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Senzagen strengthens US organisation and commercial presence with aim to enroll more licensees

SenzaGen is focusing on the chemical, cosmetics, pharmaceutical and medical device markets for global commercialization of the in vitro platform GARD®.

In 2017 and 2018, SenzaGen has gradually strengthened its commercial organisation and global presence through new agreements with strategic partners. The background to the recruitment in the US is that SenzaGen intends to accelerate its collaborations with both US licensees and industrial partners for the development of the GARD®portfolio.

“The US is a priority market, and through the recruitment of Joshua J. Schmidt, we are strengthening our organisation by adding significant network, knowledge and insight into the US market, which contributes to achieving our financial targets,” says Anki Malmborg Hager, CEO of SenzaGen

Joshua J. Schmidt has extensive business and scientific experience from 3M, Medtronic and Bruker Daltonics, most recently as Senior Account Executive for a US-based CRO, Pace Analytical Life Sciences, where he worked with testing of pharmaceutical products and medical devices in the US.

“SenzaGen’s technology is impressive and has true potential to significantly and positively impact the chemical and life science industries. I am excited to join SenzaGen at this time because I see great opportunity and potential for growth in the US and globally for GARD®”, says Joshua J. Schmidt, Business Development Director at SenzaGen Inc.

In conjunction with Joshua J. Schmidt’s appointment as Business Development Director, SenzaGen Inc becomes a wholly-owned subsidiary of SenzaGen AB (publ).

For more information, please contact:

Anki Malmborg Hager, CEO, SenzaGen AB

Email: anki.malmborg.hager@senzagen.com

Telephone: +46 768 284822

About GARD® 

GARD® is a group of tests for assessing chemical skin sensitizers. The tests make use of genetic biomarkers for more than 200 genes which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity. The tests have over 90 percent reliability.

This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75 percent. SenzaGen’s tests are also capable of measuring the potency of a substance’s allergenic properties. Consequently, GARD tests provide a much more comprehensive basis for determining whether a substance should be classified as an allergen than current testing methods.

About SenzaGen

SenzaGen makes it possible to replace animal experiments with in vitro genetic testing to determine the allergenicity of the chemicals we come into contact with in our daily lives, such as for example in cosmetics, pharmaceuticals, food products and dyes. The company’s patented tests are the most reliable on the market and provide more information than traditional evaluation methods. We ourselves sell the tests in Sweden and the USA, and we sell through partners in several other countries. Over the next few years the company will expand geographically, make alliances with more distribution partners and launch further unique tests. SenzaGen has its headquarters in Lund in Sweden and a subsidiary in Delaware USA. For more information visit http://www.senzagen.com

This information is information that SenzaGen is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person set out above on October 11, 2018, at 08.30.

SenzaGen AB is listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com

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SenzaGen presenting at Vator Securities Unicorn Summit on October 10, 2018

SenzaGen will participate in the Vator Securities Unicorn Summit, which takes place today, October 10, at Medicon Village in Lund. Anki Malmborg Hager will present Senzagen´s developments and accelerated efforts towards further strengthening the commercial organization and the global presence of SenzaGen’s platform GARD®, a group of tests for animal-free safety testing.

Unicorn Summit is a capital market day organized by Vator Securities to bring together some of the most innovative and fast-growing Swedish life science companies with investors. More information about Vator Securities www.vatorsecurities.se

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SenzaGen presenterar finansiell målsättning

SenzaGen fokuserar på kemikalie-, kosmetika-, läkemedels- och medicintekniska marknaderna för sin globala kommersialisering av in vitro-plattformen GARD®. Under 2017 och 2018 har SenzaGen successivt stärkt sin kommersiella organisation och globala närvaro med nya avtal med strategiska partners. Arbetet accelererar nu med fler samarbeten med CRO-partners samt att utveckla fler samarbeten med industriella partners för bolagets produktpipeline. Under hösten har SenzaGen kommunicerat att Bolaget även kommer att rikta sina försäljningsinsatser mot den växande medicintekniska marknaden. Dessutom har SenzaGen nyligen lanserat ytterligare ett test i sin plattform, GARDair, som är det första in vitro-testet för luftvägsallergier.  

