New clinical study supports expansion of indications for Nevisense
Study performed in Germany validates the use of Nevisense in non-melanoma skin cancer
The study publication is an important milestone in the plan to broaden the areas of use of Nevisense
A new study supporting the use of Nevisense for the evaluation of lesions where there is a suspicion of non-melanoma skin cancer (NMSC) has been published in "Acta Dermato-Venereologica". The article is authored by Dr Esra Sarac, Prof Claus Garbe and others from Eberhard Karls University in Tübingen, Germany. NMSC represents a new indication that complements the current melanoma indication and greatly expands the utility of Nevisense for clinicians working with skin cancer.
"This study shows that Nevisense is a valuable tool not only for melanoma but also for other types of skin cancer such as basal cell carcinoma and squamous cell carcinoma. These non-melanoma skin cancers are 10-15 times more prevalent than melanoma, and so the new indication will be more useful to more clinicians and patients. The publication is another milestone in our strategy to broaden the clinical applications and markets for Nevisense. Nevisense with NMSC is now in the final stages of regulatory approval in the EU as part of the new Medical Device Regulation approval route. Once approved, we expect the added indication will make Nevisense more attractive for new customers and expand the level of usage of existing customers", says Simon Grant, CEO of SciBase.
The article is titled "Diagnostic Accuracy of Electrical Impedance Spectroscopy in Nonmelanoma Skin Cancer" and evaluates the accuracy of Nevisense and Electrical Impedance spectroscopy (EIS) on suspected non-melanoma skin cancers. The article shows that Nevisense is well suited for use with NMSC and states that "EIS has good discriminative power to distinguish NMSC from benign cutaneous lesions". The conclusion in the article states: "The results of this study suggest that electrical impedance spectroscopy measurements can improve diagnostic performance with a high sensitivity in detection of non-melanoma skin cancer."
The article is now available in online form at the Acta Dermato-Venereologica's website (https://www.medicaljournals.se/acta/content/abstract/10.2340/00015555-3689) and will be distributed in print in the next issue of the publication.
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 appointments have been made in accordance with the instructions regarding principles for the appointment of the company nominating committee which were determined at the Annual General Meeting of SciBase Holding on June 17, 2020. Note, however, that the appointment took into account changes in ownership that took place during the end of 2020.
The Annual General Meeting of SciBase Holding AB (publ) will be held on May 18, 2021 in Stockholm.
Shareholders who wish to have an item considered at the Annual General Meeting can submit a request to the Board to this effect. Such a request for an item to be considered is to be sent to SciBase Holding AB (publ), Att: Chairman of the Board, Box 3337, 103 67 Stockholm, and must have been received by the Board no later than seven weeks before the Annual General Meeting, or otherwise in such good time that the matter, where necessary, can be included in the notice to attend the Annual General Meeting.
Stockholm, February 2, 2021
SciBase Holding AB (publ)
For more information, please contact: Tord Lendau, Chairmain of the board, phone +46 (0)70 810 01 67
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.
A new clinical study from Germany including nearly 1,000 patients confirms the value of Nevisense when used to evaluate suspected Non-melanoma skin cancer (NMSC)
The study publication is an important milestone in SciBase's strategy to broaden the areas of use and potential markets for Nevisense
A new clinical study evaluating the value of using Nevisense on suspected Non-melanoma skin cancer (also known as Keratinocyte cancer) in normal clinical practice is now published. The article named "Retrospective evaluation of the performance of the electrical impedance spectroscopy system Nevisense in detecting keratinocyte cancer" reviewed clinical results when Nevisense was used on lesions with a suspicion of skin cancer.
The study included a total of 1,712 lesions and 951 patients, collected at a private clinic in Germany over a period of 4 years. The study confirmed the ability of Nevisense to accurately identify non-melanoma skin cancers with a sensitivity of 98,4%. In addition, the study showed that when using Nevisense almost half of the lesions examined did not require a biopsy. The article concludes that Nevisense is a valuable adjunct support tool in clinical decisions for cases with suspicion of non-melanoma skin cancer. The article is available through the following link: http://dx.doi.org/10.1111/srt.13007
These results support a new clinical application that is an important part of our growth strategy. We continue to leverage our technology platform to both add clinical value and expand the market segments we address. We believe that the Non-melanoma Skin Cancer application will help us achieve both goals, and short term be key in accelerating our growth in Germany. We look forward to releasing the application as soon as our Medical Device Regulation approval is complete, which we expect around the end of the first quarter", 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.
STOCKHOLM, SWEDEN, - November 2, 2020 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today that they have been granted a Category III CPT®(CPT III) code from the American Medical Association (AMA) for their Nevisense melanoma detection test.
