SenzaGen presents a new commercial organization and a new financial target

The evolution of SenzaGen in recent years has seen the company change from a research organization to one with a strong focus on commercialization. Recently, a new CEO was appointed, and the company now announces a brand new commercial organizational structure with increased focus on marketing and sales.

In the past two months, SenzaGen’s strategic plan, business goals and prioritized activities have been evaluated. A first result of this work is the establishment of a new commercial organization and a new financial target.

“The first step in the commercialization is an increased focus on collaboration with existing and potential customers, and an organization that enables this approach. It is clear that the company’s platform of alternative methods meets the market’s need for accurate, ethical and cost-effective methods that replace animal testing. However, commercializing a research company within life science takes time and our analysis leads to us reaching break-even in 2022,” says Axel Sjöblad, CEO of SenzaGen.

An organization with increased focus on marketing and sales
The commercial activities will be led directly by SenzaGen’s CEO Axel Sjöblad. Peter Nählstedt, Director of the Board of SenzaGen since 2018 and former CEO of Probi AB, has been appointed Acting Sales Manager. Tina Dackemark Lawesson takes the overall responsibility for Marketing and Communications and Anna Chérouvrier Hansson manages Business Development and the recruitment of distributors and licensing partners.

Break-even 2022
The new financial target to reach break-even in 2022 was adopted by SenzaGen’s Board of Directors on September 19, 2019 and replaces the previous financial targets.

“When Axel took office, he was assigned the task of evaluating SenzaGen’s strategy, business goals and sales potential, a work he had previously done successfully as CEO of BioGaia. His business analysis confirms our strategy and business model and suggests that the company implements a new and clearer commercial structure. This results in a minor shift in the profitability target since time is needed to give the sales organization an opportunity to deliver and to reach out with our cutting-edge technology. The Board supports this change, which will be led by a strong team with proven track record,” says Carl Borrebaeck, Chairman of the Board of SenzaGen.

Conference call

SenzaGen invites press and investors to a conference call where CEO Axel Sjöblad comments on the new organization and profitability target on September 19 at 10.30 CET. The conference call will be held in English.

Phone number for the conference
To participate in the conference, use the dial-in numbers below:

SE: +46856642706
FR: +33170750720
DE: +4969222220377
NL: +31207219495
UK: +443333009267

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 19, 2019, at 08.15 CET.

For additional information, please contact:
Axel Sjöblad, CEO, SenzaGen AB
Email: axel.sjoblad@senzagen.com | Mobile: +46 705-35 93 51

Tina Dackemark Lawesson, VP Marketing & Communications
Email:
tina.lawesson@senzagen.com | Mobile: +46 708-202944

About GARD®
GARD® consists of a group of tests for analyzing chemicals’ ability to start an allergic reaction in humans. The tests are performed on human cells in test tubes (in vitro) in combination with artificial intelligence. 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 animals – which only achieves 70-75 percent accuracy. The product portfolio consists of tests for skin and respiratory allergy: GARD™skin, GARD™air, GARD™potency and GARD™skin Medical Device.

About SenzaGen AB (publ)
SenzaGen’s technology enables replacement of animal experiments with genetic testing in test tubes for determining the allergenicity of the chemicals we come into contact with in our daily lives, such as those 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. SenzaGen sells direct in Sweden and the US, and through partners in several other countries. Over the next few years the company will grow geographically, make alliances with additional distribution and license partners, and launch new unique tests. SenzaGen has its headquarters in Lund in Sweden and a subsidiary in the US. For more information, please visit 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.

Attached file

SenzaGen presenterar ny kommersiell organisation och nytt finansiellt mål

De senaste årens positiva utveckling för SenzaGen har inneburit att bolaget har gått från att vara forskningsorienterat till ett bolag i stark kommersialiseringsfas. Detta resulterade nyligen i att en ny VD tillsattes och nu meddelar bolaget en helt ny kommersiell organisationsstruktur med ökat fokus på marknad och försäljning. 

De senaste två månaderna har SenzaGens strategiska plan, affärsmål och prioriterade aktiviteter utvärderats. Ett första resultat av detta arbete är att en ny kommersiell organisation etablerats och att ett nytt finansiellt mål satts.

