LAVA Therapeutics(LVTX)

Search documents
LAVA Therapeutics Granted Full Waiver for RVO Payment Obligation
Newsfilter· 2025-04-16 11:30
Core Insights - LAVA Therapeutics has received a full waiver of a $5.1 million repayment obligation from the Netherlands Enterprise Agency, significantly strengthening its balance sheet [1][2] - The company is focusing on cost optimization initiatives to enhance operational efficiency and financial flexibility as part of its ongoing strategic review [2] Company Overview - LAVA Therapeutics N.V. is a clinical-stage immuno-oncology company that develops its proprietary Gammabody® platform, which includes bispecific gamma-delta T cell engagers aimed at treating solid tumors and hematologic malignancies [3][4] - The company utilizes engineered bispecific antibodies to selectively target and kill cancer cells by activating Vγ9Vδ2 T cell anti-tumor functions [3] Pipeline and Development - LAVA's pipeline includes three clinical-stage bispecific gamma-delta T cell engagers: LAVA 1266 targeting CD123+ cancers, PF-08046052 targeting EGFR, and JNJ-89853413 targeting hematological cancers [4] - The company also has preclinical programs in development [4]
LAVA Therapeutics(LVTX) - 2024 Q4 - Annual Report
2025-03-28 20:06
PART I [Business](index=4&type=section&id=Item%201.%20Business) LAVA Therapeutics is a clinical-stage immuno-oncology company developing its Gammabody® platform for cancer treatment, with lead candidate LAVA-1266 in Phase 1, strategic partnerships, and a recent restructuring to extend capital resources - The company is a clinical-stage immuno-oncology firm focused on its proprietary Gammabody® platform, developing bispecific gamma delta (γδ) T cell engagers to treat cancer[11](index=11&type=chunk) - In February 2025, a restructuring plan was adopted to extend capital resources, involving a **30% reduction** in the global workforce to focus on the LAVA-1266 program, expected to incur approximately **$1.0 million** in expenses[12](index=12&type=chunk) Development Pipeline Overview | Category | Candidate | Target | Indication(s) | Preclinical | Phase 1 | Phase 2 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **Proprietary Pipeline** | LAVA-1266 | CD123 | Hematologic Malignancies | ✔ | ✔ | | | | LAVA-1427 | Undisclosed | Undisclosed | ✔ | | | | | LAVA-1433 | Undisclosed | Undisclosed | ✔ | | | | **Strategic Partnerships** | PF-08046052 | EGFR | Solid Tumors | ✔ | ✔ (Pfizer) | | | | JNJ-89853413 | CD33 | Hematologic Malignancies | ✔ | ✔ (J&J) | | | **Discontinued Programs** | LAVA-1207 | PSMA | Solid Tumors | - | Discontinued | - | - The lead candidate, LAVA-1266, targets CD123 for hematological malignancies like AML and MDS, with a Phase 1 trial initiated in Q4 2024 and initial data expected by year-end 2025[18](index=18&type=chunk)[22](index=22&type=chunk)[23](index=23&type=chunk) - The LAVA-1207 program for prostate cancer was discontinued in December 2024 due to not meeting internal benchmarks, resulting in a **$3.9 million** expense for related costs[19](index=19&type=chunk)[37](index=37&type=chunk)[43](index=43&type=chunk) - The LAVA-051 clinical trial for hematological tumors was discontinued in June 2023 due to the evolving competitive landscape, resulting in a **$1.4 million** expense write-off and a **36% workforce reduction**[44](index=44&type=chunk)[45](index=45&type=chunk)[47](index=47&type=chunk) [Partnered Programs](index=11&type=section&id=Partnered%20Programs) The company maintains strategic partnerships with Pfizer and Johnson & Johnson, involving upfront payments and significant milestone potential for their respective partnered programs, PF-8046052 and JNJ-89853413 - Entered an exclusive license agreement with Pfizer in 2022 for PF-8046052, targeting EGFR-expressing solid tumors, receiving a **$50 million** upfront payment and eligible for up to **$650 million** in milestones plus royalties[28](index=28&type=chunk) - Pfizer initiated a Phase 1 trial for PF-8046052 in 2023 and paid LAVA a **$7 million** clinical milestone in March 2024[29](index=29&type=chunk)[30](index=30&type=chunk) - The collaboration with Johnson & Johnson (J&J) for JNJ-89853413, targeting CD33, has resulted in **$17.5 million** in upfront, research, and clinical milestone payments as of December 31, 2024, with an IND filed in October 2024[33](index=33&type=chunk)[34](index=34&type=chunk) [Intellectual Property](index=36&type=section&id=Intellectual%20Property) LAVA Therapeutics protects its Gammabody® platform and product candidates through a combination of patents, trade secrets, and know-how, with a portfolio including 2 issued U.S. patents and 21 pending U.S. applications as of December 31, 2024, covering core technology and specific candidates like LAVA-1266, with patents expected to expire starting in 2042 - As of December 31, 2024, the company's patent portfolio includes **2 issued U.S. patents**, **21 pending U.S. patent applications**, and over **100 patents and applications** in other territories[110](index=110&type=chunk)[111](index=111&type=chunk) - For its lead candidate LAVA-1266, the patent portfolio includes multiple pending U.S. and foreign applications, with any patents issuing expected to expire in **2042**, excluding potential extensions[114](index=114&type=chunk) - The Gammabody® platform technology is protected by **six patent families** covering antibodies that activate γδ T cells, dosing regimens, and