Recently, Help Therapeutics, a leading global platform-based company for iPSC therapeutics, announced the completion of a Series C financing round of hundreds of millions of dollars, led by Juming Venture Capital, followed by Share Capital, Bessemer Medical Fund, and Golden Rain Mogul, with additional support from our old shareholder Purple Bull Fund, and Hoyue Capital acting as the exclusive financial advisor for the round. The financing will help the company to carry out and complete the clinical trial of iPSC cardiac cell injection, a fully independent intellectual property development pipeline, and will initiate clinical studies of immune cell therapy based on iPSC technology in the coming year.

Help Therapeutics Alper Regenerative Medicine, as the first company in China to develop and manufacture cell therapy using induced pluripotent stem cell (iPSC) technology, insists on focusing on the fields of heart failure and tumor immune diseases to develop universal cell therapy products to meet clinical needs.

The company's founder, Dr. Jiaxian Wang, is a medical doctor from the University of Hong Kong and a post-doctoral fellow at Mount Sinai School of Medicine. During his time as a cardiologist, Dr. Wang became concerned that the population of heart failure patients in China has reached over 10 million, and there are about 3 million patients with severe heart failure waiting for heart transplantation every year, but only about 600 people can find a heart donor, a huge gap that has become a problem for the entire medical community. Dr. Wang chose to enter the field of iPSC cell therapy in 2010, convinced that iPSC technology is an epoch-making technology for human medicine and expecting to save heart failure patients through this innovative cutting-edge technology. After years of development, the company has developed several product pipelines based on iPSC technology, mastering advanced iPSC reprogramming technology while having the capability of large-scale automated iPSC drug production and cell quality inspection.

iPSC pipeline layout, breakthrough heart failure treatment dilemma

Help Therapeutics has laid out several R&D pipelines around the disease areas of heart failure and tumor immunity, among which iPSC technology therapies for the treatment of moderate to severe heart failure have entered several authoritative centers nationwide to conduct large-scale randomized controlled human clinical trials. Alps Regenerative Medicine has accumulated profound experience in the field of heart failure cell therapy: In 2020, Nature reported the world's first human study of iPSC cells for end-stage heart failure conducted jointly by the company and Nanjing Gulou Hospital. Based on 24-month follow-up data from three patients in this clinical trial, the efficacy and safety of Help Therapeutics iPSC-derived cardiomyocyte drugs for the treatment of severe heart failure were excellent.

The company has already obtained the first iPSC technology-based clinical study filing for heart failure cell therapy by the National Health Care Commission in China, and is also actively preparing for the clinical registration filing in China and the United States for the heart failure treatment pipeline. After clinical trials, the product is expected to be the first iPSC cell therapy drug for moderate to severe heart failure in China and the world, and its social and commercial value will be immeasurable.

Artificial intelligence fully automated production line world's first biopharmaceutical 4.0 era

With the development of cell therapy industry, both from the perspective of clinical demand and R&D exploration, the quantity and quality of cell culture are putting forward more precise and higher demand. The current manual culture of cell therapy products has long operation time, large variation between product batches, low batch culture capacity and other industry bottlenecks, thus the cost and terminal selling price of cellular drugs remain high and cannot be truly popular among the majority of patients. Therefore, addressing the commercial mass production of cells has become the core of cell therapy companies' development.

Help Therapeutics is at the forefront of cell mass production and quality assurance in the world. Its fully automated production pipeline has reached the international leading position, which has improved the quality and stability of cellular products while significantly reducing production costs.

National responsibility as its own

Help Therapeutics has the first induced pluripotent stem cell (iPSC) biospecimen bank authorized by the Ministry of Science and Technology for human genetic resources conservation in China. Commissioned by the National Human Genetic Resources Sharing Service Platform and as the only officially recognized iPSC rare disease cell repository in the 14th Five-Year Plan of China (National Science and Technology Heritage Office [2021]-BC0022), Help Therapeutics carries the heavy responsibility of human genetic material and is fully committed to promoting the role of China's iPSC technology platform and rare disease R&D treatment, providing research units and enterprises with We are committed to providing high quality and diverse biological samples to accelerate rare disease research and orphan drug development, and to help the rapid development of iPSC cell industry.

iPSC leads the field of cell therapy and accelerates the development of the industry

Induced pluripotent stem cells (iPSC) are one of the most significant discoveries in biology in recent years. Japanese scholar Shinya Yamanaka was awarded the Nobel Prize just six years later (2012) for his discovery of a method to reprogram adult cells into multifunctional stem cells in 2006.

iPSC cell therapies have significant advantages for diseases that are not well treated with existing drugs (e.g., heart failure), and there is tremendous room for growth, and the therapies are gaining the attention of international biopharmaceutical giants. For example, Novo Nordisk is investing in Heartseed's iPSC cell therapy drug pipeline for dilated cardiomyopathy in 2021. In Europe, Dr. Zimmerman, a leading German cardiologist and pharmacologist, initiated a multi-center iPSC-derived heart failure cell-based clinical phase I/II trial in February 2021.

