LONDON, UK / ACCESS Newswire / September 28, 2026 / Hemogenyx Pharmaceuticals plc ("Hemogenyx Pharmaceuticals" or the"Company") (LSE:HEMO), the biopharmaceutical group developing therapies designed to transform blood disease treatment, whose shares are admitted to the equity shares (transition) category of the Official List, announces its unaudited interim results for the six-month period ended 30 June 2026.

All financial amounts are stated in GBP British pounds unless otherwise indicated.

Key Highlights

• Second Annual IND Report submitted to the FDA and encouraging results observed in the three adult patients treated at the first dose level.
• Trial positioned for dose escalation.
• Manufacturing for HG-CT-1 established in Estonia in preparation for technology transfer, with a view to early commercialisation with Cellin Technologies OÜ ("Cellin").
• Collaboration with Vilnius university hospital Santaros Klinikos on HG-CT-1 clinical application and research.
• Operating cost base reduced through the outsourcing of HG-CT-1 manufacture to Made Scientific.
• £5.6 million raised in H1 2026 to support ongoing clinical development.

Fuller details of these developments are contained in the Interim Management Report below.

Interim Management Report

We are pleased to present the Hemogenyx Pharmaceuticals' half year report for the six months ended 30 June 2026.

2025 was the year in which Hemogenyx Pharmaceuticals proved it could operate as a clinical-stage company, and that the Company was entering what the Board believed would be the most clinically prolific period in its history. The first half of 2026 has been about converting that position into readiness: completing the manufacturing transition on which dose escalation depends, securing the regulatory clearances needed to treat children as well as adults, building the physical infrastructure for early commercialisation in Europe, and financing the Phase I programme on terms the Board considers acceptable. Each of these was achieved within the period.

These achievements were made in a challenging market environment for small-cap life sciences companies seeking capital. That we were able to raise £5.6 million in the period, including £3.0 million from a small group of institutional investors at the prevailing market bid price, is a reflection both of the progress the Company has made and of the continuing confidence of our shareholders, to whom the Board is grateful.

Clinical progress

HG-CT-1, our proprietary FLT3-targeted autologous chimeric antigen receptor T cell ("CAR-T") therapy for R/R AML, remains the Company's principal focus.

In April 2026 the Company submitted its second Annual Report to the FDA under the active Investigational New Drug ("IND") application for HG-CT-1, covering activities during the first year of the clinical trial. The report consolidated the experience of the three adult patients treated at the initial, lowest dose level. Across these patients, CAR-T cell expansion and persistence were observed in all subjects, with peak levels typically occurring between 14 and 28 days after infusion, reductions in blast burden were observed in peripheral blood and/or bone marrow, no immune effector cell-associated neurotoxicity syndrome ("ICANS"), no dose-limiting toxicities were reported and adverse events were generally low grade and manageable. While these findings remain preliminary, given the small number of patients and evaluation at a single dose level, they are consistent with the recommendation of the independent Data Safety Monitoring Board ("DSMB") in October 2025 that the study proceed to the second dose level, and they represent precisely the combination of tolerability and biological activity that a first-in-human study in this population is designed to establish.

The Company is now ready to recruit adult patients for treatment at the second, increased dose level. In parallel, following FDA clearance to initiate the Phase I trial in paediatric patients, the Company will begin recruitment of paediatric patients at the starting dose level used in adults. The extension into childhood AML, where the unmet need is particularly acute and where treatment options after relapse are scarce, is an important expansion of the programme and one which the Board considers to be among the more significant developments of the period. Since the period end, the paediatric arm has been initiated, with the first patient identified and screening under way, and the next adult cohort has been scheduled at the increased dose level.

Manufacturing and regulatory infrastructure

The most consequential operational milestone of the half-year was the completion of the technology transfer of HG-CT-1 manufacturing to Made Scientific. A comprehensive comparability data package was submitted to the FDA demonstrating that HG-CT-1 manufactured by Made Scientific is comparable to product manufactured by Hemogenyx itself. This confirmed the robustness and reproducibility of the process across sites and removed the last operational precondition to dose escalation.

