Sequana Medical — New funding to support clinical progression

Sequana Medical (BRU: SEQUA)

Last close As at 08/11/2024

2.95

0.14 (4.98%)

Market capitalisation

83m

More on this equity

Research: Healthcare

Sequana Medical — New funding to support clinical progression

Sequana Medical has raised €15.8m through a private placement of new shares and subscription rights. Roughly 4.445m new shares were issued at €3.55/share, increasing the number of shares outstanding by 18.7%, along with 1.111m subscription rights exercisable at €5.1/share for up to five years as of 30 October 2023. The financing proceeds will be used to support clinical development and the regulatory advancement of Sequana’s two core programmes, the implantable alfapump device in patients with recurrent and refractory ascites (RRA), and its direct sodium removal (DSR) 2.0 programme for diuretic-resistant congestive heart failure (CHF). Management expects the funding to extend the company’s cash runway from mid-2023 into Q124. After revising our model and expenditure assumptions, we obtain a pipeline rNPV valuation of €334.1m (vs €344.3m previously).

Written by

Pooya Hemami

Analyst - Healthcare

Healthcare

Sequana Medical

New funding to support clinical progression

Funding update

Pharma and biotech

2 May 2023

Price

€3.33

Market cap

€93m

$1.1/€

Pro forma estimated net cash (€m) at 31 March 2023 (including April 2023 equity financing)

10.4

Shares in issue (including the additional 4.45m shares issued as part of the fund raise)

28.2m

Free float

45%

Code

SEQUA

Primary exchange

Euronext

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(32.3)

(39.9)

(48.0)

Rel (local)

(32.6)

(39.0)

(44.5)

52-week high/low

€7.4

€3.1

Business description

Based in Belgium, Sequana Medical develops products to treat diuretic-resistant fluid overload, a frequent complication of liver disease and heart failure. Its proprietary alfapump and DSR approaches aim to provide significant clinical and quality-of-life benefits in these fluid overload conditions.

Next events

Start MOJAVE US Phase I/IIa study for DSR 2.0

Q223

Alfapump PMA submission to US FDA

H223

Analyst

Pooya Hemami OD MBA CFA

+1 646 653 7026

Sequana Medical is a research client of Edison Investment Research Limited

Sequana Medical has raised €15.8m through a private placement of new shares and subscription rights. Roughly 4.445m new shares were issued at €3.55/share, increasing the number of shares outstanding by 18.7%, along with 1.111m subscription rights exercisable at €5.1/share for up to five years as of 30 October 2023. The financing proceeds will be used to support clinical development and the regulatory advancement of Sequana’s two core programmes, the implantable alfapump device in patients with recurrent and refractory ascites (RRA), and its direct sodium removal (DSR) 2.0 programme for diuretic-resistant congestive heart failure (CHF). Management expects the funding to extend the company’s cash runway from mid-2023 into Q124. After revising our model and expenditure assumptions, we obtain a pipeline rNPV valuation of €334.1m (vs €344.3m previously).

Year
end

Revenue
(€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/21

0.4

(24.4)

(1.36)

0.0

N/A

N/A

12/22

0.9

(30.9)

(1.37)

0.0

N/A

N/A

12/23e

0.7

(26.3)

(0.93)

0.0

N/A

N/A

12/24e

1.7

(28.1)

(0.99)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments. EPS are fully diluted.

Improved headroom to advance assets

Sequana still intends to submit a US premarketing approval (PMA) application for the alfapump in RRA in H223, which we estimate could lead to US market launch in H224. Given recent positive CHIHUAHUA data, the company plans to initiate the US MOJAVE Phase I/IIa study for DSR 2.0 in Q223. Management estimates it will spend €7.5m on allocated alfapump development during FY23–24 and €6.5m on DSR 2.0 between FY23 and FY25. Sequana announced some cost-reduction initiatives, including decelerating the MOJAVE study (which should push the top-line readout to 2025 vs prior H224 guidance), but it expects to still report data from the open-label non-randomized cohort by end-2023, a potential catalyst for a re-rating.

