LVTX LAVA Therapeutics N.V.

6.84
-0.32  -4%
Previous Close 7.15
Open 7.07
52 Week Low 5.5
52 Week High 17.2
Market Cap $176,175,802
Shares 25,775,538
Float 14,491,057
Enterprise Value $36,614,317
Volume 11,295
Av. Daily Volume 51,897
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Upcoming Catalysts

Drug Stage Catalyst Date
LAVA-051
Chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and acute myeloid leukemia (AML)
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
LAVA-1207
Castration-resistant prostate cancer
Phase 1
Phase 1
Phase 1/2 trial to commence 2H 2021.

Latest News

  1. UTRECHT, The Netherlands and PHILADELPHIA, Oct. 15, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for the company's CD1d targeted GammabodyTM, LAVA-051, for the treatment of chronic lymphocytic leukemia (CLL). CLL is a form of leukemia characterized by progressive accumulation of abnormal lymphocytes in the peripheral blood, bone marrow and lymphoid tissues.

    "We are excited to receive our first orphan drug designation from the FDA for LAVA-051, our most advanced product candidate from our off-the-shelf GammabodyTM platform that is designed to unlock the full anti-cancer potential…

    UTRECHT, The Netherlands and PHILADELPHIA, Oct. 15, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for the company's CD1d targeted GammabodyTM, LAVA-051, for the treatment of chronic lymphocytic leukemia (CLL). CLL is a form of leukemia characterized by progressive accumulation of abnormal lymphocytes in the peripheral blood, bone marrow and lymphoid tissues.

    "We are excited to receive our first orphan drug designation from the FDA for LAVA-051, our most advanced product candidate from our off-the-shelf GammabodyTM platform that is designed to unlock the full anti-cancer potential of this specialized effector cell population," said Stephen Hurly, president and chief executive officer, LAVA Therapeutics. "This designation will be helpful in enhancing our communication with the FDA on our development of LAVA-051. We are grateful to the FDA for highlighting the need for new and improved therapies to address the unmet needs in CLL."

    The GammabodyTM LAVA-051 is a bispecific antibody that recruits the immune system to attack CD1d-expressing cancer cells via the preferential activation of both Gamma Delta T cells and type 1 natural killer T (NKT) cells. Enrollment is underway in the company's open-label, multi-center, Phase 1/2a clinical trial for the treatment of relapsed and/or refractory CLL, multiple myeloma (MM) and, later in the trial, acute myeloid leukemia (AML) (NCT04887259). Initiated in July 2021, 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 study are expected in the first half of 2022 with top line clinical data from the Phase 2a expansion cohorts expected in the second half of 2022.

    About Orphan Drug Designation

    The term orphan drug refers to pharmaceutical products developed for the prevention, diagnosis and treatment of rare diseases or conditions. In the U.S., an orphan disease is defined as a disease or condition with a U.S. prevalence of less than 200,000 people. Supporting the development and evaluation of new treatments for rare diseases is a key priority for the FDA. Since the Orphan Drug Act was passed in 1983, the U.S. government has provided incentives and policy support to encourage development of orphan drugs to meet medical unmet needs. 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.

    About LAVA-051

    LAVA-051 is a GammabodyTM designed to activate both Vγ9Vδ2 T cells and type 1 NKT cells to kill CD1d expressing tumor cells. LAVA-051 consists of two single domain antibodies linked via a short five amino acid glycine-serine linker. One domain recognizes the Vδ2 chain of the Vγ9Vδ2 T cell receptor, and the other domain is specific for CD1d, a glycoprotein involved in the presentation of (glyco)lipid antigens to distinct T cell populations including type 1 NKT cells, and that can be expressed on a wide range of hematological malignancies, including CLL, MM and AML.



