−Removed: Management’s Discussion and Analysis of Financial Condition and Results of Operations.
−Removed: reviewing Management’s Discussion and Analysis of Financial Condition and Results of Operations, you should refer to our Consolidated
−Removed: Financial Statements and the notes related thereto.
−Removed: of Operations
−Removed: Year ended October 31, 2023 compared with Fiscal Year ended October 31, 2022
−Removed: fiscal year 2023, we recorded revenue of approximately $210,000 from one license agreement related to our encrypted audio/video conference
−Removed: calling technology.
−Removed: The license agreement provided for a one-time, non-recurring, lump sum payment in exchange for a non-exclusive retroactive
−Removed: and future license, and covenant not to sue.
−Removed: Pursuant to the terms of the agreement, we have no further obligations with respect to the
−Removed: granted intellectual property rights, including no obligation to maintain or upgrade the technology, or provide future support or services.
−Removed: Accordingly, the performance obligations from the license were satisfied and 100% of the revenue was recognized upon execution of the
−Removed: license agreement.
−Removed: We did not have any revenue in fiscal year 2022.
−Removed: the past several years, our revenue, if any, was derived from technology licensing and the sale of patented technologies, including revenue
−Removed: from the settlement of litigation.
−Removed: As part of our legacy operations, the Company remains engaged in limited patent licensing activities
−Removed: in the area of encrypted audio/video conference calling.
−Removed: We do not expect these activities to be a significant part of the Company’s
−Removed: ongoing operations, nor do we expect these activities to require material financial resources or attention of senior management.
−Removed: have not generated any revenue to date from our therapeutics or vaccine programs.
−Removed: In addition, while we pursue our therapeutics and vaccine
−Removed: programs, we may also make investments in and form new companies to develop additional emerging technologies.
−Removed: We do not expect to begin
−Removed: generating revenue with respect to any of our current therapy or vaccine programs in the near term.
−Removed: We hope to achieve a profitable outcome
−Removed: by eventually licensing our technologies to large pharmaceutical companies that have the resources and infrastructure in place to manufacture,
−Removed: market and sell our technologies as therapeutics or vaccines.
−Removed: The eventual licensing of any of our technologies may take several years,
−Removed: if it is to occur at all, and may depend on positive results from human clinical trials.
−Removed: Royalties, Contingent Legal Fees, Litigation and Licensing Expenses Related to Patent Assertion
−Removed: fiscal year 2023, inventor royalties, contingent legal fees, litigation and licensing expenses related to patent assertion activities
−Removed: were approximately $161,000.
−Removed: Inventor royalties and contingent legal fees are expensed in the period that the related revenues are recognized.
−Removed: Litigation and licensing expenses related to patent assertion, other than contingent legal fees, are expensed in the period incurred.
−Removed: did not have any inventor royalties, contingent legal fees, litigation and licensing expenses related to patent assertion activities
−Removed: in fiscal year 2022.
−Removed: and Development Expenses
−Removed: and development expenses incurred in fiscal year 2023 associated with each of our development programs consisted of approximately $1,839,000
−Removed: for CAR-T therapeutics, approximately $2,682,000 for cancer vaccines, and approximately $248,000 for anti-viral therapeutics.
−Removed: and development expenses are related to the development of our cancer therapeutic and vaccine programs, and our anti-viral drug program,
−Removed: and decreased by approximately $1,934,000 to approximately $4,769,000 in fiscal year 2023, from approximately $6,703,000 in fiscal year
−Removed: The decrease in research and development expenses was primarily due to a decrease in employee stock option compensation expense
−Removed: of approximately $1,386,000, a decrease in research and development expenses related to our COVID-19 development program of approximately
−Removed: $485,000 as a result of the suspension of that program in March 2023, a decrease in license fees of approximately $225,000, a decrease
−Removed: in consultant stock option expense of approximately $213,000, a decrease in research and development expenses related to our CAR-T development
−Removed: program of approximately $156,000, and a decrease in research and development expenses related to our ovarian cancer vaccine development
−Removed: program of approximately $130,000, offset by an increase in research and development expenses related to our breast cancer vaccine development
−Removed: program of approximately $563,000 and an increase in employee compensation and related costs, other than stock option compensation expense,
−Removed: of approximately $147,000.
