GeNeuro: initial public offering on the regulated market of Euronext in Paris

Transcription

1 Press release GeNeuro: initial public offering on the regulated market of Euronext in Paris Capital increase of 35 million, with the option of increasing it to a maximum of 46.3 million if the extension clause and overallotment option 1 are exercised in full Subscription undertakings from Institut Mérieux and Servier totalling around 9.5 million 2 Indicative price range: to per share End of the subscription period for the public offering (OPO): Wednesday 13 April End of the subscription period for the international private placement: Thursday 14 April 2016 (12:00pm Paris time) Geneva, Switzerland, 31 March 2016 GeNeuro, a biopharmaceutical company developing new treatments for autoimmune diseases including multiple sclerosis (MS), has today announced the start of its initial public offering with a view to listing its shares for trading on the regulated market of Euronext in Paris. On 30 March 2016, the Autorité des Marchés Financiers (AMF) approved the French language prospectus relating to GeNeuro's initial public offering in France by granting visa no GeNeuro is developing a new approach to treating multiple sclerosis by seeking to block compounds causing inflammation and neurodegeneration upstream, rather than interfering with the body's immune response. This new approach is the result of 25 years of research into human endogenous retroviruses (HERVs) and the MSRV-Env protein, including 15 years within the Institut Mérieux and INSERM. Purpose of the IPO The IPO is intended to provide GeNeuro with the resources it needs to step up development, both of the company itself and its GNbAC1 product candidate. In descending order of priority, the proceeds of the offering will be used for: 15 to 20% of the proceeds to open clinical centers in the United States in connection with the Phase IIb study for GNbAC1 in MS and to strengthen ties to the academic milieu in the United States. These endeavors will aim to facilitate the launch of a Phase III study for GNbAC1 in MS in the United States; 60 to 70% of the proceeds to conduct preclinical and Phase II clinical studies in other indications characterized as major medical needs, i.e., diseases where MSRV-Env is detected in the affected tissues, such as type 1 diabetes (T1D) and chronic inflammatory demyelinating polyradiculoneurapathy (CIDP), or other human diseases where HERVs could play a key role and 1 Assuming an issue price located at the midpoint of the indicative range of the Offering Price 2 Assuming an issue price located at the lower end of the indicative range of the Offering Price and excluding the exercise of the Extension Clause, the subscription undertakings correspond to around 9.2 million and, upon exercise in full of the Extension Clause and on the basis of the higher end of the indicative range of the Offering Price, up to approximately 10.3 million. 1

2 that are still incurable, such as amyotrophic lateral sclerosis (ALS), as well as to strengthen related research activities in cooperation with the academic milieu. The number of projects to be pursued by the Company and the percentage of the proceeds allocated to these projects will depend in particular on the net proceeds of the Offering; and 15 to 20% of the proceeds to strengthen the Company s structure to prepare for planning and conducting a Phase III trial in the United States (comprising, in particular, administrative salaries, rent, and travel costs and the cost of counsel and consultants outside of Research & Development). GeNeuro's main strengths GNbAC1: the first treatment that directly targets a potential cause of multiple sclerosis GeNeuro has developed GNbAC1, a monoclonal antibody currently in phase IIb of clinical development as a treatment for multiple sclerosis. GNbAC1 neutralises the MSRV-Env protein without targeting the patient's immune system, and could be a treatment that is both safe and effective in slowing or stopping the disease's progress in all its forms. GeNeuro estimates that the potential sale of its main product candidate, GNbAC1 for MS, could, considering its development schedule and the development schedule, receipt of regulatory and commercialization authorizations and marketing schedule usually observed for product candidates, commence between 2022 and 2024, subject to the successful completion of the Phase IIb and Phase III trials, the absence of any event delaying the proper conduct of the trials, and the absence of other events that the Company is currently unable to identify or anticipate. A new therapeutic approach at a time when no currently available treatment appears to have any significant impact on the disease's progression Current treatments are approved for "relapsing-remitting" forms of MS, which affect 60% of patients, and they work by altering or suppressing the patient's