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CureVac (CVAC) Earnings Call Presentation
2025-07-01 11:59
Financial Status and Strategy - CureVac has a strong financial position with €550.9 million in cash as of September 30, 2024, and an expected cash runway into 2028[82, 87] - The company streamlined costs and enhanced financial discipline, including a 30% workforce reduction expected by the end of 2024[8, 85, 88] - CureVac refocused its portfolio on innovation and R&D, concentrating on high-value programs in infectious diseases and oncology[8, 9] - A strategic transformation is on track, with OPEX expected to decrease by over 30% from 2025 onwards, including a €25 million decrease in personnel costs[85] Pipeline and Development - CureVac is advancing key pipeline milestones for novel medicines targeting unmet needs, with a focus on expanding the pipeline in oncology and infectious diseases[10, 14] - In oncology, a new shared-antigen lung cancer program is set to start clinical trials in H2 2025, and personalized cancer vaccines are progressing with the first candidate expected to enter the clinic in H2 2026[14] - For infectious diseases, a new non-respiratory program was initiated for Uropathogenic E coli (UPEC) in urinary tract infections, with promising preclinical data[14] - Respiratory infectious disease programs, including seasonal influenza, avian influenza, and COVID-19, are fully out-licensed to GSK, with Phase 3 starting for seasonal flu in 2025[13, 37, 86] Technology and Manufacturing - CureVac's mRNA platform is versatile, featuring precision mRNA backbone, improved LNP delivery systems, and a strong intellectual property portfolio[12, 13] - The company utilizes advanced delivery systems, including proprietary therapeutic area-specific next-generation lipid nanoparticles, and scalable manufacturing, including The RNA Printer®[12] - CureVac's Infectious Disease LNP offers thermostability for more than 12 months at refrigerator temperature (2-8°C)[60]
CureVac Soars 41% in a Month on a $1.25B Buyout Offer From BioNTech
ZACKS· 2025-06-20 16:56
Core Insights - CureVac N.V. (CVAC) shares have increased by 40.8% in one month following a definitive acquisition agreement by BioNTech SE (BNTX) valued at approximately $1.25 billion [1][5] - Each CVAC share will be exchanged for about $5.46 worth of BNTX American Depositary Shares (ADS), representing a 55% premium over CVAC's three-month volume-weighted average price of $3.53 [2][5] - The transaction is expected to close in 2025, pending customary closing conditions and regulatory approvals [2] Company Benefits - The acquisition will enhance BioNTech's capabilities in mRNA-based cancer immunotherapies by expanding its research, development, manufacturing, and commercialization infrastructure [6] - This deal allows BioNTech to broaden its oncology pipeline and focus on newer programs across various tumor types, including mRNA-based cancer candidates and BNT327, a bispecific antibody [7] - BioNTech's existing strengths in mRNA design and delivery technologies will be complemented by CureVac's assets, further solidifying its position in the market [6] Strategic Collaborations - Earlier in June, BioNTech entered a strategic collaboration with Bristol Myers (BMY) for the co-development and co-commercialization of BNTX's BNT327, with an upfront payment of $1.5 billion and potential additional payments totaling $2 billion through 2028 [8] - BNT327 is currently in late-stage clinical studies for lung cancer and is set to enter a phase III study for triple-negative breast cancer by the end of 2025 [8]
市场监管总局:3605批次冷冻饮品抽检合格率超99.5%|首席资讯日报
首席商业评论· 2025-06-14 04:26
Group 1: Sports and Events - Sichuan's "Bashu Xiongjing Cup" will draw on the successful development experience of the "Supert League" to enhance the event system and promote fair competition [1] - The competition is scheduled to take place from June 21 to July 6, 2025, with the finals set for September 5 to September 27, featuring both men's and women's teams in an eleven-a-side format [1] Group 2: Automotive Industry - Xiaopeng Motors aims to be among the first companies to introduce advanced intelligent driving assistance in Hong Kong, with plans for vehicle readiness and software development within two months [3] - The company is looking to leverage Hong Kong as a launchpad for global expansion in the smart driving sector [3] Group 3: Financial Technology - Ant Group's Ant Digital has initiated the application for a stablecoin license in Hong Kong, having already engaged in multiple rounds of discussions with regulators [4] - The establishment of "Ant Xinneng" in collaboration with GCL-Poly is part of Ant's strategy to anchor its global financial presence [4] Group 4: Technology and AI - Scale AI has received a significant new investment from Meta, with CEO Wang Tao stepping down to join Meta while