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The Board of Directors of NeoDynamics AB (publ) ("NeoDynamics" or the “Company") has today, subject to approval by the Extraordinary General Meeting on July 27, 2023, resolved to carry out a Rights Issue of shares and warrants (“Units”) with preferential rights for the Company's existing shareholders of initially approximately SEK 72 million (the "Rights Issue"). The Company has received subscription undertakings from a selection of the Company's larger existing shareholders, including Gryningskust Holding AB (“Gryningskust”) and Rentability Sweden AB as well as from members of the Company’s Board and management, amounting to approximately SEK 14 million, corresponding to approximately 19 per cent of the initial proceeds of the Rights Issue. Furthermore, the Company has entered into agreements on guarantee commitments of approximately SEK 44 million which, together with the subscription undertakings, secures the initial proceeds of the Rights Issue up to approximately 80 per cent. In September 2022 NeoDynamics received FDA approval of its precision biopsy system NeoNavia®. The proceeds from the Rights Issue will primarily be used for continued commercialization and marketing activities in the United States of America and at selected centers in the United Kingdom, Germany, and Sweden as well as strengthen the Company’s capital structure by repayment of existing loan. The Rights Issue is subject to approval by the Extraordinary General Meeting on July 27, 2023, and the notice of the Extraordinary General Meeting will be announced in a separate press release. To finance operations until the Rights Issue has been completed, the Company has taken on bridge loans from the Company’s largest shareholder Gryningskust, Rentability Sweden AB and Formue Nord Markedsneutral A/S, totalling SEK 15.5m, in addition to previously announced loan from the largest shareholder of SEK 14m, to be offset or repaid from the initial proceeds in the Rights Issue.
Due to the Rights Issue, the Board of Directors has resolved to bring forward the publication of the Company’s Q2 report to July 31, 2023.
Summary
Background and motive for the Rights Issue
NeoDynamics is a Swedish medical technology company focused on precision biopsy in cancer. With an initial focus on supporting the diagnosis and treatment of breast cancer, the system is well documented, has substantial intellectual property rights, and provides multiple opportunities for future development and revenue growth. Future indications to evaluate include suspected cellular changes all organs accessible to core needle biopsy methods and target some of the most common cancers in both women and men. These include prostate cancer, non-Hodgkin’s lymphoma, head and neck cancer, or kidney, liver, or pancreas cancer. These are of increasing prevalence, where precision biopsy is essential to confirm the diagnosis and create individualized treatment plans using molecular genetic tools. Future applications will also focus on targeted drug delivery of cytotoxic agents directly into the target tissue to increase the efficacy and mitigate adverse systemic effects of these therapies.
The Company's primary product is the biopsy system NeoNavia® system for ultrasound-guided biopsy. The biopsy system is based on patented ultrasound-guided pulse technology developed at the Karolinska Institutet in Sweden. The pulse technique allows clinicians to move the needle in a controlled, incremental (1-2 mm/pulse) manner, providing unparalleled safety and precision when performing lesion biopsies. NeoNavia® has FDA marketing authorization in the US since September 2022 and has a CE mark in Europe, where the system has started to be used in over 30 clinics. Today, the area of use for NeoNavia® is ultrasound-guided breast biopsies and axillary lymph node biopsies.
Commercialization efforts in the United States will focus on axillary lymph node biopsy, taking advantage of current trends moving from surgical intervention to a minimally invasive technique. This is in line with the general trend in biopsy practice in breast cancer, where most procedures are performed less invasively and with ultrasound-guided imaging technology, even in outpatient care. China remains a potential marketplace and to have NeoNavia® approved by China Food and Drug Administration (CFDA). The incidence of breast cancer in China is increasing at a high rate due to increasing urbanization, delays in childbearing, and changing lifestyles.
The Rights Issue is carried out to finance NeoDynamics’ commercialization and market development in the USA and at selected centers in the United Kingdom, Germany, and Sweden, completion of the clinical program, initial measures for other indications where the precision of pulse technology is in demand (e.g. prostate cancer) preparation for registration in China and continued product development of marker.
