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 November 2021

(Commission File No. 001-40241)


LAVA Therapeutics N.V.

(Translation of registrant’s name into English)


Yalelaan 60

3584 CM Ultrecht, The Netherlands

(Address of principal executive offices)


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

Form 20-F   Form 40-F  

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101 (b) (1):

    Yes      No  

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101 (b) (7):

    Yes      No  


INCORPORATION BY REFERENCE

Exhibits 99.1 and 99.2 to this Report on Form 6-K (this “Report”) shall be deemed to be incorporated by reference into the registration statement on Form S-8 (File no. 333-256655) of LAVA Therapeutics N.V. (the “Company”) (including any prospectuses forming a part of such registration statement) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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 is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “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 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, or the 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

Exhibit

    

Description

99.1

Unaudited Condensed Consolidated Interim Financial Statements as of and for the Three and Nine Months Ended September 30, 2021

99.2

Management’s Discussion and Analysis of Financial Condition and Results of Operations as of and for the Three and Nine Months Ended September 30, 2021

99.3

Press Release dated November 15, 2021


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, thereto duly authorized.

LAVA Therapeutics, N.V.

(Registrant)

Date: November 15, 2021

By:

/s/ Edward Smith

Edward Smith

Chief Financial Officer


Table of Contents

Exhibit 99.1

LAVA THERAPEUTICS N.V.

INDEX TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

Page

Condensed Consolidated Interim Statements of Loss and Comprehensive Loss for the Three and Nine Months Ended September 30, 2021 and 2020 (unaudited)

2

Condensed Consolidated Interim Statements of Financial Position as of September 30, 2021 and December 31, 2020 (unaudited)

3

Condensed Consolidated Interim Statements of Changes in Equity for the Three and Nine Months Ended September 30, 2021 and 2020 (unaudited)

4

Condensed Consolidated Interim Statements of Cash Flows for the Nine Months Ended September 30, 2021 and 2020 (unaudited)

6

Notes to the Unaudited Condensed Consolidated Interim Financial Statements

7


Table of Contents

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

    

Nine Months Ended

September 30, 

September 30, 

    

Notes

    

2021

    

2020

    

2021

    

2020

Revenue

 

  

 

  

 

  

 

  

 

  

Research and license revenue

 

6

1,781

827

3,599

1,419

Total revenue

 

  

 

1,781

 

827

 

3,599

 

1,419

Operating expenses:

 

  

 

  

 

  

 

  

 

  

Research and development

 

7

 

(5,714)

 

(3,292)

 

(25,476)

 

(9,302)

General and administrative

 

8

 

(3,213)

 

(660)

 

(6,969)

 

(2,013)

Total operating expenses

 

  

 

(8,927)

 

(3,952)

 

(32,445)

 

(11,315)

Operating loss

 

  

 

(7,146)

 

(3,125)

 

(28,846)

 

(9,896)

Interest income

22

22

Interest expense

 

  

 

(161)

 

(92)

 

(425)

 

(200)

Foreign currency exchange loss, net

 

  

 

(139)

 

(143)

 

(486)

 

(411)

Total non-operating expenses

 

  

 

(278)

 

(235)

 

(890)

 

(611)

Loss before income tax

 

  

 

(7,424)

 

(3,360)

 

(29,736)

 

(10,507)

Income tax expense

 

  

 

(38)

 

 

(85)

 

Net loss

 

  

(7,462)

(3,360)

(29,821)

(10,507)

Foreign currency translation adjustment

 

  

 

1,582

 

(184)

 

1,178

 

(184)

Total comprehensive loss

 

  

(5,880)

(3,544)

(28,643)

(10,691)

Net loss per share

 

  

 

  

 

  

 

  

 

  

Net loss per share, basic and diluted

 

  

(0.23)

(8.43)

(1.62)

(24.38)

Weighted average common shares outstanding, basic and diluted

 

  

 

25,775,538

 

420,563

 

17,730,337

 

438,464

2


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LAVA Therapeutics N.V.

