NOTICE OF ANNUAL GENERAL MEETING OF SENZAGEN AB (Publ)

The shareholders of SenzaGen AB (Publ.), company registration number 556821–9207, (“the Company”) are hereby given notice of the annual general meeting (“AGM”) on Wednesday, 5 May 2021 at 4 PM in The Spark Sharience, Medicon Village, Scheeletorget 1, Lund, Sweden. The meeting will be held in Swedish.

Eligibility to attend the AGM and notice of attendance
Shareholders wishing to attend the AGM must be registered in the share register kept by Euroclear Sweden AB on the record date, Tuesday 27 April 2021.

Shareholders must also give notice of their attendance and that of any proxies (max two) by Thursday, 29 April 2021 by mail to SenzaGen AB, Medicon Village, 223 81 Lund, Sweden, or by email to anmalan@senzagen.com. The notice of attendance should include the full name, personal or company registration number, shareholding, address, phone number and, if applicable, information about proxies or other representatives. If applicable, the notice of attendance should be followed by a proxy document, a certificate of registration and other documentation.

Nominee shares
Shareholders who have their shares held in custody with a bank or some other nominee must have their nominee temporarily register the shares in their own name to be eligible to attend the AGM. Such registration, which normally takes a couple days, must be complete by Tuesday, 27 April 2021. Therefore, shareholders must request this registration from their nominee well in advance of this date. Registration of voting rights that has been requested by shareholders at such a time that the registration has been made by the relevant nominee no later than Thursday, April 29, 2021 will be taken into account in the production of the share register.

Proxies
Shareholders represented by proxy must grant a written and dated proxy document to the designated proxy. If the proxy was granted by a legal entity, a certified true copy of the entity's certificate of registration, or equivalent documentation proving that those who signed the proxy are authorized signatories for the legal entity, must be enclosed with the proxy. If the proxy specifically states a term of validity, this term is not permitted to exceed five years. If no term of validity is stated, the proxy will be valid for no more than one year. A copy of the proxy and, if applicable, the certificate of registration should be sent to the Company's address above well in advance of the AGM. The original proxy and the certificate of registration must also be presented at the AGM. A proxy form will be available on the Company’s website, www.senzagen.com.

Important information with regard to COVID-19 (the coronavirus)
As a precautionary measure to reduce the risk of spreading COVID-19, the Company has decided to keep the AGM as short as possible. As a result, the CEO’s address will be skipped and the general question and answer period will be limited in duration. The CEO's address will be recorded and posted to the website after the AGM. The Company’s management, board of directors and other employees who are not shareholders will attend the AGM to a limited extent. In light of government guidelines, the Company wishes to encourage all shareholders to carefully consider exercising the aforementioned option to vote by proxy instead of attending the AGM in person. This applies in particular to those who feel sick, are in a risk group, have been in an area with active community transmission or have recently been in contact with someone infected with COVID-19. No refreshments will be offered at the AGM.

The Company is carefully monitoring developments around COVID-19 and will update the measures listed above if necessary. Information about any changes will be published on the Company's website. For up-to-date information and recommendations regarding COVID-19, please refer to the Public Health Agency of Sweden, www.folkhalsomyndigheten.se.

Proposed agenda

  1. Opening of the meeting and election of AGM chairman
  2. Preparation and approval of the voting register
  3. Election of one or more people to verify the minutes
  4. Check that the AGM has been duly convened
  5. Approval of agenda
  6. Presentation of the annual report and auditor's report and of the consolidated financial statements and the auditor's report on the consolidated financial statements
  7. Resolutions to:
    1. Adopt the income statement and balance sheet and the consolidated income statement and consolidated balance sheet
    2. Appropriate the Company's profit or loss as per the adopted consolidated balance sheet
    3. Discharge the board of directors and CEO from liability
  8. Setting of the number of directors, alternates and auditors
  9. Setting of directors’ fees and auditor’s fees
  10. Election of directors, alternates and auditors
  11. Resolution to authorize the board to issue shares, stock options and/or convertibles
  12. Resolution on directed share issue of a maximum of 587,500 stock options
  13. Closing of the meeting

Proposed resolutions

Item 1: Election of AGM chairman
The Nomination Committee proposes that Board Chairman Carl Borrebaeck be elected AGM chairman.