The decision to outsource manufacturing was taken in order to reduce and manage the Company's operating costs and its burn rate. The benefit of that decision has begun to be captured in the period under review and is expected to be reflected more fully across the current financial year.

Early commercialisation in Estonia and Lithuania

In April the Company reported that the hardware and infrastructure necessary for the manufacture of HG-CT-1 in Estonia had been established, and that technology transfer to Cellin for local manufacturing was about to commence. On 11 August 2026, after the period end, the non-binding letter of intent was converted into a definitive collaboration agreement under which Cellin will act as the Company's exclusive manufacturing and operational partner in Estonia for five years under the hospital exemption pathway of Estonia's Medicinal Products Act. The Hospital Exemption pathway permits the use of advanced therapy medicinal products ("ATMPs") that have not yet received a commercial marketing authorization, prepared on a non-routine basis under the responsibility of a medical practitioner, subject to authorization by the Estonian State Agency of Medicines. The framework also allows innovators to apply for reimbursement of treatment costs through the Estonian Health Insurance Fund ("EHIF"). This provides Hemogenyx Pharmaceuticals with the opportunity to generate early revenues from HG-CT-1 while expanding the body of real-world clinical data to complement its ongoing Phase I clinical trial.

Technology transfer is anticipated to take approximately four months, and regulatory review of the hospital exemption dossier approximately 90 days. The parties will share the net operating margin generated from each patient treatment, after deduction of direct therapy costs, and Hemogenyx retains full ownership of the intellectual property, data and regulatory rights to HG-CT-1 together with all development and commercialisation rights outside Estonia and outside the hospital exemption framework.

Also after the period end, on 29 July 2026, the Company signed a letter of intent with Vilnius University Hospital Santaros Klinikos in Lithuania. The collaboration contemplates two workstreams: translational research characterising FLT3 expression and biology across subtypes and compartments of FLT3-positive AML and myelodysplastic syndromes, led by Dr Andrius Žučenka; and the establishment of point-of-care manufacturing and compassionate-use treatment with HG-CT-1 at the hospital under Lithuania's hospital exemption framework, coordinated by Dr Vladislav Sandler and Professor Laimonas Griškevičius. As with Cellin, the Company retains full ownership of all intellectual property, know-how, data and regulatory rights.

The hospital exemption route is not a substitute for full marketing authorisation, revenue under the Cellin agreement is contingent on the completion of technology transfer, Estonian regulatory authorisation and reimbursement through the Estonian Health Insurance Fund, and no minimum patient numbers or revenue levels are guaranteed. The Lithuanian arrangement is at the letter-of-intent stage. Nevertheless, taken together they offer the Company a first potential pathway to revenue from HG-CT-1, the opportunity to generate real-world clinical experience in Europe in parallel with the US trial, and a demonstration that the therapy can be manufactured and deployed at the point of care. For a company of our size, that combination of near-term commercial optionality and additional clinical data is a meaningful prize.

Financial Results

During the six months ended 30 June 2026, the Group recorded a loss before taxation of £6,557,736 (2025: £5,006,415 loss), including operating costs of £6,481,401 (2025: £4,886,532). For further comparison, the operating costs for the twelve months to 31 December 2025 were £6,980,258. The increase in reported operating costs compared with the same period in 2025 was primarily driven by a non-cash share-based payment charge of £5,543,473 arising from options granted during the period. Excluding this charge, operating costs were lower than in the comparative period, reflecting reduced underlying expenditure during the first half of 2026.

The Company had cash and cash equivalents totalling £4,584,849 as of 30 June 2026.

The Company raised £5.6 million (before expenses) during H1.

Pipeline beyond HG-CT-1

While the Company's efforts are, by design, concentrated on the HG-CT-1 clinical programme, development of the CDX bi-specific antibody for the treatment of AML and the conditioning of patients for bone marrow transplantation, and of the Chimeric Bait Receptor ("CBR") platform, continued during the period at a measured pace consistent with the Company's conservative approach to resource management. These programmes remain important sources of long-term value and the Company expects to report further progress on them in due course.

