SEC Filing - LAVA Therapeutics N.V.

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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of such registration statement) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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

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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

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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

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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

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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, 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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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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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.

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.

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 Gammabody^TM 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 Gammabody^TM 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 Gammabody^TM 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		168		25		143
Other expenses		117		185		(68)
VUmc license expenses		—		162		(162)
	€	5,714	€	3,292	€	2,422

Research and development expenses were €5.7 million for the three months ended September 30, 2021, compared to €3.3 million for the three months ended September 30, 2020. Pre-clinical and clinical trial expenses increased by €1.6 million primarily due to the start of the clinical trial for LAVA-051, clinical development preparations for LAVA-1207 and partner project expenses. The increase was furthermore due to our personnel-related costs, which increased by €0.8 million due to increased research and development headcount and associated non-cash share-based compensation expense, which increased by €0.1 million.

General and administrative expenses

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


	Three Months Ended
	September 30,
	2021		2020		Variance
Personnel-related costs	€	1,066	€	521	€	545
Share-based compensation expense		909		28		881
Facilities, fees and other related costs		754		14		740
Professional and consultant fees		484		96		387
	€	3,213	€	660	€	2,553

General and administrative expenses were €3.2 million for the three months ended September 30, 2021, compared to general administrative expenses of €0.7 million for the three months ended September 30, 2020. The increase was primarily due to the increase in share-based compensation expense of €0.9 million and personnel-related costs of €0.5 million due to the increase in general and administrative headcount. The professional and consultant fees increased by €0.4 million due to increased legal and assurance services, primarily due to becoming a publicly traded company. Facilities, fees and other related costs increased by €0.7 million, including €0.5 million of insurance costs that were in earlier periods allocated to research and development expenses that have been reclassified to general and administrative expenses.

Foreign currency exchange loss, net

Our foreign currency exchange loss was €0.2 million for the three months ended September 30, 2021, compared to €0.1 million for the three months ended September 30, 2020. The activity was primarily due to our U.S. Dollar denominated cash and investment accounts, foreign exchange cash activity with our U.S. subsidiary as well as transactions with vendors whose functional currency is not the Euro.

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

Research and license revenue

Our research and license revenue increased to €3.6 million for the nine months ended September 30, 2021 compared to €1.4 million for the nine 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 nine months ended September 30, 2021 and 2020 (in thousands):


	Nine Months Ended
	September 30,
	2021		2020		Variance
Pre-clinical and clinical trial expenses	€	8,235	€	6,755	€	1,481
Personnel-related costs		3,142		1,186		1,956
Research and development activities expenses		1,048		669		379
Share-based compensation expense		472		92		380
Other expenses		506		438		68
VUmc license expenses		12,073		162		11,911
	€	25,476	€	9,302	€	16,174

Research and development expenses were €25.5 million for the nine months ended September 30, 2021, compared to €9.3 million for the nine months ended September 30, 2020. The increase was primarily due to a VUmc license fees liability of €12.0 million triggered by our initial public offering (“IPO”). Our personnel-related costs increased by €2.0 million due to increased research and development headcount and associated non-cash share-based compensation expense increased by €0.4 million. Pre-clinical and clinical trial expenses increase by €1.5 million primarily due to the start of the clinical trial for LAVA-051 and clinical development preparations for LAVA-1207 and partner project expenses.

General and administrative expenses

Below are our general and administrative expenses for the nine months ended September 30, 2021 and 2020 (in thousands):


	Nine Months Ended
	September 30,
	2021		2020		Variance
Personnel-related costs	€	2,215	€	1,196	€	1,019
Share-based compensation expense		1,999		211		1,788
Facilities, fees and other related costs		1,424		150		1,274
Professional and consultant fees		1,331		455		875
	€	6,969	€	2,013	€	4,956

General and administrative expenses were €7.0 million for the nine months ended September 30, 2021, compared to general administrative expenses of €2.0 million for the nine months ended September 30, 2020. The increase was primarily due to the increase in personnel-related costs of €1.0 million and the share-based compensation expense of €1.8 million due to the increase in general and administrative headcount. The professional and consultant fees increased by €0.9 million due to increased legal and assurance services primarily due to becoming a publicly traded company. Facilities, fees and other related costs increased by €1.3 million primarily due to insurance costs, including €0.5 million of insurance costs that were in earlier periods allocated to research and development that have been reclassified to general and administrative expense.

Foreign currency exchange loss, net

Our foreign currency exchange loss was €0.5 million for the nine months ended September 30, 2021, compared to €0.4 million foreign currency exchange loss for the three months ended September 30, 2020. The activity was primarily due to our U.S. Dollar denominated cash and investment accounts, foreign exchange cash activity with our U.S. subsidiary as well as transactions with vendors whose functional currency is not the Euro.