Condensed Consolidated Interim Statements of Financial Position

(in thousands)

September 30, 

December 31, 

    

Notes

    

2021

    

2020

(unaudited)

Assets

 

  

 

  

 

  

Non-current assets

 

  

 

  

 

  

Property and equipment, net

 

  

1,210

906

Right-of-use assets

 

  

 

444

 

311

Deferred tax assets

 

  

 

15

 

Non-current assets and security deposits

 

  

 

605

 

626

Total non-current assets

 

  

 

2,274

 

1,843

Current assets

 

  

 

  

 

  

Trade receivables and other

 

  

 

1,209

 

929

Prepaid expenses and other current assets

 

10

 

3,784

 

95

Deferred offering costs

 

  

 

 

661

VAT receivable

 

  

 

265

 

274

Investments

11

36,159

Cash and cash equivalents

 

  

 

86,524

 

12,881

Total current assets

 

  

 

127,941

 

14,840

Total assets

 

  

130,215

16,683

Equity and Liabilities

 

  

 

  

 

  

Equity

 

  

 

  

 

  

Share capital

 

  

3,093

 €

Share premium

 

  

 

 

35,159

Equity-settled employee benefits reserve

 

  

 

3,272

 

801

Foreign currency translation reserve

 

  

 

831

 

(347)

Additional paid-in capital

 

  

 

162,813

 

Accumulated deficit

 

  

 

(59,228)

 

(29,406)

Total equity

 

  

 

110,781

 

6,207

Non-current liabilities

 

  

 

  

 

  

Deferred revenue

 

6

 

 

1,480

Lease liabilities

 

  

 

275

 

221

License liabilities

 

5

 

4,437

 

Borrowings

 

  

 

3,519

 

2,935

Total non-current liabilities

 

  

 

8,231

 

4,636

Current liabilities

 

  

 

  

 

  

Trade payables and other

 

  

 

1,646

 

760

Lease liabilities

 

  

 

294

 

168

License liabilities

 

5

 

4,437

 

Accrued expenses and other current liabilities

 

  

 

2,547

 

1,362

Deferred revenue

 

6

 

2,280

 

3,550

Total current liabilities

 

  

 

11,203

 

5,840

Total liabilities

 

  

 

19,434

 

10,476

Total equity and liabilities

 

  

130,215

16,683

3


Table of Contents

LAVA Therapeutics N.V.

Condensed Consolidated Interim Statements of Changes in Equity

(in thousands, except share amounts) (unaudited)

Preference

    

Equity-

settled

Foreign

Series A

Series B

Series C

Ordinary

employee

currency

Series A

Share

Series B

Share

Series C

Share

share

Share

benefits

translation

Accumulated

   

Note

   

shares

   

premium

   

shares

   

premium

   

shares

   

premium

   

shares

   

capital

   

reserves

   

reserve

   

APIC

   

deficit

   

Total

Balance at June 30, 2021

 

  

 

 

 

 

 

 

25,775,538

3,093

2,195

(751)

162,813

(51,764)

115,586

Loss for the period

 

  

 

 

 

 

 

 

 

 

 

 

 

 

(7,464)

 

(7,464)

Foreign currency translation adjustment

 

  

 

 

 

 

 

 

 

 

 

 

1,582

 

 

 

1,582

Share-based compensation expense

 

9

 

 

 

 

 

 

 

 

 

1,077

 

 

 

 

1,077

Balance at September 30, 2021

 

  

 

 

 

 

 

 

25,775,538

3,093

3,272

831

162,813

(59,228)

110,781

Preference

Equity-

settled

Foreign

Series A

Series B

Series C

Ordinary

employee

currency

Series A

Share

Series B

Share

Series C

Share

share

Share

benefits

translation

Accumulated

   

Note

   

shares

   

premium

   

shares

   

premium

   

shares

   

premium

   

shares

   

capital

   

reserves

   

reserve

   

