1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Thesis
3. Valuation & Price Target
4. Business & Product Moat
5. People & Governance
6. Market & Macro
7. Financial Quality
8. Risk Register
9. Prediction Market
10. 𝕏 Posts
Discussion
1. Investment Snapshot
2. Valuation
Discussion
Symbol
CVAC
Event Date
2020-08-14
IPO Date (Actual)
2020-08-12
Sector
Health Care
Subsector
Pharmaceuticals
Offer Range
$16.00-$16.00
Shares Offered
13.33M
176.46M
$3.2B
7.6%
Implied Upside vs Midpoint
Description
We are a global clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid that has the potential to improve the lives of people. Our vision is to revolutionize medicine and open new avenues for developing therapies by enabling the body to make its own drugs. Messenger ribonucleic acid, or mRNA, plays a central role in cellular biology in the production of proteins in every living cell. We are the pioneers in successfully harnessing mRNAs designed to prevent infections and to treat diseases by mimicking human biology to synthesize the desired proteins. Our technology platform is based on a natural approach to optimize mRNA constructs that encode functional proteins that replace defective or missing proteins using the cell’s intrinsic translation machinery. Our current product portfolio includes clinical and preclinical candidates across multiple disease indications in oncology, prophylactic vaccines and protein therapy. Our lead clinical program is CV8102, which we are evaluating in a Phase 1 clinical trial for the treatment of four types of solid tumors. We are also engaged in a clinical program for CV7202, which we are currently investigating in a Phase 1 clinical trial for potential vaccination against rabies. Additionally, we are rapidly advancing our mRNA vaccine program against coronavirus (SARS-CoV-2), for which we initiated a Phase 1 clinical trial in healthy volunteers in June 2020, with results expected in the fourth quarter of 2020. mRNA-based medicines represent a novel class of medicine that have the potential to address limitations of conventional treatment modalities. We believe the modular nature of mRNA has the potential for higher efficacy, greater speed and lower cost of production as compared to conventional treatment modalities. We are leveraging the inherent advantages of mRNA-based medicines in the development of our technology platform. We have built an extensive expertise in the fields of mRNA biology, optimization and production. We have continued to invest in developing our proprietary technology platform, which we refer to as the RNAoptimizer, over the past 20 years. We optimize mRNAs to preserve critical protein-RNA interactions as these are an inherent feature of the natural building blocks we employ. Our differentiated technology platform is designed to optimize each component of the mRNA-based medicine. Our RNAoptimizer platform is built on three core pillars: • Protein design: optimizing the specific properties of encoded protein; • mRNA optimization: increasing translation efficacy of the mRNA molecule; and • mRNA delivery: selecting the best-suited delivery system from our diverse portfolio of proprietary and third party delivery systems. By leveraging each of these pillars, we have observed improved protein expression levels while modulating the interaction with the immune system in preclinical and clinical trials. We continue to invest in all levels of optimization to improve the methods we currently employ and to further advance our mRNA-based medicines. We consider our manufacturing process an important part of our strategy that allows us to continuously improve our technology platform and maintain flexibility in clinical development. We control the critical steps of manufacturing in-house, which allows us to drive innovation and to maintain flexibility, which allows us to pivot quickly in clinical development and potential commercialization. For other non-critical manufacturing steps, such as starting material, formulation and fill and finish, we rely on contract manufacturing organizations, or CMOs. We currently operate three GMP-certified suites, with the capacity to supply our clinical programs and potential early commercialization activities. We are in the process of building a fourth GMP facility that will support our future commercial launches. Based on the doses and response seen in our CV7202 study, we believe our fourth GMP facility, which is being designed to cover all manufacturing steps from starting material to formulation, could potentially supply materials for billions of doses of our vaccine product candidates. In addition to our GMP manufacturing facilities, we are developing a novel