”Det första steget i kommersialiseringen är ett ökat fokus på samarbeten med existerande och nya potentiella kunder och en organisation som möjliggör denna satsning. Det är tydligt att företagets alternativa testplattform möter marknadens behov av en precis, etisk och kostnadseffektiv metod som ersätter djurförsök. Att kommersialisera ett forskningsbolag inom life science tar dock tid och den analys som vi nu gjort innebär att vi når break even 2022”, säger Axel Sjöblad, VD på SenzaGen.

En organisation med ökat fokus på marknad och försäljning
De kommersiella aktiviteterna kommer att ledas direkt av SenzaGens VD Axel Sjöblad. Till tillförordnad försäljningschef har utsetts Peter Nählstedt, styrelseledamot i SenzaGen sedan 2018 och tidigare VD för Probi AB. Tina Dackemark Lawesson får det övergripande ansvaret för marknadsföring och kommunikation och Anna Chérouvrier Hansson leder arbetet med utvecklingen av nya affärer samt rekryteringen av distributions- och licenspartners.

Break even 2022
Det nya finansiella målet att nå break even 2022 antogs av SenzaGens styrelse den 19 september 2019 och ersätter de tidigare finansiella målen.

”När Axel tillträdde fick han uppdraget att utvärdera SenzaGens strategi, affärsmål och möjliga försäljningsutveckling, ett arbete som han tidigare framgångsrikt gjort som VD för BioGaia. Hans affärsanalys konfirmerar vår strategi och affärsmodell och innebär att bolaget implementerar en ny och tydligare kommersiell struktur. Detta resulterar i en mindre förskjutning av lönsamhetsmålet då tid behövs för att ge försäljningsorganisationen en möjlighet att leverera och nå ut med vår banbrytande teknologi. Styrelsen stödjer denna förändring som kommer ledas av ett starkt team med bevisad track record”, säger Carl Borrebaeck, Styrelseordförande i SenzaGen.

Telefonkonferens
SenzaGen bjuder in media och investerare till en telefonkonferens där VD Axel Sjöblad kommenterar den nya organisationen och lönsamhetsmålet den 19 september klockan 10.30. Telefonkonferensen hålls på engelska.

Telefonnummer till konferensen
För att delta i konferensen ring ett av numren nedan:

SE: +46856642706
FR: +33170750720
DE: +4969222220377
NL: +31207219495
UK: +443333009267

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 19 september 2019, kl. 08.15 CET.


För mer information, kontakta:
Axel Sjöblad, VD, SenzaGen AB
Email: axel.sjoblad@senzagen.com | Mobil: 0705-35 93 51

Tina Dackemark Lawesson, VP Marketing & Communications
Email:
tina.lawesson@senzagen.com | Mobil: 0708-202944

Om GARD®
GARD® består av en grupp med tester för analys av kemikaliers förmåga att starta en allergisk reaktion hos människa. Testerna utförs på mänskliga celler (in vitro) i kombination med artificiell intelligens. 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 djur – som endast uppnår 70–75 procents precision. Produktportföljen består av säkerhetstester för hud- och luftrörsallergi: GARD®skin, GARD®air, GARD®potency och GARD®skin Medical Device.

Om SenzaGen AB (publ)

SenzaGen gör det möjligt att ersätta djurförsök med cellbaserade tester 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 innehåller mer information än traditionella utvärderingsmetoder. Testerna säljs i egen regi i Sverige och USA samt genom partners i flera andra länder. I strategin ingår att expandera geografiskt, knyta till sig fler distributions- och licenspartners och lansera nya, unika tester. SenzaGen har sitt huvudkontor i Lund och dotterbolag i USA. För mer information, besök 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.

Bifogat dokument

A new French distributor is joining us

We are proud to welcome PKDerm as GARD® distributor. Located in Grasse, France, PKDerm offers innovative in vitro solutions to pharmaceutical, dermo-cosmetic and chemical industries in order to evaluate the efficacy and safety of products likely to come into contact with the skin. “As a GARD distributor, we are excited to offer a solution to […]

We are proud to welcome PKDerm as GARD® distributor.

Located in Grasse, France, PKDerm offers innovative in vitro solutions to pharmaceutical, dermo-cosmetic and chemical industries in order to evaluate the efficacy and safety of products likely to come into contact with the skin.