immune system. These treatments reduce the number of inflammatory relapses with this form of MS, but can cause undesirable side-effects because of the way they affect the immune system. Moreover, there is no approved treatment for progressive forms of MS, which affect around 35% of patients. A collaboration and licensing agreement with a major French drug company GeNeuro has formed an agreement with Servier, under which Servier has undertaken to pay GeNeuro up to million, excluding royalties, depending on progress. The agreement relates solely to multiple sclerosis and does not cover either the US market the world's largest or the Japanese market. GeNeuro has therefore retained all of its rights in two thirds of the global multiple sclerosis market, along with its rights to develop its technology for other diseases. Other potentially extremely promising opportunities in areas other than multiple sclerosis GeNeuro intends to capitalise on its technology's potential by developing a therapeutic platform focusing on diseases potentially caused by human endogenous retroviruses. The other indications being explored by GeNeuro include CIDP (chronic inflammatory demyelinating polyneuropathy) an orphan neurological disease and type-1 diabetes. GeNeuro is currently planning phase IIa proof-of-concept trials in these indications. Support from renowned pharmaceutical companies Servier acquired a stake in GeNeuro in December 2015, confirming its commitment to the Company's long-term development. Together, Servier and Institut Mérieux now own over 45% of GeNeuro's equity and they have undertaken to subscribe to the IPO. 2

3 Offering details Structure of the Offering Distribution of the offered shares will be made in connection with a global placement (the Offering ) consisting of: a public offering in France only taking the form of an open price offering (the Open Price Offering or OPO ) intended principally for individuals; and a global placement (the Global Placement ) principally intended for institutional investors in France and other countries (including the United States) consisting of: Initial offering size - a private placement in France; and - an international private placement in various countries (excluding, notably, Japan, Canada and Australia), including the United States under Rule 144A under the Securities Act and outside the United States under Regulation S under the Securities Act. Issue of 2,450,000 new shares. The existing shares constituting the share capital of the Company amount to 12,119,618 shares, each with a nominal value of CHF 0.05 (taking into consideration the division of the nominal value by two). Extension clause Up to a maximum of 15% of the number of new shares initially set, i.e. a maximum of 367,500 new shares if the extension clause is exercised in full (the Extension Clause ). The Extension Clause may be exercised in part or in full, at one time, on 14 April Overallotment option 15% of the number of new shares offered, i.e. in the event of the exercise in full of the Extension Clause, a maximum of 422,625 additional new shares (the Overallotment Option ). This Overallotment Option may be exercised in part or in full until 13 May 2016 (inclusive). Indicative price range Between and per new share (the "Offering Price") 3. The price of the new shares offered in connection with the OPO will be equal to the price of the new shares offered in connection with the Global Placement. Gross proceeds from the issuance Around 35 million, that could be increased to approximately 40.3 million in the event of full exercise of the Extension Clause and approximately 46.3 million in the event of full exercise of the Extension Clause and the Overallotment Option (based on a price equal to the midpoint of the indicative Offering Price range, i.e ). 3 The Offering Price may be fixed outside this range. In the event of an increase in the upper limit, or if the Offering Price is set above the upper limit of the range (initially or, if applicable, as amended), the date on which the OPO closes may be delayed, or a new subscription period may be re-opened, as the case may be, so that there are at least two trading days between the date on which the press release is released advising of such change and the new date on which the OPO will close. Orders issued in connection with the OPO prior to release of the above-described press release will be maintained, unless they are expressly revoked prior to the new closing date of the OPO, inclusive. The Offering Price may be freely fixed below the lower limit of the indicative range of the Offering Price (in the absence of a significant impact on the other characteristics of the Offering). 3

