SenzaGen’s final validation report of GARDskin™ submitted to regulatory authorities – reveals highest test prediction accuracy in the field

Lund, January 12, 2018 – SenzaGen (Nasdaq First North: SENZA) announces today that the company has submitted the final report for the validation of GARDskin™ to the regulatory authorities. Global regulatory approval and recommendation by ECVAM and OECD on the use of GARDskin is expected in April 2019. The final result presented in the report shows an unprecedented over all prediction accuracy of 93,8% in determining whether chemical substances are at risk of causing allergies. This proves that GARDskin™ outperforms all current available validated methods.

 

The analysis of the data has been performed by an independent validation statistics consultant, according to the regulatory requirements. This analysis is the base for the official report now sent in to ECVAM. The data shows that the mean accuracy from all three independent laboratories (Eurofins BioPharma Product Testing in Germany, Burleson’s Research Technologies in the United States and SenzaGen’s own laboratory in Lund) is very high, reaching an accuracy of 93,8%.

The validation has included a large number of coded chemicals unknown to the validation laboratories, to enable the blinded testing demanded in this process. All laboratory results have been provided in a blinded manner to an external validating statistics consultant, who has now decoded the identity of the chemicals to compare the GARD classification performed at each lab, and analysed the prediction accuracy of GARD in classifying compounds as non-sensitizers or sensitizers. The validation report also includes data on the robustness of the test platform and its transferability.

The results in this report constitutes the basis for the evaluation of SenzaGen’s tests in the ECVAM Scientific Committee and within the OECD for regulatory approval and Test Guideline recommendation on the use of GARDskin. The regulatory decision from OECD is expected 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.

“These excellent validation results underpin the potential for GARD testing to become a game changer in in vitro allergy testing. We have long been aware of its high performance, and the validation now also provided by independent laboratories is of course very satisfying. Importantly, the validation has highlighted the simplicity of assay transfers to other labs. This adds to the confidence of further laboratories around the world to set up our unique assay,” says Anki Malmborg Hager, CEO of SenzaGen.

A comprehensive report of the results will be presented at the Society of Toxicology’s 57th Annual Meeting 11-15 March in San Antonio, US.

 

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

 

The information was provided by the contact person for publication on 12 January 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 www.senzagen.com

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
GARDis 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

GARDprotein demonstrates exceptional ability to identify allergens in foodstuff – new research results presented at scientific conference.

Lund, 10th October 2017 – SenzaGen (Nasdaq First North: SENZA) today announces positive results from an evaluation of GARDprotein, a test method which is developed to make it possible to eliminate allergenic proteins from today’s and tomorrow’s foodstuffs. GARDprotein has the potential to open up a new market for SenzaGen’s test platform. The results are being presented at the 3rd ImpARAS Conference in Helsingør, Denmark.

The results being reported at the conference show that GARDprotein has a unique ability to distinguish two almost identical proteins, one allergenic and the other non-allergenic. Allergy-inducing shrimp tropomyosin was correctly classified in the test as a protein allergen, while non-allergenic pork tropomyosin was correctly classified as a non-allergenic substance. A test method with this high precision and reliability can reduce the risk that foodstuffs are incorrectly categorized as allergenic or that their allergy-inducing properties are not detected in time.

This further evidence of the accuracy and reliability of a GARD test demonstrates the potential of SenzaGen’s technology platform with its associated pipeline of upcoming tests.

GARDprotein targets an important part of the market for cell-based in vitro toxicology tests, whose total size is estimated at 5.4 billion Euros in 2016.

“Many people are allergic to shrimp, while allergy to pork is extremely rare. GARDprotein is able to distinguish two almost identical proteins – the allergenic shrimp tropomyosin and the non-allergenic pork tropomyosin. This demonstrates additional test capabilities and opens a new potential market for us, as it can make our test a valuable future tool in the assessment of foodstuff’s allergy-inducing properties,” says SenzaGen CEO Anki Malmborg Hager.

The development of GARDprotein is supported by several industry partners and research institutes, including HESI PATC (the Health and Environmental Sciences Institute, Protein Allergenicity Technical Committee) consisting of Dupont, Syngenta and others. SenzaGen expects to launch the test in 2021, provided validation is successful.

ImpARAS (Improving Allergy Risk Assessment Strategy for New Food Proteins) is an interdisciplinary European scientific network dedicated to the development of more predictive methods for assessing proteins’ allergenic properties. Robin Gradin, industrial doctoral student at SenzaGen, will present the results of the GARDprotein evaluation today on 10th October  2017.

