Fresh off raising $640 million in private financing earlier this summer, Germany's Curevac BV burst onto the public market Friday with a $213.3 million Nasdaq IPO. Priced at a top-of-range $16 per share (NADAQ:CVAC), the company's stock rose more than 249% to close at $55.90 Aug. 14, buoyed by enthusiasm for its mRNA vaccine program against SARS-CoV-2. Majority shareholder and longtime Curevac backer Dievini Hopp Biotech Holding GmbH & Co. KG invested €100 million (US$118.3 million) in the company through a concurrent private placement.
Curevac, which has gained renewed attention during the COVID-19 pandemic alongside other mRNA vaccine developers, such as Moderna Inc. and Biontech SE, expects to report results of its coronavirus vaccine program, CVnCoV, in the fourth quarter. It would start a phase IIb/III trial of the vaccine in the same quarter, it said. The Tübingen-based firm is meanwhile building up its manufacturing capacity, building out a fourth GMP facility that could potentially supply materials for billions of doses of its vaccine product candidates, it said in a regulatory filing.
Curevac, which contemplated selling shares for between $14 and $16 before landing on the higher figure, sold 13.33 million shares in the IPO. Demand for the offering surged, with more than 23 million shares trading hands on Friday. Underwriters, including joint bookrunners BofA Securities, Jefferies and Credit Suisse, have an option to purchase up to an additional 1.99 million shares within 30 days.
In July, Curevac announced it had already hauled in a total of $640 million, from previously announced equity investments by the German government via the Kreditanstalt für Wiederaufbau with $343 million and Glaxosmithkline plc with £130 million (US$171 million) as well as additional new equity investments from Qatar Investment Authority and a group of existing and new investors of about $126 million.
Net proceeds of the IPO, Curevac said, will be used to fund its mRNA vaccine against SARS-CoV-2 through the completion of phase III as well as multiple other clinical and preclinical programs underway.
On the COVID-19 front, the company first needs to identify the optimal dose of the vaccine candidate, using results of its phase I study. Once those data arrive, it will embark on a global phase IIb study. That trial 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 CVnCoV in a broad population, it said. Importantly, the trial will include older adults who are at increased risk for severe illness if they contract the virus.
A phase III study to follow is also expected to be of similar design, enrolling up to 20,000 participants above the age of 18, the company said.
In addition to its COVID-19 vaccine, Curevac said it plans to invest funds raised in the IPO in advancing its lead clinical program, the cancer vaccine CV-8102, and its rabies vaccine, CV-7202, through the completion of phase II trials.
CV-8102, is a complex of single-stranded noncoding RNA which has been optimized to maximize activation of cellular receptors that normally detect viral pathogens entering the cells, mimicking a viral infection of the tumor. It's currently being evaluated in a phase I trial for the treatment of four types of solid tumors – cutaneous melanoma, adenoid cystic carcinoma, squamous cell carcinoma of the skin, and squamous cell carcinoma of the head and neck.
CV-7202, an mRNA that encodes the rabies virus glycoprotein, RABV-G, formulated with LNPs, is currently in a phase I trial for potential vaccination against rabies. Preliminary data from the study were reported in January, showing that it induced adaptive immune response after the second dose at the lowest dose levels tested. Curevac plans to report follow-up data from the trial in the fourth quarter and initiate a phase II study by mid-2021.
The IPO arrives following a tumultuous time in the company's executive suite, which saw former acting CEO Franz-Werner Haas become permanent CEO. Haas had been standing in for founding CEO Ingmar Hoerr who, after CEO Daniel Menichella departed the company in March, had taken a leave of absence from Curevac for medical reasons. At the same time as Haas took the helm on a more permanent basis, Curevac also appointed a new chief scientific officer, Igor Splawski.