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 2022

(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 ☐

LAVA Therapeutics, N.V.

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such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

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

RISK FACTORS

Our business faces significant risks. You should carefully consider all of the information set forth in this report and in our other filings with the United States Securities and Exchange Commission, 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, 2022 and 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, 2022 and 2021
99.3		Press Release dated November 15, 2022

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 16, 2022	By:	/s/ Fred Powell
	Fred Powell
	Chief Financial Officer

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Exhibit 99.1

LAVA THERAPEUTICS N.V.

INDEX TO UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

	Page
Condensed Consolidated Interim Statements of Profit and Loss and Comprehensive Profit and Loss (unaudited)	2
Condensed Consolidated Interim Statements of Financial Position (unaudited)	3
Condensed Consolidated Interim Statements of Changes in Equity (unaudited)	4
Condensed Consolidated Interim Statements of Cash Flows (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 Profit and Loss

and Comprehensive Profit and Loss

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


		Three Months Ended				Nine Months Ended
		September 30,				September 30,
	Notes	2022		2021		2022		2021
Revenue:
Research and license revenue	6	$	15,261	$	2,095	$	16,751	$	4,284
Total revenue			15,261		2,095		16,751		4,284
Operating expenses:
Research and development	7		(13,675)		(6,703)		(29,619)		(30,311)
General and administrative	8		(3,096)		(3,760)		(10,410)		(8,250)
Total operating expenses			(16,771)		(10,463)		(40,029)		(38,561)

Operating profit (loss)			(1,510)		(8,368)		(23,278)		(34,277)
Interest income (expense), net			39		(158)		(214)		(474)
Foreign currency exchange gain, net			2,515		1,637		6,763		715
Total non-operating income			2,554		1,479		6,549		241

Profit (loss) before income tax			1,044		(6,889)		(16,729)		(34,036)
Income tax expense			(47)		(44)		(182)		(100)
Profit (loss) for the year		$	997	$	(6,933)	$	(16,911)	$	(34,136)
Foreign currency translation adjustment			(5,359)		(3,317)		(14,220)		(2,748)
Total comprehensive profit (loss)		$	(4,362)	$	(10,250)	$	(31,131)	$	(36,884)
Profit (Loss) per share:
Profit (loss) per share, basic		$	0.04	$	(0.27)	$	(0.66)	$	(1.93)
Weighted-average common shares outstanding, basic			25,845,802		25,775,538		25,800,973		17,730,337
Profit (loss) per share, diluted		$	0.04		(0.27)		(0.66)		(1.93)
Weighted-average common shares outstanding, diluted			26,446,259		25,775,538		25,800,973		17,730,337

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

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LAVA Therapeutics N.V.

Condensed Consolidated Interim Statements of Financial Position

(in thousands) (unaudited)


		September 30,		December 31,
	Notes	2022		2021
Assets
Non-current assets:
Property and equipment, net		$	1,252	$	1,445
Right-of-use assets			326		501
Other non-current assets and security deposits			711		796
Total non-current assets			2,289		2,742
Current assets:
Receivables and other			50,590		363
Contract assets			2,212		—
Prepaid expenses and other current assets			1,611		2,568
Deferred financing costs			246		—
VAT receivable			217		371
Investments	10		28,392		42,334
Cash and cash equivalents			64,332		90,869
Total current assets			147,600		136,505
Total assets		$	149,889	$	139,247
Equity and Liabilities
Equity:
Share capital	11	$	3,715	$	3,653
Equity-settled employee benefits reserve			8,426		5,219
Foreign currency translation reserve			(20,444)		(6,223)
Additional paid-in capital			194,424		192,270
Accumulated deficit			(93,463)		(76,552)
Total equity			92,658		118,367
Non-current liabilities:
Deferred revenue	6		35,000		—
Lease liabilities			199		320
License liabilities	5		—		5,028
Borrowings			4,173		4,284
Total non-current liabilities			39,372		9,632
Current liabilities:
Trade payables and other			7,799		2,553
Lease liabilities			261		261
License liabilities	5		4,355		5,028
Deferred revenue	6		—		1,527
Accrued expenses and other current liabilities			5,444		1,879
Total current liabilities			17,859		11,248
Total liabilities			57,231		20,880
Total equity and liabilities		$	149,889	$	139,247

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

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LAVA Therapeutics N.V.

Condensed Consolidated Interim Statements of Changes in Equity

(in thousands, except share amounts) (unaudited)



					Equity-
					settled		Foreign
					employee		currency
		Common	Share		benefits		translation				Accumulated
	Note	shares	capital		reserves		reserve		APIC		deficit		Total
Balance at June 30, 2022		25,797,735	$	3,656	$	7,645	$	(15,085)	$	192,282	$	(94,460)	$	94,038
Profit for the period		—		—		—		—		—		997		997
Issuance of Vumc common stock		491,352		59		—		—		2,142		—		2,201
Foreign currency translation adjustment		—		—		—		(5,359)		—		—		(5,359)
Share-based compensation expense	9	—		—		781		—		—		—		781
Balance at September 30, 2022		26,289,087	$	3,715	$	8,426	$	(20,444)	$	194,424	$	(93,463)	$	92,658


					Equity-
					settled		Foreign
					employee		currency
		Common	Share		benefits		translation				Accumulated
	Note	shares	capital		reserves		reserve		APIC		deficit		Total
Balance at January 1, 2022		25,775,538	$	3,653	$	5,219	$	(6,223)	$	192,270	$	(76,552)	$	118,367
Loss for the period		—		—		—		—		—		(16,911)		(16,911)
Option exercises		22,197		3		—		—		12		—		15
Issuance of Vumc common stock		491,352		59		—		—		2,142		—		2,201
Foreign currency translation adjustment		—		—		—		(14,221)		—		—		(14,221)
Share-based compensation expense	9	—		—		3,207		—		—		—		3,207
Balance at September 30, 2022		26,289,087	$	3,715	$	8,426	$	(20,444)	$	194,424	$	(93,463)	$	92,658



					Equity-
					settled		Foreign
					employee		currency
		Common	Share		benefits		translation				Accumulated
	Note	shares	capital		reserves		reserve		APIC		deficit		Total
Balance at June 30, 2021		25,775,538	$	3,653	$	2,587	$	(13)	$	192,270	$	(61,009)	$	137,489
Loss for the period		—		—		—		—		—		(6,933)		(6,933)
Foreign currency translation adjustment		—		—		—		(3,316)		—		—		(3,316)
Share-based compensation expense	9	—		—		1,263				—		—		1,263
Balance at September 30, 2021		25,775,538	$	3,653	$	3,850	$	(3,329)	$	192,270	$	(67,942)	$	128,503

