1. 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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  2. 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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  3. 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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  4. UTRECHT, The Netherlands and PHILADELPHIA, July 13, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a biotechnology company focused on developing bispecific gamma-delta T cell engagers (bsTCEs) to transform the treatment of cancer, today announced dosing of the first patient in the company's Phase 1/2a clinical trial of LAVA-051 in patients with relapsed and/or refractory chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and acute myeloid leukemia (AML). LAVA-051, LAVA's lead product candidate, 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 dosing of the first patient with LAVA-051…

    UTRECHT, The Netherlands and PHILADELPHIA, July 13, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a biotechnology company focused on developing bispecific gamma-delta T cell engagers (bsTCEs) to transform the treatment of cancer, today announced dosing of the first patient in the company's Phase 1/2a clinical trial of LAVA-051 in patients with relapsed and/or refractory chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and acute myeloid leukemia (AML). LAVA-051, LAVA's lead product candidate, 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 dosing of the first patient with LAVA-051 is an important step towards harnessing the therapeutic potential of the Vγ9Vδ2 subset of gamma-delta T cells in the clinic," said Benjamin Winograd, M.D., Ph.D., chief medical officer of LAVA. "Our preclinical data demonstrate that LAVA-051 targets CD1d-expressing tumors by activating both Vγ9Vδ2 T cells and type 1 NKT cells, leading to robust antitumor activity. These data make us confident that our dual-targeting approach may lead to important new treatment options for CD1d expressing hematological malignancies like CLL, MM and AML, which are devastating, difficult to treat cancers, for which novel treatments are needed."

    The open-label, multi-center, Phase 1/2a clinical trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary antitumor activity of LAVA-051. The Phase 1 dose-escalation portion 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 Phase 1/2a clinical trial for LAVA-051 will initially be conducted in Europe, where the Company has already received regulatory approval for its Clinical Trial Application (CTA). LAVA expects to file an Investigational New Drug application (IND) with the U.S. Food and Drug Administration, which if accepted, will subsequently expand the trial to include patients in the United States.

    Stephen Hurly, president and chief executive officer of LAVA, added, "This important milestone marks LAVA's transition to a clinical stage company. LAVA-051, the most advanced product candidate from our off-the-shelf antibody platform, is designed to utilize bi-specifics to unlock the full anti-cancer potential of a patient's own gamma-delta T cells. We believe our approach overcomes the limitations of first-generation T cell engagers, reducing the risk of off-target toxicity, regulatory T-cell activation and cytokine release syndrome, while also amplifying efficacy through innate and adaptive immune responses. Adding to our momentum in the clinic, our second clinical program, LAVA-1207 in metastatic prostate cancer, is expected to enter the clinic before year end. We look forward to generating important clinical data to support our approach in both hematological malignancies and solid tumors."

    About LAVA-051

    LAVA-051 is a humanized gamma-delta bsTCE that activates both Vγ9Vδ2 T cells and type 1 NKT cells to kill tumor cells while leveraging their natural ability to distinguish tumor from healthy cells. LAVA-051 consists of two VHH domain antibodies linked via a short, five amino acid glycine-serine linker. One domain recognizes the Vd2 chain of the Vγ9Vδ2 T cell receptor and the other domain is specific for CD1d, a glycoprotein involved in the presentation of lipid antigens to distinct T cell populations including type 1 NKT cells, that are expressed on a wide range of hematological malignancies, including CLL, MM and AML. CD1d is also be expressed by several solid tumors, including prostate, cervical, breast, renal cell and colorectal cancers.

    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 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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  5. UTRECHT, The Netherlands and PHILADELPHIA, May 25, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a biotechnology company focused on applying its expertise in bispecific gamma-delta T cell engagers to transform cancer therapy, today announced that Stephen Hurly, chief executive officer, will present at the 2021 Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 11:30 a.m. ET.

    The presentation will be webcast and can be accessed from the investor relations section of the company's website at www.lavatherapeutics.com.

