Half-year Report
RNS Number : 2914B
Hemogenyx Pharmaceuticals PLC
30 September 2025
30 September 2025
Hemogenyx Pharmaceuticals plc
("Hemogenyx Pharmaceuticals" or the "Company")
Half-year Report
Interim Results for the period ended 30 June 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 |
| Continuing Operations | Note | 6 months to 30 June 2025 Unaudited | 6 months to 30 June 2024 Unaudited |
| £ | £ | ||
| Revenue | - | - | |
| Administrative Expenses | (2,264,292) | (2,487,975) | |
| Foreign Exchange Gain/(Loss) | (2,241,905) | 118,520 | |
| Depreciation | (313,783) | (321,685) | |
| Other Losses | 8 | (66,552) | - |
| Operating Loss | (4,886,532) | (2,691,140) | |
| Finance Income | 6 | 17,328 | |
| Finance Costs | (119,889) | (141,792) | |
| Loss before Taxation | (5,006,415) | (2,815,604) | |
| Loss attributable to: | |||
| - Equity owners | (5,004,171) | (2,812,832) | |
| - Non-controlling interests | (2,244) | (2,772) | |
| Loss for the period | (5,006,415) | (2,815,604) | |
| Other comprehensive income | |||
| Items that may be reclassified subsequently to profit or loss: | |||
| Translation of foreign operations | 2,057,106 | (102,482) | |
| Total comprehensive income for the period | (2,949,309) | (2,918,086) | |
| Total comprehensive income attributable to: | |||
| - Equity owners | (2,947,065) | (2,915,314) | |
| - Non-controlling interests | (2,244) | (2,772) | |
| Basic and diluted earnings (per share) | 5 | (0.833) | (0.951) |
| As at | As at | ||||||
| 30 June 2025 | 31 December 2024 | ||||||
| Note | Unaudited | Audited | |||||
| Assets | £ | £ | |||||
| Non-current assets | |||||||
| Property, plant and equipment | 6 | 588,209 | 759,408 | ||||
| Security deposit | 156,773 | 167,888 | |||||
| Right of use asset | 10 | 1,604,440 | 1,967,813 | ||||
| Intangible asset | 182,025 | 477,403 | |||||
| Total non-current assets | 2,531,447 | 3,372,512 | |||||
| Current assets | |||||||
| Trade and other receivables | 343,086 | 679,783 | |||||
| Cash and cash equivalents | 226,727 | 159,265 | |||||
| Total current assets | 569,813 | 839,048 | |||||
| Total assets | 3,101,260 | 4,211,560 | |||||
| Equity and Liabilities | |||||||
| Equity attributable to shareholders | |||||||
| Paid-in Capital | |||||||
| Called up share capital | 7 | 45,935 | 35,045 | ||||
| Share premium | 7 | 22,927,060 | 21,388,546 | ||||
| Deferred share capital | 7 | 13,983,115 | 13,983,115 | ||||
| Warrants reserve | 9 | - | - | ||||
| Other reserves | 1,508,572 | 1,508,572 | |||||
| Reverse asset acquisition reserve | (6,157,894) | (6,157,894) | |||||
| Foreign currency translation reserve | 1,621,151 | (435,955) | |||||
| Retained Earnings | (34,428,086) | (29,423,915) | |||||
| Equity attributable to owners of the Company | (500,147) | 897,514 | |||||
| Non-controlling interests | (46,264) | (44,020) | |||||
| Total Equity | (546,411) | 853,494 | |||||
| Liabilities | |||||||
| Non-current liabilities | |||||||
| Lease liabilities 10 | 1,789,831 | 2,199,413 | |||||
| Derivative financial instruments 8 | 535,046 | - | |||||
| Current liabilities | 2,324,877 | 2,199,413 | |||||
| Trade and other payables | 909,279 | 734,980 | |||||
| Lease liabilities 10 | 413,515 | 423,673 | |||||
| Total Current Liabilities | 1,322,794 | 1,158,653 | |||||
| Total Liabilities | 3,647,671 | 3,358,066 | |||||
| Total equity and liabilities | 3,101,260 | 4,211,560 | |||||
| Called up Share Capital | Share Premium | Deferred Share capital | Other reserves | Reverse acquisition reserve | Foreign currency translation reserve | Retained earnings | Non- Controlling interests | Total Equity | |||||||
| £ | £ | £ | £ | £ | £ | £ | £ | £ | |||||||
| As at 1 January 2024 | 11,755,660 | 19,938,556 | - | 1,164,637 | (6,157,894) | (77,496) | (23,804,734) | (37,723) | 2,781,006 | ||||||
| Loss in period | - | - | - | - | - | - | (2,812,832) | (2,772) | (2,815,604) | ||||||
| Other Comprehensive Income | - | - | - | - | - | (102,482) | - | - | (102,482) | ||||||
| Total comprehensive income for the period | - | - | - | - | - | (179,978) | (26,617,566) | (2,772) | (2,918,086) | ||||||
| Issue of shares | 1,662,500 | 1,662,500 | - | - | - | - | - | - | 3,325,000 | ||||||
