HELP Therapeutics Secures RMB 50 Million Series A+ Financing to Advance iPSC+Gene Therapy for Heart Failure Market

VCBeat learned at the earliest opportunity that,Nanjing HELP Therapeutics Co., Ltd. (HELP Therapeutics, hereinafter referred to as "HELP") recently completed a RMB 50 million Series A+ financing round.It is reported that this round of financing was led by Nanjing Dynamic Balance Capital and existing shareholder Legend Star, with full participation from existing investors including Yongchuang Capital, Ziniu Fund, and Nanjing Gaoke. Probe Capital served as the exclusive financial advisor.

The funds raised in this round will be primarily used to file Investigational New Drug (IND) applications in both China and the United States, further strengthen industrial-scale manufacturing capabilities, optimize downstream somatic cell production processes, and advance regenerative medicine cell products into clinical trials. Additionally, the funds will support the development of innovative delivery routes, expand the range of dosage forms and product formats for cardiac regenerative cell therapies, and broaden the application scenarios for heart failure treatment.

iPSC technology has been a key focus area for multinational pharmaceutical companies and venture capital firms in recent years. In 2019, BlueRock, a star company in this field, was acquired by Bayer at a $1 billion valuation. BlueRock primarily leverages iPSC technology to treat heart failure, Parkinson’s disease, and autoimmune disorders.

HELP Therapeutics, established in 2016, is a biotechnology company dedicated to treating refractory degenerative diseases using stem cell and regenerative medicine technologies.The Company leverages induced pluripotent stem cell (iPSC) technology to regenerate functional human cells and tissues for the treatment of degenerative diseases.

It is worth mentioning that,HELP Therapeutics has successfully completed the world’s first clinical trial of regenerative cardiomyocytes derived from induced pluripotent stem cells (iPSCs) for the treatment of heart failure, which was exclusively reported globally by the prestigious international academic journal Nature on May 13, 2020.Dr. Wang Jiaxian, CEO of the company, told VCBeat (WeChat ID: vcbeat) that the team plans to publish the relevant research findings this year. Furthermore, based on these results, the company has obtained ethical approval to conduct additional cardiomyocyte transplantation cases for the treatment of patients with end-stage heart failure.

Currently, HELP Therapeutics has established a comprehensive quality control system for iPSC-based products, enabling industrial-scale batch production of iPSCs.

The funds raised in this round will also be used to optimize preparation technologies and scale-up production processes, thereby raising the barriers and thresholds for industrialized manufacturing. Currently, this industry sector faces challenges such as difficulties in process scale-up and high production costs.HELP Therapeutics aims to achieve a single-cell production batch capacity sufficient to treat 100–500 patients, thereby significantly reducing the cost of cell-based products and offering a solution to the challenge of their prohibitively high future prices.

Dr. Wang Jiaxian is the Founder and CEO of HELP Therapeutics.Dr. Wang Jiaxian earned his Ph.D. in Regenerative Medicine from The University of Hong Kong and conducted related research for many years as a visiting scholar at the Icahn School of Medicine at Mount Sinai. Dr. Wang primarily focuses on cardiac regeneration, has published multiple SCI-indexed papers, participated extensively in major national special projects and National Natural Science Foundation of China grants, and serves as a Distinguished Researcher at the Institute of Scientific Research under the National Health and Family Planning Commission.

HELP Therapeutics’ founding team comprises professionals with multidisciplinary backgrounds in medicine, pharmacy, and biomedicine. In recent years, the company has also recruited several senior experts with extensive experience in drug development across both China and the United States. HELP Therapeutics boasts a rich pool of seasoned industry experts in the fields of cardiovascular and cerebrovascular diseases as well as stem cell regenerative medicine. With profound expertise in medicine and product development, the company has integrated its entire industrial chain and established a talent resource system that deeply combines R&D, manufacturing, and clinical applications.

Dr. Wang Jiaxian stated that regenerative medicine is an emerging field that, unlike traditional pharmaceuticals, requires a robust, multidisciplinary talent team to integrate the entire therapeutic value chain.

“Stem cell therapy, as an emerging technology, possesses unique characteristics in both the manufacturing and clinical stages. From a manufacturing perspective, stem cell therapies fall within the realm of pharmaceutical production, requiring deep collaboration between senior scientists in cell biology and industry experts in the pharmaceutical sector for development. In terms of application, cell therapies must be paired with the most appropriate surgical procedures, a process closely resembling medical device development. Consequently, the entire research and development process significantly increases the demand for multidisciplinary talent. Our company’s medical team has effectively complemented this need,” introduced Dr. Wang Jiaxian.

HELP Therapeutics' current business lines mainly includeCardiovascular FieldandNeurology FieldTwo pipelines.