4 Estimated net proceeds from the issuance Around 32.1 million, barring exercise of the extension clause or the overallotment option, that could be increased to approximately 37 million in the event of full exercise of the Extension Clause and approximately 42.6 million in the event of full exercise of the Extension Clause and the Overallotment Option (based on a price equal to the midpoint of the indicative Offering Price range, i.e ). Servier and Institut Mérieux's subscription undertakings Institut Mérieux and Servier International B.V. (a wholly-owned subsidiary of Servier) have undertaken to place a subscription order: - for Servier International B.V., for 209,691 shares (i.e, 8.56% of the number of new shares initially offered before exercise of the Extension Clause), plus the number of additional shares corresponding to 8.56% of the shares actually issued upon exercise of the Extension Clause (i.e. up to a total amount of approximately 3.85 million); and - for Institut Mérieux, for the number of New Shares corresponding to a total amount of 6.5 million euros (i.e. 18.6% of the gross amount of the Offering (excluding exercise of the Extension Clause and the Overallotment Option) on the basis of a price equal to the midpoint of the indicative range of the Offering Price (i.e., euros). These subscription orders are intended to be fulfilled in full and on a priority basis, it being understood that they may, however, be reduced in compliance with standard allocation principles (especially where the subscriptions received in connection with the Offering are much greater than the number of offered shares). Lock-up undertaking by holders of the Company s shares and options on the date of the Prospectus From and after the registration (visa) date of this Prospectus by the AMF and until 365 calendar days from the settlement-delivery date of the Offering, for 100% of their shares (including shares issued upon the exercise of any options), subject to certain usual exceptions; provided, however, that this commitment applies only to the Company s shares and options that they own on the day of the initial public offering. Company lock-up commitment From and after the date on which the Underwriting Agreement is executed and for 180 calendar days following the settlement-delivery date, subject to certain usual exceptions. Planned transaction timetable 31 March 2016 Beginning of the subscription period SFAF meeting in Paris 13 April 2016 Closing of the OPO at 5 p.m. (Paris time) for subscriptions at the window and 8 p.m. (Paris time) for Internet subscriptions 14 April 2016 Closing of the Global Placement at 12 noon (Paris time) Setting of the Offering Price and possible exercise of Extension Clause Release of press release indicating the Offering Price, the final number of New Shares offered, the maximum number of Additional New Shares, and the results of the Offering Start of any stabilization period 4

5 15 April 2016 Start of conditional trading of the shares on an as if and when issued basis on Euronext Paris 18 April 2016 Settlement-delivery 19 April 2016 Start of trading of the Company s shares on Euronext Paris 13 May 2016 Last date for exercising the Overallotment Option End of any stabilization period Subscription arrangements Persons wishing to participate in the OPO will have to place their orders with a financial intermediary authorized in France no later than April 13, 2016, at 5 p.m. (Paris time) for subscriptions at the window and 8 p.m. (Paris time) for subscriptions by Internet. To be taken into consideration, orders issued in connection with the Global Placement must be received by the Managers no later than April 14, 2016, at 12 noon (Paris time) (unless closed early). GeNeuro share identification codes Name: GeNeuro ISIN code: CH Ticker: GNRO Compartment: Euronext Paris (Compartment B) Business segment: 7211Z Biotech research and development Financial intermediaries Global Coordinator Joint-Lead Manager and Joint-Bookrunner Joint-Lead Manager and Joint-Bookrunner Availability of the prospectus Copies of the French language prospectus relating to the Offering approved by the AMF on 30 March, 2016 under number (the Prospectus ) are available free of charge from GeNeuro (18, chemin des Aulx, CH-1228 Plan-les-Ouates, Geneva, Switzerland) and on the websites of the Company ( and the AMF ( Risk factors Investors are invited to note the risks relating to business activities described in chapter 4 "Risk Factors" (and in particular to risk factors mentioned under Section 4.1 Risks Related to the Products, the Market and the Activity of the Group ) in the first section of the Prospectus and and in section 2 "Risk Factors Relating to the Offering" in the second section of the Prospectus. 5