Följande finansiella målsättning har idag antagits:

  • SenzaGens målsättning är att nå en omsättning om 300 MSEK år 2023 med en hållbar försäljningstillväxt överstigande 30% och en långsiktigt hållbar bruttomarginal överstigande 50% för efterföljande år.
  • Bolaget förväntar sig att nå break-even 2021 med en omsättning om 80 MSEK. 

“Det finns en rad faktorer som talar för en stark och hållbar försäljningstillväxt framöver. Intresset och efterfrågan på djurfria tester är stort och växer i takt med att nya regelverk stryper möjligheten att använda tekniskt och etiskt undermåliga djurtester. Vi kommer att fortsätta hålla produktutvecklingstakten baserat på de största och mest akuta utmaningarna som de olika industrierna måste ha en lösning på. Vi ligger mycket långt fram och vi breddar därför vår strategi nu och fokuserar kraftfullt på att rekrytera starka CRO- och industriella partners inom alla våra marknadssegment och geografier”, säger Anki Malmborg Hager, VD på SenzaGen.

SenzaGens finansiella målsättning som anges ovan utgör framåtblickande information och grundas på ett antal antaganden om den verksamhetsmiljö som

Bolaget är verksamt i vilken över tid kan variera väsentligt och bli sämre än vad SenzaGen bedömde när den finansiella målsättningen antogs. Som en följd därav omfattas SenzaGens förmåga att uppnå den finansiella målsättningen av osäkerheter och eventualiteter, varav vissa är utanför Bolagets kontroll. Det finns ingen garanti för att SenzaGen kan nå målsättningen eller att Bolagets finansiella ställning eller rörelseresultat inte kommer att skilja sig väsentligt från den finansiella målsättningen.

För mer information, kontakta:

Anki Malmborg Hager, VD, SenzaGen AB

Email: anki.malmborg.hager@senzagen.com

Telefon: 0768 284822

Om GARD®

GARD® är en grupp med tester för analys av kemikaliers förmåga att starta en allergisk reaktion hos människa. Genom att analysera hundratals markörer genererar GARD™ stora mängder data och levererar resultat med över 90 procents precision. Detta kan jämföras med dagens standardmetod – tester på möss – som endast uppnår 70-75 procents precision. SenzaGens test kan dessutom kvantifiera den allergiframkallande potentialen för en kemisk substans.

Om SenzaGen

SenzaGen gör det möjligt att ersätta djurförsök med genetiska tester i provrör för att bedöma om de kemikalier vi kommer i kontakt med i vår vardag är allergiframkallande. Det kan till exempel handla om kosmetika, läkemedel, livsmedel och färgämnen. Bolagets patentskyddade tester är de mest tillförlitliga på marknaden och ger mer information än traditionella utvärderingsmetoder. Testerna säljs i egen regi i Sverige och USA, och genom partners i flera andra länder. De närmaste åren kommer bolaget expandera geografiskt, knyta till sig fler distributionspartners och lansera nya, unika tester. SenzaGen har sitt huvudkontor i Lund och dotterbolag i San Francisco, USA. För mer information, besök http://www.senzagen.com.

Denna information är sådan information som SenzaGen är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning och lagen om värdepappersmarknaden. Informationen lämnades, genom ovanstående kontaktpersons försorg, för offentliggörande 9 oktober 2018 kl. 08:30.

SenzaGen är listat på Nasdaq Stockholm First North (ticker: SENZA). FNCA är bolagets Certified Adviser. Mer information om SenzaGen finns att tillgå via http://www.senzagen.com.

