BERLIN--(BUSINESS WIRE)--NOXXON Pharma N.V. ("NOXXON" or the "Company"), a clinical-stage biopharmaceutical company primarily focused on cancer treatment development, announces today its intention to raise new funds through an Initial Public Offering ("IPO" or the "Offering") and the listing of its ordinary shares (the "Shares") on Euronext Amsterdam and Euronext Paris. The Offering and listing, and their timing, are subject to, among other matters, market conditions.
Lead product candidate NOX-A12 is positioned as a must-have combination therapy in cancer: The Company believes that the future of cancer treatment lies in finding optimal combinations of drugs to fight cancer in multiple ways. The Company believes its lead product candidate NOX-A12 is well positioned to become a must-have combination partner for a wide range of cancer treatments, based on its complementary mode of action targeting the tumor microenvironment. As part of a combination, the Company believes NOX-A12 has broad potential in hematological and solid tumor cancers.
NOX-A12 has a clear route to market: NOX-A12 is currently being developed for treatment of multiple myeloma (a form of blood cancer), advanced solid tumor cancers and brain cancer. NOXXON has generated promising pre-clinical and clinical data, including its most recent phase 2a trials in multiple myeloma and a second hematological cancer that showed a safety profile that supports further development and first signs of efficacy. The Company believes that its planned clinical studies in multiple myeloma, brain cancer and advanced solid tumor cancers position the Company for a clear route to market of NOX-A12.
Mature pipeline of drug candidates with near term milestones: In addition to NOX-A12, the Company has a broad pipeline of drug candidates, which in the Company's view is an indication of the versatility of the Company's core technology. NOX-H94, which is in development to treat anemia of chronic disease, i.e. functional iron deficiency, is expected to deliver phase 2a data in Q1'2016. The Company is focused on developing cancer drug candidates and aims to optimize the value of its pipeline by selective partnering of certain programs.
Proprietary Spiegelmer platform generates drug candidates: NOXXON's product candidates, including NOX-A12, are so-called Spiegelmers. Spiegelmers are a new class of drugs that combine the strengths of small-molecules and antibodies. The Company has established a proprietary technology to discover and create its Spiegelmer drug candidates against a variety of targets. With its Spiegelmer platform, the Company intends to continue to generate additional drug candidates and to expand its pipeline focusing on tumor microenvironment targets.
Strong leadership team and a reputable investor base: NOXXON is led by a management team with broad experience in drug development. Furthermore, the Company is supported by reputable investor base, including TVM Capital, Sofinnova Partners, Edmond de Rothschild Investment Partners, DEWB and NGN.
Aram Mangasarian, PhD, Chief Executive Officer of NOXXON commented: "Our lead product candidate NOX-A12 has the potential to become a cornerstone of combination therapy by significantly improving the efficacy of current and future cancer treatments. The funds raised through this public offering will primarily be used to advance NOX-A12 and other oncology focused product candidates in NOXXON's broad and innovative pipeline."
Dr. Hubert Birner, Chairman of NOXXON, added: "We believe NOXXON has a tremendous opportunity to develop a series of new products to improve cancer treatment. With our unique and broadly applicable Spiegelmer platform, a strong IP position and growing clinical and pre-clinical pipeline we believe we are well positioned to further build our future and become a leading biopharmaceutical company."
Highlights of the Offering
The intended Offering would consist of newly issued Shares only.
NOXXON intends to seek admission to listing and trading of the Shares on Euronext Amsterdam and Euronext Paris.
The Offering is expected to be available to institutional investors and retail investors in the Netherlands and France, and to institutional investors in various other jurisdictions.
The Offering and the listing, and their timing, are subject to, among other matters, market conditions.
Kempen & Co N.V. is acting as Sole Global Coordinator and, together with Gilbert Dupont SNC as the Joint Bookrunners, for the Offering.
Certain of NOXXON's current shareholders have indicated their intention to subscribe for Shares in the Offering to underline their further support of the Company and its strategy.
Rationale for the Offering
The Company intends to use the net proceeds of the Offering for the further clinical development of its lead product candidate NOX-A12 in various oncology indications, advancement of its pre-clinical pipeline and discovery efforts to identify new immuno-oncology and tumor microenvironment-targeting product candidates, completion of the on-going NOX-H94 trial and general corporate purposes.
More about Spiegelmers
Spiegelmers are a new class of drug designed to combine the benefits of small chemical molecules and biologicals such as antibodies. They have been administered to more than 300 human subjects to date, with a good safety and tolerability profile. By using 'mirror image' chemistry, Spiegelmers solve two key problems that have limited the development of aptamer therapeutics. Spiegelmers have high stability in biological fluids since they are not recognized by naturally occurring enzymes that degrade RNA or DNA. Spiegelmers are also unlikely to elicit an immune reaction since they escape innate immune system surveillance. Spiegelmers can be manufactured chemically and therefore do not require complex biological production processes and NOXXON has established optimized production and quality control methods in-house and with partners for production in accordance with good manufacturing practice.
More about NOX-A12
NOX-A12 is a Spiegelmer drug candidate under development as a combination therapy in multiple cancer indications. It has shown promising results in pre-clinical and clinical studies, including in two Phase 2a trials. NOXXON intends to develop NOX-A12 in multiple myeloma, in advanced solid tumor cancers, such as lung and colorectal cancer, and in brain cancer. NOX-A12 has received orphan drug designation for two types of brain cancer; glioblastoma in the United States and glioma in Europe. NOX-A12 targets CXCL12, a key chemokine (signaling) protein, which promotes tumor proliferation, new blood vessel formation to the tumor, spread of the tumor and reduces tumor apoptosis (cell death). NOX-A12 is designed to be combined with other cancer targeting therapies to fight tumors by modulating the tumor microenvironment in three distinct ways:
Expose hidden tumor cells: NOX-A12's target, called CXCL12, attracts blood cancer cells to protective niches in the bone marrow. NOX-A12 is intended to expel tumor cells from these niches leaving cancer cells in the blood stream where they are more susceptible to tumor-killing drugs.
