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SenzaGen granted additional patent in Asia

SenzaGen today announced that the South Korean Patent Office (KIPO) has approved SenzaGen's patent application for GARD™skin. The new patent gives SenzaGen a strong intellectual property position in several strategically important markets.

The granted patent is valid until October 2031 and protects the genetic signature that forms the basis of SenzaGen’s animal-free test for whether chemicals can cause skin allergies. South Korea is a key market in Asia with expected strong growth following a ban on animal testing on cosmetic products that started in 2017.

“For a technology-driven company, it is of the utmost importance that we continuously develop our patent strategy and safeguard our most valuable assets. The patent for GARD™skin protects the method that SenzaGen’s business is built on and strengthens our long-term and global competitiveness”, says Anki Malmborg Hager, CEO of SenzaGen.

SenzaGen has a well-developed IP strategy to protect current and future innovations in important markets where the company markets or plans to market its tests. Market data show that the need for alternative testing methods is growing around the world as bans to use animals are introduced in more countries, thus boosting the market potential of SenzaGen’s animal-free testing method. Already granted in Europe, China and Hong Kong, patent applications for GARD™skin are currently being processed by the patent authorities in countries where animal testing is prohibited or where a ban is expected to be introduced, including the United States, Canada and India. In addition, the patent portfolio includes several ongoing patent applications for other GARD® products.

SenzaGen’s GARD™ product portfolio consists of a set of allergy tests with industry leading performance and accuracy. The tests are performed on human cells in test tubes (in vitro) in combination with artificial intelligence and replace animal experiments for the cosmetics, chemical and pharmaceutical industries for their tests on whether chemical substances in products can be allergenic.

For more information, please contact: 

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

Tina Dackemark Lawesson, Director Investor Relations & Corporate Communications
Email:
tina.lawesson@senzagen.com | Telephone: +46 708 202944

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 March 6, 2019, at 13.30.

About GARD®

GARD™ consists of a group of tests for analyzing chemicals’ ability to start an allergic reaction in humans. By analyzing hundreds of markers, GARD™ generates large amounts of data and delivers results with over 90 percent accuracy. This can be compared to today’s standard method – tests on mice – which only achieves 70-75 percent precision. SenzaGen’s test can also quantify the allergenic potential of a chemical substance.

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. The tests are sold via license laboratories (CRO) and distributors, and via the headquarters in Lund and the sales office in the US. 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 the USA. For more information visit http://www.senzagen.com.  

SenzaGen AB is listed on Nasdaq First North in Stockholm (ticker: SENZA) and FNCA Sweden AB, +46(0)8-528 00 399 info@fnca.se, is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com. 

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blue senzagen logo

SenzaGens bokslutskommuniké 2018

Positiv utveckling för SenzaGen – intresset för GARD® fortsätter att öka

VD-kommentar
”Under 2018 har vi etablerat en stadigt växande kundbas och antalet test som vi utfört för kunders räkning har ökat väsentligt, med en, för andra året i rad, fördubblad omsättning som resultat. Detta tillsammans med forskningsresultat om GARD®skin publicerade i Regulatory Toxicology and Pharmacology stärker vår övertygelse om att SenzaGen nu driver förändringen av den globala testningsindustrin”, säger Anki Malmborg Hager, VD.

Helår 2018

  • Nettoomsättningen uppgick till 1 997 KSEK (1 153)
  • Periodens resultat uppgick till -16 090 KSEK (-13 076)
  • Resultatet per aktie -1,04 SEK (-1,62)
  • Likvida medel per den 31 december uppgick till 56 632 KSEK (82 732)
  • Styrelsens förslag är att ingen vinstutdelning sker till bolagets aktieägare.

