LAVA Reports First Quarter 2025 Financial Results, Provides Business Update

   -- Focused on evaluation of strategic alternatives, with restructuring and 
      closure of the Netherlands operations 
 
   -- Enrollment in LAVA-1266 Phase 1 continues to progress 
 
   -- Cash, cash equivalents and short-term investments of $66.6 million as of 
      March 31, 2025 expected to fund operations into 2027 

UTRECHT, The Netherlands and PHILADELPHIA, May 14, 2025 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ: LVTX, "LAVA," "the Company"), a clinical-stage immuno-oncology company focused on its proprietary Gammabody$(R)$ bispecific gamma delta T cell engagers, today announced recent corporate highlights and financial results for the first quarter ended March 31, 2025.

"LAVA's top priority remains delivering shareholder value through an evaluation of strategic alternatives," said Steve Hurly, Chief Executive Officer of LAVA. "To support this process, we have taken actions to streamline our operations by implementing a significant reduction in workforce as part of a restructuring plan, which includes the closure of our Netherlands operations. In addition, we secured a $5.2 million repayment waiver from the Netherlands Enterprise Agency. We look forward to providing further updates on LAVA-1266, partnered programs and the evaluation of strategic alternatives."

Portfolio Highlights

LAVA-1266 -- Phase 1 Trial (ACTRN12624001214527)

Designed to target CD123+ tumor cells for the treatment of hematological malignancies

   -- Key indications: Acute myeloid leukemia $(AML.AU)$ and myelodysplastic 
      syndrome (MDS) 
 
   -- Current Status: LAVA continues to enroll patients in the 300 ug dose 
      level in the dose escalation segment of the first-in-human Phase 1, open 
      label, multi-center study in Australia and Spain. The study will evaluate 
      LAVA-1266 in up to 50 adults with CD123+ relapsed/refractory AML or 
      intermediate, high or extremely high risk MDS 

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: Include hematological cancers 
 
   -- Current Status: J&J is enrolling patients in a Phase 1, open label, 
      multi-center study, underway in Canada and Spain. The study includes a 
      dose escalation and dose expansion segment to evaluate JNJ-89853413 in 
      approximately 100 adults with relapsed/refractory (R/R) AML or R/R higher 
      risk of MDS 
 
   -- Milestone: Development milestone of $5 million received from J&J in Q4 
      2024 related to the IND filing for JNJ-89853413 

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: Include advanced solid tumors 
 
   -- Current Status: Pfizer is enrolling patients in a Phase 1 open label, 
      multi-center study, underway in the U.S. and UK. The study is intended to 
      evaluate PF08046052 in approximately 275 subjects 
 
   -- Milestone: Clinical development milestone of $7 million received from 
      Pfizer in Q1 2024 

First Quarter 2025 Financial Results

   -- As of March 31, 2025, LAVA had cash, cash equivalents, and short-term 
      investments of $66.6 million, compared to cash, cash equivalents, and 
      short-term investments of $76.6 million as of December 31, 2024. The 
      Company believes its current cash, cash equivalents and short-term 
      investments will be sufficient to fund operations into 2027. 
 
   -- Revenue from contracts with customers was zero and $7.0 million for the 
      quarters ended March 31, 2025 and 2024, respectively. The revenue for the 
      quarter ended March 31, 2024 reflects recognition of a $7.0 million 
      payment from Pfizer related to the achievement of a clinical milestone. 
 
   -- Research and development expenses were $4.2 million and $5.6 million for 
      the quarters ended March 31, 2025 and 2024, respectively. The decrease in 
      the quarter ended March 31, 2025 was primarily due to lower clinical 
      costs associated with the discontinuation of LAVA-1207, announced in 
      December 2024, slightly offset by accruals related to restructuring 
      activities and startup activities for LAVA-1266. 
 
   -- General and administrative expenses were $3.4 million for each of the 
      quarters ended March 31, 2025 and 2024. Personnel and professional fees 
      were higher for the quarter ended March 31, 2025, as compared to March 
      31, 2024, partially offset by lower share-based compensation expense as a 
      result of fewer options issued and a reduction in the Company's share 
      price. 
 