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														Equity-
		Preference												settled		Foreign
			Series A			Series B			Series C					employee		currency
		Series A	Share		Series B	Share		Series C	Share		Common	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	$	722	3,899,766	$	18,340	4,133,805	$	22,026	281,775	$	—	$	922	$	(582)	$	—	$	(33,807)	$	7,621
Loss for the period		—		—	—		—	—		—	—		—		—		—		—		(34,136)		(34,136)
Share split		—		(143)	—		(536)	—		(589)	—		1,308		—		—		(40)		—		—
Issuance of Series C preferred shares, net		—		—	—		—	9,945,221		60,373	—		1,425		—		—		—		—		61,798
Repurchase of Series A and common shares		(718,250)		(400)	—		—	—		—	(165,750)		(122)		—		—		(4,760)		—		(5,282)
Conversion of Preference shares		(319,345)		(179)	(3,899,766)		(17,804)	(14,079,026)		(81,810)	18,298,137		—		—		—		99,793		—		—
Issuance of common stock in initial public offering, net		—		—	—		—	—		—	6,700,000		947		—		—		87,779		—		88,726
Issuance of Greenshoe common stock											425,712		61						5,877				5,939
Issuance of VUmc common stock											235,664		34						3,621				3,656
Foreign currency translation adjustment		—		—	—		—	—		—	—		—		—		(2,747)				—		(2,747)
Share-based compensation expense	9	—		—	—		—	—		—	—		—		2,928		—		—		—		2,928
Balance at September 30, 2021		—	$	—	—	$	—	—	$	—	25,775,538	$	3,653	$	3,850	$	(3,329)	$	192,270	$	(67,943)	$	128,503

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

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LAVA Therapeutics N.V.

Condensed Consolidated Interim Statements of Cash Flows

(in thousands) (unaudited)


		Nine Months Ended September 30,
	Notes	2022		2021
Cash flows from operating activities:
Loss before income tax		$	(16,729)	$	(34,036)
Adjusted for:
Depreciation and amortization of non-current assets			315		235
Foreign currency exchange (gain), net			(6,763)		(715)
Amortization of right-of-use assets			195		179
Share-based compensation expense	9		3,207		2,930
Income tax expense			(181)		(99)
Amortization of premium on investments			135		184
Changes in working capital:
Receivables and other			(50,227)		(262)
VAT receivable			154		29
Contract assets			(2,212)		—
Prepaid expenses and other assets			1,042		(4,557)
Trade accounts payable and other			5,107		975
Deferred offering & financing costs			(106)		1,623
Deferred revenue	6		33,510		(3,288)
License liabilities			(2,828)		13,949
Other liabilities			3,689		1,640
Net cash used in operating activities			(31,692)		(21,213)
Cash flows from investing activities:
Purchases of property and equipment			(322)		(596)
Purchases of investments			(46,548)		(42,128)
Maturities of investments			60,355		—
Net cash provided by (used in) investing activities			13,485		(42,724)
Cash flows from financing activities:
Proceeds from option exercises			15		—
Proceeds from common shares from initial public offering, net	14		—		94,189
Proceeds from Series C financing, net			—		61,798
Payment of Series A preferred and common shares repurchased			—		(5,167)
Proceeds from borrowings			509		699
Payment of principal portion of lease liabilities			(225)		(197)
Net cash provided by financing activities			299		151,321
Net (decrease) increase in cash and cash equivalents			(17,908)		87,384
Cash and cash equivalents at the beginning of period			90,869		15,818
Effects of exchange rate changes			(8,629)		(2,836)
Cash and cash equivalents at end of period		$	64,332	$	100,366
Supplemental schedule of noncash operating and financing activities:
Issuance of 491,352 common shares to VUmc in lieu of payment for license liabilities		$	2,201	$	—
Issuance of 235,664 common shares to VUmc in lieu of payment for license liabilities		$	—	$	3,569

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

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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 immuno-oncology company utilizing its proprietary Gammabody™ platform to develop a portfolio of bispecific gamma delta T cell engagers 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.

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 Company’s common shares are listed for trading under the symbol “LVTX” on The Nasdaq Global Select Market.

The Audit Committee of the Company’s Board of Directors approved these unaudited condensed consolidated interim financial statements on November 14, 2022.

Note 2—Summary of Significant Accounting Policies

Basis of preparation

The unaudited condensed consolidated interim financial statements of the Company are prepared in accordance with International Accounting Standard 34, “Interim Financial Reporting” as issued by the International Accounting Standards Board. Certain information and disclosures normally included in the consolidated financial statements prepared in accordance with International Financial Reporting Standards (IFRS) have been condensed or omitted. Accordingly, these unaudited condensed consolidated interim financial statements should be read in conjunction with the Company’s annual consolidated financial statements for the years ended December 31, 2021 and 2020 and accompanying notes, which have been prepared in accordance with IFRS as issued by the International Accounting Standards Board.

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, 2021 and 2020.

The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting estimates and requires management to exercise its judgment in the process of applying the Company’s accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the unaudited condensed consolidated interim financial statements are disclosed in Note 3. The interim financial data as of September 30, 2022 and for the three and nine months ended September 30, 2022 and 2021 are unaudited. In the opinion of management, the interim financial data includes all adjustments, consisting only of normal recurring adjustments, necessary to a fair statement of the results for the interim periods.

License Revenue

We may enter into collaboration and licensing arrangements for research and development, manufacturing, and commercialization activities with counterparties for the development and commercialization of our product candidates. These arrangements may contain multiple components, such as (i) licenses, (ii) research and development activities, and (iii) the manufacturing of certain material. Payments

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pursuant to these arrangements may include non-refundable and refundable payments, payments upon the achievement of significant regulatory, development and commercial milestones, sales of product at certain agreed-upon amounts, and royalties on product sales.

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

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

Revision of immaterial misstatements

During the period ended June 30, 2022, the Company identified misstatements in its historical accounting for foreign currency translations in the consolidated financial statements for certain prior periods. Management evaluated the misstatements and concluded that they were immaterial, either individually or in the aggregate, to its current or previously issued consolidated financial statements. As a result, certain comparative amounts in the consolidated statements of profit and loss and comprehensive profit and loss, financial position, changes in equity and cash flows have been revised to correct for such immaterial misstatements with respect to foreign currency translations. Such revisions and their impact are disclosed more fully in Note 11, “Revision of Immaterial Misstatements.”

Going concern

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

Through September 30, 2022, the Company has funded its operations with proceeds from sales of equity, collaboration and licensing agreements, government grants and borrowings under various agreements. Since its inception, the Company has incurred recurring net losses. The Dutch Research and Development Act (WBSO) provides compensation for a part of research and development wages and other costs through a reduction in payroll taxes. WBSO grant amounts are offset against wages and salaries and included in research and development expenses in the condensed consolidated interim statements of profit and loss and comprehensive profit and loss.

As of September 30, 2022, the Company had an accumulated deficit of $93.5 million. The Company expects to continue to generate operating losses in the foreseeable future. The Company expects that its cash, cash equivalents and investments of $92.7 million as of September 30, 2022 will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months following the issuance of these financial statements. Accordingly, the condensed consolidated interim financial statements have been prepared on a going concern basis.

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

COVID-19

In March 2020, the COVID-19 virus caused a worldwide pandemic. Although the pandemic has impacted the timing of onboarding investigational sites and enrolling patients in our ongoing Phase 1/2a clinical trial for LAVA-051 and LAVA-1207, to date we have not experienced any material business disruption or impact to our condensed consolidated interim financial statements as a result of the pandemic.

