Regen BioPharma recently filed a patent related to a mRNA cancer immunotherapeutic vaccine. Does the market growth potential make RGBP a good investment opportunity?

Oncology stock Regen BioPharma (OTCMKTS: RGBP) is a penny stock listed on the OTC pink market.

Regen BioPharma, Inc focuses on the development of translational medicine platforms for the commercialization of stem cell therapies. The company aims to obtain regulatory approval and execute clinical trials in cell therapy. Regen BioPharma develops medicines for diabetes, heart-related illness, circulatory issues, and Chronic Obstructive Pulmonary Disease (COPD).

The company actively identifies small molecules that inhibit or express NR2F6 leading to immune cell activation for oncology applications and immune cell suppression for autoimmune diseases.

Regen BioPharma is in the early stages of developing its products and therapies. The business was incorporated in 2012 and is based in La Mesa, California.

Regen has identified and filed patents on small molecules that activate and inhibit a novel gene (NR2F6) which controls how the immune system reacts to cancer cells and inflammatory responses.

Its progress is currently pre-clinical, so commercialization is a long way off.

The conditions Regen hopes its investigations will eventually be able to address include:

Initial indications (inhibitor): bladder cancer, myelodysplastic syndrome, lung cancer

Initial indications (activator): rheumatoid arthritis, inflammatory bowel disease, psoriasis

Additional indications include solid tumors, acute leukemia and GVHD

Regen currently has the following products in its pipeline:

HemaXellerate: Cleared to proceed to Phase I/II clinical trials (stimulates blood production in patients whose bone marrow is not correctly functioning)

dCellVax: a breast cancer therapy (a dendritic cell-based immunotherapy that stimulates the patient's immune system)

DiffronC: a novel form of therapy called differentiation therapy that is expected to have much milder toxicity than chemotherapy.

For the quarterly period ended June 30, 2022

Revenues: $31.2k (up 6.8% Y/Y)

Total Revenues: $58.7k (up 3.7% Y/Y)

Operating Loss: -$58.9k (from -$42.4k Y/Y)

Between September 2021 and June 2022, Regen saw its cash decline by 85%. This is primarily due to paying off debts and using cash to fund the business.

Regen BioPharma is expected to report its Fiscal Year 2022 results on December 22, 2022.

RGBP stock has five billion shares outstanding.

On July 19, 2022, Regen BioPharma issued 54.5 million shares to Coventry Enterprises LLC to settle $180.5k in convertible debt.

On August 9, 2022, KCL Therapeutics, Inc. (a wholly owned subsidiary of Regen BioPharma) filed a provisional patent application with the US Patent and Trademark Office covering Regen's novel approach for enabling chimeric antigen receptor (CAR)-T cell-based therapies to kill solid tumors through prevention of a process called "T cell exhaustion." T cells are part of the immune system and develop from stem cells in the bone marrow.

Regen BioPharma's patent application protects the use of its patented survivin mRNA both as a stand-alone vaccine and as an immunotherapy.

David Koos, Chairman and CEO of Regen BioPharma, commented:

The currently filed application discloses means of significantly increasing efficacy by combining modified-mRNA with unique cellular immunotherapy as well as adjuvant approaches,

CAR-T cells have been in the clinic for 6 years, but they have hardly made a dent in treating solid tumors,

We hope that through the diligent work of our scientists and collaborators that advancements such as what we announced today will pave the way to bring this incredible cellular immunotherapy to patients suffering from solid tumors such as lung, colon, prostate and others.

Regen BioPharma is not profitable but makes a small income from royalties and anniversary fees under license agreements.

The company holds shares in Oncology Pharma (OTCMKTS: ONPH) and Zander Therapeutics.

Zander Therapeutic has been granted an exclusive license to develop and commercialize IP controlled by Regen BioPharma for non-human veterinary therapeutic use.

Meanwhile, Regen has granted an exclusive license to Oncology Pharma, Inc. to develop and commercialize "Antigen specific mRNA cellular cancer vaccines" for treating pancreatic cancer.

And KCL Therapeutics, Inc. has granted an exclusive license to Oncology Pharma, Inc. to develop and commercialize certain intellectual property for the treatment of colon cancer.

David Koos, Chairman and CEO of Regen BioPharma, said:

We are very proud of our broad, deep and cutting-edge patent portfolio,

We are continuing to develop additional IP focused on immunotherapy of cancer and look forward to developing some of these technologies in-house and some of them via outlicensing.

RGBP stock has a price-to-earnings ratio (P/E) of 48.7. Its price-to-book-value (P/BV) is negative, which means it owes more than it owns. RGBP stock does not come with a shareholder dividend.

Over the past year, Regen BioPharma Inc (RGBP) has traded between $0 and $0.08. Today the stock trades at $0.0096 and has a market cap of $48m.

Year-to-date, the RGBP stock price is down by -50%, while the S&P 500 is down -13.73% over the same period.

Furthermore, on August 22, 2022, Regen BioPharma (RGBP-US) closed down -86.3% off its 52-week high vs. the subsector average change of -39.4%.

Regen BioPharma plans to rapidly advance novel technologies through pre-clinical and Phase I/ II clinical trials. If it can successfully advance its small molecule therapies for treating cancer and autoimmune disorders, the addressable market is significant, and it could potentially make money.

Immunotherapy of cancer represents a vast market currently being led by the class of drugs called "checkpoint inhibitors" and "CAR-T" cells. To date, there is no mRNA immunotherapy available for treating cancer.

A stock with a beta higher than 1.0 is expected to be more volatile than the S&P 500. RGBP stock has a beta of 3.75, which accurately reflects its volatile nature.

Its price-to-book-value (P/BV) is negative, meaning it owes more than it owns.

RGBP common stock is a "penny stock," and therefore comes with the associated risk in dealing in penny stocks, such as lack of liquidity.

The economy is experiencing a period of high inflation, which could lead to interest rate rises and/or a recession. This is not conducive to raising funds at favorable rates and could adversely affect the company's ability to raise the money needed to conduct its research and trials.

There is a lack of liquidity in trading a stock such as Regen BioPharma. Therefore, there will probably be a large spread between the bid and ask price of RGBP shares. This means if you want to sell your shares in a hurry, you may not get a reasonable price for them.

Furthermore, the company has a history of issuing additional stock, which dilutes existing shareholder value.

Regen BioPharma stock seems like a hugely speculative investment with a lot of shareholder risk in the current investing environment.

Author: Kirsteen Mackay

This article does not provide any financial advice and is not a recommendation to deal in any securities or product. Investments may fall in value and an investor may lose some or all of their investment. Past performance is not an indicator of future performance.

Kirsteen Mackay does not hold any position in the stock(s) and/or financial instrument(s) mentioned in the above article.

Kirsteen Mackay has not been paid to produce this piece by the company or companies mentioned above.

Digitonic Ltd, the owner of ValueTheMarkets.com, does not hold a position or positions in the stock(s) and/or financial instrument(s) mentioned in the above article.

Digitonic Ltd, the owner of ValueTheMarkets.com, has not been paid for the production of this piece by the company or companies mentioned above.

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Is Regen BioPharma a Good Investment? - Value the Markets