2022-08-18 Regulatory

NeoDynamics Interim Report Jan-June 2022

Focus shifting towards the US

Second Quarter 2022

  • Revenues amounted to SEK 164 (411) thousand, of which SEK 141 (383) thousand capitalized costs and SEK 10 (0) thousand net sales, i.e., sales of finished products.
  • Net loss amounted to SEK -18,294 (-18,263) thousand.
  • Loss per share amounted to SEK -0.17 (-0.30).
  • Cash and cash equivalents amounted to SEK 49,903 (24,710 at year-end) thousand.

 

First Half 2022

  • Revenues amounted to SEK 311 (816) thousand, of which SEK 141 (762) thousand capitalized costs and SEK 103 (22) thousand net sales, i.e., sales of finished products.
  • Net loss amounted to SEK -35,485 (-35,519) thousand.
  • Loss per share amounted to SEK -0.42 (-0.59).
  • Cash and cash equivalents amounted to SEK 49,903 (24,710 at year-end) thousand.

 

Significant events during the quarter

  • NeoDynamics completed a rights issue raising approx. SEK 69.3 million before transaction costs, increasing the number of shares by 60,250,592 to 120,501,184, and the share capital by SEK 6,025,059 to SEK 12,050,118.
  • NeoDynamics was approved for trading on Nasdaq First North Growth Market in Stockholm, where the share began trading on May 2, 2022.
  • The annual general meeting held on May 12, reelected the Board of Directors.

 

Business highlights

  • Professor Marc Thill presented new data from the PULSE study at the SBI/ACR Breast Imaging Symposium in Savannah, Georgia in May, showing a success rate of 96% for NeoNavia in very complex and risky axilla biopsies.
  • Gryningskust Holding AB acquired 4,922,544 shares in NeoDynamics from Boai NKY Medical in June, thereby increasing its holding to 16,844,360 shares, representing 14 per cent of shares and votes in the company. Gryningskust thereby became the largest owner in NeoDynamics.
  • In July, NeoDynamics received ethical committee approval for a German device registry trial. The registry will be used to gather and evaluate real world data from the use of NeoNavia.

CEO Comment

Focus shifting towards the US

 

Preparations underway

The groundwork for the US commercialization and subsequent launch are in full swing. The team is working in parallel with the FDA approval process to ensure that there are no unnecessary delays, but the 510(k) application process is dependent on the FDA’s internal processes. The dialogue with the authority has been constructive and we expect that the process will be concluded before long. I remain convinced that NeoDynamics will be able to take the first steps in commercialising the NeoNavia system in the US before the year-end.

Meanwhile, NeoDynamics has set up an agile, external organization that will allow us  to swiftly initiate a launch for NeoNavia, while also taking care of administrative requirements. Once up and running, we will start to build-up internal resources to maintain an effective and cost efficient start. To help locate the sweet spots for NeoNavia, a market research report was commissioned which continues to build our knowledge and understanding of the market, including different aspects on reimbursement.

 

Europe paves the way

The efforts to enter the US market began when NeoDynamics started to engage with key clinics in Europe, designing a study program that would showcase the value of the products within a clinical setting. These activities have paved the way to where NeoDynamics stand today, presenting at important congresses and seeing the benefits of independent advocates with clinical experience using our product. This is an important point of reference when entering a large market such as the USA. We will ensure that this job on key centres in the German speaking part of Europe as well as the UK, Ireland and Sweden is continued . We are strengthening our product experience and confirm we are a reliable partner.

 

Fine-tuning the product

In Europe, the team has engaged in dialogue with key centers to further optimize the system ahead of the US launch. This has resulted in small, but necessary, fine-tuning of the needles that has led to a temporary pause in production and sales. Deliveries are expected to resume with the CorePulse needle , and the VacuPulse needle during the the last months of the year, both from our Asian supplier. This suits operations well, as the CorePulse needle is in high demand in Europe while the FlexiPulse needle and the VacuPulse needle are expected to become the center of attention in the US. The interruption in supply has not deterred interest in the product with over 35 clinics having introduced NeoNavia in their clinical practice, and some 30 running pilots. Their feedback continues to be very encouraging and I feel confident that we will have great support in our continued efforts.

 

Looking forward

I look forward to an eventful autumn, during which NeoDynamics will share important news. To stay up to date with development, you can register for our monthly newsletter on the website www.neodynamics.com.

CEO Anna Eriksrud

The report in full is attached as a pdf file to this press release and can also be found on the company's website on the following link: https://www.neodynamics.com/en-gb/reports

Watch our for a video link with CFO comment available on our website from the 19th of August.

For further information, please contact

CEO Anna Eriksrud, phone +46 (0)708 444 966, e-mail anna.eriksrud@neodynamics.com

CFO Aaron Wong, phone +46 (0)79 010 1714, e-mail aaron.wong@neodynamics.com

 

The company’s Certified Adviser is Redeye AB.

 

This information is information that NeoDynamics AB is obliged to make public pursuant to the Financial Instruments Trading Act. The information was submitted for publication at 2022-08-18 at 08.00 CET.