downsized and automated process for producing our mRNA, which we refer to as the RNA Printer. Our approach seeks to mitigate clinical and developmental risk across multiple levels to advance and expand our broad product portfolio through rational disease selection. We consider a number of factors in our disease selection process including unmet medical need, immune response, duration of expression, dosing requirements, delivery, and targeted tissue types, among other factors. Our programs target the underlying modes of action of the disease that play a critical role in the pathology of the disease. We are initially targeting diseases that require an active immune response (such as prophylactic vaccines and oncology) and require transient expression of mRNA in tissue types that are more easily accessible. We believe these initial indications are amenable to localized delivery using a lipid nanoparticle, or LNP, delivery system. Following the encouraging results from our initial prophylactic vaccines program in clinical studies and based on our advanced understanding of mRNA biology and immune stimulation control, we have expanded our product portfolio to target indications that require an immune silent approach (such as protein delivery), given the need for higher doses, repeated dosing and longer expression of the protein. These initial indications are using LNP delivery systems, or our proprietary polymer based delivery system, which we refer to as the CureVac Carrier Molecule, or CVCM. Our access to a broad range of delivery systems allows us to target multiple tissue types. We are exploring a range of potential approaches in oncology including intratumoral therapy and novel cancer vaccines targeting neoepitopes and tumor associated antigens. Our lead oncology candidate, CV8102, is a complex of single-stranded non-coding RNA which has been optimized to maximize activation of cellular receptors that normally detect viral pathogens entering the cells (such as toll-like receptor 7, or TLR7, TLR8, and retinoic acid inducible gene I, or RIG-I pathways), mimicking a viral infection of the tumor. CV8102 is designed to recruit and activate antigen-presenting cells at the site of injection to present tumor antigens released from tumor cells to T cells in the draining lymph node. This potentially leads to activation of tumor specific T cells, which can kill tumor cells at the injected site, but also at distant non-injected tumor lesions or metastases. CV8102 is currently being evaluated in a Phase 1 clinical trial for the treatment of four types of solid tumors — cutaneous melanoma, or cMEL, adenoidcystic carcinoma, or ACC, squamous cell carcinoma of skin, or SCC, and squamous cell carcinoma of head and neck, or HNSCC. As of April 2020, we have enrolled 40 patients (24 in the single agent cohort and 16 in the combination cohort with anti-PD-1) in the Phase 1 dose-escalation portion of the study. As of April 2020, we have observed preliminary evidence of single agent activity with objective tumor responses observed in two melanoma patients, and two additional patients have shown a stabilization of their disease, including shrinkage of non-injected lesions. Overall, eight out of 24 patients treated with single agent CV8102 remained free of progression for at least 24 weeks. Based on the results from the Phase 1 clinical trial, we plan to determine the recommended dose for Phase 2. Our mRNA technology platform has shown potential in the development and production of prophylactic vaccines against infectious diseases. Our lead vaccine program, CV7202, is being developed for prophylactic vaccination against rabies. CV7202 is an mRNA that encodes the rabies virus glycoprotein, RABV-G, formulated with LNPs. We are currently investigating CV7202 in Phase 1 clinical trial, evaluating safety, including reactogenicity, and immunogenicity. In January 2020, we reported preliminary data from our Phase 1 trial of CV7202 in rabies. CV7202 induced adaptive immune response as shown by rabies-specific virus-neutralizing antibody titers, or VNTs, above the World Health Organization, or WHO, thresholds considered to be protective, after the second dose in all subjects, at the lowest 1µg and 2µg dose levels. We also showed that the lowest dose levels (1µg and 2µg mRNA) were generally well tolerated.We plan to report follow up data from our Phase 1 clinical trial in the fourth quarter of 2020 and initiate a Phase 2 clinical trial by mid-2021. In response to the global pandemic due to novel coronavirus 2019 disease, or COVID-19, we have rapidly advanced our mRNA vaccine program against SARS-CoV-2. Upon publication of the sequence of the novel coronavirus disease (SARS-CoV-2), at the end of January 2020, we designed and optimized a variety of potential antigenic constructs based on the spike (S) protein to elicit high immunogenicity. Early exploratory data on these constructs indicated high immunogenicity and titers of S specific binding and neutralizing antibodies in mice after a single vaccination. The results of our preclinical studies suggested that our vaccine candidate against SARS-CoV-2 was active at low dose (2ug) and triggered fast induction of a balanced immune response with high levels of VNTs and T-cell responses. Based on the preclinical results, we initiated a Phase 1 clinical trial in healthy volunteers in June 2020, with results expected in the fourth quarter of 2020. We intend to identify the optimal dose for our CVnCoV vaccine candidate based on the results of our Phase 1 clinical study. We expect to initiate our Phase 2b/Phase 3 study in the fourth quarter 2020. The Phase 2b study is expected to be a global randomized, active controlled, observer blind study with enrollment sites in Europe, Latin America, Africa and Asia to evaluate the safety, reactogenicity and immunogenicity of our CVnCoV vaccine candidate in a broad population, including participants above the age of 60. Our Phase 3 clinical study is expected to be a global randomized, active controlled, observer blind study with enrollment sites in Europe, Latin America, Africa and Asia. We expect to enroll up to 20,000 subjects above the age of 18 years in our Phase 3 clinical trial. We are working closely with many organizations, including the Coalition for Epidemic Preparedness Innovations, or CEPI, on the development of this vaccine candidate. We have also produced material for our vaccine candidate in our GMP III facility in anticipation of clinical trials. Our development efforts for protein therapy are based on delivering optimized mRNAs to trigger production of antibodies or therapeutic proteins. Based on this “healthy” information delivered by mRNA, our cells can produce proteins, which are required to treat the disease caused by missing or inactive proteins. Protein therapy has the potential to be used as a treatment against infectious diseases and toxins and to be applied in many disease indications including cancer, cardiovascular diseases and autoimmune diseases. In preclinical studies in non-human primates, we have demonstrated that antibodies encoded by mRNA can be produced in hepatocytes very rapidly and can reach therapeutic levels in the blood stream. We are also currently advancing multiple undisclosed programs in preclinical studies across liver and rare diseases, eye disorders, lung diseases as well as delivering therapeutic antibodies. We have built an intellectual property portfolio in the United States, Europe and other major geographies. Our patent portfolio includes claims relating to our RNA technology platform, our CVCM delivery system and our CV8102, CV7202, CV-SSIV and SARS-CoV-2 product candidates. We have a history of partnering with leading biopharmaceutical companies such as Boehringer Ingelheim GmbH, or Boehringer Ingelheim, GlaxoSmithKline Biologicals SA, or GSK, CRISPR Therapeutics AG, or CRISPR Therapeutics, and Genmab B.V., or Genmab. We also have received research grants from the Bill & Melinda Gates Foundation and CEPI for the development of several prophylactic vaccines. In addition, we have collaborations with the Schepens Eye Research Institute, Harvard Medical School and the Massachusetts Eye and Ear Infirmary, collectively SERI, as well as Yale University. Our approach of partnering with a number of biopharmaceutical companies allows us to execute on a broad range of programs simultaneously, while mitigating our drug development risk. --- Our principal executive offices are located at Friedrich-Miescher-Strasse 15, 72076 Tübingen, Germany. Our telephone number at this address is +49 7071 98830. Our principal website is www.curevac.com.
CureVac N.V. annual income statement and balance sheet, FY 2021 to FY 2024, as reported in SEC filings (EUR).
| Metric | FY 2021 | FY 2022 | FY 2023 | FY 2024 |
|---|---|---|---|---|
| Revenue | EUR 103M | EUR 67.4M | EUR 53.8M | EUR 535M |
| Gross profit | (EUR 135M) | (EUR 117M) | (EUR 70.6M) | EUR 429M |
| Operating income | (EUR 412M) | (EUR 249M) | (EUR 274M) | EUR 178M |
| Net income | (EUR 412M) | (EUR 249M) | (EUR 260M) | EUR 162M |
| Metric | FY 2021 | FY 2022 | FY 2023 | FY 2024 |
|---|---|---|---|---|
| Total assets | EUR 1.2B | — | EUR 788M | EUR 803M |
| Total liabilities | EUR 470M | — | EUR 271M | EUR 106M |
| Total equity | EUR 688M | EUR 533M | EUR 517M | EUR 697M |
| Cash & equivalents | EUR 811M | EUR 496M | EUR 402M | EUR 482M |