SciBase Holding (publ), Reg. No. 556773-4768 (the ”Company”), hereby announces that the Company has entered into an agreement with Vator Securities AB (”Vator Securities”) regarding the service as a Certified Adviser. Vator Securities will be appointed Certified Adviser (CA) on 28 September 2021. Up until then, Avanza Bank AB will continue to act as Certified Adviser for the Company.
For more information, please contact: Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]
The information was submitted, through the agency of the contact person set out above, for publication at the time stated by Scibase's news distributor Cision upon publication of this press release.
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. 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 an FDA approval (PMA) 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.
I hope you are all enjoying the summer weather. For the team at SciBase, it has been an exceptionally interesting and busy half year, and we are looking forward to a similarly busy second half of 2021. Three highlights:
First, SciBase welcomes new institutional shareholders such as Van Herk, specialists within life science and melanoma, and ÖstVäst.
Second, as an important commercial leap, we have filed our first application for reimbursement coverage with CMS in Florida. Reimbursement is a catalyst for broad adoption of our test. This is the first of many such applications and is important because when approved, it means that Florida clinicians will be reimbursed financially for their time and materials when they utilize Nevisense on Medicare patients.
Third, we have received our MDR certification and have launched our Non-Melanoma Skin Cancer (NMSC) indication in Europe.
With the recent successful directed share issue of SEK 71 million, SciBase is now well-financed to further accelerate our market penetration in the US. More reimbursement applications for additional regions will follow. This funding will also support the further development of the Barrier applications where there is a lot already happening and we expect to be able to announce further updates in Q3 and Q4 of this year.
New Shareholders, and the capital increase
Last month’s directed share issue successfully strengthened our investor base and provided us with funding for our US initiatives. SciBase’s aim has been, and still is, to continue building a strong institutional and long-term investor base. Two of our new largest investors – Van Herk Investments from the Netherlands and ÖstVäst Capital Management, are seasoned in life science investments. We look forward to working with the team at Van Herk over the summer and believe that their knowledge within skin cancer and their clinical and commercial network can contribute significantly to SciBase’s development.
US Market – Important milestone reached
This year much of our focus has been on the US market, where our priorities are insurance coverage/reimbursement for our test and working with large practice groups. It was an important milestone for us to submit our first reimbursement application in Florida for Medicare patients in May. We are already underway with the process for the next application, covering New York and the North-East area. Securing coverage takes time and involves separate processes by region and insurance type. With the funds secured in the directed share issue, we are expanding our resources to handle these processes. Sales and Marketing resources will also be expanded following positive insurance decisions.
Over the last 12 months we have worked closely with the Advanced Dermatology and Cosmetic Surgery (ADCS) practice group. With over 20 systems now placed in Florida at ADCS sites, we have gained a good understanding of US market needs, and we will leverage this knowledge as we work our way across the US. It is really an honor to have Dr Matt Leavitt, the founder of ADCS join the Board of SciBase and become an investor. Matt has a unique and deep knowledge of the US Dermatology space both clinically and commercially, and we look forward to working closely with him as we penetrate the US market.
In summary, the next steps for SciBase in the US are a strengthening of the team and an acceleration of further reimbursement submissions.
Progress in other strategic growth areas
Our team in Germany led by Emanuel Von Kienlin, has been waiting patiently for the completion of our MDR certification process. We recently successfully completed our first audit under MDR and it feels very positive to have this major certification in place, when most all other companies within Dermatology are still working on this.
MDR was needed so that we can begin to sell and install our new Non-Melanoma Skin Cancer (NMSC) software module for Nevisense. This module uses the same Nevisense hardware and electrodes as the melanoma module, and as such is a reasonably simple addition for existing users. We have to date completed nearly 50 installations of this module with existing customers and have added a number of new customers. We look forward to reporting on the progress with this new indication, and we will continue to develop this module and add further functionality based on both clinical studies and development.
We continue to have new product and clinical application development as a strategic priority. The release of a research version of Nevisense Go and the NMSC indication for Nevisense were the first product milestones in this journey. Yet another milestone was the recent publication of two articles supporting the new Skin Barrier application. A groundbreaking article presenting the “epithelial barrier hypothesis” was published in Nature Reviews Immunology. The article was written by Professor Cezmi Akdis at the Swiss institute of Allergy and Asthma Research (SIAF). Prof. Akdis is the key research collaborator in SciBase’s product development for skin barrier assessment. The article presents the background for the steep increase in allergic diseases over the last decades, and how this increase is connected to industrialization and modern lifestyle. This article really spurred interest among researchers within the area of the barrier function.