Item 7.b Resolution to appropriate the Company's profit or loss as per the adopted balance sheet
The board proposes that all earnings at the disposal of the AGM be carried forward.

Items 8–10: Setting of the number of directors, alternates och auditors; setting of directors’ fees and auditor’s fees; election of directors, alternates and auditors
The Nomination Committee’s proposals are as follows:

Item 8
The board shall consist of seven directors and no alternates. The number of auditors and the number of deputy auditors shall each be one.

Item 9
Directors’ fees shall be SEK 200,000 (SEK 100,000) for each director elected by the AGM who is not employed by the Company and SEK 400,000 (SEK 200,000) for the board chairman, for a total amount of SEK 1,600,000 (SEK 800,000). The amounts in parentheses are the fees for 2020.

Auditor’s fees shall be payable on the basis of approved invoices.

Item 10
Re-election of Carl Borrebaeck, Ian Kimber, Peter Nählstedt, Laura Chirica, Anki Malmborg Hager, Paula Zeilon and Paul Yianni as directors.

Re-election of Carl Borrebaeck as board chairman.

Information about the proposed directors can be found at www.senzagen.com.

Re-election of Authorized Public Accountant Mats-Åke Andersson as the Company’s auditor, with Authorized Public Accountant Martin Gustafsson as deputy auditor.

Item 11: Resolution to authorize the board to issue shares, stock options and/or convertibles
To enable the board to raise working capital for the Company, and/or bring in new owners of strategic significance to the Company, and/or acquire other companies or businesses, the board proposes that the AGM resolve to authorize the board, for the period until the next AGM, with the shareholders’ preemptive rights waived, on one or more occasions, to decide to issue new shares, stock options or convertibles. The total number of shares that may be issued or, if convertibles or stock options are issued, added following conversion or exercise of rights under the authorization shall be limited to 20 percent of the number of shares outstanding on the date of this notice. The board shall also be entitled to resolve on whether new shares are payable in the form of cash, non-cash, offsetting, or in another manner consistent with the provisions of Chapter 2 Section 5 Paragraph 2 items 1-3 and 5 of the Swedish Companies Act.

To prevent the Company’s current shareholders from being disadvantaged in relation to external investors who could subscribe for shares in the Company, the board plans, by virtue of this authorization, to set the issue price on market terms (meaning that an issue discount on market terms may be provided) for issues with the shareholders’ preemptive rights waived.

As a result, the maximum number of shares that may be issued is 5,339,409, and the Company’s share capital may be increased by a maximum of SEK 266,970.45.

The board, or those designated by the board, are proposed to be granted authorization to make adjustments as may be necessary in conjunction with registering the resolution with the Swedish Companies Registration Office (Bolagsverket).

Item 12: Resolution on directed share issue of a maximum of 587,500 stock options
The Company’s board proposes that an extraordinary general meeting resolve to issue a maximum of 587,500 stock options, as a result of which the Company’s share capital may increase by a maximum of SEK 29,375, with an exception for possible increases caused by recalculation in the event of share issues. The stock options will entitle the holder to subscribe for new shares in the Company.

The following rules shall apply to the directed share issue:

With the shareholders’ preemptive rights waived, employees of the Company and the Group shall be entitled to subscribe for the stock options as follows:

  • Members of Group Management and key personnel comprising up to nine positions will each be offered to subscribe for a maximum of 50,000 options, altogether comprising a maximum of 450,000 options.
  • Other employees and consultants considered key personnel in the Group, comprising up to eleven individuals, will each be offered to subscribe for a maximum of 12,500 options, altogether comprising a maximum of 137,500 stock options.

Oversubscription cannot take place.

The stock options must be subscribed for by 26 May 2021 on a separate subscription list. The board shall be entitled to extend the subscription period but no later than until 1 November 2021.

