Giacomo Di Nepi, Chief Executive Office of Polyphor, said: “Resistance to antibiotics is a growing healthcare crisis. If allowed to carry on at its current pace, it is estimated antimicrobial resistance would lead to 10 million people dying every year by 2050. In murepavadin, we have brought to late stage development the first in a new class of antibiotics which we believe has the potential to be highly effective and against which pathogens may only slowly build resistance. In addition, our immuno-oncology candidate, balixafortide, could benefit certain women suffering from advanced metastatic breast cancer and potentially reach the US market with only one pivotal study. “The planned IPO will allow us to continue the development of murepavadin to treat Pseudomonas aeruginosa, the second leading cause of nosocomial pneumonia, which has mortality rates of approximately 30% - 40%, and progress the development of balixafortide and of further innovative antibiotics.”
Polyphor Overview
Polyphor is a clinical stage biopharmaceutical company based in Allschwil, Switzerland. Its lead antibiotics product candidate murepavadin (POL7080) recently entered Phase III clinical development and its immuno-oncology compound balixafortide (POL6326) has received a positive review from the FDA during an end of Phase I meeting, allowing it to potentially reach the US market with one pivotal study. POL6014, a drug for the treatment of respiratory diseases, has recently been out-licensed to Santhera. Polyphor aims to become a sustainable biopharmaceutical company focused on innovative antibiotics and other specialty pharma products, bringing first-in-class or best-in-class new medicines to patients.
Polyphor has a diverse Swiss and international investor base including Ingro Finanz, Varuma, Rosetta Capital and BioMed Partners.
Business overview and strengths
Polyphor has discovered and developed a new class of antibiotics for Gram-negative bacteria
The most aggressive pathogens are Gram-negative bacteria including a number which are among the leading causes of severe infections throughout the world. Many of their strains are becoming resistant to most - and in some cases all - commonly used antibiotics. Polyphor’s new class of antibiotics, outer membrane protein targeting antibiotics (“OMPTA”), are potentially the first new class of antibiotics against Gram-negative bacteria that have reached Phase III clinical development in more than 50 years and have the potential to be highly effective antibiotics against which bacteria may only slowly build resistance.
Murepavadin has the potential to lead to a paradigm shift in the fight against Pseudomonas aeruginosa
Pseudomonas aeruginosa is one of the most dangerous Gram-negative bacteria and the second leading cause of nosocomial pneumonia, with mortality rates of approximately 30% – 40%. Its strain that is resistant against the widely used antibiotic carbapenem has been classified as one of the top three critical pathogens by the World Health Organization (“WHO”).
Murepavadin, now in Phase III clinical development, is a pathogen-specific antibiotic and is being developed for the treatment of nosocomial pneumonia (including both hospital-acquired (“HABP”) and ventilator-associated bacterial pneumonia (“VABP”)) due to Pseudomonas aeruginosa. Based on promising Phase II results, Polyphor has agreed on a streamlined development pathway for murepavadin with the FDA and the EMA and recently started its first Phase III clinical trial.
Polyphor believes murepavadin may lead to a paradigm shift in the treatment of nosocomial pneumonia due to Pseudomonas aeruginosa and become the standard of care in the treatment of patients with confirmed nosocomial pneumonia due to multidrug resistant and extensively drug-resistant strains. Polyphor estimates that in 2028 murepavadin could potentially be addressing an overall market opportunity in the range of USD 2-3 billion.
Immuno-oncology compound, balixafortide, advancing into late-stage development in breast cancer
Balixafortide is Polyphor’s lead representative compound in immuno-oncology and is aimed at treating breast cancer in combination with other approved therapies. Balixafortide is the only CXCR4 antagonist in development for breast cancer and is the most advanced in this class being developed in solid tumours, being the first product candidate to reach proof of concept. The molecule was discovered based on Polyphor’s proprietary macrocycle technology platform. Balixafortide has shown strong results in a Phase Ib/proof of concept clinical trial in combination with eribulin in patients affected with advanced metastatic breast cancer. These were recently presented at the American Association of Cancer Research (AACR) and discussed in February 2018 in a meeting with the FDA. The development path identified with the input of the FDA is to conduct a single pivotal study to achieve approval in HER-2 negative metastatic breast cancer patients who previously received at least two chemotherapeutic regimens. Additionally, there is the possibility of achieving an accelerated conditional approval based on interim results. Balixafortide might also provide additional upside in other oncology indications or combinations. Innovative pipeline of assets provides further upside potential
Polyphor aims to select a new medium spectrum OMPTA pre-clinical candidate targeting drug resistant strains of Gram-negative bacteria and is developing an inhaled formulation of murepavadin for the treatment of chronic Pseudomonas aeruginosa infections in patients with cystic fibrosis, other respiratory conditions, and as an additional treatment for nosocomial pneumonia due to Pseudomonas aeruginosa.
Polyphor has out-licensed its product candidate POL6014 which was developed for the treatment of chronic inflammation in cystic fibrosis patients and which may have potential in other respiratory indications. Polyphor may receive milestone payments and royalties in the future.
Highly experienced team with successful track records
Polyphor has an internationally-trained team which comprises highly experienced drug development professionals with successful track records at leading companies, including Roche, Novartis and InterMune. Giacomo Di Nepi, CEO, was most recently Executive Vice President and General Manager, Europe for InterMune, where he launched an orphan drug in Europe, which grew to a USD 140 million business with 200 employees. Polyphor’s Board of Directors has complementary backgrounds in the leadership and successful stewardship of private and public pharmaceutical companies, research and development, finance and M&A.