Another key study from the Swiss institute of Allergy and Asthma Research (SIAF) was published in the European Journal of Allergy and Clinical Immunology (Allergy). In the study Nevisense was used to assess the skin barrier of patients with atopic dermatitis (AD) and could accurately detect signs of atopic dermatitis even on unaffected skin. The Nevisense measurement also correlated with relevant biomarkers for atopic dermatitis. We are now working on fine-tuning the algorithm for the barrier application and in advanced discussions with potential industry partners to further develop this area through the initiation of clinical studies.
Short term our aim is to target researchers and industry groups interested in skin barrier to sell Nevisense and Nevisense Go and collaborate to further develop the scientific evidence supporting clinical applications. We see broad potential within this space for future growth and have a number of collaborations ongoing. We strongly believe that over time the barrier applications have the potential to become a real success story for SciBase.
We expect to maintain a high pace of activities over summer. We will continue to increase the level of activities in the US as we prepare for a first positive reimbursement decision. We hope to soon be able to communicate more regarding the research and industry collaborations within the barrier indication, and we look forward to returning to the levels of growth that we have previously had, as the effects from Covid subside.
Happy summer!
For more information, please contact: Simon Grant, CEO SciBase
Phone: +46 72 887 43 99
Email: [email protected]
About SciBase andNevisense SciBase AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect 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 non-melanoma skin cancer. 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 an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com..
The loss after tax amounted to TSEK 11,151 (8,864).
The loss per share amounted to SEK 0.19 (0.38).
The cash flow from current operations was negative in the amount of TSEK 9,162 (8,704).
The gross margin reached 56.3% (55.7%).
Electrode sales volume increased by 28% and reached 5,968 (4,672) units. Repeat sales of electrodes to existing customers increased by 23%.
January - June in figures
Net sales amounted to TSEK 4,821 (4,179).
The loss after tax amounted to TSEK 19,304 (17,800).
The loss per share amounted to SEK 0.34 (0.89).
The cash flow from current operations was negative in the amount of TSEK 18,635 (16,597).
The gross margin reached 54.4% (54.7%).
Electrode sales volume increased by 19% and reached 13,464 (11,270) units. Repeat sales of electrodes to existing customers increased by 20%.
Important events during the quarter
Overall sales increased by 34% (cleared for currency effects +43%). Covid-19 continues to affect sales and the market situation remains difficult to predict going forward, due to ongoing lockdowns and reduced marketing activities. Sales in the company’s key market Germany increased by 13% (cleared for currency effects +19%).
SciBase performed two successful directed share issues which raised approximately MSEK 66.5 net, after issue costs.
SciBase submitted the first US reimbursement application to CMS’s Medicare Contractor in Florida, First Coast Service Options (FCSO). The application for Medicare coverage in Florida marks an important step in the reimbursement process for SciBase and is a necessary step towards broader penetration and usage of the Nevisense test.
SciBase received certification under the new Medical Device Regulation (MDR).
The new Non-Melanoma Skin Cancer (NMSC) clinical application was launched following the completion of the MDR certification process.
A groundbreaking article by key SciBase collaborator Professor Cezmi Akdis presenting the “epithelial barrier hypothesis” was published in Nature Reviews Immunology. The article presented the background for the steep increase in allergic and other diseases over the last decades, and how this increase is connected to degradation in barrier function in the body.
A new clinical study from the Swiss Institute of Allergy and Asthma Research (SIAF) was published in the European Journal of Allergy and Clinical Immunology (Allergy). In the study Nevisense was used to assess the skin barrier of patients with atopic dermatitis (AD) and could accurately detect signs of barrier degradation in atopic patients, even in visually unaffected skin. Nevisense measurements also correlated with relevant biomarkers for atopic dermatitis.
The notice to attend the AGM 2021 was published as well as the nominating committees supplementary proposal to nominate Dr Matt Leavitt for the Board of Directors.
The AGM 2021 was held on May 18.
An EGM was held on June 16th.
The annual report 2020 was published on April 9th.
