Cereno Scientific — CS1 shines in Phase IIa PAH trial

Cereno Scientific (OMX: CRNO-B)

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Research: Healthcare

Cereno Scientific — CS1 shines in Phase IIa PAH trial

Cereno Scientific has reported positive top-line results for the Phase IIa CS1-003 trial, which evaluated the HDAC inhibitor CS1 in pulmonary arterial hypertension (PAH). The primary endpoint of safety and tolerability was met and, importantly, CS1 delivered encouraging results on exploratory efficacy measures, creating a strong foundation for the next steps of clinical development, in our view. The recently signed agreement with medical technology company Fluidda to visualise the impact of CS1 on the reverse remodelling of pulmonary vessels is another positive step and could bolster the data package for the candidate. With the recent preclinical data on CS014, Cereno now has two HDAC inhibitors in its portfolio with disease-modifying potential and we expect this to influence discussions with regulators, as well as potential partners. As management is planning a potentially pivotal Phase IIb/III trial, we raise our probability of success for CS1 to 40% (from 25%), resulting in our valuation for Cereno upgrading to SEK13.9/share from SEK9.1/share.

Jyoti Prakash

Written by

Jyoti Prakash

Analyst, Healthcare

Healthcare

Cereno Scientific

CS1 shines in Phase IIa PAH trial

Clinical update

Pharma and biotech

2 October 2024

Price

SEK7.38

Market cap

SEK2,074m

SEK10.14/US$

Net cash (SEKm) at 30 June 2024

40.2

Shares in issue

281.0m

Free float

93%

Code

CRNO B

Primary exchange

First North Growth Market

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

10.9

53.6

355.2

Rel (local)

10.5

51.2

265.9

52-week high/low

SEK7.23

SEK1.82

Business description

Cereno Scientific is a clinical-stage biotech based in Sweden, focused on the development of innovative, effective and safe treatments for cardiovascular diseases with unmet medical needs. Cereno’s lead asset CS1 is an HDAC inhibitor that acts as an epigenetic modulator. The company reported positive top-line results from the Phase IIa study in pulmonary arterial hypertension.

Next events

CS1: FDA clearance for pivotal study

H125

CS014: Phase I initial data

Mid-2025

Analysts

Jyoti Prakash, CFA

+44 (0)20 3077 5700

Dr Arron Aatkar

+44 (0)20 3077 5700

Cereno Scientific is a research client of Edison Investment Research Limited

Cereno Scientific has reported positive top-line results for the Phase IIa CS1-003 trial, which evaluated the HDAC inhibitor CS1 in pulmonary arterial hypertension (PAH). The primary endpoint of safety and tolerability was met and, importantly, CS1 delivered encouraging results on exploratory efficacy measures, creating a strong foundation for the next steps of clinical development, in our view. The recently signed agreement with medical technology company Fluidda to visualise the impact of CS1 on the reverse remodelling of pulmonary vessels is another positive step and could bolster the data package for the candidate. With the recent preclinical data on CS014, Cereno now has two HDAC inhibitors in its portfolio with disease-modifying potential and we expect this to influence discussions with regulators, as well as potential partners. As management is planning a potentially pivotal Phase IIb/III trial, we raise our probability of success for CS1 to 40% (from 25%), resulting in our valuation for Cereno upgrading to SEK13.9/share from SEK9.1/share.

Year end

Revenue (SEKm)

PBT*
(SEKm)

EPS*
(SEK)

DPS
(SEK)

P/E
(x)

Yield
(%)

12/22

0.0

(27.6)

(0.20)

0.0

N/A

N/A

12/23

0.0

(46.4)

(0.20)

0.0

N/A

N/A

12/24e

0.0

(58.9)

(0.21)

0.0

N/A

N/A

12/25e

0.0

(56.0)

(0.20)

0.0

N/A

N/A

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

Positive CS1 Phase IIa data pave the way forward

CS1 is a histone deacetylase HDAC inhibitor (HDACi) which aims to leverage the principles of epigenetic modulation to achieve disease modification. While CS1-003 (safety: n=25; efficacy: n=21) met its primary endpoint of safety and tolerability, we were encouraged by the strong efficacy signals: 43% of patients reported improved REVEAL risk scores (with 71% improved or stable), 33% of patients improved in functional class (with 86% improved or stable) and 67% of patients had sustained pressure reduction per mean pulmonary arterial pressure (mPAP, AUC) measured using Abbott’s CardioMEMS HF System. These results, together with previously presented data, are consistent with reverse remodelling and support further clinical development of CS1 as a potentially disease-modifying treatment for PAH.

