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Clinical Laserthermia Systems AB publishes interim report January – September 2022

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Summary of the interim report (relates to the Group)

 

Nine months (01/01/2022–09/30/2022)

  • Net sales totaled SEK 1,973,000 (SEK 901,000).
  • Profit/loss after financial items totaled SEK -62,192,000 (SEK -44,221,000).
  • Basic and diluted earnings per share totaled SEK -0.90 (SEK -1.25).
  • The equity ratio at September 30, 2022, was 34% (50%).

 

Third quarter (07/01/2022–09/30/2022)

  • Net sales totaled SEK 884,000 (SEK 7,000).
  • Profit/loss after financial items amounted to SEK -30,374,000 (SEK -11,872,000).
  • Basic and diluted earnings per share totaled SEK -0.42 (SEK -0.18).
  • The equity ratio at September 30, 2022, was 34% (50%).

­Significant events in the third quarter of 2022

 

  • In September, CLS received FDA 510(k) approval for its laser ablation system for use with MRI guidance in neurosurgery. The product will be sold under the new brand name ClearPoint Prism™ Neuro Laser Therapy System.

 

  • In September, CLS completed a rights issue that was 80% subscribed, including subscription and guarantee commitments, and raised approximately SEK 55.4 million before issue costs.

 

  • In August, Rolf Ho Bornschein was appointed as the new CFO. He succeeds Lars-Erik Eriksson, who is a co-founder and remains a member of the CLS Board.

 

 

Significant events after the end of the period

 

  • In October, CLS received an order of approximately SEK 5.5 million for ClearPoint Prism™ products from its global distributor ClearPoint Neuro.

 

  • With the proceeds from the rights issue in September, CLS amortized SEK 15 million on the previous loans from Modelio Equity AB, Lubrica Equity AB and Formue Nord Fokus A/S. CLS took out a new loan on just over SEK 33 million including remaining loan capital and interests. In November, the lenders requested to perform a conversion of the new loan of approximately SEK 4.5 million, which was executed.


Comments from CEO Dan J. Mogren

 

FDA 510(k) approval opens the door to neurosurgery in the US

 

The third quarter ended on a very positive note with our FDA 510(k) approval for neurosurgery in the USA. This is a major breakthrough for our collaboration with ClearPoint Neuro, which is now transitioning to a commercial phase with the new treatment system under the brand name ClearPoint Prism™ Neuro Laser Therapy System. With the approval, ClearPoint Neuro started a limited launch of the system to selected clinics among its customers and, at the beginning of the fourth quarter, CLS received an order worth approximately SEK 5.5 million. A full-scale launch is expected by the end of 2023, following feedback from key opinion leaders.

 

Overall, this makes me feel very confident in our choice of ClearPoint Neuro as a global distributor in the neurosurgery segment. Our goal is for the ClearPoint Prism™ Neuro Laser Therapy System to become one of the leading products in the MR-LITT market in the US within the next few years.

 

The only one-stop-shop solution on the market

According to Clearpoint Neuro's updated market figures, the US market consists of approximately 26,000 annual cases of brain cancer and approximately 15,000 annual cases of drug-resistant epilepsy. In addition to these annual cases, the market is also made up of another approximately 150,000 - 200,000 patients with drug-resistant epilepsy who have untreated disease. All of these patients could be treated with MRgLITT, but only a small percentage, around 2,000 patients, are today given this treatment. Until the year 2032, this number is expected to grow significantly to nearly 10,000 patients annually, a growth that Clearpoint and CLS intend to actively pursue and participate in.

 

A major advantage of the ClearPoint Prism™ Neuro Laser Therapy System is that it integrates with ClearPoint's neuronavigation platform and MR scanners from leading manufacturers. It is the only one-stop-shop solution on the market today and can save hospitals both time and resources through simplified administration and more time-efficient treatments. We therefore hope that our system will become the preferred option for the treatment of an increasing number of patients.

 

Positive response to CLS TRANBERG® products

During the third quarter, we continued the launch of the second generation of our TRANBERG® products for the urology field, by means of product demonstrations at conferences in both Europe and the US. Small prostate centers in the US, in particular, consider our ultrasound-guided system for focal treatment to be an opportunity to add a product to their toolbox, alongside diagnostic imaging and biopsy.

 

In Europe, there is a positive response to both our MRI-guided and ultrasound-guided TRANBERG® systems, and we are now in discussions with more than 15 hospitals around Europe.

 

Financing from a new capital issue

Despite challenging market conditions, CLS managed to complete a rights issue in September, raising a total of approximately SEK 55.4 million, which is sufficient to continue to support the commercial launch and market establishment of CLS's second generation of TRANBERG® products. The financing through the rights issue is a testament to our shareholders' confidence in CLS's strategy and our products' role in the market as an alternative to traditional surgery for certain patient groups. Trading in series 5B warrants began on October 11 and will continue until February 24, 2023. It is my hope that our committed shareholders look positively on our future prospects and will take advantage of the opportunity to subscribe for new shares in the company.

 

Cost development

The overall increase in our other external expenses in the third quarter is mainly due to costs related to the rights issue in amount of approximately SEK 10 m. As we are preparing our organization to carry out and support our commercial activities, we have had increased staffing needs, which led to higher personnel expenses in the third quarter. We expect personnel expenses to continue to increase as our business grows.        

 

Increasing focus on the US

Our assessment is that launch and commercialization will be faster in the US than in Europe. This is because the US is a more homogeneous market compared to Europe, which has a different healthcare system in each country. Consequently, CLS will shift its focus more towards the US in the near future. We will therefore ensure that we provide the best possible support for ClearPoint Neuro's market launch of the new ClearPoint Prism™ Neuro Laser Therapy System product, and continue to respond to the strong interest in our ultrasound image-guided TRANBERG® system for focal treatment of localized prostate cancer in the US.

 

To support market entry for CLS, we are gathering clinical evidence through studies and looking forward to the last patient being treated in the Urological Research Network study with Focalyx in Florida, USA. Furthermore, the aim is to treat the first patient in our study of MRI-based laser ablation treatment of glioblastoma at Skåne University Hospital in Lund as soon as possible.

 

We are also continuing to establish partnering agreements with new commercial partners and aim to submit a 510(k) application to the US FDA in the first half of 2023 for our MRI-based TRANBERG® system for prostate tissue ablation in the US.

 

While we have a good wind in our sails, we are keeping a close eye on global developments to proactively address the challenges of the global business environment in terms of logistics challenges, component shortages, inflation and more, so that we limit the impact on the company’s activities as much as possible. Despite the uncertain global environment, our advances during the year point to solid demand for our products, which is also driven by strong underlying forces. My ambition is that we will be able to show further progress before 2022 comes to a close.

 

 

 

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 Nov 17, 2022 at 15:30 CET.

 

 

Contact information:


Dan J. Mogren, CEO
Tel: +46 – (0)705 – 90 11 40

E-mail: dan.mogren@clinicallaser.com

 

 

 

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 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

 

 

 

 

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 17-11-2022 15:30 CET.

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