The subscriber is entitled to subscribe for stock options free of charge. The market value of the option shall be calculated using the Black-Scholes pricing model, adjusted for barrier conditions to calculate the Company’s social security expenses. The valuation of the options shall be performed by an independent valuation institute or auditing firm. A preliminary calculation based on an exercise price and barrier conditions at the time of exercising the stock options of SEK 15.94 per share results in an option value of SEK 1.97.

The stock options allotted will be offered for subscription free of charge. Such an offer to allot stock options must be provided within 10 banking days of the date a resolution to allot options has been passed.

Each stock option entitles the holder to subscribe for one new share in the Company in exchange for cash payment, provided that the barrier conditions have been met, during the period from 1 June 2024 to 30 September 2024 or the earlier date set out in the option rules. However, the stock options shall be exercisable at an earlier point in time in the event of a merger, compulsory redemption, liquidation, or similar circumstances.

Payment for shares subscribed for by exercising stock options shall be made in cash at an exercise price of 100% of the average of the listed volume-weighted price paid for each trading day as per Nasdaq First North Growth Market’s official price list for shares in the Company during the period from 21 April 2021 to 4 May 2021. The exercise price established in this manner shall be rounded to the nearest whole tenth in SEK öre, with SEK 5 öre rounded down.

The stock options are subject to barrier conditions and cannot be exercised to subscribe for shares until the barrier level has been reached. The barriers are calculated as 158% and 300% of the average of the listed volume-weighted price paid for each trading day as per the Nasdaq First North Growth Market’s official price list for shares in the Company during the period from 21 April 2021 to 4 May 2021. Stock options subject to barriers cannot be exercised until the volume-weighted price paid measured per trading day as per the Nasdaq First North Growth Market’s official price list for shares in the Company during the share subscription period is higher than the barrier level. The barriers shall be recalculated in the same way as for the redemption price in the option rules.

New shares subscribed for by exercising stock options entitle the holder to dividends for the first time on the dividend record date most immediately following the date the new share issue was registered with the Swedish Companies Registration Office and Euroclear Sweden AB.

The purpose of the share issue and the reason for waiving shareholders’ preemptive rights is to implement an option program suited for allotment to key personnel in the Company so that they can be offered the opportunity to participate in the growth in value of the Company’s stock. This is expected to lead to stronger interest in the Company’s growth – as well as the Company’s share price performance – and stimulate continued company loyalty over the coming years.

In conjunction with the transfer of the stock options to the participants in the program, the Company reserves the right to buy back all stock options if the participant’s employment is terminated or if the participant wishes to transfer the stock options to another party during the period until 31 May 2024.

The complete rules for the stock options will be kept available on the Company’s premises and on the Company’s website no later than two (2) weeks prior to the AGM. These rules include that the exercise price and the number of shares to which a stock option entitles the holder to subscribe for may be recalculated in certain cases.

It is proposed that the board or those designated by the board be authorized to make minor adjustments to this resolution as may be necessary in conjunction with registration with the Swedish Companies Registration Office and, if applicable, with Euroclear Sweden AB.

Deliberation on the board’s proposed 2021/2024 L series incentive program, the costs of the program, other outstanding stock-based incentive programs, dilution
The proposed agenda item 12 has been deliberated on by the board in consultation with external advisers.

Valuation
The stock options shall be subscribed free of charge, which means that social security expenses for the Group may be incurred in conjunction with subscriptions for stock options. According to a preliminary valuation based on a market value of the underlying stock of SEK 15.94 , the market value of the stock option is SEK 1.97 per option with a redemption price of 15.94 per share in the 2021/2024 L series program. The Black-Scholes pricing model has been used for this valuation on the assumption of a risk-free -0.238% interest rate and 41.7% volatility and taking into account that no dividend or other transfers of value to shareholders are expected to occur during the program’s term.

Expenses and impact on financial ratios

Given that the stock options are issued free of charge, the Company estimates that fringe benefits and social security expenses will be incurred for the participant and the Company as a result of the option program. The total expenses, including other expenses in the form of fees to external advisers and expenses for the administration of the program, are estimated at around SEK 100,000 over the program’s term and the cost of social security expenses is estimated at SEK 362,916.

The program is expected to have a marginal impact on the Company’s financial ratios.