Halvåret 1 juli–31 december

  • Nettoomsättningen uppgick till 1 637 KSEK (1 079)
  • Periodens resultat uppgick till -7 614 KSEK (-4 884)
  • Resultatet per aktie -0,49 SEK (-0,35)

Väsentliga händelser under halvåret 1 juli–31 december

  • Lansering av GARD®air – världens första in vitro-test för luftvägsallergier.
  • Globalt distributionsavtal gällande GARD®tecknades med Eurosafe, en ledande aktör inom tester för kosmetikaindustrin i Frankrike.
  • SenzaGen fick patent för GARD®skin beviljat i Kina.
  • Dotterbolaget i USA är numera helägt och organisationen har förstärkts kommersiellt.
  • Finansiella målsättningar fastställdes.
  • De regulatoriska myndigheterna meddelade att OECD-godkännandet av GARD®skin senarelagts.
  • Peter Nählstedt invaldes i styrelsen.

Väsentliga händelser efter årets slut

  • Ett förberedande steg för etablering i Kina har tagits genom ett samarbetsavtal med en ledande expert.


För mer information, vänligen kontakta

Anki Malmborg Hager, VD, SenzaGen AB
Email: anki.malmborg.hager@senzagen.com | Mobil: 0768 284822

Denna information är sådan information som SenzaGen AB är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning. Informationen lämnades, genom ovanstående kontaktpersons försorg, för offentliggörande den 14 februari 2019, kl. 08.30 CET. 

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 AB (publ) 
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 USA. För mer information, besök http://www.senzagen.com.

SenzaGen är listat på Nasdaq Stockholm First North (ticker: SENZA). FNCA Sweden AB, +46(0)8-528 00 399 info@fnca.se, är bolagets Certified Adviser. Mer information om SenzaGen finns att tillgå via http://www.senzagen.com.

Bifogat dokument

SenzaGen takes a first step into China – cooperates with leading expert

SenzaGen (Nasdaq First North: SENZA) has initiated a partnership with Guangzhou Chn-Alternative Biotechnology Co., Ltd (CHNALT), a leading provider of alternative, animal-free testing methods in China. The new collaboration aims to establish local networks and ensure SenzaGen with its GARD™ genome-based testing method has a strong position as China moves towards introduction of animal-free chemical testing methods. China is one of the world's largest markets, with an expected ban on animal experiments in the cosmetics industry, for example.

Dr Shu-jun Cheng is the CEO of CHNALT and one of China’s leading toxicologists and key opinion leaders when it comes to alternative, animal-free testing methods. He is a professor at Shanghai Jiao Tong University, one of China’s most prestigious universities and research centers.

“We are very pleased to be able to initiate a formal collaboration with such an active and well-respected champion of animal-free testing in China. Dr. Cheng is a strong voice and has been driving the development of alternative testing methods in China for many years. As SenzaGen’s partner, he can offer expertise and direct contact with industry and gradually establish GARD as the first-choice method for animal-free testing. We see many opportunities arising and this collaboration will ensure we are fully prepared the day the market is ready for our products”, says Anki Malmborg Hager, CEO of SenzaGen.

SenzaGen’s strategy is to establish strong partnerships in markets where animal testing is prohibited or where a ban is expected to be introduced. So far, animal data are mostly compulsory for allergy testing of substances in China, but there are strong forces for introducing alternative methods and in the long term a ban.

“We are looking forward to driving the change within the industry and academia together with SenzaGen. Our ambition is to make alternative methods accepted for chemicals and cosmetics testing in China. We also firmly believe that GARD assays, as next generation genome-based testing methods, will serve as high-performance tools supporting the research and development of safer, allergy-free products”, says Shu-jun Cheng, CEO of CHNALT.

GARD™ is a genome-based test that has higher reliability than other available test methods on the market. The test gives customers important safety information about the risk of chemical substances causing allergies in humans.  

For more information, please contact:
Anki Malmborg Hager, CEO, SenzaGen AB
Email: anki.malmborg.hager@senzagen.com | Telephone: +46 768 284822

Tina Dackemark Lawesson, Director Investor Relations & Corporate Communications
Email: tina.lawesson@senzagen.com | Telephone: +46 708 202944

About GARD™
GARD™ is a group of tests for analyzing chemicals’ ability to start an allergic reaction in humans. By analyzing hundreds of markers, GARD® generates large amounts of data and delivers results with over 90 percent accuracy. This can be compared to today’s standard method – tests on mice – which only achieve 70-75 percent precision. SenzaGen’s test can also quantify the allergenic potential of a chemical substance.

