SenzaGen presents accelerated growth strategy and invitation to Capital Markets Day

In line with the announcement on 18 August 2021, SenzaGen’s board of directors has adopted an accelerated growth strategy that includes pursuing an active acquisition strategy targeting profitable and growing companies that complement SenzaGen’s current activities. The growth strategy will be presented in more detail at a capital markets day event on 5 October. The Company aims to be a leader in non-animal toxicology testing, a growing market internationally estimated to be worth more than USD 6 billion annually. The board worked with the new CEO to review the Company's business plan and has adopted the accelerated growth strategy, which puts increased focus on organic and acquisition-driven growth. As a result, our previous financial target of reaching profitability in 2022 will be cancelled.

New CEO and accelerated growth strategy
To create new opportunities and momentum for faster sales growth, SenzaGen’s strategy was updated with a focus on acquisition strategy, which the Company communicated at the time of Peter Nählstedt’s appointment as the new CEO on 19 August 2021. SenzaGen’s primary focus in the coming years will be on marketing investments, commercialization of a broader range of tests, and further expansion by acquiring profitable companies. The Company aims to be a leader in non-animal toxicology testing, a growing market estimated to be worth more than USD 6 billion annually. The updated growth strategy puts increased focus on organic and acquisition-driven growth.

The updated strategy, to be presented on Capital Markets Day, can be summarized as follows:

  • Continued commercialization of the GARD platform in Europe, North America and parts of Asia.
  • Expansion of the Company’s test portfolio by adding high-tech in vitro tests to support customers in cosmetics, chemicals, pharmaceuticals and medical devices with a broader range of tests.
  • Evaluation of acquisition opportunities with a focus on companies that are profitable, growing and complement SenzaGen’s offering.

“We have established an attractive position in the non-animal toxicology testing market. The European Parliament recently adopted a new resolution calling on the member states to accelerate the transition to non-animal testing, which is already underway in several industries and markets. SenzaGen will lead the way in helping companies transition from animal testing to methods better suited to reflect human biology. We will now focus on accelerating growth by combining organic growth with acquisition activities. I very much look forward to leading the implementation of this updated strategy, which will significantly increase the Company's growth," says Peter Nählstedt, CEO of SenzaGen.

Peter Nählstedt commands broad experience from both organic and acquisition-driven growth. His most recent operational role was CEO of Probi AB, in which Peter led the company to increase revenue from approximately SEK 100 to 600 million between 2014 and 2018 by combining organic international growth with acquisition activities. His past experience includes leadership positions at Trelleborg AB and GE Healthcare in Sweden and the US. He was elected to SenzaGen’s board of directors in 2018 and has worked on the Company’s commercial and strategic development in an operational capacity since then.

SenzaGen continues to enjoy strong commercial growth and has achieved key successes in 2021 despite a challenging market situation during the pandemic. The Company’s innovative GARD® technology was evaluated by an independent group of international experts. The evaluation, which was delayed as a result of the pandemic, led to the EURL ECVAM Scientific Advisory Committee (ESAC) recommending that the OECD issue test guideline status for GARD skin. The Company’s laboratory operations were broadened by adding more non-animal tests. The Company’s customer base, which consists of major international companies, grew during the year with both new customers and more loyal returning customers.

Capital Markets Day on 5 October at 10:00 AM
SenzaGen invites media and investors to a virtual capital markets day on Tuesday, 5 October at 10:00 AM where CEO Peter Nählstedt will present the Company’s updated strategy. The web conference will be held in Swedish starting with a presentation followed by a Q&A session. After the live broadcast, the web conference will be available on the Company’s website.

To participate in the web conference, please follow this link: https://youtu.be/s35MMNbbYPE

Questions may be submitted by 1 October to the following email address IR@senzagen.com.

