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LAVA Therapeutics(LVTX) - 2025 Q2 - Quarterly Report
2025-08-13 21:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition period from to Commission file number: 001-40241 LAVA Therapeutics N.V. (Exact Name of Registrant as Specified in Its Charter) The Netherlands (State or ...
LAVA Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-08-13 20:55
Announced entry into an agreement to be acquired by XOMA Royalty Corporation for between $1.16 and $1.24 per share in cash, plus a contingent value right related to LAVA’s two partnered assets and unpartnered programsConsummation of acquisition expected to occur in the fourth quarter of 2025, subject to customary closing conditions and an extraordinary general meeting of shareholdersAnnounced decision to discontinue development of LAVA-1266 for acute myeloid leukemia and myelodysplastic syndrome; wind-down ...
SHAREHOLDER INVESTIGATION: Halper Sadeh LLC Investigates SCS, LVTX, ENZB on Behalf of Shareholders
Prnewswire· 2025-08-08 05:17
Group 1: Steelcase Inc. - Steelcase Inc. is involved in a transaction where it will sell to HNI Corporation for $7.20 in cash and 0.2192 shares of HNI common stock for each share of Steelcase [1] Group 2: LAVA Therapeutics N.V. - LAVA Therapeutics N.V. is set to be acquired by XOMA Royalty Corporation for $1.16 in cash per share, with potential additional payments of up to $0.08 per share and a non-transferable contingent value right [2] Group 3: Enzo Biochem, Inc. - Enzo Biochem, Inc. is being sold to Battery Ventures for $0.70 per share in cash [3] Group 4: Legal Representation - Halper Sadeh LLC is investigating these transactions for potential violations of federal securities laws and breaches of fiduciary duties to shareholders, seeking increased consideration and additional disclosures [4] - Shareholders are encouraged to contact Halper Sadeh LLC to discuss their legal rights and options at no charge [5]
SHAREHOLDER ALERT: The M&A Class Action Firm Announces An Investigation of LAVA Therapeutics N.V. (NASDAQ: LVTX)
Prnewswire· 2025-08-07 22:29
NEW YORK, Aug. 7, 2025 /PRNewswire/ -- Class Action Attorney Juan Monteverde with Monteverde & Associates PC (the "M&A Class Action Firm"), has recovered millions of dollars for shareholders and is recognized as a Top 50 Firm in the 2024 ISS Securities Class Action Services Report. The firm is headquartered at the Empire State Building in New York City and is investigating LAVA Therapeutics N.V. (NASDAQ: LVTX) related to its sale to XOMA Royalty Corporation. Under the terms of the proposed transaction, XOMA ...
BRODSKY & SMITH SHAREHOLDER UPDATE: Notifying Investors of the Following Investigations: HilleVax, Inc. (Nasdaq – HLVX), Steelcase Inc. (NYSE – SCS), LAVA Therapeutics N.V. (Nasdaq – LVTX), Arcadia Biosciences, Inc. (Nasdaq – RKDA)
GlobeNewswire News Room· 2025-08-04 16:05
Group 1: HilleVax, Inc. - HilleVax will be acquired by XOMA Royalty Corporation for $1.95 in cash per share plus one non-transferable contingent value right (CVR) [2] - The investigation focuses on whether the HilleVax Board breached its fiduciary duties by failing to conduct a fair process and whether the consideration provides fair value to shareholders [2] Group 2: Steelcase Inc. - Steelcase will be acquired by HNI Corporation for $7.20 in cash and 0.2192 shares of HNI common stock for each share of Steelcase [4] - The implied per share purchase price is $18.30 based on HNI's closing share price of $50.62 on August 1, 2025 [4] - The investigation concerns whether the Steelcase Board breached its fiduciary duties by failing to conduct a fair process and whether the consideration provides fair value to shareholders [4] Group 3: LAVA Therapeutics N.V. - LAVA will be acquired by XOMA Royalty Corporation for between $1.16 and $1.24 per share in cash, plus a non-transferable CVR [6] - The cash amount consists of a base price of $1.16 per share and an additional amount of up to $0.08 per share [6] - The investigation focuses on whether the LAVA Board breached its fiduciary duties by failing to conduct a fair process and whether the consideration provides fair value to shareholders [6] Group 4: Arcadia Biosciences, Inc. - Arcadia will be acquired by Roosevelt Resources LP, with current equity owners of Roosevelt and Arcadia shareholders expected to own approximately 90% and 10% of the combined company, respectively [8] - The investigation concerns whether the Arcadia Board breached its fiduciary duties by failing to conduct a fair process and the potential dilution of shareholders in the combined company [8]
