News & Events
| 10/7/2013 EDISON values SYGNIS at 37.5 million euros |
| • This valuation amply exceeds the current market quotation and ascribes the shares a potential growth rate of more than 50%. • EDISON base their analysis on three of SYGNIS’ current products, including QualiPhi, which was licensed to Qiagen and will be launched in the third quarter of this year. Madrid/Heidelberg, 10 July 2013 – EDISON, international analysts who specialize in listed companies of the industry, recently published a thorough analysis of the biotech company SYGNIS Pharma AG (Frankfurt: ; ISIN: ; Prime Standard segment of the German Stock Exchange). As a result of EDISON’s analysis of the company, the objective value of SYGNIS, taking into account the launch of QualiPhi in the third quarter of 2013 – licensed by Qiagen – as well as the license of two further products this year: PrimPol and Double Switch, would reach 37.5 million euros. SYGNIS shares were listed at 2.63 euros last Tuesday at Frankfurt’s stock market, with capitalization close to 25 million euros. Therefore, EDISON’s estimations place the value of the shares at a potential increase of more than 50% for its shareholders this year. In order to undertake the analysis of the share value of SYGNIS, EDISON focused on the predicted income of three products: QualiPhi, PrimPol and Double Switch. Meanwhile, EDISON have not considered any additional products the company has been developing (DNA repair kit), thus the income assumptions can be considered conservative. QUALIPHI®, is an improved version of DNA Polymerase Phi 29. It was generated in Professor Margarita Salas’ lab, with the collaboration of Professor Luis Blanco, in the CSIC. Using this as a starting point, the X-POL team (GENETRIX Group), known today as SYGNIS, developed a product of unique characteristics, focused on isothermal DNA amplification, which was licensed to Qiagen in July 2012. The commercialization of this product will start in the third quarter of 2013. PrimPol is a new enzyme with the characteristics of a primase (it does not need random primers to initiate the process) and a polymerase with elevated proofreading capacity and high processivity, making it an optimal tool not only for DNA amplification, but also for simplifying some technical aspects of RNA amplification. DoubleSwitch is a cellular technology that identifies and quantifies interactions between proteins in a cell. Knowledge about the mechanism in which proteins interact is particularly relevant not only in proteomics, a field of growing interest, but also to develop personalized drugs. About SYGNIS Pharma AG: www.sygnis.de After the merger in 2012 between X-Pol Biotech, specialising in DNA amplification and sequencing, and SYGNIS Pharma AG, listed in the German Stock Exchange (Prime Standard segment, Tick: ; ISIN: ), SYGNIS’ new mission is to develop and distribute technologies and products from X-Pol, which has a commercial product in the DNA amplification segment, QualiPhi® and is currently developing other products in the field of Next Generation Sequencing. # # # Disclaimer: Some statements included in this press release, relating neither to proven financial results nor to other historical data, should be viewed as forward-looking, i.e. not definitive. Such statements are mainly predictions of future results, trends, plans or goals. They should not be considered to be total guarantees since given their very nature, they are subject to known and unknown risks, as well as to aspects beyond human control, and can be affected by other factors as a consequence of which the actual results, plans and goals of SYGNIS Pharma AG may deviate greatly from the established conclusions or implied predictions contained in such statements. SYGNIS does not undertake to publicly update or revise said statements in light of new information or future results or for any other reason. # # # |
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| 9/7/2013 Genetrix, between the most committed Spanish companies to innovation |
 King Juan Carlos received yesterday at Zarzuela those companies that integrate the board of Cotec, a foundation that integrates Spanish companies that most enhance innovation and to which Genetrix has recently joined.Origin and background In 1990, in response to a suggestion made by His Majesty the King, a group of entrepreneurs decided to create a business supported institution with a view to contributing to the promotion of technological innovation and increasing society’s awareness of technology. This goal, of fundamental importance in improving competitiveness, has been at the forefront of that project which adopted the Foundation status in October 1992. Today Cotec is a well-rooted mature organisation with its sights set on the future. Its completely private and indisputable business origins, the number and importance of the institutions and companies which have joined the initial project and, especially, the invaluable support received from the very beginning from the Crown, make Cotec a special organisation and, in a certain sense, unique among countries like ours. |
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| 16/5/2013 SYGNIS licenses amplification buffer to QIAGEN |
• Agreement follows a global licence agreement signed with QIAGEN in 2012. • First non-exclusive licence agreement for a new amplification buffer developed by Professor Salas at the CSIC laboratory. Madrid/Heidelberg, 16 May 2013 – Spanish-German biotech company SYGNIS Pharma AG (Frankfurt: ; ISIN: , Prime Standard segment of the German Stock Exchange) has signed a licence agreement for the distribution of a new amplification buffer with QIAGEN, the global leader in sample and assays technologies. This is the second agreement with QIAGEN within 9 months and the first licence agreement for the amplification buffer technology developed by the team led by renowned Professor Margarita Salas at the CSIC laboratory. The recently granted licence covers a new amplification buffer, a tool used in isothermal amplification, providing superior reaction performance. “With the new agreement, SYGNIS adds a global reference in the sector in the fields of DNA amplification research and commercial markets. This newly signed agreement shows that SYGNIS is making progress in the commercialization of core technologies and products designed for the DNA sequencing and amplification market. It strengthens the network of relationships we maintain with life science and diagnostics companies in the DNA amplification industry,” SYGNIS’ CEO Pilar de la Huerta commented. Background In July 2012, through X-POL, SYGNIS reached an exclusive global licence agreement with QIAGEN for the distribution of the polymerase QualiPhi®. QualiIPhi® is an upgraded version of phi 29 DNA polymerase. Compared to similar polymerase proteins on the market, the new one exhibits enhanced properties. Being less time-consuming and having highly superior performance characteristics, the method developed by SYGNIS enables DNA amplification from concentrations as low as those found in a single cell. This is extremely useful in cancer research, among other applications. Polymerase proteins are the main tool for amplifying long DNA fragments and whole genomes, and are basic in research involving analysis and modification of DNA from any species. About SYGNIS Pharma AG: www.sygnis.de After the merger in 2012 between X-Pol Biotech, specialising in DNA amplification and sequencing, and SYGNIS Pharma AG, listed in the German Stock Exchange (Prime Standard segment, Tick: ; ISIN: ), SYGNIS’ new mission is to develop and distribute technologies and products from X-Pol, which has a commercial product in the DNA amplification segment, QualiPhi® and is currently developing other products in the field of Next Generation Sequencing.// # # # Disclaimer: Some statements included in this press release, relating neither to proven financial results nor to other historical data, should be viewed as forward-looking, i.e. not definitive. Such statements are mainly predictions of future results, trends, plans or goals. They should not be considered to be total guarantees since given their very nature, they are subject to known and unknown risks, as well as to aspects beyond human control, and can be affected by other factors as a consequence of which the actual results, plans and goals of SYGNIS Pharma AG may deviate greatly from the established conclusions or implied predictions contained in such statements. SYGNIS does not undertake to publicly update or revise said statements in light of new information or future results or for any other reason. # # # |
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| 15/5/2013 SYGNIS reports results for the first quarter of 2013 |
