Announcement • Nov 21
Nasdaq Suspends Trading of Lava Therapeutics Shares As previously disclosed, on November 13, 2025, LAVA Therapeutics N.V. notified The Nasdaq Stock Market LLC (Nasdaq") of its intention to voluntarily delist its Shares from Nasdaq. Prior to the opening of trading on November 21, 2025, Nasdaq suspended trading of the Shares and filed a Form 25, Notification of Removal from Listing and/or Registration under Section 12(b) of the Exchange Act with the SEC. The Company intends to terminate its reporting obligations under the Exchange Act by filing a Form 15 with the SEC on or about December 1, 2025. Announcement • Nov 13
LAVA Announces Exceeding Minimum Condition in Tender Offer and Intent to Delist from Nasdaq LAVA Therapeutics N.V. announced that 22,877,463 of LAVA’s common shares, representing approximately 87% of LAVA’s outstanding common shares, were validly tendered and not withdrawn prior to the expiration of the initial offering period one minute after 11:59 p.m. Eastern Time on November 12, 2025. As a result, the minimum tender condition and other conditions of the previously announced tender offer (the “Offer”) of XOMA Royalty Corporation (“XOMA Royalty”) to acquire LAVA have been satisfied. All validly tendered shares are expected to be accepted for payment on or about November 13, 2025. The subsequent offering period has now commenced. LAVA shareholders who have not yet tendered their common shares may still tender during the subsequent offering period, which will expire one minute after 11:59 p.m. Eastern Time on November 20, 2025. Any common shares tendered during the subsequent offering period may not be withdrawn. LAVA’s common shares are expected to be suspended from trading on the Nasdaq Global Select Market prior to the opening of the market on or about November 21, 2025. LAVA also announced that it has submitted written notice to Nasdaq of its intention to voluntarily delist its common shares from Nasdaq. The voluntary delisting is subject to and conditioned upon the acquisition by XOMA Royalty of all common shares validly tendered and not properly withdrawn in accordance with the previously disclosed purchase agreement entered into between LAVA and XOMA Royalty. On or about November 24, 2025, LAVA expects Nasdaq will file with the U.S. Securities and Exchange Commission ("SEC") a notification of removal from listing of its common shares on Nasdaq. Completion of the tender offer remains subject to the conditions described in the tender offer statement on Schedule TO filed by XOMA Royalty with the SEC (as amended and supplemented). Announcement • Aug 04
XOMA Royalty Corporation (NasdaqGM:XOMA) entered a definitive share purchase agreement to acquire LAVA Therapeutics N.V. (NasdaqGS:LVTX) for $32.6 million. XOMA Royalty Corporation (NasdaqGM:XOMA) entered a definitive share purchase agreement to acquire LAVA Therapeutics N.V. (NasdaqGS:LVTX) for $32.6 million on August 3, 2025. XOMA Royalty will acquire LAVA for between $1.16 and $1.24 per share in cash, consisting of $1.16 (the “Base Price Per Share”) in cash per share (the “LAVA common stock”), plus an additional amount of cash of up to $0.08 per Share agreed-upon determination of Closing Net Cash on 10th Business Day before each then scheduled Expiration Time (such amount as finally determined in accordance with the Purchase Agreement, the “Additional Price Per Share,” and together with the Base Price Per Share, the “Cash Amount”), plus one non-transferable contingent value right (“CVR”) per share representing the right to receive 75% of the net proceeds related to LAVA’s two partnered assets and 75% of any net proceeds from any out license or sale of LAVA’s unpartnered programs. LAVA will be required to pay XOMA a termination fee of $750,000. Following a subsequent offering period, LAVA will undergo a corporate reorganization designed to result in XOMA Royalty acquiring 100% of the shares in LAVA’s successor and all then-remaining LAVA shareholders (other than XOMA Royalty) receiving the same cash and CVR consideration per share as is provided in the tender offer, subject to applicable withholding taxes. LAVA will hold a shareholder’s meeting in connection with the Transactions. XOMA Royalty will commence a tender offer by August 15, 2025, to acquire all outstanding shares of LAVA common stock. As a result of the Post-Offer Reorganization, LAVA will no longer be a publicly traded company, the listing of the Shares on Nasdaq Stock Market LLC will be terminated and the Shares will be deregistered under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), resulting in the cessation of LAVA's reporting obligations with respect to the Shares thereunder.
The transaction is to any applicable law or order entered, enacted, promulgated, enforced, or issued by any court or other governmental authority of competent jurisdiction prohibiting, rendering illegal, or enjoining the consummation of the Transactions; the accuracy of representations and warranties made by LAVA in the Purchase Agreement, subject compliance in all material respects by LAVA with its obligations under the Purchase Agreement, shareholders have adopted resolutions related appointing Buyer’s designees to the Board and certain transactions pursuant, the Closing Net Cash shall be no less than the amount specified in the Purchase Agreement and no termination of the Purchase Agreement. Buyer is not required to extend the Offer beyond December 31, 2025. In addition, if the only unmet Offer Condition is the Minimum Condition, Buyer may, but is not required to, extend the Offer on more than two occasions in consecutive periods of up to 10 business days. The closing of the Transactions is expected in the fourth quarter of 2025. LAVA’s Board unanimously recommends that shareholders support the Offer, accept the Offer and vote in favor of the resolutions to be proposed to LAVA’s shareholders’ meeting.