Dilution
The total number of registered shares and votes at the time of this is proposal is 21,357,636. The maximum dilutive effect of the 2021/2024 L series incentive program is estimated to be a maximum of approximately 2.7% of the total number of shares and votes in the Company (calculated based on the number of existing shares in the Company and taking into account other outstanding stock options), provided that all offered stock options are subscribed for and exercised.

There are earlier programs in which share subscription will not take place until June 2021, November 2022 and November 2023, totaling a maximum of 525,000 options with an exercise price of SEK 69.87, SEK 19.84 and SEK 39.68, respectively. If all previously issued warrants and warrants issued in incentive program 2021/2024, series L are exercised, the dilution may amount to a maximum of approximately 4.90 percent of the total number of shares and votes in the Company (calculated on the basis of the number of existing shares in the Company and taking into account other outstanding warrants).

Other outstanding stock-based incentive programs
For disclosures on the Company’s other stock-based incentive programs, please see the Company’s 2020 annual report. Apart from the programs disclosed there, the Company does not have any other stock-based incentive programs.

Majority requirement
Shareholders representing at least two thirds of both the votes cast and the shares represented at the AGM must vote for the resolution under item 11 for it to be deemed duly passed.

Shareholders representing at least nine tenths of both the votes cast and the shares represented at the AGM must vote for the resolution under item 12 for it to be deemed duly passed.

General information

Number of shares and votes
The total number of shares in the Company at the date of this notice is 21,357,636 with the same number of votes. The Company does not hold any treasury shares.

Documents
Copies of the financial statements, auditor’s report and proxy form will be kept available at the Company’s premises at Medicon Village, Scheelevägen 2, Building 401, Lund, Sweden, and on the Company’s website, www.senzagen.com no later than three (3) weeks prior to the AGM. Complete proposals and other documentation that must be made available under the Swedish Companies Act will be kept available in the locations above no later than two (2) weeks prior to the AGM. All of the aforementioned documents will sent to those shareholders who so request and provide their email address or mailing address.

Shareholders are reminded of their right, at the AGM, to request disclosures from the board and CEO under Chapter 7 Section 32 of the Swedish Companies Act.

Personal data processing
For information on how your personal data is processed, please see the privacy policy available on the Company’s website: https://senzagen.com/wp-content/uploads/2018/05/Policy-for-processing-personal-data.pdf.

* * * * *
Lund, March 2021, 
the Board of Directors of SenzaGen AB

The English translation is for convenience only and in case of any discrepancy, the Swedish text shall control.

SenzaGen’s Annual Report 2020 published

SenzaGen has today published its Annual Report 2020. A digital copy can be downloaded at www.senzagen.com or read via the link below.

The printed version of the annual report will be available in April. To request a printed copy, please email name and address to IR@senzagen.com.

2020 in short
In 2020, SenzaGen’s efforts to create a commercial enterprise proved effective. Because of the organizational changes we made and the sales focus we established, we tripled our sales from the previous year.

Strong belief in the future
SenzaGen’s plans for 2021 are based on continuing to strengthen our market presence and develop our organization in line with our six strategic initiatives updated for the year. We will work toward our profitability target by approaching customers and industries that stand to benefit from the GARD® test’s high predictivity without requiring OECD validation and are interested in the additional skin toxicology services that we will be able to offer through our GLP-certified lab.

SenzaGen and RIFM expand collaboration on the safe use of fragrances with GARD™skin Dose-Response

SenzaGen and the Research Institute for Fragrance Materials (RIFM) have expanded their collaboration on the safe use of fragrance materials to evaluate the dosage at which a fragrance may induce an allergic response. Under the collaboration agreement, SenzaGen will receive an initial grant from RIFM of SEK 0.6 million to test several substances from RIFM with GARD™skin Dose-Response, a novel test for this application. The agreement runs through 2021.

RIFM is an international scientific non-profit organization based in the United States supporting the safe use of fragrance ingredients in consumer products. RIFM’s Fragrance Ingredient Safety Assessments provide the International Fragrance Association (IFRA) with the scientific basis for developing standards for the safe use of aromatic components by the perfume industry.