| • Operating expenses decreased by over 50 percent • Operating result significantly improved • U.S. patent for flagship product QualiPhi® (after period-end) • Outlook confirmed Madrid/Heidelberg, May 15, 2013 – SYGNIS Pharma AG (Frankfurt: , ISIN: ; Prime Standard) today announced its financial results according to IFRS for the first quarter of 2013, ending 31 March 2013. In the first quarter of 2013, revenues amounted to €0.1 million; operating expenses amounted to €1.3 million. Operating expenses include sales, general & administrative costs of €0.6 million EUR as well as research & development costs of €0.7 million, focused on DNA amplification and sequencing. The resulting net loss for the period was €-1.2 million. Due to the merger of SYGNIS with X-Pol Biotech (X-Pol) effective December 4, 2012, the results for the first quarter 2013 are not fully comparable to the financial results reported for the prior-year period. Following the reverse acquisition the first quarter of 2013 includes income and expenses of the old SYGNIS group and of X-Pol, while the first quarter of the previous year only records income and expenses of X-Pol. Adjusted for this effect, i.e. assuming that the income and expenses of both parts of the business would have been fully taken into account already in the first quarter 2012, the pro forma comparison of periods shows a significant decrease in operating expenses by more than 50% to €1.3 million (pro forma Q1 2012: €2.7 million) and an improvement in the operating result of 70% to -€1.2 million (pro forma Q1 2012: €-4.0 million). As of March 31, 2013, cash and cash equivalents amounted to €0.2 million (31 December 2012: €0.5 million). Funding of ongoing activities is currently secured until mid-year with loan commitments by the main shareholders. The Company has received in the first quarter of 2013 the first tranche (€0.1 million) of the loan given by the main shareholders Genetrix Life Sciences, A.B. and dievini Hopp BioTech holding GmbH & Co. KG. Pilar de la Huerta, CEO and CFO of SYGNIS commented: "The first quarter was very successful for SYGNIS. Due to the implemented restructuring measures we were able to significantly reduce our cost base. At the same time we have reached important milestones in product development and in April we secured a key patent for our flagship product QualiPhi®.” Outlook SYGNIS confirmed the outlook stated in the Annual Report 2012, published on 30 April 2013. According to this guidance, the company expects further commercial agreements and first revenues from product sales in 2013. The company plans to reach break-even in 2014 fiscal year. The interim report for the first quarter, ended 31 March 2013, is available at www.sygnis.de. About SYGNIS Pharma AG: www.sygnis.de After the merger in 2012 between X-Pol Biotech, specialising in DNA amplification and sequencing, and SYGNIS Pharma AG, listed in the German Stock Exchange (Prime Standard segment, Tick: ; ISIN: ), SYGNIS’ new mission is to develop and distribute technologies and products from X-Pol, which has a commercial product in the DNA amplification segment, QualiPhi® and is currently developing other products in the field of Next Generation Sequencing. ### Disclaimer Some statements included in this press release, relating neither to proven financial results nor other historical data, should be viewed as forward-looking, i.e. not definite. Such statements are mainly predictions of future results, trends, plans or goals. These statements should not be considered to be total guarantees since given their very nature they are subject to known and unknown risks and imponderability and can be affected by other factors as a consequence of which the actual results, plans and goals of SYGNIS Pharma AG may deviate greatly from the established conclusions or implied predictions contained in such statements. SYGNIS does not undertake to publicly update or revise these statements in the light of new information or future results or for any other reason. ### |
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| 30/4/2013 SYGNIS reports financial results for fiscal year 2012 |
• Strategic realignment completed - discontinuation of drug development • New business model shows first commercial success • Progress in restructuring and cost saving Heidelberg, April 30, 2013 – SYGNIS Pharma AG (Frankfurt: ; ISIN: ; Prime Standard) today reported results for the fiscal year 2012 ending on December 31, 2012. The reverse acquisition of X-Pol Biotech led to a change in the fiscal year. Due to the business combination the new SYGNIS includes the total income and expenses of X-Pol for 2012 and those of old SYGNIS only for December 2012, which affects equity in the fully consolidated balance sheet accordingly. In addition, the prior year figures published relate to X-Pol Biotech fiscal year 2011, due to accounting requirements based on the reverse acquisition. Thus, the changes in financial statements primarily result from the purchase price allocation and the recognition of fair values of the old SYGNIS, while values of X-Pol products are reflected in the balance sheet only with their carrying amounts and not with their fair values. The comparability of the financial results reported with the corresponding prior-year data is therefore very limited. In 2012, SYGNIS was focussed on the strategic realignment. In this context, activities in the area of drug development for diseases of the central nervous system have been stopped and extensive restructuring measures were initiated to significantly reduce the Company’s cost basis. As a result of the business combination with the Spanish company X-Pol Biotech, which was successfully completed in December 2012, SYGNIS now owns an entirely new business model focussed on the development and marketing of novel technologies in the area of molecular diagnostics, e.g. in DNA amplification and sequencing. In July 2012, SYGNIS granted an exclusive global license to QIAGEN N.V. for the key product QualiPhi®, an improved polymerase for amplifying DNA. On this basis the Company received a one-time payment and will receive sales-dependent royalties. First revenues are expected in 2013. Pilar de la Huerta, CEO / CFO, commented: “The fiscal year 2012 of SYGNIS was marked by the successful business combination of SYGNIS and X-Pol Biotech. As a consequence, important steps for the future and restructuring measures were taken that have already been implemented. We were able also, to show first commercial success. We are delighted to have signed an exclusive worldwide license agreement with the market leader QIAGEN for our flagship product QualiPhi®. We will generate first revenues in the current year and plan break-even in fiscal year 2014.” In financial year 2012, the reported loss for the period was -€2.4 million (previous year: -€0.9 million). The decrease primarily resulted from impairments of intangible assets of €1.0 million (previous year: €0.0 million) which were necessary due to a lack of probability of the future commercialisation of assets for various projects of X-Pol Biotech. Furthermore, operating expenses of old SYGNIS are included for December. R&D expenses increased to €1.0 million (previous year: €0.5 million). Madrid, Spain/Heidelberg, Germany Revenue was €0.2 million (previous year: €0.0 million), mainly resulting from the marketing of QualiPhi®. Total assets rose from €2.2 million to €9.6 million, primarily due to the goodwill resulting from the business combination of €5.9 million, as the market value of the old SYGNIS was higher than the fair values of its assets at the acquisition date. In addition, other intangible assets increased from €1.1 million to €2.3 million. Here the major effects were the development program DoubleSwitch and the Caco2 licence business, both capitalized on the old SYGNIS business. Equity was strengthened accordingly by €5.8 million to €6.3 million. Cash outflow from operating activities was up from €0.6 million in the previous year to €1.3 million. This was especially due to the higher net loss for the period which was partly offset by increased amortization and imparments of intangible assets. Cash inflow from investing activities rose to €0.5 million (previous year: cash outflow of €0.7 million), primarily according to the cash inflow based on the reverse acquisition of €0.5 million. Based on a lower raising of non-current loans, cash flow from financing activities was reduced to €0.5 million (previous year: €1.9 million). At the end of the period, cash and cash equivalents were €0.5 million (previous year: €0.9 million). Outlook Apart from the already mentioned licensing deal, SYGNIS expects further commercial agreements with partners. At the same time the Company expects first revenues from product sales in the current fiscal year. In the mid-term, at least two new products shall be licensed annually in regional or global partnerships. The Company plans to reach breakeven in fiscal year 2014. Based on extraordinary burdens from restructuring measures, the fiscal year 2013 will still show a loss. However, the Company assumes that current cost saving measures will lead to significant effects in the course of the year. Available liquidity as of December 31, 2012 amounted to €0.5 million. Up to date, financing of current activities is secured by a shareholder loan until mid 2013. For further financing and thus the continuation, the Company is dependent on new funding from mid 2013 on. These shall be granted by new investors, further loans or by using the existing SEDA agreement. About SYGNIS After the merger in 2012 between X-Pol Biotech, specialising in DNA amplification and sequencing, and SYGNIS Pharma AG, listed in the German Stock Exchange (Prime Standard segment, Tick: ; ISIN: ), SYGNIS’ new mission is to develop and distribute technologies and products from X-Pol, which has a commercial product in the DNA amplification segment, QualiPhi® and is currently developing other products in the field of Next Generation Sequencing . ### Disclaimer Some statements included in this press release, relating neither to proven financial results nor other historical data, should be viewed as forward-looking, i.e. not definite. Such statements are mainly predictions of future results, trends, plans or goals. These statements should not be considered to be total guarantees since given their very nature they are subject to known and unknown risks and imponderability and can be affected by other factors as a consequence of which the actual results, plans and goals of SYGNIS Pharma AG may deviate greatly from the established conclusions or implied predictions contained in such statements. SYGNIS does not undertake to publicly update or revise these statements in the light of new information or future results or for any other reason. ### |
