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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): February 20, 2025

 

 

LAVA Therapeutics N.V.

(Exact name of registrant as specified in its charter)

 

 

The Netherlands 001-40241 Not Applicable
(State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.)

  

Yalelaan 62

Utrecht, The Netherlands

   3584 CM
(Address of principal executive offices)   (Zip Code)

 

+31 85 016 3100

(Registrant’s telephone number, including area code)

   

Not Applicable

(Former name or former address, if changed since last report)

 

  

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading
Symbol(s)		 Name of each exchange on which registered
Common shares, nominal value €0.12 per share LVTX NASDAQ Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company x

 

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. ¨

 

 

 

 

 

 

Item 2.05 Costs Associated with Exit or Disposal Activities.

 

On February 20, 2025, LAVA Therapeutics N.V. (the “Company”) adopted a restructuring plan to extend its capital resources in connection with initiating a process to evaluate strategic alternatives. As part of the restructuring plan, the Company is planning a workforce reduction of approximately 30%. The Company anticipates that the reduction in workforce will be completed by July 31, 2025. The Company estimates that it will incur approximately $0.5 million of one-time termination benefits and related taxes related to the workforce reduction, with the majority of such costs to be incurred in the first quarter of 2025. The estimates of the restructuring costs that the Company expects to incur, and the timing thereof, are subject to a number of assumptions and actual results may differ. The Company may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, the restructuring plan.

 

Item 7.01 Regulation FD Disclosure.

 

On February 25, 2025, the Company issued a press release entitled “LAVA Announces Evaluation of Strategic Options,” a copy of which is furnished as Exhibit 99.1 to this report and incorporated herein by reference.

 

The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information in this Item 7.01, including Exhibit 99.1, shall not be deemed incorporated by reference into any other filing with the SEC made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit
No.		   Description
99.1   Press Release, dated February 25, 2025.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

Cautionary Note Regarding Forward-Looking Statements

 

This Current Report contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipate,” “estimate,” “plan,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this Current Report and are subject to various risks and uncertainties that may cause actual results to differ materially from these forward-looking statements. Forward-looking statements contained in this Current Report include but are not limited to statements relating to the Company’s evaluation of strategic alternatives and ability to extend its capital resources, and the scope and the timing of the restructuring and the expected costs related to the restructuring, including the estimated timing and magnitude of the workforce reduction. These forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including the sufficiency of the Company’s capital resources, the Company’s ability to achieve the expected benefits of the restructuring, and other risks and uncertainties affecting the Company and its development programs, including those discussed in the section titled “Risk Factors” in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2023 and in subsequent filings with the SEC. Forward-looking statements in this Current Report are made as of the date of this Current Report, and the Company undertakes no duty to update any such statements unless required by law.

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  LAVA Therapeutics, N.V.
       
Dated: February 25, 2025 By: /s/ Fred Powell
    Name: Fred Powell
    Title: Chief Financial Officer

 

 

 

Exhibit 99.1 

 

 

 

LAVA Announces Evaluation of Strategic Options

 

Advisor engaged in evaluating strategic options to maximize shareholder value

 

Cash balance of $76.6 million as of December 31, 2024

 

Utrecht, The Netherlands, and Philadelphia, PA, US – February 25, 2025 – LAVA Therapeutics N.V. (NASDAQ: LVTX, “LAVA,” “the Company”), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody® platform of bispecific gamma delta T cell engagers, announced that the Company has initiated a process to review strategic options focused on maximizing shareholder value, and has implemented cost curtailment including a workforce reduction. The Company has retained an experienced financial advisor to support LAVA with the strategic evaluation process. LAVA will continue to enroll in the Phase 1 clinical study evaluating the safety and pharmacokinetics of LAVA-1266 in hematologic malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), and support its partnerships with Pfizer and Johnson and Johnson.

 

“While we will continue investigating LAVA-1266 in the potential treatment of AML and MDS, and supporting our Gammabody pharma partnerships, with only one product in clinical development and an early-stage pipeline, we felt it appropriate to investigate strategic opportunities to drive additional shareholder value. LAVA is in a strong position to unlock strategic opportunities for the Company, in addition to our proprietary pipeline and partnered programs,” said Steve Hurly, Chief Executive Officer of LAVA.

 

The Company will explore and evaluate diverse strategic options to maximize shareholder value, including in-licensing of assets, a sale, licensing agreement, merger, acquisition, or other strategic transactions. There can be no assurance that this process will result in any such transaction. LAVA’s Board of Directors has not set a timetable for the strategic review process. LAVA does not intend to provide updates until the Board approves a specific action or otherwise determines that disclosure is appropriate or required.

