UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 6-K


REPORT OF FOREIGN ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

OF THE SECURITIES EXCHANGE ACT OF 1934

For the month of May 2024

(Commission File No. 001-40241)


LAVA Therapeutics N.V.

(Translation of registrant’s name into English)


Yalelaan 62

3584 CM Utrecht, The Netherlands

(Address of principal executive office)


Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F   Form 40-F  


LAVA Therapeutics, N.V.

Exhibits 99.1 and 99.2 to this Report on Form 6-K shall be deemed to be incorporated by reference into the registration statement on Form S-8 (File no. 333-256655) and registration statement on Form F-3 (File no. 333-264246) of LAVA Therapeutics N.V. (including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

Exhibit 99.3 to this Report on Form 6-K is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act.

RISK FACTORS

Our business faces significant risks. You should carefully consider all of the information set forth in this report and in our other filings with the United States Securities and Exchange Commission (SEC). Our business, financial condition, results of operations and growth prospects could be materially adversely affected by any of these risks. This report also contains forward-looking statements that involve risks and uncertainties. Our results could materially differ from those anticipated in these forward-looking statements, as a result of certain factors including the risks described in our other SEC filings.

Exhibit List


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.

LAVA Therapeutics, N.V.

(Registrant)

Date: May 21, 2024

By:

/s/ Fred Powell

Fred Powell

Chief Financial Officer



LAVA Therapeutics N.V.

Condensed Consolidated Interim Statements of Loss

and Comprehensive Loss

(in thousands, except share and per share amounts) (unaudited)

    

    

    

Three Months Ended

March 31, 

    

Notes

    

2024

    

2023

Revenue:

 

  

 

  

 

  

Revenue from contracts with customers

 

5

$

6,992

$

1,224

Cost of sales of goods

5

(745)

Cost of providing services

5

(185)

Gross profit

 

  

 

6,992

 

294

Operating expenses:

 

  

 

  

 

  

Research and development

 

6

 

(6,009)

 

(9,943)

General and administrative

 

7

 

(2,935)

 

(3,890)

Total operating expenses

 

  

 

(8,944)

 

(13,833)

Operating loss

 

  

 

(1,952)

 

(13,539)

Interest income, net

 

 

810

 

617

Foreign currency exchange gain (loss), net

 

 

658

 

(947)

Total non-operating income (loss)

 

  

 

1,468

 

(330)

Loss before income tax

 

  

 

(484)

 

(13,869)

Income tax expense

 

 

(69)

 

(71)

Loss for the period

 

  

$

(553)

$

(13,940)

Items that may be reclassified to profit or loss

Foreign currency translation adjustment

 

 

(1,063)

 

1,546

Total comprehensive loss

 

  

$

(1,616)

$

(12,394)

Loss per share:

 

  

 

  

 

  

Loss per share, basic and diluted

$

(0.02)

$

(0.53)

Weighted-average common shares outstanding, basic and diluted

 

26,794,215

 

26,289,087

The accompanying notes are an integral part of the unaudited condensed consolidated interim financial statements.

2


LAVA Therapeutics N.V.

Condensed Consolidated Interim Statements of Financial Position

(in thousands) (unaudited)

March 31, 

December 31, 

    

Notes

    

2024

    

2023

Assets

 

  

 

  

 

  

Non-current assets:

 

  

 

  

 

  

Property and equipment, net

 

$

1,359

$

1,602

Right-of-use assets

 

 

796

 

892

Other non-current assets and security deposits

 

  

 

256

 

319

Total non-current assets

 

  

 

2,411

 

2,813

Current assets:

 

  

 

  

 

  

Receivables and other

 

 

737

 

1,459

Prepaid expenses and other current assets

 

 

1,188

 

1,627

VAT receivable

 

 

170

 

240

Investments

9

51,386

51,340

Cash and cash equivalents

 

 

43,187

 

44,231

Total current assets

 

  

 

96,668

 

98,897

Total assets

 

  

$

99,079

$

101,710

Equity and Liabilities

 

  

 

  

 

  

Equity:

 

  

 

  

 

  

Share capital

 

4

$

3,715

$

3,715

Equity-settled employee benefits reserve

 

8

 

12,959

 

12,005

Foreign currency translation reserve

 

 

(11,962)

 

(10,899)

Additional paid-in capital

 

 

194,432

 

194,424

Accumulated deficit

 

  

 

(148,479)

 

(148,067)

Total equity

 

  

 

50,665

 

51,178

Non-current liabilities:

 

  

 

  

 

  

Deferred revenue

 

5

 

35,000

 

35,000

Lease liabilities

 

 

387

 

591

Total non-current liabilities

 

  

 

35,387

 

35,591

Current liabilities:

 

  

 

  

 

  

Trade payables and other

 

 

3,437

 

4,446

Borrowings

5,295

5,282

Lease liabilities

 

 

450

 

440

Accrued expenses and other current liabilities

 

 

3,845

 

4,773

Total current liabilities

 

  

 

13,027

 

14,941

Total liabilities

 

  

 

48,414

 

50,532

Total equity and liabilities

 

  

$

99,079

$

101,710

The accompanying notes are an integral part of the unaudited condensed consolidated interim financial statements.

3


LAVA Therapeutics N.V.

Condensed Consolidated Interim Statements of Changes in Equity

(in thousands, except share amounts) (unaudited)

Equity-

settled

Foreign

employee

currency

Common

Share

benefits

translation

Accumulated

   

Note

   

shares

   

capital

   

reserves

   

reserve

   

APIC

   

deficit

   

Total

Balance at January 1, 2024

 

  

 

26,289,087

 

$

3,715

$

12,005

 

$

(10,899)

$

194,424

$

(148,067)

$

51,178

Loss for the period

 

  

 

 

 

 

 

(553)

 

(553)

Option exercises

3,100

0

8

8

Foreign currency translation adjustment

 

  

 

(1,063)

 

(1,063)

Reclassification of lapsed options

8

(141)

141

Share-based compensation expense

 

8

 

1,095

 

1,095

Balance at March 31, 2024

 

  

 

26,292,187

$

3,715

$

12,959

$

(11,962)

$

194,432

$

(148,479)

$

50,665

   

   

   

   

Equity-

   

   

   

   

settled

Foreign

employee

currency

Common

Share

benefits

translation

Accumulated

Note

shares

capital

reserves

reserve

APIC

deficit

Total

Balance at January 1, 2023

 

  

 

26,289,087

$

3,715

$

8,942

$

(12,972)

$

194,424

$

(108,069)

$

86,040

Loss for the period

 

  

 

 

 

 

 

 

(13,940)

 

(13,940)

Foreign currency translation adjustment

 

 

 

1,546

 

 

 

1,546

Share-based compensation expense

8

 

 

 

1,630

 

 

 

 

1,630

Balance at March 31, 2023

 

  

 

26,289,087

 

$

3,715

$

10,572

 

$

(11,426)

 

$

194,424

$

(122,009)

$

75,276

The accompanying notes are an integral part of the unaudited condensed consolidated interim financial statements.

4


LAVA Therapeutics N.V.

Condensed Consolidated Interim Statements of Cash Flows

(in thousands) (unaudited)

Three Months Ended March 31, 

    

Notes

    

2024

    

2023

Cash flows from operating activities:

 

  

 

  

 

  

Loss before income tax

 

  

$

(484)

$

(13,869)

Adjusted for:

 

  

 

 

Depreciation and amortization of non-current assets

 

  

 

144

 

129

Foreign currency exchange (gain) loss, net

 

  

 

(658)

 

947

Depreciation of right-of-use assets

 

 

103

 

184

Share-based compensation expense

 

9

 

1,095

 

1,630

Income tax expense

 

  

 

(69)

 

(71)

Amortization of premium on investments

(675)

(471)

Changes in working capital:

 

  

 

 

Receivables and other

 

 

693

 

1,283

VAT receivable

 

  

 

65

 

4

Prepaid expenses and other assets

 

 

463

 

1,168

Trade accounts payable and other

 

 

(915)

 

(916)

Other liabilities

 

 

(887)

 

1,647

Net cash used in operating activities

 

  

 

(1,125)

 

(8,335)

Cash flows from investing activities:

 

  

 

  

 

  

Purchases of property and equipment

 

 

 

(500)

Proceeds from sale of property, plant and equipment

89

Purchases of investments

 

(24,371)

 

Maturities of investments

 

  

 

25,000

 

8,177

Net cash provided by investing activities

 

  

 

718

 

7,677

Cash flows from financing activities:

 

  

 

  

 

  

Proceeds from option exercises

8

Proceeds from borrowings

 

 

130

 

117

Payment of principal portion of lease liabilities

 

  

 

(138)

 

(214)

Net cash used in financing activities

 

  

 

0

(97)

Net decrease in cash and cash equivalents

 

  

 

(407)

 

(755)

Cash and cash equivalents at beginning of period

 

44,231

100,333

Effects of exchange rate changes

 

  

 

(637)

 

1,026

Cash and cash equivalents at end of period

 

$

43,187

$

100,604

Supplemental schedule of interest cash flows included in cash flows from operating activities:

Interest received

$

970

$

810

The accompanying notes are an integral part of the unaudited condensed consolidated interim financial statements.

5


LAVA Therapeutics N.V.

Notes to the Unaudited Condensed Consolidated Interim Financial Statements

Note 1—General Information

LAVA Therapeutics N.V., together with its subsidiary, is a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody® platform of bispecific gamma-delta T cell engagers to transform the treatment of cancer. Using its Gammabody platform, the Company is developing a portfolio of novel bispecific antibodies designed to engage and leverage the potency and precision of gamma-delta (gd) T cells to elicit a robust, anti-tumor immune response and improve outcomes for cancer patients. LAVA Therapeutics N.V. was incorporated in 2016 and is headquartered in Utrecht, the Netherlands. Unless the context otherwise requires, references to the “Company,” “we,” “us” and “our” refer to LAVA Therapeutics N.V. and its subsidiary.

In connection with becoming a public company, on March 29, 2021, the Company converted from “LAVA Therapeutics, B.V.” to “LAVA Therapeutics N.V.” The address of the Company’s registered office is Yalelaan 62, 3584 CM Utrecht, the Netherlands. The Company’s common shares are listed for trading under the symbol “LVTX” on The Nasdaq Global Select Market.

The Audit Committee of the Company’s Board of Directors approved these unaudited condensed consolidated interim financial statements on May 21, 2024.

Note 2—Summary of Significant Accounting Policies

Basis of preparation

The unaudited condensed consolidated interim financial statements of the Company are prepared in accordance with International Accounting Standard 34, “Interim Financial Reporting” as issued by the International Accounting Standards Board. Certain information and disclosures normally included in the consolidated financial statements prepared in accordance with International Financial Reporting Standards (IFRS) have been condensed or omitted. Accordingly, these unaudited condensed consolidated interim financial statements should be read in conjunction with the Company’s annual consolidated financial statements for the year ended December 31, 2023 and accompanying notes, which have been prepared in accordance with IFRS as issued by the International Accounting Standards Board and are included on Form 20-F filed by the Company on March 20, 2024.

The accounting policies applied are consistent with those of the previous financial year. A description of our accounting policies is provided in the Accounting Policies section of the audited consolidated financial statements as of and for the years ended December 31, 2023 and 2022, included on Form 20-F filed by the Company on March 20, 2024.

The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting estimates and requires management to exercise its judgment in the process of applying the Company’s accounting policies. The areas involving a higher degree of judgment or complexity or areas where assumptions and estimates are significant to the unaudited condensed consolidated interim financial statements are disclosed in Note 3. The interim financial data as of March 31, 2024 and 2023, and for the three months ended March 31, 2024 and 2023, are unaudited. In the opinion of management, the interim financial data includes all adjustments, consisting only of normal recurring adjustments, necessary to a fair statement of the results for the interim periods.

License Revenue

We may enter into collaboration and licensing arrangements for research and development, manufacturing, and commercialization activities with counterparties for the development and

6


commercialization of our product candidates. These arrangements may contain multiple components, such as (i) licenses, (ii) research and development activities, and (iii) the manufacturing of certain materials. Payments pursuant to these arrangements may include non-refundable and refundable payments, payments upon the achievement of significant regulatory, development and commercial milestones, sales of products at certain agreed-upon amounts, and royalties on product sales.

In determining the appropriate amount of revenue to be recognized as we fulfill our obligations under a collaboration agreement, we perform the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are capable of being distinct; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue as we satisfy each performance obligation.

We must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation, which determines how the transaction price is allocated among the performance obligations. The estimation of the stand-alone selling price may include such estimates as forecasted revenues and costs, development timelines, discount rates and probabilities of regulatory and commercial success. We also apply significant judgment when evaluating whether contractual obligations represent distinct performance obligations, allocating transaction price to performance obligations within a contract, determining when performance obligations have been met, assessing the recognition and future reversal of variable consideration and determining and applying appropriate methods of measuring progress for performance obligations satisfied over time.

Going concern

These condensed consolidated interim financial statements have been prepared by management on the assumption that the Company will be able to continue as a going concern, which presumes that the Company will, for at least the next 12 months, be able to realize its assets and discharge its liabilities in the normal course of business.

Through March 31, 2024, the Company has funded its operations with proceeds from sales of equity, collaboration and licensing agreements, government grants and borrowings under various agreements. Since its inception, the Company has incurred net losses. The Dutch Research and Development Act (WBSO) provides compensation for a part of research and development wages and other costs through a reduction in payroll taxes. WBSO grant amounts are offset against wages and salaries and included in research and development expenses in the condensed consolidated interim statements of loss and comprehensive loss.

As of March 31, 2024, the Company had an accumulated deficit of $148.5 million. The Company expects to continue to generate operating losses in the foreseeable future. The Company expects that its cash, cash equivalents and investments of $94.6 million as of March 31, 2024, will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months following the issuance of these condensed consolidated interim financial statements. Accordingly, the condensed consolidated interim financial statements have been prepared on a going-concern basis.

Until we can generate sufficient product revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements. Disruptions in the financial markets, in general, may make equity and debt financing more difficult to obtain and may have a material adverse effect on our ability to meet our fundraising needs. If we are unable to obtain sufficient funding in a timely manner or on commercially acceptable terms, we may have to delay, reduce the scope of, or eliminate one or more of our operating activities and consider other cost-reduction initiatives, such as downsizing our operations or withholding initiation or expansion of clinical trials or research. In addition, in the event we are not able to generate sufficient funds, we may be unable to continue as a going concern, and our business, financial condition and/or results of operations could be

7


materially and adversely affected and could reduce the price of our common shares and we may ultimately go into insolvency. In addition, any perceived or actual inability by us to finance our clinical development activities and other business activities may cause the market price of our common shares to decline.

