the risk factors set forth in our 2025 Annual Report.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
There were no sales of equity securities sold during the period covered by this Quarterly Report that were not registered under the Securities Act of 1933 and were not previously reported in a Current Report on Form 8-K filed by the Company.
25
Table of Contents
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
During the fiscal quarter ended March 31, 2026, none of the Company’s directors or executive officers
26
Table of Contents
Item 6. Exhibits.
The exhibits filed or furnished as part of this Quarterly Report are set forth on the Exhibit Index, below.
Exhibit No. | | Exhibit Description |
| | |
10.1*+ | | Employment Agreement, effective as of July 6, 2020, by and between the Company and Timothy Mayer. |
| | |
31.1* | | Certification of Michael Richman pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
| | |
31.2* | | Certification of Steven P. Cobourn pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
| | |
32.1** | | Certification of Michael Richman and Steven P. Cobourn pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
| | |
EX-101.INS | | Inline XBRL Instance Document |
| | |
EX-101.SCH | | Inline XBRL Taxonomy Extension Schema Document |
| | |
EX-101.CAL | | Inline XBRL Taxonomy Extension Calculation Linkbase Document |
| | |
EX-101.DEF | | Inline XBRL Taxonomy Extension Definition Linkbase Document |
| | |
EX-101.LAB | | Inline XBRL Taxonomy Extension Label Linkbase Document |
| | |
EX-101.PRE | | Inline XBRL Taxonomy Extension Presentation Linkbase Document |
| | |
104 | | Coverage Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
*Filed herewith.
** Furnished herewith.
+ Indicates a management contract or compensatory plan.
27
Table of Contents
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| NEXTCURE, INC. | |
| ||
Date: May 7, 2026 | By: | /s/ Michael Richman |
| Name: | Michael Richman |
| President and Chief Executive Officer | |
| | |
Date: May 7, 2026 | By: | /s/ Steven P. Cobourn |
| Name: | Steven P. Cobourn |
| Chief Financial Officer | |
28