About SenzaGen
SenzaGen makes it possible to replace animal experiments with genetic tests in test tubes in order to assess whether the chemicals we come into contact with in our everyday life are allergenic or not. Examples are cosmetics, pharmaceuticals, foods and dyes. The company’s proprietary tests are the most reliable on the market and provide more information than traditional evaluation methods. The tests are sold in-house in Sweden and the US, and through partners in several other countries. Over the next few years, the company will expand geographically, add more distribution partners and launch new, unique tests. SenzaGen has its head office in Lund and subsidiary in the US. For more information, visit http://www.senzagen.com.

SenzaGen AB is listed on Nasdaq First North in Stockholm (ticker: SENZA).FNCA Sweden AB,+46(0)8-528 00 399 info@fnca.se,is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com.

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SenzaGen strengthens its organization with IR and communications director

Lund, December 5, 2018 - SenzaGen (Nasdaq First North: SENZA) today announced that the company has recruited Tina Dackemark Lawesson as communications director. Dackemark Lawesson joins SenzaGen with a wealth of experience from IR and communications positions in similar life science companies and takes up her position in December 2018.

“SenzaGen is in a very exciting development phase and we need to strengthen our organization within both IR and strategic communication. In her role as communications director, Tina will be tasked with increasing communication towards our prioritized target groups and will thus have a key position in SenzaGen,” says Anki Malmborg Hager, CEO of SenzaGen.

Dackemark Lawesson joins SenzaGen from Invisio, a Danish communication equipment company based in Copenhagen, where she was Director of Investor Relations & Corporate Communications. She previously held similar positions at Cellavision, Enzymatica and Precise Biometrics.

“SenzaGen is a very exciting company which, thanks to its technology, has the opportunity to make a real impact in the pharmaceutical and cosmetics industries. I am therefore delighted to have the opportunity of meeting the challenge of taking the company’s communications forward,” says Dackemark Lawesson.

 

For more information, please contact:

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

Tina Dackemark Lawesson, SenzaGen AB
Email: tina.lawesson@senzagen.com
Telephone: +46 708 202944

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

The information was submitted for publication, through the contact person set out above on December 5, 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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blue senzagen logo

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

Lund, October 11, 2018 - SenzaGen (Nasdaq First North: SENZA) today announces that the Company is strengthening its presence in the important US market through a major strategic recruitment. The recruitment of Dr. Joshua J. Schmidt as Business Development Director at SenzaGen Inc represents a further expansion of the Company's commercial organization and an increasing focus on establishing collaborations with both licensees and distributors, in accordance with SenzaGen’s recently communicated financial targets. In parallel with the recruitment, SenzaGen Inc also becomes a wholly-owned subsidiary, offering additional possibilities for steering the commercial strategy in the US.

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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blue senzagen logo

Senzagen presents financial targets

Lund, October 9, 2018 – The SenzaGen Board of Directors (Nasdaq First North: SENZA) announces today that it has adopted financial targets. The underlying reasons behind this decision are the successful development in-house of a broad and unique product portfolio, the growing number of partnerships being established with CROs and other industrial partners, and the identification of larger target markers which will entail entering long term contracts with major new CRO partners. Thus, SenzaGen is now considerably expanding its focus on building and strengthening its existing commercial organization.

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

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

Lund, September 18, 2018 - SenzaGen (Nasdaq First North: SENZA) announced today that the company will launch GARDair, the first in vitro test for airway allergies at ESTIV2018, the 20th International Congress on In Vitro Toxicology. Removing the need for animal testing and opening a completely new market, GARDair is based on the company’s proprietary GARD® technology platform. Using genetic biomarkers, GARDair tests whether substances and chemicals that are inhaled or come into contact with the lungs are allergenic or not, with high accuracy. 