As our financial condition and results of operations are most affected by our capital resources, continued research and development expenses and general and administrative expenses, the following may have an impact in the future:

●	availability of supplies and equipment for our laboratories;

●	availability of staff;

●	start dates and recruitment in our clinical trials due to risks of opening and available resources at clinical sites;

●	availability of study drug; and

●	fundraising and access to the capital markets.

Management will continue to closely monitor the impacts of the pandemic and, to its best ability, focus on implementing mitigating measures and contingency plans to limit and prevent any potential impact on our business operations as much as possible.

Cash and cash equivalents

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

Our objective in managing our cash resources (cash, cash equivalents and investments) is to preserve principal, achieve liquidity requirements, safeguard funds and optimize investment performance. 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 money market funds. Permitted investments include United States (U.S.) Treasury bills and agency debt obligations, securities issued by public corporations and Dutch, European Union, and other municipal debt obligations. 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.

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

Investments

As of September 30, 2022, 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 profit and loss.

Financial instruments

(i)

Financial assets

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

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

(ii)

Financial liabilities

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

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

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

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

(iii)

Fair value measurements

The Company does not hold any financial assets and financial liabilities other than those measured at amortized cost. Management assessed that the carrying values of the Company’s financial assets and financial liabilities measured at amortized cost are a reasonable approximation of their fair values.

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.

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

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sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates.

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

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

The key sources of estimation uncertainty that have a significant risk of causing a material adjustment to the carrying amount of assets and liabilities within the next financial year, primarily relate to recognition of accruals for manufacturing and clinical trial activities. No significant adjustments to accruals have been recognized during the first nine months of 2022 or 2021, due to conditions that existed as of December 31, 2021 or 2020, 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 2022 or 2021.

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, 2021 and 2020.

Note 4—Equity

On March 29, 2021, the Company completed an initial public offering (IPO) of common shares in the U.S. pursuant to its registration statement on Form F-1, as amended (File No. 333-253795). Pursuant to the registration statement, the Company issued and sold 6,700,000 shares of $0.14 par value common stock at a price of $15.00 per share. Net proceeds from the IPO were approximately $88.7 million after deducting underwriting discounts and commissions of $7.0 million and offering costs of $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 $15.00 per share resulting in additional IPO proceeds to the Company of $5.9 million after deducting underwriting discounts and commissions of $0.4 million.

In March 2021, the Company also received $56.6 million in proceeds from the Series C financing, net of repurchasing Series A Preferred shares and common shares. Prior to the IPO in March 2021, all outstanding series of preferred shares were converted to common shares.

The share capital of LAVA Therapeutics N.V. consisted of 26,289,087 outstanding common shares at a nominal value of $0.14 per share as of September 30, 2022.

Note 5—License Liabilities

On February 25, 2021, the license and assignment agreement with Stichting VUmc (VUmc) was restated, due to the Company’s IPO which triggered a $11.9 million payment (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 pay $0.2 million in cash, which was executed and paid in 2021; and

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●

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 IPO.

The first of the $4.4 million payments became due to VUmc in March 2022 and was settled through the issuance of 491,352 shares of common stock and $2.2 million in cash in August 2022. The second VUmc IPO anniversary payment is classified as a current liability in the unaudited condensed consolidated interim statements of financial position as of September 30, 2022.

Note 6—Revenue

Seagen Agreement

In September 2022, the Company entered into an exclusive license agreement (Seagen Agreement) with Seagen Inc. (Seagen). Under the Seagen Agreement, we granted an exclusive, royalty-bearing license of our compound, LAVA-1223. As compensation for this license, Seagen agreed to pay to us a nonrefundable upfront payment of $50.0 million. We are also entitled to receive up to $650.0 million in sales and development milestone payments, reimbursement of up to $6.5 million for certain research, development and manufacturing activities and royalties ranging from the single digits to the mid-teens on future sales. We also have an option, after certain clinical data become available from Seagen, to pay a one-time buy-up fee of $35.0 million to increase the future royalty percentages under this agreement. If we exercise this option in the future, certain future milestones will be decreased by 30%.

In connection with the Seagen Agreement, we recognized $15.3 million in revenue for the three and nine months ended September 30, 2022. Of that amount, $15.2 million related to the nonrefundable upfront payment and $0.1 million related to reimbursement for research activities. We determined that the one-time buy-up fee of $35.0 represents variable consideration, for which we have deferred revenue recognition until such time the option is exercised or expires. Accordingly, we established a receivable of $50.0 million and a deferred revenue liability of $35.0 million on our condensed consolidated interim statement of financial position as of September 30, 2022. The nonrefundable upfront payment was received in October 2022. We also established a contract asset of $2.2 million related to the initial drug supply of LAVA-1223 that is expected to be transferred to Seagen to fulfill their obligations under the Seagen Agreement.

Janssen Agreement

In May 2020, the Company entered into a research collaboration and license agreement (Janssen Agreement) with Janssen Biotech, Inc. (Janssen). As part of the Janssen Agreement, the Company received a non-refundable upfront payment of $8.0 million, which is being recognized on a straight-line basis over the two-year term of the research activities under the agreement. Revenues for the three months ended September 30, 2022 and 2021 were $0.0 million and $2.1 million, respectively. Revenues for the nine months ended September 30, 2022 and 2021 were $1.5 million and $4.3 million, respectively. The revenues were related to the upfront payment and also included a $1.0 million research milestone during the three months ended September 30, 2021. The straight-line method of recognition materially approximates the cost to cost method of revenue recognition. As of September 30, 2022, we had no remaining unearned income related to this payment. Revenue for the three and nine months ended September 30, 2021 have been revised for certain immaterial misstatements relating to foreign currency translation. Further information regarding the misstatements and related revision is included in Note 11 - Revision of Immaterial Misstatements.

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Note 7—Research and Development Expenses

Research and development expenses were as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2022		2021		2022		2021
Pre-clinical and clinical trial expenses	$	10,943	$	4,371	$	20,926	$	9,829
Personnel-related expenses		1,296		1,505		4,236		3,722
Research and development activities expenses		675		500		1,706		1,249
Share-based compensation expense		372		195		1,651		559
Facilities and other research and development expenses		389		132		1,100		610
VUmc license expenses		—		—		—		14,342
	$	13,675	$	6,703	$	29,619	$	30,311

Note 8—General and Administrative Expenses

General and administrative expenses were as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2022		2021		2022		2021
Personnel-related expenses	$	1,047	$	1,224	$	3,991	$	2,599
Professional and consultant fees		930		594		2,664		1,584
Insurance, facilities, fees and other related costs		711		874		2,199		1,698
Share-based compensation expense		408		1,068		1,556		2,369
	$	3,096	$	3,760	$	10,410	$	8,250

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 3,442,427 stock options outstanding as of September 30, 2022, at a weighted-average exercise price of $4.23 per share. During the nine months ended September 30, 2022, 488,458 options were granted to employees at a weighted-average exercise price of $5.15 per share. During the nine months ended September 30, 2022, 22,197 stock options were exercised and 514,467 stock options were forfeited at a weighted-average exercise price of $0.76 and $9.81 per share, respectively.