6 This document does not constitute an offer of GeNeuro s securities in any other jurisdiction in which such offer is unlawful nor does it constitute a solicitation of an offer to buy GeNeuro s securities in the United States. The securities of GeNeuro may not be offered or sold in the United States absent registration under the US Securities Act of 1933, as amended (the Securities Act ) or under an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. The offer and sale of the securities of GeNeuro has not been and will not be registered under the Securities Act and there will be no public offer of its securities in the United States. This document may not be released, published or distributed, directly or indirectly, in or into Australia, Canada, Japan or the United States. Contacts: GeNeuro Jesús Martin-Garcia Chairman and CEO investors@geneuro.com +41 (0) NewCap Investor relations Julien Perez geneuro@newcap.eu +33 (0) NewCap Media relations Nicolas Merigeau geneuro@newcap.eu +33 (0) About GeNeuro: GeNeuro, founded in 2006, is a spin-off from the Mérieux Institute and is creating a technological platform for the development of new treatments targeting potential causes of neurological disorders and autoimmune diseases such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy and type-1 diabetes. GeNeuro's first product, GNbAC1, is a monoclonal antibody that neutralises a protein expressed by human endogenous retroviruses, part of the human genome that is normally silent. GeNeuro believes that this drug candidate could become the first treatment addressing a suspected causal factor of multiple sclerosis and could therefore represent a paradigm shift in the options for treating this disease. GNbAC1 is being developed under a collaboration agreement with Servier that could generate, excluding royalties, over 360 million in revenue for GeNeuro, 37.5 million of which is to be allocated to the financing of the current Phase IIb clinical trial in multiple sclerosis. GeNeuro is based in Geneva, Switzerland and has R&D facilities in Archamps, Haute-Savoie and Lyon. It has 24 employees and rights to 16 patent families protecting its technology. For more information, visit: Disclaimer: The release, publication or distribution of this press release may violate applicable laws and regulations in some jurisdictions. Therefore, persons in such countries and in countries in which this press release is released, published or distributed must enquire about any local restrictions and comply with them. This press release may not be released, published or distributed, directly or indirectly, in or into Australia, Canada, Japan or the United States. This press release does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, securities to any person in Australia, Canada, Japan or the United States or in any jurisdiction to whom or in which such offer or solicitation is unlawful. The securities referred to herein may not be offered or sold in the United States absent registration under the US Securities Act of 1933, as amended (the Securities Act ) or another exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. Subject to certain exceptions, the securities referred to herein may not be offered or sold in Australia, Canada or Japan or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada or Japan. The offer and sale of the securities referred to herein has not been and will not be registered under the Securities Act or under the applicable securities laws of Australia, Canada or Japan. There will be no public offer of the securities in the United States. This press release is solely an advertisement and does not constitute a prospectus within the meaning of Directive 2003/71/EC of the European Parliament and the Council of November 4th, 2003 (the "Prospectus Directive"), as amended, to the extent such Prospectus Directive has been transposed in the relevant Member State of the European Economic Area. Investors in the French offering mentioned in this press release should not purchase or subscribe for any securities referred to in this press release except on the basis of information contained in the prospectus which has been granted a visa from the Autorité des marchés financiers and published by the Company in connection with the offering of such securities and their listing on the regulated market of Euronext in Paris. Investors in the Global Offering should not purchase or subscribe for any securities referred to in this press release except on the 6

7 basis of information contained in an international offering memorandum published by the Company in connection with the offering of such securities. In the United Kingdom, this press release does not constitute an approved prospectus for the purpose of and as defined in section 85 of the Financial Services and Markets Act 2000 (as amended) (the FSMA ), has not been prepared in accordance with the Prospectus Rules issued by the UK Financial Conduct Authority (the FCA ) pursuant to section 73A of the FSMA and has not been approved by or filed with the FCA or any other authority which would be a competent authority for the purposes of the Prospectus Directive. The new and existing shares in the Company may not be offered or sold