Continued progress in Phase 1/2a dose escalation for LAVA-1207, including the monotherapy arm, now enrolling in dose level 12, and the pembrolizumab combination
Favorable safety profile for LAVA-1207
Next data update for LAVA-1207 program expected in Q4 2024
Strong balance sheet with cash of $86.8 million supports runway into mid-2026
UTRECHT, The Netherlands and PHILADELPHIA, Aug. 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 T cell engagers, today announced financial results for the second quarter ended June 30, 2024 and provided an update on recent corporate highlights.
"LAVA has continued to make progress in the Phase 1/2a study for LAVA-1207, our lead Gammabody® product candidate in mCRPC. Patients in the Phase 1/2a study are being treated with LAVA-1207 monotherapy at dose level 12," said Stephen Hurly, President and Chief Executive Officer of LAVA. "In Q2 2024, we initiated dosing in the pembrolizumab combination arm and have dosed our first patients. We expect to release the next data for LAVA-1207 at a medical meeting later this year. We are also excited to start our clinical trial for LAVA-1266 for AML/MDS later this year."
Portfolio Highlights:
LAVA-1207 – In Phase 1/2a (NCT05369000) – Next update planned for Q4 2024
Designed to mediate potent killing of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) cells
Monotherapy Arm: Enrolling in dose level 12 with no ≥ Grade 2 Cytokine Release Syndrome (CRS) since the implementation of step-dosing in Q1 2024
KEYTRUDA® (pembrolizumab) Combination: Initiated dosing in the LAVA-1207 + pembrolizumab dose-escalation arm (KEYNOTE-F73) to potentially enhance the anti-tumor activity of LAVA-1207. This arm also utilizes the established step-dosing regimen
Low Dose Interleukin-2 (IL-2, LDIL-2) Combination: LDIL-2 is intended to potentially increase the number of Vγ9Vδ2 T cells for engagement by LAVA-1207. Evaluation is underway
LAVA-1266 – Trial initiation activities underway
Designed to target CD123+ tumor cells for the treatment of hematological malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
Next Step: Planning to initiate the Phase 1 trial of LAVA-1266 by year-end 2024 in Australia
Pfizer PF-08046052 – In Phase 1 (NCT05983133)
Potential first-in-class EGFR and bispecific gamma delta T cell-targeted therapy for solid tumors
Key Indications: Include colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and pancreatic ductal adenocarcinoma (PDAC)
Current Status: Monotherapy Phase 1 dose escalation study underway to evaluate the safety and tolerability in advanced EGFR-expressing solid tumors
Milestone: Clinical development milestone of $7 million received from Pfizer in Q1 2024
Johnson and Johnson Innovative Medicine Collaboration – In Research
Discovery and development of novel bispecific gamma delta T cell engager for the treatment of blood cancer
Current Status: Lead candidate bispecific candidate antibody selected for development. Efforts are underway by Johnson and Johnson Innovative Medicine to advance candidate toward the clinic
Second Quarter 2024 Financial Results
We will transition from foreign private issuer to U.S. domestic filer status beginning on January 1, 2025 and expect to incur increased costs associated with being a U.S. domestic filer, including expenses related to financial reporting, preparation of financial statements in accordance with U.S. GAAP and compliance with U.S. federal proxy rules.
As of June 30, 2024, LAVA had cash, cash equivalents and investments totaling $86.8 million, compared to cash, cash equivalents and investments of $95.6 million as of December 31, 2023. The Company believes its current cash, cash equivalents and investments will be sufficient to fund operations into mid-2026.
Revenue from contracts with customers was zero and $5.1 million for the quarters ended June 30, 2024 and 2023, respectively, and $7.0 million and $6.4 million for the six months ended June 30, 2024 and 2023, respectively. Revenue of $5.1 million for the quarter ended June 30, 2023 was comprised of $2.6 million in revenue for reimbursement of research activities and delivery of initial supply in connection with the Pfizer Agreement, and $2.5 million in revenue related to a triggered milestone payment in connection with the Janssen Agreement.
Cost of providing services and sales of goods was zero and $2.4 million for the quarters ended June 30, 2024 and 2023, respectively, and zero and $3.3 million for the six months ended June 30, 2024 and 2023, respectively. The cost in both periods of 2023 was primarily related to the cost of the initial supply delivery to Pfizer and related stability studies.
Research and development expenses were $6.3 million and $12.6 million for the quarters ended June 30, 2024 and 2023, respectively, and $12.3 million and $22.5 million for the six months ended June 30, 2024 and 2023, respectively. The decrease in both periods was primarily due to lower pre-clinical and clinical trial expenses due to the discontinuation of LAVA-051, announced in June 2023, and reduced personnel-related expenses due to a reduction in research and development headcount in the second half of 2023.
General and administrative expenses were $3.0 million and $3.7 million for the quarters ended June 30, 2024 and 2023, respectively, and $6.0 million and $7.6 million for the six months ended June 30, 2024 and 2023, respectively. The decrease in both periods was primarily due to lower non-cash share-based compensation expenses and personnel-related expenses due to a reduction in general and administrative headcount in the second half of 2023.
Net losses were $8.3 million and $12.7 million, or $0.31 and $0.48 net loss per share, for the quarters ended June 30, 2024 and 2023, respectively, and $8.8 million and $26.6 million, or $0.33 and $1.01 net loss per share, for the six months ended June 30, 2024 and 2023, respectively.
LAVA Therapeutics N.V.Condensed Consolidated Interim Statements Lossand Comprehensive Loss(in thousands, except share and per share amounts) (unaudited)
Three Months Ended
For the Six Months Ended
June 30,
June 30,
2024
2023
2024
2023
Revenue:
Revenue from contracts with customers
$
—
$
5,139
$
6,992
$
6,363
Cost of sales of goods
—
(2,361
)
—
(2,546
)
Cost of providing services
—
(27
)
—
(772
)
Gross profit
—
2,751
6,992
3,045
Operating expenses:
Research and development
(6,336
)
(12,599
)
(12,345
)
(22,542
)
General and administrative
(3,025
)
(3,697
)
(5,960
)
(7,587
)
Total operating expenses
(9,361
)