Ryan A. Murr and Branden Berns of Gibson, Dunn & Crutcher LLP and Michel van Agt and Menno Baks of Loyens & Loeff N.V. acted as legal advisors for XOMA Royalty Corporation. Kevin Cooper and Rita Sobral of Cooley LLP and Paul van der Bijl of NautaDutilh N.V. acted as legal advisors and Leerink Partners LLC acted as financial advisor for LAVA Therapeutics N.V. Announcement • Apr 17
LAVA Therapeutics N.V., Annual General Meeting, Jun 11, 2025 LAVA Therapeutics N.V., Annual General Meeting, Jun 11, 2025. Location: yalelaan 62, 3584 cm, utrecht Netherlands Announcement • Mar 02
LAVA Therapeutics Receives a Notice from the Nasdaq Stock Market On February 27, 2025, LAVA Therapeutics N.V. received a notice from The Nasdaq Stock Market that the Company is not in compliance with Nasdaq’s Listing Rule 5450(a)(1), as the minimum bid price of the Company’s common shares has been below $1.00 per share for 30 consecutive business days. The notification of noncompliance has no immediate effect on the listing or trading of the Company’s common shares on The Nasdaq Global Select Market. The Company has 180 calendar days, or until August 26, 2025, to regain compliance with the minimum bid price requirement. To regain compliance, the minimum bid price of the Company’s common shares must meet or exceed $1.00 per share for a minimum of ten consecutive business days during this 180-calendar day grace period. In the event the Company does not regain compliance with the minimum bid price requirement by August 26, 2025, the Company may be eligible for an additional 180-calendar day compliance period if it elects to transfer to The Nasdaq Capital Market to take advantage of the additional compliance period offered on that market. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and would need to provide written notice of its intention to cure the bid price deficiency during the second compliance period by effecting a reverse stock split if necessary. However, if it appears to Nasdaq that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, Nasdaq will provide notice that the Company's common shares will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. The Company intends to actively monitor the bid price of its common shares and will consider available options to regain compliance with the listing requirements. There can be no assurance that the Company will be able to regain compliance with Nasdaq’s Listing Rule 5450(a)(1) or will otherwise be in compliance with other Nasdaq listing criteria, or that Nasdaq will grant the Company a further extension of time to regain compliance, if applicable. Announcement • Jan 10
LAVA Therapeutics N.V. Doses First Patient in Phase 1 Lava-1266 Study in Hematological Cancers LAVA Therapeutics N.V. announced dosing of the first patient in the Phase 1, first-in-human study of the CD123-targeted Gammabody, LAVA-1266, an investigational agent in development for the treatment of hematologic cancers including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). LAVA-1266 is a potent bi-specific, T cell engager (bsTCE) that targets CD123+ tumor cells with V?9Vd2-T cells using LAVA’s Gammabody platform. The bsTCE was designed to lyse CD123+ tumor cells with high potency and a wide therapeutic window.Preclinical studies confirmed target cell expression by showing CD123+ expression and the presence of V?9Vd2-T cells in AML patient samples. In preclinical studies, LAVA showed that LAVA-1266 preferentially targets and kills CD123 cells and induces V?9Vd2-T cell activation. Furthermore, in preclinical studies, LAVA demonstrated that treatment with LAVA-1266 produces high levels of specific tumor cell lysis, with substantially less cytokine release, compared to CD3-based T cell engagers, and increased survival in an AML xenograft model, without the co-activation of immunosuppressive regulatory T cells. The open-label, multi-center Phase 1, first-in-human study of LAVA-1266 is currently being conducted in Australia. The study will include a dose escalation and dose expansion segment to evaluate LAVA-1266 in approximately 50 adults with CD123+ relapsed/refractory acute myeloid leukemia (AML) and certain grades of myelodysplastic syndrome (intermediate risk, high risk or extremely high risk). Patients will be dosed every two weeks (Q2W), with an initial target dose of 100 µg for the first cohort. The study will evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and preliminary anti-tumor activity. Reported Earnings • Aug 21
Second quarter 2024 earnings released: US$0.31 loss per share (vs US$0.48 loss in 2Q 2023) Second quarter 2024 results: US$0.31 loss per share (improved from US$0.48 loss in 2Q 2023). Net loss: US$8.30m (loss narrowed 35% from 2Q 2023). Revenue is forecast to grow 65% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 40% per year but the company’s share price has fallen by 36% per year, which means it is significantly lagging earnings. Announcement • Jun 13
LAVA Therapeutics N.V., Annual General Meeting, Jun 19, 2024 LAVA Therapeutics N.V., Annual General Meeting, Jun 19, 2024. Reported Earnings • May 22
