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NEUROTROPE, INC. - 10-Q - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION

August 14, 2014

This report contains forward-looking statements, including, without limitation, in the section captioned "Management's Discussion and Analysis of Financial Condition and Results of Operations," and elsewhere. Any and all statements contained in this report that are not statements of historical fact may be deemed forward-looking statements. Terms such as "may," "might," "would," "should," "could," "project," "estimate," "pro-forma," "predict," "potential," "strategy," "anticipate," "attempt," "develop," "plan," "help," "believe," "continue," "intend," "expect," "future," and terms of similar import (including the negative of any of the foregoing) may be intended to identify forward-looking statements. However, not all forward-looking statements may contain one or more of these identifying terms. Forward-looking statements in this report may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the development of commercially viable pharmaceuticals, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items, (iii) our future financial performance, including any such statement contained in a discussion and analysis of financial condition by management or in the results of operations included pursuant to the rules and regulations of the Securities and Exchange Commission (the "SEC"), and (iv) the assumptions underlying or relating to any statement described in points (i), (ii) or (iii) above.

The forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon our current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which we have no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, our inability to obtain adequate financing, the significant length of time associated with drug development and related insufficient cash flows and resulting illiquidity, our inability to expand our business, significant government regulation of pharmaceuticals and the healthcare industry, lack of product diversification, volatility in the price of our raw materials, existing or increased competition, results of arbitration and litigation, stock volatility and illiquidity, and our failure to implement our business plans or strategies. A description of some of the risks and uncertainties that could cause our actual results to differ materially from those described by the forward-looking statements in this report appears in the section captioned "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2013 filed with the SEC and elsewhere in this report. Readers should carefully review this report in its entirety, including but not limited to our financial statements and the notes thereto and the risks described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2013, filed with the SEC. We advise you to carefully review the reports and documents we file from time to time with the SEC, particularly our quarterly reports on Form 10-Q and our current reports on Form 8-K.

Readers are cautioned not to place undue reliance on forward-looking statements because of the risks and uncertainties related to them and to the risk factors. We disclaim any obligation to update the forward-looking statements contained in this report to reflect any new information or future events or circumstances or otherwise.

On August 23, 2013, a wholly owned subsidiary of Neurotrope, Inc. (formerly "BlueFlash Communications, Inc."), Neurotrope Acquisition, Inc., a corporation formed in the State of Nevada on August 15, 2013 merged (the "Reverse Merger") with and into Neurotrope BioScience, Inc. ("Neurotrope Bioscience, or NBI"). Neurotrope BioScience was the surviving corporation in the Reverse Merger and became the Company's wholly owned subsidiary. All of the outstanding Neurotrope BioScience common stock was converted into shares of Neurotrope, Inc. common stock on a one-for-one basis. As the result of the Reverse Merger and the change in business and operations of the Company, from engaging in the business of providing software solutions to deliver geo-location targeted coupon advertising to mobile internet devices, to the business of developing two product platforms, including a drug candidate called bryostatin for the treatment of Alzheimer's disease ("AD") and, potentially, a diagnostic test for AD, a discussion of the past financial results of Neurotrope, Inc. (formerly BlueFlash Communications, Inc.) is not pertinent, and under applicable accounting principles, the historical financial results of Neurotrope BioScience, the accounting acquirer, prior to the Merger, are considered the historical financial results of the Company.

The following discussion highlights the Company's results of operations and the principal factors that have affected our financial condition as well as our liquidity and capital resources for the periods described, and provides information that management believes is relevant for an assessment and understanding of the statements of financial condition and results of operations presented herein. The following discussion and analysis are based on the Company's unaudited financial statements contained in this report, which we have prepared in accordance with United States generally accepted accounting principles. You should read the discussion and analysis together with such financial statements and the related notes thereto.

Basis of Presentation



References in this section to "Neurotrope," "we," "us," "our," "the Company" and "our Company" refer to Neurotrope, Inc. and its consolidated subsidiary Neurotrope BioScience.

The unaudited financial statements, for our fiscal quarters ended June 30, 2014 and 2013, include a summary of our significant accounting policies and should be read in conjunction with the discussion below. In the opinion of management, all material adjustments necessary to present fairly the results of operations for such periods have been included in these unaudited financial statements. All such adjustments are of a normal recurring nature.