“We are very proud of RIFM’s continued trust in us and that our most recently launched test GARDskin Dose-Response may contribute to progress in terms of sustainability and ethics in the testing market. With its strong position and broad scientific expertise, RIFM helps promote new technology and knowledge in the cosmetics and consumer product industry. RIFM’s cooperation with us confirms GARD technology’s strength and that it meets critical needs in these and our other prioritized industries. Access to more detailed information on skin sensitizing substances is important for companies developing products,” says Axel Sjöblad, CEO of SenzaGen.

“We look forward to our continued collaboration with SenzaGen to evaluate GARDskin Dose-Response as we refine our understanding of several fragrance ingredients. Identifying the dosage at which a fragrance may induce sensitization is a need that fragrance industry stakeholders have expressed for a long time. This project demonstrates our commitment to non-animal testing methods and supports our mission to provide the fragrance industry with data that meets internationally-recognized scientific standards,” says Mihwa Na, PhD, Senior Scientist at RIFM.

Since 2020, SenzaGen and RIFM have been collaborating on the continued development of an application that can assess whether fragrance materials could induce skin allergies when exposed to sunlight (photosensitization).

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

Mihwa Na, 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 70,000 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 secures SEK 0.6 m order from a new European customer in the chemical industry

SenzaGen has received an order with a value of approximately SEK 0.6 million from a new global customer in the chemical industry. The order includes SenzaGen's tests to assess whether chemical substances in products can cause allergic reactions to skin (GARD™skin) or in the respiratory tract (GARD™air). The tests will be carried out in SenzaGen's GLP certified laboratory in Lund.

The customer has its headquarters in Europe and is a leading supplier of specialty chemicals and sustainable technologies. With the combination of GARD tests, the customer can identify substances with various allergy-causing effects during both product development and manufacturing for the first time, which contributes to cost savings for the company and safer products to society. At the same time, the customer minimizes the risk during chemical manufacturing by offering a safer work environment.

“The chemical industry has a great need for chemical sensitization testing and is one of our prioritized target markets. With this order we continue to deliver in line with our strategic initiatives. The fact that the customer tests difficult-to-test samples for both skin and respiratory allergies makes this an important reference order”, says Axel Sjöblad, CEO of SenzaGen.

SenzaGen’s test platform GARD targets companies looking to optimize their in vitro testing strategy; increasing the accuracy of their test results while avoiding animal testing. Through its high accuracy, GARD improves the quality of customers’ decision-making and contributes to increased product safety in people’s everyday lives while reducing the number of animal experiments. SenzaGen is the only company that can offer a non-animal, so called in vitro test, for chemical respiratory allergens.

SenzaGen 2020 Year-end report: Tripled sales for the full year

CEO comment
”Looking back on 2020, I am pleased to report that SenzaGen’s progress on commercialization has had a positive impact and we are in a much better position today than we were a year ago. Despite the challenges posed by the ongoing pandemic, we succeeded in establishing our GARD® technology with new, international customers and tripling our sales from the previous year. In 2021, we will continue working toward our profitability target by approaching customers and industries that stand to benefit from the GARD® test’s high predictivity and are interested in the additional skin toxicology services that we will be able to offer through our own now GLP-certified lab.”

Axel Sjöblad, CEO

Full year 1 January–31 December

  • Net sales totaled SEK 7,958 (2,724) thousand.
  • The operating loss was SEK -27,098 (-37,927) thousand.
  • Earnings per share were SEK -1.27 (-3.11).
  • Cash and cash equivalents at 31 December amounted to SEK 89,343 (120,467) thousand.
  • The board proposes that no dividend be paid to the Company’s shareholders.

Second half year 1 July–31 December

  • Net sales totaled SEK 4,128 (1,072) thousand.
  • The operating loss was SEK -14,169 (-22,730) thousand.
  • Earnings per share were SEK -0.67 (-2.10).

