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Regen BioPharma Inc. (RGBP)

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(Majority-Owned Susidiary of BMSN)
Regen BioPharma, Inc., a subsidiary of Bio-Matrix Scientific Group, Inc. (OTCBB: BMSN)
is a biotechnology company focused on identifying undervalued regenerative medicine applications
in the stem cell space and rapidly advancing these technologies through pre-clinical andPhase I/ II clinical trials.
 

Stem Cell Medicine

 

"Our business model is to acquire and form companies around
undervalued assets identified froma highly focused analysis of issued
patents in regenerative medicinethat have demonstrated proof of concept"


 

Dr. Ichim is one of the leading authorities in the
world on stem cell biology.

"A STEM CELL INCUBATOR COMPANY"

With an emphasis on stem cell regenerative medicine
 



 

Our Business Model | Regen BioPharma
                   

our business model 

Regen BioPharma has assessed over 20,000 stem cell related issued patents, narrowed down to 2000 patents with commercial applicability, and further identified 30 patents available for licensing. The company seeks to inlicense, take the product to, and through clinical safety and efficacy "signal" and spin out technologies.

 



 

Our Approach | Regen BioPharma

 

 

      REGEN BIOPHARMA AVOIDS WASTE OF "ONE PRODUCT/ONE INFRASTRUCTURE" APPROACH

      In the "Conventional Model", stem cell companies are started with one basic technology, infrastructure is developed around that technology, then if the technology fails, significant resources are lost that have been used in the product-specific development

             Conventional Model
conventional model

             Regen BioPharma Model
regen model

 




Operational Plan
 

Month 1-2: Assembly of Team:
Regen intends to assemble a team of world-class leaders in the spheres of Technology, Intellectual Property assessment, valuation and Clinical development. Regen will seek to compile a team of Physician-Scientists with experience in the area of clinical trials for regenerative medicine/stem cell products, Regulatory experts who have successfully taken products through the FDA and corresponding agencies internationally, and Biotech Entrepreneurs who have track records of excellence in business formation and value optimization. -DONE
 
Month 1-4: Inlicensing of Intellectual Property:
The Company having already assessed over 20,000 issued patents and havingcompiled a shortlist of 30 targets; Regen will seek to execute licensing deals on an initial core of 3 technologies. Regen focuses onissued patents that have already passed preclinical studies but are not under clinical development. -DONE
 
Month 3-6: Interaction with Regulatory Agencies:
Regen intends to develop data packages for each of the technologies andinitiate interaction with Regulatory Agencies such as the FDA for initiation of trials.-DONE
 
Month 6-18: Clinical Implementation:
Regen intends to launch clinical trials with world-leading institutions to obtain human safety data and "signal" of therapeutic efficacy.  NEXT UP
 
Month 18-24: Exit:
It is intended that technologies "incubated" by Regen will be spun off either as separate companies, or sold to Large Pharma companies seeking to enhance their therapeutic pipeline.
 
 

 



"At present there exists a wealth of intellectual property that is 'collecting dust' in the corridors of Academia. Given the field of regenerative medicine and stem cell therapy is so young, and the business models are fuzzy at best in terms of valuation, we see this space as a unique opportunity for acceleration of clinical development/value optimization," said Bio-Matrix Chairman & CEO David Koos about its Regen BioPharma. "Valuations for stem cell companies that have passed the threshold of clinical safety, with signals of efficacy are astronomical. The $1.8 billion Mesoblast-Cephalon deal, as well as recent financings of private companies with as little as 3 patient data such as Promethera ($31 million) or Allocure with 16 patients ($23 million), is testimony to the extremely high valuations that are characteristic of this space."

 

 





Regen BioPharma Pipeline
 
HemaXellerate I™ FDA FILING
[Regen BioPharma filed an Investigational New Drug (IND) Application on February 5th, 2013.  Regen BioPharma has received approval from the FDA for the clinical protocol and the product manufacturing information for HemaXellerate I.  On May 9, 2014 Regen BioPharma submitted clarification on animal safety studies that the FDA requested.  On September 10, 2014 Regen BioPharma announced they were working hand-in-hand with FDA cellular specialists to finalize the animal safety studies in a GLP laboratory.]

