Sareum Holdings — SDC-1801 embarks on clinical journey in FY23

Sareum Holdings (AIM: SAR)

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Research: Healthcare

Sareum Holdings — SDC-1801 embarks on clinical journey in FY23

Sareum Holdings recently announced its FY23 results and the key highlight, which was initiation of the clinical development of SDC-1801, its lead asset, in Australia. While the Phase Ia study is continuing according to plan, we view its timely progression as a material catalyst for the company. The FY23 operating loss increased by 57.6% y-o-y to £4.1m, driven by higher R&D costs associated with the start of the Phase Ia trial. Sareum ended FY23 with a cash balance of £1m, which was further supported by the receipt of £2m in August as part of a £5m equity prepayment facility. Management estimates that, along with expected tax credits of £1.6m, the prepayment facility should fund operations into Q4 CY24, providing adequate coverage for the Phase Ia/b study of SDC-1801.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Sareum Holdings_resized

Healthcare

Sareum Holdings

SDC-1801 embarks on clinical journey in FY23

Pharma and biotech

Spotlight - Update

12 October 2023

Price

78p

Market cap

£55m

Share price graph

Share details

Code

SAR

Listing

AIM

Shares in issue

70.07m

Net cash at 30 June 2023
(excluding £2m from 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. After an unsuccessful CTA application for SDC-1801 with the UK MHRA in July 2022, Sareum initiated clinical trials in Australia in May 2023. The rights of the programme, CHK1 inhibitor SRA737, were returned by Sierra Oncology.

Bull

SDC-1801’s novel TYK2/JAK1 selectivity may be attractive to partners, pending clinical validation.

First-in-class opportunity for SDC-1802 in multiple cancer indications

Approval of Sotyktu provides regulatory feasibility for TYK2 inhibitors.

Bear

Safety profile of combined TYK2/JAK1 inhibitor not certain or proved yet.

Potential funding challenges delaying clinical progress of SDC-1801 and SDC-1802.

Markets sought by SDC-1801 and SDC-1802 are highly competitive.

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Nidhi Singh

+44 (0)20 3077 5700

Sareum Holdings is a research client of Edison Investment Research Limited

Sareum Holdings recently announced its FY23 results and the key highlight, which was initiation of the clinical development of SDC-1801, its lead asset, in Australia. While the Phase Ia study is continuing according to plan, we view its timely progression as a material catalyst for the company. The FY23 operating loss increased by 57.6% y-o-y to £4.1m, driven by higher R&D costs associated with the start of the Phase Ia trial. Sareum ended FY23 with a cash balance of £1m, which was further supported by the receipt of £2m in August as part of a £5m equity prepayment facility. Management estimates that, along with expected tax credits of £1.6m, the prepayment facility should fund operations into Q4 CY24, providing adequate coverage for the Phase Ia/b study of SDC-1801.

Historical financials

Year
end

Revenue
(£m)

PBT
(£m)

EPS*
(p)

DPS
(p)

P/E
(x)

Yield
(%)

06/20

0.04

(1.1)

(1.6)

0.0

N/A

N/A

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.

SDC-1801 clinical trial initiated in Australia

Towards the end of FY23, Sareum started the Phase Ia trial for SDC-1801 in healthy adults, following approval for its clinical trial authorisation (CTA) application by the Australian authorities in May 2023. Post the reporting period, the trial advanced to part 2 of the Phase Ia study and is expected to start a parallel part 3 (of Phase Ia) in Q4 CY23. Full data from the Phase Ia study are expected in H1 CY24 which, if favourable, should advance the trial to next stage (the Phase Ib study), likely to complete before the end of CY24. We believe that initiation of the SDC-1801 clinical trial represents a major inflection point for Sareum and its timely progression will boost investor sentiment. SDC-1801, a novel TYK2/JAK1 inhibitor, is targeting psoriasis as an initial indication.

Two patent wins add to IP portfolio

Sareum reported two patent wins in June 2023. The first related to SDC-1801 in China for inflammatory or immune disorders and is the first patent granted to SDC-1801 in any region. The second was granted to SDC-1802 in the US for autoimmune disorders, extending its scope beyond immunoncology.

Cash runway into Q4 CY24

The company ended FY23 with £1.0m in cash, which was further supported by a £2.0m initial deposit as part of a £5.0m equity prepayment facility from RiverFort Global Opportunities in August 2023. Management estimates that, along with the expected £1.6m in R&D credits, the facility, if fully drawn, could fund the Phase Ia/b clinical development of SDC-1801, providing a cash runway into Q4 CY24.