SciBase is therefore very pleased to announce that their CPT III code application for the Nevisense melanoma detection test was approved at the AMA's October meeting without opposition, according to the CPT Editorial Summary of Panel Action October 2020 which was released on October 30th. The code will be published on the 1st January 2021 and be accessible to providers and payers across the US from the 1st July 2021.
As yet, the code does not have a payment attached to it, and the company will now focus on securing a suitable payment level and coverage with selected payors. Importantly, when the code is "effective" customers will be able to easily submit claims for reimbursement through existing billing systems. This will help track utilization which will support our efforts to achieve coverage, and our first objective is to achieve local coverage by CMS (Center for Medicare and Medicaid services) in selected states in 2021.
"This approval is an important milestone in our process to secure payment and coverage for our procedure" says Simon Grant, CEO of SciBase "We are very pleased to have secured the approval; very few companies achieve this level of success. The fact that Medicare's local organisations (Medicare Administrative Contractors or MACs) have recently changed their policies means they are now open to consider procedures with CPT III codes for coverage. Our goal is for the Nevisense procedure to achieve coverage under Medicare, which would be an important step towards commercial success. We have further work to do in our discussions with payors, but this decision and our inroads in key markets mean we have a good foundation for the remainder of the process".
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.
Linn Olsen, SciBase's head of production and supply chain, has been appointed as a member of the management team.
"Our manufacturing of single use electrodes is of strategic importance to the Company and one of our more important projects going forward is to streamline the manufacturing process and increase the production capacity. Therefore, it is only natural that Linn, who started at SciBase in August, now becomes a member of the management team. With Linn on the team we get important strategic competence into the management team", says Simon Grant CEO SciBase.
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 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 7,350 (9,868).
The loss per share amounted to SEK 0.20 (0.59).
The cash flow from current operations was negative in the amount of TSEK 6,974 (10,264).
The gross margin reached 52.7% (53.4%).
Electrode sales volume increased by 46% and reached 6,924 (4,752) units. Repeat sales of electrodes to existing customers increased by 57%.
The first nine months in figures
Net sales amounted to TSEK 6,466 (6,476).
The loss after tax amounted to TSEK 25,150 (29,387).
The loss per share amounted to SEK 0.99 (1.77).
The cash flow from current operations was negative in the amount of TSEK 23,571 (29,114).
The gross margin reached 54.0% (53.1%).
Electrode sales volume increased by 10% and reached 18,194 (16,544) units. Repeat sales of electrodes to existing customers increased by 10%.
Important events during the quarter
The Covid-19 pandemic has affected SciBase from the end of Q1. There was a recovery in sales levels in Q3 due to good electrode sales to existing customers, but system sales remain affected. Sales in the company's key market Germany increased by 23% while overall sales increased by 18% in the quarter. It is however difficult to predict how Covid-19 will affect sales and Group activities going forward.
Nevisense was selected for `SpotCheck' remote melanoma detection evaluation study by The Ronald O. Perelman Department of Dermatology at NYU Langone Health in New York
Important events after the end of the period
SciBase announced the outcome of the exercise of warrants of series TO1. In total, 91.4% of the warrants were subscribed for to the set subscription price of SEK 1.75.
Nevisense Go, SciBase's next generation handheld device, was released at the end of October. The first version of Nevisense Go will be used to assess skin barrier function by researchers and industrial partners.
SciBase was granted a Category III CTP® code for the Nevisense melanoma detection test in the US
Two US studies showing improved detection of melanoma by clinicians with Nevisense were published in leading US journals. The studies compared the evaluation of atypical, pigmented skin lesions using visual evaluation alone to visual evaluation plus Nevisense.
Nevisense was included in infant study at Mount Sinai Hospital in New York. Nevisense will be used to measure skin properties including barrier function and evaluate whether these measurements can help predict the development of allergies or monitor their progress.
Linn Olsen, SciBase's head of production and supply chain, has been appointed as a member of the management team.
