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2022-06-29 Ordinarie utdelning CLS B 0.00 SEK
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2021-06-29 Ordinarie utdelning CLS B 0.00 SEK
2021-06-28 Årsstämma 2021
2021-05-19 Kvartalsrapport 2021-Q1
2021-03-31 Extra Bolagsstämma 2021
2021-02-26 Bokslutskommuniké 2020
2020-11-19 Kvartalsrapport 2020-Q3
2020-08-26 Kvartalsrapport 2020-Q2
2020-06-12 Ordinarie utdelning CLS B 0.00 SEK
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2018-11-22 Kvartalsrapport 2018-Q3
2018-08-23 Kvartalsrapport 2018-Q2
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2018-06-14 Ordinarie utdelning CLS B 0.00 SEK
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2017-06-28 Ordinarie utdelning CLS B 0.00 SEK
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2017-05-18 Kvartalsrapport 2017-Q1
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2015-06-12 Ordinarie utdelning CLS B 0.00 SEK
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2012-06-08 Ordinarie utdelning CLS B 0.00 SEK
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2011-09-26 Kapitalmarknadsdag 2010
2011-08-22 Kvartalsrapport 2011-Q2
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2011-05-20 Kvartalsrapport 2011-Q1
2011-02-24 Bokslutskommuniké 2010
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2010-05-28 Ordinarie utdelning CLS B 0.00 SEK
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2010-02-26 Bokslutskommuniké 2009
2009-11-30 Kvartalsrapport 2009-Q3

Beskrivning

LandSverige
ListaFirst North Stockholm
SektorHälsovård
IndustriMedicinteknik
Clinical Laserthermia Systems är verksamt inom medicinteknik. Bolagets vision är att utveckla och effektivisera behandlingen av solida cancertumörer, där bolaget är försäljare av sterila patientkit. Produkterna används i diverse cancerbehandlingar som vid behandling av malignt melanom, samt cancer i lungor, lever och bukspottkörtel. Bolaget grundades 2006 och har sitt huvudkontor i Lund.
2022-08-10 19:00:00

LUND, Sweden, 10 August, 2022 - The board of Directors of Clinical Laserthermia Systems AB (publ), ("CLS" or the "Company") has today, with the support of the authorization from the annual general meeting held on 28 June 2022, resolved on an issue of units, with preferential rights for existing shareholders, for an initial maximum amount of approximately SEK 69.3 million before deduction of transaction related costs, followed by a further maximum amount of approximately SEK 35 million before deduction of transaction related costs referring to the exercise of attached warrants (the "Rights Issue"). Up to 80 percent of the Rights Issue is covered by pre-subscription- and underwriting commitments from board members, senior executives, and external institutional investors as well as other professional investors. The purpose of the Rights Issue is to continue to support the commercial launch and market establishment of the new generation of TRANBERG® products in the USA, Europe, and the Asia-Pacific region, primarily in the urology and neurosurgery market segments. Furthermore, the Company intends to increase investment in further clinical collaborations to effectively support the launch and commercialization work and to improve the Company's financial flexibility and capital structure with reduced borrowing costs through the repayment of loans. A number of pre-subscribers (including the Company's CEO, CFO and chairman of the Board) have entered agreements to not sell any existing shareholdings or such holdings that are added by subscribing to the Rights Issue, for a period of six months (so-called lock-up). CLS also announces that the publication of the Company's interim report for the first half of the year and the second quarter of 2022 is brought forward to 11 August 2022.

"CLS offers an alternative treatment to the approximately 1.5 million patients who are annually diagnosed with localized prostate cancer. Our TRANBERG products for minimally invasive, image-guided laser ablation treatments make it possible to treat the disease, rather than allowing patients to wait until it has progressed to a stage where radical treatments such as radiation or surgery can be justified. Our TRANBERG products are also very precise and safe for interventions in the brain and can treat areas that cannot be reached with traditional surgery, for example the brain tumor glioblastoma. The rights issue enables CLS to meet the interest in our products and take advantage of the large market potential within these indication areas," says Dan J Mogren, CEO of CLS

"We, the board and management, wholeheartedly believe in CLS. The Company is very well positioned to meet the successive movement that is taking place in healthcare today, from costly open operations to minimally invasive, image-guided interventions for more and more patient groups. We are grateful for the support our shareholders give us and look forward to both existing and new shareholders participating in the rights issue, which aims to ensure CLS's continued market establishment", says Hans von Celsing, Chairman of the Board of Directors of CLS

Background, motive and objectives

Clinical Laserthermia Systems is a medical technology company that develops and sells products for minimally invasive laser treatment of prostate cancer, brain tumors, drug-resistant epilepsy and metastasized cancer (cancer that has spread). The product portfolio is marketed under the TRANBERG® brand and together with various imaging systems, e.g., ultrasound (US) and magnetic resonance imaging (MRI), CLS offers integrated systems for high-precision image-guided laser ablation. The Board of Directors assesses that there is large-scale global demand for this type of treatment and the Company has been working since 2018 to develop a second generation of the TRANBERG® portfolio, which is launching in 2022. The new generation of TRANBERG® can be integrated with existing imaging systems, primarily of the US and MRI type, and systems for image-guided instrument navigation and positioning for use in the market segments of urology and neurosurgery. Alongside urology and neurosurgery, the new generation of TRANBERG® has also been adapted for the additional segment of oncology.

CLS has achieved several key milestones, including market authorisation in Europe and the USA, where the Company's new generation of TRANBERG® products will initially be launched in 2022 for the ablation of tumors in localized prostate cancer in the urology market segment. To date, around 250 patients have been treated using CLS's products, primarily in the USA. CLS has also taken important steps forward by entering into study collaborations to build up a base of supporting clinical data. Clinical collaborations have been entered into with partners such as Radboud University Medical Center in Nijmegen, Netherlands and Urological Research Network LLC. in Florida, USA, in the field of urology. In spring 2022, the Company also entered into a collaboration with Skåne University Hospital for a clinical study on MRI-guided laser ablation of brain tumors (glioblastoma). The Board of Directors and management of CLS are experiencing strong interest and momentum going forward for the Company's TRANBERG® products.

In 2022, CLS has entered an extended commercial phase with the launch of the Company's second generation of TRANBERG® treatment system on the urology markets in Europe and the USA with a commercial focus on the treatment of localized prostate cancer with focal therapy. With a planned market approval for the Company's MRI-based treatment system in the USA, the Company intends to expand the launch on the urology market in 2023. In parallel with the commercialization, CLS intends to continue the work of producing supporting clinical evidence for ablation in all indication areas. The Company also aims to enter into further agreements with commercial partners for continued expansion of sales and distribution in Europe, the USA, and the Asia-Pacific region in the coming period.

In April 2021, CLS carried out a rights issue and a directed issue of units (shares and attached warrants of series TO 3 B and TO 4 B). The issues were oversubscribed, and the capital has been used, among other things, to expand clinical collaborations and to support the commercial launch and market establishment of the new generation of TRANBERG® products in the USA, Europe, and the Asia-Pacific region. The attached warrants of series TO 3 B, the exercise period for which fell during April 2022, were primarily intended to strengthen the Company's balance sheet and ensure the continued commercialization of the new generation of TRANBERG® products. However, the prevailing climate on the stock and financial markets resulted in the Company receiving only a portion of the capital that the warrants of series TO 3 B could have raised during the exercise period.

