UTRECHT, The Netherlands and PHILADELPHIA, March 28, 2025 (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 fourth quarter and year ended December 31, 2024.
"LAVA's approach to maximize shareholder value in 2025 will focus on evaluating strategic options while continuing to enroll patients in our ongoing Phase 1 study of LAVA-1266, and supporting our pharma partnerships," said Steve Hurly, Chief Executive Officer of LAVA. "The Phase 1 study of LAVA-1266 as a potential treatment for acute myeloid leukemia and myelodysplastic syndrome is progressing. Looking ahead, with a strong cash balance, we believe LAVA is well-positioned to unlock strategic opportunities, and we look forward to updating investors with our progress throughout the year."
Portfolio Highlights
LAVA-1266 – Phase 1 Trial (ACTRN12624001214527)
Designed to target CD123+ tumor cells for the treatment of hematological malignancies
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
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 for solid tumors
Fourth Quarter and Year-End 2024 Financial Results
| LAVA Therapeutics N.V. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share amounts) (unaudited) | ||||||||||||
| Three Months Ended | Year Ended | |||||||||||
| December 31, | December 31, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Revenue: | ||||||||||||
| Revenue from contracts with customers | $ | 4,990 | $ | 353 | $ | 11,982 | $ | 6,769 | ||||
| Total revenue | 4,990 | 353 | 11,982 | 6,769 | ||||||||
| Cost and expenses: | ||||||||||||
| Cost of revenue | — | (155) | — | (3,482) | ||||||||
| Research and development | (8,568) | (2,302) | (28,450) | (32,559) | ||||||||
| General and administrative | (3,344) | (3,300) | (13,225) | (14,122) | ||||||||
| Total cost and expenses | (11,912) | (5,758) | (41,675) | (50,163) | ||||||||
| Operating loss | (6,922) | (5,405) | (29,693) | (43,394) | ||||||||
| Other income (expense), net | ||||||||||||
| Interest income | 863 | 1,002 | 3,758 | 3,672 | ||||||||
| Interest expense | (125) | (117) | (515) | (470) | ||||||||
| Foreign currency exchange gain (loss), net | 2,688 | (1,851) | 1,966 | (1,422) | ||||||||
| Total other income (expense), net | 3,427 | (966) | 5,209 | 1,780 | ||||||||
| Net loss before taxes | (3,495) | (6,370) | (24,484) | (41,614) | ||||||||
| Income tax expense, net | (379) | (37) | (630) | (257) | ||||||||
| Net loss | $ | (3,874) | $ | (6,408) | $ | (25,114) | $ | (41,871) | ||||
| Other comprehensive (expense) income: | ||||||||||||
| Foreign currency translation adjustment | (2,054) | 2,159 | (1,758) | 2,075 | ||||||||
| Comprehensive loss | $ | (5,928) | $ | (4,249) | $ | (26,872) | $ | (39,796) | ||||
| Net loss per share, basic and diluted | $ | (0.14) | $ | (0.24) | $ | (0.94) | $ | (1.57) | ||||
| Weighted-average common shares outstanding, basic and diluted | 26,866,931 | 26,769,937 | 26,834,422 | 26,732,556 | ||||||||
| LAVA Therapeutics N.V. Condensed Consolidated Balance Sheets (in thousands) (unaudited) | |||||||
| As of December 31, | |||||||
| 2024 | 2023 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 35,015 | $ | 44,231 | |||
| Short-term investments | 41,561 | 51,340 | |||||
| Prepaid expenses | 1,072 | 1,627 | |||||
| Other current assets | 1,649 | 1,699 | |||||
| Total current assets | 79,297 | 98,897 | |||||
| Property and equipment, net | 1,002 | 1,602 | |||||
| Operating lease right-of-use assets | 441 | 855 | |||||
| Other non-current assets | 91 | 319 | |||||
| Total assets | $ | 80,831 | $ | 101,673 | |||
| Liabilities and shareholders' equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 2,722 | $ | 4,446 | |||
| Accrued expenses and other current liabilities | 10,083 | 4,751 | |||||
| Borrowings | 4,886 | 5,282 | |||||
| Current portion of operating lease liabilities | 315 | 415 | |||||
| Total current liabilities | 18,006 | 14,894 | |||||
| Non-current portion of deferred revenue | 35,000 | 35,000 | |||||
| Non-current portion of operating lease liabilities | 80 | 415 | |||||
| Total liabilities | 53,086 | 50,309 | |||||
| Commitments and contingencies | |||||||
| Shareholders' equity: | |||||||
| Common stock | 3,717 | 3,715 | |||||
| Additional paid-in capital | 211,656 | 208,405 | |||||
| Accumulated deficit | (174,973) | (149,859) | |||||
| Accumulated other comprehensive loss | (12,655) | (10,897) | |||||
| Total shareholders' equity | 27,745 | 51,364 | |||||
| Total liabilities and shareholders' equity | $ | 80,831 | $ | 101,673 | |||
About LAVA Therapeutics
LAVA Therapeutics N.V. is a clinical-stage immuno-oncology company focused on advancing its proprietary Gammabody® platform to develop a portfolio of 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 Vγ9Vδ2 (Vgamma9 Vdelta2) T cell anti-tumor effector functions upon cross-linking to tumor-associated antigens.
LAVA's pipeline includes three internal and 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); PF-08046052, targeting EGFR (NCT05983133); and JNJ-89853413, targeting hematological cancers (NCT06618001). 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 ability to preserve capital and the sufficiency of cash on hand, the reduction in force, as well as the therapeutic potential, development strategy and potential uses of LAVA's product candidates, including LAVA-1266, the timing of initiation of clinical trials and achievement of clinical milestones, 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 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 Company's ability to leverage its initial programs to develop additional product candidates using its Gammabody® platform, 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 to reflect any change in expectations, even as new information becomes available.
CONTACTS
Investor Relations
ir@lavatherapeutics.com
LifeSci Advisors (IR/Media)
Joyce Allaire
Jallaire@lifesciadvisors.com