First quarter 2024 earnings released: US$0.021 loss per share (vs US$0.53 loss in 1Q 2023) First quarter 2024 results: US$0.021 loss per share (improved from US$0.53 loss in 1Q 2023). Revenue: US$6.99m (up 471% from 1Q 2023). Net loss: US$553.0k (loss narrowed 96% from 1Q 2023). Revenue is forecast to grow 42% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 121% per year but the company’s share price has fallen by 37% per year, which means it is significantly lagging earnings. Reported Earnings • Mar 20
Full year 2023 earnings released: US$1.57 loss per share (vs US$1.23 loss in FY 2022) Full year 2023 results: US$1.57 loss per share (further deteriorated from US$1.23 loss in FY 2022). Net loss: US$42.0m (loss widened 32% from FY 2022). Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Germany. Announcement • Mar 05
LAVA Therapeutics N.V. Announces Clinical Development Milestone Achieved by Pfizer for PF-08046052 LAVA Therapeutics N.V. announced that Pfizer has achieved a clinical development milestone for PF-08046052 (formerly SGN-EGFRd2 /LAVA-1223), prompting the first milestone payment of $7 Million to LAVA. LAVA granted Seagen (acquired by Pfizer in December 2023) a worldwide, exclusive license to PF-08046052 in September 2022. PF-08046052 is a potential first-in-class asset utilizing the Gammabody® platform designed to conditionally activate V?9Vd2 (Vgamma9 Vdelta2) T cells, upon crosslinking to epidermal growth factor receptor (EGFR), to trigger the potent and preferential killing of EGFR-positive tumor cells. EGFR is a well-validated target that is over-expressed in multiple solid tumor types, including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HNSCC) and pancreatic ductal adenocarcinoma (PDAC). PF-08046052 is being evaluated in an ongoing Phase 1 study (NCT05983133) by Pfizer under an exclusive worldwide license agreement. In accordance with the agreement, LAVA received a $50 million upfront payment and is eligible to receive milestones of up to approximately $650 million upon achievement of development, regulatory and commercial milestones as well as royalties on potential sales. New Risk • Jan 26
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 13% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (13% average weekly change). Earnings are forecast to decline by an average of 5.2% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$74m net loss in 3 years). Market cap is less than US$100m (€37.8m market cap, or US$41.0m). Reported Earnings • Nov 17
Third quarter 2023 earnings released: US$0.34 loss per share (vs US$0.039 profit in 3Q 2022) Third quarter 2023 results: US$0.34 loss per share (down from US$0.039 profit in 3Q 2022). Revenue: US$53.0k (down 100% from 3Q 2022). Net loss: US$8.84m (down US$9.83m from profit in 3Q 2022). Revenue is expected to decline by 57% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 15%. Reported Earnings • Aug 23
Second quarter 2023 earnings released: US$0.48 loss per share (vs US$0.31 loss in 2Q 2022) Second quarter 2023 results: US$0.48 loss per share (further deteriorated from US$0.31 loss in 2Q 2022). Revenue: US$5.14m (up US$4.67m from 2Q 2022). Net loss: US$12.7m (loss widened 60% from 2Q 2022). Revenue is expected to decline by 37% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 16%. Announcement • Jun 15
LAVA Therapeutics N.V. Provides Updates on Clinical Programs and Extends the Cash Runway LAVA Therapeutics N.V. announced its decision to rationalize its pipeline and prioritize its lead solid tumor program. The Company will continue to advance LAVA-1207, its Gammabody program designed to target the prostate-specific membrane antigen (PSMA) as well as earlier stage programs. The ongoing clinical trial of LAVA-051 targeting CD1d expressing hematological tumors, including multiple myeloma (MM), chronic lymphocytic leukemia (CLL), and acute myeloid leukemia (AML) will be discontinued (NCT04887259). LAVA-051 was being evaluated in an open-label, multi-center Phase 1/2a clinical trial in patients with relapsed or refractory CLL and MM to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of LAVA-051. The decision to discontinue LAVA-051’s clinical trial follows a recent review of the competitive landscape that has continued to evolve. The decision is not due to safety concerns. LAVA-1207 is a Gammabody designed to target the prostate-specific membrane antigen (PSMA) to trigger the potent and preferential killing of PSMA-positive tumor cells in patients with metastatic castration-resistant prostate cancer (mCRPC). The ongoing Phase 1/2a study of LAVA-1207 in patients with therapy refractory mCRPC has thus far demonstrated a favorable safety profile as well as preliminary signs of anti-tumor activity with disease stabilization and PSA reduction during dose escalation in this heavily pretreated patient population. The Company expects that the discontinuation of this LAVA-051 trial and its focus on the LAVA-1207 program will result in cost savings that will extend its cash runway further into 2026. Reported Earnings • Jun 08
First quarter 2023 earnings released: US$0.53 loss per share (vs US$0.41 loss in 1Q 2022) First quarter 2023 results: US$0.53 loss per share (further deteriorated from US$0.41 loss in 1Q 2022). Revenue: US$1.22m (up 22% from 1Q 2022). Net loss: US$13.9m (loss widened 32% from 1Q 2022). Revenue is expected to decline by 9.4% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 12%. Announcement • May 31
