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EX-32 - VITRO DIAGNOSTICS INCexhibit321010.htm
EX-31 - VITRO DIAGNOSTICS INCexhibit311010.htm



 



UNITED STATES

SECURITIES AND EXCHANGE COMMISSION


Washington, D.C. 20549


FORM 10-K

 

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended October 31, 2010

 

TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission file number 1-17378


VITRO DIAGNOSTICS, INC.

(Exact name of small business issuer as specified in its charter)


Nevada

 

84-1012042

(State or other jurisdiction of
incorporation or organization)

 

(I.R.S. Employer
Identification No.)

   

4621 Technology Drive, Golden, Colorado

 

80403

(Address of principal executive offices)

 

(Zip Code)

(303) 999-2130

(Issuer's telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Exchange Act:

Common Stock, $.001 par  value

(Title of each class)

Securities registered pursuant to Section 12(g) of the Exchange Act:  None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act

[___] Yes  [__x_] No

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act.    Yes [___]  No [_x_]

Note – Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Exchange Act from their obligations under those Sections.


Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes [ x ] No [  ]


Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  [___]

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company.  See definition of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act (check one):


Large accelerated filer [___]  Accelerated filer [__]  

Non-accelerated filer [___] (Do not check if a smaller reporting company)     

 Smaller reporting company  [   X  ]





Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
[___] Yes   [_x_]  No

State issuer's revenue for its most recent fiscal year:  $15,651.

The aggregate market value of the 11,900,294 shares of voting stock held by non-affiliates of the Company at January 28, 2011, calculated by taking the last sales price of the Company's common stock of $0.24 on October 19, 2010 was $2,856,071.

The number of shares outstanding of the issuer’s common equity as of January 28, 2011 was 18,379,985.


DOCUMENTS INCORPORATED BY REFERENCE


List hereunder the following documents if incorporated by reference and the Part of the Form 10-K (e.g., Part I, Part II, etc.) into which the document is incorporated: (1) Any annual report to security holders; (2) Any proxy or information statement; and (3) Any prospectus filed pursuant to Rule 424(b) or (c) under the Securities Act of 1933.  The listed documents should be clearly described for identification purposes


Exhibits


See Part IV, Item 15.

 








Additional Information


Descriptions in this report are qualified by reference to the contents of any contract, agreement or other document described herein and are not necessarily complete.  Reference is made to each such contract, agreement or document filed as an exhibit to this report, or incorporated herein by reference as permitted by regulations of the Securities and Exchange Commission.  (See "ITEM 15. EXHIBITS.")


Special Note Regarding Forward-Looking Statements


Please see the note under "ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION," for a description of special factors potentially affecting forward-looking statements included in this report.









PART I


ITEM 1.

 BUSINESS


History


Vitro Diagnostics, Inc. ("we" or the "Company") was incorporated under the laws of the State of Nevada on February 3, 1986.  From November 1990 to July 31, 2000, the Company was engaged in the development, manufacture and distribution of purified human antigens and the development of therapeutic products and related technologies.  In August 2000, the Company sold the assets used in the manufacture and sale of purified antigens for diagnostic applications.  Since 2000, the Company has developed its stem cell technology, expanded its patent portfolio and proprietary technology and cell lines for applications in stem cell research, cancer and diabetes.  Our operations are currently focused on development, manufacturing and distribution of stem cell products and related tools for use in research and drug discovery.


Our common stock is currently traded over the counter and quoted on the OTC Bulletin Board under the ticker symbol "VODG."  Because the company is no longer involved in the manufacture of diagnostic products, we operate under the name Vitro Biopharma which is registered by the Company as a trade mark in the state of Colorado.  The legal name of the Company is Vitro Diagnostics, Inc, doing business as (dba) Vitro Biopharma. We maintain a website at www.vitrobiopharma.com.


Narrative Description of Business


Our current focus is the development and commercialization of new products derived from our stem cell research.  We presently develop, manufacture and market products for use in research and related applications that do not require approval of the United States Food and Drug Administration ("FDA") prior to market introduction.  We have previously developed products and product candidates for treatment of infertility.  


The Company’s stem cell technology includes cell lines, supporting products and methods for generation and differentiation of stem cells into products with application to treatment of numerous diseases such as heart disease, stroke, Parkinson’s and Alzheimer’s disease.  While the Company’s technology represents a platform with broad application to several medical markets, the present business model focuses on the commercialization of products targeting niche markets in research and drug development that do not require FDA pre-market approval.  The Company launched its initial product line in 2009 and we are implementing our early stage marketing program.


The predominant focus of operations during the fiscal year ended October 31, 2010, which we refer to in this report as 2010, was to continue commercialization of a series of products targeting global markets in stem cell research, including products needed by most scientists engaged in stem cell research. These products are classified as Type I Medical Devices meaning that all usage is non-therapeutic and therefore do not require FDA pre-market approval.  Thus, access to our primary market is not dependent on FDA pre-market approval.  This is also a significant market segment that is growing rapidly especially as stem cell research shows promise in the treatment of diseases and conditions that were previously under-treated or untreatable and prior restrictions on federal support



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of stem cell research by the US government have been reduced.   During 2010, we added new products for quantitative testing of stem cells, thus expanding our product offering to include stem cells & their derivatives, media for stem cell growth and differentiation and now advanced testing of stem cell functionality.


We have also developed patented and patent-pending technology for use in stem cell research, drug development and therapeutic products for treatment of cancer and diabetes.  Modern stem cell technology is rapidly evolving towards commercialization and holds promise to revolutionize medicine by allowing replacement of any type of cell within the human body. Diseases characterized by cellular degeneration, including cardiovascular disease, diabetes, spinal cord injury and several other disorders may be cured through the development and commercialization of stem cell technology. In addition, cancer may be treated by stem cells that target selective destruction of cancer cells leading to novel therapies especially for poor prognosis conditions including pancreatic, lung and brain cancer. Thus the Company’s business plan involves commercialization of research products for broad usage in the stem cell research and drug development fields while at the same time developing specific proprietary technology with application to treatment of a broad range of diseases including diabetes and cancer. A primary focus is development of novel technology for the reprogramming of adult cells to the pluripotent state whereby such stem cells may be differentiated into any type of cell in the body.


Stem Cell Products for Research and Drug Development.


Based upon a desire to produce an infinite supply of human cells for various medical applications, the Company had previously developed technology for the immortalization of cells based upon genetic engineering.  More recently, the Company has shifted its efforts to the discovery, characterization and development of methods to maintain proliferation and to induce differentiation of stem cells.


The Company’s stem cell technology focuses on adult stem cells that are derived from human tissues without the necessity of the sacrifice of embryos as is needed to generate embryonic stem cells. New advances have shown that stem cells with properties comparable to embryonic stem cells including differentiation into any cell type may be derived from adult cells.  So-called induced pluripotent stem cells (iPS) may obviate the need for embryonic stem cells in the future and also eliminate the ethical controversy surrounding use of embryonic stem cells.  In the current fiscal year, the Company expanded its proprietary position with regard to iPS technology.


During 2009, Vitro introduced into commercial distribution specialized products to support stem cell research and drug development. This new product line called, “Tools for Stem Cell and Drug Development™” features novel products to support research involving mesenchymal stem cells (MSCs), induced pluripotent stem cells (iPS) and cancer research that specifically utilizes stem cells that preferentially migrate to cancer cells and facilitate their destruction.  This initial product line includes stem cells and related products to facilitate studies of transplantation into animals, migration to certain targets and differentiation into specific cell types. Our products include adult stem cells called mesenchymal stem cells that were derived from human umbilical cord blood.  We also provide fluorescent labeled stem cells, using a variety of specific labels to enhance utility, for various applications in stem cell and cancer research.  To our knowledge, we are one of the only companies to offer fluorescent-labeled human stem cells for sale.  We also provide cell culture media



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optimized to support growth of our stem cell products. Cell culture media is a complex solution of salts and nutrients designed to support growth of living human cells; each type of cell requires specific components within the media to optimize its growth.  We offer three different kinds of media which provides researchers with various options designed to support multiple research avenues.  Some of our stem cell culture media products are specifically intended for use in clinical trial studies of human stem cells.


Stem cell therapy has the potential to revolutionize treatment of many difficult–to-treat diseases.  Scientists are rapidly developing modern stem cell therapies through targeted R&D, clinical trials and regulatory studies with the goal of obtaining FDA marketing approval for clinical use.  Vitro now provides needed stem cell and drug development tools to support critical applications of stem cell technology to develop these advanced new treatments.  Vitro’s new tools provide vital components to advance stem cell research and drug development.  These products are classified as Type I Medical Devices meaning that all usage is non-therapeutic and therefore these products do not require FDA pre-market approval.


During 2010, the Company advanced its products, technology and business capacity to accelerate commercialization of its stem cell-based products. We acquired equipment to provide substantial expansion of stem cell medium manufacturing capacity.  The Company also completed research leading to a new method for generation of a new cell lines to enable expanded differentiation capacity of stem cells through reprogramming.


We co-sponsored a scientific symposium entitled “Stem Cell Differentiation and De-Differentiation” in February 2010.  The meeting was attended by over 500 domestic and international researchers representing leaders in the field of induced pluripotent stem cells (iPS) that allows the use of reprogrammed adult cells to achieve properties of embryonic stem cells including the ability to differentiate into any type of cell in the body. IPS technology is subject to intense research because it may allow generation of stem cells with the primary properties of embryonic stem cells without sacrifice or use of embryos, thus avoiding ethical and religious controversies surrounding the use of embryonic stem cells. Vitro scientists presented evidence at this meeting that expression of a single gene within adult stem cells resulted in expanded differentiation capacity comparable to embryonic stem cells.  Vitro’s technology involving single-factor reprogramming of adult stem cells is patent pending and may lead to expanded capacity of regenerative cellular medicine to treat injury and disease.  Our current intellectual property position with regard to iPS technology is described in greater detail elsewhere (See: “Patents and Other Intellectual Property Protection”)





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The Company’s growth strategy includes a strong core stem cell product and technology base including key patent positions coupled with alliances with similar companies engaged in operations that are synergistic with those of the Company.  This strategy was reflected in the establishment during 2010 of an alliance partnership with HemoGenix, Inc., a private company that has a 10-year operating history providing basic products and services needed to measure stem cell quality, potency and the effects of toxic agents.  This platform combined with Vitro’s product line and business plan focused on similar markets yields significant synergy that management believes will both enhance and enlarge the collective footprint and capture of our target market. The alliance was immediately focused on extension of the HemoGenix® platform stem cell analysis to mesenchymal stem cells through the merging of Vitro’s high performance stem cell media with HemoGenix®’ high performance stem cell assay kits.


Together with HemoGenix®, Inc. we launched new stem cell testing products at the International Society for Stem Cell Research annual meeting during 2010. The meeting was attended by over 3,000 participants from leading global academic institutions and commercial stem cell firms. The new products extend the well established HALO® assay platform for hematopoietic stem cells, which produce blood cells, to now include mesenchymal stem cells and induced pluripotent stem cells (iPS) as well.  These new high performance assays provide an ability to analyze stem cells for determination of quality, potency and response to toxic agents.  These new products are jointly manufactured by Vitro and HemoGenix®, Inc.  Vitro provides its specialized stem cell media and stem cells while HemoGenix® provides the LUMENESC™ and LumiSTEM™ ATP bioluminescent readout reagents and assay kit materials.  


In July 2010, Vitro entered into a contract with Mokshagundam Biotechnologies, a private research organization operated by a Stanford University professor, to develop cell culture medium for use in exploration of alternative food sources derived from stem cells. Cell culture media is a complex solution of salts and nutrients designed to support growth of living cells; each type of cell requires specific components within the media to optimize its growth. This project intends to utilize cultured marine invertebrates, nourished by medium only as a source of food for fish initially and possibly domestic animals.  The initial target organism has a well-defined stem cell system that results in regeneration of body parts following amputation, and continuous growth of the organism.  Vitro has now provided prototype media to support expansion of these marine organisms without requiring additional food sources.  A university research group is testing this medium to determine if it successfully maintains growth of the marine organism comparable to traditional feeding procedures. Successful development of such a product could lead to commercial production of food sources that rely on cell culture technology utilizing cell culture medium as the primary consumable product in the manufacturing process.  


Cellular immortality as reflected in continual stem cell proliferation (self-renewal) has potential to provide limitless cells that when differentiated to muscle, for example, become the primary ingredient of meat.  This reflects the basis of alternative food derived from stem cells that is now being developed. We intend to use our expertise in stem cell media development and commercial manufacture to provide appropriate media formulations to support this nascent technology.  Our VITROGROW™ Brand of stem cell media has demonstrated performance advantages to several name brand competing products in the growth of human adult stem cells and other properties such as real-time stability and is now utilized in high performance, bioluminescent test kits (Lumenesc-Hu™ and LumiSTEM™) for measuring the quality and potency of mesenchymal and induced-



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pluripotent stem cells.  We anticipate contributing to this emerging field and plan to further develop cellular immortalization procedures that may be crucial to economic production of stem cell-derived meat.  Vitro owns United States Patent number 6,458,593 B1 for the immortalization of pituitary cells and other proprietary technology regarding small molecules for immortalization of stem cells through activation of innate pathways that direct stem cell self-renewal which are described in greater detail below.


Drug discovery and development will benefit from stem cell technology advances that provide specific human stem cell-derived systems such as cardiac muscle.  These new cellular systems will provide more accurate and definitive preclinical toxicity and discovery programs aimed at decreasing drug development costs and increasing reliability of toxicity testing through early detection of potential safety issues.  In the latter part of 2010, the Company expanded its agreement with HemoGenix®, Inc. to include development of stem cell culture media and high performance toxicity assays to provide new cell-based tools for drug discovery and development.  The partners also agreed to align their respective quality programs to assure consistency.


An initial target of the expanded alliance is the development of a highly sensitive test for liver toxicity combining Vitro’s VITROGROW™ cell culture medium, human hepatocytes and the industrially-adopted bioluminescent readout system that has been developed and perfected by HemoGenix®, Inc.  The resultant product is anticipated to provide state-of-the-art testing for detecting liver toxicity and drug-induced liver injury, which are major obstacles in the development of safe drugs and biologics.  The partners plan validation studies followed by a series of unique bioluminescent-based products incorporating highly sensitive hepatocellular viability measurements together with detection of indicative biomarkers to support safe and effective new drugs and biologics.  Liver toxicity is a common problem of approved drugs that has led to recalls of high profile drugs such as troglitazone (Rezulin®) at extensive costs. The new products will be oriented towards early in vitro detection of liver toxicity, with an overall reduction in drug development cost for drug candidates.  The partners also intend to expand the LumiSTEM™ platform for other cell-specific toxicity assays such as heart, kidney and neuronal cells.


We intend to engage in the continuous development of a broad-based stem cell product and technology portfolio.  An immediate target is expansion of our VitroGrow™ Brand of stem cell media that has recently been shown to exhibit numerous competitive advantages including improved growth, cellular recovery and quality/potency together with vastly superior shelf-life. We intend to launch line extensions of the initial products that will enhance applications of our VitroGrow™ Brand media in research and clinical studies. Also, we are engaged in further development of our patent pending iPS technology to expand our intellectual property portfolio and enhance potential to out-license this technology, which is described in greater detail below (See “Patents and Other Intellectual Property Protection).  Our growth strategy may include acquisition of complementary technology and products.  We are presently aware of such acquisition targets and these include companies with complimentary product lines to those presently marketed or in development by the Company.  Also, we see potential for banking of an individual’s personal cells through appropriate cryogenic storage and monitoring technology, e.g., umbilical cord blood derived at birth, etc coupled with developments of processing technology to render such stem cells therapeutic in numerous ways throughout the lifetime of the donating patient.  Such developments could result in a revolution in medicine whereby banked cells can be used for personalized treatment of previously untreated or



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under treated disorders such as cancer, cardiovascular disease and stroke, diabetes, Alzheimer’s disease and spinal cord injury and any other disorder characterized by cell death or degradation.

 During the two fiscal years ended October 31, 2010 and 2009, the Company spent $176,258 and $169,538, respectively, for research and development.


