Clinical Laserthermia Systems AB publishes half-year report January – June 2022

Summary of the half-year report (relates to the Group)

First six months (01/01/2022 – 30/06/2022)

• Net sales totalled SEK 1,089,000 (SEK 894,000).
• Profit/loss after financial items amounted to SEK -31,818,000 (SEK -32,589,000).
• Basic and diluted earnings per share totalled SEK -0.47 (SEK -0.66).
• The equity/assets ratio was 0% (54%) on 30 June 2022.

Second quarter (01/04/2022 – 30/06/2022)

• Net sales totalled SEK 381,000 (SEK 0,000).
• Profit/loss after financial items amounted to SEK -17,015,000 (SEK -23,127,000).
• Basic and diluted earnings per share totalled SEK -0.25 (SEK -0.44).
• The equity/assets ratio was 0% (54%) on 30 June 2022.

Significant events in the second quarter of 2022

• CLS launched the CE-marked Thermoguide™ Workstation, which is designed for use with GE Healthcare MR scanners.

• CLS Americas Inc. and Urological Research Network LLC announced that the first patient has been safely treated with laser ablation of prostate cancer in a Phase I clinical trial. The 20-patient study uses the TRANBERG® Thermal Therapy System in conjunction with Focalyx Technologies' fusion guidance platform.

• CLS entered into an agreement with Quadia Diagnostic Imaging Center in Piaseczno, Poland, for the commercial evaluation of the TRANBERG® Thermal Therapy System for MR-guided ablation of localized prostate cancer.

• CLS received approximately SEK 12.2 million by exercising warrants from series TO3.

• CLS Americas Inc. launched the fusion-guided TRANBERG® Thermal Therapy System at the American Urological Association’s Annual Meeting.

• Dan J. Mogren was appointed CEO after having been acting CEO since 1 December 2020.

Significant events after the end of the period

• The Board of Directors of CLS decided to carry out a rights issue of approximately SEK 69.3 million, followed by a further maximum of approximately SEK 35 million via warrants, and to advance the date of the interim report for the first half and second quarter of 2022.

Comments from CEO Dan J. Mogren

"Positive reception for the second generation of TRANBERG® products"

The second quarter saw the launch of our new generation of TRANBERG® products for focal laser ablation of localised prostate cancer. The products were presented at the European Conference of Interventional Oncology (ECIO) in Vienna and at the American Urological Association’s (AUA) annual meeting in New Orleans. The launches have borne fruit in the form of subsequent meetings with healthcare providers who have shown interest in our products.

In the US we have received a lot of interest, mainly from private healthcare providers, for our TRANBERG® system for ultrasound image-guided laser ablation. Small and large prostate clinics alike are finding the system to be a cost-effective focal therapy solution for the treatment of patients with early-stage prostate cancer. Ultrasound-guided laser ablation treatments have the advantage that they can be performed under local anaesthesia and the patient can go home the same day. Approximately 75% of all patients undergoing prostate cancer screening in the US go through private dedicated prostate clinics. Therefore, these are the players we are primarily targeting, and we look forward to upcoming product demonstrations and, hopefully, new commercial agreements during the year.

The positive reception in the urology market indicates that our new generation of TRANBERG® products meets the requirements for a cost-effective focal treatment of early prostate cancer. The "active surveillance" or radical surgery offered today are not optimal. Focal therapy as an effective treatment option, performed with our products, is not much more invasive than the biopsy that is often part of active monitoring of the disease, which is also an important reason why focal therapy is increasingly requested by patients and urologists alike.

Costs and financial position

We note that our deficit for the period is lower than in the previous period. This is mainly due to a decrease in the cost of other external charges, which relates to costs incurred in the previous period for capital procurement. However, there has been a slight increase in the cost of external consultants.

The effects of the COVID-19 pandemic, together with the sanctions against Russia in the context of the war in Ukraine, are negatively affecting the availability of components and raw materials around the world, creating concerns on the supply side. We are monitoring the situation and so far, CLS has not been affected by this shortage. We also closely monitor inflation, which has a direct impact on our costs.

During the quarter, CLS received SEK 12.2 million through the TO 3 warrants in a move to strengthen the balance sheet for further commercialisation. However, due to the prevailing climate in the equity and financial markets, the subscription rate was only 34%, leaving a capital requirement.

In order to strengthen the financial capacity in the long term, the Board decided after the end of the quarter to carry out a rights issue of about SEK 69.3 million initially and about another SEK 35 million, at the most, via warrants.