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


	Three Months Ended September 30,				Nine Months Ended September 30,
(in thousands)	2022		2021		2022		2021
Research and development	$	373	$	195	$	1,651	$	559
General and administrative		408		1,068		1,556		2,369
	$	781	$	1,263	$	3,207	$	2,928

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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 current quarter:


		September 30, 2022
Expected annual average volatility		83.80%
Expected life, years		6.08
Dividend yield		—
Risk-free interest rate		1.65% - 3.63%
Weighted average grant date fair value	$	3.66

The Company estimates volatility based on the historical volatility of its peer group. The unrecognized remaining stock-based compensation balance for shares issued from all option plans was approximately $3.0 million as of September 30, 2022, which is expected to amortize over a weighted-average 0.92 years.

Note 10—Investments

Our investments in debt securities consist of investments in U.S. Treasury securities, with maturities ranging from three months to one year. All of these investments are classified as held to maturity and recorded in current assets on our condensed consolidated interim statements of financial position at amortized cost. As of September 30, 2022, the carrying value of our investments were $28.4 million, which approximates fair value. Given the high quality ratings of these investments in debt securities, we have not recorded an allowance for credit losses as of September 30, 2022.

Note 11 – Revision of Immaterial Misstatements

In connection with the preparation and review of the Company's condensed consolidated interim financial statements for the three and six months ended June 30, 2022 and 2021, management identified certain immaterial misstatements in our historical financial statements primarily related to the accounting for foreign currency exchange gains and losses associated with cash balances held in USD at LAVA Therapeutics, N.V. with a functional currency of Euro. We incorrectly computed and recorded the foreign exchange gain (loss) from our USD cash account in a Euro functional entity as foreign currency translation adjustment instead of foreign currency gain (loss). We also previously reported research and license revenue at the incorrect exchange rate. In accordance with the guidance set forth in Securities and Exchange Commission (SEC) Staff Accounting Bulletin (SAB) 99, Materiality, and SEC SAB 108, Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financials, the Company concluded these misstatements were not material to the previously issued condensed consolidated interim financial statements. We are revising our historical financial statements to revise the immaterial misstatements.

The revision for the foreign currency exchange misstatements did not have an impact on comprehensive loss or total equity as of and for the three and nine months ended September 30, 2022, or any prior periods. As a result of these immaterial misstatements, net loss for the three and nine months ended September 30, 2021 were understated by $1.9 million and $1.4 million, respectively, and research and license revenue for the three and nine months ended September 30, 2021 was understated by $0.1 million and $0.3 million, respectively.

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In the Condensed Consolidated Interim Statement of Profit and Loss and Comprehensive Profit and Loss, we have revised the following:


	Three Months Ended						Nine Months Ended
	September 30, 2021						September 30, 2021
	As reported			Adjustment	As revised		As reported			Adjustment	As revised
(in thousands)
Research and license revenue	$	2,000	$	95	$	2,095	$	4,000	$	284	$	4,284
Total revenue	$	2,000	$	95	$	2,095	$	4,000	$	284	$	4,284
Operating loss	$	(8,463)	$	95	$	(8,368)	$	(34,561)	$	284	$	(34,277)
Foreign currency exchange gain (loss), net	$	(123)	$	1,760	$	1,637	$	(363)	$	1,078	$	715
Total non-operating income (expenses)	$	(281)	$	1,760	$	1,479	$	(837)	$	1,078	$	241
Loss before income tax	$	(8,744)	$	1,855	$	(6,889)	$	(35,398)	$	1,362	$	(34,036)
Loss for the period	$	(8,788)	$	1,855	$	(6,933)	$	(35,497)	$	1,362	$	(34,136)
Foreign currency translation adjustment	$	(1,462)	$	(1,855)	$	(3,317)	$	(1,386)	$	(1,362)	$	(2,748)
Total comprehensive loss	$	(10,250)	$	—	$	(10,250)	$	(36,884)	$	—	$	(36,884)

In the Condensed Consolidated Interim Statements of Financial Position and Changes in Equity, we have revised the following:



	September 30, 2022						September 30, 2021
	As reported			Adjustment	As revised		As reported			Adjustment	As revised
(in thousands)
Foreign currency translation reserve	$	(20,444)	$	—	$	(20,444)	$	(2,389)	$	(940)	$	(3,329)
Accumulated deficit	$	(93,463)	$	—	$	(93,463)	$	(68,882)	$	940	$	(67,942)
Equity:	$	92,658	$	—	$	92,658	$	128,503	$	—	$	128,503


	December 31, 2021						December 31, 2020
	As reported			Adjustment	As revised		As reported			Adjustment	As revised
(in thousands)
Foreign currency translation reserve	$	(4,042)	$	(2,181)	$	(6,223)	$	(1,003)	$	421	$	(582)
Accumulated deficit	$	(78,733)	$	2,181	$	(76,552)	$	(33,386)	$	(421)	$	(33,807)
Equity:	$	118,367	$	—	$	118,367	$	7,621	$	—	$	7,621

In the Condensed Consolidated Interim Statements of Cash Flows, we have revised the following:


	Nine Months Ended
	September 30, 2021
	As reported			Adjustment	As revised
(in thousands)
Loss before income tax	$	(35,398)	$	1,362	$	(34,036)
Foreign currency exchange gain (loss), net	$	363	$	(1,078)	$	(715)
Deferred revenue	$	(3,004)	$	(284)	$	(3,288)
Net cash used in operating activities	$	(21,213)	$	—	$	(21,213)

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, 2021 and 2020, including the notes thereto, included in our annual report on Form 20-F, filed with the Securities and Exchange Commission on March 24, 2022. 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 subsidiary, unless the context requires otherwise.

Special Note Regarding Forward-Looking Statements

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

●

our operations as a biotechnology company with limited operating history and a history of operating losses;

●

our plans to develop and commercialize our 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. In addition, there may be adverse effects on our business condition and results from general economic and market conditions and overall fluctuations in the United States and international equity markets, including deteriorating market conditions due to investor concerns regarding inflation and hostilities between Russia and Ukraine.

The following discussion reflects the Company’s revision of previously issued condensed consolidated interim financial statements to adjust for immaterial prior period misstatements, primarily related to foreign currency translations. Further information regarding the revision is included in our condensed consolidated interim financial statements, "Note 11 — Revision of Immaterial Misstatements," which is included as Exhibit 99.1 to the Form 6-K to which this management’s discussion and analysis is an exhibit.

Overview

We are a clinical-stage immuno-oncology company dedicated to rapidly developing new cancer treatments that leverage the immune system to save patients’ lives. Using our Gammabody^TM platform, we are developing a portfolio of novel bispecific antibodies designed to engage, and leverage the potency and precision of, gamma delta (gd) T cells to elicit a robust, natural anti-tumor immune response and improve outcomes for cancer patients.

In 2021, we dosed the first patient in a Phase 1/2a clinical trial evaluating our lead investigational candidate, LAVA-051, in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and multiple myeloma. Acute myeloid leukemia patients are expected to be included later in the trial once biologically relevant dosing has been reached. The open-label, multi-center clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary anti-tumor activity of LAVA-051. The Phase 1 dose-escalation portion will determine an optimal Phase 2 dose of LAVA-051. The Phase 2a portion of the trial will enroll patients in disease-specific cohorts, to confirm safety and evaluate preliminary anti-tumor activity in each disease cohort. The Phase 1/2a clinical trial for LAVA-051 is currently being conducted in Europe and we received clearance from the U.S. Food and Drug Administration (FDA) to enroll patients in the United States. In 2021, the FDA granted orphan drug designation for LAVA-051 for the treatment of CLL.