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| 23/4/2013 SYGNIS granted US patent for QUALIPHI®, the Next Generation DNA amplification tool |
| New patent opens SYGNIS and QUALIPHI® in a leading position in a €70 million global market. Madrid/Heideberg 23 April 2013 – The biotech company SYGNIS Pharma AG (Frankfurt: ; ISIN: ; Prime Standard) has been granted a patent by the USPTO (US patent and trademark office) for its flagship product, QUALIPHI® the polymerase for complete DNA amplification. Polymerase proteins are the main tool for amplifying long DNA fragments and whole genomes, and are a basic need for research involving the analysis and modification of DNA. QUALIPHI® is an upgraded version of the Phi 29 DNA polymerase used in isothermal amplification which provides enhanced properties compared to similar polymerase proteins on the market. Being less time-consuming and having highly superior performance characteristics, the method developed by SYGNIS enables DNA amplification from concentrations as low as those found in a single cell. This is extremely useful in cancer research, and many other applications. “Certainly, the need for amplification of nucleic acids from minimal concentrations as present in single cell applications will be a critical issue in the coming era of personalised medicine and NGS. We expect QUALIPHI® to become an essential tool for the DNA amplification needed in these markets”, said SYGNIS CEO, Pilar de la Huerta. With the significant growth in the field of DNA amplifications used in sequencing and personalised medicine, the market of whole genome amplification with polymerase proteins is expected to grow at over 20% per annum over the next few years. Current estimates indicate that the size of the global isothermal DNA market alone is approximately €70M, with the US as the leading market for QUALIPHI®. In 2012, SYGNIS granted an exclusive global licence to QIAGEN, including sublicensing rights, for the commercialization of QUALIPHI® in the DNA amplification market. QIAGEN is a global leader in sample and assay technologies in research and molecular diagnostics. About SYGNIS Pharma AG: www.sygnis.de After the merger in 2012 between X-Pol Biotech, specialising in DNA amplification and sequencing, and SYGNIS Pharma AG, listed in the German Stock Exchange (Prime Standard segment, Tick: ; ISIN: ), SYGNIS new mission is to develop and distribute technologies and products from X-Pol, which has a commercial product in the DNA amplification segment, QUALIPHI®, and is currently developing another products in the field of next-generation sequencing. # # # Disclaimer: Some statements included in this press release, relating neither to proven financial results nor to other historical data, should be viewed as forward-looking, i.e. not definitive. Such statements are mainly predictions of future results, trends, plans or goals. These statements should not be considered to be total guarantees since given their very nature, they are subject to known and unknown risks, as well as to aspects beyond human control, and can be affected by other factors as a consequence of which the actual results, plans and goals of SYGNIS Pharma AG may deviate greatly from the established conclusions or implied predictions contained in such statements. SYGNIS does not undertake to publicly update or revise these statements in the light of new information or future results or for any other reason. # # # |
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| 15/1/2013 SYGNIS is granted the European and US American patent for a very versatile and efficientdrug screening platform |
| Heidelberg, 15 January 2013 – The biotech company SYGNIS Pharma AG (Frankfurt: ; ISIN: ; Prime Standard) has been granted the European and US American patent for a new basic technology for the detection of protein-protein interaction, a new screening platform for the development of novel drugs. In the words of SYGNIS’ CEO, Pilar de la Huerta, “the technology will be licensed to a distribution partner and we expect to see our first revenues during the current financial year 2013.” Protein-protein interaction falls within the scope of proteomics, a field that is growing in importance for research into new customized drugs. SYGNIS’ new platform can be used to improve the characterization of new drugs in development and identification of new therapeutic targets. The SYGNIS technology will increase the potential for generating better drugs within the customised drug development field. Following its merger with the Spanish company X-POL, which forms part of the GENETRIX Group, SYGNIS aims to become a key player in the growing market for molecular tools and personalized medicine. SYGNIS aims to use these patents, together with its recent company restructuring and successful implementation of the polymerase QualiPhiTM, to achieve the impetus it announced on its merger with X-Pol and become a prominent player in the growing market for new DNA tools and customised drugs, a sector that has seen two-figure growth over the last few years. According to SYGNIS Pharma AG sources, this transformation will enable it to obtain its first revenues in 2013 and operating profit in successive years. About SYGNIS Pharma AG: www.sygnis.de SYGNIS Pharma AG (Heidelberg, Germany) is a biotech company listed in the Prime Standard of the German Stock Exchange (Ticker: ; ISIN: ). According to the 2012 newly defined business strategy, the Company focuses on the development and marketing of novel technologies in molecular biology, e.g. in the field of DNA amplification and sequencing. For the key product “QualiPhiTM”, an improved polymerase for amplifying DNA, an exclusive worldwide license has been granted to Qiagen in July 2012. ### Disclaimer Some statements included in this press release, relating neither to proven financial results nor other historical data, should be viewed as forward-looking, i.e. not definite. Such statements are mainly predictions of future results, trends, plans or goals. These statements should not be considered to be total guarantees since given their very nature they are subject to known and unknown risks and imponderability and can be affected by other factors as a consequence of which the actual results, plans and goals of SYGNIS Pharma AG may deviate greatly from the established conclusions or implied predictions contained in such statements. SYGNIS does not undertake to publicly update or revise these statements in the light of new information or future results or for any other reason. ### |
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| 6/12/2012 SYGNIS announces completion of the X-Pol Biotech Acquisition |
| • Registration of the transaction and the previous capital reduction (ratio of 8:1) in the Commercial Register • New share capital of the Company € 9,349,724 • New ISIN • New Ticker symbol Heidelberg, December 6, 2012 - SYGNIS Pharma AG (Frankfurt: ; ISIN: , Prime Standard) announced today that the merger with X-Pol Biotech S.L. (X-Pol) is completed. With the approval of the Annual General Meeting on October 17, 2012 SYGNIS acquired 100% of the shares of the Spanish X-Pol by way of a capital increase against contribution in kind. This transaction is completed with the registration of the capital increase in the Commercial Register. Thus X-Pol becomes a 100% subsidiary of SYGNIS and SYGNIS’ share capital is increased from € 2,103,688 to € 9,349,724. After this transaction, the former shareholders of X-Pol hold 77.5% of SYGNIS shares. The previous shareholders of SYGNIS now own 22.5% of the new company. No shares were sold in the capital market. Before the capital increase, a reduction of SYGNIS’ share capital from € 16,829,504 to € 2,103,688 by consolidation of shares in the ratio of 8:1 was executed. Thereby, eight no par value bearer shares with ISIN were merged into one converted no par value bearer share with the new ISIN . Accordingly, the depositary banks have converted the individual deposits of SYGNIS shares as they were on December 5, 2012. If a shareholder did not hold a number of shares divisible by eight, a fraction of shares, this means a partial entitlement to receive one share (ISIN ), is booked for the shareholder. In order to be converted into full rights (so-called peak regulation), a corresponding buy or sell order is required. Each required peak regulation will be executed by the respective custodian bank by close of business December 21, 2012. The first listing on December 6, 2012 will be based on the trading price of the SYGNIS share as of December 5, 2012 and will be correspondingly increased by a factor of eight. ### Disclaimer Some statements included in this press release, relating neither to proven financial results nor other historical data, should be viewed as forward-looking, i.e. not definite. Such statements are mainly predictions of future results, trends, plans or goals. These statements should not be considered to be total guarantees since given their very nature they are subject to known and unknown risks and imponderability and can be affected by other factors as a consequence of which the actual results, plans and goals of SYGNIS Pharma AG may deviate greatly from the established conclusions or implied predictions contained in such statements. SYGNIS does not undertake to publicly update or revise these statements in the light of new information or future results or for any other reason. ### |