Cardiovascular FieldThe research pipeline is based on regenerative cardiomyocyte therapy, covering major indications such as ischemic heart failure and rare diseases such as hereditary dilated cardiomyopathy. Currently, the pipeline has completed early-stage research and preclinical proof-of-concept studies and is at the stage of submitting an Investigational New Drug (IND) application.

Reports on Heart Transplant Surgeries Over the Years

There are approximately 25 million patients with heart failure in China, with an annual incidence rate of about 1.3%. Currently, there is a lack of truly effective treatments for heart failure. For end-stage heart failure, the most effective treatment is heart transplantation; however, donor organs are severely scarce. The population in China requiring cell therapy is estimated at around 5 million, with the total market size exceeding RMB 500 billion.

In the field of neurology, HELP Therapeutics primarily focuses on pediatric cerebral palsy.Pediatric cerebral palsy refers to a syndrome of non-progressive brain injury caused by various factors within the first month after birth. The condition is primarily characterized by central motor disorders and abnormal postures, and may be accompanied by symptoms such as intellectual disability, epilepsy, behavioral abnormalities, mental disorders, and visual, auditory, and speech impairments. It is one of the leading causes of motor disability in children.

According to foreign reports, the incidence of cerebral palsy is approximately 1.8‰–4.9‰, categorizing it as a rare disease. In China, there are approximately 1 million affected children, with an incidence rate of around 1.25‰. Currently, there are no effective clinical treatment options available, creating an urgent need for new and effective therapies. During their lifetime, each patient incurs medical costs exceeding RMB 1 million, resulting in an overall market size surpassing RMB 100 billion.

When asked about his views on the development of iPSC technology, Dr. Wang Jiaxian stated: “iPSCs offer the possibility of regenerating human tissue cells in vitro, providing a highly promising and exploratory avenue for nearly all degenerative diseases, with significant development potential.“To develop matching drugs, breakthroughs in cell differentiation technology and large-scale cell production processes are required, along with the identification of optimal delivery routes, ultimately ensuring the efficacy and safety of using regenerative cells to treat degenerative diseases. HELP Therapeutics is striving to achieve this goal and seeks to strengthen technical and business collaborations with peers in China working on related technologies, jointly advancing the treatment of degenerative diseases.”

Xu Ze’an, Head of Healthcare at Dynamic Balance Capital, spoke highly of HELP Therapeutics, stating, “Heart failure represents the final battleground in cardiovascular disease, particularly end-stage heart failure, for which clinical treatment options are severely limited. Since establishing its presence in Nanjing Life Science Town, the regenerative medicine team at HELP Therapeutics has been dedicated to R&D focused on unmet clinical needs. The company is developing and manufacturing high-purity cardiomyocytes derived from human induced pluripotent stem cells (iPSCs) and is currently advancing clinical trials for heart failure treatment, holding promise to provide patients with superior therapeutic solutions in the near future. Dynamic Balance Capital is honored to participate in this round of financing. We adhere to a ‘nanny-style’ investment approach, supporting the HELP Therapeutics team in accelerating pipeline clinical research and product commercialization through capital infusion, industrial resources, and government support, thereby contributing jointly to the advancement of regenerative medicine.”

Dr. Yu Bo, Head of Healthcare at Purple Bull Capital, extended his congratulations to HELP Therapeutics: “Congratulations to HELP Therapeutics on the successful completion of its latest round of financing. As an early investor in HELP Therapeutics, this marks our fund’s third increased investment in the company. We remain firmly optimistic about the prospects of applying induced pluripotent stem cells (iPSCs) to the treatment of degenerative diseases and regenerative medicine. At the same time, we are convinced that iPSCs, as a foundational technology platform, will leverage their pluripotency and high programmability to expand applications in fields such as tumor immunotherapy, cell therapy, and gene therapy. Since its inception, HELP Therapeutics has demonstrated its ability to translate outstanding technologies into commercial products. Led by Dr. Wang Jiaxian, the team has driven the clinical application of regenerative medicine with efficient execution, successfully completing the world’s first clinical trial of human iPSC-derived cardiomyocyte therapy for heart failure, with encouraging results. We will continue to support the company’s future development and facilitate collaboration and strategic alignment between HELP Therapeutics and other portfolio companies in the cell therapy sector.”

Leng Yan, a medical partner at Legend Star, also expressed her affirmation of HELP Therapeutics: “Legend Star has invested in this project since the angel round and subsequently participated in the Series A and Series A+ rounds. Our primary rationale was our confidence in the team’s capability for medical translation. Furthermore, there are few high-quality cell therapy targets in China. We have observed remarkable results in investigator-initiated human clinical trials. We particularly look forward to HELP Therapeutics further expanding its study sample size, standardizing its products, completing preclinical trials, and filing for regulatory approval in both China and the United States as soon as possible after the completion of this financing round.”