News
LAVA Provides Business Updates and Reports First Quarter 2024 Financial Results
LAVA Therapeutics N.V.
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LAVA-1207 dose escalation progressing in Phase 1/2a trial in prostate cancer, with pembrolizumab combination expected to begin in Q2 2024
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Received $7.0 million clinical development milestone from Pfizer for PF-08046052 (formerly LAVA-1223) in Phase 1
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LAVA-1266 on track for Q2 2024 IND submission
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Strong balance sheet with cash of $94.6 million supports runway into 2026
UTRECHT, The Netherlands and PHILADELPHIA, May 21, 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 recent corporate highlights and financial results for the first quarter ended March 31, 2024.
“LAVA continues to advance our pipeline of Gammabody programs and is excited to initiate the combination arm of pembrolizumab with LAVA-1207 this quarter. We look forward to sharing an update on the LAVA-1207 program during the second half of 2024,” said Stephen Hurly, President and Chief Executive Officer of LAVA. “We are also pleased by Pfizer’s continued progress with the Phase 1 program for PF-08046052 and the achievement of a clinical development milestone in March.”
“We are encouraged by the positive impact on the LAVA-1207 trial since we have implemented step dosing, as no ≥ Grade 2 CRS events have been reported since this change. We look forward to initiating the combination with pembrolizumab, and we continue to evaluate LAVA-1207 with low dose IL-2 and step dosing,” added Charles Morris, Chief Medical Officer of LAVA.
Portfolio Highlights:
LAVA-1207 – In Phase 1/2a (NCT05369000) – Next update H2 2024
Designed to mediate potent killing of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) cells
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Monotherapy: Enrolling patients at dose level 10. No ≥ Grade 2 Cytokine Release Syndrome (CRS) since the implementation of step dosing in Q1 2024
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KEYTRUDA® (pembrolizumab) Combination: Expecting to enroll the first patient in Q2 2024 in the LAVA-1207 + pembrolizumab dose-escalation arm (KEYNOTE-F73)
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Low Dose IL-2 (interleukin-2, LDIL-2, to increase the number of Vγ9Vδ2 T cells for engagement by LAVA-1207): Evaluating whether to continue treating patients with LDIL-2 with step dosing
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Biomarker Studies: Evaluating the potential association between Vγ9Vδ2 T cell counts and tumor responses
Pfizer PF-08046052 – In Phase 1 (NCT05983133)
Potential first-in-class EGFR and bispecific gamma delta T cell-targeted therapy for solid tumors
Story continues
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Key Indications: Include colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and pancreatic ductal adenocarcinoma (PDAC)
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Dose Escalation Trial: Underway to evaluate the safety and tolerability of PF-08046052 as a monotherapy in advanced EGFR-expressing solid tumors
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Milestone: Pfizer paid LAVA $7 million for achieving a clinical development milestone in March 2024
LAVA-1266 – IND Submission Expected in Q2 2024
Designed to target CD123 for the treatment of hematological malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
First Quarter 2024 Financial Results
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As of March 31, 2024, LAVA had cash, cash equivalents and investments totaling $94.6 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 2026.
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Revenue from contracts with customers was $7.0 million and $1.2 million for the quarters ended March 31, 2024 and 2023, respectively. Revenue of $7.0 million for the quarter ended March 31, 2024 was related to the achievement by Pfizer of a clinical development milestone for PF-08046052. Revenue of $1.2 million for the quarter ended March 31, 2023 was related to the reimbursement for research activities and delivery of initial supply product materials in connection with the Pfizer Agreement.
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Cost of providing services and sales of goods was zero and $0.9 million for the quarters ended March 31, 2024 and 2023, respectively. The $0.9 million for the quarter ended March 31, 2023 was related to the cost of the initial supply delivery to Pfizer and related stability studies.
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Research and development expenses were $6.0 million and $9.9 million for the quarters ended March 31, 2024 and 2023, respectively. The decrease 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.
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General and administrative expenses were $2.9 million and $3.9 million for the quarters ended March 31, 2024 and 2023, respectively. The decrease was primarily due to lower personnel-related expenses due to a reduction in general and administrative headcount in the second half of 2023.
