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Regen BioPharma Inc (OTCMKTS: RGBP) Northbound as Biotech Grows Valuable Patent Portfolio & Grants 2 Licenses to Oncology Pharma for $1.9 Million

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Regen BioPharma Inc (OTCMKTS: RGBP) has been moving steadily northbound in recent trading as speculators move back into the stock and bid it higher. On Friday the stock was up 26% on $1.9 million in dollar volume. This comes after the Company’s CEO David Koos issued a letter to shareholders which summarized some of the recent accomplishments including recently going “pink current” and becoming fully compliant, settlings the lawsuit with Chemdiv, growing the Companys valuable patent portfolio as well as granting two licensees to Oncology Pharma for which RGBP was paid $1,905,000 in cash and securities. 

RGBP is one of the most followed stocks in small caps with a huge investors base and it has a long history of big moves skyrocketing to 8 cents plus twice over the past 12 months. There are also plenty of buyout rumors on RGBP; according to many investors It appears there may be a possible merger acquisition looming with Precigen or another big pharma which would make sense as the CEO of Precigen (PGEN) Helen Sabzevari is on RGBP’s Scientific Advisory Board. PGEN trades on Nasdaq with a Market Cap of $766 million. RGBP is in the same clinical therapeutic niche market of Oncology-Immunology candidate drug development that Precigen is in including the same mRNA vaccine technology so logically speaking it would make sense if PGEN straight up buys-out RGBP or does a merger acquisition and the motive to do this are the numerous valuable Patents RGBP owns that address enormous billion-dollar markets.  

Regen BioPharma Inc (OTCMKTS: RGBP) “pink current” operating out of San Diego, California is a publicly traded biotechnology company that was founded in 2012 focused on the immunology and immunotherapy space. Regen BioPharma is focused on rapidly advancing novel technologies through pre-clinical and Phase I/ II clinical trials. Currently, the Company is focused on small molecule therapies for treating cancer and autoimmune disorders. RGBP is also developing products treating blood disorders using small molecules and gene silencing (DiffronC), treating cancer with cellular immunotherapy (dCellVax), modulating key molecular processes in cancer stem cell through the Company’s patented molecular targeting approaches (BORIS), & repairing damaged bone marrow in patients with aplastic anemia and chemotherapy/radiotherapy treated cancer patients (HemaXellerate). Currently RGBP has 2 investigational new drug applications (IND) filed with the FDA and 3 products in preclinical development based on the newly discovered cancer stem cell gene target 

The big story on RGBP is its valuable intellectual property portfolio consisting of a large and growing number of patents. The Company’s CEO David Koos has been working hard in recent months getting all the expired Patents updated a logical step for an acquiring company to take over the patents then turn around and file an FDA IND post buy out in order to immediately place those candidate drug Patents in their clinical trials pipeline. Recently RGBP has revived numerous valuable existing IP which had been deemed abandoned by the United States Patent and Trademark Office and been issued several new patents. CEO David Koos is a highly accomplished executive who has been working in the financial markets for 3 decades. He has a Ph.D. in Sociology and a Doctor of Business Administration with an emphasis in finance.   

Last month RGBP entered into an LOI to acquire Canary Oncoceutics, Inc., a new company developing in vitro precision oncology tests using cellular technology. The acquisition contemplated by the non-binding LOI is contingent upon several factors including, but not limited to, completion of due diligence, the completion of final negotiations, and execution of a definitive agreement. It is presently contemplated that in order for this acquisition to close, Regen must raise $50 million to support the development of the diagnostic platform. Canary Oncoceutics, Inc. is developing a precision oncology testing platform that will complement existing cancer genomic testing. 

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RGBP

Cancer genomic testing involves analyzing a sample of a cancer tumor to see how active certain genes are and if they are abnormally modified. The activity level of these genes affects factors including how likely the cancer is to grow and spread. By identifying the genetic alterations that are unique to a patient’s individual cancer, doctors are able to identify specific drugs designed to target those mutations. However, the list of drugs generated by genomic testing may be quite extensive and different patients respond differently to the same drug. Canary Oncoceutics, Inc. is developing tests that take those recommendations and test them on a patient’s tumor in a laboratory setting thereby allowing doctors to refine the list of recommendations generated through genomic testing down to those drugs or drug combinations which will work best on that specific patient. “Companion diagnostics in precision oncology is where the future of cancer treatment is heading.  The global cancer diagnostics market was $168 billion in 2020 and is expected to reach $280 billion by 20281”, said David Koos at the time. 

