NeoDynamics AB (publ) full-year report 2021

NeoNavia® is gaining ground

Fourth quarter October-December 2021

• Revenues amounted to SEK 930 (3,382) thousand, of which SEK 0 (2,963) thousand capitalized costs and SEK 839 (0) thousand net sales, ie sales of finished products.
• Loss after tax amounted to SEK -19,134 (-11,524) thousand.
• Loss per share amounted to SEK -0.32 (-0.28).
• Cash and cash equivalents amounted to SEK 24,710 (73,250) thousand.

Full year January-December 2021

• Revenues amounted to SEK 2,085 (18,558) thousand, of which SEK 785 (17,104) thousand capitalized costs.
• Loss after tax amounted to SEK -67,730 (-31,006) thousand.
• Loss per share amounted to SEK -1.12 (-1.00).

Significant events during the fourth quarter

• NeoDynamics received orders from four high-profile clinics in Germany and Switzerland for the NeoNavia biopsy system. This shows that clinicians are moving to the next step in evaluating the system and are moving towards incorporating it into their clinical practice.
• NeoDynamics started a subsidiary in Germany, NeoDynamics GmbH, to grow in this important market for the company's innovative biopsy system NeoNavia.
• The first results of the PULSE study were presented at the prestigious British Society of Breast Radiology’s (BSBR) annual scientific meeting. The study shows that NeoNavia can be successfully and widely used for sampling in the axilla with a low frequency of side effects. The data is unique and has aroused great interest.

Significant events after the end of the period

• Data from the PULSE study showing the benefits of the NeoNavia biopsy system in particularly challenging axillary lymph nodes were accepted for presentation at the SBI / ACR Breast Imaging Symposium in Savannah, Georgia, held May 16-19, 2022. The symposium is considered the most important annual meeting for breast radiologists in the U.S.
• Aaron Wong took over as CFO on February 1, 2022. Aaron Wong most recently came from a similar position at the medical technology company ADDvise Group AB.
• The Board decided on a new share issue to shareholders of approximately SEK 69.3 million, which is fully secured through subscription commitments and underwriting undertakings. The issue is conditional on the approval of an Extraordinary General Meeting.
• The Board has convened an Extraordinary General Meeting on February 25 to resolve on issues related to the rights issue and to decide on an incentive program and bonuses for employees.

CEO Comment

NeoNavia® is gaining ground step by step

Our introduction of NeoNavia in Germany and other German speaking countries, the United Kingdom and Sweden continues, and we are meeting a strong interest from radiologists and gynecologists.

Good impact on scientific meetings

The interest from the profession is also reflected in that we are being selected to present at prestigious radiologist meetings. In the fourth quarter, the first results from the PULSE study were presented at the British Society of Breast Radiologists’ annual scientific meeting. The study shows that NeoNavia can successfully, and with a low occurrence of side effects, be used widely in both very difficult and more clear-cut sampling in the axilla - which is a strong argument for choosing NeoNavia over exisiting products on the market. As this data is unique in the scientific world and has great relevance to clinical practice, it has attracted a significant amount interest. At the beginning of the year, the results of a subgroup in the PULSE study with particularly challenging biopsy conditions was accepted for oral presentation at the most important U.S. breast radiologist meeting, SBI / ACR (Society of Breast Imaging / American College of Radiologists), and their Breast Imaging Symposium held in Savannah, Georgia, in early May. Oral presentation is an opportunity that is only offered to the few, and is usually meet with a great deal of interest from the conference participants.

The US introduction draws near

This presentation at SBI / ACR is expected to underpin the planned introduction of NeoNavia in the US. The registration application is planned to be submitted to the FDA within the next few weeks, and an approval of NeoNavia in the US may follow a few months after  submission of the documentation. Together with specialist consultants, we have prepared a high quality registration application, which we expect will facilitate a smoother process with the authorites. The aim is to minimize the subsequent interaction with the authorities in order to reduce the risk of pandemic-related delays. Once the product is registered, it can start to be marketed within a reasonable preparation time since the product already has codes and compensation in place for similar products, unlike pharmaceuticals where you in practice need to wait for decisions on various insurance claims.

As the pandemic has flared up again we have encountered delayes our processes, both in the registration application in the USA and in the launch. However, this does not mean at all that the business is at a standstill.

NeoDynamics is undergoing a transformation

The study version of NeoNavia that was created in 2016, has been used in the clinical studies that are now published and gives us traction in the launch of the innovative biopsy technology. Late in 2019, a commercial version of NeoNavia with three needle types was CE approved. This version began to be presented to the market in the spring of 2020. After some intital fine-tuning, the system and needles can now be delivered in commercial form and in volume. A transfer of our needle production to Asia will be completed during the spring, lowering the production cost of these disposable needles.

We are currently working on the financing for the continued launch of NeoNavia in Europe, to prepare for the launch in the U.S. and to begin registration work in China, as well as to complete the clinical development program with NeoNavia. A small part of the planned fund raising will finance continued work with product development, both to strengthen our current offering with a tissue marker as well as to expand the use of NeoNavia from breast cancer to other cancers. We have good support from major shareholders in these efforts.

I look forward to an eventful 2022!

CEO Anna Eriksrud

This is information that NeoDynamics AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, on February 16, 2022, at 8.30 CET.

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