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Themis Bioscience ("Themis" or the "Company") announced today its intention to raise new funds through an initial public offering on Euronext Amsterdam. The Company's mission is to develop immunomodulation therapies for infectious diseases and cancer using its sophisticated measles vector technology platform. Themis is advancing a broad pipeline based on its unique platform technology and advanced understanding of the immune system. Themis' lead program for Chikungunya, an infectious disease with a high unmet medical need, recently completed Phase 2 clinical trials and is currently in preparation for a pivotal Phase 3 clinical trial.
Company Highlights:
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.
- 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 owns, co-owns or has exclusively licensed-in 12 worldwide patent families, comprising its MV-platform, product candidates and manufacturing technology.
Themis' lead product, MV-CHIK targets Chikungunya, an infectious disease with a high unmet medical need
- Chikungunya is a mosquito-borne viral disease with continued transmission and outbreaks in over 100 countries including the Caribbean, South America, India, Southeast Asia, Africa, and recently in 2017 in Europe, where the virus was imported by infected travelers.
- Clinical symptoms of the disease are fever, joint and muscle pain, headache, nausea and rash. The infection rate during an outbreak can reach or exceed 90%, and long-term effects or life-long serious health impairments are observed in up to 60% of patients. Fatal cases have also been recorded.
- 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.
Themis' lead product, MV-CHIK, has successfully completed Phase 2 clinical trials targeting Chikungunya
- In completed clinical trials MV-CHIK has demonstrated strong immunogenicity and safety in over 500 subjects around the globe. No other company, to the Management Board's knowledge, currently has an active clinical program that has completed Phase 2 trials.
- 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 FDA (BLA) and EMA (MMA) 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.
- Moreover, the FDA recently included Chikungunya as a disease covered by the Priority Research Voucher program. If it is able to successfully obtain such vouchers, Themis believes it could potentially sell them for a material sum with recent historical data implying that the price achieved could be in the range of USD 100 to 150 million.
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 has a broad pipeline of products addressing additional infectious disease indications
- 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.
- The Company recently completed a Phase I study in Zika and is evaluating additional clinical development across other specific indications.
Themis has established an 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.
Themis has secured investment from reputable specialist investors and non-dilutive grant funding
- Themis has, to date, secured investments from reputable specialist investors of EUR 25.4 million. These investors are Paris-based Ventech and Omnes Capital, Munich-based Wellington Partners, Vienna-based Gründerfonds (aws), and New York-based Global Health Investment Fund (GHIF).
- Themis has established partnerships with, and raised non-dilutive research funding totalling approximately EUR 45.0 million from the European Commission (Horizon 2020), the UK Government (Innovate UK) and the Coalition for Epidemic Preparedness Innovations (CEPI)
- Themis was the first company to be awarded an up to USD 37.5 million development contract from CEPI, a newly-created alliance of reputable organizations, such as the Bill and Melinda Gates Foundation, Wellcome Trust and the World Economic Forum, for important outbreak diseases, namely MERS and Lassa fever.
Themis has an experienced management team and supervisory board with proven track record
- 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.
- Additional board members include Dr. Jean-Paul Prieels, formerly the head of development at GSK vaccines, and Dr. Philippe Dro, a serial entrepreneur who has completed several biotech exits.
- The Supervisory Board is comprised of a number of vaccine industry experts, including Gerd Zettlmeissl, who was CEO of Intercell, a vaccine development biotech company.
"Themis has developed a robust immunomodulation platform and extensive expertise in the development of novel vaccines to prevent infectious diseases. Our most advanced product candidate, a vaccine to prevent Chikungunya fever, is now poised to enter Phase 3 clinical evaluation, which is a testament to our technology, the product itself and the ability of our team to execute and bring a new product toward the market," commented Dr. Erich Tauber, CEO and founder of Themis.