Cash and cash equivalents

Cash and cash equivalents in the condensed consolidated interim statements of financial position are comprised of cash at banks and short-term deposits with a maturity of three months or less, which are subject to an insignificant risk of changes in value. Our cash and cash equivalents are held in multiple currencies, primarily in the Euro and United States (U.S.) dollar. Accordingly, our cash balances may be exposed to foreign currency exchange risk.

For the purposes of the condensed consolidated interim statements of cash flows, cash and cash equivalents consist of cash and short-term deposits, as defined above, net of outstanding bank overdrafts.

Investments

As of March 31, 2024, we have determined that we have the intent and ability to hold all investments in debt securities until maturity. Accordingly, all investments are recorded at amortized cost on our condensed consolidated interim statements of financial position, with the amortization of bond premiums or discounts and earned interest income recorded in our condensed consolidated interim statements of loss and other comprehensive loss.

Financial instruments

(i)Financial assets

The Company’s financial assets are comprised of cash and cash equivalents, investments, trade and other receivables, security deposits, other current and non-current assets. All financial assets are recognized initially at fair value plus transaction costs that are attributable to the acquisition of the financial asset, and follow its business model of standard working capital purposes. These financial assets are subsequently measured at amortized cost, which in general, approximates to the fair value. Purchases and sales of financial assets are recognized on the settlement date; the date that the Company receives or delivers the asset. The Company classifies its financial assets primarily as cash and cash equivalents and receivables. Receivables are non-derivative financial assets, with fixed or determinable payments that are not quoted in an active market. They are included in current assets.

Financial assets are derecognized when the rights to receive cash flows from the asset have expired, or the Company has transferred its rights to receive cash flows from the asset or has assumed an obligation to pay the received cash flows in full.

(ii)Financial liabilities

The Company’s financial liabilities are comprised of trade and other payables, lease liabilities, and borrowings. All financial liabilities are recognized initially at fair value, adjusted for transaction costs.

After initial recognition, borrowings are subsequently measured at amortized cost using the effective interest method, minus transaction costs that are directly attributable to the financial liability. The effective interest method amortization is included in finance costs in the condensed consolidated interim statements of loss and other comprehensive loss.

Payables and borrowings are classified as current liabilities unless the Company has an unconditional right to defer settlement of the liability for at least 12 months after the reporting date.

8


Financial liabilities are derecognized when the obligation under the liability is discharged, canceled, or expires.

(iii)Fair value measurements

The Company does not hold any financial assets and financial liabilities other than those measured at amortized cost, as its business model is such that the Company has the intent to hold these instruments for the sole purpose of collecting contractual cash flows, and the contractual terms give rise to cash flows that are solely for payments of principal and interest. Management assessed that the carrying values of the Company’s financial assets and financial liabilities measured at amortized cost are a reasonable approximation of their fair values.

Note 3—Material Accounting Judgments, Estimates and Assumptions

In the application of our accounting policies, the Company is required to make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates.

The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period, or in the period of the revision and future periods if the revision affects both current and future periods.

Critical judgments made in the process of applying our accounting policies which have the most significant effect on the amounts recognized in our unaudited condensed consolidated interim financial statements relate to revenue recognition, share-based payments, accruals for clinical trial expenses, lease accounting, and to our research and license agreements.

The key sources of estimation uncertainty that have a significant risk of causing a material adjustment to the carrying amount of assets and liabilities within the next financial year, primarily relate to recognition of accruals for manufacturing and clinical trial activities. No material adjustments to accruals have been recognized during the first three months of 2024 or 2023, due to conditions that existed as of December 31, 2023 or 2022, respectively. Additionally, there have been no changes to the application of significant accounting estimates, and no impairment losses have been recognized during the first three months of 2024 or 2023.

New standards, interpretations and amendments

There were no new standards, interpretations, or amendments that became effective in the current reporting period which had an impact on the unaudited condensed consolidated interim financial statements.

The unaudited condensed consolidated interim financial statements do not include all disclosures for material accounting judgments, estimates and assumptions that are required in the annual consolidated financial statements and should be read in conjunction with the Company’s audited consolidated financial statements as of, and for the years ended, December 31, 2023 and 2022.

Note 4—Equity

The share capital of LAVA Therapeutics N.V. consisted of 26,292,187 issued and outstanding common shares at a nominal value of $0.14 per share as of March 31, 2024.

9


Note 5—Revenue and cost of sales

Three Months Ended March 31, 

(in thousands)

    

2024

    

2023

Pfizer Inc. - Pfizer Agreement - Milestones

$

6,960

$

Pfizer Inc. - Pfizer Agreement - Other activities

24

998

Pfizer Inc. - Additional services

8

226

$

6,992

$

1,224

Pfizer Agreement

In September 2022, the Company entered the Pfizer Agreement to develop, manufacture and commercialize EGFRd2 (PF-08046052/formerly LAVA-1223), an advanced preclinical asset that utilizes LAVA’s proprietary Gammabody technology to target EGFR-expressing solid tumors. Under the terms of the Pfizer agreement, it received a $50.0 million nonrefundable upfront payment in October 2022 and could receive up to approximately $650.0 million in potential development, regulatory and commercial milestones, and royalties ranging from high single-digit to mid-teen percentages on future sales. The Pfizer agreement also provided Pfizer with the opportunity to exclusively negotiate rights to apply our proprietary Gammabody platform on up to two additional tumor targets, which rights have expired. In March 2024, Pfizer achieved a clinical development milestone for EGFRd2 (PF-08046052), resulting in the first milestone payment of $7 million to the Company under the Pfizer Agreement.

The Company is entitled to receive tiered royalties based on commercial sales levels from high single-digit to mid-teen percentages of net sales of licensed products. Pfizer has also granted it a one-time option to obtain increased royalties if it exercises a buy-up option within a certain amount of time from certain key early clinical data becoming available for the first licensed product. The Company has a specified period of time after notice of such buy-up option to pay Pfizer a one-time fee of $35.0 million (buy-up fee). In the event the Company exercises the buy-up option and pays the buy-up fee, it is entitled to receive increased future royalty percentages to a range of low double-digit to high mid-teen percentages on future sales, and certain future milestones will be decreased by 30%. The deferred revenue balance related to the buy-up option is considered as a monetary item.

Royalties are payable on a licensed product-by-licensed product and country-by-country basis beginning with the first commercial sale of such licensed product in such country of sale and expiring ten years after such sale, subject to specified and capped reductions for the market entry of biosimilar products, loss of patent coverage of licensed products, and for payments owed to third parties for additional rights necessary to commercialize licensed products in the territory.

Under the Pfizer Agreement, the Company is also entitled to receive reimbursement of up to $6.5 million for certain agreed to research, manufacturing and supply activities, as well as the transfer of all manufacturing-related know-how and materials, including all CMC documentation, data and processes, to enable the manufacture of licensed compounds and products by Pfizer. During the three months ended March 31, 2024, the Company recognized $32 thousand of revenue of which $24 thousand relates to the Pfizer Agreement. In addition, it recognized $8 thousand of revenue for reimbursement of additional other services requested by Pfizer.