Oct 1 2019 -
July 1 - Sep 30
Jan 1 - Sep 30
Sep 30 2020
Jan 1 - Dec 31
THE GROUP
2020
2019
2020
2019
Rolling-12
2019
Net sales, SEK ths
2 287
1 940
6 466
6 476
9 266
9 276
Gross margin, %
52,7%
53,4%
54,0%
53,1%
55,2%
54,5%
Equity/Asset ratio, %
67,0%
73,4%
67,0%
73,4%
70,8%
69,4%
Net indebtness, multiple
0,49
0,36
0,49
0,36
0,41
0,44
Cash equivalents, SEK ths
21 724
35 917
21 724
35 917
21 724
26 456
Cashflow from operating activities, SEK ths
-6 974
-10 264
-23 571
-29 114
-32 413
-37 956
Earnings per share (before and after dilution), SEK
-0,20
-0,59
-0,99
-1,77
-1,93
-2,38
Shareholder's equity per share, SEK
0,71
2,53
1,02
2,53
1,46
1,93
Average number of shares, 000'
36 560
16 618
25 481
16 618
23 265
16 618
Number of shares at closing of period, 000'
36 560
16 618
36 560
16 618
36 560
16 618
Share price at end of period, SEK
4,00
5,25
4,00
5,25
4,00
4,36
Number of sold electrodes, pieces
6 924
4 752
18 194
16 544
25 374
23 724
Average number of employees
16
18
16
18
17
18
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 November 12, 2020.
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.
NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, SWITZERLAND, THE UNITED STATES, OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL.
The subscription period regarding the warrants of series TO1 which was issued in connection with SciBase Holding AB's (publ) ("SciBase" or the "Company") issue of 19,941,721 units on 26 March 2020 commence on 5 October 2020. The exercise price for exercise of warrants has been determined to SEK 1,75.
The board of directors of SciBase resolved, on 26 March 2020, to carry out a fully guaranteed rights issue of up to 19,941,721 units with a subscription price of SEK 1.25 per unit. Each unit consisted of one (1) share and one (1) warrant free of charge, and every warrant entitles the holder to subscribe for one (1) new share in the Company. The warrants (ISIN SE0014399689) may be exercised for subscription of new shares during the period 5 October -16 October 2020 and the last day of trading in the warrants is 14 October 2020.
According to the terms of the warrants, the exercise price shall correspond to 70 percent of the volume-weighted average price of the Company's share on Nasdaq First North Growth Market during a period of ten (10) trading days immediately preceding 30 September 2020 (including 30 September 2020), but not less than SEK 1 and not more than SEK 1.75 per share. The volume-weighted average price for the Company's share amounted to approximately SEK 4.06 during this period, and hence, the exercise price has been determined to SEK 1.75 pursuant to the terms of the warrants.
If all warrants are exercised for subscription of new shares, the number of shares and votes in the Company will increase by a maximum of 19,941,721, from 36,559,822 to a maximum of 56,501,543 shares and votes. The share capital will increase by a maximum of SEK 997,086.05, from SEK 1,827,991.10 to a maximum of SEK 2,825,077.15 if all warrants are exercised. Provided that all warrants are exercised for subscription of new shares, the capital contribution to the Company will amount to approximately SEK 34.9 million before issue costs.
The warrants that are not sold on 14 October 2020 at the latest, alternatively exercised on 16 October 2020 at the latest, will become void. In order for the warrants of series TO1 not to become void, a holder must actively subscribe for shares, alternatively sell warrants.
Full terms and conditions regarding the warrants and information about the Company is available in the prospectus which was approved by the Swedish Financial Supervisory Authority (the "SFSA") and published by the Company on 8 May 2020. The prospectus is available on the Company's website http://investors.scibase.se/sv as well as the SFSA's website www.fi.se.
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.
Important information
Publication, distribution or release of this release can in some jurisdictions be subject to restrictions by law and persons in those jurisdictions where this release has been published or distributed should inform themselves of and comply with such legal restrictions. The recipient of this release is responsible to use this release and information herein in accordance with applicable rules in respective jurisdiction. This release does not contain or constitute an offer, nor an invitation, to acquire or subscribe for shares or other securities in the Company in any jurisdiction, either from the Company or from any others.
The information in this release may not be distributed or sent into Australia, Canada, Hong Kong, Japan, New Zealand, Switzerland, Singapore, South Africa the United States or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures. Acts in contrary to this instruction can constitute a crime according to applicable securities laws. This release is not an offer or invitation to acquire or subscribe for shares or other securities in the United States. The securities that have been mentioned in this release are not allowed to be sold in the United States without registration, or without application of an exemption from registration, according to the applicable U.S. Securities Act from 1933 ("Securities Act"), or as a part of a transaction that is not covered by the registration requirements according to the Securities Act. There is no intention to register any shares or securities mentioned herein in the United States or to announce a public offering of such securities in the United States.
This release is not a prospectus in accordance with the definition in the Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 (the "Prospectus Regulation"). Complete information regarding the rights issue and the warrants can only be obtained through the prospectus approved by the Swedish Financial Supervisory Authority on 8 May 2020 which is available on the Company's website. Pursuant to article 2 k of the Prospectus Regulation, this press release constitutes an advertisement.