Significant events during the second half year

  • Pharmaceuticals company H. Lundbeck A/S ordered GARD®skin and GARD®air tests for SEK 0.4 million.
  • The global medical device company Sonova placed an SEK 0.6 m order after evaluation.
  • A major US chemicals company ordered GARD®skin and GARD®potency tests for SEK 0.4 million.
  • SenzaGen signed a distribution agreement with Danske Teknologisk Institut (DTI) in Denmark.
  • The ESAC’s scientific evaluation of GARD® was underway during the year. Their opinion was delayed until 2021 as a result of the COVID-19 pandemic.

Significant events after the end of the year

  • The Company’s global collaboration agreement with Charles River Laboratories was renewed and expanded.

Conference call
SenzaGen is pleased to invite press and investors to a conference call on Thursday February 18 at 9.30 CET where CEO Axel Sjöblad comments SenzaGen’s 2020 full 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.

FR: +33170750721
DE: +4969222239167
SE: +46850558368
CH: +41225675632
NL: +31107129162
UK: +443333009267

Weblink
https://tv.streamfabriken.com/senzagen-q4-2020

SenzaGen: Invitation to 2020 Year-End Report conference call on Feb 18 at 9.30 CET

SenzaGen is pleased to invite press and investors to a conference call on Thursday February 18 at 9.30 CET where CEO Axel Sjöblad comments SenzaGen’s 2020 full 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.

FR: +33170750721
DE: +4969222239167
SE: +46850558368
CH: +41225675632
NL: +31107129162
UK: +443333009267

Weblink
https://tv.streamfabriken.com/senzagen-q4-2020

SenzaGen renews and expands global collaboration agreement with Charles River Laboratories

SenzaGen has renewed and expanded its global collaboration agreement with the contract research organization Charles River Laboratories, one of the world's leading companies in laboratory services. To meet the growing interest in risk assessment of chemicals by using SenzaGen's non-animal test platform GARD®, the collaboration was broadened to now include all tests in the GARD portfolio.

Charles River Laboratories International, Inc. is a leading global contract research organization offering preclinical laboratory services to the pharmaceutical, chemical, agrochemical and medical device industries, among others. Companies in these industries are increasingly looking for alternative test methods that are more precise and cost-effective in the long run. The collaboration with SenzaGen was initiated in 2017.

“We are very pleased with our continued and expanded collaboration with Charles River Laboratories and to work with them to drive the change in establishing alternative testing methods widely. The collaboration is in line with our commercial strategy to form a global partner network and Charles River Laboratories is a leading service provider to the industries we prioritize, giving us a very strong sales channel. The fact that Charles River Laboratories continue to offer GARD to their customers and include our latest developed tests confirms the strength of our technology,” says Axel Sjöblad, CEO of SenzaGen.

“At Charles River we are passionate about our role in improving the quality of people´s lives and we strive at providing the best scientific solutions. We are happy to continue our collaboration with SenzaGen to offer the state-of-the-art GARD technology for sensitization assessments. Since 2017, our customers have been requesting GARD sensitization services and appreciate its unique ability to provide potency classification according to CLP, among other features”, says Walter Westerink, Section Head Flexible Innovation Team, Charles River Laboratories.

SenzaGen receives SEK 0.4 m order for GARD®skin and GARD®air tests from pharmaceutical company H. Lundbeck A/S

SenzaGen has been selected to test compounds from H. Lundbeck A/S. Valued at SEK 0.4 million, the project includes both GARD®skin and GARD®air. The tests will be performed in SenzaGen’s GLP-certified laboratory in Lund.

A new collaboration is being announced with H. Lundbeck A/S, a global pharmaceutical company covering the full value chain from research and development to production and promotion of treatments of disorders within CNS. The company aims to use the combination of GARD tests, which SenzaGen is unique in being able to offer, to determine whether new development candidates have sensitizing properties.

“In spite of the challenges presented by the ongoing pandemic, we continue to establish the GARD technology among international customers. We are very pleased that after a thorough evaluation based on several interactions and presentations, Lundbeck has chosen to collaborate with SenzaGen and that they have decided to test compounds with both GARDair and GARDskin. The order illustrates that our direct contacts with large international companies continue to bear fruit, and means that we, during the year, will have run tests for customers in all the major industries we cater to – pharmaceuticals, medical devices, cosmetics and chemicals,” says Axel Sjöblad, CEO of SenzaGen.