The number of patients treated in urology is increasing

CLS TRANBERG® products are compatible with existing equipment in hospitals and clinics. For example, during the quarter, we launched a CE-labelled Thermoguide™ Workstation for use with GE Healthcare MRI scanners. In urology, we have established sales in the US, selling products in MR-guided laser ablation procedures, and more than 250 treatments of localised prostate cancer have been performed so far.

Our TRANBERG® products are currently undergoing clinical trials in Europe and the US in image-guided laser ablation as focal therapy in the treatment of early prostate cancer. So far, we have treated a total of about 12 patients at the University Hospital of Magdeburg, Germany, and at the Urological Research Network, Miami, USA. These studies are ultrasound-based and intend to treat 30 patients in total. In the MR-based trials in Toronto, Canada, and Nijmegen, the Netherlands, we have reached a total of about 45 treated patients out of the 65 planned since the start of these trials in the quarter.

Preparing for neurosurgery treatments

During the quarter, patient enrolment began in CLS's pioneering clinical trial at Skåne University Hospital to investigate MR image-guided laser ablation treatment of glioblastoma, an aggressive and difficult-to-treat form of brain cancer. The first treatment is expected to take place in September. The clinic in Lund is already using our US partner ClearPoint Neuros Inc.'s stereotaxis solution for brain navigation. SVT Nyheter Skåne has reported on the operations in the MRI camera at Skåne University Hospital.

Our indications in the neurosurgery segment include glioblastoma and drug-resistant epilepsy. With our TRANBERG® products for minimally invasive laser ablation procedures, even patients who are not amenable to traditional surgery can be treated. Commercialisation will take place through our partner ClearPoint Neuro Inc., which is the market leader in stereotactic navigation systems for minimally invasive brain procedures.

New advances in oncology

In our third market segment, oncology, the first patient in Immunophotonics' Phase II clinical trial, which started in early 2022, was treated during the quarter. The study uses the CLS imILT® method of laser ablation of a solid tumour, which is intended to stimulate the immune system to attack the cancer throughout the body. In the study, the laser ablation treatment is given in combination with Immunophotonics drugs, which are also intended to activate the immune system against the cancer.

We have also made good progress on our planned studies. During the quarter, the CLS PRECISE registry study was adapted to the new EU medical device regulatory framework MDR, which means that we are now ready to accept clinicians who wish to treat patients with the imILT® protocol. The first clinic to be included in the study is Hospital da Luz, a private cancer clinic in Aveiro, Portugal, with which we already have an ongoing collaboration.

Outlook 2022

CLS is gradually adapting its organisation to meet the increased demand we see ahead. We have enhanced our capabilities, including through the recruitment of clinical application specialists, who are the link between CLS and our customers, and we expect to launch a full-scale commercial launch of our TRANBERG® products in urology in the second half of the year, starting in the US.

We also look forward to the approval of our 510(k) application to the FDA for the use of our technology in neurosurgery. Approval means can we take the next step in our collaboration with ClearPoint Neuro, which has a clear plan for launch and commercialisation, starting in the US.

As the newly appointed permanent CEO of CLS, I am proud and excited to continue to execute our commercialisation strategy and, together with skilled employees, establish the company as a global provider of devices for minimally invasive image-guided laser ablation of malignant tumour disease and other functional disorders in urology, neurosurgery and oncology.

Dan J. Mogren

CEO, Clinical Laserthermia Systems AB

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 set out below, on Aug 12, 2022 at 10:00 CEST.

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.

Contact Information:

Dan J. Mogren, CEO, Clinical Laserthermia Systems AB (publ)

Phone: +46 – (0)705 – 90 11 40 E-mail: dan.mogren@clinicallaser.com

About CLS and TRANBERG system 

Clinical Laserthermia Systems AB (publ) develops and sells the TRANBERG®|Thermal Therapy Systems, including Thermoguide Workstation and sterile disposables, for minimally invasive treatment of cancer tumors and drug-resistant epilepsy, according to regulatory approvals in the EU and the US. The products are marketed for image-guided laser ablation and used in studies for treatment with imILT®,

 the Company’s interstitial laser thermotherapy for immunostimulant ablation with potential abscopal effects. CLS is headquartered in Lund and has subsidiaries in Germany, the US and Singapore. CLS is listed on the Nasdaq First North Growth Market under the symbol CLS B. The Certified Advisor (CA) is FNCA Sweden AB, Tel: +46 8 528 00 399. E-mail: info@fnca.se.

For more information about CLS, please visit the Company's website: www.clinicallaser.se