XOMA Royalty Enters into Agreement to Acquire LAVA Therapeutics for Between $1.16 and $1.24 Per Share in Cash, Plus a Contingent Value Right
Globenewswire· 2025-08-04 11:30
XOMA Royalty adds milestone and royalty economics associated with two partnered assetsEMERYVILLE, Calif. and UTRECHT, The Netherlands and PHILADELPHIA, Aug. 04, 2025 (GLOBE NEWSWIRE) -- XOMA Royalty Corporation (“XOMA Royalty”) (NASDAQ: XOMA) and LAVA Therapeutics N.V. (“LAVA”) (NASDAQ: LVTX) announced today they have entered a definitive share purchase agreement (the “Purchase Agreement” and the transactions set forth in the Purchase Agreement, the “Transactions”) whereby XOMA Royalty will acquire LAVA for ...
LAVA Therapeutics(LVTX) - 2025 Q1 - Quarterly Report
2025-05-14 20:06
PART I. FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for Q1 2025 reflect a decrease in total assets to $71.2 million, a net loss of $3.5 million, and a $5.2 million gain on debt extinguishment [Condensed Consolidated Balance Sheets (Unaudited)](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(Unaudited)) As of March 31, 2025, total assets decreased to $71.2 million, liabilities to $45.4 million, and equity to $25.8 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $39,674 | $35,015 | | Short-term investments | $26,883 | $41,561 | | Total current assets | $69,780 | $79,297 | | **Total assets** | **$71,156** | **$80,831** | | **Liabilities & Equity** | | | | Total current liabilities | $10,366 | $18,006 | | Non-current portion of deferred revenue | $35,000 | $35,000 | | **Total liabilities** | **$45,372** | **$53,086** | | **Total shareholders' equity** | **$25,784** | **$27,745** | [Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20(Unaudited)) For Q1 2025, the company reported no revenue, a net loss of $3.5 million (or ($0.13) per share), and a $5.2 million gain on debt extinguishment Condensed Consolidated Statements of Operations (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Revenue | $0 | $6,992 | | Research and development | ($4,156) | ($5,648) | | General and administrative | ($3,432) | ($3,380) | | Operating loss | ($7,588) | ($2,036) | | Gain on extinguishment of borrowings | $5,203 | $0 | | **Net loss** | **($3,479)** | **($608)** | | **Net loss per share, basic and diluted** | **($0.13)** | **($0.02)** | [Condensed Consolidated Statements of Cash Flows (Unaudited)](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(Unaudited)) For Q1 2025, net cash used in operating activities increased to $11.6 million, and net cash provided by investing activities was $15.2 million Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($11,645) | ($843) | | Net cash provided by investing activities | $15,159 | $694 | | Net cash provided by financing activities | $0 | $8 | | **Net increase (decrease) in cash** | **$3,514** | **($141)** | [Notes to the Condensed Consolidated Financial Statements (Unaudited)](index=10&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) Notes detail the company's Gammabody® platform, liquidity, key revenue events, and significant restructuring activities during the period - The company believes its cash, cash equivalents, and short-term investments are **sufficient to fund operations for at least the next twelve months** from the financial statement issuance date[28](index=28&type=chunk) - In March 2024, Pfizer achieved a clinical development milestone, resulting in a **$7,000 thousand payment** to the company, with **no revenue recognized** under the Pfizer agreement in Q1 2025[49](index=49&type=chunk)[104](index=104&type=chunk) - In February 2025, the company initiated a restructuring plan, reducing its global workforce by approximately **30%** and incurring **$500 thousand** in associated costs during Q1 2025[55](index=55&type=chunk) - In March 2025, a remaining loan balance of **$5,200 thousand** from RVO was permanently waived, resulting in a **gain on extinguishment of debt**[58](index=58&type=chunk) - Subsequent