INVEST IN TOPADUR! HEALTH IS THE MOST IMPORTANT THING IN LIFE! TOPADUR PHARMA AG a promising Swiss start-up investment Global Medical Need: Diabetes mellitus is one of the major health concerns worldwide. In 2014, 422 million of adults had diabetes across the globe (see WHO 2016). In the population of diabetics, the annual incidence of DFU is 4-10% world-wide (see WUWHS 2016). The global prevalence of DFU across diabetics is 6.3% (see Zhang 2016). Diabetics have a 25% life time risk being afflicted with DFU (see Bakker 2016). Annual DFU care costs amount to $ 9-13 bn in the US alone (see Bakker 2016). DFU is the most frequent cause of lower extremity amputations (LEA). In fact, every 20 seconds a lower limb is lost due to diabetes somewhere in the world (see Cancelliere 2016). In spite of significant improvements with current SoC (Standard of Care) remains a pressing need for innovative treatments. Therapies based on TOPADUR s TOP-N53 medical compound are expected to provide significant benefit on top of existing treatment options for wound healing and prophylaxis of diabetic foot ulcers. TOPADUR PHARMA AG GRABENSTRASSE 11A 8952 SCHLIEREN T: +41 44 755 44 61 investors@topadur.com
Overview: Why should you invest in TOPADUR? HEALTH IS THE MOST IMPORTANT THING IN LIFE! As a consequence, our young company is putting its focus primarily into the research fields of new and innovative and sustainable medical therapies for severe wound-healing which add concrete precious value not only to patients but also to investors accompanying us on our path to success. TOPADUR follows a disciplined development strategy to efficiently guide the drug candidates through a clinical proof of concept (PoC), followed by a fast frontrunner development. Our utmost modern Research & Development (R&D) platform reflects these ambitious goals and allows the achievement of those scientific research results in an efficient and cost-effective way in comparison to our competitors in the field. In the framework of our strategical planning and during the course of 2018 we will leave the current preclinical phase and will enter clinical studies (i.e. clinical phases I III) based on our concentrated focus on our first medical compound TOP-N53. This will attract additional sustainable potential investors as the discount rate which is used for the valuation of a clinical stage company will decrease the more mature the company is. While a start-up or a company that is still in discovery stage faces a high cost of capital over 20%, a clinical stage company already use a lower discount rate. When a company has a project on market the cost of capital usually is already close to a large pharmaceutical company discount rate, i.e. between 8% and 10%. 1 So the discount rate seems to depend mainly on the stage of a company. The most important property of the stage of a company is doubtlessly its probability to ultimately take one project to the market and enter profitability. We therefore can observe a direct relationship between success rate and risk premium which of course - is also relevant to each investor in his distinguished decision-making process. TOPADUR will enter clinical phase studies in late 2018 which will 1 Source : «News in AVANCE No. 1» Valuation in Life Science, published in January 2008 by avance Corporate Finance in Life Science ; www.avance.com Seite 2/6
have a huge impact on the interest of investors not only in Switzerland but also abroad. It goes without saying that the success of TOPADUR is closely linked with its scientific research and the progress made thereto. Only with success in the lab we can enter a profitability zone for our investors. As biotech research and development is a cost intense endeavor costs, especially for clinical trials depend on the company conducting the trials. We at TOPADUR are proud to have much lower costs as competitors in the field. A rule of thumb is that clinical trials performed by pharma cost five times more than those performed by biotech which again makes us very attractive for a future acquisition or an out-licensing agreement with big pharma. This means that the numbers published by DiMasi do not apply for small biotech companies one on one. Actually, there are many sophisticated risk assessment models in literature which have been produced by Tufts University in the USA and these have in practice been accepted as an industry standard for valuations of products through the various stages of development. Those Tufts or DiMasi (named after the originator) numbers estimate the probability of success and conversely the likelihood of failure at each stage of the development process. Pharmaceutical companies cover more indications in their trials than biotech companies that conduct the minimum program. Furthermore, early stage valuations often incorporate future license contracts from which an investor in TOPADUR will be able to profit as well. In that case costs have to be adjusted for the respective company. 