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Senzagen presents financial targets

SenzaGen focuses on the chemical, cosmetics, pharmaceutical and medical device markets for the global commercialization of the in vitro platform GARD®. In 2017 and 2018, SenzaGen has gradually strengthened its commercial organization and global presence with new agreements with strategic partners. The efforts are now accelerating with both more CRO partnerships and more collaborations with industrial partners for the company’s broad product pipeline. In the autumn, SenzaGen announced that the company will also target its sales efforts towards the growing medical device market. In addition, SenzaGen has recently launched another test based on its platform, GARDair, the first in vitro test for airway allergies. 

The new financial goals being adopted are:

  • To achieve a turnover of MSEK 300 in 2023 with sustainable sales growth exceeding 30% and a sustainable gross margin exceeding 50% for the years to follow.
  • To reach break-even in 2021 with a turnover of 80 MSEK. 

“There are a number of factors that indicate strong and sustainable future sales growth. The interest and demand for animal-free tests is strong and keeps growing as new regulations reduce the possibility of using technically and ethically substandard animal tests. We will sustain our pace of product development to meet the biggest and most urgent challenges that the different industries face. We are in the forefront of the field and we are now broadening our strategy by putting a strong focus on recruiting strong CRO and industrial partners in all our market segments and geographies,” says Anki Malmborg Hager, CEO of SenzaGen.

SenzaGen’s financial targets set forth above constitute forward-looking information and are based on a number of assumptions about the operating environment in which the Company operates. This may vary significantly and be inferior to SenzaGen’s assessments when the financial targets were adopted. As a consequence, SenzaGen’s ability to achieve the financial targets will depend on uncertainties and contingencies, some of which are outside the Company’s control. There is no guarantee that SenzaGen can achieve the targets or that the Company’s financial position or operating profit will not differ significantly from the financial targets.

For more information, please contact:

Anki Malmborg Hager, CEO, SenzaGen AB

Email: anki.malmborg.hager@senzagen.com

Telephone: +46 768 284822

About GARD® 

GARD® is a group of tests for assessing chemical skin sensitizers. The tests make use of genetic biomarkers for more than 200 genes which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity. The tests have over 90 percent reliability.

This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75 percent. SenzaGen’s tests are also capable of measuring the potency of a substance’s allergenic properties. Consequently, GARD tests provide a much more comprehensive basis for determining whether a substance should be classified as an allergen than current testing methods.

About SenzaGen

SenzaGen makes it possible to replace animal experiments with in vitro genetic testing to determine the allergenicity of the chemicals we come into contact with in our daily lives, for example in cosmetics, pharmaceuticals, food products and dyes. The company’s patented tests are the most reliable on the market and provide more information than traditional evaluation methods. We ourselves sell the tests in Sweden and the USA, and we sell through partners in several other countries. Over the next few years the company will expand geographically, make alliances with more distribution partners and launch further unique tests. SenzaGen has its headquarters in Lund in Sweden and a subsidiary in San Francisco, USA. For more information visit http://www.senzagen.com

This information is information that SenzaGen is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person set out above on October 9, 2018, at 08.30.

SenzaGen AB is listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com

Attached file

Is a combination of assays really needed for non-animal prediction of skin sensitization potential? Performance of the GARD™ (Genomic Allergen Rapid Detection) assay in comparison with OECD guideline assays alone and in combination

Regulatory Toxicology and Pharmacology, Volume 98, October 2018, Pages 155-160, https://doi.org/10.1016/j.yrtph.2018.07.014.

David W.Roberts

Highlights

  • Prediction of skin sensitization potential does not need multiple assays representing Key Events of the AOP.
  • This has been argued on theoretical grounds and is now tested against published data.
  • A single assay, GARD™, can outperform combinations of OECD test guideline assays.