APIC

   

deficit

   

Total

Balance at January 1, 2021

 

  

 

1,037,595

629

 

3,899,766

16,001

 

4,133,805

18,529

 

281,775

 

801

(347)

 

(29,406)

6,207

Loss for the period

 

  

 

 

 

 

 

 

 

 

 

 

 

 

(29,822)

 

(29,822)

Share split

 

  

 

 

(124)

 

 

(468)

 

 

(497)

 

 

1,123

 

 

 

(34)

 

 

Issuance of Series C preferred shares, net

 

  

 

 

 

 

 

9,945,221

 

50,581

 

 

1,193

 

 

 

 

 

51,774

Repurchase of Series A and common shares

 

  

 

(718,250)

 

(349)

 

 

 

 

 

(165,750)

 

(106)

 

 

 

(4,153)

 

 

(4,608)

Conversion of Preference shares

 

  

 

(319,345)

 

(156)

 

(3,899,766)

 

(15,533)

 

(14,079,026)

 

(68,613)

 

18,298,137

 

 

 

 

84,302

 

 

Issuance of common stock in initial public offering, net

 

1,4

 

 

 

 

 

 

 

6,700,000

 

804

 

 

 

74,839

 

 

75,643

Issuance of Greenshoe common stock

 

  

 

 

 

 

 

 

 

425,712

 

51

 

 

 

4,887

 

 

4,938

Issuance of VUmc common stock

 

  

 

 

 

 

 

 

 

235,664

 

28

 

 

 

2,972

 

 

3,000

Foreign currency translation adjustment

 

  

 

 

 

 

 

 

 

 

 

 

1,178

 

 

 

1,178

Share-based compensation expense

 

9

 

 

 

 

 

 

 

 

 

2,471

 

 

 

 

2,471

Balance at September 30, 2021

 

  

 

 

 

 

25,775,538

3,093

3,272

831

162,813

(59,228)

110,781

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LAVA Therapeutics N.V.

Condensed Consolidated Interim Statements of Changes in Equity

(in thousands, except share amounts) (unaudited)

Preference

    

    

    

Equity-

    

    

    

    

settled

Foreign

Series A

Series B

Series C

Ordinary

employee

currency

Series A

Share

Series B

Share

Series C

Share 

share

Share

benefits

translation

Accumulated

   

Note

   

shares

   

premium

   

shares

   

premium

   

shares

   

premium

   

shares

   

capital

   

reserves

   

reserve

   

APIC

   

deficit

   

Total

Balance at June 30, 2020

 

  

 

1,755,845

 

1,065

 

3,899,766

 

16,001

 

 

 

447,525

574

(19,326)

(1,686)

Loss for the period

 

  

 

 

 

 

 

 

 

 

 

 

 

 

(3,360)

 

(3,360)

Issuance of Series C preferred shares, net

 

 

 

 

4,133,805

 

18,529

 

 

 

 

 

 

 

18,529

Repurchase of Series A and common shares

(718,250)

 

(436)

 

 

 

 

 

(165,750)

 

 

 

 

(3,643)

 

 

(4,079)

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation expense

9

 

 

 

 

 

 

 

 

 

53

 

(184)

 

 

 

(131)

Balance at September 30, 2020

 

  

 

1,037,595

629

 

3,899,766

16,001

 

4,133,805

 

18,529

 

281,775

 

627

 

(184)

 

(3,643)

(22,686)

9,273

Preference

   

   

   

   

   

   

   

   

   

   

Equity-

   

   

   

   

settled

Foreign

Series A

Series B

Series C

Ordinary

employee

currency

Series A

Share

Series B

Share

Series C

Share 

share

Share

benefits

translation

Accumulated

Note

shares

premium

shares

premium

shares

premium

shares

capital

reserves

reserve

APIC

deficit

Total

Balance at January 1, 2020

 

  

 

1,755,845

 

1,065

 

3,899,766

 

16,001

 

 

 