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Net loss was $0.5 million and $13.9 million, or $0.02 and $0.53 net loss per share, for the quarters ended March 31, 2024 and 2023, respectively.
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LAVA Therapeutics N.V. |
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Three Months Ended |
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March 31, |
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2024 |
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2023 |
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Revenue: |
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Revenue from contracts with customers |
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$ |
6,992 |
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$ |
1,224 |
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Cost of sales of goods |
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— |
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(745 |
) |
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Cost of providing services |
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— |
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|
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(185 |
) |
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Gross profit |
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6,992 |
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294 |
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Operating expenses: |
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Research and development |
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(6,009 |
) |
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(9,943 |
) |
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General and administrative |
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(2,935 |
) |
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(3,890 |
) |
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Total operating expenses |
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(8,944 |
) |
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(13,833 |
) |
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Operating loss |
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(1,952 |
) |
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(13,539 |
) |
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Interest income, net |
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810 |
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617 |
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Foreign currency exchange gain (loss), net |
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658 |
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(947 |
) |
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Total non-operating income |
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1,468 |
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(330 |
) |
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Loss before income tax |
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(484 |
) |
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(13,869 |
) |
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Income tax expense |
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(69 |
) |
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(71 |
) |
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Loss for the period |
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$ |
(553 |
) |
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$ |
(13,940 |
) |
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Items that may be reclassified to profit or loss |
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Foreign currency translation adjustment |
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(1,064 |
) |
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1,546 |
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Total comprehensive loss |
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$ |
(1,617 |
) |
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$ |
(12,394 |
) |
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Loss per share: |
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Loss per share, basic and diluted |
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$ |
(0.02 |
) |
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$ |
(0.53 |
) |
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Weighted-average common shares outstanding, basic and diluted |
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26,794,215 |
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26,289,087 |
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LAVA Therapeutics N.V. |
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March 31, |
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December 31, |
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2024 |
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2023 |
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Assets |
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Non-current assets: |
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Property and equipment, net |
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$ |
1,359 |
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$ |
1,602 |
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Right-of-use assets |
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796 |
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892 |
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Other non-current assets and security deposits |
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256 |
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319 |
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Total non-current assets |
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2,411 |
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2,813 |
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Current assets: |
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Receivables and other |
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737 |
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1,459 |
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Prepaid expenses and other current assets |
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1,188 |
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1,627 |
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VAT receivable |
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|
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170 |
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240 |
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Investments |
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51,386 |
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51,340 |
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Cash and cash equivalents |
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43,187 |
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44,231 |
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Total current assets |
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96,668 |
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98,897 |
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Total assets |
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$ |
99,079 |
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$ |
101,710 |
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Equity and Liabilities |
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Equity: |
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Share capital |
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$ |
3,715 |
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$ |
3,715 |
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Equity-settled employee benefits reserve |
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12,959 |
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12,005 |
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Foreign currency translation reserve |
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(11,962 |
) |
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(10,899 |
) |
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Additional paid-in capital |
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194,432 |
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194,424 |
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Accumulated deficit |
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(148,479 |
) |
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(148,067 |
) |
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Total equity |
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50,665 |
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51,178 |
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Non-current liabilities: |
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Deferred revenue |
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35,000 |
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35,000 |
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Lease liabilities |
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387 |
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591 |
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Total non-current liabilities |
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35,387 |
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35,591 |
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Current liabilities: |
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Trade payables and other |
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3,437 |
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4,446 |
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Borrowings |
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|
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5,295 |
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|
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5,282 |
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Lease liabilities |
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|
|
|
450 |
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|
|
440 |
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Accrued expenses and other current liabilities |
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|
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3,845 |
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|
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4,773 |
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Total current liabilities |
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13,027 |
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14,941 |
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Total liabilities |
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48,414 |
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50,532 |
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Total equity and liabilities |
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$ |
99,079 |
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$ |
101,710 |
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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.