CS014 preclinical data bolsters HDACi potential

While Cereno’s second asset, CS014, also an HDACi, is currently in a Phase I study for thrombosis prevention without increased risk of bleeding, the company recently presented encouraging new preclinical results from a well-established model of PAH, which showed a robust, dose-dependent reversal of pulmonary vascular remodelling, including statistically significant reductions in small artery vessel occlusion, plexiform lesions and small vessel-related fibrosis. Collectively, the results highlight a disease-modifying opportunity for CS014, bolstering Cereno’s HDACi programme.

Valuation: Upgraded to SEK3.9bn or SEK13.9/share

Following the positive Phase IIa results, we raise our probability of success for CS1 to 40%, from 25% previously. This results in our valuation for Cereno upgrading to SEK3.9bn or SEK13.9 per share (from SEK2.6bn or SEK9.1/share previously).

CS1 positioned for pivotal trials post Phase IIa results

CS1-003 is a randomised, open-label, blinded endpoint, multi-centre Phase IIa trial designed to evaluate the safety and tolerability of CS1 (primary endpoint), as well as pharmacokinetics (PK) and the exploratory efficacy of CS1 (Exhibit 1). A key feature of the trial is the collaboration with Abbott, enabling access to Abbott’s CardioMEMS heart failure (HF) System, which was implanted in patients and used to continuously monitor pulmonary pressure, alongside other measures of cardiopulmonary function.

Exhibit 1: CS1-003 trial design

Source: Cereno webcast presentation, September 2024

25 patients met the eligibility criteria and started in the study, and were included in the safety analyses for the trial. These 25 patients were randomised to one of the three doses: 480mg, 960mg or 1,920mg. Of the nine patients randomised to the 480mg arm, two were not evaluable, while in the 960mg and 1,920mg arms, one from each group was not evaluable. This gave seven evaluable patients in each arm of the study, all of which were included in the efficacy analyses as a pooled group due to PK observations that therapeutic drug exposure was achieved in the lowest dose group.

Green light on primary (safety and tolerability) endpoints

The CS1-003 trial was primarily intended to assess the safety and tolerability of CS1 treatment in patients with PAH (along with certain exploratory efficacy measures; study design discussed in detail later) for a 12-week treatment duration. The recently reported top-line results indicated that CS1 successfully met the primary endpoint of safety and tolerability, with no CS1-related serious adverse events at any of the administered dose levels (up to 1,920mg once a day) and only two patients discontinuing treatment due to treatment-emergent adverse events (TEAEs) (Exhibit 2). Moreover, administration of the drug did not result in clinically significant platelet reductions or bleeding events, nor were there any observed liver-related toxicities.

Exhibit 2: CS1-003 reports strong safety data

TEAEs

CS1 480mg QD
(n=9)

CS1 960mg QD
(n=8)

CS1 1,920mg QD
(n=8)

Overall
(n=25)

Any TEAEs

6 (66.7%)

5 (62.5%)

8 (100.0%)

19 (76.0%)

Serious TEAEs

2 (22.2%)

0 (0.0%)

0 (0.0%)

2 (8.0%)

Treatment-related TEAEs

2 (22.2%)

3 (37.5%)

6 (75.0%)

11 (44.0%)

Serious treatment-related TEAEs

0 (0.0%)

0 (0.0%)

0 (0.0%)

0 (0.0%)

TEAEs leading to study drug discontinuation

1 (11.1%)

1 (12.5%)

0 (0.0%)

2 (8.0%)

TEAEs leading to dose reduction

0 (0.0%)

2 (25.0%)

2 (25.0%)

4 (16.0%)

Source: Cereno webcast presentation, September 2024. Note: QD refers to once a day dosing.

