Uncategorized - SciBase

Christer Jönsson (Fouriertransform),

Iraj Arastoupour (Futur pension),

Peter Elmvik,

Tord Lendau (Chairman of the Board).

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

Michael Colérus, CFO, phone +46 70 341 34 72

Certified Advisor (CA):

Avanza

Tel: +46 8 409 421 20

Email: ca@avanza.se

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.

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: simon.grant@scibase.com

Certified Advisor:
Avanza
Tel: +46 8 409 421 20
Email: ca@avanza.se

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

For more information please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: simon.grant@scibase.com

Certified Advisor:
Avanza
Tel: +46 8 409 421 20
Email: ca@avanza.se

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

For more information please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: simon.grant@scibase.com

Certified Advisor:
Avanza
Tel: +46 8 409 421 20
Email: ca@avanza.se

The third quarter in figures

Net sales amounted to TSEK 2,287 (1,940).
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: simon.grant@scibase.com

Certified Advisor:
Avanza AB
Phone: +46 8 409 421 20
Email: ca@avanza.se

The first quarter in figures

Net sales amounted to TSEK 2,562 (2,469).
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 9^th.

			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

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: simon.grant@scibase.com

Certified Advisor:
Avanza AB
Phone: +46 8 409 421 20
Email: ca@avanza.se

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: simon.grant@scibase.com

Certified Asdvisor:
Avanza
Tel: +46 8 409 421 20
Email: ca@avanza.se

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.

Linn Olsen, SciBase's head of production and supply chain, has been appointed as a member of the management team.

For more information please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: simon.grant@scibase.com

Certified Asdvisor:
Avanza
Tel: +46 8 409 421 20
Email: ca@avanza.se

Linn Olsen, SciBase's head of production and supply chain, has been appointed as a member of the management team.

For more information please contact:
Simon Grant, CEO SciBase
Tel: +46 72 887 43 99
Email: simon.grant@scibase.com

Certified Asdvisor:
Avanza
Tel: +46 8 409 421 20
Email: ca@avanza.se

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 30^th. The code will be published on the 1^st January 2021 and be accessible to providers and payers across the US from the 1^st 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: simon.grant@scibase.com

Certified Advisor:
Avanza
Tel: +46 8 409 421 20
Email: ca@avanza.se