Private company

LAVA Therapeutics NV

In its 2025 annual report the company says: “We are a clinical stage immuno-oncology company focused on developing our proprietary Gammabody® platform of bispecific gamma delta ( g d ) T cell engagers to transform the treatment of cancer. We are focused on discovering, developing and ultimately commercializing proprietary, off-the-shelf, targeted Gammabody drug candidates that leverage the power of g d T cells with the validated benefits of antibody-based treatments.”4

Last updated Oct 20, 2026.

Overview

  • IndustryPharmaceutical Preparations1
  • HeadquartersP71
  • Incorporated inNetherlands2
  • Business addressYalelaan 62, Utrecht2
  • Filer category, Emerging growth company2

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We are a clinical stage immuno-oncology company focused on developing our proprietary Gammabody® platform of bispecific gamma delta ( g d ) T cell engagers to transform the treatment of cancer. Using our Gammabody platform, we are developing a portfolio of novel bispecific antibodies designed to engage and leverage the potency and precision of g d T cells to orchestrate a robust, natural anti-tumor immune response and improve outcomes for cancer patients. We are focused on discovering, developing and ultimately commercializing proprietary, off-the-shelf, targeted Gammabody drug candidates that leverage the power of g d T cells with the validated benefits of antibody-based treatments.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 2024

-247.8%Operating margin5
-209.6%Net margin5
77.0%Revenue growth, 20245
-90.5%Return on equity5
0.18×Debt to equity5
-$19.6MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2024

  • Research and development98¢$28.4M
  • Income tax2¢$630.0K

Out of $12.0M in revenue.5 The company lost money this year.

Financial statements

Revenue5$12.0M in 2024+77% since 2023
0$5.0M$10.0M$15.0M2023: $6.8M$6.8M20232024: $12.0M$12.0M2024+77%
Gross profit6$3.3M in 2023−39% since 2021
0$5.0M$10.0M$15.0M$20.0M2021: $5.3M$5.3M20212022: $19.4M$19.4M2022+262%2023: $3.3M$3.3M2023−83%
Operating income7865-$29.7M in 2024+210% since 2019
-$60.0M-$40.0M-$20.0M02019: -$9.6M-$9.6M20192020: -$14.7M-$14.7M2020+53%2021: -$43.6M-$43.6M2021+197%2022: -$34.8M-$34.8M2022−20%2023: -$43.4M-$43.4M2023+25%2024: -$29.7M-$29.7M2024−32%
Net income7865-$25.1M in 2024+159% since 2019
-$60.0M-$40.0M-$20.0M02019: -$9.7M-$9.7M20192020: -$15.9M-$15.9M2020+64%2021: -$42.4M-$42.4M2021+166%2022: -$31.9M-$31.9M2022−25%2023: -$41.9M-$41.9M2023+31%2024: -$25.1M-$25.1M2024−40%
Fiscal year2018201920202021202220232024
Revenue$6.8M5$12.0M5
Cost of revenue$3.5M5
Gross profit$5.3M6$19.4M6$3.3M6
Research and development$36.9M6$40.1M6$32.6M5$28.4M5
Operating expenses$50.2M5$41.7M5
Operating income-$9.6M7-$14.7M8-$43.6M6-$34.8M6-$43.4M5-$29.7M5
Interest$625.0K7
Income before tax-$42.2M6-$31.7M6-$41.6M5-$24.5M5
Income tax$157.0K6$249.0K6$257.0K5$630.0K5
Net income-$9.7M7-$15.9M8-$42.4M6-$31.9M6-$41.9M5-$25.1M5
Earnings per share-$21.657-$39.918-$2.146-$1.236-$1.575-$0.945
Earnings per share (diluted)-$21.657-$39.918-$2.146-$1.236-$1.575-$0.945
Shares (weighted, basic)19.8M shares625.9M shares626.7M shares526.8M shares5
Shares (weighted, diluted)19.8M shares625.9M shares626.7M shares526.8M shares5

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Corporate structure

LAVA Therapeutics NV sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of LAVA Therapeutics NV

