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Hemogenyx Pharmaceuticals PLC Announces Half-year Report

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Hemogenyx Pharmaceuticals plc (LSE: HEMO) has released its unaudited interim results for the six months ended 30 June 2024. Key highlights include:

  • FDA lifted the clinical hold on the IND application for HEMO-CAR-T
  • Raised £3.325 million to advance HEMO-CAR-T towards Phase I clinical trials
  • Phase I trials expected to begin shortly at M.D. Anderson Cancer Center in Texas
  • Advancements in Chimeric Bait Receptor (CBR) and bispecific antibody (CDX) programmes

The company has focused on getting HEMO-CAR-T into clinical trials while progressing other product candidates. They have evaluated its potential for pediatric AML and a subset of ALL. A clinical-grade assay for HEMO-CAR-T trials has been developed. The CBR platform is being tested against rare cancers and viral infections. CDX studies for IND application are advancing, with a new improved version showing enhanced effectiveness in lab tests.

Financial results show a loss before taxation of £2,815,604 for H1 2024, with cash and cash equivalents of £1,642,762 as of 30 June 2024.

Hemogenyx Pharmaceuticals plc (LSE: HEMO) ha pubblicato i suoi risultati intermedi non auditati per i sei mesi terminati il 30 giugno 2024. Principali evidenze includono:

  • La FDA ha sollevato il blocco clinico sull'applicazione IND per HEMO-CAR-T
  • Raccolti 3,325 milioni di sterline per portare HEMO-CAR-T verso la fase I degli studi clinici
  • Gli studi della fase I prevedono di iniziare a breve presso il M.D. Anderson Cancer Center in Texas
  • Avanzamenti nei programmi del Recettore Bait Chimerico (CBR) e degli anticorpi bispecifici (CDX)

L'azienda si è concentrata sull'introduzione di HEMO-CAR-T negli studi clinici mentre progredisce con altri candidati. Hanno valutato il suo potenziale per l'AML pediatrico e un sottoinsieme di ALL. È stato sviluppato un saggio clinico per le prove di HEMO-CAR-T. La piattaforma CBR è in fase di test contro tumori rari e infezioni virali. Gli studi CDX per l'applicazione IND stanno avanzando, con una nuova versione migliorata che mostra una maggiore efficacia nei test di laboratorio.

I risultati finanziari mostrano una perdita prima della tassazione di 2,815,604 sterline per il primo semestre del 2024, con disponibilità liquide e equivalenti di 1,642,762 sterline al 30 giugno 2024.

Hemogenyx Pharmaceuticals plc (LSE: HEMO) ha publicado sus resultados interinos no auditados para los seis meses cerrados el 30 de junio de 2024. Puntos destacados incluyen:

  • La FDA levantó la suspensión clínica de la solicitud IND para HEMO-CAR-T
  • Se recaudaron 3.325 millones de libras para avanzar HEMO-CAR-T hacia ensayos clínicos de Fase I
  • Se espera que los ensayos de Fase I comiencen pronto en el M.D. Anderson Cancer Center en Texas
  • Avances en los programas de Receptor Cibérnico Bait (CBR) y anticuerpo bispecífico (CDX)

La compañía se ha centrado en llevar HEMO-CAR-T a ensayos clínicos mientras avanza con otros candidatos. Han evaluado su potencial para AML pediátrico y un subconjunto de ALL. Se ha desarrollado un ensayo de grado clínico para los ensayos de HEMO-CAR-T. La plataforma CBR se está probando contra cánceres raros e infecciones virales. Los estudios CDX para la solicitud IND están avanzando, con una nueva versión mejorada que muestra mayor efectividad en las pruebas de laboratorio.

Los resultados financieros muestran una pérdida antes de impuestos de 2,815,604 libras para el primer semestre de 2024, con un efectivo y equivalentes de 1,642,762 libras al 30 de junio de 2024.

Hemogenyx Pharmaceuticals plc (LSE: HEMO)는 2024년 6월 30일 종료된 6개월 동안의 감사되지 않은 중간 결과를 발표했습니다. 주요 하이라이트는 다음과 같습니다:

  • FDA가 HEMO-CAR-T에 대한 IND 신청의 임상 중지를 해제했습니다.
  • HEMO-CAR-T를 1상 임상 시험으로 진전시키기 위해 332.5만 파운드를 모금했습니다.
  • 텍사스의 M.D. Anderson Cancer Center에서 1상 시험이 곧 시작될 것으로 예상됩니다.
  • Chimeric Bait Receptor (CBR) 및 이중 특이성 항체 (CDX) 프로그램의 진전을 보였습니다.

