CureVac(CVAC)
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CureVac(CVAC) - 2021 Q4 - Annual Report
2022-04-27 16:00
Exhibit 99.1 CureVac Announces Financial Results for the Fourth Quarter and Full-Year 2021 and Provides Business Update · Executing on broad vaccine development program, with new clinical studies in COVID-19 and influenza together with GSK to validate advanced second-generation mRNA backbone o Initiated Phase 1 dose-escalation study in COVID-19 with CV2CoV, validating mRNA backbone for further variant adaptation o Fully recruited Phase 1 dose-escalation study in influenza with differentiated multivalent vac ...
CureVac(CVAC) - 2021 Q4 - Annual Report
2022-04-27 16:00
Vaccine Development - The company has advanced its second-generation COVID-19 vaccine candidate, CV2CoV, to a Phase 1 clinical trial as of March 30, 2022, with plans for a pivotal study potentially starting in Q4 2022[501]. - The Phase 1 study of CV7202, a prophylactic vaccine candidate against rabies, demonstrated protective antibody titers above the WHO threshold after two doses of 1μg of mRNA[499]. - The company is developing a differentiated multivalent influenza vaccine candidate, CVSQIV, with a Phase 1 dose-escalation study initiated in February 2022 involving up to 240 healthy adult participants[512]. - The second-generation mRNA vaccine program CV2CoV for SARS-CoV-2 is currently in Phase 1 clinical study, showing improved immune responses compared to the first-generation candidate[629]. - The CVSQIV influenza vaccine candidate is also in Phase 1 clinical study, featuring multiple non-chemically modified mRNA constructs targeting four different influenza strains[630]. - The rabies vaccine candidate CV7202 has induced adaptive immune responses above WHO protective thresholds at low dose levels in Phase 1 clinical trials[631]. - The company is developing prophylactic vaccines for infectious diseases with high mortality rates in developing countries, in partnership with the Bill & Melinda Gates Foundation[633]. mRNA Technology and Manufacturing - The company has manufactured thousands of mRNA constructs and obtained manufacturing authorization for over 80 products since 2000, with plans to build a fourth GMP large-scale production facility capable of supplying hundreds of millions of doses[505]. - The company has invested in building in-house manufacturing infrastructure to produce mRNA-based medicines efficiently and cost-effectively at commercial scale[505]. - The company has developed a versatile mRNA technology platform, RNAoptimizer, which focuses on protein design, mRNA optimization, and delivery to improve safety, stability, and expression[536][537]. - The company’s mRNA production process is independent of the encoded protein, allowing for higher efficiency, greater speed, and lower costs in developing mRNA-based therapies[531]. - The company has identified over one million 5' and 3' UTRs to improve translation and stability of therapeutic mRNAs[579]. - The cap structure of mRNA is optimized to improve translation efficiency and reduce immunogenicity, enhancing overall therapeutic efficacy[577]. - The company’s mRNA constructs are designed to evade innate immune recognition, allowing sustained protein translation[575]. Clinical Trials and Efficacy - The company has a long track record of clinical trials since 2008, which has accelerated development in new therapeutic areas and approaches[538]. - The lead oncology product candidate CV8102 is currently in a Phase 1 clinical trial for treating solid tumors, activating multiple immune pathways[636]. - CV8102, the company's lead candidate, is in a Phase 1 clinical trial for treating four types of solid tumors, with 58 patients enrolled as of June 21, 2021[652][653]. - Preliminary results from the Phase 1 trial show 1 complete response and 2 partial responses in the single-agent cohort, and 2 partial responses in the combination cohort[654][655]. - The company aims to confirm the safety and