−Removed: and Administrative Expenses
−Removed: and administrative expenses decreased by approximately $881,000 to approximately $6,291,000 in fiscal year 2023, from approximately $7,172,000
+Added: Management’s Discussion and Analysis
+Added: of Financial Condition and Results of Operations
+Added: In reviewing Management’s
+Added: Discussion and Analysis of Financial Condition and Results of Operations, you should refer to our Consolidated Financial Statements and
+Added: the notes related thereto.
+Added: Results of Operations
+Added: Fiscal Year ended October 31, 2024 compared with
+Added: Fiscal Year ended October 31, 2023
+Added: We did not have any revenue in
+Added: fiscal year 2024.
+Added: In fiscal year 2023, we recorded revenue of approximately $210,000 from one license agreement related to our encrypted
+Added: audio/video conference calling technology.
+Added: The license agreement provided for a one-time, non-recurring, lump sum payment in exchange
+Added: for a non-exclusive retroactive and future license, and covenant not to sue.
+Added: Pursuant to the terms of the agreement, we have no further
+Added: obligations with respect to the granted intellectual property rights, including no obligation to maintain or upgrade the technology, or
+Added: provide future support or services.
+Added: Accordingly, the performance obligations from the license were satisfied and 100% of the revenue was
+Added: recognized upon execution of the license agreement.
+Added: Over the past several years, our
+Added: revenue, if any, was derived from technology licensing and the sale of patented technologies, including revenue from the settlement of
+Added: As part of our legacy operations, the Company remains engaged in limited patent licensing activities in the area of encrypted
+Added: audio/video conference calling.
+Added: We do not expect these activities to be a significant part of the Company’s ongoing operations,
+Added: nor do we expect these activities to require material financial resources or attention of senior management.
+Added: We have not generated any revenue
+Added: to date from our therapeutics or vaccine programs.
+Added: In addition, while we pursue our therapeutics and vaccine programs, we may also make
+Added: investments in and form new companies to develop additional emerging technologies.
+Added: We do not expect to begin generating revenue with respect
+Added: to any of our current therapy or vaccine programs in the near term.
+Added: We hope to achieve a profitable outcome by eventually licensing our
+Added: technologies to large pharmaceutical companies that have the resources and infrastructure in place to manufacture, market and sell our
+Added: technologies as therapeutics or vaccines.
+Added: The eventual licensing of any of our technologies may take several years, if it is to occur
+Added: at all, and may depend on positive results from human clinical trials.
+Added: Inventor Royalties, Contingent
+Added: Legal Fees, Litigation and Licensing Expenses Related to Patent Assertion
+Added: We did not have any inventor royalties,
+Added: contingent legal fees, litigation and licensing expenses related to patent assertion activities in fiscal year 2024.
In fiscal year 2023,
−Removed: The decrease in general and administrative expenses was principally due to a decrease in employee stock option compensation
−Removed: expense of approximately $309,000, a decrease in professional fees of approximately $239,000, a decrease in consultant warrant expense
−Removed: of approximately $221,000, a decrease in employee compensation and related costs, other than stock option compensation expense, of approximately
−Removed: $214,000, and a decrease in patent expenses of approximately $152,000, offset by an increase in director compensation expense, other
−Removed: than stock option compensation expense, of approximately $121,000 and an increase in director stock option compensation expense of approximately
−Removed: income increased to approximately $1,081,000 in fiscal year 2023 compared to approximately $104,000 in fiscal year 2022, due to an increase
−Removed: in interest rates and the increased dollar amount held in short-term investments.
−Removed: Loss Attributable to Noncontrolling Interest
−Removed: net loss attributable to noncontrolling interest, representing Wistar’s ownership interest in Certainty’s net loss, decreased
−Removed: by approximately $57,000 to approximately $119,000 in fiscal year 2023, from approximately $176,000 in fiscal year 2022, as Certainty’s
−Removed: net loss decreased.
−Removed: and Capital Resources
−Removed: primary sources of liquidity are cash, cash equivalents and short-term investments.
−Removed: on currently available information as of January 16, 2024, we believe that our existing cash, cash equivalents, short-term investments
−Removed: and expected cash flows will be sufficient to fund our activities for at least the next twelve months.
−Removed: We have implemented a business
−Removed: model that conserves funds by collaborating with third parties to develop our technologies.
−Removed: However, our projections of future cash needs
−Removed: and cash flows may differ from actual results.
