SciBase today announces the first sale and shipment of SciBase products for the evaluation of skin barrier function. The first shipment is to a prestigious hospital in Japan for research into skin barrier function in infants.
The skin’s barrier fulfils a very important role as it prevents external threats such as irritants, allergens and infectious agents from entering the body and prevents water from leaving the body. When these layers are defective or damaged, barrier related diseases can occur. The most common of these is atopic dermatitis (AD) or eczema. It has been shown, for example, that children with a defective or ‘leaky’ barrier are far more likely to develop eczema and then in turn are more likely to develop food allergies, allergic rhinosinusitis and asthma. Clinicians call this progression of disorders the ‘atopic’ or ‘allergic march’ and recent studies show this to be very-much barrier-related.
The challenge for Clinicians is that current methods are unreliable and cannot be used to assess skin barrier function in a routine clinical setting. This is where SciBase’s technology Electrical Impedance Spectroscopy (EIS) comes in. Nevisense can apply EIS in a clinical setting and this has the potential to provide clinicians with a quick and accurate assessment of the status of the skin barrier and better manage their patients.
“The publication of the first article in Allergy marked a milestone for SciBase, and we now have a second milestone with the first sale of equipment for use in assessing skin barrier function. The interest that we have seen, particularly from researchers, has been very encouraging. The potential applications are many and the market potential is large – much larger than for melanoma. We believe that this new application to evaluate skin barrier function could really be a breakthrough for SciBase as a Company and expect more sales to follow.”, says Simon Grant, CEO of SciBase.
The full article can be found here: https://onlinelibrary.wiley.com/doi/abs/10.1111/all.13824
For more information, please contact:
Simon Grant, CEO SciBase Tel: +46 72 887 43 99 Email: [email protected]
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed and sells a unique point-of-care device for evaluation of skin disorders such as skin cancer and atopic dermatitis. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. Further development has led to Nevisense also being used as a tool to assess the skin barrier and inflammation. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and a FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. SciBase is listed on First North Growth Market (“SCIB”). Further information is available at www.scibase.com.
At SciBase we have been very focused on two key development projects and a market launch over the last months, which explains the lack of CEO letters - my apologies! Now that we have come some way on the projects, I thought I’d take the chance to describe what has happened so far, and what we see coming in the near future.
The updated measurement method, Nevisense 3.0
Much of 2018 was spent overhauling the Nevisense measurement method for melanoma. Though we knew our method worked, we also knew that customers felt it involved too many steps and the time it took was too variable. Both these factors made it more difficult to include as a standard test in a busy dermatology clinic, where a single consultation often takes only 15 minutes.
Nevisense used a two-step measurement process – first a reference measurement on healthy skin and then a lesion measurement itself, and our goal was to remove the need for the reference measurement completely. The team worked extremely hard and found a way to extract reference information from the lesion measurement itself. When we validated the updated method in June last year, we saw that in addition to being simpler, the new process actually improved the clinical results.
We launched the new method in September, and I can say that within three months the majority of users had upgraded to the new method and are very happy with the improvements. With over ten thousand patients now tested with the new method, we see increased usage and significantly increased electrode sales – and to us this shows that the improvement was well worth the effort. The new clinical guidelines released in November were a bonus for us and are helping to cement Nevisense 3.0 as a best practice method in Europe’s largest market, Germany.
Skin Barrier Application
The second project is the result of three years of work cooperating with the SIAF institute in Davos, Switzerland. We have spoken for some time about our strategy to broaden the number of clinical applications for Nevisense and Electrical Impedance Spectroscopy (EIS).
Together with the team in Davos, we are developing a new application called ‘Skin Barrier function testing’. The first scientific article resulting from this cooperation is an animal study entitled ‘Direct assessment of skin epithelial barrier by electrical impedance spectroscopy’ which has just been published in the journal Allergy. The publication of this article, and an ongoing human trial mark SciBase’s entry into the barrier assessment space.
Skin barrier is an area with a very high level of clinical interest, and interest exists even at consumer level. The next time you are in a pharmacy, take a look at the number of moisturizers and skin cremes that mention ‘barrier’. The interest in barrier is growing exponentially and SciBase has found itself well positioned to take advantage of this interest.
So, what is the skin ‘barrier’? In the simplest sense, the skin’s barrier prevents external threats such as irritants, allergens and infectious agents from entering the body and prevents water from leaving the body. It achieves this through a complex combination of layers and mechanisms, but the most important of these from a barrier function perspective are two mechanical barriers – the outermost ‘stratum corneum’ layer and the epithelial cell layer with its ‘tight junctions’ in the underlying ‘stratum granulosum’ layer.