The assessment of the Board of Directors is that capital is still required for at least the next twelve months in order to satisfy the Company's operations. In order to provide additional working capital to improve the Company's financial flexibility, strengthen the balance sheet and continue to support the commercial launch and market establishment of the new generation of TRANBERG® products at the desired pace, the Board of Directors of the Company has resolved on a rights issue of units. The main intention is to use the proceeds from the Rights Issue, including the exercise of warrants of series TO 5 B, to continue to support the ongoing market establishment and commercial launch of the new generation of TRANBERG® products in the USA, Europe and the Asia-Pacific region, principally within the urology and neurosurgery market segments. The Company also intends to increase its investment in further clinical collaborations to effectively support its launch and commercialization work and to improve the Company's financial flexibility and capital structure with reduced borrowing costs through the repayment of loans. With a fully subscribed Rights Issue, and with the full exercise of attached warrants at the highest strike price in February 2023, it is the Board of Directors assessment that CLS will be able to make immediate capital structure improvements and that no further capital need will arise until autumn 2023 at the earliest.

Terms for the Rights Issue

The Board of Directors has today, with the support of the authorization from the annual general meeting held on 28 June 2022, decided on a new share issue of a maximum of 34,653,275 units, consisting of 69,306,550 new B-shares and 34,653,275 new attached warrants of series TO 5 B ("TO 5 B") that are issued free of charge. The Rights Issue may initially provide the Company a maximum amount of approximately SEK 69.3 million before deduction of transaction related costs, followed by a further maximum amount of approximately SEK 35 million before deduction of transaction related costs referring to the exercise of attached warrants. CLS's existing shareholders have preferential rights to subscribe for units in relation to existing shareholdings. The subscription price in the Rights Issue is SEK 2.00 per unit, which corresponds to SEK 1.00 per new B-share, and units must be subscribed during the subscription period starting from 23 August until and including 6 September 2022. The public also has the right to subscribe for units in the Rights Issue.

Shareholders who are registered as a shareholder in CLS on the record date of 18 August 2022, is entitled to one (1) unit right for each existing share, regardless of share type. Two (2) unit rights entitle the holder to subscribe for one (1) unit. One (1) unit consists of two (2) new B-shares and one (1) new warrant of series TO 5 B. The last day of trading in CLS shares including the right to receive subscription rights in the Rights Issue is 16 August 2022. First day of trading in CLS shares excluding the right to receive subscription rights in the Rights Issue is 17 August 2022.

The initial part of the Rights Issue will result in an increase in the share capital of a maximum of approximately SEK 6,410,855.91, from approximately SEK 6,410,856.00 to a maximum of approximately SEK 12,821,711.91, through the issue of a maximum of 69,306,550 new B -shares. After the initial issue, upon full subscription, the number of shares in CLS will amount to a maximum of 138,613,101 shares, of which 600,000 A-shares and 138,013,101 B-shares. Existing shareholders who choose not to participate in the Rights Issue will be subject to a dilution effect corresponding to approximately 48.13 percent of the votes and 50 percent of the capital, calculated on the number of shares in the Company after the initial Rights Issue, upon full subscription. Shareholders who choose not to participate in the Rights Issue have the opportunity to compensate for the financial dilution effect by selling their subscription rights no later than 1 September 2022.

Complete terms and conditions for the Rights Issue as well as more information about the Company will be presented in the prospectus which is expected to be published on CLS's website around 16 August 2022.

Terms for warrants of series TO 5 B

The subscription price in the following warrant exercise of series TO 5 B amounts to seventy (70) percent of the average volume-weighted price for the B-share according to Nasdaq First North Growth Market's official price statistics during a period of 10 trading days ending two (2) banking days before the exercise period begins. The Company will publish the subscription price the day before the first day of the exercise period. One (1) TO 5 B gives the right to subscribe for one (1) new B-share in CLS. The subscription price must be rounded to the nearest whole Swedish öre and may not exceed SEK 1,00 per new B-share and not fall below the share's quota value. The exercise period for TO 5 B runs from 14 February 2023, until and including 28 February 2023. Provided a fully subscribed Rights Issue and full utilization of TO 5 B, the utilization means a further dilution of approximately 19.4 percent of the votes and approximately 20 percent of the capital. TO 5 B is intended to be admitted to trading on Nasdaq First North Growth Market after final registration with the Swedish Companies Registration Office. The last day of trading is then estimated to 24 February 2023.