SenzaGen receives SEK 0.7m order for GARD®skin from one of the world’s largest pharmaceuticals companies

SenzaGen has been selected to test substances from a leading global pharmaceuticals company. Valued at SEK 0.7 million, the project involves testing using SenzaGen’s non-animal skin sensitization test, GARD®skin. The testing will be performed at SenzaGen’s GLP-certified laboratory in Lund, Sweden.

The pharmaceuticals company, which is one of the largest in the world, has global operations with a uniquely wide range of treatment areas. With GARD®skin, the company aims to determine whether new development candidates can cause allergic reactions on the skin.

“We are delighted that one of the largest pharmaceutical companies in the world has chosen to partner with SenzaGen and has decided to test substances with GARD®skin, which once again validates the value of GARD®skin internationally. Our test method provides them with fast and reliable results, making it possible to ensure that their substances cannot cause skin allergies already during the development phase. This project serves as further proof that our innovative technology is highly interesting to leading companies in the pharmaceuticals industry. With this new key order, we are continuing to expand our customer base, adding another world leader to our ranks,” says Peter Nählstedt, CEO of SenzaGen.

SenzaGen’s GARD® test platform is designed for companies looking to improve their testing strategy and enhance the accuracy of their test results while avoiding animal testing.

SenzaGen’s 2021 Half-Year Report: Positive ESAC opinion on GARD®skin and expanded range of tests open up new commercial opportunities

Message from the CEO
“SenzaGen continues to enjoy strong commercial growth and achieved key successes as a company in the first six months of the year. Our innovative GARD® technology was validated by an independent group of international experts in the summer, making it the first genomic based test to achieve stand-alone status for identifying skin allergens. We broadened our lab operations in line with our strategy by adding more non-animal tests. This creates new opportunities for accelerated sales growth. I would like to thank my predecessor Axel Sjöblad for his excellent work as CEO that made these successes possible, thus creating a stable platform for continuing growth. We will further expand our lab operations in non-animal skin toxicology as soon as this fall, both by launching more tests and by pursuing supplementary mergers and acquisitions, which is a key part of our growth strategy.”

Peter Nählstedt, CEO

Half year 1 January–30 June

  • Net sales totaled SEK 5,015 (3,830) thousand.
  • The operating loss was SEK -13,995 (-12,929) thousand.
  • Earnings per share were SEK -0.65 (-0.60).
  • Cash and cash equivalents at 30 June amounted to SEK 75,571 (101,536) thousand.

Significant events during the first half year

  • Lab operations were broadened within in vitro skin toxicology.
  • SenzaGen received an SEK 0.6 million GARD® order from a new European customer in the chemicals industry.
  • Collaboration with RIFM on the safe use of fragrances with GARD®skin Dose-Response was expanded with an SEK 1.2 million grant.
  • The global collaboration agreement with Charles River Laboratories was renewed and expanded.

Significant events after the end of the period

  • Peter Nählstedt was appointed CEO.
  • A very positive opinion on GARD®skin from ESAC experts paves the way for OECD validation.
  • An SEK 0.65 million order for GARD®skin Dose-Response was secured from one of the world’s largest cosmetics companies.
  • An SEK 0.65 million order for skin allergy and irritation tests was received from a global consumer products company.

Conference call
SenzaGen is pleased to invite press and investors to a conference call on Thursday, August 19 at 10:30 CEST where CEO Peter Nählstedt will comment on SenzaGen’s 2021 half-year results. The conference call, which will be held in English, will begin with a presentation of the report followed by a Q&A session.

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

SE: +46850558358
FR: +33170750721
DE: +4969222239166
CH: +41225805976
NE: +31107129163
UK: +443333009260

Weblink
https://tv.streamfabriken.com/senzagen-q2-2021

SenzaGen appoints Peter Nählstedt as new CEO

The Board of Directors at SenzaGen has appointed Peter Nählstedt Chief Executive Officer. Peter Nählstedt takes on his new role on August 19, succeeding Axel Sjöblad, who wishes to resign as CEO in order to take on a new position outside the company. Over the last few years SenzaGen has made major progress in marketing and sales. With focus on a growth strategy, including acquisitions of profitable and growing companies, Peter Nählstedt will drive the company into a new phase. Peter recently held the position as CEO of Probi and has been a board member of SenzaGen since 2018, working on its commercial development.

