Concussion and traumatic brain injury (TBI) are significant health risks that lack modern therapeutic approaches beyond physical therapy and rehabilitation. The TBI incidence in the US is 1.5 to 1.7 million new cases per year and is estimated to cost $75 billion per year in the US only. Concussion is a growing issue within professional athletes including the NFL where significant health problems are derived from football-related concussion. Military service personnel and numerous others are also significantly impacted by TBI. We began development of stem cell activation technology and products during 2014 and expanded these activities in during 2015 to include treatment of concussion. We have developed patent-pending technology for treatment of neurological conditions through the activation of stem cells residing within the body. This is a process for administration of stem cell therapeutic benefit without stem cell transplants.
During 2015 we:
- Submitted and received exemption from IND filing from the FDA for our novel therapy opening opportunities for clinical testing.
- Filed patent applications entitled “Treatment of Neurological Conditions by Stem Cell Activation” in the United States, and other countries. Our patent includes several methods of stem cell activation & transplantation of activated stem cells together with diagnostic tools to assess the extent of stem cell activation and measurement of brain regeneration processes including neurogenesis, angiogenesis, neuroprotection and reduction of cell death/inflammation.
- Expanded our medical team to administer clinical trials.
- Added in-house analytical capacity to perform advanced biomarker profiling at high levels of efficiency and accuracy. Our diagnostic procedures include quantitative assessment of the extent of injury during TBI that we are correlating with TBI outcome.
Our plans for 2016 include addition of support services to assist concussion victims including advanced diagnostics, consultation and information regarding therapeutic options related to activation of stem cells within the brain to heal concussion-related injury. Also, we intend to implement Phase I clinical trials at various centers in the US and off-shore facilities as well. There are similar opportunities for advanced treatment of autism based on our proprietary method of stem cell activation. Our early stage trials in the EU support this approach and we plan to expand testing in the US during 2016. Our proprietary method of stem cell activation has application to other neurological conditions including stroke that is also under-treated and represents a large health care burden to society.
We expanded our research products during 2015 to include a variety of cells derived from adult stem cells including neural, cardiac and renal cells as well as an expanding line of cancer-associated fibroblasts. Revenues derived from our cell lines increased by 67% during 2015 as compared to 2014. Also, sales of our cell culture media expanded by 100% in 2015 compared to 2014 due to increased demand for our research products and especially to sales of clinical grade cell culture media to an international stem cell firm that uses our MSC-Gro™ media to expand adipose-derived MSCs prior to autologous transplantation to treat skeletal-muscular conditions including osteoarthritis.
Our cardiac, neural cells and renal cells derived through differentiation of human MSCs have application to cell-based assays for drug discovery and toxicity. Well-characterized human cells provide a platform for relevant toxicology & drug discovery screening as compared to animal cells. Furthermore, co-culture systems including human hepatocytes extend screening to include drug metabolites as well as the drug or drug candidate itself. We have ongoing collaborations underway to expand commercial opportunities for these products.
While 2015 yielded significant development of the Company’s ability to enter clinical markets, overall revenues decreased compared to 2014 by about 30% on an unaudited basis. The revenues gained from our EU partnership in 2014 diminished considerably during 2015 due primarily to decreased demand related to political unrest in eastern European.
In closing, 2015 saw further advances in the translation of our research products &technology into clinical products especially through sales of clinical grade MSC-Gro™ and expanded therapeutic options for concussion/TBI. Since the market size for advanced diagnostics & therapy of concussion/TBI is considerably larger than presently-targeted markets, we look forward to significantly increased revenues in 2016. We are now bringing our SEC filings current and also pursuing appropriate strategic combinations to accelerate growth.
James R. Musick, Ph.D.
President, Chairman of the Board & CEO
About Vitro Biopharma
Vitro Biopharma’s mission is “Harnessing the Power of Cells™” for the advancement of regenerative medicine to its full potential. Vitro Biopharma operates within a modern, GMP-compliant biotechnology manufacturing and R&D facility in Golden, Colorado. Vitro Biopharma manufactures and sells “Tools for Stem Cell and Drug Development™”, including human mesenchymal stem cells and derivatives, the MSC-Gro™ Brand of optimized media for MSC self-renewal and lineage-specific differentiation. Our cell lines also include cancer-associated fibroblasts (CAFs) and MSC-derived progenitor cells, including neural stem cells as well as a growing line of terminally differentiated cells: alpha-motor neurons, dopaminergic neurons, osteoblasts, chondrocytes, cardiomyocytes, proximal tubular epithelial cells, etc. A key target of these terminally differentiated cells is their use in cell-based assays of pre-clinical toxicology of drugs, drug candidates and drug combinations that may produce toxic effects on cardiac, neural or renal cells either as drugs or drug metabolites derived from interaction with specific cells such as liver cells. Vitro Biopharma is developing clinical products through various partnerships that include providing its clinical grade media for expansion of stem cells prior to transplantation and preliminary studies of stem cell activation in ASD & autoimmunity in central Europe.
Vitro Biopharma received the Frost and Sullivan Technology Innovation Leadership Award for the industry sector: Stem Cell Tools and Technology in North America, 2014.
Safe Harbor Statement
Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward looking statements are identified by words such as “intends,” “anticipates,” “believes,” “expects” and “hopes” and include, without limitation, statements regarding the Company’s plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company’s products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company’s filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward looking statements, whether as a result of new information, future events or otherwise.
Dr. James Musick
Chief Executive Officer
(303) 999-2130 Ext. 3
E-mail: [email protected]