Important events after the end of the period
SciBase has entered into an agreement with Vator Securities AB (”Vator Securities”) regarding the service as a Certified Adviser. Vator Securities will take over as Certified Adviser on September 28, 2021. Until Vator Securities takes over, Avanza Bank AB will continue to act as Certified Adviser for the Company.
July 1 2020 -
Apr 1 - June 30
Jan 1 - June 30
June 30 2021
Jan 1 - Dec 31
THE GROUP
2021
2020
2021
2020
Rolling-12
2020
Net sales, SEK ths
2 258
1 683
4 821
4 179
10 163
9 521
Gross margin, %
56,3%
55,7%
54,4%
54,7%
52,5%
52,5%
Equity/Asset ratio, %
87,3%
69,2%
87,3%
69,2%
81,7%
79,1%
Net indebtness, multiple
0,15
0,44
0,15
0,44
0,22
0,26
Cash equivalents, SEK ths
88 192
30 450
88 192
30 450
88 192
41 427
Cashflow from operating activities, SEK ths
-9 162
-8 704
-18 635
-16 597
-35 899
-33 861
Earnings per share (before and after dilution), SEK
-0,19
-0,38
-0,34
-0,89
-0,72
-1,12
Shareholder's equity per share, SEK
1,59
1,44
1,65
1,68
1,25
1,50
Average number of shares, 000'
59 265
23 265
57 023
19 942
50 949
31 287
Number of shares at closing of period, 000'
68 236
36 560
68 236
36 560
68 236
54 780
Share price at end of period, SEK
5,52
2,44
5,52
2,44
5,52
4,62
Number of sold electrodes, pieces
5 968
4 672
13 464
11 270
27 880
25 686
Average number of employees
17
16
17
16
17
16
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 August 19, 2021.
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]
About SciBase and Nevisense SciBase AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect 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 non-melanoma skin cancer. 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 an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
The Board of Directors of SciBase Holding AB (publ.) (“SciBase” or the “Company”) has, with support of the authorization granted by the annual general meeting on 18 May 2021 decided on a directed issue of 13,456,021 shares to a number of Swedish and international investors, including Van Herk Investments B.V. and ÖstVäst Capital Management. Furthermore, the Board of Directors has, conditioned by the approval at the extra general meeting, decided on a directed issue of 239,000 shares to the newly elected Board of Director Dr. Matt Leavitt. Notice of the extraordinary general meeting for approval of the share issue to Dr. Matt Leavitt will be announced separately.
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, HONG KONG, JAPAN, CANADA, NEW ZEALAND, SWITZERLAND, SINGAPORE, SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES.
The share issues have been carried out at a subscription price of SEK 5.20 per share and provides the Company with approximately SEK 71.2 million before transaction-related costs.“So far in 2021 we have received MDR certification, launched our NMSC (non-melanoma skin cancer) indication in Europe and filed an application for reimbursement coverage with CMS in Florida, US. With the share issues, we will further accelerate our strategic growth areas and our market penetration in the US by applying for reimbursement in additional regions. Furthermore, we will continue to develop our skin barrier application with a focus on securing additional partnerships. In summary, the share issues provide SciBase with the financing needed to achieve reimbursement in the US, while also strengthening the shareholder base through welcoming new local and international institutional owners such as ÖstVäst Capital Management and the specialist investor Van Herk Investments B.V. Through its investments in BioInvent, Immunicum and Zealand Pharma, Van Herk has shown great success in life science and in addition they also have good knowledge within the field of skin cancer.”, says Simon Grant, CEO of SciBase.
SciBase has carried out a capital raise of approximately SEK 71.2 million. The capital raise is divided into two directed share issues, one to a number of Swedish and international investors, including Van Herk Investments B.V. and ÖstVäst Capital Management, and the other to the Board member Dr. Matt Leavitt who was newly elected on the annual general meeting 2021.
The share issues have been carried out at a subscription price of SEK 5.20 per new share, corresponding to a discount of approximately 11.0 per cent in relation to the volume weighted average price during the previous five (5) trading days of the Company's shares on the Nasdaq First North Growth Market. The subscription price has been determined through negotiations at arm’s length with investors and is assessed to reflect current market conditions and demand.
In connection with the share issues, lock-up agreements with Board members and senior executives of the Company who own shares in the Company have been entered into, including customary terms and exemptions under the direction of Vator Securities.