LAVA Therapeutics N.V., Annual General Meeting, Jun 14, 2023 LAVA Therapeutics N.V., Annual General Meeting, Jun 14, 2023, at 14:00 Central European Standard Time. Reported Earnings • Apr 12
Full year 2022 earnings released: US$1.23 loss per share (vs US$2.30 loss in FY 2021) Full year 2022 results: US$1.23 loss per share (improved from US$2.30 loss in FY 2021). Revenue: US$19.4m (up 288% from FY 2021). Net loss: US$31.9m (loss narrowed 30% from FY 2021). Revenue is expected to decline by 7.7% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 21%. Announcement • Feb 17
LAVA Therapeutics N.V. Announces Initial Data from the Ongoing Phase 1/2A Clinical Trial of Lava-1207 in Therapy Refractory mCRPC at the 2023 ASCO GU Symposium LAVA Therapeutics N.V. announced initial clinical data from its ongoing Phase 1/2a study of LAVA-1207 in patients with therapy refractory metastatic castration resistant prostate cancer (mCRPC). The data are presented in a poster presentation at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) taking place in San Francisco from February 16-18, 2023. The objectives of the Phase 1/2a study (EudraCT 2021-001789-39; NCT05369000) are to investigate safety and tolerability, evaluate pharmacokinetic and pharmacodynamic effects, immunogenicity and preliminary antitumor activity of LAVA-1207. LAVA-1207 is administered via intravenous infusion every two weeks. The data presented to date show that a total of 20 patients have been treated with doses ranging from 1.5 to 120 micrograms of LAVA-1207, with treatment duration ranging from 4 to 38 weeks. The safety profile is favorable to date, without occurrence of high grade (>2) cytokine release syndrome or dose-limiting toxicities. LAVA-1207 showed predictable and linear pharmacokinetics and on-mechanism pharmacodynamics including V<GAMMA>9V 2-T cell activation. Preliminary signs of anti-tumor activity were observed at week 8, with iRECIST stable disease (iSD) in 8 out of 14 evaluable patients and PSA levels stabilizing or decreasing. The large overall decrease in PSA was 61% (46% vs baseline). The patient improved clinically with improvement in pain and fatigue. Dose escalation is continuing both in Europe and the U.S. Announcement • Feb 07
LAVA Therapeutics N.V. Announces the Appointment of Dr. Charles Morris as Chief Medical Officer LAVA Therapeutics N.V. announced that Dr. Charles Morris has joined LAVA as chief medical officer effective February 6, 2023. Dr. Morris will replace Benjamin Winograd, MD, PhD. Dr. Morris is a medical oncologist with over 25 years of oncology drug development experience working with global biotech and pharmaceutical companies and managing numerous drug approvals. Most recently, he was the chief medical officer for Celyad Oncology, a biotechnology company focused on the research and discovery of chimeric antigen receptor T cell (CAR T) therapies for cancer. Dr. Morris also served as chief medical officer of Radius Health and held leadership positions at PsiOxus Therapeutics, ImmunoGen and Allos Therapeutics, where he contributed to all phases of development for solid and hematological tumor indications. He was also vice president of worldwide clinical research at Cephalon where he supported the approval of TREANDA(R) (bendamustine) for the treatment of indolent non-Hodgkin lymphoma and chronic lymphocytopenia. He began his career at AstraZeneca and held roles of increasing responsibility including global medical lead for Faslodex(R) (fulvestrant) which he managed through its approval for breast cancer.Dr. Morris holds a Bachelor of Medicine, Bachelor of Surgery and Bachelor of Medical Science in Clinical Pharmacology and Therapeutics degree from Sheffield University Medical School in the UK and is a Member of the Royal College of Physicians of London. Announcement • Jan 07
LAVA Therapeutics N.V. Announces Board Changes LAVA Therapeutics N.V. announced the appointment of two new directors to its Board of Directors. Peter A. Kiener, DPhil, a research and development veteran in biologics, immunotherapy, and biopharmaceuticals, and Mary Wadlinger, a recognized leader in high-growth biotechnology and biopharmaceuticals organizational and business issues were appointed effective January 1, 2023. Additionally, Guido Magni, M.D., Ph.D. will step down from his role on the LAVA Board. Dr. Peter Kiener is an industry veteran with extensive experience in both biologics and immunotherapy, andbiopharmaceutical research and development. Previously, he was chief scientific officer at Sucampo, which was acquired by Mallinckrodt and served as chief scientific officer of Ambrx Inc., a clinical-stage biopharmaceutical company focused on the development of antibody-drug conjugates (ADCs). Dr. Kiener was also president and co-founder of Zyngenia Inc., an early-stage biopharmaceutical company and served as executive vice president and global head of biologics research and development at MedImmune LLC, the global biologics arm of AstraZeneca. He received a Bachelor of Science from Lancaster University in Lancaster, UK and his DPhil from Oxford University, Sir William Dunn School of