to quarter end, in May 2025, the company approved a further restructuring plan to eliminate remaining Netherlands employee positions and terminate a lease, with expected costs of approximately **$2,000 thousand**[70](index=70&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the Gammabody® platform, LAVA-1266 clinical trial, 2025 restructuring, and Q1 2025 financial performance and liquidity [Overview](index=22&type=section&id=Overview) LAVA Therapeutics focuses on its Gammabody® platform and LAVA-1266 clinical development, initiating 2025 restructuring plans to extend capital - The company is conducting a Phase 1 study of LAVA-1266 in patients with AML or MDS, with the first patient dosed in **December 2024** and initial data expected by **year-end 2025**[82](index=82&type=chunk) - In February 2025, the company implemented a restructuring plan including a **30% workforce reduction** to align resources with its focus on LAVA-1266[73](index=73&type=chunk) - In December 2024, the company announced the **discontinuation of the Phase 1 clinical trial for LAVA-1207** in mCRPC after it did not meet internal benchmarks[84](index=84&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Q1 2025 results show revenue decreased to zero, R&D expenses declined, and other income increased due to a $5.2 million gain on debt extinguishment Comparison of Results of Operations (in thousands) | Line Item | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $0 | $6,992 | $(6,992) | | Research and development | $(4,156) | $(5,648) | $(1,492) | | General and administrative | $(3,432) | $(3,380) | $52 | | **Operating loss** | **$(7,588)** | **$(2,036)** | **$5,552** | | **Net loss** | **($3,479)** | **($608)** | **$2,871** | - Revenue was **$0** in Q1 2025 compared to **$7,000 thousand** in Q1 2024, with the 2024 revenue stemming from a clinical development milestone payment from Pfizer[103](index=103&type=chunk)[104](index=104&type=chunk) - R&D expenses decreased by **$1,492 thousand**, mainly due to a **$2,300 thousand reduction** in pre-clinical and clinical trial expenses following the discontinuation of the LAVA-1207 trial[106](index=106&type=chunk)[107](index=107&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held $66.6 million in cash and investments, deemed sufficient to fund operations for at least 12 months - As of March 31, 2025, the company had cash, cash equivalents, and short-term investments totaling **$66,600 thousand**[116](index=116&type=chunk) - Management believes the current cash position is **sufficient to fund projected cash requirements for at least 12 months** from the date of the report[116](index=116&type=chunk) - In March 2025, a **$5,200 thousand** Innovation Credit balance was permanently waived, which was recognized as a non-cash gain[112](index=112&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, LAVA Therapeutics is **not required to provide quantitative and qualitative disclosures about market risk**[129](index=129&type=chunk) [Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control over financial reporting - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were **effective at a reasonable assurance level**[130](index=130&type=chunk) - No changes in internal control over financial reporting occurred during Q1 2025 that materially affected, or are reasonably likely to materially affect, internal controls[132](index=132&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - The company is **not currently a party to any material legal proceedings**[133](index=133&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the risk factors previously disclosed in the Annual Report on Form 10-K for 2024 were reported - No material changes to the risk factors disclosed in the Annual Report on Form 10-K for the year ended December 31, 2024, were reported[134](index=134&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=42&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities and no material change in the planned use of IPO proceeds - There were **no unregistered sales of equity securities** in the quarter[135](index=135&type=chunk) - There has been **no material change in the planned use of proceeds** from the company's IPO[136](index=136&type=chunk) [Other Information](index=42&type=section&id=Item%205.%20Other%20Information) This section incorporates details on the company's restructuring and confirms no Rule 10b5-1 trading plan changes by directors or officers - Information regarding the restructuring plan, closure of Netherlands operations, and workforce reduction is **incorporated by reference from Note 10** of the financial statements[139](index=139&type=chunk) - During the fiscal quarter ended March 31, 2025, **no directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement**[140](index=140&type=chunk)