The net proceeds from the share issues will primarily be used for penetration of the U.S. market, including reimbursement activities and strengthening of the local sales and customer support organization, and for the development of new applications.
The share issue directed to Swedish and international investors has been carried out based on the authorization granted at the annual general meeting on 18 May 2021. The share issue directed to the Board member Dr. Matt Leavitt (who was newly elected on the annual general meeting 2021) is covered by the so-called Leo Act (Chapter 16 of the Swedish Companies Act) and is thus subject to approval from a general shareholder meeting. Notice of an extraordinary general meeting will be announced through a separate press release.
The reasons for the deviation from shareholders’ preemption rights are to raise capital in a cost and time effective manner, diversify the ownership of the Company and to make it possible for the Board member Matt Leavitt to invest and thus achieving alignment with the Company’s shareholders.
To facilitate the completion of the share issue directed to Swedish and international investors, the new shares have been subscribed to by Vator Securities AB as issuing agent at an amount corresponding to the quota value of the shares, for subsequent transfer to the final investors at a price of SEK 5.20 per share, which is finally reported to the Company.
Through the share issues the number of shares in the Company will increase by 13,695,021, from 54,780,086 to 68,475,107 and the share capital will increase by SEK 684,751.05 from SEK 2,739,004.30 to SEK 3,423,755.35. The dilution for existing shareholders amounts to approximately 20 per cent.
Advisers
Vator Securities AB is sole global coordinator and bookrunner and Eversheds Sutherland Advokatbyrå AB is legal advisor to SciBase in connection with the share issues.
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 persons set out above, at 8.55 CEST on 31 May 2021.
About SciBase och Nevisense
SciBase AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect 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 non-melanoma skin cancer. 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 an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
Important information
Release, announcement or distribution of this press release may, in certain jurisdictions, be subject to restrictions according to law and people in those jurisdictions, in which this press release has been announced or distributed, should inform themselves of and follow such legal restrictions. This press release does not constitute an offer, or a solicitation of any offer, to buy or subscribe for any securities in SciBase in any jurisdiction.
This press release does not constitute or form part of an offer or solicitation to purchase or subscribe for securities in the United States. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the US Securities Act of 1933, as amended. The information in this press release may not be announced, published or distributed to Australia, Hong Kong, Japan, Canada, New Zeeland, Singapore, South Afrika, the United States the United States, or in any other jurisdiction where the announcement, publication or distribution of the information would not comply with applicable laws and regulations.
In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” (within the meaning of the United Kingdom version of the EU Prospectus Regulation (2017/1129/ EU) which is part of United Kingdom law by virtue of the European Union (Withdrawal) Act 2018) who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); (ii) high net worth entities etc. falling within Article 49(2)(a) to (d) of the Order; or (iii) such other persons to whom such investment or investment activity may lawfully be made available under the Order (all such persons together being referred to as “relevant persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it.
Forward-looking statements
This press release contains forward-looking statements that reflect the Company’s intentions, beliefs, or current expectations about and targets for the Company’s future results of operations, financial condition, liquidity, performance, prospects, anticipated growth, strategies and opportunities and the markets in which the Company operates. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim” or “might”, or, in each case, their negative, or similar expressions. The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialize or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not guarantee that the assumptions underlying the forward-looking statements in this press release are free from errors and readers of this press release should not place undue reliance on the forward-looking statements in this press release. The information, opinions and forward-looking statements that are expressly or implicitly contained herein speak only as of its date and are subject to change without notice. Neither the Company nor anyone else undertake to review, update, confirm or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this press release, unless it is not required by law or Nasdaq First North Growth Market’s rule book for issuers.
The shareholders of SciBase Holding AB (publ), reg.no 556773-4768 (the "Company") are hereby summoned to an extraordinary general meeting on Wednesday 16 June 2021. The meeting will be held through postal voting only.
The board of directors has, in light of continued spread of the coronavirus and in accordance with the Swedish Act (2020:198) on temporary exceptions to facilitate the execution of general meetings in companies and other associations, decided that the extraordinary general meeting shall be held without physical presence of shareholders, proxies and/or external parties and that the shareholders shall have only the opportunity to vote by mail prior to the meeting.
The Company welcomes all shareholders to exercise their voting rights at the meeting through postal voting as described below. Information on the resolutions passed at the meeting will be published on Wednesday 16 May 2021, as soon as the result of the postal voting has been finally confirmed.