When these layers are defective or damaged, barrier related disorders often occur. The most common of these is atopic dermatitis (AD) or eczema. It has been shown that children with a defective or ‘leaky’ barrier are far more likely to develop eczema – so the barrier problem precedes the symptoms we know as eczema. Put simply, a poor barrier allows irritants to penetrate the skin and cause inflammation which we see as eczema rashes, itchiness and so on. We also know that children with a poor barrier function are more likely to develop food allergies, as the new understanding is that food allergies develop after sensitization that occurs through the skin. So a poor skin barrier is also a very important risk factor in the development of food allergies. Furthermore, diseases such as allergic rhinosinusitis and asthma also appear to be barrier-related and a subset of children who develop AD also go on to develop these diseases.
Clinicians call this progression of disorders the ‘atopic’ or ‘allergic march’ and recent studies show this to be very-much barrier-related. These disorders are very common and consume a lot of healthcare resources – for example atopic dermatitis affects 20% of children and 2-8% of adults. Understanding the integrity of the skin barrier is extremely important in the characterization and management of these disorders.
The challenge is that the method used to measure skin barrier function, called Trans Epidermal Water Loss (TEWL) is not a clinical method because it is time consuming and very sensitive to environmental and patient artifacts.
This is where EIS comes in. We know from work done fifteen years ago by Stig Ollmar that EIS is inversely correlated to TEWL – in other words that EIS can be used as a measure of barrier function. What the work in Davos has shown is that this correlation still holds, and our hope is that even more information is available from the measurement of EIS. Barrier diseases like AD are systemic diseases and so measurement on healthy skin can provide important information also.
SciBase has been fully occupied with new research co-operations within the area of skin barrier testing and we look forward to announcing new clinical studies at top research centers in the near future. We also see the potential to partner with one of the many industry players developing therapies in this space.
Looking to the near future, we believe that EIS can provide a quick and simple method for the measurement of the skin barrier. By leveraging our current platform and our machine learning tools, we hope to develop analyses that add real clinical value in this space of barrier-related disorders.
Looking to the mid-term future, we will continue to execute on our strategy and complete development of a simpler and easier next generation EIS device – and in doing so provide a platform for a screening device for EIS that can result in broad adoption both within and outside our current core customer group Dermatologists.
In the next CEO letter, we will update you on the further development of these areas and discuss the progress of Nevisense in the US.
For more information, please contact: Simon Grant, CEO SciBase Tel: +46 72 887 43 99 Email: [email protected]
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed and sells a unique point-of-care device for evaluation of skin disorders such as skin cancer and atopic dermatitis. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and a FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. SciBase is listed on Nasdaq First North (“SCIB”). Further information is available at www.scibase.com.
The information was submitted for publication, through the agency of the contact person set out above, at 08.00 CET on April 25, 2019.
About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed and sells a unique point-of-care device for evaluation of skin disorders such as skin cancer and atopic dermatitis. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and a FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. SciBase is listed on Nasdaq First North (“SCIB”). Further information is available at www.scibase.com.
The loss after tax amounted to TSEK 8,906 (9 656).
The loss per share amounted to SEK 0.54 (0.58).
The cash flow from current operations was negative in the amount of TSEK 8,950 (9 682).
The gross margin increased to 52.6% (46.4%).
Electrode sales in volume increased by 47% and reached 6,080 (4,134) units. Repeat sales of electrodes to existing customers increased by 59%.
Important events during the quarter
Sales on the company’s key market Germany increased by 23% in the quarter following record electrode sales.
The first supplement to the US PMA approval for Nevisense was approved, and Nevisense 2 was launched in the US.
Important events after the end of the period
A new study was published that opened up the skin barrier assessment application for SciBase’s product Nevisense. The paper, entitled ‘Direct assessment of skin epithelial barrier by electrical impedance spectroscopy’, was published online in the journal Allergy, European Journal of Allergy and Clinical Immunology.
Nevisense was included in US and European investigator-initiated studies utilizing Nevisense for skin barrier function assessment.
The notice of the AGM 2019 was published April 8th.
The annual report 2018 was published on April 25th.
Apr 1 2018 -
Jan 1 - Mar 31
Mar 31 2019
Jan 1 - Dec 31
THE GROUP
2019
2018
Rolling-12
2018
Net sales, SEK ths
2 368
1 939
7 327
6 899
Gross margin, %
52,6%
46,4%
53,7%
52,0%
Equity/Asset ratio, %
79,0%
91,9%
86,6%
88,1%
Net indebtness, multiple
0,27
0,09
0,15
0,13
Cash equivalents, SEK ths
58 057
95 542
58 057
67 514
Cashflow from operating activities, SEK ths
-8 950
-9 682
-36 751
-37 482
Earnings per share (before and after dilution), SEK
-0,54
-0,58
-2,62
-2,66
Shareholder's equity per share, SEK
3,78
6,38
7,98
4,30
Average number of shares, 000'
16 618
16 618
10 576
16 618
Number of shares at closing of period, 000'
16 618
16 618
16 618
16 618
Share price at end of period, SEK
4,14
7,45
4,14
3,10
Number of sold electrodes, pieces
6 080
4 134
14 512
12 566
Average number of employees
19
20
20
19
This interim report has not been subject to review by the Company’s auditors.This information is information that SciBase Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08.00 CET on May 10, 2019.
