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
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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,
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2025 2024
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