Marketing and Distribution. To capture niche markets in stem cell research and drug development involves implementation of a multi-faceted marketing and sales initiative including various approaches such as: a strong internet marketing program, direct sales to end-users, identification and interaction with medical decision makers, selective use of distributors and in certain cases market generation efforts.  During 2010, the Company gained visibility and sales of its products through trade show attendance, expanded its marketing efforts through its alliance with HemoGenix®, Inc. and pursued distribution agreements with third parties perceived to offer expanded opportunities for distribution of the Company’s products.  Management is attempting to identify suitable partners to assist with product distribution and is presently engaged in discussions with global leaders in the distribution of life sciences products.  We consider this strategic approach most appropriate for our limited resources and current focus on product development and manufacturing. Modern marketing of stem cell products requires numerous skills & resources; there are several life science firms committed to these specialized capabilities.  Also, out-licensing of our stem cell-related intellectual property is an attractive option that we intend to pursue.  We also plan attendance at trade shows in 2011 to expand awareness of our products, technology and business opportunities.


Fertility Drug Candidates.  


The Company's previous manufacture and sale of purified antigens for diagnostic purposes resulted in the discovery of several products and technologies with potential application for therapeutic purposes.  An initial target was the pituitary hormone FSH and related products, since FSH has been used as a drug to treat infertility for the past 35 years.  The worldwide market for FSH and related products is approximately $1.3 billion per year.  However, in the recent past, the Company has utilized its limited resources for its stem cell research in an effort to establish financial support and revenue from product sales in the near term.  During 2010, we began negotiations for out-licensing of our patented technology related to FSH manufacture.  We anticipate establishment of a license agreement in the near future.  We may also provide the licensee with assistance in sourcing necessary raw materials, distribution of finished product and options to advanced stem-cell based methods for FSH production.  The Company's stem cell technology has potential application to generation of new cell lines for FSH production but this development would require additional R&D to demonstrate feasibility.


Description of Products and Product Candidates.  VITROPIN™ is highly purified FSH derived from the urine of post-menopausal women.  It is produced through the Company's patented technology that management believes represents a significant improvement over previous methods used to produce this product.  FSH has been used for over 40 years as a drug to treat infertility by inducing follicle development in the ovary.


The Company’s efforts to commercialize this product have not yet yielded a viable commercial product.  During 2010 the Company engaged in discussions regarding possible license of its patents related to manufacture of VITROPIN.  The U.S. Food and Drug Administration ("FDA") has not yet



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approved any of these products for commercial distribution within the United States.  The absence of FDA approval of this product may be an obstacle to sale of these assets.


Patents and Other Intellectual Property Protection


The Company has applied for and has obtained or is in the process of obtaining patents and other protection for its intellectual property in order to protect its investments.  The United States Patent and Trademark Office, or USPTO, issued the Company's first patent on November 23, 1999 (US Patent No. 5,990,288).  This invention was entitled "Methods for Purifying FSH" and details methods to manufacture highly purified FSH from various sources.  Management believes this invention represents a significant advance in the methods previously used to purify FSH and to produce therapeutic FSH.  The Company maintains this patent in an active status.


The Company was granted another patent by the USPTO (No. 6,458,593 B1) in 2002 entitled, "Immortalized Cell Lines and Methods of Making the Same."  This patent provides protection to the Company's technology related to immortalization of pituitary cells by genetic engineering.  This technology has potential application to the commercial production of FSH and other human pituitary hormones through immortalization of the cells of the pituitary gland that normally produce these hormones.  The Company maintains this patent in an active status.


In May, 2009 the Company was awarded United States Patent number 7,527,971 entitled, “Generation and Differentiation of Adult Stem Cells.” The patent provides protection to a specific cell line derived from human pancreatic tissues that gives rise to structures comparable to the Islets of Langerhans (beta islets).  These islets also synthesize and secrete insulin in response to elevated glucose levels, as do beta islets contained within pancreatic tissue.  Vitro has also developed a process for the commercial production its cell line-derived islets.  Furthermore, the Company previously obtained regulatory approval for an animal protocol to determine reversal of Type I diabetes, a critical step in the demonstration of efficacy.  Thus, the recently issued patent affords an exclusive proprietary position to the Company for a new cellular therapy to treat Type I diabetes. We are presently pursuing suitable partners for out-license opportunities.


During January 2009 & January 2010, the Company also filed provisional patent applications with the USPTO concerning use of its stem cell technology in cancer treatments, “MATERIALS AND METHODS USEFUL TO RESEARCH AND TREAT CANCER.” The Company has developed cell lines and compositions with potential application to the targeted eradication of cancer stem cells which may occur without significant side-effects. This application has now lapsed, but the Company may elect to advance development of this technology at a later point in time, with adequate resources.  We do not believe that our prior patent applications will limit our ability to gain future patent protection.


During December 2009 the Company filed a new United States patent application entitled “POU5-F1 EXPRESSION IN HUMAN MESENCHYMAL STEM CELLS”, based on the development of new technology related to generation of human induced pluripotent stem cells (iPS). IPS technology allows the use of reprogrammed adult cells to achieve properties of embryonic stem cells including the ability to differentiate into any type of cell in the body. IPS technology is subject to intense research because it may allow generation of stem cells with the primary properties of embryonic



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stem cells without sacrifice or use of embryos, thus avoiding ethical and religious controversies surrounding the use of embryonic stem cells.


Human iPS technology was originally reported in 2007 and evolved from increased understanding of the function of genetic factors controlling cellular fate and specific genes involved in the determination of “stemness”, i.e., those genes whose expression result in classic stem cell properties.  The original methods of iPS generation involved genetic engineering of human fibroblast (skin) cells to express elevated levels of four key genes. Vitro’s new technology involves elevated expression of a single gene called POU5-F1, which is considered a master regulatory element or gatekeeper of pluripotentiality.   Such cells may be used to eventually generate iPS without use of genetic engineering, which is a key goal necessary for clinical application of iPS technology.


The Company recently filed an additional international patent application entitled:  “Induced Pluripotent Stem Cells and Related Methods.” The application extends prior applications and describes a method for the generation of iPS cells from adult stem cells that completely avoids introduction of foreign DNA or RNA by using environmental factors only to induce pluripotency in adult stem cells.  This technology arose from the company’s demonstration that over-expression of just a single gene is required to induce pluripotent properties if adult stem cells are reprogrammed instead of somatic cells such as skin fibroblasts.  This finding has also been independently confirmed by other research groups.  From this discovery and the well-known, complex regulatory systems affecting expression of this gene, Vitro scientists determined methods for the inducing pluripotency through use of appropriate environmental factors. The Company believes that such technology has significant application to the field of regenerative medicine. Thus, the new patent allows generation of personalized, autologous stem cells from adult stem cell cells such as those present in bone marrow, blood and adipose tissue, etc that may differentiate into any cell type.  Such autologous stem cells may be used as substitutes for embryonic stem cells even though the cells are derived from adult stem cells.


There can be no assurance that the Company will succeed in obtaining any patent protection from its pending applications or that its issued patents would withstand legal challenges.

 

The Company's technology related to the production of cell culture media is protected as trade secret.  


The Company has established trademark claims to its VITROPIN™ product informally by publication.  This trademark is thus a common law mark that may be challenged by the owners of similar, established and registered marks that existed prior to initial publication by the Company, but no such challenge has occurred since original publication in 2000.  The Company also has the following trademarks registered in the State of Colorado: "Vitro Biopharma", "VITROCELL" and "Harnessing the Power of Cells"; these registrations expire on 7/2/2012, 11/25/2013 and 11/25/2013 respectively.  The Company has also established a common law mark for the phrase, “Tools for Stem Cell and Drug Development™, and VitroGrow™.”  The Company may elect to formally protect some or all of these marks through registration with the USPTO in the future.  However, we do not believe the absence of formal trademark protection will adversely affect our business.  The registered domain names owned by the company include vitrodiag.com, vitrogrow.com, vitrostemcells.com and common derivatives thereof.




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Some of the limitations of intellectual property protection are:


·

No assurance can be given that any patent will be issued or that the scope of any patent protection will exclude competitors or that any patent, if issued, will be held valid if subsequently challenged.

·

When we apply for registration of trademarks and registered domain names in an effort to protect them, we cannot be sure of the nature or extent of the protection afforded, since trademark registration does not assure any enforceable rights under many circumstances and there exists significant uncertainty surrounding legal protections of domain names.


·

There can be no assurance that any steps the Company takes in this regard will be adequate to deter misappropriation of its proprietary rights or independent third parties developing functionally equivalent products.  Despite precautions, unauthorized parties may attempt to engineer, reverse engineer, copy, or obtain and use the Company’s products or other information.


·

Although management believes that the Company’s products do not infringe on the intellectual property rights of others, there can be no assurance that an infringement claim will not be asserted in the future.  The prosecution or defense of any intellectual property litigation can be extremely expensive and would place a material burden upon the Company’s’ working capital.



Regulatory Approval


Drugs used to treat human infertility require registration with, and approval from, appropriate government authorities prior to sale.  In the United States, the U.S. Food and Drug Administration, or FDA, oversees approval of such products.  Since the FDA has previously approved FSH, the Company has determined that the appropriate means to gain VITROPIN™ approval is a type of abbreviated version of a new drug application.  The process of FDA can be time consuming and require millions of dollars in capital expenditures.  The Company has no plans to make such application in the foreseeable future.


Competition and Competitive Advantages


Products to support stem cell research are also produced and marketed by other companies with substantially greater resources than the Company.  Present suppliers of human stem cells and related products include In-Vitrogen, Millipore, Stem Cell Technologies and several other firms.  Most of these firms have long-standing histories and significant financial resources. Recent studies by the Company of our VitroGrow™ Brand of stem cell media have provided results showing performance advantages of VitroGrow™ compared to major competitors including In-Vitrogen, Lonza and Stem Cell Technologies, Inc.  These results will be described in greater detail in subsequent reports since this work was completed in fiscal year 2011.  However, management considers superior competitive advantages to be a key factor in gaining market penetration and plans



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to further publicize these results to gain maximum effect on its ongoing commercialization efforts.  Several other independent third parties have also provided corroborating evidence showing performance advantages of the Company’s VitroGrow™ Brand of stem cell media in a variety of applications extending the commercial utility of these products.


We believe our products for use in stem cell and cancer research have competitive features unlike other marketed products.  We may be the only commercial source of fluorescent-labeled stem cells.  As we develop additional media products, we anticipate comparable competitive advantages since these formulations are based upon the original VitroGrow™ low-serum formulation. We also have unique methods for the shipment and customs clearance of our stem cells, which is especially important to offshore customers. Our patented cell lines are unique and solely owned by the Company. Recent DNA “finger print” analysis by a third party laboratory shows that the probability of an identical match to one of our cell lines is 1/1017 or one chance in 100 quadrillion.  Thus, the chance of replication of our patented cell lines is extremely remote as is our possible infringement of a patent held by another company. Given that effective therapies can be derived from these cell lines such as cell-mediated treatment of cancer, we believe these products will not infringe on others and will become valuable commodities in stem cell approaches to cancer treatment and management.  We further intend to patent additional products that we may develop providing exclusive use of such products to the Company and its licensees.


The Company faces competition from a number of larger, well-established entities in the area of fertility treatment.  Serono-Merck controls approximately 50% of the worldwide FSH market.  The Organon Biosciences, now owned by Schering Plough, has the majority of the remaining market and Ferring Pharmaceuticals has the remaining share of the market.  These manufacturers have diversified product lines including impure LH/FSH combination drugs, purified urinary and recombinant FSH.


Employees


The Company presently has one full time employee, the Company's President, CEO, Chairman, and CFO.  This individual provides primary support of technical operations, including research and development, production of the current stem cell product line and all administrative functions of the Company.  The Company's Vice President provides the Company with periodic consultation related to the achievement of its business objectives.  


During 2007, the Company entered into a consulting agreement with Superior Toxicology and Wellness, a consulting firm located in Superior Colorado.  Superior provides the Company with assistance in business development with an emphasis on marketing and sales of the Company’s stem cell products to the pharmaceutical manufacturing sector.


The Company also utilizes the services of other consultants and advisors to supplement the resources of its employee from time to time.  These include scientific and laboratory personnel, accountants, auditors and attorneys.  Some of these positions, especially those of a technical nature, may be converted to employment if and when the Company's business requires and resources permit.




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ITEM 1B

UNRESOLVED STAFF COMMENTS


None.



ITEM 2.

DESCRIPTION OF PROPERTY


The Company owns no real property.  During mid-2008 the Company moved into an expanded facility located at 4621 Technology Drive, Golden Colorado.  The Company leases 1200 square feet and has access to common areas.  The lease began July 1, 2008 and has a five-year term.     


ITEM 3.

LEGAL PROCEEDINGS


There are currently no legal matters or other regulatory proceedings pending or, to the knowledge of our management, threatened that involve the Company or its property or any of the principal shareholders, officers or directors in their capacities as such.


ITEM 4.

SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS


There were no matters submitted to a vote of security holders during the fourth quarter of the fiscal year covered by this Report.




11







PART II


ITEM 5.

MARKET FOR REGISTRANT’S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS


The following information sets forth the high and low bid price for the Company's common stock for each quarter within the last two fiscal years.  The Company's common stock is traded over-the-counter and quoted on the OTC Bulletin Board.  The following information was obtained from Yahoo.com.  The prices set forth below do not include retail mark-ups, mark-downs or commissions, and may not represent prices at which actual transactions occurred.


Fiscal Quarter Ended

High

Low

2010

  

January 31

$0.37

$0.14

April 30

0.30

0.16

July 31

0.25

0.06

October 31

0.23

0.11

2009

  

January 31

$0.28

$0.02

April 30

0.30

0.10

July 31

0.44

0.17

October 31

0.42

0.15

 



 




Rules Restricting Trading Activity in our Stock


The Company's common stock is presently classified as a "penny stock" under existing securities laws since the stock is not listed on a national securities exchange and trades below $5 per share and since the Company does not meet the minimum financial requirements established by these rules.  Since our stock is characterized as a penny stock, our stock is subject to rules adopted by the SEC regulating broker-dealer practices in connection with transactions in penny stocks.  The broker or dealer proposing to effect a transaction in a penny stock must furnish his customer a document containing information prescribed by the SEC and obtain from the customer an executed acknowledgment of receipt of that document.  The broker or dealer must also provide the customer with pricing information regarding the security prior to the transaction and with the written confirmation of the transaction.  The broker or dealer must also disclose the aggregate amount of any compensation received or receivable by him in connection with such transaction prior to consummating the transaction and with the written confirmation of the trade.  The broker or dealer must also send an account statement to each customer for which he has executed a transaction in a penny stock each month in which such security is held for the customer’s account.  The existence of these rules may have an effect on the price of our stock, and the willingness of certain brokers to effect transactions in our stock.




12





Holders of our Common Stock


As of January 18, 2011, the Company had approximately 1937 shareholders of record, not including persons who hold their shares in "street name".


Dividends


The Company has paid no dividends since inception and it is not anticipated that any will be paid in the foreseeable future.  The payment of dividends in the future is dependent on the generation of revenue and profit, and the discretion of the Board of Directors based upon such matters as the Company's capital needs and costs of obtaining capital from outside sources.


Recent Sales of Unregistered Securities


1.

     The following sets forth the information required by Item 701 of Regulation S-K with respect to the unregistered sales of equity securities by Vitro Diagnostics, Inc., a Nevada corporation (the "Company"), completed on September 17, 2010:


a.

On September 17, 2010, the Company agreed to issue, an aggregate of 300,000 shares of common stock, $.05 par value (the “Common Stock” or “Shares”) at a purchase price of $0.10 per share (the “Securities”).  


b.

The shares were issued to two persons, each of whom qualified as an  "accredited investor" within the meaning of Rule 501(a) of Regulation D under the Securities Act of 1933 as amended (the "Securities Act").    The shares issued were “restricted securities” under the Securities Act.


c.

The Company paid no fees or commissions in connection with the issuance of the Shares.

 

d.