Pathology. Ms. Wadlinger brings 25 years of experience as a strategic human resources leader in biotechnology and global biopharmaceuticals. Most recently, Ms. Wadlinger was senior vice president and Chief Human Resources Officer at Forma Therapeutics where she led the organization and people strategy through critical growth and reorganization as the company transformed from drug discovery to a fully integrated drug development and commercial readiness company. Prior to Forma, she served as vice president, human resources at Millennium Pharmaceuticals, a subsidiary of Takeda Pharmaceuticals where she served as a key leader in numerous corporate transformations, growth initiatives, M&A activity, and overall integration within Takeda. Ms. Wadlinger earned a Bachelor of Science degree in Finance from the University of Maine Business School. Announcement • Dec 11
LAVA Therapeutics N.V. Announces Updated Data from the Phase 1/2A Clinical Trial of LAVA-051 at the 64th American Society of Hematology Annual Meeting and Exposition LAVA Therapeutics N.V. announced a poster presentation highlighting updated data, including safety, pharmacodynamics (PD) and pharmacokinetics (PK) from the ongoing Phase 1/2a clinical trial of LAVA-051 in patients with relapsing/refractory (R/R) chronic lymphocytic leukemia (CLL) and multiple myeloma (MM) at the 64thAmerican Society of Hematology (ASH) Annual Meeting and Exposition, taking place in New Orleans, Louisiana and virtually December 10–13, 2022. The presentation includes initial data from patients receiving LAVA-051 subcutaneously, along with updates on the intravenous dosing-cohorts. In addition to the favorable safety profile demonstrated as of the data cutoff (November 11, 2022), LAVA-051 showed predictable and linear pharmacokinetics and on-mechanism pharmacodynamic parameters consistent with V?9Vd2-T cell engagement, including increasing occupancy of patient V?9Vd2-T cells with LAVA-051 and consistent increases in the expression of T-cell activation markers. Moreover, potential signs of clinical activity of LAVA-051 were seen. LAVA-051 is a humanized Gammabody™ designed to activate both V?9Vd2 (Vgamma9 Vdelta2) 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 antibody recognizes the Vd2 chain of the V?9Vd2 T cell receptor, and the other domain antibody is specific for CD1d, a glycoprotein involved in the presentation of (glyco)lipid antigens to distinct T cell populations including type 1 NKT cells, that can be expressed on a wide range of hematologic malignancies, including chronic lymphocytic leukemia, multiple myeloma, and acute myeloid leukemia. Reported Earnings • Nov 21
Third quarter 2022 earnings released: EPS: US$0.039 (vs US$0.27 loss in 3Q 2021) Third quarter 2022 results: EPS: US$0.039 (up from US$0.27 loss in 3Q 2021). Revenue: US$15.3m (up US$13.2m from 3Q 2021). Net income: US$997.0k (up US$7.93m from 3Q 2021). Profit margin: 6.5% (up from net loss in 3Q 2021). The move to profitability was driven by higher revenue. Revenue is expected to decline by 47% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 25%. Board Change • Nov 16
Less than half of directors are independent There are 5 new directors who have joined the board in the last 3 years. Of these new board members, 1 was an independent director. The company's board is composed of: 2 independent directors. 5 non-independent directors. Independent Non-Executive Director Karen Wilson was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Announcement • Nov 02
LAVA Therapeutics N.V. Announces Appointment of Fred M. Powell as Chief Financial Officer LAVA Therapeutics N.V. announced the appointment of Fred M. Powell as Chief Financial Officer, effective today. Mr. Powell brings over 20 years of global CFO experience in the biopharmaceutical industry, including investor relations, administration, operations and information technology. Most recently, Mr. Powell served as the executive vice president and chief financial officer of Antares Pharma, playing a leading strategic role in the successful $1.0 billion acquisition of Antares by Halozyme Therapeutics in May 2022. He was also CFO at Celator Pharmaceuticals (acquired by Jazz Pharmaceuticals), OraPharma Inc. (acquired by Valeant Pharmaceuticals International) and BMP Sunstone Corporation (acquired by Sanofi-Aventis) and held various positions of increasing responsibility at KPMG LLP. Mr. Powell is the vice chairman of the Advisory Board for Penn State Scranton. He holds a B.S. in accounting from Pennsylvania State University. Reported Earnings • Sep 15
Second quarter 2022 earnings released: US$0.31 loss per share (vs US$0.32 loss in 2Q 2021) Second quarter 2022 results: US$0.31 loss per share (improved from US$0.32 loss in 2Q 2021). Net loss: US$7.92m (loss narrowed 1.5% from 2Q 2021). Revenue is expected to decline by 24% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 19%. Announcement • Jun 17