“As a GARD distributor, we are excited to offer a solution to customers in various industries for their in vitro testing needs. GARD has shown impressive performance in skin sensitization, and its ability to evaluate a large variety of substances combined with potency measurement makes it truly unique. We expect the GARD assays to become an essential complement to our portfolio”, says Hanan Osman-Ponchet, PKDerm’s founder and CEO.

Hanan Osman-Ponchet, PKDerm’s founder and CEO.

Follow this link to contact PKDerm for your next or current testing project.

The GARD Skin Assay: A New In Vitro Testing Strategy for Skin Sensitization

E. Schmidt, V. Zuckerstätter, H. Gehrke | Eurofins BioPharma Product Testing Munich GmbH Introduction  A skin sensitiser refers to a substance that will lead to an allergic response following skin contact as defined by the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). The potential to induce skin sensitisation is […]

E. Schmidt, V. Zuckerstätter, H. Gehrke | Eurofins BioPharma Product Testing Munich GmbH

Introduction 
A skin sensitiser refers to a substance that will lead to an allergic response following skin contact as defined by the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). The potential to induce skin sensitisation is an important consideration included in procedures for the safe handling, packaging and transports of chemicals.

The assessment of skin sensitisation typically involves the use of laboratory animals. Classical methods comprise the Magnusson Kligman Guinea Pig Maximisation Test, the Buehler Test (TG 406) as well as the local lymph node assay, in its radioactive and non-radioactive form (TG 429, TG 442A/B). In order to replace in vivo experiments validation studies on alternative, mechanistically based in chemico and in vitro test methods on skin sensitisation were conducted under the auspices of ECVAM and have been considered scientifically valid for the evaluation of the skin sensitisation hazard of chemicals.

Genomic Allergen Rapid Detection (GARDTM) is an in vitro assay designed to predict the ability of chemical substances to induce skin sensitisation based on the analysis of the relative expression levels of a biomarker signature of 196 genes using a human myeloid leukaemia cell line called SenzaCells. The GARDTM assay is based on chemical stimulation of the SenzaCells, acting as an in vitro model of human Dendritic Cells (DCs). The readout of the assay is a transcriptional quantification of the genomic predictors, collectively termed the GARDTM Prediction Signature (GPS), using Nanostring nCounter technology.

Conclusion
The DPRA, KeratinoSensTM and h-CLAT are well known sensitization assays which address three different key events of the AOP. The GARDTM skin assay is a new procedure that analyses the sensitization potential based on almost 200 human genes. If a substance is a skin sensitiser with the GARDTM skin assay you have the benefit of measuring the potency on top with a different code set to make a 1A or 1B classification.
The GARDTM skin assay is especially for products that have a high log Pow (h-CLAT > 3.5, KeratinoSensTM > 7) because in those cases the classical sensitization tests are inconclusive if negative and there is no option for a replacing test method. Therefore, the GARDTM skin assay is not only an excellent alternative of the sensitization methods for these cases but it can furthermore predict the potency of a skin sensitiser, a unique feature, which makes it a testing method needed in the future.

Link to poster

Poster publication at Eurotox, Helsinki, Sep 9, 2019.

 

In vitro skin sensitization testing of Medical Devices using GARD®

Rose-Marie Jenvert, Angelica Johansson, Olivia Larne, Emelie Danefur, Emil Altonen, Anders Jerre, Robin Gradin, Gunilla Grundström. SenzaGen, Lund, Sweden. Introduction All medical devices need to be evaluated for the end point skin sensitization according to the Biological Evaluation of Medical Devices (ISO 10993-1:2018), today commonly involving in vivo assays. Here, we show that the in […]
Rose-Marie Jenvert, Angelica Johansson, Olivia Larne, Emelie Danefur, Emil Altonen, Anders Jerre, Robin Gradin, Gunilla Grundström.
SenzaGen, Lund, Sweden.

Introduction
All medical devices need to be evaluated for the end point skin sensitization according to the Biological Evaluation of Medical Devices (ISO 10993-1:2018), today commonly involving in vivo assays. Here, we show that the in vitro assay GARD®skin Medical Devices can classify leachables as either skin sensitizers or non-sensitizers in polar and non-polar extraction of Medical Devices.