“Lundbeck is pleased to initiate this collaboration with SenzaGen. The introduction of new innovative assays such as the GARD tests is part of our commitment to constantly expand our expertise in safety testing. By doing this, we pursue our goals of providing a safe and healthy work environment for our employees and improving the quality of life for people living with brain disorders,” says Allan Dahl Rasmussen, Director of Regulatory Toxicology in Lundbeck.

With excellent predictivity, the GARD® technology improves the quality of customers’ decision-making and contributes to increased product safety while reducing the number of animal tests.

OECD GARD® adoption update: The COVID-19 pandemic reschedules the scientific ESAC opinion on GARD®

EURL-ECVAM has informed SenzaGen that due to COVID-19, the next plenary meeting for its Scientific Advisory Committee (ESAC) has been rescheduled from November 2020 to March 2021. The change delays the expected ESAC opinion on the GARD®skin and GARD®potency assays. The OECD adoption of GARD may not take place in 2021.

“It is unfortunate that COVID-19 delays the ESAC GARD opinion, but I understand the decision considering the current circumstances. During the year we have had productive and fruitful virtual meetings with ESAC Working Group representatives and members from EURL ECVAM’s Joint Research Center. We have answered to their questions and made all necessary information available to ensure that they are on top of the GARD review and hope for an endorsement in March 2021. Looking ahead, the GARD OECD adoption may not take place in 2021. Despite COVID-19, we have seen an increasing demand for our services and during the first six months we doubled sales compared to the same period last year. We will continue to work towards our 2022 break-even target by addressing customers and industries that benefit from the high accuracy of the GARD assays and the additional services we can offer without the need of a GARD OECD adoption”, says Axel Sjöblad, CEO of SenzaGen.

The following information has been published today on the EURL ECVAM TSAR webpage https://tsar.jrc.ec.europa.eu/test-method/tm2011-09:

“Third meeting of the ESAC Working Group on the GARD to discuss additional information provided by the test submitter. Due to the situation with the COVID-19 pandemic, the ESAC face-to-face plenary meeting initially scheduled for November 2020 has been postponed to March 2021. The November meeting has been converted into a virtual meeting of the ESAC Working Group on the GARD to grant more time to the experts to discuss the GARD submission due to the impossibility of organising a face-to-face meeting. The Working Group is aiming at finalising their peer-review report with a view of discussing and possibly endorsing the ESAC Opinion in March 2021.”

The GARD regulatory process
The GARD regulatory process is underway for the GARD®skin and GARD®potency tests. The review is being 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 are being evaluated by EURL ECVAM’s Scientific Advisory Committee (ESAC). Following the scientific evaluation, EURL ECVAM will issue 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: Global medical device company places SEK 0.6 million order

A global medical device company has decided to continue using SenzaGen’s most recently launched test, GARD®skin Medical Device, for risk assessment of their materials to prevent skin allergies. The order is valued at approximately SEK 0.6 million, and the tests will be performed in accordance with the OECD Principles of Good Laboratory Practice (GLP) at SenzaGen’s laboratory in Lund.

The medical device company placed the order after evaluating the GARD test method on a small scale earlier this year. The company operates globally based out of Europe and engages in innovative product development in-house with an aim to replace animal testing with alternative methods in the material risk assessment process to the greatest degree possible.

“We are very pleased with this key customer’s continued trust in both SenzaGen and our tests. Our test method gives the customer rapid and reliable answers to whether substances in their products can cause allergies, even for substances that are traditionally more difficult to test. The order shows that we meet the needs of the medical device industry, one of the industries we prioritize in our marketing and sales activities," says SenzaGen CEO Axel Sjöblad.

Launched in fall 2019, the GARD®skin Medical Device test provides a highly accurate and ethical alternative to skin sensitization testing of materials in medical devices. An update process is currently underway for the global medical device ISO standard, which advocates the inclusion of alternative risk assessment methods to replace animal testing in biological evaluation for medical device filings. SenzaGen’s goal is for GARD®skin Medical Device to be included in the new ISO standard.