CLS publishes interim report January – March 2024

Summary of the interim report (relates to the Group)

Three months (01/01/2024–03/31/2024)

• Net sales totaled SEK 3,140,000 (SEK 587,000).
• Profit/loss after financial items totaled SEK -12,397,000 (SEK -21,464,000).
• Basic and diluted earnings per share totaled SEK -0.01 (SEK -0.15).
• The equity ratio on March 31, 2024, was 81% (7.5%).

 

Significant events in the first quarter of 2024

• An order for ClearPoint Prism Neuro Laser Therapy System products was received from ClearPoint Neuro, Inc (Nasdaq: CLPT), with an approximate value of SEK 8.1 million.
• Mobile Service Provider agreement signed with Rose Urology LLC, Florida, USA.
• CLS raised approximately SEK 23.5 million following closure of the TO 6 B warrant series, corresponding to a subscription rate of 100 percent.
• The Singapore Health Sciences Authority gave market approval for TRANBERG Thermal Therapy Systems, kick starting commercialization in the Asia Pacific.

 

 

Significant events after the end of the period

• First patients safely treated at the San Luigi Gonzaga University Hospital, Turin, Italy, using the TRANBERG Thermal Therapy System.
• A second order of single-use sterile instruments from the National Institutes of Health Clinical Center, USA, for use with the TRANBERG Thermal Therapy System valued at KSEK 370.
• CLS entered into an exclusive distribution agreement with MTEC Company to market and sell the CLS TRANBERG product portfolio in France.
• Pursuant to a resolution passed at an extraordinary general meeting on April 14, a reverse split was carried out, meaning that 200 existing shares were merged into one share; this is deemed to create better conditions for broadening share ownership as part of the company's long-term capitalization efforts.
• CLS presented a revised strategy that involves the company focusing on the neurosurgery market segment to increase the possibility of achieving positive cash flow by 2026.

 

Comments from CEO Dan J. Mogren

 

The first quarter of 2024 saw continued growth for CLS. Revenues for the quarter were SEK 2.55 million, which is an increase of 335% compared to the same period last year. The new order from ClearPoint Neuro validated the existing strategy in the neurosurgery segment and provided a basis for upgrading its future potential. In the urology segment, we signed a new Mobile Service Provider agreement in the US. During the quarter, CLS strengthened its cash position by SEK 23.5 million due to the ending of the exercise period for the TO 6 B warrant series.

Revised strategy with increased focus on neurosurgery going forward

In January, we received an order from ClearPoint Neuro worth approximately SEK 8.1 million, with planned deliveries and invoicing during the year. We continue to receive very positive feedback from ClearPoint Neuro with regard to the Limited Market Release of the ClearPoint Prism Neuro Laser Therapy System that is currently ongoing in the US, which together with the order confirms the potential of the neurosurgery market and the strength of our partnership with ClearPoint Neuro.

As we announced after the end of the period, we are now revising our strategy so that we can focus more of our resources on neurosurgery, to further improve the ClearPoint Prism Neuro Laser Therapy System, obtain additional market approvals and complete the planned Full Market Release in the US in the second half of this year. Our aim is to expand the use of the ClearPoint Prism Neuro Laser Therapy System beyond the MR suite into the operating room and to obtain approval for use with 1.5 Tesla MRI scanners as well, which together will provide access to approximately 90 percent of the US market for NeuroLITT treatment in the brain.

The increased focus on neurosurgery will significantly improve our ability to exploit the full potential of the market.

Increased revenue and continued cost discipline

While the US remains the company’s main market, approval of the TRANBERG Thermal Therapy System in Singapore and treatment of the first patients in Italy following the end of the quarter points the way to a broader geographical spread in revenues in the future. We also continue to increase revenues in both our neurosurgery and urology segments.

We are also continuing to focus on cost discipline. The change in the prioritization of the main direction of the business that we have decided upon means that the company's costs are estimated to fall by approximately SEK 65 million during the period 2024–2026. As a result of stricter prioritization, it will be possible for us to have better control over operational expenditure and ensure that our financial resources enable better growth.

Following the closure of the TO 6 B warrant series in January, we received an additional SEK 23.5 million before issuing costs, which corresponded to a subscription rate of 100 percent based on the exercising of warrants and underwriting commitments. This injection of capital will be used for further commercialization activities.

Market approval for TRANBERG in Singapore lays the foundation for starting up in the region

With the signing of a new agreement with Florida based Rose Urology LLC in March, there are now four MSP agreements in the US relating to our TRANBERG Thermal Therapy System. A benefit of the MSP agreement is that CLS can offer rapid access to the TRANBERG Thermal Therapy System for urology clinics without there being any capex requirements, as the clinics pay per procedure.

Foundations were also laid during Q1 for the starting up of our urology business in the Asia-Pacific region following approval of the TRANBERG Thermal Therapy System by the Singapore Health Science Authority. Singapore is a major gateway for medical services in the region and together with our highly credentialled Singapore-based partner, Advanced Medical Systems, we are now starting commercialization in Singapore as a first step in this region.

Following the end of the quarter, the first patients were treated with the TRANBERG Thermal Therapy System at the San Luigi Gonzaga University Hospital in Turin, Italy. This is an important step in the commercialization of our urology business in Europe and we anticipate that experiences from this renowned clinic will facilitate our continued growth both in Italy and in other key European markets.

Securing our technology and IP

Our technology and IP are essential for the continued success of our commercialization. In January we announced a new agreement with Image Guided Therapy SA (IGT) under which CLS will acquire all rights to IGT's technology for MRI-based temperature measurement and control of laser-based tissue ablation. The technology covered by the agreement is used across the full spectrum of CLS MR image guided products and protocols. The agreement also provides continued access to IGT resources and skills to support ongoing product development and commercialization.

A patent application was filed in January which, if approved, will provide protection for the CLS non-cooled laser applicator until 2044. At the same time, we are continuing to work on the transition to EU MDR certification.

A strong Q1 and a busy 2024 ahead

Looking back at the first quarter of 2024, it has been a period in which we were able to achieve growth in both commercial segments of our business as well as lay important foundations for accelerating our earning power. This was reflected in new orders and agreements in neurosurgery and urology, and approval for the TRANBERG system in Singapore. By now focusing our efforts on neurosurgery for the next 12 to 18 months, we are laying the basis for making 2024 an exciting year.

We look forward to you continuing to be a part of what should be an exciting and busy 2024 with an increased focus on neurosurgery.

 

 

Dan J. Mogren

CEO, Clinical Laserthermia Systems AB

 

 

 

 

For more information, please contact:


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

Phone: +46 (0)705 90 11 40

E-mail: [email protected]

 

 

About CLS

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 fort reatment 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.

 

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

 

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 29-05-2024 12:00 CET.