회사는 HEMO-CAR-T를 임상 시험에 투입하는 데 집중하면서 다른 후보 제품도 진행 중입니다. 그들은 소아 AML 및 ALL의 하위 집합에 대한 잠재력을 평가했습니다. HEMO-CAR-T 시험을 위한 임상 등급의 분석법이 개발되었습니다. CBR 플랫폼은 희귀 암 및 바이러스 감염에 대해 테스트되고 있습니다. IND 신청을 위한 CDX 연구가 진행 중이며, 새로운 개선된 버전이 실험실 테스트에서 향상된 효과를 보여주고 있습니다.

재무 결과는 2024년 상반기에 2,815,604 파운드의 세전 손실을 보였으며, 2024년 6월 30일 기준 현금 및 현금성 자산은 1,642,762 파운드입니다.

Hemogenyx Pharmaceuticals plc (LSE: HEMO) a publié ses résultats intermédiaires non audités pour les six mois clos le 30 juin 2024. Points saillants comprennent :

  • La FDA a levé la suspension clinique sur la demande IND pour HEMO-CAR-T
  • 3,325 millions de livres ont été levés pour faire avancer HEMO-CAR-T vers les essais cliniques de phase I
  • Les essais de phase I devraient commencer prochainement au M.D. Anderson Cancer Center au Texas
  • Avancées dans les programmes de Récepteurs Chimeriques Bait (CBR) et d'anticorps bispécifiques (CDX)

L'entreprise s'est concentrée sur l'introduction de HEMO-CAR-T dans les essais cliniques tout en progressant avec d'autres candidats produits. Ils ont évalué son potentiel pour l'AML pédiatrique et un sous-ensemble de ALL. Un test de qualité clinique pour les essais HEMO-CAR-T a été développé. La plateforme CBR est testée contre les cancers rares et les infections virales. Les études CDX pour la demande IND avancent, avec une nouvelle version améliorée montrant une efficacité accrue dans les tests de laboratoire.

Les résultats financiers montrent une perte avant impôts de 2.815.604 livres pour le premier semestre 2024, avec des liquidités et équivalents de 1.642.762 livres au 30 juin 2024.

Hemogenyx Pharmaceuticals plc (LSE: HEMO) hat seine ungeprüften Zwischenberichte für die sechs Monate bis zum 30. Juni 2024 veröffentlicht. Wichtige Punkte umfassen:

  • Die FDA hat das klinische Halt der IND-Anträge für HEMO-CAR-T aufgehoben.
  • 3,325 Millionen Pfund wurden gesammelt, um HEMO-CAR-T in Richtung Phase-I-Studien voranzubringen.
  • Die Phase-I-Studien sollen bald im M.D. Anderson Cancer Center in Texas beginnen.
  • Fortschritte in den Programmen Chimeric Bait Receptor (CBR) und bispezifische Antikörper (CDX)

Das Unternehmen hat sich darauf konzentriert, HEMO-CAR-T in klinische Studien zu bringen, während es andere Produktkandidaten weiterentwickelt. Es wurde das Potenzial für pädiatrische AML und eine Untergruppe von ALL bewertet. Ein klinisches Testverfahren für HEMO-CAR-T-Studien wurde entwickelt. Die CBR-Plattform wird gegen seltene Krebserkrankungen und Virusinfektionen getestet. CDX-Studien für die IND-Anträge schreiten voran, wobei eine neue verbesserte Version eine höhere Effektivität in Labortests zeigt.

Die finanziellen Ergebnisse zeigen im ersten Halbjahr 2024 einen Verlust vor Steuern von 2.815.604 Pfund, mit liquiden Mitteln und liquiden Mitteln in Höhe von 1.642.762 Pfund zum 30. Juni 2024.

Positive
  • FDA lifted clinical hold on HEMO-CAR-T IND application
  • Successful fundraising of £3.325 million for HEMO-CAR-T clinical trials
  • Phase I clinical trials for HEMO-CAR-T to begin shortly at M.D. Anderson Cancer Center
  • Development of clinical-grade assay for HEMO-CAR-T trials completed
  • Expansion of HEMO-CAR-T potential to pediatric AML and subset of ALL
  • Advancements in CBR platform for rare cancers and viral infections
  • Improved version of CDX showing enhanced effectiveness in lab tests
  • Reduction in operating costs compared to previous period
Negative
  • Loss before taxation of £2,815,604 for H1 2024
  • Delay in starting clinical trials from original timeline
  • Postponement of University of Pennsylvania Medical Center's participation in trials to 2025

LONDON, UNITED KINGDOM / ACCESSWIRE / September 27, 2024 / 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 2024.

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

Key Highlights

  • The U.S. Food and Drug Administration ("FDA") lifted the clinical hold on the Investigational New Drug ("IND") application for HEMO-CAR-T.

  • Raised £3.325 million to advance HEMO-CAR-T towards Phase I clinical trials.

  • Phase I clinical trials expected to begin shortly at M.D. Anderson Cancer Center ("MD Anderson") in Texas.

  • Continuing to make advancements with the Company's Chimeric Bait Receptor ("CBR") and bispecific antibody ("CDX") programmes.

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

Interim Management Report

We are pleased to present Hemogenyx Pharmaceuticals' half year report for the period ending 30 June 2024. The past six months have been a time of significant progress and strategic advancement for our company as we continue to develop novel therapies inter alia for the treatment of serious blood diseases.

During the first half of 2024, the Company has been mainly focussed on getting its lead product, HEMO-CAR-T, into clinical trials, while continuing to progress its other main product candidates, CBR and CDX.

HEMO-CAR-T

In February 2024, the FDA lifted the clinical hold on the IND application for HEMO-CAR-T, our treatment for acute myeloid leukemia ("AML"), which had been imposed in June 2023. The FDA confirmed that we have satisfactorily addressed all issues identified in its prior clinical hold letter, allowing us to proceed with the Phase I clinical study of HEMO-CAR-T. Following the reopening of the IND, we successfully raised £3.325 million (before expenses) at 2p per share, issuing 166,250,000 ordinary shares, to advance HEMO-CAR-T into Phase I clinical trials.

The trials are expected to begin shortly at MD Anderson in Texas, one of the leading cancer treatment centers in the U.S. As shareholders know, we have been collaborating with the University of Pennsylvania Medical Center ("Penn") to conduct the trials at their facility. While Penn remains supportive and wishes to participate, several issues have delayed their proposed schedule. Fortunately, we connected with MD Anderson regarding their participation in the trials. MD Anderson is a large and highly reputable centre for cancer treatment, including AML, and they are confident in maintaining a consistent and reliable flow of trial candidates. It is important to note that every patient from the very first one treated in the HEMO-CAR-T clinical study will produce valuable data regarding the safety and potentially efficacy of the treatment.

We are now in the final stages of the opening a clinical site at MD Anderson and expect to treat the first patient soon. Penn remains eager to participate in the trials at a later stage, and we hope they will do so, though likely not until 2025.

While we have been discussing partnerships with potential hospital collaborators, we have made significant progress with HEMO-CAR-T during the period under review. We have evaluated its potential to treat pediatric AML and a subset of pediatric acute lymphoblastic leukemia ("ALL") in young patients. An amendment to include pediatric AML in our clinical protocol has been reviewed by independent experts, and we will extend the protocol accordingly. If approved as expected, we plan to initiate clinical trials for pediatric AML and a subset of ALL at MD Anderson. These indications are of particular concern because current treatments are risky and have low success rates. There is an urgent need for effective therapies, and we believe HEMO-CAR-T can provide a valuable solution.

In addition, the Company recently announced that it has successfully completed the development of a clinical-grade assay for use in HEMO-CAR-T clinical trials, a project the Company has been working on for some time. This assay is designed to assess and ensure the proper identification and recruitment of suitable patients for the clinical trials.

We are continuing our collaboration with Prevail Infoworks, the contract research organization that will manage and oversee the planning and execution of our clinical trials. Currently, they are working closely with us to bring HEMO-CAR-T into the clinic. When the trials commence, we will manufacture the HEMO-CAR-T cells at our New York facility for use in each individual patient. Prevail Infoworks will coordinate the logistical aspects of the trials, including patient enrolment, data management, regulatory compliance, and overall trial monitoring, ensuring that the studies are conducted efficiently and effectively.

Although we had hoped to start the trials sooner, we have used this time to further advance development of the HEMO-CAR-T program, which will make the execution and assessment of the trials easier. Developing the clinical-grade assay and focusing on pediatric opportunities are significant steps forward. These advancements will help us carry out the clinical trials more effectively and broaden the potential use of HEMO-CAR-T to additional leukaemia patients who currently have very limited treatment options.

CBR and CDX

As we have been waiting for the HEMO-CAR-T clinical trials to commence, we have been able to apply more effort to progress our other product candidates, in particular the CBR and the CDX programs.

Our CBR platform is an advanced immunotherapy designed to reprogram or redirect immune cells, such as macrophages, to prevent and combat infections from both existing and emerging viral threats, as well as to eliminate specific types of cancer. Our research originally focused on the former where, for example, we established in vitro that CBR could treat viruses such as COVID and potentially a much wider range of viruses. More recently, we have established that it could also be used against a range of cancers. We are developing and testing multiple CBR constructs to identify the best candidates for targeting rare cancers such as epithelial ovarian carcinoma. Selected CBR candidates will undergo rigorous testing to advance them to IND enabling studies. In addition, we have established a means of delivering CBR intranasally, for treating airborne viral infections which would significantly ease the use of CBRs in the field. We have also recently made improvements in the stability of mRNA-based CBRs to further enhance the effectiveness of this treatment.

