Clinical Laserthermia Systems AB publishes interim report January – March 2022

Summary of the interim report (relates to the Group)

Three months (01/01/2022 – 03/31/2022)

• Net sales amounted to SEK 708,000 (SEK 893,000).
• Profit/loss after financial items amounted to SEK -13.824 million (SEK -9.461 million).
• Basic and diluted earnings per share amounted to SEK -0.21 (SEK -0.21).
• The equity/assets ratio was 12% (7%) on March 31, 2022.

Significant events in the first quarter of 2022

• CLS and Skåne University Hospital initiated a collaboration to conduct a clinical study of MR image-guided laser ablation treatment of glioblastoma using the CLS TRANBERG® Thermal Therapy System with the Thermoguide™ Workstation.
• Acting CEO Dan J. Mogren took planned sick leave from February 10 to March 31. Lars-Erik Eriksson, the company’s CFO and former CEO, was appointed Deputy CEO during this period.
• Radboud University Medical Center in Nijmegen, Netherlands, received ethical approval to initiate an investigator-initiated study of MR-guided focused laser ablation for the treatment of prostate cancer using the TRANBERG® Thermal Therapy System with the Thermoguide™ Workstation.
• CLS launched a new website, to further strengthen the company’s communication with its customers. The website is built on a new brand platform with clear messaging relating to CLS’s market segments of urology, neurosurgery and oncology.
• A new product and method patent was obtained in China for use of the imILT® protocol for immunostimulatory treatment of cancer.
• CLS Americas Inc. and Urological Research Network LLC., a non-profit research organization based in Florida, USA, announced a clinical study for laser ablation of low to intermediate grade prostate cancer in which Focalyx Technologies, a developer of image-guided fusion technology, uses the TRANBERG® Thermal Therapy System.

Significant events after the end of the period

• Acting CEO Dan J. Mogren returned to work after his planned period of sick leave.
• CLS launched the CE-marked Thermoguide™ Workstation, which is designed for use with GE Healthcare MR scanners. The new version is the result of a successful collaboration with GE Healthcare and the CLS partner Image Guided Therapy, and further broadens the market served by CLS. The Thermoguide™ Workstation is already available for customers with Siemens Healthineers 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 the recently announced study using the CLS TRANBERG® Thermal Therapy System in combination with the Focalyx® Fusion image guidance device.
• 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. The agreement states the intention of Quadia to purchase CLS products after the evaluation.
• CLS received approximately SEK 12.2 million via the exercising of warrants from series TO3. The exercising of the warrants increases the number of shares in CLS to 69,306,551, from the previous 65,822,310, representing a dilution of 5 percent for existing shareholders who did not exercise any warrants.
• The CLS Board of Directors announced that Dan J. Mogren has been appointed CEO of CLS AB after having been acting CEO since December 1, 2020.

Comments from CEO Dan J. Mogren

During the first quarter, CLS took several important steps toward achieving our vision of introducing minimally-invasive laser ablation as an effective standard treatment that is a safer alternative than surgery for several patient groups. The initial focus in this regard is on the market segments urology, neurosurgery and oncology. During the period, discussions continued with potential new commercial partners in the urology market segment and three new clinical studies in urology and neurosurgery were initiated.

The tragic war in Ukraine is not currently affecting CLS’s business activities directly, but we are closely monitoring developments, including the possible impact of the sanctions imposed on Russia.

Cost developments over the period are increased costs for external expert consultants and increased personnel costs. Increased personnel costs relate to increased salary and payroll costs associated with the hiring carried out in the areas of quality assurance and clinical business operations to meet our greater needs in these areas, both in Europe and the US.

Two new studies in urology

During the year, we plan to initiate several investigator-initiated studies in Europe and the United States to introduce our TRANBERG® Thermal Therapy System to opinion-leading urologists and radiologists who are planning to offer minimally-invasive image-guided laser ablation to their prostate cancer patients as a safer, faster and more effective treatment option. This is a market that is in its early stages but which we consider to have enormous potential. An important event during the quarter was therefore the start of the investigator-initiated study of MR image-guided focal laser ablation treatment for localized prostate cancer at Radboud University Medical Center, Nijmegen, Netherlands. The study is being conducted with MR scanning equipment from Siemens Healthineers. A similar study is already being performed at Toronto General Hospital, Canada, using MR equipment from GE Healthcare.