    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…

    UTRECHT, The Netherlands and PHILADELPHIA, May 25, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a biotechnology company focused on applying its expertise in bispecific gamma-delta T cell engagers to transform cancer therapy, today announced that Stephen Hurly, chief executive officer, will present at the 2021 Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 11:30 a.m. ET.

    The presentation will be webcast and can be accessed from the investor relations section of the company's website at www.lavatherapeutics.com.

    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 based on its proprietary platform. The company's innovative approach utilizes bispecific antibodies engineered to selectively kill cancer cells and induce gamma-delta T cell-mediated immunity through activation of Vγ9Vδ2 T cells upon cross-linking to tumor associated antigens. A Phase 1/2a clinical study evaluating LAVA-051 in patients with certain hematologic malignancies is anticipated to generate top line clinical data in the first half of 2022. The Company expects 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.

    Contact

    Chelcie Lister

    THRUST Strategic Communications

    chelcie@thrustsc.com



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  6. IPO bolsters balance sheet to $160 million in cash and cash equivalents; expected to fund operations at least into the second half of 2023

    Clinical development plans on schedule in both hematological and solid tumor programs

    Leadership strengthened through key management and board appointments

    UTRECHT, The Netherlands and PHILADELPHIA, May 20, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a biotechnology company focused on applying its expertise in gamma-delta bispecific T cell engagers (bsTCEs) to transform cancer therapy, today reported its business update and first quarter 2021 financial results.

    "We continue to make important strides across all aspects of our business as we transition to a clinical…

    IPO bolsters balance sheet to $160 million in cash and cash equivalents; expected to fund operations at least into the second half of 2023

    Clinical development plans on schedule in both hematological and solid tumor programs

    Leadership strengthened through key management and board appointments

    UTRECHT, The Netherlands and PHILADELPHIA, May 20, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a biotechnology company focused on applying its expertise in gamma-delta bispecific T cell engagers (bsTCEs) to transform cancer therapy, today reported its business update and first quarter 2021 financial results.

    "We continue to make important strides across all aspects of our business as we transition to a clinical stage organization," said Stephen Hurly, chief executive officer of LAVA Therapeutics. "With the recent additions to our leadership team and board and the proceeds from our IPO, we are well-positioned to advance our pipeline as we work toward our mission of transforming cancer therapy for patients."

    Recent Business and Pipeline Highlights

    Phase 1/2a Clinical Trial of LAVA-051 for Multiple Hematological Malignancies on Track: LAVA is on track to initiate its open-label, multi-center, Phase 1/2a clinical trial of LAVA-051 for the treatment of relapsed and/or refractory chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and acute myeloid leukemia (AML) in the first half of 2021. The trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary antitumor activity of LAVA-051.

    Preclinical Data Supporting Anti-Tumor Activity of LAVA-051 Presented at AACR Virtual 2021 Annual Meeting: In April 2021, LAVA presented preclinical data on LAVA-051 at the virtual American Association for Cancer Research (AACR) Annual Meeting. The data demonstrated that LAVA-051 exerted substantial antitumor activity against patient derived CLL, MM and AML cells that express CD1d. In addition, improved survival was observed in in vivo AML and MM mouse xenograft models treated with LAVA-051.

    Successful Initial Public Offering Completed: In March 2021, LAVA priced its initial public offering (IPO) at $15.00 per share. In connection with the offering, the Company issued 7,125,712 common shares resulting in gross proceeds, before deducting underwriting discounts and commissions and offering expenses payable by LAVA, of approximately $107 million.

    Leadership Team Strengthened by Appointment of Edward Smith as Chief Financial Officer: In March 2021, LAVA further strengthened its management team with the appointment of Edward F. Smith as its chief financial officer. Ed has more than 20 years of executive finance and operational leadership experience in publicly traded biotechnology companies from early stage through commercialization. Ed most recently served as chief financial officer of Marinus Pharmaceuticals and is currently a member of the board of directors of Benitec Biopharma, Inc.