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


The information was provided by the contact person for publication on October 10 at 11:00.

Press release in pdf

All laboratory elements completed in the regulatory part of the validation process for SenzaGen’s GARDskin allergy test

Lund, 6th October, 2017. SenzaGen (Nasdaq First North: SENZA) announces today that all laboratory elements in the validation of GARDskin have been completed according to plan. After data processing and statistical analysis, the results will be compiled and reported to the international regulatory authorities ECVAM and OECD. The results of the analysis will also be published in conjunction with the submission of this report.

The purpose of this final step of the validation process is to document reproducibility in the use of GARDskin. Three laboratories (Eurofins in Germany, Burleson’s Research Technologies in the USA and Senzagen’s own laboratory) have independently carried out tests of 28 coded chemicals on three separate occasions, and this work has now been completed.

The validation element for reproducibility follows evaluations demonstrating that GARDskin can be set up in laboratories other than SenzaGen’s own (transferability). The results of these evaluations were published at the European Toxicology Conference EuroTox in Bratislava in September 2017, showing 100% transferability.

“Every step in the validation process brings us closer to our goal of establishing GARD as the new global industry standard for animal-free toxicological testing and as the natural choice for screening new drug candidates to make it possible at an early stage to weed out substances that are harmful and will not be usable as medicines,” says SenzaGen’s CEO, Anki Malmborg Hager.

After all the results from the different stages of the validation process have been compiled and reported, an assessment will take place in the ECVAM Scientific Committee and within the OECD. Regulatory approval and the OECD’s recommendations concerning the use of GARDskin are expected in April 2019. GARDpotency, which is based on the same biological platform, is to be evaluated in parallel with GARDskin, and is thus expected to be approved and recommended at the same time.

 

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 

The information was provided by the contact person for publication on October 6 at 11:30.

First day of trading in SenzaGen shares on Nasdaq First North in Stockholm

THIS PRESS RELEASE WAS ORIGINALLY RELEASED IN SWEDISH FOR THE SWEDISH MARKET AND HAS LATER BEEN TRANLSATED TO ENGLISH FOR GENERAL AWARENESS ON THE GLOBAL MARKET

 

Trading in SenzaGen AB’s shares was launched today on Nasdaq First North in Stockholm under the short name “SENZA” with ISIN code SE SE0010219626.

SenzaGen AB (“SenzaGen” or “the Company”) announces that trading in the Company’s shares began today on Nasdaq First North. As previously announced, the SenzaGen share offering was heavily oversubscribed prior to the listing.

“We are delighted to be listed on Nasdaq First North and we are proud of the support we have received from investors who have put their trust in us as they join us on our journey as a listed company. The listing and the capital injection will accelerate the development of SenzaGen so that we can offer society a new global industry standard of animal-free testing,” says SenzaGen CEO Anki Malmborg Hager.

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

blue senzagen logo

SenzaGen approved for trading on Nasdaq First North

THIS PRESS RELEASE WAS ORIGINALLY RELEASED IN SWEDISH FOR THE SWEDISH MARKET AND HAS LATER BEEN TRANLSATED TO ENGLISH FOR GENERAL AWARENESS ON THE GLOBAL MARKET

 

SenzaGen AB (“SenzaGen” or “the Company”) has today been approved by Nasdaq Stockholm AB as an issuer of shares on Nasdaq First North in Stockholm. The first trading day for the Company’s shares is 21st September 2017.

At the request of Nasdaq Stockholm AB, the Company has provided certain additional information relating to its listing on Nasdaq First North, and this information has been collated in the document “Additional information in relation to listing on Nasdaq First North” which is available on the Company’s website www.senzagen.com/investors/prospekt-listning-nasdaq-first-north/.

The share offer for listing on Nasdaq First North
The application period for SenzaGen’s offer for the Company’s listing on Nasdaq First North ended on September 12th 2017. The offer was addressed to both institutional and professional investors as well as to the general public in Sweden. Through the share issue, the Company has acquired more than 1,000 new shareholders.

Certified Adviser and Issuing agent
Vator Securities are the Company’s financial adviser and Baker McKenzie is the Company’s legal adviser. The issuing agent for the transaction is Nordnet Bank.