−Removed: If current cash on hand, cash equivalents, short-term investments and cash that may be
−Removed: generated from our business operations are insufficient to continue to operate our business, or if we elect to invest in or acquire a
−Removed: company or companies or new technology or technologies that are synergistic with or complementary to our technologies, we may be required
−Removed: to obtain more working capital.
−Removed: Under our at-the-market equity program, which is currently effective and may remain available for us
−Removed: to use in the future, as of October 31, 2023, we may sell up to $100 million of common stock.
−Removed: We did not sell any shares under our at-the-market
−Removed: equity program during the fiscal year ended October 31, 2023.
+Added: inventor royalties, contingent legal fees, litigation and licensing expenses related to patent assertion activities were approximately
+Added: Inventor royalties and contingent legal fees are expensed in the period that the related revenues are recognized.
+Added: and licensing expenses related to patent assertion, other than contingent legal fees, are expensed in the period incurred.
+Added: Research and Development
+Added: In fiscal year 2024, research and development expenses
+Added: were related to the development of our cancer therapeutics and vaccine programs and the expenses incurred consisted
+Added: of approximately $3,748,000 and $2,648,000 for cancer vaccines and CAR-T therapeutics, respectively.
+Added: In fiscal year 2023, research and development expenses were related to the development of our cancer therapeutics
+Added: and vaccines, as well as our anti-viral therapeutics program, and the expenses incurred consisted of approximately $2,682,000, $1,839,000
+Added: and $248,000 for cancer vaccines, CAR-T therapeutics and anti-viral therapeutics, respectively.
+Added: Research and development expenses
+Added: increased by approximately $1,627,000 to approximately $6,396,000 in fiscal year 2024, from approximately $4,769,000 in fiscal year 2023.
+Added: The increase in research and development expenses was primarily due to an increase in research and development expenses related to our
+Added: CAR-T development program of approximately $845,000, an increase in research and development expenses related to our breast cancer vaccine
+Added: development program of approximately $834,000, an increase in research and development expenses related to our new vaccine discover program
+Added: of approximately $113,000, an increase in clinical trial consulting services of approximately $101,000, offset by a decrease in research
+Added: and development expenses related to our ovarian cancer vaccine development program of approximately $170,000 and a decrease in consultant
+Added: stock option expense of approximately $137,000.
+Added: General and Administrative
+Added: General and administrative expenses
+Added: increased by approximately $1,144,000 to approximately $7,435,000 in fiscal year 2024, from approximately $6,291,000 in fiscal year 2023.
+Added: The increase in general and administrative expenses was principally due to an increase in investor and public relations firm expenses
+Added: of approximately $629,000, an increase in stock compensation for investor and public relations firm of approximately $145,000, an increase
+Added: in employee compensation and related costs, other than stock option compensation expense, of approximately $141,000 and an increase in
+Added: employee stock option compensation expense of approximately $111,000.
+Added: Interest Income
+Added: Interest income increased to approximately
+Added: $1,133,000 in fiscal year 2024 compared to approximately $1,081,000 in fiscal year 2023, due to an increase in interest rates and the
+Added: increased average dollar amount held in short-term investments.
+Added: Net Loss Attributable to
+Added: Noncontrolling Interest
+Added: The net loss attributable to noncontrolling
+Added: interest, representing Wistar’s ownership interest in Certainty’s net loss, increased by approximately $25,000 to approximately
+Added: $144,000 in fiscal year 2024, from approximately $119,000 in fiscal year 2023, as Certainty’s net loss increased.
+Added: Liquidity and Capital Resources
+Added: Our primary sources of liquidity
+Added: are cash, cash equivalents and short-term investments.
+Added: Based on currently available information
+Added: as of January 10, 2025, we believe that our existing cash, cash equivalents, short-term investments and expected cash flows will be sufficient
+Added: to fund our activities for at least the next twelve months.
+Added: We have implemented a business model that conserves funds by collaborating
+Added: with third parties to develop our technologies.
+Added: However, our projections of future cash needs and cash flows may differ from actual results.
+Added: If current cash on hand, cash equivalents, short-term investments and cash that may be generated from our business operations are insufficient
+Added: to continue to operate our business, or if we elect to invest in or acquire a company or companies or new technology or technologies that
+Added: are synergistic with or complementary to our technologies, we may be required to obtain more working capital.
+Added: During the year ended October
+Added: 31, 2024, we raised approximately $2,955,000, net of expenses, through an at-the-market equity offering of 785,290 shares of common stock.
