Oryzon Genomics — Final update from Phase IIa CLEPSIDRA trial

Oryzon Genomics (BME: ORY)

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Research: Healthcare

Oryzon Genomics — Final update from Phase IIa CLEPSIDRA trial

On 17 September Oryzon presented an update from its Phase IIa CLEPSIDRA trial with iadademstat, a selective LSD1 inhibitor, in combination with platinum/etoposide at the virtual ESMO congress. CLEPSIDRA was an open-label, single-arm Phase II study. It enrolled 14 patients, 10 of which were evaluable for efficacy as per protocol. The patients had relapsed, extensive disease small cell lung cancer (ED-SCLC). The safety profile did not allow for this combination to proceed in the second line (2L) ED-SCLC despite attempts to modify the dosing regimen. However, efficacy rates compare well with other therapies in this setting. Oryzon will explore iadademstat combinations with non-haematotoxic agents in SCLC. Our post private-placement valuation is €527m or €9.9 per/share versus €496m or €10.8 per/share previously.

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Healthcare

Oryzon Genomics

Final update from Phase IIa CLEPSIDRA trial

R&D results

Pharma & biotech

28 September 2020

Price

€2.9

Market cap

€154m

Net cash (€m) at end Q220

33.7

Shares in issue

53.1m

Free float

70%

Code

ORY

Primary exchange

Madrid Stock Exchange

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

5.6

(0.5)

10.5

Rel (local)

13.3

9.1

51.4

52-week high/low

€3.70

€1.63

Business description

Oryzon Genomics is a Spanish biotech focused on epigenetics. Iadademstat (Phase IIa) is being explored for acute leukaemias and SCLC; vafidemstat, its CNS product, has completed several Phase IIa trials and a Phase IIb trial in borderline personality disorder is in preparation. Newer asset ORY-3001 is being developed for certain orphan indications.

Next events

Potential start of Phase IIb PORTICO trial with vafidemstat in aggression in BPD. Timeline to be confirmed after the extent of COVID-19 pandemic is known

2020

Updated data from iadademstat Phase IIa ALICE in AML 2020

2020

Analyst

Jonas Peciulis

+44 (0)20 3077 5728

Oryzon Genomics is a research client of Edison Investment Research Limited

On 17 September Oryzon presented an update from its Phase IIa CLEPSIDRA trial with iadademstat, a selective LSD1 inhibitor, in combination with platinum/etoposide at the virtual ESMO congress. CLEPSIDRA was an open-label, single-arm Phase II study. It enrolled 14 patients, 10 of which were evaluable for efficacy as per protocol. The patients had relapsed, extensive disease small cell lung cancer (ED-SCLC). The safety profile did not allow for this combination to proceed in the second line (2L) ED-SCLC despite attempts to modify the dosing regimen. However, efficacy rates compare well with other therapies in this setting. Oryzon will explore iadademstat combinations with non-haematotoxic agents in SCLC. Our post private-placement valuation is €527m or €9.9 per/share versus €496m or €10.8 per/share previously.

Year end

Revenue (€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/18

6.8

(3.7)

(0.03)

0.0

N/A

N/A

12/19

10.3

(4.6)

(0.09)

0.0

N/A

N/A

12/20e

9.9

(4.7)

(0.07)

0.0

N/A

N/A

12/21e

9.9

(4.2)

(0.06)

0.0

N/A

N/A

Note: *Normalised, excluding amortisation of acquired intangibles and exceptional items.

Triple combination in 2L SCLC not viable, but…

The most common side effects of the combination were haematological changes seen in 11 out of 14 patients, which included decreased platelets, neutrophils and anaemia. Serious adverse events were also reported in seven patients (50%). The investigators tried different dosing regimens, however, the conclusion was made that such combination therapy is not suitable in this 2L ED-SCLC setting. Notably, iadademstat monotherapy did not show any haematological toxicity, while etoposide and platinum have known haematological side effects.

