May 24, 2022

ศึกษาข่าวจากต่างประเทศโดยเรียนบางแสน

โครงการข่าวต่างประเทศโดยนักเรียน

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 study and treatment of cancer. Currently focused on the development of its NR2F6 therapies, RGBP a an extensive portfolio of patents and its applying for more. Despite trading at a dip, RGBP stock is a biotech play which many consider to have buyout potential. While hindered by the heavy costs of research and development, RGBP stock may be one to watch for updates.

Fundamental Analysis

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.

Patents

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.

Oncology Pharma

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.

Uplisting

At the same time, the company has been updating its filings in preparation for uplisting 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 that 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 very good working relationship with RGBP for over 5 years.

Eli Lilly

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.

Canary Oncoceutics, Inc.

However, RGBP is currently working to finish its strategic growth plan for the upcoming 5 years which includes diversifying the company’s operations. On that note RGBP signed a non-binding Letter of Intent (LOI) to acquire Canary Oncoceutics, Inc. which is developing an oncology diagnostic platform. This platform could be very important because it complements the existing cancer genomic testing that is used to measure how likely cancer could grow and spread. With that in mind, Canary seems like the perfect fit for RGBP’s plans for diversifying into the in-vitro diagnostics industry. But this acquisition is dependent on a variety of factors including RGBP raising $50 million for the platform’s development.

However, RGBP’s CEO – 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.

Convertible Notes

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.

mRNA Vaccine

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.

NR2F6 Therapies

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.

Patent

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.

Canary Oncoceutics, Inc.

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.

AS Increase

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 noteholder. 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.

NR2F6 Patent
RGBP updated its shareholders with news that its patent titled “Small Molecule Agonists and Antagonists of NR2F6 Activity in Humans” was submitted to the US Patent Office. RGBP received approval for some claims in its application highlighting several entities integral in modulating NR2F6. According to the company, “These composition of matter claims which have been allowed, and the patent that will accordingly be granted, reflect multiple structural entities that modulate NR2F6.”

RGBP already holds a patent for “Small Molecule Modulators of NR2F6 Activity” and has applied for a number of patents related to NR2F6 which is an intracellular immune checkpoint that suppresses adaptive anti-cancer immune responses. Some of its published patents are related to NR2F6 and cannabidiol for Reduction of Post-Surgery Cancer Metastasis and Enhanced Dendritic Cell Immune Activation.

Its important to understand that NR2F6 has emerged as a novel cancer therapeutic target. This is supported by studies of mice with Nr2f6−/− which “spontaneously reject tumors and develop host-protective immunological memory, a consequence of NR2F6 acting as an immune checkpoint in effector T cells.” Data suggests that modulation of NR2F6 activity “may have important clinical applications in the fight against cancer”. For this reason, the nuclear receptor superfamily has proven to be an excellent source of targets for therapeutic intervention of a broad range of diseases and approximately 15% of FDA approved drugs target NRs.

In light of this, RGBP’s recent patent application could be a stepping stone for the company as it seeks to develop its cancer treatments and capitalize on its range of granted patents. It has also retained Dr . Harry Lander to work with RGBP’s patent attorney as it responds to the USPTO regarding its patent applications.

In other news, the company has clarified that it terminated its involvement with Canary because it was not a good fit with Regen’s business model. The company initially announced its LOI to acquire Canary Oncoceutics, Inc. in November but chose a different route after further consideration.

Short Term Goals

All in all, the company has made progress on the short term goal laid out by RGBP’s CEO Dr . Koos in September. In his shareholder update, Dr . Koos outlined his plans to:

1) Settle all outstanding convertible notes payable in order that the Company will have no convertible instruments outstanding.

2) Hire a Chief Scientific Officer

3) Seek out and enter into alliances, co-development agreements and additional licensing agreements with regard to our proprietary mRNA and NR2F6 portfolios.

4) Obtain OTCQB listing for our securities on the OTC Market.

5) Establish a social media presence in order to more easily provide updates to our shareholders, the investment community, the scientific community and the public at large.

On that note, RGBP has reduced its convertible debt owed to a shareholder from $1.5 million to $982.8 thousand. Many shareholders are optimistic that once its convertible debt is paid off, the company will be in a stronger position to pursue its goals.

Future Plans

According to the company’s report, RGBP intends to “engage primarily in the development of regenerative medical applications which we intend to license from other entities up to the point of successful completion of Phase I and or Phase II clinical trials after which we would either attempt to sell or license those developed applications or, alternatively, advance the application

further to Phase III clinical trials.”

At this time, RGBP is working to actively identify small molecules that inhibit or express NR2F6 leading to immune cell activation for oncology applications and immune cell suppression for autoimmune disease. RGBP has also worked on a mRNA vaccine for the treatment of cancer which researchers at the Duke University School of Medicine are also investigating for its oncological purposes.

RGBP Stock Financials

Annual Report

Shareholders have been reenergized 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 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.

Quarterly Report

However, according to its latest quarterly report, RGBP has $77.3 million in liabilities – a large portion of which is derivative liability. RGBP has clarified that “A derivative liability is not a liability in the “common sense” meaning of the term in that it does not represent a bill or Note that must be paid nor is a Derivative Gain or Loss an actual transactional monetary gain or loss as most people understand the term..Accounting rules require the Company to separately account for the conversions features of certain convertible instruments and carry these features at “fair value” as determined by a complex pricing model and that is how Derivative Liabilities and the corresponding gain/loss is determined.”

In terms of revenues, RGBP reported $58.3 thousand – an increase from the $27.4 thousand reported in the same year-ago period. This 112% increase is due to $30,945 of revenue recognized during the period thanks to a license granted to Oncology Pharma , Inc. However, its operating Loss was $76,494 and its net loss was $67 million due to its derivative loss. Meanwhile, RGBP reported assets of $630.8 thousand. Given that RGBP is focused on its research and development, its not surprising that the company is operating at a loss. But whether the company is able to sustain its operations without being hampered by its derivative losses remains to be seen.

Technical Analysis

Currently trading at $.0043, RGBP stock is dropping closer to a strong support set in April of 2021. The stock is clearly bottomed out after dropping almost 30% since the start of May. The RSI is oversold at 19 and the MACD is bearish but approaching a crossover. Meanwhile accumulation shows a slight uptick. With a support at .004 and .0023, RGBP shows a resistance at .0064 as well as .0071. RGBP could be due for a rebound off of its support with a proper catalyst. Otherwise it may continue dropping to April 2021’s support level of .0029.

Considering the bearish OTC market, RGBP stock has hit bottom like many other OTC stocks. It could be due for a turn around as more liquidity floods back into microcaps. Once the company becomes more active on Twitter or communicative with shareholders, there will likely be more catalysts in store to help push RGBP higher.

RGBP Forecast

Currently, the company is focused on developing its NR2F6 therapies as well as as continuing its mRNA vaccine. With partnerships in place with Oncology Pharma , RGBP will be able to continue pursuing these plans

It appears that RGBP is strategizing to successfully complete Phase I and or Phase II clinical trials for its treatments before attempting to sell or license the developed applications. As with most biotech companies the real payout comes with FDA approval and commercialization. For this reason, investors should consider the company’s pipeline of products, patents, potential, and plans when investing.

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