A Phase 1/2a dose escalation study (NCT05369000) to evaluate the lead program, LAVA-1207, in patients with metastatic castration-resistant prostate cancer (mCRPC) is actively enrolling in Europe and the United States in a study evaluating monotherapy and with interleukin-2 (IL-2). The Company is expanding the Phase 1/2a study to include a combination arm with KEYTRUDA®(pembrolizumab) through a clinical collaboration with Merck & Co., Inc., Rahway, NJ, USA. The Company licensed PF-08046052 (formerly LAVA-1223) to Pfizer Inc. for clinical development and commercialization. The pipeline also includes several pre-clinical programs. For more information, please visit www.lavatherapeutics.com, and follow us on LinkedIn, X, and YouTube.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. LLC, Rahway, NJ, USA
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, including with respect to the Company’s anticipated growth and clinical development plans including the timing and results of clinical trials. 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 the therapeutic potential, development and potential uses of LAVA’s product candidates, the timing of initiation of clinical trials, including the expansion phase of the Phase 1/2a trial to evaluate LAVA-1207 in combination with KEYTRUDA®, the timing of regulatory submissions, including an IND for LAVA-1266 in AML and MDS, LAVA’s cash runway and the sufficiency of resources to pursue development activities, availability of information regarding clinical development plans, progress and data from clinical trials, the ability of LAVA’s product candidates to treat various tumor targets, including CRC, NSCLC, PDAC and HNSCC, and improve patient outcomes and the sufficiency of resources to pursue development activities. 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 our Gammabody® platform, and 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 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, 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 between Russia and Ukraine or the Israel-Hamas war. These and other risks are described in greater detail under the caption “Risk Factors” and included in LAVA’s filings 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
The spotlight next week will shift somewhat to the Federal Reserve’s second-quarter earnings season and monetary policy. Market watchers will be treated to results from several major names, including Dow 30 components Goldman Sachs (GS), UnitedHealth (UNH), Johnson & Johnson (JNJ) and American Express (AXP), along with streaming giant Netflix (NFLX).
The Fed will still attract some attention as investors will be eager to hear from a packed lineup of central bank speakers just before the policy meeting lockout period.
In terms of the economic calendar, after fifteen days of labor market and inflation indicators, activity data will gain momentum in the form of the latest retail sales and industrial production reports.
Earnings Highlight: Monday, July 15 – Goldman Sachs (GS) and BlackRock (Black). See the full earnings calendar.
Earnings Highlight: Tuesday, July 16 – UnitedHealth (UNH), Bank of America (BAC), Progressive (PGR), Morgan Stanley (IN), PNC Financial (PNC) and JB Hunt Transport (JBHT). See the full earnings calendar.
Earnings Highlight: Wednesday, July 17 – Johnson & Johnson (JNJ), US Bancorp (USB), Morgan Children (KMI), United Airlines (UAL) and Ally Financial (ALLY). See the full earnings calendar.
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Earnings Highlight: Friday, July 19 – American Express (AXP), Halliburton (THANKS) and Travelers (VRT (return to recoverable value)) See the full earnings calendar.
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Police cars outside the residence of Thomas Matthew Crooks, the suspected shooter at a Trump rally on Saturday, investigate the area in Pennsylvania. Following the incident, one rally attendee was killed, two rally attendees are in critical condition and Donald Trump suffered a non-fatal gunshot wound. The shooter is dead after being shot dead by the United States Secret Service. (Photo by Kyle Mazza/Anadolu via Getty Images)
Investors will initially favor traditional safe-haven assets and may lean toward trades more closely tied to former President Donald Trump’s chances of winning the White House after he survived an assassination attempt, according to market watchers.
“There will undoubtedly be some protectionist or safe-haven flows into Asia early this morning,” said Nick Twidale, chief market analyst at ATFX Global Markets. “I suspect gold could test all-time highs, we’ll see the yen being bought and the dollar, and flows into Treasuries as well.”
Early market commentary suggested Trump’s shooting at a rally in Pennsylvania on Saturday could also prompt traders to increase his likelihood of success in the November election. His support for looser fiscal policy and higher tariffs is generally seen as likely to benefit the dollar and weaken Treasuries.
An indicator of market sentiment heading into the weekend: Bitcoin surged above $60,000, likely reflecting Trump’s pro-crypto stance.
Other assets positively linked to the so-called Trump trade include stocks of energy companies, private prisons, credit card companies and health insurers.
Traders will also be closely watching market measures of expected volatility on Monday, such as those in the tariff-sensitive Chinese yuan and Mexican peso, which have begun to price in the U.S. vote.