Abstract
To meet regulatory requirements, and avoid or minimize animal testing, there is a need for non-animal methods to assess the potential of chemicals to cause skin sensitization. It is widely assumed that no one test will be sufficient and that combined data from several assays spanning key events from the adverse outcome pathway will be required. This paper challenges that assumption. The predictive performance of a single assay, the Genomic Allergen Rapid Detection (GARD™) assay, was compared with the performance, singly and in combination, of three formally validated non-animal approaches that appear as OECD test guidelines: the direct peptide reactivity assay (DPRA), the ARE-Nrf2 luciferase test method, and the human cell line activation test (h-CLAT).

It is shown here that GARD™ alone outperforms each of DPRA, ARE-Nrf2 luciferase or h-CLAT, alone or in any combination as a 2 out of 3 strategy, in terms of sensitivity, specificity and accuracy.

Based on the datasets analysed here, the sensitivity and specificity of GARD™ alone are 90–92% and 79–84% (“2 out of 3”, 86% and 76%). Thus, in any situation where the 2 out of 3 strategy is considered adequate, GARD™ alone could be used with equal or better performance.

Keywords
Skin sensitization potential, Non-animal assays, Integrated testing strategies, GARD™

Full article
Article on line

SenzaGen to attend the Medicon Valley Inhalation Symposium 2018

SenzaGen will attend the 7th Medicon Valley Inhalation Symposium – Future Opportunities of Inhalation 2018, 3- 4 October at Medicon Village. A two-day symposium on New drugs, Inhalation devices, Dissolutions, Tox and Pre-Clinical testing and Regulatory updates. 

Dr Henrik Johansson will hold a presentation on Thursday, October 4 at 09:25, on the topic “Predictive Respiratory Toxicology with the GARD In-Vitro Testing Platform”. Come and get the latest updates, meet us and all the experts and stakeholders there!

GARD® and SenzaGen mentioned in Chemical Risk Manager, September 18, 2018

Don’t miss the interesting article in Chemical Risk Manager in Chemical Watch, written by Dr. Emma Davies, with the title; Skin sensitization integrated testing strategies need rethink, expert suggests.

Emma Davies is interviewing the UK academic Dr. David Roberts after his publication of an article in Regulatory Toxicology and Pharmacology in July where he is discussing the relevance of Integrated Testing Strategy (ITS) for skin sensitization testing as well as he is presenting data on the performance of the GARDskin test method compared to the OECD -tests.  

In short, David Roberts from Liverpool John Moores University questions the science behind integrated testing strategies (ITS) for combining in vitro test methods to predict skin sensitisation, as required by REACH. Instead, Roberts suggests, ”… that the genomic allergen rapid detection (GARD) assay for skin sensitisation may outperform other OECD validated test methods, either alone or in combination.”

Dr. David Roberts will present his data and the research behind the article at the EUSAAT meeting 23-26 September in Linz, and at the ESTIV conference 15-18 October in Berlin

Read the article here (requires subscription to Chemical Watch):
https://chemicalwatch.com/crmhub/70359/skin-sensitisation-integrated-testing-strategies-need-rethink-expert-suggests

 

 

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Inspelning samt transkript från telefonkonferens gällande ECVAMs utvärdering av GARDskin flyttad till våren 2019

Inspelning från telefonkonferens (19 september, 2018) gällande ECVAMs utvärdering av GARDskin flyttad till extra möte i den vetenskapliga kommittén under våren 2019, på svenska.

Recording from telephone conference (September 19, 2018) regarding ECVAM evaluation of GARDskin rescheduled to an extra scientific committee meeting in spring 2019, in Swedish.

 

Nedan finner du även transkript från telefonkonferensen, på svenska.

Below you will find a transcript from the telephone conference, in Swedish.

