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Tigenix: Schitterende results

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[verwijderd] 13 mei 2014 07:09

Schitterende results, vandaag 30% erbij, alles boven de verwachtingen;

[verwijderd] 13 mei 2014 07:09

Published: 07:00 CEST 13-05-2014 /GlobeNewswire /Source: TiGenix /XBRU: TIG /ISIN: BE0003864817

TiGenix rapporteert business en financiële resultaten voor het eerste kwartaal van 2014

GEREGLEMENTEERDE INFORMATIE
13 MEI 2014

TiGenix rapporteert business en financiële resultaten
voor het eerste kwartaal van 2014

Waardecreatie op korte en lange termijn
dankzij ChondroCelect®-overeenkomsten

Leuven, België - 13 mei 2014 - TiGenix NV (Euronext Brussels: TIG), de Europese leider in celtherapie, gaf vandaag een businessupdate en maakte zijn financiële resultaten voor 2013 bekend.

Business highlights

In april werd de overeenkomst ondertekend voor de toekenning van de exclusieve marketing- en distributierechten voor ChondroCelect aan Sobi, een internationaal farmaceutisch bedrijf dat gespecialiseerd is in zeldzame ziekten.
Overeenkomst over de verkoop van een Nederlandse productievestiging aan PharmaCell voor een totaal bedrag van 5,75 miljoen EUR.
De rekrutering van patiënten voor het Europese fase III-onderzoek van Cx601 ligt op schema.
De selectie van een Amerikaanse CMO (Contract Manufacturing Organisation) voor Cx601-technologieoverdracht is aan de gang.
Post-fase IIa-ontwikkelingsplan voor Cx611 wordt afgerond na overleg met deskundigen inzake diverse ontstekings- en auto-immuunziekten.
Financiële highlights

Omzet van ChondroCelect® gestegen met 26 % ten opzichte van eerste kwartaal 2013.
Er is een totaal vermogen van 25,7 miljoen EUR beschikbaar.
"De overeenkomsten over de toekenning van de marketing- en distributierechten van ChondroCelect aan Sobi en over de verkoop van onze Nederlandse productievestiging aan PharmaCell waren de highlights in het eerste kwartaal van dit jaar", aldus Eduardo Bravo, CEO van TiGenix. "Samen vormen deze twee overeenkomsten een mijlpaal in het transformatieproces van TiGenix die ervoor zorgt dat we met ChondroCelect zowel onmiddellijk als op lange termijn waarde kunnen creëren voor onze aandeelhouders, en dat we hierdoor veel meer patiënten in veel meer landen kunnen bereiken. Wat de toekomst betreft, kan TiGenix zich nu uitsluitend concentreren op de verdere ontwikkeling van zijn veelbelovende nieuwe producten die in laat klinische testfases zijn voor patiënten die lijden aan ziekten waarvoor de medische wereld nog te weinig oplossingen heeft."

Businessupdate

De overeenkomsten over de toekenning van de marketing- en distributierechten van ChondroCelect aan Sobi en over de verkoop van onze Nederlandse productievestiging aan PharmaCell zijn ondertekend.

Om het commerciële bereik van ChondroCelect uit te breiden en het waardepotentieel van dit product op korte en lange termijn te benutten, werd in april een licentieovereenkomst ondertekend met Sobi (Swedish Orphan Biovitrum AB). Dit internationale farmaceutische bedrijf is gespecialiseerd in zeldzame ziekten.

Om van ChondroCelect een succes te maken, is eerst een aanzienlijke investering nodig om terugbetaling te verkrijgen, de markt voor te bereiden, medische centra te openen en op te leiden, en de medische opleiding te kunnen verstrekken die nodig is om ChondroCelect te vestigen als de gouden standaard voor de juiste patiënten. Naast een veel bredere geografische dekking heeft Sobi de infrastructuur, de capaciteiten, de ervaring en de financiële middelen om ChondroCelect aan veel meer patiënten in veel meer landen ter beschikking te kunnen stellen.

Volgens de voorwaarden van de overeenkomst, die op 1 juni 2014 ingaat, krijgt Sobi de marketing- en distributierechten voor ChondroCelect op de Europese markten waar het product momenteel beschikbaar is, net als voor de registratie, terugbetaling, marketing en distributie van ChondroCelect in andere markten in Europa, Turkije, Rusland, het Midden-Oosten en Noord-Afrika. In ruil daarvoor betaalt Sobi aan TiGenix een vergoeding van 20 % (22 % in het eerste jaar) van de nettoverkoop van ChondroCelect, net als het leeuwendeel van alle kosten die verband houden met het product. Hierdoor heeft TiGenix een product met een positieve cashflow en een veel hogere operationele marge in handen, wat goed is voor de groei van ChondroCelect.

