First day of trading of the shares is currently expected to take place on November 9, 2018 under the symbol “THISR”. Themis’ mission is to develop immunomodulation therapies for infectious diseases and cancer using its sophisticated Measles Vector (MV) technology platform. The Company’s lead program for Chikungunya, an infectious disease with a high unmet medical need, recently completed Phase 2 clinical trials. The compelling results including a favourable safety profile and a 96% seroconversion rate are accepted to be published in a high impact journal. Themis is currently in preparation for a pivotal Phase 3 clinical trial.
- The Offering consists of up to 3,608,247 ordinary shares, which may be increased by up to 15% (the Increase Option, as defined below) resulting in up to 4,149,484 new ordinary shares to be offered (the “Offer Shares”).
- Over-allotment option of additional ordinary shares equal to up to 15% of the Offer Shares subscribed for in the Offering, that is exercisable within 30 calendar days after the First Trading Date (as defined below) to cover short positions resulting from any over-allotments made in connection with the Offering (if any) (the “Over-Allotment Option”).
- The Offering comprises:
- A public offering to retail investors in the Netherlands;
- A private placement in the United States to persons who are reasonably believed to be qualified institutional buyers (“QIBs”) as defined in Rule 144A (“Rule 144A”) under the US Securities Act of 1933, as amended (the “US Securities Act”), in reliance on Rule 144A; and
- Private placements to certain institutional investors under applicable laws of certain other jurisdictions. The Offering outside the United States will be made in compliance with Regulation S under the US Securities Act (“Regulation S”).
- The price range for the Offering is set at EUR 9.70 and EUR 11.60 per Offer Share (the “Price Range”), implying a pre-money valuation range of EUR 85.4m to EUR 102.1m.
- The size of the Offering will be approximately EUR 35m based on the low-end of the Price Range (assuming the placement of all Offer Shares but no exercise of the Increase Option and Over-Allotment Option). The size of the Offering will be approximately EUR 55.3m based on the high-end of the Price Range (assuming the placement of all Offer Shares including the exercise in full of the Increase Option and Over-Allotment Option). The implied market capitalization of the Company at listing will range between approximately EUR 120.4m and EUR 157.5m respectively.
- Global Health Investment Fund I, LLC, WELLINGTON Partners Nominee Ltd., aws Gründerfonds Beteiligungs GmbH & Co KG, FPCI Ventech Capital III and Werner Lanthaler, who are existing shareholders of the Company, have committed to subscribe for Offer Shares in the Offering for an aggregate amount of EUR 8.6m. Furthermore, the Company has secured an investment from funds managed by Omnes Capital of EUR 1.4m in convertible loan notes that will convert at settlement at the Offer Price (as defined below).
- The Company anticipates using the net proceeds of the Offering to conduct the Phase 3 clinical trials for Chikungunya, including manufacturing the vaccine and reporting Phase 3 data; to drive research and development of its MV platform towards the immuno-oncology field; to expand commercialization capabilities; and for general corporate purposes.
- The results of the Offering and the final offer price (the “Offer Price”) are expected to be published in a pricing statement on or about November 8, 2018.
- The Company’s shares are expected to be admitted to trading on the regulated market of Euronext Amsterdam on an ‘as-if-and-when-issued’ basis on or about November 9, 2018 (the “First Trading Date”).
Dr. Erich Tauber, CEO and founder of Themis commented: “Our platform is built on the combination of a strong scientific foundation and our advanced manufacturing capabilities, which together we believe have the potential to provide meaningful near-term impact on global public health. The funds raised through this offering will enable the Phase 3 clinical evaluation and regulatory registration for our lead program in Chikungunya as well as propell the first candidate in oncology into the clinic while further supporting the advance of our broad pipeline.”