combination therapies[116](index=116&type=chunk) [Government Regulation](index=41&type=section&id=Government%20Regulation) The company's operations are subject to extensive regulation by the FDA, EMA, and other global authorities, covering all stages from R&D to post-approval marketing, requiring comprehensive testing, BLA/MAA submissions, cGMP compliance, and adherence to healthcare laws regarding fraud, abuse, data privacy, and pricing - The company's biologic products are extensively regulated by the FDA in the U.S. and the EMA in Europe, covering research, development, manufacturing (cGMP), and marketing[123](index=123&type=chunk) - The approval process requires successful completion of preclinical studies and **three phases** of human clinical trials to establish safety and efficacy before submitting a BLA (U.S.) or MAA (E.U.)[124](index=124&type=chunk)[129](index=129&type=chunk) - The company may seek expedited review programs such as Fast Track, Breakthrough Therapy, or Accelerated Approval to potentially speed up development and review timelines[143](index=143&type=chunk)[145](index=145&type=chunk)[147](index=147&type=chunk) - Post-approval, the company is subject to ongoing regulations, including REMS, post-marketing studies, and strict rules on advertising and promotion to prevent off-label use[140](index=140&type=chunk)[156](index=156&type=chunk)[158](index=158&type=chunk) - Operations are also governed by healthcare laws like the Anti-Kickback Statute, False Claims Act, and data privacy regulations such as HIPAA and GDPR, with non-compliance carrying substantial penalties[171](index=171&type=chunk)[172](index=172&type=chunk)[179](index=179&type=chunk) [Human Capital](index=67&type=section&id=Human%20Capital) As of December 31, 2024, LAVA Therapeutics had 34 full-time employees, primarily in R&D, with a reduction in force initiated in February 2025 to decrease European employees to 6, and a human capital strategy focused on attracting and retaining talent through equity incentive plans - As of December 31, 2024, the company had **34 full-time employees**, with **23** in research and development and **11** in general and administrative roles[199](index=199&type=chunk) - A reduction in force was initiated in February 2025, which will reduce the number of full-time employees in Europe to **6**, effective April 30, 2025[199](index=199&type=chunk) [Risk Factors](index=67&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including a history of operating losses, the need for substantial additional funding, uncertain clinical development pathways for its novel Gammabody® platform, dependence on LAVA-1266 and third-party collaborations, reliance on single-source suppliers, intense competition, potential Nasdaq delisting, and the successful execution of its strategic review and restructuring - The company is a clinical-stage entity with a history of significant operating losses (**$25.1 million** in 2024, **$41.9 million** in 2023) and anticipates continued losses, with no guarantee of ever achieving profitability[204](index=204&type=chunk)[206](index=206&type=chunk)[208](index=208&type=chunk) - Substantial additional funding is required to complete development and commercialization, and failure to raise capital could force delays, reductions, or termination of programs[204](index=204&type=chunk)[220](index=220&type=chunk) - The Gammabody® platform is a novel approach, making it difficult to predict development time, cost, and regulatory approval, as no bispecific γδ T cell engagers are currently approved by the FDA or EMA[204](index=204&type=chunk)[233](index=233&type=chunk) - The company relies on a single-source supplier for bulk drug substance for its programs, and the loss of this supplier could significantly impair and delay development[207](index=207&type=chunk)[298](index=298&type=chunk) - The ongoing strategic review and workforce reduction may not achieve intended outcomes and could lead to loss of institutional knowledge and decreased morale[207](index=207&type=chunk)[371](index=371&type=chunk)[372](index=372&type=chunk) - The company received a notice of non-compliance from Nasdaq on February 27, 2025, for its stock price falling below **$1.00**, though compliance was regained on March 11, 2025, but future non-compliance could lead to delisting[461](index=461&type=chunk) [Cybersecurity](index=98&type=section&id=Item%201C.%20Cybersecurity) The company manages cybersecurity risks through internal processes and third-party providers, with oversight from the Audit Committee and implementation by senior management, including the CFO, through risk assessments, monitoring, incident response, and technical controls - The Audit Committee of the Board of Directors is responsible for overseeing the company's cybersecurity risk management processes[503](index=503&type=chunk) - Cybersecurity risk management is implemented by senior management, including the Chief Financial Officer (CFO), with assistance from third-party service providers and consultants[499](index=499&type=chunk)[504](index=504&type=chunk) - The company maintains an information security policy, an incident response policy, and various technical controls like data encryption, network security, and access controls to mitigate threats[500](index=500&type=chunk) [Properties](index=99&type=section&id=Item%202.