LAVA Reports First Quarter 2025 Financial Results, Provides Business Update
GlobeNewswire News Room· 2025-05-14 11:30
Core Insights - LAVA Therapeutics is focused on delivering shareholder value through strategic alternatives and has initiated a restructuring plan that includes workforce reduction and closure of its Netherlands operations [2][5][9] - The company is advancing its clinical pipeline, particularly LAVA-1266, which is in a Phase 1 trial targeting CD123+ tumor cells for hematological malignancies [3][6][14] - Financial results for Q1 2025 show a net loss of $3.5 million, with cash and short-term investments totaling $66.6 million, expected to fund operations into 2027 [4][9][11] Corporate Updates - The company has implemented a significant reduction in workforce, approximately 30%, to align resources with its focus on LAVA-1266 [9][10] - A repayment waiver of $5.2 million was secured from the Netherlands Enterprise Agency, aiding in financial restructuring [2][9] - The closure of the Utrecht facility is expected to incur approximately $0.9 million in expenses, while the termination of the lease in Den Bosch is projected to cost around $2.0 million [9][10] Financial Performance - Revenue from contracts with customers was zero for Q1 2025, compared to $7.0 million in Q1 2024, which included a milestone payment from Pfizer [6][9] - Research and development expenses decreased to $4.2 million in Q1 2025 from $5.6 million in Q1 2024, primarily due to lower clinical costs [9][10] - The company reported a comprehensive loss of $2.5 million for Q1 2025, compared to a loss of $1.7 million in Q1 2024 [10][12] Clinical Pipeline - LAVA-1266 is currently enrolling patients in a Phase 1 trial in Australia and Spain, targeting relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) [6][14] - Johnson & Johnson's partnered program, JNJ-89853413, is also in a Phase 1 trial for hematological cancers, with a milestone payment of $5 million received in Q4 2024 [6][9] - Pfizer's partnered program, PF08046052, is in a Phase 1 trial for advanced solid tumors, with a clinical development milestone of $7 million received in Q1 2024 [6][9]
LAVA Therapeutics Granted Full Waiver for RVO Payment Obligation
Newsfilter· 2025-04-16 11:30
Core Insights - LAVA Therapeutics has received a full waiver of a $5.1 million repayment obligation from the Netherlands Enterprise Agency, significantly strengthening its balance sheet [1][2] - The company is focusing on cost optimization initiatives to enhance operational efficiency and financial flexibility as part of its ongoing strategic review [2] Company Overview - LAVA Therapeutics N.V. is a clinical-stage immuno-oncology company that develops its proprietary Gammabody® platform, which includes bispecific gamma-delta T cell engagers aimed at treating solid tumors and hematologic malignancies [3][4] - The company utilizes engineered bispecific antibodies to selectively target and kill cancer cells by activating Vγ9Vδ2 T cell anti-tumor functions [3] Pipeline and Development - LAVA's pipeline includes three clinical-stage bispecific gamma-delta T cell engagers: LAVA 1266 targeting CD123+ cancers, PF-08046052 targeting EGFR, and JNJ-89853413 targeting hematological cancers [4] - The company also has preclinical programs in development [4]
LAVA Therapeutics(LVTX) - 2024 Q4 - Annual Report
2025-03-28 20:06