Further information
For further information, please refer to the Prospectus, which has been approved by and registered with the Swedish Financial Supervisory Authority with regard to the share issue, prior to the planned listing on Nasdaq First North. NOT RELEVANT FO MARKET OUTSIDE SWEDEN

For further information, please visit the Company’s website, www.senzagen.com or contact: Anki Malmborg Hager, CEO of SenzaGen AB, email: anki.malmborg.hager@senzagen.com, telephone: +46 76 828 48 22.

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

 

Important information

This announcement is not and does not form a part of any offer for sale of securities.

Copies of this announcement are not being made and may not be distributed or sent into the United States, Australia, Canada, Japan, New Zealand, South Africa, Hong Kong, Singapore or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures. The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and accordingly may not be offered or sold in the United States absent registration or an exemption from the registration requirements of the Securities Act and in accordance with applicable U.S. state securities laws. The Company does not intend to register any offering in the United States or to conduct a public offering of securities in the United States.

An offering of the securities referred to in this announcement is made by means of the prospectus referred to herein. This announcement is not a prospectus for the purposes of Directive 2003/71/EC (together with any applicable implementing measures in any Member State, the “Prospectus Directive”). Investors should not invest in any securities referred to in this announcement except on the basis of information contained in the aforementioned prospectus.

Matters discussed in this announcement may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe,” “expect,” “anticipate,” “intends,” “estimate,” “will,” “may,” “continue,” “should” and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond its control. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice.

blue senzagen logo

SenzaGen’s share offer heavily oversubscribed prior to listing on Nasdaq First North

THIS PRESS RELEASE WAS ORIGINALLY RELEASED IN SWEDISH FOR THE SWEDISH MARKET AND HAS LATER BEEN TRANLSATED TO ENGLISH FOR GENERAL AWARENESS ON THE GLOBAL MARKET

 

The offer of shares in SenzaGen AB (“SenzaGen” or “the Company”) prior to the Company’s listing on Nasdaq First North was heavily oversubscribed. The Company expects to raise SEK 90.1 million through this new share offer, before issue costs. Estimated first day of trading in the Company’s shares on Nasdaq First North is 21th September 2017, provided that Nasdaq Stockholm AB approves the Company’s application.

The application period for SenzaGen’s offer ended on September 12th 2017. The offer was addressed to both institutional and professional investors, as well as the general public in Sweden. When the offer has been registered with the Swedish Companies Registration Office (Bolagsverket), the number of shares will increase by 4,645,000 to a total of 15,461,000 shares. Through the share issue, the Company has acquired more than 1,000 new shareholders.

Subscription undertakings
Prior to the subscription period, most existing as well as new institutional and qualified investors had undertaken to subscribe in advance for shares to a total of approximately SEK 75 million, corresponding to 83 percent of the offer. Among those who undertook to subscribe in advance are Ålandsbanken Funds Ltd, Leif GW Persson, Jörgen Book (formerly with global market responsibility for strategy and pricing of respiratory products at AstraZeneca) and Per Lindberg (former global technology analyst and now an investor).

Certified Adviser and Issuing agent
Vator Securities are the Company’s financial adviser and Baker McKenzie is the Company’s legal adviser. The issuing agent for the transaction is Nordnet Bank.

Further information
For further information, please refer to the Prospectus (available in Swedish only), which has been approved by and registered with the Swedish Financial Supervisory Authority with regard to the share issue, prior to the planned listing on Nasdaq First North.

For further information, please visit the Company’s website, www.senzagen.com or contact: Anki Malmborg Hager, CEO of SenzaGen AB, email: anki.malmborg.hager@senzagen.com, telephone: +46 76 828 48 22.
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

 

Important information
This announcement is not and does not form a part of any offer for sale of securities.

Copies of this announcement are not being made and may not be distributed or sent into the United States, Australia, Canada, Japan, New Zealand, South Africa, Hong Kong, Singapore or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures. The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and accordingly may not be offered or sold in the United States absent registration or an exemption from the registration requirements of the Securities Act and in accordance with applicable U.S. state securities laws. The Company does not intend to register any offering in the United States or to conduct a public offering of securities in the United States.

An offering of the securities referred to in this announcement is made by means of the prospectus referred to herein. This announcement is not a prospectus for the purposes of Directive 2003/71/EC (together with any applicable implementing measures in any Member State, the “Prospectus Directive”). Investors should not invest in any securities referred to in this announcement except on the basis of information contained in the aforementioned prospectus.

Matters discussed in this announcement may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe,” “expect,” “anticipate,” “intends,” “estimate,” “will,” “may,” “continue,” “should” and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond its control. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice.