In 2022, we announced preliminary clinical data, and presented clinical pharmacokinetic and pharmacodynamic data in 2022 from the first four patient cohorts of the Phase 1 dose-escalation study. This data demonstrated that LAVA-051 was well tolerated with no dose limiting toxicities or cytokine release syndrome observed. No patient had to discontinue treatment due to adverse events. Drug exposure and Vgamma9 Vdelta2 (Vg9Vd2) T cell receptor occupancy of LAVA-051 increased with LAVA-051 dose increases and peripheral blood Vg9Vd2 T cells expressed increased levels of activation markers throughout

the patients’ treatment period. One CLL patient experienced multiple enlarged tender diseased lymph nodes one week after first dosing that subsequently regressed, reminiscent of a tumor flare reaction that has been reported as a potential sign of anti-tumor activity in CLL patients treated with another immuno-oncology drug. The patient was assessed as stable disease at the pre-planned 12 week on-study assessment along with a significant reduction in clonal B-cell count. Dosing in the study is continuing, with subsequent cohorts planned to enroll patients in separate cohorts for intravenous and subcutaneous dosing. Additional clinical data from the study are expected in the fourth quarter of 2022 and the first half of 2023.

In 2022, we dosed the first patient in a Phase 1/2a clinical trial evaluating LAVA-1207 in patients with metastatic castration-resistant prostate cancer (mCRPC). The open-label, multi-center, Phase 1/2a clinical trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary anti-tumor activity of LAVA-1207. The Phase 1 dose-escalation phase will determine a recommended Phase 2a 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 the preliminary anti-tumor activity of LAVA-1207 in patients with mCRPC.

We received regulatory approval for our Clinical Trial Application (CTA) and clearance from the FDA for a Phase 1/2a clinical trial for LAVA-1207. Enrollment for the Phase 1/2a clinical trial for LAVA-1207 is ongoing and being conducted in Europe and the United States. We currently expect to have initial data from the Phase 1 dose escalation phase of the trial in the fourth quarter of 2022 and additional data in the first half of 2023.

In September 2022, we entered into an exclusive worldwide license agreement with Seagen Inc. (Seagen) to develop, manufacture and commercialize LAVA-1223, an advanced preclinical asset that utilizes LAVA’s proprietary Gammabody technology to target epidermal growth factor receptor (EGFR)-expressing solid tumors. Under the terms of the agreement, we received a $50 million nonrefundable upfront payment in October 2022 and could receive approximately $650 million in potential development, regulatory and commercial milestones, and royalties ranging from the single digits to the mid-teens on future sales. The agreement also provides Seagen with the opportunity to exclusively negotiate rights to apply LAVA's proprietary Gammabody platform on up to two additional tumor targets.

We are also developing LAVA-1266, a CD123 Gammabody for the treatment of hematologic malignancies, for which we intend to file a CTA and/or IND in 2024.

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 recurring losses. As of September 30, 2022, we had an accumulated deficit of $93.5 million.

Effective November 1, 2022, the Board of Directors appointed Fred Powell as Chief Financial Officer.

Factors affecting our Financial Condition and Results of Operations

Impact of COVID-19 Pandemic

●

availability of supplies and equipment for our laboratories;

●

availability of staff;

●

start dates and recruitment in our clinical trials due to risks of opening and available resources at clinical sites;

●

discontinuation of enrolled patients due to a COVID-19 infection;

●

availability of study drug; and

●

fundraising and access to the capital markets.

Comparison of the Three Months Ended September 30, 2022 and 2021 (unaudited):

Research and license revenue

In September 2022, the Company entered into an exclusive license agreement (Seagen Agreement) with Seagen Inc. (Seagen). Under the Seagen Agreement, we granted an exclusive, royalty-bearing license of our compound, LAVA-1223. As compensation for this license, Seagen agreed to pay to us a nonrefundable upfront payment of $50.0 million, which was received in October 2022. We are also entitled to receive up to $650.0 million in sales and development milestone payments, reimbursement of up to $6.5 million for certain research, development and manufacturing activities and royalties ranging from the single digits to the mid-teens on future sales. We also have an option, after certain clinical data become available from Seagen, to pay a one-time buy-up fee of $35.0 million to increase the future royalty percentages under this agreement. If we exercise this option in the future, certain future milestones will be decreased by 30%.

In connection with the Seagen Agreement, we recognized $15.3 million in revenue for the three months ended September 30, 2022. Of that amount, $15.2 million related to the nonrefundable upfront payment and $0.1 million related to reimbursement for research activities. We determined that the one-time buy-up fee of $35.0 represents variable consideration, for which we have deferred revenue recognition until such time the option is exercised or expires.

Our research and license revenue was $2.1 million for the three months ended September 30, 2021, which was solely attributable to our collaboration agreement with Janssen Biotech, Inc. (Janssen Collaboration Agreement), which we entered into in May 2020. In connection with this collaboration, we received a non-refundable upfront payment of $8.0 million that was being recognized on a straight-line basis over the two-year term of the research activities under the Janssen Collaboration Agreement, as this method approximated the underlying research and development activities over time. As of September 30, 2022, we had no remaining unearned income related to this payment.

Research and development expenses

Below were our research and development expenses:


	Three Months Ended
	September 30,
(in thousands)	2022		2021		Variance
Pre-clinical and clinical trial expenses	$	10,943	$	4,371	$	6,572
Personnel-related expenses		1,296		1,505		(209)
Research and development activities expenses		675		500		175
Share-based compensation expense		372		195		177
Facilities and other research and development expenses		389		132		257
	$	13,675	$	6,703	$	6,972

The primary driver of our increase in research and development expenses for the three months ended September 30, 2022 were pre-clinical and clinical trial expenses, which increased by $6.6 million. This increase was primarily due to the initiation and ongoing activities of the clinical trials for LAVA-051 and LAVA-1207 and partner project expenses as well as manufacturing scale-up costs. Other research and

development expenses increased primarily due to expanded operations within research and development, non-cash share-based compensation expense from new stock option grants and increased travel activities.

General and administrative expenses

Below were our general and administrative expenses:


	Three Months Ended
	September 30,
(in thousands)	2022		2021		Variance
Personnel-related expenses	$	1,047	$	1,224	$	(177)
Professional and consultant fees		930		594		336
Insurance, facilities, fees and other related costs		711		874		(163)
Share-based compensation expense		408		1,068		(660)
	$	3,096	$	3,760	$	(664)

Personnel-related costs decreased $0.2 million primarily due to reductions in general and administrative headcount. Professional and consultant fees increased by $0.3 million due primarily to additional costs associated with being a public company and temporary staff. The decrease of $0.7 million in share-based compensation expense was due primarily to the reversal of expenses associated with stock option forfeitures due to the departure of our former chief financial officer.