PART I [Business](index=4&type=section&id=Item%201.%20Business) LAVA Therapeutics is a clinical-stage immuno-oncology company developing its Gammabody® platform for cancer treatment, with lead candidate LAVA-1266 in Phase 1, strategic partnerships, and a recent restructuring to extend capital resources - The company is a clinical-stage immuno-oncology firm focused on its proprietary Gammabody® platform, developing bispecific gamma delta (γδ) T cell engagers to treat cancer[11](index=11&type=chunk) - In February 2025, a restructuring plan was adopted to extend capital resources, involving a **30% reduction** in the global workforce to focus on the LAVA-1266 program, expected to incur approximately **$1.0 million** in expenses[12](index=12&type=chunk) Development Pipeline Overview | Category | Candidate | Target | Indication(s) | Preclinical | Phase 1 | Phase 2 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **Proprietary Pipeline** | LAVA-1266 | CD123 | Hematologic Malignancies | ✔ | ✔ | | | | LAVA-1427 | Undisclosed | Undisclosed | ✔ | | | | | LAVA-1433 | Undisclosed | Undisclosed | ✔ | | | | **Strategic Partnerships** | PF-08046052 | EGFR | Solid Tumors | ✔ | ✔ (Pfizer) | | | | JNJ-89853413 | CD33 | Hematologic Malignancies | ✔ | ✔ (J&J) | | | **Discontinued Programs** | LAVA-1207 | PSMA | Solid Tumors | - | Discontinued | - | - The lead candidate, LAVA-1266, targets CD123 for hematological malignancies like AML and MDS, with a Phase 1 trial initiated in Q4 2024 and initial data expected by year-end 2025[18](index=18&type=chunk)[22](index=22&type=chunk)[23](index=23&type=chunk) - The LAVA-1207 program for prostate cancer was discontinued in December 2024 due to not meeting internal benchmarks, resulting in a **$3.9 million** expense for related costs[19](index=19&type=chunk)[37](index=37&type=chunk)[43](index=43&type=chunk) - The LAVA-051 clinical trial for hematological tumors was discontinued in June 2023 due to the evolving competitive landscape, resulting in a **$1.4 million** expense write-off and a **36% workforce reduction**[44](index=44&type=chunk)[45](index=45&type=chunk)[47](index=47&type=chunk) [Partnered Programs](index=11&type=section&id=Partnered%20Programs) The company maintains strategic partnerships with Pfizer and Johnson & Johnson, involving upfront payments and significant milestone potential for their respective partnered programs, PF-8046052 and JNJ-89853413 - Entered an exclusive license agreement with Pfizer in 2022 for PF-8046052, targeting EGFR-expressing solid tumors, receiving a **$50 million** upfront payment and eligible for up to **$650 million** in milestones plus royalties[28](index=28&type=chunk) - Pfizer initiated a Phase 1 trial for PF-8046052 in 2023 and paid LAVA a **$7 million** clinical milestone in March 2024[29](index=29&type=chunk)[30](index=30&type=chunk) - The collaboration with Johnson & Johnson (J&J) for JNJ-89853413, targeting CD33, has resulted in **$17.5 million** in upfront, research, and clinical milestone payments as of December 31, 2024, with an IND filed in October 2024[33](index=33&type=chunk)[34](index=34&type=chunk) [Intellectual Property](index=36&type=section&id=Intellectual%20Property) LAVA Therapeutics protects its Gammabody® platform and product candidates through a combination of patents, trade secrets, and know-how, with a portfolio including 2 issued U.S. patents and 21 pending U.S. applications as of December 31, 2024, covering core technology and specific candidates like LAVA-1266, with patents expected to expire starting in 2042 - As of December 31, 2024, the company's patent portfolio includes **2 issued U.S. patents**, **21 pending U.S. patent applications**, and over **100 patents and applications** in other territories[110](index=110&type=chunk)[111](index=111&type=chunk) - For its lead candidate LAVA-1266, the patent portfolio includes multiple pending U.S. and foreign applications, with any patents issuing expected to expire in **2042**, excluding potential extensions[114](index=114&type=chunk) - The Gammabody® platform technology is protected by **six patent families** covering antibodies that activate γδ T cells, dosing regimens, and combination therapies[116](index=116&type=chunk) [Government Regulation](index=41&type=section&id=Government%20Regulation) The company's operations are subject to extensive regulation by the FDA, EMA, and other global authorities, covering all stages from R&D to post-approval marketing, requiring comprehensive testing, BLA/MAA submissions, cGMP compliance, and adherence to healthcare laws regarding fraud, abuse, data privacy, and pricing - The company's biologic products are extensively regulated by the FDA in the U.S. and the EMA in Europe, covering research, development, manufacturing (cGMP), and marketing[123](index=123&type=chunk) - The approval process requires successful completion of preclinical studies and **three phases** of human clinical trials to establish safety and efficacy before submitting a BLA (U.S.) or MAA (E.U.)