Peter Nählstedt has extensive experience in developing global growth companies in Life Science. He was appointed to SenzaGens board of directors in 2018 and also held operational roles within the company including commercial development. He has in recent years lead several international growth projects in Life Sciences as a consultant and a board professional. His most recent operative assignment was as CEO of Probi AB. During his time as CEO of Probi from 2014 to 2018, the company increased its revenues from 103 to 612 MSEK by combining organic international growth with acquisition activities. Prior to working for Probi, Peter has held leading positions at Trelleborg AB and GE Healthcare in Sweden and US. He holds an MSc in Chemical Engineering and a BSc in Business Administration from Lund University.

“We are delighted to welcome Peter Nählstedt as CEO during this strategic growth phase with a novel focus on broadening our test portfolio with acquisitions. Peter has a proven international and commercial track record in the Life Science sector including both organic and Mergers & Acquisitions experience. He has the necessary skills and vision to make a seamless transition of leadership and drive the commercial growth of the company” says Carl Borrebaeck, Chairman of SenzaGen.

“SenzaGen has already developed and commercialized a revolutionary in vitro test with the GARD platform. By acquiring profitable and growing companies with complementary products and services, we have an opportunity to become a global leader in in vitro toxicology and safety assessment. As I have been working with the company for a few years, I am well-acquainted with SenzaGen´s great team and services – I am now very much looking forward to leading the Company into the next phase in which we will continue to commercialize the GARD® platform, add more tests to our portfolio and actively seek acquisition opportunities,” says Peter Nählstedt.” 

During Axel Sjöblad’s two years as CEO, SenzaGen has developed as a commercial company with a new structure, a broader customer offering, a substantially larger customer base and a positive statement from ESAC setting the company up for the next growth phase.

“Axel Sjöblad has done a great job and the company has rapidly evolved commercially and increased its sales significantly since he joined in 2019. With the recent positive ESAC opinion, we reached an important milestone and will now embark on an accelerated growth strategy”, says Carl Borrebaeck, Chairman of SenzaGen.

For more information, please contact:
Carl Borrebaeck, Chairman of the board, SenzaGen AB
Email: carl.borrebaeck@immun.lth.se | Mobile: +46 708 218330

Tina Dackemark Lawesson, VP Marketing & Communications
Email: tina.lawesson@senzagen.com | Mobile: +46 708-20 29 44

Invitation to SenzaGen’s 2021 half year report conference call on Aug 19 at 10.30 CET

SenzaGen is pleased to invite press and investors to a conference call on Thursday August 19 at 10.30 CEST where CEO Axel Sjöblad comments SenzaGen’s 2021 half year results. The conference call, which will be held in English, will begin with a presentation of the report followed by a Q&A session.

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

SE: +46850558358
FR: +33170750721
DE: +4969222239166
CH: +41225805976
NE: +31107129163
UK: +443333009260

Weblink
https://tv.streamfabriken.com/senzagen-q2-2021

SenzaGen receives SEK 0.65 million order for in vitro skin allergy and irritation tests from global consumer product company

SenzaGen continues to receive orders from large global companies. A leading consumer product company has now entrusted SenzaGen to test product candidates during their product development phase. Valued at SEK 0.65 million, the project includes non-animal tests for both skin sensitization and skin irritation.

SenzaGen has started to collaborate with a global consumer product company with operations in several business areas and product groups. The company aims to use the combination of tests to evaluate whether product candidates may cause skin sensitization or irritation. Since July 1, 2021, SenzaGen’s expanded service offerings include in vitro tests for skin irritation and corrosion, as a complement to the innovative GARD® platform with tests for skin and respiratory sensitization.