remaining on Scale AI's board [5] - The company is actively seeking a new CTO to strengthen its engineering team [5] Group 5: Market Regulation - The State Administration for Market Regulation reported that over 99.5% of 3,605 batches of frozen beverages passed inspection, indicating a stable improvement in food safety [6] Group 6: Robotics and Elderly Care - The Ministry of Industry and Information Technology and the Ministry of Civil Affairs are launching pilot projects for smart elderly care robots in various settings, with preparations already underway in Hunan [7] Group 7: Corporate Earnings - Adobe reported Q2 revenue of $5.87 billion, exceeding analyst expectations of $5.8 billion, with projected digital media revenue for Q3 between $4.37 billion and $4.4 billion [8] Group 8: Mergers and Acquisitions - BioNTech has signed an agreement to acquire CureVac for $1.25 billion, aimed at enhancing its mRNA cancer immunotherapy research and commercialization efforts [9] Group 9: Stock Market Regulation - The Hong Kong Securities and Futures Commission is considering optimizing the Stock Connect program and adjusting the minimum trading lot size to enhance market liquidity [11][12] Group 10: Real Estate Initiatives - The Guangxi government aims to acquire 25,000 units of existing commercial housing by 2025 as part of its consumption promotion strategy [13]
SHAREHOLDER INVESTIGATION: Halper Sadeh LLC Investigates CVAC, KNW, SOAR, HLGN on Behalf of Shareholders
GlobeNewswire News Room· 2025-06-13 17:19
Group 1: Company Transactions - CureVac N.V. is proposed to be sold to BioNTech SE, with each CureVac share exchanged for approximately $5.46 in BioNTech ADSs, resulting in CureVac shareholders owning between 4% and 6% of BioNTech post-transaction [1] - Know Labs, Inc. is set to be sold to Goldeneye 1995 LLC, with details on shareholder rights available [2] - Volato Group, Inc. will merge with M2i Global, Inc., with current Volato shareholders expected to own approximately 10% of the combined entity after the merger [2] - Heliogen, Inc. is proposed to be sold to Zeo Energy Corp., with Heliogen's securityholders receiving shares valued at approximately $10 million based on a price of $1.5859 per share, subject to adjustments [3] Group 2: Legal Rights and Options - Halper Sadeh LLC is investigating potential violations of federal securities laws and breaches of fiduciary duties related to the aforementioned transactions, and may seek increased consideration for shareholders [4] - Shareholders are encouraged to contact Halper Sadeh LLC to discuss their legal rights and options at no charge [5]
CureVac Stock Soars on BioNTech Buyout
Schaeffers Investment Research· 2025-06-12 15:08
Biotech stock CureVac NV (NASDAQ:CVAC) was last seen up 32.2% at $5.37, after news that BioNTech (BNTX) is acquiring the company in all-stock deal worth $1.25 billion. The merger is still awaiting review from the German Economy Ministry.Today's pop has CVAC trading at 52-week highs, conquering resistance at the $5 level, which kept it in penny stock territory for the last year. Since the start of 2025, the equity is up 63.5%. CureVac stock's typically quiet options pits are booming today. The stock has alre ...
BioNTech Expands mRNA Cancer Portfolio With CureVac $1.25 Billion All-Stock Deal
Benzinga· 2025-06-12 15:07
Core Viewpoint - BioNTech SE has agreed to acquire CureVac N.V. in an all-stock transaction valued at approximately $1.25 billion, aiming to enhance its capabilities in mRNA-based cancer immunotherapy [1][3]. Group 1: Transaction Details - Shareholders of CureVac can exchange their shares for about $5.46 in BioNTech ADSs, with the equity value of the deal being around $1.25 billion [1]. - The transaction includes a collar mechanism affecting the exchange ratio based on the 10-day volume weighted average price (VWAP) of BioNTech ADSs, with specific ratios set for prices above $126.55 and below $84.37 [2]. - Upon closing, CureVac shareholders are expected to own between 4% and 6% of BioNTech [2]. Group 2: Strategic Implications - The acquisition is part of BioNTech's oncology strategy, which includes mRNA-based cancer immunotherapy candidates and a bispecific antibody candidate, BNT327 [4]. - BioNTech plans to integrate CureVac's research and manufacturing site in Tübingen, enhancing its research, development, and manufacturing capabilities [4]. Group 3: Financial Context - BioNTech had €15.9 billion in cash, cash equivalents, and security investments as of March 31 [5]. - The transaction was unanimously approved by both companies' management and supervisory boards and is expected to close in 2025 [5]. Group 4: Related Agreements - BioNTech has a co-development and co-commercialization agreement with Bristol Myers Squibb, which includes an upfront payment of $1.5 billion and potential additional payments totaling up to $7.6 billion [6].
