RCS - Synairgen PLC - Business Update

Mitsubishi UFJ FinancialAnnouncement

04/09/2025 18:15

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250904:nRSD0911Ya&default-theme=true

RNS Number : 0911Y  Synairgen PLC  04 September 2025

 

 LETTER FROM THE CHAIRMAN OF SYNAIRGEN LIMITED

 (Incorporated in England and Wales with Registered No. 05233429)
 Directors:                          Registered Office:
 Mark Parry-Billings (Executive Chairman)              Mailpoint 810, Level F, South Block

 Joseph Colliver (Chief Executive Officer)             Southampton General Hospital

 Martin Murphy (Non-Executive Director)                Tremona Road

 John Bradshaw (Non-Executive Director)                Southampton

                                                       SO16 6YD

 To all Shareholders

 4 September 2025

 Dear Shareholders,
 Business Update

 The Company is pleased to be writing to you today to update you on the
 Company's progress in connection with the Phase 2 (INVENT) clinical study and
 to give you information on some other developments.

 Phase 2 INVENT Clinical Study

 The Company has spent much of 2025 preparing for the start of the INVENT
 study: a large phase 2 study to investigate SNG001 (inhaled interferon-beta)
 in mechanically-ventilated patients infected with a range of respiratory
 viruses. If the study is positive, it is structured (with mortality as the
 primary endpoint) and powered to provide, in our view, a very compelling basis
 to proceed to phase 3.  The essential preparatory work has included a
 comprehensive and cross-functional programme of activities, with important and
 positive progress in at least the six main areas which are outlined below.

 In summary, the programme plan maintains delivery of the interim analysis of
 the study in mid-2026 and the final analysis in mid-2027.  As with all
 clinical studies, not least in such a specialised intensive care unit setting,
 there are a number of risks which we are seeking to mitigate.  That said, we
 are very encouraged by the progress made in the period, as follows.

 ·      Establishing a network of more than 60 clinical study sites

 Working in partnership with our selected global clinical research
 organisation, we have conducted detailed feasibility of in excess of 200
 clinical sites and have identified suitable clinical investigators and
 hospital centres in the US, UK and four European countries, who have the
 necessary skills and experience to execute the study.  The group of carefully
 chosen clinical sites represents the fundamental expert network which is
 clearly essential to execute such a specialised study in the intensive care
 setting.

 ·      Securing regulatory agency and ethics committee approvals

 Significant progress has been made towards securing the approvals which are
 mandated prior to initiation of patient recruitment.  The novel and
 specialised aerosol technology being employed to deliver SNG001 efficiently to
 the lungs of patients whilst on invasive mechanical ventilation has
 necessitated separate regulatory agency applications in the UK and in the four
 separate European countries, as a result of specific European medical device
 regulations.  These device-focused applications have been submitted in
 parallel with drug product-focused applications to the regulators.  In
 parallel, in the US, we have undertaken a formal advice interaction with the
 Food and Drug Administration (US FDA) and incorporated the agency's feedback
 in the clinical study protocol.  Additionally, we have followed the FDA's
 request for further characterisation of SNG001 delivery to
 mechanically-ventilated patients.  The majority of this laboratory work was
 executed in-house by the Company's science team and demanded development of
 selected new analytical methods prior to an intense period accelerating the
 studies and reporting the results to the agency.  We were delighted to have
 confirmation recently of FDA clearance for initiation of patient recruitment,
 which is made possible as we open clinical sites in the US.

 In addition to progressing this significant series of international regulatory
 agency approvals for SNG001 and for the drug delivery technology, the
 necessary ethics committee applications have also progressed in all six
 countries.

 ·      Effective collaboration with our network of partners and
 contractors

 Close and effective collaboration with our US-headquartered global clinical
 research organisation has and will be essential for execution of the INVENT
 study.  This important relationship and work are being driven by our clinical
 operations team, who will also be the primary interface with the clinical
 study sites in the UK.  Pharmacovigilance and medical insight is essential
 particularly in this critically-ill patient population, and this is being led
 by the Company's Chief Medical Officer with appropriate contractor support.
 The drug delivery component of this combination product is supplied by our
 partner, Aerogen Ltd., a global leader in nebulised drug delivery. Their close
 collaboration and technical leadership are integral to the programme's
 success. Collaborations are also in place with other key contractors for
 activities including SNG001 and placebo supply, manufacture, release, and
 distribution, biological sample shipment, data management and statistical
 analysis.  All collaborations and contracted activities for INVENT are
 overseen and contributed to by the many specialists within the company that
 form the INVENT study team.

 .

 ·      Constructive dialogue with leading respiratory and intensive care
 experts

 Best practice dictates that company-sponsored clinical research must be
 optimised through an ongoing dialogue with subject matter experts in the
 field.  The company has an established and growing network of key opinion
 leaders in intensive care medicine / infectious diseases, who have been
 instrumental in ensuring that core elements of the clinical protocol are not
 only fit-for-purpose for effective study conduct, but also maximize the chance
 of a successful study outcome.  To this end, and also in light of the
 regulatory agency interactions (outlined above), some key elements of the
 study protocol have been optimised, not least the total number of patients to
 be recruited has been increased from 450 to 550.

