Hepion Pharmaceuticals — Phase IIa trial commenced

Hepion Pharmaceuticals (US: HEPA)

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Research: Healthcare

Hepion Pharmaceuticals — Phase IIa trial commenced

On 5 August 2020, Hepion announced that it had dosed the first NASH patient with CRV431 in its Phase IIa ‘AMBITION’ pilot study. The primary endpoint of AMBITION is to assess the safety and tolerability of CRV431 at a 75mg dose and the company expects data from the trial in Q420. The goal of the study outside the endpoints is to gather a range of different biomarkers in these patients to examine CRV431 for activity, which will be used to support the design of future studies.

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Written by

Healthcare

Hepion Pharmaceuticals

Phase IIa trial commenced

Development update

Pharma & biotech

7 August 2020

Price

US$4.4

Market cap

US$40m

Net cash ($m) at 31 March 2020 + ATM

20.55

Shares in issue

9.03m

Free float

99.47%

Code

HEPA

Primary exchange

NASDAQ

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

53.1

170.6

90.1

Rel (local)

45.4

130.1

63.6

52-week high/low

US$7.0

US$1.2

Business description

Hepion Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapeutics for chronic liver disease. The company’s lead asset is CRV431, a cyclophilin inhibitor being developed for the treatment of non-alcoholic steatohepatitis.

Next events

Completion of Phase Ib dosing study

Q320

Data from Phase Ib dosing study

Q320

Data from Phase IIa study

Q420

Initiate Phase IIb study

Q221

Analysts

Nathaniel Calloway

+1 646 653 7036

Wiktoria O’Hare

+1 646 653 7028

Hepion Pharmaceuticals is a research client of Edison Investment Research Limited

On 5 August 2020, Hepion announced that it had dosed the first NASH patient with CRV431 in its Phase IIa ‘AMBITION’ pilot study. The primary endpoint of AMBITION is to assess the safety and tolerability of CRV431 at a 75mg dose and the company expects data from the trial in Q420. The goal of the study outside the endpoints is to gather a range of different biomarkers in these patients to examine CRV431 for activity, which will be used to support the design of future studies.

Year end

Revenue ($m)

PBT*
($m)

EPS*
($)

DPS
($)

P/E
(x)

Yield
(%)

12/18

0.0

(9.8)

(55.87)

0.0

N/A

N/A

12/19

0.0

(7.9)

(4.32)

0.0

N/A

N/A

12/20e

0.0

(15.0)

(1.79)

0.0

N/A

N/A

12/21e

0.0

(11.4)

(1.33)

0.0

N/A

N/A

Note: *PBT and EPS are normalized, excluding intangible amortization, exceptional items and share-based payments.

First patient dosed in Phase IIa trial

Hepion initiated its Phase IIa trial AMBITION and announced the first patient was dosed with CRV431. The primary objective of the study is to assess the safety and tolerability of a once daily 75mg dose over 28 days. The secondary objective is to evaluate the percentage decrease of non-invasive anti-fibrotic markers from baseline to the end of the study. The company aims to generate exploratory anti-fibrotic biomarker data and utilize the information in future clinical trials. The study is a multi-centre, single-blind, placebo-controlled design with an expected cohort of 18 subjects. CRV431 will be administered orally to patients presumed to have NASH with stage 2 or 3 fibrosis. Hepion expects data from the Phase IIa trial by year end.

Phase Ib dosing study data expected soon

On 29 June 2020, the company stated that it had progressed to the final dose level of 375mg in the multiple ascending dose study. Completion of the study is expected in Q320 followed by data shortly thereafter. CRV431 was administered once daily for 28 days to 16 healthy volunteers at increasing dose levels (75mg, 150mg, 225mg and 300mg), all of which were deemed to be safe and well tolerated with no dose-limiting side effects. The results for the final dose are yet to be announced.

Clinical trial program outlook

Following successful completion of the smaller Phase IIa trial later this year, Hepion expects to initiate a larger Phase IIb trial in Q221. The company will look to enrol approximately 200 NASH patients once daily for 24 weeks at a dose yet to be determined.

Valuation: No change at $53.5m or $5.93/basic share

Our valuation remains at $53.5m or $5.93/basic share ($5.91 diluted). We will re-evaluate our model on the announcement of data from the Phase I multiple-ascending dose study.

Moving on up

The current Phase IIa study announced on 5 August is a pilot study designed to examine a range of biomarkers for clinical activity in NASH patients. The study will use a much lower dose of drug (75mg) than has been tested in the Phase I dosing study, because it is not designed to measure NASH resolution, but rather just those early biochemical signs of efficacy. This will allow the program to be completed quickly as patients will only be followed for 28 days of once-daily dosing and we should have a much better idea at its completion if the drug has clinical activity without having to commit to a major clinical program.