SDC-1801 treading the clinical pathway

In FY23, Sareum was mainly focused on advancing SDC-1801, its lead asset and a novel TYK2/JAK1 inhibitor targeting a range of autoimmune indications, with an initial emphasis on psoriasis, to the clinical stage. After receiving approval for its CTA from the Australian authorities in May 2023, Sareum started dosing the first subjects in its Phase Ia study for SDC1801 in June 2023. Previously, the UK MHRA had informed Sareum that it would not approve the CTA until an additional review of certain preclinical data was completed by the UK Good Laboratory Practice Monitoring Authority (November 2022). To move out of standstill, Sareum decided to turn its focus to Australia as an alternative location to conduct the SDC-1801 Phase I trials and filed an application in March 2023 under the Clinical Trial Notification scheme. We believe Sareum’s decision to conduct clinical trials of SDC-1801 in Australia is logical, given the country’s strong infrastructure, favourable regulatory environment and relatively low study costs, along with government tax incentives for early-stage companies (rebates of up to 43.5% of eligible R&D expenditure).

We view the initiation of dosing as an important step in SDC-1801’s clinical journey and timely progression of the trial represents an important catalyst for the company. Full safety data from Phase Ia trial are anticipated in H1 CY24 which, if favourable, will likely be followed by a Phase Ib study in psoriasis patients. In the Phase Ib study, Sareum intends to recruit up to 24 patients to assess the efficacy of the drug. It expects to complete the study before the end of CY24, subject to regulatory, financing and recruitment factors. Management then plans to explore licensing deals for the drug, provided that results from the Phase I trial are supportive.

In terms of design, the Phase Ia study is a randomised and placebo-controlled trial with single and multiple oral dose components, evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of SDC-1801 in healthy adults. It will be conducted in three parts: a single ascending dose (SAD) study (part 1), followed by a multiple ascending dose (MAD) study (part 2) and a food effects study (part 3). Part 1 will evaluate 48 subjects, categorised into six ascending dose groups with eight subjects in each, for six weeks ranging from a screening visit to a follow-up visit. These groups will be administered either SDC-1801 or placebo in a 3:1 ratio. After a successful review of clinical data from at least the first three cohorts in part 1 by the safety review committee, part 2 will be initiated. Part 2 is designed to assess at least four sequential and ascending doses of SDC-1801 or matched placebo across four groups of eight subjects in each (n=32 for part 2) for eight weeks of total assessment. Concurrently with part 2, the company plans to run part 3 of the study, which will evaluate the effects of food on the absorption of SDC-1801.

In a recent update, Sareum announced that the first participants in the MAD study had been dosed, marking the start of part 2 of the Phase Ia trial. This followed approval of the preliminary data, generated under part 1 (SAD) of the study, by the safety review committee. Management states that safety and pharmacokinetics data from the initial three cohorts in part 1 demonstrate a favourable profile and support oral dosing of patients once a day. We note that the part 2 study will run alongside the continued dose escalation under part 1. Part 3 of the study is scheduled to start in Q4 CY23.

In terms of intellectual property, Sareum received first patent (CN113056456) related to SDC-1801 in China for inflammatory or immune disorders in June 2023. We note that this is the first patent granted to SDC-1801 in any territory. Several patent applications are under review in Europe (EP3864009), the US (US2021387981) and other regions.

Exhibit 1: SDC-1801 clinical development plan

Source: Company presentation, October 2023

Psoriasis: A sizeable market opportunity

Sareum’s lead product, SDC-1801, is a JAK inhibitor engineered to selectively target the TYK2/JAK1 enzymes with the aim of circumventing the safety/toxicity issues related to the JAK2 and JAK3 isoforms. Although SDC-1801 is designed to target a range of autoimmune diseases, the initial focus is on psoriasis. Psoriasis is an autoimmune dermatological condition that affects more than 125 million people globally, ie 2–3% of the world’s population. More than eight million people have psoriasis in the US alone. The global psoriasis market is currently valued at US$24.7bn, a sizeable opportunity for Sareum, and it is expected to grow to US$31.9bn by 2028 (source: EvaluatePharma).

Exhibit 2: Worldwide sales estimates (US$bn) for psoriasis treatment

Exhibit 3: Estimated Sotyktu sales (US$bn)

Source: EvaluatePharma

Source: EvaluatePharma

Exhibit 2: Worldwide sales estimates (US$bn) for psoriasis treatment

Source: EvaluatePharma

Exhibit 3: Estimated Sotyktu sales (US$bn)

Source: EvaluatePharma

The US FDA approval of Bristol Myers Squibb’s first-in-class, selective TYK2 asset, Sotyktu (deucravacitinib), without the typical class-level black box warnings (increased risk of malignancy, thrombosis and cardiac events) for JAK inhibitors and without restricted usage (limited to patients refractory to biologics and other available treatments), demonstrated the potential of selective TYK2 inhibition in treating autoimmune diseases (moderate-to-severe plaque psoriasis in this case). We note that Sotyktu selectively targets TYK2 compared to the broad action of first-generation JAK inhibitors. Sotyktu is the first selective TYK2 inhibitor to be approved for any indication and is the first innovation in oral treatment for moderate-to-severe plaque psoriasis in approximately 10 years. In addition, the acquisition of Nimbus Therapeutics’ Phase III-ready TYK2 programme NDI-034858 (now TAK-279) by Takeda in February 2023 for up to US$6bn (US$4bn upfront and up to US$2bn related to sales milestones) provided additional validation of the commercial potential for this class of drug.