The sale of the Securities was undertaken without registration under the Securities Act in reliance upon an exemption from the registration requirements of the Securities Act set forth in Sections 4(2) thereunder.  The investors each qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D.  In addition, the Securities, which were taken for investment purposes and not for resale, were subject to restrictions on transfer.  We did not engage in any public advertising or general solicitation in connection with this transaction, and we provided the investors with disclosure of all aspects of our business, including providing the investor with our reports filed with the Securities and Exchange Commission and other financial, business and corporate information.  Based on our investigation, we believed that the accredited investors obtained all information regarding the Company that they requested, received answers to all questions posed and otherwise understood the risks of accepting our Securities for investment purposes.


e.

Not applicable.




13





f.

The proceeds received were used for working capital to support product marketing.



2.

The following sets forth the information required by Item 701 of Regulation S-K with respect to the unregistered sales of equity securities by Vitro Diagnostics, Inc., a Nevada corporation (the "Company"), completed on September 8, 2010:


a.

Effective September 8, 2010, the Company entered into an Agreement to Convert Debt with Clifford L. Neuman, PC, the Company’s legal counsel (“Neuman”) pursuant to which Neuman agreed to accept, and the Company agreed to issue, 71,429 shares of common stock, $.001 par value (the “Common Stock” or “Shares”) in satisfaction of $10,000 in unpaid fees for his services as legal counsel.  


b.

The shares issued upon conversion of the debt were issued exclusively to one person who qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D under the Securities Act of 1933 as amended (the "Securities Act").    The shares issued upon conversion of the debt were “restricted securities” under the Securities Act.


c.

The Company paid no fees or commissions in connection with the issuance of the Shares.


d.

The sale of the Securities was undertaken without registration under the Securities Act in reliance upon an exemption from the registration requirements of the Securities Act set forth in Sections 4(2) thereunder.  The investor qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D.  In addition, the Securities, which were taken for investment purposes and not for resale, were subject to restrictions on transfer.  We did not engage in any public advertising or general solicitation in connection with this transaction, and we provided the investors with disclosure of all aspects of our business, including providing the investor with our reports filed with the Securities and Exchange Commission and other financial, business and corporate information.  Based on our investigation, we believe that the accredited investor obtained all information regarding the Company that he requested, received answers to all questions posed and otherwise understood the risks of accepting our Securities for investment purposes.


e.

Not applicable.


f.

There were no proceeds as a result of the conversion of debt.


3.

The following sets forth the information required by Item 701 of Regulation S-K with respect to the unregistered sales of equity securities by Vitro Diagnostics, Inc., a Nevada corporation (the "Company"), completed on September 8, 2010:


a.

Effective September 8, 2010, the Company entered into an Agreement to Convert Debt with Todd Huss (“Huss”) pursuant to which Huss agreed to accept, and the Company agreed to issue, 59,286 shares of common stock, $.001 par value (the “Common Stock” or “Shares”) in satisfaction of $8,300 in unpaid fees for his services rendered.   


b.

The shares issued upon conversion of the debt were issued exclusively to one person



14





who qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D under the Securities Act of 1933 as amended (the "Securities Act").    The shares issued upon conversion of the debt were “restricted securities” under the Securities Act.


c.

The Company paid no fees or commissions in connection with the issuance of the Shares.


d.

The sale of the Securities was undertaken without registration under the Securities Act in reliance upon an exemption from the registration requirements of the Securities Act set forth in Sections 4(2) thereunder.  The investor qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D.  In addition, the Securities, which were taken for investment purposes and not for resale, were subject to restrictions on transfer.  We did not engage in any public advertising or general solicitation in connection with this transaction, and we provided the investors with disclosure of all aspects of our business, including providing the investor with our reports filed with the Securities and Exchange Commission and other financial, business and corporate information.  Based on our investigation, we believe that the accredited investor obtained all information regarding the Company that he requested, received answers to all questions posed and otherwise understood the risks of accepting our Securities for investment purposes.


e.

Not applicable.


f.

There were no proceeds as a result of the conversion of debt.


4.  The following sets forth the information required by Item 701 of Regulation S-K with respect to the unregistered sales of equity securities by Vitro Diagnostics, Inc., a Nevada corporation (the "Company"), completed on February 18, 2010:



a.

On February 18, 2010, the Company awarded an aggregate of 148,936 shares of common stock, $.001 par value (the “Common Stock” or “Shares”) valued at $0.235 per share in consideration of services provided by the Company’s directors.  


b.

The shares were issued to two persons, each of whom qualified as an  "accredited investor" within the meaning of Rule 501(a) of Regulation D under the Securities Act of 1933 as amended (the "Securities Act").  The shares issued were “restricted securities” under the Securities Act.


c.

The Company paid no fees or commissions in connection with the issuance of the Shares.

 

d.

The sale of the Securities was undertaken without registration under the Securities Act in reliance upon an exemption from the registration requirements of the Securities Act set forth in Sections 4(2) thereunder.  The investors each qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D.  In addition, the Securities, which were taken for investment purposes and not for resale, were subject to restrictions on transfer.  We did not engage in any public advertising or general solicitation in connection with this transaction, and we provided the investors with disclosure of all aspects of our business, including providing the investor with our



15





reports filed with the Securities and Exchange Commission and other financial, business and corporate information.  Based on our investigation, we believed that the accredited investors obtained all information regarding the Company that they requested, received answers to all questions posed and otherwise understood the risks of accepting our Securities for investment purposes.


e.

Not applicable.


f.

Not applicable.



5.

   The following sets forth the information required by Item 701 of Regulation S-K with respect to the unregistered sales of equity securities by Vitro Diagnostics, Inc., a Nevada corporation (the "Company"), completed on December 29, 2009:


a.

On December 29, 2009, the Company agreed to issue, an aggregate of 500,000 shares of common stock, $.05 par value (the “Common Stock” or “Shares”) and an aggregate of 500,000 warrants exercisable for 12 months to purchase one additional share of Common Stock at a purchase price of $0.175 per share (the “Securities”) in consideration of an initial investment of $87,500, with an additional $87,500 should the warrants be exercised.


b.

The shares were issued to three persons, each of whom qualified as an  "accredited investor" within the meaning of Rule 501(a) of Regulation D under the Securities Act of 1933 as amended (the "Securities Act").    The shares issued were “restricted securities” under the Securities Act.


c.

The Company paid no fees or commissions in connection with the issuance of the Shares.

 

d.

The sale of the Securities was undertaken without registration under the Securities Act in reliance upon an exemption from the registration requirements of the Securities Act set forth in Sections 4(2) thereunder.  The investors each qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D.  In addition, the Securities, which were taken for investment purposes and not for resale, were subject to restrictions on transfer.  We did not engage in any public advertising or general solicitation in connection with this transaction, and we provided the investors with disclosure of all aspects of our business, including providing the investor with our reports filed with the Securities and Exchange Commission and other financial, business and corporate information.  Based on our investigation, we believed that the accredited investors obtained all information regarding the Company that they requested, received answers to all questions posed and otherwise understood the risks of accepting our Securities for investment purposes.


e.

Not applicable.




16





f.

The proceeds received were used for working capital.


6.

The following sets forth the information required by Item 701 of Regulation S-K with respect to the unregistered sales of equity securities by Vitro Diagnostics, Inc., a Nevada corporation (the "Company"), completed on November 2, 2009:


a.        On November 2, 2009, the Company agreed to issue 4,546 shares of common stock, $.05 par value (the "Common Stock" or "Shares") in consideration of $1,000 in consultant services.

b.        The shares were issued to one person, who qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D under the Securities Act of 1933 as amended (the "Securities Act").    The shares to be issued will be "restricted securities" under the Securities Act.

c.        The Company paid no fees or commissions in connection with the issuance of the Shares.

d.        The sale of the Securities was undertaken without registration under the Securities Act in reliance upon an exemption from the registration requirements of the Securities Act set forth in Sections 4(2) thereunder. The investor qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D. In addition, the Securities, which were taken for investment purposes and not for resale, were subject to restrictions on transfer. We did not engage in any public advertising or general solicitation in connection with this transaction, and we provided the investor with disclosure of all aspects of our business, including providing the investor with our reports filed with the Securities and Exchange Commission and other financial, business and corporate information. Based on our investigation, we believed that the accredited investor obtained all information regarding the Company that it requested, received answers to all questions posed and otherwise understood the risks of accepting our Securities for investment purposes.

e.        Not applicable.

f.        The proceeds received are to be used for working capital.


7.

The following sets forth the information required by Item 701 of Regulation S-K with respect to the unregistered sales of equity securities by Vitro Diagnostics, Inc., a Nevada corporation (the "Company"), completed on October 29, 2009:


a.        On October 29, 2009, the Company agreed to issue 36,216 shares of common stock, $.05 par value (the "Common Stock" or "Shares") in consideration of $6,700 in services.

b.        The shares were issued to one person, who qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D under the Securities Act of 1933 as amended (the "Securities Act").    The shares to be issued will be "restricted securities" under the Securities Act.

c.        The Company paid no fees or commissions in connection with the issuance of the Shares.

d.        The sale of the Securities was undertaken without registration under the Securities Act in reliance upon an exemption from the registration requirements of the Securities Act set forth in Sections 4(2) thereunder. The investor qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D. In addition, the Securities, which were taken for investment purposes and not for resale, were subject to restrictions on transfer. We did not engage in any public advertising or general solicitation in connection with this transaction, and we provided the investor



17





with disclosure of all aspects of our business, including providing the investor with our reports filed with the Securities and Exchange Commission and other financial, business and corporate information. Based on our investigation, we believed that the accredited investor obtained all information regarding the Company that it requested, received answers to all questions posed and otherwise understood the risks of accepting our Securities for investment purposes.

e.        Not applicable.

f.        The proceeds received are to be used for working capital.


8.

The following sets forth the information required by Item 701 of Regulation S-K with respect to the unregistered sales of equity securities by Vitro Diagnostics, Inc., a Nevada corporation (the "Company"), completed on September 25, 2009:


a.        On September 25, 2009, the Company agreed to issue 3,334 shares of common stock, $.05 par value (the "Common Stock" or "Shares") in consideration of $1,000 in consultant services.

b.        The shares were issued to one person, who qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D under the Securities Act of 1933 as amended (the "Securities Act").    The shares to be issued will be "restricted securities" under the Securities Act.

c.        The Company paid no fees or commissions in connection with the issuance of the Shares.

d.        The sale of the Securities was undertaken without registration under the Securities Act in reliance upon an exemption from the registration requirements of the Securities Act set forth in Sections 4(2) thereunder. The investor qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D. In addition, the Securities, which were taken for investment purposes and not for resale, were subject to restrictions on transfer. We did not engage in any public advertising or general solicitation in connection with this transaction, and we provided the investor with disclosure of all aspects of our business, including providing the investor with our reports filed with the Securities and Exchange Commission and other financial, business and corporate information. Based on our investigation, we believed that the accredited investor obtained all information regarding the Company that it requested, received answers to all questions posed and otherwise understood the risks of accepting our Securities for investment purposes.

e.        Not applicable.

f.        The proceeds received are to be used for working capital.


9.

The following sets forth the information required by Item 701 of Regulation S-K with respect to the unregistered sales of equity securities by Vitro Diagnostics, Inc., a Nevada corporation (the "Company"), completed on February 17, 2009:


a.        On February 17, 2009, the Company agreed to issue 300,000 shares of common stock, $.05 par value (the "Common Stock" or "Shares") in consideration of $15,000.

b.        The shares were issued to one person,  who qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D under the Securities Act of 1933 as amended (the "Securities Act").    The shares to be issued will be "restricted securities" under the Securities Act.



18





c.        The Company paid no fees or commissions in connection with the issuance of the Shares.

d.        The sale of the Securities was undertaken without registration under the Securities Act in reliance upon an exemption from the registration requirements of the Securities Act set forth in Sections 4(2) thereunder. The investor qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D. In addition, the Securities, which were taken for investment purposes and not for resale, were subject to restrictions on transfer. We did not engage in any public advertising or general solicitation in connection with this transaction, and we provided the investors with disclosure of all aspects of our business, including providing the investor with our reports filed with the Securities and Exchange Commission and other financial, business and corporate information. Based on our investigation, we believed that the accredited investor obtained all information regarding the Company that it requested, received answers to all questions posed and otherwise understood the risks of accepting our Securities for investment purposes.

e.        Not applicable.

f.        The proceeds received are to be used for working capital.


10.

The following sets forth the information required by Item 701 of Regulation S-K with respect to the unregistered sales of equity securities by Vitro Diagnostics, Inc., a Nevada corporation (the "Company"), completed on February 16, 2009:


a.        On February 16, 2009, the Company agreed to issue 12,000 shares of common stock, $.05 par value (the "Common Stock" or "Shares") for advisor services.

b.        The shares are to be issued to one person, who qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D under the Securities Act of 1933 as amended (the "Securities Act").    The shares to be issued will be "restricted securities" under the Securities Act.

c.        The Company paid no fees or commissions in connection with the issuance of the Shares.

d.        The sale of the Securities was undertaken without registration under the Securities Act in reliance upon an exemption from the registration requirements of the Securities Act set forth in Sections 4(2) thereunder. The investor qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D. In addition, the Securities, which were taken for investment purposes and not for resale, were subject to restrictions on transfer. We did not engage in any public advertising or general solicitation in connection with this transaction, and we provided the investor with disclosure of all aspects of our business, including providing the investor with our reports filed with the Securities and Exchange Commission and other financial, business and corporate information. Based on our investigation, we believed that the accredited investor obtained all information regarding the Company that he requested, received answers to all questions posed and otherwise understood the risks of accepting our Securities for investment purposes.

e.        Not applicable.

f.        Not applicable.




19





11.

The following sets forth the information required by Item 701 of Regulation S-K with respect to the unregistered sales of equity securities by Vitro Diagnostics, Inc., a Nevada corporation (the "Company"), completed on February 12, 2009:


a.        On February 12, 2009, the Company agreed to issue 250,000 shares of common stock, $.05 par value (the "Common Stock" or "Shares") valued at $0.10 per share for total consideration of $25,000.

b.        The shares were issued to one person, who qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D under the Securities Act of 1933 as amended (the "Securities Act").    The shares issued were "restricted securities" under the Securities Act.

c.        The Company paid no fees or commissions in connection with the issuance of the Shares.

d.        The sale of the Securities was undertaken without registration under the Securities Act in reliance upon an exemption from the registration requirements of the Securities Act set forth in Sections 4(2) thereunder. The investor qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D. In addition, the Securities, which were taken for investment purposes and not for resale, were subject to restrictions on transfer. We did not engage in any public advertising or general solicitation in connection with this transaction, and we provided the investor with disclosure of all aspects of our business, including providing the investor with our reports filed with the Securities and Exchange Commission and other financial, business and corporate information. Based on our investigation, we believed that the accredited investor obtained all information regarding the Company that he requested, received answers to all questions posed and otherwise understood the risks of accepting our Securities for investment purposes.

e.        Not applicable.

f.        The proceeds received were used for working capital.


12.

The following sets forth the information required by Item 701 of Regulation S-K with respect to the unregistered sales of equity securities by Vitro Diagnostics, Inc., a Nevada corporation (the "Company"), completed on November 12, 2008:


a.        On November 12, 2008, the Company sold to one executive officer an aggregate of 226,667 shares of common stock, $.05 par value (the "Common Stock" or "Shares") valued at $0.0375 per share for total consideration of $8,500.

b.        The shares were issued to one person who serves as an executive officer and member of the board of directors and who qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D under the Securities Act of 1933 as amended (the "Securities Act").    The shares issued were "restricted securities" under the Securities Act.

c.        The Company paid no fees or commissions in connection with the issuance of the Shares.

d.        The sale of the Securities was undertaken without registration under the Securities Act in reliance upon an exemption from the registration requirements of the Securities Act set forth in Sections 4(2) thereunder. The investor qualified as an "accredited investor" within the meaning of Rule 501(a) of Regulation D. In addition, the Securities, which were taken for investment purposes and not for resale, were subject to restrictions on transfer. We did not engage in any public



20





advertising or general solicitation in connection with this transaction, and we provided the investor with disclosure of all aspects of our business, including providing the investor with our reports filed with the Securities and Exchange Commission and other financial, business and corporate information. Based on our investigation, we believed that the accredited investor obtained all information regarding the Company that he requested, received answers to all questions posed and otherwise understood the risks of accepting our Securities for investment purposes.

e.        Not applicable.

f.        The proceeds received were used for working capital.