Overview



Neurotrope Bioscience was founded as a Delaware corporation in October 2012. Activities since the Company's inception through June 30, 2014, were devoted primarily to the development and commercialization of Alzheimer's disease ("AD") therapeutic products related diagnostics for large and growing markets using innovative licensed patented technology. This technology, licensed by us from Blanchette Rockefeller Neurosciences Institute ("BRNI") and its affiliate, NRV II, LLC pursuant to a technology license and services agreements (the "BRNI License Agreement"), has been under development since 1999 and has been financed by BRNI from a variety of non-investor sources including not-for-profit foundations, the National Institute of Health and individual philanthropists up until March 2013. From March 2013 forward, the licensed technology has been funded principally through collaboration by BRNI with Neurotrope Bioscience. (See the description of Neurotrope Bioscience financings below in "Financial Condition, Liquidity and Capital Resources - Sources and Uses of Liquidity.")

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On May 12, 2014, the Company entered into a license agreement with The Board of Trustees of the Leland Stanford Junior University, or the Stanford Agreement, pursuant to which Stanford has granted to us a revenue-bearing, world-wide right and exclusive license, with the right to grant sublicenses (on certain conditions), under certain patent rights and related technology for the use of bryostatin structural derivatives, known as "bryologs," for use in the treatment of central nervous system disorders, lysosomal storage diseases, stroke, cardioprotection and traumatic brain injury, for the life of the licensed patents. Pursuant to the Stanford Agreement, the Company paid a $60,000 license initiation fee to Stanford. The Company will also pay Stanford (i) a $10,000 annual license maintenance fee, (ii) milestone payments in the aggregate amount of up to $3,700,000 upon the achievement of certain product development events commencing upon the filing of the first IND application through approval of an applicable product, and (iii) low single-digit royalties on net sales of the licensed products. Each party has the right to terminate the Stanford Agreement for an uncured material breach of the other party. Additionally, the Company may terminate the Stanford Agreement at any time upon sixty (60) days written notice to Stanford.

On May 15, 2014, the Company entered into an agreement with an internationally recognized contract research organization to conduct its clinical trial relating to AD. The Company has agreed to pay fees to the CRO totaling $715,159 based upon signing of the agreement and the CRO achieving certain clinical trial milestones, plus reasonable out-of-pocket expenses.

On July 14, 2014, NBI entered into an Exclusive License Agreement, or the Mount Sinai Agreement, with Icahn School of Medicine at Mount Sinai. Pursuant to the Mount Sinai Agreement, Mount Sinai granted NBI a revenue-bearing, world-wide right and (i) exclusive license, with the right to grant sublicenses (on certain conditions), under Mount Sinai's interest in certain joint patent rights, as well as in certain test results and data and (ii) non-exclusive license, with the right to grant sublicenses on certain conditions, to certain technical information. The Mount Sinai Agreement allows NBI to research, discover, develop, make, have made, use, have used, import, lease sell, have sold and offer for sale the Mount Sinai licensed products relating to the diagnostic, prophylactic or therapeutic use for treating diseases or disorders in humans relying on activation of PKCepsilon, which includes Niemann-Pick C Disease. Pursuant to the Mount Sinai Agreement, NBI paid a $25,000 license initiation fee to Mount Sinai. NBI will also pay Mount Sinai (i) a $10,000 annual license maintenance fee until minimum royalty payments are due, (ii) milestone payments in the aggregate amount of up to $3,500,000 upon the achievement of certain product development events relating to the approval of a licensed product in the United States and other jurisdictions, (iii) low single-digit royalties on net sales of the Mount Sinai Licensed Products, and (iv) a portion of sublicense fees ranging from a significant double-digit percentage based on sublicensing before completion of in vivo proof-of-concept experiments to a mid-single digit percentage after product approval. Each party has the right to terminate the Mount Sinai Agreement for an uncured material breach of the other party. Additionally, NBI may terminate the Agreement at any time upon sixty (60) days written notice to Mount Sinai. Further, upon termination, NBI may continue to sell any and all Mount Sinai Licensed Products, provided that NBI will pay Mount Sinai a reduced royalty for Mount Sinai Licensed Products that are indicated as therapeutics or diagnostics for Niemann Pick disease which are sold following termination of the Mount Sinai Agreement.