HemaXellerate I is a cellular therapy designed to heal damaged bone marrow. HemaXellarate I utilizes a collection of cells harvested from the patient’s own adipose (fat) tissue to repair damaged bone marrow and stimulate production of blood cells . The initial application of HemaXellerate I will be the treatment of severe aplastic anemia, a rare and serious condition in which the bone marrow fails to make enough blood cells: red blood cells, white blood cells, and platelets. In practice, the physician is shipped a kit, which is used to collect adipose tissue. The tissue is sent to a processing facility, and a standardized cellular product is delivered in a ready-to-use manner for administration into the patient intravenously.

**The Company intends to seek Orphan Drug Designation under the Orphan Drug Act of 1983 from the US Food and Drug Administration for HemaXellerate I**

 
dCellVax™
[Regen BioPharma is currently in the preclinical stage of development for dCellVax and plans to file an Investigational New Drug Application in Fall 2014]

The dCellVax therapeutic product is based on extracting blood from patients, growing a specialized type of immune cell from the blood called the "dendritic cell" and then subsequently genetically modifying the dendritic cell to become resistant to cancer's immune suppressive activity. It is known that cancer modifies the immune system by producing proteins which result in immune suppression. One such protein which cancer stimulates is an enzyme, indolamine 2,3 deoxygenase (IDO), which cancer turns on in dendritic cells. While dendritic cells are usually immune stimulators, dendritic cells found in cancer patients suppress the immune system as a result of expressing IDO.

The dCellVax therapeutic product uses patents that Regen BioPharma has in-licensed from Dr. Wei-Ping Min coupled with patents in-licensed from Benitec BioPharma.  By utilizing methods covered in both of these patents Regen BioPharma hopes to develop an immune-based, non-toxic cancer treatment initially targeting breast cancer.

HemaXellerate II™
[Regen BioPharma is currently in the preclinical stage of development for HemaXellerate II]

HemaXellerate II is intended to be a universal donor endothelial cell based therapeutic and is intended to be manufactured by obtaining cells from a part of the placenta called the “vascular lobules”. The cells are processed and utilized for the purpose of stimulating bone marrow hematopoetic stem cell repair and proliferation. The mechanism of action for HemaXellerate II is similar to HemaXellerate I whereby the harvested and processed cells would produce growth factors which would mediate the therapeutic effects of the product.
 
Cancer Treatment via siRNA and Innate Immune System Stimulation     NEW 9/16/14!!!
[Regen BioPharma is currently in the preclinical stage of development for this treatment.  A patent application was filed for this novel cancer treatment on 9/16/2014]

This novel cancer treatment utilizes siRNA to stimulate the innate immune system in order to eradicate cancer.  Preclinical data from the company suggests that this treatment is effective in eradicating various cancers in humans such as lung, skin, glioma, and breast cancers.
 



Managent Team | Regen BioPharma
 



David R. Koos, PhD, DBA

Chairman and Chief Executive Officer

David Koos is the Founder, Chairman & CEO of Entest BioMedical Inc. Dr. Koos has over 26 years of investment banking and venture capital experience with a primary focus on fully reporting medical and biotechnology ventures. He holds a Ph.D. degree in Sociology and a Doctor of Business Administration in Finance. Additionally, he has authored or co-authored several peer reviewed journal articles primarily on biotechnology related subjects.





Thomas E. Ichim, PhD

Chief Scientific Officer and Board Member

Dr. Ichim is a seasoned biotechnology entrepreneur with a track record of scientific excellence. He has founded/co-founded several companies including Medvax Pharma Corp, ToleroTech Inc, bioRASI, and OncoMune LLC. Dr. Ichim is a member of Vendevia Group, an innovative venture development organization focused on optimization of value in biotechnology ventures. He is scientific advisor to Orcrist Bio, Entest, and MBVaX. To date he has published 91 peer-reviewed articles and is co-editor of the textbook “RNA Interference: From Bench to Clinical Translation”. Ichim is an ad-hoc editor and sits on several editorial boards. Ichim is inventor on over 30 patents and patent applications. CV

 



Advisory Board | Regen BioPharma

 



Weiping Min, M.D.