21





ITEM 6.

SELECTED FINANCIAL DATA


We have set forth below certain selected financial data.  The information has been derived from the financial statements, financial information and notes thereto included elsewhere in this report.


Statement of Operations Data:

 

Year Ended Oct.,

31, 2010

 

Year Ended Oct.

31, 2009

Total revenues

 

$        15,651

 

$          6,103

Operating expenses

 

$      269,675

 

$      238,957

Net loss

 

$    (257,132)

 

$    (271,081)

Basic and diluted loss per common share

 

$          (0.01)

 

$          (0.02)

Shares used in computing basic and diluted loss per share

 

17,869,924

 

16,658,163

     

Balance Sheet Data:

 

Oct. 31, 2010

 

Oct. 31, 2009

Working capital deficit

 

$  (1,654,888)

 

$    (1,492,663)

Total assets

 

$       116,080

 

$         101,450

Total liabilities

 

$    1,701,820

 

$      1,538,904

Stockholders' deficit

 

$  (1,585,740)

 

$    (1,437,454)




22






ITEM 7.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION


Introduction


The following discussion and analysis summarizes the financial condition of the Company at fiscal year end October 31, 2010, and compares that to its financial condition at October 31, 2009.  It also analyzes our results of operation for the year ended October 31, 2010 and compares those results to the year ended October 31, 2009.  This discussion and analysis should be read in conjunction with our financial statements and notes appearing elsewhere in this report.  The discussion should also be read with the cautionary statements and risk factors appearing at the end of this section.


Overview


The Company raised outside capital from a group of private investors who had previously invested in the Company both in the early and later portions of fiscal year 2010 and additional funding was provided through increased product sales and debt financing which resulted in:  


A.

Increased Revenue from Product Sales: Our “Tools for Stem Cell and Drug Development™” were launched during 2009 and resulted in increased product sales during 2010 compared to 2009.  In addition, the Company laid foundations for further revenue increases in 2011 including expanded product offerings in stem cell testing through its strategic alliance partners and also for increased sales of its stem cell media.  The Company’s stem cell media known as the VitroGrow™ Brand has recently been shown to exhibit substantial competitive advantages over major competitors. The Company is pursuing distribution agreements with well-established life science firms to enhance the global commercialization of the VitroGrow™ product line.  The Company is also developing new media for use in the generation of stem cell-derived food that may in the future lead to increased revenues as these products are further developed.  The Company is also exploring the possibility of licensing the Company’s fertility drug technology.


B.

Establishment of Key Strategic Alliances: During 2010, the Company established a strategic alliance with HemoGenix®, Inc., a well-established, privately held stem cell company located in Colorado Springs, CO.  Through this arrangement, new products were developed and launched during 2010 for advanced testing of the quality, potency and response to toxic agents of specific types of stem cells known as mesenchymal stem cells and induced pluripotent stem cells.  This alliance was further extended in the latter part of 2010 to include joint development of cell-specific assays of liver, heart and nerve cell toxicity, which are critical needs in the development safer drugs and biologics.


C.

Advancement of Patent-Pending Stem Cell Technology: In February 2010, the Company was a co-sponsor of a Keystone Symposium entitled, “Stem Cell Differentiation and De-differentiation” where Company scientists presented evidence for a simplified method of generation of induced pluripotent stem cells from adult stem cells. This new method involves use of a single genetic factor instead of four genes as previously used to reprogram adult cells to pluripotency, a property of embryonic stem cells enabling differentiation into any cell type.  The Company has extended its



23





patent position with respect to iPS technology by filing a new, international application for its novel method of reprogramming to the pluripotent state by use of environmental factors only, potentially enabling a new area of regenerative medicine where a patient’s adult stem cells may be converted to the functional equivalent of embryonic stem cells.


Liquidity and Capital Resources


In 2010, the Company continued to experience a working capital deficit and shortage of liquidity while product revenues increased as did opportunities for near term revenue increases.  At fiscal year end October 31, 2010, the Company had a working capital deficit of $1,654,888, consisting of current assets of $38,076 and current liabilities of $1,692,964.  The working capital deficit increased by $162,225 from fiscal year end October 31, 2009.  Current assets increased by $19,407 from year-end 2009 to 2010 while total assets increased $14,630 during that time, both principally from increased inventory and increased cash.  Increased inventory reflects current needs for commercialization, and cash at year end reflects investment capital derived through private placement of the Company’s securities. Current liabilities increased $181,632 at October 31, 2010 compared to October 31, 2009, while total liabilities increased $162,916, each predominantly from the increased advances from an officer, accrued payroll expenses and valuation of our outstanding warrants to purchase common stock, which have subsequently expired on December 31, 2010 without being exercised.  The majority of the working capital deficit and debt carried by the Company is due to accrued salaries and notes/advances due to the president and CEO.  Management is actively pursuing measures to reduce corporate debt while at the same time implementing various measures to increase revenues, as described elsewhere in this report.


The Company remains dependent on receipt of additional cash to continue its business plan and achieve profitability in the future.  The report of the independent accountant that audited the Company's financial statements for the year ended October 31, 2010 includes a qualification that the Company may not continue as a going concern.  In that event, the Company might be liquidated and its assets sold to satisfy any claims of creditors.  See Note A to the financial statements attached to this report for a more complete description of this contingency.  Subsequent to fiscal year end 2010, the Company showed substantial competitive advantages of its VitroGrow™ Brand of stem cell culture media.  The Company is actively marketing this product in an effort to increase revenue to the Company from this product line, although there are no assurances regarding whether these efforts will be successful.  If the Company succeeds in increased revenue generation from the successful marketing of its products, it will diminish its needs for outside capital to maintain and expand its operations.


During the fiscal year ended October 31, 2010, the Company's financing activities provided $155,792 to support operations.  During that time, the Company's operations used $123,450 of cash compared to $126,872 of cash used during the twelve months ended October 31, 2009.  The use of cash during 2010 reflects a cash requirement of about $10,300 per month for operations while the cash raised from financing activities was primarily from product revenues, cash advances provided by its president and proceeds from the sale of common stock.  Since most R&D necessary for manufacture of the current line of products has been performed previously, the Company focused its efforts on manufacturing and was able to slightly decrease its cash expenditures for fiscal year 2010.




24





The Company had lines of credit totaling $68,500 with $1,905 in available credit at fiscal year end 2010.  The Company must continue to service debt and the Chairman personally guarantees most of the Company debt.  


Sales of products and services increased from $6,103 in 2009 to $15,651 in 2010, a 2.6-fold increase over 2009.  Management anticipates substantially larger increases in revenue during fiscal year 2011 due to a shifted focus to the establishment of distribution agreements for sales of VitroGrow™ Media as described in greater detail in Section 1 and out-licensing of its patented and patent-pending technology related to treatment of infertility.  We are also in discussion with other companies who have expressed interest in marketing the company’s products and forming strategic alliances for enhancement of mutual business development interests.  Management has also conserved working capital by reducing administrative expenses and expenditures related to its operational activities.  The Company is also pursuing other approaches to increase its capital resources such as combination with revenue-generating private entities, out-licensing of its intellectual property, sale of assets or other transactions that may be appropriate.  


Results of Operations


Year Ended October 31, 2010: During the year ended October 31, 2010, the Company realized a net loss of $257,132, or ($.01) per share, with $15,651 in revenue from products and services.  The operating loss in 2010 was $13,949 less than the operating loss of $271,081 in 2009.  The decreased operating loss during 2010 as compared to 2008 was primarily due to increased revenues and the valuation of stock purchase warrants, which offset increased operating expenses.  Research and development expenses increased by $7,970 and selling, general and administrative expenses increased by $22,748 in 2010.  Revenue increased 2.6-fold during 2010 as the Company continued the early phases of the commercialization of its new stem cell-based products. The Company has initiated a multi-faceted product marketing plan including internet marketing, direct sales, use of distributors and attendance at trade shows.  The Company believes it has significant prospective sales opportunities that management is pursuing to the full extent possible.  These efforts have been bolstered by a recently completed Company study showing performance advantages of its VitroGrow™ Brand of stem cell media over major leaders of this market segment.  We plan to leverage the competitive advantages of our VitroGrow™  product line into significant penetration of this market through alliances with major distributors of life science products.  The Company is engaged in discussions with prospective partners and intends to pursue development of these business relations to the full extent possible. These potential partners possess manufacturing capabilities and well-established, global distribution channels, but lack product offerings that are equivalent to the VitroGrow™ stem cell media product line We further intend to license our patent-pending stem cell lines related to iPS generation to customers as this technology is further developed while directly selling supporting devices and some stem cell lines without licensing agreements. Management hopes for greater sales of its stem cell-based products during 2011, especially its VitroGrow™ Brand of stem cell media and the advanced stem cell testing products, including Lumenesc-Hu™ and LumiSTEM™, that were jointly developed and launched by Vitro and HemoGenix®, Inc. during 2010.


Also, the Company has gained opportunities for commercialization of its fertility drug technology during 2010 and hopes to establish a licensing agreement of its related intellectual property during



25





2011.  This agreement, if consummated, may also increase revenues through licensing fees and sales royalties.


Total operating expenses were $30,718 more in 2010 than in 2009, primarily due to increased selling, general and administrative expenses including marketing expenses of attendance at two trade shows, marketing brochures and website expansion, etc.


Research and development expenses (R&D) increased by $7,970 during fiscal year 2010 compared to fiscal year 2009.  While the R& D necessary for launch of its initial products was completed in 2009, the Company continued development of its technology related to generation of induced pluripotent stem cells as detailed elsewhere in this report (Part I, Item 1).    Management believes that commercial launch of its novel stem cell products and their competitive advantages position the Company to realize accelerated revenue generation, near-term achievement of profitability and growth of earnings through expansion of target markets to include for example stem cell-derived terminally differentiated cell systems for use in drug discovery and development.  Management is also pursuing opportunities for key strategic alliances to leverage its technology and products to approach other market segments within the stem cell industry. There are numerous unfolding therapeutic markets that the Company also intends to pursue initially with regard to therapeutic application of its novel and highly competitive stem cell culture media, but also to treatment of various diseases including cancer, cardiovascular disease and stroke, diabetes, Alzheimer’s disease and spinal cord injury and any other disorder characterized by cell death or degradation..


Year Ended October 31, 2009:  During the year ended October 31, 2009, the Company realized a net loss of $271,081, or ($.02) per share, on $6,103 of revenue.  


Operating expenses decreased $140,710 from fiscal 2008 to fiscal 2009, due to decreased accrued salary expenses.  Selling, general and administrative expenses decreased by $54,421 in 2009, while research and development expenses decreased by $86,289 in 2009.


Other expenses decreased from fiscal 2008 to 2009 by $10,626.









26








RISK FACTORS


This 10-K report, including Management's Discussion and Analysis of Financial Condition and Results of Operation, contains forward-looking statements that may be materially affected by several risk factors including those discussed below.


1.

The Company is wholly dependent on the efforts and expertise of its sole employee to further its business plan, and the loss of his service for any reason would have a material adverse effect on the Company and its business and may require a suspension of operations.  Achievement of the objectives described in this report depends critically upon Dr. James Musick, who has contributed substantially to the development of the products and technology presently owned by the Company.  At present, the Company has an employment contract with Dr. Musick.  However, the Company does not maintain "key man" life insurance on his life.  Loss of his services would adversely impact the efforts to commercialize of the Company's products.


2.

There is a very limited trading market for the Company's common stock, and investors may have difficulty selling their stock, should they desire to do so.  There is presently limited liquidity in the public stock of the Company as indicated by relatively low price of the Company's stock and a relatively low volume of trading.  This limited liquidity is related in part to the fact that the Company's stock is traded on the OTC Bulletin Board and is considered a "penny stock."  Such limited liquidity of the Company's securities may limit the funding abilities of the Company that are related to equity transactions and may adversely affect the ability of shareholders to sell their stock at an acceptable price.


3.

We are dependent on receipt of regulatory approval to commence marketing our fertility drug candidates, and this approval process will be extremely costly and time consuming.  Prior to the marketing and sale of the Company's fertility drug products, regulatory approval is essential.  While the Company maintains relationships with advisors who provide counsel to the Company regarding its filings for registration by the FDA and other regulatory authorities, there can be no assurance that the Company will receive the requisite approvals to market its products.  At the time of this report, no such filings have been made with the FDA or other regulatory authorities.  The absence of regulatory approval together with a lack of working capital, essentially blocks the commercialization of the Company's fertility drug products.


4.

We are required to formally assess our internal controls under Section 404 of the Sarbanes-Oxley Act of 2002 and any adverse results from such assessment could result in a loss of investor confidence in our financial reports and have a material adverse effect on the price of our common stock.




27





The Sarbanes-Oxley Act of 2002 (SOX), which became law in July 2002, has required changes in some of our corporate governance, securities disclosure and compliance practices. In response to the requirements of SOX, the SEC and major stock exchanges have promulgated new rules and listing standards covering a variety of subjects. Compliance with these new rules and listing standards that are likely to increase our general and administrative costs, and we expect these to continue to increase in the future. In particular, we are required to include the management report on internal control as part of this and future annual reports pursuant to Section 404 of SOX. We have evaluated our internal control systems in order (i) to allow management to report on, as required by these laws, rules and regulations, (ii) to provide reasonable assurance that our public disclosure will be accurate and complete, and (iii) to comply with the other provisions of Section 404 of SOX.  Future compliance with SOX 404 will require a significant expenditure of human resources and finances, and could adversely impact our operations.  Furthermore, there is no precedent available by which to measure compliance adequacy.  If we are not able to implement the requirements relating to internal controls and all other provisions of Section 404 in a timely fashion or achieve adequate compliance with these requirements or other requirements of SOX, we might become subject to sanctions or investigation by regulatory authorities such as the SEC or NASD. Any such action may materially adversely affect our reputation, financial condition and the value of our securities, including our common stock. We expect that SOX and these other laws, rules and regulations will increase legal and financial compliance costs and will make our corporate governance activities more difficult, time-consuming and costly. We also expect that these new requirements will make it more difficult and expensive for us to obtain director and officer liability insurance.


5.

We have concerns regarding the current economic situation.  The United States and the global business community are experiencing severe instability in the commercial and investment banking systems which is likely to continue to have far-reaching effects on the economic activity in the country for an indeterminable period. The long-term impact on the United States economy and the Company’s operating activities and ability to raise capital cannot be predicted at this time, but may be substantial.



ITEM 7A.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.


Not applicable.





28







ITEM 8.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA



       The following consolidated financial statements are filed as part of this report:


   
 

1.

Report of Independent Registered Public Accounting Firm – Schumacher & Associates, Inc.

   
 

2.

Balance Sheets at October 31, 2010 and 2009

   
 

3.

Statements of Operations for the years ended October 31, 2010 and 2009

   
 

4.

Statement of Changes in Shareholders’ Deficit for the years ended

October 31, 2010 and 2009

   
 

5.

Statements of Cash Flows for the Years Ended October 31, 2010 and 2009

   
 

6.

Notes to Financial Statements








F-1






Report of Independent Registered Public Accounting Firm

Board of Directors

Vitro Diagnostics, Inc.


We have audited the accompanying balance sheets of Vitro Diagnostics, Inc., as of October 31, 2010 and 2009, and the related statements of operations, shareholders’ (deficit), and cash flows for the two years ended October 31, 2010 and 2009. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States of America). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe our audits provide a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Vitro Diagnostics, Inc. as of October 31, 2010 and 2009, and the results of its operations and cash flows for the two years ended October 31, 2010 and 2009, in conformity with accounting principles generally accepted in the United States of America.