On July 29, 2014, the Company announced that it had initiated a Phase 2a clinical trial to evaluate bryostatin for the treatment of patients with AD. The Company plans to enroll a total of 15 patients in the randomized, double-blind, placebo-controlled, single dose study. The Company plans that ten patients will be randomized to receive bryostatin by injection and five will receive a matching placebo control. The primary objective of the clinical trial will be to assess the safety and tolerability of a single dose of bryostatin in the treatment of patients with AD. The secondary objectives of the study are the preliminary evaluation of the efficacy of a single dose of bryostatin in the treatment of patients with AD, its pharmacokinetics and pharmacodynamics and to correlate the changes in PKCe with plasma levels of bryostatin and with improvement in cognitive function. BRNI previously conducted one compassionate use protocol in familial AD with the experimental drug bryostatin under a U.S. Food and Drug Administration approved study protocol. This initial protocol has concluded, and the Company understands that BRNI plans to modestly expand its clinical effort in Alzheimer's Disease in the 2014 - 2015 timeframe and is currently proceeding with an additional single patient compassionate use protocol.

As of June 30, 2014, the Company had devoted substantially all of its efforts to product development, raising capital and building infrastructure through utilizing its strategic alliances, specifically with BRNI. The Company did not, as of that date, realize any revenues from its planned principal operations.

Strategy



One of the central tenets of BRNI's research and development is the belief that the neurodegeneration underlying these neurological diseases can be halted and reversed if treatment is initiated early enough. This process occurs by an improvement in nerve cell viability and synaptic function through activation of an enzyme called protein kinase C (PKC). This enzyme is actually a super family of isozymes (?, ?, ?, ?, ?) which have different activities in different tissues. The PKCepsilon (aka PKC?) variant has a very high concentration in the synapses of neurons, suggesting it plays a role in maintaining synaptic function. Deficient activity or low concentrations of PKC? in aging subjects is thought to be one of the main causes of the neurodegeneration seen in AD. Through a variety of the latest biomedical techniques and animal models developed to map and quantify neuroregeneration, BRNI has established a central role for PKC? in re-modeling or restoring synaptic function in both healthy and diseased neurons in the central nervous system.

The flagship product in the Neurotrope armamentarium is bryostatin. This drug has previously been evaluated in 1,200 patients at the National Cancer Institute ("NCI") for the treatment of various forms of cancer. While bryostatin did not show sufficient anti-cancer effects to warrant commercialization of the compound, much useful information on the safety, pharmacodynamics, and toxicity of the drug was gleaned from these in-human trials.

It was discovered by BRNI that at a much lower dose than that which was used in these anti-cancer trials, bryostatin is a potent activator of PKC? and may have efficacy in treating AD. Activation of PKC? has now been shown to partially restore synaptic function in neurons damaged by AD, ischemic stroke or traumatic brain injury in in vitro and in vivo animal models.

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The NCI has allowed BRNI access to the valuable chemical, animal and human data from its cancer studies, to which the Company, in turn, has access under the BRNI License Agreement to be used in our own research and regulatory programs.

Since licensing the AD diagnostic technology from BRNI, the Company's Board of Directors and management have conducted extensive analyses of the underlying AD diagnostic technology and the Company's other programs and are continuing to conduct market research to evaluate physician acceptability, commercial sales potential and product development costs of an AD diagnostic product.

The Company's strategy is to efficiently utilize our licensed proprietary and patented technologies to further the development of those technologies toward commercializing a therapeutic and, potentially, a diagnostic product for AD and potentially utilize these technologies to diagnose and treat other neurological diseases. We may also seek to acquire, by license or otherwise, other development stage products that are consistent with our product portfolio objectives and commercialization strategy.