447,525

324

(12,179)

5,211

Loss for the period

 

  

 

 

 

 

 

 

 

 

 

 

 

 

(10,507)

 

(10,507)

Issuance of Series C preferred shares, net

 

 

 

 

4,133,805

 

18,529

 

 

 

 

 

 

 

18,529

Repurchase of Series A and common shares

(718,250)

 

(436)

 

 

 

 

 

(165,750)

 

 

 

 

(3,643)

 

 

(4,079)

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation expense

9

 

 

 

 

 

 

 

 

 

303

 

(184)

 

 

 

119

Balance at September 30, 2020

 

  

 

1,037,595

629

 

3,899,766

16,001

 

4,133,805

 

18,529

 

281,775

 

627

 

(184)

 

(3,643)

(22,686)

9,273

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LAVA Therapeutics N.V.

Condensed Consolidated Interim Statements of Cash Flows

(in thousands) (unaudited)

Nine Months Ended September 30, 

    

Notes

    

2021

    

2020

Cash flows from operating activities

 

  

 

  

 

  

Loss before income tax

 

  

(29,736)

(10,507)

Adjusted for:

 

  

 

  

 

  

Depreciation and amortization of non-current assets

 

  

 

196

 

135

Foreign currency exchange loss, net

 

  

 

487

 

411

Non-cash lease amortization

 

  

 

(133)

 

169

Share-based compensation expense

 

9

 

2,471

 

303

Income tax expense

 

  

 

(85)

 

Amortization of premium on investments

134

Changes in working capital:

 

  

 

  

 

  

Trade receivables and other

 

  

 

(281)

 

(53)

VAT receivable

 

  

 

9

 

(150)

Other assets

 

  

 

(3,682)

 

(115)

Trade accounts payable and other

 

  

 

885

 

1,225

Deferred revenue

 

6

 

(2,750)

 

5,978

License liabilities

 

  

 

11,873

 

Other liabilities

 

  

 

1,185

 

690

Net cash used in operating activities

 

  

 

(19,427)

 

(1,914)

Cash flows from investing activities

 

  

 

  

 

  

Purchase of property and equipment

 

  

 

(500)

 

(378)

Purchase of investments

(36,292)

Net cash used in investing activities

 

  

 

(36,792)

 

(378)

Cash flows from financing activities

 

  

 

  

 

  

Proceeds from common shares from initial public offering, net

 

14

 

81,242

 

Proceeds from Series C preferred financing, net

 

  

 

51,774

 

18,907

Payment of Series A preferred and common shares repurchased

 

  

 

(4,609)

 

(4,079)

Proceeds from borrowings

 

  

 

584

 

1,327

Payment of principal portion of lease liabilities

 

  

 

180

 

(102)

Net cash provided by financing activities

 

  

 

129,171

 

16,053

Net increase in cash and cash equivalents

 

  

 

72,952

 

13,761

Cash and cash equivalents at the beginning of year

 

  

12,881

6,544

Effects of exchange rate changes on the balance of cash held in foreign currencies

 

  

 

691

 

(595)

Cash and cash equivalents at end of the period

 

  

86,524

19,710

Supplemental schedule of noncash investing and financing activities:

 

  

 

 

  

Issuance of 235,664 common shares to VUmc in lieu of payment for license liabilities

 

  

3,000

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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 biotechnology company utilizing its proprietary Gammabody™ platform to develop a portfolio of bispecific gamma delta T cell engagers (gamma delta bsTCEs) for the potential treatment of solid tumors and hematological malignancies. The company’s innovative approach utilizes bispecific antibodies engineered to selectively kill cancer cells via the triggering of Vγ9Vδ2 T cell antitumor effector functions upon cross-linking to tumor associated antigens. 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.

On March 29, 2021, the Company completed an initial public offering (“IPO”) of common shares in the United States pursuant to its registration statement on Form F-1, as amended (File No. 333-253795). The common shares are listed for trading under the symbol “LVTX” on The Nasdaq Global Select Market (“Nasdaq”). Pursuant to the registration statement, the Company issued and sold 6,700,000 shares of €0.12 par value common stock at a price of €12.60 or $15.00 per share. Net proceeds from the IPO were approximately €75.5 million ($89.0 million) after deducting underwriting discounts and commissions of €5.9 million ($7.0 million) and offering costs of €3.8 million ($4.5 million). In March 2021, the Company also received €47.2 million in proceeds from the Series C financing, net of repurchasing Series A Preferred and common shares.

On April 19, 2021, underwriters of the Company’s IPO consummated the exercise of their option to purchase 425,712 common shares from the Company at the price of €12.60 or $15.00 per share resulting in additional IPO net proceeds to the Company of €4.9 million ($5.9 million) after deducting underwriting discounts and commissions of €0.3 million ($0.4 million).

In connection with becoming a public company, on March 29, 2021 the Company changed its name from “LAVA Therapeutics, B.V.” to “LAVA Therapeutics N.V.” The address of the Company’s registered office is Yalelaan 60, 3584 CM Utrecht, the Netherlands.

The Audit Committee of the Company’s Board of Directors approved these unaudited condensed consolidated interim financial statements on November 10, 2021.

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.” 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 years ended December 31, 2020 and 2019 and accompanying notes, which have been prepared in accordance with IFRS as issued by the International Accounting Standards Board, or IASB.

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, 2020 and 2019.

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.

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Cash and Cash Equivalents

Cash and cash equivalents in the condensed consolidated interim statements of financial position is comprised of cash at banks and on hand and short-term deposits with a maturity of three months or less, which are subject to an insignificant risk of changes in value.

Our objective in managing our cash resources (cash, cash equivalents and marketable securities) is to preserve principal, achieve liquidity requirements, and safeguard funds. We maintain our cash resources in accordance with our investment policy, which defines allowable investments, specifies credit quality standards and is designed to limit our credit exposure to any single issuer. Cash and cash equivalents include deposits and investments. Marketable securities include commercial paper, treasury bills and securities issued by several public corporations and the Dutch, EU or U.S. Treasury. A minimum of two times the amount of expected monthly cash outflow must be liquid at the beginning of each month. Our invested cash resources are deployed to achieve our operating objectives in furthering our programs. We are prohibited from borrowing for investment purposes and from engaging in any non-business related investment activity that would be considered speculative according to the principles of conservative investment management.

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

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.

Investments in Debt Securities

As of September 30, 2021, 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.

Reclassification

Certain prior period amounts have been reclassified to conform to the current quarter presentation, including insurance costs of €0.5 million that, for the six months ended June 30, 2021, were allocated to research and development and are now fully allocated as a general and administrative expense, with no impact to earnings per share. This reclassification more accurately reflects the nature of these insurance costs as general and administrative expenses rather than an indirect cost allocated to research and development expenses. There was no impact to any period during the fiscal year ended December 31, 2020 as a result of this reclassification.

Note 3—Significant 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 and that have the most significant effect on the amounts recognized in our unaudited condensed consolidated interim financial statements relate to revenue recognition, share-based payments, lease accounting, and to our research and license agreements.

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Table of Contents

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 significant adjustments to accruals have been recognized during the first nine months of 2021 or 2020, due to conditions that existed at December 31, 2020, or 2019, respectively. Additionally, there have been no changes to the application of significant accounting estimates, and no impairment losses have been recognized during the first nine months of 2021 or 2020.

The unaudited condensed consolidated interim financial statements do not include all disclosures for critical accounting estimates and judgments 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, 2020 and 2019.

Note 4—Initial Public Offering

On March 29, 2021, the Company completed an IPO of common shares pursuant to its registration statement on Form F-1, as amended (file 333-253795) under the symbol “LVTX” in the United States on Nasdaq. Pursuant to the registration statement, the Company issued and sold 6,700,000 shares of €0.12 par value common share at a price of €12.60 or $15.00 per share. Net proceeds from the IPO were approximately €75.5 million ($89.0 million) after deducting underwriting discounts and commissions of €5.9 million ($7.0 million) and offering costs of €3.8 million ($4.5 million).