Interest income (expense), net

Interest income, net was $39 thousand for the three months ended September 30, 2022, compared to interest expense, net of $0.2 million for the three months ended September 30, 2021. Interest income (expense), net includes interest on borrowings associated with our Innovation Credit from Rijksdienst voor Ondernemend Nederland, lease interest and negative interest on cash deposits held at financial institutions, net of interest income.

Foreign currency exchange gain (loss), net

For the three months ended September 30, 2022 and 2021, foreign currency exchange gain (loss), net increased by $0.7 million, from a gain of $1.6 million during the three months ended September 30, 2021 to a gain of $2.3 million during the three months ended September 30, 2022. This increase was due to the fluctuation of the U.S. Dollar (USD) currency rate compared to the Euro as a result of transaction gains and losses on cash and investments and other transactions denominated in USD held and occurring in a Euro functional currency entity.

Comparison of the Nine Months Ended September 30, 2022 and 2021 (unaudited):

Research and license revenue

In connection with the Seagen Agreement, we recognized $15.3 million in revenue for the nine months ended September 30, 2022. Of that amount, $15.2 million related to the nonrefundable upfront payment and $0.1 million related to reimbursement for research activities. We determined that the one-time buy-up fee of $35.0 represents variable consideration, for which we have deferred revenue recognition until such time the option is exercised or expires.

Additionally, we had research and license revenue of $1.5 million and $2.2 million for the nine months ended September 30, 2022 and 2021, respectively, attributable to our Janssen Collaboration Agreement, which we entered into in May 2020. In connection with this collaboration, we received a non-refundable upfront payment of $8.0 million that was being recognized on a straight-line basis over the two-year term of the research activities under the Janssen Collaboration Agreement, as this method approximated the underlying research and development activities over time. As of September 30, 2022, we had no remaining unearned income related to this payment.

Research and development expenses

Below were our research and development expenses:


	For the Nine Months Ended
	September 30,
(in thousands)	2022		2021		Variance
Pre-clinical and clinical trial expenses	$	20,926	$	9,829	$	11,097
Personnel-related expenses		4,236		3,722		514
Share-based compensation expense		1,651		559		1,092
Research and development activities expenses		1,706		1,249		457
Facilities and other research and development expenses		1,100		610		490
VUmc license expenses		—		14,342		(14,342)
	$	29,619	$	30,311	$	(692)

The primary driver of our increase in research and development expenses for the nine months ended September 30, 2022 were pre-clinical and clinical trial expenses, which increased by $11.1 million. This increase was primarily due to the initiation and ongoing activities of the clinical trials for LAVA-051 and LAVA-1207 and partner project expenses as well as manufacturing scale-up costs. Our personnel-related costs increased by $0.5 million and associated non-cash share-based compensation expense increased by $1.1 million due to increased research and development headcount. These increases were offset by a $14.3 million decrease due to the VUmc license expenses recorded in 2021.

General and administrative expenses

Below were our general and administrative expenses:


	For the Nine Months Ended
	September 30,
(in thousands)	2022		2021		Variance
Personnel-related expenses	$	3,991	$	2,599	$	1,392
Professional and consultant fees		2,664		1,584		1,080
Insurance, facilities, fees and other related costs		2,199		1,698		501
Share-based compensation expense		1,556		2,369		(813)
	$	10,410	$	8,250	$	2,160

Personnel-related costs increased by $1.4 million due to the increase in general and administrative headcount and severance costs. Insurance, facilities, fees and other related costs increased by $0.5 million primarily due to insurance programs established at the time of our IPO. Professional and consultant fees increased by $1.1 million due primarily to costs associated with being a public company and temporary staff. The decrease of $0.8 million in share-based compensation expense was due primarily to the reversal of expenses associated with stock option forfeitures due to the departure of our former chief financial officer.

Interest income (expense), net

Interest income (expense), net was expense of $0.2 million and $0.5 million for the nine months ended September 30, 2022 and 2021, respectively. Interest income (expense), net includes interest on borrowings associated with our Innovation Credit from Rijksdienst voor Ondernemend Nederland, lease interest and negative interest on cash deposits held at financial institutions, net of interest income.

Foreign currency exchange loss, net

For the nine months ended September 30, 2022 and 2021, foreign currency exchange gain (loss), net increased by $5.8 million, from a gain of $0.7 million during the nine months ended September 30, 2021 to a gain of $6.5 million during the nine months ended September 30, 2022. This increase was due to the fluctuation of the USD currency rate compared to the Euro as a result of transaction gains and losses on cash

and investments and other transactions denominated in USD held and occurring in a Euro functional currency entity.

Liquidity and Capital Resources

As of September 30, 2022, we had cash, cash equivalents and investments totaling $92.7 million, compared to cash, cash equivalents and investments of $133.2 million as of December 31, 2021. We have historically funded our operations primarily through the issuance of preference shares prior to our IPO and from the sale of common shares in our IPO. Our expenditures are primarily related to research and development activities and general and administrative activities to support business operations.

In March 2021, we received net proceeds from our IPO of approximately $88.7 million after deducting underwriting discounts and commissions of $7.0 million and offering costs of $4.5 million. In April 2021, we received additional net proceeds from the IPO of $5.9 million from the exercise of the overallotment option from the underwriters. In addition, we received $56.6 million in net proceeds from our Series C financing, net of repurchasing Series A Preferred and common shares in March 2021.

In April 2022 we entered into an Equity Distribution Agreement (EDA) with JMP Securities LLC (JMP) under which JMP, as our exclusive agent, at our discretion and at such times that we may determine from time to time, may sell over a three-year period from the execution of the agreement up to a maximum of $50 million of shares of our common stock. We did not sell any shares of our common stock during the three and nine months ended September 30, 2022 under the EDA.

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

Based on our current operating plan, we believe that our existing cash, cash equivalents and investments as of September 30, 2022, and nonrefundable Seagen payment received in October 2022, 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-1266;

●

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

●

our ability to receive payments for LAVA-1223 under the Seagen Agreement, including milestones payments;

●

develop processes and scale manufacturing production for our current and future product candidates in accordance with cGMP;

●

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

●

discover and develop additional bispecific gamma delta engagers and make further investments in our Gammabody platform to identify additional product candidates;

●

maintain, protect and expand our intellectual property portfolio; including costs associated with opposing and invalidating competitor patents and licensing other technologies for our product candidates;

●

establish a sales, marketing, manufacturing and distribution, supply chain and other commercial infrastructure in the future to commercialize any current or future product candidate for which we may obtain marketing approval;

●

expand our operations in the U.S. and Europe;

●

add clinical, scientific, operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts;

●

acquire or in-license additional product candidates and technologies;

●

potentially develop a companion diagnostic;

●

incur additional legal, accounting and other expenses associated with operating as a public company; and

●

address any ancillary effects of the COVID-19 pandemic on our business.

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

The following is a summary of our cash flows:


	For the Nine Months Ended
	September 30,
(in thousands)	2022		2021
Net cash used in operating activities	$	(31,692)	$	(21,213)
Net cash provided by (used in) investing activities		13,485		(42,724)
Net cash provided by financing activities		299		151,321
Net (decrease) increase in cash and cash equivalents	$	(17,908)	$	87,384

Cash Flows Used in Operating Activities

Net cash used in operating activities for the nine months ended September 30, 2022 was $31.7 million. Our net loss before income tax was $16.7 million. We also had foreign currency exchange gain of $6.8 million, partially offset by noncash share-based compensation expense of $3.2 million. Additionally, we had changes in working capital of $11.9 million primarily impacted by the effects of the Seagen transaction, partially offset by increases in trade accounts payable and accrued expenses.