%20Properties) The company leases approximately 8,471 square feet of office and laboratory space for its headquarters in Utrecht, Netherlands, until March 2026, and 5,621 square feet of office space in Philadelphia, Pennsylvania, until December 2025 - The company's headquarters is located in Utrecht, the Netherlands, occupying approximately **8,471 sq. ft.** of leased office and lab space with a lease expiring **March 31, 2026**[509](index=509&type=chunk) - A U.S. office of approximately **5,621 sq. ft.** is leased in Philadelphia, PA, with the lease term ending in **December 2025**[509](index=509&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=100&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) LAVA Therapeutics' common shares trade on the Nasdaq Global Select Market under the symbol "LVTX" since March 26, 2021, with 2,313 holders of record as of March 21, 2025, and the company has never paid cash dividends, intending to retain earnings for business development, with IPO net proceeds of approximately $94.2 million - Common shares are traded on the Nasdaq Global Select Market under the symbol "LVTX" since **March 26, 2021**[513](index=513&type=chunk) - The company has never paid cash dividends and does not intend to in the foreseeable future, retaining funds for business expansion[515](index=515&type=chunk) - The IPO generated net proceeds of approximately **$94.2 million**, which have been invested in money market funds and short-term investments[518](index=518&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=101&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For the year ended December 31, 2024, LAVA Therapeutics reported a net loss of $25.1 million, a decrease from $41.9 million in 2023, with revenue increasing to $12.0 million driven by milestone payments, and R&D expenses decreasing to $28.5 million, while existing cash of $76.6 million is deemed sufficient for at least 12 months Results of Operations (FY 2024 vs. FY 2023) | (in thousands) | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | **Total Revenue** | **$11,982** | **$6,769** | **$5,213** | | Research and development | ($28,450) | ($32,559) | $4,109 | | General and administrative | ($13,225) | ($14,122) | $897 | | **Operating Loss** | **($29,693)** | **($43,394)** | **$13,701** | | **Net Loss** | **($25,114)** | **($41,871)** | **$16,757** | - Revenue in 2024 was primarily driven by a **$7.0 million** clinical milestone payment from Pfizer and a **$5.0 million** development milestone payment from Johnson & Johnson[549](index=549&type=chunk)[550](index=550&type=chunk) - Research and development expenses decreased by **$4.1 million** year-over-year, mainly due to reduced manufacturing costs for LAVA-1266 and lower personnel-related expenses following headcount reductions in late 2023[552](index=552&type=chunk) - The company believes its existing cash, cash equivalents, and investments are sufficient to fund operations for at least **12 months** from the report date[561](index=561&type=chunk) Cash Flow Summary (FY 2024 vs. FY 2023) | (in thousands) | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(19,544) | $(40,283) | | Net cash generated from (used in) investing activities | $12,475 | $(17,636) | | Net cash used in financing activities | $(569) | $— | | **Net decrease in cash and cash equivalents** | **$(7,638)** | **$(57,919)** | [Controls and Procedures](index=111&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2024, with previously identified material weaknesses in IT general controls and segregation of duties fully remediated through additional accounting resources, enhanced policies, and improved IT controls - Management concluded that as of December 31, 2024, the company's disclosure controls and procedures were effective at a reasonable assurance level[578](index=578&type=chunk) - Material weaknesses previously identified in the 2023 Annual Report, related to IT general controls and segregation of duties, were fully remediated as of December 31, 2024[492](index=492&type=chunk)[581](index=581&type=chunk)[584](index=584&type=chunk) - Remediation actions included hiring additional accounting personnel, enhancing formal policies and procedures, redesigning internal controls, and improving IT general controls such as change management and user access[583](index=583&type=chunk) [Other Information](index=113&type=section&id=Item%209B.%20Other%20Information) On March 27, 2025, the company amended CEO Stephen Hurly's employment agreement, primarily modifying Change in Control severance benefits to a full 1.5 times his target bonus, removing the pro-rated calculation - On **March 27, 2025**, the company amended the employment agreement with CEO Stephen Hurly[587](index=587&type=chunk) - The amendment modified the Change in Control severance benefit, entitling Mr. Hurly to a lump-sum payment equal to **1.5 times** his target bonus, removing the previous pro-rated calculation[588](index=588&type=chunk) PART III [Directors, Executive Officers, Corporate Governance, Compensation, and Principal Accountant Fees](index=115&type=section&id=Item%2010%2C%2011%2C%2012%2C%2013%2C%2014) Information for Items 10 through 14, covering directors, executive officers, corporate governance, compensation, security ownership, related transactions, and principal accountant fees, is incorporated by reference from the company's forthcoming 2025 Proxy Statement - Information regarding Directors, Executive Officers, Corporate Governance (Item 10), Executive Compensation (Item 