On April 19, 2021, underwriters of the Company’s IPO consummated the exercise of their option to purchase 425,712 common shares from the Company at the price of €12.60 or $15.00 per share resulting in additional IPO proceeds to the Company of €4.9 million ($5.9 million) after deducting underwriting discounts and commissions of €0.3 million ($0.4 million).

Note 5—License Liabilities

On February 25, 2021, the VUmc Agreement was restated, due to the Company’s IPO which triggered a €12.1 million payment (the VUmc payment). The VUmc payment was calculated as the following:

The Company shall issue common shares equal to €3.0 million divided by the IPO price and €200,000 in cash; and
On each of the first and second anniversary of the IPO, the Company shall pay €4.4 million. Such payment shall be made in cash or common shares, at the election of the Company, valued using the closing price of common shares on the date two trading days prior to the respective anniversary of the initial public offering.

During the nine months ended September 30, 2021, the Company issued 235,664 common shares at €12.73 per share representing the €3.0 million in accordance with the VUmc agreement. Of the remaining part of the VUmc payment of €9.1 million, €4.4 million was classified as a non-current liability and €4.4 million was classified as a current liability in the unaudited condensed consolidated interim statements of financial position as of September 30, 2021.

Note 6—Revenue

Research and License Revenue

In May 2020, the Company entered into the Janssen Agreement. As part of the Janssen Agreement, the Company received a non-refundable upfront payment of €7.4 million, which is being recognized on a straight-line basis over the two-year term of the research activities under agreement. As of September 30, 2021 there was €2.3 million of remaining unearned income related to this payment. During the three months ended September 30, 2021, we earned a €0.9 million research milestone under the agreement.

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Table of Contents

The Company’s deferred revenue balance relates to amounts received, but not yet earned under the Janssen Agreement. The following table presents changes in the deferred revenue balance (in thousands):

Balance at January 1, 2020

    

Deferral of revenue

 

7,397

Recognized during the period

 

(2,367)

Balance at December 31, 2020

 

5,030

Recognized during the period

 

(2,750)

Balance at September 30, 2021

2,280

Revenue for the nine months ended September 30, 2021 and 2020 was €3.6 million and €1.4 million, respectively, which related to the upfront payment.

Note 7—Research and Development Expenses

Research and development expenses for the three and nine months ended September 30, 2021 and 2020 were as follows (in thousands):

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2021

    

2020

    

2021

    

2020

Pre-clinical and clinical trial expenses

3,710

2,155

8,235

6,755

Personnel-related costs

 

1,295

 

536

 

3,142

 

1,186

Research and development activities expenses

 

424

 

229

 

1,048

 

669

Share-based compensation expense

 

168

 

25

 

472

 

92

Other expenses

 

117

 

185

 

506

 

438

VUmc license expenses

 

 

162

 

12,073

 

162

5,714

3,292

25,476

9,302

Note 8—General and Administrative Expenses

General and administrative expenses for the three and nine months ended September 30, 2021 and 2020 were as follows (in thousands):

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2021

    

2020

    

2021

    

2020

Personnel-related costs

1,066

521

2,215

1,196

Share-based compensation expense

 

909

 

28

 

1,999

 

211

Facilities, fees and other related costs

 

754

 

14

 

1,424

 

150

Professional and consultant fees

 

484

 

96

 

1,331

 

455

3,213

660

6,969

2,013

Note 9—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 2,373,633 stock options outstanding as of September 30, 2021 at a weighted-average exercise price of €3.93 per share. During the nine months ended September 30, 2021, 684,088 options were granted to employees and directors at a weighted-average exercise price of €10.10 per share.

