Renovaro BioSciences Inc. (NASDAQ: RENB)

Renovaro BioSciences Inc. (NASDAQ: RENB), formerly Enochian BioSciences Inc., is an advanced, pre-clinical biotechnology firm in cell, gene and immunotherapy focused on solid tumors with short life expectancy. The company aims to unlock potentially long-term or life-long cancer remission in some of the deadliest cancers, and to potentially treat or cure serious infectious diseases such as Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) infection.

The oncology platform is now at the forefront of Renovaro's development activities. While Renovaro's current efforts focus primarily on pancreatic cancer, it plans to include other solid tumors with short life-expectancy in the first in human Phase I/IIa studies that are on track to start by mid-2024. The company's Pre-Investigational New Drug (pre-IND) submission included a human study plan covering pancreatic cancer, as well as other cancers that are difficult to treat, potentially including triple-negative breast cancer, head and neck cancers and mesothelioma.

Renovaro's proprietary, novel technology uses cell- and gene-therapy to promote a renewed immune response against solid tumors. Important confirmatory results from two humanized mouse models using the company's novel dendritic cell-based therapy, independently conducted by Dr. Anahid Jewett, a renowned cancer researcher in the field of immunotherapy at UCLA, were presented previously at two scientific conferences and were the foundation supporting a pre-IND submission to the U.S. Food and Drug Administration. Notably, Dr. Jewett's findings from these studies consistently demonstrated 80% to 90% pancreatic tumor reduction in size and weight that was correlated with significant enhancement of key aspects of the immune response.

Renovaro is headquartered in Los Angeles, California.

RENB-DC11

Renovaro's product development strategy is anchored in the use of "non-self" or allogeneic cells that enhance targeted immune response. Its lead candidate, RENB-DC11, is an innovative therapeutic vaccination platform that could potentially be used to induce life-long remissions from some of the deadliest solid tumors.
Treatment with RENB-DC11 has now been shown to significantly reduce the size of human pancreatic tumors in humanized mice in three independent studies. The reduction in tumor size correlated with statistically significant increases in key components of an immune response.

Pre-IND was completed in June 2023, with IND filing forecast for first half of 2024. First in-human Phase I/IIa trials are predicted shortly after in H1 of 2024, including pancreatic and other solid tumors with poor treatment options and life-expectancy.

Renovaro believes that RENB-DC11 could represent the most promising and effective strategy to achieve life-long remission for a number of common and deadly tumors.

Other Development Candidates

In addition to its lead oncology platform, Renovaro's development pipeline includes a platform targeting infectious diseases, including:

• RENB-HV12 – An engineered allogeneic T-Cell vaccine, this therapeutic HIV vaccine candidate enhances immune infiltration, immune killing and immune surveillance. Potential pre-IND submission is planned for first half of 2024, with IND-submission expected in second half of 2024.
• RENB-HV21 – Leveraging allogeneic NK plus Gamma Delta T (GDT) cells as potential therapy for HIV, ENOB-HV21 shows promising preliminary results without confounding factors. Renovaro owns an exclusive license and has completed the Pre-IND submission, with a potential IND submission and human trials expected in 2024.
• RENB-HV01 – Caring Cross, a non-profit corporation, has shown that its proprietary CAR-T cells cure HIV in a mouse model. Studies in humans have begun. Renovaro has entered into a profit-sharing sublicense with Caring Cross and would share in profits if the product is commercialized.
• RENB-HB01 – This therapeutic approach aims to eliminate all HBV rapidly ("seek and kill") with a two to three dose treatment regimen. It is expected to be applicable for early disease to maximize impact with low risk of toxicity. Pre-IND comments have been received from the FDA for its AAV-delivery system.
  LOI to Merge with GEDi Cube International Ltd.

On August 9, 2023, Renovaro announced its execution of a binding, exclusive letter of intent to merge a subsidiary with cutting-edge health AI company GEDi Cube International Ltd. The combined company is expected to create a potential multiplier effect to accelerate earlier diagnosis, more effective therapy, and precision in silico drug discovery.

