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8-K - VITRO DIAGNOSTICS, INC. - VITRO DIAGNOSTICS INCvitro_8k.htm

Press Release

  Source: Vitro Diagnostics, Inc.

 

 

2017 CEO Shareholder Letter: Translation from R&D to Stem Cell Therapies Accelerates Revenue and Prospects for Future Growth

Golden, Colorado—December 20, 2017Vitro Diagnostics, Inc. (OTCQB: VODG), dba Vitro Biopharma, announced its CEO letter to its shareholders including discussion of 2016 & 2017 results and plans for 2018 including regenerative medicine initiatives for expanding indications.  

Dear Shareholders,

In 2016-2017 we achieved:

Accelerated translation from research products to stem cell therapies. 

Expansion of our facility costing $125,000 to comply with FDA Good Manufacturing Practices (GMP) for clinical manufacturing. Thus, positioning us for regulatory certifications. 

Expanded our management team to include a seasoned executive as CFO who has executed numerous M&A transactions, raised substantial capital and grown revenues exceeding $250 million per year in his prior companies. 

Added stem cell medical experts to our advisory board and clinical trial support team. 

Increased revenues by 153% with the addition of 40% of total revenue derived from stem cell therapy products and services in 2017. 

Filed 7 patents protecting novel technology for stem transplants, stem cell activation and diagnostics. 

Raised $400,000 in capital and financing to fund expansion of clean room operations and new product development. 

Golden, Colorado—December, 20, 2017 Vitro Diagnostics, Inc. (OTCPK: VODG), dba Vitro Biopharma, announced record revenues for 2017 of $262,148 vs. $171,772 in 2016 based on both expansion of revenues from its core products, including cancer-associated fibroblasts used to accelerate development of immunotherapy of solid tumors and especially new revenues derived from stem cell therapies $104,919 in 2017 vs. $38,860 in 2016.  The financial statements (unaudited) for 2016 & 2017 are attached below.

 

The Company raised capital to install a GMP-compliant clean-room for manufacturing of all clinical products and develop a Quality Management System (QMS).  This is important since clinical trial protocols require adherence to GMP guidelines issued by the FDA.  The Company plans near-term completion of ISO (International Standards Organization) certification together with CLIA (Clinical Laboratory Improvement Act) certification, for manufacturing and clinical diagnostics, respectively. We also intend appropriate FDA filings to support our clinical manufacturing. Our current clinical trials include autism and anti-inflammation though collaborators in the Czech Republic and Cayman


Islands respectfully.  We also supply our first in class stem cell expansion culture medium (MSC-Gro™) to an Australian firm conducting clinical trials of MSC transplants for osteoarthritis (OA).    All clinical manufacturing operations occur within a sterile clean room environment that is rigorously controlled to ensure sterility and the absence of contamination during the processing of cellular materials and cell culture media.  

 

We also expanded our intellectual property (IP) to include a novel stem cell line patent application for use in  numerous regenerative medicine applications including auto-immune disorders such as Lupus, cardiovascular disease, musculoskeletal conditions such as OA and various neurodegenerative disorders.  Additional patent applications have been filed for treatment of neurological disorders by activation of stem cells within the brain. Our IP now allows proprietary therapies of neurological conditions including Parkinson’s disease, Alzheimer’s disease and traumatic brain injury (TBI), etc.  Neurological conditions have been under-treated for many years while stem cell therapies offer potentially effective solutions. Hence, we plan commercialization of TBI therapies beginning in early 2018.  There are more than 1.7 million TBI patients per year in the US while therapy consists of life-saving measures followed by rehabilitation with minimal therapeutic options.  Recent advances in stroke recovery by stem cell therapy highlight the regenerative potential of stem cell therapies for neurodegenerative conditions and support the concept of brain regeneration by stem cell therapy.  Our TBI initiative involves stem cell activation therapy and advanced diagnostics including biomarker profiling and brain scans.

 

Current management has decided to focus our operational resources to achieve rapid revenue growth & profitability in our high value-added Stem Cell therapies while seeking appropriate strategic alliances and partnerships.  Our eventual goal is to be acquired by a larger firm with complimentary resources to those of the Company. The company has made a strategic decision to focus its resources on expanding its revenue base driven by internal growth and limited capital raising.  This decision will minimize shareholder dilution while building the company’s market value. We do not intend to maintain SEC reporting compliance because of the excessive cost burden of Audits and SEC legal compliance.  The company will provide unaudited financial reports and publication of material transactions while maintaining future options to becoming fully reporting with the SEC if required or be acquired in an acquisition transaction.

 

In summary, Vitro Biopharma is advancing as a key player in regenerative medicine with 10-years’ experience in the development and commercialization of stem cell products for research, recognized by a Best in Practice Technology Innovation Leadership award for Stem Cell Tools and Technology and a growing track record of successful translation to therapy. We plan to leverage our proprietary technology platform to the establishment of international Stem Cell Centers of Excellence and regulatory approvals in the US.

 

Sincerely yours,

 

James R. Musick, PhD.

President, CEO & Chairman of the Board


Forward-Looking Statements

 

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company’s auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain “forward-looking statements”.  Such forward looking statements are identified by words such as “intends,” “anticipates,” “believes,” “expects” and “hopes” and include, without limitation, statements regarding the Company’s plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures.  Factors that could cause actual results to differ materially include, among others, acceptability of the Company’s products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company’s filings with the Securities and Exchange Commission.  Most of these factors are outside the control of the Company.  Investors are cautioned not to put undue reliance on forward-looking statements.  Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

 

CONTACT:

Dr. James Musick

Chief Executive Officer 

Vitro Biopharma 

(303) 999-2130 Ext. 3  

E-mail: jim@vitrobiopharma.com  

 

Source: Vitro Diagnostics, Inc.