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| 29/10/2012 Changes in senior management of Spanish biotech group GENETRIX |
| • The Merger of Genetrix’s subsidiary, X-Pol Biotech with the German company SYGNIS PHARMA, AG has led to changes in management of the company. • Current CEO of Genetrix, Pilar de la Huerta, will take on the role of CEO of Sygnis Pharma AG, becoming one of the most important figures in the organization. • Juan Carlos de Castillo, former General Manager of X-Pol Biotech, to assume the title General Manager of the Genetrix Group. October 29th 2012.- Resulting from the merger of GENETRIX’s subsidiary, X-Pol Biotech with the German company SYGNIS PHARMA AG, the Board of Directors at GENETRIX has applied a few stategic changes with regard to its senior management. The CEO of GENETRIX, Pilar de la Huerta, will combine his duties with those of CEO (Chief Executive Officer) of the new SYGNIS PHARMA, AG, becoming one of the most essential figues in the organization. The late General Manager of X-Pol, Juan Carlos de Castillo takes up his new role as General Manager of the GENETRIX Group. These changes will effectively ensure success in the fushion of X-Pol Biotech, with the German company SYGNIS Pharma AG (Francfort: LIOK; ISIN ; Prime Standard) while at the same time reinforcing the internationalisation and diversification of the Spanish biotech group. |
| 18/10/2012 GENETRIX merges its subsidiary X-Pol Biotech, with german listed company SYGNIS |
| Madrid, 18th October 2012 – SYGNIS Pharma AG (Francfort: LIOK; ISIN ; Prime Standard) and GENETRIX, following their binding agreement three months ago, have announced the approval by the shareholder’s general meeting of the German company, of the merger between Sygnis Pharma AG and Xpol, Genetrix subsidiary focused on the development of DNA sequencing and amplification products. In this way, Xpol becomes the second subsidiary of the Genetrix biotechnology group that achieves an international listing following the corporate merger between Tigenix NV (NYSE Euronext: TIG) and Cellerix SA in 2010. The mission of the new SYGNIS will be to develop and commercialize Xpol technologies and products. Xpol has already brought to market a first product for DNA amplification currently licensed to Qiagen, validating Xpol’s technology platform, and is developing a follow up product aimed at new generation sequencing applications. With this new drive, the new SYGNIS will evolve from its current focus on the development of biopharmaceuticals, to enter the market for new DNA tools and personalized medicine, sectors that are expected to achieve double digit growth in the next few years. The merger will bring revenues to the company as early as 2013 with operating profits in successive years. Xpol current shareholders (Genetrix and Profs. Luis Blanco and Margarita Salas) will hold a stake of 77,5% in the new SYGNIS, while the German company will acquire Xpol by means of a rights issue against a contribution in kind. As a consequence, X-pol will become 100% subsidiary of SYGNIS. These changes have led to a restructuring of the Supervisory Board of Sygnis that will be chaired by Cristina Garmendia and will include Invitrogen’s founder: Joseph M. Fernández and Genetrix current shareholders, Gonzalo Rodriguez-Fraile Díaz and Pedro Agustín del Castillo Machado. The board membership is completed with Friedrich von Bohlen und Halbach and Wolf-Dieter Starp who have been ratified in their position as non executive directors. Following her appointment, Cristina Garmendia said “Adding complementary capacities and finding synergies is key to the enhancement and internationalization of biotechnological projects. Spain and Germany are leaders in this field and we will focus our efforts on placing this first Spanish-German company as a reference in the international market.” Friedrich von Bohlen und Halbach, who has also been appointed vice-chairperson, has taken the opportunity to thank the efforts of the previous team and wish every success to the new management, which has been also restructured and will be led by Pilar de la Huerta, who becomes CEO, Peter Willinger, who will remain as CFO, while Frank Rathgeb will leave the company to pursue new challenges in biopharmaceutical development. About SYGNIS Pharma AG SYGNIS Pharma AG (Heidelberg, Germany) is currently a specialty drug development company, focusing on innovative treatments for underserved human diseases. Early in 2012 the company decided to discontinue its Phase II lead program AX200 in stroke. While the company continued research activities in the field of cognitive disorders, it started at the same time a systematic M&A process, to add new operational assets and activities to SYGNIS Pharma AG. SYGNIS Pharma AG is listed in the Prime Standard of the Frankfurt Stock Exchange under the ticker: LIOK; and ISIN: . About GENETRIX, S.L.: genetrix.es GENETRIX, S.L., is a Spanish biotechnology holding company that was founded in 2001 as an incubator for Spanish biotechnology companies established in academic settings. Since inception, GENETRIX, S.L., has invested more than €36 million in nine companies focused on three biotechnology areas: healthcare technologies, human therapies and diagnosis. The portfolio includes holdings in six companies, including Cellerix-Tigenix SA, which was initially established in the holding company and after nine years of operations merged with the Belgian public listed company Tigenix, X-Pol Biotech, which focuses on the development of tools and technologies for the DNA amplification and sequencing market, and Coretherapix, a company centred on developing cellular therapy for treating acute myocardial infarction. About X-Pol Biotech, S.L.: www.xpolbiotech.com A biotechnology company created by Prof. Luis Blanco and GENETRIX in 2008 with a focus on the development of tools and technologies for the DNA amplification and sequencing market. GENETRIX currently controls 84% of the company. Other shareholders include renowned scientists, Professor Luis Blanco and Professor Margarita Salas. “Qualiphi®” was licensed with the Spanish National Research Council (CSIC) in 2010. ### Disclaimer This publication is intended for information only and constitutes neither an offer to sell nor an invitation to buy securities. Some statements included in this press release, relating neither to proven financial results nor other historical data, should be viewed as forward-looking, i.e. not definite. Such statements are mainly predictions of future results, trends, plans or goals. These statements should not be considered to be total guarantees since given their very nature they are subject to known and unknown risks and imponderability and can be affected by other factors as a consequence of which the actual results, plans and goals of SYGNIS Pharma AG may deviate greatly from the established conclusions or implied predictions contained in such statements. SYGNIS does not undertake to publicly update or revise these statements in the light of new information or future results or for any other reason. ### |
| 16/10/2012 Publication Confirmation of an Announcement according to the German Securities Acquisition and Takeover Act (WpÜG) for the Bidder Genetrix, S.L. |
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| 20/9/2012 Genetrix, key participant at Biospain 2012 |
| The stand holding the Spanish biotechnology ´Genetrix´ has become a star this morning by catching the eye of Prince Phillip during the inauguration of the International biotech trade fair `Biospain 2012´ held in Bilbao. The Prince of Asturias was received and presented to the company by the CEO of the Genetrix group, Pilar de la Huerta. Genetrix actively participates in this international biotechnology meeting, the most important event in Spain for this sector, that celebrates its VI meeting at the Bilbao Exhibition Centre (BEC) from today until the 21st of September. The group arrive in Bilbao with two important news announcments. The first is the presentation of its new Qualiphi polymerase – that allows amplification of large fragments of DNA in much less time than has been done before-, the second, the recent confirmation of a global licence agreement for Qualiphi with the German multinational pharmaceutical company, Qiagen. Qualiphi is a polymerase of DNA licensed with the CSIS Advisory Council back in 2010. Due to its unique characteristics, primary studies suggest that it has the potential to enhance the amplifications of complete genomes and large sequences of DNA. Present estimations show that the global market in the isothermal amplification of DNA will be 70 million euros alone. Genetrix is a leading biotechnology holding in Spain that was created as a spin-off from the National Centre for Biotechnology Information (NCBI) and has since been transformed into a key player in the three principle fields of the Life Sciences sector: Biotechnology, Medical technology and diagnostics. Recently, pharmacutical groups SYGNIS Pharma AG and GENETRIX have signed a Binding Letter of Intent, prosing the merging of X-Pol Biotech and SYGNIS with the objective of rapidly enhancing the merchansize of X-Pol products and technologies. SYGNIS Pharma AG is listed in the ´Prime Standard´of the Frankfurt Stock Exchange. |