LAVA Therapeutics Highlights Encouraging Clinical Updates on Lead Program, LAVA-051, in Chronic Lymphocytic Leukemia and Multiple Myeloma Patients LAVA Therapeutics N.V. hosted a clinical update call focused on encouraging initial Phase 1/2a clinical data for LAVA-051 in patients with chronic lymphocytic leukemia (CLL) and multiple myeloma (MM) patients following poster presentations at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting held June 3-7, 2022, and the European Hematology Association (EHA) 2022 Congress, held June 9-12, 2022. In the Phase 1/2a clinical study of LAVA-051 in patients with CLL and MM, the primary objectives are to investigate safety and tolerability and determine the recommended Phase 2 dose, while the secondary objectives are to evaluate pharmacokinetics, pharmacodynamics, immunogenicity and preliminary anti-tumor activity. Following intravenous dosing, subcutaneous dosing will also be evaluated. AML patients will be included later in the study. Announcement • Jun 16
LAVA Therapeutics N.V. Announces Board Changes LAVA Therapeutics N.V. announced the appointments of James Noble and Jay Backstrom, M.D., M.P.H., as non-executive directors to its board of directors. The Company also announced that Erik van den Berg, co-founder of LAVA and chief executive officer of AM-Pharma, Joël J.P. Jean-Mairet, Ph.D., managing partner and co-founder of Ysios Capital, and Nanna Lüneborg, Ph.D., general partner of Forbion, are stepping down from the board following the conclusion of the annual general meeting held on, June 15. Mr. Noble most recently served as chief executive officer of Adaptimmune Therapeutics plc until 2019 after co-founding it in 2008; he remains on the board. Prior, Mr. Noble was chief executive officer of Immunocore, which he also co-founded. Mr. Noble has also served as a non-executive board director for publicly traded life science companies, including as deputy chairman of GW Pharmaceuticals until its acquisition by Jazz Pharmaceuticals in 2021. Currently, Mr. Noble is chairman of Orexo AB, Sutura Therapeutics and Celleron Therapeutics. Mr. Noble received an M.A. from the University of Oxford. Dr. Backstrom most recently served as executive vice president, research and development, at Acceleron Pharma through its acquisition by Merck in 2021. Previously, Dr. Backstrom was chief medical officer and head of regulatory affairs for Celgene Corporation, where he was instrumental in bringing REBLOZYL®, co-developed by Celgene and Acceleron, through to regulatory approval. Prior, he worked as vice president of clinical research and development, myelodysplastic syndrome and acute myeloid leukemia, as well as chief medical officer, through the completion of the Bristol Myers Squibb-Celgene merger in 2019. Dr. Backstrom now serves as a non-executive board director of Autolus Therapeutics, Be Biopharma and Disc Medicine. He earned his M.D. and completed medical training at the Lewis Katz School of Medicine at Temple University, and he received a Master’s in public health from the Saint Louis University School of Public Health. Announcement • Jun 03
LAVA Therapeutics N.V., Annual General Meeting, Jun 15, 2022 LAVA Therapeutics N.V., Annual General Meeting, Jun 15, 2022, at 07:30 Central European Standard Time. Location: Beethovenstraat 400, 1082 PR Amsterdam Netherlands Agenda: To consider adoption of the annual accounts over the financial year 2021; to consider explanation of the dividend and reservation policy; to consider appointment of the external auditor for the financial year 2022 for purposes of Dutch law; to consider release from liability for the Company's directors with respect to the performance of their duties during the financial year ended December 31, 2021; to consider appointment of James Nobel as non-executive director of the Company; to consider appointment of Jay Backstrom as non-executive director of the Company; to consider extension of authorization of the Company's board of directors to acquire shares; and to transact other matters. Announcement • Jun 02
LAVA Therapeutics N.V. to Present Initial Phase 1/2a Clinical Trial Dose Escalation Data of LAVA-051 in Chronic Lymphocytic Leukemia and Multiple Myeloma Patients at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting LAVA Therapeutics N.V. announced the presentation of initial dose-escalation data from the Phase 1/2a clinical trial of LAVA-051 in patients with chronic lymphocytic leukemia (CLL) and multiple myeloma (MM) at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago and virtually June 3-7, 2022. In the Phase 1/2a clinical study of LAVA-051 in patients with CLL and MM, the primary objectives are to investigate safety and tolerability and determine the recommended Phase 2 dose, while the secondary objectives are to evaluate pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity. Acute myeloid leukemia (AML) patients will be included later in the study. In addition to the favorable safety profile demonstrated to date, LAVA-051 showed predictable and linear pharmacokinetics and on-mechanism pharmacodynamic parameters consistent with V?9Vd2-T cell engagement, including increasing occupancy of LAVA-051 on patient V?9Vd2-T cells and consistent increases in the expression of T-cell activation markers. In these initial data, potential signs of clinical anti-tumor activity were also observed: a CLL patient experienced early enlargement and tenderness of several CLL-affected lymph nodes followed by a regression of those lymph nodes, resulting in a stable disease