Dr. Min is Associate Professor, Department of Surgery at the University of Western Ontario. His clinical research is focused on using siRNA to inhibit disease modalities, including cancer and organ rejection. He earned graduate and medical degrees from Nanchang University Medical School and the Ph.D. degree from Kyushu University.




David James Graham White, M.D., Ph.D.

Dr. White is a member of the Surgery and Immunology faculty of The Schulic School of Medicine, University of Western Ontario. He is one of the leading experts on using regenerative medicine transplant procedures to treat pancreatic conditions, including diabetes. He is also the Chief Scientific Officer of Sernova Corp and was formerly a Therapeutic Area Head for Novartis. He received the B.Sc. degree from the University of Surrey and the M.D. and Ph.D. degrees from Cambridge University.

David A. Suhy, PhD

Dr Suhy has a long-term interest in development of shRNA based therapeutics to treat human diseases. He is in the unique position of seeing of directing the research of a RNAi-based therapeutic from its earliest inception until it reaches clinical trials. Development of a shRNA therapeutic against the Hepatitis C virus (HCV) was initiated at Avocel in 2003. Financial constraints caused the company to shutter research operations in 2006.Upon raising venture capital, Tacere Therapeutics acquired the rights to the HCV family of drugs and brought back Dr. Suhy to head the program. Partnered with Pfizer shortly thereafter, this drug is their first foray into gene therapy-based approaches and is the first shRNA program partnered with a large pharma. Given Pfizer’s lack of experience in both areas, Dr. Suhy has played a pivotal role in its development as Tacere has continued to lead the research efforts for advancement of this product into the clinic and has stood side-by-side with Pfizer through all of the regulatory agency meetings.
 



 

Current Business Partners | Regen BioPharma

 
                                                                
                                         
   

 
 


Regen BioPharma Share Structure:

UPDATE per latest 10-Q (as
of December 31, 2016)
145,412,605
shares issued and outstanding
UPDATE per latest 10-Q (as
of June 30, 2016)
134,548,138
shares issued and outstanding

 UPDATE = Checked Again 2/29/2016 = Regen Biopharma, Inc. only has 
127,253,938 common shares issued and outstanding. 
A/S = 500,000,000


RGBP Transfer Agent:
Securities Transfer Corporation

2591 Dallas Parkway Suite 102

Frisco, Texas 75034

Phone - 469-633-0101

FAX 469-633-0088
 

LATEST NEWS - 
Regen BioPharma Files Patent Application on New Therapy That Uses the "Innate" Immune System to Kill Cancer
http://www.otcmarkets.com/stock/RGBP/news

