Overview
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- TickerNXTC on Nasdaq2
- IndustryPharmaceutical Preparations2
- HeadquartersBeltsville, United States2
- Incorporated inDE3
- Business address2850 Quarry Lake Drive, Suite 280, Baltimore, Md 212093
- Filer categoryNon-accelerated filer, Smaller reporting company3
- Legal formCorporation2
- LEI549300Y5PR6RJR1STI242
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressC/O THE CORPORATION TRUST COMPANY, 19801 Wilmington, United States2
- Registered withDivision of Corporations, Department of State, 58157722
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These statements, and other forward-looking statements, are based on management’s current expectations, estimates, forecasts and projections about our business and industry, are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control, and that may cause our actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. Forward-looking statements contained in this Annual Report should be considered in light of these factors and the factors set forth under “Risk Factor Summary” below and the factors described elsewhere in this Annual Report, including in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These factors, and the other caut…4 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2020
Where the money goes
Where each dollar of revenue went, fiscal 2020
- Research and development100¢$46.6M
- Interest0¢$183.0K
Out of $22.4M in revenue.5 The company lost money this year.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.10
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Research and development | $44.9M | $41.5M |
| General and administrative | $12.7M | $15.7M |
| Restructuring and asset impairment charges | $2.5M | |
| Total operating expenses | $57.6M | $59.7M |
| Loss from operations | -$57.6M | -$59.7M |
| Other income, net | $1.8M | $4.1M |
| Basic (in dollars per share) | -$19.65 | -$23.88 |
| Diluted (in dollars per share) | -$19.65 | -$23.88 |
| Basic (in shares) | 2.8M shares | 2.3M shares |
| Diluted (in shares) | 2.8M shares | 2.3M shares |
| Net loss | -$55.8M | -$55.7M |
| Unrealized gain on marketable securities | $17.0K | $226.0K |
| Total comprehensive loss | -$55.8M | -$55.4M |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 3 fiscal years (annual) or 3 quarters (quarterly), latest first.10
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $26.0M | $27.7M | |
| Marketable securities | $15.8M | $40.9M | |
| Prepaid expenses and other current assets | $1.9M | $3.2M | |
| Total current assets | $43.7M | $71.8M | |
| Property and equipment, net | $3.3M | $5.5M | |
| Right of use assets | $2.6M | $3.3M | |
| Other assets | $546.0K | $332.0K | |
| Total assets | $50.2M | $80.9M | |
| Accounts payable | $2.0M | $5.4M | |
| Accrued liabilities and other liabilities | $8.6M | $4.2M | |
| Total current liabilities | $10.6M | $9.6M | |
| Lease liabilities, long term | $4.1M | $5.2M | |
| Other long-term liabilities | $526.0K | $661.0K | |
| Total liabilities | $15.2M | $15.4M | |
| Common stock, par value of $0.001 per share; 100,000,000 shares authorized at December 31, 2025 and December 31, 2024; 3,505,621 and 2,333,896 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively | $4.0K | $2.0K | |
| Additional paid-in capital | $470.9M | $445.6M | |
| Accumulated other comprehensive income | $21.0K | $4.0K | |
| Accumulated deficit | -$436.0M | -$380.1M | |
| Total stockholders' equity | $34.9M | $65.5M | $114.4M |
| Total liabilities and stockholders' equity | $50.2M | $80.9M | |