“It is promising that we already get orders for our new endpoint skin irritation. The order confirms the feedback we have received from customers, and our strategy to broaden our testing services by offering customers in our priority markets a wider range of tests within non-animal skin toxicology, in this case both skin sensitization and skin irritation", says Axel Sjöblad, CEO of SenzaGen.

Demand for contract research services for non-animal skin toxicological testing is continuously growing in SenzaGen’s target markets, where the company is well positioned. The testing and assessment of toxicity and potential risk of chemicals, drug candidates, and medical devices is a requirement for regulatory filings.

Positive scientific ESAC opinion on GARD®skin paves the way for OECD validation and opens new commercial opportunities

EURL ECVAM, the EU Reference Laboratory for alternatives to animal testing, has announced that ESAC, their scientific advisory committee, has issued a positive opinion on the GARD®skin test method. Depending on the regulatory context, positive results obtained with GARD®skin can be used stand-alone to identify skin sensitizers and the method is recommended to be adopted as an OECD Test Guideline for skin sensitization. The announcement marks a major milestone in the regulatory approval process for GARD®, opening up new commercial opportunities for the company.

ESAC has now completed its scientific evaluation, which shows that the GARD®skin assay meets the EURL ECVAM requirements for reliability in testing in preparation for regulatory filing. This means that the test is science- and evidence-based, can be transferred to other laboratories, and delivers the same performance regardless of who conducts the test. In their report, ESAC states that GARD®skin can, depending on the regulatory context, be used as stand-alone for positive results when identifying skin sensitizers, which means that no additional testing is needed. A negative result must be considered together with additional evidence.

“This report is a key milestone for the company and I am very pleased that we have received a positive ESAC opinion for GARD®skin as the first genomic test for identifying skin sensitizers. I would like to thank EURL ECVAM and ESAC for their professionalism and a well-written report,” says Axel Sjöblad, CEO of SenzaGen. “According to the positive opinion, ESAC recommends that OECD include GARD®skin on their list of internationally agreed test methods. Furthermore, it means that our groundbreaking GARD®-technology, which is based on both genomics and machine learning, has now been validated by an objective group of international experts. With the final OECD approval in place, we will be able to offer the GARD®-tests to a significantly broader customer base in various industries, such as cosmetics and chemicals in the EU, the US and Asia. This paves the way for an accelerated market growth and from now on we will refer to ESAC’s positive opinion in all our external communications,” Axel Sjöblad continues.

“When an international regulatory authority approves such a technologically advanced test system as GARD®, it sends a strong message,” says Henrik Johansson, Chief Scientist at SenzaGen. “The positive news confirms that GARD® is a science-based, and a technically sound method for the prediction of skin sensitization. With this endorsement, a range of technical components such as high-dimensional predictive modeling and cloud-based analytic tools are also introduced as novelties in regulatory toxicology. This establishes SenzaGen as a strong player in the market, especially in the development of future tests based on our key competences,” he says.

Furthermore, ESAC considers that GARD®skin and GARD®potency are functional and valid test methods ready for use in industrial screening applications. SenzaGen is now building more data for GARD®potency regarding predictivity and reproducibility, so that GARD®potency can also be used in a regulatory context.

The ESAC opinion
ESAC’s opinion is available on the JRC Publications Repository webpage:
https://publications.jrc.ec.europa.eu/repository/handle/JRC125963

Webcast
SenzaGen invites media and investors to a webcast on July 29 at 15.00 CEST, when CEO Axel Sjöblad and Chief Scientist Henrik Johansson will comment on the ESAC opinion. The webcast will be held in English. It will start with a presentation which will be followed by a Q&A session.

To participate in the webcast, register well in advance using the following link: https://attendee.gotowebinar.com/register/8998421169786434061

After the live broadcast, a recording will be available on the company’s website.