SenzaGen to present at EUROTOX Congress in Slovakia

SenzaGen announces today that the company will be presenting two scientific abstracts and hold a presentation titled “21st century testing: Can one test be stand alone?” at the upcoming EUROTOX Congress in Bratislava, Slovakia.

The 53rd European Congress of the European Societies of Toxicology, EUROTOX, is to be held in Bratislava, Slovakia on September 10-13, 2017. The congress will include a multitude of symposia and workshops as well as a large exhibition area and is an important meeting point for research community and industry.

On 12 September, SenzaGen’s new Chief Scientific Officer Henrik Appelgren will give an Exhibitor Hosted presentation at the congress with the full title “21st century testing for skin sensitisation: Can one test be stand alone? Regulatory challenges and GARD applications update” Furthermore, SenzaGen is also exhibiting at the congress (Booth 25) and is presenting two scientific posters on the transferability of the GARDskin assay to two independent laboratories and the GARD platform for potency assessment of skin sensitizing chemicals.

For additional information regarding Henrik Appelgren’s presentation, visit:
www.eurotox2017.com/programme/exhibitors-meetings/senzagen/
or SenzaGen web site www.senzagen.com/event-calendar/

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 90% reliability. This compares with the current predominant test method, experiments on mice, which has a reliability rating of 72%. 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

 

blue senzagen logo

SenzaGen publishes Prospectus prior to listing on Nasdaq First North

THIS PRESS RELEASE WAS ORIGINALLY RELEASED IN SWEDISH FOR THE SWEDISH MARKET AND HAS LATER BEEN TRANLSATED TO ENGLISH FOR GENERAL AWARENESS ON THE GLOBAL MARKET.

NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN OR REPUBLIC OF SOUTH AFRICA OR IN ANY OTHER JURISDICTION IN WHICH OFFERS OR SALES WOULD BE PROHIBITED BY APPLICABLE LAW.

 

SenzaGen AB (“SenzaGen” or “the Company”) announces a public offering of the Company’s shares and applies for listing of these shares on Nasdaq First North in Stockholm (“the Offer”). The Company has therefore prepared a prospectus (“the Prospectus”) which has today been approved by and registered with Finansinspektionen, the Swedish Financial Supervisory Authority. The Prospectus is now available on the Company’s website, www.senzagen.com/investors, and elsewhere.

SenzaGen has decided to offer shares in the Company to the general public in Sweden and Denmark (with certain restrictions) as well as to institutional investors in Sweden and abroad, and is therefore applying for listing on Nasdaq First North in Stockholm. The purpose of the Offer is to finance the expansion of the Company’s sales organization and its existing product portfolio with new tests based on the existing GARD platform.

The Offer and the subsequent listing on Nasdaq First North will give the Company access to capital markets, create liquidity in the Company’s shares, and also bring new shareholders to SenzaGen, thereby strengthening the Company’s development. SenzaGen’s listing is also expected to have a positive effect on the Company’s relationships with partners and potential customers.

The offer in brief

  • The Offer consists of up to 4,645,000 shares.
  • The subscription price has been set at 19.40 SEK per share.
  • The Offer amounts to a total of approximately SEK 90 million.
  • The portion of the Offer relating to the general public in Denmark is limited to shares totalling less than 1 million euros or equivalent amount in SEK.
  • The total Offer corresponds to a valuation of SenzaGen of approximately SEK 210 million (pre-money).
  • The application period for the public will last from 4thSeptember to 12th September 2017.
  • The settlement date is September 19th
  • Estimated first day of trading, provided that Nasdaq Stockholm AB approves the Company’s application, is September 21st

The application form will be available on SenzaGen’s website, www.senzagen.com/investors, Vator Securities website, www.vatorsecurities.se and Nordnet’s website, www.nordnet.se/emissioner, throughout the application period.

Subscription undertakings
The majority of existing as well as new institutional and qualified investors have already undertaken to subscribe for shares to a total of approximately SEK 75 million, equivalent to 83 percent of the Offer. Among these are Ålandsbanken Funds Ltd, Leif GW Persson, Jörgen Book, formerly with global market responsibility for strategy and pricing of respiratory products at AstraZeneca, and Per Lindberg, former global technology analyst and now an investor.

The Prospectus
For full details of the Offer, please refer to the Prospectus (available in Swedish only). The Prospectus has today been approved by and registered with the Swedish Financial Supervisory Authority (Finansinspektionen) and is available on SenzaGen’s website, www.senzagen.com/investors, Vator Securities website, www.vatorsec.se and will be available on the Finansinspektionen website, www.fi.se, within a few days.