Runway further supported by loan terms’ amendment

Sequana also reported certain amendments to existing loan agreements with Kreos Capital (€10m, July 2022) and PMV Standaardleningen, Belfius Insurance and Sensinnovat BV (combined €6.7m, July 2020). These amendments enable the deferral of repayment timelines due before March 2024 (offset by an increase in fees), although full repayment remains due in September 2025.

Valuation: Updated for new financing

We have rolled our estimates forward and adjusted for forex ($1.10/€ vs $1.07/€ previously), a more gradual initial North American alfapump roll-out and the equity financing. We now obtain a pipeline rNPV of €334.1m versus €344.3m previously. After adding €10.4m pro forma Q123e net cash (ex lease liabilities), we obtain an equity valuation of €344.5m, or €12.22/share (€11.14 fully diluted given options outstanding) versus €14.59/share (€13.09 fully diluted) previously.

Financials and strategic considerations

We note that the effective price per share of the equity issue (€3.55 per share), without considering the attached subscription rights, reflected a 29.8% discount to the 24 April closing price of €5.06/share. In our view, this reflects particularly challenging market conditions for development-stage or early commercial-stage life sciences companies such as Sequana, despite material positive operational successes for the company in the past year, including positive primary efficacy endpoint data for alfapump in the North American POSEIDON pivotal study, positive SAHARA data for the DSR 1.0 product in diuretic-resistant CHF patients with persistent congestion, and positive preclinical GLP and CHIHUAHUA study data for the second-generation DSR 2.0 product candidate.

Sequana indicated in its financing pre-announcement that it is undertaking measures to reduce costs, including decelerating further progression of the MOJAVE study, which aims to enrol CHF patients with persistent congestion. We interpret its planned MOJAVE deceleration as meaning that the company will take more time to analyse and report data from the study’s open-label non-randomized cohort (planned enrolment of three patients), before proceeding with the randomized cohort (a total of 30 patients planned for enrolment including 20 to be randomised to DSR 2.0 on top of usual care and 10 to usual care alone). On 2 May 2023, the company reported that the US FDA had cleared its Investigational New Drug (IND) application for DSR 2.0 for the treatment of CHF. IND clearance enables the company to start the MOJAVE study in Q223 as planned. It expects the first patient to be enrolled in Q223 and data from the non-randomized cohort is anticipated by the end of 2023.

The company believes that interim efficacy data from these patients will likely be able to demonstrate proof-of-concept and provide an early indicator of the DSR 2.0’s potential efficacy in reducing congestion, given the very significant effects already shown for the first-generation product (DSR 1.0) in the SAHARA and RED DESERT studies. While we note that the sample size of the non-randomized cohort (n=3) is small, the company had already reported in SAHARA that all 10 evaluable patients from that study ‘safely, effectively and rapidly eliminated the persistent congestion and achieved euvolemia within one week of commencing intensive DSR therapy’. Hence, the non-randomized cohort of MOJAVE may provide a strong efficacy signal in terms of reducing congestion and restoring euvolemia. If this is the case, results from the non-randomized cohort may provide a meaningful clinical validation of the DSR 2.0 product and its method of administration (through a peritoneal catheter), which may provide the opportunity for a re-rating of the shares ahead of the company’s next fund-raising need window (we expect the company will likely seek additional funding in H124). Altogether we expect that top-line efficacy data from the randomized cohort will be reported in 2025, as opposed to prior guidance of H224. We believe the company also plans to report interim data on the randomized cohort, which may provide indications of efficacy prior to the top-line readout.

Sequana also signalled that it is delaying the establishment of a new production facility for the US alfapump programme, but this postponement should not affect the company’s planned US launch activities (assuming FDA approval) given its existing supply chain infrastructure and access to commercial production are still expected to meet US requirements. The company’s existing production facility in Switzerland is capacity-constrained to 1,000 units per year (which would reflect c €25m in annual revenue) and hence the rationale for an expanded production site would be to meet longer-term demand. We note that we do not expect alfapump volumes to approach 1,000 units per year until FY27. The company estimates it will take 2.0–2.5 years from identification to being ready and FDA-authorized for commercial production and hence we expect Sequana will likely wait for a more favourable funding environment (potentially in FY24–25) before working to expand its alfapump production capabilities. As it relates to its European alfapump commercial activities, the company indicates it is moving to a more ‘reactive’ than ‘proactive’ commercial stance, which we believe suggests it will reduce its alfapump-related marketing costs for the European market.

Given the above we have made some adjustments to our forecasts. We have reduced our FY23 and FY24 R&D expenditure estimates for MOJAVE and the DSR 2.0 programme and have deferred such costs into FY25. For alfapump in RRA in the North American market, we have pushed our launch expectation to H224 (vs mid-2024 previously) and we now also expect that the initial North American sales and marketing roll-out and sales growth ramp for the first 12–18 months will be more modest than previously assumed, although our peak North American alfapump sales forecasts are essentially unchanged. We now assume FY24 and FY25 North American alfapump sales of $1.1m and $5.5m, respectively, versus our prior assumptions of $2.4m and $10.2m.

We have also updated our financial model to reflect the €15.8m financing and updated forex rates ($1.10/€ vs $1.07/€ previously). For the DSR 2.0 programme, we are maintaining our estimate for a potential 2028 launch, but we believe there could be scope for our commercial timing forecasts to be pushed back, pending future capital availability and allocation decisions. Our previous forecasts already reflected relatively modest future alfapump sales gains for Europe, but we have now reduced our sales and marketing expenses for the region and have reduced our European alfapump sales growth forecasts to a long-term growth rate of 5% (vs 10% previously).

Altogether, we now assume the company’s operating cash burn rates for FY23 and FY24 will be €26.2m and €27.3m, respectively, versus our prior forecasts of €27.3m and €28.3m, respectively.

Sequana finished FY22 with €18.9m in gross cash and €16.7m in debt (including €4.5m in short-term borrowings and the drawing of a €10m loan from the Kreos financing facility in H222), excluding €0.9m in lease liabilities. After including the €15.8m April financing, we estimate a pro forma (at 31 March) gross cash position of €22.9m and a net cash position of €10.4m. Our local currency operating expense forecasts are essentially unchanged, as described in our prior note. We now expect the company’s funds on hand to be sufficient for it to maintain operations into Q124.

Given the April 2023 financing, we now expect the company will require an additional €105m, versus €120m previously, over the next few years until it starts to generate sustained positive operating cash flows (which we continue to expect in H128). As per our usual policy, we model all future fund-raising requirements as illustrative debt. We note the company has signalled it is assessing whether partnerships or licensing arrangements can be entered regarding its alfapump or DSR products to support their development or commercialisation. The company indicates that ‘no concrete plans are on the table’ but we believe that, given the current challenging fund-raising environment, the company may be more amenable to entering commercial transactions or licensing arrangements at earlier product development stages (we previously anticipated the company would await the reporting of MOJAVE interim data on the randomized cohort before considering commercial arrangements for the DSR 2.0 product).

Valuation

We have rolled our estimates forward and adjusted for forex ($1.10/€ vs $1.07/€ previously) and the equity financing. Given the above changes, we now obtain a pipeline rNPV of €334.1m versus €344.3m previously. After adding €10.4m pro forma Q123e net cash (ex lease liabilities), we obtain an equity valuation of €344.5m or €12.22/share (€11.14 fully diluted given options outstanding), versus €14.59/share (€13.09 fully diluted) previously.

Exhibit 1: Sequana Medical rNPV assumptions

Product contribution

Indication

Stage

NPV (€m)

Probability of success

rNPV (€m)

rNPV/ basic share (€)

Launch year

Sales in 2032 (€m)

alfapump in North America (net of R&D and SG&A costs)

Refractory and recurrent ascites and malignant ascites

Pivotal studying ongoing

263.6

80%

210.9

7.48

H224

189.9

alfapump in Europe and ex-NA regions (net of SG&A costs)

Refractory and recurrent ascites and malignant ascites

Commercial/ marketed

(1.5)

100%

(1.5)

(0.05)

2013

1.0

DSR 2.0 (short-term DSR)

Fluid overload in heart failure

Human feasibility studies

806.9

25%

190.7

6.77

2028

347.1*

Corporate costs

(66.0)

100%

(66.0)

(2.34)

Total

1,003.0

334.1

11.85

Pro-forma net cash (31 March 2023) excluding lease liabilities

10.4

10.4

0.37

Total equity value

1,013.3

344.5

12.22

Basic shares outstanding (000s) (following April 2023 equity offering)

28,192

Outstanding warrants and share options (000s)

2,722

Fully diluted shares outstanding (000s)

30,914

Source: Edison Investment Research. Note: *Reflects estimate of projected royalty revenue to Sequana Medical rather than end-market commercial sales.

As a sensitivity, our equity valuation per basic share would be adjusted to €7.53/share if we assume that our total assumed future funding need (€105m) is met through equity issuances at the current share price (c €3.33/share).

Exhibit 2: Financial summary

€’000s

2018

2019

2020

2021

2022

2023e

2024e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

1,029

971

963

371

923

673

1,738

Cost of Sales

(158)

(198)

(202)

(77)

(205)

(135)

(348)

Gross Profit

871

773

761

294

718

538

1,390

General & Administrative

(8,206)

(7,102)

(6,738)

(7,177)

(8,927)

(9,741)

(14,983)

Net Research & Development

(5,816)

(7,652)

(11,835)

(16,935)

(20,416)

(16,000)

(12,050)

Operating profit before exceptionals

(13,150)

(13,981)

(17,813)

(23,818)

(28,625)

(25,203)

(25,643)

EBITDA

 

 

(13,070)

(13,737)

(17,506)

(23,409)

(28,313)

(24,500)

(25,083)

Depreciation & other

(81)

(244)

(307)

(409)

(312)

(703)

(560)

Operating Profit (before amort. and except.)

(13,150)

(13,981)

(17,813)

(23,818)

(28,625)

(25,203)

(25,643)

Exceptionals including asset impairment

74

18

41

1,205

530

0

0

Operating Profit

(13,077)

(13,964)

(17,771)

(22,613)

(28,095)

(25,203)

(25,643)

Net Interest

(883)

(878)

(1,178)

(608)

(2,282)

(1,124)

(2,446)

Profit Before Tax (norm)

 

 

(14,033)

(14,859)

(18,991)

(24,426)

(30,907)

(26,327)

(28,089)

Profit Before Tax (FRS 3)

 

 

(13,960)

(14,841)

(18,949)

(23,221)

(30,377)

(26,327)

(28,089)

Tax

(24)

(136)

(157)

(393)

(387)

0

0

Profit After Tax and minority interests (norm)

(14,057)

(14,995)

(19,148)

(24,819)

(31,294)

(26,327)

(28,089)

Profit After Tax and minority interests (FRS 3)

(13,983)

(14,977)

(19,106)

(23,614)

(30,764)

(26,327)

(28,089)

Average Number of Shares Outstanding (m)

10.0

12.3

15.3

18.2

22.8

28.2

28.3

EPS - normalised (€)

 

 

(1.41)

(1.22)

(1.25)

(1.36)

(1.37)

(0.93)

(0.99)

EPS - normalised and fully diluted (€)

 

(1.41)

(1.22)

(1.25)

(1.36)

(1.37)

(0.93)

(0.99)

EPS - (IFRS) (€)

 

 

(1.40)

(1.22)

(1.25)

(1.30)

(1.35)

(0.93)

(0.99)

Dividend per share (€)

0.0

0.0

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

242

829

772

1,814

2,936

2,502

2,359

Tangible Assets

184

765

705

1,732

2,850

2,416

2,273

Investments in long-term financial assets

58

63

67

82

86

86

86

Current Assets

 

 