The GARD regulatory process
The GARD regulatory process is underway for the GARD® test method. The evaluation has been conducted by the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) on behalf of the OECD. A key step in the process is evaluating whether the tests are scientifically evidence based, can be set up in other laboratories (transferability) and can deliver the same performance regardless of who conducts the tests (robustness). For this purpose, SenzaGen has conducted a large validation study and its results have been evaluated by EURL ECVAM’s Scientific Advisory Committee (ESAC). Following the scientific evaluation, ESAC has issued a recommendation to the OECD, which will be the foundation for issuing a Test Guideline. An issued OECD Test Guideline will allow customers to use GARD® test results in product registrations. SenzaGen has prepared a Test Guideline draft and is in regular contact with both the Swedish Chemicals Agency and OECD.

SenzaGen and RIFM begin part two of the GARD®skin Dose-Response program

SenzaGen is launching part two of a project together with the Research Institute for Fragrance Materials (RIFM) to determine the dose at which a fragrance ingredientcan be used without inducing skin allergy. With the support of a new grant of SEK 0.6 million from RIFM, SenzaGen will test additional substances with the unique GARD®skin Dose-Response assay.

The program on the safe use of fragrances began in the spring of 2021 when SenzaGen tested several substances for RIFM with satisfactory results. In the second round of tests, which runs until the end of 2021, RIFM wants to test more fragrance ingredients to get detailed information on skin sensitizers and the dosage at which they may induce sensitization.

“We are pleased to be able to contribute to this important project and look forward to our continued collaboration with RIFM”, says Axel Sjöblad, CEO of SenzaGen. “Through the project, the fragrance industry will receive valuable information about skin sensitizing fragrance ingredients while actively supporting sustainable and ethical development in the test market. The fact that the independent Expert Panel for Fragrance Safety was impressed by the results in the first part of the project confirms the strength of the GARD® technology and that our unique method meets important needs in the industry.” (The Expert Panel for Fragrance Safety is an independent, international team of researchers and academics with no ties to the fragrance industry.)

“Together with the Expert Panel, we have decided to continue testing priority fragrances for which we want more data,” says Mihwa Na, PhD, Senior Scientist at RIFM. “Part one of the program returned impressive results. The information we obtained will be used to determine whether GARD®skin Dose-Response is appropriate for predicting the safe use levels of the fragrance materials.”

Since 2020, SenzaGen and RIFM have also collaborated on the continued development of an application that can assess whether fragrance materials could induce skin allergies when exposed to sunlight (photosensitization). The collaborators will present scientific data from this project at the World Congress on Alternatives and Animal Use at the Life Sciences Conference on August 23–September 2, 2021.

For more 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: +46 708-20 29 44

Mihwa Na, PhD, Senior Scientist, RIFM
Email: mna@rifm.org | Phone: +1.201.689.8089 ext. 108

About RIFM
Established in 1966, the Research Institute for Fragrance Materials (RIFM) generates, analyzes, evaluates, and distributes data to provide a scientific basis for the safe use of fragrances. RIFM has compiled the most comprehensive, worldwide source of toxicology data, literature, and general information on fragrance and flavor raw materials. RIFM’s Fragrance Ingredient Safety Assessment program draws from its comprehensive database of over 75,000 references and more than 135,000 human health and environmental studies.

RIFM assesses the safety of fragrance ingredients by the most current, internationally accepted guidelines—and has done so since its founding. The Expert Panel for Fragrance Safety, an independent, international team of researchers and academics with no ties to the fragrance industry, reviews all of RIFM’s work before RIFM submits it for peer-reviewed publication in a reputable scientific journal. RIFM makes all of its published, peer-reviewed work—current and historical—available for free at fragrancematerialsafetyresource.elsevier.com.