Offer summary
The envisaged offering is expected to consist of a public offering in Switzerland and private placements in Switzerland and internationally, including to qualified institutional buyers in the US under Rule 144A. The offering is expected to be in the range of CHF 100 to 150 million and comprise solely a primary offering with no secondary share sales and existing shareholders subject to customary lock-ups.
UBS AG and Deutsche Bank AG have been appointed as Joint Global Coordinators and Joint Bookrunners for the proposed IPO and Cantonal Bank of Zurich and Cantor Fitzgerald as Co-Lead Managers. Octavian acts as Selling Agent. Skadden, Arps, Slate, Meagher & Flom LLP and VISCHER AG are acting as legal advisors to Polyphor. Linklaters LLP and Bär & Karrer Ltd. are representing the Joint Global Coordinators.
For further information please contact:
Company:
Franziska Daabour
Communications
Polyphor Ltd.
Tel: +41 61 567 16 00
Email: PR@polyphor.com
For Investors:
Kalina Scott
Chief Financial Officer
Polyphor Ltd.
Tel: +41 61 567 16 67
Email: PR@polyphor.com
Swiss media:
Dynamics Group
Edwin van der Geest/Alexandre Muller
Tel: +41 43 268 32 32
Email: amu@dynamicsgroup.ch
International media:
Consilium Strategic Communications
Chris Gardner/Lindsey Neville
Tel: +44 (0) 203 709 5700
Email: polyphor@consilium-comms.com
About Polyphor
Polyphor is a clinical stage, privately held Swiss specialty pharma company which has discovered and is developing the OMPTA (Outer Membrane Protein Targeting Antibiotics). The OMPTA are potentially the first new class of antibiotics against Gram-negative bacteria to have reached phase III stage in the last 50 years. The company’s lead product, murepavadin, (POL7080) is in Phase III development against Pseudomonas aeruginosa – recognized as a critical priority 1 pathogen by WHO. Polyphor is also developing an immuno-oncology candidate, balixafortide (POL6326), which has achieved clinical proof of concept in a Phase Ib/proof of concept study in combination with eribulin in patients with advanced breast cancer, and a pipeline of further preclinical antibiotics based on its OMPTA platform. Polyphor is based in Allschwil near Basel. For more information, please visit www.polyphor.com
Disclaimer
These materials may not be published, distributed or transmitted in the United States, Canada, Australia or Japan. These materials do not constitute an offer of securities for sale or a solicitation of an offer to purchase securities (the “Securities”) of Polyphor Ltd. (the “Company”) in the United States, Switzerland or any other jurisdiction. The Securities of the Company may not be offered or sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended (the “Securities Act”). The Securities of the Company have not been, and will not be, registered under the Securities Act. Any sale in the United States of the securities mentioned in this communication will be made solely to “qualified institutional buyers” as defined in, and in reliance on, Rule 144A under the Securities Act.
This publication constitutes neither an offer to sell nor a solicitation to buy any securities. This document is not an issuance or listing prospectus or a similar document in the sense of article 652a, article 752 and/or article 1156 of the Swiss Code of Obligations or articles 27 et seq. of the Listing Rules of the SIX Swiss Exchange Ltd. and was not reviewed by any competent authority. Any offer of securities of the Company will be made solely by means of, and on the basis of, an offering memorandum that will contain detailed information about the Company and its management as well as risk factors and financial statements. Any person considering the purchase of any securities of the Company must inform itself independently based solely on such offering memorandum (including any supplement thereto).
This document does not constitute an “offer of securities to the public” within the meaning of Directive 2003/71/EC of the European Union, as amended (the “Prospectus Directive”) of the securities referred to herein in any member state of the European Economic Area (the “EEA”). Any offers of the securities referred to in this document to persons in the EEA will be made pursuant to an exemption under the Prospectus Directive, as implemented in member states of the EEA, from the requirement to produce a prospectus for offers of the Securities. In any EEA Member State that has implemented the Prospectus Directive, this document is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Directive, i.e., only to investors who can receive the offer without an approved prospectus in such EEA Member State.
In the United Kingdom, this document is only being distributed to and is only directed at persons who (i) are investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended) (the “Order”) or (ii) are persons falling within Article 49(2)(a) to (d) of the Order (high net worth companies, unincorporated associations, etc.) (all such persons together being referred to as “Relevant Persons”). This document is directed only at Relevant Persons and must not be acted on or relied on by persons who are not Relevant Persons. Any investment or investment activity to which this document relates is available only to Relevant Persons and will be engaged in only with Relevant Persons.
This communication may contain statements about the future that use words such as, for example, “believe”, “assume”, “expect”, “forecast”, “project”, “may”, “could”, “might”, “will” and other similar expressions. Such statements about the future are subject to known and unknown risks, uncertainties, and other factors, which can cause the true results, financial situation, development or performance of the Company to differ significantly from that which is expressly or implicitly assumed in these statements. In view of these uncertainties, the reader should not depend on this type of statement about the future. The Company gives no undertaking whatever to update such statements regarding the future, or to adapt them to future events or developments.
Original Article: Polyphor announces plans to IPO and list on SIX Swiss Exchange