“Over the last years, Themis has developed a robust immunomodulation platform that offers great potential not only in infectious disease but also cancer indications. I applaud the team on their ability to execute, demonstrated primarily by the development achievements with the lead program in Chikungunya. The Company has set all the right mechanisms in place to create long-term value for their shareholders,” added Dr. Gerd Zettlmeissl, Chairman of the Board of Directors.
Themis’ versatile platform technology
- Themis’ versatile measles vaccine-based platform technology (MV-platform) has potentially broad application in the treatment and prevention of infectious diseases and cancer.
- The technology, licensed from leading institutions, the Institut Pasteur and the Max-Planck-Institute, for infectious diseases and oncology, respectively, is a modified measles virus, based on the viral genome sequence of the established measles vaccine strain. This strain is one of the safest and most efficacious vaccines, having been used to immunize billions of people worldwide, including over one billion children.
- Themis has further developed the measles vaccine into an active delivery vehicle that enables the addition of antigens that are designed to protect against or treat other diseases.
Lead program in Chikungunya Phase 3 ready
- Themis’ lead product, MV-CHIK, targets Chikungunya, an infectious disease with a high unmet medical need and has successfully completed Phase 2 demonstrating strong immunogenicity and safety in over 500 subjects around the globe.
- Themis is currently in regulatory discussions and preparation for a pivotal Phase 3 clinical trial, targeted to start in early 2020, with final results expected in the second half of 2020, submissions to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulatory authorities in early 2021 and approval targeted during mid-2021.
- Themis has received EMA PRIME designation for MV-CHIK, emphasizing the current unmet medical need, which should facilitate an accelerated regulatory approval track towards approval with the EMA.
- Chikungunya has an estimated worldwide market potential of USD 500 million in 2035 based on a combination of demand from travelers and endemic populations, as well as governmental contracts, for which Themis is well positioned to be first to market.
- There are currently no approved vaccines for Chikungunya fever. People can protect themselves only by preventing mosquito bites.
Broad pipeline of products, well positioned
- The strong safety profile and immunogenicity in terms of humoral (antibodies) and cellular (T cells) responses demonstrated in the pre-clinical and clinical trials of MV-CHIK to date provide positive indications for the broad applicability of the MV Platform in immuno-oncology and other infectious diseases.
- Themis’ immunomodulation technology platform is well positioned in immuno-oncology.
- The measles virus has innate anti-cancer properties, for example, mediating tumor cell lysis, T cell activation and specific tumor cell targeting.
- Themis’ ability to integrate antigens into the backbone of the measles virus can also be utilized to engineer additional tumor killing and immune-modulatory payloads, making it a prime building block for an effective immuno-oncology virotherapy.
- Both in vitro and animal pre-clinical experiments have already demonstrated the existing ability of this vector in destroying tumor cells.
- Following the promising pre-clinical safety and efficacy data, Themis anticipates generating first-in-human data in the second half of 2019 with an initial focus on gastrointestinal tumors.
- Themis is progressing various other programs alone or through partnerships. These include vaccine programs against RSV, Noro virus, CMV, Zika virus, MERS and Lassa fever.
Optimized cGMP manufacturing technology
- Themis believes that the proprietary vaccine manufacturing technology it has developed allows significantly shortened development cycles from design to cGMP manufacturing.
- Themis’ technology has been developed to allow for a “plug-and-play” manufacturing system. This means that its technology can be applied without re-development requirements or adaptations, which allows Themis to transfer process knowledge and data from one program candidate to other drug candidates, potentially significantly shortening development times of new product candidates.
Experienced management team and reputable investor base
- Themis’ management team brings together immunology experts with a proven track-record in immunomodulation based drug development, including CEO Dr. Erich Tauber, who was responsible for the development and commercialization of a vaccine against Japanese encephalitis.
- Themis is backed by reputable specialist investors including Paris-based Ventech and Omnes Capital, Munich-based Wellington Partners, Vienna-based Gründerfonds (aws), and New York-based Global Health Investment Fund (GHIF).