On December 30 RGBP CEO David Koos wished shareholders a happy holiday season in a letter to shareholders stating: “When I returned to Regen on March 23, 2021 in order to serve as Chairman and Chief Executive Officer, I found myself at the helm of a company on the verge of collapse. We were behind in bills, at risk of losing patent protection on valuable IP, and delinquent in our SEC filing obligations. Worse of all we were being sued by  Chemdiv-our Contract Research Organization- in a complaint seeking damages of $1,200,000 which also threatened our ownership rights to valuable intellectual property 

As the year progressed, we faced the challenges that lay before us and conquered them. Regen has revived numerous valuable existing IP which had been deemed abandoned by the United States Patent and Trademark Office, settled its lawsuit with Chemdiv, been issued several new patents, entered into two non-related party licensing agreements and became current in its SEC filing obligations eliminating the risk that the public trading market for both the common and Series A preferred shares would disappear. 

Becoming current in our SEC reporting obligations after such a long delinquency was a significant achievement.  Recent amendments to SEC Rule 15c2-11 threatened the public trading status of delinquent issuers.  I have received numerous texts, emails and phone calls regarding our restatement of our third quarter financials. During the quarter ended June 30, 2021 the Company was paid $1,905,000 in cash and securities resulting from two licenses granted in April, 2021 to Oncology Pharma, Inc. (“ONPH”).  

Looking into the New Year I will work diligently towards the goal of entering into additional co-development projects and collaborations that I believe will benefit Regen’s shareholders and   I expect to identify a contract research organization that will help us move the Company’s intellectual propriety towards clinical trials.  

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RGBP has been moving steadily northbound in recent trading as speculators move back into the stock and bid it higher. On Friday the stock was up 26% on $1.9 million in dollar volume. This comes after the Company’s CEO David Koos issued a letter to shareholders which summarized some of the recent accomplishments including recently going “pink current” and becoming fully compliant, settlings the lawsuit with Chemdiv, growing the Companys valuable patent portfolio as well as granting two licensees to Oncology Pharma for which RGBP was paid $1,905,000 in cash and securities. RGBP is one of the most followed stocks in small caps with a huge investors base and it has a long history of big moves skyrocketing to 8 cents plus twice over the past 12 months. There are also plenty of buyout rumors on RGBP; according to many investors It appears there may be a possible merger acquisition looming with Precigen or another big pharma which would make sense as the CEO of Precigen (PGEN) Helen Sabzevari is on RGBP’s Scientific Advisory Board. PGEN trades on Nasdaq with a Market Cap of $766 million. RGBP is in the same clinical therapeutic niche market of Oncology-Immunology candidate drug development that Precigen is in including the same mRNA vaccine technology so logically speaking it would make sense if PGEN straight up buys-out RGBP or does a merger acquisition and the motive to do this are the numerous valuable Patents RGBP owns that address enormous billion-dollar markets. We will be updating on RGBP when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with RGBP.

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Disclosure: we hold no position in RGBP either long or short and we have not been compensated for this article

BioPharma

Advancing Medical Frontiers: Elutia Inc.’s(NASDAQ: ELUT) Strategic Vision in a $600 Million Market

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Elutia Inc (NASDAQ: ELUT) shares bolstered a whopping 33% today as the company recently shared that they’ve secured about $10.5 million in funding through a private investment round. If all the warrants are cashed in as part of this funding, the total could go up to $26.2 million.

Latest Changes:

Just last week, Aziyo Biologics changed its name to Elutia Inc. Following this change, Elutia made an announcement about selling its Orthobiologics business unit to Berkeley Biologics, a subsidiary of GNI Group Ltd. This move is set to bring in a substantial amount of cash, totalling up to $35 million for Elutia. This sum includes a notable upfront payment of $15 million, plus additional potential earnings of up to $20 million over five years. The deal is expected to be finalized in the fourth quarter of 2023.

This sale is a big step for Elutia, especially in the realm of drug-eluting biomatrix technology (DEB). Elutia is actively seeking approval from the FDA for their main product, CanGaroo RM. This product utilizes innovative biomatrix technology with antibiotics rifampin and minocycline (RM), providing long-term protection for cardiac pacemakers and defibrillators. This tackles a huge market estimated to be worth around 600 million. Elutia is aiming to introduce CanGaroo RM to the market in the first half of 2024.