The list of biomarkers that the company stated it will examine are presented in Exhibit 1. These include both biomarkers for fibrosis and NASH (such as collagen and Pro-C3 respectively) as well as broader exploratory targets such as genomics and gene-gene interactions. All of the data gathered across these categories will be combined with the measured safety and pharmacokinetic data and integrated into the company’s big data analytics platform termed AI-POWR. The goal with AI-POWR is to provide additional insight by examining how these markers form a network of responses to the drug using machine learning and other analytics. A major limitation of studying NASH has historically been the lack of definitive diagnostics outside of biopsy, and we believe this platform (and moreover this study in general) is an attempt to gain some traction in understanding the effects of this drug without having to resort to repeated biopsy. This being said, we have relatively little insight into what is powering AI-POWR and what insight it will be able to reveal outside the basic biomarker data, and any assumptions that machine learning can provide improved insight should be accompanied with caveats that this is entirely dependent on the quality of the machine learning and the data provided to it. We expect the data set from the AMBITION study to be incredibly rich and at the very least, we hope that AI-POWR will aid in its understanding.

Exhibit 1: Biomarkers examined in the Phase IIa AMBITION study

Biomarker

Note

Collagen

A major component of fibrotic tissue, a target of cyclophilin

Matrix metalloproteinases

Proteins that degrade fibrotic tissue

Lipidomics

To examine lipid release from liver fat

Genomics

Gene expression profiles

Liver transaminases

Released as signs of liver damage

Pro-C3

A proposed biomarker for NASH

ELF score

A score of biochemical markers correlated with fibrosis

Gene-gene and gene-protein network analysis

To probe deeper interactions

Fibroscan

A specialized ultrasound to identify steatosis

Biomarker

Collagen

Matrix metalloproteinases

Lipidomics

Genomics

Liver transaminases

Pro-C3

ELF score

Gene-gene and gene-protein network analysis

Fibroscan

Note

A major component of fibrotic tissue, a target of cyclophilin

Proteins that degrade fibrotic tissue

To examine lipid release from liver fat

Gene expression profiles

Released as signs of liver damage

A proposed biomarker for NASH

A score of biochemical markers correlated with fibrosis

To probe deeper interactions

A specialized ultrasound to identify steatosis

Source: Edison Investment Research

Although the company has started the Phase IIa study, it is still engaged in the ongoing Phase Ib dosing study. The final dosing cohort (375mg) in the Phase Ib was announced on 29 June because the company had not reached a dose-limiting toxicity on the previous dose levels. The multiple-ascending dose portion of the study is examining the safety and pharmacokinetics of volunteers exposed to once-daily CRV431 for 28 days. We expect the study to be completed in Q320 and data to be announced in the same quarter, but the decision to progress the clinical program to the Phase IIa study suggests that no major issues have been raised to date.


Valuation

Our valuation remains at $53.5m or $5.93/basic share ($5.91 diluted). We will re-evaluate our model on the announcement of data from the Phase I multiple-ascending dose study. Although we are encouraged by the fact that the clinical program is progressing, we want to evaluate the existing data before drawing judgements regarding the viability of the program.

Exhibit 2: Valuation

Program

Market

Probability of success

Launch year

Peak revenue ($m)

Valuation
($m)

CRV431

US

10%

2026

370.8

23.71

Europe

10%

2027

373.0

19.42

R&D & milestones

100%

(10.18)

Total

32.95

Net cash and equivalents (Q120 + ATM)

20.55

Total firm value ($m)

53.50

Total basic shares (m)

9.03

Value per basic share ($)

5.93

Convertible preferred stock (m)

0.02

Dilutive options and warrants (m)

0.0

Total diluted shares (m)

9.1

Value per diluted share ($)

5.91

Source: Edison Investment Research

Exhibit 3: Financial summary

$'000

2018

2019

2020e

2021e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

INCOME STATEMENT

Revenue

 

 

0.0

0.0

0.0

0.0

Cost of Sales

0.0

0.0

0.0

0.0

Gross Profit

0.0

0.0

0.0

0.0

R&D

(7,593.7)

(3,184.1)

(8,995.6)

(5,147.3)

SG&A

(7,000.4)

(4,586.0)

(6,105.9)

(6,289.1)

EBITDA

 

 

(14,340.9)

(7,677.2)

(15,009.2)

(11,370.2)

Normalised operating profit

 

 

(14,359.6)

(7,703.9)

(15,035.3)

(11,370.2)

Amortisation of acquired intangibles

0.0

0.0

0.0

0.0

Exceptionals

0.0

0.0

0.0

0.0

Share-based payments

(234.5)

(66.2)

(66.2)

(66.2)

Reported operating profit

(14,594.2)

(7,770.1)

(15,101.5)

(11,436.3)

Net Interest and financial income

4,608.9

(175.9)

0.2

0.0

Joint ventures & associates (post tax)

0.0

0.0

0.0

0.0

Exceptionals

0.0

0.0

0.0

0.0

Profit Before Tax (norm)

 

 

(9,750.8)

(7,879.8)

(15,035.1)

(11,370.2)

Profit Before Tax (reported)

 

 

(9,985.3)

(7,946.0)

(15,101.3)

(11,436.3)

Reported tax

536.0

1,227.3

2,332.5

1,766.4

Profit After Tax (norm)

(10,274.2)

(8,832.6)

(16,940.6)

(13,275.6)

Profit After Tax (reported)

(9,449.3)

(6,718.7)

(12,768.8)