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Table of Contents

Total compensation cost recognized for all stock option awards for the three and nine months ended September 30, 2021 and 2020 were as follows (in thousands):

Three Months Ended September 30, 

Nine Months Ended September 30, 

    

2021

    

2020

    

2021

    

2020

Research and development

168

25

472

92

General and administrative

 

909

 

28

 

1,999

 

211

1,077

53

2,471

303

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 nine months ended September 30, 2021:

Expected annual volatility

    

80.10%

Expected life, years

 

6.08

Dividend yield

 

Risk-free interest rate

 

(0.53%) - 1.18%

Weighted average grant date fair value

 

6.90

The Company estimates volatility based on the historical volatility of its peer group. The unrecognized remaining stock-based compensation balance for shares issued inside of the Plan was approximately $3.3 million as of September 30, 2021, which is expected to amortize over 1.5 years.

Note 10—Prepaid Expenses

Prepaid expenses as of September 30, 2021 and December 31, 2020 were as follows (in thousands):

September 30, 

December 31, 

    

2021

    

2020

Pre-clinical and clinical trial expenses

2,133

 

Insurance expenses

 

1,406

 

License fees

 

 

44

Interest income receivable

221

Other expenses

 

24

 

51

3,784

95

Note 11—Investments in Debt Securities

Our investments in debt securities consist entirely of investments in highly-rated corporate bonds, with maturities ranging from three months to one year. All of these investments are classified as current assets on our condensed consolidated interim statements of financial position. As of September 30, 2021 the carrying value and fair value of our investments each was €36.2 million.

All investments in debt securities have investment-grade credit quality indicators as published by Moody’s and Standard & Poor’s (S&P). As of September 30, 2021, our investments in debt securities had credit quality indicators ranging from A3 – AAA as published by Moody’s, and A- - AAA as published by S&P. Given the high quality ratings of these investments in debt securities, we have not recorded an allowance for credit losses as of September 30, 2021.

Note 12—Share Capital

The share capital of LAVA Therapeutics N.V. consisted of 25,775,538 outstanding common shares at a nominal value of €0.12 per share as of September 30, 2021.

11


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 years ended December 31, 2020 and 2019, including the notes thereto, included in our Registration Statement on Form F-1 (File No. 333-253795). 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 unaudited condensed consolidated interim 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 subsidiaries, 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 discussion 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 a number of places in this discussion 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 Registration Statement on Form F-1 for the years ended December 31, 2020 and 2019. 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 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 expectations regarding the impact of the COVID-19 pandemic on our business, our industry and the economy;
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 such product candidates;
our continued reliance on third parties to conduct clinical trials of our product candidates and manufacture our product 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 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.”

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.

Overview

We are a clinical-stage biotechnology company focused on transforming cancer treatment by developing a platform of novel bispecific antibodies designed to selectively induce gamma-delta T cell-mediated immunity against cancer cells. Our GammabodyTM platform consists of bispecific antibodies that activate Vγ9Vδ2 T cells, a relatively abundant effector T cell subset, upon cross-linking to a selected tumor target. Vγ9Vδ2 T cells have a natural ability to distinguish tumor cells from healthy cells by sensing certain intracellular metabolites that are enriched in cancer cells. Activated Vγ9Vδ2 T cells are engaged for direct tumor cell killing and, in addition, can orchestrate an immunological cascade response that includes activation of innate and adaptive immune cells in the tumor microenvironment. Our preclinical data demonstrate that our GammabodyTM platform conditionally triggers Vγ9Vδ2 T cell activation and potent and specific killing of patient-derived tumor cells. We believe this provides a significant opportunity to address unmet medical needs with the potential to elicit potent and durable responses in patients. Pre-clinical data to-date suggest that our bi-specific approach may provide a superior therapeutic window compared to other approaches by avoiding on target/off tumor mediated toxicity, cytokine release syndrome (CRS) and activation of regulatory T cells. We believe we are the only company with bispecific gamma-delta T cell engaging antibodies in clinical development for the treatment of cancer.