| Cost of capital | - | (164,510) | - | - | - | - | - | - | (164,510) | ||||||
| Issue of options | - | - | - | - | - | - | - | - | - | ||||||
| As at 30 June 2024 (Unaudited) | 13,418,160 | 21,436,546 | - | 1,164,637 | (6,157,894) | (179,978) | (26,617,566) | (40,495) | 3,023,410 | ||||||
| As at 1 January 2025 | 35,045 | 21,388,546 | 13,983,115 | 1,508,572 | (6,157,894) | (435,955) | (29,423,915) | (44,020) | 853,494 | ||||||
| Loss in period | - | - | - | - | - | - | (5,004,171) | (2,244) | (5,006,415) | ||||||
| Other Comprehensive Income | - | - | - | - | - | 2,057,106 | - | - | 2,057,106 | ||||||
| Total comprehensive income for the period | - | - | - | - | - | 2,057,106 | (5,004,171) | (2,244) | (2,949,309) | ||||||
| Issue of shares | 9,940 | 1,473,267 | - | - | - | - | - | - | 1,767,257 | ||||||
| Cost of capital | - | (218,803 | - | - | - | - | - | - | (218,803) | ||||||
| Issuance of convertible loan notes | - | 284,050 | 950 | - | - | - | - | - | 950 | ||||||
| Conversion of convertible loan notes | 950 | - | (950) | - | - | - | - | - | - | ||||||
| As at 30 June 2025 | 45,935 | 22,927,060 | 13,983,115 | 1,508,572 | (6,157,894) | 1,621,151 | (34,428,086) | (46,264) | (546,411) | ||||||
| Group | Note | 6 months to 30 June 2025 Unaudited | 6 months to 30 June 2024 Unaudited |
| £ | £ | ||
| Cash flows generated from operating activities | |||
| Loss for the period | (5,006,415) | (2,815,604) | |
| Depreciation | 6, 10 | 313,783 | 321,685 |
| Foreign exchange gain | 3,464 | (14,630) | |
| Interest income | (6) | (17,328) | |
| Interest expense | 10 | 119,889 | 141,792 |
| Change in fair value of derivative liabilities | 66,552 | - | |
| Changes in right of use asset and lease liability, net | 136,773 | - | |
| (Decrease)/increase in trade and other payables | 305,011 | (65,400) | |
| Decrease/(increase) in trade and other receivables | 97,799 | (17) | |
| Decrease/(Increase) in prepaid and deposits | 179,941 | 98,682 | |
| Net cash outflow used in operating activities | (3,783,209) | (2,350,820) | |
| Cash flows generated from financing activities | |||
| Proceeds from issuance of shares, net of direct costs | 7 | 2,017,898 | 3,160,490 |
| Payment of lease liabilities | 10 | (345,832) | (317,872) |
| Net cash flow generated from/(used in) financing activities | 1,672,066 | 2,842,618 | |
| Cash flows generated from investing activities | |||
| Interest income | 6 | 17,328 | |
| Security deposit | (4,007) | - | |
| Intangible assets | 267,969 | - | |
| Purchase of property, plant & equipment | 6 | (3,921) | - |
| Net cash flow generated from investing activities | 260,047 | 17,328 | |
| Net increase (decrease) in cash and cash equivalents | (1,851,096) | 509,126 | |
| Effect of exchange rates on cash and cash equivalents | 1,918,558 | (113,965) | |
| Cash and cash equivalents at the beginning of the period | 159,265 | 1,247,601 | |
| Cash and cash equivalents at the end of the period | 226,727 | 1,642,762 |
| Deferred Shares | Ordinary Shares | Deferred share capital £ | Called up share capital £ | Share premium £ | |||
| As at 31 December 2024 | 1,401,815,988 | 3,504,540 | 13,983,115 | 35,045 | 21,388,546 | ||
| Issue of shares | - | 994,000 | - | 9,940 | 1,941,761 | ||
| Derivative liability | - | - | - | - | (468,494) | ||
| Conversion of convertible loan notes | - | 95,000 | - | 950 | 284,050 | ||
| Share issuance costs | - | - | - | - | (218,803) | ||
| As at 30 June 2025 | 1,401,815,988 | 4,593,540 | 13,983,115 | 45,935 | 22,927,060 |
| Warrants | Warrant liability £ | |
| As at 31 December 2024 | - | - |
| Issue of warrants | 500,000 | 468,494 |
| Change in fair value | - | 66,552 |
| As at 30 June 2025 | 500,000 | 535,046 |
| Stock price | £1.53 |
| Annual equity volatility | 87.8% |
| Risk-free rate | 3.7% |
| Term to maturity | 2.85 years |
| Discount rate | 15% |
| Number of options | |
| Members of the Scientific Advisory Board | 31,205 |
| Employees, including directors | 260,817 |
| Total | 292,022 |
| Warrants | |
| As at 31 December 2024 | - |
| Issue of warrants | 247,000 |
| Issuance of warrants on conversion of convertible loan notes | 95,000 |
| As at 30 June 2025 | 342,000 |