11), Security Ownership (Item 12), Certain Relationships and Related Transactions (Item 13), and Principal Accountant Fees and Services (Item 14) is incorporated by reference from the forthcoming 2025 Proxy Statement[597](index=597&type=chunk)[598](index=598&type=chunk)[600](index=600&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=116&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all exhibits filed with the Form 10-K, including corporate governance documents, material contracts, and certifications, such as Amended and Restated Articles of Association, license agreements, stock plans, employment agreements, and CEO/CFO certifications - This item lists all exhibits filed as part of the annual report, including material contracts and required certifications[605](index=605&type=chunk)[607](index=607&type=chunk) Financial Statements [Consolidated Financial Statements](index=219&type=section&id=Consolidated%20Financial%20Statements) The audited consolidated financial statements for the years ended December 31, 2024 and 2023, show a decreased net loss to $25.1 million in 2024, with total assets of $80.8 million, total liabilities of $53.1 million, and total shareholders' equity of $27.7 million as of December 31, 2024 Consolidated Balance Sheet Data (as of Dec 31) | (in thousands) | 2024 | 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $35,015 | $44,231 | | Short-term investments | $41,561 | $51,340 | | **Total Assets** | **$80,831** | **$101,673** | | Total current liabilities | $18,006 | $14,894 | | Non-current portion of deferred revenue | $35,000 | $35,000 | | **Total Liabilities** | **$53,086** | **$50,309** | | **Total Shareholders' Equity** | **$27,745** | **$51,364** | Consolidated Statement of Operations Data (Year Ended Dec 31) | (in thousands) | 2024 | 2023 | | :--- | :--- | :--- | | Total Revenue | $11,982 | $6,769 | | Research and development | $(28,450) | $(32,559) | | General and administrative | $(13,225) | $(14,122) | | **Operating Loss** | **$(29,693)** | **$(43,394)** | | **Net Loss** | **$(25,114)** | **$(41,871)** | | Net loss per share | $(0.94) | $(1.57) | - The company transitioned from IFRS to U.S. GAAP for all periods presented, as it no longer qualified as a Foreign Private Issuer (FPI) as of **June 30, 2024**[640](index=640&type=chunk) - As of December 31, 2024, the company had Dutch tax loss carryforwards of **$106.5 million**, which are fully offset by a valuation allowance[543](index=543&type=chunk)[762](index=762&type=chunk)
LAVA Therapeutics(LVTX) - 2024 Q4 - Annual Results
2025-03-28 11:35
[Corporate and Strategic Highlights](index=1&type=section&id=Corporate%20and%20Strategic%20Highlights) LAVA Therapeutics will prioritize evaluating strategic options and advancing the LAVA-1266 Phase 1 trial in 2025, supported by a 30% workforce reduction and a strong $76.6 million cash balance projected to fund operations into 2027 - The company's primary focus for 2025 is to evaluate strategic options to maximize shareholder value[3](index=3&type=chunk) - A restructuring plan was adopted, resulting in a **30% reduction** in the global workforce to extend capital resources[5](index=5&type=chunk)[10](index=10&type=chunk) - The cash balance was **$76.6 million** as of December 31, 2024, projected to fund operations into **2027**[5](index=5&type=chunk)[10](index=10&type=chunk) - Achieved and received a **$5.0 million** development milestone from Johnson & Johnson in Q4 2024[5](index=5&type=chunk)[7](index=7&type=chunk) [Portfolio Highlights](index=1&type=section&id=Portfolio%20Highlights) LAVA's clinical pipeline is advancing with its proprietary LAVA-1266 program and two Phase 1 partnered programs with Johnson & Johnson and Pfizer, both yielding significant milestone payments in 2024 [LAVA-1266 Program](index=1&type=section&id=LAVA-1266%20%E2%80%93%20Phase%201%20Trial) LAVA-1266, an internally developed candidate targeting CD123+ tumor cells for AML and MDS, is actively enrolling patients in a Phase 1 study in Australia, currently in its second dose escalation level - Targets **CD123+ tumor cells** for treating hematological malignancies, specifically Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)[4](index=4&type=chunk)[6](index=6&type=chunk) - Currently enrolling patients in a Phase 1 study in Australia, progressing to the **second dose level of 300 µg**[6](index=6&type=chunk) [Johnson & Johnson (J&J) Partnered Program (JNJ-89853413)](index=2&type=section&id=Johnson%20%26%20Johnson%20%28J%26J%29%20Partnered%20Program) The J&J partnered program, JNJ-89853413, targets CD33 for hematological cancers, with J&J conducting a Phase 1 study in Canada and Spain, and LAVA receiving a **$5.0 million** milestone payment in Q4 2024 - Targets **CD33** for hematological cancers, including relapsed/refractory AML and moderate or higher risk MDS[7](index=7&type=chunk)[9](index=9&type=chunk) - J&J is actively enrolling patients in a Phase 1, open-label, multi-center study in Canada and Spain[9](index=9&type=chunk) - LAVA received a **$5.0 million** development milestone payment from J&J in Q4 2024[7](index=7&type=chunk) [Pfizer Partnered Program (PF-08046052)](index=2&type=section&id=Pfizer%20Partnered%20Program) The Pfizer partnered program, PF-08046052, targets EGFR in solid tumors, with Pfizer enrolling patients in a Phase 1 study in the U.S. and UK, and LAVA receiving a **$7.0 million** milestone payment in Q1 2024 - A potential first-in-class