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PostSubject
#29674  Sticky Note Let's look objectively at both the science and cvinvestor 10/05/16 04:03:02 PM
#27909  Sticky Note ELI LILLY HAS RGBP SCREENING COMPOUNDS FOR THEM!!!!!!!!!!! gotinearly 06/30/16 09:23:49 AM
#32607   Wow! Still under 3 cents and still as SidVicious 06/15/18 04:44:05 PM
#32606   Wow. Huge volume on green. Jeremyan7 06/15/18 04:32:41 PM
#32605   Bring on the NEWS!!!! $$$$$ marchon 06/15/18 03:25:28 PM
#32601   There was no reason for Konman Koos to SidVicious 06/14/18 08:30:06 AM
#32600   Oh yeah, for sure, gotta string people along SanDiegoAlan 06/14/18 06:13:28 AM
#32599   Once the new shares settle, betting on news jeffshir 06/13/18 03:54:37 PM
#32598   Astute fans of science... Goldstrike 06/13/18 01:03:10 PM
#32597   Technicals on Watch For Regen Biopharma Inc ( RGBP ) jedijazz 06/13/18 11:32:19 AM
#32596   under the new law, results from tests in gotinearly 06/13/18 09:44:25 AM
#32595   Yet you have a buy order. Jeremyan7 06/13/18 08:37:11 AM
#32594   Wrong and false. HemaX from $RGBP wasn't able SidVicious 06/13/18 06:44:31 AM
#32593   Right to try...baby! gotinearly 06/12/18 08:50:32 PM
#32592   False. There are plenty of longs who invested Jeremyan7 06/12/18 01:59:49 PM
#32591   It is because Koos couldn't convince a living SidVicious 06/12/18 10:44:12 AM
#32589   Yes please. Why did Regen not follow through SanDiegoAlan 06/11/18 05:11:30 AM
#32588   why did regen not follow through and start SidVicious 06/10/18 08:49:01 AM
#32587   That is false. Jeremyan7 06/10/18 08:20:01 AM
#32586   Did you know that Regen abandoned not just SidVicious 06/08/18 04:49:36 PM
#32585   Patience and belief in the science WILL pay ChazzMaTazz 06/08/18 01:19:02 PM
#32584   You got that right Goldstrike. HUGE rewards marchon 06/07/18 02:57:36 PM
#32583   RGBP and astute fans of science will be Goldstrike 06/07/18 02:04:07 PM
#32582   I could not disagree with you more. marchon 06/07/18 11:52:25 AM
#32581   I'm sure "RBBP" as you wrote will be SidVicious 06/07/18 11:34:18 AM
#32580   Won't be long now before we hear some marchon 06/07/18 11:20:05 AM
#32578   Yeah, it failed. Didn't work. More vaporware from SidVicious 06/06/18 02:07:44 PM
#32574   I do not know what does it mean cool_lion 06/05/18 07:26:14 PM
#32572   Has HemaXellerate centsability4me 06/05/18 01:28:16 PM
#32571   News is coming soon. Hold your breath for SidVicious 06/05/18 08:27:00 AM
#32570   Could be... Goldstrike 06/04/18 07:54:22 PM
#32569   Bring on the NEWS!!!! marchon 06/04/18 02:36:19 PM
#32566   What a great message Jeremyan7 06/04/18 09:06:11 AM
#32565   Not to worry. Koos his finishing the touches SidVicious 06/04/18 08:21:50 AM
#32564   Has this been the longest dry spell between SanDiegoAlan 06/04/18 02:03:58 AM
#32563   I am all for the "right-to-try" legislation. scoobey-do 06/03/18 03:01:13 PM
#32562   When one continues to adhere to a failed SidVicious 06/03/18 11:39:40 AM
#32561   Wish you were serious about that. LOL !! archer111 06/02/18 10:48:09 PM
#32560   I'm a firm believer in the product centsability4me 06/02/18 12:01:43 PM
#32559   Past results determine future probability=logical fallacy. Goldstrike 06/02/18 10:18:34 AM
#32558   Gap up on Monday. Huge news to be SidVicious 06/02/18 12:47:22 AM
#32557   Even nostradumas can't predict the outcome. Anything Goldstrike 06/01/18 04:02:42 PM
#32556   Yee-haw the action was great this week. Git archer111 06/01/18 12:31:51 PM
#32555   The only thing that will break soon here ADVFN_franknstein 06/01/18 10:52:04 AM
#32554   When news breaks... Goldstrike 06/01/18 10:23:47 AM
#32553   I'm very bullish on the potential of Regen. marchon 06/01/18 10:14:58 AM
#32552   well , centsability4me 06/01/18 09:28:07 AM
#32551   The new law will help those that much SidVicious 06/01/18 07:23:39 AM
#32550   let's see what happens centsability4me 05/31/18 09:36:56 AM
#32549   hmmm, I wonder if Hema and dcellvax may gotinearly 05/31/18 09:30:02 AM
#32548   I agree but it won’t be about Regen. SidVicious 05/31/18 01:23:17 AM
#32547   BIG NEWS AHEAD!!!! marchon 05/30/18 10:06:23 AM
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