assessment after 12 weeks of therapy in combination with a reduction in the peripheral blood leukemic cell count over five cycles of LAVA-051; a MM patient showed a 23% reduction in myeloma cell-produced M-protein levels in the blood. LAVA-051 is a humanized Gammabody™ designed to activate both V?9Vd2 (Vgamma9 Vdelta2) 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 antibody recognizes the Vd2 chain of the V?9Vd2 T cell receptor, and the other domain antibody is specific for CD1d, a glycoprotein involved in the presentation of (glyco)lipid antigens to distinct T cell populations including type 1 NKT cells, that is expressed on a wide range of hematologic malignancies, including chronic lymphocytic leukemia, multiple myeloma, and acute myeloid leukemia. Reported Earnings • May 20
First quarter 2022 earnings released: US$0.41 loss per share (vs US$11.96 loss in 1Q 2021) First quarter 2022 results: US$0.41 loss per share (up from US$11.96 loss in 1Q 2021). Net loss: US$10.6m (loss narrowed 46% from 1Q 2021). Over the next year, revenue is expected to shrink by 37% compared to a 30% growth forecast for the industry in Germany. Announcement • May 18
LAVA Therapeutics N.V. Announces the Resignation of Ed Smith as Chief Financial Officer LAVA Therapeutics N.V. announced Ed Smith, chief financial officer has resigned to pursue other interests, effective as of May 17, 2022. He may serve in a consulting capacity to support the Company's transition. The Company has commenced a search for Mr. Smith's permanent replacement. Announcement • May 13
Lava Therapeutics N.V. Announces FDA IND Clearance for Lava-051 for the Treatment of Hematologic Malignancies LAVA Therapeutics N.V. announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for LAVA-051, the Company’s lead product candidate for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and acute myeloid leukemia (AML). The Phase 1/2a clinical trial currently includes patients with relapsed or refractory CLL and MM. AML patients will be included later in the study. In October 2021, the FDA granted Orphan Drug Designation for LAVA-051 for the treatment of CLL. Announcement • Apr 28
LAVA Therapeutics to Present Updated LAVA-051 Clinical Data at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting LAVA Therapeutics N.V. announced the Company will present updated interim data from the dose escalation phase of the ongoing Phase 1/2a clinical trial of LAVA-051 in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and multiple myeloma (MM) at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago and virtually June 3-7, 2022. Board Change • Apr 27
Less than half of directors are independent There are 7 new directors who have joined the board in the last 3 years. Of these new board members, 1 was an independent director. The company's board is composed of: 7 new directors. 5 experienced directors. No highly experienced directors. 3 independent directors (5 non-independent directors). Independent Non-Executive Director Erik van den Berg is the most experienced director on the board, commencing their role in 2017. Independent Non-Executive Director Karen Wilson was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors. Announcement • Mar 10
LAVA Therapeutics N.V. Presents Initial LAVA-051 Clinical Data at the ESMO Targeted Anticancer Therapies Congress 2022 LAVA Therapeutics N.V. announced initial data from its first clinical study with LAVA-051. LAVA chief scientific officer Hans van der Vliet, M.D., Ph.D. will deliver the presentation “Bispecific ?d T cell engagers for the treatment of cancer” during the Bispecifics and T cell Engagers session in the Channel 1 virtual room from 14.35 – 14.55 CET at the ESMO Targeted Anticancer Therapies Congress 2022. The presentation will include data from the first three cohorts of the LAVA-051 Phase 1/2a clinical trial along with preclinical data on its two lead programs, LAVA-051 and LAVA-1207, that illustrate characteristics of its Gammabody™ platform. The first three dose-escalation cohorts showed LAVA-051 to be safe and well tolerated with no dose limiting toxicities or cytokine release syndrome (CRS) observed. Per the study protocol, the cohort three dose was 33-times that of the cohort one dose. Drug exposure and V?9Vd2 T cell receptor occupancy of LAVA-051 increased with LAVA-051 dose increases and peripheral blood V?9Vd2 T cells also expressed higher levels of activation markers after LAVA-051 dosing. One patient with chronic lymphocytic leukemia (CLL) experienced multiple enlarged tender diseased lymph nodes one week after first dosing that subsequently regressed, reminiscent of tumor flare. The Phase 1/2a clinical trial currently includes patients with relapsed or refractory CLL and multiple myeloma (MM). The first three cohorts enrolled one patient per dose escalation and future cohorts will enroll at least three patients per cohort. Acute Myeloid Leukemia (AML) patients will be included later in the study. Additional data from the dose escalation phase of the trial is expected in the second quarter of 2022 and from the disease-specific expansion cohorts in the second half of 2022. The Phase 1/2a clinical trial for LAVA-051 is initially being conducted in Europe and LAVA expects to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA), which, if accepted, will subsequently include patients in the United States. In October 2021, the FDA granted orphan drug designation for LAVA-051 for the treatment of CLL. LAVA-051 is a Gammabody™ designed to activate both V?9Vd2 (Vgamma9 Vdelta2) T cells and type 1 NKT cells to kill CD1d-expressing tumor cells. LAVA-051 consists of two humanized single domain antibodies linked via a short five amino acid glycine-serine linker. One domain antibody recognizes the Vd2 chain of the V?9Vd2 T cell receptor, and the other domain antibody 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. Announcement • Feb 02