efficacy of CV8102 at a 600 µg dose in the ongoing Phase 1 trial expansion, which has enrolled 30 patients with PD-1 refractory melanoma[656][657]. - The mechanism of action for CV8102 involves activating immune responses by mimicking viral infections, potentially leading to tumor-specific T cell activation[658][659]. - The Phase 1 clinical trial is designed to evaluate the maximum tolerated dose and safety of CV8102, with secondary endpoints focused on anti-tumor activity[667]. Delivery Systems and Optimization - The company utilizes a combination of delivery systems tailored to specific diseases, considering factors like immunogenicity and targeted tissue type[595]. - The company has extensively tested over 40 different delivery solutions and selected the most efficient lipid nanoparticle (LNP) technologies for licensure[602]. - The proprietary CVCM delivery technology offers advantages such as stability, low excipient to cargo ratio, and immunosilence, making it suitable for sensitive tissues like the eye and lung[606][610]. - The CVCM formulation allows for high levels of protein expression following intrapulmonary administration, indicating its effectiveness for lung delivery[614]. - The company is exploring multiple delivery systems for mRNA, including the CVCM delivery system for lung and eye diseases[648][649]. Strategic Partnerships and Intellectual Property - The company has entered into strategic partnerships with leading biopharmaceutical companies, including GSK, to expand the applications of its technology platform[506]. - The company aims to selectively seek strategic partnerships to expedite the discovery and development of product candidates, aiming to mitigate drug development risk while retaining economic rights to strategically important candidates[516]. - The company is exploring strategic acquisitions or in-licenses of complementary technology or assets to enhance its mRNA technology platform, which has been optimized over 21 years[517]. - The company intends to strengthen its intellectual property portfolio to protect advancements in its technology platform, manufacturing processes, and product candidates[518]. - As of March 23, 2022, the company owns approximately 1,056 issued patents worldwide, including 85 issued U.S. patents and 62 issued European patents[507]. Safety and Adverse Events - 100% of patients experienced at least one adverse event, with 38% experiencing grade 3 adverse events[694]. - The most common adverse events included fatigue (34%), injection site pain (21%), and influenza-like illness (16%) among all patients[694]. - CV8102 is administered weekly for the first five cycles, totaling eight injections or until disease progression[689]. - The study continues with dose escalation for both single-agent CV8102 and the combination with anti-PD-1 therapy[690].
CureVac(CVAC) - 2021 Q3 - Earnings Call Transcript
2021-11-19 23:05
CureVac N.V. (NASDAQ:CVAC) Q3 2021 Earnings Conference Call November 19, 2021 8:00 AM ET Company Participants Sarah Fakih – Vice President-Corporate Communications and Investor Relations Franz-Werner Haas – Chief Executive Officer Klaus Edvardsen – Chief Development Officer Pierre Kemula – Chief Financial Officer Mariola Fotin-Mleczek – Chief Technology Officer Conference Call Participants Manos Mastorakis – Deutsche Bank Evan Wang – Guggenheim Securities Jonathan Miller – Evercore ISI Zhiqiang Shu – Berenb ...
CureVac(CVAC) - 2021 Q2 - Quarterly Report
2021-06-29 16:00
Exhibit 99.1 CureVac Final Data from Phase 2b/3 Trial of First-Generation COVID-19 Vaccine Candidate, CVnCoV, Demonstrates Protection in Age Group of 18 to 60 · Unique pivotal study conducted in 10 countries in fast changing variant environment; 15 COVID-19 variant strains present for ef icacy analysis; original strain almost completely absent · Statistical success criteria for primary endpoint met on basis of 228 adjudicated cases · Vaccine ef icacy of 48% against COVID-19 of any severity across all age gr ...