The Company's Board of Directors assess that the existing working capital is insufficient to meet the Company’s current needs during the coming twelve-month period, calculated from the prospectus date. To enable the current business plan, the Board decided on the Rights Issue on June 22, 2023, subject to approval at the extraordinary general meeting on July 27, 2023. If the Rights Issue is fully subscribed, the Company will receive initial proceeds of approximately SEK 72 million, before deduction of issue related costs. Guarantee commitments and subscription undertakings have been submitted corresponding to 80 per cent of the Rights Issue. The guarantee commitments are not secured by bank guarantee, blocking funds, pledging, or similar arrangements.
To finance operations until the Rights Issue has been completed, the Company has taken on the Bridge Loan from the Company’s largest shareholder Gryningskust, Rentability Sweden AB the chairman of the board as well as Formue Nord Markedsneutral A/S, totalling SEK 15.5m in addition to the previously announced loan from Gryningskust of SEK 14m. The Bridge Loans will be offset through conversion to Units corresponding to commitments made from the Lenders. Any remaining part of the Bridge Loans will be repaid with the initial proceeds from the Rights Issue.
If the Rights Issue is not subscribed to the required extent and the guarantors do not fulfill their commitments, or if the cash flow does not develop following the Board’s expectations, the Company intends to investigate alternative financing options such as additional capital acquisition, grants or bank loans, or alternatively - operate the business at a slower pace than planned until additional capital can be raised. NeoDynamics will then primarily focus on the activities deemed essential for the Company’s development.
Upon full subscription of the Rights Issue, NeoDynamics will receive initial proceeds of approximately SEK 72 million before issue costs (excluding issue proceeds from the exercise of warrants of series TO2 and series TO3). The issue costs (including costs for guarantee commitments of approximately SEK 3.8 million) are estimated to amount to about SEK 9 million.
Following offsetting and repayment of loans, the Company intends to use the expected net proceeds from the Rights Issue, in the following order of priority and with an approximate stated proportion, to:
In the event that all warrants of series TO2 and series TO3 are exercised for the subscription of shares, the Company will receive additional issue proceeds of a maximum of approximately SEK 90 million before issue related costs. The net proceeds from the warrants of series TO2 and series TO3 are thus intended to be used for the same areas of use with an order of priority and approximate stated share as above.
Terms of the Rights Issue
Persons who are registered as a shareholder on the record date of July 31, 2023, has preferential rights to subscribe for Units in the Rights Issue in relation to the number of shares held on the record date. One (1) existing share in the Company entitles to one (1) Unit right. One (1) Unit right entitles to subscribe for one (1) new Unit. In addition, investors are offered the opportunity to sign up for shares without the support of unit rights.
The record date for the Rights Issue is July 31, 2023, and the subscription period runs from August 2, 2023, until August 16, 2023.
One (1) Unit consists of six (6) shares and two (2) warrants of series TO2, as well as three (3) warrants of series TO3. The warrants are issued free of charge.
The subscription price is SEK 0.6 per Unit, corresponding to SEK 0.1 per new share (current quota value of the shares).
Each (1) warrant of series TO2 shall entitle to subscription of one (1) new share in the Company at a subscription price corresponding to 70 per cent of the average volume-weighted share price of the Company’s share during the period from November 3, 2023 up to and including November 16, 2023, however, not less than the shares then current quota value rounded up to two decimals and not more than SEK 0.15 per share. Subscription of shares with warrants of series TO2 shall take place in accordance with the terms and conditions for the warrants during the period from November 20, 2023, up to and including December 1, 2023.
Each (1) warrant of series TO3 shall entitle to subscription of one (1) new share in the Company at a subscription price corresponding to 70 per cent of the average volume-weighted share price of the Company’s share during the period from February, 1 2024 up to and including February 15, 2024, however, not less than the shares then current quota value rounded up to two decimals and not more than SEK 0.15 per share. Subscription of shares with warrants of series TO3 shall take place in accordance with the terms and conditions of the warrants during the period from February 19, 2024, up to and including March 1, 2024.
If all of the Units are not subscribed for with unit rights, the board of directors shall, up to the maximum amount of the Rights Issue, resolve on allocation of Units which have been subscribed for without unit rights, in accordance with the following allocation principles:
The Board intends to propose to the Extraordinary General Meeting on July 27, 2023, to approve the board's decision that the share capital should increase by a total of no more than SEK 132,551,302.40 from SEK 12,050,118.40 to SEK 144,601,420.80 (of which a maximum of SEK 72,300,710.40 is attributable to an increase due to the Issue of shares and a maximum of SEK 60,250,592.00 is attributable to an increase due to the Issue of warrants), through a new issue of a maximum of 120,501,184 Units with preferential rights for existing shareholders according to the following conditions.