He further added: "With the recent addition of our license agreement with the Max-Planck-Institute, we are expanding the indications of our MV-platform beyond infectious disease to include cancer. Our goal as a company is to develop transformative immuno-oncology therapeutics to improve the treatment outcomes for cancer patients and to advance best-in-class vaccines to treat infectious diseases."
Strategy
Themis aims to develop vaccines for use against infectious diseases and biotherapy-based cancer treatment using its MV-platform. Themis' primary focus is the continued development of its MV-CHIK program, whilst also focusing on the development of its earlier-stage pipeline in both infectious diseases and immuno-oncology.
Assuming MV-CHIK is approved, Themis will consider a range of options to access the Chikungunya market opportunity. These include full commercialization through an internal sales force or licensing of the product to a third party. Currently, Themis expects that its commercialization strategy will form a hybrid model comprising an internal sales force distributing in certain territories with distribution partners in certain other regions.
The Offering and Use of Proceeds
Subject to the approval of the prospectus by the Dutch Authority for the Financial Markets, Themis intends to offer new ordinary shares in the IPO with admission to trading of all shares on Euronext Amsterdam. The intended offering is expected to consist of (i) a public offering to retail and institutional investors in the Netherlands and (ii) a private placement to certain institutional and other eligible investors in various other jurisdictions.
The proceeds of the offering are intended to allow the Company to conduct the Phase 3 clinical trials for Chikungunya, including manufacturing of the vaccine, reporting of topline data through to submission and ultimately regulatory approval; to drive research and development of its MV platform towards the immuno-oncology field; to expand commercialization capabilities; and for general corporate purposes.
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.
About Themis
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.
Important Legal Information
These materials are not for release, distribution or publication, whether directly or indirectly and whether in whole or in part, into or in the United States (including its territories and possessions, any state of the United States and the District of Columbia), Canada, Australia or Japan or any other jurisdiction where to do so would constitute a violation of the relevant laws of such jurisdiction.
These materials are for information purposes only and are not intended to constitute, and should not be construed as, an offer to sell or a solicitation of any offer to buy the securities of Themis Bioscience N.V. (the "Company", and such securities, the "Shares") in the United States, Canada, Australia, or Japan or in any other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration, exemption from registration or qualification under the securities laws of such jurisdiction.
The Shares mentioned herein have not been, and will not be, registered under the United States Securities Act of 1933 (the "Securities Act"). The Shares may not be offered or sold in the United States except pursuant to an exemption from or in a transaction not subject to the registration requirements of the Securities Act. The Company has no intention to register any part of the offering in the United States or make a public offering of Shares in the United States.
In the United Kingdom, these materials are only being distributed to, and are only directed at, and any investment or investment activity to which they relate is available only to, and will be engaged in only with, "qualified investors" (as defined in section 86(7) of the Financial Services and Markets Act 2000) and who are (i) persons having professional experience in matters relating to investments who fall within the definition of "investment professionals" in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "relevant persons"). Persons who are not relevant persons should not take any action on the basis of these materials and should not act or rely on them.
The Company has not authorised any offer to the public of Shares in any Member State of the European Economic Area other than the Netherlands. With respect to any Member State of the European Economic Area, other than the Netherlands, which has implemented the Prospectus Directive (each a "Relevant Member State"), no action has been undertaken or will be undertaken to make an offer to the public of Shares requiring publication of a prospectus in any Relevant Member State. As a result, the Shares may only be offered in Relevant Member States (i) to any legal entity which is a qualified investor as defined in the Prospectus Directive; or (ii) in any other circumstances falling within Article 3(2) of the Prospectus Directive. For the purpose of this paragraph, the expression "offer of securities to the public" means the communication in any form and by any means of sufficient information on the terms of the offer and the Shares to be offered so as to enable the investor to decide to exercise, purchase or subscribe for the Shares, as the same may be varied in that Member State by any measure implementing the Prospectus Directive in that Member State and the expression "Prospectus Directive" means Directive 2003/71/EC, as amended.