Net cash used in operating activities for the nine months ended September 30, 2021 was $21.2 million. Our net loss before income tax was $34.0 million, partially offset by noncash share-based compensation expense of $2.9 million and changes in working capital of $10.1 million. Our changes in working capital were primarily impacted by the exit payment to VUmc partially offset by increases in prepaid expenses of $4.6 million.

Cash Flows Provided by (Used in) Investing Activities

Cash flows provided by investing activities for the nine months ended September 30, 2022 were $13.5 million, compared to cash flows used in investing activities for the nine months ended September 30, 2021 of $43.0 million. During the nine months ended September 30, 2022, $60.4 million of investments matured, offset by additional investment purchases of $46.5 million and equipment purchases of $0.3 million. Cash flows used in investing activities for the nine months ended September 30, 2021 consisted of $44.9 million in investment purchases and $0.6 million in equipment purchases, offset by $2.5 million in investment maturities.

Cash Flows Provided by Financing Activities

Cash flows provided by financing activities for the nine months ended September 30, 2022 primarily consisted of proceeds from Innovation Credit borrowings of $0.5 million offset by $0.2 million in principal payments on operating lease liabilities. Cash flows provided by financing activities for the nine months ended September 30, 2021 primarily consisted of net proceeds from our IPO, including the exercise of the

underwriters’ over-allotment option, of $94.2 million, net proceeds from the Series C financing of $61.8 million and proceeds from borrowings of $0.4 million, partially offset by payment of $5.2 million for the Series A share repurchases and $0.1 million in principal payments on operating lease liabilities.

Off-Balance Sheet Arrangements

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

Quantitative and Qualitative Disclosures about Market Risk

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

Interest Rate Risk

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

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

Credit Risk

We consider all of our material counterparties to be creditworthy. While the concentration of credit risk may be significant, we consider the credit risk for each of our counterparts to be low. Our exposure to credit risk primarily relates to our cash and cash equivalents, comprising bank deposits and short-term marketable securities with a maturity of three months or less at the date of acquisition. The credit risk on bank deposits is limited because the counterparties, holding significant deposits, are banks with high credit ratings assigned by international credit-rating agencies. 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.

We hold a portion of our bank deposits in a money market fund invested in short-term U.S. Treasury securities to further diversify the credit risk. 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, continuously monitoring our cash forecasts and actual cash flows and matching the maturity profiles of financial assets and liabilities. We monitor the risk of a shortage of funds using a liquidity planning tool, to ensure enough funds are available to settle liabilities as they fall due.

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

RISK FACTORS

The risk factors set forth under the caption “Risk Factors” in Item 3 of our annual report on Form 20-F filed by the Company on March 24, 2022 shall be deemed to be incorporated by reference herein and to be a part hereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished. Additional risks and uncertainties not currently known to the Company, or that the Company currently deems to be immaterial, may also affect its business, financial condition and/or future operating results.

Exhibit 99.3

LAVA Therapeutics Provides Business Update and Reports Third Quarter Financial Results

●

LAVA-051 updated interim data from ongoing Phase 1/2a clinical trial in patients with relapsed or refractory chronic lymphocytic leukemia and multiple myeloma to be presented at 2022 American Society of Hematology (ASH) Annual Meeting

●

Presented LAVA-051 clinical pharmacodynamic data demonstrating consistency with mechanism of action data at the Society for Immunotherapy for Cancer (SITC) 2022 Annual Meeting

●

Announced exclusive worldwide license agreement with Seagen to advance LAVA-1223, a preclinical bispecific gamma delta T cell engager for EGFR-expressing solid tumors

●

Cash and investments of $92.7 million as of September 30, 2022, plus $50.0 million received from Seagen in October provide cash runway beyond 2024

Utrecht, The Netherlands, and Philadelphia, USA – November 16, 2022 – LAVA Therapeutics N.V. (Nasdaq: LVTX), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody™ platform of bispecific gamma delta T cell engagers, today announced recent corporate highlights and financial results for the third quarter ended September 30, 2022.

“The third quarter was productive for LAVA, underscored by the recent and upcoming presentations of additional interim clinical data from the Phase 1/2a trial of our lead clinical program, LAVA-051, at SITC and ASH, respectively,” said Stephen Hurly, president and chief executive officer of LAVA Therapeutics. “We were also pleased to announce our worldwide license agreement with Seagen for the development of LAVA-1223, our advanced preclinical asset targeting EGFR-expressing solid tumors. This partnership represents a major step toward our goal of creating effective Gammabody medicines for patients with cancer and enables LAVA to progress additional candidates from our early-stage pipeline of bispecific gamma delta T cell engagers.”

Recent Pipeline and Business Highlights

LAVA-051

Gammabody targeting CD1d-expressing tumors, including multiple myeloma (MM), chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML)

●

Announced the presentation of updated interim data from the ongoing Phase 1/2a clinical trial of LAVA-051 at the ASH 64^th Annual Meeting, being held December 10-13 in New Orleans, LA and virtually. Arnon Kater, M.D., Ph.D., chairman of the Dutch/Belgium HOVON CLL working group and professor of translational hematology at the Amsterdam University Medical Center, and LAVA-051 clinical trial investigator, will present abstract #2014, “LAVA-051, a Novel Bispecific Gamma-Delta T-Cell Engager (Gammabody), in Relapsed/Refractory MM and CLL: Pharmacodynamic and Early Clinical Data,” in the session, “Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster I,” on Saturday, December 10, 2022, at 5:30–7:30 p.m. CST.

●

Presented clinical pharmacodynamic data from the ongoing Phase 1/2a study that demonstrates consistency with preclinical mechanism of action data for LAVA-051 during the SITC 37^th Annual Meeting.

LAVA-1207

Gammabody targeting the prostate-specific membrane antigen (PSMA) to trigger the potent and preferential killing of PSMA-positive tumor cells, including metastatic castration-resistant prostate cancer (mCRPC)

●

Enrollment continues in Europe and the U.S. in the open-label, multi-center Phase 1/2a clinical trial evaluating the tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary antitumor activity of LAVA-1207 in patients with mCRPC. Additional clinical data from the Phase 1 dose escalation portion of the trial, which will determine the optimal Phase 2 dose to be used in the subsequent Phase 2a expansion cohort, are expected around year-end 2022. The Company is planning to present these data at an upcoming medical meeting in the first quarter of 2023.