+Added: Under our at-the-market equity program, which is currently effective and may remain available for us to use in the future, as of October
+Added: 31, 2024, we may sell up to $97 million of common stock.
We may seek to obtain working capital during our fiscal year 2025 or thereafter
4 unchanged sentences
for additional funding, the sale of additional equity securities or convertible debt will result in dilution to our stockholders.
−Removed: can give no assurance that we will generate sufficient cash flows in the future to satisfy our liquidity requirements or sustain future
−Removed: operations, or that other sources of funding, such as sales of equity or debt, would be available or would be approved by our security
−Removed: holders, if needed, on favorable terms or at all.
−Removed: If we fail to obtain additional working capital as and when needed, such failure could
−Removed: have a material adverse impact on our business, results of operations and financial condition.
−Removed: Furthermore, such lack of funds may inhibit
−Removed: our ability to respond to competitive pressures or unanticipated capital needs, or may force us to reduce operating expenses, which would
−Removed: significantly harm the business and development of operations.
+Added: give no assurance that we will generate sufficient cash flows in the future to satisfy our liquidity requirements or sustain future operations,
+Added: or that other sources of funding, such as sales of equity or debt, would be available or would be approved by our security holders, if
+Added: needed, on favorable terms or at all.
+Added: If we fail to obtain additional working capital as and when needed, such failure could have a material
+Added: adverse impact on our business, results of operations and financial condition.
+Added: Furthermore, such lack of funds may inhibit our ability
+Added: to respond to competitive pressures or unanticipated capital needs, or may force us to reduce operating expenses, which could significantly
+Added: harm the business and development of operations.
the fiscal year ended October 31, 2024, cash used in operating activities was approximately $7,335,000.
−Removed: Cash used in investing activities
−Removed: was approximately $5,602,000, resulting from the purchase of short-term investments of approximately $44,411,000, which was offset by
−Removed: the proceeds on maturities of short-term investments of approximately $38,809,000.
+Added: Cash provided by investing activities
+Added: was approximately $4,276,000, resulting from the proceeds on maturities of short-term investments of approximately $68,046,000, which
+Added: was offset by the purchase of short-term investments of approximately $63,770,000.
Cash provided by financing activities was approximately
−Removed: $366,000, resulting from proceeds from the exercise of stock options of approximately $353,000 and proceeds from the sale of common stock
−Removed: pursuant to an employee stock purchase plan of approximately $13,000.
−Removed: As a result, our cash, cash equivalents, and short-term investments
−Removed: at October 31, 2023 decreased approximately $5,843,000 to approximately $23,844,000 from approximately $29,687,000 at the end of fiscal
−Removed: have expected future cash obligations related to the lease of our offices through 2026, estimated at approximately $202,000.
−Removed: Sheet Arrangements
−Removed: have no variable interest entities or other significant off-balance sheet obligation arrangements.
−Removed: Accounting Policies
−Removed: Company’s consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United
−Removed: States of America.
−Removed: In preparing these financial statements, we make assumptions, judgments and estimates that can have a significant
−Removed: impact on amounts reported in our consolidated financial statements.
−Removed: We base our assumptions, judgments and estimates on historical experience
−Removed: and various other factors that we believe to be reasonable under the circumstances.
−Removed: Actual results could differ materially from these
−Removed: estimates under different assumptions or conditions.
−Removed: On a regular basis, we evaluate our assumptions, judgments and estimates and make
−Removed: changes accordingly.
−Removed: believe that, of the significant accounting policies discussed in Note 2 to our Consolidated Financial Statements, the following accounting
−Removed: policies require our most difficult, subjective, or complex judgments:
−Removed: Compensation;
−Removed: and Development Expense.
−Removed: revenue has been derived solely from technology licensing and the sale of patented technologies.
−Removed: Revenue is recognized upon transfer
−Removed: of control of intellectual property rights and satisfaction of other contractual performance obligations to licensees in an amount that
−Removed: reflects the consideration we expect to receive.
−Removed: revenue recognition policy requires us to make certain judgments and estimates in connection with the accounting for revenue.
