- 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® 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) and myelodysplastic syndrome (MDS)
- Current Status: LAVA continues to enroll patients in the 300 µg 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 | ||||||||
| Assets | |||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | $ | 39,674 | $ | 35,015 | |||||
| Short-term investments | 26,883 | 41,561 | |||||||
| Prepaid expenses | 1,561 | 1,072 | |||||||
| Other current assets | 1,662 | 1,649 | |||||||
| Total current assets | 69,780 | 79,297 | |||||||
| Property and equipment, net | 928 | 1,002 | |||||||
| Operating lease right-of-use assets | 353 | 441 | |||||||
| Other non-current assets | 95 | 91 | |||||||
| Total assets | $ | 71,156 | $ | 80,831 | |||||
| Liabilities and shareholders' equity | |||||||||
| Current liabilities: | |||||||||
| Accounts payable | $ | 1,520 | $ | 2,722 | |||||
| Accrued expenses and other current liabilities | 8,540 | 10,083 | |||||||
| Borrowings | - | 4,886 | |||||||
| Current portion of operating lease liabilities | 306 | 315 | |||||||
| Total current liabilities | 10,366 | 18,006 | |||||||
| Non-current portion of deferred revenue | 35,000 | 35,000 | |||||||
| Non-current portion of operating lease liabilities | 6 | 80 | |||||||
| Total liabilities | 45,372 | 53,086 | |||||||
| Commitments and contingencies | |||||||||
| Shareholders' equity: | |||||||||
| Common shares | 3,717 | 3,717 | |||||||
| Additional paid-in capital | 212,196 | 211,656 | |||||||
| Accumulated deficit | (178,452) | (174,973) | |||||||
| Accumulated other comprehensive loss | (11,677) | (12,655) | |||||||
| Total shareholders' equity | 25,784 | 27,745 | |||||||
| Total liabilities and shareholders' equity | $ | 71,156 | $ | 80,831 | |||||
About LAVA Therapeutics
LAVA Therapeutics N.V. is a clinical-stage immuno-oncology company focused on its proprietary Gammabody® bispecific gamma-delta T cell engagers for the potential treatment of solid tumors and hematologic malignancies. The Company utilizes bispecific antibodies engineered to selectively kill cancer cells by triggering V?9Vd2 (Vgamma9 Vdelta2) T cell anti-tumor effector functions upon cross-linking to tumor-associated antigens.
LAVA's pipeline includes one internal and two partnered clinical-stage bispecific gamma-delta T cell engagers for the treatment of solid tumor and hematological cancers including LAVA 1266, targeting CD123+ cancers (ACTRN12624001214527); JNJ-89853413, targeting hematological cancers (NCT06618001); and PF-08046052, targeting EGFR (NCT05983133). The pipeline also includes preclinical programs. For more information on LAVA, please visit our website at www.lavatherapeutics.com or follow us on LinkedIn, X, and YouTube.
Gammabody® is a registered trademark of LAVA Therapeutics N.V.
LAVA's Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipate", "believe", "could", "will", "may", "expect", "should", "plan", "intend", "estimate", "potential", "suggests", and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on LAVA's expectations and assumptions as of the date of this press release and are subject to various risks and uncertainties that may cause actual results to differ materially from these forward-looking statements. Forward-looking statements contained in this press release include but are not limited to statements relating to LAVA's evaluation of strategic alternatives and transactions to maximize shareholder value, LAVA's restructuring initiatives to increase cost optimization and efficiencies through the reduction in force and other ongoing measures, LAVA's expectations regarding additional costs related to workforce reduction and restructuring, LAVA's cash runway and the sufficiency of resources to pursue development activities, progress and data from clinical trials, and the ability of LAVA's product candidates to treat various hematologic and tumor targets and improve patient outcomes, among others. Many factors, risks and uncertainties may cause differences between current expectations and actual results, including, among other things, the failure of LAVA's collaborators to support or advance collaborations or LAVA's product candidates, the timing and results of LAVA's research and development programs and preclinical and clinical trials, the possibility that clinical trials may fail to establish sufficient efficacy, the risk that adverse events or safety signals may occur in clinical trials, the risk that results obtained in preclinical studies or clinical trials to date may not be indicative of results obtained in ongoing or future trials, the risk that adverse regulatory actions or other setbacks could occur in clinical trials even after promising results in earlier clinical trials or preclinical studies, the Company's ability to obtain regulatory approval for and commercialize its product candidates, LAVA's ability to identify any strategic alternatives or if so identified, be able to consummate any such transactions on terms acceptable to LAVA and its shareholders, and the risk that setbacks in development could occur as a result of the difficulty and uncertainty of pharmaceutical product development and other factors. There may be adverse effects on the Company's business condition and results from general economic and market conditions and overall fluctuations in the United States and international equity markets, including as a result of inflation, heightened interest rates, recent and potential future pandemics and other health crises, and hostilities, including the Russian invasion of Ukraine and the conflict in the Middle East. These and other risks are described in greater detail under the caption "Risk Factors" in LAVA's most recent Annual Report on Form 10-K and other filings the Company makes with the Securities and Exchange Commission. LAVA assumes no obligation to update any forward-looking statements contained herein whether as a result of any new information, future events, change in expectations or otherwise, except as otherwise required by law.
CONTACTS
Investor Relations
ir@lavatherapeutics.com
LifeSci Advisors (IR/Media)
Joyce Allaire
Jallaire@lifesciadvisors.com