    An open-label, Phase 1/2a study of LAVA-051 as monotherapy in patients with relapsed or refractory CD1d-positive CLL, MM or AML is currently ongoing (NCT04887259). The Phase 1 dose-escalation portion of the study will determine an optimal Phase 2 dose of LAVA-051. Once a recommended Phase 2 dose has been established, the trial will expand into the Phase 2a portion, which will enroll patients in three disease specific cohorts for relapsed and/or refractory CLL, MM and AML, to confirm safety and evaluate preliminary antitumor activity in each disease cohort. The trial is initially being conducted in Europe and is planned to later expand to the U.S. The company expects to report data from the Phase 1 dose escalation phase of the study in the first half of 2022 with top line clinical data from the Phase 2a expansion cohorts expected in the second half of 2022.

    About LAVA Therapeutics

    LAVA Therapeutics N.V. is a clinical-stage biotechnology company utilizing its proprietary Gammabody™ platform to develop a portfolio of bispecific gamma delta T cell engagers (gamma delta bsTCEs) for the treatment of solid tumors and hematological malignancies. The company's innovative approach utilizes bispecific antibodies engineered to selectively kill cancer cells via the triggering of Vγ9Vδ2 T cell antitumor effector functions upon cross-linking to tumor associated antigens. A Phase 1/2a clinical study evaluating LAVA-051 in patients with certain hematological malignancies is enrolling patients (NCT04887259). The company plans to initiate a Phase 1/2a clinical study to evaluate LAVA-1207 in patients with prostate cancer in the second half of 2021. For more information, please visit www.lavatherapeutics.com and follow us on LinkedIn and Twitter.

    LAVA's Cautionary Note on Forward-Looking Statements

    This press release contains forward-looking statements, including in respect of the company's anticipated growth and clinical developments plans, including the timing of clinical trials. Words such as "anticipate," "believe," "could," "will," "may," "expect," "should," "plan," "intend," "estimate," "potential" 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 about the preclinical data, clinical development and scope of clinical trials, and the potential use of our product candidates to treat various tumor targets. Many factors, risks and uncertainties may cause differences between current expectations and actual results including, among other things, the timing and results of our research and development programs and preclinical and clinical trials, our ability to obtain regulatory approval for and commercialize our product candidates, our ability to leverage our initial programs to develop additional product candidates using our GammabodyTM platform, and the, failure of LAVA's collaborators to support or advance collaborations or our product candidates. In addition, the COVID-19 pandemic may disrupt our business and that of the third parties on which we depend, including delaying or otherwise disrupting our clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity. LAVA assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

    CONTACT

    Edward Smith

    Chief Financial Officer

    ir@lavatherapeutics.com

    Catherine Day

    +1-917-763-2709

    Catherine@newdaybioconsulting.com



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  2. UTRECHT, The Netherlands and PHILADELPHIA, Oct. 07, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a clinical-stage biotechnology company focused on developing bispecific gamma delta T cell engagers (bsTCEs) to transform the treatment of cancer, today announced that Hans van der Vliet, M.D,. Ph.D., chief scientific officer at LAVA, will present at the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics being held October 7-10, 2021.

    "Gamma delta T cells play an important role in antitumor immunity," said Hans van der Vliet, M.D., Ph.D. "I look forward to sharing our platform approach to harnessing the potent and precise antitumor properties of V9V2 T cells, along with the preclinical…

    UTRECHT, The Netherlands and PHILADELPHIA, Oct. 07, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a clinical-stage biotechnology company focused on developing bispecific gamma delta T cell engagers (bsTCEs) to transform the treatment of cancer, today announced that Hans van der Vliet, M.D,. Ph.D., chief scientific officer at LAVA, will present at the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics being held October 7-10, 2021.

    "Gamma delta T cells play an important role in antitumor immunity," said Hans van der Vliet, M.D., Ph.D. "I look forward to sharing our platform approach to harnessing the potent and precise antitumor properties of V9V2 T cells, along with the preclinical data from our LAVA-051 program demonstrating an attractive therapeutic window supportive of moving into the clinic last quarter."