This information is only being distributed to and is only directed at persons in the United Kingdom that are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order") or (ii) high net worth entities, and other persons to whom this announcement may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "Relevant Persons"). This information must not be acted on or relied upon by persons who are not Relevant Persons. An investment or an investment activity referred to in this release is only available in the United Kingdom for Relevant Persons and will only be conducted with Relevant Persons.
This release may include forward-looking statements. Forward looking statements are statements that are not historical facts and may be identified by words such as "believe", "expect", "anticipate", "intends", "estimate", "will", "may", "continue", "should" and similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that these assumptions were reasonable when made, these assumptions are inherently subject to significant known and unknown risks, uncertainties, contingencies and other important factors which are difficult or impossible to predict and beyond the Company's control. 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 information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice.
Information to distributors
For the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended ("MiFID II"); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) national implementing measures, (together the "MiFID II Product Governance Requirements"), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any "manufacturer" (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the offered shares have been subject to a product approval process, who have established that these shares are: (i) suitable for a target marked consisting of non-professional investors and investors who fulfil the criteria for professional clients and eligible counterparties, each as defined in MiFID II, and (ii) suitable for distribution through all distribution channels that has been approved in MiFID II ("Target Market Assessment"). Irrespective of the Target Market Assessment, distributors should note that: the price of the shares in the Company may decline and investors could lose all or part of their investment; the Company's shares offer no guaranteed income and no capital protection; and an investment in the Company's shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The target market assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the issues.
The target market assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, purchase, or take any other action whatsoever with respect to the Company's shares.
Each distributor is responsible for undertaking its own target market assessment in respect of the Company's shares and determining appropriate distribution channels.
SciBase Holding AB (publ) ("SciBase" or the "Company") today announces the outcome of the exercise of warrants of series TO1 which were issued in connection with the Company's 19,941,721 units issue on 26 March 2020. The outcome shows that a total of 18,220,264 warrants were exercised for subscription of 18,220,264 new shares in the Company, corresponding to 91.4 percent of the total number of warrants issued in series TO1.
NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, SWITZERLAND, THE UNITED STATES, OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL.
The board of directors of SciBase resolved, on 26 March 2020, to carry out a fully guaranteed rights issue of up to 19,941,721 units at a subscription price of SEK 1.25 per unit. Each unit consisted of one (1) share and one (1) warrant free of charge, and every warrant entitled the holder to subscribe for one (1) new share in the Company.
In total, 18,220,264 warrants of series TO1 have been used for subscription of 18,220,264 shares, meaning that approximately 91.4 percent of the total number of warrants issued in series TO1 were used for subscription of shares. SciBase is hereby provided with a total of approximately SEK 31.9 million before deduction of issue costs.
Through the exercise of 18,220,264 warrants of series TO1, the number of shares and votes in the Company will increase by 18,220,264, from 36,559,822 to 54,780,086 shares and votes. The share capital hereby increases with SEK 911,013.20, from SEK 1,827,991.10 to SEK 2,739,004.30. The dilution for shareholders' who did not exercise any warrants for subscription of new shares amounts to a total of approximately 33.3 percent based on the total number of shares in the Company following the completion of the rights issue and the exercise of the warrants.
The new shares subscribed for by exercise of warrants series TO1 are expected to be admitted for trading on First North Growth Market around October 29, 2020.
Full terms and conditions regarding the warrants and information about the Company is available in the prospectus which was approved by the Swedish Financial Supervisory Authority (the "SFSA") and published by the Company on 8 May 2020. The prospectus is available on the Company's website http://investors.scibase.se/sv as well as the SFSA's website www.fi.se.
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.
Important information
Publication, distribution or release of this release can in some jurisdictions be subject to restrictions by law and persons in those jurisdictions where this release has been published or distributed should inform themselves of and comply with such legal restrictions. The recipient of this release is responsible to use this release and information herein in accordance with applicable rules in respective jurisdiction. This release does not contain or constitute an offer, nor an invitation, to acquire or subscribe for shares or other securities in the Company in any jurisdiction, either from the Company or from any others.
The information in this release may not be distributed or sent into Australia, Canada, Hong Kong, Japan, New Zealand, Switzerland, Singapore, South Africa the United States or any other jurisdiction in which such distribution would be unlawful or would require registration or other measures. Acts in contrary to this instruction can constitute a crime according to applicable securities laws. This release is not an offer or invitation to acquire or subscribe for shares or other securities in the United States. The securities that have been mentioned in this release are not allowed to be sold in the United States without registration, or without application of an exemption from registration, according to the applicable U.S. Securities Act from 1933 ("Securities Act"), or as a part of a transaction that is not covered by the registration requirements according to the Securities Act. There is no intention to register any shares or securities mentioned herein in the United States or to announce a public offering of such securities in the United States.