… the totality of data provides pathway in SCLC

The triple combination therapy achieved partial responses (PRs) in four patients and long-term stable disease in two patients (out of 10). So, the total relevant clinical benefit ratio was 60%. The objective response rate (ORR) of 40% (four PRs) compares well with the historical average of SCLC 2L chemotherapy drug topotecan (15–24%), lurbinectedin (35%), or 3L immune checkpoint inhibitor pembrolizumab (19%, Saleh, 2019). Furthermore, this efficacy rate was achieved at suboptimal doses of iadademstat and there were also signs that iadademstat has effect as monotherapy. Oryzon indicated it will aim to explore combinations with non-haematotoxic agents in future.

Valuation: €527m or €9.9 per share

In June 2020, Oryzon completed a private placement of €20m by issuing 7.3m new shares (15.9% of the previously outstanding number) at €2.75 per share, a 10.7% discount to the last closing price. Our updated valuation is €527m or €9.9 per share compared to €496m or €10.8 per share previously. At end-Q220, Oryzon reported €48.9m in cash (includes the new private placement) and €15.2m in total debt. For now, we leave our rNPV unchanged but we will reconsider our assumptions once Oryzon provides further details on its development strategy for iadademstat in SCLC.

Phase IIa CLEPSIDRA trial final update

On 17 September 2020, Oryzon presented an update from its Phase IIa CLEPSIDRA trial with iadademstat, a selective LSD1 inhibitor, at the virtual ESMO congress. This followed a similar poster presentation at the last year’s ESMO congress, which we have described in our previous reports. Some monitoring and data-cleaning activities were delayed due to the COVID-19 pandemic, therefore the study database is not locked yet. However, from a practical perspective Oryzon considers this to be the final follow-up.

CLEPSIDRA was an open-label, single-arm, multicentre Phase II study and the poster presentation detailed the results from 14 enrolled patients, of which 10 were evaluable for efficacy as per protocol. The patients had relapsed ED-SCLC. The goals of this exploratory trial were to:

assess the safety and tolerability of iadademstat in combination with a chemotherapy of platinum plus etoposide (PE); the patients had to be relapsed, but still sensitive to platinum (2L rechallenge chemotherapy);

assess if iadademstat is adding a therapeutic benefit to PE chemotherapy in this setting; and

explore the potential of the use of two proprietary biomarkers to select patients more responsive to iadademstat.

The patients received four to six cycles of iadademstat plus carboplatin-etoposide chemotherapy (triple combination). Subsequently, they may have been given iadademstat monotherapy.

Safety/tolerability

The most common side effects of the combination were haematological changes seen in 11 out of 14 patients, which included decreased platelets, neutrophils and anaemia. Serious adverse events were reported in seven patients (50%). No other organ-specific side effects, such as neurological, hepatic or renal toxicity, were observed. The investigators tried different dosing regimens, including skipping iadademstat, combined with treatment dose reductions to achieve normal platelet values at the beginning of each cycle, or the use of filgrastim to manage the reduction in neutrophils. However, the haematological toxicity of the triple combination was still not satisfactory. In the end the conclusion was made that such combination therapy is not suitable in this 2L ED-SCLC setting. Notably, iadademstat monotherapy did not produce any significant haematological or other side effects (Exhibit 1A).

Efficacy

As mentioned, 10 out of 14 patients were evaluable for efficacy as per protocol. Due to the attempts to find a more tolerable dose, the patients received iadademstat at doses on average 30–60% lower per cycle than intended. Within this backdrop, the triple combination therapy achieved PRs in four patients and long-term stable disease in two patients (out of 10). So, the total relevant clinical benefit ratio was 60% (Exhibit 1B). The mean duration of response was 4.5 months.

Of note is the patient 102. After six cycles of treatment with iadademstat plus carboplatin-etoposide combination for six cycles, this patient showed an initial 79% tumour reduction (RECIST criteria). Thereafter, the patient received 15 cycles of iadademstat monotherapy, which was well tolerated. The tumour reduction continued under iadademstat monotherapy and reached 90%. This patient achieved the longest progression free survival of 15.1 months, of which 10 months were iadademstat monotherapy.

