Core Insights - LAVA Therapeutics is focused on maximizing shareholder value in 2025 by evaluating strategic options while continuing patient enrollment in the Phase 1 study of LAVA-1266, a treatment for acute myeloid leukemia and myelodysplastic syndrome [2][5] - The company reported a cash balance of $76.6 million as of December 31, 2024, which is expected to fund operations into 2027 [5][9] Clinical Development Highlights - LAVA-1266 is currently in a Phase 1 trial targeting CD123+ tumor cells for hematological malignancies, evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity [3][6] - The partnered program with Johnson & Johnson (JNJ-89853413) is also in a Phase 1 trial, targeting CD33 and gamma delta T cells, with a development milestone of $5 million received in Q4 2024 [4][5] - Pfizer's partnered program (PF08046052) is in a Phase 1 trial for solid tumors, with a clinical development milestone of $7 million received in Q1 2024 [5][9] Financial Performance - Revenue from contracts with customers increased to $5.0 million in Q4 2024 from $0.4 million in Q4 2023, and for the full year, revenue rose to $12.0 million from $6.8 million [9][10] - Research and development expenses for Q4 2024 were $8.6 million, up from $2.3 million in Q4 2023, primarily due to costs associated with the discontinuation of LAVA-1207 [9][10] - The net loss for Q4 2024 was $3.8 million, compared to a net loss of $6.4 million in Q4 2023, with a full-year net loss of $25.1 million compared to $41.9 million in 2023 [9][10] Workforce and Restructuring - The company adopted a restructuring plan in February 2025, resulting in a 30% reduction in workforce to extend capital resources and focus on strategic options and the Phase 1 study for LAVA-1266 [5][9]

Core Viewpoint - LAVA Therapeutics N.V. is initiating a strategic review process aimed at maximizing shareholder value, which includes cost-cutting measures and workforce reduction [2][4][5] Financial Position - As of December 31, 2024, the company's cash balance, cash equivalents, and investments totaled $76.6 million [6] Strategic Options - The company is exploring various strategic options such as in-licensing assets, sales, licensing agreements, mergers, acquisitions, or other strategic transactions [4] - There is no set timetable for the strategic review process, and updates will only be provided once specific actions are approved by the Board [4] Workforce Reduction - LAVA is implementing a restructuring plan that includes a workforce reduction of approximately 30% to enhance cost containment and conserve cash [5] - The company anticipates incurring approximately $0.5 million in one-time costs related to this workforce reduction, primarily in Q1 2025 [5] Clinical Development - LAVA will continue its Phase 1 clinical study of LAVA-1266 for hematologic malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) [2][3] - The company is also committed to supporting its partnerships with Pfizer and Johnson & Johnson [2] Leadership Statement - The CEO of LAVA expressed the company's commitment to exploring strategic opportunities to enhance shareholder value, given the current focus on a single product in clinical development and an early-stage pipeline [3]

Core Insights - LAVA Therapeutics N.V. has initiated dosing of the first patient in a Phase 1, first-in-human study of LAVA-1266, a CD123-targeted Gammabody for treating hematologic cancers such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) [1][4] - The company is optimistic about LAVA-1266's preclinical safety and efficacy profile, which demonstrated tumor cell lysis with limited off-target effects [1][3] - Initial results from the dose escalation study are expected by the end of 2025 [7] Company Overview - LAVA Therapeutics is a clinical-stage immuno-oncology company focused on developing bispecific gamma-delta T cell engagers using its proprietary Gammabody platform [6] - The company aims to selectively kill cancer cells by activating Vγ9Vδ2 T cell anti-tumor functions [6] Product Details - LAVA-1266 is designed to target CD123+ tumor cells and engage Vγ9Vδ2-T cells, showing high potency and a wide therapeutic window [2] - Preclinical studies confirmed that LAVA-1266 preferentially targets and kills CD123+ cells while inducing Vγ9Vδ2-T cell activation, leading to significant tumor cell lysis and increased survival in AML models [3] Clinical Study Information - The Phase 1 study is open-label and multi-center, enrolling approximately 50 adults with CD123+ relapsed/refractory AML and certain grades of MDS [4][5] - Patients will receive doses every two weeks, starting with an initial target dose of 100 µg for the first cohort [4] Pipeline Overview - LAVA's pipeline includes three clinical-stage bispecific gamma-delta T cell engagers targeting various cancers, including LAVA-1266 for CD123+ cancers, PF-08046052 for EGFR, and JNJ-89853413 for hematological cancers [8]

[Unaudited Condensed Consolidated Interim Financial Statements](index=1&type=section&id=Unaudited%20Condensed%20Consolidated%20Interim%20Financial%20Statements) [Condensed Consolidated Interim Statements of Loss and Comprehensive Loss](index=2&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Loss%20and%20Comprehensive%20Loss) LAVA Therapeutics significantly narrowed its net loss for the nine months ended September 30, 2024, driven by reduced operating expenses despite stable revenue Statement of Loss Summary (Nine Months Ended September 30) | Financial Metric (in thousands) | 2024 | 2023 | Change (YoY) | | :------------------------------ | :--------- | :--------- | :------------------------------------------------------------------------------------------------------- | | Revenue | $6,992 | $6,416 | Increased, primarily from a $7.0M milestone payment from Pfizer | | Gross Profit | $6,992 | $3,088 | Increased significantly due to revenue mix and lower cost of sales | | Research and Development | ($20,844) | ($30,454) | Decreased, reflecting lower clinical trial and personnel-related expenses | | General and Administrative | ($8,745) | ($10,445) | Decreased, due to lower professional fees and share-based compensation | | Operating Loss | ($22,597) | ($37,811) | Narrowed due to reduced operating expenses | | Loss for the period | ($21,144) | ($35,476) | Narrowed significantly | | Loss per share (basic & diluted) | ($0.79) | ($1.35) | Improved due to lower net loss | [Condensed Consolidated Interim Statements of Financial Position](index=3&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Financial%20Position) Total assets and equity decreased as of September 30, 2024, primarily due to a reduction in cash and accumulated net losses from operations Financial Position Summary (in thousands) | Account | Sep 30, 2024 | Dec 31, 2023 | | :---------------------------- | :----------- | :----------- | | **Assets** | | | | Cash and cash equivalents | $26,963 | $44,231 | | Investments | $51,921 | $51,340 | | Total Current Assets | $81,538 | $98,897 | | **Total Assets** | **$83,357** | **$101,710** | | **Liabilities & Equity** | | | | Deferred revenue (Non-current) | $35,000 | $35,000 | | Total Liabilities | $50,364 | $50,532 | | Total Equity | $32,993 | $51,178 | | **Total Equity & Liabilities**| **$83,357** | **$101,710** | [Condensed Consolidated Interim Statements of Changes in Equity](index=4&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Changes%20in%20Equity) Total equity decreased significantly from January 1 to September 30, 2024, primarily due to the net loss for the period Changes in Equity for the Nine Months Ended September 30, 2024 (in thousands) | Description | Amount | | :--------------------------------- | :--------- | | Balance at January 1, 2024 | $51,178 | | Loss for the period | ($21,144) | | Share-based compensation expense | $2,636 | | Other adjustments (options, FX) | $323 | | **Balance at September 30, 2024** | **$32,993**| [Condensed Consolidated Interim Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly improved for the nine months ended September 30, 2024, with cash and equivalents decreasing overall Cash Flow Summary (Nine Months Ended September 30, in thousands) | Cash Flow Activity | 2024 | 2023 | | :------------------------ | :---------- | :---------- | | Net cash used in operating| ($18,139) | ($28,507) | | Net cash from (used in) investing | $1,504 | ($8,948) | | Net cash used in financing| ($363) | ($736) | | **Net decrease in cash** | **($16,998)** | **($38,191)** | | **Cash at end of period** | **$26,963** | **$62,663** | [Notes to the Condensed Consolidated Interim Financial Statements](index=7&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Interim%20Financial%20Statements) These notes provide critical details on the company's accounting policies, financial position, and significant events, including its going concern status and post-period developments [Note 1—General Information](index=7&type=section&id=Note%201%E2%80%94General%20Information) LAVA Therapeutics is a clinical-stage immuno-oncology company transitioning to a U.S. domestic filer in 2025 - The company is a clinical-stage immuno-oncology firm focused on its **Gammabody® platform** to develop **bispecific gamma-delta T cell engagers** for cancer treatment[65](index=65&type=chunk) - Effective **January 1, 2025**, the company will transition to a **U.S. domestic filer** and will prepare its financial statements in accordance with **U.S. GAAP**, filing future annual reports on **Form 10-K**[20](index=20&type=chunk) [Note 2—Summary of Significant Accounting Policies](index=7&type=section&id=Note%202%E2%80%94Summary%20of%20Significant%20Accounting%20Policies) The company's interim financial statements are prepared under IAS 34, with an immaterial revision made to cash flow presentation - The company identified and revised an **immaterial misstatement** in the presentation of its condensed consolidated interim statements of **cash flows** related to **accrued interest** on the RVO debt agreement[10](index=10&type=chunk)[24](index=24&type=chunk) - The correction **reclassified accrued interest** from a cash inflow from financing activities to a **non-cash adjustment** in operating activities, and the company concluded the revision was **not material** to any prior