Ghent, Belgium, 7 March 2022 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, announces today the launch of an equity offering to raise an amount of approximately up to EUR 28 million by means of a private placement via an accelerated bookbuild offering (the “Offering“), with the possibility to increase the size of the Offering.

Sequana Medical currently envisages using the net proceeds of the Offering for:

• POSEIDON, the North American pivotal study of the alfapump® in recurrent and refractory liver ascites with primary endpoint read-out planned for Q4 2022 and progressing the study towards secondary endpoint readout planned for Q2 2024. The total study cost is estimated at approximately EUR 12.2 million of which EUR 5.8 million has been spent up to H1 2021;

• activities for the preparation of the PMA (Pre-Market Approval) of the alfapump, with planned submission to the FDA mid-2023. The total project cost is estimated at approximately EUR 6.9 million of which EUR 0.9 million has been spent up to H1 2021;

• completion of SAHARA DESERT study, the alfapump DSR® study in decompensated heart failure patients, to enable reporting of top line data in H2 2022. The total study cost is estimated at approximately EUR 2.2 million of which EUR 0.3 million has been spent up to H1 2021;

• completion of development work for DSR Infusate 2.0 to enable use in the MOJAVE DESERT clinical study. The total study cost is estimated at approximately EUR 1.6 million of which EUR 0.1 million has been spent up to H1 2021;

• the initiation of MOJAVE DESERT, the first U.S. feasibility study for Short-term DSR® therapy with DSR infusate 2.0, expected in H2 2022. The total study cost is estimated at approximately EUR 3.1 million of which EUR 0 has been spent up to H1 2021;

• for working capital and other general corporate purposes.
  

The net proceeds from the Offering are expected to extend the current cash runway of the Company from Q2 2022 into Q2 2023.

 

Details of the Offering

The Offering shall be structured as an accelerated bookbuilding, and the bookbuilding procedure will commence immediately.

The Company will announce the results of the Offering as soon as possible after closing of the bookbuilding in a subsequent press release (including the final number of the new shares to be issued and the offer price).

Trading in Sequana Medical shares on Euronext Brussels will be suspended during the bookbuilding period. Trading in the shares is expected to resume following the publication of the results of the Offering.

KBC Securities NV (“KBC Securities“), Bank Degroof Petercam NV/SA (“Bank Degroof Petercam“), and Belfius Bank NV/SA (acting together with its subcontractor Kepler Cheuvreux S.A.) (“Belfius“, and together with KBC Securities and Bank Degroof Petercam, the “Underwriters“) are acting as Joint Global Coordinators of the Offering.

Partners in Equity V B.V. (“PiE”) (an experienced investor who invests amongst others in the healthcare sector) has committed to submit a subscription order in the Offering for an amount of EUR 20 million. In addition, Dr. Erik Amble, a director of the Company, committed to submit a subscription order for new shares in the Offering for an amount of EUR 100,000. The subscription commitment of PiE is subject (amongst other things) to the condition that the Company shall allocate to PiE the maximum number of whole new shares that can be subscribed for at the applicable issue price for the commitment amount of EUR 20 million (the “Guaranteed Allocation”). Without prejudice to the Guaranteed Allocation, the Offering is open to institutional, qualified, professional and/or other investors, as permitted under applicable private placement exemptions, and any final allocation to investors, as the case may be, will be made based on customary objective and pre-identified criteria. Other than the aforementioned Guaranteed Allocation to PiE, no guarantee will be or has been given as to the final allocation to any other investors, shareholders or persons, that any allocation will be made to them, or as to the size of any such allocation.

The Company also agreed that, provided the closing of the Offering has occurred and PiE has complied with its commitment, and for as long as PiE owns 5% of the shares in the Company, PiE shall have the right to have a non-voting board observer at the board of directors of the Company.

It is currently anticipated that the number of shares to be issued in the Offering shall exceed the number of shares that can be admitted to listing and trading on the regulated market of Euronext Brussels without listing prospectus. PiE and Dr. Erik Amble agreed that the Company and the Underwriters will have the ability to allocate new shares that shall not be immediately admitted to listing and trading upon their issuance. In such case, the Company undertakes to apply to Euronext Brussels for the admission to trading and listing of those unlisted new shares, as soon as practicable after their issuance.

In relation to the Offering, the Company has agreed with the Underwriters to a 180-days standstill period on future share issuances waivable by the Underwriters and subject to (i) an exception for the issuance of a number of shares, subscription rights or other securities exercisable, convertible or exchangeable for shares up to 7.5% of the Company’s outstanding shares after the Offering pursuant to alternative or additional funding obtained by the Company, and (ii) other customary exceptions. The members of the executive management have agreed with the Underwriters to a market customary 180-days lock-up period waivable by the Underwriters and subject to customary exceptions.

 

Additional Information

The following information is provided, as far as needed and applicable, pursuant to Article 7:97, §4/1 of the Belgian Companies and Associations Code.

As mentioned above, Dr. Erik Amble, a director of the Company, is supportive of the Offering and committed to submit a subscription order for new shares in the Offering for an amount of EUR 100,000 Dr. Erik Amble also agreed to be allocated shares that are not immediately admitted to listing, as aforementioned.

As a director of the Company, Dr. Erik Amble is a “related party” in the sense of the International Financial Reporting Standards, as adopted by the European Union (IFRS), as referred to in Article 7:97 of the Belgian Companies and Associations Code. In view hereof, the board of directors of the Company applied, as far as needed and applicable, the procedure of Article 7:97 of the Belgian Companies and Associations Code in connection with the commitment by Dr. Amble. Dr. Amble did not participate in the deliberation and voting by the board of directors in relation to the Offering.

Within the context of the aforementioned procedure, prior to the launch of the Offering, a committee of three independent directors of the Company (the “Committee“) issued an advice to the board of directors in which the Committee assessed the participation of Dr. Amble in the Offering. In its advice to the board of directors, the Committee concluded the following: “The Committee believes that the envisaged transaction, including the commitment of Dr. Erik Amble, is in the interest of the Company and of its shareholders, and is not manifestly abusive. The commitment from Dr. Erik Amble provides evidence of the personal support for the Company’s business and strategy by an existing director of the Company. The commitment is therefore an important means that can be used in the solicitation of interest with other potential investors for the purpose of the envisaged capital raising. While the envisaged capital raising may entail a dilution for the shareholders and holders of subscription rights (share options) of the Company, a successful capital raising would be in the interest of the Company as, amongst other things, it would allow the Company to have access to equity financing in a fast and efficient manner to fund its activities and its ongoing working capital requirements. The Committee also notes that the Company did not undertake to a guaranteed allocation of new shares to Dr. Erik Amble. The Committee notes in particular that, subject to the launch of the transaction, the offering will be open to institutional, qualified, professional and/or other investors as permitted under the applicable private placement exemptions, and that any final allocation to investors in excess of any guaranteed allocation will be made on the basis of customary objective and pre-identified criteria, and that upon successful completion of the capital raising, the same issue price of the new shares shall apply to all investors to which shares will be allocated, as the case may be. In view hereof, the Committee issues a favourable and unqualified opinion to the board of directors of the Company.”

The Company’s board of directors did not deviate from the Committee’s favourable and unqualified conclusion. The Company’s statutory auditor’s assessment of the Committee’s opinion and the minutes of the Company’s meeting of the board of directors relating to the Offering, is as follows:

“The procedures performed are as follows:

• Validated that the financial and accounting data stated in the opinion of the Committee of independent directors dated 7 March 2022 are consistent with the underlying accounting records;

 

• Validated that the financial and accounting data stated in the minutes of the Board of Directors dated 7 March 2022 are consistent with the underlying accounting records.

On the basis of our procedures, as described in this report, we have no exceptions to be noted.”

A copy of the reports that were prepared by the Company’s board of directors and statutory auditor in accordance with Article 7:198 juncto Articles 7:179, 7:191 and 7:193 of the Belgian Companies and Associations Code will be available on the Company’s website upon completion of the Offering.