Contact person: Michael Colérus, CFO. +46 70 341 34 72
For more information, please contact: Simon Grant, CEO SciBase Phone: +46 72 887 43 99 Email: [email protected]
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed and sells a unique point-of-care device for evaluation of skin disorders such as skin cancer and atopic dermatitis. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and a US FDA-approval (PMA). Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. SciBase is listed on Nasdaq First North (“SCIB”). Further information is available at www.scibase.com.
The loss after tax amounted to TSEK 11,506 (10,295).
The loss per share amounted to SEK 0.69 (1.13).
The cash flow from current operations was negative in the amount of TSEK 9,990 (11,358).
The gross margin increased to 52.1% (31,5%).
Electrode sales in volume decreased by 2% and reached 3,872 (3,936) units. Repeat sales of electrodes to existing customers increased by 6%.
The full year in figures
Net sales amounted to TSEK 6,899 (6,859).
The loss after tax amounted to TSEK 44,215 (42,464).
The loss per share amounted to SEK 2.66 (5.00).
The cash flow from current operations was negative in the amount of TSEK 37,482 (44,180).
The gross margin increased to 52.0% (35.4%).
Electrode sales in volume decreased by 7% and reached 15,478 (16,704) units. Repeat sales of electrodes were at the same level as 2017.
Important events during the quarter
Sales on the company’s key market Germany increased by 41% in the quarter driven by system sales to new customers.
A new German clinical guideline supported by Onkoderm was published. The guidelines support the use of Nevisense in the evaluation of lesions with suspicion of melanoma and also include a recommendation for reimbursement.
SciBase and the Swiss Institute of Allergy and Asthma Research, Davos Switzerland (SIAF-SFI) announced the signing of a formal collaboration agreement within the area of barrier function testing using Electrical Impedance Spectroscopy (EIS). In addition the partners have jointly filed a patent application covering the use of electrical impedance testing for the evaluation of epithelial barrier function, potentially a unique tool to help address some of the most common disorders such as eczema, food allergy, allergic rhinitis and asthma.
A new US study was published online in the Journal of the American Academy of Dermatology (JAAD) that showed good potential for Nevisense to improve clinical decision-making.
The Company participated in the Fall Clinical meeting in Las Vegas.
A nominating committee was appointed
Important events after the end of the period
No significant events have occurred after the end of the period.
Oct 1 - Dec 31
Jan 1 - Dec 31
THE GROUP
2018
2017
2018
2017
Net sales, SEK ths
2 030
1 886
6 899
6 859
Gross margin, %
52,1%
31,5%
52,0%
35,4%
Equity/Asset ratio, %
88,1%
90,5%
88,1%
90,5%
Net indebtness, multiple
0,13
0,11
0,13
0,11
Cash equivalents, SEK ths
67 514
110 015
67 514
110 015
Cashflow from operating activities, SEK ths
-9 990
-11 358
-37 482
-44 180
Earnings per share (before and after dilution), SEK
-0,69
-1,13
-2,66
-5,00
Shareholder's equity per share, SEK
4,30
12,69
4,30
13,63
Average number of shares, 000'
16 618
9 118
16 618
8 493
Number of shares at closing of period, 000'
16 618
16 618
16 618
16 618
Share price at end of period, SEK
3,10
7,80
3,10
7,80
Number of sold electrodes, pieces
3 872
3 936
15 478
16 704
Average number of employees
19
20
19
21
This interim report has not been subject to review by the Company’s auditors.This information is information that SciBase Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 12.15 CET on February 20, 2019.
Contact person: Michael Colérus, CFO. +46 70 341 34 72
For more information, please contact: Simon Grant, CEO SciBase Phone: +46 72 887 43 99 Email: [email protected]
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and a FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. SciBase is listed on Nasdaq First North (“SCIB”). Further information is available at www.scibase.com.
The shareholders of SciBase Holding AB (publ), reg. no. 556773-4768, (hereinafter the “Company”) are hereby invited to the Annual General Meeting to be held on Thursday May 16, 2019 at 4.00 p.m. CET at Setterwalls Advokatbyrå’s offices with address at Sturegatan 10 in Stockholm.