    Details of the upcoming presentation at the AACR-NCI-EORTC conference are as follows:

    Title: Bispecific gamma delta T cell engagers for the treatment of cancer

    Presenter: Hans van der Vliet, M.D., Ph.D., chief scientific officer, LAVA Therapeutics

    Session: Plenary Session 3: Bispecific T cell Engagers and Next-gen CAR T Therapies: Pros and Cons of These Strategies

    Session Date/Time: Fri., Oct. 8, 2021, 12:05 – 1:55 p.m. ET

    Session Panel Discussion: To follow completion of Plenary Session 3 presentations

    Additional information on the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutic is available through the conference website at https://www.aacr.org/meeting/aacr-nci-eortc-international-conference-on-molecular-targets-and-cancer-therapeutics/

    About LAVA

    LAVA Therapeutics N.V. is a clinical stage biotechnology company developing a portfolio of bispecific gamma-delta T cell engagers (gamma-delta bsTCEs) for the treatment of solid tumors and hematological malignancies. The company's innovative approach utilizes bispecific antibodies engineered to selectively kill cancer cells via the triggering of Vγ9Vδ2 T cell antitumor effector functions upon cross-linking to tumor associated antigens. A Phase 1/2a clinical study evaluating LAVA-051 in patients with certain hematological malignancies is enrolling patients. The Company currently estimates to have data from the Phase 1 dose escalation phase of the study in the first half of 2022 with top line clinical data from the Phase 2a expansion cohorts expected in the second half of 2022. The Company plans to initiate a Phase 1/2a clinical study to evaluate LAVA-1207 in patients with prostate cancer in the fourth quarter of 2021. For more information, please visit www.lavatherapeutics.com.

    LAVA's Cautionary Note on Forward-Looking Statements

    This press release contains forward-looking statements, including in respect of the company's anticipated growth and clinical developments plans, including the timing of clinical trials. Words such as "anticipate," "believe," "could," "expect," "should," "plan," "intend," "estimate," "potential" 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. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the preclinical data, clinical development and scope of clinical trials, and the potential use of our product candidates to treat various tumor targets. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical trials, changes in expected or existing competition, changes in the regulatory environment, failure of LAVA's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes, among others. In addition, the COVID-19 pandemic may disrupt our business and that of the third parties on which we depend, including delaying or otherwise disrupting our clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity. LAVA assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

    CONTACT:

    Catherine Day

    +1-917-763-2709

    catherine@newdaybioconsulting.com



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  3. Forbion Appoints Nanna Lüneborg as a General Partner

    - Brings extensive international investment and board experience in life sciences companies of all sizes including company creations, private venture deals and IPOs -

    Naarden, The Netherlands, 1 September 2021 – Forbion, a leading European life sciences venture capital firm, today announces the appointment of Nanna Lüneborg, PhD as a General Partner to work on the €360m Forbion Growth Opportunities Fund.

    Prior to joining Forbion, Nanna was a Partner at Novo Ventures and a key member of the European deal team focussing on late-stage biopharma investments across Europe. During her 10 years at Novo, Nanna was involved in numerous successful European growth stage investments including high-profile…

    Forbion Appoints Nanna Lüneborg as a General Partner

    - Brings extensive international investment and board experience in life sciences companies of all sizes including company creations, private venture deals and IPOs -

    Naarden, The Netherlands, 1 September 2021 – Forbion, a leading European life sciences venture capital firm, today announces the appointment of Nanna Lüneborg, PhD as a General Partner to work on the €360m Forbion Growth Opportunities Fund.

    Prior to joining Forbion, Nanna was a Partner at Novo Ventures and a key member of the European deal team focussing on late-stage biopharma investments across Europe. During her 10 years at Novo, Nanna was involved in numerous successful European growth stage investments including high-profile cross-over deals and IPOs. Notable investments led by Nanna include NBE Therapeutics GmbH, which was later acquired by Boehringer Ingelheim, LAVA Therapeutics N.V. (NASDAQ:LVTX) Orphazyme A/S (ORPHA.CO; ORPH), Inventiva S.A. (NASDAQ:IVA), ObsEva SA (NASDAQ:OBSV, SIX: OBSN))), Numab Therapeutics AG, Nodthera Limited and ReViral Ltd.

    Nanna began her career in venture capital at Apposite Capital and worked as a Senior Business Analyst at Cancer Research UK. Nanna holds an MBA from the University of Cambridge, a PhD in Neuroscience from University College London, and a BA in Physiology and Psychology from the University of Oxford.

    Sander Slootweg, Managing Partner at Forbion, commented, "Nanna is a highly respected and accomplished life sciences venture capitalist with a strong track record for building life science companies at all stages of development, leading deals with academic institutions and small start-ups, growth stage companies and larger public companies. We are delighted to welcome Nanna on board."

    Dirk Kersten, General Partner at Forbion, added, "I am excited that Nanna decided to join the Forbion Growth team. In her role as a General Partner, Nanna will play a pivotal role in sourcing new investment opportunities in late-stage European biotech companies. Over the past 13 years, Nanna built a very strong reputation in Europe and brings a unique network of biotech entrepreneurs and specialist life science investors. With Nanna joining, the Forbion Growth team expanded to a group of 8 life science investment professionals; with an exclusive focus on serving the European market of life sciences growth capital."

    Nanna Lüneborg, newly appointed General Partner at Forbion said, "Forbion is one of Europe's leading life science venture capital firms and its strength in the life science space is recognised globally. Forbion's philosophy distinguishes it from its peers, through the broad expertise of the team which supports portfolio companies as they grow, to develop and commercialize their products. I look forward to working closely with the Forbion team to help implement its strategy: to enable the most innovative companies to bring new impactful treatments and therapies to market."

    Nanna will relocate from Denmark to The Netherlands and will be working from the company's headquarters in Naarden.

    ENDS

    For more information please contact:

    Media Enquiries

    Laura Asbjornsen, Head of Communications

    Email: laura.asbjornsen@forbion.com

    Tel: +31 (0) 35 699 30 00

    Consilium Strategic Communications

    Ashley Tapp, Sue Charles

    Email: forbion@consilium-comms.com

    Tel: +44 (0)20 3709 5700

    About Forbion

    Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the (bio-) pharmaceutical space. Forbion manages well over EUR 1.7 billion across multiple fund strategies that cover all stages of (bio-) pharmaceutical drug development. Forbion's current team consists of 20 life sciences investment professionals that have built an impressive performance track record since the late nineties with successful investments in over 70 companies. The firm is a signatory to the United Nations Principles for Responsible Investment. Besides financial objectives, Forbion selects investments that will positively affect the health and well-being of patients. Its investors include the EIF, through its European Recovery Programme (ERP), LfA, Dutch Venture Initiative (DVI), AMUF and EFSI facilities and KfW Capital through the Programme, "ERP – Venture Capital Fonds investments". Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany.

    For more information, please visit: www.forbion.com



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  4. Enrollment continues in Phase 1/2a trial evaluating LAVA-051 in hematological malignancies

    CTA accepted and IND cleared for Phase 1/2a trial evaluating LAVA-1207 in metastatic castrate resistant prostate cancer; on track to begin later this year

    Collaboration with Janssen Biotech, Inc. remains on track and progressing towards potential milestones

    Cash balance of $151 million expected to fund operations into the second half of 2023

    UTRECHT, The Netherlands and PHILADELPHIA, Aug. 16, 2021 (GLOBE NEWSWIRE) --  LAVA Therapeutics N.V. (NASDAQ:LVTX), a clinical-stage biotechnology company focused on developing bispecific gamma-delta T cell engagers (bsTCEs) to transform the treatment of cancer, today announced financial results…

    Enrollment continues in Phase 1/2a trial evaluating LAVA-051 in hematological malignancies

    CTA accepted and IND cleared for Phase 1/2a trial evaluating LAVA-1207 in metastatic castrate resistant prostate cancer; on track to begin later this year

    Collaboration with Janssen Biotech, Inc. remains on track and progressing towards potential milestones

    Cash balance of $151 million expected to fund operations into the second half of 2023

    UTRECHT, The Netherlands and PHILADELPHIA, Aug. 16, 2021 (GLOBE NEWSWIRE) --  LAVA Therapeutics N.V. (NASDAQ:LVTX), a clinical-stage biotechnology company focused on developing bispecific gamma-delta T cell engagers (bsTCEs) to transform the treatment of cancer, today announced financial results for the second quarter ended June 30, 2021 and recent corporate highlights.

