CLS Publishes Half-year Report January - June 2026

Highlights of Half-year Report 2026

During the second quarter, CLS sales of Prism® products towards its partner in neurosurgery rebounded following the strategic alignment and agreement on commitments to accelerate growth of the Prism business. CLS also received the largest purchase order in the Company's history while continuing to strengthen its operational foundation to execute on the acceleration.

• CLS continued to see growth in ClearPoint Prism® System installations and procedures in the U.S, reflecting underlying clinical and commercial momentum.
• CLS sales of Prism products towards its partner in neurosurgery rebounded following the strategic alignment and agreement on mutual commitments for accelerating growth of the Prism business. As a result, revenue for the quarter amounted to above SEK 7.6 million, which compared to the first quarter is an increase of approximately 485% and close to CLS record revenue of SEK 9.3 million during the same period last year.
• Following the established growth plan and mutual commitments, CLS received purchase orders in early May for Prism products from its neurosurgery partner, totaling approximately SEK 23 million (€2.1 million), with requested delivery within the following 9-12 months.
• CLS continued its interaction with its notified body regarding the CE marking application for the ClearPoint Prism® Neuro Laser Therapy System for use with 1.5T and 3.0T MRI guidance. CLS maintains its expectation that regulatory clearance in Europe can be granted during the second half of 2026 and is anticipated to support further market expansion and growth acceleration.
• CLS extended its research collaboration with the U.S. National Cancer Institute (NCI), part of the National Institutes of Health (NIH), until 2029. The collaboration aims to further evaluate the clinical use of CLS's Tranberg Thermal Therapy System for MRI/Ultrasound Fusion-guided thermal ablation of prostate tissue and prostate cancer. The research will also explore potential immune-related effects in blood and tissue samples after ablation procedures. The agreement is a non-sponsored research collaboration under standard commercial terms.
• CLS expects to require additional capital to execute its business plan through expected positive cash flow in the first quarter of 2028. The Board of Directors and management are actively preparing financing intended to provide the company with the resources required to continue executing the Company's commercial growth strategy and meet its financial commitments.

CLS expects to communicate further information regarding this financing in the near future.

Outlook 2026

CLS re-iterates it expects full-year 2026 revenue to show strong double-digit growth, compared to 2025, with performance weighted towards the second half of the year.

• Through a secured meaningful portion of expected short-term revenue, providing a solid foundation for the year.
• Additional revenue is expected to be generated from an increasing number of LITT procedures performed on an expanded installed base of Prism systems.
• Through growing commercial activities reinforced by our partner's enlarged commercial team and capacity, as the accelerated growth plan is implemented.

Revenue development remains dependent on the timing of system placements and the ramp-up of LITT procedure volumes and may therefore vary between quarters.

This outlook reflects CLS' current expectations based on available information. The outlook further assumes that the Company completes its planned financing activities, providing the financial flexibility required to execute its accelerated commercialization strategy and meet known financial commitments.

Summary of the Half-year Report (relates to the Group)

Comments from CEO

In the second quarter we continued to see solid clinical momentum and increasing adoption of Prism for neuro LITT procedures within neurosurgery, driven by our partner's commercial activities and supported by our team, updated clinical guidelines, established reimbursement and a growing addressable market in the U.S.

CLS sales of Prism® products toward our partner rebounded in the second quarter to above SEK 7.6 million, supported by April's strategic alignment and agreement on mutual commitments to accelerate and scale the Prism business and was followed by CLS receiving the largest purchase order in the Company's history, totaling approx. SEK 23 million, in early May.

Our gross margin continues to be stable at 62% in the second quarter and YTD. Operating expenses are in line with expectations, the increase in the second quarter, compared to the first quarter, is due to seasonal variations such as specific projects rather than general cost increase.

Following an audit of a historical EU Horizon 2020 grant awarded approximately ten years ago, which provided non-dilutive funding for research and development activities that today form the foundation of the Company's commercial technology platform and its use, we received a decision in April on a partial grant repayment of approx. EUR 600k, based on various project costs reported by the executive management of CLS at the time, that were assessed as not meeting the eligibility criteria under the grant agreement. The amount has been fully recognized in the second quarter, negatively impacting our otherwise positively developing Profit/Loss with SEK 6,7 million as a one-time adjustment. The repayment is expected to be made in installments over an anticipated period of approximately 24 months and thus does not affect CLS's commercial strategy or growth ambitions. The start date for the repayment is not currently known and is yet to be established.