(9,669.9)

Minority interests

0.0

0.0

0.0

0.0

Deemed Dividend

(8,451.9)

(5,442.9)

0.0

0.0

Discontinued operations

0.0

0.0

0.0

0.0

Net income (normalised)

(10,274.2)

(8,832.6)

(16,940.6)

(13,275.6)

Net income (reported)

(17,901.1)

(12,161.6)

(12,768.8)

(9,669.9)

Basic average number of shares outstanding (m)

184

2,043

9,476

9,950

EPS - basic normalised ($)

 

 

(55.87)

(4.32)

(1.79)

(1.33)

EPS - diluted normalised ($)

 

 

(55.87)

(4.32)

(1.79)

(1.33)

EPS - basic reported ($)

 

 

(97.35)

(5.95)

(1.35)

(0.97)

Dividend ($)

0.00

0.00

0.00

0.00

BALANCE SHEET

Fixed Assets

 

 

5,221.2

6,043.9

5,943.0

5,779.0

Intangible Assets

1,870.9

1,870.9

1,870.9

1,870.9

Tangible Assets

32.4

57.2

28.9

28.9

Investments & other

3,317.8

4,115.9

4,043.2

3,879.2

Current Assets

 

 

2,968.0

14,388.7

29,771.3

19,386.1

Stocks

0.0

0.0

0.0

0.0

Debtors

0.0

0.0

0.0

0.0

Cash & cash equivalents

2,832.4

13,923.0

28,511.4

18,126.2

Other

135.6

465.7

1,259.9

1,259.9

Current Liabilities

 

 

(2,849.9)

(1,251.9)

(3,041.4)

(2,095.9)

Creditors

(748.4)

(491.6)

(1,861.8)

(1,410.0)

Tax and social security

0.0

0.0

0.0

0.0

Short term borrowings

(1,440.0)

0.0

0.0

0.0

Other

(661.4)

(760.3)

(1,179.6)

(685.9)

Long Term Liabilities

 

 

(3,364.3)

(2,995.1)

(17,966.6)

(17,966.6)

Long term borrowings

0.0

0.0

(15,000.2)

(15,000.2)

Other long-term liabilities

(3,364.3)

(2,995.1)

(2,966.4)

(2,966.4)

Net Assets

 

 

1,975.1

16,185.6

14,706.3

5,102.6

Minority interests

0.0

0.0

0.0

0.0

Shareholders' equity

 

 

1,975.1

16,185.6

14,706.3

5,102.6

CASH FLOW

Op Cash Flow before WC and tax

(14,340.9)

(7,677.2)

(15,009.2)

(11,370.2)

Working capital

(970.5)

(754.6)

853.8

(945.5)

Exceptional & other

(870.7)

(360.6)

73.2

164.0

Tax

536.0

1,227.3

2,332.5

1,766.4

Net operating cash flow

 

 

(15,646.0)

(7,565.1)

(11,749.7)

(10,385.2)

Capex

0.0

(51.5)

0.0

0.0

Acquisitions/disposals

900.0

0.0

0.0

0.0

Net interest

0.0

0.0

0.0

0.0

Equity financing

12,192.5

19,826.5

11,290.0

0.0

Dividends

0.0

0.0

0.0

0.0

Other

(1,000.0)

(1,119.4)

48.0

0.0

Net Cash Flow

(3,553.5)

11,090.5

(411.7)

(10,385.2)

Opening net debt/(cash)

 

 

(5,954.0)

(1,392.5)

(13,923.0)

(13,511.3)

FX

0.0

0.0

0.0

0.0

Other non-cash movements

(1,008.0)

1,440.0

0.0

0.0

Closing net debt/(cash)

 

 

(1,392.5)

(13,923.0)

(13,511.3)

(3,126.1)

Source: Source: Hepion reports, Edison Investment Research

General disclaimer and copyright

This report has been commissioned by Hepion Pharmaceuticals and prepared and issued by Edison, in consideration of a fee payable by Hepion Pharmaceuticals. 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

1,185 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 Hepion Pharmaceuticals and prepared and issued by Edison, in consideration of a fee payable by Hepion Pharmaceuticals. 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

1,185 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: Healthcare

Shield Therapeutics — AEGIS-H2H update – non-inferiority at 24 weeks

Shield Therapeutics (STX) has announced a technical update to findings from the AEGIS-H2H post-marketing study. The re-analysis demonstrates that Feraccru/Accrufer is a credible alternative to IV iron therapy for iron deficiency anaemia (IDA) in the long term. We note the product did not meet the primary endpoint of non-inferiority at 12 weeks vs IV iron, but did correct anaemia and maintain Hb levels over the long term phase (as defined by the 40-week extension phase of the trial). While we note AEGIS H2H was not required as a registration study (thus the regulatory status of the product is unaffected by the study), the headline results of long-term Hb correction is comparable to IV iron for chronic conditions of anaemia. We believe this will have positive implications for health economic outcomes, pricing strategies and partnering opportunities. The next key inflection point is a US partnering deal; we expect Accrufer launch later this year once a partner has been found. Our valuation of STX is unchanged at £381.7m or 326p/share.

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