Hemogenyx Pharma Stock Price, News & Analysis

Hemogenyx Pharma PLC (HOPHF), known in its regulatory and news disclosures as Hemogenyx Pharmaceuticals plc (LSE: HEMO), is a clinical stage biopharmaceutical group focused on developing new medicines and treatments for blood and autoimmune diseases. The company is headquartered in London and has US operating subsidiaries, Hemogenyx Pharmaceuticals LLC and Immugenyx LLC, located in New York City. Its activities fall within research and development in biotechnology and the broader professional, scientific, and technical services sector.

According to multiple company announcements, Hemogenyx Pharmaceuticals describes itself as a biopharmaceutical group developing several distinct and complementary product candidates, as well as platform technologies that it uses as engines for novel product development. The company’s work is centered on therapies designed to transform the treatment of blood diseases, including blood cancers, and to address areas of significant unmet medical need.

Clinical stage focus and HG-CT-1 program

Hemogenyx Pharmaceuticals is a clinical stage company, meaning its lead programs have progressed from preclinical research into human clinical trials. A central focus of its recent disclosures is HG-CT-1, described as an autologous Chimeric Antigen Receptor T-cell (CAR-T) therapy targeting fms-like tyrosine kinase 3 (FLT3) for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML). The company reports that HG-CT-1 is being evaluated in an ongoing Phase I clinical trial in adult patients with R/R AML, with the trial designed as a dose-escalation study to assess safety, tolerability, and preliminary efficacy.

Company announcements state that the first-in-human treatment with HG-CT-1 has been successfully administered and that three adult patients have been treated at the initial dose level. Hemogenyx Pharmaceuticals reports that these patients passed initial safety evaluations, with early signs of clinical efficacy observed, including the absence of detectable leukemic cells by standard assays in one case. Safety data from these patients are being reviewed by an independent Data Safety Monitoring Board (DSMB) to determine progression to higher dose levels within the trial.

Pediatric expansion and regulatory interactions

Hemogenyx Pharmaceuticals has highlighted steps to broaden the scope of the HG-CT-1 Phase I trial. The company reports that regulatory clearance has been obtained to initiate a pediatric expansion of the study, allowing enrollment of children and adolescents with relapsed or refractory AML. An Institutional Review Board (IRB) at MD Anderson Cancer Center approved an amendment to the clinical protocol to include pediatric patients, and company disclosures indicate that pediatric recruitment is expected to proceed at the lowest dose level used in the initial adult cohort.

In its interim reporting, Hemogenyx Pharmaceuticals notes that the US Food and Drug Administration (FDA) accepted an annual Investigational New Drug (IND) report for HG-CT-1 and cleared a pediatric protocol amendment. These regulatory interactions form part of the company’s pathway to advance HG-CT-1 through early-stage clinical development.

Manufacturing partnerships and operational foundations

To support the clinical and potential future commercial supply of HG-CT-1, Hemogenyx Pharmaceuticals has entered into a manufacturing partnership with Made Scientific, a US-based cell therapy contract development and manufacturing organization (CDMO). Company announcements describe this collaboration as focused on technology transfer and scale-up of HG-CT-1 production at Good Manufacturing Practice (GMP) facilities in the United States. Hemogenyx Pharmaceuticals states that this partnership is intended to enhance its manufacturing capacity and resilience and to support both adult and potential pediatric cohorts in the clinical trial.

In addition, the company reports securing a grant described as a G-Rex grant to optimize and scale CAR-T production, with the goal of improving efficiency and cost-effectiveness as the HG-CT-1 program expands. Hemogenyx Pharmaceuticals links these operational steps to its broader strategy of aligning manufacturing readiness with clinical progress.

Potential early revenue pathway and international collaboration

Beyond its clinical trial activities, Hemogenyx Pharmaceuticals has disclosed a letter of intent (LOI) with Cellin Technologies OÜ, an Estonian cell therapy company. Under this non-binding LOI, the parties are exploring commercialization of HG-CT-1 for R/R AML through the hospital exemption pathway under Estonia’s Medicinal Products Act. Company announcements explain that this pathway permits the use of certain advanced therapy medicinal products that have not yet received full marketing authorization, provided there is sufficient preclinical or Phase I clinical data and that treatments are administered within a hospital setting.

According to the company, this framework offers a potential route for early revenue generation from HG-CT-1 while simultaneously expanding real-world clinical data to complement the ongoing Phase I trial. Hemogenyx Pharmaceuticals states that it would retain full ownership of intellectual property, know-how, data, and regulatory rights related to HG-CT-1, while Cellin would provide local manufacturing, regulatory, and operational support in Estonia, subject to definitive agreements.

Capital markets presence and share-related activity

Hemogenyx Pharmaceuticals is publicly traded on the London Stock Exchange under the symbol HEMO, with its shares admitted to the equity shares (transition) category of the Official List. The over-the-counter symbol HOPHF reflects trading in another market. Company announcements describe various capital markets activities, including the issuance and allotment of new ordinary shares arising from the exercise of warrants, the vesting of restricted stock units, and obligations under a deed of variation. These share issuances are accompanied by applications for admission of the new shares to the FCA’s Official List and to trading on the main market of the London Stock Exchange.

The company has also published a prospectus in connection with the admission of new ordinary shares to listing and trading following the conversion of convertible loan notes and the exercise of warrants. These disclosures emphasize compliance with regulatory requirements in the United Kingdom, including the Financial Conduct Authority’s rules and the Market Abuse Regulation framework.