 

For more information, please contact:

Sequana Medical

Lies Vanneste, Director Investor Relations Tel: +32 (0) 498 05 35 79
Email: IR@sequanamedical.com

LifeSci Advisors

Guillaume van Renterghem
Tel: +41 79 367 6254
Email: gvanrenterghem@lifesciadvisors.com

 

About Sequana Medical
Sequana Medical is a commercial stage medical device company utilizing its proprietary alfapump® and DSR® (Direct Sodium Removal) technologies to develop innovative treatments for fluid overload in liver disease, malignant ascites and heart failure where diuretics are no longer effective. Fluid overload is a frequent complication of many large diseases – including advanced liver disease driven by NASH (nonalcoholic steatohepatitis)-related cirrhosis and heart failure – with diuretic resistance being widespread. The U.S. market for the alfapump resulting from NASH-related cirrhosis is forecast to exceed €3 billion annually within the next 10-20 years. The heart failure market for DSR and the alfapump DSR® is estimated to be over €5 billion annually in the U.S. and EU5 by 2026.

The alfapump is Sequana Medical’s unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination. DSR is Sequana Medical’s proprietary approach to managing sodium and fluid overload through use of a sodiumfree infusate administered into the abdominal cavity.

In the U.S., the Company’s key growth market, the alfapump has been granted breakthrough device designation by the FDA for recurrent or refractory ascites due to liver cirrhosis. Interim data from the ongoing North American pivotal study (POSEIDON) showed positive outcomes against all primary endpoints and a rapid and persistent clinically important improvement in quality of life. All patients have been enrolled in the study and primary endpoint reporting is planned for Q4 2022. This study is intended to support a future marketing application of the alfapump in the U.S. and Canada. In Europe, the alfapump is CE-marked for the management of refractory ascites due to liver cirrhosis and malignant ascites and is included in key clinical practice guidelines. Over 900 alfapump systems have been implanted to date.

Sequana Medical has combined its proven alfapump and proprietary DSR therapy, and is developing the alfapump DSR, a breakthrough approach to fluid overload due to heart failure. RED DESERT demonstrated that repeated DSR therapy in diuretic-resistant heart failure patients is able to manage their fluid and sodium balance, improve their cardio-renal status and restore their diuretic response for months posttreatment. Interim results from the ongoing SAHARA DESERT study of alfapump DSR in decompensated heart failure patients indicated a safe, effective and rapid elimination of persistent congestion and restoration of euvolemia, together with a considerable benefit in cardio-renal status and a dramatic improvement in diuretic responsiveness. Reporting of top-line data is planned for H2 2022.

Sequana Medical is headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.

 

Important Regulatory Disclaimers:
The alfapump® system is not currently approved in the United States or Canada. In the United States and Canada, the alfapump® system is currently under clinical investigation (POSEIDON Study) and is being studied in adult patients with refractory or recurrent ascites due to cirrhosis. For more information regarding the POSEIDON clinical study see www.poseidonstudy.com. The DSR® therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. The DSR therapy is not currently approved for clinical research in the United States or Canada. There is no link between the DSR® therapy and ongoing investigations with the alfapump® system in Europe, the United States or Canada.

Note: alfapump® is a registered trademark. DSR® is a registered trademark in Australia, the Benelux, the EU, United Kingdom, Hong Kong, Israel, Norway, and Switzerland. alfapump DSR® is a registered trademark in Australia, the Benelux, China, the EU, United Kingdom, Hong Kong, Israel, New Zealand, and Norway.

 

Important information:

The information contained in this announcement is for general information only and does not purport to be full or complete. This announcement does not constitute, or form part of, an offer to sell or issue, or any solicitation of an offer to purchase or subscribe for shares, and any purchase of, subscription for or application for, shares. This announcement and the information contained herein are not for publication, distribution or release in, or into, directly or indirectly, the United States of America, Australia, Canada, Japan, South Africa or any other jurisdiction where to do so would be prohibited by applicable law or require registration thereof in, such jurisdiction. Any persons reading this announcement should inform themselves of and observe any such restrictions.

This announcement is not for distribution, directly or indirectly, in or into the United States. It does not constitute or form a part of any offer or solicitation to purchase or subscribe for securities in the United States. The securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended from time to time (the “U.S. Securities Act“), and the securities may not be offered or sold in the United States (as defined in Regulation S under the U.S. Securities Act) unless these securities are registered under the U.S. Securities Act, or an exemption from the registration requirements of the U.S. Securities Act is available. The Company and its affiliates have not registered, and do not intend to register, any portion of the offering of the securities concerned in the United States, and do not intend to conduct a public offering of securities in the United States.