Critical Accounting Policies, Estimates, and Judgments

Our financial statements are prepared in accordance with accounting principles that are generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities, 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. We continually evaluate our estimates and judgments, the most critical of which are those related to our commitments to strategic alliance partners and the timing of the achievement of collaboration milestones. We base our estimates and judgments on historical experience and other factors that we believe to be reasonable under the circumstances. Materially different results can occur as circumstances change and additional information becomes known. Besides the estimates identified above that are considered critical, we make many other accounting estimates in preparing our financial statements and related disclosures. All estimates, whether or not deemed critical, affect reported amounts of assets, liabilities, revenues and expenses, as well as disclosures of contingent assets and liabilities. These estimates and judgments are also based on historical experience and other factors that are believed to be reasonable under the circumstances. Materially different results can occur as circumstances change and additional information becomes known, even for estimates and judgments that are not deemed critical.

Results of Operations



Six months ended June 30, 2014

Revenues



The Company has not generated any revenues for the six months ended June 30, 2014.

Operating Expenses Overview



Total operating expenses for the six months ended June 30, 2014 were $3,726,292 versus $1,325,545 for the six months ended June 30, 2013, an increase of 181%. The increase in operating expenses is due primarily to several factors including the acceleration of product research and development activities, relating to its collaboration with BRNI, to treating and diagnosing neurodegenerative diseases, general and administrative expenses for salaries, overhead and public company-related activities.

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Research and Development Expenses

For the six months ended June 30, 2014, the Company incurred $1,063,228 of research and development - related party expenses versus $318,894 for the six months ended June 30, 2013. These expenses are incurred pursuant to our strategic alliance with BRNI for ongoing research and development principally relating to the development of the Company's potential therapeutic and diagnostic products. Of these expenses, for the six months ended June 30, 2014 and 2013, $822,738 and $318,894, respectively, related to the continuing development of the Company's potential AD diagnostic product. In addition, during the six months ended June 30, 2014, $125,342 related to the development of the Company's potential AD therapeutic product, and $115,148 was incurred for patent expenses associated with the two licensed technology platforms from BRNI.

For the six months ended June 30, 2014, the Company incurred $405,968 of research and development expenses versus $0 for the six months ended June 30, 2013. These expenses are incurred pursuant to developing the potential AD therapeutic product. Of these expenses, for the six months ended June 30, 2014, $354,801 related to producing and storing drug product for clinical trial patient dosing and the start of the Company's Phase 2a clinical trial and $51,167 was incurred for inventory management of drug product for clinical trials.

General and Administrative Expenses

The Company incurred related party general and administrative expenses totaling $188,267 and $660,327 for the six months ended June 30, 2014 and 2013, respectively, a decrease of 71%. The decrease is based upon the Company becoming less reliant on services from BRNI and contracting for those services directly with third parties. The decrease is primarily attributable to the payment of a royalty of $469,898 to BRNI and $42,972 paid to consultants during the six month period ended June 30, 2013. For the six months ended June 30, 2014, the Company incurred $134,267 related to issuance of stock options as a non-cash expense and $54,000 was paid to our prior Chairman for services provided to the Company. In addition, for the six months ended June 30, 2013, $83,333 of wages and consulting fees relating to the Company's former President and Chief Executive Officer were classified as related party expenses.

The Company incurred $2,068,829 and $346,324 of other general and administrative expenses for the six months ended June 30, 2014 and 2013, respectively, an increase of approximately 497%. Of the amounts for the six months ended June 30, 2014, $796,569 was incurred for wages, vacation pay and taxes, for seven employees, versus $41,666 for one employee for the comparable 2013 period, $259,478 for ongoing legal expenses versus $30,089 for the comparable 2013 period, $491,283 was incurred for outside operations consulting services versus $5,016 for the comparable 2013 period, $131,663 was incurred for travel expenses, versus $1,594 for the comparable 2013 period, $27,531 was incurred for investor relations services, $82,095 was incurred for professional fees associated with auditing, financial, accounting and tax advisory services, $202,217 for issuance of stock options as a non-cash expense, and $77,983 was incurred for office supplies, insurance, license fees, filing costs, advertising and other versus $1,440 for dues, licenses and supplies for the comparable 2013 period.

Other Income



The Company earned $8,883 of interest income for the six months ended June 30, 2014 on funds temporarily deposited in an interest bearing money market account versus $0 for the six months ended June 30, 2013.