Upon full subscription in the Rights Issue, the share capital will initially increase by a maximum of 72,300,710.40 SEK to 84,350,828.80 SEK by issuing a maximum of 723,007,104 new shares, which results in the total number of outstanding shares in the Company increasing from 120,501,184 to 843,508,288.
In case of full subscription in the Rights Issue and full utilization of all warrants of series TO2 and series TO3 issued in the Rights Issue, the share capital will increase by a further maximum of SEK 60,250,592.00 to SEK 144,601,420.80 by issuing a maximum of 602,505,920 new shares, which results in the total number of outstanding shares in the Company increasing further from 843,508,288 to 1,446,014,208.
Shareholders who choose not to participate in the Rights Issue will, on condition that the Rights Issue is fully subscribed, have their shares diluted by approximately 85.7 per cent. Nevertheless, they have the opportunity to financially compensate for this dilution by selling their unit rights. Furthermore, shareholders who choose not to exercise their warrants, provided that the Rights Issue is fully subscribed and the warrants are fully exercised, will have their shares diluted by an additional approximately 47.2 per cent.
The Board has the right to extend the subscription and payment period. The subscription period runs from August 2, 2023, until August 16, 2023. Trading in unit rights takes place on Nasdaq First North from August 2, 2023, to August 11, 2023, and trading in BTUs (paid subscribed Units) takes place from August 2, 2023, until the Rights Issue is registered with the Swedish Companies Registration Office (Sw. Bolagsverket).
Full terms and conditions for the Rights Issue and other information about NeoDynamics will be presented in the prospectus, which is expected to be published by the Company on its website, www.neodynamics.com, around July 31, 2023.
Subscription undertakings and guarantee commitments
NeoDynamics has received subscription undertakings from a selection of the Company’s major existing shareholders, including Gryningskust, Rentability Sweden AB, and members of the Company’s board and management team, amounting to approximately SEK 14 million, corresponding to about 19.2 per cent of the Rights Issue. Furthermore, the Company has entered into an agreement on guarantee commitments which consists partly of a so-called bottom guarantee of approximately SEK 32 million, corresponding to about 44 per cent of the Rights Issue, as well as a so-called top guarantee of approximately SEK 12 million, corresponding to about 17 per cent of the Rights Issue. The bottom guarantee ensures, provided that subscription takes place at least corresponding to the subscription undertakings, that approximately 63 per cent of the Rights Issue is subscribed for. The top guarantee ensures, provided that subscription corresponds to at least the subscription undertakings and the bottom guarantee, that approximately 80 per cent of the Rights Issue is subscribed for. Gryningskust, owned by Johan Thorell, and Rentability Sweden AB, owned by the chairman of the board Ingrid Salén, has undertaken to guarantee SEK 11.6 million and SEK 0.8 million respectively in the top guarantee. For the bottom guarantee a guarantee fee of 12per cent of the guaranteed amount is paid in cash compensation, alternatively an optional compensation of 14 per cent in the form of Units. In the event guarantors choose compensation in the form of Units, this will be carried out as a directed issue of Units after the completion of the Rights Issue. No compensation is paid for the top guarantee or for subscription commitments.
Gryningskust, who owns shares corresponding to approximately 14 per cent of the total number of shares and votes in the Company, has in connection to the rights issue entered into a subscription- and guarantee commitment with the Company. Upon fulfilment of its subscription- and guarantee undertaking as well as exercising the warrants received, Gryningskust may hold more than 30 percent of the shares and votes in the Company. Gryningskust has been granted an exemption by the Swedish Securities Council (Sw. Aktiemarknadsnämnden) from the mandatory bid obligation in the event that Gryningskust' shareholding in the Company by fulfilling its subscription- and guarantee undertaking as well as exercise of the warrants received would equal or exceed 30 percent of the votes in the Company. Conditions for the Swedish Securities Council’s decision to grant Gryningskust an exemption from the mandatory bid obligation are that the shareholders, before the general meeting, are informed of the maximum capital and voting rights that Gryningskust can receive as a result of its guarantee undertaking as well as exercise of the warrants received, and that the resolution on the rights issue is approved by shareholders holding not less than two-thirds of both the votes cast and the shares represented at the general meeting, excluding the shares held and represented by Gryningskust at the general meeting. The maximum portion of the capital and voting rights that Gryningskust can receive in case the guarantee undertaking should be utilised in full and the warrants exercised in full is 49.69 percent, provided that no one else exercises warrants.