De overeenkomst voor de verkoop van de Nederlandse productievestiging wordt naar verwachting in het tweede kwartaal afgesloten. Zo is meteen ook de strategische herpositionering van het bedrijf rond. De vestiging wordt voor 5,75 miljoen EUR, inclusief een vooruitbetaling van 3,5 miljoen euro EUR, verkocht aan PharmaCell. Deze toonaangevende Europese producent is actief op het vlak van celtherapie en regeneratieve geneeskunde. In het kader van een langetermijncontract tussen de partijen zal men ChondroCelect blijven produceren in deze vestiging.

De twee overeenkomsten leveren TiGenix een onmiddellijke kasstroom van 3,5 miljoen EUR op, plus een verlichting van minstens 5 miljoen EUR van de jaarlijkse operationele kosten voor de productie, verkoop en marketing van ChondroCelect. Na verloop van tijd zal TiGenix meer waarde kunnen creëren op de lange termijn dankzij het bredere geografische bereik dat Sobi biedt voor ChondroCelect.

Rekrutering van patiënten met Cx601 op schema

De rekrutering van patiënten voor het Europese fase III ADMIRE-CD-onderzoek (Cx601) met complexe perianale fistels bij de ziekte van Crohn zal naar verwachting tegen eind 2014 zijn afgerond. De onderzoeksresultaten worden verwacht in het derde kwartaal van 2015, zodat begin 2016 de marktgoedkeuring kan worden aangevraagd bij het Europees Geneesmiddelenbureau (EMA).

Post-fase IIa-ontwikkelingsplan voor Cx611 binnenkort afgerond

Gezien de bemoedigende resultaten van het fase IIa-onderzoek van Cx611 bij reumatoïde artritis, werkt TiGenix nauw samen met belangrijke internationale opinieleiders aan het juiste ontwerp van opvolgingsstudies voor Cx611 bij ontstekings- en auto-immuunziekten. TiGenix verwacht de volgende stappen van het ontwikkelingsplan in het tweede kwartaal van dit jaar te kunnen afronden en aankondigen.

Financiële update

Verkoop ChondroCelect blijft gestaag groeien

De omzet van ChondroCelect is in de eerste drie maanden tot 31 maart 2014 met 26 % gestegen tot 1,3 miljoen EUR, ten opzichte van 1,0 miljoen EUR in dezelfde periode vorig jaar.

TiGenix kan onderzoeksresultaten Cx601 veiligstellen dankzij beschikbare middelen

Met de 17,2 miljoen EUR die het bedrijf op 31 maart 2014 cash had, de 5 miljoen EUR openstaande middelen die beschikbaar zijn via de kredietovereenkomst met Kreos en de 3,5 miljoen EUR die PharmaCell aan TiGenix moet betalen bij de verkoop van de Nederlandse productievestiging, heeft TiGenix een totaal vermogen van 25,7 miljoen EUR beschikbaar. Hierdoor kan het bedrijf de onderzoeksresultaten van het Europese fase III-onderzoek (Cx601) veiligstellen.

Operationele verwachtingen voor de komende twaalf maanden

Rekrutering voltooien van patiënten voor het Europese fase III-onderzoek van Cx601 tegen het einde van 2014
Een Amerikaanse CMO (Contract Manufacturing Organisation) inhuren en beginnen met de technologieoverdracht voor Cx601
Aanvraag voor een SPA (Special Protocol Assessment) indienen voor Cx601 bij de Amerikaanse Food and Drug Administration (FDA)
Post-fase IIa-ontwikkelingsplan voor Cx611 in Europa voltooien en voorstellen

Meer informatie

Richard Simpson
Senior Consultant, Comfi bvba
T: +32 494 578 278
richard@comfi.be

[verwijderd] 28 augustus 2015 21:19

TiGenix Achieves First Ever Success In Allogeneic Stem Cell Phase 3 Trial

[verwijderd] 28 augustus 2015 21:20

TiGenix Achieves First Ever Success In Allogeneic Stem Cell Phase 3 Trial
Aug. 27, 2015 11:07 AM ET | 16 comments | About: Tigenix Sa (TGXSF), Includes: CAPR, CLBS, CYAD, GLPG, GRFS, GSK, JNJ, MEOBF, NVS, PHG, SSH, VCEL
Disclosure: I am/we are long TGXSF, SSH. (More...)
Summary

