Hemogenyx Pharmaceuticals PLC Announces Half-year Report

Rhea-AI Summary

Hemogenyx Pharmaceuticals (LSE:HEMO) has reported significant progress in its H1 2025 interim results, highlighting key developments in its HG-CT-1 clinical program for treating relapsed/refractory acute myeloid leukemia (R/R AML). The company successfully treated three patients in its Phase I trial, with all passing initial safety evaluations and showing encouraging efficacy signs.

Financial results show a loss before taxation of £5,006,415, with the company raising £2.24 million in H1 2025. Notable developments include FDA clearance for pediatric trial expansion and a strategic manufacturing partnership with Made Scientific. Post-period, Hemogenyx signed an LOI with Cellin Technologies for potential early commercialization in Estonia under a hospital exemption pathway.

The company had £226,727 in cash as of June 30, 2025, and raised an additional £2.2 million post-period.

Positive

• All three Phase I trial patients showed positive safety profiles with early efficacy signs
• FDA cleared pediatric expansion of the Phase I trial
• Strategic manufacturing partnership established with Made Scientific
• Secured US$120,000 G-Rex® grant for CAR-T production optimization
• Potential early revenue opportunity through Estonian hospital exemption pathway with Cellin Technologies

Negative

• Increased loss before taxation to £5,006,415 (vs £2,815,604 in H1 2024)
• Low cash position of £226,727 as of June 30, 2025
• £2,241,905 negative impact from unfavorable GBP/USD exchange rate movements

Interim Results for the period ended 30 June 2025

LONDON, UK / ACCESS Newswire / September 30, 2025 / Hemogenyx Pharmaceuticals plc (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 2025.

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

Key Highlights

• First-in-human treatment with HG-CT-1 successfully administered.

• Three patients treated to date in Phase I trial; all passed initial safety evaluations with encouraging early signs of efficacy.

• FDA accepted Annual IND report for HG-CT-1.

• Pediatric expansion of the Phase I trial cleared by FDA following protocol amendment.

• £2.24 million raised in H1 2025 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 period ended 30 June 2025. The first half of 2025 has been one of steady and meaningful progress. Our principal focus remains the clinical development of HG-CT-1, our fms-like tyrosine kinase 3 ("FLT3")-targeted autologous CAR-T cell therapy for the treatment of relapsed or refractory acute myeloid leukaemia ("R/R AML"). Alongside advancing this programme, we have recently strengthened our operational and manufacturing foundations while reducing our operating costs, secured grant and financing support, and positioned the Company for potential early revenue generation under an innovative regulatory framework.

Our mission remains clear: to develop and deliver transformative therapies for patients with life-threatening blood cancers while creating sustainable value for our shareholders.

Clinical developments

The Phase I clinical trial of HG-CT-1 in adult R/R AML patients has been our principal focus. During the first half of the year we treated the second adult patient and confirmed in June that both the first and second patients had successfully passed their initial safety evaluations.

Since the close of the reporting period, we have continued to build momentum, and with the third adult patient being treated in August, thereby completing the first adult dose cohort. We reported that this patient had passed the initial safety evaluation and, importantly, that early signs of clinical efficacy were observed. Leukemic cells were no longer detectable by standard assays, providing the first clear evidence that HG-CT-1 is beginning to deliver therapeutic benefit.

These achievements reinforced the emerging safety profile of HG-CT-1 at the opening dose level and provided the foundation for continued enrolment.

The safety data from the first three patients will now be submitted to the independent Data Safety Monitoring Board ("DSMB"), which will determine whether the trial can progress to the next dose level. Subject to DSMB approval, we will proceed into dose escalation, a critical milestone in defining both the safety and therapeutic potential of HG-CT-1.

During the reporting period we have also prepared to broaden the scope of the trial. A paediatric protocol amendment was submitted in May, and in June regulatory clearance was obtained to initiate a paediatric expansion of the study. This development reflects our determination to address the particularly acute unmet need in childhood AML.

Operational and manufacturing progress

Clinical progress must be matched by operational readiness. To that end, we have entered into a strategic manufacturing partnership with Made Scientific, a US-based contract development and manufacturing organisation, to support technology transfer and scale-up of HG-CT-1 production. This partnership enhances both our capacity and resilience in manufacturing.

During the reporting period we also secured a US$120,000 G-Rex® grant to optimise and scale CAR-T production, supporting efficiency and cost-effectiveness as the programme expands.

These steps are designed to ensure that Hemogenyx Pharmaceuticals can meet the growing demands of its clinical trial and be well prepared for potential commercialisation.

Potential revenue opportunity

A significant post-period corporate development has been the signing of a letter of intent ("LOI") with Cellin Technologies OÜ ("Cellin"), a leading Estonian cell therapy company. This agreement contemplates the commercialisation of HG-CT-1 under Estonia's recently amended hospital exemption pathway for advanced therapy medicinal products.