Certified Adviser and Issuing agent
Vator Securities are the Company’s financial adviser and Baker McKenzie is the Company’s legal adviser. The issuing agent for the transaction is Nordnet Bank.


Further information

For further information, please refer to the Prospectus, which has been approved by and registered with the Swedish Financial Supervisory Authority with regard to the share issue, prior to the planned listing on Nasdaq First North.

For further information, please visit the Company’s website, www.senzagen.com or contact: Anki Malmborg Hager, CEO of SenzaGen AB, email: anki.malmborg.hager@senzagen.com, telephone: +46 76 828 48 22.

 

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

 

Important information

This announcement is not and does not form a part of any offer for sale of securities.

Copies of this announcement are not being made and may not be distributed or sent into the United States, Australia, Canada, Japan, New Zealand, South Africa, Hong Kong, Singapore or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures. The securities referred to in this announcement have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and accordingly may not be offered or sold in the United States absent registration or an exemption from the registration requirements of the Securities Act and in accordance with applicable U.S. state securities laws. The Company does not intend to register any offering in the United States or to conduct a public offering of securities in the United States.

An offering of the securities referred to in this announcement is made by means of the prospectus referred to herein. This announcement is not a prospectus for the purposes of Directive 2003/71/EC (together with any applicable implementing measures in any Member State, the “Prospectus Directive”). Investors should not invest in any securities referred to in this announcement except on the basis of information contained in the aforementioned prospectus.

Matters discussed in this announcement may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe,” “expect,” “anticipate,” “intends,” “estimate,” “will,” “may,” “continue,” “should” and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and are beyond its control. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice.

 

SenzaGen’s chairman Carl Borrebaeck has received the Biotech Builders Award 2017

SenzaGen’s chairman, Professor Carl Borrebaeck, has received the prestigious BiotechBuilders Award for his ground-breaking medical research and prominent role as entrepreneur in Life Science, including being the co-founder of SenzaGen, Immunovia, Alligator Bioscience and BioInvent. The award was announced at the annual BiotechBuilder’s meeting in Stockholm on 28 August. Through his involvement in SenzaGen, Carl Borrebaeck has contributed to the development of GARD™ – a gene-based test that evaluates the allergenic properties of chemical substances, thus eliminating the need for animal testing.

Carl Borrebaeck was given the award on the grounds of being a successful entrepreneur who contributed to the start of several new life science companies, including, Alligator Bioscience, Immunovia, BioInvent and SenzaGen, of which the first three have been introduced on the Swedish stock market. His efforts to build scientific networks, including Medicon Village, NOME (Nordic Mentor Network for Entrepreneurship) and Cancer Crosslink Conference, also contribute to his election as an outstanding “biotech builder” and good representative of Swedish life science industry.

Carl Borrebaeck’s latest start-up company SenzaGen, has its base at Medicon Village in Lund. The company develops and sells allergy tests, mainly to the cosmetics and chemical industry. SenzaGen’s test, the GARD™ (Genomic Allergen Rapid Detection) is an alternative method for allergy testing that eliminates the need for animal testing. The method has been developed for over 10 years by a research group at Lund University, led by Carl Borrebaeck, Professor and at the time Head of Institution, and Malin Lindstedt, Professor and Senior Lecturer, both at the Institution of Immunotechnology. GARD utilizes the human genome to classify chemicals, and evaluate their ability to induce allergic reactions in human cells. Today, SenzaGen owns the patents and drives the development as well as the global marketing and sales of GARD. SenzaGen is planning a listing on Nasdaq First North in September 2017.

For more information:
Anki Malmborg Hager,
CEO, SenzaGen AB
Email:  anki.malmborg.hager@senzagen.com
Phone:  +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 90% reliability. This compares with the current predominant test method, experiments on mice, which has a reliability rating of 72%. 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

About Biotech Builders
BiotechBuilders was first initiated in Denmark, 2002, by Dr Jørgen Thorball an early morning at Copenhagen Airport.  The news about the dying Biotech industry called for action to energize the entrepreneurs and bring new life to the industry. Dr Torberg invited the leading life science companies to initiate the first BiotechBuilders event. In this playful and inspiring environment, company founders, visionaries, venture capitalist and CEOs had the opportunity to network and exchange ideas. In 2009 the event was brought to Sweden and have since been held annually in Stockholm, and it has been a great success and much appreciated among the participating people.