| 18/7/2012 SYGNIS and GENETRIX Announce Proposed Combination of Businesses of SYGNIS and GENETRIX’ subsidiary X-Pol |
| Heidelberg, July 18, 2012 – SYGNIS Pharma AG (Frankfurt: LIOK; ISIN ; Prime Standard) and GENETRIX announced today, that the biotechnology companies SYGNIS and GENETRIX have signed a binding Term Sheet under which the companies propose to combine the GENETRIX’ DNA sequencing subsidiary X-Pol Biotech and SYGNIS. Goal is to develop and market X-Pol Biotech, S.L.’s DNA sequencing technologies and products. SYGNIS will acquire 100% ownership of X-Pol by way of capital increase against contribution in kind and therefore X-Pol will become a 100% subsidiary of SYGNIS. After the proposed transaction, the existing shareholders of X-Pol are expected to hold 77.5% of SYGNIS shares. Cash and existing financial facilities, such as SEDA are expected to cover the financial needs of SYGNIS after the transaction until achieving positive cash flows. The executive and supervisory boards of both companies have voted unanimously for the proposed key terms of the transaction. The transaction is subject to an exemption granted by BaFin from the obligations pursuant to Section 35 of the German Takeover Act (Wertpapiererwerbs- und Übernahmegesetz), in particular to submit a mandatory tender offer to the existing shareholders of SYGNIS in connection with the transaction. It is also dependent on the approval of SYGNIS shareholders at the next shareholders’ meeting. It is proposed that Pilar de la Huerta (CEO of GENETRIX) will join the SYGNIS Management Board following the closing of the transaction. The transaction takes advantage of SYGNIS’ long lasting expertise in the biotechnology business and its stock listing in combination with GENETRIX’ expertise in the upcoming field of molecular diagnostics. “Qualiphi®” is the most advanced commercial product in the X-Pol portfolio. Very recently GENETRIX signed a first global and exclusive licensing agreement for X-Pol´s “Qualiphi®” polymerase product with Qiagen, the global sample and assay technologies company. X-Pol`s DNA polymerases, due to their unique properties, are believed to increase the performance of DNA amplifications significantly. X-Pol’s polymerases enable a wide range of applications for DNA amplification, repair, sequencing and modification of genetic targets of research and clinical interest. Polymerases such as “Qualiphi®” are necessary for the amplification of large DNA fragments and complete genomes, and are an essential tool for any research that requires the use of DNA from any species. In conjunction with the advances made in the field of DNA sequencing and personalised medicine, the market for polymerases is estimated to grow by 25% annually for the coming years. Current estimates have calculated the current global isothermal DNA amplification market alone to be of up to €70 million. Peter Willinger, CFO of SYGNIS commented: “We are very excited to leverage our assets and, thus, create a new SYGNIS, with a new profile based on its long lasting expertise. The company will have an entirely new focus and business and will provide a lower risk profile with the near term visibility of revenues and profitability.” Dr. Frank Rathgeb, CMO of SYGNIS complemented: “The scientific team of X-Pol is a frontrunner in the polymerases field. We are happy to join forces with these excellent scientists and will put a clear focus on building on the X-Pol DNA sequencing business and related activities within the field of molecular diagnostics.” Pilar de la Huerta, CEO of GENETRIX added: “The combination of both companies offers great opportunities: access to the international healthcare capital markets and cash to advance our technologies and products and to build a strong company on top of that. The SYGNIS team and its Heidelberg biotech network offer us direct access to the scientific excellence of that region; we will use this huge potential to its full effect.” About SYGNIS Pharma AG: www.sygnis.de SYGNIS Pharma AG (Heidelberg, Germany) is currently a specialty drug development company, focusing on innovative treatments for underserved human diseases. Early in 2012 the company decided to discontinue its Phase II lead program AX200 in stroke. While the company continued research activities in the field of cognitive disorders, it started at the same time a systematic M&A process, to add new operational assets and activities to SYGNIS Pharma AG. SYGNIS Pharma AG is listed in the Prime Standard of the Frankfurt Stock Exchange under the ticker: LIOK; and ISIN: . About GENETRIX, S.L.: genetrix.es GENETRIX, S.L., is a Spanish biotechnology holding company that was founded in 2001 as an incubator for Spanish biotechnology companies established in academic settings. Since inception, GENETRIX, S.L., has invested more than €36 million in nine companies focused on three biotechnology areas: healthcare technologies, human therapies and diagnosis. The portfolio includes holdings in six companies, including Cellerix-Tigenix SA, which was initially established in the holding company and after nine years of operations merged with the Belgian public listed company Tigenix, X-Pol Biotech, which focuses on the development of tools and technologies for the DNA amplification and sequencing market, and Coretherapix, a company centred on developing cellular therapy for treating acute myocardial infarction. About X-Pol Biotech, S.L.: www.xpolbiotech.com A biotechnology company created by Prof. Luis Blanco and GENETRIX in 2008 with a focus on the development of tools and technologies for the DNA amplification and sequencing market. GENETRIX currently controls 84% of the company. Other shareholders include renowned scientists, Professor Luis Blanco and Professor Margarita Salas. “Qualiphi®” was licensed with the Spanish National Research Council (CSIC) in 2010. ### Disclaimer This publication is intended for information only and constitutes neither an offer to sell nor an invitation to buy securities. Some statements included in this press release, relating neither to proven financial results nor other historical data, should be viewed as forward-looking, i.e. not definite. Such statements are mainly predictions of future results, trends, plans or goals. These statements should not be considered to be total guarantees since given their very nature they are subject to known and unknown risks and imponderability and can be affected by other factors as a consequence of which the actual results, plans and goals of SYGNIS Pharma AG may deviate greatly from the established conclusions or implied predictions contained in such statements. SYGNIS does not undertake to publicly update or revise these statements in the light of new information or future results or for any other reason. ### |
| 16/7/2012 GENETRIX accorde la licence de la polymérase “Qualiphi” à QIAGEN |
| • Le premier accord de licence mondial de GENETRIX • Validation commerciale de la technologie polymérase Qualiphi de X-Pol Biotech • Grand intérêt commercial pour X-Pol et GENETRIX 16 juillet 2012.- Madrid : la société holding biotechnologique espagnole Genetrix a signé, à travers sa filiale X-Pol Biotech, un accord de licence mondial et exclusif pour son produit polymérase "Qualiphi" avec QIAGEN, la société mondiale spécialisée dans les technologies d'échantillonnage et d'essais. Qualiphi est une polymérase d'ADN brevetée par le Conseil espagnol de recherche (CSIC) en 2010. Les premières études laissent penser qu'elle a le potentiel permettant d'améliorer les amplifications de génomes entiers et de grands fragments d'ADN. Les polymérases jouent un rôle clé dans l'amplification des grands fragments d'ADN et des génomes complets, et sont un outil essentiel pour tout travail de recherche analysant ou modifiant l'ADN de toute espèce. Grâce aux importants progrès dans le domaine du séquençage d'ADN et de la médecine personnalisée, la croissance de marché pour de telles polymérases d'amplification de génomes entiers est estimée à environ 25% pour les années à venir. Les estimations actuelles s'élèvent à environ 70 millions d'euros pour le seul marché mondial de l'amplification isotherme de l'ADN. Qualiphi a été générée dans le laboratoire de la professeure Margarita Salas en collaboration avec le professeur Luis Blanco. C'est à travers cette recherche que l'équipe de GENETRIX a développé un produit aux caractéristiques uniques. D'après la directrice du Groupe GENETRIX, Pilar de la Huerta, "X-pol est appelée à devenir une référence mondiale dans le développement des technologies d'ADN de pointe et de séquençage, et cet accord avec QIAGEN représente une validation importante pour l'équipe et la première étape vers ce but. Cela a aussi une importance pour X-Pol et pour le groupe en termes économiques." |
| 16/7/2012 GENETRIX licenses “Qualiphi” polymerase to QIAGEN |
