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Tuesday
Nov162010

Entest BioMedical, Inc. (OTCBB: ENTB)

Entest BioMedical, Inc. (OTCBB: ENTB) is a biotechnology company focused on Veterinary Treatments that harness the animal’s reparative/ immunological mechanisms. Current market segments addressed by the Company’s treatments are:

  1. Canine immuno-therapeutic cancer vaccines (dogs),
  2. Expanded applications of immuno-therapeutic cancer vaccine for treating exotic species / zoo animals,
  3. Development of Stem Cell related therapies for treating other veterinary maladies.

Entest also plans to acquire veterinary clinics for the marketing and distribution of its veterinary therapies. These clinics would provide immediate revenue and cash flow to fund development of the Company’s veterinary therapies. Entest believes it has the ability to self-fund R&D though internally generated cash flow.

The Company is also currently developing a stem cell therapy treatment for Chronic Obstructive Pulmonary Disease (COPD) in thoroughbred race horses, and Entest hopes to eventually sell/license/partner with large pharmaceutical company to bring this product to the much larger human market. Stem Cell Research has been in the news this past election season, and Entest is NOT subject to the recent court decisions as the Company has adopted a veterinary first approach, believing once efficacy in animals is established and near term revenue achieved, viability in transitioning to human applications can be made via joint ventures and license agreements.

CEO David Koos on ENTB Overview

Part II of David Koos Video Interview

ENTB

ENTB Stock Profile @ OTCBB

  • Common Shares Outstanding: 19.5 M
  • Insiders & Affiliates: 79% ownership
  • Shares in the Float: N/A
  • Stock Price as of 11/8/10: $1.09
  • Market Capitalization: $21.2 M
  • Total Assets: $143 K as of 5/31/10
  • Equity: $(53K) as of 5/31/10

Investment Highlights:

  • Veterinary Biotechnology: Entest is a developer of advanced medical therapies that address sizeable and underserved markets with the potential for faster commercialization than human therapies;
  • Veterinary Oncology: Developing next generation veterinary oncology therapies with first product expected to hit the market within 8-12 month;
  • Veterinary Clinic Acquisitions: Entest plans to generate near-term revenue by consolidating profitable independent veterinary clinics at low market multiples, and has signed a Letter of Intent for their first clinic;
  • Ability to self-fund R&D though internally generated cash flow;
  • 7 patents pending;
  • The Entest BioMedical model of “Pets First” is historically an underserved market with a shorter path to regulatory approval;
  • Ability to generate near-term cash flow will help fund long- term human trials;
  • Management expects that successful clinical trials and commercialization may help attract interest from larger pharmaceutical companies for human development;
  • One in every four dogs will develop cancer during its lifetime; kills nearly half of pet dogs over the age ten;
  • $300 million veterinary cancer care market;
  • 49.7% of pet owners consider their pets to be family member;
  • Cancer in canines is stiil predominantly treated through surgical excision, chemotherapy and radiation which is highly invasive and can result in numerous unpleasant side-effects

COPD in humans is a progressive disease that makes it hard to breathe. "Progressive" means the disease gets worse over time. COPD can cause coughing that produces large amounts of mucus (a slimy substance), wheezing, shortness of breath, chest tightness, and other symptoms. Cigarette smoking is the leading cause of COPD. Most people who have COPD smoke or used to smoke. Long-term exposure to other lung irritants, such as air pollution, chemical fumes, or dust, also may contribute to COPD.

Capital Raise

 

Entest Veterinary Oncology Centers (VOC)

The goal of Entest is to become the "Cleveland Clinic of Veterinary Oncological Medicine" with revenue from established veterinary clinics. Entest management believes it has the ability to acquire small veterinary clinics for approximately 3 times net income, and the clinics acquired are intended to provide:

  • Platform for clinical studies and marketing new “Vet First” drugs;
  • Stable and predictable source of cash flow;
  • 12 month target is to acquire 5 to 10 clinics producing $3 million in revenue;
After acquiring Vet Clinics, Entest would establish the Veterinary Oncology Center where they would either buy or build out a VOC's. Entest vet clinics’s would refer an average of 750 canine cancer cases per year to Entest VOC's which normally get referred to outside VOC's. Management estimates the VOC's could generate:
  • 750 canine cancer cases @ $5,000 per dog = $3,750,000 in revenue;
  • Expected revenue from VOC servicing 4 VetC’s after 12 months = $15,000,000;
  • Establish national brand "Entest Veterinary Oncology Center";
  • Currently there are only 20 Veterinary Onology Centers nationwide.