period[41](index=41&type=chunk)[42](index=42&type=chunk) [Note 3—Material Accounting Judgments, Estimates and Assumptions](index=11&type=section&id=Note%203%E2%80%94Material%20Accounting%20Judgments%2C%20Estimates%20and%20Assumptions) The company maintains sufficient liquidity for at least 12 months, with critical accounting judgments impacting revenue and expense recognition - The company expects its cash, cash equivalents, and investments of **$78.9 million** as of September 30, 2024, will be **sufficient to fund operations for at least the next 12 months**, supporting the **going-concern basis** of the financial statements[44](index=44&type=chunk) - **Critical judgments** in applying accounting policies significantly affect amounts recognized for **revenue recognition**, **share-based payments**, **clinical trial expense accruals**, and **lease accounting**[82](index=82&type=chunk) [Note 4—Equity](index=14&type=section&id=Note%204%E2%80%94Equity) As of September 30, 2024, the company's share capital consisted of 26,298,665 issued and outstanding common shares, each with a nominal value of $0.14 - As of September 30, 2024, LAVA Therapeutics N.V. had **26,298,665 common shares** issued and outstanding[84](index=84&type=chunk) [Note 5—Revenue and cost of sales](index=14&type=section&id=Note%205%E2%80%94Revenue%20and%20cost%20of%20sales) Revenue is primarily derived from collaboration agreements, with a significant milestone payment recognized from Pfizer in March 2024 - In March 2024, Pfizer achieved a clinical development milestone for EGFRd2 (PF-08046052), triggering a **$7.0 million milestone payment** to the company, which was recognized as revenue[57](index=57&type=chunk) Revenue from Contracts with Customers (Nine Months Ended Sep 30, in thousands) | Source | 2024 | 2023 | | :----------------------------------- | :------ | :------ | | Pfizer Inc. - Milestones | $6,960 | $0 | | Pfizer Inc. - Other activities | $24 | $3,422 | | Pfizer Inc. - Additional services | $8 | $504 | | Johnson & Johnson Agreement - Milestones | $0 | $2,490 | | **Total Revenue** | **$6,992** | **$6,416** | [Note 6—Research and Development Expenses](index=16&type=section&id=Note%206%E2%80%94Research%20and%20Development%20Expenses) Research and development expenses decreased significantly for the nine months ended September 30, 2024, driven by lower pre-clinical and clinical trial costs R&D Expense Breakdown (Nine Months Ended Sep 30, in thousands) | Expense Category | 2024 | 2023 | | :----------------------------------- | :---------- | :---------- | | Pre-clinical and clinical trial | $12,836 | $20,542 | | Personnel-related | $3,830 | $5,346 | | Facilities and other | $2,024 | $1,297 | | Share-based compensation | $962 | $1,427 | | Other | $1,192 | $1,842 | | **Total R&D Expenses** | **$20,844** | **$30,454** | [Note 7—General and Administrative Expenses](index=17&type=section&id=Note%207%E2%80%94General%20and%20Administrative%20Expenses) General and administrative expenses decreased for the nine months ended September 30, 2024, primarily due to reduced professional fees and share-based compensation G&A Expense Breakdown (Nine Months Ended Sep 30, in thousands) | Expense Category | 2024 | 2023 | | :----------------------------------- | :--------- | :---------- | | Personnel-related | $2,937 | $2,932 | | Professional and consultant fees | $2,356 | $2,667 | | Insurance, facilities, and other | $1,778 | $2,159 | | Share-based compensation | $1,674 | $2,687 | | **Total G&A Expenses** | **$8,745** | **$10,445** | [Note 8—Share-based Awards](index=17&type=section&id=Note%208%E2%80%94Share-based%20Awards) The company recognized $2.6 million in share-based compensation expense, with a significant number of stock options outstanding and remaining unrecognized compensation - As of September 30, 2024, there were **6,584,726 stock options outstanding**, with **3,592,462 vested and exercisable**[92](index=92&type=chunk) - The unrecognized remaining stock-based compensation balance was approximately **$2.4 million** as of September 30, 2024, which is expected to be recognized over a weighted-average period of **0.79 years**[95](index=95&type=chunk) [Note 9—Investments](index=19&type=section&id=Note%209%E2%80%94Investments) The company's investments consist of U.S. Treasury securities with maturities of three to six months, classified as held-to-maturity and recorded at amortized cost - Investments consist of U.S. Treasury securities classified as held-to-maturity, with a carrying value of **$51.9 million** at September 30, 2024[96](index=96&type=chunk) [Note 10–Subsequent Events](index=19&type=section&id=Note%2010%E2%80%93Subsequent%20Events) Significant subsequent events include a $5.0 million milestone payment from J&J, a debt settlement with RVO, and the discontinuation of the LAVA-1207 clinical trial - In October 2024, a **$5.0 million** milestone payment from J&J was triggered following a Phase 1 clinical trial filing with health authorities[116](index=116&type=chunk) - In December 2024, the company discontinued the **LAVA-1207 clinical trial** after determining that signs of activity did not meet internal benchmarks[98](index=98&type=chunk) - In October 2024, the RVO required a payment of **$0.6 million**, with the remaining **$5.2 million** balance being conditionally waived for one year[97](index=97&type=chunk)