Vitro Diagnostics Inc.

 

 

 

 Year Ended Oct 31;

2017

 

2016

 Income Statement

 

 

 

 

 

 

 

 

 

Stem Cell Therapies

 

          104,919

 

           38,860

Stem Cell Products

 

          150,203

 

         126,438

Other

 

 

              7,026

 

             6,474

Total Revenues

 

$      262,148

 

$     171,772

 

 

 

 

 

 

Cost of Goods Sold

 

          104,707

 

           65,130

 

 

 

 

 

 

Gross Profit

 

         157,440

 

         106,642

 

 

 

 

 

 

SGA Expenses

 

          165,588

 

           48,073

Office Expenses

 

            27,986

 

           20,512

Legal, Accounting, Banking Fees & Expenses

          137,460

 

           77,036

Laboratory R&D & Q.C. Expenses

          122,170

 

           92,386

Total Operating Expenses

         453,203

 

         238,006

 

 

 

 

 

 

Net Operating Profit (Loss)

        (295,763)

 

       (131,364)

 

 

 

 

 

 

 

 

 

 

 

 

Non-Cash Interest on Secured Notes Payable

          (10,417)

 

 

Non-Cash Interest on Shareholder Debt

        (144,018)

 

       (125,868)

 

 

 

 

 

 

Net Income (Loss)

 

        (450,198)

 

       (257,232)

 

 

 

 

 

 

 

 

The company provides its financial information for investor purposes the results published however are not audited or necessarily SEC compliant.


Vitro Diagnostics Inc.

 

 

 

 Year Ended Oct 31;

2017

 

2016

 Balance Sheet

 

 

 

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

Cash

 

              2,612

 

             3,121

 

Accounts Receivable

            40,882

 

           32,979

 

Inventory

 

            24,978

 

           28,806

 

Fixed Assets

          172,519

 

           49,681

 

Intangible Assets

            22,269

 

           29,131

 

Total Assets

         263,260

 

         143,718

 

 

 

 

 

 

LIABILITIES

 

 

 

 

 

 

 

 

 

 

 

Accounts Payable

            49,929

 

         153,366

 

Short Term Credit Cards

            53,365

 

           41,717

 

Capital Lease Obligations

            18,544

 

           11,495

 

Current Liabilities

         121,838

 

         206,578

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Secured Notes Payable

          360,417

 

                    -   

 

Capital Lease Obligations

            74,178

 

                    -   

 

Shareholder Accrued Compensation Payable

      1,205,958

 

      1,205,958

 

Shareholder Debts Payable

      1,532,785

 

      1,365,900

 

Long Term Liabilities

      3,173,338

 

     2,571,857

 

 

 

 

 

 

 

Total Liabilities

      3,295,176

 

     2,778,436

 

 

 

 

 

 

SHAREHOLDERS EQUITY

 

 

 

 

 

 

 

 

 

 

Common Stock

            21,432

 

           20,372

 

Paid in Capital

      5,508,387

 

      5,456,447

 

Retained Earnings

     (8,111,537)

 

    (7,854,305)

 

Net Income

        (450,198)

 

       (257,232)

 

Total Equity

    (3,031,916)

 

    (2,634,718)

 

 

 

 

 

 

TOTAL LIABILITES AND EQUITY

         263,260

 

         143,718

 

 

 

 

 

 

 

The company provides its financial information for investor purposes the results published however are not audited or necessarily SEC compliant.


STATEMENTS OF CASH FLOW

2017

 

 

For the year ended:

 

 

 

 

 

 

 

 

 

Net Loss

 

 

        (450,198)

 

 

 

 

 

 

 

 

 

Non-Cash Depreciation

              9,220

 

 

 

Amortization of Intangible Assets, net

            (6,862)

 

 

 

Increase in current Assets

              3,567

 

 

 

Increase in Current Liabilities

          (84,740)

 

 

 

Principal payments on capital leases

          (36,312)

 

 

 

Net cash used in operating activities

        (115,126)

 

 

 

 

 

 

 

 

Cashflows from Investing Activities

 

 

 

 

Halo Intercompany Account, net

          (37,532)

 

 

 

Purchases of equipment

        (125,930)

 

 

 

Equipment Financed

          120,459

 

 

 

Draws on lines of credit, net

            11,648

 

 

 

Secured Notes Payable

          360,417

 

 

 

Increase in Shareholder Debt

            28,318

 

 

 

Non-Cash Services provided for Stock

            53,000

 

 

 

Non-Cash Shareholder Debt Interest

          154,435

 

 

 

Net Cash provided by Financing Activities

         564,815

 

 

Net Change in Cash

 

 

 

 

 

 

 

               (509)

 

 

Cash Beginning of the year.

 

 

 

 

 

 

3,121

 

 

Cash End of the year

 

 

 

 

 

 

              2,612

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

STATEMENT OF CHANGES IN SHAREHOLDER EQUITY

Shares

Par Value

Paid in Capital

 

 

 

 

 

 

Balance October 31, 2016

    20,371,822

    20,371

     5,456,447

 

 

 

 

 

 

Services Paid with Stock 2017

      1,060,000

       1,060

           51,940

 

 

 

 

 

 

Balance October 31, 2017

    21,431,822

    21,431

     5,508,387

 

The company provides its financial information for investor purposes the results published however are not audited or necessarily SEC compliant.