   -- Other income, net was $4.3 million and $1.5 million for the quarters 
      ended March 31, 2025 and 2024, respectively. The increase is primarily 
      due to the $5.2 million gain on extinguishment of borrowings due to the 
      Netherlands Enterprise Agency (Rijksdienst voor Ondernemend Nederland, 
      RVO) waiver of repayment in March 2025. 
 
   -- Net loss was $3.5 million and $0.6 million for the quarters ended March 
      31, 2025 and 2024, respectively, or $0.13 and $0.02 net loss per share, 
      respectively. 

Corporate Updates

   -- Strategic Alternatives and Restructuring: In February 2025, the Company 
      adopted a restructuring plan to extend its capital resources in 
      connection with initiating a process to evaluate strategic alternatives. 
      As part of the restructuring plan, the Company approved a reduction of 
      approximately 30% of the global workforce to better align the Company's 
      resources with its focus on LAVA-1266. During the three months ended 
      March 31, 2025, the Company recognized $0.5 million of expenses 
      associated with the workforce reduction. No amounts had been paid as of 
      March 31, 2025. The Company does not anticipate incurring any additional 
      costs as part of this workforce reduction. 
 
   -- Utrecht Facility Closure: In April 2025, the Company entered into an 
      agreement to terminate its operating lease arrangement for laboratory and 
      office space in Utrecht, the Netherlands and sell a portion of the 
      remaining fixed assets to the landlord and new tenant. The Company 
      expects to incur approximately $0.9 million of expenses associated with 
      the lease termination during the three months ending June 30, 2025, net 
      of approximately $0.3 million of proceeds received from the sale of the 
      assets. 
 
   -- Netherlands Closure: In May 2025, the Board of Directors approved an 
      additional restructuring plan in connection with the ongoing process to 
      evaluate strategic alternatives and better align the Company's resources 
      with its focus on LAVA-1266. As part of this restructuring plan, the 
      Board of Directors approved the elimination of the positions of the 
      Company's remaining Netherlands employees by July 31, 2025 and the 
      termination of its lease arrangement in Den Bosch, the Netherlands 
      effective August 1, 2025. The Company expects to incur approximately $2.0 
      million of expenses related to this restructuring during the year ending 
      December 31, 2025. 
 
 
                     LAVA Therapeutics N.V. 
       Condensed Consolidated Statements of Operations and 
                 Comprehensive Loss (Unaudited) 
       (in thousands, except share and per share amounts) 
 
                                         Three Months Ended 
                                             March 31, 
                                      ------------------------ 
                                         2025         2024 
                                      -----------  ----------- 
  Revenue: 
    Revenue from contracts with 
     customers                        $        --  $     6,992 
  Total revenue                                --        6,992 
                                       ----------   ---------- 
  Cost and expenses: 
    Research and development              (4,156)      (5,648) 
    General and administrative            (3,432)      (3,380) 
  Total cost and expenses                 (7,588)      (9,028) 
                                       ----------   ---------- 
  Operating loss                          (7,588)      (2,036) 
  Other income (expense), net 
    Interest income                           713          970 
    Interest expense                        (129)        (130) 
    Foreign currency exchange (loss) 
     gain, net                            (1,453)          657 
    Gain on extinguishment of 
    borrowings                              5,203           -- 
  Total other income, net                   4,334        1,497 
                                       ----------   ---------- 
  Net loss before taxes                   (3,254)        (539) 
  Income tax expense, net                   (225)         (69) 
                                       ----------   ---------- 
  Net loss                            $   (3,479)  $     (608) 
  Other comprehensive (loss) 
  income: 
    Foreign currency translation 
     adjustment                               978      (1,047) 
  Comprehensive loss                  $   (2,501)  $   (1,655) 
                                       ==========   ========== 
 
  Net loss per share, basic and 
   diluted                            $    (0.13)  $    (0.02) 
  Weighted-average common shares 
   outstanding, basic and diluted      26,892,575   26,794,215 
 
 
 
 
 
                      LAVA Therapeutics N.V. 
         Condensed Consolidated Balance Sheets (Unaudited) 
        (In thousands, except nominal value and share data) 
                                        March 31,    December 31, 
                                        ----------  -------------- 
                                           2025          2024 

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