On November 16, 2023 LAVA Therapeutics N.V. (Nasdaq: LVTX), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody platform of bispecific gamma-delta T cell engagers, reported recent corporate highlights and financial results for the quarter ended September 30, 2023 (Press release, Lava Therapeutics, NOV 16, 2023, View Source [SID1234637737]).

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"We continue to advance our lead program, LAVA-1207, in patients with mCRPC in our Phase 1/2a escalation study," said Steve Hurly, president and chief executive officer of LAVA. "Our Gammabody platform continues to receive the support of investigators and patients and enrollment remains on track. We are also pleased with the progress of our partnered programs, particularly the initiation of the Phase 1 study of SGN-EGFRd2 (LAVA-1223) in advanced solid tumors which provides additional validation of our platform. With an expected cash runway into 2026, LAVA remains well-positioned to bring meaningful benefits to patients in areas of high unmet need and to deliver shareholder value."

LAVA-1207

Gammabody designed to target the prostate-specific membrane antigen (PSMA) to trigger the potent and preferential killing of PSMA-positive tumor cells in patients with metastatic castration-resistant prostate cancer (mCRPC). The safety, tolerability, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of LAVA-1207 in patients with mCRPC are being evaluated in an ongoing dose escalation phase 1/2a, first-in-human study.

● Trial enrollment is progressing across 10 clinical trial sites in Europe and the United States.
● The Company expects to report additional data for the dose escalation phase of the trial in the third quarter of 2024, which if positive, we expect these results to allow us to rapidly design and enter into a dose expansion study to support a potential pivotal future trial.
Partnered Programs

Seagen- SGN-EGFRd2 (LAVA-1223)

● During the third quarter, Seagen began recruitment in a Phase 1 study evaluating the safety and tolerability of SGN-EGFRd2 (LAVA-1223) as a monotherapy administered intravenously in advanced solid tumors. The study design has three parts: Parts A and B of the study will identify dosage for SGN-EGFRd2 and Part C will use the findings in Parts A and B for a dose to determine safety and efficacy of SGN-EGFRd2. Eligible patients for Part A include patients with colorectal cancer, non-small cell lung cancer or head and neck squamous cancer that is relapsed, refractory, or be intolerant to standard of care therapies. For more information, please refer to clinicaltrials.gov (NCT05983133).

Janssen Biotech – Undisclosed Candidate

● Earlier this year, Janssen selected a lead candidate aimed at an undisclosed tumor-associated antigen for further development towards a phase 1 clinical trial. A milestone payment was received in July 2023.

Third Quarter 2023 Financial Results

The financial information provided below reflects changes made to previously issued consolidated financial statements to revise immaterial prior-period misstatements. Further information regarding the revision is included in LAVA’s consolidated financial statements, "Note 12 — Revision of Immaterial Misstatements," included in Exhibit 99.1 to the report on Form 6-K to be filed with the SEC on the date hereof.

● As of September 30, 2023, LAVA had cash, cash equivalents and investments totaling $104.6 million compared to cash, cash equivalents and investments of $132.9 million as of December 31, 2022. The Company believes its current cash, cash equivalents and investments will be sufficient to fund operations into 2026.
● Revenue from contracts with customers was less than $0.1 million and $15.3 million for the quarters ended September 30, 2023 and 2022, respectively, and $3.1 million and $16.8 million for the nine months ended September 30, 2023 and 2022, respectively. In connection with the license agreement with Seagen, we recognized less than $0.1 million in revenue for the three months ended September 30, 2023, related to reimbursement for research activities and initial supply related stability studies. Revenue from contracts with customers was $15.3 million for the three months ended September 30, 2022, related to the Seagen Agreement. Of that amount, $15.2 million related to the nonrefundable upfront payment and $0.1 million related to reimbursement for research activities.
● Cost of providing services and sales of goods was less than $0.1 million and zero for the quarters ended September 30, 2023 and 2022, respectively, and $3.3 million and zero for the nine months ended September 30, 2023 and 2022, respectively. The increase in cost was due to the cost of the initial supply delivery to Seagen and related stability studies.
● Research and development expenses were $7.9 million and $13.7 million for the quarters ended September 30, 2023 and 2022, respectively, and $30.5 million and $29.6 million for the nine months ended September 30, 2023 and 2022, respectively. The decrease was primarily due to reduced manufacturing scale-up costs and clinical trial activities due to the discontinuation of the activities for LAVA-051, announced in June 2023.
● General and administrative expenses were $2.9 million and $3.1 million for the quarters ended September 30, 2023 and 2022, respectively, and $10.4 million and $10.5 million for the nine months ended September 30, 2023 and 2022, respectively. The decrease for both periods was primarily due to lower personnel-related expenses due to a reduction in general and administrative headcount.
● Net loss was $8.8 million and net profit was $0.9 million for the quarters ended September 30, 2023 and 2022, respectively, or $0.34 net loss and $0.04 net profit per share for the quarters ended September 30, 2023 and 2022, respectively. Net losses were $35.5 million and $17 million for the nine months ended September 30, 2023 and 2022, respectively, or $1.35 and $0.66 net loss per share for the nine months ended September 30, 2023 and 2022, respectively.