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As described in Note A, the Company has suffered significant losses since inception and has working capital and shareholders’ deficits at October 31, 2010, which raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to this matter are also discussed in Note A. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.


SCHUMACHER & ASSOCIATES, INC.

Denver, Colorado
January 28, 2011







F-2








VITRO DIAGNOSTICS, INC.

  

Balance Sheets

  
  

October 31, 2010

 

October 31, 2009

Assets

   

Current assets:

   
 

Cash

 $                     17,313

 

 $                          104

 

Accounts receivable

                             270

 

                             802

 

Inventory, at cost

                        20,493

 

                        17,763

 

     Total current assets

                        38,076

 

                        18,669

Equipment, net of accumulated depreciation of $60,570 and $43,799

                        47,933

 

                        54,015

Patents, net of accumulated amortization of $4,525 and $1,386 (Note A)

                        26,860

 

                        26,317

Deferred costs (Note A)

                             762

 

                                -   

Other assets

                          2,449

 

                          2,449

 

     Total assets

 $                   116,080

 

 $                   101,450

Liabilities and Shareholders' Deficit

   

Current liabilities:

   
 

Current maturities on capital lease obligation (Note E)

 $                     14,028

 

 $                       9,535

 

Accounts payable

                        44,429

 

                        58,103

 

Accrued expenses

                          8,589

 

                          2,500

 

Advances and accrued interest payable to officer (Note B)

                      155,733

 

                        90,800

 

Accrued payroll expenses (Note B)

                   1,350,053

 

                   1,258,177

 

Lines of credit (Note D)

                        90,832

 

                        92,217

 

Stock purchase warrants (Note F)

                        29,300

 

                                -   

 

     Total current liabilities

                   1,692,964

 

                   1,511,332

Long-term debt (Note E):

   
 

Capital lease obligation, less current maturities (Note E)

                          8,856

 

                        27,572

 

     Total liabilities

                   1,701,820

 

                   1,538,904

Commitments and contingencies (Notes A, B, C, D, E, F, G, and H)

   

Shareholders' deficit (Note F):

   
 

Preferred stock, $.001 par value; 5,000,000 shares authorized;

   
 

   -0- shares issued and outstanding

                                -   

 

                                -   

 

Common stock, $.001 par value; 50,000,000 shares authorized;

   
 

   18,379,985 and 17,214,620 shares issued and outstanding

                        18,380

 

                        17,214

 

Additional paid-in capital

                   5,312,853

 

                   5,203,219

 

Services prepaid with common stock

                         (3,559)

 

                         (1,605)

 

Accumulated deficit

                  (6,913,414)

 

                  (6,656,282)

 

     Total shareholders' deficit

                  (1,585,740)

 

                  (1,437,454)

 

     Total liabilities and shareholders' deficit

 $                   116,080

 

 $                   101,450




The accompanying notes are an integral part of these financial statements

F-3






  

VITRO DIAGNOSTICS, INC.

   
  

Statements of Operations

   
      
   

For the Years Ended

   

October 31,

   

2010

 

2009

Sales of product and services

 $          15,651

 

 $            6,103

 

Cost of goods sold

           (7,199)

 

             (3,049)

  

Gross profit

               8,452

 

               3,054

      

Operating costs and expenses:

   
 

Research and development

           177,508

 

           169,538

 

Selling, general and administrative

             92,167

 

             69,419

  

Total operating costs and expenses

           269,675

 

           238,957

  

Loss from operations

          (261,223)

 

          (235,903)

      

Other income (expense):

   
 

Interest expense

           (41,609)

 

           (35,178)

 

Fair value of stock purchase warrants (Note F)

             45,700

 

                   -   

   

 

 

 

  

Loss before income taxes

          (257,132)

 

          (271,081)

      

Provision for income taxes (Note C)

                   -   

 

                   -   

      
  

Net loss

 $       (257,132)

 

 $       (271,081)

      

Basic and diluted net loss per common share

 $            (0.01)

 

 $            (0.02)

Shares used in computing basic and diluted

   
 

Net loss per common share

       17,869,924

 

       16,658,163






The accompanying notes are an integral part of these financial statements

F-4








VITRO DIAGNOSTICS, INC.

Statement of Changes in Shareholders' Deficit

 
                
           

Services

    
         

Additional

 

Prepaid with

    
 

Preferred Stock

 

Common Stock

 

Paid-in

 

Common

 

Accumulated

  
 

Shares

 

Amount

 

Shares

 

Par Value

 

Capital

 

Stock

 

Deficit

 

Total

Balance, October 31, 2008

             -   

 

 $         -   

 

     15,143,681

 

 $   15,144

 

 $ 4,921,958

 

 $   (6,680)

 

 $ (6,385,201)

 

 $ (1,454,779)

Sale of common stock to officer (Note B)

             -   

 

            -   

 

         226,667

 

          227

 

 8,273

     

        8,500

Sales of common stock to investors (Note B)

             -   

 

            -   

 

         550,000

 

          550

 

 39,450

 

              -   

 

              -   

 

     40,000

Shares issued to director for future services (Note F)

             -   

 

            -   

 

           12,000

 

            12

 

 1,788

 

    (1,800)

 

            -   

 

         -   

Conversion of debt and accrued interest to officer (Note B)

             -   

 

            -   

 

       1,238,176

 

        1,237

 

   223,094

 

          -   

 

              -   

 

    224,331

Conversion of amounts due on account (Note F)

             -   

 

            -   

 

           36,216

 

            36

 

  6,664

 

          -   

 

               -   

 

      6,700

Prepaid services earned (Note F)

             -   

 

            -   

 

                 -   

 

            -   

 

                   -   

 

    6,875

 

              -   

 

      6,875

Common stock issued under consulting contract (Note G)

    

             7,880

 

              8

 

  1,992

 

         -   

 

              -   

 

     2,000

Net loss for the year ended October 31, 2009

             -   

 

            -   

 

                 -   

 

            -   

 

                   -   

 

         -   

 

      (271,081)

 

   (271,081)

Balance, October 31, 2009

             -   

 

 $         -   

 

     17,214,620

 

 $   17,214

 

 $ 5,203,219

 

 $  (1,605)

 

 $  (6,656,282)

 

 $ (1,437,454)

Conversions of amounts due on account (Note F)

             -   

 

            -   

 

         216,429

 

          217

 

  33,083

 

           -   

 

              -   

 

       33,300

Sale of common stock and stock purchase warrants (Note F)

             -   

 

            -   

 

         500,000

 

          500

 

 12,000

 

         -   

 

             -   

 

      12,500

Private placement of common stock (Note F)

             -   

 

            -   

 

         300,000

 

          300

 

  29,700

 

         -   

 

              -   

 

     30,000

Common stock issued to director (Note F)

             -   

 

            -   

 

           63,830

 

            64

 

            14,936

 

         -   

 

             -   

 

     15,000

Common stock issued to directors for future services (Note F)

             -   

 

            -   

 

           85,106

 

            85

 

            19,915

 

      (20,000)

 

                    -   

 

          -   

Prepaid services earned (Note F)

             -   

 

            -   

 

                 -   

 

            -   

 

                   -   

 

        18,046

 

                    -   

 

      18,046

Net loss for the year ended October 31, 2010

             -   

 

            -   

 

                 -   

 

            -   

 

                   -   

 

              -   

 

      (257,132)

 

    (257,132)

Balance, October 31, 2010

             -   

 

 $         -   

 

     18,379,985

 

 $   18,380

 

 $     5,312,853

 

 $     (3,559)

 

 $ (6,913,414)

 

 $ (1,585,740)





The accompanying notes are an integral part of these financial statements

F-5






VITRO DIAGNOSTICS, INC.

Statements of Cash Flows

  

For The Years Ended

  

October 31,

  

2010

 

2009

Cash Flows from operating activities:

   
 

Net loss

 $     (257,132)

 

 $     (271,081)

 

Adjustments to reconcile net loss to net cash used in

   
 

  operating activities:

   
 

Depreciation and amortization

           19,910

 

           17,816

 

Stock-based compensation

           33,046

 

             6,875

 

Impairment of patent

                 -   

 

             8,551

 

Common stock issued for consulting services

                 -   

 

             2,000

 

Fair value of stock purchase warrants

          (45,700)

 

                 -   

 

Changes in current assets and current liabilities:

   
 

  (Increase) in accounts receivable, inventories,

   
 

   prepaid expenses and deposits

           (2,198)

 

          (16,123)

 

  Increase in accounts payable, accrued expenses,

   
 

   deferred revenue and payroll taxes payable

         128,624

 

         125,090

Net cash used in operating activities

        (123,450)

 

        (126,872)

     

Cash flows from investing activities:

   
 

Purchases of equipment

          (10,689)

 

              (995)

 

Payments for patents and deferred costs

           (4,444)

 

              (989)

Net cash used in investing activities

          (15,133)

 

           (1,984)

     

Cash flows from financing activities:

   
 

Proceeds from advances from officer

           53,900

 

           80,972

 

(Payments) draws on lines of credit, net

           (1,385)

 

             1,997

 

Principal payments on capital lease

          (14,223)

 

           (9,277)

 

Proceeds from sale of common stock

         117,500

 

           48,500

Net cash provided by financing activities

         155,792

 

         122,192



CONTINUED ON FOLLOWING PAGE




The accompanying notes are an integral part of these financial statements

F-6






VITRO DIAGNOSTICS, INC.

Statements of Cash Flows


CONTINUED FROM PREVIOUS PAGE

 

For The Years Ended

 

October 31,

 

2010

 

2009


     
 

Net change in cash

           17,209

 

           (6,664)

Cash, beginning of year

               104

 

             6,768

 

Cash, end of period

 $        17,313

 

 $             104

     

Supplemental disclosure of cash flow information:

   
 

Cash paid during the year for:

   
 

   Interest

 $        30,576

 

 $        30,475

 

   Income taxes

 $               -   

 

 $               -   

 

Non-cash investing and financing activities:

   
 

Equipment acquired under capital lease

 $               -   

 

 $        10,394

 

  Conversion of note payable, amounts due officer and accrued interest

 $               -   

 

 $       224,333

 

  Common stock issued to directors for future services

 $        20,000

 

 $          1,800

 

  Conversion of amounts due on account to common stock

 $        33,300

 

 $          6,700






The accompanying notes are an integral part of these financial statements

F-7



VITRO DIAGNOSTICS, INC.

Notes to Unaudited Financial Statements





NOTE A: NATURE OF ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES



Nature of Organization


The Company was incorporated under the laws of Nevada on February 3, 1986.  From November of 1990 through July 31, 2000, the Company was engaged in the development, manufacturing and distribution of purified human antigens (“Diagnostics”) and the development of therapeutic products (“Therapeutics”) and related technologies.  The Company’s sales were solely attributable to the sales of purified human antigens.   


Following the transfer of its Diagnostics operations in August of 2000, the Company began devoting all efforts to its therapeutic drug development and related technologies.  A present target area for the Company’s therapeutic products is the development and commercialization of stem cell technology for use in diabetes and cancer research and treatment.  The Company has been granted a patent for its proprietary technology related to the immortalization of human cells and subsequently expanded this technology to include patented and patent-pending technology involving generation of stem cells with potential application to a variety of commercial opportunities including the treatment of degenerative diseases and drug discovery.


The Company also owns patented technology related to treatment of human infertility.  The Company has been granted a US patent for its process to manufacture VITROPIN™.  VITROPIN™ is a highly purified urinary follicle-stimulating hormone (“FSH”) preparation produced according to the Company’s patented purification process.


The Company also owns patented technology that provides protection to a specific cell line derived from human pancreatic tissues that gives rise to structures comparable to the Islets of Langerhans (beta islets).  These islets also synthesize and secrete insulin in response to elevated glucose levels, as do beta islets contained within pancreatic tissue.  Vitro has also developed a process for the commercial production its cell line-derived islets.  Furthermore, the Company previously obtained regulatory approval for an animal protocol to determine reversal of Type I diabetes, a critical step in the demonstration of efficacy.  This patent affords an exclusive proprietary position to the Company for a new cellular therapy to treat Type I diabetes.


Basis of Presentation – Going Concern


The accompanying financial statements have been prepared in conformity with generally accepted accounting principles, which contemplate continuation of the Company as a going concern. However, the Company has suffered significant losses since inception and has working capital and shareholders’ deficits at October 31, 2010, that raise substantial doubt about its ability to continue as a going concern. In view of these matters, realization of certain of the assets in the accompanying balance sheet is dependent upon continued operations of the Company, which in turn is dependent upon the Company’s ability to meet its financial requirements, raise additional capital, and generate revenues and profits from operations.



F-8



VITRO DIAGNOSTICS, INC.

Notes to Unaudited Financial Statements




The financial statements do not include any adjustments relating to the recoverability of assets and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. During the years ended October 31, 2010 and 2009, the president and chairman has advanced the Company funds for working capital on an “as needed” basis.  During the years ended October 31, 2010 and 2009, the president and chairman advanced the company a total of $134,872 for working capital purposes.  There is no assurance that these advances will continue in the future. In December 2009 the Company raised $87,500 through a private placement of common stock and warrants.  And in September 2010, the Company raised $30,000 in a private placement of common stock to two investors.  During the year ended October 31, 2009, the Company raised $40,000 in working capital through sales of common stock to private investors, and $8,500 through sales of common stock to its president.

 

The Company has formed strategic alliances and is presently engaged in discussions with other companies that have expressed interest in the commercialization of the Company’s stem cell and fertility drug technology. Management intends to pursue these and other opportunities with the objective of establishing strategic alliances to enhance its revenue generation and to fund further development and commercialization of its key technologies. Also, the Company has new stem cell products that were launched during fiscal year 2009.  Initial revenues from these products have been established and management intends to pursue enhanced revenue generation from this product line and development of other related products to the fullest extent possible given its resources.  A current focus is expanded distribution of the Company’s advanced stem cell media, VitroGrow™, since management believes that  these products show performance advantages over the current leaders in this market sector.  These business development activities are described in greater detail elsewhere in this report (See: Item 2. Management’s Discussion and Analysis or Plan of Operations.) There is no assurance that any of these initiatives will yield sufficient capital to maintain the Company’s operations. In such an event, management intends to pursue various strategic alternatives.


Summary of Significant Accounting Policies


Use of estimates


The preparation of the financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.


Cash equivalents


For the purposes of the statement of cash flows, the Company considers all highly liquid debt instruments purchased with an original maturity of three months or less to be cash equivalents.




F-9



VITRO DIAGNOSTICS, INC.

Notes to Unaudited Financial Statements



Accounts receivable


Accounts receivable consists of amounts due from customers.  The Company considers accounts more than 30 days old to be past due. The Company uses the allowance method for recognizing bad debts. When an account is deemed uncollectible, it is written off against the allowance. The Company generally does not require collateral for its accounts receivable.  At October 31, 2010 and October 31, 2009 no allowances were recorded and all amounts due from customers were considered collectible.


Inventory


Inventories, consisting of raw materials and finished goods, are stated at the lower of cost (using the specific identification method) or market.  Finished goods inventories include certain allocations of labor and overhead.  At October 31, 2010 and October 31, 2009, finished goods included approximately $10,100 and $9,200, respectively, of labor and overhead allocations.  Inventories consisted of the following:



 

October 31, 2010

 

October 31,

 2009

Raw materials

 $   7,603

 

 $     6,987

Finished goods

12,890

 

          10,776

 

 $  20,493

 

 $     17,763



Research and development


The Company’s operations are predominantly in research and development (“R&D”).  These costs are expensed as incurred and are primarily comprised of costs for: salaries, overhead and occupancy, contract services and other outside costs, quality assurance and analytical testing. As the Company has also expanded its operations to include manufacturing and R&D, we report cost of goods sold, including estimates of labor, materials and overhead allocations to the production of specific products. 


Property, equipment and depreciation


Property and equipment are stated at cost and are depreciated over the assets’ estimated useful lives using the straight-line method.  Depreciation expense totaled $16,771 and $13,499 for the years ended October 31, 2010 and 2009, respectively.