  • Gilde Healthcare U.a. Cooperatieve Iv. Filed SCHEDULE 13D/A on LAVA Therapeutics NV, latest Oct 22, 2025 (3 filings since Oct 14, 2025)
  • Shay Capital LLC Filed SCHEDULE 13G on LAVA Therapeutics NV, latest Sep 26, 2025
  • Versant Venture Capital VI, L.P. Filed SCHEDULE 13D/A on LAVA Therapeutics NV, latest Sep 23, 2025 (2 filings since Sep 18, 2025)
  • BML Investment Partners, L.P. Filed SCHEDULE 13G on LAVA Therapeutics NV, latest Mar 3, 2025
  • Novo Holdings A/S Filed SC 13D/A on LAVA Therapeutics NV, latest Mar 7, 2024 (6 filings since Sep 30, 2022)
  • Redmile Group, LLC Filed SC 13G/A on LAVA Therapeutics NV, latest Feb 14, 2024 (2 filings since Feb 14, 2022)
  • LAVA Therapeutics NV P7
    • LAVA Therapeutics (Australia) Pty Ltd Subsidiary · Australia

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What LAVA Therapeutics NV 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

ItemLatestA year beforeChange
Property and equipment, before depreciation$3.0M5 Dec 31, 2024$3.3M5 Dec 31, 2023−9.9%
Accumulated depreciation$2.0M5 Dec 31, 2024$1.7M5 Dec 31, 2023+15.6%
Property and equipment, net$1.0M5 Dec 31, 2024$1.6M5 Dec 31, 2023−37.5%
Operating-lease assets (leased space)$441.0K5 Dec 31, 2024$855.0K5 Dec 31, 2023−48.4%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$35.0M5 Dec 31, 2024$44.2M5 Dec 31, 2023−20.8%
Marketable securities, current$41.6M5 Dec 31, 2024$51.3M5 Dec 31, 2023−19.0%

Properties, in its own words

During the first quarter of 2023, we moved our headquarters from Yalelaan 60 to Yalelaan 62, 3584 CM Utrecht, the Netherlands. In August 2023, we notified the landlord that we would terminate a portion of the lease in the first quarter of 2024 such that we now occupy approximately 8,471 square feet of office and laboratory space under a lease that expires March 31, 2026. The lease of our previous headquarters at Yalelaan 60 expired and ended in the second quarter of 2023. We also occupy a small office space of approximately 5,621 square feet located at 520 Walnut Street, Suite 1150, Philadelphia, Pennsylvania 19106, U.S. until December 2025. We believe that our facilities are adequate to meet our current needs and that additional space can be obtained on commercially reasonable terms as needed.

Item 2 of the 10-K filed Mar 28, 2025.4

Leadership

Who has led LAVA Therapeutics NV, and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Stephen A. Hurly2025–now

Chief financial officer

  1. Fred M. Powell2025–now
Board members and other officers (9)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • LAVA Therapeutics (Australia) Pty Ltd Queensland, Australia3
  • LAVA Therapeutics, Inc. Delaware, United States of America3

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Former names

  • LAVA Therapeutics BVJan 25, 2021 to Mar 24, 20212

Timeline

  1. Nov 21, 20258-K Completed an acquisition or sale; Listing notice or transfer; Change to shareholders' rights21
  2. Nov 13, 20258-K Listing notice or transfer; Change in control; Executive or director change22
  3. Nov 7, 20258-K Shareholder vote23
  4. Oct 17, 20258-K Entered a material agreement; Other events24
  5. Oct 2, 20258-K Other events25
  6. Sep 30, 20258-K Other events26
  7. Aug 14, 20258-K Regulation FD disclosure; Other events27
  8. Aug 4, 20258-K Entered a material agreement; Regulation FD disclosure; Other events28
  9. Jun 13, 20258-K Shareholder vote29
  10. May 23, 20258-K Change of auditor30
  11. Mar 28, 20258-K Results of operations31
  12. Feb 28, 20258-K Listing notice or transfer32
  13. Jan 2, 2025New chief executive Stephen A. Hurly becomes CEO11

Calendar

When it reported results

  1. Mar 28, 2025Reported quarterly or annual results31

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

135 filings to the SEC since October 2021: 5 annual reports, 3 quarterly reports, 14 major events, 36 insider forms, 15 large holders, 62 other. The latest 20:

  1. Dec 16, 202515-12G EDGAR
  2. Nov 21, 2025S-8 POS EDGAR
  3. Nov 21, 2025S-8 POS EDGAR
  4. Nov 21, 2025SC 14D9/A EDGAR
  5. Nov 21, 20258-K EDGAR
  6. Nov 17, 20254 EDGAR
  7. Nov 17, 20254 EDGAR
  8. Nov 17, 20254 EDGAR
  9. Nov 17, 20254 EDGAR
  10. Nov 17, 20254 EDGAR
  11. Nov 17, 20254 EDGAR
  12. Nov 17, 20254 EDGAR
  13. Nov 17, 20254 EDGAR
  14. Nov 17, 20254 EDGAR
  15. Nov 13, 2025SC 14D9/A EDGAR
  16. Nov 13, 20258-K EDGAR
  17. Nov 10, 2025SC 14D9/A EDGAR
  18. Nov 7, 20258-K EDGAR
  19. Nov 6, 202510-Q EDGAR
  20. Oct 22, 2025SCHEDULE 13D/A EDGAR

The 135 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

11 open-market trades by officers, directors and large owners since October 2021: 0 buys and 11 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Oct 17, 2025Cooperatieve Gilde Healthcare IV U.A.10% ownerSale1,181,131$1.47$1.7MForm 4
Oct 16, 2025Cooperatieve Gilde Healthcare IV U.A.10% ownerSale690,239$1.49$1.0MForm 4
Oct 14, 2025Cooperatieve Gilde Healthcare IV U.A.10% ownerSale227,341$1.51$343.3KForm 4
Oct 13, 2025Cooperatieve Gilde Healthcare IV U.A.10% ownerSale47,686$1.54$73.4KForm 4
Oct 10, 2025Gilde Healthcare Holding B.V.10% ownerSale49,869$1.55$77.3KForm 4
Oct 9, 2025Gilde Healthcare Holding B.V.10% ownerSale48,169$1.56$75.1KForm 4
Oct 8, 2025Gilde Healthcare Holding B.V.10% ownerSale28,954$1.57$45.5KForm 4
Sep 19, 2025Versant Vantage I, L.P.10% ownerSale2,903,403$1.40$4.1MForm 4
Sep 18, 2025Versant Vantage I GP-GP, LLC10% ownerSale594,902$1.44$856.7KForm 4
Sep 17, 2025Versant Vantage I GP-GP, LLC10% ownerSale589,532$1.49$878.4KForm 4
Sep 16, 2025Versant Vantage I GP-GP, LLC10% ownerSale500,000$1.53$765.0KForm 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.

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.

YearExecutiveAgeSalaryTotal pay
2024Stephen HurlyChief Executive Officer and Director57$602.1K$1.2M39
2024Charlie MorrisChief Medical Officer60$501.1K$851.4K39
2024Fred PowellChief Financial Officer63$444.1K$730.2K39
2023Charlie MorrisChief Medical Officer60$429.3K$1.2M39
2023Stephen HurlyChief Executive Officer and Director57$576.2K$819.9K39
2023Fred PowellChief Financial Officer63$425.0K$574.2K39

SEC filer profile

How LAVA Therapeutics NV is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARLAVA Therapeutics NV1
  • CIK0001840748
  • Employer ID (EIN)84-27454844
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inNetherlands4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business addressYalelaan 62, Utrecht, Netherlands1
  • Phone31 6 3000 30351
  • Shares outstanding26,305,295 as of Nov 3, 202510
  • Public float$29.0M as of Jun 28, 20244
  • AuditorPricewaterhouseCoopers Accountants N.V., Eindhoven, The Netherlands PCAOB ID 1395; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceJan 25, 20211
  • Filings172 in all: 6-K (30), 4 (24), 8-K (14), 3 (12), CORRESP (9), UPLOAD (8), SC 13D/A (6), SC 14D9/A (6)1
    All 43 form types

