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| Share Name | Share Symbol | Market | Stock Type |
|---|---|---|---|
| Hemogenyx Pharmaceuticals Plc | HEMO | London | Ordinary Share |
| Price Change | Price Change % | Share Price | Last Trade
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|---|---|---|---|---|
| -0.083 | -5.78% | 1.352 | 08:30:09 |
| Open Price | Low Price | High Price | Close Price | Previous Close |
|---|---|---|---|---|
| 1.352 | 1.352 | 1.352 | 1.435 |
| Industry Sector |
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| PHARMACEUTICALS & BIOTECHNOLOGY |
| Top Posts |
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Posted at 20/11/2024 11:32 by luckyabbeygale All the other bio tech company's are a waste of time compare to Hemo. Only Hemo holds the cure to potentially all cancers in the long term. |
Posted at 02/10/2024 13:18 by jaknife gah123,"Even if you're correct which is highly questionable there could be another premium placing, grant, partner funding etc etc. We have enough for the trials - that's all that matters to me." I am correct and my numbers are perfect, if you actually thought otherwise you would criticise the numbers rather than making vague noises about how they make you cry. And HEMO doesn't have enough cash for the trials. Phase 1 trials costs loads. Take a look at Avacta as an example. They started Phase 1 trials in August 2021 and still haven't finished, meanwhile they've burnt £20m+ a year for the last three years on those trials. 1. HEMO only has enough cash to last to the end of this month. 2. The connected party deal that it's announced this morning won't bring any cash in until March next year (if at all). 3. HEMO hasn't even started its Phase 1 trials and probably doesn't have enough cash to pay the first bill! 4. A significant cash raise is needed, not a piddly silly £269k, which doesn't even keep the lights on for one month! JakNife |
Posted at 02/10/2024 10:45 by apotheki Strategic Investment from Prevail Partners, LLC· Prevail Partners, LLC to invest again in Hemogenyx Pharmaceuticals · Prevail InfoWorks, Inc. to act as Clinical Research Organization (CRO) for upcoming Phase I pediatric clinical study Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, announces that Prevail Partners, LLC ("Prevail Partners"), an investment fund, has agreed to invest a total of $350,000 (approximately £269,000) in the Company through a subscription for ordinary shares in the Company at a price of US$0.075 per share (approximately 5.6p). This follows a similar investment in the Company by Prevail Partners announced on 18 September 2024. The subscription price represents a premium of approximately 275% to the Company's closing share price on 1 October 2024. The subscription will take effect in March 2025 ahead of the planned HEMO-CAR-T pediatric study. This will follow the initiation of the adult clinical trial in HEMO-CAR-T at the MD Anderson Cancer Center, Texas, which is expected to commence later this year. The agreement governing the subscription contains customary warranties from the Company and Prevail Partners. The Company's wholly owned subsidiary, Hemogenyx Pharmaceuticals LLC, has also signed an amendment to the Master Service and Technology Agreement ("MSTA"), (the "Amendment") with Prevail InfoWorks, Inc. ("InfoWorks"), the Philadelphia, PA based Clinical Research Organization ("CRO"), and affiliate of Prevail Partners. Infoworks is already contracted by the Company in relation to the existing planned HEMO-CAR-T clinical trials in adult patients. Under the terms of the Amendment, InfoWorks is to provide clinical services and technologies for the Company's upcoming Phase I study of its anti-FLT3 chimeric antigen receptor-redirected T cells ("CAR-T cells") in pediatric subjects with relapsed/refractory acute myeloid leukemia (AML) and a subset of acute lymphoblastic leukaemia (ALL). The Amendment will come into effect in March 2025. Services to be provided under the terms of the Amendment include clinical site coordination, project management, data management, clinical monitoring, and pharmacovigilance (safety management) services, and the use of InfoWorks' integrated real-time data analytics platform, the Single Interface®, for clinical support and real-time data analysis. The MSTA has an initial term of 26 months, and Hemogenyx Pharmaceuticals LLC has agreed an initial statement of works relating to the Phase I pediatric AML/ALL study. The pediatric study is expected to commence in the first half of 2025. The subscription funds received from Prevail Partners will in large part defray the payment made by the Company for the first stage of the work to be undertaken by InfoWorks under the Amendment. Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "As we seek to bring the curative power of cell therapies to children suffering from the otherwise largely incurable life-threatening diseases, AML and ALL, we are very confident in Prevail InfoWorks' ability to coordinate our Phase I clinical trial in pediatric relapsed/refractory AML and ALL. Their operational experience and expertise will enable a smooth execution of the study, while their specialization in real-time data integration and analytics will ensure fast, reliable data access to lower our clinical risk and potentially speed up our regulatory timeline. Prevail Partners' strategic investment in the Company, once again at a price very substantially above the Company's existing share price, demonstrates their confidence in our CAR-T program and in our ability to execute the upcoming clinical study." Mary Schaheen, President of Prevail Partners, stated: "Everyone at our fund is confident in the growth and success of Hemogenyx Pharmaceuticals as they develop CAR-T cells to target acute myeloid leukaemia and a subset of acute lymphoblastic leukaemia in children. Furthermore, Hemogenyx Pharmaceuticals has a seasoned management team with the expertise to accelerate the Company to a significant value inflection point through the completion of its planned clinical trial." |
Posted at 27/9/2024 06:40 by apotheki Half-year ReportInterim Results for the period ended 30 June 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 |
Posted at 09/9/2024 06:55 by apotheki FLT3 Assay Ready for Phase I Trials at MD AndersonHemogenyx Pharmaceuticals plc (LSE: HEMO), a clinical-stage biopharmaceutical group focused on developing treatments for cancers and viral diseases, is pleased to announce the successful completion of the development of a clinical-grade assay ("Assay") designed to assess FLT3 protein expression in acute myeloid leukemia ("AML") cells. Assessing FLT3 protein expression in AML cells is crucial for the accurate identification and recruitment of patients for the imminent Phase I clinical trials of the Company's HEMO-CAR-T product candidate. The trials are expected to commence shortly at MD Anderson Cancer Center ("MD Anderson"), one of the world's most respected centers devoted exclusively to cancer patient care, research, education and prevention. The Phase I clinical trials are planned to expand to the University of Pennsylvania Medical Center thereafter. Dr Vladislav Sandler, CEO and Co-Founder of Hemogenyx Pharmaceuticals, commented: "The completion of our FLT3 assay marks a critical milestone in advancing our HEMO-CAR-T product candidate into clinical trials. This Assay will ensure we can accurately identify and recruit the right patients for the trials, bringing us one step closer to providing a potentially life-saving treatment for those battling AML. We are excited to begin our Phase I trials imminently at MD Anderson Cancer Center, a leading institution in cancer care, and look forward to expanding our efforts to the University of Pennsylvania Medical Center." |
Posted at 02/9/2024 08:10 by ashleyjv 2 September 2024Hemogenyx Pharmaceuticals plc ("Hemogenyx Pharmaceuticals" or the "Company") CDX Development Update Hemogenyx Pharmaceuticals plc (LSE: HEMO), a clinical-stage biopharmaceutical group focused on developing treatments for cancers and viral diseases, is pleased to announce that it has developed a new and improved version of its bi-specific antibody ("CDX") for the treatment of relapsed/refractory acute myeloid leukaemia ("AML"), a subset of acute lymphoblastic leukaemia ("ALL"), and potentially for conditioning in bone marrow transplantations. The Company's scientists utilised Lonza's bYlok bispecific pairing technology to develop a new and improved version of CDX, which has demonstrated significantly enhanced efficacy in in vitro testing. Additional in vivo studies are currently underway. Dr. Vladislav Sandler, CEO and Co-Founder of Hemogenyx Pharmaceuticals, commented: "The development of an improved version of our CDX bi-specific antibody holds significant promise for enhancing treatment outcomes for patients battling often incurable blood cancers. This advancement could accelerate the progress of this product candidate and allow us to resume its development toward the clinic. It may also attract new industry partners interested in fast-tracking the co-development of CDX." |
Posted at 17/6/2024 06:55 by apotheki Hemogenyx Pharmaceuticals plc (LSE:HEMO), the clinical stage biopharmaceutical group developing treatments for cancers and viral diseases, is pleased to provide an update on its ongoing activities and progress.1. HEMO-CAR-T Clinical Trials Progress: · Additional Clinical Trial Site: The Company has added an additional prestigious US medical center to its list of clinical trial sites. This will enhance the scope and expedite the timeline for the implementation of clinical trials. · Clinical Site Setup: The setup of clinical sites at the University of Pennsylvania ("PENN") and the new medical centre is underway. This multi-step process involves thorough internal reviews by the science review committee and the internal review board of both clinical sites, as well as budget negotiations and logistics planning. The Company continues to work with Prevail Infoworks, a contract research organization ("CRO"), to manage and oversee the planning for the clinical trials. Expansion into Pediatric Indications: Pediatric AML and ALL: The Company is seeking to expand the HEMO-CAR-T indication to include pediatric acute myeloid leukemia ("AML") and a subset of pediatric acute lymphoblastic leukemia ("ALL") patients. An amendment to the clinical protocol to include pediatric AML is currently under review by third party experts. If approved, the Company will seek to implement the clinical trials for pediatric AML at the newly established clinical site. This area is of particular concern, and there is an urgent need for effective treatments for these conditions, which the Company believes HEMO-CAR-T will be able to provide. 2. Chimeric Bait Receptor ("CBR") Platform The Company's CBR platform is an advanced immunotherapy designed to reprogram or redirect innate 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. Development and Testing: · CBR Constructs: Scientists at Hemogenyx Pharmaceuticals are developing and testing multiple CBR constructs to identify the best candidates for targeting rare cancers such as epithelial ovarian carcinoma. Selected candidates will undergo rigorous testing to advance them to investigational new drug (IND) enabling studies. mRNA-Based Delivery of CBR: · Intranasal Delivery for Viral Infections: The Company continues to develop mRNA-based delivery of CBRs for treating airborne viral infections via intranasal administration. Recent improvements in the stability of mRNA-based CBRs are expected to enhance the effectiveness of this treatment. 3. CDX - Bispecific Antibody IND-Enabling Studies: · Progress: The Company is advancing IND-enabling studies for CDX, a bispecific antibody designed for treating relapsed and/or refractory AML, a subset of ALL, and for conditioning in bone marrow transplants. Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "We are excited about the progress we are making across our various programs. The addition of a world-renowned medical center to our HEMO-CAR-T clinical trial sites marks a significant step forward in our mission to develop life-saving therapies. Our expansion into pediatric indications for HEMO-CAR-T highlights our commitment to addressing unmet medical needs in both adult and pediatric populations. "Furthermore, our advancements in the CBR platform and the development of mRNA-based delivery systems for treating airborne viral infections demonstrate our innovative approach to tackling complex diseases. The progress in our CDX bispecific antibody program also underscores our dedication to bringing effective treatments to patients with relapsed or refractory AML and other severe conditions. "We are diligently pursuing non-dilutive financing options to support these initiatives and remain focused on translating our scientific discoveries into clinical success. We look forward to updating our shareholders and the market as we continue to make strides in our development programs." |
Posted at 21/2/2024 14:55 by apotheki Hemogenyx Pharmaceuticals Announces Strategic Investment from Prevail Partners, LLC· Prevail Partners, LLC to invest in Hemogenyx Pharmaceuticals. · Prevail InfoWorks, Inc. to act as Contract Research Organization (CRO) for upcoming Phase I clinical study, expected to commence in 2023. Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, announces that Prevail Partners, LLC ("Prevail Partners"), an investment fund, has agreed to invest in the Company through a subscription for 11,066,667 ordinary shares (the "New Ordinary Shares") at a price of US$0.075 per share (approximately £0.06) for the total sum of $830,000 (approximately £668,000). The subscription price represents a premium of approximately 240% to the Company's closing share price on 14 September 2023, when agreement was reached as to the final terms of the investment. The agreement governing the subscription (the "Subscription Agreement") contains customary warranties from the Company and Prevail Partners. Following allotment, Prevail Partners will hold approximately 0.96% of the Company's issued share capital. The Company's wholly owned subsidiary, Hemogenyx Pharmaceuticals LLC, has also signed a Master Service and Technology Agreement ("MSTA") with Prevail InfoWorks, Inc. ("InfoWorks"), a Philadelphia, PA based Contract Research Organization (CRO) and affiliate of Prevail Partners. Under the terms of the MSTA, InfoWorks is to provide clinical services and technologies for the Company's upcoming Phase I study of its anti-FLT3 chimeric antigen receptor-redirected T cells ("CAR-T cells") in subjects with relapsed/refractory acute myeloid leukemia (AML). Services include clinical site coordination, project management, data management, clinical monitoring, and pharmacovigilance (safety management) services, and the use of InfoWorks' integrated real-time data analytics platform, The Single Interface®, for clinical support and real-time data analysis. The MSTA has an initial term of 40 months, and Hemogenyx Pharmaceuticals LLC has agreed an initial statement of works relating to the Phase I AML study. The subscription funds will in large part defray the payment made by the Company for the first stage of the work being undertaken by InfoWorks under the MSTA. Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "As we seek to bring the curative power of cell therapies to a greater number of patients suffering from otherwise incurable life-threatening diseases, we are very confident in Prevail InfoWorks' ability to coordinate our Phase I clinical trial in relapsed/refractory AML. Their operational experience and expertise will enable a smooth execution of the study, while their specialization in real-time data integration and analytics will ensure fast, reliable data access to lower our clinical risk and potentially speed up our regulatory timeline. Prevail Partners' strategic investment in the Company demonstrates their confidence in our CAR-T program and in our ability to execute the upcoming clinical study." Mary Schaheen, President of Prevail Partners, stated: "Everyone at our fund is confident in the growth and success of Hemogenyx Pharmaceuticals as they develop CAR-T cells to target acute myeloid leukemia. Furthermore, Hemogenyx Pharmaceuticals has a seasoned management team with the expertise to accelerate the company to a significant value inflection point through the completion of its planned clinical trial." |
Posted at 16/2/2024 16:55 by apotheki HemoGenyx Pharmaceuticals / LSE:HEMOHemogenyx Pharmaceuticals achieves breakthrough with HEMO-CAR-T program, CBR platform HemoGenyx Pharmaceuticals (LSE:HEMO) CEO Dr Vladislav Sandler and non-executive director Peter Redmond joined Proactive's Stephen Gunnion after the company pioneering breakthrough treatments for life-threatening diseases, including blood and solid cancers, achieved a number of significant milestones. Sandler highlighted the company's significant progress with its HEMO-CAR-T program after it received the green light from the US Food and Drug Administration (FDA) to enter Phase 1 clinical trials for acute myeloid leukaemia, marking its transition to a clinical-stage biopharmaceutical company. This development symbolizes a pivotal milestone, offering potential life-changing treatments for patients with limited options. Additionally, Hemogenyx is advancing its proprietary Chimeric Bait Receptor (CBR) platform, announcing that it has demonstrated in vivo that the CBR can be delivered intranasally in the form of messenger RNA (mRNA) for the potential treatment of airborne viral infections. As 2024 unfolds, Hemogenyx anticipates starting clinical trials and advancing its CBR platform towards IND-enabling studies, signaling a landmark year with promising outcomes for investors and patients alike. Proactive interview:::: |
Posted at 16/2/2024 08:55 by apotheki 18 September 2023Hemogenyx Pharmaceuticals plc ("Hemogenyx Pharmaceuticals" or the "Company") Hemogenyx Pharmaceuticals Announces Strategic Investment from Prevail Partners, LLC · Prevail Partners, LLC to invest in Hemogenyx Pharmaceuticals. · Prevail InfoWorks, Inc. to act as Contract Research Organization (CRO) for upcoming Phase I clinical study, expected to commence in 2023. Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, announces that Prevail Partners, LLC ("Prevail Partners"), an investment fund, has agreed to invest in the Company through a subscription for 11,066,667 ordinary shares (the "New Ordinary Shares") at a price of US$0.075 per share (approximately £0.06) for the total sum of $830,000 (approximately £668,000). The subscription price represents a premium of approximately 240% to the Company's closing share price on 14 September 2023, when agreement was reached as to the final terms of the investment. The agreement governing the subscription (the "Subscription Agreement") contains customary warranties from the Company and Prevail Partners. Following allotment, Prevail Partners will hold approximately 0.96% of the Company's issued share capital. The Company's wholly owned subsidiary, Hemogenyx Pharmaceuticals LLC, has also signed a Master Service and Technology Agreement ("MSTA") with Prevail InfoWorks, Inc. ("InfoWorks"), a Philadelphia, PA based Contract Research Organization (CRO) and affiliate of Prevail Partners. Under the terms of the MSTA, InfoWorks is to provide clinical services and technologies for the Company's upcoming Phase I study of its anti-FLT3 chimeric antigen receptor-redirected T cells ("CAR-T cells") in subjects with relapsed/refractory acute myeloid leukemia (AML). Services include clinical site coordination, project management, data management, clinical monitoring, and pharmacovigilance (safety management) services, and the use of InfoWorks' integrated real-time data analytics platform, The Single Interface®, for clinical support and real-time data analysis. The MSTA has an initial term of 40 months, and Hemogenyx Pharmaceuticals LLC has agreed an initial statement of works relating to the Phase I AML study. The subscription funds will in large part defray the payment made by the Company for the first stage of the work being undertaken by InfoWorks under the MSTA. Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "As we seek to bring the curative power of cell therapies to a greater number of patients suffering from otherwise incurable life-threatening diseases, we are very confident in Prevail InfoWorks' ability to coordinate our Phase I clinical trial in relapsed/refractory AML. Their operational experience and expertise will enable a smooth execution of the study, while their specialization in real-time data integration and analytics will ensure fast, reliable data access to lower our clinical risk and potentially speed up our regulatory timeline. Prevail Partners' strategic investment in the Company demonstrates their confidence in our CAR-T program and in our ability to execute the upcoming clinical study." Mary Schaheen, President of Prevail Partners, stated: "Everyone at our fund is confident in the growth and success of Hemogenyx Pharmaceuticals as they develop CAR-T cells to target acute myeloid leukemia. Furthermore, Hemogenyx Pharmaceuticals has a seasoned management team with the expertise to accelerate the company to a significant value inflection point through the completion of its planned clinical trial." |
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