Registration
Shareholders who wish to attend the Annual General Meeting must be recorded in the share register kept by Euroclear Sweden AB as per Friday May 10, 2019 and notify the Company of their intention to attend by no later than Friday May 10, 2019, preferably before 3.00 p.m. CET. Notice of attendance is made in writing to SciBase Holding AB (publ), P.O. Box 3337, SE-103 67 Stockholm, Sweden, or by e-mail to [email protected] or by phone +46-8-410 620 00. The notice of attendance shall include name, personal or corporate ID number, address and phone number. The same dates, addresses, and formal requirements apply for notifying the Company of any accompanying advisors. Powers of attorneys, certificates of incorporation and other documents of authorization must be presented at the Annual General Meeting, but can preferably be sent to the Company in connection with the notice of attendance.
Shareholders whose shares are registered in the names of nominees must temporarily register the shares in their own name in order to be entitled to attend the Annual General Meeting (so called voting registration). In order for such voting registration to be completed as per May 10, 2019 the shareholders must inform their nominees well before this date.
A shareholder's rights at the meeting may be exercised by a proxy empowered by a power of attorney. The power of attorney shall be in writing, dated and signed and must not be older than five years. The original power of attorney must be presented at the meeting. Those representing a legal person must also present a certificate of registration or the similar showing the authorized signatories. A proxy form is available on the Company’s website, www.scibase.com.
Proposed agenda
Opening of the meeting;
Election of chairman of the meeting;
Drawing up and approval of the voting list;
Approval of the agenda;
Election of one or two persons to verify the minutes;
Determination as to whether the meeting has been duly convened;
Presentation of the annual report and the auditor's report on the annual report and the consolidated annual report and the auditor’s report on the consolidated annual report;
Resolutions regarding:
i. adoption of the income statement and balance sheet and the consolidated income statement and consolidated balance sheet;
ii. allocation of the Company's result according to the adopted balance sheet; and
iii. discharge from liability for the members of the Board of Directors and the Managing Director;
Resolution regarding the number of members and deputies of the Board of Directors and number of auditors;
Resolution regarding the remuneration for the members of the Board of Directors and the auditor;
Election of Board of Directors and auditor;
Resolution regarding appointment of Nomination Committee;
Resolution on guidelines for determination of salary and other remuneration to senior management;
Resolution regarding authorisation for the Board of Directors to resolve upon issues of shares, warrants and convertibles;
Closing of the meeting.
Resolution proposals
Item 2 – Election of chairman of the meeting
The Nomination Committee proposes that Attorney-at-law Jörgen S. Axelsson is appointed chairman of the meeting.
Item 8 (ii) – Allocation of the Company's result according to the adopted balance sheet
The Board of Directors and the Managing Director proposes that the result for the year is allocated so that SEK 135,443,035 is carried forward. No dividend to the shareholders is thus proposed.
Item 9 – Resolution regarding the number of members and deputies of the Board of Directors and number of auditors
The Nomination Committee proposes that the Company's Board of Directors shall consist of four ordinary members and no deputy directors.
Item 10 – Resolution regarding the remuneration for the members of the Board of Directors and the auditor
The Nomination Committee proposes that a fee of SEK 200,000 shall be paid to the Chairman of the Board of Directors and SEK 150,000 to external members of the Board of Directors who are not employed by a larger shareholder in the Company.
Fees to the Company's auditor shall be paid in accordance with approved invoices.
Item 11 – Election of members, deputies and Chairman of the Board of Directors and auditor
The Nomination Committee proposes election of members, deputies and Chairman of the Board of Directors and auditor for the period until the end of the next Annual General Meeting, as follows:
Board members:
Diana Ferro (re-election)
Thomas Eklund (re-election)
Thomas Taapken (re-election)
Tord Lendau (re-election)
Chairman:
Tord Lendau (re-election)
Auditor:
Re-election of the chartered auditing firm PricewaterhouseCoopers AB (PwC), with Magnus Lagerberg as responsible auditor.
Item 12 – Resolution regarding appointment of Nomination Committee
The Nomination Committee proposes the following decision for election of a Nomination Committee for the Annual General Meeting 2019:
The Nomination Committee for the Annual General Meeting 2020, which shall comprise of four members, shall be appointed by way of that the Chairman of the Board of Directors will consult with the three largest shareholders of the Company at the end of the third quarter of 2019. These shareholders will be requested to each appoint one member who, together with the Chairman of the Board of Directors, will form the Nomination Committee. The composition of the Nomination Committee shall be publicly announced no later than six months prior to the Annual General Meeting. The Nomination Committee, whose mandate period applies until the time a new Nomination Committee has constituted itself, shall appoint a chairman among its members. The Nomination Committee shall prior to the Annual General Meeting 2020 prepare and submit proposals regarding the election of the chairman of the Annual General Meeting, the number of board members and deputy members, the election of board members, chairman, deputy members and auditor, remuneration for the Board of Directors and the auditor, as well as guidelines for the appointment of the Nomination Committee for the following Annual General Meeting. The Nomination Committee’s proposals shall be presented in the notice to a General Meeting where election of board members and auditor shall take place and on the Company’s website. Should a member of the Nomination Committee resign from its assignment, a replacement shall be sought from the shareholder that appointed the departing member. Should a shareholder that has appointed a member of the Nomination Committee substantially decrease its ownership in the Company, the next shareholder in size order shall, if the Nomination Committee so resolves, be requested to appoint a member to the Nomination Committee.