BioNTech以12.5亿美元收购CureVac以增强癌症业务
news flash· 2025-06-12 10:51
Core Insights - BioNTech has acquired CureVac for $1.25 billion to enhance its cancer business [1] Company Summary - The acquisition is aimed at strengthening BioNTech's position in the oncology sector [1] - The deal reflects BioNTech's strategic focus on expanding its cancer treatment portfolio [1] Industry Summary - The acquisition highlights the growing trend of consolidation in the biotechnology industry, particularly in cancer research and treatment [1] - This move may signal increased competition in the oncology market as companies seek to innovate and expand their therapeutic offerings [1]
6月12日电,BioNTech以12.5亿美元收购CureVac以增强癌症业务。
news flash· 2025-06-12 10:49
Group 1 - BioNTech has acquired CureVac for $1.25 billion to enhance its cancer business [1] - The acquisition is part of BioNTech's strategy to expand its portfolio in oncology [1] - This move indicates a growing trend in the biotech industry towards consolidation to strengthen capabilities in cancer treatment [1]
CureVac(CVAC) - 2025 Q1 - Quarterly Report
2025-05-20 20:23
[Unaudited Interim Condensed Consolidated Financial Statements](index=2&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) [Consolidated Statements of Operations and Other Comprehensive Income (Loss)](index=2&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Other%20Comprehensive%20Income%20(Loss)) CureVac significantly reduced its net loss to **€52.1 million** in Q1 2025, primarily due to lower cost of sales despite decreased revenue Q1 2025 vs. Q1 2024 Statement of Operations Highlights | Metric | Three months ended March 31, 2024 (EUR k) | Three months ended March 31, 2025 (EUR k) | Change | | :--- | :--- | :--- | :--- | | **Revenue** | 12,373 | 893 | -92.8% | | **Operating loss** | (73,317) | (54,727) | +25.3% | | **Net loss for the period** | (70,553) | (52,084) | +26.2% | | **Total comprehensive loss** | (70,609) | (52,197) | +26.1% | | **Net loss per share (basic and diluted)** | (€0.31) | (€0.23) | +25.8% | [Consolidated Statements of Financial Position](index=3&type=section&id=Interim%20Condensed%20Consolidated%20Statements%20of%20Financial%20Position) As of March 31, 2025, CureVac's total assets decreased to **€742.3 million**, primarily due to lower cash, while total equity also declined to **€646.7 million** Financial Position as of March 31, 2025 | Metric | December 31, 2024 (EUR k) | March 31, 2025 (EUR k) | Change | | :--- | :--- | :--- | :--- | | **Total Assets** | 802,827 | 742,267 | -7.5% | | Cash and cash equivalents | 481,748 | 438,331 | -9.0% | | **Total Liabilities** | 106,219 | 95,578 | -10.0% | | **Total Equity** | 696,608 | 646,689 | -7.2% | [Consolidated Statements of Changes in Shareholders' Equity](index=4&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders'%20Equity) Total equity decreased by **€50.0 million** in Q1 2025, primarily driven by the net loss for the period, partially offset by share-based payments and tax benefits - The decrease in total equity during Q1 2025 was primarily driven by the net loss of **€52.1 million**[8](index=8&type=chunk) Changes in Equity for Q1 2025 | Description | Amount (EUR k) | | :--- | :--- | | **Balance as of January 1, 2025** | **696,608** | | Net loss | (52,084) | | Other comprehensive loss | (113) | | Share-based payment expense | 1,156 | | Realized tax benefits | 1,122 | | **Balance as of March 31, 2025** | **646,689** | [Consolidated Statements of Cash Flows](index=5&type=section&id=Unaudited%20Interim%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) CureVac significantly reduced its net cash used in operating activities to **€41.4 million** in Q1 2025, leading to a total cash decrease of **€43.4 million** Q1 2025 vs. Q1 2024 Cash Flow Summary | Metric | Three months ended March 31, 2024 (EUR k) | Three months ended March 31, 2025 (EUR k) | | :--- | :--- | :--- | | **Net cash flow used in operating activities** | (96,554) | (41,374) | | Net cash flow used in investing activities | (5,088) | (511) | | Net cash flow used in financing activities | (1,124) | (1,312) | | **Net decrease in cash and cash equivalents** | (102,766) | (43,196) | | **Cash and cash equivalents, end of period** | 300,152 | 438,331 | [Notes to the Consolidated Financial Statements](index=6&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements) [Corporate Information and Basis of Preparation](index=6&type=section&id=1.