LAVA Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Business Update
Focused on the evaluation of strategic alternatives
Adopted a restructuring plan to extend capital resources, incurring a reduction in workforce of 30% to support the evaluation of strategic options and the Phase 1 study for LAVA-1266
Phase 1 enrollment in LAVA-1266 clinical trial underway
Johnson and Johnson development milestone of $5.0 million achieved and received in Q4 2024
Cash balance of $76.6 million as of December 31, 2024 expected to fund operations into 2027
UTRECHT, The Netherlands and PHILADELPHIA, March 28, 2025 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX, "LAVA, " "the Company")), 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 fourth quarter and year ended December 31, 2024.
"LAVA's approach to maximize shareholder value in 2025 will focus on evaluating strategic options while continuing to enroll patients in our ongoing Phase 1 study of LAVA-1266, and supporting our pharma partnerships," said Steve Hurly, Chief Executive Officer of LAVA. "The Phase 1 study of LAVA-1266 as a potential treatment for acute myeloid leukemia and myelodysplastic syndrome is progressing. Looking ahead, with a strong cash balance, we believe LAVA is well-positioned to unlock strategic opportunities, and we look forward to updating investors with our progress throughout the year."
Portfolio Highlights
LAVA-1266, Phase 1 Trial (ACTRN12624001214527)
Designed to target CD123+ tumor cells for the treatment of hematological malignancies
Key indications: Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
Current Status: LAVA is enrolling patients in the second dose level at 300 µg in a first-in-human Phase 1, open label, multi-center study in Australia. The study includes a dose escalation and dose expansion segment to evaluate LAVA-1266 in approximately 50 adults with CD123+ relapsed/refractory AML or intermediate, high or extremely high risk MDS.The study is evaluating safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and preliminary anti-tumor activity.
Johnson & Johnson (J&J) Partnered Program (JNJ-89853413), Phase 1 Trial (NCT06618001)
Designed to target CD33 and gamma delta T cells with a bispecific gamma delta T cell engager
Key Indications: Include hematological cancers
Current Status: J&J is enrolling patients in a Phase 1, open label, multi-center study underway in Canada and Spain. The study includes a dose escalation and dose expansion segment to evaluate JNJ-89853413 in approximately 100 adults with relapsed/refractory AML or moderate or higher risk MDS. The study is evaluating safety, tolerability, PK, PD, immunogenicity and preliminary anti-tumor activity.J&J presented preclinical data for JNJ-89853413 at the Annual Meeting of the American Society of Hematology (ASH 2024) on December 7, 2024 (Abstract 2054).
Milestone: Development milestone of $5 million received from J&J in Q4 2024 related to the IND filing for JNJ-89853413
Pfizer Partnered Program (PF08046052), Phase 1 Trial (NCT05983133)
Potential first-in-class epidermal growth factor receptor (EGFR) and bispecific gamma delta T cell receptor-targeted therapy for solid tumors
Key Indications: Include colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and pancreatic ductal adenocarcinoma (PDAC)
Current Status: Pfizer is enrolling patients in a Phase 1 open label, multi-center study, underway in the U.S. and UK. The study will include dose escalation and dose expansion segments to evaluate PF08046052 in approximately 275 subjects with metastatic, non-resectable solid tumor cancers. The study will evaluate safety, tolerability, PK, immunogenicity and preliminary anti-tumor activity.
Milestone: Clinical development milestone of $7 million received from Pfizer in Q1 2024
Fourth Quarter and Year-End 2024 Financial Results
In February 2025, the Company adopted a restructuring plan to extend its capital resources in connection with initiating a process to evaluate strategic alternatives. As part of the restructuring plan, the Company's board of directors approved a reduction of approximately 30% of the Company's global workforce to better align resources with the Company's focus on the evaluation of strategic options and the Phase 1 study for LAVA-1266. The Company expects approximately $1.0 million of expenses related to the restructuring to be incurred during the six months ended June 30, 2025, of which approximately $0.3 million of cash payments are expected to be made during 2025.
As of December 31, 2024, LAVA had cash, cash equivalents, and investments of $76.6 million, compared to cash, cash equivalents, and investments of $95.6 million as of December 31, 2023. The Company believes its current cash, cash equivalents and investments will be sufficient to fund operations into 2027.
Revenue from contracts with customers was $5.0 million and $0.4 million for the quarters ended December 31, 2024 and 2023, respectively, and $12.0 million and $6.8 million for the years ended December 31, 2024 and 2023, respectively. The increase in revenue for the quarter ended December 31, 2024 compared to 2023 was primarily due to the $5.0 million milestone related to J&J's IND filing in October 2024. The increase in revenue for the year ended December 31, 2024 compared to 2023 was primarily related to $7.0 million the Company recognized in revenue in connection with its agreement with Pfizer related to the achievement of a clinical development milestone and $5.0 million the Company recognized as revenue in connection with J&J's IND filing. In comparison, in 2023, revenue included $4.3 million related to the Company's agreement with Pfizer and $2.5 million related to the Company's agreement with J&J.
Cost of sales of goods and providing services was zero and $0.2 million for the quarters ended December 31, 2024 and 2023, respectively, and zero and $3.5 million for the years ended December 31, 2024 and 2023, respectively. The cost in 2023 was due to the initial drug supply delivery to Pfizer and related stability studies.
Research and development expenses were $8.6 million and $2.3 million for the quarters ended December 31, 2024 and 2023, respectively, and $28.5 million and $32.6 million for the years ended December 31, 2024 and 2023, respectively. The increase for the quarter ended December 31, 2024, as compared to December 31, 2023, was primarily due to costs associated with the discontinuation of LAVA-1207, announced in December 2024. The decrease for the year ended December 31, 2024, as compared to December 31, 2023, was primarily due to reduced manufacturing scale-up costs and headcount reductions that occurred in the second half of 2023, offset by costs associated with the discontinuation of LAVA-1207.
General and administrative expenses were $3.3 million for each of the quarters ended December 31, 2024 and 2023, and $13.2 million and $14.1 million for the years ended December 31, 2024 and 2023, respectively. The decrease for the year ended December 31, 2024, as compared to December 31, 2023, was primarily due to lower share-based compensation expense as a result of fewer options issued and a reduction in the Company's share price.
Net loss was $3.8 million and $6.4 million for the quarters ended December 31, 2024 and 2023, respectively, or $0.14 and $0.24 net loss per share for the quarters ended December 31, 2024 and 2023, respectively. Net losses were $25.1 million and $41.9 million for the years ended December 31, 2024 and 2023, respectively, or $0.94 and $1.57 net loss per share for the years ended December 31, 2024 and 2023, respectively.
LAVA Therapeutics N.V. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts) (unaudited)
Three Months Ended
Year Ended
December 31,
December 31,
2024
2023
2024
2023
Revenue:
Revenue from contracts with customers
$
4,990
$
353
$
11,982
$
6,769
Total revenue
4,990
353
11,982
6,769
Cost and expenses:
Cost of revenue
—
(155)
—
(3,482)