3,099

8,522

13,441

12,890

23,089

7,699

10,504

Short-term investments

0

0

0

0

0

0

0

Cash

1,318

5,586

11,016

9,600

18,875

7,413

9,649

Other

1,782

2,935

2,425

3,290

4,214

287

855

Current Liabilities

 

 

(18,727)

(5,315)

(5,966)

(7,180)

(15,149)

(10,086)

(10,250)

Creditors

(6,654)

(4,855)

(5,966)

(7,180)

(10,666)

(5,603)

(5,767)

Short term borrowings

(12,073)

(459)

0

0

(4,483)

(4,483)

(4,483)

Long Term Liabilities

 

 

(3,374)

(3,110)

(8,135)

(8,312)

(13,030)

(13,030)

(43,030)

Long term borrowings

(2,582)

(2,261)

(7,473)

(7,325)

(12,193)

(12,193)

(42,193)

Other long term liabilities

(792)

(849)

(662)

(987)

(837)

(837)

(837)

Net Assets

 

 

(18,760)

926

113

(788)

(2,154)

(12,915)

(40,417)

CASH FLOW

Operating Cash Flow

 

 

(8,987)

(17,596)

(15,791)

(22,786)

(24,822)

(25,060)

(24,901)

Net interest and financing income (expense)

(883)

(878)

(1,178)

(608)

(2,282)

(1,124)

(2,446)

Tax

(5)

(9)

(36)

(222)

(378)

0

0

Net Operating Cash Flow

 

 

(9,875)

(18,482)

(17,005)

(23,616)

(27,482)

(26,184)

(27,346)

Capex

(39)

(106)

(138)

(326)

(677)

(269)

(417)

Acquisitions/disposals

0

0

0

0

0

0

0

Financing (net of costs)

2

26,165

19,000

22,771

28,420

14,991

0

Dividends

0

0

0

0

0

0

0

Other

0

0

0

0

0

0

0

Net Cash Flow

(9,912)

7,576

1,857

(1,171)

261

(11,462)

(27,763)

Opening net debt/(cash)

 

 

0

13,337

(2,866)

(3,543)

(2,275)

(2,199)

9,263

HP finance leases initiated

0

0

0

0

0

0

0

Other

(3,425)

8,627

(1,179)

(97)

(337)

0

0

Closing net debt/(cash)

 

 

13,337

(2,866)

(3,543)

(2,275)

(2,199)

9,263

37,027

Lease debt

N/A

504

387

760

916

916

916

Closing net debt/(cash) inclusive of IFRS 16 lease debt

13,337

(2,362)

(3,157)

(1,515)

(1,283)

10,179

37,943

Source: Company reports, Edison Investment Research


General disclaimer and copyright

This report has been commissioned by Sequana Medical and prepared and issued by Edison, in consideration of a fee payable by Sequana Medical. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2023 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

General disclaimer and copyright

This report has been commissioned by Sequana Medical and prepared and issued by Edison, in consideration of a fee payable by Sequana Medical. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2023 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

More on Sequana Medical

View All

Latest from the Healthcare sector

View All Healthcare content

Research: Healthcare

Actinogen Medical — Continued focus on Xanamem

Actinogen’s Q323 update reiterated the company’s focus on advancing its lead asset Xanamem. Patient recruitment in the Phase IIa XanaCIDD study in cognitive impairment (CI) associated with major depressive disorder (MDD) is ongoing, and the company plans to start the Phase IIb portion of the XanaMIA study in Q2 CY23 in the company’s lead indication, Alzheimer’s disease (AD). This study portion is designed to assess Xanamem in a population of patients with mild CI and/or mild AD, who at baseline will have been confirmed as biomarker-positive for progressive AD. We continue to see the results from the XanaCIDD study (expected in late CY23 or early CY24) as the next major clinical data milestone and a potential share price catalyst. We expect the company’s A$12.3m cash balance at 31 March to fund operations into Q4 CY23.

Continue Reading

Subscribe to Edison

Get access to the very latest content matched to your personal investment style.

Sign up for free