%20Corporate%20Information%20and%202.%20Basis%20of%20preparation) CureVac, an mRNA biopharmaceutical company, underwent a 2024 restructuring to focus on oncology and infectious diseases, reclassifying manufacturing costs to R&D expenses - In 2024, the company implemented an organizational restructuring, including an approximately **30% headcount reduction**, to focus resources on mRNA opportunities in oncology and infectious diseases[12](index=12&type=chunk) - Following the strategic change, costs related to the manufacturing organization are now recognized as 'Research and Development Expenses' instead of 'Cost of sales'[12](index=12&type=chunk) - The company's largest shareholder and de facto parent is dievini Hopp BioTech holding GmbH & Co. KG, holding approximately **37% of shares and voting rights**[13](index=13&type=chunk) [Notes to the Consolidated Statements of Operations](index=6&type=section&id=3.%20Notes%20to%20the%20Consolidated%20Statements%20of%20Operations) This section details the income statement, highlighting a sharp revenue decline due to the new GSK agreement, a dramatic fall in cost of sales, and increased R&D expenses from reclassification [3.1 Revenue from contract with customers](index=6&type=section&id=3.1%20Revenue%20from%20contract%20with%20customers) Revenue decreased by **92.8%** to **€0.9 million** in Q1 2025, primarily due to the new 2024 GSK Licensing Agreement replacing prior collaboration revenue streams Revenue by Customer | Customer | Q1 2024 (EUR k) | Q1 2025 (EUR k) | | :--- | :--- | :--- | | GSK | 8,895 | 306 | | CRISPR | 3,478 | 586 | | **Total** | **12,373** | **893** | - The new 2024 GSK Licensing Agreement replaced all previous financial considerations from prior collaboration agreements, leading to a significant change in revenue recognition, with only **€306k** recognized under this new agreement in Q1 2025[18](index=18&type=chunk) [3.2 Cost of sales](index=9&type=section&id=3.2%20Cost%20of%20sales) Cost of sales dramatically decreased to **€0.9 million** in Q1 2025, primarily due to the reclassification of manufacturing costs to R&D and a prior-year provision for a CMO dispute - The significant decrease in cost of sales is primarily due to the change in corporate strategy, resulting in the reclassification of manufacturing organization costs to R&D expenses[22](index=22&type=chunk) - Cost of sales in Q1 2024 included a significant increase in a provision related to a dispute with a contract manufacturing organization (CMO)[22](index=22&type=chunk)[31](index=31&type=chunk) [3.3 Research and development expenses](index=9&type=section&id=3.3%20Research%20and%20development%20expenses) R&D expenses increased by **35%** to **€37.6 million** in Q1 2025, mainly due to the reclassification of manufacturing costs and higher IP litigation expenses R&D Expense Breakdown | Category | Q1 2024 (EUR k) | Q1 2025 (EUR k) | | :--- | :--- | :--- | | Personnel | (9,058) | (18,122) | | Patents and fees | (4,459) | (5,767) | | Third-party services | (4,684) | (6,155) | | **Total** | **(27,825)** | **(37,593)** | - The increase in R&D expenses is attributed to the reclassification of manufacturing costs (especially personnel) and higher expenses for IP litigations[23](index=23&type=chunk) [3.4 General and administrative expenses](index=9&type=section&id=3.4%20General%20and%20administrative%20expenses) General and administrative expenses decreased to **€16.4 million** in Q1 2025, primarily due to reduced personnel and third-party service expenses following the 2024 workforce reduction - The decrease in G&A expenses was primarily due to reduced personnel expenses related to the workforce reduction from the 2024 strategic restructuring[24](index=24&type=chunk) [Equity and Share-Based Payments](index=11&type=section&id=4.%20Issued%20Capital%20and%20Reserves%20%26%205.%20Share-based%20payments) As of March 31, 2025, common shares outstanding increased to **225.2 million**, while share-based payment expenses more than doubled to **€1.2 million** in Q1 2025 Change in Common Shares Outstanding | Date | Common Shares Issued and Outstanding | | :--- | :--- | | December 31, 2024 | 224,338,257 | | March 31, 2025 | 225,159,362 | Share-Based Payment Expense | Period | Total Expense (EUR k) | | :--- | :--- | | Q1 2024 | (487) | | Q1 2025 | (1,156) | - In Q1 2025, the Group granted a total of **5,898,413 options** to key employees, the Executive Board, and Supervisory Board members under its LTIP[27](index=27&type=chunk)[28](index=28&type=chunk) [Liabilities, Provisions, and Taxes](index=12&type=section&id=6.