−Removed: may include determining the existence of a contract and identifying each party’s rights and obligations to transfer goods and services,
−Removed: identifying the performance obligations in the contract, determining the transaction price and allocating the transaction price to separate
−Removed: performance obligations, estimating the timing of satisfaction of performance obligations, determining whether a promise to grant a license
−Removed: is distinct from other promised goods or services and evaluating whether a license transfers to a customer at a point in time or over
−Removed: revenue arrangements provide for the payment, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up
−Removed: license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies
−Removed: owned or controlled by the Company.
+Added: $3,415,000, resulting from the sale of 785,290 shares of common stock in at at-the-market equity offering of approximately $2,955,000,
+Added: proceeds from the exercise of stock options of approximately $456,000 and proceeds from the sale of common stock pursuant to an employee
+Added: stock purchase plan of approximately $10,000, offset by the purchase of treasury stock of approximately $6,000.
+Added: As a result, our cash,
+Added: cash equivalents, and short-term investments at October 31, 2024 decreased approximately $3,920,000 to approximately $19,924,000 from
+Added: approximately $23,844,000 at the end of fiscal year 2023.
+Added: have expected future cash obligations related to the lease of our offices through 2029 , inclusive of extension periods , estimated at approximately $312,000.
+Added: Off-Balance Sheet Arrangements
+Added: We have no variable interest entities
+Added: or other significant off-balance sheet obligation arrangements.
+Added: Critical Accounting Policies
+Added: The Company’s consolidated
+Added: financial statements are prepared in conformity with accounting principles generally accepted in the United States of America.
+Added: these financial statements, we make assumptions, judgments and estimates that can have a significant impact on amounts reported in our
+Added: consolidated financial statements.
+Added: We base our assumptions, judgments and estimates on historical experience and various other factors
+Added: that we believe to be reasonable under the circumstances.
+Added: Actual results could differ materially from these estimates under different
+Added: assumptions or conditions.
+Added: On a regular basis, we evaluate our assumptions, judgments and estimates and make changes accordingly.
+Added: We believe that, of the significant
+Added: accounting policies discussed in Note 2 to our Consolidated Financial Statements, the following accounting policies require our most difficult,
+Added: subjective, or complex judgments:
+Added: Revenue Recognition;
+Added: Stock-Based Compensation;
+Added: Research and Development Expense.
+Added: Revenue Recognition
+Added: Our revenue has been derived solely
+Added: from technology licensing and the sale of patented technologies.
+Added: Revenue is recognized upon transfer of control of intellectual property
+Added: rights and satisfaction of other contractual performance obligations to licensees in an amount that reflects the consideration we expect
+Added: Our revenue recognition policy
+Added: requires us to make certain judgments and estimates in connection with the accounting for revenue.
+Added: Such areas may include determining
+Added: the existence of a contract and identifying each party’s rights and obligations to transfer goods and services, identifying the
+Added: performance obligations in the contract, determining the transaction price and allocating the transaction price to separate performance
+Added: obligations, estimating the timing of satisfaction of performance obligations, determining whether a promise to grant a license is distinct
+Added: from other promised goods or services and evaluating whether a license transfers to a customer at a point in time or over time.
+Added: Our revenue arrangements provide
+Added: for the payment, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up license fees in settlement
+Added: of litigation and in consideration for the grant of certain intellectual property rights for patented technologies owned or controlled
+Added: by the Company.
These arrangements typically include some combination of the following:
−Removed: (i) the grant of a non-exclusive,
−Removed: retroactive and future license to manufacture and/or sell products covered by patented technologies owned or controlled by the Company,
−Removed: (ii) a covenant-not-to-sue, (iii) the release of the licensee from certain claims, and (iv) the dismissal of any pending litigation.
−Removed: In such instances, the intellectual property rights granted have been perpetual in nature, extending until the expiration of the related
−Removed: Pursuant to the terms of these agreements, we have no further obligations with respect to the granted intellectual property
−Removed: rights, including no obligation to maintain or upgrade the technology, or provide future support or services.
−Removed: Licensees obtained control
−Removed: of the intellectual property rights they have acquired upon execution of the agreement.
−Removed: Accordingly, the performance obligations from
−Removed: these agreements were satisfied and 100% of the revenue was recognized upon the execution of the agreements.
−Removed: compensation cost for service-based stock options granted to employees, directors and consultants is measured at the grant date, based
−Removed: on the fair value of the award using the Black-Scholes pricing model, and is recognized as an expense on a straight-line basis over the
−Removed: requisite service period (the vesting period of the stock option) which is one to four years.