[124](index=124&type=chunk)[129](index=129&type=chunk) - The company may seek expedited review programs such as Fast Track, Breakthrough Therapy, or Accelerated Approval to potentially speed up development and review timelines[143](index=143&type=chunk)[145](index=145&type=chunk)[147](index=147&type=chunk) - Post-approval, the company is subject to ongoing regulations, including REMS, post-marketing studies, and strict rules on advertising and promotion to prevent off-label use[140](index=140&type=chunk)[156](index=156&type=chunk)[158](index=158&type=chunk) - Operations are also governed by healthcare laws like the Anti-Kickback Statute, False Claims Act, and data privacy regulations such as HIPAA and GDPR, with non-compliance carrying substantial penalties[171](index=171&type=chunk)[172](index=172&type=chunk)[179](index=179&type=chunk) [Human Capital](index=67&type=section&id=Human%20Capital) As of December 31, 2024, LAVA Therapeutics had 34 full-time employees, primarily in R&D, with a reduction in force initiated in February 2025 to decrease European employees to 6, and a human capital strategy focused on attracting and retaining talent through equity incentive plans - As of December 31, 2024, the company had **34 full-time employees**, with **23** in research and development and **11** in general and administrative roles[199](index=199&type=chunk) - A reduction in force was initiated in February 2025, which will reduce the number of full-time employees in Europe to **6**, effective April 30, 2025[199](index=199&type=chunk) [Risk Factors](index=67&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including a history of operating losses, the need for substantial additional funding, uncertain clinical development pathways for its novel Gammabody® platform, dependence on LAVA-1266 and third-party collaborations, reliance on single-source suppliers, intense competition, potential Nasdaq delisting, and the successful execution of its strategic review and restructuring - The company is a clinical-stage entity with a history of significant operating losses (**$25.1 million** in 2024, **$41.9 million** in 2023) and anticipates continued losses, with no guarantee of ever achieving profitability[204](index=204&type=chunk)[206](index=206&type=chunk)[208](index=208&type=chunk) - Substantial additional funding is required to complete development and commercialization, and failure to raise capital could force delays, reductions, or termination of programs[204](index=204&type=chunk)[220](index=220&type=chunk) - The Gammabody® platform is a novel approach, making it difficult to predict development time, cost, and regulatory approval, as no bispecific γδ T cell engagers are currently approved by the FDA or EMA[204](index=204&type=chunk)[233](index=233&type=chunk) - The company relies on a single-source supplier for bulk drug substance for its programs, and the loss of this supplier could significantly impair and delay development[207](index=207&type=chunk)[298](index=298&type=chunk) - The ongoing strategic review and workforce reduction may not achieve intended outcomes and could lead to loss of institutional knowledge and decreased morale[207](index=207&type=chunk)[371](index=371&type=chunk)[372](index=372&type=chunk) - The company received a notice of non-compliance from Nasdaq on February 27, 2025, for its stock price falling below **$1.00**, though compliance was regained on March 11, 2025, but future non-compliance could lead to delisting[461](index=461&type=chunk) [Cybersecurity](index=98&type=section&id=Item%201C.