Third Quarter 2023

• Revenues amounted to SEK 569 (222) thousand, of which SEK 0 (33) thousand net sales, i.e., sales of finished products.

• Net loss amounted to SEK -25,257 (-14,383) thousand.

• Loss per share amounted to SEK -0.09 (-0.12).

• Cash and cash equivalents amounted to SEK 4,609 (39,966 at year-end) thousand.

Significant events during the quarter

• NeoDynamics AB (publ.) raised approximately SEK 58 million before the deduction of transaction costs, in a rights issue carried out during August. The rights issue was subscribed to approximately 80%, including guarantee commitments. Those subscribing by use of their exercise rights, corresponded to approximately 46.4%, with approximately 31.7% allocated to guarantors.

• In connection with the rights issue, NeoDynamics AB (publ.) also launched two warrant programes, the T02 and T03. Details of both programes can be found on the NeoDynamics website, www.neodynamics.com within the Investor section page.

• NeoDynamics AB (publ.) announced the initiation of their first NeoNavia® order from a prominent US university hospital specializing in the treatment of breast cancer. However modest in size, the order served as an important reference as the commercial rollout continues to garner interest and acceptance at both academic and community-based breast centers throughout the U.S. This milestone further demonstrates the commercial viability of the innovative pulse technology.

Significant events after the end of the quarter

• NeoDynamics AB (publ.) announced the receipt of a new order for FlexiPulse needles from Western Rhineland-Palatinate Hospital in Germany. The hospital is among the top 100 rated and distinguished hospitals in Germany, and it serves as academic training hospital for the University of Mains. It has a large interdisciplinary sonography department performing all kinds of biopsies.

• NeoDynamics AB (publ.) announced cost reduction plan. The Board of Directors and Management Team decided to streamline the Company’s operations to maximize its return on investment in key launch regions. As a result of these challenging but necessary changes to the organizational structure, dedicated team members will be impacted as the Company operates with a reduced headcount moving forward.

• In addition to the cost reduction plan, the Board of Directors are working to secure short-term financing by means of a bridge loan. The long-term solution that the board are exploring, is to secure sufficient capital to continue the commercialisation of NeoNavia® in Europe and the US, and includes, but is not limited to, early discussions about a potential sale of the company. There are no guaranties that the efforts to secure short or long-term financing will be successful.

CEO Comment

Cost reduction plan and streamlining of operations

During 2023, we have achieved several important milestones. However, we have faced delays in the product development. We chose, based on the feedback from our customers, to improve and finetune our needles, in particular, the CorePulse and VacuPulse. As a result, our sales development has been slower than expected as we have not had the full suite of needles.

Our finanancing has been linked closely to our expectations around the product availability, which we have tried to manage carefully. In general, the market has been difficult to operate in, especially when we consider how and when we raise capital for the company and the stage we are at.

Due to the combination of these factors, both internal and external, we have made the decision to reduce costs with due consideration to our current cash position. We truly believe we are close to a commercial breakthrough, which has been validated by positive customer feedback and recent orders. However, the fact that we did not secure as much financing in connection with the rights issue in August as intended, means that our current cash position is lower than anticipated. We therefore need to balance our cash, costs, and commercial activities in the short term.
We are having early discussions regarding a loan and potential sale of the company.

Promising customer feedback

In general, we are getting very promising feedback from hospitals in both Europe and US.

Developments in Europe are quite satisfactory. Over the past months, we have held numerous workshops in Germany, Austria and the UK, and started a number of new pilots on various hospitals and clinics. Also, we have participated in the British Society of Breast Radiology (BSBR) meeting in Belfast, which has resulted in new orders and new pilot sites signed up. Likewise, we have successfully attended the DEGUM (German Society for Ultrasound in Medicine) at the Technical University of Munich with participation of doctors from Germany, Austria and Switzerland.

Some weeks ago, we were pleased to announce a new order for FlexiPulse needles from Western Rhineland-Palatinate Hospital which is among the top 100 rated and distinguished hospitals in Germany.

Our COMPULSE study in the UK, which is a comparative study using the Flexipulse needle to demonstrate product performance for ultrasound-guided biopsies of axillary lymph nodes in patients with breast cancer, is progressing according to plan. More than 148 patients (out of 400) have now been recruited (and biopsied). All COMPULSE study centers have confirmed that they intend to use our needles commercially, in parallel to participating in the study.
In the US, it is a waiting game. It takes time to get the final “go” in connection with the first order from a new customer. Thus, there is a lot of paperwork, compliance, administrative and legal tasks at the hospitals, that makes the route to success very cumbersome. This is not specific to NeoDynamics, but true for all companies in health care.
We are pleased, however, that we were able to announce our first order from a prominent University Hospital in the US in August. Also, we are currently in intense negotiations with Tier One Hospitals and are confident that we will be able to announce positive news in the near future.

All three needles are ready

The fine-tuning of the CorePulse needle has been finalized, and the needle is now available for sale again. The same goes for the VacuPulse needle which has been improved both in vacuum strength and sharpness.

It means that our innovative biopsy system NeoNavia ® is now fully functioning and available for sale with a full suite of improved needles; VacuPulse, CorePulse and FlexiPulse in all our targeted markets in Europe, while the FlexiPulse and VacuPulse needles are available for sale in the USA. The easiness of the “click and go” system as well as the simplicity of having one system for all three needles is seen as one of the great features of NeoNavia by practitioners.

Market update

NeoDynamics addresses an unmet need in the biopsy-based diagnosis of breast cancer, the most prevalent female cancer type, with an expected global market size of approx. USD 1.2bn by 2030 with a CAGR of approximately 7% according to MRFR 2023, which confirms our growth expectations. The NeoNavia Pulse technology offers a highly precise needle delivery, with high-yielding tissue samples without the need for surgical procedures and improves the outcome for practitioners and quality of life for patients, which makes it a very strong product offering.

CEO Anna Eriksrud

The company will present the report on Wednesday 28th November at 9:30am via the below link:

https://www.inderes.dk/videos/neodynamics-presentation-of-q3-interim-report-2023