SenzaGen receives SEK 0.65 million order for GARD®skin Dose-Response from one of the world’s leading cosmetics companies

SenzaGen has been selected to test ingredients in cosmetics products from one of the world's largest cosmetics companies. Valued at SEK 0.65 million, the project includes SenzaGen’s unique GARD™skin Dose-Response assay. The tests will be performed in SenzaGen's GLP-certified laboratory in Lund.

SenzaGen now starts to collaborate with one of the world's leading companies in the beauty and cosmetics market. With GARDskin Dose-Response, the company wants to determine the dose at which a substance or a mixture in a cosmetic product cause allergy. This may apply, for example, to certain perfumes, preservatives, herbal ingredients, or hair dyes.

“We are very pleased that one of the largest cosmetics companies and top beauty brands chooses to test ingredients with our unique test method GARD™skin Dose-Response and see it as a great recognition of both SenzaGen and GARD™. The collaboration confirms the trust in that the GARD technology is able to identify the dosage at which a substance may induce sensitization, and further demonstrates SenzaGen’s strong position in this market segment. It is a verification that GARD™skin Dose-Response meets a need that companies and researchers in the cosmetics industry have expressed for a long time and that we are one of the first companies to fulfil. We look forward to providing data that ensures that the company’s products do not contain allergenic substances that may cause problems for consumers around the world”, says Axel Sjöblad, CEO of SenzaGen.

The GARDskin Dose-Response test provides information on the dose at which a substance causes allergy. The test enables companies in industries including cosmetics, pharmaceuticals, and chemicals to identify the highest possible quantity of a chemical that they can include in their products (“the Dose of Departure”). This serves as crucial information for prioritization and decision-making in research and development. The new test is an expanded application domain of GARDskin, and it is one of the first of its kind on the market.

SenzaGen expands services within in vitro skin toxicology

Due to market demand, and as a complement to the company’s innovative GARD® test platform for skin and respiratory allergies, SenzaGen is expanding its service offerings with in vitro tests for irritation and corrosion beginning July 1, 2021. SenzaGen will now provide customers with a wider range of tests in additional areas of non-animal skin toxicology, thus strengthening the company’s overall market position in in vitro skin toxicology testing.

Demand for contract research services for non-animal skin toxicological testing is growing in SenzaGen’s target markets. To meet customer requests and needs, the company is now expanding its testing services beyond skin sensitization to include irritation and corrosion as part of a broader risk assessment of customers’ substances. The testing and assessment of toxicity and potential risk of chemicals, drug candidates, and medical devices is a requirement for a variety product development benchmarks, including regulatory filings.

“We very much welcome that the market wants to perform more high-quality tests with the company,” says Axel Sjöblad, CEO of SenzaGen. “With an expanded range of tests, we further strengthen our position and meet our customers’ needs in a growing market. At the same time, we are increasing our competitiveness as one of the Nordic region’s few GLP-certified contract laboratories for cell-based toxicology tests. The expansion is part of our commercialization strategy and in line with our mission to offer best-in-class alternatives to animal testing across a variety of test areas. As early as the fall of 2021, we intend to again further expand the range of our testing services,” he says.

SenzaGen’s high-tech lab in Lund, Sweden serves as the company’s hub for customer studies, research, and product development. On behalf of customers, the lab currently performs in vitro toxicology testing using the GARD assay to evaluate the skin and respiratory sensitization potential and risk of various test items, with an expertise in substances traditionally considered difficult-to-test. This testing is critical for companies developing products in a variety of industries to provide safe, sustainable products and create better production environments for their employees, all while reducing the number of animals used in experimentation.

Skin sensitization, combined with irritation and corrosion, is one of ten subsegments of in vitro toxicology testing and accounts for approximately 5.5% of the current total market. This segment, in particular, is also growing the fastest with 9.5% growth annually and is expected to be valued at approximately SEK 5 billion by 2023, according to the 2018 report “In Vitro Toxicology” by Kalorama Information. SenzaGen’s service expansion looks to build upon this growth and meet the increasing needs of product developers and regulatory bodies alike.