TiGenix's pivotal Phase 3 trial in Europe met its primary endpoint in an indication targeting a potential $2 billion orphan market.
As predicted in my previous article, owing to solid trial design and sound science, this is the first Phase 3 success in an allogeneic stem cell trial worldwide.
Following the FDA's agreement on the company's proposed SPA, the way is now widely open for a U.S. approval as well.
TiGenix has also expanded its pipeline of product candidates for a various range of major diseases (RA, sepsis...) by acquiring a Phase 2 stem cell treatment for acute myocardial infarction.
Despite clear clinical successes and strong management, the company is still deeply undervalued and a short-term upside of 150% is anticipated, with a probable NASDAQ IPO in sight.
TiGenix (OTC:TGXSF) - listed on Euronext Brussels under ticker "TIG" - is a leading European stem cell company. The small-cap biotech has already one product on the market (ChondroCelect, an autologous chondrocyte implantation or ACI) and just announced positive Phase 3 efficacy results from its allogeneic adipose-derived stem cell treatment for Crohn's disease fistulas, Cx601. The therapy met its primary endpoint, confirming its strong potential in a $2 billion orphan market. I have extensively written before on the tremendous opportunity presented by this under-the-radar, little-known pioneering biotech with great ambitions - see a full investment thesis here and my focus article on Cx601 here - detailing why I predicted that TiGenix's Phase 3 trial would likely be a success.

Not only does Cx601 become the first ever recorded successful allogeneic "off-the-shelf" stem cell therapy to go through a large, randomized controlled trial, but also it is first and foremost a solid product which answers an unmet therapeutic need in a highly debilitating condition and brings hope to thousands of patients across the world. A single injection of Cx601 in highly refractory Crohn's disease patients with complex perianal fistulas was able to completely cure about 50% of all patients, whereas even the more advanced medical options like biologics (or anti-TNF alpha drugs) have poor efficacy rates (about 23%) and potentially dangerous side effects. In comparison with conventional treatments, Cx601's safety profile proved to be stellar with less treatment-related adverse events observed in the Cx601 treatment arm than in the placebo arm.

In brief, what this means is that about one out of two patients treated with Cx601 will be spared the otherwise unavoidable surgical procedure needed to close their fistulas, which is the only option available to about four out of five patients today - surgery is a risky and painful procedure to which many doctors are reluctant, due to the difficulty of achieving sustainable results and patients' satisfaction since the rate of relapse is still very high and the outcome variable (including risks of anal incontinence). Therefore, with a much better safety profile and a more reliable closure rate than any other non-surgical option, the company's treatment becomes a significant, life-changing option, which makes it very likely that the acceptance of the product will be strong within the medical community and capture a significant portion of the target population, which represents about 120,000 new patients each year in the U.S. and Europe alone (see my previous focus article for more details).

Cx601 is now a mostly de-risked and deeply undervalued asset...

With this in mind and according to pricing estimations - based on Remicade which is priced around $20k per year even with less-than-impressive results and a questionable safety profile - it is estimated that peak sales of Cx601 could reach over $670 million per year with reasonable market share assumptions (see Table 1 below).

Besides, TiGenix confirmed recently that it has obtained the FDA's endorsement on a Special Protocol Assessment (SPA), clearing the pathway to start a single pivotal Phase 3 trial that could lead to U.S. market approval - an explicit acknowledgement by the FDA of the quality of the scientific data produced by TiGenix so far. The company describes the primary endpoint of its upcoming U.S. Phase 3 trial as "in line with the one for the European Phase 3 trial", meaning that the clear clinical success of the European trial has very high chances of being replicated in the U.S. trial, thus opening the way for a likely U.S. approval of Cx601 as well.

In terms of timing to market and thanks to its first Phase 3 success, Cx601 could be launched on the European market by early 2017 (filing is already in preparation) and could reach the U.S. by 2020 after completion of the U.S. trial.

