REGEN BIOPHARMA IN PFD SER A (OTCMKTS:RGBPP) is the preferred series A share structure of an interesting small-molecule biotechnology company aiming to identify undervalued regenerative medicine applications in the immunotherapy and stem cell space. The Company is setting up for completion of a robust lead optimization process next year that will lay a foundation for rapidly advancing these technologies through pre-clinical and Phase I/ II clinical trials.

The company has recently started the process of USPTO IP protection with a composition of matter patent application covering these novel NR2F6 small molecule modulators. According to a late October release, “having recently completed preliminary experiments demonstrating immunological effects of these compounds, the next strategic steps are to further solidify the data, understand mechanisms of action and specificity, along with optimizing these compounds.”

REGEN BIOPHARMA IN PFD SER A (OTCMKTS:RGBPP) promulgates itself as a company that focuses on the development of regenerative medical applications in the United States. It intends to provide various products, including HemaXellerate I, a cellular therapy designed to heal damaged bone marrows; HemaXellerate II, a donor endothelial cell based therapeutic product; dCellVax, a gene silenced dendritic cell immunotherapy for the treatment of breast cancer; and NR2F6, a nuclear receptor cell line. The company was founded in 2012 and is based in La Mesa, California.

Regen BioPharma, Inc. is a subsidiary of Bio-Matrix Scientific Group, Inc. RGBP is a publicly traded biotechnology company that seeks to identify undervalued regenerative medicine applications in the immunotherapy and stem cell space. The Company is focused on rapidly advancing these technologies through pre-clinical and Phase I/ II clinical trials.

Currently the Company is focused on gene silencing therapy and small molecule therapies for treating cancer, along with developing stem cell treatments for aplastic anemia and disorders of the bone marrow.

Digging Deeper

One critical factor in the company’s favor is their agreement with Eli Lilly and Co (NYSE:LLY) as part of their Innovation Drug Discovery Program, which allows Regen to receive compounds from Lilly for drug discovery purposes and allows Regen to share structural information on compounds of mutual interest.

In addition, the company has completed pre-clinical research indicating that, by inhibiting NR2F6, cancer stem cells can be converted into normal cells, thus potentially curing the patient of cancer. Additionally, activators of NR2F6 have the potential to provide relief from autoimmune diseases such as arthritis. They have licensed this associated technology out to Zander Therapeutics, primarily for use by that company’s wholly owned subsidiary, Entest BioMedical Inc. (ENTB), a publicly traded biotechnology company focused on veterinary medicine.

According to a recent release, “NR2F6 is a molecular switch known as an ‘orphan nuclear receptor’, which controls genes associated with the immune response as well as genes associated with the ability of cancer stem cells to propagate. Zander Therapeutics, Inc. has been granted an exclusive worldwide license by Regen BioPharma, Inc. to develop and commercialize veterinary applications of NR2F6.

“Between 15 million and 20 million dogs are currently kept as pets in the United States. Due to advances in technology and nutrition, the average life expectancy of a dog has increased in recent years. It is estimated that over 35% of the current dog population are age 7 years old or older. With the increase in lifespan of dogs has come an increase in the incidence of cancer among the populations of dogs. According to the European Society of Veterinary Oncology and other sources, about 50% of dogs over ten years old develop a cancer-related condition at some point.  In the United States, about 6 million dogs are diagnosed with cancer each year.”

President and Chief Scientific Officer Harry Lander recently provided some new clarity for stakeholders about the therapeutic drug development process, noting that therapeutic drugs come in many forms, such as small molecules, biologics, gene therapies, nucleic acids, cell therapies and vaccines. Of these, only small molecule drugs have the most well-defined process for getting to market and possess the advantages inherent in the ability to control the chemistry involved in the manufacture of the drug.

The kicker is the point made at the end of the piece: “Regen’s program, although early, remains robust and is on track to complete the Lead Optimizations stage in third or fourth quarter of 2017.” That puts this company on a path to generate real excitement very soon as the market for shares potentially ramps up into headlines surrounding initial conversations with FDA about the architecture of a robust and credible trial process.

RGBPP has about $140k in cash on the books, which leans up against a manageable debt load a bit over $370K. That’s a relatively untroubled balance sheet situation. Given its viable path to the market from here and its potentially powerful relationship with industry powerhouse Eli Lilly, Inc., the company may actually compare favorably at this stage to others in the same $73 billion end market such as StemCells Inc (NASDAQ:STEM), where profits have been falling and analysts have been backing away.

Overall, Regen is an interesting small-molecule, small-cap biotech play right now that appears to have big things ahead in a huge end market lacking true leadership. We will follow up soon with another update on this exciting story in the making.