On August 13, 2025 LAVA Therapeutics N.V. (NASDAQ: LVTX, "LAVA," or the "Company"), a clinical-stage immuno-oncology company historically focused on its proprietary Gammabody bispecific gamma delta T cell engagers, reported financial results for the second quarter ended June 30, 2025 and provided a corporate update (Press release, Lava Therapeutics, AUG 13, 2025, View Source [SID1234655305]).
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"We are pleased to announce that LAVA has recently entered into a definitive agreement to be acquired by XOMA Royalty Corporation," said Steve Hurly, Chief Executive Officer of LAVA. "This deal is the outcome of a comprehensive and diligent strategic review process by management and our Board of Directors, conducted under the guidance of our legal and financial advisors, with the objective of maximizing value for our shareholders while supporting the sustained success of LAVA’s business. Our Board of Directors has unanimously determined that the deal is in the best interests of all of our shareholders and has approved the proposed acquisition."
Entry into Share Purchase Agreement; Tender Offer
On August 4, 2025, the Company announced that it has entered a definitive share purchase agreement (the "Purchase Agreement" and the transactions set forth in the Purchase Agreement, the "Transactions") with XOMA Royalty Corporation ("XOMA"), whereby XOMA will acquire all of the issued and outstanding common shares of the Company through a cash tender offer for (i) between $1.16 and $1.24 per share in cash, consisting of (A) $1.16 per share, plus (B) an additional amount of up to $0.08 per share, plus (ii) a non-transferable contingent value right per share representing the right to receive potential contingent cash payments following the closing related to the Company’s two partnered assets as well as its unpartnered programs. Pursuant and subject to the terms of the Purchase Agreement, XOMA will commence a tender offer by August 15, 2025 to acquire all of the Company’s outstanding common shares. The closing of the Transactions is subject to customary closing conditions and is expected to close in the fourth quarter of 2025.
Discontinued LAVA-1266 Program
On August 4, 2025, the Company announced its plans to discontinue its Phase 1 clinical trial of LAVA-1266 for acute myeloid leukemia and myelodysplastic syndrome, and initiate the wind-down of the LAVA-1266 program.
Updates Regarding Partnered Programs
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: relapsed or refractory (R/R) acute myeloid leukemia (AML) or R/R higher-risk type of myelodysplastic neoplasms (MDS)
· Current Status: J&J is enrolling patients in a Phase 1, open label, multi-center trial, currently underway in Canada and Spain. The trial includes a dose escalation and dose expansion segment to evaluate JNJ-89853413 in approximately 100 adults with R/R AML or R/R higher risk type of MDS
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
· Key Indications: advanced solid tumors
· Current Status: Pfizer is enrolling patients in a Phase 1 open label, multi-center trial, currently underway in the US and UK. The trial is intended to evaluate PF08046052 in approximately 290 subjects
Second Quarter 2025 Financial Results
· As of June 30, 2025, LAVA had cash, cash equivalents, and short-term investments of $56.2 million, compared to cash, cash equivalents, and short-term investments of $76.6 million as of December 31, 2024.
· Revenue from contracts with customers was zero for the quarters ended June 30, 2025 and 2024, respectively, and zero and $7.0 million for the six months ended June 30, 2025 and 2024, respectively. Revenue of $7.0 million received in the six months ended June 30, 2024 was comprised of a $7.0 million payment from Pfizer related to the achievement of a clinical milestone.
· Research and development expenses were $4.7 million and $6.0 million for the quarters ended June 30, 2025 and 2024, respectively, and $8.9 million and $11.6 million for the six months ended June 30, 2025 and 2024, respectively. The decrease in both periods was primarily due to a reduction in headcount related to restructuring activities and resulting decrease in research and development activity, with lower preclinical and clinical expenses due to the discontinuation of the LAVA-1207 program and a reduction in the estimated remaining clinical trial activities, partially offset by activities for LAVA-1266 occurring in the quarter ended June 30, 2025.
· General and administrative expenses were $2.6 million and $3.4 million for each of the quarters ended June 30, 2025 and 2024, respectively and $6.0 million and $6.8 million for the six months ended June 30, 2025 and 2024, respectively. The decrease reflected in both periods was due to lower headcount and an overall streamlining of administrative and operating costs related to the Company’s restructuring activities, partially offset by increased professional and consultant fees related to the Company’s transition to US GAAP reporting as well as increased severance payments related to the Company’s restructuring action in February 2025.
· Other income (expense), net was a $1.3 million other expense, net and $1.2 million other income, net for the quarters ended June 30, 2025 and 2024, respectively, with other income, net of $3.1 million and $2.7 million for the six months ended June 30, 2025 and 2024, respectively. For the three months ended June 30, 2025 and 2024, the decrease is primarily due to foreign exchange loss, due to fluctuations in the US dollar currency rate compared to the Euro, as well as lower interest rates for cash held in money market accounts, partially offset by lower interest expense incurred as the Company’s outstanding innovation credit from Rijksdienst voor Ondernemend Nederland (RVO) was forgiven in March 2025. Forgiveness of the RVO credit balance also increased other income, net for the six months ended June 30, 2025.
· Net loss was $8.6 million and $8.3 million for the quarters ended June 30, 2025 and 2024, respectively, or $0.32 and $0.31 net loss per share, respectively, and $12.1 million and $8.9 million, or $0.45 or $0.33 net loss per share, for the six months ended June 30, 2025 and 2024, respectively.