The ORR of 40% compares well with the historical average of SCLC 2L chemotherapy drug topotecan (15–24%) or lurbinectedin (35%). SCLC is generally considered a non-immunogenic cancer, so reported ORRs to immune checkpoint inhibitors are also relatively low: 22% nivolumab plus ipilimumab and 19% pembrolizumab as monotherapy (Saleh, 2019).

A higher efficacy rate than other novel therapies but lower than intended doses of iadademstat could indicate the selected biomarkers may be valuable in enriching the patient population with those more sensitive to LSD1 inhibitor iadademstat.

Exhibit 1: Cyclic haematotoxicity of the combination in a representative patient (A) and efficacy results (B)

Source: Oryzon. Note: ANC: absolute neutrophil count.

Our view

In our previous reports we highlighted that haematopoiesis (blood production) is a known target of LSD1 inhibition, so the haematological side effects at higher doses are predictable. Oryzon’s iadademstat, however, demonstrated a good safety profile in the preclinical and Phase I studies. The company has therefore decided to target this highly difficult-to-treat group of patients. Etoposide and platinum have known haematological side effects and Oryzon hoped that with dose adjustments a viable combination could be found, which, if effective, would have opened a very lucrative opportunity. The safety/benefit profile was still not acceptable despite various attempts to modify the dosing regimens, so Oryzon will not pursue this triple combination further.

CLEPSIDRA was an exploratory study and served its purpose – to provide information how to progress iadademstat further. Somewhat remarkably, iadademstat monotherapy did not produce any significant haematological or other side effects (Exhibit 1A). The efficacy, even at lower-than-optimal doses, seems to compare well with several other therapies in this setting. There were also signs that iadademstat has effect as monotherapy. Furthermore, the combination of comparable efficacy rate at suboptimal dosing could indicated that patient selection using the proprietary biomarkers was working. This would allow the enrichment of subsequent trials with patients who are likely more responsive to iadademstat.

We note that epigenetic anticancer therapies represent a novel and very different class of drugs compared to conventional chemotherapy or targeted therapies, such as monoclonal antibodies. The rationale to test iadademstat for SCLC comes from the fact that the inhibition of LSD1 activates the NOTCH pathway resulting in the suppression of ASCL1 (a known SCLC tumour driver). Complete and durable tumour regression was seen with iadademstat in in vivo PDX models (discussed in our previous report).

Next steps

Oryzon indicated that it will use all this information to design the next trials in SCLC. SCLC, in general, is the most challenging form of lung cancer with few effective treatment options, so the unmet need here is huge. Iadademstat’s good safety profile as a monotherapy suggests the combinations with non-haematotoxic agents is a rational strategy. Oryzon indicated that potential combinations with checkpoint inhibitors could be explored. More concrete plans should be announced soon.

Exhibit 2: Financial summary

€000s

 

2018

2019

2020e

2021e

Year end 31 December

Local GAAP

Local GAAP

Local GAAP

Local GAAP

PROFIT & LOSS

Revenue

 

 

6,781

10,278

9,857

9,857

Cost of Sales

0

0

0

0

Gross Profit

6,781

10,278

9,857

9,857

Research and development

(7,412)

(11,322)

(11,060)

(11,060)

EBITDA

 

 

(2,766)

(3,679)

(4,091)

(4,095)

Operating Profit (before amort. and except.)