%20Other%20liabilities%20and%20provisions%20%26%207.%20Income%20tax) Other liabilities and provisions decreased in Q1 2025 due to restructuring provision utilization, contrasting with a significant prior-year charge from a CMO dispute - The decrease in other liabilities in Q1 2025 was primarily due to the usage of restructuring provisions amounting to **€1,259k** for severance payments[30](index=30&type=chunk) - The comparative period in 2024 was affected by an additional charge of **€17,000k** recorded in cost of sales related to a dispute with a former contract manufacturing organization (CMO), Celonic[31](index=31&type=chunk) - The income tax expense for Q1 2025 was **€429k**, primarily attributable to deferred tax expenses of CureVac N.V[32](index=32&type=chunk) [Earnings Per Share](index=12&type=section&id=8.%20Earnings%20per%20share) Basic and diluted net loss per share improved to **€0.23** in Q1 2025, with potentially dilutive securities excluded due to the company's net loss position Earnings Per Share Comparison | Metric | Q1 2024 | Q1 2025 | | :--- | :--- | :--- | | **Net loss per share (basic and diluted)** | (€0.31) | (€0.23) | | Weighted average shares (basic) | 224,349,604 | 225,150,339 | - For Q1 2025, **7,199,489 share options and RSUs** were excluded from the diluted EPS calculation because their effect would have been antidilutive[36](index=36&type=chunk) [Related Party Disclosures](index=14&type=section&id=9.%20Related%20party%20disclosures) dievini Hopp BioTech holding GmbH & Co. KG, the de facto parent, holds approximately **37%** of CureVac's shares, with related party transactions having no significant financial impact in Q1 2025 - dievini Hopp BioTech holding GmbH & Co. KG is the de facto parent of the Group, holding approximately **37% of shares and voting rights**[37](index=37&type=chunk) - Transactions with dievini and its related entities had no significant impact on the financial statements for the three months ended March 31, 2025[38](index=38&type=chunk)
CureVac(CVAC) - 2024 Q4 - Annual Report
2025-04-10 21:58
mRNA Technology and Development - The company has a broad portfolio of mRNA-based medicines in preclinical and clinical development stages, with a focus on efficacy, safety, and protein expression at relatively low doses[380]. - The company has developed proprietary lipid nanoparticle (LNP) delivery systems that improve mRNA vaccine activity and thermostability, with candidates shown to be stable for over 12 months at room temperature[382]. - The company has made significant advancements in its mRNA technology platform over the past 24 years, focusing on optimizing mRNA for higher efficacy, greater speed, and lower production costs[387]. - The mRNA technology platform allows for rapid development and production of vaccines without the need for live pathogens, enhancing safety and efficiency[460]. - The optimization of the open reading frame (ORF) is crucial for maximizing protein expression, with engineered ORFs showing higher protein levels in mouse liver compared to wild-type[442]. - The mRNA optimization process includes enhancing translation, stability, and immunogenicity, with specific elements like the 5' cap and poly-A tail being critical for mRNA efficacy[429]. - The company employs a combinatorial approach to identify and create optimized UTR combinations for specific constructs, improving therapeutic mRNA performance[434]. - The company is developing proprietary lipid-nanoparticle (LNP) delivery systems tailored for specific therapeutic areas, enhancing the efficacy of mRNA-based treatments[449]. Clinical Trials and Studies - The company announced positive interim data from the COVID-19 Phase 2 clinical study for the monovalent mRNA vaccine candidate, CV0601, and the bivalent mRNA candidate, CV0701, completed in August 2024[381]. - In oncology, the candidate CVGBM, featuring a multi-epitope design, is currently being tested in a Phase 1 study for patients with resected glioblastoma, with preliminary results showing 77% of evaluable patients induced cancer antigen-specific T-cell responses[381]. - The Phase 2 study for a COVID-19 