Conclusion
GARD®skin Medical Device

  • is an in vitro alternative for assessment of skin sensitization of Medical Devices
  • is compatible with the extraction vehicles salin, olive oil and sesame oil.

Link to poster

Poster publication at Eurotox, Helsinki, Sep 9, 2019.

 

Extended solvent selection for in vitro sensitization testing using GARD®

Olivia Larne, Ulrika I Torstensdotter Mattson, Rikard Alm, and Gunilla Grundström. SenzaGen, Lund, Sweden. Introduction The GARD®skin assay is an in vitro assay developed for the assessment of skin sensitizers. It is based on SenzaCells™, a human dendritic-like cell line, and a biomarker signature analyzed by a prediction model including pattern recognition and machine learning. […]
Olivia Larne, Ulrika I Torstensdotter Mattson, Rikard Alm, and Gunilla Grundström.
SenzaGen, Lund, Sweden.

Introduction
The GARD®skin assay is an in vitro assay developed for the assessment of skin sensitizers. It is based on SenzaCells™, a human dendritic-like cell line, and a biomarker signature analyzed by a prediction model including pattern recognition and machine learning.

During the development of the GARD®skin platform, two solvents were used: DMSO (0.1%) and water. To increase the applicability domain of GARD®skin and the possibility to dissolve certain test items, for e.g. hard to dissolve substances and UVCBs, where show a broader range of solvents compatible with GARD®skin. Also, use of higher concentrations of the tested solvents were explored for the possibility to increase test item concentrations.

Concluding highlights
GARD®skin compatible solvents:

  • Acetone
  • DMF
  • DMF/Glycerol
  • DMSO
  • Ethanol
  • Glycerol
  • Isopropanol

Increased applicability domain.

Link to poster

Poster publication at Eurotox, Helsinki, Sep 9, 2019.

 

SenzaGen expands its product portfolio with a test for the Medical Devices market

SenzaGen today announced an expansion of its product portfolio with the launch of GARD™skin Medical Device – a new test to assess whether medical devices can cause skin allergies. Regulatory changes are already underway in the market, which will mean increased requirements for product safety. Together with the ongoing trend towards reducing animal testing in general, this increases the need for alternative testing methods. The launch of GARD™skin Medical Device will take place at the Eurotox congress in Helsinki on September 8-11, 2019.

The Medical Devices market is a large and very interesting market for the company. The target group for GARD™skin Medical Device is initially medical device companies that perform sensitization tests during their product development and have high quality and safety requirements for the risk assessment related to their materials. With this test, SenzaGen meets the needs of an additional customer group and strengthens its position in the global market for cell-based in vitro tests.

“With our test method we can offer the industry a cost efficient and better method which gives more accurate results without animal testing. By identifying strategically important product development customers, we can already now generate sales and help them prepare for when the new regulations are in place. The ultimate goal is to see the test method being part of the international ISO standard so that it can be used instead of animal testing when registering medical devices,” says Axel Sjöblad, CEO of SenzaGen.

Increased demand for care and technological advances drive the need for a new generation of medical devices. The global Medical Devices market is estimated to be worth $410 billion in 2023 with an annual increase of 4.5% from 2018 to 2023. All medical devices that come into physical contact with the patient must undergo risk assessment for allergy before they can be sold. Since there are currently no validated alternative methods, most tests are currently done on guinea pigs, despite varying results using that method. Within the EU, a change in the regulatory framework (MDR) is underway which will lead to an increased demand for quality, safety and documentation of the products. In parallel, the new ISO standard for biological evaluation of medical devices advocates alternatives to animal testing. When the new regulations have come into force, SenzaGen estimates the value of its addressable market in Europe and the US to approximately SEK 1.6 billion.

As part of the launch, the company will also be presenting at the NABS conferences in Minneapolis, USA on September 18 and Symbioteq Biocompatibility of Medical Device in Gothenburg on October 1-2, as well as holding an online webinar in November.

For more information, please contact:

Axel Sjöblad, VD, SenzaGen AB

Email: axel.sjoblad@senzagen.com | Mobil: +46 705 35 93 51

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

About GARD®

GARD® consists of a group of tests for analyzing chemicals’ ability to start an allergic reaction in humans. The tests are performed on human cells in test tubes (in vitro) in combination with artificial intelligence. 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 animals – which only achieves 70-75 percent precision. The product portfolio consists of tests for skin and respiratory allergy: GARDskin, GARDair, GARDpotency and GARDskin Medical Device.