    "We continue our strong execution, meeting key milestones and progressing our two lead, first-in-class bispecific gamma-delta T cell engager clinical programs," said Stephen Hurly, chief executive officer of LAVA Therapeutics. "Building on our clinical momentum initiated with the start of our LAVA-051 trial in hematological malignancies earlier this quarter, we are excited to bring our second program, LAVA-1207 in metastatic castration resistant prostate cancer, into the clinic later this year. As we look towards the second half of the year, our expanding leadership, clinical progress and strong balance sheet position LAVA well to drive value as we work toward our mission of building transformative treatments that harness the potential of engaging gamma-delta T cells to potently and precisely fight cancer."



    Recent Business and Pipeline Highlights

    Dosing of the First Patient in Phase 1/2a Trial of LAVA-051: In July, LAVA announced it had initiated dosing in the Company's Phase 1/2a clinical trial evaluating LAVA-051 in patients with relapsed and/or refractory chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and acute myeloid leukemia (AML). LAVA-051 is a humanized bsTCE engineered to selectively target CD1d-expressing hematological cancers through activation of both gamma-delta T cells and type 1 natural killer T (NKT) cells. The trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of LAVA-051. Initially conducted in Europe, the Phase 1/2a clinical trial will expand to the United States after the Investigational New Drug (IND) application has been accepted. The Company expects to report data from the Phase 1 dose escalation phase of the study in the first half of 2022, with top line clinical data from the Phase 2a expansion cohorts expected in the second half of 2022.

    Acceptance of CTA and IND for LAVA-1207: The Company's CTA was accepted and the IND was cleared to initiate a Phase 1/2a clinical study to assess tolerability and efficacy of LAVA-1207 in patients with metastatic castration-resistant prostate cancer. LAVA-1207 is a gamma-delta bsTCE targeting the prostate-specific membrane antigen (PSMA) that demonstrated preclinical proof-of-concept. The Company anticipates that patient enrollment will begin in Europe later this year, and in the U.S. shortly thereafter.

    Research and License Agreement with Janssen.  Under the terms of the agreement, the Company is performing discovery and product development activities with novel bispecific antibodies to gamma-delta T cells for the treatment of cancer.  The collaboration is on track and, in addition to an upfront payment, the Company is eligible to receive potential development and commercial milestones and future tiered royalties based on the development of the collaboration.

    Executive Leadership Team Strengthened by Appointment of Amy Garabedian as General Counsel: Amy Garabedian was appointed as general counsel and corporate secretary in July 2021. Ms. Garabedian is a recognized leader with over 15-years of corporate and transactional expertise within the life science industry. Ms. Garabedian previously served as associate general counsel of Spark Therapeutics (Roche) where she helped drive the successful U.S. launch of the first gene therapy in a genetic disease. She also led key business development transactions enabling pre-clinical, clinical, and commercial product development.

    Second Quarter Financial Results

    • Cash and cash equivalents were €128.4 million as of June 30, 2021, compared to €12.9 million as of December 31, 2020. The increase in cash and cash equivalents was attributable to proceeds from the Series C financing and subsequent IPO during the first quarter of 2021, partially offset by operating expenses.
    • Research and license revenue increased to €0.9 million and €1.8 million for the three and six months ended June 30, 2021, respectively, compared to €0.6 million for the three and six months ended June 30, 2020. Research and license revenue is solely attributable to the company's collaboration with Janssen Biotech, Inc., which was entered into in May 2020.
    • Research and development expenses were €4.5 million and €20.2 million for the three and six months ended June 30, 2021, respectively, compared to €3.1 million and €6.0 million for the three and six months ended June 30, 2020. The increase for the three months ended June 30, 2021 was primarily due to increases in headcount and costs associated with the commencement of our LAVA-051 clinical trial. The increase for the six months ended June 30, 2021 was additionally due to license fees of €12.1 million triggered by the IPO, most of which will be paid on the first and second anniversaries of the IPO and may be paid in either cash or common stock of the Company.
    • General and administrative expenses were €1.9 million and €3.3 million for the three and six months ended June 30, 2021, respectively, compared to general administrative expenses of €0.7 million and €1.4 million for the three and six months ended June 30, 2020. The increase in both periods is primarily due to the increase in personnel-related costs, non-cash share-based compensation expense and additional costs associated with being a publicly traded company in the United States.
    • Net loss was €5.8 million and €22.4 million, or €0.23 and €1.64 loss per share, for of the three and six months ended June 30, 2021, respectively, compared to €3.5 million and €7.1 million, or €7.75 and €15.97 loss per share, for the three and six months ended June 30, 2020.