Liquidity and Capital Resources

As of September 30, 2021, we had cash, cash equivalents and investments totaling €122.7 million compared to cash and cash equivalents of €12.9 million as of December 31, 2020. We have historically funded our operations primarily through issuance of preference shares prior to our IPO and from the sale of common shares in our IPO. Our expenditures are primarily related to research and development activities and general and administrative activities to support business operations.

In March 2021, we closed our IPO and received net proceeds from the IPO of 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 April 2021, we received additional net proceeds from the IPO of €4.9 million ($5.9 million) from the exercise of the overallotment option from the underwriters. In addition, we received €47.2 million in net proceeds from our Series C financing, net of repurchasing Series A Preferred and common shares.

Based on our current operating plan, we believe that our existing cash and cash equivalents as of September 30, 2021 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 candidates, including LAVA-051, LAVA-1207 and LAVA-1223;

●

initiate, conduct and complete any ongoing, anticipated or future preclinical studies and clinical trials for our current and future product candidates;

●

seek regulatory and marketing approvals for LAVA-051, LAVA-1207 and any of our other product candidates that successfully complete clinical trials;

●

maintain, protect and expand our intellectual property portfolio;

●

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;

●

seek to identify, discover, develop and commercialize additional product candidates;

●

hire and retain additional clinical, regulatory and scientific personnel;

●

add 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; and

●

develop a potential companion diagnostic.

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 table summarizes our cash flows for each of the unaudited nine months periods ended September 30, 2021 and 2020 (in thousands):


	For the Nine Months Ended
	September 30,
	2021		2020
Net cash used in operating activities	€	(19,427)	€	(1,914)
Net cash used in investing activities		(36,792)		(378)
Net cash provided by financing activities		129,171		16,053
Net increase in cash and cash equivalents	€	72,952	€	13,761

Cash Flows Used in by Operating Activities

Net cash used in operating activities for the nine months ended September 30, 2021 was €19.4 million compared to net cash used in operating activities of €1.9 million for the nine months ended September 30, 2020. The increase was primarily due to an increase in loss before income tax of €19.2 million, partially offset by an increase of €2.1 million of increased operating expenses including share-based compensation, depreciation, lease amortization and foreign currency exchange and a decrease in changes in working capital of €0.4 million.

Cash Flows Used in Investing Activities

Cash flows used in investing activities for the nine months ended September 30, 2021 were €36.8 million compared to €0.4 million for the nine months ended September 30, 2020. During the nine months ended September 30, 2021, we purchased €36.3 million in investments in debt securities. We also made equipment purchases of €0.5 million and €0.4 million for the nine months ended September 30, 2021 and 2020, respectively.

Cash Flows Provided by Financing Activities

Cash flows provided by financing activities for the nine months ended September 30, 2021 of €129.2 million were primarily comprised of net proceeds from our IPO, including the exercise of the underwriters’ over-allotment option of €81.2 million, net proceeds from the Series C financing of €51.8 million and proceeds from borrowings of €0.6 million, less payment of €4.6 million for the Series A share repurchases.

Cash flows provided by financing activities for the nine months ended September 30, 2020 of €16.1 million was primarily related to net proceeds from our Series C preferred financing of €18.9 million and proceeds from debt borrowings of €1.3 million, offset by Series A preferred payments and common stock repurchases of €4.1 million.

Off-Balance Sheet Arrangements

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

Qualitative Disclosures about Market Risk

Our activities expose us to the financial risks of changes in foreign currency exchange rates and interest rates. 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 the U.S. Dollar. We have received payments in U.S. Dollars under our collaborations and the proceeds from our initial public offering in March 2021 was in U.S. Dollars. 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 an interest-bearing debt to 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 individual 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. We also hold investments in debt securities with highly-rated corporate entities. All of these investments hold investment-grade ratings as published by Moody’s and Standard & Poor’s. The 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.

In March 2021, after the closing of the IPO, we transferred a portion of our bank deposits into a money market fund invested in short-term U.S. Treasury securities to further diversify the credit risk. As the securities are short-term with a maturity of three months or less at the date of acquisition, they are classified as cash and cash equivalents in the statement of financial position. In order to manage and reduce credit risk on marketable securities, our investment policy only allows investment in securities with high credit ratings assigned by international credit-rating agencies. Because of the nature of the securities, high credit ratings and the short-term duration, the risk of expected credit loss is deemed low. Accordingly, no provision for expected credit loss has been made.

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, and by continuously monitoring our cash forecasts and actual cash flows, and by 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 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.

RISK FACTORS

The risk factors set forth under the caption “Risk Factors” in the final prospectus for the Company’s IPO filed by the Company pursuant to Rule 424(b)(4) on March 26, 2021 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, also may affect its business, financial condition and/or future operating results.