In July 2021, we dosed the first patient in the Phase 1/2a clinical trial of our lead investigational candidate, LAVA-051, in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and, later in the study, acute myeloid leukemia (AML). The open-label, multi-center, Phase 1/2a clinical trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary antitumor activity of LAVA-051. The Phase 1 dose-escalation portion will determine an optimal Phase 2 dose of LAVA-051. Once a recommended Phase 2 dose has been established, the trial will expand into the Phase 2a portion, which will enroll patients in three disease specific cohorts for relapsed and/or refractory CLL, MM and AML, to confirm safety and evaluate preliminary antitumor activity in each disease cohort. The Phase 1/2a clinical trial for LAVA-051 is initially being conducted in Europe, where we have already received regulatory approval for our Clinical Trial Application (CTA). We expect to file an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA), which if accepted, will subsequently expand the trial to include patients in the United States. In October 2021, the FDA granted orphan drug designation for LAVA-051 for the treatment of CLL. We currently expect to have data from the Phase 1 dose escalation phase of the trial in the first half of 2022 with top line clinical data from the Phase 2a expansion cohorts expected in the second half of 2022.


We are initiating a Phase 1/2a clinical trial to evaluate LAVA-1207 in patients with metastatic castration-resistant prostate cancer and expect to enroll our first patient in the fourth quarter of 2021. The open-label, multi-center, Phase 1/2a clinical trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary antitumor activity of LAVA-1207. The Phase 1 dose-escalation portion will determine a recommended optimal Phase 2 dose of LAVA-1207. Once a recommended Phase 2 dose has been established, the trial will expand into the Phase 2a portion to confirm safety and evaluate preliminary antitumor activity. The Phase 1/2a clinical trial for LAVA-1207 will be initially conducted in Europe and will later expand to sites in the United States. We have received regulatory approval for our CTA and the FDA has accepted our IND for the Phase 1/2a clinical trial for LAVA-1207.

In addition to our two lead programs, we are developing a portfolio of earlier stage programs; including LAVA-1223, a GammabodyTM directed at the epidermal growth factor receptor (EGFR) for the treatment of solid tumors, for which we intend to file a CTA and/or IND in late 2022.

We were incorporated in February 2016 in 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, including €29.8 million for the nine months ended September 30, 2021. As of September 30, 2021, we had an accumulated deficit of €59.2 million.

Factors affecting our Financial Condition and Results of Operations

Impact from COVID-19 Pandemic

Our financial condition and results of operations are most affected by our capital resources, continued research and development expenses and general and administrative expenses. Although the COVID-19 pandemic has impacted the timing of onboarding investigational sites and enrolling patients in our ongoing Phase 1/2a clinical trial for LAVA-051, to date we have not experienced any material business disruption as a result of the COVID-19 pandemic.

Comparison of the Three Months Ended September 30, 2021 and 2020 (unaudited):

Research and license revenue

Our research and license revenue increased to €1.8 million for the three months ended September 30, 2021 compared to €0.8 million for the three months ended September 30, 2020. Research and license revenue is solely attributable to our collaboration with Janssen Biotech, Inc., which we entered into in May 2020. In connection with this collaboration, we received a non-refundable upfront payment of €7.4 million that is being recognized on a straight-line basis over the two-year term of the research activities under agreement. As of September 30, 2021, we had €2.3 million of unearned income related to this payment. During the three months ended September 30, 2021 we earned a €0.9 million research milestone under the agreement and we may in the future receive other research, development and commercial milestones and tiered royalty payments under the agreement.

Research and development expenses

Below are our research and development expenses for the three months ended September 30, 2021 and 2020 (in thousands):

    

Three Months Ended

    

    

September 30, 

    

2021

    

2020

    

Variance

Pre-clinical and clinical trial expenses

3,710

2,155

1,556

Personnel-related costs

 

1,295

 

536

 

759

Research and development activities expenses

 

424

 

229

 

195

Share-based compensation expense