2023-05-11 Regulatory

NeoDynamics AB (publ) first quarter 2023

Progress in the US

First Quarter 2023

  • Revenues amounted to SEK 318 (328) thousand, of which SEK 97 (92) thousand net sales, i.e., sales of finished products.
  • Net loss amounted to SEK -23,233 (-15,852) thousand.
  • Loss per share amounted to SEK -0.19 (-0.26).
  • Cash and cash equivalents amounted to SEK 5,366 (20,067 at year-end) thousand.

Significant events during the quarter

  • NeoDynamics partners with Uniphar for US distribution and logistics. Uniphar is a global distribution and logistics giant and will help to ensure a successful US launch of NeoNavia®
  • In February 2023 NeoDynamics' largest owner Gryningskust Holding AB offered the company a loan of SEK 14 million, with a fixed interest rate of 8%, which is within the market price range considering other similar financing. The loan maturity date is August 15th, 2023. The loan is intended to be converted into shares if the company issues new shares in the future, subject to shareholder approval.
  • NeoDynamics announced that Jie Bao and Xiaojun Xu will step down from the Board of Directors as of 2023-02-14 based on a mutual agreement. They will instead focus on supporting the company and its plans for the Chinese market.
  • NeoDynamics was granted Chinese patent for FlexiPulse needle design.

Significant events after the end of the quarter

  • NeoDynamics announces the delivery of CorePulse Needles to 23 Hospitals in the UK and Germany.
  • NeoDynamics, Inc. announces U.S. availability of NeoNavia®, the first and only pulse biopsy technology, FDA-cleared in breast and axillary lymph node biopsies.
  • The Extraordinary General Meeting resolved to adopt new Articles of Association where the limits for the share capital (§ 4) and the limits for the number of shares (§ 5) are changed, as regards the share capital to a ratio of SEK 12,000,000 to SEK 48,000,000 and as regards the number of shares to a ratio of 120,000,000 to 480,000,000 shares. The Extraordinary General Meeting also resolved that the board of directors, for the period until the end of the next annual general meeting, shall consist of four directors (previously six) and no deputy directors (unchanged) and to re-elect Ingrid Salén (chairman), Carina Bolin, Claes Pettersson and Matthew E. Colpoys, Jr.
  • The final data set from NeoDynamics’ PULSE study shows favorable safety and efficacy profile of NeoNavia for ultra-sound guided biopsies in the axillary lymph nodes. The data was presented at The SBI Breast Imaging Symposium., which took place on May 4-7, 2023.

CEO Comment
Progress in the US

One of our top priorities for this year is to ensure a successful launch of NeoNavia in the US. Operations are already in place through outsourced customer care and logistics. To drive sales, we have three very experienced sales representatives in the field who are establishing contact with top university hospitals and actively engaging with purchasing departments. We are satisfied with the progress so far.

NeoNavia was commercially launched at the American Society of Breast Surgeons (ASBrS) in Boston in the last week of April and at the SBI Breast Imaging Symposium in Maryland in the first week of May. This was a great opportunity for us to meet and interact with key opinion leaders and practitioners. ASBrS serves as the primary leadership organization for general surgeons who treat patients with breast disease and has grown to more than 3,000 members in the United States and 35 countries throughout the world.  SBI is the leading network of breast radiologists and medical physicists in the U.S. Our PULSE study was accepted for electronic presentation at SBI which we are proud of as far from all abstracts are accepted.

Advancement of our clinical program
Clinical tests typically start with a study to demonstrate the product’s performance. This is the purpose of our PULSE study in Germany which included 138 patients diagnosed with breast cancer and in need of an axillary lymph node biopsy. The study has showed an impressive 93% success rate. The advantage of NeoNavia is that it is a minimally invasive option designed to provide controlled needle insertion, accurate lesion targeting, and high tissue yield from technically difficult lesions as well as difficult to access pathology. 

Next step is to run a comparative study, where the product is compared with today’s standard biopsy needle. Our COMPULSE study in the UK 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. Our product is tested on every second patient, while every other patient is treated with a standard needle. The study was put on hold during the pandemic but has now been restarted. More than 400 patients will be recruited for this study, and the recruitment process has reached a key milestone of 100 patients.

Supply of CorePulse needles in Europe and early feedback

In Europe, activity has picked up since the beginning of April, where the first production run of the new version of our CorePulse needle was shipped and delivered to hospitals in UK and Germany. The needles will now be used and evaluated in clinical practice.

Regarding feedback, firstly, we received very positive comments related to the yield. What we saw in our bench studies was replicated in clinical practice. Secondly, ease of use. Our product received positive comments regarding its simplcity to use; it’s a one button press to initiate the procedure.

Actions to secure financing

In the first quarter of 2023, we secured a loan from the Company’s largest shareholder, Gryningskust Holding AB of SEK 14m, of which SEK 7m has been provided to kick-start the planned launch of NeoNavia® in the US. The loan is intended to be converted into shares if the Company issues new shares in the future. We are still in the process of exploring various options to raise long-term capital which includes, but is not limited to; debt financing, issuance of new shares, warrants and/or convertible instruments.
CEO Anna Eriksrud

The interim report is attached to this press release and can also be found on the company’s website https://www.neodynamics.com/en-gb/reports

The company’s Certified Adviser is Redeye AB, e-mail address: certifiedadviser@redeye.se and telephone number +46 8 121 576 90.