| • GENETRIX`s first global licensing agreement • Commercial validation of X-Pol Biotech`s Qualiphi polymerase technology • High commercial relevance for X-Pol and GENETRIX 16 July 2012.- Madrid; Genetrix, the Spanish biotechnology holding company, through its X-Pol Biotech subsidiary, has signed a global and exclusive licensing agreement for its “Qualiphi” polymerase product with QIAGEN, the global sample and assay technologies company. Qualiphi is a DNA polymerase that was licensed from the Spanish National Research Council (CSIC) in 2010. Due to its unique properties, first studies suggest that it has the potential to improve the amplifications of whole genomes and large stretches of DNA. Polymerases are the key tools used in the amplification of large DNA fragments and complete genomes, and are an essential tool for any research that analyses or modifies DNA from any species. Primarily due to significant growth in the field of DNA sequencing and personalised medicine, the market growth for such whole genome amplification polymerases is estimated to grow by about 25% in the upcoming years. Current estimates have calculated the global isothermal DNA amplification market alone to be of up to €70 million. Qualiphi was generated in the laboratory of Professor Margarita Salas with the collaboration of Professor Luis Blanco. Using this research, the GENETRIX team has developed a product with unique characteristics. Pilar de la Huerta, CEO of the GENETRIX Group, commented: “X-pol is committed to becoming a worldwide reference in the development of cutting edge DNA and sequencing technologies, and this agreement with QIAGEN is an important validation for the team and the first step towards this goal. It is as well in commercial terms significant for X-Pol and the group.” |
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| 20/3/2012 Genetrix forecasts annual revenues of €10 million as of 2014 |
| The biotechnology holding will focus on the companies X-Pol Biotech and Coretherapix, with an investment of €10 million over the next two years. Madrid, 20 March 2012. Genetrix foresees a turnover of more than €10 million in 2014, by which time and according to the Group’s forecast it will have launched several products in the market, based on the results of its recent research activity. The holding plans to invest €10 million during the 2012-2014 period to finance R&D, clinical trials and license agreements with leading pharmaceutical companies. The announcement was made today at a press conference breakfast by Pilar de la Huerta, Chief Executive Officer of Genetrix, a private holding founded in 2001 as a spin-off of the National Center for Biotechnology (CNB), which has become a leading Spanish institution in the Life Sciences sector and a major player in its three main areas: Biotechnology, Medical Technology and Diagnostics. Genetrix, which has invested over €36 million since it was founded, is currently made up by five different companies: X-Pol Biotech, Coretherapix, Axontherapix, Fénix Biotech and Biobide. In addition, the company is a shareholder in Tigenix, a listed company that signed a merger agreement with its subsidiary Cellerix last year. As announced by Pilar de la Huerta, for the next two years Genetrix will focus most of its R&D and investment efforts on X-Pol Biotech, specializing in DNA tools for research and future personalized medicine, and Coretherapix, a company devoted to the development of a cell therapy for the treatment of patients with myocardial infarction who have subsequently developed heart failure. In the case of X-Pol Biotech, the company has already reached a high level of development and is prepared for a license agreement with a leading multinational company in the DNA market, which could be signed in the first half of this year. According to Genetrix’s forecast, X-Pol Biotech is expected to provide the Group with €5 million in annual revenues, mainly from royalties from its flagship product, QualiPhi. QualiPhi is a new polymerase (an enzyme associated with DNA amplification) with features far superior to those of other products currently on the market. The aim of the company is for QualiPhi to become the new standard in the DNA amplification market, with the potential to become a benchmark in the market of next-generation sequencing, where the future of personalized medicine lies. The X-Pol Biotech research programs are headed by internationally renowned Spanish scientists, such as Prof. Margarita Salas and Prof. Luis Blanco. Furthermore, one of Coretherapix's two products is about to enter the human clinical trial phase. The first one is an allogeneic stem-cell product used to treat acute myocardial infarction and chronic heart failure. The second product is a cocktail of growth factors for the treatment of acute phase of infarction. Ms De la Huerta highlighted the great potential of cell therapy for cardiac tissue regeneration after acute myocardial infarction. The results obtained in animals are extremely promising, as are those obtained in human patients by other research teams using an autologous procedure (the patient’s own cells). De la Huerta cited the market figures for cardiac regeneration for the treatment of myocardial infarction and heart failure in the United States, which amounted to USD400 million and USD1.85 billion respectively in 2008. ‘Hence we are considering the possibility of signing a license agreement with a leading pharmaceutical company in 2014, by which time we will have obtained our first clinical results on efficacy,’ she announced. Growing value To quote Genetrix’s Chief Executive Officer, ‘We expect Genetrix to generate an annual revenue of more than €10 million over the next two years, based on income from X-Pol Biotech alone. Moreover, the value of Coretherapix will increase manifold once its product enters the clinical phase, so we expect the Group’s market value to quadruple over the next three years.’ The management team at Genetrix have been able to clinch deals with leading international companies, such as Cellerix (owned by Genetrix), which merged in February 2011 with Tigenix, a company listed on the Belgian Stock Exchange. |
| 14/3/2012 Biobide demuestra que inhibidores de enzima quinasa disminuyen la formación de vasos cancerígenos en el pez cebra |
| La compañía biotecnológica BIOBIDE, integrada en Grupo Genetrix, ha demostrado que dos inhibidores de la enzima quinasa originan una marcada interrupción en la reproducción de vasos y células cancerígenas en el pez cebra. Este descubrimiento, publicado en la prestigiosa publicación científica Oncogene, es la primera evidencia del papel una determinada quinasa juega en el desarrollo vasos en tumores cancerígenos. El descubrimiento se ha producido en el marco del proyecto europeo ZF-Cáncer, en el que participan BIOBIDE, Centro de Medicina Regenerativa de Barcelona liderado por el prestigioso científico Juan Carlos Izpisúa Belmonte (Presidente del Comité Asesor científico Biobide) y la empresa Galápagos. En primer lugar, se realizó la selección de los compuestos de una biblioteca de la compañía Galápagos, BV, en el ensayo automatizado de inhibición de la angiogénesis en la plataforma de selección de alto rendimiento de Biobide. Se seleccionaron dos nuevos compuestos que se encontraron en el ensayo como inhibidores de la angiogénesis y se identificó la quinasa PhKG1 como diana. Finalmente se confirmó que los dos compuestos inhiben específicamente el proceso angiogénico de nuevos vasos, en oposición a la inhibición de la vasculogénesis en general. La importancia del descubrimiento radica en su utilidad para el desarrollo de estudios de nuevos fármacos contra el cáncer que utilicen los inhibidores de la citada enzima, que se convierte en una nueva diana terapéutica antiangiogénica. Es decir, si se diseñan moléculas contra esa diana, éstas serán efectivas también para el tratamiento de enfermedades oncológicas. Según explican desde BIOBIDE, el objetivo del proyecto ZF-Cáncer ha sido desarrollar un ensayo para seleccionar y evaluar nuevas moléculas de la industria farmacéutica en el campo del cáncer determinando, por una parte, si éstas pueden ser efectivas para pasar a fases más avanzadas de desarrollo (selección) y, por otra, determinar dónde están actuando, “lo cual es muy importante para conocer nuevas dianas terapéuticas”. En este sentido, recuerdan que el pez cebra constituye un modelo muy interesante, “ya que permite un cribado de alto rendimiento de coste efectivo que hace que las fases posteriores del descubrimiento de nuevos fármacos se acorten y sean menos costosas”. En este sentido, los resultados del proyecto ZF-Cáncer han evidenciado una vez más el valor del pez cebra como modelo para técnicas de cribado de alto rendimiento. El pez cebra destaca por una alta coincidencia genética con los seres humanos, además de que sus embriones son transparentes y se desarrollan en 24-48 horas. Estas cualidades permiten estudiar los efectos que se producen en estos animales cuando se les administran nuevos compuestos, con menores costes y en unos tiempos sensiblemente inferiores que otros modelos animales disponibles. |
| 8/11/2011 Zebrafish used as research model to test drug efficacy against cancer |