Entest filed an 8-K on October 28, 2010 in reference to their first acquision. Entest signed a LOI with the McDonald Animal Hospital which operates a full service veterinary clinic in Santa Barbara, California. The clinic has operated at its current location for approximately 12 years and has generated revenues in excess of $650,000 for the 12 months ended December 31, 2009. There are additional clinics which have been identified in the McDonald Animal Hospital, Inc.  geographical area which the Company anticipates attempting to acquire and merge into McDonald Animal Hospital. Entest has identified seven additional clinics for sale which have been represented to the Company as historically having produced average annual revenue of $500,000 per clinic.

Products

ImenVax (TM) - Immuno-Therapeutic Cancer Treatment for Canines
In the encapsulated ImenVax™ device, a “cocktail” of integral immuno-catalysts are enclosed. From this ImenVax™ device immuno-catalysts are released which activate the patient’s immune cell. These immune cells carry on their normal course of activity by entering the lymph nodes and cause T-Cell adaptation. These T-Cells are what attack and kill the tumor.
The initial focus is treatment of cancer in canines, and the data from canine treatment is used to support eventual use in humans. This does not result in the deleterious side effects associated with traditional therapies. It utilizes an animal’s own tumor cells to induce the immune system to attack remaining tumor cells. These cells are extracted from subject and are loaded into implantable device(s). The encapsulated tumor cells shed antigens as cells atrophy to induce anti‐tumor response that kills the remaining tumor.
ImenVax receives a "Veterinarian exemption" during the regulatory process as the veterinarian-client-patient (VCP) relationship under 9 CFR 107.1 allows use without veterinary biologics license once the Company completes a 10 dog safety study.
Entest has developed a microsphere/nanoparticle‐based method which provides for local controlled release of immuno-catalysts. This design avoids the typical limited effects and adverse responses believed due to current short term delivery methods.
Regulatory Process ImenVax™ II
  • Veterinary Biologic regulated by USDA, under the 1913 Virus-Serum-Toxin Act;
  • Exempt from USDA licensing if manufactured and dispensed in accordance with the Veterinary Safe Harbor;
  • Veterinary Biologics Establishment License and Veterinary Biologics Product License are required for sales not exempted   under the Veterinary Safe Harbor.

Steps to Market ImenVax™ II

  • Complete clinical trials (up to 18 months);
  • Create sales through veterinary clinics (including ones acquired by Entest);
  • Obtain Veterinary Biologics Establishment License and Veterinary Biologics Product License ( up to 24 months)
  • Create wider distribution through sales not falling under “Veterinary Safe Harbor". ImenVax III is an “off the shelf” canine cancer vaccine that does not require tumor processing resulting in substantial cost savings. It treats existing tumors through stimulating immune responses to kill tumor cells directly and it indirectly kills tumor cells by cutting off the tumor blood supply. This blocks the ability of the tumor to suppress the immune system. In a published study by Dr. Thomas Ichim, ImenVax III demonstrated efficacy in treatment of mouse melanoma model.
The regulatory process for ImenVax™ III if for U.S. FDA approval of New Animal Drug Application since it is a combination product. Completed clinical trials are expected in 18 months with regulatory approval in 24 months. Entest will begin marketing immediately following regulatory approval, and will drive sales through veterinary clinics (including ones acquired by Entest).

 

 

ENT-576 (TM) - Stem Cell Therapy for Chronic Obstructive Pulmonary Disease (COPD)

ENT-576™ is a non-invasive therapy that mobilizes stem cells to the damaged areas of the lung to increase regenerative cell growth. After a patient is administered the FDA approved stem cell mobilizer, a “homing” device is used to attract these stem cells to the areas of the lungs affected by COPD. It is the presence of these stem cells that lung regeneration will occur.