Sareum claims that SDC-1801 offers differentiation in its dual TYK2 and JAK1 inhibition, which could result in better efficacy (without safety trade-offs) in psoriasis compared to agents that target only one of the two kinases. The TYK2/JAK1 inhibition mechanism targeted by SDC-1801 is designed to address the deregulated signalling pathways in multiple autoimmune diseases including psoriasis, lupus, psoriatic arthritis and inflammatory bowel disease, thereby broadening the addressable market potential.

Other assets in development

SDC-1802: Sareum’s other asset in development is SDC-1802, a TYK2/JAK1 inhibitor, which is being developed for multiple oncology indications in both haematological (blood-related) malignancies and solid tumours. The company continues to work on translational studies to identify an optimal cancer indication and patient population before undertaking further toxicology and manufacturing studies. SDC-1802’s TYK2/JAK1 selectivity accords it first-in-class potential for therapeutic treatment in cancer, although it comes with particular development risks given past failures in this space. We believe the clinical progression for SDC-1802 is contingent on the headway made with SDC-1801. In June 2023, Sareum was granted a patent for SDC-1802 in the US for autoimmune disorders, potentially extending its scope beyond immunoncology. This follows the initial patent for the compound in April 2022, protecting the molecular and pharmaceutical preparations of SDC1802 as a therapeutic to treat Tcell acute lymphoblastic leukaemia and other cancers, dependent on TYK2 kinase for survival.

SRA737: CRT Pioneer Fund (Sareum's codevelopment partner) is actively exploring potential development opportunities for the asset. SRA737 is a clinical-stage (Phase I/II) oral checkpoint kinase 1 (CHK1) inhibitor targeting the DNA damage response network in the treatment of solid tumours, which was previously out-licensed to Sierra Oncology. In November 2022, Sierra Oncology returned its rights to SRA737 (held in partnership with the CPF; Sareum has a 27.5% economic interest) following GlaxoSmithKline’s US$1.9bn acquisition of Sierra Oncology in July 2022 (primarily for its lead asset momelotinib targeting myelofibrosis, a haematological cancer of the bone marrow).

Exhibit 4: Sareum’s development pipeline

Source: Company presentation, October 2023

Financials

Sareum’s operating loss stood at £4.1m in FY23, higher than £2.6m in FY22, mainly driven by increased R&D expenses related to preparatory activities and the commencement of clinical studies for SDC-1801 in Australia. FY23 net loss was £3.2m, which included an R&D tax credit of £0.8m versus £0.4m in FY22. With the recent initiation of the SDC-1801 clinical trial at the end of FY23, operating expenses are likely to increase further in FY24. Reflecting higher operating expenses during the period, net cash outflow from operating activities was £3.3m compared to £2.1m in FY22.

The cash balance at end FY23 stood at £1.0m versus £2.9m at end H123 and £4.3m at end FY22. This was further supported by an equity prepayment facility of up to £5m from RiverFort Global Opportunities (a UK-based investment company) in August 2023. Sareum received the first deposit of £2m (net of associated costs) against the issue of c 1.95m shares at a reference price of 102.4p each. According to management, the second and third deposits of £0.3m each are likely to be received after three and six months of the first deposit, along with a fourth deposit (of up to £1.4m) due in six months (subject to pre-agreed conditions). The balance and final deposit (of up to £1m) will be mutually agreed between the parties at a later date. The equity prepayment facility will be similar to an at-the-market equity arrangement, whereby the company will issue new shares at the time of each deposit. The number of shares to be issued at each deposit will be determined based on the volume-weighted average price for the five days preceding the date of the relevant deposit, but at the same nominal value of 1.25p each. As an additional benefit, RiverFort will be issued warrants equal to 45% of each deposit and exercisable at a 40% premium to the relevant reference price and with a 48month term. At the issue of the first deposit, RiverFort was granted 879k warrants, exercisable at 143.3p each. Management estimates that, along with expected tax credits of £1.6m, the £5m equity prepayment facility, if fully drawn, could provide for a cash runway to Q4 CY24.

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 2023 Edison Investment Research Limited (Edison).

Australia

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

New Zealand

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

United Kingdom

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

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

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

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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

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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 2023 Edison Investment Research Limited (Edison).

Australia

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

New Zealand

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

United Kingdom

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

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

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

United States

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

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

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