Regen BioPharma Inc (RGBP)

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20/20 Review of Regen Biopharma - An Up & Coming Player In The Immuno-Oncology Market

https://pennystocks.today/rgbp-stock-the-biotech-stock-to-look-out-for-in-2022/

Specializing in the treatment of cancer and autoimmune diseases, Regen BioPharma Inc. (OTC: RGBP) and (OTC: RGBPP) is a biotech penny stock making notable contributions to the industry and particularly the immunology and immunotherapy space. Despite trading at a dip, RGBP stock has a number of upcoming catalysts which could send it to new highs in the long-term.
Catalysts

At the forefront of the biotech industry, Regen BioPharma’s portfolio of patents has allowed the company to make notable leaps. Earlier this year, the company obtained a license entitling it to exclusive rights for developing and marketing IP for the treatment of pancreatic cancer. This prompted a runup of 1076% for RGBPP (preferred stock) and 2723% for RGBP (common stock) in April.

The company obtained two other patents by the second quarter of 2021, the first one for using T regulatory cells in the treatment of arthritis and autoimmunity. Currently, testing this cell treatment on animals, Regen BioPharma will have a lengthy review process with the FDA before it becomes marketable. However, the global market for Rheumatoid Arthritis drugs alone was forecast to reach $36.11 billion by 2027. If this treatment proves successful, the ROI could be significant.

In October, RGBP obtained yet another patent for its “Universal Donor Checkpoint Inhibitor Silenced/Gene Edited Cord Blood Killer Cells” which covers RGBP’s invention of treatments that induce an “anticancer” response in patients. It’s therapeutic use can trigger an antitumor immune response from the body which has the potential to be revolutionary for the company.

Another patent was granted to RGBP for Antigen specific mRNA cellular cancer vaccines which could be a lucrative patent considering that mRNA is currently a leading treatment in the biotech industry. With this in mind, the company has been exploring ways to capitalize on its patents leading it to give a Scope of Work order to Biotech Research Group in October in an attempt to strategize methods of commercializing its NR2F6 intellectual property. This is important because the NR2F6 nuclear receptor was identified as a potential immune cell inhibitor that can help trigger the immune system to fight cancer as well as autoimmunity diseases and chronic inflammation.

Meanwhile, the company seems to be building on two successful deals with Oncology Pharma from earlier this year as it sets out to commercialize its research. RBGP made these agreements with Oncology Pharma giving the latter the exclusive right to develop and commercialize IP related to the treatment of cancer. In October, RGBP agreed to provide Oncology Pharma with intellectual property related to the mRNA used to treat pancreatic cancer as well. In exchange, RGBP received a fee of $55,000, and will take 5% royalties in net sales as well as 10% of all consideration from sublicensees.

At the same time, the company has been updating its filings in preparation for up-listing to the OTCQB. Its decision to opt for full reporting status has fueled speculation of a possible Big Pharma buyout that would require this level of detailed reporting. This has led some to speculate RGBP could be an acquisition target for Oncology Pharma considering their successful relationship. But Precigen was also rumored to be a buyout candidate due to Precigen’s CEO – Helen Sabzevari – former role on RGBP’s Scientific Advisory Board. But many are hopeful that Eli Lilly is the potential target since it has maintained a working relationship with RGBP for over 5 years.

Beginning in 2016 with a definitive agreement allowing Regen to receive compounds from Lilly for drug discovery purposes and to exchange information of mutual interest, the two companies have since covered a lot of ground together. In 2017, Eli Lilly’s former Executive led RGBP’s newly formed Business Advisory Board. Because there is a Drug Discovery Pact between both parties, some are wondering if RGBP may be a target for the massive company.

RGBP’s CEO –Dr. David Koos – appears very bullish, saying “Companion diagnostics in precision oncology is where the future of cancer treatment is heading.” He went on to explain that the global cancer diagnostics market is growing rapidly – increasing from $168 billion in 2020 to a predicted valuation of $280 billion by 2028.

It also seems RGBP has been cleaning house after settling convertible notes equivalent to $1,023,454. But the company has evidently been on a campaign to pay off its debts for several months now, paying off $539,392 in other fees through the issuance of roughly 706.4 million common shares and 23.7 million Series A Preferred shares. This appears to have nearly erased the company’s debt except for a remaining $1,340,621 in convertible notes.

Shareholders have been re-energized with the release of RGBP’s new 10-K which shows that the company’s CEO – David Koos – is still holding Common 3.18 million common stock shares, 38% of A Preferred shares, and 26.14% of M Preferred shares as well as 100% of AA Preferred and NC preferred shares. His heavy investment in the company is definitely a bullish sign that has helped offset the dip following an announcement from Pomerantz Law Firm that it is investigating claims on behalf of Regen BioPharma, Inc.’s shareholders.

The reason for the firm’s investigation appears to be that the previously issued Balance Sheet, Statement of Operations, Statement of Shareholders Equity and Statement of Cash Flow for period ending June 30, 2021 “should not be relied upon” because it had determined that the $1,905,000 in revenue recognized from license grant to an unrelated third party should be recognized over the 15 year term of the license.

While this news shook some shareholders, most have been buoyed by the results of the company’s latest quarterly report which is unaffected by this investigation. Furthermore, Pomerantz Law Firm is not seen as a highly reputable firm having filed numerous lawsuits on similar charges.

In any case, according to RGBP’s financial document the company has $727,162 cash on hand and total assets amounting to $1.2 million. The company also recorded $171,194 in revenue but is operating at a loss of $6.7 million as is typical of biotech companies which move on binary events.

Building on its mRNA patent, RGBP has been developing a program to commercialize its anti-cancer vaccine. In the program’s first phase, RGBP will perform initial pre-clinical studies required for FDA submission.
This technology uses modified mRNA molecules to target the Survivin protein which blocks the death of cancer cells. Following this, the molecules are infused into cancer patients’ blood where they destroy cancer cells. Considering that similar trials on this subject are ongoing around the world, RGBP believes that this would support its anticipated FDA submission.

To facilitate this, RGBP will partner with Oncology Pharma to accelerate the development of RGBP’s patented mRNA vaccines. According to this partnership, RGBP will provide its scientific background, laboratories, and the modified mRNAs required for the completion of the studies while Oncology Pharma will finance the studies.

Although both companies are confident they will close this partnership, it is dependent on the execution of a number of definitive agreements and finances.
In addition to this, RGBP plans to speed up the clinical development of its NR2F6 therapies by combining its modified mRNA technology with its siRNA IP. RGBP has already filed an Investigational New Drug Application with the FDA for its new drug – tCellVax.

This new drug stimulates the immune cells to eliminate cancer cells by employing RGBP’s siRNA technology to silence NR2F6 activity in the immune system. In light of this, RGBP has contracted Dyo-Biotechnologies to assist the company in advancing this new technology.

On that note, many investors are bullish on this development given the experience Dyo’s management has in the biotech industry. With over 25 years of experience, Dyo is led by Dr. Harry Lander – well known for having relationships with several small and large biotechnology companies. Through these relationships, RGBP has the potential to grow its business financially and scientifically.

With RGBP receiving a patent for its small molecule modulators, Koos believes that “by adding our new mRNA intellectual property to tCellVax we can simplify its administration to patients and thus create a much more marketable drug” and that “An RNA-based checkpoint inhibitor will be a first-in-class drug”. In light of this, RGBP’s new drug could revolutionize cancer treatments after receiving approval from the FDA.

After partnering with Oncology Pharma to finance the acceleration of its mRNA vaccine, RGBP decided to cancel its acquisition of Canary Oncoceutics. In light of this, many investors are relieved that RGBP will no longer have to raise the $50 million stated in the LOI. Investors are also speculating that the termination of this acquisition could be due to the company pursuing a buyout deal.

Recently, RGBP provided an update to its shareholders regarding the company’s share structure. Based on this update, the company increased its authorized shares to 5.8 billion – due to an obligation to a note holder. However, RGBP assured its shareholders that the additional shares have not been issued.

Given that medical treatments have a long timeline before receiving approval from the FDA, RGBP stock has the potential to be a profitable long-term hold. However, recently many investors are feeling bullish about the company’s future after RGBP began its pre-clinical trials for a Myelodysplastic syndromes drug in March. As the company provides updates on the trials, RGBP could see an uptick with positive news.