[verwijderd] 28 augustus 2015 21:22

Table 1: Peak sales projections (EU+US) for Cx601

(click to enlarge)

I strongly believe that the outcome of the Cx601 European trial is just the first step towards truly transformational and exciting years to come for the company. As of today, TiGenix still owns 100% of worldwide rights to Cx601, and the biotech is now in a very favorable position to conclude high-value partnering or buy-out deals. Updating my previous value estimate to take into account the clear positive outcome of the trial (including the excellent safety profile of the therapy) and based on Cx601's value alone, I estimate TiGenix's fair value to be over $400 million - this represents a 150% upside at time of writing, illustrating why I believe TiGenix to be one of the most "deeply undervalued" biotech on the market.

…and TiGenix has many other promising stem cell products in development

TiGenix is not a one-product company. In fact, it has a strong, mostly mid-stage pipeline of stem cell product candidates, based on its proprietary expanded adipose-derived stem cell (eASC) platform in diversified indications covering autoimmune diseases (including rheumatoid arthritis) and systemic infection (sepsis).

In addition to that, the company announced a few weeks ago that it had acquired a small private biotech, Coretherapix, which is developing AlloCSC-01, an allogeneic cardiac stem cell product currently in a Phase 2 clinical trial for the treatment of patients suffering from acute myocardial infarction (AMI), or heart attack, thus entering the hot field of cardiology with a new promising stem cell treatment added to its current pipeline (see Figure 1).

Figure 1: TiGenix's pipeline (as of August 2015)

[verwijderd] 28 augustus 2015 21:23

In the next sections of this article, I will elaborate on this latest deal and more specifically on the opportunities presented by stem cell treatments in treating cardiac pathologies.

Expanding stem cell pipeline and entering the cardiology field

The buyout operation agreed with Coretherapix appears to be an interesting and well-constructed deal, minimizing current risks for TiGenix and leaving ample room for further developments. While the total worth of the deal could amount to ~$320 million, TiGenix and Genetrix (Coretherapix's parent company) actually agreed upon a $7.3 million upfront payment, of which only $1.3 million will be paid in cash and the rest (~$6 million) in new TiGenix shares. Additionally, Genetrix may receive up to ~$17 million in new TiGenix shares depending on the results of the ongoing clinical trial of AlloCSC-01.

Other than that, all subsequent payments will be closely tied to sales milestones, as Genetrix will be entitled to receive up to ~$270 million upon reaching certain levels of sales, plus a percentage of the direct net sales of the first product. The first sales milestones will be due only when annual net sales of AlloCSC-01 eventually reach ~$165 million and the last one will be payable once annual net sales are above ~$820 million - considering those sales numbers, both companies seem to share very solid sales projections for this new post-AMI treatment.

At the moment, more than 60% of patients have been treated in AlloCSC-01's Phase 2 trial which started patient enrolment in January 2015, and the final results of the trial should be released in H1-2017. Before that, a six-month efficacy interim analysis is expected to provide data in H1-2016.

So, what the structure of this deal actually means is that as of today, TiGenix has acquired a new Phase 2 asset, already fully launched in the clinic (with interim results expected in about six months) and mostly financed, while limiting the current risk to a bit more than $1 million in cash and less than 5% stock dilution (~7.7 million shares issued as the second part of the upfront payment to Genetrix) - a very reasonable price, considering some other deals covering very similar technology.

Indeed, in January 2014, big pharma company Johnson & Johnson (NYSE:JNJ) agreed to an upfront payment of $12.5 million to nano-cap biotech Capricor Therapeutics (NASDAQ:CAPR) for the sole purpose of getting a premium ticket to license Capricor's allogeneic cardiosphere-derived post-AMI treatment after Phase 2 results are delivered. If J&J opts to exercise its licensing rights, it will then be committed to milestone payments of up to $325 million, plus royalties on any sales. In comparison, a $1 million cash upfront payment for AlloCSC-01, a product with similar market opportunities and Phase 2 development status, seems like a fair deal for TiGenix.

The opportunities for heart disease stem cell treatments

An estimated 1.9 million people suffer from heart attacks (AMI) each year in the U.S. and Europe. While several treatments performed right after AMI, such as PCI and stent implantation, have been successful at reducing the immediate mortality rate of patients, damaged tissue in the heart is not regenerated by those treatments which often leads to cardiac remodeling and the onset of congestive heart failure (CHF), also known as Chronic Heart Failure) in the aftermath of the attack - see Figure 2 below.

As a result of this post-AMI remodeling, the heart's function as a pump becomes progressively inadequate to deliver oxygen-rich blood to the body, which often leads to shortness of breath and fluid build-up in the lungs, legs and other organs. CHF is a chronic, progressive disease, with 18% annual mortality rate and no existing cure besides heart transplantation. In the U.S. alone, the economic burden of treating heart failure patients was estimated at $31 billion per year and is expected to grow to $70 billion by 2030

[verwijderd] 28 augustus 2015 21:25

Figure 2: Cardiac remodeling after AMI and onset of CHF

(click to enlarge)

TiGenix's new stem cell treatment, which consists of adult allogeneic cardiac stem cells isolated from the right atrial appendages of donors, is to be administered by intra-coronary injection 5 to 8 days after patients suffered from AMI. The aim of this therapy is to improve significantly the heart's ability to regenerate by stimulating tissue regeneration, controlling inflammation and activating cardio-protective factors (see Figure 3). By doing that, it is hoped that AlloCSC-01 will be able to mitigate or delay the onset of CHF for a significant proportion of the patient population, which would result in improving long-term survival rates and lessening the economic burden of treating deteriorating patients.

Figure 3: Mechanisms of action of AlloCSC-01

(click to enlarge)

Source: TiGenix

The primary endpoint of AlloCSC-01's Phase 2 trial is improving all-cause mortality and MACE (Major Adverse Cardiac Events) at 30 days. Secondary endpoints include efficacy MRI parameters (evolution of infarct size and evolution of biomechanical parameters) and other clinical parameters (including MACE, mortality, the 6-minute walking test and the NYHA scale) measured at 6 and 12 months.

AlloCSC-01's previous results

AlloCSC-01 has been developed and financed within the framework of a European Commission's Research and Development project, the CARE-MI initiative. Coretherapix, which was leading a consortium made of several companies and top-EU universities and hospitals, got the opportunity and financing to work extensively on every aspect of product development during more than four years. Results achieved include the complete characterization of allogeneic cardiac stem cells and their mechanism of action (see i.a. Boukouaci et al., 2014 and Lauden et al., 2013), the design of a GMP-compliant production method, the start of the first clinical trial and the optimization of analysis procedures for cardiac parameter readouts (in collaboration with Philips (NYSE:PHG)).

So far, preclinical work in pig models has shown a favorable biodistribution of AlloCSC-01's administration via coronary injection (which means that the product is compatible with current standards of care such as PTCA - see Figure 4) and a very clear, significant dose-dependant effect on cardiac remodeling and improvement of cardiac functions (augmentation of ejection fraction), as shown in Figure 5 below:

aossa 28 augustus 2015 22:45

seekingalpha.com/article/3471356-tige...

of via: www.nasdaq.com/symbol/glpg/real-time (inloggen onnodig) column News rechterzijde

Einde artikel:

In TiGenix's case, I believe that this is due to the company's current status as an under-the-radar European biotech. Despite clear ties with big pharma companies - such as the position on TiGenix's board of directors of Jean Stéphenne, former boss of GlaxoSmithKline Biologicals (NYSE:GSK), and capital investments from Novartis and Grifols (NASDAQ:GRFS) - TiGenix remains a little-know specialized biotech in a field that suffers from many resounding failures in the past years.

What could change this situation?

First, as confirmed by the company's management, significant partnering deals will be signed in the coming months for Cx601's commercialization in Europe and in the U.S. - if the terms are good, this will clearly remind to the market how much value currently lies in the biotech.

Second, TiGenix's management has repeatedly alluded to a probable NASDAQ IPO, in the like of other Belgian biotechs which recently launched similar operations with great success such as Celyad and Galapagos (NASDAQ:GLPG). A NASDAQ IPO would give TiGenix broadened worldwide visibility and could accelerate its much deserved revaluation. Obviously, my opinion is that until it does, buying TiGenix at current share price is nothing short of an alpha opportunity.

Risks

The company currently has enough resources for about 12 months of operations at current cash burn. Management has announced that further financing will be needed to launch both European commercialization and U.S. Phase 3 trial. Funds could be obtained through commercial partnerships, loans and/or capital increase, the latter of which could lead to stock dilution. However, since TiGenix still owns 100% of Cx601's worldwide distribution rights, it is likely that the company will be able to negotiate partial or complete non-dilutive financing, thus limiting the amount of stock dilution needed to achieve financing goals.

Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. Please be aware of the risks associated with these stocks.

aossa 29 augustus 2015 17:36

TiGenix boekt klinisch succes
24/08/15 om 18:42

Kanaal.Z Ilse De Winne, journalist.

kanaalz.knack.be/nieuws/tigenix-boekt...

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