Transkript/Transcript

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Senzagen lanserar det första in vitro testet för luftvägsallergier – GARDair – på ESTIV2018

Luftvägsallergier eller respiratorisk sensibilisering, som uttrycker sig framförallt i form av astma, är ett växande problem. Cirka 8-10 % av den svenska befolkningen lider av astma och mer än 300 miljoner personer globalt är diagnosticerade med astma – en siffra som förväntas växa de närmaste åren. Idag finns det inga metoder för testning av huruvida kemikalier har en förmåga att inducera eller orsaka allergiska reaktioner i luftvägarna. GARDair använder sig av genetiska biomarkörer, som tillsammans täcker in hela immunreaktionen och är relevanta för att förutsäga risken för överkänslighet med hög tillförlitlighet. GARDair riktar sig främst till kemisk, farmaceutisk och kosmetisk industri där det finns ett utbrett behov av tester av allt från bekämpningsmedel till dofter. GARDair kommer att marknadsföras genom SenzaGens laboratorium i Lund och bolagets licenslaboratorier, vilket gör att testet direkt kommer att bli tillgängligt i Europa och USA.

Med samma teknikplattform som för redan lanserade GARDskin, stödjs GARDair av EUs SME-program Horizon2020 och har utvecklats i samarbete med AstraZeneca.

“I min egenskap som extern och oberoende Horizon2020-coach har jag bistått SenzaGen med rådgivning kring förberedelserna inför kommersialisering av GARDair”, säger Paul Yianni, Horizon2020-coach. ”För mig är SenzaGen en sann EU-framgångssaga genom att uppfylla syftet med Horizon2020, nämligen att utnyttja en förträfflig teknologiplattform till att utveckla en rad utmärkta produkter och erbjudanden för marknaden. Detta är på alla sätt en High-Tech business. De har unika produkter på växande marknader och utmärkt ledning. Jag tror att GARDair kommer att bidra till att göra SenzaGen till ett mycket lönsamt och framgångsrikt företag.”

“Det finns en stor efterfrågan på GARDair från kunder inom kemikalie-, läkemedels- och kosmetikabranscherna. Möjligheten att, utan djurförsök, göra tester av huruvida ämnen kan framkalla luftvägsallergier erbjuder stora fördelar”, säger Anki Malmborg Hager, VD på SenzaGen. ”Det handlar dels om att säkerställa att bättre och säkrare produkter kan utvecklas och dels om att kunna erbjuda anställda en säker produktions- och arbetsmiljö.

GARDair i kombination med GARDskin ger oss ny kunskap och även nya möjligheter för

våra kunder att aktivt undvika kemikalier med flera olika typer av allergiframkallande effekter”.

SenzaGen lanserar GARDair på 20th International Congress on In Vitro Toxicology (ESTIV2018), 15-18 October 2018.

 

För mer information, kontakta:
Anki Malmborg Hager, VD, SenzaGen AB
Email: anki.malmborg.hager@senzagen.com
Telefon: 0768 284822

 

Om GARD®
GARD® är en grupp med tester för analys av kemikaliers förmåga att starta en allergisk reaktion hos människa. Genom att analysera hundratals markörer genererar GARD® stora mängder data och levererar resultat med över 90 procents precision. Detta kan jämföras med dagens standardmetod – tester på möss – som endast uppnår 70-75 procents precision. SenzaGens test kan dessutom kvantifiera den allergiframkallande potentialen för en kemisk substans.

Om SenzaGen
SenzaGen gör det möjligt att ersätta djurförsök med genetiska tester i provrör för att bedöma om de kemikalier vi kommer i kontakt med i vår vardag är allergiframkallande. Det kan till exempel handla om kosmetika, läkemedel, livsmedel och färgämnen. Bolagets patentskyddade tester är de mest tillförlitliga på marknaden och ger mer information än traditionella utvärderingsmetoder. Testerna säljs i egen regi i Sverige och USA, och genom partners i flera andra länder. De närmaste åren kommer bolaget expandera geografiskt, knyta till sig fler distributionspartners och lansera nya, unika tester. SenzaGen har sitt huvudkontor i Lund och dotterbolag i San Francisco, USA. För mer information, besök http://www.senzagen.com.

