Sareum Holdings — Positive clinical step forward in SDC-1801

Sareum Holdings (AIM: SAR)

Last close As at 18/05/2024

GBP0.37

−2.45 (−6.17%)

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Research: Healthcare

Sareum Holdings — Positive clinical step forward in SDC-1801

Sareum Holdings has announced positive clinical progression for SDC-1801, its lead asset and novel TYK2/JAK1 inhibitor targeting the autoimmune space (with an initial focus on psoriasis). Preliminary data from the single ascending dose (SAD) study (part 1) and the food effects study (part 3), from its ongoing Phase Ia trial (in healthy volunteers) for SDC-1801, indicated a favourable safety profile and were supportive of once-daily oral dosing. The multiple ascending dose (MAD) arm continues to onboard patients and the Phase Ia trial’s full safety data are expected in H1 CY24. The swift progression of SDC-1801 through the clinic is encouraging, given that the study commenced in May 2023, and we see the initiation of a Phase Ib study (if Phase Ia data are supportive) in psoriasis patients in H224 (target completion end-CY24) as a major inflection point. Management expects to be funded to this milestone, supported by the £5m equity prepayment facility (£2.3m drawn down to date) and expected tax credits of £1.6m.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

Sareum Holdings

Positive clinical step forward in SDC-1801

Pharma and biotech

Spotlight - Flash

19 February 2024

Price

40p

Market cap

£28m

Share price graph

Share details

Code

SAR

Listing

AIM

Shares in issue

70.26m

Net cash at 30 June 2023 (excluding the total £2.3m utilised to date from the August 2023 equity prepayment facility)

£1.0m

Business description

Sareum Holdings is a UK-based drug development company, specialising in small molecule kinase inhibitors. Its lead programmes are TYK2/JAK1 inhibitors, SDC-1801 for autoimmune diseases and SDC-1802 for cancer. Sareum initiated clinical trials for SDC-1801 in Australia in May 2023 (Phase Ia), with safety data expected in H124. Other programmes include the CHK1 inhibitor SRA737, which was outlicensed to an unnamed private US-based pharma company by co-development partner CRT Pioneer Fund LP in January 2024.

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Jyoti Prakash, CFA

+44 (0)20 3077 5700

Dr Arron Aatkar

+44 (0)20 3077 5700

Sareum Holdings is a research client of Edison Investment Research Limited

Sareum Holdings has announced positive clinical progression for SDC-1801, its lead asset and novel TYK2/JAK1 inhibitor targeting the autoimmune space (with an initial focus on psoriasis). Preliminary data from the single ascending dose (SAD) study (part 1) and the food effects study (part 3), from its ongoing Phase Ia trial (in healthy volunteers) for SDC-1801, indicated a favourable safety profile and were supportive of once-daily oral dosing. The multiple ascending dose (MAD) arm continues to onboard patients and the Phase Ia trial’s full safety data are expected in H1 CY24. The swift progression of SDC-1801 through the clinic is encouraging, given that the study commenced in May 2023, and we see the initiation of a Phase Ib study (if Phase Ia data are supportive) in psoriasis patients in H224 (target completion end-CY24) as a major inflection point. Management expects to be funded to this milestone, supported by the £5m equity prepayment facility (£2.3m drawn down to date) and expected tax credits of £1.6m.

Historical financials

Year
end

Revenue
(£m)

PBT
(£m)

EPS*
(p)

DPS
(p)

P/E
(x)

Yield
(%)

06/21

0.00

(1.7)

(2.3)

0.0

N/A

N/A

06/22

0.00

(2.6)

(3.2)

0.0

N/A

N/A

06/23

0.00

(4.0)

(4.7)

0.0

N/A

N/A

Source: Company data. Note: *EPS figures have been adjusted retrospectively for the 50:1 share consolidation in March 2022.

Sareum’s lead asset, SDC-1801, is a novel TYK2/JAK1 inhibitor targeting a range of autoimmune indications, with initial emphasis on psoriasis. The efficacy and utility of TYK2-targeting drugs has been validated by the September 2022 approval of Bristol Myers Squibb’s TYK2 inhibitor Sotyktu (projected peak sales of c $4bn), with commercial potential reinforced by the acquisition by Takeda of Nimbus Therapeutics’ Phase IIb asset, TAK-279 (formerly NDI-034858), for an upfront payment of $4bn. SDC-1801 is a dual inhibitor of both TKY2 and JAK1, potentially supporting superior efficacy in autoimmune conditions, in our view.

The ongoing Australia-based Phase Ia study for SDC-1801 is a randomised, placebo-controlled trial (n=96) with single and multiple oral dose arms, evaluating safety, tolerability and pharmacokinetics/pharmacodynamics in healthy adults. Part 1 (SAD) and part 3 (food effects study) are now complete and highlighted desirable safety. The SAD part randomised participants in a 3:1 ratio to a single ascending dose (ranging from 5-300mg) of SDC-1801 or placebo in six dose cohorts with eight subjects each. Part 2 (MAD) is ongoing (four sequential and ascending doses tested on four dose cohorts with eight participants each). Full safety data from the Phase Ia study are expected in H1 CY24. If supportive, this will be followed by a Phase Ib trial with 24 psoriasis patients, which is anticipated to complete by end-CY24. Sareum believes it is capitalised to this milestone, supported by an (up to) £5m prepayment facility from RiverFort Global Opportunities (£2.3m drawn down to date) and expected tax credits of £1.6m. Management plans to explore licensing deals for the drug, provided results from Phase I are supportive.

General disclaimer and copyright

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

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

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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 2024 Edison Investment Research Limited (Edison).

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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

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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.

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London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

General disclaimer and copyright

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

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

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

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

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

Copyright: Copyright 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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