Any offer of securities to which this announcement relates is only addressed to and directed at persons in the United Kingdom and member states of the European Economic Area (the “EEA“) (each a “Member State“) who are “qualified investors” within the meaning of Article 2(e) of Regulation 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC, as amended from time to time, to the extent implemented in the relevant Member State of the EEA and any implementing measure in each relevant Member State of the EEA or, for the United Kingdom, as it forms part of retained EU law as defined in the EU (Withdrawal) Act 2018 (the “Prospectus Regulation“) (“Qualified Investors“), or such other investors as shall not constitute an offer to the public within the meaning of Article 3.1 of the Prospectus Regulation. Each person in the United Kingdom or a Member State who initially acquires any of the Company’s securities or to whom any offer of the Company’s securities may be made and, to the extent applicable, any funds on behalf of which such person is acquiring the Company’s securities that are located in the United Kingdom or a Member State will be deemed to have represented, acknowledged and agreed that it is a Qualified Investor.

In addition, any offer of securities to which this announcement relates is in the United Kingdom, being distributed only to, and is directed only at, (i) persons who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended from time to time (the “Order“), (ii) high net worth entities etc. falling within Article 49(2)(a) to (d) of the Order, and (iii) any other person to whom it may otherwise lawfully be communicated (all such persons together being referred to as “relevant persons”). The offering of securities to which this announcement relates will only be available to, and any invitation, offer or agreement to subscribe for, purchase, or otherwise acquire securities will be engaged in only with relevant persons. Any person who is not a relevant person should not act or rely on this announcement or any of its contents.

In Switzerland, any offer of securities to which this announcement relates is only addressed and directed to ‘professional clients’ (as defined in the Swiss Federal Act on Financial Services (Finanzdienstleitungsgesetz) of 15 June 2018, as amended (the “FinSa“).

This communication is not a prospectus for the purposes of the Prospectus Regulation. This communication cannot be used as basis for any investment agreement or decision. Acquiring investments to which this announcement relates may expose an investor to a significant risk of losing the entire amount invested. Persons considering making such investments should consult an authorised person specialising in advising on such investments. This announcement does not constitute a recommendation concerning the securities referred to herein.

No announcement or information regarding the offering, listing or securities of the Company referred to above may be disseminated to the public in jurisdictions where a prior registration or approval is required for such purpose. No steps have been taken, or will be taken, for the offering or listing of securities of the Company in any jurisdiction where such steps would be required, except for the admission of the offered shares on the regulated market of Euronext Brussels. The issue, exercise, or sale of, and the subscription for or purchase of, securities of the Company are subject to special legal or statutory restrictions in certain jurisdictions. The Company is not liable if the aforementioned restrictions are not complied with by any person.

Certain statements, beliefs and opinions in this announcement are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ current expectations and projections concerning future events such as the Company’s results of operations, financial condition, liquidity, performance, prospects, growth, strategies and the industry in which the Company operates. By their nature, forward- looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this announcement regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this announcement, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward- looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this announcement as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward- looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this announcement or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this announcement.

 

Information to Distributors:

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended from time to time (“MiFID II“); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements“), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any ‘manufacturer’ (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the offered shares have been subject to a product approval process, which has determined that the offered shares are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment“). Notwithstanding the Target Market Assessment, distributors should note that: the price of the offered shares may decline and investors could lose all or part of their investment; the offered shares offer no guaranteed income and no capital protection; and an investment in the offered shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Offering. Furthermore, it is noted that, notwithstanding the Target Market Assessment, the Underwriters will only procure investors who meet the criteria of professional clients and eligible counterparties.

For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the offered shares.

Each distributor is responsible for undertaking its own target market assessment in respect of the offered shares and determining appropriate distribution channels.

The Underwriters are acting exclusively for the Company and no one else in connection with the Offering. In connection with such matters, they, their affiliates and their respective directors, officers, employees and agents will not regard any other person as their client, nor will they be responsible to any other person for providing the protections afforded to their clients or for providing advice in relation to the Offering or any other matters referred to in this announcement.