(3,660)

(2,905)

(2,905)

(3,820)

Intangible Amortisation

(7)

(9)

0

0

Exceptionals

(4)

(11)

0

0

Other

0

0

0

0

Operating Profit

(2,916)

(3,839)

(4,225)

(4,225)

Exceptionals

0

0

0

0

Net Interest

(796)

(737)

(471)

0

Profit Before Tax (norm)

 

 

(3,701)

(4,557)

(4,696)

(4,225)

Profit Before Tax (reported)

 

 

(3,712)

(4,576)

(4,696)

(4,225)

Tax

2,535

892

1,713

1,302

Profit After Tax (norm)

(1,166)

(3,666)

(2,983)

(2,922)

Profit After Tax (reported)

(1,177)

(3,685)

(2,983)

(2,922)

Average Number of Shares Outstanding (m)

31.7

34.6

41.6

45.8

EPS - normalised (€)

 

 

(0.03)

(0.09)

(0.07)

(0.06)

EPS - reported (€)

 

 

(0.03)

(0.09)

(0.07)

(0.06)

Dividend per share (€)

0.0

0.0

0.0

0.0

Gross Margin (%)

100.0

100.0

100.0

100.0

EBITDA Margin (%)

N/A

N/A

N/A

N/A

Operating Margin (before GW and except.) (%)

N/A

N/A

N/A

N/A

BALANCE SHEET

Fixed Assets

 

 

31,786

42,357

52,196

62,039

Intangible Assets

29,330

39,938

49,795

59,653

Tangible Assets

665

631

613

598

Investments

1,791

1,788

1,788

1,788

Current Assets

 

 

35,664

37,738

43,012

29,445

Stocks

135

289

289

289

Debtors

971

2,071

1,521

1,796

Cash

34,320

35,111

40,935

27,093

Other

239

267

267

267

Current Liabilities

 

 

(10,441)

(10,546)

(9,642)

(8,840)

Creditors

(2,192)

(4,000)

(3,096)

(2,293)

Short term borrowings

(8,249)

(6,547)

(6,547)

(6,547)

Long Term Liabilities

 

 

(11,884)

(8,420)

(8,420)

(8,420)

Long term borrowings

(9,977)

(6,699)

(6,699)

(6,699)

Other long term liabilities

(1,907)

(1,721)

(1,721)

(1,721)

Net Assets

 

 

45,125

61,129

77,146

74,223

CASH FLOW

Operating Cash Flow

 

 

(2,799)

(3,610)

(4,916)

(5,172)

Net Interest

2,133

(324)

0

0

Tax

0

0

1,713

1,302

Capex

(170)

(115)

(115)

(115)

Acquisitions/disposals

0

0

0

0

Financing

11,949

18,374

19,000

0

Other*

(6,576)

(9,916)

(9,858)

(9,590)

Dividends

0

0

0

0

Net Cash Flow

4,538

4,409

5,824

(13,575)

Opening net debt/(cash)

 

 

(11,555)

(16,093)

(21,866)

(27,689)

HP finance leases initiated

0

0

0

0

Other

0

1,364

0

0

Closing net debt/(cash)

 

 

(16,093)

(21,866)

(27,689)

(14,114)

Source: Edison Investment Research, Oryzon Genomics accounts. Note: Oryzon reports in Spanish GAAP. *Includes cash outflows related to development costs that were capitalised.


General disclaimer and copyright

This report has been commissioned by Oryzon Genomics and prepared and issued by Edison, in consideration of a fee payable by Oryzon Genomics. Edison Investment Research standard fees are £49,500 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 2020 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.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

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Germany

London +44 (0)20 3077 5700

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1185 Avenue of the Americas

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United States of America

Sydney +61 (0)2 8249 8342

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Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

General disclaimer and copyright

This report has been commissioned by Oryzon Genomics and prepared and issued by Edison, in consideration of a fee payable by Oryzon Genomics. Edison Investment Research standard fees are £49,500 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 2020 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.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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Research: Financials

Nürnberger Beteiligungs — Maintaining positive earnings momentum

Nürnberger Beteiligungs (NBG) has weathered the COVID-19 crisis quite well so far, with improving gross premiums booked (despite somewhat lower new business), higher investment income in its traditional insurance business and limited growth in claims expenses in H120. After NBG almost doubled its net income in H120, management expects a y-o-y increase in FY20 earnings, assisted by higher premiums booked and visible growth in new business at a group level. At its AGM in April NBG approved the €3.30 dividend per share, which is 10% higher than last year.

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