PARTICIPATION
A Shareholder wishing to attend the meeting shall:
be recorded in the share register maintained by Euroclear Sweden AB on Tuesday 8 June 2021; and
notify the Company of its intention to attend the meeting not later than on Tuesday 15 June 2021 by submitting a complete voting form and, where applicable, proxies, registration certificates and other corresponding authorization documents in accordance with the instructions under the heading “Information on postal voting” below.
To be entitled to attend the meeting, shareholders whose shares are nominee-registered must, in addition to giving notice of attendance to the Company by casting their postal vote, register such shares in their own names so that the shareholder is recorded in the share register as of Tuesday 8 June 2021. Such registration may be temporary (so called voting right registration) and request for such registration shall be made to the nominee in accordance with the nominee's routines in such time in advance as decided by the nominee. Voting rights registrations effected no later than the second banking day after 8 June 2021 (i.e. 10 June 2021) will be considered in the preparation of the share register.
INFORMATION ON POSTAL VOTING
Postal voting
The shareholders may exercise their voting rights at the meeting only by voting in advance, so-called postal voting, in accordance with Section 22 of the Swedish Act (2020:198) on temporary exceptions to facilitate the execution of general meetings in companies and other associations.
A special form shall be used for postal voting. The form will be available on the Company's website, http://investors.scibase.se/.The postal voting form is considered as the notification of participation at the annual general meeting.
The completed voting form must be received by Eversheds Sutherland Advokatbyrå AB no later than Tuesday 15 June 2021. The form may be submitted by post to Eversheds Sutherland Advokatbyrå AB Attn: Rasmus Laws, Box 14055, 104 40 Stockholm or via e-mail to [email protected].
The shareholder may not provide special instructions or conditions in the voting form. If so, the vote (i.e. the postal vote in its entirety) is invalid. Further instructions and conditions are included in the form for postal voting. The shareholders may request in the postal voting form that a resolution on one or several of the matters on the proposed agenda below should be deferred to a so-called continued general meeting, which cannot be conducted solely by way of postal voting. Such general meeting shall take place if the meeting so resolves or if shareholders with at least one tenth of all shares in the Company so requests.
Proxy voting
A shareholder represented by proxy shall issue a power of attorney which shall be dated and signed by the shareholder. If the shareholder postal votes by proxy, the power of attorney shall be enclosed to the form. If issued by a legal entity, the power of attorney shall also be accompanied by registration certificate or, if not applicable, equivalent documents of authority. Power of attorney forms for those shareholders wishing to postal vote by proxy will be available on the Company's website http://investors.scibase.se/.
PROPOSED AGENDA
The Board of Directors' proposed agenda for the meeting:
Opening of the meeting
Appointment of chairman of the meeting
Preparation and approval of the voting list
Approval of the agenda for the meeting
Appointment of one or two persons to verify the minutes of the meeting
Determination of whether the meeting has been duly convened
Resolution on approving the Board of Director’s resolution on a directed share issue
Closing of the meeting
PROPOSED RESOLUTIONS
Appointment of Chairman of the meeting (item 2)
The Board of Directors proposes that Johan Engström (Eversheds Sutherland) is appointed as the chairman of the meeting.
Preparation and approval of voting list (item 3)
The voting list which is to be prepared based on the meeting's share register and postal votes received is proposed as voting list for the meeting.
Election of one or two persons to verify the minutes (item 5)
The Board of Directors proposes that Rasmus Laws (Eversheds Sutherland), or, if unable to attend the meeting, any of the persons assigned by the Board of Directors, shall verify the minutes. The persons verifying the minutes shall also control the voting list and that received postal votes are correctly reflected in the minutes.
Resolution on approving the Board of Director’s decision on a directed share issue (item 7)
The Board of Directors in the Company proposes that the meeting approves the Board of Directors’ decision from 31 May 2021, to issue not more than 239,000 shares. As a result of the new share issue, the share capital may increase by not more than SEK 11,950. The resolution shall otherwise be governed by the following terms and conditions.
The right to subscribe for the shares shall, disapplying from the shareholders’ preemption rights, be vested in the Company’s board member Matt Leavitt.