Trump said he was shot in the right ear after a shooting at his rally. His campaign said in a statement that he was “fine” after the incident, which prompted him to rush off the stage.
“Currencies will be the first major market on Monday in Asia to react to the weekend’s shots. There’s potential for extra volatility, and getting a clear reading could be especially difficult because liquidity will be hurt by Japan’s national holiday,” said Garfield Reynolds, Asia team leader for Bloomberg Markets Live.
Strategists had already expected a volatile run-up to the election, particularly as Democrats are still agonizing over President Joe Biden’s candidacy after his poor performance in last month’s debate raised questions about his age. Investors were also grappling with the possibility that the election could end in a drawn-out dispute or political violence.
But there is little precedent for events like those in Pennsylvania. When President Ronald Reagan was shot four decades ago, the stock market plunged before closing early. The next day, March 31, 1981, the S&P 500 rose more than 1% and benchmark 10-year Treasury yields fell 9 basis points to 13.13%, according to data compiled by Bloomberg.
Bond investors should pay particular attention as the attack is likely to boost Trump’s election chances and ultimately lead to concerns about the fiscal outlook, according to Marko Papic, chief strategist at California-based BCA Research Inc.
“The bond market must at some point become aware of President Trump’s greater chances of winning the White House than any of his rivals,” Papic wrote. “And I continue to believe that as his chances increase, so too must the likelihood of a bond market revolt.”
Kyle Rodda, senior financial markets analyst at Capital.com, said he was seeing client flows into Bitcoin and gold following the shooting.
“This news marks a turning point in American policy norms,” he said. “For markets, it means safe-haven trades, but more tilted toward non-traditional safe-havens.”
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Jio Financial share price: Should you buy this Reliance group stock on Monday ahead of Q1 FY2024 results?
Q1 2024 Results: Jio Financial Share Price will be in focus on Monday as the Reliance Group company has a fixed board meeting on July 15, 2024 to consider and approve the company’s unaudited standalone and consolidated financial results. Trust Group company informed about the Q1 2024 Results date on Wednesday last week via an exchange filing. According to stock market experts, Jio Financial Services Limited is poised to deliver impressive Q1 results for FY25 on solid operating income. They have forecast a healthy QoQ PAT for the company in Q1 FY25.
Jio Financial Services News
Speaking on the Jio Financial Services Q1 2024 results, Manish Chowdhury, Head of Research, StoxBox, said, “We believe Jio Financial Services is poised to deliver impressive results in Q1FY25 aided by its operating income, which is likely to show robust growth driven by strong investment income, which in turn should lead to healthy PAT growth on a sequential basis. Jio Financial Services continues to make strategic moves such as launching digital products and expanding its ecosystem, with a clear focus on future growth. The company has announced plans to introduce products for lending against stocks and mutual funds, leveraging Jio’s large user base, which could be a significant growth driver in the coming quarters.”
“Furthermore, with the NBFC receiving RBI approval to become a primary investment company, Jio Financial Services is well-positioned to unlock value from its investments. Overall, we expect the company to report robust numbers in the upcoming quarter,” the StoxBox expert added.
Jio Financial Stock Target Price
Speaking about the technical outlook of Jio Financial share price, Ganesh Dongre, Senior Manager, Technical Research at Anand Rathi, said, “Jio Financial Services share price is poised to make a fresh high at the ₹260 apiece level. If the stock breaks above this mark, the Reliance Group stock could make a fresh high by touching the ₹290-₹295 zone. Hence, those with Jio Finance stock in their portfolio are advised to stick to the script by keeping a stop loss at ₹205. If the stock breaks above ₹260 decisively, then one can upgrade the stop loss at ₹240 for the near-term target of ₹295.”
On the advice to new buyers regarding Jio Financial stock, Ganesh Dongre said, “New buyers are advised to wait for the breakout. Once the stock breaks above ₹260, one can buy this Reliance Group stock at the short term target of ₹295, keeping a stop loss of ₹240 apiece.”
Disclaimer: The views and recommendations made above are those of individual analysts or brokerage firms, and not of Mint. Investors are advised to consult with certified experts before making any investment decisions.
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