Upon retirement or disposition of equipment, the cost and accumulated depreciation are removed from the accounts and any resulting gain or loss is reflected in operations.  Repairs and maintenance are charged to expense as incurred and expenditures for additions and improvements are capitalized.




F-10



VITRO DIAGNOSTICS, INC.

Notes to Unaudited Financial Statements



Patents, deferred costs and amortization


Patents consist of costs incurred to acquire issued patents.  Amortization commences once a patent is granted.  Costs incurred to acquire patents that have not been issued are reported as deferred costs.  If a patent application is denied or expires, the costs incurred are charged to operations in the year the application is denied or expires.


The Company amortizes its patents over a period of ten years.  Amortization expense totaled $3,139 and $4,317 for the years ended October 31, 2010 and 2009, respectively.  Estimated aggregate amortization expense for each of the next five years is as follows:


Year ended October 31,

 

 

2011

$

3,160 

2012

 

3,160 

2013

 

3,160 

2014

 

3,160 

2015

 

      3,160

Thereafter

 

11,060

 

$

26,860 




F-11



VITRO DIAGNOSTICS, INC.

Notes to Unaudited Financial Statements



On May 5, 2009 the United States Patent Office issued patent number 7,527,971 to the Company for its stem cell technology, “Generation and Differentiation of Adult Stem Cell Lines.”


The Company’s patents consisted of the following at October 31, 2010:

Generation and differentiation of adult stem cell lines

 $

31,385 

This patent is for a proprietary stem cell line with potential application to treatment of diabetes in both animals and humans.

 

 

    Less accumulated amortization

 

(4,525)

 

 $

26,860


During the year ended October 31, 2010 the Company incurred costs totaling $762 relating to the filing of a new United States patent application entitled “POU5-F1 Expression in Human Mesenchymal Stem Cells” and the development of new technology related to generation of human induced pluripotent stem cells (iPS).  These costs are included as deferred patent costs in the accompanying balance sheet at October 31, 2010.


Impairment and Disposal of Long-Lived Assets


The Company evaluates its long-lived assets for impairment when events or changes in circumstances indicate, in management's judgment, that the carrying value of such assets may not be recoverable.  If such assets are considered impaired, the impairment to be recognized is determined as the amount by which the carrying value exceeds the fair value of the assets.


The Company periodically reviews the carrying amount of it long-lived assets for possible impairment.  At October 31, 2009 the Company determined that one of its patents named “Immortalized cell lines and methods of making the same” was impaired and as such recognized an impairment charge of $8,551 on this patent on October 31, 2009.  The Company recorded no asset impairment charges during the year ended October 31, 2010.  A contingency exists with respect to these matters, the ultimate resolution of which cannot presently be determined.


Income taxes


The Company uses the liability method of accounting for income taxes.  Accordingly, deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statements carrying amounts of existing assets and liabilities and their respective tax bases.  Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. A valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized.




F-12



VITRO DIAGNOSTICS, INC.

Notes to Unaudited Financial Statements



Revenue recognition


The Company recognizes revenue when persuasive evidence of an arrangement exists, delivery has occurred (or service has been performed), the sales price is fixed and determinable, and collectability is reasonably assured.


Advertising Costs


The Company expenses all advertising costs as they are incurred.  Advertising costs were $14,211 and $1,527 for the years ended October 31, 2010 and 2009, respectively.


Fair value of financial instruments


The carrying amounts of cash, accounts receivable, accounts payable and other accrued liabilities approximate fair value due to the short-term maturity of the instruments. Based on the borrowing rates currently available to the Company for loans with similar terms and average maturities, the fair value of long-term obligations consisting of various capital lease obligations approximates its carrying value.


Concentrations of credit risk


Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of temporary cash investments and cash equivalents, and trade accounts receivable.  As of October 31, 2010 and 2009, the Company had no amounts of cash or cash equivalents in financial institutions in excess of amounts insured by agencies of the U.S. Government.


Net loss per share


The Company reports net loss per share using a dual presentation of basic and diluted loss per share. Basic net loss per share excludes the impact of common stock equivalents.  Diluted net loss per share utilizes the average market price per share when applying the treasury stock method in determining common stock equivalents.  Common stock options and warrants outstanding at October 31, 2010 and 2009 were not included in the diluted loss per share as all 2,043,500 and 1,543,500 options and warrants outstanding, respectively, were anti-dilutive.  Therefore, basic and diluted losses per share at October 31, 2010 and 2009 were equal.


Stock-based compensation


Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (the “ASC”) Topic 718, “Stock Compensation,” establishes fair value as the measurement objective in accounting for share based payment arrangements, and requires all entities to apply a fair value based measurement method in accounting for share based payment transactions with employees.  Stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as expense on a straight-line basis over the period during which the holder is required to provide services in exchange for the award, i.e., the vesting period.




F-13



VITRO DIAGNOSTICS, INC.

Notes to Unaudited Financial Statements



Recent accounting standards

The FASB’s Accounting Standards Codification is effective for all interim and annual financial statements issued after September 15, 2009.  The ASC is now the single official source of authoritative, nongovernmental generally accepted accounting principles (GAAP) in the United States.  The historical GAAP hierarchy was eliminated and the ASC became the only level of authoritative GAAP, other than guidance issued by the Securities and Exchange Commission.  Our accounting policies were not affected by the conversion to ASC.  However, we have conformed references to specific accounting standards in these notes to our consolidated financial statements to the appropriate section of ASC.

There were various accounting standards and interpretations issued during 2010 and 2009, none of which are expected to have a material impact on the Company’s consolidated financial position, operations, or cash flows.


NOTE B: RELATED PARTY TRANSACTIONS

Advances and accrued interest payable to officer


During the years ended October 31, 2009 and 2008, the Company’s chief executive officer advanced the Company a total of $85,782 used for working capital, and during the year ended October 31, 2010 an additional $53,900 of working capital advances were made by the officer.  The advances are uncollateralized, due on demand and accrue interest on the unpaid principal at a rate of 10% per annum.  Accrued interest payable on the advances totaled $16,050 and $5,018 at October 31, 2010 and 2009, respectively.  The total advances plus accrued interest totaling $155,733 and $90,800 at October 31, 2010 and 2009, respectively, are included as “Advances and accrued interest payable to officer” in the accompanying financial statements.


Employment agreements and accrued compensation


Effective May 1, 2008, the Company entered into a new Executive Employment Agreement with its CEO.  The Agreement establishes annual base salaries of $80,000, $85,000, and $90,000 over the three years of the Agreement.  The Agreement also provides for incentive compensation based on the achievement of minimum annual product sales and an option to purchase one million shares of the Company’s common stock that includes contingent vesting requirements. The employment agreement includes changes in control given exercise of underlying stock options and also includes severance provisions.


The Company accrued the salaries of its CEO through April 30, 2008 under an old agreement due to a lack of working capital.  Accrued salaries and payroll taxes totaled $1,350,053 and $1,258,177 at October 31, 2010 and 2009, respectively.  His accrued salaries totaled $1,099,982 and $1,012,482 as of October 31, 2010 and 2009, respectively.  His salary is allocated as follows: 70% to research and development and 30% to administration.


In addition, accrued salaries for a previous officer of the Company totaled $200,833 at October 31, 2010 and 2009.




F-14



VITRO DIAGNOSTICS, INC.

Notes to Unaudited Financial Statements



Total accrued payroll taxes on the above salaries totaled $49,238 and $44,862 at October 31, 2010 and 2009, respectively.


Conversion of debt and accrued interest to officer


During the period from August 2002, to October 2007, the president loaned the Company a total of $168,150 through various notes that had also accrued interest in the amount of $35,483.   In October 2007, these notes and the accrued interest were consolidated into a single note of $203,633, and accrued interest on the unpaid principle at a rate of 10% per annum.  Additional interest of $15,170 had accrued on this note.  This note was collateralized by a first lien on the FSH patents owned by the Company, the same collateral that had secured a prior note between the Company and the officer.


On July 29, 2008, the Board of Directors approved the issuance of 1,238,176 shares of the Company’s common stock in exchange for the notes payable plus accrued interest to an officer not to exceed $225,000.  At that time the Note was cancelled effective July 29, 2008.  The exchange was completed on February 10, 2009.  A total of $224,331, representing the balance of the note payable and accrued interest, plus the outstanding balance of the indebtedness to the officer of $5,530 was exchanged for 1,238,176 shares of the Company’s common stock.


Common stock sales


In November 2008, the Company sold 226,667 shares of its common stock to an officer of the Company for $8,500, or $.0375 per share.  The transaction was recorded at fair value, which was determined to be 75% of the quoted market price on the day of the approval of sale of stock due to the restricted nature of the shares.


Office lease


On July 1, 2008, the Company entered into a five-year non-cancelable operating lease for a facility located in Golden, Colorado.  The facility has been leased from a company that is owned by the president’s wife.


Future minimum rental payments for the fiscal years ending are as follows:

October 31,

  
    
 

2011

 $         22,380

 

2012

            22,380

 

2013

            14,920

   

 $         59,680


The total rental expense was $23,827 and $27,347 for the years ended October 31, 2010 and 2009, respectively.




F-15



VITRO DIAGNOSTICS, INC.

Notes to Unaudited Financial Statements



Other


The president has personally guaranteed all debt instruments of the Company including all credit card debt.


NOTE C: INCOME TAXES


A reconciliation of the U.S. statutory federal income tax rate to the effective rate is as follows for the years ended:

 

October 31,

 

2010

 

2009

Benefit related to U.S. federal statutory graduated rate

-28.37%

 

-29.48%

Benefit related to State income tax rate, net of federal benefit

-3.32%

 

-3.27%

Accrued officer salaries

11.32%

 

10.46%

Net operating loss for which no tax benefit is currently available

20.37%

 

22.29%

 

Effective rate

0.00%

 

0.00%


The primary components of temporary differences that give rise to the Company’s net deferred tax assets are as follows:


      

 

October 31,

 

2010

 

2009

Net operating loss and tax credit carryforwards

$

   1,522,860 

 

$

    1,445,310 

Accrued officer salaries

 

      500,330 

 

 

        466,280 

Deferred tax asset (before valuation allowance)

 $

   2,023,190 

 

     1,911,591 



At October 31, 2010, deferred taxes consisted of a net tax asset of $2,023,190, due to operating loss carryforwards and other temporary differences of $8,203,608, which was fully allowed for in the valuation allowance of $2,023,190.  The valuation allowance offsets the net deferred tax asset for which there is no assurance of recovery.  The changes in the valuation allowance for the years ended October 31, 2010 and 2009 totaled $111,599 and $58,623, respectively.  Net operating loss carryforwards will expire in various years through 2030.




F-16



VITRO DIAGNOSTICS, INC.

Notes to Unaudited Financial Statements



The Company is delinquent on filing its federal and state tax returns and may be subject to penalties and interest.  A contingency exists with respect to this matter, the ultimate resolution of which may not be presently determined.


The valuation allowance will be evaluated at the end of each year, considering positive and negative evidence about whether the asset will be realized.  At that time, the allowance will either be increased or reduced; reduction could result in the complete elimination of the allowance if positive evidence indicates that the value of the deferred tax asset is no longer impaired and the allowance is no longer required.


Should the Company undergo an ownership change as defined in Section 382 of the Internal Revenue Code, the Company’s tax net operating loss carryforwards generated prior to the ownership change will be subject to an annual limitation, which could reduce or defer the utilization of these losses.



NOTE D: LINES OF CREDIT


The Company has a $12,500 line of credit of which $488 was unused at October 31, 2010.  The interest rate on the credit line was 18.00% at October 31, 2010.  The credit line is collateralized by the Company’s checking account.  Principal and interest payments are due monthly.


The Company also has five credit cards with a combined credit limit of $56,000, of which $1,417 was unused at October 31, 2010.  The interest rates on the credit cards range from 10.24% to 29.99% as of October 31, 2010.  In addition, one of the Company’s credit cards was closed by the creditor in May 2009.  At October 31, 2010 the account had a balance of $24,237 and carries an annual interest rate of 34.99%.


NOTE E: CAPITAL LEASE OBLIGATIONS


In July 2007, the Company entered into a capital lease agreement to acquire laboratory equipment.  The Company is obligated to make 3 monthly payments of $25 and monthly payments of $382 through August 2012.  


In June 2008, the Company entered into a capital lease agreement, also for the acquisition of laboratory equipment.  The Company is obligated to make monthly payments of $830 through May 2012.


In July 2009, the Company entered into a capital lease agreement, also for the acquisition of laboratory equipment.  The Company is obligated to make monthly payments of $570 through June 2011.



F-17



VITRO DIAGNOSTICS, INC.

Notes to Unaudited Financial Statements



Future maturities of the Company’s capital lease obligations are as follows:


Year ended October 31,

  

2011

$

 17,572 

2012

 

  9,628 

 

 

27,200 

Less: imputed interest

 

 (4,316)

Present value of net minimum lease payments

$

 22,884 


The president of the Company has personally guaranteed the lease obligations.


NOTE F: SHAREHOLDERS’ DEFICIT


Preferred Stock


The Company has authorized 5,000,000 shares of $.001 par value preferred stock, of which none were issued and outstanding at October 31, 2010.  These shares may be issued in series with such rights and preferences as may be determined by the Board of Directors.


Sales of common stock


In September 2010, the Company sold 300,000 shares of its common stock to two investors for $30,000, or $.10 per share.  The transaction was recorded at fair value, which was determined to be 83% of the quoted market price on the day prior to the negotiated sale of stock, due to the restricted nature of the shares.


In February 2009, the Company sold 250,000 shares of its common stock to an investor for $25,000, or $.10 per share.  Also in February 2009, the Company completed the sale of 300,000 shares of its common stock to one investor for $15,000, or $.05 per share, which was negotiated in January 2009.  Proceeds from the sales of common stock were used for general working capital purposes.  The transaction was recorded at fair value, which was determined to be 75% of the quoted market price on the day prior to the negotiated sale of stock, due to the restricted nature of the shares.


Sale of Common Stock and Warrants


On December 29, 2009 the Company sold an aggregate of 500,000 shares of common stock together with an aggregate of 500,000 warrants for $87,500 to three investors.  The warrants are exercisable for a period of twelve months from the date of issuance to purchase an additional 500,000 shares of common stock at an exercise price of $0.175 per share.


The Company applied the provisions of ASC Topic 815, “Derivatives and Hedging” and related standards for the accounting of the valuation of the common stock warrants issued as part of the private placement of common stock completed on December 29, 2009. Accordingly, the Company


F-18



VITRO DIAGNOSTICS, INC.

Notes to Unaudited Financial Statements



recorded a warrant liability upon the issuance of its common stock, equal to the estimated fair market value of the various features of the warrants.  The initial warrant liability of $75,000 represented a non-cash adjustment to the carrying value of the related financial instruments.  The warrants are exercisable upon issuance, and expire on December 29, 2010, and as such the liability is classified as a current liability at October 31, 2010.  The liability is adjusted quarterly to the estimated fair market value based upon then current market conditions, and any change, if any, in the estimated fair market value is charged to the Company’s operating results.

  

The following assumptions were utilized to determine the estimated fair value of the warrants upon issue:


Expected volatility

 

142%

Contractual term

 

1 year

Risk free interest rate

 

0.47%

Expected dividend rate

 

0%

   

The fair value of the warrants was determined to be $29,300 at October 31, 2010.  As such, an adjustment to the warrant liability of $45,700 was recorded with a corresponding adjustment to the Company’s operating results for the year ended October 31, 2010.  The following assumptions were utilized to determine the estimated fair value of the warrants at October 31, 2010:



Expected volatility

 

177%

Contractual term

 

3 months

Risk free interest rate

 

0.12%

Expected dividend rate

 

0%


The warrants have subsequently expired on December 29, 2010.  None of the warrants were exercised prior to their expiration.


Common stock issued for services


On March 25, 2008, the Company issued a consultant 12,000 additional shares of the Company’s common stock as compensation to serve on the Company’s Scientific Advisory Board (“SAB”) for a period of two years.  The transaction was valued at $2,400, or $.20 per share, based on the fair value of the stock on the transaction date.  The transaction is being expensed over the period of the service.  As of October 31, 2010, the entire $2,400 has been expensed.