Preliminary timeline for the Rights Issue
July 27, 2023 | Extraordinary General Meeting |
July 27, 2023 | Last day of trading in the share incl. preferential rights |
July 28, 2023 | First day of trading in the share excl. preferential rights |
July 31, 2023 | Estimated date for publication of the prospectus |
July 31, 2023 | Record date in the Rights Issue |
August 2, 2023 – August 11, 2023 | Trading in unit rights |
August 2, 2023 – August 16, 2023 | Subscription period |
August 2, 2023 – Until the Rights Issue is registered with the Swedish Companies Registration Offices | Trading in paid subscribed Units (Sw. “BTU”) |
August 31, 2023 | Estimated date for publication of the outcome in the Rights Issue |
Publication of the Company’s Q2 report in 2023
Due to the Rights Issue, the Board of Directors of NeoDynamics has decided to advance the publication of the Company’s Q2 report to July 31, 2023, instead of August 17, 2023, as previously communicated.
Extraordinary General Meeting
An extraordinary general meeting is planned to be held on Thursday, July 27, 2023. The Board’s proposal for resolutions includes, in addition to the Rights Issue, decisions on (i) new articles of association and (ii) authorization for the Board to resolve on the new Issue of shares, and (iii) reduction of share capital. For further information, please see the separate press release with the extraordinary general meeting notice.
Prospectus
Complete conditions and instructions for the Rights Issue and other information about the Company and subscription undertakings and guarantee commitments will appear in the prospectus that the Company is expected to publish around July 31, 2023.
Advisers
Redeye AB is a financial advisor in connection with the Rights Issue. Advokatfirman Lindahl KB acts as legal advisor to NeoDynamics in connection with the Rights Issue. Nordic Issuing AB acts as the issuing agent in connection with the Rights Issue.
For further information, please contact:
Anna Eriksrud, CEO NeoDynamics AB, phone 708 444 966 or e-mail anna.eriksrud@neodynamics.com
Aaron Wong, CFO NeoDynamics AB, phone 735 972 011 or e-mail aaron.wong@neodynamics.com
About NeoDynamics
NeoDynamics AB (publ) is a Swedish Medical Technology Company dedicated to advancing diagnosis and care of cancer. The company’s first product NeoNavia®, a new innovative pulse biopsy system for ultrasound-guided tissue sampling, is currently being introduced to the market. NeoNavia® is CE approved, and in September 2022, received a 510k approval from the FDA. The biopsy system is built on a patented pulse technology, based on research at the Karolinska Institutet in Sweden. NeoNavia is evaluated for breast cancer diagnosis at leading clinics in Europe and launches in USA during 2023. NeoDynamic’s shares are listed on Nasdaq First North Growth Market Stockholm (ticker: NEOD). The company’s Certified Adviser is Redeye AB.
About NeoNavia®
NeoNavia® is the trade name for the complete biopsy system intended for use in ultrasound-guided sampling. NeoNavia® consists of a base unit, a hand unit, and three types of biopsy needles. The pulse technology drives the respective needle type, which facilitates needle insertion and placement in the suspected tumor. The system is designed to offer physicians and patients precise and robust tissue sampling for accurate diagnosis and individualized treatment.
About the pulse technology
The patented pulse technology is based on a pneumatically driven mechanism that enables high precision and control when inserting and positioning the biopsy needle, regardless of tissue type. The pneumatic drive unit that generates pulses is located in a hand-held instrument. With power from the base unit, the hand-held driver accelerates the biopsy needle with great control, even over short distances, enabling a distinct step-by-step insertion without affecting the surrounding tissue. This enables good access and flexibility in sampling, even in tiny and tricky localized tumors.
For more information, please visit Neodynamics.com.