Pre-subscription- and underwriting commitments

The initial part of the Rights Issue is covered up to 80 percent (corresponding to approximately SEK 55.4 million) by pre-subscription- and underwriting commitments from Board members, senior executives and external institutional investors as well as other professional investors. Approximately SEK 0.9 million of the total commitment corresponds to pre-subscription commitments and approximately SEK 54.5 million corresponds to underwriting commitments. Entered pre-subscription commitments and underwriting commitments are not secured via bank guarantee, pledging or similar arrangements. For the underwriting commitments, a compensation of twelve (12) percent of the guaranteed amount is paid in cash. No compensation is paid for the pre-subscription commitments.

Lock-up agreements

A number of the pre-subscribers (including the Company's CEO, CFO and chairman of the Board) have together, through a so-called lock-up agreement, with Sedermera Corporate Finance AB as counterparty, undertaken, with customary exceptions, not to sell any existing shareholdings or such shareholdings that are added through subscription in the Rights Issue during a period of six months from the publication of the Rights Issue. Existing shareholdings under lock-up corresponds to approximately two (2) percent of the total number of shares before the Rights Issue.

Timetable for the Rights Issue
  • Last day of trading in shares including the right to participate in the Rights Issue: 16 August 2022

  • Prospectus published on the Company's website: Around 16 August 2022

  • First day for trading in shares excluding the right to participate in the Rights Issue: 17 August 2022

  • Record date for participation in the Rights Issue: 18 August 2022

  • Trading in unit rights: 23 August - 1 September 2022

  • Subscription period: 23 August - 6 September 2022

  • Publication of final outcome in the Rights Issue: Around 9 September 2022

  • Trading in BTU (paid subscribed unit): From 23 August 2022 until around 3 October 2022

CLS brings forward the publication of the interim report

In connection with the decision on the Rights Issue, CLS also announces that the Company is bringing forward the publication of the interim report for the first half of the year and the second quarter of 2022 to 11 August 2022. The previous date for the publication was 25 August 2022. The reason is to provide shareholders and the public with an updated current situation before the Rights Issue, and to give the Board and senior executives the opportunity to participate in the now decided Rights Issue.

Advisors

In connection with the Rights Issue, CLS has assigned Sedermera Corporate Finance AB as the financial advisor, Markets & Corporate Law Nordic AB as the legal advisor and Nordic Issuing AB as the issuing agent. Shark Communication AB has assisted the Company with advice regarding communication.

For further information about the Rights Issue, please contact:

Sedermera Corporate Finance AB

Phone: +46 40615 14 10

E-mail: cf@sedermera.se

www.sedermera.se

For more information about CLS, please contact:

Dan J Mogren, CEO

Phone: +46 (0) 70-590 11 40

E-mail: dan.mogren@clinicallaser.com

Website: www.clinicallaser.se

Certified Adviser

FNCA Sweden AB

Phone: +46 8528 00399

E-mail: info@fnca.se

This information is such information that Clinical Laserthermia Systems AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person set out above on 10 August 2022.

This press release has been translated from Swedish. The Swedish text shall govern for all purposes and prevail in case of any discrepancy with the English version.

Clinical Laserthermia Systems AB (publ), develops and sells the TRANBERG®|Thermal Therapy System, including Thermoguide Workstation and sterile disposable material, for minimally invasive treatment of cancer tumors and drug-resistant epilepsy, according to regulatory approvals within the EU and the US respectively. The products are marketed for image-guided laser ablation and used in studies for treatment with imILT®, the Company's interstitial laser thermotherapy for immunostimulating ablation with potential abscopal treatment effect. CLS has its headquarters in Lund as well as subsidiaries in Germany, the US and a marketing company in Singapore. CLS is listed on the Nasdaq First North Growth Market under the symbol CLS B.

This disclosure contains information that CLS is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 10-08-2022 19:00 CET.