LAVA-1207 dose escalation progressing in Phase 1/2a trial in prostate cancer, with pembrolizumab combination expected to begin in Q2 2024 Received $7.0 million clinical development milestone from Pfizer for PF-08046052 (formerly LAVA-1223) in Phase 1 LAVA-1266 on track for Q2 2024 IND submission Strong balance sheet with cash of $94.6 million supports runway into 2026 UTRECHT, The Netherlands and PHILADELPHIA, May 21, 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, today announced recent corporate highlights and financial results for the first quarter ended March 31, 2024. "LAVA continues to advance our pipeline of Gammabody programs and is excited to initiate the combination arm of pembrolizumab with LAVA-1207 this quarter. We look forward to sharing an update on the LAVA-1207 program during the second half of 2024," said Stephen Hurly, President and Chief Executive Officer of LAVA. "We are also pleased by Pfizer's continued progress with the Phase 1 program for PF-08046052 and the achievement of a clinical development milestone in March." "We are encouraged by the positive impact on the LAVA-1207 trial since we have implemented step dosing, as no ≥ Grade 2 CRS events have been reported since this change. We look forward to initiating the combination with pembrolizumab, and we continue to evaluate LAVA-1207 with low dose IL-2 and step dosing," added Charles Morris, Chief Medical Officer of LAVA. Portfolio Highlights: LAVA-1207 – In Phase 1/2a (NCT05369000) – Next update H2 2024 Designed to mediate potent killing of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) cells Monotherapy: Enrolling patients at dose level 10. No ≥ Grade 2 Cytokine Release Syndrome (CRS) since the implementation of step dosing in Q1 2024 KEYTRUDA® (pembrolizumab) Combination: Expecting to enroll the first patient in Q2 2024 in the LAVA-1207 + pembrolizumab dose-escalation arm (KEYNOTE-F73) Low Dose IL-2 (interleukin-2, LDIL-2, to increase the number of Vγ9Vδ2 T cells for engagement by LAVA-1207): Evaluating whether to continue treating patients with LDIL-2 with step dosing Biomarker Studies: Evaluating the potential association between Vγ9Vδ2 T cell counts and tumor responses Pfizer PF-08046052 – In Phase 1 (NCT05983133)  Potential first-in-class EGFR and bispecific gamma delta T cell-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) Dose Escalation Trial: Underway to evaluate the safety and tolerability of PF-08046052 as a monotherapy in advanced EGFR-expressing solid tumors Milestone: Pfizer paid LAVA $7 million for achieving a clinical development milestone in March 2024 LAVA-1266 – IND Submission Expected in Q2 2024 Designed to target CD123 for the treatment of hematological malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) IND Submission: Preparations underway First Quarter 2024 Financial Results As of March 31, 2024, LAVA had cash, cash equivalents and investments totaling $94.6 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 2026. Revenue from contracts with customers was $7.0 million and $1.2 million for the quarters ended March 31, 2024 and 2023, respectively. Revenue of $7.0 million for the quarter ended March 31, 2024 was related to the achievement by Pfizer of a clinical development milestone for PF-08046052. Revenue of $1.2 million for the quarter ended March 31, 2023 was related to the reimbursement for research activities and delivery of initial supply product materials in connection with the Pfizer Agreement. Cost of providing services and sales of goods was zero and $0.9 million for the quarters ended March 31, 2024 and 2023, respectively. The $0.9 million for the quarter ended March 31, 2023 was related to the cost of the initial supply delivery to Pfizer and related stability studies. Research and development expenses were $6.0 million and $9.9 million for the quarters ended March 31, 2024 and 2023, respectively. The decrease 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 $2.9 million and $3.9 million for the quarters ended March 31, 2024 and 2023, respectively. The decrease was primarily due to lower personnel-related expenses due to a reduction in general and administrative headcount in the second half of 2023. Net loss was $0.5 million and $13.9 million, or $0.02 and $0.53 net loss per share, for the quarters ended March 31, 2024 and 2023, respectively. LAVA Therapeutics N.V.Condensed Consolidated Interim Statements of Lossand Comprehensive Loss(in thousands, except share and per share amounts) (unaudited)     Three Months Ended     March 31,     2024     2023   Revenue:             Revenue from contracts with customers   $ 6,992     $ 1,224   Cost of sales of goods     —       (745 ) Cost of providing services     —       (185 ) Gross profit     6,992       294                 Operating expenses:             Research and development     (6,009 )     (9,943 ) General and administrative     (2,935 )     (3,890 ) Total operating expenses     (8,944 )     (13,833 )               Operating loss     (1,952 )     (13,539 ) Interest income, net     810       617   Foreign currency exchange gain (loss), net     658       (947 ) Total non-operating income     1,468