The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system. Therefore, the Zacks rating upgrade for LAVA Therapeutics basically reflects positivity about its earnings outlook that could translate into buying pressure and an increase in its stock price. The change in a company's future earnings potential, as refle ...

UTRECHT, The Netherlands and PHILADELPHIA, June 20, 2024 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ: LVTX, "LAVA"), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody® platform of bispecific gamma delta T cell engagers, today announced that Stephen Hurly, President and Chief Executive Officer of LAVA Therapeutics, will present at the H.C. Wainwright 2nd Annual Immune Cell Engager Virtual Conference. LAVA Therapeutics N.V. is a clinical-stage immuno-oncology comp ...

All relevant documents and information relating to the annual general meeting, including the notice and agenda for the annual general meeting, are available in the "Investors" section of LAVA's website (www.lavatherapeutics.com) under "Annual Meeting." The documents will also be made available on the SEC's website at www.sec.gov. Shareholders who wish to attend the meeting should register as described in the notice and agenda for the annual general meeting. LAVA Therapeutics N.V. is a clinical-stage immuno- ...

UTRECHT, The Netherlands and PHILADELPHIA, June 10, 2024 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ: LVTX, "LAVA"), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody® platform of bispecific gamma delta T cell engagers, today announced the annual general meeting of shareholders will take place on Wednesday, June 19, 2024 at 2:00 pm CEST. All relevant documents and information relating to the annual general meeting, including the notice and agenda for the annual ...

Core Insights - LAVA Therapeutics is advancing its Gammabody® platform, focusing on bispecific gamma delta T cell engagers for cancer treatment, with significant updates expected in 2024 [2][12] Pipeline Developments - LAVA-1207 is in Phase 1/2a trials targeting metastatic castration-resistant prostate cancer (mCRPC), with a combination arm with pembrolizumab set to begin in Q2 2024 [3][5] - Pfizer's PF-08046052 is in Phase 1, representing a potential first-in-class therapy for solid tumors, with a $7 million milestone achieved in March 2024 [5][9] - LAVA-1266 is on track for an Investigational New Drug (IND) submission in Q2 2024, aimed at treating hematological malignancies [3][5] Financial Performance - As of March 31, 2024, LAVA reported cash and investments totaling $94.6 million, a slight decrease from $95.6 million at the end of 2023, providing a runway into 2026 [4][7] - Revenue for Q1 2024 was $7.0 million, a significant increase from $1.2 million in Q1 2023, primarily due to a milestone payment from Pfizer [9][10] - Operating loss for Q1 2024 was $1.95 million, a substantial improvement compared to a loss of $13.54 million in Q1 2023 [8][9] Operational Highlights - The company has successfully implemented step dosing in the LAVA-1207 trial, resulting in no ≥ Grade 2 Cytokine Release Syndrome (CRS) events reported since the change [2][6] - The company is evaluating the combination of LAVA-1207 with low dose IL-2 to enhance treatment efficacy [6][12]

TABLE OF CONTENTS SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS Page | PART I | | | | | --- | --- | --- | --- | | Item 1. | | Identity of Directors, Senior Management and Advisors | 4 | | Item 2. | | Offer Statistics and Expected Timetable | 4 | | Item 3. | | Key Information | 4 | | Item 4. | | Information on the Company | 58 | | | Item 4A. | Unresolved Staff Comments | 86 | | Item 5. | | Operating and Financial Review and Prospects | 86 | | Item 6. | | Directors, Senior Management and Employees | 95 | ...