On May 26, 2021 CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), reported business updates and financial results for the first quarter of 2021 (Press release, CureVac, MAY 26, 2021, View Source [SID1234580611]).
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"The COVID-19 reality has changed dramatically since the beginning of this year and is today characterized by the rapid spread of Variants of Concern as well as the emergence of new strains, which together have now all but supplanted the original virus strain that we fought throughout 2020," said Franz-Werner Haas, Chief Executive Officer of CureVac. "In this variant rich environment, we are convinced that our first-generation COVID-19 vaccine candidate, CVnCoV, will make an important contribution to the pandemic vaccination programs, for which availability of potent vaccines is now more important than ever to stop the virus from evolving further. CVnCoV is in the final stage of clinical development in what we believe is one of the most diverse efficacy trials in terms of the range of virus variants. For CVnCoV, which we advance together with our partner Bayer, we are expecting the data readout from the pivotal Phase 2b/3 trial in the second quarter, which will enable us to finalize our rolling submission with EMA. Our second-generation vaccine candidate, CV2CoV, is developed together with GSK and is planned to enter clinic trials in the third quarter of 2021. First preclinical data showed high potential for even lower doses that is expected to enable multivalent or combination vaccines to flexibly address different variants or different diseases in one vaccine."
"In the first quarter of 2021, we were able to continue to build and strengthen our strong cash position with our first follow-on financing in February 2021, raising $517.5 million in aggregated gross proceeds," said Pierre Kemula, Chief Financial Officer of CureVac. "Together with our strategic partners Bayer and GSK, we are fully dedicated to create sustainable value with our COVID-19 vaccine program – for the pandemic and beyond. This is further enabled by the ongoing ramp-up of our broad and integrated European manufacturing network as well as the RNA Printer, our autonomous and mobile manufacturing unit well suited to address pandemic preparedness. Build-up of our commercial infrastructure is progressing well as we prepare to potentially launch our first product and work toward our goal of becoming an integrated biopharma company."
Selected Business Updates
CVnCoV – First-Generation COVID-19 Vaccine Candidate
CVnCoV is CureVac’s first-generation vaccine candidate in its clinical COVID-19 vaccine program. Based on optimized, non-chemically modified mRNA, CVnCoV was shown to be well tolerated and induced robust immune responses at a 12µg dose in our Phase 1 clinical trial. Additionally, CVnCoV has shown to enable delivery logistics at standard refrigerator temperature – a critical advantage as the world faces a pandemic that demands safe vaccines produced and distributed on a global scale.
Phase 3 in Belgium Including Participants with Comorbidities
A Phase 3 trial to evaluate the safety, reactogenicity and immunogenicity of CVnCoV in adults with an elevated risk of severe COVID-19 disease due to comorbidities started in late April with vaccination of the first participant. The multicenter trial includes people with selected comorbidities such as obesity, chronic cardiovascular disease, chronic kidney disease, chronic obstructive pulmonary disease (COPD), HIV, type 2 diabetes mellitus and post-renal transplantation. It is currently being conducted in Belgium and is expected to enroll approximately 1,200 participants.
Phase 2a in Peru and Panama
To offer the best protection in the context of spreading virus variants, additional data is needed concerning the longevity of protection of current vaccines, as well as the need for and timing of potential booster vaccination.
CureVac is currently assessing the benefit of a booster vaccination in its clinical Phase 2a trial in Peru and Panama. The Phase 2a trial, which serves as a dose-confirmation trial of a 12µg dose of CVnCoV for advanced clinical testing, is fully recruited at 674 participants and features approximately 270 participants in the important group above the age of 60, who received 12µg of CVnCoV. To assess the age-related need for a booster vaccination, the two-dose vaccination schedule was further extended by a third booster vaccination, administered to trial participants above the age of 60 one month after the second dose and to all trial participants above the age of 18 six months after the second dose. No increase in reactogenicity was observed following administration of the booster vaccination compared to administration of the two doses of the primary vaccination.
Inclusion of CVnCoV in UK COVID-19 Cov-Boost Vaccine Study
On May 19, the UK Government announced the upcoming Cov-Boost trial, further extending current clinical research of booster vaccinations by investigating whether it is safe and effective to boost using a different vaccine from the one originally used for immunization.
The study, which is the first of its kind, is scheduled to start at the beginning of June. It will be conducted at 18 sites across the UK and is expected to include a total of 2,886 participants. Cov-Boost will evaluate several different COVID-19 vaccines as potential boosters, including CVnCoV, administered at least three months after participants have received their second initial vaccine dose. Each participant will receive one booster vaccine, which could be different from the one they have already received. Initial results of the study are expected in September 2021.
