October 31, 2018 04:42 ET
Novoheart to Generate USD $1.7m From Strategic Partnership to Build Good Manufacturing Practice Facility to Create Clinical-Grade Human Stem Cell Libraries
- Phase 1 (6 to 9 months) of potential multi-year effort
- Service agreement to generate US$1.7M of revenue
- Novoheart will have exclusive rights to the iPSC cell lines for cardiac applications
- Partnership is another step towards clinical translation of Novoheart’s technologies
VANCOUVER, BC – October 31, 2018 – Novoheart (“Novoheart” or the “Company”) (TSXV: NVH; FWB: 3NH), a global stem cell biotechnology company, is pleased to announce that it has entered into a service agreement with Xellera Therapeutics Limited, representing Phase 1 of an intended long-term strategic partnership between the companies. The vision of the long-term partnership is to build clinical-grade human stem cell libraries for the development of cell-based therapies. Phase 1 will focus on the first steps towards Xellera Therapeutics building a Good Manufacturing Practice (GMP) facility for generating clinical-grade human stem cell lines, initially within the Southern Chinese population.
Xellera Therapeutics is a precision medicine company founded by prominent stem cell experts from the U.K., U.S. and Hong Kong with the mission of building haplotype-matched human stem cell libraries for commercializing cell-based therapies for various degenerative conditions affecting organ systems such as the heart, the eye and the central nervous system. These clinical-grade stem cell libraries will allow quicker identification of suitable donor material for cell-based therapies, minimizing the wait and avoiding complications commonly associated with transplantation, such as immune rejection or side effects caused by immunosuppression.
Under the service agreement, Novoheart has agreed to assist in the development of the haplobank of clinical-grade stem cells. Phase 1 will generate US$1.7M of revenue for Novoheart, with the services anticipated to be provided over the next 6 to 9 months. As part of the agreement, Novoheart will have exclusive rights to the human stem cell lines for producing clinical-grade human heart cells and cardiac derivatives, which it can commercialize at its discretion for research and therapeutic use. This arrangement will allow Novoheart to build a valuable new bank of clinical-grade, haplotype-matched human heart cells to develop cell-based heart therapies, and will further expand its offering into clinical applications, in addition to preclinical drug screening with the MyHeartTM Platform.
“This is an exciting partnership that represents our commitment to regenerative medicine,” said Novoheart CSO Kevin Costa. “The work we’re carrying out in this service agreement provides an exceptional opportunity to translate our pioneering technologies and experiences in heart engineering into developments of clinical therapies that will have direct benefits to patients. This ultimately creates significant value for both our clients and investors."
Novoheart is a global stem cell biotechnology company pioneering an array of next-generation human heart tissue prototypes. It is the first company in the world to have engineered miniature living human heart pumps that can revolutionize drug discovery, helping to save time and money for developing new therapeutics. Also known as 'human heart-in-a-jar', Novoheart’s bio-artificial human heart constructs are created using state-of-the-art and proprietary stem cell and bioengineering approaches and are utilized by drug developers for accurate preclinical testing as to the effectiveness and safety of new drugs, maximizing the successes in drug discovery whilst minimizing costs and harm caused to patients.
About Xellera Therapeutics Limited:
Xellera Therapeutics Limited (XT) is dedicated to developing cell- and gene-based therapies. XT’s mission is to bring advanced therapeutic options to patients in an era of precision medicine.
Related Party Disclosure
As one of the scientists involved in establishing Xellera Therapeutics, Dr. Ronald Li, Novoheart’s Chief Executive Officer, received an indirect minority interest in Xellera Therapeutics. Dr. Li is therefore considered a “control person” of Xellera Therapeutics, and as Dr. Li is a “control person” of Novoheart by virtue of his ownership of Novoheart shares, Xellera Therapeutics is considered a “related party” of Novoheart and the service agreement entered into by Novoheart with Xellera Therapeutics is considered a “related party transaction” within the meaning of Multilateral Instrument 61-101 - Protection of Minority Security Holders in Special Transactions (“MI 61-101”). It is also contemplated that Dr. Li will be appointed as a director of Xellera Therapeutics, but that his personal time commitment to Xellera Therapeutics will not be material to fulfilment of his duties as a director and CEO of Novoheart.