Regarding CDX, we have been advancing the studies required for an IND application. CDX is designed to prepare patients with AML for bone marrow transplants and, we believe, may also be directly capable of treating relapsed or refractory AML. Meanwhile, we have developed a new and improved version of CDX. Our scientists used bispecific pairing technology to create this version, and it has shown significantly enhanced effectiveness in the laboratory (in vitro) tests. Additional animal (in vivo) studies are currently underway.

HEMO-CAR-T and CDX offer different yet complementary approaches to treating AML. CDX is specifically designed to target AML cells and has the potential to condition patients for bone marrow transplants. By directly attacking AML and preparing patients for transplants, CDX provides a dual strategy in combating this aggressive cancer. On the other hand, HEMO-CAR-T involves modifying a patient's T-cells to seek out and destroy cancer cells. By developing both therapies, we increase our chances of success and aim to offer effective treatment options to a broader range of AML patients.

Financial Results

During the six months ended 30 June 2024, the Group recorded a loss before taxation of £2,815,604 (2023: £4,323,564 loss), including operating costs of £2,369,455 (2023: £3,896,308). For further comparison, the operating costs for the twelve months to 31 December 2023 were £5,820,165. The reduction in costs for the period ended 30 June 2024 compared to the same period in 2023 is due to two principal factors: a significant favourable movement in the UK sterling and US dollar exchange rate accounting for a variance of £1,039,436 and a reduction in research and development costs of £413,419. This is primarily due to a reduction in payments to WuXi in respect of the Company's advancement to the clinical trial phase. These costs concluded in March 2024.

The Company had cash and cash equivalents totalling £1,642,762 as of 30 June 2024.

Conclusion

We have now reached a pivotal stage where our lead product, HEMO-CAR-T, is set to enter the clinic, a development that undeniably elevates us to a clinical-stage company. Meanwhile, our other product candidates are also making significant strides forward. We are confident in our ability to finance their development through a combination of equity capital, industry partnerships, and non-dilutive funding. We look forward to bringing our potentially life-saving therapies into use and delivering positive returns to our shareholders.

Responsibility Statement

We confirm that to the best of our knowledge:

  • the Half Year Report has been prepared in accordance with International Accounting Standard 34 'Interim Financial Reporting'; and

  • gives a true and fair view of the assets, liabilities, financial position and loss of the Group; and

  • the Half Year Report includes a fair review of the information required by DTR 4.2.7R of the Disclosure and Transparency Rules, being an indication of important events that have occurred during the first six months of the financial year and their impact on the set of interim financial statements; and a description of the principal risks and uncertainties for the remaining six months of the year; and

  • the Half Year Report includes a fair review of the information required by DTR 4.2.8R of the Disclosure and Transparency Rules, being the information required on related party transactions; there were no such transactions in the six months ended 30 June 2024.

The Half Year Report was approved by the Board of Directors and the above responsibility statement was signed on its behalf by:

Dr Vladislav Sandler
CEO

26 September 2024

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

Click on, or paste the following link into your web browser, to view the associated PDF document.

http://www.rns-pdf.londonstockexchange.com/rns/9035F_1-2024-9-26.pdf

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.

SOURCE: Hemogenyx Pharmaceuticals PLC



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FAQ

What is the status of HEMO-CAR-T clinical trials for Hemogenyx Pharmaceuticals (HOPHF)?

Phase I clinical trials for HEMO-CAR-T are expected to begin shortly at M.D. Anderson Cancer Center in Texas, following the FDA's lifting of the clinical hold on the IND application.

How much funding did Hemogenyx Pharmaceuticals (HOPHF) raise in 2024?

Hemogenyx Pharmaceuticals raised £3.325 million (before expenses) at 2p per share, issuing 166,250,000 ordinary shares, to advance HEMO-CAR-T into Phase I clinical trials.

What are the financial results for Hemogenyx Pharmaceuticals (HOPHF) in H1 2024?

Hemogenyx Pharmaceuticals reported a loss before taxation of £2,815,604 for the six months ended 30 June 2024, with cash and cash equivalents totalling £1,642,762 as of 30 June 2024.

What progress has Hemogenyx Pharmaceuticals (HOPHF) made with its CBR and CDX programs?

Hemogenyx is developing CBR constructs for rare cancers and viral infections, and has created an improved version of CDX showing enhanced effectiveness in laboratory tests. CDX studies for IND application are advancing.

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