IMPORTANT INFORMATION
The information in this press release neither contains nor constitutes an offer to acquire, subscribe or otherwise trade in shares, warrants, or other securities in NeoDynamics. No action has been taken, and no action will be taken to permit an offer to the public in any jurisdiction other than Sweden.
This press release is not a prospectus within the meaning of the Prospectus Regulation (EU) 2017/1129 (the "Prospectus Regulation") and has not been approved by any regulatory authority in any jurisdiction. This press release neither identifies nor purports to identify risks (direct or indirect) that may be associated with an investment in shares, warrants, or other securities in NeoDynamics. A prospectus will be prepared in connection with the Rights Issue, and it will also be reviewed and approved by the Swedish Financial Supervisory Authority (Sw. Finansinspektionen) as the competent authority in Sweden following the Prospectus Regulation. Any investment decision should be made solely based on the prospectus’s information in order for an investor to fully understand the potential risks and benefits associated with the decision to participate in the Rights Issue. An investor is therefore advised to read the entire prospectus. This press release constitutes marketing following Article 2 k of the Prospectus Regulation.
The information contained in this press release may not be disclosed, published, or distributed, directly or indirectly, within or to the United States, Australia, Belarus, Hong Kong, Japan, Canada, New Zealand, Russia, Switzerland, Singapore, South Africa, South Korea or any other jurisdiction where such action would be illegal, subject to legal restrictions or require measures other than those that follow from Swedish law. Actions contrary to this instruction may constitute a violation of applicable securities legislation. No shares, warrants, or other securities of NeoDynamics have been registered, and no shares, warrants, or other securities will be registered, under the United States Securities Act of 1933 (the “Securities Act”) or the securities laws of any state or other jurisdiction from time to time. In the United States and may not be offered, sold, or otherwise transferred, directly or indirectly, in or to the United States, except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and pursuant to securities laws in the relevant state or other jurisdiction of the United States.
Within the European Economic Area ("EEA"), no offer of shares, warrants or other securities ("Securities") is made to the public in any country other than Sweden. In other member countries of the European Union (“EU”), such an offer of Securities can only be made in accordance with exceptions in the Prospectus Regulation (EU) 2017/1129. In other countries in the EEA that have implemented the Prospectus Regulation in national legislation, such an offer of Securities can only be made in accordance with exceptions in the Prospectus Regulation and in accordance with any relevant implementation measure. In other countries in the EEA that have not implemented the Prospectus Regulation in national legislation, such an offer of Securities can only be made in accordance with the applicable exception in national legislation.
In the United Kingdom, this document, and other materials relating to the securities referred to herein, are distributed and directed only to, and an investment or investment activity attributable to this document is only available to and will only be able to be exercised by “qualified investors” (in a sense in the UK version of Regulation (EU) 2017/1129 which is part of UK legislation by the European Union (Withdrawal) Act 2018) who are (i) persons who have professional experience in dealings relating to investments and who fall within the definition of “ investment professionals” in Article 19(5) of the UK Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Regulation”); (ii) “high net worth entities” etc. as referred to in Article 49(2)(a)-(d) of the Regulation; or (iii) such other persons to whom such investment or investment activity may lawfully be directed under the Regulations (all such persons are collectively referred to as “relevant persons”). An investment or an investment measure to which this notice relates is available in the United Kingdom only to relevant persons and will only be carried out with relevant persons. Persons who are not relevant persons shall not take any action based on this document nor act or rely on it.
This press release may contain certain forward-looking information that reflects the Company's current view of future events as well as financial and operational development. Words such as “intends”, “estimates", “expects", “may", “plans", "believes", "estimates" and other expressions that imply indications or predictions of future developments or trends, and are not based on historical facts, constitute forward-looking information. Forward-looking information is inherently associated with known and unknown risks and uncertainties because it depends on future events and circumstances. Forward-looking information does not guarantee future performance or development, and actual outcomes may differ materially from what is stated in the forward-looking information.
Redeye AB is acting as financial advisor to NeoDynamics in connection with the transaction and not to anyone else and will not be liable to anyone other than NeoDynamics for providing the protection provided to its customers or for providing advice in connection with the transaction or otherwise matter referred to herein.
The English text is an unofficial translation of the original Swedish text. In case of
any discrepancies between the Swedish text and the English translation, the
Swedish text shall prevail.