| Preferred stock, par value per share | $0.00 | $0.00 | |
| Preferred stock, number of shares authorized | 10.0M shares | 10.0M shares | |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value per share | $0.00 | $0.00 | |
| Common stock, number of shares authorized | 100.0M shares | 100.0M shares | |
| Common stock, shares issued | 3.5M shares | 2.3M shares | |
| Common stock, shares outstanding | 3.5M shares | 2.3M shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2023-12-31 |
|---|---|---|---|
| Cash and cash equivalents | $26.0M | $27.7M | |
| Marketable securities | $15.8M | $40.9M | |
| Prepaid expenses and other current assets | $1.9M | $3.2M | |
| Total current assets | $43.7M | $71.8M | |
| Property and equipment, net | $3.3M | $5.5M | |
| Right of use assets | $2.6M | $3.3M | |
| Other assets | $546.0K | $332.0K | |
| Total assets | $50.2M | $80.9M | |
| Accounts payable | $2.0M | $5.4M | |
| Accrued liabilities and other liabilities | $8.6M | $4.2M | |
| Total current liabilities | $10.6M | $9.6M | |
| Lease liabilities, long term | $4.1M | $5.2M | |
| Other long-term liabilities | $526.0K | $661.0K | |
| Total liabilities | $15.2M | $15.4M | |
| Common stock, par value of $0.001 per share; 100,000,000 shares authorized at December 31, 2025 and December 31, 2024; 3,505,621 and 2,333,896 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively | $4.0K | $2.0K | |
| Additional paid-in capital | $470.9M | $445.6M | |
| Accumulated other comprehensive income | $21.0K | $4.0K | |
| Accumulated deficit | -$436.0M | -$380.1M | |
| Total stockholders' equity | $34.9M | $65.5M | $114.4M |
| Total liabilities and stockholders' equity | $50.2M | $80.9M | |
| Preferred stock, par value per share | $0.00 | $0.00 | |
| Preferred stock, number of shares authorized | 10.0M shares | 10.0M shares | |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value per share | $0.00 | $0.00 | |
| Common stock, number of shares authorized | 100.0M shares | 100.0M shares | |
| Common stock, shares issued | 3.5M shares | 2.3M shares | |
| Common stock, shares outstanding | 3.5M shares | 2.3M shares |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 2 fiscal years, latest first.10
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$55.8M | -$55.7M |
| Depreciation and amortization | $2.2M | $2.9M |
| Amortization of premiums and discounts on marketable securities | -$481.0K | -$1.2M |
| Stock-based compensation | $3.0M | $6.3M |
| Asset impairment | $1.8M | |
| Noncash operating lease expense | $587.0K | $561.0K |
| Prepaid expenses and other assets | $1.1M | $2.8M |
| Accounts payable | -$3.3M | $3.0M |
| Accrued liabilities and other liabilities | $4.3M | -$332.0K |
| Lease liabilities | -$1.0M | -$796.0K |
| Other long-term liabilities | -$135.0K | -$124.0K |
| Net cash used in operating activities | -$49.6M | -$40.8M |
| Sales and maturities of marketable securities | $52.3M | $104.2M |
| Purchases of marketable securities | -$26.7M | -$48.4M |
| Purchases of property and equipment | -$474.0K | |
| Net cash provided by investing activities | $25.6M | $55.3M |
| Proceeds from exercise of stock options | $23.0K | |
| Proceeds from shares issued under ESPP | $36.0K | $82.0K |
| Net cash provided by financing activities | $22.3M | $144.0K |
| Net increase (decrease) in cash and cash equivalents | -$1.7M | $14.6M |
| Cash paid for interest | $62.0K | $72.0K |
| Issuance costs | $1.2M |
No quarter-by-quarter statement was filed.
Corporate structure
NextCure, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of NextCure, Inc.
