LAVA Reports Third Quarter 2024 Financial Results and Announces Pipeline Reprioritization and Cash Runway Extension into 2027
- Reprioritized pipeline to focus on LAVA-1266, with continued support for partnered programs with Pfizer (PF-08046052) and Johnson and Johnson (JNJ-89853413) and plan to discontinue development of LAVA-1207
- Fourth quarter pipeline advances include initiation of the Phase 1 trial for LAVA-1266, for hematologic malignancies, and a $5.0 million milestone payment from Johnson and Johnson
- Cash runway extended into 2027, based on a cash balance of $78.9 million, as of September 30, 2024
UTRECHT, The Netherlands and PHILADELPHIA, Dec. 10, 2024 (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, reported financial results for the third quarter ended September 30, 2024 and announced a strategic pipeline reprioritization.
“LAVA’s goal is to develop immuno-oncology medicines to improve the lives of cancer patients. While we are disappointed that LAVA-1207 did not reach our predetermined success criteria, we are reprioritizing our pipeline to focus on LAVA-1266, for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), and will continue to support our partnered programs. We are pleased by the progress of our partnered programs, including a preclinical data presentation by Johnson and Johnson at ASH 2024 and ongoing enrollment in the Phase 1 program by Pfizer,” said Stephen Hurly, President and Chief Executive Officer of LAVA Therapeutics. “LAVA is well capitalized, with approximately $79 million in cash, and with this pipeline reprioritization, we expect our cash balance to fund the Company into 2027.”
“We thank the patients, investigators, and our employees for supporting the LAVA-1207 clinical study,” said Charlie Morris, MD, Chief Medical Officer of LAVA Therapeutics. “The longer time to progression, with several patients on trial beyond 6 months, and duration of treatment observed for patients with higher circulating gamma delta2 T cells are consistent with the mechanism of action and supports continued clinical investigation of the platform.”
Portfolio Highlights:
LAVA-1266 – In 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: Phase 1 dose escalation study initiated in Australia
Johnson & Johnson Partnered Program (JNJ-89853413) – Phase 1 Trial (NCT06618001)
Designed to target CD33 and Vδ2 T cells with a bispecific gamma delta T cell engager
- Key Indications: include hematological cancers
- Current Status: Johnson and Johnson has filed with health authorities to start a Phase 1 study. Johnson & Johnson presented preclinical data for JNJ-89853413 at the Annual Meeting of the American Society of Hematology (ASH 2024) on December 7, 2024 (Abstract 2054: 2054).
- Milestone: Development milestone of $5 million received from Johnson and Johnson in Q4 2024 related to the IND filing for JNJ-89853413
Pfizer Partnered Program –(PF08046052) – In 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: Monotherapy Phase 1 dose escalation study underway to evaluate the safety and tolerability in advanced EGFR-expressing solid tumors
- Milestone: Clinical development milestone of $7 million received from Pfizer in Q1 2024
LAVA-1207 – Discontinued
Designed to target prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC)
- The Phase 1 study of LAVA-1207 did not reach LAVA’s internal benchmarks and the program and drug will be made available for patients currently receiving LAVA-1207 for as long as considered necessary by their treating physician. The decision to discontinue LAVA-1207 is not due to safety concerns. Clinical signals recorded in several patients, including PSA reductions and extended time on study for patients with higher baseline circulating Vd2 T cells, as well as the encouraging safety and tolerability profile, are consistent with the intended mechanism of action and support further investigation of the platform. Learnings, especially related to the favorable overall safety profile and tolerability of LAVA-1207, will be incorporated into further development of the Company’s pipeline programs.
Third Quarter 2024 Financial Results
- As of September 30, 2024, LAVA had cash, cash equivalents and investments totaling $78.9 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 zero and $0.1 million for the quarters ended September 30, 2024 and 2023, respectively, and $7.0 million and $6.4 million for the nine months ended September 30, 2024 and 2023, respectively. Revenue of $0.1 million for the quarter ended September 30, 2023 was related to reimbursement for research activities and initial stability studies for clinical supplies.