Research and development orientation

Across its news releases and interim reporting, Hemogenyx Pharmaceuticals consistently describes itself as a clinical stage biopharmaceutical group developing medicines and treatments for blood and autoimmune diseases. It states that it is advancing several distinct and complementary product candidates and platform technologies, which it refers to as engines for novel product development. While HG-CT-1 is a central focus of current clinical activity, the company also references a broader therapeutic pipeline and intellectual property portfolio underpinning its research and development efforts.

Within the research and development in biotechnology industry, Hemogenyx Pharmaceuticals positions its work around advanced cell therapies and related technologies aimed at life-threatening blood cancers and other serious conditions. Its disclosures highlight a mission to develop therapies for patients with acute unmet medical needs, particularly in the context of relapsed or refractory acute myeloid leukemia.

Geographic footprint and organizational structure

Hemogenyx Pharmaceuticals states that it is headquartered in London, United Kingdom, and that its US operating subsidiaries, Hemogenyx Pharmaceuticals LLC and Immugenyx LLC, are located in New York City. This structure reflects a transatlantic footprint, with corporate and capital markets activities centered in the UK and operational and clinical activities involving US institutions and partners.

Investor considerations and reporting

In its half-year report for the period ended 30 June 2025, Hemogenyx Pharmaceuticals describes its principal focus as the clinical development of HG-CT-1, alongside efforts to strengthen operational and manufacturing foundations, secure grant and financing support, and explore potential early revenue opportunities. The company outlines priorities such as DSMB review and dose escalation within the Phase I trial, operationalizing pediatric enrollment, progressing manufacturing scale-up, and advancing discussions under the Estonian hospital exemption framework.

As a listed company, Hemogenyx Pharmaceuticals provides regular updates through regulatory news services, including information on clinical milestones, financing transactions, share capital changes, and strategic collaborations. Investors and observers can use these disclosures to follow the progression of its clinical programs, operational initiatives, and capital structure.

FAQs about Hemogenyx Pharma PLC (HOPHF)

• What does Hemogenyx Pharma PLC do?
  According to its public announcements, Hemogenyx Pharmaceuticals plc is a clinical stage biopharmaceutical group developing new medicines and treatments for blood and autoimmune diseases. It reports that it is advancing several distinct and complementary product candidates and platform technologies used as engines for novel product development.
• What is HG-CT-1?
  Company disclosures describe HG-CT-1 as an autologous Chimeric Antigen Receptor T-cell (CAR-T) therapy targeting FLT3 for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML). It is being evaluated in a Phase I dose-escalation clinical trial in adult patients, with early safety and preliminary efficacy data reported.
• What stage of development is Hemogenyx Pharmaceuticals in?
  Hemogenyx Pharmaceuticals refers to itself as a clinical stage biopharmaceutical group. Its lead program, HG-CT-1, is in a Phase I clinical trial, and the company reports that multiple patients have been treated at the initial dose level with initial safety evaluations completed.
• Where is Hemogenyx Pharmaceuticals based?
  The company states that it is headquartered in London, with US operating subsidiaries Hemogenyx Pharmaceuticals LLC and Immugenyx LLC located in New York City. It conducts corporate and capital markets activities in the UK and collaborates with US institutions and partners for clinical and manufacturing work.
• On which exchanges does Hemogenyx trade?
  Hemogenyx Pharmaceuticals plc reports that its shares are admitted to the equity shares (transition) category of the Official List maintained by the UK Financial Conduct Authority and to trading on the main market for listed securities of the London Stock Exchange under the symbol HEMO. The symbol HOPHF represents trading in another market.
• What is the focus of Hemogenyx’s clinical trial program?
  Company announcements indicate that the principal focus is a Phase I clinical trial of HG-CT-1 in adult patients with relapsed or refractory acute myeloid leukemia. The trial is designed to evaluate safety, tolerability, and preliminary efficacy, with secondary endpoints including AML-specific responses, progression-free survival, duration of response, and overall survival.
• Is Hemogenyx developing therapies for pediatric patients?
  Yes. Hemogenyx Pharmaceuticals reports that regulatory and institutional review board clearances have been obtained to initiate pediatric enrollment in the HG-CT-1 Phase I trial, allowing children and adolescents with relapsed or refractory AML to be included at the lowest dose level used in adults.
• What manufacturing arrangements does Hemogenyx have for HG-CT-1?
  The company has announced a manufacturing partnership with Made Scientific, a US-based cell therapy CDMO, to support technology transfer and scale-up of HG-CT-1 production at GMP facilities. It also reports receiving a grant to optimize and scale CAR-T production.
• What is the significance of the letter of intent with Cellin Technologies?
  Hemogenyx Pharmaceuticals describes the LOI with Cellin Technologies OÜ as a framework to explore commercialization of HG-CT-1 in Estonia under the hospital exemption pathway. The company views this as a potential near-term revenue opportunity and a way to gather real-world clinical data alongside its Phase I trial.
• How does Hemogenyx communicate with investors?
  As a listed company, Hemogenyx Pharmaceuticals issues regulatory news releases covering clinical trial updates, interim financial reports, share issuances, strategic partnerships, and other material developments. These announcements are disseminated through recognized news services associated with the London Stock Exchange.