- ADAR1 Capital Management, LLC Filed SCHEDULE 13G on NextCure, Inc., latest Aug 14, 2026
- Ikarian Capital, LLC Filed SCHEDULE 13G/A on NextCure, Inc., latest Aug 14, 2026 (2 filings since Feb 17, 2026)
- Squadron Capital Management LLC Filed SCHEDULE 13G/A on NextCure, Inc., latest Aug 14, 2026 (3 filings since Oct 24, 2025)
- Affinity Asset Advisors, LLC Filed SCHEDULE 13G/A on NextCure, Inc., latest Aug 13, 2026 (5 filings since Jun 27, 2024)
- Adage Capital Management, L.P. Filed SCHEDULE 13G on NextCure, Inc., latest Aug 12, 2026
- SILVERARC CAPITAL MANAGEMENT, LLC Filed SCHEDULE 13G/A on NextCure, Inc., latest May 13, 2026 (2 filings since Feb 12, 2026)
- Simcere Zaiming, Inc. Filed SCHEDULE 13G/A on NextCure, Inc., latest May 6, 2026 (2 filings since Aug 19, 2025)
- Sofinnova Venture Partners IX, L.P. Filed SCHEDULE 13D/A on NextCure, Inc., latest Mar 5, 2026
- Pfizer Filed SCHEDULE 13G/A on NextCure, Inc., latest Feb 13, 2026
- Citigroup Filed SCHEDULE 13G on NextCure, Inc., latest May 12, 2025
- Logos Global Management LP Filed SCHEDULE 13G/A on NextCure, Inc., latest Feb 14, 2025 (3 filings since Apr 1, 2024)
- ORBIMED ADVISORS LLC Filed SC 13D/A on NextCure, Inc., latest Mar 8, 2024
- NextCure, Inc. Beltsville, Maryland, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What NextCure, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $28.6M10 Dec 31, 2025 | $28.6M10 Dec 31, 2024 | 0% |
| Accumulated depreciation | $25.3M10 Dec 31, 2025 | $23.1M10 Dec 31, 2024 | +9.5% |
| Property and equipment, net | $3.3M10 Dec 31, 2025 | $5.5M10 Dec 31, 2024 | −40.0% |
| Operating-lease assets (leased space) | $2.6M10 Dec 31, 2025 | $3.3M10 Dec 31, 2024 | −19.8% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $26.0M10 Dec 31, 2025 | $27.7M10 Dec 31, 2024 | −6.3% |
Properties, in its own words
Our corporate headquarters is located in Beltsville, Maryland and consists of approximately 28,500 square feet of office, 20,600 square feet of laboratory and manufacturing and 20,200 square feet of warehouse space. The lease terms expire in March 2030. We believe that these facilities are adequate for our current needs and that suitable additional or substitute space will be available in the future if needed.
Item 2 of the 10-K filed Mar 5, 2026.4
Leadership
Who has led NextCure, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
Chief operating officer
- Chief executive officerMichael Richman May 8, 2019 to now11
- PresidentMichael Richman May 8, 2019 to now11
- Chief financial officerSteven P. Cobourn May 8, 2019 to now12
- Chief operating officerTimothy Mayer Mar 3, 2020 to now13
Board members and other officers (22)
- Chief Medical OfficerUdayan Guha Feb 6, 2025 to now14
- Sr VP, Legal AffairsKevin G. Shaw Feb 28, 2023 to Mar 1, 202315
- Chief Medical OfficerHan Myint Jan 19, 2021 to Apr 2, 202416
- Sr VP, Dev. & Mfg.Sourav Kundu Jul 15, 2021 to now17
- Chief Development OfficerJames B. Bingham May 8, 2019 to Mar 3, 202018
- Chief Medical OfficerKevin N. Heller May 8, 2019 to Jul 16, 202019
- SVP, ResearchLinda Liu May 8, 2019 to Feb 2, 202220
- Chief Scientific OfficerSol Langermann May 8, 2019 to Feb 3, 202521
- SVP, Corporate DevelopmentTimothy Mayer May 8, 2019 to May 8, 201922
- Board memberAnne Elizabeth Borgman Oct 5, 2021 to now23
- Board memberEllen Feigal Oct 5, 2021 to now24
- Board memberGarry A. Nicholson Apr 1, 2020 to Jun 23, 202325
- Board memberJohn G. Houston Sep 14, 2020 to now26
- Board memberBriggs Morrison May 8, 2019 to Jun 15, 202027
- Board memberChau Quang Khuong May 8, 2019 to Jun 23, 202328
- Board memberDavid S. Kabakoff May 8, 2019 to now29
- Board memberElaine Jones V. May 8, 2019 to now30
- Board memberJudith Li May 8, 2019 to Jun 15, 202031
- Board memberMichael Richman May 8, 2019 to now11
- Board memberStella Xu May 8, 2019 to Jun 28, 202132
- Board memberTimothy M. Shannon May 8, 2019 to Jun 17, 201933
- General counselKevin G. Shaw Feb 1, 2024 to now34
Named in SEC Form D filings
People the company listed in its private-offering notices.