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

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Anki Malmborg Hager-9.jpg

ECVAM evaluation of GARDskin rescheduled to an extra scientific committee meeting in spring 2019

Lund, September 18, 2018 - SenzaGen (Nasdaq First North: SENZA) has been notified by the European Center for the Validation of Alternative Methods (ECVAM) authority that due to time constrains their scientific committee (ESAC) will not be able to evaluate tests in the category ”Test Guidelines on Health Effects”, to which GARDskin belongs, this year. The authority cites high workload as reason for the delay. Instead, ECVAM has announced that the evaluation of GARDskin is now scheduled for an extra meeting to be held during spring 2019. 

SenzaGen originally submitted the final validation report for GARDskin to the regulatory authorities in 2018, thereby fully complying with ECVAM and OECD deadlines. The report shows that GARDskin can determine with 93.8% accuracy if chemical substances pose a risk of causing allergies. This result confirms the superiority of GARDskin over all currently available validated methods. It is also the first test to include the long required potency classification in vitro, which is a requirement for registration of chemicals and also requested by customers. GARDskin is unique in that it provides a holistic view by including analysis of multiple human immunological responses in a single test. In addition, GARDskin is the first test to be validated in which biology, genomics and high-tech algorithms are combined, leading to high safety levels.

ECVAM (European Centre for the Validation of Alternative Methods) has announced that because of a high workload the evaluation of GARDskin is now scheduled for an extra meeting to be held in the spring of 2019. This in turn means that a decision by the OECD regarding the validation of GARDskin is now expected in 2020.

“SenzaGen has had a broad marketing strategy from our start and we are constantly working to expand it further. This has involved focusing the company’s resources on large markets and applications where demand for regulatory approval is limited and thus our total future revenues are only partially dependent on an OECD validation,” says SenzaGen CEO Anki Malmborg Hager.

A telephone conference is scheduled on September 19, 2018, 8:00 am CET to answer questions and further elaborate on this news. The conference will be held in Swedish.

Participant dial in numbers:

SE: +46856642662
UK: +442033645373

On the SenzaGen website, under Investors/Pressmeddelanden (http://senzagen.com/investors/pressmeddelanden/) there will be an MP3 file for those who want to listen to the conference call later, the file is available within two hours of the end of the conference call.

 

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

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blue senzagen logo

SenzaGen targets the growing medical device market

Lund, August 29, 2018 - SenzaGen (Nasdaq First North: SENZA) announces today that the Company is now expanding its market focus to the medical device market. This market is in strong growth as a result of a growing and aging population in combination with a new regulatory framework for medical devices and increased quality standards.

Today, SenzaGen focuses on the chemicals, cosmetics and pharmaceutical markets for its global commercialization of GARD®, an in vitro platform for risk assessment of chemicals. Now, the Company has decided to further expand its market presence and will also focus its efforts on the global market for medical devices.

“We see significant opportunities in the medical device market. Large underlying growth combined with a willingness to use in vitro tests to assess the risk profile of medical devices and a new regulatory framework means that the medical device market will be a natural next step for SenzaGen,” says Anki Malmborg Hager, CEO of Senzagen.

The global medical technology market is estimated to be worth $410 billion in 2023 with an annual increase of 4.5% in 2018-2023. All medical devices that come into contact with the patient must be assessed for allergy before they can be sold. The market potential of testing and risk assessment of medical devices is therefore very large and increasing. At the moment, changes are made in the EU regulatory framework for medical devices while the global ISO Standard ISO 10993 for the approval of medical devices is updated. So far, ISO 10993 has required tests on guinea pigs for sensitization, but work is ongoing to update the standard to include animal-free tests, which SenzaGen can capitalize on.

In order to increase the introduction pace, the Company has signed a cooperation agreement with Research Institutes of Sweden (RISE) in order to adapt GARD® for testing medical devices. Furthermore, Eurofins, licensee to GARD®, is a major player in the medical devices market and will therefore be able to expand its offer to this market.

A first step in the adaptation of GARD® for medical devices will be presented as a poster at the EUROTOX conference in Brussels, 2-5 September 2018.

 

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

The information was submitted for publication, through the contact person set out above on the August 29, 2018 at 08.45. 

SenzaGen AB are 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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Notice of extraordinary General meeting of SenzaGen AB

The shareholders of SenzaGen AB, reg. no. 556821-9207, (the “Company”) are hereby summoned to the extraordinary general meeting on Friday 7 September 2018 at 08.00 at Medicon Village, building 401 Länken 2, Scheelevägen 2 in Lund.