Principal Risks and Uncertainties

The Group operates in an uncertain environment and is subject to a number of risk factors. The Directors have carried out a robust assessment of the principal risks facing the Group over the remainder of 2026, including those that threaten its business model, future performance, solvency or liquidity. The Directors consider the current foreseen risks and uncertainties to be aligned with those disclosed in the Group's 2025 Annual Financial Statements, and the below risks which the Board believe are applicable to the period ended 30 June 2026 and at least the next twelve months.

It should be noted that the list is not exhaustive and that other risk factors not presently known or currently deemed immaterial may apply.

Reliance on third-party manufacturing

The Group has outsourced the manufacture of HG-CT-1 for its clinical programme to Made Scientific, a contract development and manufacturing organisation. Consequently, the Group is dependent on Made Scientific to manufacture product of the required quality, in the required quantities and within the required timelines to support the ongoing Phase I clinical trial. There can be no assurance that Made Scientific will perform as expected. Manufacturing failures, deviations from the approved process, batch failures, capacity constraints, loss of regulatory compliance, or the termination or non-renewal of the arrangement could delay or interrupt the supply of HG-CT-1 to patients, delay the clinical programme, require the Group to qualify an alternative manufacturer at additional cost and with further delay, and adversely affect the Group's results of operations and prospects.

Collaboration and commercialisation arrangements in Estonia and Lithuania

After the period end, the Company entered into a definitive collaboration agreement with Cellin Technologies OÜ for the manufacture and clinical implementation of HG-CT-1 under the hospital exemption framework in Estonia, and signed a non-binding letter of intent with Vilnius University Hospital Santaros Klinikos in Lithuania. These arrangements are at an early stage and there can be no assurance that they will be completed, brought to fruition or deliver the anticipated benefits. Their success depends on a number of factors, many of which are outside of the Group's control, including the successful completion of technology transfer to Cellin, the grant and maintenance of regulatory authorisation under Estonia's hospital exemption pathway, reimbursement through the Estonian Health Insurance Fund, the identification and referral of eligible patients, the performance of the Group's counterparties, and the conversion of the Lithuanian letter of intent into definitive agreements on acceptable terms, or at all. Any of these arrangements may be delayed, may not proceed or may be terminated for reasons that may be unrelated to the Group. No minimum patient numbers or revenue levels are guaranteed, the hospital exemption route is not a substitute for full marketing authorisation, and the failure or delay of any of these arrangements could adversely affect the Group's prospects and results of operations.

Outlook

The Company's priorities are; first, the treatment of adult patients at the second dose level and the progression of the trial through further dose levels, from which the earliest meaningful efficacy data are expected to emerge; second, the enrolment and treatment of the first paediatric patients; third, the completion of technology transfer to Cellin and the submission and review of the hospital exemption dossier in Estonia, with a view to treating the first patients under that framework; and fourth, the maturation of the Vilnius collaboration into definitive arrangements and fifth, continued financial discipline so that the resources raised in the period are deployed where they generate the greatest value.

The risks inherent in early-stage oncology drug development remain real, and the Board will continue to report candidly on both progress and setbacks. The first half of 2026, however, has delivered what it needed to deliver: a trial cleared to escalate in adults and to open in children, a manufacturing base capable of supporting it, the first binding commercial arrangement for the therapy, and the capital advance the programme.

On behalf of the Board I thank our scientists and clinical operations colleagues, our clinical investigators at MD Anderson, our partners at Made Scientific, Prevail InfoWorks and Cellin, and our advisers and brokers. Above all, we thank the patients and their families who have consented to participate in the HG-CT-1 trial. A first-in-human study in relapsed or refractory AML is demanding for everyone involved, and nothing the Company has achieved would be possible without them.

Marc Feldmann
Chairman
28 September 2026

Market Abuse Regulation (MAR)Disclosure

The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulation ("MAR") (EU) No. 596/2014, as incorporated into UK law by the European Union (Withdrawal) Act 2018. Upon the publication of this announcement, this inside information is now considered to be in the public domain.

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SOURCE: Hemogenyx Pharmaceuticals PLC