Prior to entering into the service agreement with Xellera Therapeutics, a special committee of independent directors of Novoheart was formed with a mandate to: review and make a recommendation with respect to Dr. Li’s involvement in Xellera Therapeutics; review the proposed service agreement with Xellera Therapeutics; and, if thought fit, make a recommendation to Novoheart’s board of directors. Novoheart has approved Dr. Li’s participation in Xellera Therapeutics and entered into the service agreement with Xellera Therapeutics on the basis of its assessment of the potential benefits to Novoheart and the desire of the parties to commence phase 1 relating to the GMP stem cell facility on an expeditious basis. A material change report in respect of the service agreement will be filed within 10 days of the date of this press release, which will contain a description of the process undertaken by the special committee and the board of directors of Novoheart. Information in this press release regarding Xellera Therapeutics and Dr. Li’s participation in that company has been provided to Novoheart by Dr. Li.
For further information, please contact:
Ronald Li, CEO
Babak Pedram, Investor Relations
Virtus Advisory Group
For media enquiries or interviews, please contact:
Josh Stanbury, Media Relations
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Cautionary Note Regarding Forward-Looking Statements
Information set forth in this news release may involve forward-looking statements under applicable securities laws. Forward-looking statements are statements that relate to future, not past, events. In this context, forward-looking statements often address expected future business and financial performance, and often contain words such as "anticipate", "believe", "plan", "estimate", "expect", and "intend", statements that an action or event "may", "might", "could", "should", or "will" be taken or occur, or other similar expressions. All statements, other than statements of historical fact, included herein including, without limitation: statements about the Company’s future plans, its goals and expectations, and the potential applications of its MyHeartTM platform; the expected revenue from phase 1 of the service agreement with Xellera Therapeutics, and the retention by Novoheart of the intellectual property resulting from its services to Xellera Therapeutics; the entry into of additional agreements with Xellera Therapeutics and any long-term strategic relationship; the benefits of any long-term strategic relationship with Xellera Therapeutics; the construction of a Good Manufacturing Practice facility by Xellera Therapeutics; the building of clinical-grade human stem cell libraries for the development of cell-based therapies; the benefits of such clinical-grade stem cell libraries; the clinical translation of Novoheart’s technologies and expansion of its offerings into clinical applications; the commercialization of the exclusive rights to the human stem cell lines for producing clinical-grade human heart cells and cardiac derivatives and the expected benefits therefrom; the benefits to patients from Novoheart’s platforms; and the value of the strategic relationship to Novoheart’s clients and investors, are forward-looking statements. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, that Xellera Therapeutics may not obtain the funding necessary to construct a Good Manufacturing Practice facility or may otherwise fail to construct such a facility on time or at all; that Novoheart and Xellera may fail to negotiate additional agreements or a long-term strategic relationship or that the terms of any such agreements or relationship may prove less beneficial to Novoheart than expected; the initial service agreement with Xellera Therapeutics may not be completed on time or on budget, if at all; the service agreement with Xellera Therapeutics may fail to produce clinical-grade stem cell libraries or the application or benefits therefrom may prove less than expected; Novoheart may fail to commercialize any intellectual property developed or may be unable to enforce its intellectual property rights; Novoheart may be unable to translate its offerings into clinical applications; Novoheart’s current or future technologies may have fewer benefits to patients, if any; and the risks identified under the heading “Risk Factors” in Novoheart’s annual information form for the year ended June 30, 2018, a copy of which is available under Novoheart’s profile on SEDAR at www.sedar.com and as otherwise disclosed from time to time in Novoheart’s filings with the TSX Venture Exchange and applicable Canadian securities regulators. Forward-looking statements are made based on management's beliefs, estimates and opinions on the date that statements are made and the respective companies undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change, except as required by applicable securities laws. Investors are cautioned against attributing undue certainty to forward-looking statements.