The pathway permits the clinical use of certain advanced therapy medicinal products that have not yet received full marketing authorisation, provided that they are manufactured for and administered within a hospital setting. This collaboration with Cellin represents Hemogenyx Pharmaceutical's first potential near-term revenue opportunity for HG-CT-1, while also offering the prospect of gathering valuable real-world patient data alongside our ongoing clinical trial.

The Board views this agreement as an important strategic complement to our Phase I programme; it provides a pathway to early commercial uptake in Europe, strengthens international partnerships, and demonstrates the versatility of HG-CT-1 as both a clinical and potentially commercial asset.

Financial Results

During the six months ended 30 June 2025, the Group recorded a loss before taxation of £5,006,415 (2024: £2,815,604 loss), including operating costs of £4,819,980 (2024: £2,691,140). For further comparison, the operating costs for the twelve months to 31 December 2024 were £6,465,846. The increase in costs for the period ended 30 June 2025 compared to the same period in 2024 is primarily due to an unfavourable movement in the UK sterling and US dollar exchange rate, which accounted for a variance of approximately £2,241,905. Research and development expenditure was broadly consistent year-on-year, with continued investment in the Phase I clinical trial of HEMO-CAR-T and related development activities.

The outsourcing of manufacture is now more economical than in-house manufacturing and the steps we have taken are now having a significant impact on our operating costs.

The Company had cash and cash equivalents totalling £226,727 as of 30 June 2025.

The Company raised £2.24 million (before expenses) during H1 and has raised a further £2.2 million post period end.

Path forward

Our priorities for the remainder of 2025 are clear:

1. DSMB review and dose escalation; submit the combined data from the first three patients to the DSMB and, subject to its approval, advance into the next dose cohort.

2. Paediatric expansion; operationalise the regulatory clearance to initiate enrolment of paediatric patients with AML.

3. Manufacturing scale-up; progress technology transfer with Made Scientific and deploy the G-Rex® grant to strengthen manufacturing efficiency and scalability.

4. Revenue optionality; finalise discussions with Cellin to define and implement a framework for HG-CT-1 supply under the Estonian hospital exemption pathway, balancing patient access with early revenue generation.

5. Financial discipline; continue to manage resources prudently, aligning financing decisions with clinical and corporate milestones.

Conclusion

The first half of 2025 has confirmed both the safety and the promise of HG-CT-1. The successful treatment of three adult patients at the lowest dose level, together with the first signals of clinical efficacy, mark a pivotal stage in the Company's development. With DSMB review and dose escalation moving ahead, and with preparations for paediatric expansion under way, the clinical pathway is well defined.

At the same time, the Company has built resilience through strengthened manufacturing partnerships, secured targeted grant support, and taken a pragmatic approach to financing. Importantly, the LOI with Cellin opens the possibility of early revenue generation in Europe, alongside the collection of meaningful patient data in a real-world setting.

We enter the second half of 2025 with momentum and with confidence. Our mission remains to deliver life-changing therapies to patients with acute unmet needs, while building long-term value for our shareholders.

On behalf of the Board, I wish to thank our staff, directors, collaborators, and shareholders for their continued support.

Marc Feldmann
Chairman

30 September 2025

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.

Enquiries:

Hemogenyx Pharmaceuticals plc	https://hemogenyx.com
Dr Vladislav Sandler, Chief Executive Officer & Co-Founder	headquarters@hemogenyx.com
Peter Redmond, Director	peter.redmond@hemogenyx.com
SP Angel Corporate Finance LLP	Tel: +44 (0)20 3470 0470
Matthew Johnson, Vadim Alexandre, Adam Cowl
Peterhouse Capital Limited	Tel: +44 (0)20 7469 0930
Lucy Williams, Duncan Vasey, Charles Goodfellow

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SOURCE: Hemogenyx Pharmaceuticals PLC

View the original press release on ACCESS Newswire

FAQ

What were the key results from Hemogenyx's HG-CT-1 Phase I trial in H1 2025?

Three patients were treated in the Phase I trial, with all passing initial safety evaluations. The third patient showed particularly promising results with leukemic cells no longer detectable by standard assays, demonstrating early signs of therapeutic benefit.

How much money did Hemogenyx (HOPHF) raise in H1 2025 and what was their financial position?

Hemogenyx raised £2.24 million in H1 2025 and an additional £2.2 million post-period. The company reported cash and cash equivalents of £226,727 as of June 30, 2025.

What is the significance of Hemogenyx's agreement with Cellin Technologies?

The LOI with Cellin Technologies provides Hemogenyx's first potential near-term revenue opportunity through Estonia's hospital exemption pathway, allowing HG-CT-1 clinical use before full marketing authorization while gathering real-world patient data.

What are Hemogenyx's main priorities for the remainder of 2025?

Key priorities include DSMB review and dose escalation for the next cohort, initiating pediatric patient enrollment, progressing manufacturing scale-up with Made Scientific, finalizing the Cellin Technologies framework, and maintaining financial discipline.

How has the GBP/USD exchange rate affected Hemogenyx's financial performance in H1 2025?

Unfavorable movements in the GBP/USD exchange rate resulted in approximately £2,241,905 negative impact on operating costs compared to the same period in 2024.