    SC TO-T/A (6), DEFA14A (5), SCHEDULE 13D/A (5), 10-Q (3), 20-F (3), SC 13D (3), DEFR14A (2), EFFECT (2), F-1/A (2), S-8 (2), S-8 POS (2), SC 13G (2), SC 13G/A (2), SCHEDULE 13G (2), SEC STAFF LETTER (2), 10-K (1), 144 (1), 15-12G (1), 20-F/A (1), 25-NSE/A (1), 424B4 (1), 8-A12B (1), ARS (1), CERT (1), DEF 14A (1), DEFM14A (1), DRS (1), F-1 (1), F-3 (1), PRE 14A (1), PREM14A (1), SC 14D9 (1), SC TO-C (1), SC TO-T (1), SC14D9C (1)

  • Latest filingsAnnual report (10-K) Mar 28, 2025
    Quarterly report (10-Q) Nov 6, 2025
    Proxy statement (DEF 14A) Apr 28, 2025
    Latest 8-K (8-K) Nov 21, 2025

Securities registered for trading

ClassSymbolExchange
Common shares, nominal value €0.12 per shareLVTXThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 28, 2025 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks LAVA Therapeutics NV names in Item 1A of its 10-K filed Mar 28, 2025: 72 risks under these headings, as written.4