- DirectorStephen G. Webster named Dec 10, 202535
Timeline
- Sep 25, 20268-K Other events36
- Sep 3, 20268-K Entered a material agreement37
- Aug 6, 20268-K Results of operations38
- Jul 14, 20268-K Entered a material agreement; Exit or restructuring costs; Change in control39
- Jun 25, 20268-K Executive or director change; Shareholder vote40
- Jun 1, 20268-K Regulation FD disclosure; Other events41
- May 7, 20268-K Results of operations42
- Mar 5, 20268-K Results of operations43
- Jan 23, 20268-K Results of operations; Regulation FD disclosure; Other events44
- Dec 19, 20258-K Other events45
- Nov 17, 20258-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure46
- Nov 5, 20258-K Results of operations47
- May 8, 2019New chief executive Michael Richman becomes CEO11
Calendar
Coming up
- Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($3.22) a share, on Nov 5, 2025.48
When it reported results
- Aug 6, 2026Reported quarterly or annual results38
- May 7, 2026Reported quarterly or annual results42
- Mar 5, 2026Reported quarterly or annual results43
- Jan 23, 2026Reported quarterly or annual results44
- Nov 5, 2025Reported quarterly or annual results47
- Aug 7, 2025Reported quarterly or annual results49
- May 1, 2025Reported quarterly or annual results50
- Mar 6, 2025Reported quarterly or annual results51
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
221 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 47 major events, 86 insider forms, 27 large holders, 1 private raises, 40 other. The latest 20:
- Oct 1, 2026S-4/A EDGAR
- Sep 25, 2026425 EDGAR
- Sep 25, 20268-K EDGAR
- Sep 3, 20268-K EDGAR
- Aug 18, 2026S-4 EDGAR
- Aug 14, 2026SCHEDULE 13G/A EDGAR
- Aug 14, 2026SCHEDULE 13G/A EDGAR
- Aug 14, 2026SCHEDULE 13G EDGAR
- Aug 13, 2026SCHEDULE 13G/A EDGAR
- Aug 12, 20264 EDGAR
- Aug 12, 2026SCHEDULE 13G EDGAR
- Aug 10, 2026425 EDGAR
- Aug 6, 202610-Q EDGAR
- Aug 6, 20268-K EDGAR
- Aug 4, 2026425 EDGAR
- Aug 3, 20264 PRIMARY DOCUMENT EDGAR
- Jul 29, 20264 PRIMARY DOCUMENT EDGAR
- Jul 29, 20263 PRIMARY DOCUMENT EDGAR
- Jul 16, 2026425 EDGAR
- Jul 14, 2026425 EDGAR
The 221 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
6 open-market trades by officers, directors and large owners since October 2021: 5 buys and 1 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Aug 10, 2026 | Jiangsu Simcere Zaiming Pharmaceutical Co., Ltd. | Sale | 30,000 | $6.16 | $184.8K | Form 4 |
| Jul 31, 2026 | ADAR1 Capital Management, LLC10% owner | Buy | 36,303 | $4.94 | $179.3K | Form 4 |
| Jul 30, 2026 | ADAR1 Capital Management, LLC10% owner | Buy | 292,850 | $4.93 | $1.4M | Form 4 |
| Jul 29, 2026 | ADAR1 Capital Management, LLC10% owner | Buy | 3,410 | $5.00 | $17.1K | Form 4 |
| Jul 28, 2026 | ADAR1 Capital Management, LLC10% owner | Buy | 6,400 | $4.95 | $31.7K | Form 4 |
| Jul 27, 2026 | ADAR1 Capital Management, LLC10% owner | Buy | 7,798 | $5.00 | $39.0K | Form 4 |
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- ADAR1 Capital Management, LLCSCHEDULE 13G, 1 filing Aug 14, 202652
- Ikarian Capital, LLCSCHEDULE 13G/A, 2 filings Feb 17, 2026 to Aug 14, 202653
- Squadron Capital Management LLCSCHEDULE 13G/A, 3 filings Oct 24, 2025 to Aug 14, 202654
- Affinity Asset Advisors, LLCSCHEDULE 13G/A, 5 filings Jun 27, 2024 to Aug 13, 202655
- Adage Capital Management, L.P.SCHEDULE 13G, 1 filing Aug 12, 202656
- SILVERARC CAPITAL MANAGEMENT, LLCSCHEDULE 13G/A, 2 filings Feb 12, 2026 to May 13, 202657
- Simcere Zaiming, Inc.SCHEDULE 13G/A, 2 filings Aug 19, 2025 to May 6, 202658
- Sofinnova Venture Partners IX, L.P.SCHEDULE 13D/A, 1 filing Mar 5, 202659
- PfizerSCHEDULE 13G/A, 1 filing Feb 13, 202660
- CitigroupSCHEDULE 13G, 1 filing May 12, 202561
- Logos Global Management LPSCHEDULE 13G/A, 3 filings Apr 1, 2024 to Feb 14, 202562
- ORBIMED ADVISORS LLCSC 13D/A, 1 filing Mar 8, 202463
- MILLENNIUM MANAGEMENT LLCSC 13G/A, 2 filings Jan 24, 2023 to Jan 19, 202464
- Lilly Asia Ventures Fund III, L.P.SC 13G/A, 2 filings Feb 9, 2022 to Feb 6, 202365
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2025 | Michael RichmanPresident and Chief Executive Officer | 65 | $609.3K | $941.7K66 |
| 2025 | Udayan Guha, M.D., Ph.D. Chief Medical Officer | 54 | $474.2K | $639.2K66 |
| 2025 | Timothy Mayer, Ph.D.Chief Operating Officer | 62 | $468.4K | $633.2K66 |
| 2024 | Michael RichmanPresident and Chief Executive Officer | 65 | $591.5K | $1.5M66 |
| 2024 | Timothy Mayer, Ph.D.Chief Operating Officer | 62 | $454.7K | $872.2K66 |
Money raised
Private offerings the company reported to the SEC on Form D.
- Nov 12, 2025Raised $21.5 million in a private offering of equity Form D: 12 investors so far Form D
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 30. Change is in shares since the quarter before.
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How NextCure, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARNextCure, Inc.1
- CIK0001661059
- Employer ID (EIN)47-52312474
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
- Incorporated inDelaware4
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address2850 Quarry Lake Drive, Suite 280, Baltimore, MD 212091
- Mailing addressPo Box 1052, Frederick, MD 21702-00521
- Phone240-399-49001
- Shares outstanding4,577,359 as of Jul 31, 20269
- Public float$12.6M as of Jun 30, 20254
- AuditorErnst & Young LLP, Baltimore, Maryland PCAOB ID 42; no auditor attestation of internal control over financial reporting4
- On EDGAR sinceJan 11, 20161
- Filings390 in all: 4 (127), 8-K (66), 3 (29), 10-Q (23), SC 13G/A (13), SC 13G (12), SCHEDULE 13G/A (10), DEFA14A (9)1
All 43 form types
CORRESP (8), 10-K (7), DEF 14A (7), SCHEDULE 13G (7), UPLOAD (7), EFFECT (6), 425 (5), S-8 (5), S-1/A (4), SEC STAFF LETTER (4), 424B5 (3), D (3), DRSLTR (3), S-3 (3), SC 13D/A (3), 424B4 (2), DRS (2), DRS/A (2), PRE 14A (2), S-1 (2), SC 13D (2), 10-K/A (1), 3/A (1), 424B1 (1), 424B2 (1), 8-A12B (1), ARS (1), CERT (1), POS AM (1), POSASR (1), S-1MEF (1), S-3ASR (1), S-4 (1), S-4/A (1), SCHEDULE 13D/A (1)
- Latest filingsAnnual report (10-K) Mar 5, 2026
Quarterly report (10-Q) Aug 6, 2026
Proxy statement (DEF 14A) Apr 24, 2026
Latest 8-K (8-K) Sep 25, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.001 par value per share | NXTC | Nasdaq Global Select Market |
From the cover page of the 10-K filed Mar 5, 2026 (Section 12(b) of the Exchange Act).4
Risk factors and legal proceedings
The risks NextCure, Inc. names in Item 1A of its 10-K filed Mar 5, 2026: 71 risks under these headings, as written.4
- Risks Related to Our Financial Position and Need for Additional Capital
- We have a limited operating history and no products approved for commercial sale. We have a history of significant losses, expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability.