Competition

Pfizer's PALLADIA is currently the only FDA approved veterinary drug for an oncology indication. Palladia (toceranib phosphate) is indicated for the treatment of Patnaik grade II or III, recurrent, cutaneous mast cell tumors with or without regional lymph node involvement in dogs.Potential Drawbacks to Palladia:

  • Kinase inhibitors lead to drug resistance: temporary solution as tumor mutates,
  • Targets pathways used by the body for healthy functions (kinases),
  • Partial responses that often result in relapse,
  • In mast cell tumors, 37-42% response rate, responses 12-18 weeks  (London et al. Clinical Cancer Research June 2009 15; 3856).
Oncept Merial is the only USDA approved biologic agent. Oncept is a transdermal  vaccine consisting of plasmid DNA encoding human tyrosinase protein.  The vaccine is indicated for the treatment of dogs with stage II or stage III oral melanoma.   The USDA has issued a conditional U.S. Veterinary Biological Product License for this therapeutic vaccine.
  • Potential Drawbacks to Oncept: Every melanoma is different, tyrosinase expression only in proportion of tumors, tumors then can lose expression;Requirement for gene gun. 
  • ImenVax™ Advantages: Managment believes ImenVax to be more effective than alternative treatments because as tumor mutates, the immune system also adapts (less possibility of resistance). ImenVax™ Tumor Vaccine reprograms immune system to only kill tumor cells (augmenting body’s own natural ability to fight cancer).

Entest BioMedical, Inc. Patent Applications

  • 61/262,081  Use of an Implantable Chamber Device for Induction of Immune Tolerance
  • 61/316,151  Method for Regeneration of Tissue with Mobilized Stem Cells
  • 61/319,214  Improving Quality of a Cellular Graft
  • 61/364,662  Method for Producing RBC from Immortalized Hematopoietic Lineage Cells
  • 61/352,227  Treatment of Human and Companion Animal Tumors
  • 61/367,521  Ex Vivo Treatments for Enhancing Anti-Tumor Effects of Autologous Vaccines
  • 61/371,815  Implantable Device for In Vivo Drug Delivery

Management 

David R. Koos, PhD, DBA – Chairman & CEO - David Koos has over 26 years of investment banking and venture capital experience with a primary focus on medical and biotechnology ventures. He has authored / co‐authored peer reviewed journal articles on biotechnology and related subjects including immunotherapy and COPD. David has a Ph.D. degree in Sociology and a Doctor of Business Administration in Finance.

Tammy L. Reynolds, CPA – Chief Financial Officer, Director - Tammy previously worked with Science Applications International Corporation (SAIC) dealing in mergers and acquisitions, financial reporting, fixed asset reconciliation, compliance and budgeting / forecasting. She is a former Senior Accountant with Bruno Skorheim, LLP where she worked with corporate clients in the areas of financial reporting and tax compliance. Tammy has a Bachelor of Science degree from San Diego State University in Business.

Feng Lin, MD, PhD – Director of Research - Dr. Feng Lin has a strong background in cell biology, cancer biology and therapy. He also has extensive experience with tissue imaging, and stem cell differentiation. Previously, Dr. Lin was a Senior Research Scientist, Research & Development with Inovio BC, San Diego and Postdoctoral Fellow in the Burnham Institute for Medical Research, La Jolla. He received his M.D. from Central South University Xiangya School of Medicine, Changsha, China, along with a M.S. Biochemistry & Molecular Biology and a Ph.D. Hematology & Physiology from the same institution. Dr. Lin's research work has been widely published in international scientific journals.

Scientific Advisors

Dr Gregory McDonald 

Dr. Gregory McDonald was added to the Scientific Advisory Board (SAB) in November 2010. The Company views this as a major step in moving forward with its immuno-therapeutic cancer vaccine for dogs, as Dr. McDonald is a practicing veterinarian and typically treats more than 700 dogs per year that have various forms of cancer. Dr. McDonald joins Entest with a strong background in both clinical and research aspects of cancer therapy. He has authored numerous publications on many aspects of veterinary medicine. He received his Doctor of Veterinary Medicine degree (DVM) from Ohio State University in 1979. Additionally, Dr. McDonald has been involved with veterinary applications of stem cell therapies, focusing on leading edge treatments for his patients.