  • Risks related to our financial position and capital needs
  • We are a clinical-stage immuno-oncology company and have incurred significant operating losses since inception. We anticipate that we will continue to incur substantial operating losses for the foreseeable future and may never achieve or maintain profitability.
  • Global economic uncertainty, changes in geopolitical conditions, changes in trade agreements and disputes and other macroeconomic factors and changes could adversely affect our operations and liquidity.
  • Our limited operating history may make it difficult to evaluate the success of our business to date and assess our future viability.
  • We will require substantial additional funding to finance our operations to complete the development and commence commercialization of our current and future product candidates. If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate certain of our development programs or other operations.
  • We will need to raise additional capital, which may not be available on acceptable terms, or at all. Raising additional capital may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our current and future product candidates.
  • We expect to receive Australian government research and development income tax incentive refunds. If our research and development expenditures are not deemed to be eligible for the refund, proposed modifications to the tax incentive program are enacted, or the tax incentive program is discontinued by the Australian government, it could have a negative effect on our future cash flows and the funding of future research and development projects.
  • Exchange rate fluctuations could negatively affect our financial condition.
  • Risks related to the development and commercialization of our product candidates
  • Our product candidates, development candidates and related technologies, including LAVA-1266, which are based on bispecific gd T cell engagers, are novel approaches to cancer treatment, which makes it difficult to predict the time and cost of development and subsequent regulatory approval. Currently, there are no bispecific gd T cell engagers that have been approved for cancer treatment by the United States Food and Drug Administration (FDA) or European Medicines Agency (EMA).
  • We are dependent on the successful clinical development and regulatory approval of our product candidates. We cannot give any assurance that LAVA-1266 or any of our future product candidates will receive regulatory approval, and if we are not able to obtain required regulatory approvals, we will not be able to commercialize our product candidates, which will adversely affect our ability to generate product revenue.
  • We are conducting our Phase 1 clinical trial of LAVA-1266 outside of the United States, and we may in the future continue to use sites outside of the United States for clinical trials. The FDA may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business.
The other 62 risks
  • Success in preclinical studies or early-stage clinical trials may not be indicative of results in future clinical trials.
  • We may be unable to expand our discovery and development pipeline, which could limit our growth and revenue potential.
  • We have in the past, and in the future may enter into collaborations with third parties to conduct, supervise and monitor our preclinical studies and clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business and delay or impair our ability to obtain regulatory approval or otherwise commercialize our product candidates.
  • Disruptions at the FDA and other government agencies caused by funding shortages, layoffs, shifting priorities under the new administration, market conditions or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being advanced, developed, cleared or approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • Regulatory authorities may require concurrent approval of a companion diagnostic device with our product candidates, which could be time consuming and costly and may delay our ability to commercialize such product candidate.
  • Development of a product candidate intended for use in combination with an already approved therapy may present increased complexity and more or different challenges than development of a product candidate for use as a single agent or monotherapy.
  • If we encounter difficulties in enrolling, qualifying or retaining patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • Serious adverse events (SAEs) or undesirable or unexpected side effects of our current or future product candidates may be identified during development or after approval, which could lead to the discontinuation of our clinical development programs, refusal by regulatory authorities to approve our product candidates or, if discovered following marketing approval, revocation of marketing authorizations or limitations on the use of our product candidates thereby limiting the commercial potential of such product candidate.
  • There may be potential unforeseen business disruptions or market fluctuations that delay our business operations, product development, supply chain or clinical trials and increase our costs or expenses, such as general economic and market conditions, overall fluctuations in the United States and international equity markets, including deteriorating market conditions, unauthorized access, terrorism, war, natural disasters, strikes, geopolitical conflicts, restrictions on trade, import or export restrictions, tariffs or public health crises, such as pandemics.
  • Interim, “top-line” and preliminary data from current or future clinical trials that we announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.
  • We face significant competition, and many of our competitors have substantially greater experience and resources than we have. Our competitors may achieve regulatory approval before us or develop therapies that are more advanced or effective than ours, which may adversely affect our financial condition and our ability to successfully market or commercialize our product candidates.
  • Risks related to manufacturing and reliance on third parties
  • The manufacture of biotechnology products is complex, and manufacturers often encounter difficulties in production, which could negatively affect our ability to develop or commercialize our current and future product candidates.
  • We rely on a single-source supplier for bulk drug substance (BDS) and drug manufacturing for our product candidate and development programs. The loss of this supplier or its failure to supply us with BDS on a timely basis could impair our ability to develop our product candidate or otherwise delay the development process, which could adversely affect our business.
  • We currently store our Gammabody product candidate at specialized external storage facilities operating under established rules and regulations, and any damage or loss to storage freezers if not detected and remediated in time, would cause delays in replacement, and our business could suffer.
  • We rely on third party Contract Development Manufacturing Organizations (CDMOs) to manufacture our product candidate and development candidates. If our CDMOs cannot manufacture our product candidate reliably or in sufficient amounts, at acceptable costs and on a timely basis, we may be unable to supply sufficient product candidates for nonclinical studies or clinical trials or to support commercialization of our product candidate, if approved.
  • Risks related to our intellectual property
  • Licensing of intellectual property is of critical importance to our business and involves complex legal, business and scientific issues. If we are unable to obtain or protect rights relating to our technology and current and future product candidates, or if our intellectual property rights are inadequate, we might not be able to compete effectively.
  • If we are unable to obtain and maintain patent and other intellectual property protection for current and future product candidates and technology, or if the scope of protection obtained is not sufficiently broad or robust, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our product candidates and technology may be adversely affected.
  • Obtaining and maintaining our patent rights 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 noncompliance with these requirements.
  • Patent terms may be inadequate to protect the competitive position of our current and future product candidates for an adequate amount of time.
  • Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property or other proprietary rights, the outcome of which would be uncertain and could have a negative impact on the success of our business.
  • Intellectual property rights of third parties could adversely affect our ability to commercialize our current or future technologies or product candidates, and we might be required to litigate or obtain licenses from third parties to develop or market our current or future technologies or product candidates, which may not be available on commercially reasonable terms or at all.
  • 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 or claims asserting ownership of what we regard as our own intellectual property.
  • We may be involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property or proprietary rights, which could be expensive, time-consuming and unsuccessful.
  • Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our current and any future product candidates.
  • We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business.
  • Reliance on third parties requires us to share our know-how or trade secrets, which increases the possibility that a competitor will discover them or that our know-how or trade secrets will be misappropriated or disclosed.
  • If we are unable to protect the confidentiality of our know-how or trade secrets, our business and competitive position would be harmed.
  • If our trademarks are not adequately protected, then we may not be able to build name recognition in our markets of interest, resulting in harm to our business.
  • Intellectual property rights do not necessarily address all potential threats to the competitive advantages maintained by our business.
  • Risks related to our business operations, employee matters and managing growth
  • We are highly dependent on the services of our senior management team and if we are not able to retain our current management team or recruit and retain additional management, clinical and scientific personnel, our business will be harmed.
  • We may experience difficulties in right-sizing our organization for our stage of development, which could disrupt our operations.
  • Our strategic review and workforce reduction may not achieve our intended outcomes.
  • We are, and expect to continue to be, reliant on third parties for key aspects of our business and operations, including our existing and future research, manufacturing and supply. If such parties fail to adequately perform or we are not able to maintain our current relationships or enter new strategic relationships with such third parties, our business, financial condition, commercialization prospects and results of operations may be adversely affected.
  • If any of our current collaborations are delayed or terminated, or if any of our collaboration partners materially breach its obligations thereunder, it could cause significant delays in the development efforts of the Gammabody platform and our financial performance.
  • Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards, which could adversely affect the development of current and future product candidates and our business.
  • We may be classified as a passive foreign investment company (PFIC) for U.S. federal income tax purposes, which could result in adverse U.S. federal income tax consequences to U.S. investors in our common shares.
  • There are risks inherent in our business that may subject us to potential product liability suits and other claims, which may require us to engage in expensive and time-consuming litigation or pay substantial damages and may harm our reputation, which could negatively impact our business.
  • Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental, health and safety laws and regulations, which can be expensive and restrict or interrupt our business.
  • Risks related to regulatory compliance
  • The regulatory approval process of FDA, EMA and other comparable foreign regulatory authorities is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our current or future product candidates.
  • If we are successful in obtaining regulatory approvals for LAVA-1266 or other product candidates, we will be subject to ongoing regulatory oversight.
  • Even if a product candidate receives marketing approval, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.
  • We may seek orphan drug designation for some or all of our current or future product candidates and may be unsuccessful or may be unable to maintain the benefits associated with orphan drug designation, including the potential for supplemental market exclusivity.
  • We may not elect or be able to take advantage of any expedited development or regulatory review and approval processes available to product candidates granted breakthrough therapy or fast track designation by the FDA.
  • We expect the product candidates we develop will be regulated as biologics, and may be subject to competition sooner than anticipated.
  • Our relationships with customers, physicians, and third-party payors will be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, including anti-kickback and false claims laws, transparency laws, local and foreign environmental and safety laws, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • Coverage and adequate reimbursement may not be available for our product candidates, which could make it difficult for us to sell profitably, if approved.
  • Healthcare legislative reform measures may have a negative impact on our business and results of operations.
  • European drug marketing and reimbursement regulations may materially affect our ability to market and receive coverage for our products in the European member states.
  • The increasing use of social media platforms presents new risks and challenges.
  • If our information technology systems or those of third parties with whom we work or our data, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.
  • Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data, as well as regulatory compliance obligations and risks.
  • We are subject to U.S. and foreign anti-corruption and anti-money laundering laws with respect to our operations and non-compliance with such laws can subject us to criminal or civil liability and harm our business.
  • Risks related to ownership of our common shares
  • If we fail to satisfy all applicable requirements of Nasdaq and it determines to delist our common shares, the delisting could adversely affect the market liquidity of our common shares and the market price of our common shares could decrease.
  • The market price of our common shares has been and may continue to be volatile and fluctuate substantially, and you could lose all or part of your investment. Such volatility could subject us to securities litigation.
  • Investors may have difficulty enforcing civil liabilities against us or the members of our board of directors and/or our officers (functionarissen).
  • Shareholders may not be able to exercise pre-emption rights and, as a result, may experience substantial dilution upon future issuances of common shares.
  • Concentration of ownership of our common shares among our existing executive officers, directors and principal shareholders may prevent new investors from influencing significant corporate decisions.
  • If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our common shares, the price of our common shares could decline.
  • General Risk Factors
  • Further downgrades of the U.S. credit rating, automatic spending cuts, or another government shutdown could negatively impact our liquidity, financial condition and earnings.
  • We are an “emerging growth company” and a “smaller reporting company,” and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our common shares less attractive to investors.
  • We will continue to incur 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 and corporate governance practices.
  • We may become subject to the Dutch large company regime which would affect our governance structure, including how members of our board are appointed and dismissed.

Legal proceedings

From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not currently subject to any material legal proceedings.

The opening of Item 3, Legal Proceedings.4

Sources

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    SEC EDGAROther events
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    SEC EDGAROther events
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