Another important study in the urology segment was announced by our subsidiary CLS Americas in the US, where Focalyx Technologies is evaluating the use of the TRANBERG® Thermal Therapy System with Focalyx® Fusion1 for minimally-invasive laser ablation of patients with low-grade and intermediate-grade localized prostate cancer. The treatment, which only takes about 90 minutes, is performed in a urology clinic under local anesthetic, with planned discharge for the patient on the same day. The study is being conducted by Urological Research Network in Miami.

Dr Fernando J. Bianco, the principal investigator at Urological Research Network, is known as a pioneer in minimally-invasive prostate ablation therapy. We are very hopeful that this study will also provide good results, as Dr Bianco’s feedback after 5 patients was very positive. A similar study is already being carried out in Europe, at the Otto von Guericke University Hospital in Magdeburg, Germany, which includes similar equipment from another supplier for the planning and image guidance of the ablation.

Breakthrough agreement with Skåne University Hospital

In neurosurgery, a breakthrough agreement was reached with Skåne University Hospital to conduct a clinical study of MR image-guided laser ablation treatment of glioblastoma. The aim of the study is to open up the first indication for our technology in neurosurgery. We are particularly looking forward to this study because it is close to home, which means that together with our US partner ClearPoint Neuro Inc. we can follow the study at close quarters.

Together with ClearPoint Neuro Inc., we offer a complete system with a next-generation fully integratable navigation and laser ablation platform, consisting of ClearPoint’s stereotaxis solution and our TRANBERG® Thermal Therapy System with the Thermoguide™ Workstation. With regard to market approval for our product in neurosurgery, the study at Skåne University Hospital will generate data for CE marking in Europe, while in the US we are one step further along such a process. There, CLS submitted a jointly drafted 510(k) application to the US Food and Drug Administration (US FDA) at the end of last year. With a clearance in place, launch activities will be initated by Clearpoint Neuro without delay.

Launch in the urology market segment

Since the end of the period, treatment has successfully started in our new studies in the urology segment. Seven patients have so far been treated in the US and Europe combined. We have also initiated the launch of our new TRANBERG® products for image-guided FLA treatment of localized prostate cancer at leading conferences in Europe and the US.

The products were presented to urologists and radiologists, who could also try them out. This was done in conjunction with CLS’s participation at the European Conference on Interventional Oncology in Vienna, Austria, and at the annual meeting of the American Urological Association in New Orleans, USA. The outcome was very good and we note in particular the interest in our TRANBERG system developed for treatment performed at urology clinics under local anesthesia and with the patient returning home on the same day.

This means that we are now entering a commercial phase with our new TRANBERG® products in the urology segment, which is a very important milestone for CLS. We are initially prioritizing the clinics and hospitals that intend to enter into contracts for the evaluation of our products prior to making a procurement decision.

Milestones in 2022

During the remaining part of 2022, our ambition is to sign additional agreements with commercial partners in the urology segment and further evaluation agreements with, in particular, opinion-leading urologists and radiologists in the area of minimally-invasive treatment of prostate cancer in Europe and the US.

We also look forward to an approval of the 510(k) application submitted to the US FDA together with ClearPoint Neuro Inc. This approval will mean that we can enter a commercial phase for CLS technology in neurosurgery in the US via our partnership with ClearPoint Neuro Inc. Our objective is also to obtain product approvals at CLS Asia Pacific and thus be able to start clinical collaborations and initial sales based in Singapore.

Overall, several important milestones for 2022 have been achieved so far and we are continuing to accelerate our clinical programs and the launch of our new generation of products in Europe and the US.

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 May 19, 2022, at 08:30 CEST.

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

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