Exhibit 99.3

LAVA THERAPEUTICS PROVIDES BUSINESS UPDATE AND REPORTS THIRD QUARTER FINANCIAL RESULTS

LAVA-051 Phase 1/2a trial actively enrolling in hematological malignancies on track to report initial data in H1 2022

LAVA-1207 Phase 1/2a trial in metastatic castrate resistant prostate cancer on track to begin enrolling later this quarter

LAVA-051 granted orphan drug designation by the U.S. FDA for the treatment of CLL

Cash and investments of $142 million as of Sept. 30, 2021

Utrecht, The Netherlands and Philadelphia, USA – NOV. 15, 2021 – LAVA Therapeutics N.V. (Nasdaq: LVTX), a clinical-stage biotechnology company focused on developing its proprietary Gammabody™ platform of bispecific gamma delta T cell engagers (bsTCEs) to transform the treatment of cancer, today announced financial results for the third quarter ended Sept. 30, 2021 and recent corporate highlights.

“This was a transformational quarter for LAVA,” said Stephen Hurly, president and chief executive officer. “With our lead Gammabody^TM program in the clinic and actively enrolling patients in hematological malignancies and our second program on track to enroll its first prostate cancer patient later this quarter, LAVA is poised for potential product and platform validating data milestones in 2022. Our progress in the clinic, along with our recent senior leadership hires and strong balance sheet, position us well to execute on our mission to unlock the value of our Gammabody^TM platform to deliver transformative treatments to those suffering from cancer.”

Recent Business and Pipeline Highlights

LAVA-051 Phase 1/2a Trial on Track: Enrollment is ongoing in the Phase 1/2a clinical trial (NCT04887259) evaluating LAVA-051 in hematological malignancies. The trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary antitumor activity of LAVA-051. Data from the Phase 1 dose escalation phase of the trial are expected in the first half of 2022 and top line data from the Phase 2a expansion cohorts in the second half of 2022. The trial was initiated in July 2021 in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and multiple myeloma (MM) and will, later in the trial, also include patients with acute myeloid leukemia (AML).

LAVA-051 Granted U.S. FDA Orphan Drug Designation: On October 15, the company announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to LAVA-051 for the treatment of CLL, a rare form of leukemia characterized by progressive accumulation of abnormal lymphocytes in the peripheral blood, bone marrow and lymphoid tissues. This orphan drug designation from the FDA qualifies LAVA for various incentives related to the development of LAVA-051, including tax credits for qualified clinical trials, exemption from user fees and the potential for seven years of U.S. market exclusivity for the treatment of CLL.

LAVA-1207 Phase 1/2a Trial Plans on Track: LAVA is on track to initiate the company’s Phase 1/2a clinical trial of LAVA-1207 in patients with metastatic castration-resistant prostate cancer (mCRPC) later in the fourth quarter. LAVA-1207 is a Gammabody™ that targets the prostate specific membrane antigen (PSMA) and has demonstrated preclinical proof-of-concept in a variety of preclinical models to support acceptance of a CTA/IND to study in humans. The open-label, multi-center, Phase 1/2a clinical trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary antitumor activity of LAVA-1207 in patients with mCRPC. The Phase 1 dose-escalation portion of the study will determine the recommended Phase 2 dose/schedule to be used in the subsequent Phase 2a expansion cohort to confirm safety and tolerability of LAVA-1207 in mCRPC patients.

Strategic Management Team Expansion with Three Key Appointments: On November 9, the company announced three strategic appointments to the management team.

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Jessica Truscello, vice president of clinical operations, brings more than 22 years of clinical trial and clinical operations experience to LAVA and most recently served six years at Immunocore where she supported first-in-human programs through pivotal and late-stage programs and the successful development of their clinical compliance program.

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Sumeet Ambarkhane, M.D., executive medical director, a clinical development physician with more than 17 years of experience with expertise in oncology, hemato-oncology and immunology. Dr. Ambarkhane was previously at MorphoSys, where he led medical and clinical strategy for its hemato-oncology clinical development program.

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Wouter van Hunnik, vice president of human resources, joins the company from Philips with more than 15 years of experience in building excellence and taking innovative approaches to human resources (HR) recruitment, culture shaping and capability building.

Third Quarter Financial Results

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Cash, cash equivalents and investments were €122.7 million as of Sept. 30, 2021, compared to €12.9 million as of Dec. 31, 2020. The increase in cash and cash equivalents was attributable to proceeds from the Series C financing and subsequent IPO during the first quarter of 2021, partially offset by operating expenses.