Item 13 – Resolution on guidelines for determination of salary and other remuneration to senior management
The Board of Directors proposes that the Annual General Meeting resolves to adopt the following guidelines for the remuneration to senior management members for the period extending until the 2020 Annual General Meeting.
The remuneration to the Group’s senior management members shall comprise fixed salary, variable salary, pension and other benefits. The total remuneration package shall be based on market terms, be competitive and reflect the individual’s performance and responsibilities as well as the Group’s earnings trend.
The variable salary may comprise annual incentives in cash and long-term incentives in cash, shares and /or share-based instruments in the Company. Variable salary in cash is conditional upon the fulfillment of defined and measurable goals and should be maximized in relation to the fixed salary. Long-term incentives in the form of shares and /or share-based instruments in the Company may be provided through participation in long-term incentive programs approved by the General Meeting. Terms and conditions for variable salary should be designed so that the Board of Directors, if exceptional economic circumstances prevail, has the option of limiting or refraining from payment of variable salary if such a measure is considered reasonable.
In specific cases, agreements may be reached regarding one-off remuneration amounts provided that such remuneration does not exceed an amount corresponding to the individual’s annual fixed salary and maximum variable salary in cash, and is not paid more than once per year and individual.
Pension benefits should either be defined benefit or defined contribution, or a combination thereof. The retirement age is minimum 60 years for the Managing Director and minimum 62 years for other senior management members.
Members of the senior management generally have a period of notice of not more than 12 months. The Board of Directors shall have the right to depart from the guidelines resolved on by the Annual General Meeting if, in an individual case, there are special reasons for doing so.
The sphere of senior executives encompassed by these guidelines comprises the Managing Director and other members of the Group’s senior management.
Item 14 – Resolution regarding authorization for the Board of Directors to resolve upon issues of shares, warrants and convertibles
The Board of Directors proposes that the Annual General Meeting resolves to authorise the Board of Directors to, until the next Annual General Meeting, on one or more occasions, decide upon issuances of new shares, issuance of warrants and/or convertibles. New issues of shares and issues of warrants and/or convertibles may occur with or without preferential rights for shareholders of the Company, and may be made either in cash and/or by way of set-off or contribution in kind or otherwise on specific terms. The number of shares issued, or number of shares created in connection with exercise of warrants or conversion of convertibles, shall not exceed 1,661,810 (corresponding to approx. 10 percent of the number of shares in the Company at the date of the issuance of the notice).
Information at the Annual General Meeting
Upon request by any shareholder and where the Board of Directors believes that such may take place without significant harm to the Company, the Board of Directors and the Managing Director should provide information at the Annual General Meeting in respect of any circumstances which may affect the assessment of a matter on the agenda, and any circumstances which may affect the assessment of the Company’s or a subsidiary’s financial position and as regards the Company’s relationship to other group companies.
Majority requirements
Resolution in accordance with item 14 on the agenda requires that the General Meeting’s resolution is supported by shareholders representing at least two thirds of the shares represented at the General Meeting as well as of the votes cast.
Number of shares and votes
At the time of the issuance of this notice, the total number of shares and votes in the Company amounted to 16,618,101.
Documents
The financial statements and auditor's report will be available at the Company's offices and at the Company’s website www.scibase.com no later than 25 April 2019. Copies of the aforementioned documents will also be sent by post to shareholders who so request and provide their postal addresses. The proposals of the Board of Directors and the Nomination Committee are set out in full in the notice.
* * * * * *
Stockholm in April 2019
SciBase Holding AB (publ)
The Board of Directors
For more information, please contact: Simon Grant, CEO SciBase Tel: +46 72 887 43 99 Email: [email protected]
The information was submitted, through the contact person (s) above, for publication at 3.00 pm on April 8, 2019 .
About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed and sells a unique point-of-care device for evaluation of skin disorders such as skin cancer and atopic dermatitis. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and a FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. SciBase is listed on Nasdaq First North (“SCIB”). Further information is available at www.scibase.com.
The Swiss Institute of Allergy and Asthma Research (SIAF) and SciBase announce today the publication of a breakthrough animal study within the area of skin barrier assessment. The paper, which is entitled ‘Direct assessment of skin epithelial barrier by electrical impedance spectroscopy’, was published online in the journal Allergy, European Journal of Allergy and Clinical Immunology. The study was performed in Davos by SIAF with support from SciBase, and the lead author for the publication was Prof. Cezmi A. Akdis, Director of SIAF.
Building on work done within atopic dermatitis (AD) by Stig Ollmar and SciBase over a decade ago, SIAF applied SciBase’s combination of unique electrode design and electrical impedance spectroscopy (EIS) methodology to assess skin barrier function in mice. The aim of the study was to establish a method to assess the skin epidermal barrier function in vivo with good environmental stability, so that it could be used as a diagnostic tool for barrier-related inflammatory disorders of the skin, such as AD. The study concluded that ‘EI spectroscopy is a rapid and reliable diagnostic tool to detect skin barrier defects’.
Given that Nevisense is already established as a clinical method within melanoma detection, the study illustrates clear potential for the use of Nevisense in routine clinical evaluation of the barrier, and the investigation of barrier-related disorders. Nevisense is commercially available today for general investigation and research of the skin.
There is an increasing realization of the importance of the barrier in the development, characterization and management of a range of disorders. Barrier defects have been reported in atopic dermatitis (AD), asthma, chronic rhinosinusitis, allergic rhinitis, esophagitis and colitis. Assessment of barrier impairment provides insight into these disorders, but the assessment of skin barrier has to date been limited to research methods.
“Our aim is to bring this method to daily patient care as a biomarker for analysing treatment responses and selection of skin barrier defective patients. In addition, early detection of skin barrier defective babies before atopic dermatitis starts is an unmet need, because these babies can be included in skin barrier protection programs to prevent the development of atopic dermatitis. Atopic dermatitis affects more than 10% of the world’s population and 80% of the patients are babies”, says Professor Cezmi A. Akdis
“The publication of this paper marks a milestone for SciBase. For the first time there is a device available that could be used to investigate the barrier quickly and easily in a routine clinical setting. The breadth of the potential applications is extraordinary – disorders such as eczema, food allergies and asthma, and even some gastrointestinal disorders involve the barrier.
The really exciting thing is that this first study utilizes only a fraction of the impedance information available. There is much, much more information in the Nevisense impedance measurements and SciBase believe this can provide significantly more insight and utility to clinicians in the future.
We expect that this study will generate a lot of interest from researchers and look forward to addressing that market. Clinical trials with different patient groups are ongoing and together with SIAF, we look forward to developing broadly useful clinical tools for different conditions”, says Simon Grant, CEO of SciBase.
The full article can be found here: https://onlinelibrary.wiley.com/doi/abs/10.1111/all.13824
For more information, please contact: Simon Grant, CEO SciBase Tel: +46 72 887 43 99 Email: [email protected]
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed and sells a unique point-of-care device for evaluation of skin disorders such as skin cancer and atopic dermatitis. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and a FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. SciBase is listed on Nasdaq First North (“SCIB”). Further information is available at www.scibase.com.
About SIAF-SFI
The Swiss Institute of Allergy and Asthma Research (SIAF) is a department of the foundation Swiss Research Institutes for High Altitude Climate and Medicine Davos (SFI), an affiliated institute of the University of Zurich, and member of the Life Science Zurich Graduate School. SIAF members play leading roles in national and international organizations, such as European Academy of Allergy and Clinical Immunology and in editorial boards and editorships of top Journals in the field of allergy asthma and clinical immunology. At the same time, SIAF fulfills teaching obligations in the University of Zurich. The research activities at SIAF are focused on patient-relevant translational research and the investigation of the immunological principles in the field of skin atopic dermatitis, allergies and asthma to develop approaches for new preventive and curative treatments for patients. SIAF also promotes personalized medicine to develop treatment approaches that are better tailored to the needs of individual patients. These personalized medicine research activities are expected to not only help to find tailor-made therapies but also to develop more precise diagnosis. The continuously growing SIAF is one of the most cited and leading institutes in its area worldwide with more than 50,000 citations and 1,000 original research articles in the last 20 years. SIAF organizes the internationally renowned World Immune Regulation Meeting (WIRM) in Davos every year. SIAF works in close collaboration with the Christine Kühne-Center for Allergy Research and Education (CK-CARE), Davos. SIAF is preparing to move to its new building within the Alpine Allergy Campus in Davos-Wolfgang and looking forward to work knee to knee with Hochgebirgsklinik Davos and CK-CARE to bring solutions to allergy patients. Further information is available at www.siaf.uzh.ch.
The loss after tax including an extraordinary one-time charge amounted to TSEK 12,754 (8,810).
The loss per share amounted to SEK 0.77 (1.06).
The cash flow from current operations was negative in the amount of TSEK 7,692 (9,796).
The gross margin was 52.6% (56.8%).
Electrode sales in volume decreased by 10% and reached 3,088 (3,440) units. Repeat sales of electrodes decreased by 19% partly affected by timing of purchases and partly by customers having a “wait and see” attitude towards the in September launched new Nevisense 3.0.
The first 9-months in figures
Net sales amounted to TSEK 4,869 (4,973).
The loss after tax amounted to TSEK 32,709 (32,168).
The loss per share amounted to SEK 1.97 (3.88).
The cash flow from current operations was negative in the amount of TSEK 27,492 (32,821).
The gross margin was 51.9% (36.8%).
Electrode sales in volume decreased by 9% and reached 11,606 (12,768) units. Repeat sales of electrodes decreased by 2%.
Important events during the quarter
Nevisense 3.0, an improved version of Nevisense, was presented for the first time at the FOBI meeting in Munich in July. The update streamlines the measurement procedure and significantly improves usability, making the product easier to integrate into a dermatology clinic’s patient workflow. At the meeting Prof Axel Hauschild also presented Nevisense in a workshop with nearly 100 attendees.The improvement has been received very positively by customers and almost 100 Nevisense systems have been upgraded to date.
Important events after the end of the period
A new US study was published online in the Journal of the American Academy of Dermatology (JAAD).
The Company participated in the Fall Clinical meeting in Las Vegas.
A nominating committee has been appointed.
Oct 1 2017 -
July1 - Sep 30
Jan 1 - Sep 30
Sep 30 2018
Jan 1 - Dec 31
THE GROUP
2018
2017
2018
2017
Rolling-12
2017
Net sales, SEK ths
1 359
1 172
4 869
4 973
6 755
6 859
Gross margin, %
52,6%
56,8%
51,9%
36,8%
46,2%
35,4%
Equity/Asset ratio, %
89,2%
86,9%
89,2%
86,9%
88,2%
90,5%
Net indebtness, multiple
0,12
0,15
0,12
0,15
0,13
0,11
Cash equivalents, SEK ths
77 551
50 948
77 551
50 948
77 551
110 015
Cashflow from operating activities, SEK ths
-7 692
-9 796
-27 492
-32 821
-38 850
-44 180
Earnings per share (before and after dilution), SEK
-0,77
-1,06
-1,97
-3,88
-3,40
-5,00
Shareholder's equity per share, SEK
4,97
7,31
4,97
7,31
6,76
13,63
Average number of shares, 000'
16 618
8 285
16 618
8 285
10 576
8 493
Number of shares at closing of period, 000'
16 618
8 285
16 618
8 285
16 618
16 618
Share price at end of period, SEK
4,52
18,09
4,52
18,09
4,52
7,80
Number of sold electrodes, pieces
3 088
3 440
11 606
12 768
15 542
16 704
Average number of employees
19
21
19
22
20
21
This information is information that SciBase Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out below, at 08.00 CET on November 13, 2018.
Contact person:
Michael Colérus, CFO
For more information, please contact: Simon Grant, CEO SciBase Phone: +46 72 887 43 99 Email: [email protected]
About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia, and now also a FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies. SciBase is listed on Nasdaq First North (“SCIB”). Avanza is the certified advisor. Further information is available on www.scibase.com.
A new clinical guideline supporting the use of Nevisense in the evaluation of lesions with suspicion of melanoma has been published in the German magazine “Der Deutsche Dermatologe”. The guideline is written by Prof Julia Welzel, Augsburg and Prof Uwe Reinhold, Bonn and has the backing and support of Onkoderm, a German dermatology society for skin cancer prevention and therapy.
The article is titled “EIS: Atypien von Hautveränderungen präzise messen” or in English “EIS: Precise measurement of atypia of skin lesions”. It outlines a recommended protocol for the use of Nevisense in the evaluation of lesions where there is suspicion of malignant melanoma and the recommended action based on the result of the Nevisense measurement. The article also includes a reimbursement recommendation from Onkoderm.
The article describing the guideline is now available in online form at the Der Deutsche Dermatologe website (https://www.springermedizin.de/der-deutsche-dermatologe-11-2018/16277500) and will be distributed in print to German Dermatologists and associated professionals.
“Guidelines are an essential step along the way to becoming standard of care, and we are very happy the pre-eminent German organization within skin cancer, OnkoDerm, has chosen to support this guideline and reimbursement approach. We believe that this, combined with our improved system Nevisense 3.0, will drive both our user base and existing customers’ usage in German speaking countries. ”, says Simon Grant, CEO of SciBase.