mRNA vaccine candidate was completed in August 2024, showing favorable reactogenicity and meaningful titers of neutralizing antibodies[385]. - The company has initiated a Phase 1 study for CVGBM, targeting newly diagnosed glioblastoma patients, with 16 patients recruited across four dose levels[474]. - Preliminary results show that 77% of evaluable patients developed cancer antigen-specific T-cell responses after treatment with CVGBM[475]. - The treatment was well tolerated, with 91% of treatment-related adverse events being mild to moderate, resolving within 1-2 days post-injection[479]. - The company has initiated a Phase 2 study for a multivalent influenza vaccine candidate, with promising interim data reported on April 4, 2024[461]. - The Phase 1 part of the combined seasonal influenza/COVID-19 vaccine study initiated by GSK in November 2024 aims to assess safety and immunogenicity[505]. Intellectual Property and Licensing - As of February 28, 2025, the company owns approximately 619 issued patents worldwide, including 119 issued U.S. patents and 36 issued European patents, making it one of the leaders in mRNA intellectual property[382]. - The company plans to strengthen and expand its intellectual property portfolio to protect advancements in its technology platform and product candidates[388]. - The company has trademark registrations for CureVac and its logo in the United States and certain foreign jurisdictions[587]. - The company relies on trade secrets and know-how, protected through confidentiality agreements with collaborators and employees[588]. - The company has entered into a new licensing agreement with GSK, known as the 2024 GSK Agreement, which became effective on July 11, 2024, after receiving approval from German Antitrust Authorities[523]. - GSK paid the company an upfront payment of €400 million and the company is eligible to receive up to €1.05 billion in development, regulatory, and sales milestones under the 2024 GSK Agreement[528]. Strategic Partnerships and Collaborations - The company is selectively seeking strategic partnerships to develop and commercialize product candidates, aiming to mitigate drug development risk while retaining economic rights to strategically important candidates[388]. - The collaboration with M.D. Anderson Cancer Center aims to develop differentiated cancer precision immunotherapy candidates for high unmet medical needs[469]. - The company has established a consortium with GSK for pandemic preparedness, which includes a framework agreement to provide production capacities for mRNA vaccines, allowing for 80 million doses per year until 2029[533]. - The company has received $1 million in development cost reimbursements from Genmab, with no additional fees or milestone payments received as of December 31, 2024[535]. Financials and Milestones - The company achieved regulatory milestones with its manufacturing system, obtaining a manufacturing license for an mRNA construct in cancer precision immunotherapy in November 2023 and a drug substance framework manufacturing license in December 2023[388]. - The company has received a total of €15.1 million in payments from CRISPR Therapeutics and has invoiced €1.9 million for various costs as of December 31, 2024[548]. - The Gates Foundation has provided up to $3.0 million in funding for the development of a vaccine for rotaviruses, with the company having received the full amount as of December 31, 2024[551]. - The company received a $40 million equity investment from the Gates Foundation to support the development of its RNA technology platform and the construction of a cGMP production facility[552]. Regulatory and Compliance - The company expects its product candidates to be regulated as biological products under U.S. law, with compliance required throughout the development process[591]. - The submission of an IND application is required before human clinical trials can begin, which becomes effective 30 days after receipt by the FDA unless concerns are raised[593]. - Clinical trials must be conducted under GCP requirements and include detailed study protocols submitted to the FDA as part of the IND[595]. - An IRB must review and approve each clinical trial, considering design, patient consent, and safety factors[597]. - The FDA may impose a clinical hold on trials at any time, delaying the study until concerns are resolved[594].