Early-Stage Gammabody Pipeline Development

LAVA-1223, a Gammabody directed at the epidermal growth factor receptor (EGFR) for the treatment of solid tumors which induces tumor cell lysis independent of EGFR downstream signaling mutations (e.g. KRAS/BRAF)

●

Announced an exclusive global license agreement with Seagen to develop, manufacture and commercialize LAVA-1223, an advanced preclinical asset that utilizes LAVA’s proprietary Gammabody technology to target epidermal growth factor receptor (EGFR)-expressing solid tumors. Under the terms of the agreement, LAVA received a $50 million upfront payment and could receive up to approximately $650 million in potential development, regulatory and commercial milestones, and royalties ranging from the single digits to the mid-teens on future sales. The agreement also provides Seagen with the opportunity to exclusively negotiate rights to apply LAVA's proprietary Gammabody platform on up to two additional tumor targets.

Business Update

●

Effective November 1, 2022, LAVA’s Board of Directors appointed Fred Powell as chief financial officer.

Third Quarter Financial Results

●

As of September 30, 2022, LAVA had cash, cash equivalents and investments totaling $92.7 million compared to cash and cash equivalents of $133.2 million as of December 31, 2021. The cash balance at the end of the third quarter does not reflect the $50 million upfront payment that was received from Seagen in October. Including the payment, the Company’s cash balance is expected to be sufficient to fund the Company beyond 2024.

●

Research and license revenue of $15.3 million for the three months ended September 30, 2022 was solely attributable to our exclusive global license agreement with Seagen to develop, manufacture and commercialize LAVA-1223. Research and license revenue of $16.8 million for the nine months ended September 30, 2022 included revenue from the Company’s collaboration with Janssen Biotech, Inc., which was entered into in May 2020.

●

Research and development expenses were $13.7 million and $29.6 million for the three and nine months ended September 30, 2022, respectively, compared to $6.7 million and $30.3 million for the three and nine months ended September 30, 2021. The increase for the three months ended September 30, 2022 was primarily driven by the initiation and ongoing activities of the clinical trials for LAVA-051 and LAVA-1207 and partner project expenses as well as manufacturing scale-up costs and increased headcount. For the nine months ended September 30, 2022, the decrease was primarily driven by the $14.3 million VUmc license fees incurred in the first quarter of 2021, partially offset by the initiation and ongoing activities of the clinical trials for LAVA-051 and LAVA-1207 and partner project expenses as well as manufacturing scale-up costs and increased headcount.

●

General and administrative expenses were $3.1 million and $10.4 million for the three and nine months ended September 30, 2022, respectively, compared to $3.8 million and $8.3 million for the three and nine months ended September 30, 2021. The decrease for the three months ended September 30, 2022 was primarily due to reductions in general and administrative headcount and the reversal of expenses associated with stock option forfeitures, partially offset by additional costs associated with being a public company and temporary staff. The increase for the nine months ended September 30, 2022 was primarily due to additional costs associated with being a public company, insurances established as part of being a public company, severance expenses and temporary staff.

●

For the three months ended September 30, 2022, net profit was $0.1 million, or $0.04 per share as compared to $6.9 million net loss, or $0.27 per share for the prior year period. For the nine months ended September 30, 2022, net loss was $16.9 million, or $0.66 per share, as compared to $34.1 net loss, or $1.93 per share for the prior year period. The change from the prior year periods was due primarily to the effects of revenue from the Seagen Agreement.

LAVA Therapeutics N.V.

Condensed Consolidated Interim Statements of Profit and Loss

and Comprehensive Profit and Loss

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


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2022		2021		2022		2021
Revenue:
Research and license revenue	$	15,261	$	2,095	$	16,751	$	4,284
Total revenue		15,261		2,095		16,751		4,284
Operating expenses:
Research and development		(13,675)		(6,703)		(29,619)		(30,311)
General and administrative		(3,096)		(3,760)		(10,410)		(8,250)
Total operating expenses		(16,771)		(10,463)		(40,029)		(38,561)

Operating profit (loss)		(1,510)		(8,368)		(23,278)		(34,277)
Interest income (expense), net		39		(158)		(214)		(474)
Foreign currency exchange gain, net		2,515		1,637		6,763		715
Total non-operating income		2,554		1,479		6,549		241

Profit (loss) before income tax		1,044		(6,889)		(16,729)		(34,036)
Income tax expense		(47)		(44)		(182)		(100)
Profit (loss) for the year	$	997	$	(6,933)	$	(16,911)	$	(34,136)
Foreign currency translation adjustment		(5,359)		(3,317)		(14,220)		(2,748)
Total comprehensive profit (loss)	$	(4,362)	$	(10,250)	$	(31,131)	$	(36,884)
Profit (Loss) per share:
Profit (loss) per share, basic	$	0.04	$	(0.27)	$	(0.66)	$	(1.93)
Weighted-average common shares outstanding, basic		25,845,802		25,775,538		25,800,973		17,730,337
Profit (loss) per share, diluted	$	0.04		(0.27)		(0.66)		(1.93)
Weighted-average common shares outstanding, diluted		26,446,259		25,775,538		25,800,973		17,730,337

LAVA Therapeutics N.V.

Condensed Consolidated Interim Statements of Financial Position

(in thousands) (unaudited)



	September 30,		December 31,
	2022		2021

Assets:
Non-current assets	$	2,289	$	2,742
Other current assets		54,876		3,302
Cash, cash equivalents, and investments		92,724		133,203
Total assets	$	149,889	$	139,247

Equity and Liabilities:
Total Equity	$	92,658	$	118,367

Deferred revenue		35,000		1,527
Lease liabilities		459		581
License liabilities		4,355		10,056
Borrowings		4,173		4,284
Trade payables and other		7,799		2,553
Accrued expenses and other current liabilities		5,445		1,879
Total liabilities		57,231		20,880

Total equity and liabilities	$	149,889	$	139,247

About LAVA Therapeutics

LAVA Therapeutics N.V. is a clinical-stage immuno-oncology company utilizing its proprietary Gammabody™ platform to develop a portfolio of bispecific gamma delta T cell engagers for the potential treatment of solid and hematologic malignancies. The Company utilizes bispecific antibodies engineered to selectively kill cancer cells by triggering Vγ9Vδ2 (Vgamma9 Vdelta2) T cell antitumor effector functions upon cross-linking to tumor-associated antigens. LAVA-051, the Company’s lead candidate for the treatment of multiple myeloma, chronic lymphocytic leukemia and acute myeloid leukemia, is enrolling patients in a Phase 1/2a clinical study (NCT04887259). A Phase 1/2a clinical study to evaluate LAVA-1207 in patients with metastatic castration-resistant prostate cancer (mCRPC) is also enrolling (NCT05369000). For more information, please visit www.lavatherapeutics.com, and follow us on LinkedIn, Twitter and YouTube.

LAVA’s Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements, including with respect to the Company’s anticipated growth and clinical development plans including the timing and results of clinical trials. Words such as “anticipate,” “believe,” “could,” “will,” “may,” “expect,” “should,” “plan,” “intend,” “estimate,” “potential” 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™ platform, and the failure of LAVA’s collaborators to support or advance collaborations or our product candidates. 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. In addition, there may be adverse effects on our business condition and results from general economic and market conditions and overall fluctuations in the United States and international equity markets, including deteriorating market conditions due to investor concerns regarding inflation and hostilities between Russia and Ukraine. LAVA assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

CONTACTS

Investor Relations

ir@lavatherapeutics.com

Argot Partners (IR/Media)

212-600-1902
lava@argotpartners.com