GEDi Cube's innovative technology, developed over nearly a decade, has already validated earlier diagnoses of lung cancer in humans at a leading university hospital. GEDi Cube has likewise created the early diagnosis technology for 12 additional cancers, including pancreatic and breast cancer.

"I believe joining forces with GEDi Cube could enhance the efficacy of our upcoming trials and speed up the discovery of novel treatment approaches, thereby extending our life-saving technology to more cancer patients and renewing hope for them and their families," Dr. Mark Dybul, CEO of Renovaro, stated in the news release.

GEDi Cube is led by CEO Craig Rhodes, who brings to that company tremendous industry experience leading life sciences groups at industry leaders Intel, Oracle and NVIDIA.

Market Opportunity

Pancreatic cancer alone is diagnosed globally in approximately 495,000 people each year, including roughly 64,000 in the U.S. Nearly 466,000 of those patients die annually, including approximately 51,000 in the U.S. Because of limited treatment options, life expectancy is very poor – with an approximately 10% patient survival rate at five years after diagnosis.

The global pancreatic cancer treatment market was valued at $2.15 billion in 2021 and is projected to grow from $2.48 billion in 2022 to $6.85 billion by 2029, according to Fortune Business Insights. That growth represents a CAGR of 15.7% for the forecast period.

A separate report from Fortune Business Insights projects that the global HIV drug market will grow from $30.46 billion in 2021 to $45.58 billion in 2028, recording a CAGR of 5.9% over the forecast period.

According to GlobalData, the value of the market for hepatitis B treatment is forecast to experience a significant increase in the coming years, with revenues expected to grow from $1.6 billion in 2022 to $10.5 billion in 2029. That represents a very rapid CAGR of 30% over the period. An estimated 296 million people suffer from the condition worldwide.

Management Team

Dr. Mark Dybul is the CEO of Renovaro. He has served as a tenured professor in the Department of Medicine at Georgetown University Medical Center since June 2017. He also served as Faculty Co-Director of the Center for Global Health and Quality from 2017-2021. Dr. Dybul has worked on HIV and public health for nearly 30 years as a clinician, scientist, teacher and administrator, including as an architect and eventually the Global Ambassador of the U.S. President's Emergency Plan for AIDS Relief and the Executive Director of the Global Fund to Fight AIDS, Tuberculosis and Malaria from 2013 through May of 2017, and as the co-director of the Global Health Law Program at the O'Neill Institute for National and Global Health Law from 2009 through 2012. He is a member of the U.S. National Academy of Medicine.

Luisa Puche is the company's CFO. She has served as a senior accounting and financial advisor and president of Puche Group LLC from 2015-2019. She served in various key executive roles, including Interim Chief Accounting Officer, at Brightstar Corp., a $10 billion global wireless device services provider. Ms. Puche began her career at Ernst & Young, where she served for approximately 10 years. Leveraging her broad global audit, advisory and corporate expertise, she has provided strong cross-functional leadership experience managing small and large projects for both publicly traded and privately held companies in various industries, including a global implementation of the latest revenue recognition accounting standard for Del Monte, as well as the global implementation of their SOX-404 program.

Francois Binette, Ph.D., is the Chief Operating Officer and Executive Vice President of Research & Development at Renovaro. He has over 25 years of product development expertise in Advanced Therapies and Regenerative Medicine. His broad industry experience spans a wide range of serious medical conditions, from orthopedics to ophthalmology, CNS and immuno-oncology. His career includes positions at Genzyme, Biosyntech, the DePuy Franchise of Johnson and Johnson, Medtronic and Lineage Cell Therapeutics. He received his Ph.D. from Laval University in Québec, followed by post-doctoral training at the Sanford-Burnham Institute in La Jolla and Harvard Medical School in Boston.