The Company determined that the Pfizer Agreement and the research, manufacturing and supply activities and materials transfer fall within the scope of IFRS 15, Revenue from Contracts with Customers (IFRS 15). In calculating the transaction price, it determined the following four performance obligations under the agreement: (i) provide exclusive license; (ii) provide manufacturing technology transfer activities; (iii) provide initial drug supply; and (iv) research activities, including data and support for regulatory submission.

10


The Company allocated the transaction price to the performance obligations as of March 31, 2024 and 2023 as follows:

Revenue Recognized

Cumulative Revenue

Transaction

for the quarter ended

Recognized

Other assets as of

(in thousands)

    

Price

    

March 31, 2024

    

as of March 31, 2024

    

March 31, 2024

License

$

50,000

$

$

15,165

$

Manufacturing technology transfer activities

2,167

24

2,296

Initial supply

3,583

3,443

Research activities

750

687

Buy-up fee (*)

(35,000)

$

21,500

$

24

$

21,591

$

(*) Buy-up fee remains deferred until option expires or is exercised

Revenue Recognized

Cumulative Revenue

Transaction

for the quarter ended

Recognized

Other assets as of

(in thousands)

    

Price

March 31, 2023

    

as of March 31, 2023

    

March 31, 2023

License

$

50,000

$

$

15,165

$

Manufacturing technology transfer activities

2,167

63

2,136

Initial supply

3,583

924

924

2,364

Research activities

750

11

674

Buy-up fee (*)

(35,000)

$

21,500

$

998

$

18,899

$

2,364

(*) Buy-up fee remains deferred until option expires or is exercised

For the three months ended March 31, 2024, the revenue was primarily from manufacturing technology transfer related stability studies. For the three months ended March 31, 2023, revenue of $1.0 million was recognized. Of the initial supply revenue of $0.9 million recognized during the three months ended March 31, 2023, $0.7 million related to services provided in relation to stability studies, and $0.2 million related to the cost of drug supply provided to Pfizer.

Note 6—Research and Development Expenses

Research and development expenses were as follows:

Three Months Ended March 31, 

(in thousands)

    

2024

    

2023

  

Pre-clinical and clinical trial expenses

$

3,403

$

6,557

Personnel-related expenses

1,159

1,706

Research and development activities expenses

 

701

 

509

Share-based compensation expense

443

477

Facilities and other research and development expenses

 

303

 

694

$

6,009

$

9,943

11


Note 7—General and Administrative Expenses

General and administrative expenses were as follows:

Three Months Ended March 31, 

(in thousands)

    

2024

    

2023

Personnel-related expenses

$

957

$

1,065

Professional and consultant fees

 

682

 

778

Share-based compensation expense

652

1,153

Insurance, facilities, fees and other related costs

 

644

 

894

$

2,935

$

3,890

Note 8—Share-based Awards

As of March 25, 2021, the 2018 Stock Option Plan and the 2020 U.S. Stock Option Plan ceased to have any future shares available, and the Company established the 2021 Long-Term Incentive Option Plan (the Plan) for all its employees, members of the Board of Directors and select external consultants.

Stock Options

There were 6,742,065 stock options outstanding as of March 31, 2024, at a weighted average exercise price of $3.30 per share. During the three months ended March 31, 2024, 1,542,740 options were granted to employees and non-employee directors at a weighted-average exercise price of $1.59. During the three months ended March 31, 2024, 3,100 stock options were exercised and 234,322 stock options were forfeited at a weighted-average exercise price of $2.71 and $5.00 per share, respectively.

Total compensation cost recognized for all stock option awards was as follows:

Three Months Ended March 31, 

(in thousands)

    

2024

    

2023

Research and development

$

443

$

477

General and administrative

 

652

 

1,153

$

1,095

$

1,630

During the three months ended March 31, 2024, the Company transferred $0.1 million from the equity settled employee benefits reserve to accumulated deficit as a result of forfeited vested options. For these forfeited vested options there is no longer a requirement for a legal reserve as there are no limitations for distribution within equity.

The fair value of the share options has been measured using the Black-Scholes model. The assumptions used in the measurement of the fair values and the weighted average of the share options granted during the three months ended March 31, 2024:

    

March 31, 2024

NL & US

Expected annual average volatility

    

91.0%

Expected life, years

 

6.08

Fair value of the share options

$

1.22 - 1.57

Exercise price

$

1.58 - 2.03

Dividend yield

 

Risk-free interest rate

 

4.07% - 4.34%

Weighted average grant date fair value

 

$

1.23

12


The Company estimates volatility based on the historical volatility of its peer group. The unrecognized remaining stock-based compensation balance for shares issued from all option plans was approximately $4.1 million as of March 31, 2024, which is expected to amortize over a weighted-average 0.88 years.

Note 9—Investments

Our investments in debt securities consist of investments in U.S. Treasury securities, with maturities ranging from three months to one year. All of these investments are classified as held to maturity and recorded in current assets on our condensed consolidated interim statements of financial position at amortized cost. As of March 31, 2024, the carrying value of our investments was $51.4 million, which approximates fair value. Given the high-quality ratings of these investments in debt securities, the Company has not recorded an allowance for credit losses as of March 31, 2024.

13


Exhibit 99.2

LAVA THERAPEUTICS, N.V.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS

You should read the following management’s discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated interim financial statements, including the notes thereto, included with this report, as well as our audited consolidated financial statements as of, and for the year ended, December 31, 2023, including the notes thereto, included in our annual report on Form 20-F, filed with the Securities and Exchange Commission on March 20, 2024. The following discussion is based on our financial information prepared in accordance with International Accounting Standard 34, “Interim Financial Reporting.” Certain information and disclosures normally included in the consolidated financial statements prepared in accordance with International Financial Reporting Standards (IFRS) have been condensed or omitted. Throughout this management’s discussion and analysis, “we,” us,” “our,” “LAVA,” and the “Company” refer to LAVA Therapeutics N.V. and its consolidated subsidiary, unless the context requires otherwise.

Special Note Regarding Forward-Looking Statements

This management’s discussion and analysis contains statements that constitute forward-looking statements. Many of the forward-looking statements contained in this management’s discussion and analysis can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate” and “potential,” among others. Forward-looking statements appear in several places in this management’s discussion and analysis and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to, those identified under the section titled “Risk Factors” in our annual report on Form 20-F. Forward-looking statements include, but are not limited to, statements about:

our operations as a biotechnology company with limited operating history and a history of operating losses;
our plans to develop and commercialize our current and future product candidates;
the initiation, timing, progress and results of our current and future preclinical studies and clinical trials and our research and development programs;
our ability to successfully acquire or in-license additional product candidates on reasonable terms;
our ability to maintain and establish collaborations or obtain additional funding;
our ability to obtain regulatory approval of our current and future product candidates;
our expectations regarding the potential market size and the rate and degree of market acceptance of our product candidates;
our continued reliance on third parties to conduct clinical trials of our product candidate and future product candidates and manufacture our development candidates for preclinical studies and clinical trials;
our ability to fund our working capital requirements and expectations regarding the sufficiency of our capital resources;
the implementation of our business model and strategic plans for our business and product candidates;

our ability to establish sales, marketing and distribution capabilities;
our ability to enter into and maintain collaborations with third parties for the development or commercialization of our product candidates;
our intellectual property position and the duration of our patent rights;
our estimates regarding expenses, future revenues, capital requirements and our needs for additional financing;
the impact of government laws and regulations on our business;
our need to hire additional personnel and our ability to attract and retain such personnel;
our ability to compete in the markets we serve;
developments relating to our competitors and our industry; and
other risk factors discussed under “Risk Factors” in our annual report on Form 20-F.

Forward-looking statements speak only as of the date they are made, and we do not undertake any obligation to update them in light of new information or future developments or to release publicly any revisions to these statements in order to reflect later events or circumstances or to reflect the occurrence of unanticipated events, except to the extent required by applicable law. In addition, there may be adverse effects on our business condition and results from rising interest rates, recent and potential future pandemics or other health crises, general economic and market conditions and overall fluctuations in the United States and international equity markets, including deteriorating market conditions due to investor concerns regarding inflation and international hostilities including the Russian invasion of Ukraine and the Israel-Hamas war.

Overview

We are a clinical stage immuno-oncology company focused on developing our proprietary Gammabody® platform of bispecific gamma delta (gd) 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 gd T cells to orchestrate a robust anti-tumor immune response and improve outcomes for cancer patients.

We were incorporated in February 2016 in the Netherlands and are currently headquartered in Utrecht, the Netherlands. In 2019, we established our wholly owned U.S. subsidiary, which began business in January 2020. We have not generated any revenue from the sale of products. Since inception, we have incurred losses. As of March 31, 2024, we had an accumulated deficit of $148.5 million.

LAVA-1207

In 2022, we dosed the first patient in a first-in-human clinical trial evaluating LAVA-1207 in patients with mCRPC. The open-label, multi-center, Phase 1/2a clinical trial evaluates safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary anti-tumor activity of LAVA-1207. The Phase 1 dose-escalation phase is designed to determine recommended Phase 2a dose(s) for optimization in Phase 2a. Once recommended Phase 2a dose(s) have been established, the trial will expand into the Phase 2a portion to confirm safety and evaluate the preliminary anti-tumor activity of LAVA-1207 in patients with mCRPC. Enrollment for the Phase 1/2a clinical trial for LAVA-1207 is ongoing and as of the date of this report, we have nine clinical trial sites open to enrollment in Europe and the United States.

In February 2023, at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), we reported the most recent clinical data for the ongoing Phase 1/2a clinical trial of LAVA-1207. For the first five cohorts, these initial data demonstrated predictable and linear pharmacokinetics and on-mechanism pharmacodynamics and a favorable safety profile. Preliminary signs of anti-tumor activity were observed at week 8, with iRECIST stable disease (iSD) in 8 out of 14 evaluable patients and PSA levels stabilizing or decreasing in several patients. iRECIST is the immune response evaluation criteria in solid tumors, a set of published rules that define whether tumors in cancer patients have improved, stayed the same or worsened during treatment.


Currently, LAVA-1207 is enrolling dose level ten in the EU and the United States. With the goal of maintaining low rates of CRS and minimizing the risk of CRS events >grade 2, we have introduced premedication and step-dosing to the protocol. This is a common approach in clinical trials of other T-cell engagers. No CRS events greater than grade 2 have been observed in the trial. A single dose-limiting toxicity (DLT) of subdural hematoma was reported in cohort 6 and is the only DLT reported in the LAVA-1207 monotherapy arm. As of the date of this quarterly report and since the initiation of step dosing, no CRS events ≥ grade 2 have been reported.

In June 2023, we announced that we had introduced cohorts of patients who would receive one of two schedules of low-dose interleukin-2 (LDIL-2) beginning the day after LAVA-1207 dosing for the first four doses. LDIL-2 has the potential to increase the number of Vγ9Vδ2-T cells available for engagement by LAVA-1207. Three DLTs were reported in patients receiving LDIL-2 in addition to LAVA-1207 in cohort 7A2, a cohort with multiple doses of LDIL-2 per cycle. These events occurred prior to the introduction of step-dosing. Since we amended the DLT criteria for AST/ALT increases and initiated step dosing, we have not observed any DLTs in patients dosed with LDIL-2. We continue to evaluate whether to treat patients with multiple doses of LDIL-2 per cycle with step dosing.

In January 2024, we announced we had entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc. to evaluate its anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in combination with LAVA-1207. Under the terms of this agreement, we will be provided with pembrolizumab for the dose escalation and expansion phases of LAVA’s ongoing Phase 1/2a study of LAVA-1207 (NCT05369000) (KEYNOTE-F73), with the combination arm expected to be initiated in the second quarter of 2024.

We plan to provide new data for LAVA-1207 at an upcoming medical conference in the second half of 2024.

PF-08046052 (formerly LAVA-1223)

In 2022, we entered into an exclusive worldwide license agreement with Pfizer, Inc. (Pfizer Agreement) to develop, manufacture and commercialize PF-08046052, an advanced preclinical asset that utilizes our proprietary Gammabody technology to target EGFR-expressing solid tumors. Under the terms of the Pfizer Agreement, we received a $50 million nonrefundable upfront payment in October 2022 and are eligible to receive up to approximately $650 million upon the achievement of development, regulatory and commercial milestones, as well as royalties ranging from the single digits to the mid-teens on future sales. The Pfizer Agreement also provided Pfizer with the opportunity to exclusively negotiate rights to apply our proprietary Gammabody™ platform on up to two additional tumor targets, which Pfizer did not exercise. In 2023, we entered into a supply agreement with Pfizer to fulfill part of our obligations under the Pfizer Agreement and began shipping investigational drug supply to Pfizer in March 2023. As of September 30, 2023, all initial drug supply was shipped to Pfizer. In 2023, Pfizer received investigational new drug application clearance for PF-08046052 in advanced solid tumors from the FDA and initiated a Phase 1 trial (NTC0598133) of PF-08046052 to evaluate the safety and tolerability of this molecule as a monotherapy in advanced EGFR expressing solid tumors. In March 2024, Pfizer paid us $7 million for achieving a clinical development milestone.

Comparison of the Three Months Ended March 31, 2024 and 2023 (unaudited):

Revenue from contracts with customers

Our revenue from contracts with customers was $7.0 million and $1.2 million for the three months ended March 31, 2024 and 2023, respectively. In connection with the Pfizer Agreement, we recognized $7.0 million in revenue for the three months ended March 31, 2024, primarily related to the achievement by Pfizer of a clinical development milestone for PF-08046052 (formerly LAVA-1223).

Revenue from contracts with customers of $1.2 million for the three months ended March 31, 2023 primarily related to the reimbursement for delivery of initial supply and related services in connection with the Pfizer Agreement.


Cost of sales of goods and providing services

Our cost of sales of goods and providing services was zero and $0.9 million for the three months ended March 31, 2024 and 2023, respectively. Of this amount for the three months ended March 31, 2023, $0.7 million related to costs of services related to stability studies for the products materials and $0.2 million related to costs of product materials under the supply agreement with Pfizer.

Research and development expenses

Below were our research and development expenses:

    

Three Months Ended

    

    

March 31, 

(in thousands)

    

2024

    

2023

    

Variance

Pre-clinical and clinical trial expenses

$

3,403

$

6,557

$

(3,154)

Personnel-related expenses

 

1,159

 

1,706

 

(547)

Research and development activities expenses

 

701

 

509

 

192

Share-based compensation expense

 

443

 

477

 

(34)

Facilities and other research and development expenses

 

303

 

694

 

(391)

$

6,009

$

9,943

$

(3,934)

Research and development expenses were $6.0 million for the three months ended March 31, 2024, compared to $9.9 million for the three months ended March 31, 2023. Pre-clinical and clinical trial expenses decreased by $3.2 million, primarily due to reduced manufacturing scale-up costs and reduced activities of the clinical trials as a result of the discontinuation of LAVA-051, announced in June 2023. Personnel-related expenses decreased by $0.5 million primarily due to research and development headcount reductions which occurred in the second half of 2023. Facilities and other research and development expenses decreased by $0.4 million primarily due to reduced office and laboratory leases and related costs. Research and development activity expenses increased by $0.2 million due to increased patent costs.

General and administrative expenses

Below were our general and administrative expenses:

Three Months Ended

March 31, 

(in thousands)

    

2024

    

2023

    

Variance

Personnel-related expenses

$

957

$

1,065

$

(108)

Professional and consultant fees

 

682

 

778

 

(96)

Share-based compensation expense

652

1,153

(501)

Insurance, facilities, fees and other related costs

 

644

 

894

 

(250)

$

2,935

$

3,890

$

(955)

General and administrative expenses were $2.9 million for the three months ended March 31, 2024, compared to $3.9 million for the three months ended March 31, 2023. Non-cash share-based compensation expenses and personnel-related expenses decreased by $0.5 million and $0.1 million, respectively, primarily due to a reduction in general and administrative headcount, which occurred in the second half of 2023. Insurance, facilities, fees and other related costs decreased by $0.3 million, primarily due to reduced directors and officers insurance premiums and reduced office leases. Professional and consultant fees decreased by $0.1 million for the three months ended March 31, 2024, as compared to the same period in 2023.

Interest income, net

Interest income, net was $0.8 million for the three months ended March 31, 2024, compared to $0.6 million for the three months ended March 31, 2023. The increase in interest income was primarily due to higher interest yields on our investments in 2024. Interest income, net includes interest income from


investments, net of interest on borrowings associated with our Innovation Credit from Rijksdienst voor Ondernemend Nederland and lease interest.

Foreign currency exchange gain (loss), net

For the three months ended March 31, 2024 and 2023, foreign currency exchange gain increased by $1.6 million, from a loss of $0.9 million during the three months ended March 31, 2023 to a gain of $0.7 million during the three months ended March 31, 2024. This increased gain was due to the impact of the fluctuation of the USD currency rate compared to the Euro on transaction gains and losses on cash and investments and other transactions denominated in USD held and occurring in the Euro functional currency entity.

Liquidity and Capital Resources

As of March 31, 2024, we had cash, cash equivalents and investments totaling $94.6 million, compared to cash, cash equivalents and investments of $95.6 million as of December 31, 2023. We have historically funded our operations primarily through the issuance of preference shares prior to our IPO and from the sale of common shares in our IPO in March 2021, and proceeds from the Pfizer Agreement and Janssen Agreement. Our expenditures are primarily related to research and development activities and general and administrative activities to support business operations.

In April 2022, we entered into an Equity Distribution Agreement (EDA) with JMP Securities LLC (JMP) under which JMP, as our exclusive agent, at our discretion and at such times that we may determine from time to time, may sell over a three-year period from the execution of the agreement up to a maximum of $50 million of shares of our common stock. We have not sold any of our common shares under the EDA to date.

In September 2022, we entered into the Pfizer Agreement for the development, manufacture and commercialization of PF-08046052 (formerly LAVA-1223), an advanced preclinical asset that utilizes LAVA’s proprietary Gammabody technology to target epidermal growth factor receptor (EGFR)-expressing solid tumors. Under the terms of the agreement, we received a $50 million nonrefundable upfront payment in October 2022. In March 2024, we received a milestone payment of $7.0 million from Pfizer following the achievement of a clinical milestone for PF-08046052.

Cash and cash equivalents, and short-term marketable securities are financial instruments that potentially subject the Company to concentrations of credit risk. As of March 31, 2024 and December 31, 2023, cash consists of cash deposited with three financial institutions; account balances may exceed federally insured limits.

Based on our current operating plan, we believe that our existing cash, cash equivalents and investments as of March 31, 2024 are sufficient to meet our projected cash requirements for at least 12 months from the date of this report. However, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned. Our future funding requirements will depend on many factors, including, but not limited to, our ability to:

continue the ongoing and planned development of our product candidate, LAVA-1207;
initiate, conduct and complete any ongoing, anticipated or future preclinical studies and clinical trials for our current and future product candidates;
develop processes and scale manufacturing production for our current and future product candidates in accordance with cGMP;
seek regulatory and marketing approvals for LAVA-1207 and any of our other development candidates that successfully complete clinical trials;
discover and develop additional bispecific gd engagers and make further investments in our Gammabody platform to identify additional product candidates;

maintain, protect and expand our intellectual property portfolio; including costs associated with opposing and invalidating competitor patents and licensing other technologies for our product candidates;
establish a sales, marketing, manufacturing and distribution, supply chain and other commercial infrastructure in the future to commercialize any current or future product candidate for which we may obtain marketing approval;
expand our operations in the United States and Europe;
add clinical, scientific, operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts;
acquire or in-license additional product candidates and technologies;
develop a potential companion diagnostic;
incur additional legal, accounting and other expenses associated with operating as a public company;
address any events outside of our control, including, but not limited to, outbreaks of infectious diseases; and
face general economic and market conditions and overall fluctuations in the United States and international equity markets, such as deteriorating conditions due to investor concerns regarding inflation and the Russian invasion of Ukraine, the Israel-Hamas war and other geopolitical conditions.

Additional funds may not be available when we need them on terms that are acceptable to us, or at all. If adequate funds are not available to us on a timely basis, we may be required to delay, limit, scale back or cease our research and development activities, preclinical studies and clinical trials for our product candidates and our establishment and maintenance of sales and marketing capabilities or other activities that may be necessary to commercialize our product candidates.

The following is a summary of our cash flows:

For the Three Months Ended

March 31, 

(in thousands)

    

2024

    

2023

Net cash used in operating activities

$

(1,125)

$

(8,335)

Net cash provided by investing activities

 

718

 

7,677

Net cash used in financing activities

 

0

 

(97)

Net decrease in cash and cash equivalents

$

(407)

$

(755)

Cash Flows Used in Operating Activities

Net cash used in operating activities for the three months ended March 31, 2024 was $1.1 million compared to $8.3 million for the three months ended March 31, 2023. During the three months ended March 31, 2024, we incurred net losses of $0.5 million and had $0.7 million amortization of premium on investments, $0.7 million foreign currency exchange gains and changes in working capital of $0.5 million, primarily offset by noncash share-based compensation expenses of $1.1 million. During the three months ended March 31, 2023, we incurred net losses of $13.9 million and had $0.5 million amortization of premium on investments, primarily offset by noncash share-based compensation expenses of $1.6 million, foreign currency exchange losses of $0.9 million and changes in working capital of $3.2 million. The reduction in net losses in the first quarter of 2024 compared to 2023, was largely due to the receipt of the clinical development milestone of $7.0 million from Pfizer in the first quarter of 2024 and reduced research and development expenses as a result of the discontinuation of LAVA-051, announced in June 2023.

Cash Flows Provided by Investing Activities

Cash flows provided by investing activities for the three months ended Mach 31, 2024 were $0.7 million and primarily consisted of $25.0 million of investments matured, offset by $24.4 million purchases of investments. Cash flows provided by investing activities for the three months ended March 31, 2023 were


$7.7 million and primarily consisted of $8.2 million on investments matured, offset by $0.5 million of equipment purchases.

Cash Flows Used in Financing Activities

Cash flows used in financing activities for the three months ended March 31, 2024 were zero and consisted of $0.1 million in principal payments on operating lease liabilities, offset by $0.1 million in proceeds from Innovation Credit borrowings. Cash flows used in financing activities for the three months ended March 31, 2023, were $0.1 million and consisted of $0.2 million in principal payments on operating lease liabilities, offset by $0.1 million in proceeds from Innovation Credit borrowings.

Off-Balance Sheet Arrangements

We have not entered into any off-balance sheet arrangements or any holdings in variable interest entities.

Quantitative and Qualitative Disclosures about Market Risk

We are exposed to a variety of risks in the ordinary course of our business, including, but not limited to, foreign currency risk and interest rate risk. We regularly assess each of these risks to minimize any adverse effects on our business as a result of those factors.

Foreign Currency Risk

We are exposed to foreign exchange risk arising from various currency exposures, primarily with respect to USD. We have received payments in USD under our collaborations, and the proceeds from our initial public offering in March 2021 were in USD and we execute some transactions in USD. As a result, we are exposed to volatility in the condensed consolidated interim statements of profit and loss related to USD amounts and transactions occurring in a Euro-functional entity, the impacts of which we have disclosed above. We regularly assess our foreign currency risk, maintain cash positions in the currencies in which we expect to incur the majority of our future expenses and may engage in hedging activities consistent with our investment policy to minimize this risk and preserve our capital.

Interest Rate Risk

We have interest-bearing debt with third parties. In addition, while we have no derivatives or financial assets and liabilities measured at fair value, our exposure to interest rate risk primarily relates to the interest rates for our positions of cash and cash equivalents, including short-term marketable securities. Our future interest income from interest-bearing bank deposits and short-term investments may fall short of expectations due to changes in interest rates. We do not consider the effects of interest rate fluctuations to be a material risk to our financial position.

We have adopted an investment policy with the primary purpose of preserving capital, fulfilling our liquidity needs and diversifying the risks associated with cash and marketable securities. This investment policy establishes minimum ratings for institutions with which we hold cash, cash equivalents and marketable securities, as well as rating and concentration limits for marketable securities that we may hold.

Credit Risk

We consider all of our material counterparties to be creditworthy. While the concentration of credit risk may be significant, we consider the credit risk for each of our counterparts to be low. Our exposure to credit risk primarily relates to our cash and cash equivalents, comprising bank deposits and short-term marketable securities with a maturity of three months or less at the date of acquisition. The credit risk on bank deposits is limited because the counterparties holding significant deposits are banks with high credit ratings assigned by international credit-rating agencies. Our banks are reviewed on a regular basis, and our deposits may be transferred during the year to mitigate credit risk. We have considered the risk of expected credit loss on our cash deposits, including the hypothetical impact arising from the probability of default, considering in


conjunction with the expected loss given default from banks with similar credit ratings and attributes. In line with previous periods, our assessment did not reveal a material impairment loss, and accordingly, no provision for expected credit loss has been made. We hold a portion of our bank deposits in a money market fund invested in short-term U.S. Treasury securities to further diversify the credit risk.

For other financial assets, including deposits and receivables, we consider the credit risk to be low and no provision for expected credit loss has been made.

Liquidity Risk

We manage our liquidity risk by maintaining adequate cash reserves and banking facilities, continuously monitoring our cash forecasts and actual cash flows and matching the maturity profiles of financial assets and liabilities. We monitor the risk of a shortage of funds using a liquidity planning tool to ensure enough funds are available to settle liabilities as they fall due.

Historically we have addressed the risk of insufficient funds through the proceeds from our Series C financing and our IPO in March 2021, and research and license agreements with strategic partners.

Critical Accounting Estimates

The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting estimates and requires management to exercise its judgment in the process of applying our accounting policies. The areas involving a higher degree of judgment or complexity or areas where assumptions and estimates are significant to the unaudited condensed consolidated interim financial statements are disclosed in Note 3 to our condensed consolidated interim financial statements. The interim financial data as of March 31, 2024 and 2023 are unaudited. In the opinion of management, the interim financial data includes all adjustments, consisting only of normal recurring adjustments, necessary to a fair statement of the results for the interim periods.


RISK FACTORS

The risk factors set forth under the caption “Risk Factors” in Item 3 of our annual report on Form 20-F filed by the Company on March 20, 2024 shall be deemed to be incorporated by reference herein and to be a part hereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished. Additional risks and uncertainties not currently known to the Company, or that the Company currently deems to be immaterial, may also affect its business, financial condition and/or future operating results.


Exhibit 99.3

LAVA Provides Business Updates and

Reports First Quarter 2024 Financial Results

LAVA-1207 dose escalation progressing in Phase 1/2a trial in prostate cancer, with pembrolizumab combination expected to begin in Q2 2024
Received $7.0 million clinical development milestone from Pfizer for PF-08046052 (formerly LAVA-1223) in Phase 1
LAVA-1266 on track for Q2 2024 IND submission
Strong balance sheet with cash of $94.6 million supports runway into 2026

Utrecht, The Netherlands, and Philadelphia, USA – May 21, 2024 – 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, today announced recent corporate highlights and financial results for the first quarter ended March 31, 2024.

“LAVA continues to advance our pipeline of Gammabody programs and is excited to initiate the combination arm of pembrolizumab with LAVA-1207 this quarter. We look forward to sharing an update on the LAVA-1207 program during the second half of 2024,” said Stephen Hurly, President and Chief Executive Officer of LAVA. “We are also pleased by Pfizer’s continued progress with the Phase 1 program for PF-08046052 and the achievement of a clinical development milestone in March.”

“We are encouraged by the positive impact on the LAVA-1207 trial since we have implemented step dosing, as no ≥ Grade 2 CRS events have been reported since this change. We look forward to initiating the combination with pembrolizumab, and we continue to evaluate LAVA-1207 with low dose IL-2 and step dosing,” added Charles Morris, Chief Medical Officer of LAVA.