While Cereno has not specified the exact treatment-related TEAEs, the company reported that there were no CS1-related side effects serious enough to require hospitalisation or to cause mortality. In our opinion, this compares favourably so far with other available treatment options for PAH which often come with challenging side effects. For example, prostanoids/prostacyclin analogues from a class of drugs termed vasodilators (used in combination background therapy for PAH) come with difficult side effects such as nausea, vomiting, diarrhoea, dizziness and headache. Sotatercept (brand name Winrevair; Merck), the recently approved treatment for PAH, is also associated with serious side effects such as (but not limited to): bleeding, erythema, diarrhoea and dizziness. We note that in addition to safety and tolerability, CS1 is differentiated by its convenient oral dosing, compared to the injectable or infusion routes used in the aforementioned treatment options.

Robust efficacy shown in exploratory indicators

While we note that the CS1-003 trial was not powered for statistically significant tests of efficacy-related parameters, the descriptive analyses of the exploratory efficacy endpoints are encouraging, in our opinion. The company reported results for three standard efficacy measures in PAH:

The Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) risk scores.

Functional class changes: PAH is classified under four functional classes by the New York Heart Association (NYHA) and World Health Organization, ranging from I (no symptoms) to IV (debilitating symptoms).

Hemodynamics: mPAP, measured as area under curve (AUC).

REVEAL risk scores is an approach which assigns scores based on a range of distinct variables (including demographic data, clinical characteristics, laboratory data and hemodynamic results) to predict survival in patients with PAH. The risk scores range from 0 to 22, with the latter representing the highest risk. Patients with a risk score of 1–6 are considered to be low risk (12-month mortality risk of ≤2.6%), 7–9 are termed intermediate risk (12-month mortality risk of 6–7%) and those with a score of ≥9 are labelled high risk (12-month mortality risk of ≥10.7%).

According to the reported data from the CS1-003 study, 43% of the patients (nine out of 21) reported at least a one-point improvement on the REVEAL risk score, with 71% patients (15 out of 21) having an improved or stable risk score (Exhibit 3). This is important, as a one-point reduction in risk score over a 12-week period is associated with a material 23% reduction in relative risk of death after 12 months. We also believe that 29% (six out of 21) of the patients having stable scores is also meaningful, given that PAH is otherwise a fast-progressing condition lacking spontaneous improvement.

The second efficacy measure used in the study was the change in the NYHA Functional Class (FC) from baseline, an indicator of the physical activity levels and movement in patients. The 25 randomised patients in the CS1-003 study were categorised as FC II (slight limitation of activity; 10 patients) and III (marked limitation of activity; 15 patients). Of the 21 evaluable patients, the study results indicated that 33% (seven out of 21) reported an improvement in FC, while 86% (18 out of 21) noted improved or stable functional class (Exhibit 4).

Exhibit 3: REVEAL risk score data showing changes from baseline

Exhibit 4: NYHA FC data showing changes from baseline

Source: Cereno webcast presentation, September 2024

Cereno webcast presentation, September 2024

Exhibit 3: REVEAL risk score data showing changes from baseline

Source: Cereno webcast presentation, September 2024

Exhibit 4: NYHA FC data showing changes from baseline

Cereno webcast presentation, September 2024

The third efficacy parameter for which data were reported was the change in mPAP. Cereno collaborated with Abbott’s CardioMEMS HF System to take daily readings of pulmonary pressure (85 readings, as an average over 20 seconds, per patient over the 12-week study duration), which provided a robust and objective basis for the analysis. Normal pulmonary artery pressure is 11–20mmHg at rest and a reading of >20mmHg is associated with PAH patients.

The study results indicate that two-thirds (67%) of the patients had a sustained reduction in mPAP (14 out of 21). Moreover, the reduction in mPAP was as high as 5mmHg for one of the patients, with the reduction ranging from 0.3–4.3mmHg for the other patients who reported improvement with the treatment (Exhibit 5). For reference, management highlighted the strong correlation between reduction in estimated pulmonary artery diastolic pressure (ePAD, similar to PAP) and mortality rates, with one study indicating a 5mmHg reduction in ePAD from baseline over six months to reduce mortality risk by 30%.