- Research and development expenses were $8.5 million and $7.9 million for the quarters ended September 30, 2024, and 2023, respectively, and $20.8 million and $30.5 million for the nine months ended September 30, 2024 and 2023, respectively. The increase for the quarter ended September 30, 2024, as compared to 2023 was the result of increased pre-clinical and clinical trial expenses due to increased clinical trial activities for LAVA-1207, partly offset by reduced manufacturing costs for LAVA-1266 and other product candidates. The decrease between the nine months ended September 30, 2024 and 2023, respectively, was primarily due to lower pre-clinical and clinical trial expenses due to the discontinuation of LAVA-051, announced in June 2023, and reduced personnel-related expenses due to a reduction in research and development headcount in the second half of 2023.
- General and administrative expenses were $2.8 million and $2.9 million for the quarters ended September 30, 2024 and 2023, respectively, and $8.7 million and $10.4 million for the nine months ended September 30, 2024 and 2023, respectively. The decrease in both periods was primarily due to lower non-cash share-based compensation expenses and personnel-related expenses due to a reduction in general and administrative headcount in the second half of 2023.
- Net losses were $12.3 million and $8.8 million, or $0.46 and $0.34 net loss per share, for the quarters ended September 30, 2024 and 2023, respectively, and $21.1 million and $35.5 million, or $0.79 and $1.35 net loss per share, for the nine months ended September 30, 2024 and 2023, respectively.
LAVA will transition from foreign private issuer to U.S. domestic filer status beginning on January 1, 2025. The Company expects to incur increased costs associated with this transition, including expenses related to financial reporting, preparation of financial statements in accordance with U.S. GAAP, and compliance with U.S. federal proxy rules.
LAVA Therapeutics N.V. Condensed Consolidated Interim Statements Loss and Comprehensive Loss (in thousands, except share and per share amounts) (unaudited) | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||||
Revenue: | |||||||||||||||||
Revenue from contracts with customers | $ | — | $ | 53 | $ | 6,992 | $ | 6,416 | |||||||||
Cost of sales of goods | — | — | — | (2,546 | ) | ||||||||||||
Cost of providing services | — | (10 | ) | — | (782 | ) | |||||||||||
Gross profit | — | 43 | 6,992 | 3,088 | |||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | (8,500 | ) | (7,912 | ) | (20,844 | ) | (30,454 | ) | |||||||||
General and administrative | (2,785 | ) | (2,858 | ) | (8,745 | ) | (10,445 | ) | |||||||||
Total operating expenses | (11,285 | ) | (10,770 | ) | (29,589 | ) | (40,899 | ) | |||||||||
Operating loss | (11,285 | ) | (10,727 | ) | (22,597 | ) | (37,811 | ) | |||||||||
Interest income, net | 805 | 809 | 2,426 | 2,124 | |||||||||||||
Foreign currency exchange (loss) gain, net | (1,720 | ) | 1,132 | (723 | ) | 429 | |||||||||||
Total non-operating (loss) income | (915 | ) | 1,941 | 1,703 | 2,553 | ||||||||||||
Loss before income tax | (12,200 | ) | (8,786 | ) | (20,894 | ) | (35,258 | ) | |||||||||
Income tax expense | (96 | ) | (50 | ) | (250 | ) | (218 | ) | |||||||||
Loss for the period | $ | (12,296 | ) | $ | (8,836 | ) | $ | (21,144 | ) | $ | (35,476 | ) | |||||
Items that may be reclassified to profit or loss | |||||||||||||||||
Foreign currency translation adjustment | 1,688 | (1,385 | ) | 296 | (82 | ) | |||||||||||
Total comprehensive loss | $ | (10,608 | ) | $ | (10,221 | ) | $ | (20,848 | ) | $ | (35,558 | ) | |||||
Loss per share: | |||||||||||||||||
Loss per share, basic and diluted | $ | (0.46 | ) | $ | (0.34 | ) | $ | (0.79 | ) | $ | (1.35 | ) | |||||
Weighted-average common shares outstanding, basic and diluted | 26,846,006 | 26,289,087 | 26,814,113 | 26,289,087 |
LAVA Therapeutics N.V. Condensed Consolidated Statements of Financial Position (in thousands) (unaudited) | |||||||||
September 30, | December 31, | ||||||||
2024![]()
By: GlobeNewswire
- 10 Dec 2024
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