In February 2009, the Company appointed Dr. Pamela L. Rice to its Scientific Advisory Board.  The Company issued 12,000 shares of the Company’s common stock as compensation for her commitment to serve on the SAB.  The transaction was valued at $1,800, or $.15 per share based on the fair value of the stock on the transaction date.  As of October 31, 2010 a total of $1,575 had been expensed, and $225 is included as “Services paid with common stock” in the accompanying condensed balance sheet.




F-19



VITRO DIAGNOSTICS, INC.

Notes to Unaudited Financial Statements



On October 29, 2009, the Company agreed to convert certain amounts due to a consultant who provides various professional accounting services.  As a result of the agreement, $6,700 of amounts due the consultant was converted to 36,216 shares of common stock at a price of $0.185 per share, which approximated the market value of the stock on the date of the transaction.


On December 21, 2009 the Company agreed to convert to common stock certain amounts due an attorney who provides various legal services to the Company.  As a result, $15,000 of amounts due the attorney was converted to 85,714 shares of common stock at a price of $0.175 per share, which approximated the market value of the stock on the date of the transaction.


In February 2010, the Company appointed Mr. Richard Huebner to its Board of Directors.  The Company issued to Mr. Huebner 106,383 shares of the Company’s common stock as compensation for his commitment to serve on the Company’s board of directors.  The transaction was valued at $25,000, or $.235 per share based on the fair value of the stock on the transaction date.  Of the total transaction amount, $15,000 was considered as incentive to serve as a director, and as such the amount was charged to operations as stock compensation expense for the year ended October 31, 2010.  The remaining $10,000 was considered as compensation to be earned during his service in 2010.   As of October 31, 2010 a total of $8,333 had been expensed, and $1,667 is included as “Services paid with common stock” in the accompanying condensed balance sheet.


Also in February 2010, the Company issued 42,553 shares of the Company’s common stock to Mr. Erik Van Horn, Director as compensation to be earned during his service in 2010.  The transaction was valued at $10,000, or $.235 per share based on the fair value of the stock on the transaction date.  As of October 31, 2010 a total of $8,333 had been expensed, and $1,667 is included as “Services paid with common stock” in the accompanying condensed balance sheet.


On September 8, 2010 the Company agreed to convert to common stock certain amounts due an attorney who provides various legal services to the Company.  As a result, $10,000 of amounts due the attorney was converted to 71,429 shares of common stock at a price of $0.14 per share, which approximated the market value of the stock on the date of the transaction.


Also on September 8, 2010 the Company agreed to convert to common stock certain amounts due a consultant who provides various professional accounting services to the Company.  As a result, $8,300 of amounts due the consultant was converted to 59,286 shares of common stock at a price of $0.14 per share, which approximated the market value of the stock on the date of the transaction.


Stock options granted to officer


On May 1, 2008, the Company granted a stock option to its president to purchase 1,000,000 shares of the Company’s common stock at an exercise price of $.19 per share.  On the grant date, the traded market value of the stock was $.19 per share.  The options vest upon the achievement of certain contingencies.  None of the contingencies have been met, and as a result, no stock-based compensation was recorded for the options for the years ended October 31, 2010 or 2009.  The fair value of the options will be recorded as stock-based compensation upon achievement of these contingencies. The weighted average exercise price and weighted average fair value of these options on the grant date were $.19 and $.19, respectively.  




F-20



VITRO DIAGNOSTICS, INC.

Notes to Unaudited Financial Statements



The fair value of the options was determined to be $189,000, and was estimated at the date of grant using the Black-Scholes option-pricing model with the following assumptions:


Risk-free interest rate

3.68%

Dividend yield

0.00%

Volatility factor

228.72%

Weighted average expected life

6.5 years



Incentive plans


Effective December 2, 2000, the Company’s Board of Directors adopted an Equity Incentive Plan (the “Plan”), which replaced the Company’s 1992 Stock Option Plan.  The purpose of the Plan is to attract and retain qualified personnel, to provide additional incentives to employees, officers, consultants and directors, and to promote the Company’s business.  The Plan authorizes total awards of up to 1,000,000 shares of the Company's common stock. Awards may take the form of incentive stock options, non-qualified stock options, restricted stock awards, stock bonuses and other stock grants. If an award made under the Plan expires, terminates, is canceled or settled in cash without the issuance of all shares of common stock covered by the award, those shares will be available for future awards under the Plan. Awards may not be transferred except by will or the laws of descent and distribution. No awards may be granted under the Plan after September 30, 2010.


The Plan is administered by the Company's Board of Directors, which may delegate its authority to a committee of the Board of Directors. The Board of Directors has the authority to select individuals to receive awards, to determine the time and type of awards, the number of shares covered by the awards, and the terms and conditions of such awards in accordance with the terms of the Plan. In making such determinations, the Board of Directors may take into account the recipient's current and potential contributions and any other factors the Board of Directors considers relevant. The recipient of an award has no choice regarding the form of a stock award. The Board of Directors is authorized to establish rules and regulations and make all other determinations that may be necessary or advisable for the administration of the Plan. All options granted pursuant to the Plan shall be exercisable at a price not less than the fair market value of the common stock on the date of grant. Unless otherwise specified, the options expire ten years from the date of grant.




F-21



VITRO DIAGNOSTICS, INC.

Notes to Unaudited Financial Statements



The following schedule summarizes the changes in the Company’s stock options:


   

Number of Shares

 

Exercise Price Per Share

 

Weighted Average Remaining Contractual Life

 

Weighted Average Exercise Price Per Share

Balance at October 31, 2008

 

    1,605,864

 

$0.08 to $0.81

 

8.29 years

 

 $ 0.20

 

Options granted

 

   -

      
 

Options exercised

 

  -

      
 

Options expired

 

              (62,364)   

     

$ 0.63

Balance at October 31, 2009

 

  1,543,500

 

$0.08 to $0.81

 

7.60 years

 

 $ 0.18

 

Options granted

 

-

      
 

Options exercised

 

-

      
 

Options expired

 

                          -

      

Balance at October 31, 2010

 

           1,543,500

 

$0.08 to $0.81

 

6.60 years

 

$ 0.18

Exercisable at October 31, 2009

 

     543,500

 

$0.08 to $0.81

 

5.48 years

 

 $ 0.16

Exercisable at October 31, 2010

 

     543,500

 

$0.08 to $0.81

 

4.48 years

 

 $ 0.16



NOTE G: CONSULTING AGREEMENTS


On August 20, 2007, the Company entered into a Consulting Agreement with Mr. Joe Nieusma of Superior Toxicology & Wellness (“Superior”).  This agreement was initially extended without modification through August 20, 2010, and the Company expects to further extend the agreement although no extension has been made as of the date of this report.  Under the terms of the original agreement, Superior will provide services including, but not limited to:


·

The development and funding of the Company’s current business plan;


·

The launch of products targeting applications in the development and discovery of new drug and biological products; and


·

The marketing and sales of all existing and proposed products and technology that are now available, or will be available for commercial distribution during the term of the agreement.


In exchange for the above services, the Company will pay Superior $50 per hour capped at a maximum of 240 hours for the term of the agreement.  In addition, the Company has agreed to issue Mr. Nieusma the following stock bonuses to be paid in shares of the Company’s common stock:


a.

100,000 shares upon the sale of stem-derived human beta islets as evidenced by issuance of a commercial invoice;


b.

100,000 shares upon the submission of a validation package to the United States Food and Drug Administration requesting approval of the use of Vitro’s stem cell-derived human beta islets for safety and efficacy testing and the use of this data within applications submitted for marketing approval of new drugs and biological products; and



F-22



VITRO DIAGNOSTICS, INC.

Notes to Unaudited Financial Statements




c.

100,000 shares upon the receipt of $100,000 or more in capital funding of the Company based upon Vitro’s current business plan or subsequent versions thereof.  This event occurred during fiscal year ending October 31, 2008 and the Company issued 100,000 shares to its consultant on March 27, 2008.


Compensation for the successful sale of Vitro’s products, patent licenses or other revenue-generating event shall be based on industry standards and include a gross sales commission of 15% in addition to the compensation described above.


On June 3, 2009 the Company entered into a business development consulting agreement with Seraphim Life Sciences Consulting LLC, to provide services primarily designed to identify and bring to Vitro potential industrial partners that could benefit from Vitro’s technologies.  The agreement entitles the consultant to performance based compensation in the amount of 8% of all consideration received by the Company resulting from the consultant’s services.  The agreement also provides for compensation at hourly rates for services not considered project specific as may be requested by Vitro.  The agreement may be terminated at any time by either party with thirty days written notice.  As of October 31, 2010 no services have been performed and no compensation has been paid under the agreement.


On July 27, 2009 the Company entered into a consulting agreement with SK Helsel & Associates LLC to provide certain public relations and media services.  The agreement provides compensation in the total amount of $2,500 per press release, to be paid with a combination of common stock and cash.  The agreement also provides for other related hourly based consulting services to be provided on an as-needed basis as requested by Vitro.  As of October 31, 2010 a total of $3,719 in cash and 7,880 shares of the Company’s common stock at an average price of $0.25 per share had been paid the consultant under the term of the agreement.



NOTE H: JOINT PRODUCT DEVELOPMENT, MANUFACTURE AND DISTRIBUTION AGREEMENTS


On May 29, 2010 the Company executed an Agreement with Mokshagundam Biotechnologies for the development of a medium formulation for growth of marine invertebrates as a potential food source.  Initially, a basal medium formulation consisting of macro nutritional substances is to be developed and this will be supplemented with growth factors commonly used in stem cell media formulations.  The Agreement provides for the Company to provide a pilot batch of medium for testing consisting of macro-nutritional support plus a mixture of common growth factors necessary for in-vitro support of self-renewal in stem cells of higher organisms.  This medium was delivered to Mokshagundam during fiscal year 2010.  The Agreement provides for a payment of $5,000 to the Company upon execution of the Agreement as an advance for the product development, and is included in the Company’s revenues for the year ended October 31, 2010.


On April 27, 2010 the Company executed an Agreement for Joint Product Development, Manufacture and Distribution (“Agreement”) with HemoGenix, Inc., a privately held biotechnology firm located in Colorado Springs, Colorado.  The Agreement provides for the joint manufacture and distribution of stem cell analysis tools.  The agreement provides for the expansion of assay platforms



F-23



VITRO DIAGNOSTICS, INC.

Notes to Unaudited Financial Statements



from HemoGenix, in particular, LUMENESC for mesenchymal stem cells (MSC) and LumiSTEM for induced pluripotent stem cells (iPS).

Also, this original agreement between the Company and HemoGenix® was expanded during the latter portions of 2010 to include joint development of cell-specific toxicity assays including those targeting liver cells, heart, kidney and neuronal cells.  Furthermore, the strategic partners intend to jointly develop additional stem cell media products and align their respective quality programs to ensure consistency.


NOTE I: SUBSEQUENT EVENTS


The Company has evaluated subsequent events through the date which the financial statements were available to be issued.


As discussed above in Note F, certain warrants to purchase the Company’s common stock issued as part of a private placement of common stock and warrants completed on December 29, 2009 expired unexercised on December 29, 2010.







F-24





ITEM 9.

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS


None



ITEM 9A.

CONTROLS AND PROCEDURES


(a) Evaluation of Disclosure Controls and Procedures.  Our management, with the participation of our President, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. Based on that evaluation, our President concluded that our disclosure controls and procedures as of the end of the period covered by this report were effective such that the information required to be disclosed by us in reports filed under the Securities Exchange Act of 1934 is (i) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, including our President, as appropriate to allow timely decisions regarding disclosure. A controls system cannot provide absolute assurance, however, that the objectives of the controls system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.


Management’s Annual Report on Internal Control over Financial Reporting.  Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act). Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States.


Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance of achieving their control objectives. Furthermore, smaller reporting companies face additional limitations.  Smaller reporting companies employ fewer individuals and find it difficult to properly segregate duties.  Often, one or two individuals control every aspect of the Company’s operation and are in a position to override any system of internal control.  Additionally, smaller reporting companies tend to utilize general accounting software packages that lack a rigorous set of software controls.


Our management, with the participation of the President, evaluated the effectiveness of the Company’s internal control over financial reporting as of October 31, 2010.  In making this assessment, our management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control — Integrated Framework.  Based on this evaluation, our management, with the participation of the President, concluded that, as of October 31, 2010, our internal control over financial reporting was not effective due to material weaknesses in the system of internal control.


Specifically, management identified the following control deficiencies.  (1) The Company has not properly segregated duties as its President initiates, authorizes, and completes all transactions.  The


29





Company has not implemented measures that would prevent the President from overriding the internal control system.  The Company does not believe that this control deficiency has resulted in deficient financial reporting because the President is aware of his responsibilities under the SEC’s reporting requirements and personally certifies the financial reports.  In addition, the Company engaged a financial consultant to review all financial transactions to determine that they have been properly recorded in the financial statements. (2) The Company has installed accounting software that does not prevent erroneous or unauthorized changes to previous reporting periods and does not provide an adequate audit trail of entries made in the accounting software.  The Company does not think that this control deficiency has resulted in deficient financial reporting because the Company has implemented a series of manual checks and balances to verify that previous reporting periods have not been improperly modified and that no unauthorized entries have been made in the current reporting period.


Accordingly, while the Company has identified certain material weaknesses in its system of internal control over financial reporting, it believes that it has taken reasonable steps to ascertain that the financial information contained in this report is in accordance with generally accepted accounting principles.  Management has determined that current resources would be appropriately applied elsewhere and when resources permit, they will alleviate material weaknesses through various steps.


(b)  Changes in Internal Control over Financial Reporting.  During fiscal year ended October 31, 2010, there were no changes in the Company’s internal controls over financial reporting that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.



ITEM 9B.

OTHER INFORMATION


None





30






PART III


ITEM 10.

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE


The following individuals presently serve as officers and directors of the Company:


Name

Age

Position

James R. Musick, Ph.D.

64

Chairman of the Board, President, Chief Executive Officer, Chief Financial Officer and Secretary

Erik D. Van Horn

42

Vice President and Director

   

Richard Huebner

59

Director


Directors of the Company serve until the next annual meeting of shareholders and until their successors are elected and qualified.  Officers serve at the will of the Board of Directors.  


The Company currently has no audit, compensation, nomination or other committee of the Board of Directors and no financial experts on its Board.  The entire Board of Directors performs the functions typically performed by an audit committee.  There is no “audit committee financial expert” on the Board, as defined by SEC rule.  The absence of a financial expert has historically been due to the Company’s inability to attract any additional candidates to its Board due to its limited working capital, but hopes to identify one or more individuals in the future to add to its existing membership.


The following represents a summary of the business history of each of the foregoing individuals for at least the last five years:


JAMES R. MUSICK, Ph.D. was appointed President and Chief Executive Officer of the Company on August 7, 2000 where he served until April 2005.  He then resigned those positions to become the Chairman and Chief Operating Officer.  On May 19, 2006 he was re-appointed President and Chief Executive Officer.  From September 1, 1989 until August 7, 2000, Dr. Musick served as Vice President, Secretary and Chief Operating Officer of the Company.  He has also served as a director of the Company since September 1, 1989.  Dr. Musick received a Bachelor of Arts in Biological Sciences in 1968 and a doctorate in Biological Sciences in 1975 from Northwestern University in Evanston, Illinois.


ERIK D. VAN HORN was appointed Vice President of the Company on August 7, 2000.  He was also the Production Manager from 1993 to 2000 and a director of the Company from 1993 to 2004.  Mr. Van Horn is presently employed as a Manufacturing Senior Specialist with Amgen, Inc. in Longmont Colorado.  He received his Bachelor of Science in Chemical Engineering from the University of Colorado in 1990. He was appointed to the Board of Directors of the Company in May 2008.



