Novoheart to Co-develop First of its Kind Human Heart-in-a-Jar Model of Heart Failure with AstraZeneca

• Heart failure is a global pandemic with an estimated 64.3 million cases worldwide in 2017, costing over US$100B per year
• Drug developers currently lack effective humanized models for preclinical testing of targeted drug candidates in heart failure with preserved ejection fraction
• The collaboration aims to provide a unique solution for future assessment of novel therapeutics

HONG KONG, Nov. 26, 2019 /PRNewswire/ -- Novoheart ("Novoheart" or the "Company") (TSXV: NVH; FWB: 3NH), a global stem cell biotechnology company, is pleased to announce a collaboration with global biopharmaceutical company AstraZeneca, in an effort to develop the world's first human-specific in vitro, functional model of heart failure with preserved ejection fraction (HFpEF), a common condition especially among the elderly and in women, with the reported prevalence approaching 10% in women over the age of 80 years.^[1]

Heart failure (HF) is a global pandemic with an estimated 64.3 million cases worldwide in 2017, with an increasing trend in prevalence^[2]. The annual global economic burden of HF is estimated at over US$100 billion^[3]. Accounting for approximately 50% of HF cases, HFpEF in particular is a major and growing public health problem worldwide, with its pathological mechanisms and diverse etiology poorly understood. Due to these complexities, models of the disease available to date, including various animal models, have limited ability to mimic the clinical presentation of HFpEF^[4]. Therefore, drug developers lack an effective tool for preclinical testing of drug candidates for efficacy, and as a result, clinical outcomes for HFpEF have not improved over the last decades, with no effective therapies available.

In collaboration with the Cardiovascular, Renal and Metabolism therapy area of AstraZeneca, the initial phase of the project aims to establish a new in vitro model, leveraging Novoheart's proprietary 3-D human ventricular cardiac organoid chamber (hvCOC) technology, that reproduces key phenotypic characteristics of HFpEF. Also known as "human heart-in-a-jar", the hvCOC is the only human engineered heart tissue available on the market to date that enables clinically informative assessment of human cardiac pump performance including ejection fraction and developed pressure. Unlike animal models, engineered hvCOCs can be fabricated with specific cellular and matrix compositions, and patient-specific human induced pluripotent stem cells (iPSCs), that allow control over their physical and mechanical properties to mimic those observed in HFpEF patient hearts. Together with Novoheart's proprietary hardware and software, this aims to provide a unique assay for understanding the mechanisms of HFpEF, identification of new therapeutic targets, and assessment of novel therapeutics for treating HFpEF patients. Novoheart will exclusively own the intellectual property rights to the newly developed HFpEF hvCOC model.

"We are delighted to partner with AstraZeneca, an organization which has long invested in cardiovascular research and is committed to bringing new therapeutic solutions to patients with heart failure," said Novoheart CSO, Dr. Kevin Costa. "We look forward to co-developing this new HFpEF hvCOC model into a powerful new tool in the worldwide battle against heart failure."

Regina Fritsche Danielson, Senior Vice President, Head of Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, said, "There are significant unmet treatment needs in patients with heart failure with preserved ejection fraction. By combining Novoheart's proprietary hvCOC model with our expertise in heart failure, we aim to create the first in vitro model reproducing phenotypic characteristics of heart failure with preserved ejection fraction. This could bridge the gap between in vivo animal models and clinical trials to help accelerate the drug discovery process by providing human-specific preclinical data."

About Novoheart:

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 of the effectiveness and safety of new drugs, maximizing the successes in drug discovery whilst minimizing costs and harm caused to patients. With the recent acquisition of Xellera Therapeutics Limited for manufacturing Good Manufacturing Product (GMP)-grade clinical materials, Novoheart is now developing gene- and cell-based therapies as well as next-generation therapeutics for cardiac repair or regeneration.

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. 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, the risks identified in under the heading "Risk Factors" in Novoheart's annual information form for the year ended June 30, 2018 or other reports and 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.

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SOURCE Novoheart