and will not be offered or sold to the public in the United Kingdom (within the meaning of sections 85 and 102B of the FSMA) save in the circumstances where it is to be lawful to do so without an approved prospectus (within the meaning of section 85 of the FSMA) being made available to the public before the offer is made. In the United Kingdom, this press release, insofar as it constitutes an invitation or inducement to participate in the offering, is only being distributed to and only directed at (1) persons who have professional experience in matters related to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") or high net worth entities falling within Article 49(2)(a)-(d) of the Order or (2) persons to whom it may otherwise lawfully be communicated (all such persons together being referred to as "relevant persons"). The securities are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with, relevant persons. Copies of the French language prospectus approved by the AMF on 30 March 2016 under number (the Prospectus ) are available free of charge from the Company s registered office (18, chemin des Aulx, CH-1228 Planles-Ouates, Geneva, Switzerland) and may be downloaded from the websites of the Company ( and the French Autorité des marchés financiers ( Investors are invited to note the risks relating to business activities described in chapter 4 "Risk Factors" (and in particular to risk factors mentioned under Section 4.1 Risks Related to the Products, the Market and the Activity of the Group ) in the first section of the Prospectus and in section 2 "Risk Factors Relating to the Offering" in the second section of the Prospectus. With respect to the Member States of the European Economic Area which have 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 the securities requiring a publication of a prospectus in any Relevant Meber State, other than France. As a result, the new or existing shares of the Company may not be offered or will not be offered in any Relevant Member State other than France, except, (i) to any legal entity which is a qualified investor as defined under the Prospectus Directive; (ii) to fewer than 100, or, if the Relevant Member State has implemented the relevant provisions of Directive 2010/73/EU, 150, natural or legal persons (other than qualified investors as defined in the Prospectus Directive) as permitted under the Prospectus Directive; or in any other circumstances not requiring the Company to publish a prospectus as provided under Article 3(2) of the Prospectus Directive and/or regulations applicable in this Relevant Member State, provided that no such offer of new or existing shares of the Company shall result in a requirement for the Company to publish a prospectus pursuant to Article 3 of the Prospectus Directive or supplement a prospectus pursuant to Article 16 of the Prospectus Directive. For the purposes of this provision, the expression an offer to the public in relation to the new or existing shares of the Company in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and the new or existing shares of the Company to be offered so as to enable an investor to decide to purchase the new or existing shares of the Company, as the same may be varied in that Member State by any measure implementing the Prospectus Directive in that Member State. In connection with the Offering, Bryan, Garnier & Co and Société Générale (the "Stabilising Manager") (or persons acting on behalf of the Stabilising Manager) may, to the extent permitted by applicable law, over-allot shares up to a maximum of 15% of the total number of shares comprised in the global offering and effect transactions that stabilise or maintain the market price of the Shares at a level higher above those which might otherwise prevail in the regulated market of Euronext in Paris. Such transactions may commence on or after 14 April 2016 and will end no later than 13 May Such transactions may be effected on the regulated market of Euronext in Paris, in the over-thecounter market or otherwise. There is no assurance that such stabilisation will be undertaken and, if it is undertaken, it may be discontinued at any time. This press release contains certain forward-looking statements concerning GeNeuro and its business, including the Company s strategy and plans for the Company s products. Such forward-looking statements are, by their nature, subject to a number of important risks and uncertainties, and the actual results, financial condition, performance or achievements of GeNeuro may be materially different from the plans, objectives and expectations expressed or implied in such forward-looking statements. Forward-looking statements speak only as of the date on which they are made, and GeNeuro undertakes no obligation to update or revise any of them, whether as a result of new information, future events or otherwise, except as required by law. 7