therapy targeting **EGFR** for solid tumors like CRC, NSCLC, HNSCC, and PDAC[8](index=8&type=chunk)[10](index=10&type=chunk) - Pfizer is enrolling patients in a Phase 1, open-label, multi-center study in the U.S. and UK[10](index=10&type=chunk) - LAVA received a **$7.0 million** clinical development milestone payment from Pfizer in Q1 2024[10](index=10&type=chunk) [Fourth Quarter and Year-End 2024 Financial Results](index=2&type=section&id=Fourth%20Quarter%20and%20Year-End%202024%20Financial%20Results) LAVA's full-year 2024 revenue increased to **$12.0 million** due to milestone payments, while the net loss significantly decreased to **$25.1 million** from **$41.9 million** in 2023, driven by reduced R&D and G&A expenses Key Financial Highlights | Financial Metric | Q4 2024 | Q4 2023 | FY 2024 | FY 2023 | | :--- | :--- | :--- | :--- | :--- | | **Revenue** | $5.0M | $0.4M | $12.0M | $6.8M | | **R&D Expenses** | $8.6M | $2.3M | $28.5M | $32.6M | | **G&A Expenses** | $3.3M | $3.3M | $13.2M | $14.1M | | **Net Loss** | $3.8M | $6.4M | $25.1M | $41.9M | | **Net Loss Per Share** | $0.14 | $0.24 | $0.94 | $1.57 | - The increase in full-year revenue was driven by a **$7.0 million** milestone from Pfizer and a **$5.0 million** milestone from J&J[11](index=11&type=chunk) - The decrease in full-year R&D expenses was mainly due to reduced manufacturing scale-up costs and headcount reductions from the second half of 2023[11](index=11&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) The condensed consolidated financial statements show a full-year 2024 net loss of **$25.1 million**, with total assets at **$80.8 million** and shareholders' equity at **$27.7 million** as of December 31, 2024 Condensed Consolidated Statements of Operations and Comprehensive Loss This statement details revenues, costs, and expenses, showing a decreased net loss for both Q4 and full-year 2024, with the annual net loss at **$25.1 million** compared to **$41.9 million** in 2023 | (in thousands, except per share data) | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | **Total revenue** | $11,982 | $6,769 | | **Total cost and expenses** | ($41,675) | ($50,163) | | **Operating loss** | ($29,693) | ($43,394) | | **Net loss** | ($25,114) | ($41,871) | | **Net loss per share, basic and diluted** | ($0.94) | ($1.57) | Condensed Consolidated Balance Sheets This statement presents the financial position as of December 31, 2024, showing total assets decreased to **$80.8 million**, liabilities increased to **$53.1 million**, and shareholders' equity decreased to **$27.7 million** | (in thousands) | As of Dec 31, 2024 | As of Dec 31, 2023 | | :--- | :--- | :--- | | **Cash, cash equivalents, and short-term investments** | $76,576 | $95,571 | | **Total assets** | $80,831 | $101,673 | | **Total liabilities** | $53,086 | $50,309 | | **Total shareholders' equity** | $27,745 | $51,364 |
LAVA Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Business Update
Newsfilter· 2025-03-28 11:30
Core Insights - LAVA Therapeutics is focusing on maximizing shareholder value in 2025 by evaluating strategic options while continuing patient enrollment in the Phase 1 study of LAVA-1266, a treatment for acute myeloid leukemia and myelodysplastic syndrome [2][3] Corporate Highlights - The Phase 1 trial of LAVA-1266 is designed to target CD123+ tumor cells for hematological malignancies, evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity [3] - LAVA has partnered with Johnson & Johnson and Pfizer for additional programs, with ongoing Phase 1 trials targeting CD33 and EGFR respectively [4][5] - A restructuring plan was adopted to extend capital resources, resulting in a 30% reduction in workforce to support strategic evaluations and the LAVA-1266 study [4][10] Financial Results - As of December 31, 2024, LAVA reported a cash balance of $76.6 million, expected to fund operations into 2027 [4][10] - Revenue from contracts with customers increased to $5.0 million for Q4 2024, up from $0.4 million in Q4 2023, and $12.0 million for the year ended 2024, compared to $6.8 million in 2023 [10][11] - The net loss for Q4 2024 was $3.8 million, compared to a net loss of $6.4 million in Q4 2023, with a total net loss of $25.1 million for the year 2024, down from $41.9 million in 2023 [10][11] Pipeline Overview - LAVA's pipeline includes three clinical-stage bispecific gamma-delta T cell engagers: LAVA-1266 for CD123+ cancers, PF-08046052 for EGFR, and JNJ-89853413 for hematological cancers [15] - The ongoing studies involve dose escalation and expansion segments to evaluate safety and preliminary anti-tumor activity across various cancer types [5][15]
LAVA Reports Fourth Quarter and Full Year 2024 Financial Results and Provides a Business Update
Globenewswire· 2025-03-28 11:30