 

In connection with the evaluation of strategic alternatives, LAVA is implementing a restructuring plan that includes a workforce reduction of approximately thirty percent, furthering cost-containment and cash conservation measures. The Company intends to retain all employees essential for supporting value creation as part of its strategic review. The Company estimates that it will incur approximately $0.5 million of one-time costs primarily incurred in Q1 2025 related to the workforce reduction.

 

“I want to express my sincere gratitude to each of our employees being affected by this workforce reduction,” said Mr. Hurly. “We thank them for their dedicated service and contribution to LAVA’s mission to advancing the portfolio of bispecific T cell engagers and our proprietary Gammabody platform.”

 

 

 

 

As of December 31, 2024, the Company’s cash, cash equivalents, and investments were $76.6 million (unaudited).

 

About LAVA Therapeutics

 

LAVA Therapeutics N.V. is a clinical-stage immuno-oncology company focused on advancing its proprietary Gammabody® platform to develop a portfolio of bispecific gamma-delta T cell engagers for the potential treatment of solid tumors and hematologic malignancies. The Company utilizes bispecific antibodies engineered to selectively kill cancer cells by triggering Vγ9Vδ2 (Vgamma9 Vdelta2) T cell anti-tumor effector functions upon cross-linking to tumor-associated antigens.

 

LAVA’s pipeline includes three internal and partnered clinical-stage bispecific gamma-delta T cell engagers for the treatment of solid tumor and hematological cancers including LAVA 1266, targeting CD123+ cancers (ACTRN12624001214527); PF-08046052, targeting EGFR (NCT05983133); and JNJ-89853413, targeting hematological cancers (NCT06618001). The pipeline also includes preclinical programs. For more information on LAVA, please visit our website at www.lavatherapeutics.com or follow us on LinkedIn, X, and YouTube.

 

Gammabody® is a registered trademark of LAVA Therapeutics N.V.

 

 

 

 

LAVA’s Cautionary Note on Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipate”, “believe”, “could”, “will”, “may”, “expect”, “should”, “plan”, “intend”, “estimate”, “potential”, “suggests”, and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on LAVA’s expectations and assumptions as of the date of this press release and are subject to various risks and uncertainties that may cause actual results to differ materially from these forward-looking statements. Forward-looking statements contained in this press release include but are not limited to statements relating to LAVA’s evaluation of strategic alternatives and transactions to maximize shareholder value, LAVA’s ability to preserve capital and the sufficiency of cash on hand, the reduction in force in employees at the Company, as well as the therapeutic potential, development strategy and potential uses of LAVA’s product candidates, including LAVA-1266, the timing of initiation of clinical trials and achievement of clinical milestones, LAVA’s cash runway and the sufficiency of resources to pursue development activities, progress and data from clinical trials, and the ability of LAVA’s product candidates to treat various tumor targets and improve patient outcomes, among others. Many factors, risks and uncertainties may cause differences between current expectations and actual results, including, among other things, the Company’s ability to leverage its initial programs to develop additional product candidates using its Gammabody® platform, the failure of LAVA’s collaborators to support or advance collaborations or LAVA’s product candidates, the timing and results of LAVA’s research and development programs and preclinical and clinical trials, the possibility that clinical trials may fail to establish sufficient efficacy, the risk that adverse events or safety signals may occur in clinical trials, the risk that results obtained in preclinical studies or clinical trials to date may not be indicative of results obtained in ongoing or future trials, the risk that adverse regulatory actions or other setbacks could occur in clinical trials even after promising results in earlier clinical trials or preclinical studies, the Company’s ability to obtain regulatory approval for and commercialize its product candidates, LAVA’s ability to identify any strategic alternatives or if so identified, be able to consummate any such transactions on terms acceptable to LAVA and its shareholders, and the risk that setbacks in development could occur as a result of the difficulty and uncertainty of pharmaceutical product development and other factors. There may be adverse effects on the Company’s business condition and results from general economic and market conditions and overall fluctuations in the United States and international equity markets, including as a result of inflation, heightened interest rates, recent and potential future pandemics and other health crises, and hostilities, including between Russia and escalating tension in the Middle East. These and other risks are described in greater detail under the caption “Risk Factors” in LAVA’s most recent Annual Report on Form 20-F and other filings the Company makes with the Securities and Exchange Commission. LAVA assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

 

CONTACTS

Investor Relations

ir@lavatherapeutics.com

 

LifeSci Advisors (IR/Media)

Joyce Allaire

Jallaire@lifesciadvisors.com