    About LAVA

    LAVA Therapeutics N.V. is a clinical-stage biotechnology company developing a portfolio of bispecific gamma-delta T cell engagers (gamma-delta bsTCEs) for the treatment of solid tumors and hematological malignancies. The company's innovative approach utilizes bispecific antibodies engineered to selectively kill cancer cells via the triggering of Vγ9Vδ2 T cell antitumor effector functions upon cross-linking to tumor associated antigens. A Phase 1/2a clinical study evaluating LAVA-051 in patients with certain hematological malignancies is enrolling patients. The Company currently anticipates data from the Phase 1 dose escalation phase of the study in the first half of 2022 with top line clinical data from the Phase 2a expansion cohorts expected in the second half of 2022. The Company plans to initiate a Phase 1/2a clinical study to evaluate LAVA-1207 in patients with prostate cancer in the second half of 2021. For more information, please visit www.lavatherapeutics.com.

    LAVA's Cautionary Note on Forward-Looking Statements

    This press release contains forward-looking statements, including in respect of the company's anticipated growth and clinical developments plans, including the timing of clinical trials. Words such as "anticipate," "believe," "could," "expect," "should," "plan," "intend," "estimate," "potential" 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. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for LAVA's product candidates, and the potential use of our product candidates to treat various tumor targets. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical trials, changes in expected or existing competition, changes in the regulatory environment, failure of LAVA's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes, among others. In addition, the COVID-19 pandemic may disrupt our business and that of the third parties on which we depend, including delaying or otherwise disrupting our clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity. LAVA assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

    Condensed Consolidated Interim Statements of Loss

    EUR (000's) (unaudited)

       Three Months Ended

    June 30,
      Six Months Ended

    June 30,
     
       2021  2020  2021  2020 
    Research and license revenue  897  592  1,818  592 
    Operating expenses:                 
    Research and development   (4,506)  (3,074)  (20,245)  (6,010)
    General and administrative   (1,858)  (672)  (3,273)  (1,353)
    Total operating expenses   (6,364)  (3,746)  (23,518)  (7,363)
                      
    Operating loss   (5,467)  (3,154)  (21,700)  (6,771)
    Total non-operating expenses   (292)  (318)  (6,110)  (376)
    Loss before income tax   (5,759)  (3,472)  (22,311)  (7,147)
    Income tax (expense) benefit   (25)  3   (47)   
    Net loss  (5,784) (3,469) (22,358) (7,147)
    Net loss per share, in Euros                 
    Net loss per share, basic and diluted  (0.23) (7.75) (1.64) (15.97)
    Weighted average common shares outstanding, basic and diluted   25,523,501   447,525   13,641,062   447,525 

    Condensed Consolidated Interim Statements of Financial Position

    EUR (000's)

       June 30,  December 31, 
       2021  2020 
       (unaudited)     
    Assets         
    Non-current assets  1,786  1,843 
    Other current assets   4,788   1,959 
    Cash and cash equivalents   128,354   12,881 
    Total assets  134,928  16,683 
              
    Equity and Liabilities         
    Total Equity  115,586  6,207 
              
    Deferred revenue   3,212   5,030 
    Lease liabilities   366   389 
    License liabilities   9,074    
    Borrowings   3,262   2,935 
    Trade payables and other   1,820   760 
    Accrued expenses and other current liabilities   1,608   1,362 
    Total liabilities   19,342   10,476 
              
    Total equity and liabilities  134,928  16,683 

    Investor Contact:

    Corey Davis, Ph.D.