CureVac(CVAC) - 2020 Q4 - Annual Report
2021-04-26 16:00
Financial Performance - Revenue for the year ended December 31, 2020, was €48.87 million, a significant increase from €17.42 million in 2019, representing a growth of approximately 180%[33] - The net loss for the year ended December 31, 2020, was €129.12 million, up from a net loss of €99.87 million in 2019, indicating a worsening of approximately 29%[46] - The operating loss for the year ended December 31, 2020, was €109.82 million, compared to €99.50 million in 2019, indicating a decline in operational performance[33] - The accumulated deficit as of December 31, 2020, reached €645.1 million, highlighting the ongoing financial challenges faced by the company[46] - The company expects to continue incurring losses in the foreseeable future as it invests in research and development and seeks regulatory approvals for its product candidates[45] Research and Development - Research and development expenses surged to €113.81 million in 2020, compared to €43.24 million in 2019, reflecting an increase of about 163%[33] - The company anticipates substantial future expenditures related to the development and commercialization of its proprietary product candidates[41] - The company intends to focus on developing product candidates with the highest likelihood of success, potentially foregoing other opportunities[52] - The company has completed recruitment and dosing for its Phase 1 clinical trial of the COVID-19 product candidate, CVnCoV, and is currently monitoring patients with ongoing Phase 2a and Phase 2b/3 trials[62] - An interim data readout for the CV7202 (Rabies vaccine) product candidate has been completed, with ongoing Phase 1 clinical trials for CV8102 (cMEL, ACC, SCC, and HNSCC) and Phase 1/2 trials for BI 1361849 (formerly CV9202) targeting Non-Small-Cell Lung Cancer (NSCLC)[62] Clinical Trials and Regulatory Risks - The company has not yet completed any late-stage clinical studies, making it difficult to predict the time and cost of product candidate development[63] - The company faces risks related to clinical trial delays, including regulatory refusals, patient enrollment issues, and compliance with good clinical practice standards[68] - The company acknowledges that clinical trial results may not be predictive of future outcomes, and significant variability in results can occur due to numerous factors[70] - The company may need to conduct additional clinical trials or testing if initial results are unfavorable, which could delay marketing approval or lead to narrower indications[71] - The company emphasizes that top-line data from clinical trials should be viewed with caution as they are subject to change upon further analysis[72] COVID-19 Impact - The ongoing COVID-19 pandemic has caused disruptions that could materially affect the company's business plan and clinical trials[76] - Clinical trial sites in countries like France, Italy, and Spain were inaccessible from February to May 2020, impacting patient enrollment[78] - The company is prioritizing the development of a COVID-19 vaccine, which may delay other product candidates and increase costs[78] - There is a risk that participants in clinical trials may acquire COVID-19, potentially impacting trial results and increasing adverse events[79] - Disruptions in the supply chain due to COVID-19 could impair the company's ability to meet clinical supply demands[80] Financing and Capital Requirements - The company requires substantial financing, which may not be available on acceptable terms, potentially leading to dilution of shareholder interests[50] - In June 2020, the company signed a financing arrangement with the European Investment Bank for a line of credit of up to €75 million, subject to restrictive covenants[50] - The company expects expenses to continue to increase in connection with planned operations, which may impact its ability to conduct business[50] Strategic Partnerships and Collaborations - The company has established strategic partnerships with entities such as Genmab, Boehringer Ingelheim, and GSK to develop and commercialize its product candidates[55] - Collaborators may not perform their obligations as expected, which could negatively impact the company's business and product development timelines[60] - Existing collaboration agreements impose various obligations that could restrict the company's ability to license its intellectual property[59] Intellectual Property Risks - The company relies on various collaboration agreements that impose obligations and restrictions, which could affect its ability to develop and commercialize products[147] - The existence of issued patents does not guarantee the right to commercialize patented products, as third parties may have competing rights[142] - The company may face substantial costs and risks associated with enforcing its patent rights, which could divert attention from other business aspects[142] - The company may need to defend against infringement claims, which could divert resources and management attention[153] Market and Competitive Risks - Competition in the market is substantial, which may result in others developing or commercializing products before the company[217] - The biotechnology and pharmaceutical industries face intense competition from various sources, including large pharmaceutical companies and academic institutions, which may impact the company's market position[218] - Competitors may have greater financial and technical resources, potentially leading to faster regulatory approvals and stronger market positions for their products[220] Regulatory Environment - The regulatory approval process for the company's mRNA-based product candidates is lengthy and unpredictable, with no prior submissions for biologics license applications (BLAs) made to the FDA[85][96] - The company plans to seek regulatory approval for its product candidates in the United States and the European Union, but must comply with varying regulatory requirements in different jurisdictions[85] - The FDA and EMA have substantial discretion in the approval process, and even promising clinical trial data may not guarantee approval[99] Operational Challenges - The company faces risks related to stringent privacy laws and data protection regulations, which could adversely affect its business and financial condition[212] - Compliance with evolving data privacy laws, such as the California Consumer Privacy Act (CCPA) and the General Data Protection Regulation (GDPR), may increase operational costs and risks of noncompliance[214][216] - The company may face challenges in managing growth effectively, which could lead to operational mistakes and reduced productivity[211]