About SenzaGen

SenzaGen’s technology enables replacement of animal experiments with genetic testing in test tubes for determining the allergenicity of the chemicals we come into contact with in our daily lives, such as those 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 the USA. For more information, please visit 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.

Attached file

SenzaGen utökar produktportföljen med test för den medicintekniska marknaden

SenzaGen utökar sin produktportfölj och lanserar ett nytt test för bedömning om medicintekniska produkter kan orsaka hudallergier, GARD®skin Medical Device. På denna stora marknad pågår idag regulatoriska förändringar, vilket kommer att innebära ökade krav på produktsäkerhet, som i kombination med trenden att minska djurförsök driver behovet av alternativa testmetoder. Lanseringen av GARD®skin Medical Device kommer att ske på branschmässan Eurotox i Helsingfors den 8–11 september 2019. 

Den medicintekniska marknaden är en stor och mycket intressant marknad för bolaget. Målgruppen för GARD®skin Medical Device är inledningsvis medicintekniska bolag som utför sensibiliseringstester under sin produktutveckling och som har höga kvalitets- och säkerhetskrav för riskbedömningen av sina material. Med testet möter SenzaGen behoven hos ytterligare en kundgrupp och stärker därmed sin position på den globala marknaden för cellbaserade in vitro tester.

”Med vår testmetod kan vi erbjuda industrin en kostnadseffektiv och bättre metod som ger säkrare resultat utan djurförsök. Genom att identifiera strategiskt viktiga produktutvecklingskunder kan vi redan nu skapa försäljning och möta deras ökade behov av tester när de nya regelverken är på plats. Slutmålet är att få testmetoden införd i den internationella ISO-standarden så att den kan användas istället för djurtester vid registrering av medicintekniska produkter”, säger Axel Sjöblad, VD på SenzaGen.

Ett ökat vårdbehov och tekniska framsteg ligger bakom efterfrågan på nya generationer av medicintekniska produkter. Den globala medicinsktekniska marknaden beräknas vara värd 410 miljarder USD år 2023 med en årlig ökning på 4,5% under 2018–2023. Alla medicintekniska produkter som kommer i fysisk kontakt med patienten måste riskbedömas för allergi innan de får säljas. Eftersom det idag inte finns utvärderade alternativa metoder till djurförsök, görs de flesta testerna idag på marsvin, trots att metoden ger varierande resultat. Inom EU pågår en förändring av regelverket (MDR) som kommer att innebära ett ökat krav på produkternas kvalitet, säkerhet och dokumentation. Parallellt förespråkar den nya ISO-standarden för biologisk utvärdering av medicintekniska produkter alternativ till djurförsök. När de nya regelverken har trätt i kraft, uppskattar SenzaGen värdet på sin adresserbara marknad i Europa och USA till cirka 1,6 miljarder SEK.

Som en del av lanseringen kommer företaget även att presentera på konferenserna NABS i Minneapolis, USA den 18 september och Symbioteq Biocompatibility of Medical Device i Göteborg den 1–2 oktober samt hålla ett onlinebaserat webinarium i november.

För mer information, kontakta:

Axel Sjöblad, VD, SenzaGen AB

Email: axel.sjoblad@senzagen.com | Mobil: 0705-35 93 51

Tina Dackemark Lawesson, Director Investor Relations & Corporate Communications
Email:
tina.lawesson@senzagen.com | Mobil: 0708-202944

Om GARD®
GARD® består av en grupp med tester för analys av kemikaliers förmåga att starta en allergisk reaktion hos människa. Testerna utförs på mänskliga celler (in vitro) i kombination med artificiell intelligens. 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 djur – som endast uppnår 70–75 procents precision. Produktportföljen består av säkerhetstester för hud- och luftrörsallergi: GARD®skin, GARD®air, GARD®potency och GARD®skin Medical Device.


Om SenzaGen AB (publ)
SenzaGen gör det möjligt att ersätta djurförsök med cellbaserade tester 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 innehåller mer information än traditionella utvärderingsmetoder. Testerna säljs i egen regi i Sverige och USA samt 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 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.

Bifogat dokument