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• LAVA-1207 progressing in Phase 1/2a study, with pembrolizumab combination expected to begin in Q2 2024
• In March 2024, Pfizer paid LAVA $7 million for achieving a clinical milestone for EGFRd2 (PF-08046052/formerly LAVA-1223)

• LAVA 1266 tracking to Q2 2024 IND submission
• Strong balance sheet with cash of $95.6 million supports runway into 2026

UTRECHT, The Netherlands and PHILADELPHIA, March 20, 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 (?2) T cell engagers, today announced recent corporate highlights and financial results for the fourth quarter and year ended December 31, 2023.

“In 2023, we advanced our portfolio of proprietary Gammabody® programs. LAVA-1207 has enrolled dose level 9 in our Phase 1/2a trial of patients with metastatic castration-resistant prostate cancer (mCRPC). We will soon be enrolling the patients in our pembrolizumab combination arm. We continue to be encouraged by the favorable safety profile and preliminary signs of anti-tumor activity. We plan to provide new data for LAVA-1207 at an upcoming medical conference in the second half of 2024,” said Stephen Hurly, President and Chief Executive Officer of LAVA. “We are also very excited by Pfizer’s clinical progress. They have been a great partner and we look forward to continuing to support them. We plan to submit an IND for LAVA-1266, our investigational asset designed to target CD123 for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), in Q2 2024,” continued Mr. Hurly. “These advances represent important steps for our proprietary Gammabody® T-cell engagers as we evaluate their potential to treat cancer. We believe that 2024 will be a significant year and we look forward to sharing our ongoing progress with investors and stakeholders.”

LAVA 1207 – In Phase 1/2a -- Next update expected H2 2024 targeting a medical conference
Designed to mediate potent killing of prostate-specific membrane antigen (PSMA)-positive prostate cancer cells

• The first-in-human Phase 1/2a clinical trial is enrolling patients in monotherapy and combination arms
• Completed enrollment in dose level 9 monotherapy arm.
• Expect to begin enrolling in the dose escalation and dose expansion arm, in combination with KEYTRUDA® (pembrolizumab) in the coming months
• Evaluating low dose Interleukin-2 (“IL-2”) in the Phase 1/2a study in order to increase the number of V?9V?2 T cells for engagement by LAVA-1207
• With the goal of maintaining low rates of cytokine release syndrome (CRS) and to minimize the risk of CRS events >grade 2, we have introduced premedication and step-dosing to the protocol.
• Three dose limiting toxicities (DLTs) were observed in patients receiving IL-2 in addition to LAVA-1207, in a cohort with multiple doses of IL-2 per cycle. Since we amended the DLT criteria and initiated step dosing, we have not observed any CRS or DLTs in patients dosed with IL-2 to date.
• Additional biomarker studies are underway to understand the relationship between ?2 T cells and tumor response, and to investigate other factors that may impact patient selection and show early evidence of anti-tumor activity.
  

EGFRd2 (PF-08046052/formerly LAVA-1223) – In Phase 1
Designed to trigger the potent and preferential killing of EGFR-positive tumor cells in solid tumors such as colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and head and neck squamous cell carcinoma (HNSCC)

• Potential first-in-class agent
• Dose escalation trial is underway to evaluate the safety and tolerability of EGFRd2 (PF-08046052) as a monotherapy in advanced EGFR-expressing solid tumors
• In March 2024, Pfizer paid LAVA $7 million for achieving a clinical milestone
  

LAVA-1266 – IND Submission Expected in Q2 2024
Designed to target CD123 for the treatment of hematological malignancies, including AML and MDS

• Currently engaged in IND enabling activities
• Planning for IND submission in Q2 2024

Fourth Quarter and Year-End 2023 Financial Results

• As of December 31, 2023, LAVA had cash, cash equivalents and investments totaling $95.6 million compared to cash, cash equivalents and investments of $132.9 million as of December 31, 2022. The Company believes its current cash, cash equivalents and investments will be sufficient to fund operations into 2026.
• Revenue from contracts with customers was $0.4 million and $2.6 million for the quarters ended December 31, 2023 and 2022, respectively, and $6.8 million and $19.4 million for the years ended December 31, 2023 and 2022, respectively. In connection with the license agreement with Pfizer (formerly Seagen), we recognized $0.3 million in revenue for the three months ended December 31, 2023, related to reimbursement for research activities and initial supply-related stability studies, and $2.6 million for the three months ended December 31, 2022. The decrease of revenue from contracts with customers for the year ended December 31, 2023 compared to 2022 was primarily due to a $15.2 million nonrefundable upfront payment received in 2022 in connection with the Pfizer agreement.
• Cost of sales of goods and providing services was $0.2 million and zero for the quarters ended December 31, 2023 and 2022, respectively, and $3.5 million and zero for the years ended December 31, 2023 and 2022, respectively. The cost in 2023 was due to the initial drug supply delivery to Pfizer and related stability studies.
• Research and development expenses were $3.4 million and $10.5 million for the quarters ended December 31, 2023 and 2022, respectively, and $33.8 million and $40.1 million for the years ended December 31, 2023 and 2022, respectively. The decrease for both periods was primarily due to reduced manufacturing scale-up costs, negotiated reduction in contract manufacturing invoices, and reduced clinical trial activities due to the discontinuation of the activities for LAVA-051, announced in June 2023.
• General and administrative expenses were $2.3 million and $3.6 million for the quarters ended December 31, 2023 and 2022, respectively, and $12.7 million and $14.1 million for the years ended December 31, 2023 and 2022, respectively. The decrease for both periods was primarily due to lower personnel-related expenses due to a reduction in general and administrative headcount in 2023.
• Net loss was $6.5 million and $14.9 million for the quarters ended December 31, 2023 and 2022, respectively, or $0.24 and $0.57 net loss per share for the quarters ended December 31, 2023 and 2022, respectively. Net losses were $42.0 million and $31.9 million for the years ended December 31, 2023 and 2022, respectively, or $1.57 and $1.23 net loss per share for the years ended December 31, 2023 and 2022, respectively.