2 TOPADUR is an attractive alternative investment for you and you are cordially invited to become part of our success story and to support us in our challenging field of scientific research in new diabetes mellitus medical therapy product development. Together with you TOPADUR will shape the future! TOPADUR s mission is to maximize value for patients, you as our investor and employees through unlocking the potential of the available assets for the benefit of the patient community. TOPADUR is targeting unmet medical needs in big therapeutic areas focusing on wound healing. We discover, develop and commercialize new and patented highly active drugs for topical delivery. While focusing the drug discovery efforts on topical drugs, other drug candidates will be evaluated for potential oral or slow release application as well to maximize the value of TOPADUR s prime product pipeline to become a first-entrant in the global markets with new and innovative drugs. Assets: TOPADUR s lead R&D programs are locally active, dual mode of action highly potent drug candidates, which are effective and safe therapeutic principles. We own drug candidates with game-changing potential for the treatment of non-healing wounds (TOP-N53) and the prevention of excessive scar formation (TOP-N44). For both development candidates back-up compounds are available. Based on the important discovery to design super-potent dual mode of action drugs, designed to increase local blood flow, TOPADUR owns an opportunistic medicinal chemistry program around a third product called TOP-N73 with the objective of out-licensing in indications not followed by TOPADUR as exemplified by local treatment of erectile dysfunction. This drug candidate has a comparable dual mode of action like TOP-N53 and should be much superior compared with drugs on the market for the target indications. 2 Quelle: www.avance.ch «News in Avance Valuation in Life Sciences», Januar 2008 Ausgabe No.1. Seite 3/6
TOPADUR s development candidates work on validated drug targets leading to higher than average clinical success chances. Both drug candidates are unique, first in class products targeting huge markets with unmet medical needs and as such allowing the investor to participate in the leveraging of profits. TOP-N73 is an out-licensing opportunity for topical erectile dysfunction and pulmonary arterial hypertension PAH indications, which are not in the main focus for us at TOPADUR. This drug candidate, however, has a comparable dual mode of action like TOP-N53 and should be much superior compared with drugs on the market for the target indications. Thus, an investment in TOPADUR is not only a promising Return on Investment (ROI) but also and this should particularly be emphasized will directly offer you as our sophisticated investor a clear participation with your own personal contribution and mission participation in the development and creation game-changing future oriented modern medical therapies in areas of huge medical need. In other words you are doing good things with an investment in TOPADUR and will change the world for better! So why should you not grant us your allegiance and your support and together with us enter the risk to create a flagship medical product to become part of an INVESTMENT IN THE FUTURE and become yourself a part of a success story to change the world for the better? Please note that currently TOPADUR is so far only accepting investments on the basis of Convertible Loans / Private Equity. The planned investor exit is scheduled for 2022 the latest after successful completion of clinical phases I/II by way of an out-licensing agreement to a strategical partner. Should you request additional information please do not hesitate to contact us directly. We will be proud to present to you as our potentially interested investor here on location at our state-of-the-art laboratories within BiotechPark in Schlieren near Zurich (Switzerland) our exclusive TOPADUR Family in person. By way of a personal visit you meet the brains behind TOPADUR s success story and our scientists and we will be glad to guide you through our distinguished organization. You are welcome to join us after a phone call or e-mail announcement as we are happy to meet you in person (see also CONTACT ADDRESS for INVESTORS RELATIONS on front sheet). Business and Operational Strategy: The ultimate vision is to bring two innovative products to the market addressing huge unmet medical needs as outlined above. TOP-N53 enabling healing of chronic, non-healing wounds (e.g. DFU) and TOP- N44 inhibiting formation of hypertrophic scars / keloids. Revenues will be generated through the outlicensing & partnering process. In order to efficiently advance the already available products and maximize value for patients TOPADUR may decide on internal clinical development programs (orphan & hospital-based indications), in which TOPADUR aims to become a prime niche player with own innovative products in smaller markets with high-unmet medical need. Our USP (Unique Sales Proposition) will automatically place TOPADUR on another level playing field for each investor as due to our innovative strategy we are becoming of utmost interest not only to big pharma but also to other global acting strategic companies operating in our field of research. Seite 4/6