Exhibit 5: Changes in mPAP measured by CardioMEMS (AUC, day 1–85)

Source: Cereno webcast presentation, September 2024. Note: To calculate the mean reduction in pulmonary arterial pressure, the values on the y-axis ned to be divided by 85, given that the presented area under the curve data is for days 1–85.

We highlight that the case shown in green in Exhibit 5 relates to a patient case study. The patient was the first to complete the treatment protocol and reported significant improvement on all PAH measures, including a 30% reduction in mPAP, and improvement from FC II to FC I (see our initiation note for more detail). The full study results highlight that 10 patients exhibited greater reductions in mPAP than this case study patient, emphasising the potential of CS1 to induce clinically meaningful benefits in PAH, in our view.

In addition to the three exploratory efficacy endpoints, management presented further insights from the Phase IIa clinical data, of which pulmonary vascular resistance (PVR) serves as an indirect hemodynamic measure of reverse remodelling and therefore potential for disease modification. PVR is an indicator of obstruction in the vessels and measures resistance against blood flow. It is measured in Wood units with <2 Wood units reflecting normal PVR and ≥3 Wood units indicating pulmonary hypertension.

A more detailed analysis of the data indicates that 10 of the 21 patients who completed the study showed an improvement in PVR (Exhibit 6). For one of the patients, the PVR value improved by more than 50%, from 12 Wood units (as highlighted on the x-axis) to 6 Wood units (y-axis). Moreover, five patients reported improvements between 35% and 51%, with a mean improvement of 45% among these five. Importantly, four of five best responders in terms of PVR improvement were from the low-dose group, indicating that therapeutically efficacious results were achieved in the low to mid-dose ranges (480–960mg), which we believe will likely be the doses tested in the next stage of clinical development.

For the five patients with the highest PVR improvement, management noted the inverse relation between PVR values and stroke volumes, highlighting the potential of CS1 in improving right heart function (and therefore disease-modifying capability) through improvement in PVR (Exhibit 7).

Exhibit 6: PVR data

Exhibit 7: Relation between PVR and stroke volume

Source: Cereno Scientific webcast, September 2024

Source: Cereno Scientific webcast, September 2024

Exhibit 6: PVR data

Source: Cereno Scientific webcast, September 2024

Exhibit 7: Relation between PVR and stroke volume

Source: Cereno Scientific webcast, September 2024

Collectively, we view the trial results as highly encouraging for Cereno’s HDACi programme. We highlight that these results add to the data package to support valproic acid (VPA, the active ingredient in CS1 and a form of which was the active ingredient in CS014) as a potentially disease-modifying treatment for PAH. This is underpinned by previously published data (further details in our initiation note) showcasing the potential of VPA to prevent and reverse vascular remodelling, recently complemented by new CS014 data which show a dose-dependent effect on remodelling (further details below).

We note that while the small size of CS1-003 may limit wider conclusions on efficacy, the data presented are sufficiently encouraging to warrant further clinical development, in our view. Management has indicated that it will engage with regulators to discuss plans for a potentially pivotal trial in PAH, which we believe will need to be placebo controlled. We expect to hear the outcome of a regulatory decision on this in H125, with the subsequent Phase IIb/III trial likely to commence from early 2026. While it is unclear whether a second Phase III study will be required for regulatory filing, for now we assume one late-stage trial will be sufficient, with potential market launch from 2029, provided the subsequent trial results are supportive.

Next steps: Expanded access programme; Fluidda agreement

While Cereno prepares for its discussions with the regulators on the next steps for CS1, it continues to progress with its Expanded Access Programme (EAP) for CS1, which is applicable to the patients who have completed the initial 12-week Phase IIa study. The EAP, which was approved by the FDA in January 2024, dosed its first patient in August 2024 and we expect long-term data from this in H125.

Cereno also recently announced an agreement with medical technology company Fluidda to visualise CS1’s impact on inducing long-term reverse remodelling in PAH, using Fluidda’s Respiratory Imaging solutions in a clinical trial setting. Management has communicated that discussions are ongoing with a PAH specialist to launch an investigator-initiated trial (IIT) with CS1 in collaboration with Fluidda (update in H125). Some of the patients currently enrolled in the EAP are also intended to be included in the IIT.

