Clinical Laserthermia Systems

­

Significant events in the first quarter of 2025

• CLS announced that the outcome of the Investigator Initiated Trial (IIT) in Nijmegen evaluating the safety and feasibility of MR-guided focal laser ablation (MRgFLA) for localized prostate cancer, using the TRANBERG® Thermal Therapy System with Thermoguide™ Workstation has been published by a study team lead by Principal Investigator Prof Jürgen Fütterer.
• Lars-Erik Eriksson, co-founder, long-time board member and former CEO, left the board of directors at his own request.
• CLS announced, based on authorization from the Annual General Meeting on June 28, 2024, to carry out a directed issue of 5,500,000 units (the “Issue”). Each unit consists of one (1) share of series B and one (1) warrant of series TO 8B (“Unit”) at a subscription price of SEK 2.90 per Unit, corresponding to SEK 2.90 per new B-share. The warrants are issued free of charge. Through the Issue, the Company will initially raise approximately SEK 16 million before transaction costs. If all warrants of series TO 8B are fully exercised, CLS will raise an additional approximately SEK 21 million before transaction costs, increasing the total capital raised in the Issue to approximately SEK 37 million before transaction costs. The funds will be used to accelerate commercialization, with a focus on entering into partnerships in neurosurgery.  The Issue has been directed to a limited number of qualified investors, including a number of existing shareholders.

Significant events after the end of the period

• CLS announced that updated clinical guidelines with recommendations supporting the use of Laser Interstitial Thermal Therapy (LITT) has been published by Congress of Neurological Surgeons (CNS).
• CLS with its partner ClearPoint Neuro, announced FDA submission to expand the labeling of ClearPoint Prism® to include 1.5 T MRI guidance.

Comments from CEO Dan J. Mogren

The first quarter of 2025 marked significant progress for CLS as we advanced our mission to provide innovative, minimally invasive laser therapy products for large patient populations with severely debilitating and difficult-to-treat illnesses and complications, initially within the neurosurgery market.

Revenues for the quarter were SEK 4,5 million, which is an increase of 43% compared to the same period last year.

Improved operating profit

Operating profit improved significantly from -17,0 MSEK Q1 last year to -7,9 MSEK in Q1, 2025. The improvement comes from increased revenue, improved gross margin and lower operating expenses. Operationally, we continued to implement cost-saving measures towards our goal of reducing operating expenses by at least 30% in 2025 vs 2024, enhancing our financial sustainability.

Further strengthening of our financial position

We further strengthened our financial position in February through a directed issue of units, each unit consisting of one share and one warrant. The company initially raised approximately SEK 16 million and, with all warrants fully exercised, CLS will raise an additional approximately SEK 21 million in September of this year, increasing the total capital raised to approximately SEK 37 million before transaction costs.

510(k) Submission to expand labeling of ClearPoint Prism®

A key milestone, reached in April, was our 510(k) submission to the U.S. FDA. We are seeking to expand the labeling of the ClearPoint Prism system to include compatibility also with 1.5T MRI scanners. This expansion aims to broaden access to laser interstitial thermal therapy (LITT) procedures for neurosurgical patients by unlocking a substantial additional portion of the U.S. MRI guided neuro LITT market.

Our partner ClearPoint Neuro has entered a new chapter – Fast.Forward - 2025-2027

ClearPoint Neuro has entered a new chapter - "Fast.Forward". This includes growing the laser therapy business by, for example, expanding and developing the product range with a focus on simplifying workflows and reducing procedure times for increased throughput in hospitals. We are excited about the additional business potential that "Fast.Forward" could offer CLS.

Looking ahead

We remain focused on delivering value to patients, caregivers and shareholders by expanding and growing our laser ablation business in a sustainable way in collaboration with our partners.

I would like to acknowledge the efforts of our team and partners and thank our shareholders for their continued support in our work to advance patient care through innovative solutions for cost-effective laser ablation in surgery.

Dan J. Mogren

CEO, Clinical Laserthermia Systems AB

Contact information:


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

Tel: +46 – (0)705 – 90 11 40


E-mail: dan.mogren@clinicallaser.com

About CLS

Clinical Laserthermia Systems AB (publ), develops and sells TRANBERG® Thermal Therapy System and ClearPoint Prism® Neuro Laser Therapy System with sterile disposables, for minimally invasive treatment of cancer tumors and drug-resistant epilepsy. The products are marketed and sold through partners for image-guided laser ablation and are used in studies for treatment with imILT®, the company's interstitial laser thermotherapy for immune stimulating ablation with potential abscopal treatment effect. CLS is headquartered in Lund, Sweden, with subsidiaries in Germany, the United States and a marketing company in Singapore. CLS is listed on Nasdaq First North Growth Market under the symbol CLS B. Certified adviser (CA) is FNCA Sweden AB.

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