    Industry Veterans Appointed to Board of Directors:

    • In February 2021, LAVA appointed Dr. Kapil Dhingra as chairman of the board of directors. Kapil is a medical oncologist and physician-scientist and brings more than 30 years of experience in oncology clinical research and drug development within the biotechnology and pharmaceutical industries. Most recently, he served as vice president, head of the oncology disease biology leadership team and head of oncology clinical development at Hoffmann-La Roche, during which he led numerous drug approvals, including Herceptin®, Tarceva® and Avastin®. In addition to LAVA, he is currently a member of the boards of directors of Black Diamond Therapeutics, Inc., Replimune, Inc., Five Prime Therapeutics, Inc., Autolus Therapeutics plc, and Median Technologies.
    • In April 2021, LAVA appointed biopharmaceutical finance executive, Karen Wilson, to its board of directors and as chair of its Audit Committee. Karen brings more than 30 years of finance and leadership experience in the life sciences industry, most recently serving as senior vice president of finance at Jazz Pharmaceuticals plc. In addition to LAVA, she currently serves on the board of directors of Angion Biomedica, Connect Biopharma and Vaxart, Inc.

    First Quarter Financial Results

    • Cash and cash equivalents were €134.7 million as of March 31, 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 for the three months ended March 31, 2021 compared to no such revenue for the three months ended March 31, 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 €15.7 million for the three months ended March 31, 2021, an increase of €12.8 million, compared to €2.9 million for the three months ended March 31, 2020. The increase was primarily 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. In addition, personnel-related costs increased €0.5 million due to increased headcount.

    • General and administrative expenses were €1.4 million for the three months ended March 31, 2021, an increase of €0.7 million, compared to general administrative expenses of €0.7 million for the three months ended March 31, 2020. The increase is primarily due to the increase in personnel-related costs of €0.3 million and the non-cash share-based compensation expense of €0.3 million due to the increase in headcount.

    • Net loss was €16.6 million, or €10.19 per share, for the first quarter of 2021, compared to €3.7 million, or €8.22 per share, for the first quarter of 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 based on its proprietary platform. The company's innovative approach utilizes bispecific antibodies engineered to selectively kill cancer cells and induce gamma-delta T cell-mediated immunity through activation of Vγ9Vδ2 T cells upon cross-linking to tumor associated antigens. A Phase 1/2a clinical study evaluating LAVA-051 in patients with certain hematologic malignancies is anticipated to generate top line clinical data in the first half of 2022. The Company expects 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 enrollment in and progress of clinical trials and reporting of results thereof. 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.



    Unaudited Condensed Consolidated Interim Statements of Profit or Loss

    EUR (000's)

        Three Months Ended March 31, 
      Notes 2021  2020 
    Research and license revenue   921  - 
    Operating expenses:          
    Research and development    (15,739)  (2,935)
    General and administrative    (1,415)  (682)
    Total operating expenses    (17,154)  (3,617)
               
    Operating loss    (16,233)  (3,617)
    Total non-operating expenses    (320)  (58)
    Loss before income tax    (16,553)  (3,675)
    Income tax benefit (expense)    (21)  (3)
    Loss for the period   (16,574) (3,678)
    Loss per share, in Euros          
    Loss per share, basic and diluted   (10.19) (8.22)
    Weighted average common shares outstanding, basic and diluted    1,626,598   447,525 



    Condensed Consolidated Interim Statements of Financial Position

    EUR (000's)

        March 31,  December 31, 
      Notes 2021  2020 
        (unaudited)     
    Assets          
    Non-current assets   1,875  1,843 
    Other current assets    1,013   1,959 
    Cash and cash equivalents    134,745   12,881 
    Total assets   137,633  16,683 
               
    Equity and Liabilities          
    Total Equity   113,471  6,207 
               
    Deferred revenue    4,109   5,030 
    Lease liabilities    384   389 
    License liabilities    12,073   - 
    Borrowings    3,010   2,935 
    Trade payables and other    1,464   760 
    Accrued expenses and other current liabilities    3,122   1,362 
    Total liabilities    24,162   10,476 
               
    Total equity and liabilities   137,633  16,683 



    Contact

    Investors:

    Chelcie Lister

    THRUST Strategic Communications

    chelcie@thrustsc.com



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  7. UTRECHT, The Netherlands and PHILADELPHIA, May 18, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a biotechnology company focused on applying its expertise in bispecific gamma-delta T cell engagers to transform cancer therapy, today announced that Stephen Hurly, chief executive officer, will present at the 2021 UBS Global Healthcare Virtual Conference on Wednesday, May 26, 2021 at 1:00 p.m. ET.