%20Cybersecurity) The company manages cybersecurity risks through internal processes and third-party providers, with oversight from the Audit Committee and implementation by senior management, including the CFO, through risk assessments, monitoring, incident response, and technical controls - The Audit Committee of the Board of Directors is responsible for overseeing the company's cybersecurity risk management processes[503](index=503&type=chunk) - Cybersecurity risk management is implemented by senior management, including the Chief Financial Officer (CFO), with assistance from third-party service providers and consultants[499](index=499&type=chunk)[504](index=504&type=chunk) - The company maintains an information security policy, an incident response policy, and various technical controls like data encryption, network security, and access controls to mitigate threats[500](index=500&type=chunk) [Properties](index=99&type=section&id=Item%202.%20Properties) The company leases approximately 8,471 square feet of office and laboratory space for its headquarters in Utrecht, Netherlands, until March 2026, and 5,621 square feet of office space in Philadelphia, Pennsylvania, until December 2025 - The company's headquarters is located in Utrecht, the Netherlands, occupying approximately **8,471 sq. ft.** of leased office and lab space with a lease expiring **March 31, 2026**[509](index=509&type=chunk) - A U.S. office of approximately **5,621 sq. ft.** is leased in Philadelphia, PA, with the lease term ending in **December 2025**[509](index=509&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=100&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) LAVA Therapeutics' common shares trade on the Nasdaq Global Select Market under the symbol "LVTX" since March 26, 2021, with 2,313 holders of record as of March 21, 2025, and the company has never paid cash dividends, intending to retain earnings for business development, with IPO net proceeds of approximately $94.2 million - Common shares are traded on the Nasdaq Global Select Market under the symbol "LVTX" since **March 26, 2021**[513](index=513&type=chunk) - The company has never paid cash dividends and does not intend to in the foreseeable future, retaining funds for business expansion[515](index=515&type=chunk) - The IPO generated net proceeds of approximately **$94.2 million**, which have been invested in money market funds and short-term investments[518](index=518&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=101&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For the year ended December 31, 2024, LAVA Therapeutics reported a net loss of $25.1 million, a decrease from $41.9 million in 2023, with revenue increasing to $12.0 million driven by milestone payments, and R&D expenses decreasing to $28.5 million, while existing cash of $76.6 million is deemed sufficient for at least 12 months Results of Operations (FY 2024 vs. FY 2023) | (in thousands) | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | **Total Revenue** | **$11,982** | **$6,769** | **$5,213** | | Research and development | ($28,450) | ($32,559) | $4,109 | | General and administrative | ($13,225) | ($14,122) | $897 | | **Operating Loss** | **($29,693)** | **($43,394)** | **$13,701** | | **Net Loss** | **($25,114)** | **($41,871)** | **$16,757** | - Revenue in 2024 was primarily driven by a **$7.0 million** clinical milestone payment from Pfizer and a **$5.0 million** development milestone payment from Johnson & Johnson[549](index=549&type=chunk)[550](index=550&type=chunk) - Research and development expenses decreased by **$4.1 million** year-over-year, mainly due to reduced manufacturing costs for LAVA-1266 and lower personnel-related expenses following headcount reductions in late 2023[552](index=552&type=chunk) - The company believes its existing cash, cash equivalents, and investments are sufficient to fund operations for at least **12 months** from the report date[561](index=561&type=chunk) Cash Flow Summary (FY 2024 vs. FY 2023) | (in thousands) | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(19,544) | $(40,283) | | Net cash generated from (used in) investing activities | $12,475 | $(17,636) | | Net cash used in financing activities | $(569) | $— | | **Net decrease in cash and cash equivalents** | **$(7,638)** | **$(57,919)** | [Controls and Procedures](index=111&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2024, with previously identified material weaknesses in IT general controls and segregation of duties fully remediated through additional accounting resources, enhanced policies, and improved IT controls - Management concluded that as of December 31, 2024, the company's disclosure