The reasons for disapplying the shareholders’ preemption rights are to raise capital in a cost and time effective manner as well as o make it possible for the Board member Matt Leavitt to invest and thus achieving alignment with the Company’s shareholders.
The shares shall be issued at a subscription price of SEK 5.20 per share. The subscription price has been determined following negotiations at arm’s length with investors and it is the Board of Directors’ assessment that the price reflects current market conditions and demand.
The share premium shall be transferred to the unrestricted premium reserve.
Subscription for the shares shall take place on the date of the resolution of the issue.
Payment for subscribed shares shall take place within two days from the date of the shareholders’ approval of the share issue at a general meeting in the Company.
The Board of Directors shall be entitled to extend the subscription and the payment period.
The new shares entitle the holder to dividend from the date on which the shares are entered in the share register maintained by Euroclear Sweden AB.
The Board of Directors or a person appointed by the Board of Directors shall be authorized to make any minor adjustments required to register the resolution with the Swedish Companies Registration Office and Euroclear.
The resolution proposed under this item must be approved by shareholders representing not less than nine tenths (9/10) of the votes cast and shares represented at the meeting.
OTHER
Shareholders' right to request information
Shareholders have the right to request information from the Board of Directors and the CEO in accordance with Chapter 7 Section 32 of the Swedish Companies Act regarding conditions that may affect the assessment of a matter on the agenda and conditions that may affect the assessment of the Company's financial situation. The Board of Directors and the CEO shall disclose such information if the Board of Directors considers that this can be done without significant damage to the Company. The disclosure obligation also applies to the Company's relationship with another group company, the group accounts and such matters as mentioned above with regard to subsidiaries.
Requests for such information must be submitted in writing to the Company no later than ten days before the meeting, i.e. no later than 6 June 2021, to the Company's address SciBase Holding AB (publ), Box 3337, 103 67 Stockholm, Sverige, Sweden or by e-mail to [email protected]. The information is provided by the Company by keeping it available on the Company's website www.scibase.com and at the Company at the above address no later than five days prior to the meeting, i.e., 11 June 2021. The information is also sent to shareholders who have requested it and who have provided their address.
Processing of personal data
For information regarding how your personal data is processed in connection with the meeting, please refer to the privacy policy on Euroclear Sweden AB's website: https://www.euroclear.com/dam/ESw/Legal/Privacy-notice-bolagsstammor-engelska.pdf.
Number of shares and votes in the Company
The total number of shares in the Company at the time of issuance of this notice is 54,780,086. An additional 13,456,021 shares are currently subject to registration. The Company does not hold any of its own shares.
Documents
Documents pursuant to the Chapter 13, section 6 of the Swedish Companies Act will be available at the Company’s office and website two weeks prior to the meeting. Copies of the documents will be sent by mail upon request to shareholders’ stating their address. The board of directors’ proposals are set out in full in the notice.
SciBase AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect 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 non-melanoma skin cancer. 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 an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
The extraordinary general meeting in SciBase Holding AB (publ) (the "Company") was held today on 16 June 2021. Due to the extraordinary situation following the COVID-19 pandemic, the extraordinary general meeting was carried out through postal voting only, without any physical attendance. The general meeting resolved, with the required majority, as follows:
Approval of the Board of Director's resolution on a directed share issue
The extraordinary general meeting resolved, with required majority, to approve the Board of Director's decision from 31 May 2021, on a directed issue of 239,000 shares to a subscription price of SEK 5.20, resulting in an increase of the share capital of SEK 11,950. The right to subscribe shares in the share issue was vested in the Company's Board of Director Dr. Matt Leavitt.
Following registration of the share issue the Company's share capital amounts to SEK 3,423,755.35 divided on 68,475,107 shares. The dilution for existing shareholders amounts to approximately 0.35 per cent.
SciBase AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect 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 non-melanoma skin cancer. 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 an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
STOCKHOLM, SWEDEN, — May 11, 2021 – SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today the launch of the new Non-Melanoma Skin Cancer (NMSC) clinical application following the completion of their MDR certification process.
SciBase’s strategy is to leverage the Nevisense technology platform to launch additional clinical applications and products. The first clinical application or indication to be added is NMSC, initially for Nevisense 3.0.