- We have never generated revenue from product sales and may never be profitable.
- We will require substantial additional financing to pursue our business objectives, which may not be available on acceptable terms, or at all. A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development, commercialization efforts or other operations.
- Risks Related to the Discovery and Development of Our Product Candidates
- As an organization, we have limited experience designing and implementing clinical trials, and we have never conducted pivotal clinical trials. Failure to adequately design a trial, or incorrect assumptions about the design of the trial, could adversely affect the ability to initiate the trial, enroll patients, complete the trial, or obtain regulatory approval on the basis of the trial results, as well as lead to increased or unexpected costs and in delayed timelines.
- Our business is dependent on our ability to advance our current and future product candidates through clinical trials, obtain marketing approval and ultimately commercialize them.
- The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be materially harmed.
- Clinical development involves a lengthy and expensive process with uncertain outcomes. We may incur additional costs and experience delays in developing and commercializing or be unable to develop or commercialize our current and future product candidates.
- Preclinical development is uncertain. Our preclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all.
- Interim and preliminary results from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit, validation and verification procedures that could result in material changes in the final data.
- Because the numbers of subjects in our Phase 1/2 and Phase 1 clinical trials are small, the results from each of these trials, once completed, may be less reliable than results achieved in larger clinical trials.
The other 61 risks
- Our approach to the discovery and development of product candidates using our FIND platform is unproven and may not result in marketable products.
- Our current or future product candidates may cause undesirable side effects or adverse events, including death, or have other properties when used alone or in combination with other approved products or investigational new drugs that could halt their clinical development, delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.
- If there are difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise be adversely affected.
- We may be required to suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive or the trials are not well designed.
- We have chosen to prioritize development of SIM0505 and LNCB74. We may expend our limited resources on product candidates or indications that do not yield a successful product and fail to capitalize on other candidates or indications for which there may be a greater likelihood of success or may be more profitable.
- We may need to develop, or enter into a collaboration or partnership to develop, complementary or companion diagnostics for our current or future product candidates. If we, or our future collaborators, are unable to successfully develop complementary or companion diagnostics, or experience significant delays in doing so, we may not realize the full commercial potential of our current or future product candidates.
- Risks Related to the Regulatory Approval and Commercialization of Product Candidates and Other Legal Compliance Matters
- We may be unable to obtain FDA approval of our product candidates under applicable regulatory requirements. The denial or delay of any such approval would prevent or delay commercialization of our product candidates and adversely impact our potential to generate revenue, our business and our results of operations.
- Even if a current or future product candidate receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
- The market opportunities for any current or future product candidate we develop, if approved, may be limited to those patients who are ineligible for established therapies or for whom prior therapies have failed, and may be small.
- We may study SIM0505 and LNCB74 in combination with other therapies and future product candidates in combination with other therapies, which exposes us to additional regulatory risks.
