SenzaGen reports positive results from ring trial in the validation of GARDskin™

Lund, 14th December 2017 – SenzaGen (Nasdaq First North: SENZA) today reports highly positive results from the final laboratory stage in the validation of GARDskin™. The results form an important part of the evidence in the approval process for the validation by ECVAM and OECD International Regulatory Authorities. In the recently completed evaluation, GARDskin continues to exhibit high accuracy and excellent reproducibility of test results, both within laboratories and between different laboratories. These data suggest that GARDskin outperforms all currently available validated methods.

The comprehensive laboratory evaluation of GARDskin, which is required for final regulatory validation, has produced excellent results. Three independent laboratories (Eurofins BioPharma Product Testing in Germany, Burleson's Research Technologies in the United States and SenzaGen's own laboratory in Lund) have carried out blind analyses of a large number of chemicals. The process has been repeated on several different occasions, in accordance with the OECD validation process. The purpose is to validate the transferability, robustness and reproducibility of the test, in order to demonstrate that GARDskin can deliver reliable results with higher accuracy than existing tests, even when used in external laboratories.

The results will be presented in detail at SOT, the International Society of Toxicology Conference, in Texas in March, and subsequently in scientific publications.

"The validation study provides convincing evidence that GARDskin works well even when the test method is used in external laboratories. The results reinforce the scientific basis for GARDskin in the process of obtaining regulatory approval and inclusion in international test guidelines. We are delighted with the outcome which shows that GARD consistently outperforms all existing validated test methods," says SenzaGen's CEO, Anki Malmborg Hager.

The results from the completed validation study constitute an important part of the basis for the forthcoming evaluation of SenzaGen's tests in the ECVAM Scientific Committee and within the OECD. Regulatory approval and recommendation on the use of GARDskin are expected from the OECD in April 2019. GARDpotency™, which is based on the same biological platform, is being validated in parallel with GARDskin, and is thus expected to be approved and recommended at the same time.

GARDskin will have significant potential to meet the increasing demand in the cosmetics, chemicals and pharmaceutical industries for reliable, animal-free testing methods to assess the allergy-inducing properties of chemical substances.


For more information:
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 up to 90% reliability. This compares with the current predominant test method, experiments on mice, which has an accuracy of 70-75%. 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 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 the 14 December 2017 at 08:30.

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

SenzaGen AB delårsrapport januari-juni 2017

Lund, Sverige – SenzaGen AB publicerar idag sin rapport för perioden 1 januari till 30 juni.

”Under perioden har SenzaGen påbörjat lanseringen av GARDpotency, tecknat ett utvecklingssamarbete kring GARDair med AstraZeneca och publicerat positiva forskningsresultat i en välrenommerad vetenskaplig tidskrift. Samtidigt har förberedelserna fortsatt inför den planerade listningen på Nasdaq First North”, säger SenzaGens verkställande direktör Anki Malmborg Hager.

PERIODEN 1 JANUARI – 3O JUNI

  • Nettoomsättningen uppgick till 74 KSEK (348)
  • Periodens resultat uppgick till -8 192 KSEK (-5 241)
  • Resultatet per aktie -3,79 SEK (-2,42)
  • Likvida medel per den 30 juni uppgick till 18 503 KSEK (29 685)

VÄSENTLIGA HÄNDELSER UNDER PERIODEN

  • SenzaGen lanserade GARDpotency för pilotförsäljning. GARDpotency är den första djurfria analysmetoden för kvantifiering av kemiska ämnens allergiframkallande egenskaper.
  • SenzaGen och AstraZeneca inledde samarbete för att utveckla GARDair – en ny metod för att särskilja luftvägsallergener och -irratanter.
  • Positiva forskningsresultat för GARDpotency publicerades i ledande vetenskaplig tidskrift.
  • Vid bolagets årsstämma i juni fattades de nödvändiga besluten inför den planerade listningen på Nasdaq First North.
  • Dr Laura Chirica valdes in i styrelsen.

VÄSENTLIGA HÄNDERLSER EFTER PERIODEN

  • SenzaGen ingick ett distributionsavtal med Charles River Laboratories för global distribution av GARDskin och GARDpotency.
  • SenzaGens ledning förstärktes med anställning av Chief Commercial Officer och Chief Scientific Officer.

Den fullständiga rapporten finns tillgänglig på bolagets hemsida, www.senzagen.com.


För mer information vänligen kontakta:

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


Om GARD
Genom att analysera 200 respektive 389 markörer beroende på test, genererar GARD stora mängder data och levererar resultat med upp till 90 % precision. Detta kan jämföras med den gyllene standarden som är djurtester på möss som har endast 70-75% precision. SenzaGens test har därtill förmågan att mäta potensen (styrkan) av en substans och kan därmed avgöra till vilken grad en substans orsakar allergi.

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 www.senzagen.com.