Hemogenyx advances lead CAR-T trial and secures funding to complete Phase 1

HemoGenyx Pharmaceuticals Plc ( (GB:HEMO) ) just unveiled an update.

Hemogenyx Pharmaceuticals reported its final audited results for 2025, highlighting significant clinical and operational progress as it advances its lead CAR-T therapy, HG-CT-1, for relapsed or refractory acute myeloid leukaemia. The company has transitioned into a functioning clinical-stage business despite challenging capital markets, supported by strategic manufacturing and clinical partnerships.

During 2025, Hemogenyx dosed its first three patients in a Phase 1 trial of HG-CT-1, observed encouraging early biological activity with no dose-limiting toxicities at the starting dose, and received Data Safety Monitoring Board approval to proceed to dose escalation. The DSMB also cleared the opening of a paediatric arm, marking an expansion into childhood AML where unmet need is particularly acute.

The company strengthened its regulatory footing by filing its first Annual IND Report with the U.S. FDA, securing clearance for paediatric expansion, and obtaining protocol approval from MD Anderson’s Institutional Review Board, enabling paediatric recruitment alongside adult dose escalation. These steps build a framework for continued enrolment and support progression toward later-stage development.

Operationally, Hemogenyx partnered with contract manufacturer Made Scientific to transfer HG-CT-1 production to GMP-ready facilities, a move aimed at lowering operating costs and creating a scalable manufacturing base suitable for future pivotal trials. It also extended its collaboration with CRO Prevail InfoWorks, whose affiliate Prevail Partners made a strategic investment, aligning operational execution with long-term partner capital.

On the early commercialisation front, the company signed a non-binding letter of intent with Estonian cell therapy group Cellin Technologies to explore hospital exemption-based commercialisation of HG-CT-1 in Estonia. This potential pathway could generate early revenues and real-world patient data to complement the Phase 1 trial, offering commercial optionality and additional evidence for stakeholders.

To fund its expanded clinical activities, Hemogenyx raised £2.7 million in 2025 through equity, convertible debt, and warrants, and secured an additional £5.5 million in early 2026, capital the board believes is sufficient to complete the Phase 1 programme. Rising operating expenditure reflects the shift to active clinical operations, but recent manufacturing outsourcing decisions are expected to yield substantial cost savings in the current year, bolstering the company’s ability to sustain its development trajectory.

Spark’s Take on HEMO Stock

According to Spark, TipRanks’ AI Analyst, HEMO is a Neutral.

The score is held down primarily by very weak financial performance (no revenue, ongoing losses and cash burn, and higher balance-sheet risk from lower equity and increased leverage). Technicals provide some offset with strong recent momentum, but overbought indicators add near-term risk, and valuation support is limited due to a negative P/E and no dividend yield.

To see Spark’s full report on HEMO stock, click here.

More about HemoGenyx Pharmaceuticals Plc

Hemogenyx Pharmaceuticals plc is a UK-listed biopharmaceutical group focused on developing novel cell-based and immunotherapies for blood cancers and other serious blood diseases. Its lead product, HG-CT-1, is a proprietary CAR-T cell therapy targeting relapsed or refractory acute myeloid leukaemia in adults and children, positioning the company within the high-need oncology and cell therapy markets.

Average Trading Volume: 28,980

Technical Sentiment Signal: Sell

Current Market Cap: £43.69M

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