There are two types of skin cancer: melanoma and non-melanoma skin cancer (NMSC). NMSC is more than ten times more prevalent than melanoma and comes itself in primarily two forms: basal cell carcinoma and squamous cell carcinoma. Although NMSC is less harmful and deadly than melanoma, it is still important that it is detected early and is managed with the most appropriate therapy. Because Dermatologists see many more patients with suspected non-melanoma skin cancer than suspected melanoma, there is potential for greatly increased use of Nevisense. SciBase estimates that the global potential for the use of diagnostic devices such as Nevisense for this indication could exceed 4 million tests annually. Adding the NMSC application to the current melanoma application potential of 5-7 million annual tests increases the market opportunity substantially for SciBase.
The development of the NMSC application has been driven by a demand from the German customer base and is an important part of our continued growth in Germany. Recent publications support the use of Nevisense in NMSC. A study published in November 2020 by Sarac, Garbe and others confirmed the ability of Nevisense to accurately identify non-melanoma skin cancers. In the study Nevisense showed good discriminative power to distinguish NMSC from benign lesions and concluded that Nevisense can support clinicians in the early diagnosis of NMSC.
The NMSC application is a software update and as such can be easily deployed to almost all existing Nevisense users. It also uses the same Nevisense electrode and business model as melanoma. The first step in the launch is to update the existing customer base, initially in Germany.
“The launch of the NMSC application is a key part of our growth strategy. The demand from our German customer base has been the driver behind the development. As the current melanoma reimbursement in Germany should also apply to NMSC we expect increased electrode usage by existing customers and increased appeal to new customers given they will be able to use the system on a larger patient base. 2021 looks to be an exciting year for SciBase with a number of milestones already reached, and plenty more to come” 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 global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect 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 non-melanoma skin cancer. 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 an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
The loss after tax amounted to TSEK 8,153 (8,936).
The loss per share amounted to SEK 0.15 (0.54).
The cash flow from current operations was negative in the amount of TSEK 9,473 (7,893).
The gross margin reached 52.7% (54.0%).
Electrode sales volume increased by 14% and reached 7,496 (6,562) units, a new quarterly high. Repeat sales of electrodes to existing customers increased by 18%.
Important events during the quarter
Covid-19 continues to affect sales and the market situation remains difficult to predict going forward, due to ongoing lockdowns and reduced marketing activities. Sales in the company’s key market Germany increased by 3%(cleared for currency effects +9%) while overall sales increased by 3% (cleared for currency effects +9%).
A further German study evaluating the value of using Nevisense on suspected Non-melanoma skin cancer (NMSC, also known as Keratinocyte cancer) in normal clinical practice was published.
David Melin, SciBase’s head of product development, has chosen to leave his position and accept a role at another company. The Company is now looking for the right profile to take the product/technology platform forward.
A nominating committee was appointed.
Important events after the end of the period
SciBase submitted the first US reimbursement application to CMS’s Medicare Contractor in Florida, First Coast Service Options (FCSO). The application for Medicare coverage in Florida marks an important step in the reimbursement process for SciBase and is a necessary step towards broader penetration and usage of the Nevisense test.
SciBase received certification under the new Medical Device Regulation (MDR).
The new Non-Melanoma Skin Cancer (NMSC) clinical application was launched following the completion of the MDR certification process.
A groundbreaking article by key SciBase collaborator Professor Cezmi Akdis presenting the “epithelial barrier hypothesis” was published in Nature Reviews Immunology. The article presented the background for the steep increase in allergic and other diseases over the last decades, and how this increase is connected to degradation in barrier function in the body.
A new clinical study from the Swiss Institute of Allergy and Asthma Research (SIAF) was published in the European Journal of Allergy and Clinical Immunology (Allergy). In the study Nevisense was used to assess the skin barrier of patients with atopic dermatitis (AD) and could accurately detect signs of barrier degradation in atopic patients, even in visually unaffected skin. Nevisense measurements also correlated with relevant biomarkers for atopic dermatitis.
The notice to attend the AGM 2021 was published as well as the nominating committees supplementary proposal to nominate Dr Matt Leavitt for the Board of Directors.
The annual report 2020 was published on April 9th.