−Removed: For employee options vesting if the trading
−Removed: price of the Company’s common stock exceeds certain price targets, we use a Monte Carlo Simulation in estimating the fair value
−Removed: at grant date and recognize compensation cost over the implied service period.
−Removed: For stock-based awards that vest upon the achievement
−Removed: of a performance metric, the Company recognizes the estimated fair value of the award when achievement becomes probable.
−Removed: stock awards granted to employees and directors that vest at date of grant, we recognize expense based on the grant date market price
−Removed: of the underlying common stock.
−Removed: For restricted stock awards vesting upon achievement of a price target of our common stock, we use a
−Removed: Monte Carlo Simulation in estimating the fair value at grant date and recognize compensation cost over the implied service period (median
−Removed: time to vest).
−Removed: Black-Scholes pricing model and the Monte Carlo Simulation we use to estimate fair value requires valuation assumptions of expected term,
−Removed: expected volatility, risk-free interest rates and expected dividend yield.
−Removed: The expected term of stock options represents the weighted
−Removed: average period the stock options are expected to remain outstanding.
−Removed: For employees, we use the simplified method, which is a weighted
−Removed: average of the vesting term and contractual term, to determine expected term.
−Removed: The simplified method was adopted since we do not believe
−Removed: that historical experience is representative of future performance because of the impact of the changes in our operations and the change
−Removed: in terms from historical options.
−Removed: For consultants we use the contract term for expected term.
−Removed: Under the Black-Scholes pricing model,
−Removed: we estimated the expected volatility of our shares of common stock based upon the historical volatility of our share price over a period
−Removed: of time equal to the expected term of the grants.
−Removed: We estimated the risk-free interest rate based on the implied yield available on the
−Removed: applicable grant date of a U.S.
−Removed: Treasury note with a term equal to the expected term of the underlying grants.
−Removed: We made the dividend yield
−Removed: assumption based on our history of not paying dividends and our expectation not to pay dividends in the future.
−Removed: will reconsider use of the Black-Scholes pricing model and the Monte Carlo Simulation if additional information becomes available in
−Removed: the future that indicates another model would be more appropriate.
−Removed: If factors change and we employ different assumptions in future periods,
−Removed: the compensation expense that we record may differ significantly from what we have recorded in the current period.
+Added: (i) the grant of a non-exclusive, retroactive
+Added: and future license to manufacture and/or sell products covered by patented technologies owned or controlled by the Company, (ii) a covenant-not-to-sue,
+Added: (iii) the release of the licensee from certain claims, and (iv) the dismissal of any pending litigation.
+Added: In such instances, the intellectual
+Added: property rights granted have been perpetual in nature, extending until the expiration of the related patents.
+Added: Pursuant to the terms of
+Added: these agreements, we have no further obligations with respect to the granted intellectual property rights, including no obligation to
+Added: maintain or upgrade the technology, or provide future support or services.
+Added: Licensees obtained control of the intellectual property rights
+Added: they have acquired upon execution of the agreement.
+Added: Accordingly, the performance obligations from these agreements were satisfied and
+Added: 100% of the revenue was recognized upon the execution of the agreements.
+Added: Stock-Based Compensation
+Added: The compensation cost for service-based
+Added: stock options granted to employees, directors and consultants is measured at the grant date, based on the fair value of the award using
+Added: the Black-Scholes pricing model, and is recognized as an expense on a straight-line basis over the requisite service period (the vesting
+Added: period of the stock option) which is one to four years.
+Added: For employee options vesting if the trading price of the Company’s common
+Added: stock exceeds certain price targets, we use a Monte Carlo Simulation in estimating the fair value at grant date and recognize compensation
+Added: cost over the implied service period.
+Added: For stock-based awards that vest upon the achievement of a performance metric, the Company recognizes
+Added: the estimated fair value of the award when achievement becomes probable.
+Added: For stock awards granted to employees
+Added: and directors that vest at date of grant, we recognize expense based on the grant date market price of the underlying common stock.
+Added: restricted stock awards vesting upon achievement of a price target of our common stock, we use a Monte Carlo Simulation in estimating
+Added: the fair value at grant date and recognize compensation cost over the implied service period (median time to vest).
+Added: The Black-Scholes pricing model
+Added: and the Monte Carlo Simulation we use to estimate fair value requires valuation assumptions of expected term, expected volatility, risk-free
+Added: interest rates and expected dividend yield.
+Added: The expected term of stock options represents the weighted average period the stock options
+Added: are expected to remain outstanding.
+Added: For employees, we use the simplified method, which is a weighted average of the vesting term and contractual
+Added: term, to determine expected term.
+Added: The simplified method was adopted since we do not believe that historical experience is representative
+Added: of future performance because of the impact of the changes in our operations and the change in terms from historical options.
+Added: For consultants
+Added: we use the contract term for expected term.
+Added: Under the Black-Scholes pricing model, we estimated the expected volatility of our shares
+Added: of common stock based upon the historical volatility of our share price over a period of time equal to the expected term of the grants.
+Added: We estimated the risk-free interest rate based on the implied yield available on the applicable grant date of a U.S.
+Added: Treasury note with
+Added: a term equal to the expected term of the underlying grants.
+Added: We made the dividend yield assumption based on our history of not paying dividends
+Added: and our expectation not to pay dividends in the future.
+Added: We will reconsider use of the
+Added: Black-Scholes pricing model and the Monte Carlo Simulation if additional information becomes available in the future that indicates another
+Added: model would be more appropriate.
+Added: If factors change and we employ different assumptions in future periods, the compensation expense that
+Added: we record may differ significantly from what we have recorded in the current period.
and Development Expense
−Removed: recognize research and development expenses as incurred.
−Removed: Advance payments for future research and development activities are deferred
−Removed: and expensed as the services are performed.
−Removed: We recognize our preclinical studies and clinical trial expenses based on the services performed
−Removed: pursuant to contracts with research institutions, clinical research organizations (“CROs”), clinical manufacturing organizations
−Removed: (“CMOs”), and other parties that conduct and manage various stages of research and development activities on our behalf.
−Removed: Fees for such services are recognized based on management’s estimates after considering the activities and tasks completed by each
−Removed: service provider in a given period, the time period over which services are expected to be performed, and the level of effort expended
−Removed: in each reporting period.
−Removed: each balance sheet date, management estimates prepaid and accrued research and development costs by discussing progress or stage of completion
−Removed: of activities with internal personnel and external service providers, and comparing this information to payments made, invoices received,
−Removed: and the agreed-upon contractual fee to be paid for such services in the applicable contract or statements of work.
−Removed: addition, we allocate certain internal compensation costs to research and development expenses based on management’s estimates
−Removed: of each employee’s time and effort expended.
−Removed: of Recent Accounting Pronouncements
−Removed: discuss the effect of recently issued pronouncements in Note 2 to the Consolidated Financial Statements.
−Removed: Quantitative and Qualitative Disclosures About Market Risk.
−Removed: required for a smaller reporting company.
−Removed: Financial Statements and Supplementary Data.
−Removed: accompanying “Index to Consolidated Financial Statements.”
−Removed: Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
+Added: research and development expenses as incurred.
+Added: Advance payments for future research and development activities are deferred and expensed
+Added: as the services are performed.
+Added: We recognize our preclinical studies and clinical trial expenses based on the services performed pursuant
+Added: to contracts with research institutions, clinical research organizations (“CROs”), clinical manufacturing organizations (“CMOs”),
+Added: and other parties that conduct and manage various stages of research and development activities on our behalf.
+Added: Fees for such services
+Added: are recognized based on management’s estimates after considering the activities and tasks completed by each service provider in
+Added: a given period, the time period over which services are expected to be performed, and the level of effort expended in each reporting period.
+Added: At each balance sheet date, management
+Added: estimates prepaid and accrued research and development costs by discussing progress or stage of completion of activities with internal
+Added: personnel and external service providers, and comparing this information to payments made, invoices received, and the agreed-upon contractual
+Added: fee to be paid for such services in the applicable contract or statements of work.
+Added: In addition, we allocate certain
+Added: internal compensation costs to research and development expenses based on management’s estimates of each employee’s time and
+Added: effort expended.
+Added: Effect of Recent Accounting Pronouncements
+Added: We discuss the potential expected impacts of recently
+Added: issued pronouncements in Note 2 to the Consolidated Financial Statements.
+Added: Quantitative and Qualitative Disclosures
+Added: About Market Risk
+Added: Not required for a smaller reporting
+Added: Financial Statements and Supplementary
+Added: See accompanying “Index
+Added: to Consolidated Financial Statements.”
+Added: Changes in and Disagreements With Accountants
+Added: on Accounting and Financial Disclosure
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.