31






RICHARD HUEBNER joined the Company’s Board of Directors in February 2010.  Mr. Huebner is a Senior Managing Partner of GVC Capital, LLC (formerly Bathgate Capital Partners, LLC) a Denver-based investment bank focused on microcap companies.  Mr. Huebner has an extensive, 30-year background in the securities industry.  He received a BA in Economics and Business Administration from Hastings College and a J.D. from the University of Nebraska.  He was previously General Counsel for Hanifen, Imhoff, Inc. from 1984 to 1995 where he served in numerous positions.  Following the sale of Hanifen, Imhoff to Fiserv, Inc in 1997, he continued with that firm.  He joined Bathgate Capital in 2001.  Mr. Huebner assists the Company in fund raising and its capital structure.


The Company has not established a code of ethics for its principal executive officers due to the cost of such procedure, but may consider adopting such code in the future as its resources permit.


Section 16(a) Beneficial Ownership Reporting Compliance


Under the securities laws of the United States, the Company's directors, its executive officers and any persons holding more than 10% of the Company's common stock are required to report their ownership of the Company's common stock and any changes in that ownership to the Securities and Exchange Commission.  Specific due dates for these reports have been established by rules adopted by the SEC and the Company is required to report in this Annual Statement any failure to file by those deadlines.  


Based solely upon public reports of ownership filed by such persons and the written representations received by the Company from those persons, all of our officers, directors and 10% owners have satisfied these requirements during its most recent fiscal year.   





32





ITEM 11.

EXECUTIVE COMPENSATION


The following table summarizes the total compensation of (i) the principal executive officer of the Company; (ii) any person who served as the principal executive officer during the last fiscal year, and (iii) the other individual who served as an executive officer at the end of the last fiscal year (the “Named Officers”):


SUMMARY COMPENSATION TABLE


Name

Year ended

October 31,

Salary

Total

James R. Musick, Chairman

2010

$87,500(2)

$87,500

President, Chief Executive

2009

$82,500(2)

$82,500

Officer, Chief Operating Officer, Chief Financial Officer

2008

$190,000(1)

$190,000

  



  



Eric Van Horn, Vice President

2010

-0-

-0-

 

2009

-0-

-0-

2008

-0-

-0-

  



  




(1)

Of this amount, $156,667 was accrued.

(2)

All of this amount was accrued.


Employment Contracts


Effective April 8, 2005, the Company entered into an employment agreement with Dr. Musick.  This agreement provided for an initial term of three years and is automatically renewable for an additional three-year period unless either party gives notice to the other that the agreement will be terminated.


The agreement provided a base salary of $180,000 per annum for the first year, $250,000 per annum for the second year, and $300,000 per annum during the third year.  The agreement also provided that if the Company obtained financing of $3 million or more during the first two years of the agreement, the base salary would automatically increase to $300,000 per annum effective with the closing of the financing.  Dr. Musick agreed to accrue salary until such time as the Company obtains sufficient working capital.


The agreement with Dr. Musick provided for the grant of stock options as follows:


·

Options to purchase 150,000 shares of the Company’s common stock at a price of $.17 per share, vesting at such time as the Company reports cumulative product sales of $125,000 during any one year as reported in any financial statement filed with the Securities and Exchange Commission on Form 10-Q or 10-K; and




33





·

Options to purchase an additional 150,000 shares of the Company’s common stock at market price, vesting at such time as the Company reports cumulative product sales of $250,000 during any one year as reported in any financial statement filed with the Commission on Form 10-Q or 10-K.


All of the options that were subject to vesting expire ten years from the date of vesting.  Further, each of the options would terminate ninety days from the date the employee’s employment with the Company is terminated.  All of the options were intended to be granted as “incentive stock options” under the Company’s Equity Incentive Plan of 2000, although the Plan must be amended and approved by the shareholders to increase the amount of common stock reserved under the Plan in order to provide for some of the options.


The Agreement also provided that if the Employee is terminated without cause or the employee resigns with “good reason,” the Company shall pay Employee one (1) year’s base salary at the rate prevailing for employee immediately prior to such termination as severance pay, payable in accordance with Company’s policy.  Employee shall also be entitled to receive benefits to which he was entitled immediately preceding the date of termination for a period of twelve (12) months from date of termination.  Resignation with good reason includes resignation following a change in control, as defined in the agreement.


Effective May 1, 2008, the Company entered into a new Executive Employment Agreement with its sole officer.  The Agreement establishes annual base salaries of $80,000, $85,000, and $90,000 over the three years of the Agreement.  The Agreement also provides for incentive compensation based on the achievement of minimum annual product sales and an option to purchase one million shares of the Company’s common stock that includes contingent vesting requirements. The new employment agreement includes changes in control given exercise of underlying stock options and also includes severance provisions.


Compensation of Directors


On May 1, 2008, the Company’s Board of Directors appointed Erik Van Horn to the Board.  The Board agreed to compensate Mr. Van Horn in the amount of $10,000, payable immediately, for one year of service on the Board and that the compensation may be applied to the exercise of outstanding options to purchase 100,000 shares of the Company’s common stock.  Mr. Van Horn notified the Board of his intention to utilize the compensation to exercise the stock options.  Effective May 1, 2008, the options were exercised and 100,000 shares of the Company’s common stock were issued to Mr. Van Horn.  In addition, in February 2010, the Company granted a total of 42,553 shares of the Company’s common stock to Mr. Van Horn for services to be earned during his service in 2010.


In February 2010, the Company appointed Mr. Richard Huebner to its Board of Directors.  The Company issued to Mr. Huebner 106,383 shares of the Company’s common stock as compensation for his commitment to serve on the Company’s board of directors.  The transaction was valued at $25,000, or $.235 per share based on the fair value of the stock on the transaction date.  Of the total transaction amount, $15,000 was considered as incentive to serve as a director, and as such the amount was charged to operations as stock compensation expense for the year ended October 31, 2010.  The remaining $10,000 was considered as compensation to be earned during his service in 2010.



34






Each board member is entitled to be reimbursed for reasonable expenses incurred in attending meetings or other service to the Company.


Outstanding Equity Awards at Fiscal Year-End


The following table summarizes the amount of our executive officers’ equity-based compensation outstanding at the fiscal year ended October 31, 2010:  


 

Option Awards

Stock Awards

Name

Number of Securities Underlying Unexercised Options Exercisable

Number of Securities Underlying Unexercised Options Unexercisable

Equity Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned Options

Option Exercise Price

Option Expiration Date

Number of Shares or Units of Stock That Have Not Vested

Market Value of
Shares
Or Units That Have Not Vested

Equity Incentive Plan Awards: Number of Unearned Shares, Units or Other Rights That Have Not Vested

Equity Incentive Plan Awards: Market or Payout Value of Unearned Shares, Units or Other Rights That Have Not Vested

 

(#)

(#)

(#)

($)

 

(#)

(#)

(#)

($)

 




 

 





James R. Musick

200,000

0

0

 $0.08

2/10/2016





James R. Musick

0

0

 300,000

 $0.17

4/01/2015





James R. Musick

0

0

 1,000,000

 $0.19

4/30/2018





 




 

 





  


Stock Option Plan


The Company adopted an Equity Incentive Plan on October 9, 2000 (the "Plan") for the benefit of key personnel and others providing significant services to the Company.  The Plan replaced the 1992 Equity Incentive Plan (the "1992 Plan").  The 1992 Plan will remain effective only so long as options remain outstanding under the 1992 Plan.  No new options will be granted under the 1992 Plan, and the only shares that will be issued under the 1992 Plan are those shares underlying currently outstanding options.  


The Plan authorizes total awards of up to 1,000,000 shares of the Company's common stock.  Awards may take the form of incentive stock options, non-qualified stock options, restricted stock awards, stock bonuses and other stock grants.  If an award made under the Plan expires, terminates, is canceled or settled in cash without the issuance of all shares of common stock covered by the award, those shares will be available for future awards under the Plan.  Awards may not be transferred except by will or the laws of descent and distribution.  No awards may be granted under the Plan after September 30, 2010.


The Plan is administered by the Company's Board of Directors, which may delegate its authority to a committee of the Board of Directors.  The Board of Directors has the authority to select individuals to receive awards, to determine the time and type of awards, the number of shares covered by the awards, and the terms and conditions of such awards in accordance with the terms of the Plan.  In making such determinations, the Board of Directors may take into account the recipient's current and potential contributions and any other factors the Board of Directors considers relevant.  The Board of Directors is authorized to establish rules and regulations and make all other determinations that may be necessary or advisable for the administration of the Plan.




35





All options granted pursuant to the Plan shall be exercisable at a price not less than the fair market value of the common stock on the date of grant.  Unless otherwise specified, the options expire ten years from the date of grant.  


The following table illustrates the number of shares remaining available for issuance under the Plan.


Equity Compensation Plan Information


Plan Category

Number of securities to be issued upon exercise of outstanding options, warrants and rights
(a)

Weighted-average exercise price of outstanding options, warrants and rights
(b)

Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))
(c)

Equity compensation plans approved by security holders

543,500

$0.15

0

Equity compensation plans not approved by security holders

162,364

$0.30

0

TOTAL

705,864

$0.18

0


Compensation plan not approved by security holders included the 1992 equity incentive plan.


ITEM 12.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS


The following table sets forth information as of January 18, 2011 based solely on information available to the Company, with respect to the ownership of the Company's common stock by all officers and directors individually, all officers and directors as a group, and all shareholders known to the Company to hold beneficially more than five percent (5%) of the Company's common stock.  The percentages in the table assume that any options or warrants owned by the beneficial owner exercisable within 60 days are exercised, but that no other outstanding options or warrants are exercised.  At January 28, 2011, the Company had outstanding 18,379,985 shares of common stock, the only class of voting stock outstanding.




36





The following shareholders have sole voting and investment power with respect to the shares, unless it is indicated otherwise.  


Name and Address of Beneficial Owner

Number of Shares

%

Officers and Directors

  
   

James R. Musick(1) (2)
4621 Technology Drive,
Golden, Colorado 80403

5,250,755

28.26%

 



Erik Van Horn
4621 Technology Drive,
Golden, Colorado 80403

342,553

1.86%

 



Richard Huebner



4621 Technology Drive,
Golden, Colorado 80403

106,383

0.58%

 



Officers and Directors as a group(1) (2)
(3 individuals)

5,699,691

31.01%

 



Other Shareholders



 



Lloyd Hansen
2646 S.W. Mapp Rd, Ste. #304
Palm City, FL 34990

980,000

5.33%

___________________

(1)

Includes 200,000 shares of common stock underlying an option immediately exercisable.

(2)

Includes 2,665,257 shares held by The James R. Musick Trust, of which Mr. Musick is a trustee and beneficiary.


Changes in Control


The Company knows of no arrangement, including the pledge by anyone of any securities of the Company that may result in a change in control.




37





ITEM 13.

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.


In November 2008, the Company sold 226,667 shares of its common stock to the Company's Chairman, James Musick for $8,500, or $.0375 per share.  


Between August 2002 and October 2007, the Company's Chairman, James Musick, loaned the Company $168,150 for working capital.  This loan and the accrued interest of $35,483 have been represented by a single promissory note in the amount of $203,633 dated October 31, 2007 bearing interest at the rate of 10% per year.  The note replaced a previous note.  This note was due on October 31, 2008 and was collateralized by the Company's patents regarding purification of FSH. On July 29, 2008, the Board of Directors approved the issuance of 1,238,176 shares of the Company’s common stock in exchange for the notes payable plus accrued interest to an officer not to exceed $225,000.  At that time the Note was canceled effective July 29, 2008.  The exchange was completed in February 2009.  A total of $224,333, representing the balance of the note payable and accrued interest, plus the outstanding balance of other indebtedness to the officer of $5,530 was exchanged for 1,238,176 shares of the Company’s common stock.


During November, 2006, the Company sold 535,714 shares of its common stock to Dr. Musick of the Company for $30,000, or $.056 per share.  During August 2006, the Company sold 535,714 shares of its common stock to Dr. Musick for $30,000, or $.056 per share.  During May 2006, the Company sold 625,000 additional shares of its common stock to Dr. Musick for $20,000, or $.032 per share.  Finally, during February 2006, the Company sold 312,500 shares of its commons stock to Dr. Musick for $20,000, or $.064 per share.


The Company's Board of Directors is of the opinion that the terms of these transactions are no less favorable than could be obtained from an unaffiliated third party.


ITEM 14

PRINCIPAL ACCOUNTANT FEES AND SERVICES.


The following table details the aggregate fees billed to the Company by Schumacher & Associates, Inc., its current accountant, for each of the last two fiscal years:


  

2010

2009

 

Audit Fees

$11,800

$9,450

 

Audit-Related Fees

-

-

 

Tax Fees

-

-

 

All Other Fees

______-

              -

    
 

Total

$11,800

$9,450


       The caption "Audit Fees" includes professional services rendered for the audit of the annual consolidated financial statements and review of the quarterly consolidated financial statements.


       It is the policy of the Board of Directors, acting as the audit committee to pre-approve all services to be performed by the independent accountants.



38






PART IV


ITEM 15.

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES


The following is a list of exhibits filed or incorporated by reference into this Report:


No.

Description

1

Not applicable.

2

Not applicable.

3.1.1(1)

Articles of Incorporation of the Company as filed March 31, 1986 with the Nevada Secretary of State.

3.1.2(2)

Certificate of Merger of Domestic and Foreign Corporations as filed December 17, 1986 with the Nevada Secretary of State.

3.1.3(3)

Certificate of Amendment of Articles of Incorporation as filed February 6, 1987 with the Nevada Secretary of State.

3.1.4(2)

Certificate of Amendment of Articles of Incorporation as filed May 18, 1988 with the Nevada Secretary of State.

3.1.5(4)

Amended and Restated Articles of Incorporation of the Company , as filed July 20, 2001 with the Nevada Secretary of State

3.2(3)

Bylaws of the Company.

4.1(3)

Specimen certificate for Common Shares, $.001 par value per share.

9

Not applicable.

10.1(5)

Equity Incentive Plan dated October 9, 2000

10.2

Promissory note issued by the Company to James R. Musick dated October 31, 2007.

10.3(6)

Executive Employment Agreement between the Company and James R. Musick dated April 1, 2005.

10.4(7)

Common Stock and Warrant Purchase Agreement

10.5(8)

Form of Class A Warrant Agreement

11

Not applicable.

13

Not applicable.

14

Not applicable.

16

Not applicable.

18

Not applicable.

20

Not applicable.

21

Not applicable.

22

Not applicable

23

Not applicable.

24

Not applicable.

31.1

Certification pursuant to Rule 13a-14(a) or 15d-14(a) under the Securities Exchange Act of 1934, as amended.

32

Certifications pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

99

Not applicable.

___________________

(1)

Filed as an Exhibit to Form 10-KSB dated October 31, 2000.

(2)

Filed as an Exhibit to Form 10-KSB/A dated July 31, 2000.



39





(3)

Filed as an Exhibit to Registration Statement on Form SB-2, SEC File No. 33-59230 and incorporated herein by reference.

(4)

Filed as an Exhibit to Form 10-KSB for the year ended October 31, 2001.

(5)

Filed as an Exhibit to the definitive Proxy Statement on Schedule 14/A as filed with the Commission on October 30, 2000 and incorporated herein by reference.

(6)

Filed as Exhibit 10.1 to the Form 8-K dated April 8, 2005 and incorporated herein by reference.

(7)

Filed as Exhibit 10.1 to the Form 8-K dated January 31, 2008.

(8)

Filed as Exhibit 10.2 to the Form 8-K dated January 31, 2008





40






SIGNATURES


Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has caused this Report to be signed on its behalf by the undersigned thereunto duly authorized in Aurora, Colorado on the 28TH day of January, 2011.


VITRO DIAGNOSTICS, INC.



By:

 /s/ James R. Musick

James R. Musick, Chairman


Pursuant to the requirements of the Security Exchange Act of 1934, as amended, this Report has been signed by the following persons in the capacities and on the dates indicated.


Signatures

Title

Date

   

/s/ James R. Musick

James R. Musick

President, Chairman of the Board, Chief Executive Officer, Principal Financial and Accounting Officer, Director

January 28, 2011

   

/s/ Erik D. VanHorn

Erik D. VanHorn

Vice President and Director

January 28, 2011



_/s/ Richard Huebner

Director

January 28, 2011

Richard Huebner