| The biotechnology company BIOBIDE, part of the Genetrix Group, has developed a method using the zebrafish animal model to measure the pharmacological efficacy of new medications in the research stage for treating cancer. This new trial, in which two important pharmaceutical companies have already expressed interest, strengthens Biobide’s support for the zebrafish. The growing number of applications for the zebrafish in the Drug Discovery and Development process has increased the demand for this type of services. This is a trend that is expected to continue in the future. Specifically, Biobide has developed a trial that makes it possible to detect a compound’s capacity to inhibit angiogenesis (the formation of new blood vessels from those already existing). This physiological process is fundamental for tumor growth in metastasis. This process is involved in other pathologies, such as diabetic retinopathy and psoriasis, among others; this is why it is important to have a method to validate compounds that might affect it. This anti-angiogenesis trial, which is totally automated on Biobide’s High Throughput Screening platform and already available to their clients, was validated using more than 230 compounds with very satisfactory results. It should be pointed out that this trial is the result of Biobide’s participation in the Seventh European Community Framework Program, which promotes the use of animal models in Drug Discovery processes. New lines of research in Oncology As a result of the advances made in their research, Biobide was invited to participate in the “European Cancer Cluster Partnering” (ECCP), a European event dedicated to oncology held in the city of Toulouse. There, Scientific Director Carles Callol Massot presented the work and advances made by Biobide in the area of oncology. Callol also discussed the possibilities presented by the use of zebrafish embryos in the validation of new therapeutic targets in the development of new drugs to fight cancer. The zebra fish stands out for having a greater than 85% genetic match with humans, and the fact that its embryos are transparent and develop in 24-48 hours. These characteristics enable us to study the effects of new compounds administered to these animals at a lower cost and considerably faster than with the other animal models available. Biobide considered their participation in the “European Cancer Cluster Partnering” to be a very positive experience, as they were able to meet with and present their research lines to biotechnology and pharmaceutical companies from the United States and Europe. These companies have already expressed interest in the company’s work in the area of oncology and the role of the zebrafish applied to Drug Discovery and Development. |
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| 30/3/2011 X-Pol Biotech launches QualiPhi©, the future standard for DNA amplification and an essential tool in the development of personalised medicine |
| X-Pol Biotech, a company that is part of the Genetrix Group, which was founded in partnership with Professor Luis Blanco and was later joined by Professor Margarita Salas, both from the Severo Ochoa Molecular Biology Centre (a joint facility run by the Universidad Autónoma de Madrid and the state funded CSIC agency), announces the forthcoming launch of a new product: QualiPhi©. QualiPhi© is a combination of an optimised version (chimera) of the bacteriophage Phi29 DNA polymerase and a new formulation, which improves the responsiveness of a procedure extensively used in molecular biology laboratories: DNA amplification. The amplification potential of QualiPhi© is between 1,000 and 10,000 times greater than that of the enzymes currently in use, allowing scientists to obtain sufficient DNA to carry out numerous laboratory tests, such as genomic and clinical analysis or forensic studies, even from the smallest initial specimen. DNA amplification is an essential element in the development of personalised medicine, an innovative research field in which individualised and optimal treatments can be generated for each patient, based on an understanding of their individual genetic characteristics. For personalised medicine to become universal, new and more powerful tools are needed to help reduce the costs involved in identifying the drugs and dosages best suited to each patient. The current standard technique for amplifying large quantities of high-quality DNA uses the natural version of the bacteriophage Phi29 DNA polymerase, which has recorded annual global sales of approximately $250 million over the last decade. This DNA polymerase was identified by Professors White and Chambers in 1984, who described its peculiar amplification properties in 1989, the same year that it was patented. This patent has been commercially exploited by General Electric. Now the improved product (QualiPhi©) has been licensed to X-Pol Biotech, a Spanish company that forms part of the Genetrix Group and has worked for many years in partnership with CSIC, and has thus been granted global production and marketing rights. The experimental research into modifying the natural Phi29 DNA polymerase, on which QualiPhi© is based, was carried out by Miguel de Vega, José Mª Lázaro, Mario Mencía, Luis Blanco and Margarita Salas, the results of which were published in September 2010 in the prestigious US scientific journal Proceedings of the National Academy of Science (vol. 107, p. 16506-16511). The results had a significant impact in both the academic world and amongst biotechnology companies working in the field of DNA amplification. X-Pol Biotech expects sales of QualiPhi© to generate revenues of one million euros in 2011, a figure that is set to grow exponentially over forthcoming years. Genetrix Group, the parent company of X-Pol, has stated that the launch of QualiPhi© confirms the success of its strategy of stable collaboration with the Spanish academic world, and believes that QualiPhi© will play a decisive role in the success of its business plan, monetising the support it has given Spanish Biotechnology over the last ten years. According to Professors Luis Blanco and Margarita Salas from the "Severo Ochoa" Molecular Biology Centre, "the applicability of the Phi29 DNA polymerase as a tool for DNA amplification has been a huge international success over the last decade. We are convinced that the new version of the enzyme, QualiPhi©, will become the new standard for DNA amplification at molecular biology laboratories around the world." "We are delighted to add this product to our portfolio," said Pilar de la Huerta, CEO of Genetrix and X-Pol Biotech, "not only because of its market potential, but because we see this as an example of how good science is being done in our country, and of the potential that collaborations between the business world and academia can have. QualiPhi© is a product that has emerged from research and development carried out at the Severo Ochoa Molecular Biology Centre by Professors Margarita Salas and Luis Blanco, and has the potential to become a global mass market product. This is a great example of what can be achieved with a firm commitment to innovation." |
| 25/2/2011 TiGenix announces proposed combination with Cellerix |
| Combination will create the European cell therapy leader with two marketed products and a promising pipeline. Leuven (BELGIUM) / Tres Cantos (SPAIN, February 25, 2011 - TiGenix NV (NYSE Euronext Brussels: TIG) and Cellerix SA a privately held company based in Spain, announce that the two cell therapy-focused biotechnology companies and Cellerix’shareholders have entered into a contribution agreement to combine the operations of both companies by means of a share for share exchange. The combination of TiGenix’ marketed product portfolio and proprietary pre-clinical stem cell platform with a clinical stage allogeneic stem cell platform and pipeline is part of TiGenix’ external growth strategy and further strengthens its position as an internationaleading player in the fast-growing field of regenerative medicine and cell therapy. TiGenix also announces its intention to raise approximately EUR 15 million through a public rights offering, of which EUR 10 million has already been secured via precommitments from certain existing shareholders and new investors. Together with a EUR 18 million capital increase by Cellerix investors prior to the transaction, the combined group is expected to have a proforma cash position of at least EUR 33 million at closing. |
| 30/9/2010 Genetrix and the Botín Foundation create Axontherapix, a company dedicated to the development of a new anti-Parkinson treatment |
| Genetrix S.L., the parent company of one of the largest biotechnology groups in Spain, has founded Axontherapix after reaching an agreement with the University of Seville, the Virgen del Rocío University Hospital and the Botín Foundation to further develop the research undertaken over the past few years by the group led by Dr. López Barneo at said hospital. The experiments performed by this research group have shown the existence of a population of stem cells in a gland in the neck, specifically in the carotid artery, which have produced highly promising results in the treatment of animals with Parkinson's disease. Axontherapix's goal is to develop an effective treatment for Parkinson's disease in humans on the basis of these preliminary results. The company intends to speed up the pre-clinical research program to reach clinical trials as soon as possible. Axontherapix, which is the first initiative of the Genetrix Group in Andalusia, will require an investment of close to six million euros in its first three years and will result in the creation of around 20 new, highly qualified jobs. Eduardo González, President of Genetrix, has stated that “We firmly believe that the foundation of Axontherapix is a good example of what can be achieved by a public-private partnership between institutions such as the Regional Government of Andalusia, the University of Seville, the Virgen del Rocío Hospital, the Botín Foundation and the Genetrix Group, which is committed to the development of new business initiatives to convert the state-of-the-art research undertaken in our country into a profitable reality. Although Parkinson's disease has become a major socio-health problem, we are convinced that, building on the results obtained by Dr. Barneo's research group, we will be able to develop a new treatment that will offer one more alternative to those patients suffering from this disease." With this initiative, the Genetrix Group strengthens its commitment to the therapeutic potential of stem cells, a field in which it currently has two companies, namely Cellerix, which focuses on the development of medications for the treatment of autoimmune diseases such as rheumatoid arthritis, and Coretherapix, which develops treatments to stimulate regeneration of the heart in patients who have suffered a myocardial infarction. |