 The Company has also constituted a strategic advisory board to engage going
 forward to provide further guidance and insights into business- and
 programme-critical topics.

 ·      Consolidating and enhancing our internal team and management

 Our new CEO, Joseph Colliver, has stepped up very positively from his previous
 role as CFO.  He has deep understanding and insights into the business, not
 only in the financial area, but also as a business leader, which is proving
 already to be highly effective in driving the SNG001 programme and the company
 as a whole.  Alongside this very positive evolution of the company's
 leadership, I am now working more closely, not only with Joseph, but with the
 senior management team following my transition from non-executive to executive
 chairman, and looking to leverage my more than 30-year industry track record,
 which has been largely focused on therapeutics and drug delivery in the field
 of respiratory medicine.    The company's senior management team remains
 very strong with subject matter experts leading the key disciplines of
 clinical operations, medical, regulatory, pharmaceutical development, science,
 human resources and finance.

 ·      Building a compelling business case for SNG001

 Alongside the intense preparatory work to launch the INVENT clinical study, we
 have advanced a programme of work to update and refine the business case for
 our core asset.  This has been co-ordinated by an external consultant with
 deep expertise in the field including as CEO of a US NASDAQ-listed biotech and
 in key roles in venture capital.  This important work is ongoing and includes
 outreach to US payors to understand the potential optimal price point in the
 market.  In summary, we are growing increasingly confident about the
 commercial value of the programme, if the INVENT study is successful.

 Financial position and planning

 The Company's Annual Report & Accounts for 2024 will be published by the
 end of September (in line with the timeline agreed with Companies House), and
 will provide a full breakdown and report on performance in the period.

 The recent dialogue regarding optimisation of the INVENT clinical study
 design, summarised above and including an increase in patient numbers, has
 been made very deliberately to support a robust study readout.  With these
 changes and the current detailed projected timelines, the Company is currently
 undertaking a careful and comprehensive  review of our financial plans to
 ensure delivery of the interim analysis.

 Amendment to the articles of association

 The Company intends to amend the articles of association, with such amendments
 being subject to the appropriate Shareholder resolutions.  More specifically,
 these amendments relate to the removal of the Right of First Refusal (ROFR)
 and the Drag Along Right.  On 3 April 2025, the Company announced the waiving
 of the ROFR rights in specific circumstances.  However, notwithstanding this
 waiver, certain Shareholders have raised points of attention regarding the
 rights. The Company takes the concerns of its minority shareholders very
 seriously and as such is pleased to confirm that it has now reached agreement
 with TFG Asset Management UK that the above waiver should be formalised by
 legally removing such rights, as well as the Drag Along Right, from the
 current articles entirely.

 Share trading and Asset Match

 As previously announced, the Company has appointed Asset Match to facilitate
 trading in the ordinary shares following the Company's cancellation from
 trading on AIM. Asset Match, a firm authorised and regulated by the Financial
 Conduct Authority (FRN 579310), will operate an electronic off-market dealing
 facility for the shares. This facility will allow existing Shareholders and
 new investors to trade ordinary shares by matching buyers and sellers through
 periodic auctions.

 The Asset Match trading facility operates under its own code of practice which
 governs the behaviour of participants and the running of periodic auctions.
 Asset Match operates an open auction system where volumes of bids and offers
 at different prices are displayed on its website together with the closing
 date of the auction. At the end of each auction period Asset Match passes this
 information through a non-discretionary algorithm that determines a
 "market-derived" share price based on supply and demand and allocates
 transactions accordingly. Bids and offers may be made and withdrawn at any
 time before the closing date of each auction.

 Given the ongoing review of our financial planning, the Company is
 rescheduling the first auction on Asset Match, and will share further
 information regarding timings as soon as practicable.

 Since the Company's Orindary Shares were cancelled from trading on AIM, they
 are now held in physical form (i.e. share certificates) rather than in CREST.
 The company's registrars, MUFG Corporate Markets (formerly Link Group), issue
 all certificates on behalf of SNG and have provided them to all registered
 legal shareholders, being the individuals or nominees whose names were on the
 share register at the time of the AIM cancellation. If you have not received
 your share certificate, please contact the registrars
 at shareholderenquiries@cm.mpms.mufg.com
 (mailto:shareholderenquiries@cm.mpms.mufg.com) .

 In summary

 The Company has made very significant and positive progress this year to
 launch the INVENT clinical study, starting in the leading market of the US,
 and with the programme remaining on track to deliver the interim analysis in
 mid-2026.

 We look forward to updating shareholders on the clinical programme and all
 related developments, as matters progress, and to continuing the dialogue
 going forward.

 Yours sincerely

 Mark Parry-Billings

 Chairman

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAUPUAABUPAGCC