Hemogenyx Pharmaceuticals Regulatory News (HEMO)

Hemogenyx Pharmaceuticals plc 

("Hemogenyx" or the "Company")

Collaboration with Orgenesis for Hu-PHEC development

Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group developing new therapies and treatments designed to transform bone marrow transplantation for the treatment of blood diseases, announces that its wholly owned subsidiary, Hemogenyx-Cell S.A. ("Hemogenyx-Cell") has entered into a further collaboration agreement with Orgenesis, Inc ("Orgenesis"). Orgenesis (NASDAQ: ORGS) is a vertically-integrated biopharmaceutical company with expertise and experience in cell therapy development and manufacturing.

Orgenesis will collaborate with Hemogenyx-Cell on the further development and commercialization of its Human Postnatal Hemogenic Endothelial Cell ("Hu-PHEC") technology. Hu-PHEC is a cell replacement product candidate that is being developed to generate cancer-free, patient-matched blood stem cells after transplantation into the patient.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx, commented: "We are very pleased to announce this further collaboration with Orgenesis to rapidly develop and bring to the market our Hu-PHEC technology. The collaboration is a testiment to the value of our Hu-PHEC based approach to drastically improving bone marrow transplants."

Vered Caplan, CEO of Orgenesis, commented: "We are excited to collaborate with Hemogenyx, as this technology has significant potential to transform bone marrow transplantation and potentially solve the problem of lack of donors. Our goal is to advance the field of cell therapy through using this unique and innovative approach for generation of blood stem cells."

According to the terms of the agreement, Orgenesis and/or one or more qualified investors ("Investors") will advance to Hemogenyx-Cell a convertible loan in an amount of not less than US$1,000,000 (the "Convertible Loan"). As part of the Agreement, the Investors shall have the right to convert the outstanding Convertible Loan amount into either: (i) shares of Hemogenyx-Cell at a price per share based on a pre-money valuation of US$12,000,000; or (ii) shares of Orgenesis' common stock at a price per share equal to the weighted average trading price of Orgenesis' common stock for the three trading days preceding conversion.

Orgenesis and/or the Investors shall have the option, exercisable at any time up to the third anniversary of the closing of the transaction, to invest additional funds in an amount of up to US$1,000,000 and not less than US$500,000 in Hemogenyx-Cell.

Orgenesis shall have the right to market products incorporating Hemogenyx-Cell technology ("Hemogenyx Products") and shall serve as a distributor of Hemogenyx Products subject to and in accordance with the terms of a separate distribution agreement to be executed between Orgenesis and Hemogenyx-Cell.

Orgenesis will exclusively supply Hemogenyx Product under a separate Manufacturing and Supply Agreement at the end of the clinical development stage. Should the parties fail to sign such an agreement for any Hemogenyx Product, Hemogenyx-Cell shall pay Orgenesis an amount equal to 4% of gross revenue derived from the sale of the respective Hemogenyx Products.

Under the terms of the collaboration agreement, Hemogenyx-Cell has granted Orgenesis and its Affiliates a perpetual, non-exclusive, worldwide, sublicensable through multiple tiers license to use, manufacture, make, market, sell and otherwise commercialize the Hemogenyx technology, Hemogenyx patents and/or Hemogenyx Products ("License"). In consideration for the License, Orgenesis shall pay Hemogenyx-Cell a royalty of 12% of Orgenesis' net revenues generated from Hemogenyx' technology.

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About Hemogenyx Pharmaceuticals plc

Hemogenyx Pharmaceuticals plc is a publicly traded company (LSE: HEMO) headquartered in London, with its wholly owned US operating subsidiary, Hemogenyx LLC, located in Brooklyn, New York at its state-of-the-art research facility.

Bone marrow transplantation has been used for more than 50 years to save the lives of patients suffering from blood diseases. The risks of toxicity and death that are associated with bone marrow transplantation, however, have meant that the procedure is used only as a last resort and its use is restricted. Hemogenyx's technology has the potential to enable many more patients suffering from devastating blood diseases such as leukemia and lymphoma, as well as severe autoimmune diseases such as multiple sclerosis, aplastic anemia and systemic lupus erythematosus (Lupus), to benefit from bone marrow transplantation.

Hemogenyx is a pre-clinical stage biopharmaceutical group developing new medicines and treatments to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases. Hemogenyx is developing two distinct and complementary products, as well as a platform technology that it uses as an engine for novel product development.