Apr 1 2020 -
Jan 1 - Mar 31
Mar 31 2021
Jan 1 - Dec 31
THE GROUP
2021
2020
Rolling-12
2020
Net sales, SEK ths
2 562
2 496
9 588
9 521
Gross margin, %
52,7%
54,0%
52,2%
52,5%
Equity/Asset ratio, %
79,6%
64,8%
73,3%
79,1%
Net indebtness, multiple
0,26
0,54
0,36
0,26
Cash equivalents, SEK ths
31 403
17 970
31 403
41 427
Cashflow from operating activities, SEK ths
-9 473
-7 893
-35 441
-33 861
Earnings per share (before and after dilution), SEK
-0,15
-0,38
-0,84
-1,12
Shareholder's equity per share, SEK
0,70
1,40
0,76
1,50
Average number of shares, 000'
54 780
16 618
40 828
31 287
Number of shares at closing of period, 000'
54 780
16 618
54 780
54 780
Share price at end of period, SEK
4,78
1,84
4,78
4,62
Number of sold electrodes, pieces
7 496
6 598
26 584
25 686
Average number of employees
18
16
17
16
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 12, 2021.
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]
About SciBase and Nevisense SciBase AB is a global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect 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 non-melanoma skin cancer. 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 an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
Today, the annual general meeting of 2021 was held in SciBase Holding AB (publ) (the “Company” or “SciBase”). Below follows a summary of the resolutions passed at the annual general meeting.
The annual general meeting resolved:
to adopt the profit and loss statement and the balance sheet and the group profit and loss statement and the group balance sheet for the financial year 2020;
that SEK 175,081,224 shall be carried forward in new account and that no dividend shall be paid;
to grant the board members and the CEO discharge from liability for the financial year 2020;
that the board of directors shall consist of four ordinary members without deputy members and that a registered accounting firm shall be elected as auditor;
that the fees payable to the board of directors for the period until the end of the next annual general meeting shall be SEK 200,000 for the chairman of the board and SEK 150,000 to each of the other ordinary board members (who are not employed by a larger shareholder in the Company)and that fees payable to the auditor is to be paid in accordance with approved invoices;
for the period until the end of the next annual general meeting, to re-elect Diana Ferro, Thomas Taapken and Tord Lendau and to new-elect Dr. Matt Leavitt as board members, to re-elect Tord Lendau as chairman of the board of directors and to re-elect the auditing firm PricewaterhouseCoopers AB (PwC) as auditor for the Company, with Magnus Lagerberg as auditor-in-charge;
to adopt principles for the appointment of a nomination committee (same principles as previous year); and
to authorize the board of directors to increase the share capital through issuance of new shares, warrants and/or convertible debentures through which the Company’s share capital may be increased by an amount corresponding to not more than 20 per cent of the share capital after such issue(s);
For more information, please contact: Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: [email protected]
The information was submitted, through the agency of the contact person set out above, for publication at the time stated by Scibase's news distributor Cision upon publication of this press release.
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. 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 an FDA approval (PMA) 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.
SciBase a leading developer of augmented intelligence-based solutions for skin disorders, announced today that CEO Simon Grant will, on June 2 at 8.50 am, present the latest developments in SciBase at the Redeye Growth Day 2021. The presentation will be broadcasted live and can be followed at https://www.redeye.se/events/808637/redeye-growth-day-2021 where it also will be available afterwards, and in parallel it will be made available at the Company’s page on Redeye.se https://www.redeye.se/company/scibase-holding
“We have achieved many exciting and important milestones recently at SciBase. After a long process we received our MDR-certification which enabled us to launch our NMSC (non-melanoma skin cancer) application in Europe, which is a key part of our growth strategy. We have also entered a new phase in the US by submitting our first application for reimbursement coverage – another very important milestone for the company. Within the skin barrier application two significant and groundbreaking clinical studies have recently been published. Barrier-related diseases are widespread, and using Nevisense as a tool for the assessment of the barrier can really help better understand and manage patients,” says Simon Grant, CEO 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 global medical technology company based in Stockholm, Sweden that develops unique point-of-care devices for the evaluation of skin disorders such as skin cancer and atopic dermatitis. SciBase's first product, Nevisense, helps clinicians detect 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 non-melanoma skin cancer. 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 an FDA approval (PMA) in the United States. SciBase technology is based Electrical Impedance Spectroscopy (EIS) combined with Artificial Intelligence (AI) algorithms that interpret the varying electrical properties of human tissue to detect malignancies and abnormalities. SciBase Holding AB is listed on First North Growth Market ("SCIB"). Further information is available at www.scibase.com.