Break tumor protection: CXCL12 forms a protective biochemical 'wall' around certain solid tumors, blocking entry of immune system cells that can kill tumor cells. NOX-A12 has the potential to destroy the 'wall,' enabling active immune cells, such as killer T-cells, to enter the tumor with the aim of unleashing the full potential of immuno-oncology approaches such as immune checkpoint inhibitors.
Block tumor repair: CXCL12 attracts 'repair cells' to tumors damaged by anti-cancer therapy, for instance following radiotherapy. NOX-A12 is aimed at blocking this effect to prevent tumor re-growth.
NOXXON Pharma N.V. is a clinical-stage biopharmaceutical company focused on cancer treatment. NOXXON is using its proprietary class of drugs, "Spiegelmers", to target the tumor microenvironment, the new frontier in cancer treatment. NOXXON's goal is to significantly enhance the effectiveness of cancer treatments including immuno-oncology approaches (such as immune checkpoint inhibitors) and current standards of care (such as chemotherapy and radiotherapy). NOXXON's Spiegelmer platform has generated a broad proprietary pipeline of clinical-stage product candidates including its lead cancer drug candidate NOX-A12. NOXXON is supported by a strong group of leading international investors, including TVM Capital, Sofinnova Partners, Edmond de Rothschild Investment Partners, DEWB and NGN. NOXXON has its statutory seat in Amsterdam, The Netherlands and its office in Berlin, Germany. Further information can be found at: www.noxxon.com.
Important Legal Information
This announcement is not an advertisement within the meaning of the Prospectus Directive and does not constitute a prospectus. The offer to acquire Shares 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 made available in connection with such offering. When made available, copies of the prospectus may be obtained at no cost from the Company and through the website of the Company.
These materials are for informational purposes only and are not intended to constitute, and should not be construed as, an offer to sell or subscribe for, or the announcement of a forthcoming offer to sell or subscribe for, or a solicitation of any offer to buy or subscribe for, or the announcement of a forthcoming solicitation of any offer to buy or subscribe for, ordinary Shares in the share capital of the Company in the United States, Australia, Canada, Japan or in any jurisdiction to whom or in which such offer or solicitation is unlawful. Persons into whose possession this communication comes should inform themselves about and observe any such restrictions. Any failure to comply with these restrictions may constitute a violation of the security laws of any such jurisdiction.
The Shares have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "Securities Act") and may only be offered or sold in the United States pursuant to registration or an exemption from registration under the Securities Act. The Company does not intend to register any portion of the contemplated offering of Shares in the United States or to conduct a public offering of Shares in the United States. 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 Company has not authorized any offer to the public of Shares in any Member State of the European Economic Area, except in the Netherlands and France. With respect to any Member State of the European Economic Area which has implemented the Prospectus Directive (each a "Relevant Member State"), none of the Shares may be offered or sold to the public in that Relevant Member State prior to the publication of a prospectus in relation to the Shares, which has been approved by the competent authority in that Relevant Member State or, where appropriate, approved in another Relevant Member State and notified to the competent authority in that Relevant Member State, all in accordance with the Prospectus Directive, except that an offer of such Shares may be made to the public in Relevant Member States:
(i) to any legal entity which is a "qualified investor" as defined in the Prospectus Directive;
(ii) to fewer than 150 natural or legal persons (other than qualified investors as defined in the Prospectus Directive), as permitted under the Prospectus Directive; or
(iii) in any other circumstances falling within Article 3(2) of the Prospectus Directive, provided that no such offer of Shares shall require the Company to publish a prospectus or a supplement to an existing prospectus pursuant to Article 3 of the Prospectus Directive or any measure implementing the Prospectus Directive in a Relevant Member State and each person who initially acquires any Shares or to whom any offer is made under the offering of the Shares will be deemed to have represented, acknowledged, and agreed that it is a "qualified investor" within the meaning of Article 2(1)(e) 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 Relevant Member State by any measure implementing the Prospectus Directive in that Relevant Member State and the expression "Prospectus Directive" means Directive 2003/71/EC (as amended, including by Directive 2010/73/EU), and includes any relevant implementing measure in the Relevant Member State.
In the United Kingdom, this document and any other materials in relation to the Shares is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates 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"). This communication is directed only at relevant persons. Persons who are not relevant persons should not take any action on the basis of this document and should not act or rely on it. No action has been taken by the Company that would permit an offer of the Shares or the possession or distribution of this press release or any other offering or publicity material relating to such Shares in any jurisdiction where action for that purpose is required. Any investment activity to which this communication relates will only be available to and will only be engaged with, relevant persons.
Some of the information in these materials may contain projections or other forward-looking statements regarding future events or the future financial performance of the Company. You can identify forward-looking statements by terms such as "expect", "believe", "anticipate", "estimate", "intend", "will", "could", "may" or "might", the negative of such terms or other similar expressions. These statements are only predictions, actual events or results may differ materially and will not be updated to reflect events and circumstances occurring after the date hereof or to reflect the occurrence of unanticipated events. Many factors could cause the actual results to differ materially from those contained in projections or forward-looking statements of the Company, including, among others, general economic conditions, the competitive environment, rapid technological and market change in the industries the Company operates in, as well as many other risks specifically related to the Company and its operations.