Our cash flow from operations continued its positive development with 40% reduced cash spent YTD due to tight cash management and monitoring.

Looking ahead

As previously communicated, aligning on the accelerated growth strategy with our partner in neurosurgery in April changed the Company's capital requirements and financial planning going forward, reflecting investments in product scalability, regulatory expansion, commercialization and the working capital required to support increasing market activity.

Key priorities include:

• Grow market share and broader U.S. adoption of Prism under the expanded clearance
• Accelerate growth in collaboration with a strengthened commercial team of our partner
• Advance regulatory initiatives in Europe
• Continue to develop and expand our strategic partnership model
• Maintain a disciplined cost structure while enabling growth

As mentioned before, we expect commercial activities and revenue to pick up in the coming quarters, with some variability between quarters depending on the timing of system placements and procedure ramp-up.

Significant unmet medical needs exist across several established and emerging indications addressed by the Prism product portfolio, including LITT treatment of drug-resistant epilepsy, primary brain tumors, metastatic brain tumors, radiation necrosis, as well as future brain and spine applications.

To capture these opportunities, we continue to invest in:

• Product scalability
• Regulatory expansion
• Next-generation joint product development
• Expansion of its strategic partnership model

CLS expects to require additional capital to execute its business plan through expected positive cash flow in the first quarter of 2028. The Board of Directors and management are actively preparing financing intended to provide the company with the resources required to continue executing the Company's commercial growth strategy and meet its financial commitments.

The Company expects to communicate further information regarding this financing in the near future.

Following several years of strategic repositioning, organizational streamlining and the establishment of a strengthened commercial platform together with our strategic partner, I believe CLS now enters a new phase focused on execution, scaling and long-term value creation. We have significant work ahead of us, but also the strongest commercial platform in the Company's history.

I would like to thank our employees, partners, and shareholders for your continued trust as we build CLS toward sustainable profitability and long-term value creation for patients, healthcare providers and shareholders alike.

Dan J. Mogren, CEO

Clinical Laserthermia Systems AB

Significant events in the second quarter of 2026

• CLS announced it has reached an agreement with its strategic partner on an alignment to accelerate the growth of the ClearPoint Prism® business in the U.S. The plan includes market expansion, product development, and revenue growth with strengthened long-term outlook. The commercial partnership runs through 2030, with an option for further extension, supporting CLS aim to become market leader in minimally invasive Laser Interstitial Thermal Therapy (LITT) within neurosurgery.
• CLS announced that it has received purchase orders totaling approximately SEK 23 million (€2.1 million) for its neurosurgery ClearPoint Prism® business from its strategic partner in neurosurgery. The orders represent the largest purchase order received to date for the Prism business and form part of the previously communicated agreement between the parties to accelerate the growth of the Prism business beginning in 2026.
• Following the European Commission's decision in April, following on an audit of the historical Horizon 2020 grant received approximately ten years ago, CLS will repay approximately EUR 600k (ca 27% of the total grant received) in installments over an anticipated period of approximately 24 months upon an established payment plan.
• CLS announced it has extended its research collaboration with the U.S. National Cancer Institute (NCI), part of the National Institutes of Health (NIH), through a new agreement that will last until 2029. This builds on a partnership that began in 2023. The collaboration aims to further evaluate the clinical use of CLS's Tranberg Thermal Therapy System for MRI/Ultrasound Fusion-guided thermal ablation of prostate tissue and prostate cancer. The research will also explore potential immune-related effects in blood and tissue samples after ablation procedures. The agreement is a non-sponsored research collaboration under standard commercial terms.
• At the end of the quarter, the AGM resolved that Peter Max, Lena Höglund, Veronica Byfield Sköld, Thomas Binzer and Jerker Nygren are re-elected as Board members. Peter Max was re-elected as Chairman of the Board.
• Furthermore, the AGM resolved, in accordance with the Board's proposal, to amend the Articles of Association such that the limits for the share capital are changed to not less than SEK 3,116,659.40 and not more than SEK 12,466,637.60, and the limits for the number of shares are changed to not less than 31,166,594 and not more than 124,666,376 shares and to reduce the company's share capital by SEK 68,865,088.446183 for allocation to unrestricted equity, from SEK 71,981,747.846183 to SEK 3,116,659.40, without cancellation of shares. The resolution is conditional the authorization of the Swedish Companies Registration Office (Bolagsverket) or a general court.

Significant events after the end of the period

• There were no significant events following the end of the period.

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 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. 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