LAVA Q2 2024 Financial Results and Business Update

LAVA Therapeutics N.V., a clinical-stage immuno-oncology company, recently disclosed its financial results for the second quarter ending June 30, 2024, while also providing updates on its corporate activities. LAVA is developing its proprietary Gammabody® platform of bispecific gamma delta T cell engagers, targeting both solid tumors and hematologic malignancies. The company is listed on NASDAQ under the ticker LVTX.

Stephen Hurly, President and CEO of LAVA, highlighted the continued advancements in the Phase 1/2a study of LAVA-1207, designed for patients with metastatic castration-resistant prostate cancer (mCRPC). This study is currently in its monotherapy arm at dose level 12, with no cases of Grade 2 or higher Cytokine Release Syndrome reported since the introduction of step-dosing in early 2024. The company also started dosing in the pembrolizumab combination arm in the second quarter of 2024 and anticipates releasing further data in the fourth quarter of the year. Additionally, the initiation of a clinical trial for LAVA-1266, targeting acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), is on track to begin by the end of the year.

Key highlights of LAVA’s portfolio include:

LAVA-1207:
- Designed to effectively target PSMA-positive mCRPC cells.
- Monotherapy Arm: Currently enrolling at dose level 12 with a favorable safety profile since implementing step-dosing.
- Pembrolizumab Combination Arm: Initiated dosing to potentially enhance LAVA-1207’s anti-tumor activity, using an established step-dosing regimen.
- Low Dose Interleukin-2 (LDIL-2) Combination: Under evaluation to possibly increase the number of Vγ9Vδ2 T cells for better engagement by LAVA-1207.

LAVA-1266: 
- Aimed at targeting CD123+ tumor cells for treating hematological malignancies like AML and MDS.
- Plans are underway to initiate a Phase 1 trial in Australia by the end of 2024.

Pfizer PF-08046052:
- Represents a potential first-in-class EGFR and bispecific gamma delta T cell-targeted therapy for solid tumors.
- Indications include colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and pancreatic ductal adenocarcinoma (PDAC).
- A Phase 1 monotherapy dose escalation study is ongoing to assess safety and tolerability in advanced EGFR-expressing solid tumors.
- A clinical development milestone of $7 million was received from Pfizer in the first quarter of 2024.

Johnson & Johnson Collaboration:
- Focuses on discovering and developing novel bispecific gamma delta T cell engagers for blood cancer treatment.
- The lead bispecific candidate antibody has been selected for development, with Johnson & Johnson working to advance it toward clinical trials.

Financially, LAVA reported having cash, cash equivalents, and investments totaling $86.8 million as of June 30, 2024, a decrease from $95.6 million at the end of 2023. The company believes this financial position will support operations into mid-2026. Revenue from contracts with customers was zero for the second quarter of 2024, compared to $5.1 million in the same period in 2023. This previous revenue included $2.6 million for research activities and initial supply delivery under the Pfizer Agreement and $2.5 million from a milestone payment associated with the Janssen Agreement.

Operational expenses saw a reduction, with research and development costs at $6.3 million for the second quarter of 2024, down from $12.6 million in the same quarter of 2023. This decrease is attributed to lower pre-clinical and clinical trial expenses following the discontinuation of LAVA-051 and reduced personnel-related costs due to a headcount reduction. General and administrative expenses also saw a decline to $3.0 million from $3.7 million year-over-year, mainly due to lower non-cash share-based compensation and reduced headcount.

The company reported net losses of $8.3 million for the second quarter of 2024, an improvement from the $12.7 million loss reported in the same period of the previous year. For the first six months of 2024, net losses were $8.8 million, down from $26.6 million in the corresponding period of 2023. 

Overall, LAVA continues to advance its clinical programs and maintain a strong financial position to support future growth and development in the biopharmaceutical sector.

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