Page 1

LAVA THERAPEUTICS LAVA Therapeutics Provides Business Update and Reports Third Quarter Financial Results November 15 , 2021 • LAVA - 051 Phase 1 / 2a trial actively enrolling in hematological malignancies on track to report initial data in H1 2022 • LAVA - 1207 Phase 1 / 2a trial in metastatic castrate resistant prostate cancer on track to begin enrolling later this quarter • LAVA - 051 granted orphan drug designation by the U.S. FDA for the treatment of CLL • Cash and investments of $ 142 million as of Sept. 30 , 2021 UTRECHT , The Netherlands and PHILADELPHIA , Nov. 15 , 2021 ( GLOBE NEWSWIRE ) -- LAVA Therapeutics N.V. ( Nasdaq : LVTX ) , a clinical - stage biotechnology company focused on developing its proprietary Gammabody ™ platform of bispecific gamma delta T cell engagers ( bsTCEs ) to transform the treatment of cancer , today announced financial results for the third quarter ended Sept. 30 , 2021 and recent corporate highlights . TM " This was a transformational quarter for LAVA , " said Stephen Hurly , president and chief executive officer . " With our lead Gammabody program in the clinic and actively enrolling patients in hematological malignancies and our second program on track to enroll its first prostate cancer patient later this quarter , LAVA is poised for potential product and platform validating data milestones in 2022. Our progress in the clinic , along with our recent senior leadership hires and strong balance sheet , position us well to execute on our mission to unlock the value of our Gammabody VTM platform to deliver transformative treatments to those suffering from cancer . " Recent Business and Pipeline Highlights LAVA - 051 Phase 1 / 2a Trial on Track : Enrollment is ongoing in the Phase 1 / 2a clinical trial ( NCT04887259 ) evaluating LAVA - 051 in hematological malignancies . The trial is designed to evaluate the safety , tolerability , pharmacokinetics , pharmacodynamics , immunogenicity and preliminary antitumor activity of LAVA - 051 . Data from the Phase 1 dose escalation phase of the trial are expected in the first half of 2022 and top line data from the Phase 2a expansion cohorts in the second half of 2022. The trial was initiated in July 2021 in patients with relapsed or refractory chronic lymphocytic leukemia ( CLL ) and multiple myeloma ( MM ) and will , later in the trial , also include patients with acute myeloid leukemia ( AML ) . LAVA - 051 Granted U.S. FDA Orphan Drug Designation : On October 15 , the company announced that the U.S. Food and Drug Administration ( FDA ) granted orphan drug designation to LAVA - 051 for the treatment of CLL , a rare form of leukemia characterized by progressive accumulation of abnormal lymphocytes in the peripheral blood , bone marrow and lymphoid tissues . This orphan drug designation from the FDA qualifies LAVA for various incentives related to the development of LAVA - 051 , including tax credits for qualified clinical trials , exemption from user fees and the potential for seven years of U.S. market exclusivity for the treatment of CLL . LAVA - 1207 Phase 1 / 2a Trial Plans on Track : LAVA is on track to initiate the company's Phase 1 / 2a clinical trial of LAVA - 1207 in patients with metastatic castration - resistant prostate cancer ( mCRPC ) later in the fourth quarter . LAVA - 1207 is a Gammabody ™ that targets the prostate specific membrane antigen ( PSMA ) and has demonstrated preclinical proof - of - concept in a variety of preclinical models to support acceptance of a CTA / IND to study in humans . The open - label , multi - center , Phase 1 / 2a clinical trial will evaluate safety , tolerability , pharmacokinetics , pharmacodynamics , immunogenicity and preliminary antitumor activity of LAVA - 1207 in patients with mCRPC . The Phase 1 dose - escalation portion of the study will determine the recommended Phase 2 dose / schedule to be used in the subsequent Phase 2a expansion cohort to confirm safety and tolerability of LAVA - 1207 in mCRPC patients . Strategic Management Team Expansion with Three Key Appointments : On November 9 , the company announced three strategic appointments to the management team . • Jessica Truscello , vice president of clinical operations , brings more than 22 years of clinical trial and clinical operations experience to LAVA and most recently served six years at Immunocore where she supported first - in - human programs through pivotal and late - stage programs and the successful development of their clinical compliance program . • Sumeet Ambarkhane , M.D. , executive medical director , a clinical development physician with more than 17 years of experience with expertise in oncology , hemato - oncology and immunology . Dr. Ambarkhane was previously at MorphoSys , where he led medical and clinical strategy for its hemato - oncology clinical development program . • Wouter van Hunnik , vice president of human resources , joins the company from Philips with more than 15 years of experience in building excellence and taking innovative approaches to human resources ( HR ) recruitment , culture shaping