Half-Year Results for the Six Months Ended 31 December 2021 and Notice of Investor Presentation

Half-Year Results for the Six Months Ended 31 December 2021 and Notice of Investor Presentation 

Cambridge, UK, 21 February 2022 – Sareum Holdings plc (AIM: SAR), the specialist drug development company delivering targeted small molecule therapeutics to improve the treatment of autoimmune diseases and cancer, announces its unaudited half-year results for the six months ended 31 December 2021 and provides an update on significant post-period developments. The full report is attached.

The Company will be holding a presentation to investors on Monday, 28 February 2022, immediately following the planned extraordinary general meeting, via the Investor Meet Company platform – please click on this link to register to attend:  

https://www.investormeetcompany.com/sareum-holdings-plc/register-investor 

OPERATIONAL HIGHLIGHTS (including post-period updates) 

Proprietary Programmes – Selective TYK2/JAK1 Inhibitors 

SDC-1801 (autoimmune diseases and severe Covid-19)  

• Progress made advancing SDC-1801 towards clinical development as a potential treatment for autoimmune diseases and the acute respiratory symptoms of Covid-19 
• Final toxicology and safety studies required to file for an exploratory Clinical Trial Authorisation (“CTA”) were successfully completed in Q4 2021, and the final report is expected in Q1 2022 
• Preliminary findings from these studies continue to support Sareum’s plans to enter SDC-1801 into a first-in-human (Phase 1a) clinical study in healthy volunteers, and allow selection of an initial dose range  
• The CTA is expected to be filed during mid-2022 
• The synthesis of SDC-1801 drug substance under GMP conditions for formulating as an oral capsule is nearing completion. Development of the capsule formulation, also under GMP, intended for use in the Phase 1 trial is progressing to plan 
• Planning for first clinical study is underway and the trial is expected to begin in H2 2022, subject to CTA approval and drug product supply 
•  

SDC-1802 (cancer immunotherapy) 

• Translational studies underway to define the optimal cancer application prior to completing toxicology and manufacturing studies 
• New US patent granted (September 2021) strengthening patent protection for SDC-1802, which is now in place across all major territories  
•  

Licensed Programmes 

SRA737: A Selective Chk1 inhibitor (cancer) 

• During the second half of 2021 and early 2022, Sierra Oncology, Inc. (“Sierra”), the licence holder for SRA737, noted it is finalising the design of several potential clinical trials to advance its pipeline candidates, including SRA737, which could start in 2022. These trials are expected to investigate SRA737 in combination with other agents in haematologic and solid tumour indications 
• The dosing of the first patient with SRA737 in any new clinical trial would result in a $2.0m payment from Sierra under the amended $290m licensing deal on SRA737 between Sierra and CRT Pioneer Fund LP. Under the amended agreement, Sareum continues to be eligible to receive a 27.5% share of this and any future milestone payments as well as royalties on any future sales 
•  

FINANCIAL HIGHLIGHTS (unaudited) 

• Raised £3.9m before expenses in the second half of 2021 largely through three subscriptions by high-net-worth individuals, bringing the total raised before expenses in 2021 to £6.3m 
• Cash at bank as of 31 December 2021 of £5.6m (£2.7m as of 30 June 2021; £1.3m as of 31 December 2020) 
• R&D tax credit of £0.2m received in December 2021 
• Loss on ordinary activities (after taxation) for the six months ended 31 December 2021 of £0.9m (2020: loss of £0.5m), reflecting the increased R&D expenditure required for preclinical development 
•  

Post Period End 

• On 4 February 2022, the Company published a circular containing details of the proposed adoption of new articles of association (the “New Articles”) and a proposed 50:1 consolidation of the Company’s Ordinary Shares (the “Consolidation”). Implementation of the Consolidation and adoption of New Articles are both conditional upon approval by the Company’s shareholders at an extraordinary general meeting to be held at 2:30 p.m. on 28 February 2022 at The City Centre, 80 Basinghall Street, London EC2V 5AG. Copies of the Circular and Notice are available at www.sareum.com 
•  

Dr Tim Mitchell, CEO of Sareum, commented:  

“We continue to advance SDC-1801 towards its first clinical trial as a potential new treatment for autoimmune diseases including the acute respiratory symptoms of Covid-19. The preliminary findings from the safety and toxicology studies completed in late 2021 were highly encouraging and give us confidence in the promising safety profile of SDC-1801. We look forward to receiving the final report in the coming weeks, and to progressing our plan to begin the first clinical trial with SDC-1801 during H2 2022 – an important and exciting milestone for Sareum and supported by the substantial additional funding raised during 2021. These new funds will also enable us to accelerate the preclinical development of SDC-1802 through preclinical development. 

“Furthermore, we are also very encouraged that Sierra Oncology is considering several clinical combination studies with SRA737 and that these may begin in the first half of 2022. We look forward to further updates on the clinical development of this candidate as the programme progresses.” 

For further information, please contact: