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MTST > SEC Filings for MTST > Form 10-Q on 15-Jul-2013All Recent SEC Filings

Show all filings for METASTAT, INC.

Form 10-Q for METASTAT, INC.


15-Jul-2013

Quarterly Report


Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.

References in this report to "we," "us," "our," "the Company" and "MetaStat" refer to MetaStat, Inc. and its subsidiary. References to the "SEC" refer to the U.S. Securities and Exchange Commission.

Forward-Looking Statements

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our consolidated financial statements and the related notes included elsewhere in this interim report. Our consolidated financial statements have been prepared in accordance with U.S. GAAP. Our consolidated financial statements and the financial data included in this interim report reflect our reorganization and have been prepared as if our current corporate structure had been in place throughout the relevant periods. The following discussion and analysis contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934 (the "Exchange Act"), including, without limitation, statements regarding our expectations, beliefs, intentions or future strategies that are signified by the words "expect," "anticipate," "intend," "believe," or similar language. All forward-looking statements included in this document are based on information available to us on the date hereof, and we assume no obligation to update any such forward-looking statements. Our business and financial performance are subject to substantial risks and uncertainties. Actual results could differ materially from those projected in the forward-looking statements. In evaluating our business, you should carefully consider the information set forth under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended February 28, 2013. Readers are cautioned not to place undue reliance on these forward-looking statements.

The following discussion of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and the related notes thereto and other financial information appearing in our Annual Report on Form 10-K for the year ended February 28, 2013.

Business Overview

We are a development stage life sciences company that is focused on developing and commercializing novel diagnostic technologies and therapeutics for the early and reliable prediction and treatment of systemic metastasis - cancer that spreads from a primary tumor through the bloodstream to other areas of the body. Systemic metastasis is responsible for ~90% of all solid tumor cancer related deaths and as such, we believe the more effective treatment of metastatic disease and/or the prevention of systemic metastasis is needed to improve patient outcomes.

We are developing two function-based diagnostic product lines, MetaSite Breast™ and MenaCalc™. The MetaSite Breast™ test measures the process of systemic metastasis and is intended for early stage breast cancer patients. MenaCalc™, a platform of diagnostic assays, based on the measurement of the balance of the Mena protein isoforms, is broadly applicable in solid epithelial-based cancers, including breast, prostate, lung and colorectal. Both our MetaSite Breast™ and MenaCalc™ diagnostics are designed to accurately predict the probability of systemic metastasis and to allow clinicians to better "customize" cancer treatment decisions by positively identifying patients with a high-risk of systemic metastasis who need aggressive therapy and by sparing patients with a low-risk of systemic metastasis from the harmful side effects and expense of chemotherapy.

Additionally, we are developing our MenaBloc™ therapeutic platform, with the goal of discovering inhibitors of the Mena pathway that can be advanced as anti-cancer therapeutics in multiple epithelial-based tumor types.

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In January 2013, we completed a 500 patient study of the MetaSite Breast™ test. The data from this study has been analyzed and submitted for publication in a peer-reviewed journal. We anticipate establishing a laboratory that will be a clinical reference laboratory as defined under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA"). Based on CLIA certification, we anticipate commencing initial marketing of the MetaSite Breast™ test in 2014 followed by our MenaCalc™ diagnostic assay for breast cancer in 2015. We plan to initially market to a select number of physicians and cancer centers in a few select markets in the United States. We believe a subsequent increase in demand will result from the publication of further studies in one or more peer-reviewed scientific/medical journals and the presentation of study results at gatherings such as the ASCO meeting and the San Antonio Breast Cancer Symposium. However, any increased demand for our product is not necessarily indicative of future growth rates, and we cannot assure you that this level of increased demand can be sustained. Initially, we expect our reference laboratory will have the capacity to process up to 1,000 tests per quarter, and our current expansion plan contemplates that we will have capacity to process up to 15,000 tests per quarter by the end of calendar 2015.