Regulatory Pathway
CureVac’s recently founded Swiss subsidiary announced the initiation of a rolling submission process with the Swiss regulatory authority Swissmedic on April 19, 2021. Regulatory clearance of CVnCoV with Swissmedic will allow CureVac to serve the order of the Swiss federal government for the supply of five million vaccine doses, which forms part of the delivery agreement between the European Commission and CureVac. Next to Germany and Austria, Switzerland represents one of the three countries for which CureVac holds exclusive commercialization rights for Program Products in the context of its broad GSK partnership in vaccines for infectious diseases as well as second-generation vaccines for COVID-19.
CV2CoV – Second-Generation COVID-19 Vaccine Candidate
CV2CoV is CureVac’s second-generation vaccine candidate in its COVID-19 vaccine program, developed in collaboration with GSK. Also based on non-chemically modified mRNA, CV2CoV features a new mRNA backbone optimized to improve intracellular mRNA translation for increased and extended protein expression. CV2CoV optimizations target strong immune responses at even lower doses compared to CVnCoV and could support the development of multivalent vaccines to target rapidly spreading COVID-19 variants. First clinical trials for CV2CoV are expected to start in the third quarter of 2021.
First Preclinical Study of CV2CoV on Immunogenicity and Variant Cross-Neutralization
On May 13, CureVac published the first preclinical data of its second-generation COVID-19 vaccine candidate, CV2CoV, demonstrating high levels of antigen production in an in vitro setup as well as strong and dose-dependent immune responses in an established rat model. Preclinical data in animals immunized with two doses of CV2CoV in the dose range of 0.5-40µg demonstrated fast onset of strong immune responses already after the first dose. In addition, the serum of vaccinated animals showed significant cross-neutralization against variants first discovered in Denmark (B.1.1.298), the UK (B.1.1.7) and South Africa (B.1.351). The full manuscript is available on the pre-print server bioRxiv.
Financial Update for the First Quarter of 2021
Cash Position
Cash and cash equivalents increased from €1,323 million as of December 31, 2020, to €1,497 million as of March 31, 2021, mainly due to the raising of €405 million in net proceeds in a follow-on public offering, which closed in February 2021. In the first three months of 2021, cash used in operations was mainly used to advance all R&D activities for CVnCoV, our first-generation COVID-19 vaccine candidate.
Revenues
Revenue was €10.0 million for the first three months of 2021, representing an increase of €6.9 million or 221.6% compared to revenue of €3.1 million for the same period in 2020.
This increase was primarily driven by €9.1 million in revenue recognized under our collaboration agreement with GlaxoSmithKline plc (GSK), entered into in July 2020, for the research, development, manufacturing and commercialization of mRNA-based vaccines and monoclonal antibodies targeting infectious disease pathogens. In the first three months of 2020, revenue primarily consisted of €2.0 million recognized under our collaboration with Eli Lilly, which terminated later in June 2020.
Operating result
Operating loss was €115.8 million for the first three months of 2021, representing an increase of €92.6 million, or 339.0%, from operating loss of €23.2 million for the same period in 2020.
This increase in operating loss was mainly driven by higher research and development costs from our ongoing Phase 2/3 clinical trials of CVnCoV. Such increased R&D costs consist primarily of cost incurred to clinical research organizations and for personnel costs for employees involved in the CVnCoV development, as well as materials used in the administration of CVnCoV clinical trials. We also recognized increased cost of sales mainly due to set-up activities for production processes for our COVID-19 vaccine candidate. Additionally, we recognized increased general and administrative expenses mainly due to consulting services for product launch readiness and personnel-related costs from an increased headcount. These increases in expenses were partially offset by other operating income recognized under our grant from the German Federal Ministry of Education and Research (BMBF) for the development and production of our COVID-19 vaccine candidate.
Financial Result
Financial result for the first three months of 2021 was a gain of €3.6 million, representing an increase of €4.3 million, or 630.9%, from a loss of €0.7 million for the same period in 2020. This net gain was driven mainly by foreign exchange gains, which were partly offset by negative interest on cash, which is being held in liquid funds to be available for use in our CVnCoV R&D and manufacturing activities.
Pre-Tax Loss
Pre-tax loss was €112.2 million for the first three months of 2021, compared to €23.9 million for the same period in 2020.