- Even if we receive marketing approval of a product candidate, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. If we fail to comply or experience unanticipated problems with our products, we may be subject to administrative and judicial enforcement, including monetary penalties, for non-compliance and our approved products, if any, could be deemed misbranded or adulterated and prohibited from continued distribution.
- Obtaining and maintaining marketing approval of our current and future product candidates in one jurisdiction does not mean that we will be successful in obtaining and maintaining marketing approval of our current and future product candidates in other jurisdictions.
- We depend on data and our information technology systems, and any failure of these systems could harm our business. Security breaches, loss of data, and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business, results of operations and financial condition.
- The successful commercialization of our product candidates will depend in part on the extent to which third-party payors, including governmental authorities and private health insurers, provide coverage and adequate reimbursement levels, as well as implement pricing policies favorable for our product candidates. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.
- Enacted healthcare legislation, changes in healthcare law and implementation of regulations, as well as changes in healthcare policy, may increase the difficulty and cost for us to commercialize our product candidates, may impact our business in ways that we cannot currently predict, could affect the prices we may set, and could have a material adverse effect on our business and financial condition.
- The pharmaceutical industry is subject to extensive regulatory obligations and policies that may be subject to significant and abrupt change, including due to judicial challenges, election cycles, and resulting regulatory updates and changes in policy priorities.
- Our relationships with customers, third-party payors and others may be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
- We are subject to certain U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations. We can face serious consequences for violations.
- If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
- Risks Related to Manufacturing
- Given our limited operating history, our manufacturing experience as an organization and with our manufacturing facility is limited, particularly following a recent restructuring that paused manufacturing operations.
- We may be unable to successfully scale-up manufacturing of our product candidates in sufficient quality and quantity, which would delay or prevent us from developing and, if approved, commercializing our product candidates.
- The loss of our third-party manufacturing partners or our, or our partners’, failure to comply with applicable regulatory requirements or to supply sufficient quantities at acceptable quality levels or prices, or at all, would materially and adversely affect our business.
- We are subject to multiple manufacturing risks, any of which could substantially increase our costs and limit supply of our product candidates.
- We depend on third-party suppliers for key materials used in our manufacturing processes, and the loss of these third-party suppliers or their inability to supply us with adequate materials, or rising prices due to inflation, could harm our business.
- Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
- Risks Related to Intellectual Property
- We have filed patent applications for our product candidates, but no patent has yet issued from these applications. If we are unable to obtain and maintain patent protection for our product candidates, or if the scope of the patent protection obtained is not sufficiently broad or robust, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our product candidates may be adversely affected.
- We are party to a license agreement with Yale University under which we acquired rights to intellectual property related to certain of our product candidates. If we breach our obligations under this agreement, the agreement could be terminated, which would adversely affect our business and prospects.
- Our intellectual property agreements with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of our rights to the relevant intellectual property or technology or increase our financial or other obligations to our licensors.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- We may not be able to protect our intellectual property rights throughout the world.
- Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
- We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time-consuming and unsuccessful.
- Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court. We may not be able to protect our trade secrets in court.
- Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business and financial condition.
- Others may claim an ownership interest in our intellectual property and our product candidates, which could expose us to litigation and have a significant adverse effect on our prospects.
- If we are unable to protect the confidentiality of our proprietary information, the value of our technology and products could be adversely affected.
- We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers.
- If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
- Intellectual property rights do not necessarily address all potential threats.
- Risks Related to Reliance on Third Parties
- We rely or will rely on third parties to help conduct our ongoing and planned preclinical studies and clinical trials for SIM0505, LNCB74 and any future product candidates we develop. If these third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize SIM0505, LNCB74 and any future product candidates we develop, and our business could be materially harmed.
- We may seek to establish additional collaborations and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
- Risks Related to Our Business
- There is substantial doubt as to our ability to continue as a going concern, which may affect our ability to obtain future financing and may require us to curtail or cease our operations. We will require substantial additional funding in the immediate term to continue operations as planned.