Core Insights - LAVA Therapeutics is focused on maximizing shareholder value in 2025 by evaluating strategic options while continuing patient enrollment in the Phase 1 study of LAVA-1266, a treatment for acute myeloid leukemia and myelodysplastic syndrome [2][5] - The company reported a cash balance of $76.6 million as of December 31, 2024, which is expected to fund operations into 2027 [5][9] Clinical Development Highlights - LAVA-1266 is currently in a Phase 1 trial targeting CD123+ tumor cells for hematological malignancies, evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity [3][6] - The partnered program with Johnson & Johnson (JNJ-89853413) is also in a Phase 1 trial, targeting CD33 and gamma delta T cells, with a development milestone of $5 million received in Q4 2024 [4][5] - Pfizer's partnered program (PF08046052) is in a Phase 1 trial for solid tumors, with a clinical development milestone of $7 million received in Q1 2024 [5][9] Financial Performance - Revenue from contracts with customers increased to $5.0 million in Q4 2024 from $0.4 million in Q4 2023, and for the full year, revenue rose to $12.0 million from $6.8 million [9][10] - Research and development expenses for Q4 2024 were $8.6 million, up from $2.3 million in Q4 2023, primarily due to costs associated with the discontinuation of LAVA-1207 [9][10] - The net loss for Q4 2024 was $3.8 million, compared to a net loss of $6.4 million in Q4 2023, with a full-year net loss of $25.1 million compared to $41.9 million in 2023 [9][10] Workforce and Restructuring - The company adopted a restructuring plan in February 2025, resulting in a 30% reduction in workforce to extend capital resources and focus on strategic options and the Phase 1 study for LAVA-1266 [5][9]
LAVA Announces Evaluation of Strategic Options
Globenewswire· 2025-02-25 12:00
Core Viewpoint - LAVA Therapeutics N.V. is initiating a strategic review process aimed at maximizing shareholder value, which includes cost-cutting measures and workforce reduction [2][4][5] Financial Position - As of December 31, 2024, the company's cash balance, cash equivalents, and investments totaled $76.6 million [6] Strategic Options - The company is exploring various strategic options such as in-licensing assets, sales, licensing agreements, mergers, acquisitions, or other strategic transactions [4] - There is no set timetable for the strategic review process, and updates will only be provided once specific actions are approved by the Board [4] Workforce Reduction - LAVA is implementing a restructuring plan that includes a workforce reduction of approximately 30% to enhance cost containment and conserve cash [5] - The company anticipates incurring approximately $0.5 million in one-time costs related to this workforce reduction, primarily in Q1 2025 [5] Clinical Development - LAVA will continue its Phase 1 clinical study of LAVA-1266 for hematologic malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) [2][3] - The company is also committed to supporting its partnerships with Pfizer and Johnson & Johnson [2] Leadership Statement - The CEO of LAVA expressed the company's commitment to exploring strategic opportunities to enhance shareholder value, given the current focus on a single product in clinical development and an early-stage pipeline [3]
LAVA Doses First Patient in Phase 1 LAVA-1266 Study in Hematological Cancers
Globenewswire· 2025-01-10 13:23
Core Insights - LAVA Therapeutics N.V. has initiated dosing of the first patient in a Phase 1, first-in-human study of LAVA-1266, a CD123-targeted Gammabody for treating hematologic cancers such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) [1][4] - The company is optimistic about LAVA-1266's preclinical safety and efficacy profile, which demonstrated tumor cell lysis with limited off-target effects [1][3] - Initial results from the dose escalation study are expected by the end of 2025 [7] Company Overview - LAVA Therapeutics is a clinical-stage immuno-oncology company focused on developing bispecific gamma-delta T cell engagers using its proprietary Gammabody platform [6] - The company aims to selectively kill cancer cells by activating Vγ9Vδ2 T cell anti-tumor functions [6] Product Details - LAVA-1266 is designed to target CD123+ tumor cells and engage Vγ9Vδ2-T cells, showing high potency and a wide therapeutic window [2] - Preclinical studies confirmed that LAVA-1266 preferentially targets and kills CD123+ cells while inducing Vγ9Vδ2-T cell activation, leading to significant tumor cell lysis and increased survival in AML models [3] Clinical Study Information - The Phase 1 study is open-label and multi-center, enrolling approximately 50 adults with CD123+ relapsed/refractory AML and certain grades of MDS [4][5] - Patients will receive doses every two weeks, starting with an initial target dose of 100 µg for the first cohort [4] Pipeline Overview - LAVA's pipeline includes three clinical-stage bispecific gamma-delta T cell engagers targeting various cancers, including LAVA-1266 for CD123+ cancers, PF-08046052 for EGFR, and JNJ-89853413 for hematological cancers [8]
LAVA Therapeutics(LVTX) - 2024 Q3 - Quarterly Report
2024-12-10 21:05
[Unaudited Condensed Consolidated Interim Financial Statements](index=1&type=section&id=Unaudited%20Condensed%20Consolidated%20Interim%20Financial%20Statements) [Condensed Consolidated Interim Statements of Loss and Comprehensive Loss](index=2&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Loss%20and%20Comprehensive%20Loss) LAVA Therapeutics significantly narrowed its net loss for the nine months ended September 30, 2024, driven by reduced operating expenses despite stable revenue Statement of Loss Summary (Nine Months Ended September 30) | Financial Metric (in thousands) | 2024 | 2023 | Change (YoY) | | :------------------------------ | :--------- | :--------- | :------------------------------------------------------------------------------------------------------- | | Revenue | $6,992 | $6,416 | Increased, primarily from a $7.0M milestone payment from Pfizer | | Gross Profit | $6,992 | $3,088 | Increased significantly due to revenue mix and lower cost of sales | | Research and Development | ($20,844) | ($30,454) | Decreased, reflecting lower clinical trial and personnel-related expenses | | General and Administrative | ($8,745) | ($10,445) | Decreased, due to lower professional fees and share-based compensation | | Operating Loss | ($22,597) | ($37,811) | Narrowed due to reduced operating expenses | | Loss for the period | ($21,144) | ($35,476) | Narrowed significantly | | Loss per share (basic & diluted) | ($0.79) | ($1.35) | Improved due to lower net loss | [Condensed Consolidated Interim Statements of Financial Position](index=3&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Financial%20Position) Total assets and equity decreased as of September 30, 2024, primarily due to a reduction in cash and accumulated net losses from operations Financial Position Summary (in thousands) | Account | Sep 30, 2024 | Dec 31, 2023 | | :---------------------------- | :----------- | :----------- | | **Assets** | | | | Cash and cash equivalents | $26,963 | $44,231 | | Investments | $51,921 | $51,340 | | Total Current Assets | $81,538 | $98,897 | | **Total Assets** | **$83,357** | **$101,710** | | **Liabilities & Equity** | | | | Deferred revenue (Non-current) | $35,000 | $35,000 | | Total Liabilities | $50,364 | $50,532 | | Total Equity | $32,993 | $51,178 | | **Total Equity & Liabilities**| **$83,357** | **$101,710** | [Condensed Consolidated Interim Statements of Changes in Equity](index=4&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Changes%20in%20Equity) Total equity decreased significantly from January 1 to September 30, 2024, primarily due to the net loss for the period Changes in Equity for the Nine Months Ended September 30, 2024 (in thousands) | Description | Amount | | :--------------------------------- | :--------- | | Balance at January 1, 2024 | $51,178 | | Loss for the period | ($21,144) | | Share-based compensation expense | $2,636 | | Other adjustments (options, FX) | $323 | | **Balance at September 30, 2024** | **$32,993**| [Condensed Consolidated Interim Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly improved for the nine months ended September 30, 2024, with cash and equivalents decreasing overall Cash Flow Summary (Nine Months Ended September 30, in thousands) | Cash Flow Activity | 2024 | 2023 | | :------------------------ | :---------- | :---------- | | Net cash used in operating| ($18,139) | ($28,507) | | Net cash from (used in) investing | $1,504 | ($8,948) | | Net cash used in financing| ($363) | ($736) | | **Net decrease in cash** | **($16,998)** | **($38,191)** | | **Cash at end of period** | **$26,963** | **$62,663** | [Notes to the Condensed Consolidated Interim Financial Statements](index=7&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Interim%20Financial%20Statements) These notes provide critical details on the company's accounting policies, financial position, and significant events, including its going concern status and post-period developments [Note 1—General Information](index=7&type=section&id=Note%201%E2%80%94General%20Information) LAVA Therapeutics is a clinical-stage immuno-oncology company transitioning to a U.S. domestic filer in 2025 - The company is a clinical-stage immuno-oncology firm focused on its **Gammabody® platform** to develop **bispecific gamma-delta T cell engagers** for cancer treatment[65](index=65&type=chunk) - Effective **January 1, 2025**, the company will transition to a **U.S. domestic filer** and will prepare its financial statements in accordance with **U.S. GAAP**, filing future annual reports on **Form 10-K**[20](index=20&type=chunk) [Note 2—Summary of Significant Accounting Policies](index=7&type=section&id=Note%202%E2%80%94Summary%20of%20Significant%20Accounting%20Policies) The company's interim financial statements are prepared under IAS 34, with an immaterial revision made to cash flow presentation - The company identified and revised an **immaterial misstatement** in the presentation of its condensed consolidated interim statements of **cash flows** related to **accrued interest** on the RVO debt agreement[10](index=10&type=chunk)[24](index=24&type=chunk) - The correction **reclassified accrued interest** from a cash inflow from financing activities to a **non-cash adjustment** in operating activities, and the company concluded the revision was **not material** to any prior period[41](index=41&type=chunk)[42](index=42&type=chunk) [Note 3—Material Accounting Judgments, Estimates and Assumptions](index=11&type=section&id=Note%203%E2%80%94Material%20Accounting%20Judgments%2C%20Estimates%20and%20Assumptions) The company maintains sufficient liquidity for at least 12 months, with critical accounting judgments impacting revenue and expense recognition - The company expects its cash, cash equivalents, and investments of **$78.9 million** as of September 30, 2024, will be **sufficient to fund operations for at least the next 12 months**, supporting the **going-concern basis** of the financial statements[44](index=44&type=chunk) - **Critical judgments** in applying accounting policies significantly affect amounts recognized for **revenue recognition**, **share-based payments**, **clinical trial expense accruals**, and **lease accounting**[82](index=82&type=chunk) [Note 4—Equity](index=14&type=section&id=Note%204%E2%80%94Equity) As of September 30, 2024, the company's share