LAVA Therapeutics N.V. Announces Dosing of the First Patient in the Phase 1/2A Clinical Trial of LAVA-1207 in Patients with Metastatic Castration-Resistant Prostate Cancer LAVA Therapeutics N.V. announced dosing of the first patient in the company’s Phase 1/2a clinical trial of LAVA-1207 in patients with metastatic castration-resistant prostate cancer (mCRPC). LAVA-1207 is a Gammabody™ that targets the prostate-specific membrane antigen (PSMA) and has demonstrated preclinical proof-of-concept driving antitumor responses in a variety of prostate cancer models. The open-label, multi-center, Phase 1/2a clinical trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary antitumor activity of LAVA-1207 in patients with mCRPC. The Phase 1 dose-escalation portion of the study will determine the optimal Phase 2 dose to be used in the subsequent Phase 2a expansion cohort. The Phase 1/2a clinical trial for LAVA-1207 was initiated in Europe and will subsequently expand to enroll patients in the United States. Announcement • Jan 19
LAVA Therapeutics N.V. Presents Preclinical Data on its Gammabody™ T Cell Engager Platform at the 21st Annual PepTalk Conference LAVA Therapeutics N.V. announced it will present preclinical data on its Gammabody™ platform and data on its lead solid tumor Gammabody™ LAVA-1207. The presentation will also include new non-human primate data with a fully cross-reactive gamma delta bsTCE utilizing a surrogate Fc-containing Gammabody™ format to assess the safety of its most advanced solid tumor programs, LAVA-1207 and LAVA-1223. Paul W.H.I. Parren, Ph.D., executive vice president, head of research and development, will present these data at the 21st Annual PepTalk Conference Jan. 18, 2022 from 5:00 – 5:30 p.m. PST in the Sapphire Session Room in San Diego. The presentation will be available on the conference website for viewing during and after the meeting. In preclinical experiments, LAVA-1207 has shown the ability to activate V?9Vd2 (Vgamma9 Vdelta2) T cells to exert cytotoxicity toward PSMA (prostate specific membrane antigen)-expressing tumor cells at picomolar concentrations. Using prostate cancer patient samples, LAVA-1207 activated autologous V?9Vd2 T cells and triggered lysis of tumor cells, while sparing normal prostate tissue. The mechanism of preferential tumor cell killing may be due to a demonstrated overexpression of a range of V?9Vd2 T cell ligands on tumor cells. A first-in-human Phase 1/2a open-label trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and antitumor activity of LAVA-1207 in patients with therapy refractory metastatic castration-resistant prostate cancer (mCRPC) is currently recruiting. In addition, data from the non-human primate study showed an EGFR (epidermal growth factor receptor)-targeted surrogate Gammabody™ to be safe and well-tolerated in non-human primates. The EGFR Gammabody™ was administered at doses up to 23 mg/kg leading to high sustained plasma levels and dose-dependent accumulation in relevant tissues with no safety-related effects and no signs of cytokine release syndrome (CRS). LAVA’s clinical stage PSMA Gammabody™, LAVA-1207, is an Fc-containing Gammabody™ for which pre-clinical data from in vitro, ex vivo and in vivo models will also be presented. In the non-human primate study, animals were administered weekly intravenous doses of 1, 5 or 23 mg/kg of an EGFR gamma delta bsTCE that is fully cross-reactive with EGFR and V?9 T cells in non-human primates. At all doses, the EGFR gamma delta bsTCE only induced minimal levels of cytokines such as IL-2, IL-6 and IFN-gamma and there were no signs of CRS. No changes in general health parameters, clinical chemistry, hematology or histopathology were observed. The compound was pharmacologically active in the animals, with V?9-positive T cells expressing markers indicating activation (CD25 and CD69). Presence of the injected compound in EGFR-expressing tissues, such as skin, muscle and colon, was demonstrated using immune-histochemistry. The elimination half-life was similar to the half-life of regular human IgG and ranged between 84.7 and 127.4 hours. Reported Earnings • Nov 16
Third quarter 2021 earnings released: €0.29 loss per share Third quarter 2021 results: Net loss: €7.46m (loss widened 132% from 3Q 2020). Announcement • Jul 15
LAVA Therapeutics Announces Treatment of First Patient in Phase 1/2a Clinical Trial of LAVA-051 for Multiple Hematological Malignancies LAVA Therapeutics N.V. 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 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.