This document does not constitute or form part of any offer or invitation to sell, or any solicitation of any offer to purchase and does not constitute a prospectus for the purposes of the Prospectus Directive. The offer to acquire securities pursuant to the proposed offering will be made, and any investor should make his investment decision, solely on the basis of information that will be contained in the prospectus to be approved by the Dutch Authority for the Financial Markets (Stichting Autoriteit Financiële Markten) (the "AFM") and to be made generally available in the Netherlands in connection with such offering. This document should not be published, reproduced, distributed or otherwise made available, in whole or in part, to any other person without the prior consent of the Company. When made generally available, copies of the prospectus may be obtained at no cost from the Company and through its website (www.themisbio.com).
No action has been taken by the Company that would permit an offer of Shares or the possession or distribution of these materials or any other offering or publicity material relating to such Shares in any jurisdiction where action for that purpose is required.
The release, publication or distribution of these materials in certain jurisdictions may be restricted by law and therefore persons in such jurisdictions into which they are released, published or distributed, should inform themselves about, and observe, such restrictions. Failure to comply may violate securities laws of any such jurisdiction.
This announcement does not constitute a prospectus. An offer to acquire Shares pursuant to the proposed offering will be made, and any investor should make his investment, solely on the basis of information that will be contained in the prospectus to be made generally available in the Netherlands in connection with such offering and the admission to listing and trading of the Shares on Euronext in Amsterdam. When made generally available, copies of the prospectus may be obtained at no cost from the Company or through its website.
This announcement may include statements, including the Company's financial and operational medium-term objectives that are, or may be deemed to be, 'forward-looking statements'. These forward-looking statements may be identified by the use of forward-looking terminology, including the terms 'believes', 'estimates', 'plans', 'projects', 'anticipates', 'expects', 'intends', 'may', 'will' or 'should' or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. Forward-looking statements may and often do differ materially from actual results. Any forward-looking statements reflect the Company's current view with respect to future events and are subject to risks relating to future events and other risks, uncertainties and assumptions relating to the Company's business, results of operations, financial position, liquidity, prospects, growth or strategies. Forward-looking statements speak only as of the date they are made.
Each of the Company and the Underwriters (as defined below) and their respective affiliates expressly disclaims any obligation or undertaking to update, review or revise any forward-looking statement contained in this announcement whether as a result of new information, future developments or otherwise.
Each of NIBC Bank N.V., Stifel Nicolaus Europe Limited and Erste Group Bank AG (collectively, the "Underwriters") is acting exclusively for the Company and no-one else in connection with any offering of Shares. They will not regard any other person as their respective clients in relation to the offering and will not be responsible to anyone other than the Company for providing the protections afforded to their respective clients, nor for providing advice in relation to the offering, the contents of this announcement or any transaction, arrangement or other matter referred to herein. None of the Underwriters or any of their respective subsidiary undertakings, affiliates or any of their respective directors, officers, employees, advisers, agents, alliance partners or any other entity or person accepts any responsibility or liability whatsoever for, or makes any representation, warranty or undertaking, express or implied, as to the truth, accuracy, completeness or fairness of the information or opinions in this announcement (or whether any information has been omitted from the announcement) or any other information relating to the group, its subsidiaries or associated companies, whether written, oral or in a visual or electronic form, and howsoever transmitted or made available or for any loss howsoever arising from any use of this announcement or its contents or otherwise arising in connection therewith. Accordingly, the Underwriters disclaim, to the fullest extent permitted by applicable law, all and any liability, whether arising in tort or contract or that they might otherwise be found to have in respect of this announcement and/or any such statement.
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Contacts:
For Themis:
Dr. Erich Tauber, CEO
Phone: +43 1 236 7151
erich.tauber@themisbio.com
or
Media & Investor Inquiries for Themis:
Gretchen Schweitzer or Dr. Stephanie May
Trophic Communications
Phone: +49 89 2388 7730 or +49 171 185 56 82
may@trophic.eu