Net loss and earnings per share

The Company incurred losses of $3,717,409 and $1,325,545 for the six months ended June 30, 2014 and 2013, respectively. The increased loss was primarily due to the Company's increased activities and new employee hiring during the current period. Earnings per share were ($0.17) and ($0.06) for the six months ended June 30, 2014 and 2013, respectively. The increase in loss per share is primarily attributable to the increase in the Company's operating loss for the current period.

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Three months ended June 30, 2014

Revenues



The Company has not generated any revenues for the three months ended June 30, 2014.

Operating Expenses Overview



Total operating expenses for the three months ended June 30, 2014 were $2,031,366 versus $807,054 for the three months ended June 30, 2013, an increase of 152%. The increase in operating expenses is due primarily to several factors including the acceleration of product research and development activities, relating to its collaboration with BRNI, to treating and diagnosing neurodegenerative diseases, general and administrative expenses for salaries, overhead and public company-related activities.

Research and Development Expenses

For the three months ended June 30, 2014, the Company incurred $411,369 of research and development - related party expenses versus $318,894 for the three months ended June 30, 2013. These expenses are incurred pursuant to our BRNI License Agreement for ongoing research and development principally relating to the development of the Company's potential therapeutic and diagnostic products. Of these expenses, for the three months ended June 30, 2014 and 2013, $411,369 and $318,894, respectively, related to the continuing development of the Company's potential AD diagnostic product.

For the three months ended June 30, 2014, the Company incurred $405,968 of research and development expenses versus $0 for the three months ended June 30, 2013. These expenses are incurred pursuant to developing the potential AD therapeutic product. Of these expenses, for the three months ended June 30, 2014, $354,801 related to producing and storing drug product for clinical trial patient dosing and the start of the Company's Phase 2a clinical trial and $51,167 was incurred for inventory management of drug product for clinical trials.

General and Administrative Expenses

The Company incurred related party general and administrative expenses totaling $94,504 and $221,641 for the three months ended June 30, 2014 and 2013, respectively, a decrease of 57%. The decrease is primarily attributable to the payment of a royalty of $0 and $60,349 paid to BRNI, $0 versus $25,000 of transaction expenses, $0 versus $27,091 of travel expenses and $0 versus $39,124 of travel, insurance and other expenses incurred during the three months ended June 30, 2014 and 2013, respectively which is offset by $27,000 versus $13,835 of consulting fees during the three months ended June 30, 2014 and 2013, respectively. In addition, for the three months ended June 30, 2013, $42,260 of wages, consulting fees and travel relating to the Company's former President and Chief Executive Officer were re-classified as general and administrative expenses versus related party expenses.

The Company incurred $1,119,525 and $266,519 of other general and administrative expenses for the three months ended June 30, 2014 and 2013, respectively, an increase of approximately 320%. Of the amounts for the three months ended June 30, 2014, $406,467 was incurred for wages, vacation pay and taxes, for seven employees, versus -$43,260 for the reclassification of expenses attributable to the Company's former President and Chief Executive Officer for the comparable 2013 period, $121,772 for ongoing legal expenses versus $123,530 for the comparable 2013 period, $299,699 was incurred for outside operations consulting services versus $77,332 for the comparable 2013 period, $70,423 was incurred for travel expenses, versus $0 for the comparable 2013 period, $6,901 was incurred for investor relations services, $63,535 was incurred for professional fees associated with financial, audit, accounting and tax advisory services versus $102,613 for the comparable 2013 period, $98,060 for issuance of stock options as a non-cash expense, and $52,658 was incurred for office supplies, insurance, license fees, filing costs, advertising and other versus $6,304 for dues, licenses and supplies for the comparable 2013 period.

23 Other Income



The Company earned $4,454 of interest income for the three months ended June 30, 2014 on funds temporarily deposited in an interest bearing money market account versus $0 for the three months ended June 30, 2013.

Net loss and earnings per share

The Company incurred losses of $2,026,912 and $807,054 for the three months ended June 30, 2014 and 2013, respectively. The increased loss was primarily due to the Company's increased activities and new employee hiring during the current period. Earnings per share were ($0.09) and ($0.04) for the three months ended June 30, 2014 and 2013, respectively. The increase in loss per share is primarily attributable to the increase in the Company's operating loss for the current period.