    LifeSci Advisors

    cdavis@lifesciadvisors.com

    212-915-2577

     



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  5. UTRECHT, The Netherlands and PHILADELPHIA, July 27, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a clinical-stage biotechnology company focused on developing bispecific gamma-delta T cell engagers to transform the treatment of cancer, today announced the appointment of Amy Garabedian as general counsel and corporate secretary. Ms. Garabedian is a seasoned leader with extensive corporate and transactional expertise within the life science industry.

    "We are very pleased to welcome Amy to our executive team. Amy's proven experience across a wide range of complex strategic legal and corporate matters in life sciences will be invaluable as our differentiated pipeline of bispecific gamma-delta T cell engagers for both solid…

    UTRECHT, The Netherlands and PHILADELPHIA, July 27, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a clinical-stage biotechnology company focused on developing bispecific gamma-delta T cell engagers to transform the treatment of cancer, today announced the appointment of Amy Garabedian as general counsel and corporate secretary. Ms. Garabedian is a seasoned leader with extensive corporate and transactional expertise within the life science industry.

    "We are very pleased to welcome Amy to our executive team. Amy's proven experience across a wide range of complex strategic legal and corporate matters in life sciences will be invaluable as our differentiated pipeline of bispecific gamma-delta T cell engagers for both solid and hematological malignancies further advances into the clinic," said Stephen Hurly, president and chief executive officer of LAVA Therapeutics.

    Ms. Garabedian stated, "I have spent my career combining my passion for science and law to create innovative business solutions to help improve the lives of patients. LAVA is well-positioned to be a leader in developing selective and transformative cancer treatments and I look forward to helping shape our evolving business, science, development programs and efforts to bring bispecific gamma-delta T cell engagers to patients during this important stage of significant growth and opportunity."

    Amy Garabedian has over 15-years of experience advising pharmaceutical and biotechnology companies from early-stage start-ups to multi-national public companies. Most recently, Ms. Garabedian served as associate general counsel of Spark Therapeutics (Roche) where she helped drive the successful U.S. launch of the first gene therapy and led key business development transactions enabling pre-clinical, clinical and commercial product development. She holds a B.S. in genetics and developmental biology from Penn State University, a M.S. in regulatory affairs from Temple University and a J.D. from Widener University Delaware School of Law.

    About LAVA

    LAVA Therapeutics N.V. is a clinical-stage biotechnology company developing a portfolio of bispecific gamma-delta T cell engagers for the treatment of solid and hematological malignancies. The company's innovative approach utilizes bispecific antibodies engineered to selectively kill cancer cells via the triggering of Vγ9Vδ2 T cell antitumor effector functions upon cross-linking to tumor associated antigens. A Phase 1/2a clinical study evaluating LAVA-051 in patients with certain hematological malignancies is enrolling patients. The Company currently estimates to have data from the Phase 1 dose escalation phase of the study in the first half of 2022 with top line clinical data from the Phase 2a expansion cohorts expected in the second half of 2022. The Company plans to initiate a Phase 1/2a clinical study to evaluate LAVA-1207 in patients with prostate cancer in the second half of 2021. For more information, please visit www.lavatherapeutics.com.

    LAVA's Cautionary Note on Forward-Looking Statements

    This press release contains forward-looking statements, including in respect of the company's anticipated growth and clinical developments plans, including the timing of clinical trials. Words such as "anticipate," "believe," "could," "expect," "should," "plan," "intend," "estimate," "potential" 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. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for LAVA's product candidates, and the potential use of our product candidates to treat various tumor targets. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical trials, changes in expected or existing competition, changes in the regulatory environment, failure of LAVA's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes, among others. In addition, the COVID-19 pandemic may disrupt our business and that of the third parties on which we depend, including delaying or otherwise disrupting our clinical trials and preclinical studies, manufacturing and supply chain, or impairing employee productivity. LAVA assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

    Investor Contact:

    Corey Davis, Ph.D.

    LifeSci Advisors

    cdavis@lifesciadvisors.com

    212-915-2577



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