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Several Trials of Co.’s Fluid Pump To Read Out This Year


September 14, 2022 ( Newswire) Positive topline data could boost the share price of this Swiss medical device firm, noted an H.C. Wainwright & Co. report.

Sequana Medical NV (SEQUA:EBR) expects to read out three studies evaluating its implantable alfapump system, designed to manage body fluid overload, by year-end 2022, reported H.C. Wainwright & Co. analyst Dr. Yi Chen in a September 9, 2022 research note.

“We believe positive data from these studies could significantly increase the valuation of the company,” Chen wrote.

Topline results are expected in Q4/22 of the POSEIDON study in patients with recurrent and refractory ascites due to liver cirrhosis, noted Chen. If data are positive, Sequana could file a premarket approval application with the U.S. Food and Drug Administration in H2/23 for the alfapump in this indication.

By year-end, results are also due out from the SAHARA DESERT study of the alfapump DSR (direct sodium removal) and DSR 2.0 in decompensated heart failure patients, wrote Chen.

Additionally, Sequana intends to extend SAHARA DESERT to evaluate alfapump DSR 2.0, and results from this short-duration study are due to read out by year-end 2022, too.

Chen relayed that because DSR 2.0 was designed to have a better safety profile than DSR 1.0, Sequana plans to submit to the FDA an investigational new drug application for DSR 2.0 without the alfapump for a future study MOJAVE DESERT that could commence in H1/23. MOJAVE would evaluate, in about 30 diuretic-resistant chronic heart failure patients, short-term DSR with DSR 2.0 administered via a peritoneal catheter plus standard of care therapy versus standard of care therapy alone.

Also, in his report, Chen summarized Sequana’s financials for Q1/22 ending June 30, 2022, highlighting the company beat H.C. Wainwright’s estimates.

Specifically, Sequana’s Q1/22 revenue was EUR0.46 million (EUR0.46M), up from EUR0.02M a year earlier and higher than H.C. Wainwright’s forecast of EUR0.03M. Chen ascribed the beat to “resumed commercial activity in Europe as COVID impact declines.”

Despite the boost in revenue, cash flow from operations was -EUR13.7M, and the company’s net loss for the quarter was higher than H.C. Wainwright’s projection, at EUR14.9M versus EUR12.6M.

As for cash, Sequana had EUR23.8M at quarter’s end and expects to get EUR10M later this month from a loan facility; Chen relayed and noted the combined amounts should be sufficient to fund operations into Q3/23.

H.C. Wainwright has a Buy rating and a EUR16 per share price target on Sequana, the current share price of which is about EUR5.70.


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Disclosures For H.C.Wainwright & Co., Sequana Medical NV, September 9, 2022

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.

I, Yi Chen, Ph.D. CFA and Raghuram Selvaraju, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst’s household has a financial interest in the securities of Sequana Medical NV (including, without limitation, any option, right, warrant, future, long or short position). As of August 31, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Sequana Medical NV. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The Firm or its affiliates did not receive compensation from Sequana Medical NV for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

The Firm does not make a market in Sequana Medical NV as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously.

No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report.

H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report. H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.

The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

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