- The Company has further established partnerships with, and raised non-dilutive research funding from the European Commission (Horizon 2020), the UK Government (Innovate UK) and the Coalition for Epidemic Preparedness Innovations (CEPI).
Details of the Offering
The Offering consists of (i) a public offering to retail investors in the Netherlands and (ii) a private placement to certain institutional investors in various other jurisdictions. The Offer Shares are being offered (i) within the United States to QIBs in reliance on Rule 144A or pursuant to another exemption from, or in a transaction not subject to, the registration requirements of the U.S. Securities Act, and (ii) outside the United States in offshore transactions in reliance on Regulation S. The Offer Shares are being offered only in those jurisdictions in which, and only to those persons to whom, offers of shares may lawfully be made.
The Company is offering up to a total of 3,608,247 Offer Shares within a price range of EUR 9.70 to EUR 11.60 (inclusive) per Offer Share.
The Company reserves the right to, after consultation with the Joint Global Coordinators, increase the total number of Offer Shares by up to 15%, up to 4,149,484 Offer Shares (the “Increase Option”) or to decrease the total number of Offer Shares.
The Company has granted the Joint Global Coordinators, on behalf of the Underwriters, the Over-Allotment Option, exercisable within 30 calendar days after the First Trading Date, pursuant to which the Joint Global Coordinators, on behalf of the Underwriters, may require the Company to issue at the Offer Price up to 541,237 Additional Shares (or up to 622,422 Additional Shares in the event that the Increase Option is exercised in full), comprising up to 15% of the total number of Offer Shares sold in the Offering, to cover over-allotments or short positions (if any) in connection with the Offering.
The Offering will begin on October 29, 2018 and is expected to end on November 8, 2018 (the “Offering Period”). On the final day of the Offering Period, subject to acceleration and extension of the timetable for the Offering and barring unforeseen circumstances, prospective retail investors may submit offers to purchase shares until 12:00 Central European Time (“CET”) and institutional investors may subscribe for Offer Shares until 16:00 CET.
The Offer Price and the exact number of Offer Shares offered will be stated in a pricing statement which will be published in a press release that will also be posted on Themis’ website and filed with the AFM (as defined below).
NIBC Bank N.V. and Stifel Nicolaus Europe Limited are acting as Joint Global Coordinators and Joint Bookrunners for the offering. Erste Group Bank AG is acting as Co-Bookrunner.
Themis Bioscience has prepared a prospectus relating to the Offering and the contemplated listing of its shares on Euronext Amsterdam dated October 29, 2018 (the “Prospectus”). The Prospectus constitutes a prospectus for the purposes of article 3 of the Directive 2003/71/EC as amended (the “Prospectus Directive”) and has been prepared pursuant to article 5:2 of the Dutch Financial Supervision Act (Wet op het financieel toezicht) and the rules promulgated thereunder. The Prospectus has been approved by and filed with the Netherlands Authority for the Financial Markets (Stichting Autoriteit Financiële Markten, the “AFM”). The Prospectus includes a section entitled “Risk Factors” and prospective investors should carefully consider the risks described in this section prior to making an investment decision. The Prospectus is available on the Company’s website: www.themisbio.com/investors
Themis is developing immunomodulation therapies for infectious diseases and cancer. Through advanced understanding of immune system mechanisms, the Company has built a sophisticated and versatile technology platform for the discovery, development and production of vaccines as well as other immune system activation approaches. Initially focused on preventing infectious diseases, the Company has demonstrated the potential of its versatile platform through the rapid progression into Phase 2 clinical development for a vaccine against Chikungunya, a debilitating disease with global outbreak potential. Funded to date by leading Europe-based VCs, Themis has also gained prestigious non-dilutive funding for emerging infectious disease indications. The Company will apply its platform and commercial manufacturing capabilities to diseases with high market potential both alone and for its partners. For more information, visit http://www.themisbio.com.