LAVA Updates Business and Reports Q1 2024 Financials

LAVA Therapeutics N.V. is a clinical-stage company specializing in immuno-oncology, with its proprietary Gammabody® platform focused on developing bispecific gamma delta T cell engagers. On May 21, 2024, the company shared recent corporate highlights and financial outcomes for the first quarter ending March 31, 2024.

LAVA-1207, a key program under the company’s portfolio, is advancing through Phase 1/2a trials aimed at treating metastatic castration-resistant prostate cancer (mCRPC). In this context, an essential update is anticipated in the second half of 2024. Currently, patients in the trial are being enrolled at dose level 10, with no significant cases of Grade 2 or higher Cytokine Release Syndrome (CRS) reported since the introduction of step dosing in the first quarter of 2024. Additionally, the company is set to initiate a combination arm with pembrolizumab (KEYTRUDA®) in the second quarter of 2024. LAVA is also assessing the potential of combining LAVA-1207 with low-dose interleukin-2 (IL-2) to enhance the number of Vγ9Vδ2 T cells for engagement.

Pfizer’s PF-08046052, previously known as LAVA-1223, is in Phase 1 trials and represents a potential first-in-class treatment targeting EGFR and bispecific gamma delta T cells for various solid tumors. The key indications include colorectal cancer, non-small cell lung cancer, head and neck squamous cell carcinoma, and pancreatic ductal adenocarcinoma. Pfizer has progressed significantly in this program, meriting a $7 million milestone payment to LAVA in March 2024.

Another promising candidate, LAVA-1266, is on track for an Investigational New Drug (IND) submission in the second quarter of 2024. This treatment is designed to target CD123 for addressing hematological malignancies like acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

Financially, LAVA Therapeutics reported having $94.6 million in cash, cash equivalents, and investments as of March 31, 2024, marginally down from $95.6 million on December 31, 2023. This financial positioning is expected to support the company’s operations until 2026. Revenue for the first quarter of 2024 stood at $7.0 million, primarily attributed to the clinical development milestone achieved by Pfizer for PF-08046052. Comparatively, the first quarter of 2023 saw revenue of $1.2 million from the reimbursement of research activities and the initial supply delivery to Pfizer.

The company’s cost of services and goods was zero for the first quarter of 2024 but was $0.9 million for the same period in 2023, associated with initial supply costs and related studies for Pfizer. Research and development expenses dropped significantly to $6.0 million in the first quarter of 2024 from $9.9 million in the previous year, primarily due to the discontinuation of LAVA-051 and a reduction in R&D personnel. General and administrative expenses also decreased to $2.9 million from $3.9 million, driven by a reduction in headcount.

LAVA reported a net loss of $0.5 million for the first quarter of 2024 compared to $13.9 million for the same period in 2023. This translates to a net loss per share of $0.02 for 2024, significantly lower than the $0.53 reported in the previous year.

In summary, LAVA Therapeutics continues to make strides in its clinical programs, with key developments in its Gammabody® platform and collaborations with industry giants like Pfizer. The company remains financially robust, positioning itself well to advance its pipeline and achieve significant milestones in the coming years.

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