Brian Koos, M.D., D.Phil.
Professor of Obstetrics and Gynecology
David Geffen School of Medicine
University of California at Los Angeles (UCLA)
 
Dr. Koos is an internationally-recognized clinician-scientist who has published in diverse areas ranging from gestational diabetes to circulating endothelial progenitor cells, to adenosine receptors.  To date he has 52 publications on Pubmed.  He is board certified in maternal and fetal medicine, as well as obstetrics and gynecology.  Dr. Koos has a clinical interest in Amniocentesis, Chorionic Villi Sampling, Clinical Trials, Early Amniocentesis, External Cephalic Version, Fetal Diagnostic, General Obstetrics, Genetics, High Risk Pregnancy, Maternal Fetal Medicine, Obstetrical Ultrasound, and Recurrent Pregnancy Loss.  He obtained his MD from Loma Linda University in 1974, his internship and residency were at the Harvard Affiliate Brigham and Women’s Hospital from 1975-1979.  He received a Doctor of Philosophy (D.Phil.) degree in 1982 from Oxford University and a Fellowship in Maternal-Fetal Medicine at USC from 1982-1983.
 
Ewa Carrier, M.D.
Associate Professor of Clinical Medicine and Pediatrics
University of California San Diego (UCSD)
Blood and Marrow Transplant Program 

Dr. Carrier’s research focuses on stem cell biology and its transplantation to cancer and organ repair. She focuses on the properties of pluripotent stem cells, including embryonic, fetal, mesenchymal and bone marrow stem cells, to generate differentiation protocols for the treatment of a variety of disorders. Clinically, Dr. Carrier works on multiple protocols related to stem cell transplant for cancers, such as leukemias, lymphomas and multiple myeloma as well as autoimmune diseases. She participates in the protocols within the NIH-sponsored Clinical Trial Network, and is a member of NIH-funded national consortium to treat autoimmune diseases with stem cells. 

Steven Josephs, Ph.D.
Chief Science Officer
Therinject LLC, San Diego, CA 

Dr. Josephs has 34 years of experience in research and clinical product development and production for biologics, gene therapy and medical devices. He has previously served as Director of Research and Development for Therapheresis, Inc., Head of Virology and Senior Research Scientist for Baxter Healthcare Corporation, and Director of Molecular Biology at Universal Biotechnology, Inc. where Dr. Josephs directed a group performing contract molecular biology services for government and private industry. Dr. Josephs has also served for the National Cancer Institute, where his duties included studies of the human T-cell leukemia virus as well as sequence determination and functional analyses of HIV. Dr. Josephs holds a B.A. in Chemistry, a Ph.D. in Chemistry and has been granted a Professional Certificate in Drug Development and an ADMET process certificate by the University of California, San Diego. He has also earned a Master of Science in Science Teaching.

Vladimir Bogin MD.
CEO
Cromos Pharma LLC
 
Dr. Bogin is currently the President and CEO of Cromos Pharma, a contract research organization that specializes in biopharmaceutical clinical outsourcing into areas with the most compelling environment for biopharmaceutical research: Russia and Eastern Europe. From 2008 to 2009 he was also the Director of Boehringer Ingelheim (a privately held pharmaceutical company) where he was in charge of the phase IV program for Dabigatran Etexilate. While first being published in 1995 on the subject of liver care, he has continuously spanned his focus and research capturing the therapies for HIV, liver failure, Budd-Chirari Syndrome, Nontropical Pyomyositis, donor transplantations, endometrial regenerative cells (ERC),  exosomes as a tumor immune escape mechanism, atrial fibrillation, COPD, and most recently left atrial enlargement. Dr. Bogin studied medicine at the Yale University School of Medicine and the University of Rochester School of Medicine and Dentistry.

 

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