capital consisted of 26,298,665 issued and outstanding common shares, each with a nominal value of $0.14 - As of September 30, 2024, LAVA Therapeutics N.V. had **26,298,665 common shares** issued and outstanding[84](index=84&type=chunk) [Note 5—Revenue and cost of sales](index=14&type=section&id=Note%205%E2%80%94Revenue%20and%20cost%20of%20sales) Revenue is primarily derived from collaboration agreements, with a significant milestone payment recognized from Pfizer in March 2024 - In March 2024, Pfizer achieved a clinical development milestone for EGFRd2 (PF-08046052), triggering a **$7.0 million milestone payment** to the company, which was recognized as revenue[57](index=57&type=chunk) Revenue from Contracts with Customers (Nine Months Ended Sep 30, in thousands) | Source | 2024 | 2023 | | :----------------------------------- | :------ | :------ | | Pfizer Inc. - Milestones | $6,960 | $0 | | Pfizer Inc. - Other activities | $24 | $3,422 | | Pfizer Inc. - Additional services | $8 | $504 | | Johnson & Johnson Agreement - Milestones | $0 | $2,490 | | **Total Revenue** | **$6,992** | **$6,416** | [Note 6—Research and Development Expenses](index=16&type=section&id=Note%206%E2%80%94Research%20and%20Development%20Expenses) Research and development expenses decreased significantly for the nine months ended September 30, 2024, driven by lower pre-clinical and clinical trial costs R&D Expense Breakdown (Nine Months Ended Sep 30, in thousands) | Expense Category | 2024 | 2023 | | :----------------------------------- | :---------- | :---------- | | Pre-clinical and clinical trial | $12,836 | $20,542 | | Personnel-related | $3,830 | $5,346 | | Facilities and other | $2,024 | $1,297 | | Share-based compensation | $962 | $1,427 | | Other | $1,192 | $1,842 | | **Total R&D Expenses** | **$20,844** | **$30,454** | [Note 7—General and Administrative Expenses](index=17&type=section&id=Note%207%E2%80%94General%20and%20Administrative%20Expenses) General and administrative expenses decreased for the nine months ended September 30, 2024, primarily due to reduced professional fees and share-based compensation G&A Expense Breakdown (Nine Months Ended Sep 30, in thousands) | Expense Category | 2024 | 2023 | | :----------------------------------- | :--------- | :---------- | | Personnel-related | $2,937 | $2,932 | | Professional and consultant fees | $2,356 | $2,667 | | Insurance, facilities, and other | $1,778 | $2,159 | | Share-based compensation | $1,674 | $2,687 | | **Total G&A Expenses** | **$8,745** | **$10,445** | [Note 8—Share-based Awards](index=17&type=section&id=Note%208%E2%80%94Share-based%20Awards) The company recognized $2.6 million in share-based compensation expense, with a significant number of stock options outstanding and remaining unrecognized compensation - As of September 30, 2024, there were **6,584,726 stock options outstanding**, with **3,592,462 vested and exercisable**[92](index=92&type=chunk) - The unrecognized remaining stock-based compensation balance was approximately **$2.4 million** as of September 30, 2024, which is expected to be recognized over a weighted-average period of **0.79 years**[95](index=95&type=chunk) [Note 9—Investments](index=19&type=section&id=Note%209%E2%80%94Investments) The company's investments consist of U.S. Treasury securities with maturities of three to six months, classified as held-to-maturity and recorded at amortized cost - Investments consist of U.S. Treasury securities classified as held-to-maturity, with a carrying value of **$51.9 million** at September 30, 2024[96](index=96&type=chunk) [Note 10–Subsequent Events](index=19&type=section&id=Note%2010%E2%80%93Subsequent%20Events) Significant subsequent events include a $5.0 million milestone payment from J&J, a debt settlement with RVO, and the discontinuation of the LAVA-1207 clinical trial - In October 2024, a **$5.0 million** milestone payment from J&J was triggered following a Phase 1 clinical trial filing with health authorities[116](index=116&type=chunk) - In December 2024, the company discontinued the **LAVA-1207 clinical trial** after determining that signs of activity did not meet internal benchmarks[98](index=98&type=chunk) - In October 2024, the RVO required a payment of **$0.6 million**, with the remaining **$5.2 million** balance being conditionally waived for one year[97](index=97&type=chunk)
All You Need to Know About LAVA Therapeutics (LVTX) Rating Upgrade to Strong Buy
ZACKS· 2024-07-22 17:00
The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system. Therefore, the Zacks rating upgrade for LAVA Therapeutics basically reflects positivity about its earnings outlook that could translate into buying pressure and an increase in its stock price. The change in a company's future earnings potential, as refle ...
LAVA Therapeutics to Participate in the H.C. Wainwright 2nd Annual Immune Cell Engager Virtual Conference
GlobeNewswire News Room· 2024-06-20 11:30
UTRECHT, The Netherlands and PHILADELPHIA, June 20, 2024 (GLOBE NEWSWIRE) -- LAVA Therapeutics N.V. (NASDAQ: LVTX, "LAVA"), a clinical-stage immuno-oncology company focused on developing its proprietary Gammabody® platform of bispecific gamma delta T cell engagers, today announced that Stephen Hurly, President and Chief Executive Officer of LAVA Therapeutics, will present at the H.C. Wainwright 2nd Annual Immune Cell Engager Virtual Conference. LAVA Therapeutics N.V. is a clinical-stage immuno-oncology comp ...