Dr. Jiaxian Wang, founder of Help Therapeutics, said that Alp Regenerative Medicine, as the first echelon in developing cell therapies using iPSC technology in China, insists on continuing to plow deeper in the layout of the iPSC pipeline and pushing forward with clinical research, believing that there will be very good results. In the early years of cell therapy drugs on the market, cell therapy in China is likely to be a self-funded market. From the patient's perspective, the technology and production strength of Alper Regenerative Medicine is the most effective way to bring down the cost of cell therapy as well as pricing, and we are confident that more patients will become the beneficiaries of the cell therapy industry.

Dr. Yongling Shi, a partner at Juming Ventures, said that iPSC has great applications in drug screening, disease modeling and cell therapy, and that Alp Therapeutics' first product has opened a new chapter in heart failure treatment. The company is poised to become the best in the world in this field. At the same time, Help Therapeutics, as a company focused on the entire process of iPSC reprogramming, cell preparation, storage, differentiation and expansion, has also developed a product pipeline in other iPSC applications. Juming will continue to focus on Help Therapeutics and support the company's development in the future.

Mr. Huang, Partner of Share Capital, expressed his optimism about the future of induced pluripotent stem cell (iPSC) therapy technology. iPSC technology has developed rapidly since its invention by Yamanaka in 2006 and has a very promising market application. Help Therapeutics' self-developed fully automated cell production and quality control system provides controlled and scalable cell preparation stability necessary for cell-based drug clinical therapies. Cell therapy is also an innovative technology that Share Capital focuses on. Investing in Help Therapeutics' stem cell therapeutics is another layout of Share Capital's investment logic in precision medicine.

Ms. Ying Liu, Partner of Besen Medical Fund, said that induced pluripotent stem cell therapy technology, as a global technology hotspot, is developing rapidly in clinical application and has a broad market application prospect, and the country has continuously issued policies to encourage its clinical validation and development. The company's research and clinical progress is at the leading edge of the world, with positive results from the world's first scientific clinical trial of iPSC-derived regenerative cardiomyocytes for heart failure. In particular, the company's self-developed fully automated cell production and quality control system, which improves the stability of cell preparation, can truly achieve the accessibility and scale of clinical cell therapy. We have been following this market segment for over a year and Alpine Regenerative Medicine fits well with Bessemer Healthcare's philosophy and preference to invest in hardcore technologies and early stage innovation.

Mr. Wang Dong, partner of Jin Yu Maohua, said that Help Therapeutics is the first-tier company in China to develop cell therapy using iPSC technology, and the company has solved the problem of drug formation of cellular drugs better by relying on its self-developed fully automated cell production. In addition, the company's R&D pipeline is well laid out, and the drug being developed for the treatment of heart failure will soon enter clinical trials in China and the United States, while the development of a number of drugs such as Car-NK is also progressing in an orderly manner. Jin Yu Bogor is very optimistic about Help Therapeutics' continuous R&D capability and will continue to provide support and services for the company's development, believing that it can grow into a cell therapy company with international influence in the future.

Dr. Bo Yu, Executive Director of Purple Bull Fund, expressed his congratulations to Help Therapeutics on the successful completion of its new round of financing. Our fund shows its support to the company with the continued ramp-up. We are firmly optimistic about the application prospects of iPSC for degenerative disease treatment and regenerative medicine, and strongly believe in the expanding application of iPSC as the underlying technology platform in tumor immunotherapy, cell therapy, and gene therapy with its all-powerful and highly programmable nature. Since its inception, Dr. Jiaxian Wang has led his team to demonstrate excellent execution and tenacity, leading the company to drive the iPSC industry from pipeline development to scale up production. We will continue to support the company's future development and facilitate the collaboration and industry deployment of the Fund's other cell therapy portfolio companies with Help Therapeutics.

As one of the hottest technologies in biopharmaceutical research, iPSC technology is a groundbreaking technology that can solve problems that cannot be solved by traditional drugs and can fundamentally regenerate cells. As a leading company in iPSC technology, the team has accumulated pioneering results in the field of moderate to severe heart failure and other diseases. We expect Help Therapeutics to grow stronger with the help of capital, accelerate the advancement of its heart failure and tumor immunization pipeline, and become a global leader in iPSC.