Right to attend the general meeting and notification

Shareholders who wish to attend the extraordinary general meeting must be included in the share register maintained by Euroclear Sweden AB on the record date, which is Saturday 1 September 2018, (since the record day occurs on a Saturday a shareholder must be registered in the share register maintained by Euroclear Sweden AB no later than on 31 August 2018).

Shareholders shall also to notify the Company of their participation and any assistants (no more than two) in the extraordinary general meeting no later than Monday 3 September 2018. The notification shall be in writing to SenzaGen, Medicon Village, building 401, 223 81 Lund or via e-mail: anmalan@senzagen.com. The notification should state the name, personal/corporate identity number, shareholding, address and telephone number and, when applicable, information about representatives, counsels and assistants. When applicable, complete authorization documents, such as registration certificates and powers of attorney for representatives and assistants, should be appended the notification.

Nominee shares

Shareholders, whose shares are registered in the name of a bank or other nominee, must temporarily register their shares in their own name with Euroclear Sweden AB in order to be entitled to participate in the general meeting. Such registration, which normally is processed in a few days, must be completed no later than 31 August 2018 and must therefore be requested from the nominee well before this date.

Proxy etc.

Shareholders represented by proxy shall issue dated and signed power of attorney for the proxy. If the proxy is issued by a legal entity, attested copies of the certificate of registration or equivalent authorization documents, evidencing the authority to issue the proxy, shall be enclosed. The proxy’s validity may not be more than five years from the issuance. A copy of the proxy in original and, where applicable, the registration certificate, should be submitted to the Company by mail at the address set forth above well in advance of the extraordinary general meeting. The proxy in original and, when applicable, the certificate of registration must be presented at the extraordinary general meeting. A form proxy will be available for downloading on the Company’s website http://www.senzagen.com.

Proposed agenda

  1. Election of chairman of the meeting.
  2. Preparation and approval of voting list.
  3. Election of one or two persons to certify the minutes.
  4. Question whether the general meeting has been duly convened.
  5. Approval of the agenda.
  6. Election of new director of the board.
  7. Closing of the meeting.

Proposed resolutions

Item 1: Election of chairman of the meeting

The board of directors proposes that Carl Borrebaeck is elected as chairman of the general meeting.

Item 6.: Election of new director of the board

It is proposed that the board of directors shall comprise of five directors.

It is further proposed that the remuneration to the director proposed for election shall be SEK 100,000. The total remuneration for the board of directors will amount to SEK 600,000 in accordance with the remuneration resolved on by the annual general meeting.

It is proposed to elect Peter Nählstedt as new director. The directors Carl Borrebaeck (chairman), Ann Gidner, Ian Kimber and Laura Chirica remain as directors.

Further information regarding the proposed director

Peter Nählstedt 

Education and background

Peter Nählstedt holds a M.Sc. in engineering and a Bachelor’s degree in Business administration. Peter was previously CEO of Probi AB and chairman of the board of International Probiotics Association Europe. He has also held several positions within GE Healthcare Life Sciences, such as general manager of BioProcess North America, and as director of South America Trelleborg Marine Systems.

Current Assignments: None

Year of birth: 1974

Nationality: Swedish 

Direct or related person ownership in the Company: 0

Number of shares and votes

The total number of shares in the Company as of the date hereof amounts to 15,559,250 shares, with a corresponding number of votes. The Company holds no own shares.

Documents

The complete proposals are included in this notice. The notice and proxy forms are available at the Company at Medicon Village, building 401 in Lund and at the Company’s website http://www.senzagen.com, at least two (2) weeks in advance of the extraordinary general meeting. All documents will be sent to shareholders who request it and provide their e-mail or postal address.

The shareholders hereby notified regarding the right to, at the extraordinary general meeting, request information from the board of directors and managing director according to Ch. 7 § 32 of the Swedish Companies Act.

Lund in August 2018

SenzaGen AB

The Board of Directors

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

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 at August 22, 2018, at 09.30.

SenzaGen AB are 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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