NeoDynamics AB (publ) Half year report 2020

NeoNavia ready for market

The English text is an unofficial translation of the Swedish report.

Second quarter 2020

• There were no sales during the period. Revenue amounted to SEK 6.263 m (6.328 m) including capitalized costs of SEK 5.787 m (6.328 m).
• Loss after tax amounted to SEK -5.516 m (-3.981 m).
• Losss per share amounted to SEK -0.18 (-0,26).

Half year 2020

• There were no sales during the period. Revenue amounted to SEK 12.531 m (11.748 m), whereof capitalized costs SEK 12.090 m (11.745 m).
• Costs for product development was higher than expected.
• Loss after tax amounted to SEK -12.751 m (-8.115 m).
• Loss per share amounted to SEK -0.53 (-0.53).
• Equity per share was  SEK 2.68 (4.34).
• Equity ratio was 94 (91) per cent.

Significant events during the second quarter

• The Board decided to convert all convertible debt to shares.
• After the rights issue in January and conversion in April, the share capital after registration is SEK 344,561.20 divided into 33,445,612 shares.
• A directed share issue raised SEK 7.684 m that will be paid in during the third quarter.
• The Annual General Meeting re-elected Ingrid Salén, Ulf Boberg, Carina Bolin, Claes Pettersson and Xiaojun Xu as Board members and elected Jie Bao as a new Board member.

Significant events after the period

• For several years, the company has been collaborating with leading breast cancer clinics in Germany to support the introduction of NeoNavia and thus pave the way for a successful market introduction in Europe. The first hospitals to confirm their status as reference hospitals for NeoNavia are AGAPLESION Markus Krankenhaus in Frankfurt and Frauenklinik r.d. Isar, der TU in Munich.
• Patient recruitment for the UK COMPULSE study resumed following a temporary hiatus due to the covid-19 pandemic. The study compares NeoNavia with current standard ultrasound-guided breast biopsies.
• An Extraordinary General Meeting on 13 August resolved on an incentive program for employees with a maximum of 1,021,900 warrants. Each warrant entitles the rightholder to subscribe one (1) share in the Company at a subscription price 150 per cent of the volume weighted average price ten days prior to the extra general meeting.

CEO´s comments

NeoNavia ready for market

After several years of development work, NeoNavia, a system for ultrasound-guided tissue sampling, is ready for launch and thus to improve diagnostic quality for women who are diagnosed with breast cancer. The launch will start in Europe where the system is  being used at specialist clinics in Germany, UK and in Sweden. The market introduction of NeoNavia will focus on these markets. In 2021, NeoDynamics also plan to be present on the US market.

So far in 2020, NeoDynamics has focused on finalizing the new products to further increase their competitiveness. The Base unit, Driver and the needles (three different forms of probes/needles that can replace other ultrasound guided tissue sampling) have been fine-tuned so that each sampling will give high-quality tissue with ample volume.

Adequate samples in sufficient volume provide the basis that modern cancer diagnosis requires for an early and conclusive diagnosis. The facts that it is also time-saving for the clinics and results in fewer needle insertions for the patients, add to the advantages.

NeoDynamics have methodically reviewed the new products and also carried out bench studies to document the results. NeoNavia has already in its study version been shown to provide three times as much tissue as traditional technology. At the end of 2020, these new studies will be published to show the performance of the finetuned products. This will provide powerful arguments when showing clinics the superiority of NeoDynamics’ versus existing biopsy technology.

In parallel, studies with NeoNavia continue in clinical practice in hospitals in Germany and the United Kingdom. After the UK gave special priority to cancer care, patient recruitment in the COMPULSE study resumed in July after a temporary hiatus due to the pandemic. New patients have since been included in the studies that compare NeoNavia to the current standard for ultrasound-guided breast biopsy.

The use of NeoNavia in German hospitals greatly contributed to NeoDynamics being able to start a collaboration with leading German breast cancer clinics in early July, which in a role as reference centres will also support the introduction of NeoNavia at other clinics. These reference centres are also expected to become the first buyers of the new system.

Work continues to secure sufficient funding for the coming years.

I am impressed by how focused the organization worked during the first half of the year and I am sensing the impatience in getting started with selling NeoNavia.

NeoDynamics is heading for a very exciting autumn.

CEO Anna Eriksrud

For further information about NeoDynamics, please contact:                       

Anna Eriksrud, CEO NeoDynamics AB (publ), telephone: +46 708 444 966 , e-mail: anna.eriksrud@neodynamics.com, or

Jörgen Vrenning, CFO/IR NeoDynamics AB (publ), Telephone: +46 708 519 648, email: jorgen.vrenning@neodynamics.com

About NeoDynamics

NeoDynamics AB (publ) is a Swedish Medical Technology Company dedicated to advancing diagnosis and care of breast cancer. The company has an innovative biopsy system, NeoNavia®. The precision biopsy system is built on a patented micro-pulse technology, based on research at the Karolinska Institutet in Sweden. The system is designed to offer clinicians and patients accurate lesion targeting and high tissue yield for correct diagnosis and individualized treatment. NeoNavia® is evaluated at leading clinics in UK, Germany and Sweden. A commercial launch is expected in 2020.

About NeoNavia

NeoNavia is the brand name for the entire biopsy system intended to be used under ultrasound guidance. NeoNavia consists of a base unit, a handheld driver and three different types of biopsy needles. Each needle type is driven by the micro-pulses enabling high precision and control when inserting and positioning the biopsy needle in a suspicious lesion. The system is designed to offer accurate lesion targeting and high tissue yield for correct diagnosis and individualized treatment.

About the micro-pulse technology

The patented micro-pulse technology is based on a pneumatically driven mechanism that enables high precision and control when inserting and positioning the biopsy needle, independent of tissue type. The pneumatic driver that generates micro-pulses is placed in a handheld instrument. With power from the base-unit, the driver accelerates the needle with great control even over a short distance, enabling its distinct stepwise insertion without the risk of destroying surrounding tissue. This facilitates ease of access and flexibility in sampling, even in very small lesions in delicate and difficult locations.