    The presentation will be webcast and can be accessed from the investor relations section of the company's website at www.lavatherapeutics.com.

    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…

    UTRECHT, The Netherlands and PHILADELPHIA, May 18, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a biotechnology company focused on applying its expertise in bispecific gamma-delta T cell engagers to transform cancer therapy, today announced that Stephen Hurly, chief executive officer, will present at the 2021 UBS Global Healthcare Virtual Conference on Wednesday, May 26, 2021 at 1:00 p.m. ET.

    The presentation will be webcast and can be accessed from the investor relations section of the company's website at www.lavatherapeutics.com.

    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 based on its proprietary platform. The company's innovative approach utilizes bispecific antibodies engineered to selectively kill cancer cells and induce gamma-delta T cell-mediated immunity through activation of Vγ9Vδ2 T cells upon cross-linking to tumor associated antigens. A Phase 1/2a clinical study evaluating LAVA-051 in patients with certain hematologic malignancies is anticipated to generate top line clinical data in the first half of 2022. The Company expects 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.

    Contact

    Chelcie Lister

    THRUST Strategic Communications

    chelcie@thrustsc.com



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  8. UTRECHT, The Netherlands and PHILADELPHIA, April 01, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a biotechnology company focused on applying its expertise in bispecific gamma-delta T cell engagers (bsTCEs) to transform cancer therapy, today announced that Karen J. Wilson has been appointed to its Board of Directors and as chair of its Audit Committee. Ms. Wilson brings more than three decades of finance and leadership experience in the life sciences industry.

    "I am delighted to welcome Karen to our Board of Directors," said Stephen Hurly, Chief Executive Officer and President. "She joins us at an exciting time for our company as our first gamma-delta bsTCE candidates progress towards the clinic. Her deep experience leading…

    UTRECHT, The Netherlands and PHILADELPHIA, April 01, 2021 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ:LVTX), a biotechnology company focused on applying its expertise in bispecific gamma-delta T cell engagers (bsTCEs) to transform cancer therapy, today announced that Karen J. Wilson has been appointed to its Board of Directors and as chair of its Audit Committee. Ms. Wilson brings more than three decades of finance and leadership experience in the life sciences industry.

    "I am delighted to welcome Karen to our Board of Directors," said Stephen Hurly, Chief Executive Officer and President. "She joins us at an exciting time for our company as our first gamma-delta bsTCE candidates progress towards the clinic. Her deep experience leading finance organizations across both clinical- and commercial-stage public life science companies will be invaluable to LAVA as we advance our pipeline aimed at improving patient outcomes and creating value for our shareholders."

    Ms. Wilson is a biopharmaceutical finance executive and board member with experience in life science companies across finance, strategy, and risk management. She currently serves on the Board of Directors of Angion Biomedica, Connect Biopharma, and Vaxart, Inc. She was most recently Senior Vice President of Finance at Jazz Pharmaceuticals plc until September 2020 after serving as Vice President of Finance and Principal Accounting Officer. Prior to joining Jazz Pharmaceuticals in February 2011, Ms. Wilson served as Vice President of Finance and Principal Accounting Officer at PDL BioPharma, Inc. She also previously served as a Principal at the consulting firm of Wilson Crisler LLC, Chief Financial Officer of ViroLogic, Inc., Chief Financial Officer and Vice President of Operations for Novare Surgical Systems, Inc., and as a consultant and auditor for Deloitte & Touche LLP. Ms. Wilson is a Certified Public Accountant and received a B.S. in Business from the University of California, Berkeley.