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Research and license revenue increased to €1.8 million and €3.6 million for the three and nine months ended Sept. 30, 2021, respectively, compared to €0.8 million and €1.4 million for the three and nine months ended Sept. 30, 2020. Research and license revenue is solely attributable to the company’s collaboration with Janssen Biotech, Inc., which was entered into in May 2020. During the three months ended Sept. 30, 2021, the company earned a €0.9 million research milestone under the agreement.

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Research and development expenses were €5.7 million and €25.5 million for the three and nine months ended Sept. 30, 2021, respectively, compared to €3.3 million and €9.3 million for the three and nine months ended Sept. 30, 2020. The increase for the three months ended Sept. 30, 2021, was primarily due to increases in headcount and costs associated with the commencement of our LAVA-051 clinical trial. The increase for the nine months ended Sept. 30, 2021 was additionally due to license fees of €12.0 million triggered by the IPO, most of which will be paid on the first and second anniversaries of the IPO and may be paid in either cash or common stock of the Company.

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General and administrative expenses were €3.2 million and €7.0 million for the three and nine months ended Sept. 30, 2021, respectively, compared to general administrative expenses of €0.7 million and €2.0 million for the three and nine months ended Sept. 30, 2020. The increase in both periods is primarily due to the increase in personnel-related costs, non-cash share-based compensation expense and additional costs associated with being a publicly traded company in the United States.

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Net loss was €7.5 million and €29.8 million, or €0.23 and €1.62 loss per share for the three and nine months ended Sept. 30, 2021, respectively, compared to €3.4 million and €10.5 million, or €8.43 and €24.38 loss per share, for the three and nine months ended Sept. 30, 2020.

About LAVA Therapeutics

LAVA Therapeutics N.V. 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. A Phase 1/2a clinical study evaluating LAVA-051 in patients with certain hematological malignancies is currently enrolling (NCT04887259). The company currently anticipates data from the Phase 1 dose escalation phase of the study in the first half of 2022 with top line clinical data from the Phase 2a expansion cohorts expected in the second half of 2022. The company plans to initiate a Phase 1/2a clinical study to evaluate LAVA-1207 in patients with prostate cancer in the fourth quarter of 2021. For more information, please visit www.lavatherapeutics.com and follow us on LinkedIn and Twitter.

LAVA’s Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements, including in respect of the company’s anticipated growth and clinical developments plans, including the timing of clinical trials. Words such as “anticipate,” “believe,” “could,” “will,” “may,” “expect,” “should,” “plan,” “intend,” “estimate,” “potential” 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 about the preclinical data, clinical development and scope of clinical trials, and the potential use of our product candidates to treat various tumor targets. Many factors, risks and uncertainties may cause differences between current expectations and actual results including, among other things, the timing and results of our research and development programs and preclinical and clinical trials, our ability to obtain regulatory approval for and commercialize our product candidates, our ability to leverage our initial programs to develop additional product candidates using our Gammabody^TMplatform, and the failure of LAVA’s collaborators to support or advance collaborations or our product candidates. In addition, the COVID-19 pandemic may disrupt our business and that of the third parties on which we depend, including delaying or otherwise disrupting our clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity.

LAVA assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

LAVA Therapeutics N.V.

Unaudited Condensed Consolidated Interim Statements of Loss and Comprehensive Loss

EUR (000’s)


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2021		2020		2021		2020
Revenue
Research and license revenue	€	1,781	€	827	€	3,599	€	1,419
Total revenue		1,781		827		3,599		1,419
Operating expenses:
Research and development		(5,714)		(3,292)		(25,476)		(9,302)
General and administrative		(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)
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

LAVA Therapeutics N.V.

Condensed Consolidated Interim Statements of Financial Position

EUR (000’s)


	September 30,		December 31,
	2021		2020
	(unaudited)			(1)
Assets
Non-current assets	€	2,274	€	1,843
Other current assets		5,258		1,959
Cash, cash equivalents and investments		122,683		12,881
Total assets	€	130,215	€	16,683

Equity and Liabilities
Total Equity	€	110,781	€	6,207

Deferred revenue		2,280		5,030
Lease liabilities		569		389
License liabilities		8,873		—
Borrowings		3,519		2,935
Trade payables and other		1,646		760
Accrued expenses and other current liabilities		2,547		1,362
Total liabilities		19,434		10,476

Total equity and liabilities	€	130,215	€	16,683

(1)

Derived from the audited consolidated financial statements of LAVA Therapeutics N.V. for the year ended December 31, 2020, included on the Form F-1 filed with the Securities and Exchange Commission on March 29, 2021.

CONTACTS

Edward SmithCatherine Day

Chief Financial Officer+1-917-763-2709

ir@lavatherapeutics.comcatherine@newdaybioconsulting.com