Financial Condition, Liquidity and Capital Resources

Since its inception, the Company has primarily devoted its efforts to negotiating the BRNI License Agreement and using BRNI's and its own resources to further the development of the Company's therapeutic and diagnostic products toward commercialization while conducting business planning and recruiting executive management.

Cash and Working Capital



Since inception, the Company incurred negative cash flows from operations. As of June 30, 2014, the Company had an accumulated deficit of $12,746,775 and had working capital of $11,509,462 as compared to working capital of $14,890,387 as of December 31, 2013. The $3,380,925 decrease in working capital was attributable to the Company's expenditures relating to development of a potential therapeutic and potential diagnostic product and general and administration expenses which resulted in a net loss of $3,717,409 offset by non-cash expenses of $336,484 for the six months ended June 30, 2014.

Sources and Uses of Liquidity

Since inception, the Company has satisfied its operating cash requirements from the private placement of Series A Stock sold principally to outside investors.

In February, 2013, through a private placement, the Company issued 9,073,300 shares of Series A preferred stock at $1.00 per share, resulting in gross proceeds of $9,073,300. In connection with the closing of the private placement, the Company paid a placement agent $882,330. In May, 2013, the Company issued an additional 1,313,325 shares of Series A preferred stock at $1.00 per share, resulting in gross proceeds of $1,313,325, on which the Company paid a placement agent $131,332. In August, 2013, through an additional private placement, the Company issued 11,533,375 of Series A preferred stock at $1.00 per share, resulting in gross proceeds of $11,533,375. In connection with the closing of the August 2013 private placement, the Company paid a placement agent $1,103,338. Further, Neurotrope Bioscience became a wholly-owned subsidiary of a publicly traded company in the Merger, which management believes will provide additional alternatives to issue securities and raise capital in the future. In October, 2013, through an additional private placement, the Company issued 1,080,000 of Series A preferred stock at $1.00 per share, resulting in gross proceeds of $1,080,000. In connection with the closing of the private placement, the Company paid a placement agent $108,000.

As of June 30, 2014, the Company had cash and cash equivalents totaling $12.0 million, which decreased to approximately $11.0 million as of the date of this report. With the proceeds from the private placements of Series A preferred stock, management believes the Company has sufficient capital to fund the Company for at least the next 15 to 21 months of operations under its current product development plans. However, if our operating plan changes or we incur significant unanticipated expenses, we may require additional capital before this timeframe. During the next two years, we expect to spend up to approximately $10.5 million on development of both our potential AD diagnostic and therapeutic products. With these expenditures, we anticipate conducting significant clinical trials on our AD therapeutic. We expect to also incur up to approximately $6.0 million in general and administrative costs in that period to support our ongoing research and development expenses and our expenses associated with being a publicly traded company. If development of the AD diagnostic continues at its current pace, management believes the Company will generate revenues through commercialization of its diagnostic product within the next 36 months. Additional funds may be raised through debt financing and/or the issuance of equity securities; at this time no additional fundraising has been initiated, and no specific terms have been set. There can be no assurance that financing will be available when required in sufficient amounts, on acceptable terms or at all.

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Pursuant to a statement of work, or SOW, signed with BRNI on August 28, 2013, we are obligated to pay BRNI a total of $1,645,470 in twelve equal monthly installments of $137,123, payable on the first business day of each month, commencing September 2013. In addition, we have agreed to pay to BRNI an estimated $877,300 in external pass-through costs to complete the first clinical trial of its AD diagnostic. As of June 30, 2014, up to approximately $1.2 million remained potentially payable under this SOW.

On March 12, 2014, we signed an SOW with BRNI to continue pre-clinical activities relating to the commercialization of the Company's therapeutic product. The Company is obligated to pay BRNI a total of $465,000 (subject to a 20% cost overage, which may not be exceeded without our consent). Of this amount, the Company has paid $358,470, and the remainder of the total ($106,530) is to be paid upon the completion by BRNI of certain activities relating to: transferring test materials; bio-analytical testing; contracting with a suitable contract research organization; completion of testing assays; and finalizing a clinical study protocol.


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