| 26/9/2010 ADE Gestión Sodical se incorpora al accionariado de Fénix Biotech |
| Fénix Biotech S.L. ha hecho pública la incorporación a su capital social de ADE Gestión Sodical SGECR, S.A., sociedad gestora de entidades de capital riesgo participada por Ade Financiación, S.A. y las Cajas de Ahorro de Castilla y León. ADE Gestión Sodical SGECR se une, de esta manera, a los socios fundadores de Fénix Biotech S.L., creada por las compañías biotecnológicas Genetrix y Advancell. La inversión se ha instrumentado a través del fondo de inversión ADE FINANCIACION CAPITAL SEMILLA FCR por una cuantía total de 180.000 euros, lo que supone una valoración total de la compañía de tres millones de euros. Fénix Biotech S.L. centra su actividad en la investigación, el desarrollo y la comercialización de soluciones terapéuticas basadas en nanopartículas que permitan el tratamiento de enfermedades monogénicas. Este tipo de enfermedades, como la fibrosis quística o la epidermólisis bullosa, se producen por el mal funcionamiento de un gen, lo que provoca serias complicaciones a los afectados y, en algunos casos, puede resultar mortal. El principal fin de este proyecto, y lo más novedoso, es precisamente encontrar un sistema innovador que permita la administración de un gen a través de la nanomedicina, con el fin de poder aplicar este tratamiento. Es por este motivo que este proyecto contará con los conocimientos en nanomedicina de Advancell, que ha inaugurado recientemente su laboratorio en esta materia en Santiago de Compostela. Con la inversión realizada, Fénix Biotech se garantiza la disponibilidad de fondos para desarrollar el proyecto hasta la fase de investigación preclínica, para, a continuación, poder realizar los primeros estudios en pacientes. Eduardo González, Presidente de Genetrix, ha declarado: “Creemos que la inversión realizada por ADE Gestión Sodical SGECR es un ejemplo de colaboración público-privada que contribuirá al desarrollo en Castilla y León de un sector de futuro como es la biotecnología, que busca el desarrollo de nuevos medicamentos y tratamientos capaces de ofrecer a los enfermos alternativas inexistentes hoy en día”. Para el Presidente de Advancell, Davide Sirtoli, “la importancia de este proyecto radica en que puede abrir una nueva vía para el tratamiento de enfermedades monogénicas, que actualmente no cuentan con ninguna solución eficaz y que afectan enormemente a la calidad de vida de quienes las padecen”. Fénix Biotech estará ubicada en el Parque Tecnológico de Boecillo (Valladolid. |
| 17/12/2009 Genetrix secures €9 million in financing |
| Genetrix has announced in a press release that it has closed a €9 million financing round which has been subscribed to by the group's current partners and by the investment firm Casticapital. As part of the transaction, Casticapital becomes a new shareholder and has assumed a position on the board of directors, states Genetrix, also explaining that, after the closing of this round of financing, the group has participated in two of the three main capital increases in the biotechnology sector in 2009. In fact, this investment round can be added to those that have been recently closed by the companies Cellerix and Biobide, affiliates of the Genetrix Group, for the sums of €27 million and €3 million respectively. After the operation announced today, the biotechnology group’s companies counted together have secured capital reaching a total value of €39 million, exceeding €80 million in private investments in the last 5 years. Genetrix was advised by 'La Caixa’ Corporate Finance in its search for investors interested in making cash contributions that will be allocated to strengthening its commitment to subsidiaries such as Coretherapix, focussed on cell therapy for regeneration of the heart post-heart attack. The money received will also be allocated to another group company called X-Pol, which this month announced the launch of “Magniphi®”, its first product on the market, intended for research use in laboratories and with an estimated market in Europe of €750 million annually. The new funds will also help to continue financing preclinical programmes and those in the early research phase, being carried out by the rest of the companies within the group. According to the chairman of Genetrix, Eduardo González, the capital injection shows the "strong" support of the shareholders “in such a difficult economic climate". “The group is considered by the market to be an extremely attractive investment, thanks to the favourable progress of the companies in its portfolio”, he added. |
| 4/12/2009 X-Pol Biotech launches its product MagniPhi® |
| X-Pol Biotech, a company within the Genetrix Group, founded in May 2008 with Prof. Luis Blanco, announces the forthcoming commercialization of its MagniPhi® product (Phi29, DNA polymerase). Research conducted by the company, and led by Prof. Margarita Salas and Prof. Luis Blanco has led to the development of MagniPhi®, a high quality and high purification grade Phi29 DNA polymerase. These characteristics differentiate the product from other amplification enzymes commercialized by other companies in the sector. The main target users of MagniPhi® will be scientists focused on basic research, for use in DNA amplification and for the labelling and modification of 3´ ends. In parallel with the launch of its first product, X-Pol Biotech will continue its research and development of DNA polymerases and their applications in biotechnology. This research will provide new products that will be launched by the company during 2010 and beyond. X-Pol Biotech’s long term mission is to become an international reference company in the development and exploitation of polymerases. To reach that goal, X-Pol Biotech counts on professionals with a extensive and recognised experience in this field. |
| 12/11/2009 Cellerix raises €27 million in a first closing |
| Cellerix, a product-focused biopharmaceutical company which develops innovative medicines based on cell therapy, today announced the successful first closing of its financing round, raising €27 million. Participants in this capital increase included current shareholders and a select group of new investors. Cellerix completed another financing round for €27.2 million in September 2007. This round was led by the leading life science venture capital funds YSIOS Capital Partners, LSP (Life Science Partners) and Ventech. Grupo Genetrix also played a key role in the deal, and two of Cellerix’ current investors (Roche Venture Fund and Novartis Venture Fund) have significantly increased their stake. Furthermore, A&G and Cellerix’ management team have also subscribed to the capital increase. Florent Gros (representing Novartis) and a second representative from Genetrix, still to be designated, will join Cellerix board of directors. The new Cellerix shareholders include Bankinter S.A., Capital Riesgo Madrid and JV Risk Technologies S.L. Joël Jean-Mairet, Cellerix’s Chairman has commented “The size of this round and the quality of the participants show investor’s confidence in the potential of Cellerix and its management team. I believe Cellerix is becoming a world reference in the emerging cell therapy area as it moves towards the market launch of its first product backed by a very interesting pipeline”. The funds raised by Cellerix in this financing round will be used for funding the completion of the clinical development of its lead product - Ontaril® - and preparation for its market launch in H2 2011. The proceeds of the round will also be used for funding the development additional products in the pipeline, including allogenic programs for the treatment of the autoimmune diseases. Eduardo Bravo, Cellerix’ CEO added “This capital injection will allow us to continue with the development of all of our programs following the planned schedule, as well as enabling us to defend and increase Cellerix’ leading position in the field, helping us to become the first company to commercialise a cell therapy medicine in Europe”. |
| 22/9/2008 Genetrix, official sponsor Biospain 2008 |
| José Torres Hurtado, Mayor of Granada, welcomed the participants of Biospain and thanked the organization for having chosen Granada as the host city of Biospain 2008. Eduardo González, Genetrix´s President conveyed his pride in participating in Biospain 2008, adding that he is convinced that this event will be the main showcase of Spanish biotechnology worldwide. He also stated that he considered the support of Granada´s Administration as key to Biospain´s success in improving Spanish competitiveness. |
| 17/9/2008 - 19/9/2008 GENETRIX, official sponsor of BIOSPAIN 2008 |
| Genetrix has signed a collaborative agreement with the association of biotechnology companies (ASEBIO) for which becomes official sponsor of Biospain 2008. This event, sponsored by ASEBIO and SEBIOT among other organizers, will take place in Grenada next September. Biospain event aims to become a scientific reference and attracting investment in our country for the biotechnology sector. |
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