For more information, please contact: Simon Grant, CEO SciBase Tel: +46 72 887 43 99 Email: [email protected]
This information is information that SciBase Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 15.30 CET on November 19, 2018.
About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and a FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies. SciBase is listed on Nasdaq First North (“SCIB”). Avanza is the certified advisor. Further information is available on www.scibase.com.
SciBase and Swiss Institute of Allergy and Asthma Research, Davos Switzerland (SIAF-SFI) announced today the signing of a formal collaboration agreement within the area of barrier function testing using Electrical Impedance Spectroscopy (EIS). In addition the partners have jointly filed a patent application covering the use of electrical impedance testing for the evaluation of epithelial barrier function, potentially a unique tool to help address some of the most common disorders such as eczema, food allergy, allergic rhinitis and asthma.
The agreement formalises a research co-operation project that has been ongoing over a period of nearly three years. That co-operation recently resulted in the submission of an animal study research paper to a leading scientific journal which outlines the use and potential of EIS in skin barrier evaluation.
The research has applied SciBase’s Electrical Impedance Spectroscopy (EIS) system Nevisense, to a new clinical area, barrier-related disorders. By utilizing EIS to test the skin’s ‘barrier function’, a clearer understanding of the status of the skin is available quickly and easily, even if no clinical signs are present. This improves the clinician’s ability to diagnose, manage and treat diseases like atopic dermatitis or eczema. Atopic dermatitis is extremely common, affecting up to 20% of children, and 2-10% of adults. This, if the clinical data shows positive results, could result in products that open up a large new market for SciBase addressing an unmet medical need. It could also open up opportunities to partner with therapy companies in this space. A research version to measure barrier is already available and we intend to work to release further product versions during 2019.
“Epithelial barrier defects are becoming more and more prominent in the pathogenesis of chronic inflammatory diseases of the skin and mucosa and quantitative measurement of barrier integrity at the point of care is essential. I am very happy that we are going into a co-development agreement with SciBase for efficient barrier detection for prevention and treatment strategies of allergic skin diseases and further on other barrier- related diseases”, says Professor Cezmi Akdis, MD, Director SIAF.
“Our collaboration with Prof. Akdis and SIAF-SFI is the foundation of the work we do within this exciting new application for EIS. Scientific interest in barrier function as a central factor in atopic dermatitis continues to grow. There are also several disorders such as food allergy and asthma that are related to atopic dermatitis and the barrier. The ability to understand barrier function could therefore improve our ability to manage these and other very common disorders and this opens up a number of research and commercial opportunities”, says Simon Grant, CEO of SciBase.
For more information, please contact: Simon Grant, CEO SciBase Tel: +46 72 887 43 99 Email: [email protected]
About SciBase and Nevisense
SciBase AB is a Swedish medical technology company, headquartered in Stockholm that has developed a unique point-of-care device for the accurate detection of malignant melanoma. Its first product, Nevisense, helps doctors to detect malignant melanoma, the most dangerous type of skin cancer. SciBase was founded by Stig Ollmar, Associate Professor at The Karolinska Institute in Stockholm, Sweden. Nevisense is based on substantial research and has achieved excellent results in the largest clinical study ever conducted on the detection of malignant melanoma. Nevisense is CE marked in Europe, has TGA approval in Australia and a FDA clearance in the United States. Nevisense is based on a method called Electrical Impedance Spectroscopy (EIS), which uses the varying electrical properties of human tissue to categorize cellular structures and thereby detect malignancies and abnormalities. SciBase is listed on Nasdaq First North (“SCIB”). Avanza is the certified advisor. Further information is available at www.scibase.com.
About SIAF-SFI
The Swiss Institute of Allergy and Asthma Research (SIAF) is a department of the foundation Swiss Research Institutes for High Altitude Climate and Medicine Davos (SFI), an affiliated institute of the University of Zurich, and member of the Life Science Zurich Graduate School. SIAF members play leading roles in national and international organizations, such as European Academy of Allergy and Clinical Immunology and in editorial boards and editorships of top Journals in the field of allergy asthma and clinical immunology. At the same time, SIAF fulfills teaching obligations in the University of Zurich. The research activities at SIAF are focused on patient-relevant translational research and the investigation of the immunological principles in the field of skin atopic dermatitis, allergies and asthma to develop approaches for new preventive and curative treatments for patients. SIAF also promotes personalized medicine to develop treatment approaches that are better tailored to the needs of individual patients. These personalized medicine research activities are expected to not only help to find tailor-made therapies but also to develop more precise diagnosis. The continuously growing SIAF is one of the most cited and leading institutes in its area worldwide with more than 50,000 citations and 1,000 original research articles in the last 20 years. SIAF organizes the internationally renowned World Immune Regulation Meeting (WIRM) in Davos every year. Further information is available at www.siaf.uzh.ch