Portfolio Highlights:

LAVA-1207 – In Phase 1/2a (NCT05369000) – Next update H2 2024

Designed to mediate potent killing of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) cells

Monotherapy: Enrolling patients at dose level 10. No ≥ Grade 2 Cytokine Release Syndrome (CRS) since the implementation of step dosing in Q1 2024
KEYTRUDA® (pembrolizumab) Combination: Expecting to enroll the first patient in Q2 2024 in the LAVA-1207 + pembrolizumab dose-escalation arm (KEYNOTE-F73)
Low Dose IL-2 (interleukin-2, LDIL-2, to increase the number of Vγ9Vδ2 T cells for engagement by LAVA-1207): Evaluating whether to continue treating patients with LDIL-2 with step dosing
Biomarker Studies: Evaluating the potential association between Vγ9Vδ2 T cell counts and tumor responses

Pfizer PF-08046052 – In Phase 1 (NCT05983133) 

Potential first-in-class EGFR and bispecific gamma delta T cell-targeted therapy for solid tumors

Key Indications: Include colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and pancreatic ductal adenocarcinoma (PDAC)
Dose Escalation Trial: Underway to evaluate the safety and tolerability of PF-08046052 as a monotherapy in advanced EGFR-expressing solid tumors
Milestone: Pfizer paid LAVA $7 million for achieving a clinical development milestone in March 2024


LAVA-1266 – IND Submission Expected in Q2 2024

Designed to target CD123 for the treatment of hematological malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)

IND Submission: Preparations underway

First Quarter 2024 Financial Results

As of March 31, 2024, LAVA had cash, cash equivalents and investments totaling $94.6 million, compared to cash, cash equivalents and investments of $95.6 million as of December 31, 2023. The Company believes its current cash, cash equivalents and investments will be sufficient to fund operations into 2026.
Revenue from contracts with customers was $7.0 million and $1.2 million for the quarters ended March 31, 2024 and 2023, respectively. Revenue of $7.0 million for the quarter ended March 31, 2024 was related to the achievement by Pfizer of a clinical development milestone for PF-08046052. Revenue of $1.2 million for the quarter ended March 31, 2023 was related to the reimbursement for research activities and delivery of initial supply product materials in connection with the Pfizer Agreement.
Cost of providing services and sales of goods was zero and $0.9 million for the quarters ended March 31, 2024 and 2023, respectively. The $0.9 million for the quarter ended March 31, 2023 was related to the cost of the initial supply delivery to Pfizer and related stability studies.
Research and development expenses were $6.0 million and $9.9 million for the quarters ended March 31, 2024 and 2023, respectively. The decrease was primarily due to lower pre-clinical and clinical trial expenses due to the discontinuation of LAVA-051, announced in June 2023, and reduced personnel-related expenses due to a reduction in research and development headcount in the second half of 2023.
General and administrative expenses were $2.9 million and $3.9 million for the quarters ended March 31, 2024 and 2023, respectively. The decrease was primarily due to lower personnel-related expenses due to a reduction in general and administrative headcount in the second half of 2023.
Net loss was $0.5 million and $13.9 million, or $0.02 and $0.53 net loss per share, for the quarters ended March 31, 2024 and 2023, respectively.

LAVA Therapeutics N.V.

Condensed Consolidated Interim Statements Loss

and Comprehensive Loss

(in thousands, except share and per share amounts) (unaudited)

    

Three Months Ended

March 31, 

    

2024

    

2023

Revenue:

 

  

 

  

Revenue from contracts with customers

 

$

6,992

$

1,224

Cost of sales of goods

(745)

Cost of providing services

(185)

Gross profit

 

 

6,992

 

294

Operating expenses:

 

 

  

 

  

Research and development

 

 

(6,009)

 

(9,943)

General and administrative

 

 

(2,935)

 

(3,890)

Total operating expenses

 

 

(8,944)

 

(13,833)

Operating loss

 

 

(1,952)

 

(13,539)

Interest income, net

 

 

810

 

617

Foreign currency exchange gain (loss), net

 

 

658

 

(947)

Total non-operating income

 

 

1,468

 

(330)

Loss before income tax

 

 

(484)

 

(13,869)

Income tax expense

 

 

(69)

 

(71)

Loss for the period

 

$

(553)

$

(13,940)

Items that may be reclassified to profit or loss

Foreign currency translation adjustment

 

 

(1,063)

 

1,546

Total comprehensive loss

 

$

(1,616)

$

(12,394)

Loss per share:

 

 

  

 

  

Loss per share, basic and diluted

$

(0.02)

$

(0.53)

Weighted-average common shares outstanding, basic and diluted

 

26,794,215

 

26,289,087


LAVA Therapeutics N.V.

Condensed Consolidated Statements of Financial Position

(in thousands) (unaudited)

March 31, 

December 31, 

    

2024

    

2023

Assets

 

  

 

  

Non-current assets:

 

  

 

  

Property and equipment, net

 

$

1,359

$

1,602

Right-of-use assets

 

 

796

 

892

Other non-current assets and security deposits

 

 

256

 

319

Total non-current assets

 

 

2,411

 

2,813

Current assets:

 

 

  

 

  

Receivables and other

 

 

737

 

1,459

Prepaid expenses and other current assets

 

 

1,188

 

1,627

VAT receivable

 

 

170

 

240

Investments

51,386

51,340

Cash and cash equivalents

 

 

43,187

 

44,231

Total current assets

 

 

96,668

 

98,897

Total assets

 

$

99,079

$

101,710

Equity and Liabilities

 

 

  

 

  

Equity:

 

 

  

 

  

Share capital

 

$

3,715

$

3,715

Equity-settled employee benefits reserve

 

 

12,959

 

12,005

Foreign currency translation reserve

 

 

(11,962)

 

(10,899)

Additional paid-in capital

 

 

194,432

 

194,424

Accumulated deficit

 

 

(148,479)

 

(148,067)

Total equity

 

 

50,665

 

51,178

Non-current liabilities:

 

 

  

 

  

Deferred revenue

 

 

35,000

 

35,000

Lease liabilities

 

 

387

 

591

Total non-current liabilities

 

 

35,387

 

35,591

Current liabilities:

 

 

  

 

  

Trade payables and other

 

 

3,437

 

4,446

Borrowings

5,295

5,282

Lease liabilities

 

 

450

 

440

Accrued expenses and other current liabilities

 

 

3,845

 

4,773

Total current liabilities

 

 

13,027

 

14,941

Total liabilities

 

 

48,414

 

50,532

Total equity and liabilities

 

$

99,079

$

101,710


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.

A Phase 1/2a dose escalation study (NCT05369000) to evaluate the lead program, LAVA-1207, in patients with metastatic castration-resistant prostate cancer (mCRPC) is actively enrolling in Europe and the United States in a study evaluating monotherapy and with interleukin-2 (IL-2). The Company is expanding the Phase 1/2a study to include a combination arm with KEYTRUDA®(pembrolizumab) through a clinical collaboration with Merck & Co., Inc., Rahway, NJ, USA. The Company licensed PF-08046052 (formerly LAVA-1223) to Pfizer Inc. for clinical development and commercialization. The pipeline also includes several pre-clinical programs. For more information, please visit www.lavatherapeutics.com, and follow us on LinkedInX, and YouTube.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. LLC, Rahway, NJ, USA

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, including with respect to the Company’s anticipated growth and clinical development plans including the timing and results of clinical trials. 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 the therapeutic potential, development and potential uses of LAVA’s product candidates, the timing of initiation of clinical trials, including the expansion phase of the Phase 1/2a trial to evaluate LAVA-1207 in combination with KEYTRUDA®, the timing of regulatory submissions, including an IND for LAVA-1266 in AML and MDS, LAVA’s cash runway and the sufficiency of resources to pursue development activities, availability of information regarding clinical development plans, progress and data from clinical trials, the ability of LAVA’s product candidates to treat various tumor targets, including CRC, NSCLC, PDAC and HNSCC, and improve patient outcomes and the sufficiency of resources to pursue development activities. 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 our Gammabody® platform, and 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 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, 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 Ukraine or the Israel-Hamas war. These and other risks are described in greater detail under the caption “Risk Factors” and included in LAVA’s filings 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



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