- We are highly dependent on our key personnel, and if we are not successful in attracting, motivating and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
- We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
- We may need to grow the size of our organization, and we may experience difficulties in managing future growth.
- If we are unable to establish marketing, sales and distribution capabilities for SIM0505, LNCB74 or any other product candidate that may receive regulatory approval, we may not be successful in commercializing those product candidates if and when they are approved.
- Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of our product candidates.
- Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
- Our ability to use our net operating loss carryforwards to offset future taxable income may be subject to certain limitations.
- Natural disasters or other unexpected events may disrupt our operations, adversely affect our results of operations and financial condition, and may not be covered by insurance.
- Risks Related to Our Common Stock
- The price of our common stock has been and may continue to be volatile and fluctuate substantially.
- If securities analysts do not publish research or reports about our business or if they publish inaccurate or unfavorable research about our business, the price of our stock could decline.
- Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall, even if our business is doing well.
- Our executive officers, directors and current beneficial owners of 5% or more of our common stock and their respective affiliates exercise significant influence over our company, which limits your ability to influence corporate matters and could delay or prevent a change in corporate control.
- We had and may in the future be subject to securities litigation, which can be expensive and could divert management’s attention.
- Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
- If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, investors may lose confidence in our financial reporting and the trading price of our common stock may decline.
- We do not intend to pay dividends on our common stock, so any returns will be limited to the value of our stock.
- We have incurred and will continue to incur significantly increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.
- Our amended and restated bylaws designate the Court of Chancery of the State of Delaware or the United States District Court for the District of Delaware as the exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Legal proceedings
The information set forth under the heading “Legal Proceedings” in Note 10, Commitments and Contingencies, in Notes to Financial Statements in Part II Item 8 of this Annual Report, is incorporated herein by reference.
The opening of Item 3, Legal Proceedings.4
Sources
The numbers on this page point here. Each one links to the record it came from.
- 1SEC EDGARNextCure, Inc. filings on SEC EDGAR
- 2
- 3SEC EDGARNextCure, Inc. filings on SEC EDGAR
- 4
- 5SEC EDGARNextCure, Inc. 10-K for fiscal 2020
- 6SEC EDGARNextCure, Inc. 10-K for fiscal 2020
- 7SEC EDGARNextCure, Inc. 10-K for fiscal 2019
- 8SEC EDGARNextCure, Inc. 10-Q for fiscal 2026
- 9SEC EDGARNextCure, Inc. 10-Q for fiscal 2026
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- 14SEC EDGARUdayan Guha, Chief Medical Officer
- 15SEC EDGARKevin G. Shaw, Sr VP, Legal Affairs
- 16SEC EDGARHan Myint, Chief Medical Officer
- 17SEC EDGARSourav Kundu, Sr VP, Dev. & Mfg.
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- 20SEC EDGARLinda Liu, SVP, Research
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- 23SEC EDGARAnne Elizabeth Borgman, Board member
- 24SEC EDGAREllen Feigal, Board member
- 25SEC EDGARGarry A. Nicholson, Board member
- 26SEC EDGARJohn G. Houston, Board member
- 27SEC EDGARBriggs Morrison, Board member
- 28SEC EDGARChau Quang Khuong, Board member
- 29SEC EDGARDavid S. Kabakoff, Board member
- 30SEC EDGARElaine Jones V., Board member
- 31SEC EDGARJudith Li, Board member
- 32SEC EDGARStella Xu, Board member
- 33SEC EDGARTimothy M. Shannon, Board member
- 34SEC EDGARKevin G. Shaw, General counsel
- 35
- 36SEC EDGAROther events
- 37SEC EDGAREntered a material agreement
- 38SEC EDGARResults of operations
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- 40
- 41
- 42SEC EDGARResults of operations
- 43SEC EDGARResults of operations
- 44
- 45SEC EDGAROther events
- 46
- 47SEC EDGARResults of operations
- 48NasdaqNasdaq calendar
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