    "With two candidates expected to enter the clinic in 2021 following a successful IPO, I am thrilled to join LAVA's Board," Ms. Wilson said. "I am very excited about the potential of the LAVA platform to potentially transform the cancer treatment landscape. I look forward to working with the rest of the Board and management team to build on LAVA's success and optimize the value of its unique gamma-delta T cell engager platform in oncology."

    About LAVA

    LAVA Therapeutics N.V. is a biotechnology company developing a portfolio of bispecific gamma-delta T cell engagers (gamma-delta bsTCEs) for the treatment of solid tumors and hematologic malignancies based on its proprietary platform. The company's innovative approach leverages bispecific antibodies to activate Vγ9Vδ2 T cells upon binding to membrane-expressed tumor associated antigens. Activated Vγ9Vδ2 T cells are engaged for direct, selective tumor cell killing. The company's lead program, LAVA-051, is expected to enter a Phase 1/2a clinical study in hematologic malignancies in the first half of 2021. The company has established a highly experienced research and development team located in Utrecht, the Netherlands and Philadelphia, USA.

    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, 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, failure of LAVA's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes, among others. 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

    Keely Zipp

    k.zipp@lavatherapeutics.com



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  9. UTRECHT, The Netherlands, March 25, 2021 (GLOBE NEWSWIRE) -- Gilde Healthcare, a specialized healthcare investor with $1.8 billion under management, today announced that its portfolio company, LAVA Therapeutics (NASDAQ:LVTX), has successfully achieved pricing of its Nasdaq initial public offering (IPO), expected to result in gross proceeds of approximately $100 million. LVTX shares are expected to begin trading on March 25, 2021.

    LAVA is a biotechnology company focused on transforming cancer treatment by developing a platform of novel bispecific antibodies engineered to selectively induce gamma-delta T cell-mediated immunity against tumor cells.

    Gilde Healthcare has played an active role in LAVA's maturation as it progressed to its IPO…

    UTRECHT, The Netherlands, March 25, 2021 (GLOBE NEWSWIRE) -- Gilde Healthcare, a specialized healthcare investor with $1.8 billion under management, today announced that its portfolio company, LAVA Therapeutics (NASDAQ:LVTX), has successfully achieved pricing of its Nasdaq initial public offering (IPO), expected to result in gross proceeds of approximately $100 million. LVTX shares are expected to begin trading on March 25, 2021.

    LAVA is a biotechnology company focused on transforming cancer treatment by developing a platform of novel bispecific antibodies engineered to selectively induce gamma-delta T cell-mediated immunity against tumor cells.

    Gilde Healthcare has played an active role in LAVA's maturation as it progressed to its IPO. Gilde Healthcare acted as the lead investor in the first institutional investment round of €16M in LAVA in 2018 and has been the only Dutch institutional shareholder to date. Additionally, Gilde Healthcare's Operational Partner Prof. Dr. Paul Parren is Executive Vice President and Head of R&D of LAVA. Gilde Healthcare also has been instrumental in relocating LAVA´s headquarters and labs to the Utrecht Science Park, establishing a US subsidiary, hiring key management and taking part in the $83 million Series C financing together with other leading investors.

    Stefan Luzi, Partner at Gilde Healthcare and Member of the LAVA Board of Directors, commented: "We are proud to have been purposefully involved in the growth of LAVA from its first institutional investment round to its NASDAQ IPO in just 3 years. LAVA represents a clear case study in how we can contribute, above and beyond providing financial resources, and will serve as a model, which we aim to replicate for other differentiated healthcare companies."

    Gilde Healthcare is a specialized healthcare investor with $1.8 billion under management across two fund strategies: Venture & Growth and Private Equity. The firm operates out of offices in Utrecht (The Netherlands), Frankfurt (Germany) and Cambridge (United States).

    Gilde Healthcare Venture & Growth invests in innovative companies active in (Bio)Pharmaceuticals, HealthTech and MedTech. The portfolio of the Venture & Growth fund is balanced with fast growing life science companies from Europe and North America.

    For more information, please visit www.gildehealthcare.com.

    Investor & Media Contact

    Chris Maggos

    LifeSci Advisors

    +41 79 367 6254

    chris@lifesciadvisors.com



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