Denna information är sådan information som SenzaGen är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning och lagen om värdepappersmarknaden. Informationen lämnades, genom ovanstående kontaktpersons försorg, för offentliggörande den 18 september 2018 kl. 17.30

SenzaGen är listat på Nasdaq Stockholm First North (ticker: SENZA). FNCA är bolagets Certified Adviser. Mer information om SenzaGen finns att tillgå via http://www.senzagen.com.

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SenzaGen launches the first in vitro airway allergy test – GARDair – at ESTIV2018

Respiratory allergies or respiratory sensitization, which manifests itself primarily in the form of asthma, is a growing problem. About 8-10% of the Swedish population suffer from asthma and more than 300 million people worldwide are diagnosed with asthma – a figure that is expected to increase in the next few years. There are currently no methods available for testing if chemicals can contribute to or cause allergic reactions in the respiratory tract. GARDair makes use of genetic biomarkers which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity with high accuracy. GARDair is targeted primarily at the chemical, pharmaceutical and cosmetic industries where there are a wide range of testing needs from pesticides to fragrances. GARDair will be marketed through SenzaGen’s laboratory in Lund and the company’s licensing laboratories, which will allow immediate availability in Europe and the United States.

Using the same technology platform as the already launched GARDskin, GARDair is supported by the EU’s SME program Horizon2020 and has been developed in cooperation with AstraZeneca.

“I have been advising SenzaGen in their preparations for the commercialization of GARDair in my capacity as external and independent Horizon2020 coach. SenzaGen is for me a true EU success story and meets the aims of Horizon2020 by translating an excellent technology platform into a number of excellent products and offerings for the market. It is a true ’High-Tech’ business. They have unique products in growth markets and excellent management. I believe that GARDair will contribute to making SenzaGen a very profitable and successful company,” says Paul Yianni, Horizon2020 coach.

“There is a huge demand for GARDair from customers in the chemicals, pharmaceutical and cosmetics industries. The ability to test without using animal models whether substances might cause airway allergies brings major benefits in several ways – not only when it comes to developing better and safer products, but also by offering employees a safe production and working environment. GARDair in combination with GARDskin provides new insights and thereby new opportunities for our customers to actively avoid chemicals with multiple allergenic effects,” says Anki Malmborg Hager, CEO of SenzaGen.

SenzaGen will unveil GARDair at the 20th International Congress on In Vitro Toxicology (ESTIV2018), October 15-18, 2018 in Berlin, Germany.

 

For more information, please contact:

Anki Malmborg Hager, CEO, SenzaGen AB
Email: anki.malmborg.hager@senzagen.com
Telephone: +46 768 284822

 

About GARD®
GARD® is a group of tests for assessing chemical skin sensitizers. The tests make use of genetic biomarkers for more than 200 genes which cover the entire immune reaction and are relevant to predicting the risk of hypersensitivity. The tests have over 90 percent reliability. This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75 percent. SenzaGen’s tests are also capable of measuring the potency of a substance’s allergenic properties. Consequently, GARD tests provide a much more comprehensive basis for determining whether a substance should be classified as an allergen than current testing methods.

 

About SenzaGen
SenzaGen makes it possible to replace animal experiments with in vitro genetic testing to determine the allergenicity of the chemicals we come into contact with in our daily lives, such as for example in cosmetics, pharmaceuticals, food products and dyes. The company’s patented tests are the most reliable on the market and provide more information than traditional evaluation methods. We ourselves sell the tests in Sweden and the USA, and we sell through partners in several other countries. Over the next few years the company will expand geographically, make alliances with more distribution partners and launch further unique tests. SenzaGen has its headquarters in Lund in Sweden and a subsidiary in San Francisco, USA. For more information visit http://www.senzagen.com

This information is information that SenzaGen is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person set out above on September 18, 2018, at 17:30.

SenzaGen AB is listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com

Attached file