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Standard Of Care:

Medtronic (NYSE: MDT) stands as the exclusive provider of the antibiotic envelope within the current market. This envelope is crafted using synthetic mesh infused with antibiotics. Back in 2014, Medtronic acquired this technology, making a strategic investment of up to $200 million. Primarily intended for Cardiac Implantable Electronic Device (CIED) revision procedures, this product boasts estimated annual sales in the range of $250 to $300 million.

However, despite its market presence and revenue generation, the Medtronic antibiotic envelope has notable limitations. While it effectively combats infections, its synthetic composition renders it less effective in supporting wound healing. Moreover, it poses challenges in accommodating larger devices like Subcutaneous Implantable Defibrillators (SCID).

Drug-eluting biomatrix (DEB):

Drug-eluting biomatrix (DEB) involves a specialized approach to drug delivery using a biomatrix as a carrier or platform. In simple terms, it’s a technique where a biomaterial matrix, often a biocompatible polymer or similar substance, is used to release drugs in a controlled and targeted manner.

The biomatrix acts as a support structure that can hold and gradually release drugs or therapeutic agents at a specific site in the body, typically over an extended period. This is particularly useful in medical applications where a localized and sustained delivery of medication is necessary.

For instance, in the context of Elutia’s CanGaroo RM, a biomatrix incorporating antibiotics rifampin and minocycline is used to provide prolonged protection for cardiac pacemakers and defibrillators. The biomatrix slowly releases these antibiotics at the surgical site, preventing infections and promoting healing.

DEB technology is gaining traction because it enhances treatment efficiency by ensuring the drug is delivered directly to the target area, minimizing side effects, and optimizing therapeutic outcomes. It’s a promising approach in the field of medical advancements, especially in areas like cardiology, oncology, and orthopedics.

Post-mastectomy Breast Reconstruction:

On top of this, the company also has plans to develop an RM version of its SimpliDerm biomatrix tailored for breast reconstruction procedures. The rate of infections after this surgery is quite high, more than 10%, highlighting a big medical need in a market valued at over $500 million. Elutia is stepping up to address this issue by developing SimpliDerm® RM, which incorporates their unique DEB technology. The funds raised through the private investment round (PIPE) and the sale of the Orthobiologics business unit will not only boost Elutia’s efforts in advancing their drug-eluting biomatrix products for the cardiac pacemaker and defibrillator market, but also for post-mastectomy breast reconstruction.

What’s next:

As mentioned earlier, their biomatrix platform serves two major markets. CanGaroo RM, their upcoming product, is slated for a 1H of 2024 market release and is poised to be a pioneer in a $600 million market. Furthermore, their SimpliDerm RM product utilizes the same proprietary antibiotic-eluting technology found in CanGaroo RM, which serves a 1.6B market according to their presentation deck. They aim to secure an IDE by Q4 2024, and upon achieving these milestones, they plan to venture into neurostimulator markets, particularly in pain management, to further drive their growth.

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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ZyVersa Therapeutics’ (NASDAQ: ZVSA) Breakthrough: A Super Tool for Tackling Inflammation in ALS and Beyond

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ZyVersa Therapeutics (NASDAQ: ZVSA) had a spectacular day on the market, with its stock surging by almost 50% following a significant announcement about one of their promising drug candidates, IC-100. This drug is designed to combat inflammation in the context of Inflammatory Diseases, and the latest data is incredibly promising. For those who are new to this field of investment, we’ve taken the liberty of rephrasing the press release in simpler terms.

The Release:

When you’re dealing with diseases like ALS that affect your brain and nerves, shutting down the inflammasome pathway NLRP3 (a multi-protein that regulates the immune system and inflammatory signaling), is not enough.

To address this, ZyVersa is working on something called Inflammasome ASC Inhibitor IC-100. It’s like a super tool designed to block not just NLRP3 but a bunch of other inflammasome pathways too – up to 12 of them. This helps keep inflammation in check, whether it’s in the central nervous system (CNS) or other parts of the body where inflammation is causing problems.

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In a recent paper published in Frontiers in Immunology, they pointed out that focusing only on NLRP3 might not do the trick when it comes to calming CNS inflammation in ALS and similar diseases. They did experiments with cells and even used mice to back up their point. Turns out, just targeting NLRP3 didn’t stop the release of those pesky proinflammatory chemicals or the damage they were causing in the spinal cord.

The authors of the paper basically said, “Maybe we should aim to tackle multiple inflammasome pathways when it comes to diseases like ALS, where lots of inflammasomes are going haywire.”

The CEO and president at ZyVersa, Stephen C. Glover mentioned “Our research shows that to really put the brakes on inflammation driven by multiple inflammasomes, we need more than just NLRP3 inhibition.” He added that IC-100 is like a superhero in the world of inflammation control. It stops the formation of different types of inflammasomes, preventing the start of the inflammation chain reaction, and also puts a halt to something called ASC specks, which keep the inflammation going. You can dive deeper into how IC 100 works by checking out their website here.

So, in plain speak, ZyVersa is cooking up a promising solution for folks dealing with inflammation-related problems, especially those tied to the brain and nerves. They’re not just focusing on one troublemaker; they’re going after a whole gang to keep things under control.

Overall ZyVersa is a company on a mission to create groundbreaking treatments for kidney and inflammatory diseases, and IC-100 could help them in this mission.

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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Creative Medical Technology NASDAQ: CELZ) Major Breakthrough: Allogeneic Cell Line Paves the Way for Diabetes Treatment

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Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) has recently seen a substantial intraday gain of over 15% in its share price. Despite the absence of any recent news or filings, this surge could suggest significant progress in the realm of allogeneic cell therapy.

Background:

The company is known for its regenerative approaches in various medical areas, including immunotherapy, endocrinology, urology, gynecology, and orthopedics, and made a significant announcement. In the fourth quarter of 2022,They successfully developed a new allogeneic cell line called AlloStem™. AlloStem™ is derived from human perinatal tissue and includes a Master Cell Bank and a Drug Master File. Now, with FDA approval, their program, known as CELZ-201, is being used in an early clinical trial for type 1 diabetes and will continue to be developed for both type 1 and type 2 diabetes treatment.

Additionally, the company is using the AlloStem™ line for its StemSpine® procedure to help treat chronic back pain. They report remarkable results, including over a 90% reduction in narcotic usage, more than an 80% reduction in pain scores, and over a 50% reduction in the Oswestry score in patients treated with AlloStem™.

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Allogeneic Cell Therapy:

Allogeneic Cell Therapy is a treatment that uses cells from healthy donors to treat patients with otherwise untreatable diseases. These cells can come from various sources, like bone marrow, blood, or umbilical cord blood. This approach shows great promise in the medical field.

Allogeneic cell therapy offers potentially curative options for patients when traditional treatments fall short. While still a relatively new field, ongoing research into allogeneic cell therapies holds great potential for patients suffering from these diseases. Companies like Argan Inc. are also exploring the benefits of allogeneic cells.

With FDA approval and ongoing clinical trials, Creative Medical Technology’s recent developments open doors to innovative treatments that could significantly enhance the lives of those dealing with diabetes and other diseases. The global market for allogeneic cell therapy reached $255.6 million in 2022 and is expected to grow at a rate of 27.4% from 2023 to 2030, emphasizing the importance of continued research. As the company remains dedicated to medical innovation, their efforts have the potential to improve the health outcomes of people worldwide.

Latest Release:

The company recently shared key updates on its financial status and drug pipeline for Q3 2023. The biotech company, known for its regenerative medical solutions, reported being debt-free with $14.6 million in cash and $14.4 million in working capital, sufficient to cover expenses through 2024.

Their advancements in treating type 1 diabetes include FDA clearance for a groundbreaking clinical trial using CELZ-201 (AlloStem™). The company obtained Institutional Review Board approval and partnered with Syneos Health for this study. They also filed for Orphan Drug Designation to tackle brittle type 1 diabetes.

Promising results emerged from the CELZ-001 treatment for type 2 diabetes, demonstrating substantial reductions in insulin requirements with no safety concerns.

A pilot study on the StemSpine® procedure, using donor cells (AlloStem), showed impressive reductions in narcotic usage, pain scores, and improved functionality for chronic lower back pain patients.

Creative Medical Technology’s ImmCelz platform proved efficient, requiring fewer donor cells and yielding high-quality results.

They also collaborated with Greenstone Biosciences Inc. to develop a human-induced pluripotent stem cell (iPSC) pipeline, iPScelzTM, aimed at expediting drug discovery. The development of this cell line is expected to save the company two to three years in research and development time, along with associated expenses. Additionally, it will accelerate its drug discovery program by leveraging artificial intelligence.

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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