controls and procedures were effective at a reasonable assurance level[578](index=578&type=chunk) - Material weaknesses previously identified in the 2023 Annual Report, related to IT general controls and segregation of duties, were fully remediated as of December 31, 2024[492](index=492&type=chunk)[581](index=581&type=chunk)[584](index=584&type=chunk) - Remediation actions included hiring additional accounting personnel, enhancing formal policies and procedures, redesigning internal controls, and improving IT general controls such as change management and user access[583](index=583&type=chunk) [Other Information](index=113&type=section&id=Item%209B.%20Other%20Information) On March 27, 2025, the company amended CEO Stephen Hurly's employment agreement, primarily modifying Change in Control severance benefits to a full 1.5 times his target bonus, removing the pro-rated calculation - On **March 27, 2025**, the company amended the employment agreement with CEO Stephen Hurly[587](index=587&type=chunk) - The amendment modified the Change in Control severance benefit, entitling Mr. Hurly to a lump-sum payment equal to **1.5 times** his target bonus, removing the previous pro-rated calculation[588](index=588&type=chunk) PART III [Directors, Executive Officers, Corporate Governance, Compensation, and Principal Accountant Fees](index=115&type=section&id=Item%2010%2C%2011%2C%2012%2C%2013%2C%2014) Information for Items 10 through 14, covering directors, executive officers, corporate governance, compensation, security ownership, related transactions, and principal accountant fees, is incorporated by reference from the company's forthcoming 2025 Proxy Statement - Information regarding Directors, Executive Officers, Corporate Governance (Item 10), Executive Compensation (Item 11), Security Ownership (Item 12), Certain Relationships and Related Transactions (Item 13), and Principal Accountant Fees and Services (Item 14) is incorporated by reference from the forthcoming 2025 Proxy Statement[597](index=597&type=chunk)[598](index=598&type=chunk)[600](index=600&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=116&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all exhibits filed with the Form 10-K, including corporate governance documents, material contracts, and certifications, such as Amended and Restated Articles of Association, license agreements, stock plans, employment agreements, and CEO/CFO certifications - This item lists all exhibits filed as part of the annual report, including material contracts and required certifications[605](index=605&type=chunk)[607](index=607&type=chunk) Financial Statements [Consolidated Financial Statements](index=219&type=section&id=Consolidated%20Financial%20Statements) The audited consolidated financial statements for the years ended December 31, 2024 and 2023, show a decreased net loss to $25.1 million in 2024, with total assets of $80.8 million, total liabilities of $53.1 million, and total shareholders' equity of $27.7 million as of December 31, 2024 Consolidated Balance Sheet Data (as of Dec 31) | (in thousands) | 2024 | 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $35,015 | $44,231 | | Short-term investments | $41,561 | $51,340 | | **Total Assets** | **$80,831** | **$101,673** | | Total current liabilities | $18,006 | $14,894 | | Non-current portion of deferred revenue | $35,000 | $35,000 | | **Total Liabilities** | **$53,086** | **$50,309** | | **Total Shareholders' Equity** | **$27,745** | **$51,364** | Consolidated Statement of Operations Data (Year Ended Dec 31) | (in thousands) | 2024 | 2023 | | :--- | :--- | :--- | | Total Revenue | $11,982 | $6,769 | | Research and development | $(28,450) | $(32,559) | | General and administrative | $(13,225) | $(14,122) | | **Operating Loss** | **$(29,693)** | **$(43,394)** | | **Net Loss** | **$(25,114)** | **$(41,871)** | | Net loss per share | $(0.94) | $(1.57) | - The company transitioned from IFRS to U.S. GAAP for all periods presented, as it no longer qualified as a Foreign Private Issuer (FPI) as of **June 30, 2024**[640](index=640&type=chunk) - As of December 31, 2024, the company had Dutch tax loss carryforwards of **$106.5 million**, which are fully offset by a valuation allowance[543](index=543&type=chunk)[762](index=762&type=chunk)