We believe the key factors that will drive broader adoption of our function-based diagnostic assays will be acceptance by healthcare providers of their clinical benefits, demonstration of the cost-effectiveness of using our tests, expansion of our sales force and increased marketing efforts and expanded reimbursement by third-party payors. Reimbursement by third-party payors is essential to our commercial success. In general, clinical laboratory testing services, when covered, are paid under various methodologies, including prospective payment systems and fee schedules. Reimbursement from payors depends upon whether a service is covered under the patient's policy and if payment practices for the service have been established. As a relatively new diagnostic test, we may be considered investigational by payors and not covered under current reimbursement policies. Until we reach agreement with an insurer on contract terms or establish a policy for payment of our function-based diagnostic tests, we expect to recognize revenue on a cash basis.

Upon commercialization of the MetaSite Breast™ test, we will begin working with third-party payors to establish reimbursement coverage policies. Where policies are not in place, we will pursue case-by-case reimbursement. We believe that as much as 20% of our future revenues may be derived from tests billed to Medicare. We will begin working with many payors, including Medicare, to establish policy-level reimbursement, which, if in place, will allow us to recognize revenues upon submitting an invoice. We do not expect to recognize the majority of revenues in this manner until calendar 2015, at the earliest.

Since our inception, we have generated significant net losses. As of May 31, 2013, we had an accumulated deficit of $8,184,422. We incurred net losses of $2,821,943 and $390,958 in the quarter ended May 31, 2013 and May 31, 2012, respectively. We expect our net losses to continue for at least the next several years. We anticipate that a substantial portion of our capital resources and efforts will be focused on research and development both to develop additional tests for breast cancer and to develop products for other cancer indications, and to scale up our commercial organization, and other general corporate purposes. Our financial results will be limited by a number of factors, including establishment of coverage policies by third-party insurers and government payors, our ability in the short term to collect from payors often requiring a case-by-case manual appeals process, and our ability to recognize revenues other than from cash collections on tests billed until such time as reimbursement policies or contracts are in effect. Until we receive routine reimbursement and are able to record revenues as tests are processed and reports delivered, we are likely to continue reporting net losses.

Going Concern

As of May 31, 2013, the Company had an accumulated deficit of $8,184,422. The Company currently anticipates that its cash and cash equivalents will be sufficient to fund its operations through October 2013, without raising additional capital. The continuation of the Company as a going concern is dependent upon continued financial support from its shareholders, the ability of the Company to obtain necessary equity and/or debt financing to continue operations, and the attainment of profitable operations. These factors raise substantial doubt regarding the Company's ability to continue as a going concern. The Company cannot make any assurances that additional financings will be completed on a timely basis, on acceptable terms or at all. If the Company is unable to complete a debt or equity offering, or otherwise obtain sufficient financing when and if needed, it would negatively impact it's business and operations, which could cause the price of its common stock to decline. It could also lead to the reduction or suspension of the Company's operations and ultimately force the Company to go out of business.

Critical Accounting Policies and Significant Judgments and Estimates

This discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles. The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as revenues and expenses during the reporting periods. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results could therefore differ materially from those estimates under different assumptions or conditions.

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Our significant accounting policies are described in Note 2 to our consolidated financial statements included in this Form 10-Q. We believe the following critical accounting policies reflect our more significant estimates and assumptions used in the preparation of our financial statements.

Revenue Recognition

We have generated no revenues since our inception. Product revenues for our first product, the MetaSite Breast™ test, are expected to be generated from the projected commercial launch in 2014, and are expected to be recognized on a cash basis because we will have limited collection experience and a limited number of contracts. In accordance with our policy, revenues for tests performed will be recognized on an accrual basis when the related costs are incurred, provided there is a contract or coverage policy in place and the following criteria are met:

? persuasive evidence that an arrangement exists;

? delivery has occurred or services rendered;

? the fee is fixed and determinable; and

? collectability is reasonably assured.

Determination of the last two criteria will be based on management's judgment regarding the nature of the fee charged for products or services delivered and the collectability of those fees.

We expect to generally bill third-party payors for the MetaSite Breast™ test upon generation and delivery of a Metastasis Score report to the physician. Accordingly, we take assignment of benefits and the risk of collection with the third-party payor. We expect to bill the patient directly for amounts owed after multiple requests for payment have been denied or only partially paid by the insurance carrier. As a new test, the MetaSite Breast™ test may be considered investigational by payors and not covered under their reimbursement policies. Consequently, we expect to pursue case-by-case reimbursement where policies are not in place or payment history has not been established.

Financial Operations Overview

Revenues

We currently do not have any revenues. We expect to derive our revenues from product sales and operate in one industry segment. Initially, our product revenues will be derived solely from the sale of the MetaSite Breast™ test. Payors will be generally billed upon generation and delivery of a Metastasis Score report to the physician. Product revenues will be recorded on a cash basis unless a contract or policy is in place with the payor at the time of billing and collectability is reasonably assured. Initially, all product revenues recognized will probably reflect cash collections.

Cost of Product Revenues

Cost of product revenues represents the cost of materials, direct labor, costs associated with processing tissue samples including histopathology, anatomical pathology, paraffin extraction, and quality control analyses, license fees and delivery charges necessary to render an individualized test result. Costs associated with performing our test will be recorded as tests are processed. License fees to third-party vendors would be recorded at the time product revenues are recognized or in accordance with other contractual obligations. We expect that license fees will represent a significant component of our cost of product revenues and are expected to remain so for the foreseeable future.

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General and Administrative Expenses

General and administrative expenses from our inception through May 31, 2013 were $3,230,287. Our general and administrative expenses consist primarily of personnel related costs, legal costs, including intellectual property, accounting costs and other professional and administrative costs.

Research and Development Expenses

Research and development expenses from our inception through May 31, 2013 were $1,640,918, and substantially all of these expenses were focused on the research and development of the MetaSite Breast™ test. During this time, the MetaSite Breast™ test was not the only product under development. Research and development expenses also represent costs incurred to develop our MenaCalc™ platform of diagnostic assays in breast, lung, and prostate cancers and initial research on our MenaBloc™ therapeutic platform.

We charge all research and development expenses to operations as they are incurred. All potential future product programs, apart from the MetaSite Breast™ test for breast cancer metastasis, are in the clinical research phase, and the earliest we expect another cancer program to reach the clinical development stage is late 2013. However, the expected time frame that a product related to one of these other cancers can be brought to market is uncertain given the technical challenges and clinical variables that exist between different types of cancers.

We do not record or maintain information regarding costs incurred in research and development on a program or project specific basis. Our research and development staff working under sponsored research agreements and consulting agreements and associated infrastructure resources are deployed across several programs. Many of our costs are thus not attributable to individual programs. We believe that allocating costs on the basis of time incurred by our employees does not accurately reflect the actual costs of a project.

As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development programs or when, if ever, and to what extent we will receive cash inflows from the commercialization and sale of a product.

Selling and Marketing Expenses

Our selling and marketing expenses that we expect to incur coincident with the launch of the MetaSite Breast™ test will consist primarily of personnel costs and education and promotional expenses. We expect these expenses will include the costs of educating physicians, laboratory personnel and other healthcare professionals regarding our technologies, how our MetaSite Breast™ test was developed and validated and the value of the quantitative information that the MetaSite Breast™ test provides. Selling and marketing expenses will also include the costs of sponsoring continuing medical education, medical meeting participation and dissemination of our scientific and economic publications related to the MetaSite Breast™ test. Sales and marketing expenses from our inception through May 31, 2013 were $0.

Results of Operations

Comparison of the Three Months Ended May 31, 2013 and May 31, 2012

Revenues. There were no revenues for the three months ended May 31, 2013 and May 31, 2012, respectively, because we have not yet commercialized any of our function-based diagnostic tests.

Cost of Product Revenues. No cost of product revenues were recorded in the three months ended May 31, 2013 and May 31, 2012, respectively, because we have not yet commercialized any of our function-based diagnostic tests.

General and Administrative Expenses. General and administrative expenses totaled $565,103 for the three months ended May 31, 2013 as compared to $332,858 for the three months ended May 31, 2012. This represents an increase of $232,245 for the three months ended May 31, 2013 over the three months ended May 31, 2012. This increase was due in part to increases in costs for employee salaries, legal, including intellectual property, accounting and other professional costs.

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Research and Development Expenses. Research and development expenses were $99,715 for the three months ended May 31, 2013 as compared to $56,000 for the three months ended May 31, 2012. This represents an increase of $43,715 for the three months ended May 31, 2013 over the three months ended May 31, 2012. This increase resulted primarily that payments for the analysis of the MetaSite Breast™ test and to further the development of the MenaCalc™ assay.

Selling and Marketing Expenses. There were no selling and marketing expenses recorded for the three months ended May 31, 2013 and May 31, 2012, respectively, because we have not yet commercialized any of our function-based diagnostic tests.

Accretion Expense. Warrant expenses were $173,982 for the three months ended May 31, 2013 as compared to $0 for the three months ended May 31, 2012.

Stock-based Compensation. Stock-based compensation was $1,972,079 for the three months ended May 31, 2013 as compared to $0 for the three months ended May 31, 2012.

Interest Income and Other Income/ Expense. We recorded interest income of $61 during the three months ended May 31, 2013 and $232 during the three months ended May 31, 2012.

Interest Expense. We made no interest payments on borrowings during the three months ended May 31, 2013 and May 31, 2012, respectively.

Net Loss. As a result of the factors described above, we had a net loss of $2,821,943 for the three months ended May 31, 2013 as compared to $390,958 for the three months ended May 31, 2012.

Liquidity and Capital Resources

Since our inception, we have incurred significant losses and, as of May 31, 2013, we had an accumulated deficit of $8,184,422. We have not yet achieved profitability and anticipate that we will continue to incur net losses for the foreseeable future. We expect that our research and development, general and administrative and selling and marketing expenses will continue to grow and, as a result, we will need to generate significant product revenues to achieve profitability. We may never achieve profitability.

Sources of Liquidity

Since our inception, substantially all of our operations have been financed through the sale of our common stock and convertible promissory notes. Through May 31, 2013, we had received net proceeds of $4,283,755 through the sale of common stock to investors and $1,487,000 from the sale of convertible promissory notes. As of May 31, 2013, we had cash and cash equivalents of $934,817 and net debt of $1,560,177. As a result of the most recent sale of shares of common stock and convertible promissory notes through May 31, 2013, we have issued and outstanding warrants to purchase 2,810,552 shares of our common stock at a weighted average exercise price of $1.18, which will result in proceeds to us of approximately $3.3 million if all outstanding warrants are exercised.

Cash Flows

As of May 31, 2013, we had $934,817 in cash and cash equivalents, compared to $1,704,516 on May 31, 2012.

Net cash used in operating activities was $806,407 for the three months ended May 31, 2013 compared to $614,925 for the three months ended May 31, 2012. The increase in cash used of $191,482 was primarily due to employee salaries and professional fees.

Net cash used in investing activities was $1,141 for the three months ended May 31, 2013, compared to $278,889 for the three months ended May 31, 2012. This decrease of $277,748 was attributed to a decrease in cash paid for certificate of deposits and for the purchase of equipment. We expect amounts used in investing activities to increase in fiscal year 2013 and beyond as we grow our corporate operations, expand research and development activities and establish and add capacity in our commercial laboratory.

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Net cash provided by financing activities during the three months ended May 31, 2013 was $773,177, compared to $1,720,000 for the three months ended May 31, 2012. Financing activities consisted primarily of the sale of convertible promissory notes and warrants for the three months ended May 31, 2013 and the sale our common stock and warrants for the three months ended May 31, 2012, respectively.

Contractual Obligations

As of May 31, 2013, we had the following contractual commitments:

                                                Payments Due by Period
                                                                                     More
                                      Less than                                     than 5
Contractual Obligations    Total        1 Year        1-3 Years       4-5 Years     Years
                                                    (In thousands)
License Agreement          $  385     $       30     $       155     $     200     $  (a)

Second License Agreement   $  297     $       12     $       110     $     175        (b)

Third License Agreement $ 297 $ 12 $ 110 $ 175 (c)

(a) Amount of additional payments depends on several factors, including the duration of the License Agreement, which depends on expiration of the last patent to be issued pursuant to the License Agreement. That duration is uncertain because the last patent has not yet been issued.

(b) Amount of additional payments depends on several factors, including the duration of the Second License Agreement, which depends on expiration of the last patent to be issued pursuant to the Second License Agreement. That duration is uncertain because the last patent has not yet been issued.

(c) Amount of additional payments depends on several factors, including the duration of the Third License Agreement, which depends on expiration of the last patent to be issued pursuant to the Third License Agreement. That duration is uncertain because the last patent has not yet been issued.

License Agreement

The Company entered into a Patent and Technology License Agreement (the "License Agreement") with the Albert Einstein College of Medicine of Yeshiva University, Massachusetts Institute of Technology, Cornell University, and the IFO-Regina Elena Cancer Institute (together the "Licensors") during August 2010. In conjunction with entering into the License Agreement, the Company also entered into a Stock Subscription Agreement (the "Subscription Agreement") and a Stockholders Agreement (the "Stockholders Agreement") with the Licensors, which included provisions such as participation rights in future financings, co-sale rights, and certain limited anti-dilution rights. The Subscription Agreement and Stockholders Agreement were terminated as of February 27, 2012. The License Agreement grants the Company a world-wide exclusive license to materials and methods for use in the diagnosis and treatment of metastatic spread of solid tumor cancers. In return, the Company has agreed to grant Company equity to the Licensors, to reimburse the Licensors patent expenses thus far incurred, to pay all future patent expenses, pay a royalty on any sales of product using licensed technology, as well as certain minimum royalties and milestone payments.

Pursuant to the License Agreement, we are required to make a series of annual minimum royalty or "license maintenance" payments under the License Agreement beginning on the first anniversary date, or August 26, 2011. For a period of seven years on each anniversary, we are required to make additional payments in amounts that gradually increase beginning in year five. To date, we have satisfied both the initial payment for 2011 and the second payment for 2012 in the amount of $30,000, respectively. We are required to make additional payments of $30,000 in each of 2013 and 2014, $50,000 in 2015, $75,000 in 2016 and $100,000 in 2017 and every year the license is in effect thereafter.

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Second License Agreement and Third License Agreement

Additionally, effective in March 2012, the Company entered into two additional license agreements with the Albert Einstein College of Medicine of Yeshiva University ("Einstein"). The second license agreement with Einstein (the "Second License Agreement") and the third license agreement with Einstein (the "Third License Agreement") both cover pending patent applications, patent disclosures, cell lines and technology surrounding discoveries in the understanding of the underlying mechanisms of systemic metastasis in solid epithelial cancers. The Second License Agreement and the Third License Agreement both require certain customary payments such as a license signing fee, reimbursement of patent expenses, annual license maintenance fees, milestone payments, and the payment of royalties on sales of products or services covered under such agreements.

Pursuant to the Second License Agreement, we are required to make a series of annual minimum royalty or "license maintenance" payments beginning on the first anniversary date of the effective date, or January 3, 2013. For a period of seven years on each anniversary, we are required to make additional payments in amounts that gradually increase beginning in year three. We have satisfied the license maintenance payment of $12,000 for the first anniversary in 2013. We are required to make additional payments of $12,000 in 2014, $30,000 in each of 2015, 2016, $50,000 in 2017, $75,000 in 2018 and $100,000 in 2019 and every year the license is in effect thereafter.

Pursuant to the Third License Agreement, we are required to make a series of annual minimum royalty or "license maintenance" payments beginning on the first . . .

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