We expect these two initiatives to support Cereno in gaining additional insights on CS1’s potential in PAH, while helping secure the data package to aid subsequent regulatory discussions as the asset progresses to the later stages of clinical development.

CS014, another HDACi with potential in PAH

Cereno’s portfolio also includes CS014 which, like CS1, is an HDACi that has been optimised for thrombosis prevention, for which preclinical data have indicated that this may be achieved without increased risk of bleeding. The candidate entered a Phase I study in June 2024 and Cereno recently presented encouraging preclinical data highlighting the potentially disease-modifying properties of CS014 in PAH and related pulmonary vascular indications. The new data come from what the company reports as a well-established model of PAH and demonstrate a robust, dose-dependent reversal of pulmonary vascular remodelling, including statistically significant reductions in small artery vessel occlusion, plexiform lesions and small vessel-related fibrosis.

We believe these observations, along with the encouraging Phase IIa CS1 data, reinforce Cereno’s efforts on building its HDACi programme, which plans to leverage epigenetic modulation to develop effective and potentially disease-modifying treatments for cardiovascular conditions. Management is targeting CS014 Phase I completion in H125, along with the required regulatory approvals for a Phase III trial. We look forward to further updates from the company on this front.

Financials and valuation

Cereno recently reported Q224 results. For a more detailed discussion of the company’s current financial position and other ongoing activities, please refer to our previous update note.

We continue to value Cereno using a risk-adjusted net present value (rNPV) approach, but increase the probability of success of the CS1 programme to 40% (from 25% previously). We plan to revisit these assumptions once there is more clarity on the next stage of clinical development. We understand that regulatory clearance for the next stage of clinical development will most likely be from H125 and could represent a major upcoming catalyst for Cereno. Provided regulators are supportive, this would lead to the subsequent trial potentially commencing from early 2026. As a result of this adjustment, we upgrade our valuation for Cereno to SEK3.9bn or SEK13.9/share from SEK2.6bn or SEK9.1/share previously (see Exhibit 8).

Exhibit 8: Valuation of Cereno (rNPV)

Asset

Indication

Development phase

Launch

Peak sales
($m)

Peak sales year

NPV (SEKm)

Probability

rNPV
(SEKm)

rNPV/share
(SEK)

CS1

PAH

Phase II

2029

2,113

2038

8,898.6

40%

3,559.5

12.7

CS014

Thrombosis

Phase I

2031

1,863

2042

3,906.1

7.5%

293.0

1.0

Total

12,804.8

3,852.4

13.7

Net cash at 30 June 2024

40.2

0.1

Valuation

3,892.6

13.9

Source: Edison Investment Research. Note: The per-share valuation is based on outstanding shares of 281m.

Exhibit 9: Financial summary

Accounts: K3, year-end: 31 December, SEK’000s

 

2021

2022

2023

2024e

2025e

PROFIT & LOSS

 

 

 

 

 

 

Net sales

 

0

0

0

0

0

Capitalised work for own account

 

44,805

57,538

49,277

79,615

87,007

Total revenues

 

44,805

57,538

49,277

79,615

87,007

Cost of sales

 

0

0

0

0

0

Gross profit

 

44,805

57,538

49,277

79,615

87,007

Total operating expenses

 

(59,811)

(85,037)

(93,927)

(131,763)

(140,537)

R&D and other expenses

 

(57,797)

(76,620)

(71,152)

(110,156)

(117,854)

Of which - R&D expenses

 

(44,805)

(57,538)

(49,277)

(79,615)

(87,007)

Of which - other expenses

 

(12,815)

(18,899)

(21,658)

(30,321)

(30,625)

Personnel costs

 

(1,789)

(7,514)

(18,763)

(21,607)

(22,683)

Other operating items

 

(226)

(903)

(4,012)

0

0

Operating income (reported)

 

(15,006)

(27,499)

(44,650)

(52,148)

(53,529)

EBITDA (normalised)

 

(14,992)