This release is not a prospectus in accordance with the definition in the Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 (the "Prospectus Regulation"). Complete information regarding the rights issue and the warrants can only be obtained through the prospectus approved by the Swedish Financial Supervisory Authority on 8 May 2020 which is available on the Company's website.
This information is only being distributed to and is only directed at persons in the United Kingdom that are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order") or (ii) high net worth entities, and other persons to whom this announcement may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "Relevant Persons"). This information must not be acted on or relied upon by persons who are not Relevant Persons. An investment or an investment activity referred to in this release is only available in the United Kingdom for Relevant Persons and will only be conducted with Relevant Persons.
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STOCKHOLM, SWEDEN, - October 30, 2020 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today the release of the first device based on their new platform, Nevisense Go.
Nevisense Go is a handheld and fully portable device the size of a large Pen. It combines the company's core Electrical Impedance Spectroscopy (EIS) measurement technology with a new AI-based analysis platform embedded in the device. The result is a flexible platform that will be significantly easier to both collect data and develop applications on. It will also mean products that are easier for clinicians to use and to integrate into a clinic, and better acceptance by patients.
As previously communicated, the first Nevisense Go version is released for skin barrier assessment and is targeted at researchers and Industry Partners. One of the first sales of the product is to one of the largest global industrial players, and it is this type of customer that we are initially focused on. The first release is for research and does not include a clinical indication (i.e. is released as a non-medical device), but there is significant potential within the research market, and we believe it will lead to many new applications for the technology. From this base, SciBase will continue to develop the platform, add indications and work through the regulatory processes to deliver the next generation of new products.
`Nevisense Go represents an important milestone for SciBase. We have spent several years gaining acceptance for our methodology and we have developed a platform that builds on what we have learned but adds many advantages for our customers and broadens considerably the potential size of our market' says Simon Grant, CEO of SciBase `Today's release is the first step with our new platform and as we deliver clinical indications from next year, we expect this to drive revenue, especially when it comes to electrode sales. In the medium term we hope to expand the use of Nevisense Go into broad new areas and to broader customer groups - expending from specialists to GPs and even potentially to use in the home.'
SciBase's product Nevisense for melanoma detection was one of the first AI-based products approved within medicine. Nevisense Go is the next generation of that product platform and builds on the experience that SciBase has gained in over 100,000 clinical patient tests. Nevisense Go is the culmination of 5 years of work and 20+ years of diagnostic experience. Together with the KTH Royal Institute of Technology, SciBase has miniaturized their EIS measurement technology onto a single `chip' or application specific integrated circuit (ASIC). Together with our AI partner Peltarion SciBase has developed an agile environment for AI algorithm development and together with the Swiss Institute of Allergy and Asthma Research (SIAF), our research partner in Davos, SciBase has developed the world's first AI-algorithms for assessment of the skin barrier. Studies in SIAF demonstrated the correlation of EIS measurements with skin barrier defects caused by enzymes, toxins and environmental agents such as detergents in mouse models and in skin barrier defective patients.
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.
Stockholm, Sweden and New York, USA - August 26, 2020 - SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today that they will participate in a clinical study to run parallel to the ACTIVATE study (sponsored by the Immune Tolerance Network and the NIAID/NIH), which is being conducted by the Department of Pediatric Allergy at Mount Sinai Hospital in New York.
The goal of the ACTIVATE study is to explore how differences in the gut microbiome of an infant affect its susceptibility to allergies. The study will compare groups born vaginally with those born by Cesarean section with and without so-called "vaginal seeding" of the infant microbiome. The study will examine whether vaginal seeding lowers the risk that infants test positive for allergies at one year of age. ACTIVATE will enroll 120 pregnant women and their babies, and will focus on those babies that are at higher-risk for developing allergies.
The infants will be followed for the first year of life, and SciBase's product Nevisense will be used to measure skin properties including barrier function and evaluate whether these measurements can help predict the development of allergies or monitor their progress.
"We look forward to adding Nevisense to the study and together with SciBase identify opportunities where these measurements can help clinicians manage these patients" says Dr. Hugh Sampson, Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai and Director Emeritus of the Jaffe Food Allergy Institute.
"We are excited to participate in this clinical study which may help provide important guidance on how to reduce the risk that an infant will develop allergies. We look forward to seeing how our unique measurement methodology can help clinicians gain new insight into the skin of these infants and in doing so hopefully help this patient group" 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 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.