This is also why we focus with increased energy on optimizing our R&D efforts to reach an early Proof of Concept (PoC) in human in our early-stage company strategy. This will allow TOPADUR to become an early-entrant in the market leveraging your profits even more in the years to come. We are in fact envisaging market-leadership and as such both out-licensing models and strategic partnership and alliances with big pharma are options we pro-actively pursue with our future-oriented modern and cost-effective strategy. TOPADUR truly an investment opportunity not to be missed! TOPADUR Leadership: TOPADUR s management team consolidates more than 75 years of experience in drug discovery and drug development in globally operating pharmaceutical companies and has made many key contributions to several drugs on the market. The management team integrates long-standing experience in the management of drug discovery (lead discovery and optimization) and development projects including for topical products and in the target class addressed in the current application, of large groups in biomedical research and development organizations and finance & administration. In the area of finance, we are competent and professional partners for you as our highly appreciated investor in a fellowship to success. We are glad to provide you with further insights and discuss further details on investment opportunities in TOPADUR with you and our CEO. Beginning of May 2017, we were able and proud to welcome our latest member of the board, Dr. Dominik Escher, in our exclusive leadership circle and we do hope to be able to attract additional economic or scientific minds in our executive board. The huge experience and competencies on various fields of pharma and biotechnology make our board unique amongst other start-ups and create a momentum of fruitful discussions amongst them board members. Innovative ideas, creativity and efficiency are therefore guiding and truly lived principles of our senior management: Topadur Board (please note that our CEO Dr. Reto Naef is not presented here. You are welcome to meet him up close and personal on our special website: www.topadur.com ) Seite 5/6
IP Strategy: TOPADUR has strong, broad compound IP for all three products. The first key patent covering TOP-N53 has been filed in November 2015. The second key patent covering TOP-N44 was filed during the course of Q4 2016 followed by the third compound patent for TOP-N73 which was filed in Q1 2017. Close collaborations with elite Universities and CROs: Moderate internal growth is a strategic component and realized by consequently envisaging a small but efficient overhead; managing and quality control through carefully selected high-caliber external academic collaborators & profound CRO (Contract Research Organizations) activities. Outsourcing of R&D activities will be strongly supported by the broad network of the experienced management team and their prime global networks. In order to allow a timely but budget-sensitive advancement of both projects, TOPADUR has established R&D collaborations with CRO s and universities (Swiss Federal Institute of Technology (ETH) Zurich, University Hospital Zurich, Valencia University Hospital and University Hospital of Schleswig-Holstein in Lübeck). Negotiations with additional CRO s and big pharma partners are ongoing and preliminary talks were initiated by the CEO in 2017. Financials: TOPADUR has raised CHF 2.2 million in a Series A investment round (March 2016) and has approved CTI and EUROSTARS grants for CHF 1.1 million, which will allow to conduct proof of concept studies in animals for both development compounds. Another milestone for us was the achievement of CTI label in July 2016. The second financing round was successfully finalized in Q2 2017 and added an additional CHF 6 million as Series B investment, of which CHF 4 million have been committed by the series A investors showing the trust existing investors put in our team. This financing round will enable us to complete the preclinical development of both compounds described above and the proof of concepts in humans by the end of 2018 with one of the development drugs. Last but not least of key importance to you as potential new investor is the fact that we currently work on establishing a new Series C investment gathering round for selected investors until year-end 2018. We are looking forward to welcoming you in our exclusive investor family of TOPADUR should you also take this exclusive investment proposals into further consideration to participate in a very promising investment. Schlieren (Zurich), 25th January 2018 MD/em Seite 6/6