(27,485)

(44,636)

(52,102)

(53,485)

Finance income/(expense)

 

(1,245)

(149)

(3,456)

(6,761)

(2,437)

Exceptionals and adjustments

 

0

0

0

0

0

Profit before tax (reported)

 

(16,251)

(27,649)

(48,106)

(58,910)

(55,966)

Profit before tax (normalised)

 

(16,251)

(27,649)

(46,436)

(58,910)

(55,966)

Income tax expense (includes exceptionals)

 

(4)

(6)

0

0

0

Net income (reported)

 

(16,255)

(27,654)

(48,106)

(58,910)

(55,966)

Net income (normalised)

 

(16,255)

(27,654)

(46,436)

(58,910)

(55,966)

End of period number of shares, '000

 

105,262

137,515

233,775

281,702

281,702

Basic EPS (SEK)

 

(0.15)

(0.20)

(0.21)

(0.21)

(0.20)

Adjusted EPS (SEK)

 

(0.15)

(0.20)

(0.20)

(0.21)

(0.20)

BALANCE SHEET

 

 

 

 

 

 

Intangible Assets

 

89,449

146,987

196,264

275,879

362,886

Fixtures, tools and installation

 

43

29

14

886

842

Other long-term receivables

 

8

10

9

9

9

Total non-current assets

 

89,500

147,025

196,287

276,774

363,737

Other receivables

 

1,363

1,248

1,124

1,305

1,336

Prepaid expenses and accrued income

 

240

335

407

407

407

Cash and bank balance

 

89,635

67,046

87,169

68,988

26,675

Total current assets

 

91,238

68,629

88,699

70,700

28,418

Accounts Payable

 

2,884

9,411

6,930

9,722

10,369

Other Current Liabilities

 

2,589

4,331

16,231

16,231

16,231

Short-term Debt

 

4,800

0

0

0

0

Total current liabilities

 

10,273

13,742

23,162

25,954

26,601

Long-term Debt

 

0

0

45,000

90,000

190,000

Other debt

 

400

400

400

400

400

Total non-current liabilities

 

400

400

45,400

90,400

190,400

Equity attributable to company

 

170,065

201,511

216,424

231,120

175,154

CASH FLOW STATEMENT

 

 

 

 

 

 

Net profit

 

(16,255)

(27,654)

(48,106)

(58,910)

(55,966)

Depreciation

 

14

14

14

47

44

Translation difference

 

(321)

(90)

34

0

0

Accrued costs

 

1,230

450

777

0

0

Share based payments

 

0

0

1,671

0

0

Taxes paid

 

(1)

(4)

0

0

0

Movements in working capital

 

2,196

8,669

8,695

2,611

616

Cash from operations (CFO)

 

(13,137)

(18,615)

(36,915)

(56,252)

(55,305)

Purchase of intangible assets

 

(44,805)

(57,538)

(49,277)

(79,615)

(87,007)

Purchase of PPE

 

0

0

0

(918)

0

Other investing activities

 

0

0

0

0

0

Cash used in investing activities (CFIA)

 

(44,805)

(57,538)

(49,277)

(80,533)

(87,007)

Loans received

 

0

0

45,000

45,000

100,000

Loan repayments

 

(5,000)

(5,000)

0

0

0

Equity issued

 

91,398

58,791

61,315

73,605

0

Other Financing Cash Flows

 

(4,825)

(226)

0

0

0

Cash from financing activities (CFF)

 

81,573

53,564

106,315

118,605

100,000

Cash and equivalents at beginning of period

 

66,004

89,635

67,046

87,169

68,988

Increase/(decrease) in cash and equivalents

 

23,630

(22,589)

20,123

(18,180)

(42,313)

Effect of FX on cash and equivalents

 

0

0

0

0

0

Cash and equivalents at end of period

 

89,635

67,046

87,169

68,988

26,675

Net (debt)/cash

 

84,435

66,646

41,769

(21,412)

(163,725)

Source: Company reports, Edison Investment Research

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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.

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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.

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20 Red Lion Street

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London │ New York │ Frankfurt

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United Kingdom

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Copyright: Copyright 2024 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

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