−Removed: for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
+Added: for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of
+Added: Equity Securities.
common stock is listed and traded on the NYSE American under the symbol AIM.
1 unchanged sentence
of March 25 2022, there were approximately 150 holders of record of our Common Stock.
−Removed: This number was determined from
−Removed: records maintained by our transfer agent and does not include beneficial owners of our securities whose securities are held in
−Removed: the names of various dealers and/or clearing agencies.
+Added: This number was determined from records
+Added: maintained by our transfer agent and does not include beneficial owners of our securities whose securities are held in the names of various
+Added: dealers and/or clearing agencies.
Authorized for Issuance Under Equity Compensation Plans
−Removed: about securities authorized for issuance under our equity compensation plans is incorporated herein by reference to Item 12 of
−Removed: Part III of this Annual Report.
+Added: about securities authorized for issuance under our equity compensation plans is incorporated herein by reference to Item 12 of Part III
+Added: of this Annual Report.
have not paid any cash dividends on our Common Stock in recent years.
−Removed: It is management’s intention not to declare or pay
−Removed: dividends on our Common Stock, but to retain earnings, if any, for the operation and expansion of our business.
+Added: It is management’s intention not to declare or pay dividends
+Added: on our Common Stock, but to retain earnings, if any, for the operation and expansion of our business.
Sales of Unregistered Securities
−Removed: the year ended December 31, 2020, we issued and sold the following unregistered securities:
−Removed: share and per share numbers in this have been adjusted to reflect the one-for-44 reverse stock split of our issued and outstanding
−Removed: shares of common stock effected on June 10, 2019.
−Removed: July 7, 2020, the board of directors approved up to $500,000 for all directors, officers and employees to buy company shares from
−Removed: us at the market price.
−Removed: As of August 31, 2020, we had issued 10,730 shares of our common stock at a price of $2.33 for a total
−Removed: This plan expired September 10, 2020.
−Removed: September 4, 2020, the board of directors approved up to $500,000 for all directors, officers and employees to buy company shares
−Removed: from us at the market price.
−Removed: As of October 31, 2020, we have issued 12,316 shares of our common stock at a price of $2.03 for
−Removed: a total of $25,000.
−Removed: This plan expired November 1 ,2020.
−Removed: November 5, 2020, the board of directors approved up to $500,000 for all directors, officers and employees to buy company shares
−Removed: from the Company at the market price.
−Removed: As of December 31, 2020, the Company has issued 14,435 shares of its common stock at a price
−Removed: of $1.72 for a total of $25,000.
−Removed: This plan expired January 2, 2021.
−Removed: June 11, 2019, the board of directors approved up to $500,000 for all directors, officers and employees to buy company shares
+Added: the year ended December 31, 2021, we issued and sold the following unregistered securities under the 2018 Equity Incentive Plan, effective
+Added: September 12, 2018 which will continue in effect for a period of 10 years from its effective date:
+Added: July 7, 2020, the board of directors approved a plan pursuant to which all directors, officers, and employees could purchase from the
+Added: Company up to an aggregate of $500,000 worth of shares at the market price.
+Added: Pursuant to NYSE American rules, this plan was effective
+Added: for a sixty-day period commencing upon the date that the NYSE American approved the Company’s Supplemental Listing Application.
+Added: The Company issued 10,730 shares of its common stock at a price of $2.33 for a total of $25,000 under this plan.
+Added: When this plan expired,
+Added: the board of directors approved subsequent similar $500,000 plans for all directors, officers and employees to buy Company shares
from the Company at the market price.
−Removed: As of June 28, 2019, the Company has issued 67,767 shares of its common stock at prices
−Removed: between $4.03 and $4.37 for a total of $274,000.
−Removed: This plan expired August 19, 2019.
−Removed: 2009 Equity Incentive Plan, effective June 24, 2009, as amended, authorizes the grant of non-qualified and incentive stock options,
−Removed: stock appreciation rights, restricted stock and other stock awards.
−Removed: A maximum of 500,000 shares of common stock is reserved for
−Removed: potential issuance pursuant to awards under the 2009 Equity Incentive Plan.
−Removed: Unless sooner terminated, the 2009 Equity Incentive
−Removed: Plan will continue in effect for a period of 10 years from its effective date.
−Removed: During 2018, there were 106,255 options granted
−Removed: by the Company under this Plan.
−Removed: 2018 Equity Incentive Plan, effective September 12, 2018, authorizes the grant of (i) Incentive Stock Options, (ii) Nonstatutory
−Removed: Stock Options, (iii) Stock Appreciation Rights, (iv) Restricted Stock Awards, (v) Restricted Stock Unit Awards, (vi) Performance
−Removed: Stock Awards, (vii) Performance Cash Awards, and (viii) Other Stock Awards.
−Removed: Initially, a maximum of 159,091 shares of common stock
−Removed: is reserved for potential issuance pursuant to awards under the 2018 Equity Incentive Plan.
−Removed: Unless sooner terminated, the 2018
−Removed: Equity Incentive Plan will continue in effect for a period of 10 years from its effective date.
−Removed: On October 17, 2018, the board
−Removed: of directors issued 26,234 options to the officers and directors at the exercise price of $9.68 expiring in 10 years, and on November
−Removed: 14, 2018, the board of directors issued 23 options to each employee, officer and director at the exercise price of $9.68 expiring
−Removed: in ten years.
−Removed: On January 28, 2019, 39,268 options were issued to the officers and directors with an exercise price of $9.68 for
−Removed: a period of ten years with a vesting period of one year.
−Removed: offers, sales and issuances of securities described above was deemed to be exempt from registration under the Securities Act in
−Removed: reliance on either Section 4(a)(2) in that the issuance of securities to the accredited investors did not involve a public offering,
−Removed: or Rule 701 in that the transactions were under compensatory benefit plans and contracts relating to compensation as provided
−Removed: under Rule 701.
+Added: Subsequent plans were approved by the board of directors upon the expiration of prior plans.
+Added: latest plan was approved by the board of directors on September 14, 2021.
+Added: the fiscal year ended December 31, 2020, the Company issued a total of 27,501 shares of its common stock at prices ranging from $1.72
+Added: to $2.03 for a total of $50,000.
+Added: the fiscal year ended December 21, 2021, the Company issued a total of 132,238 shares of its common stock at prices ranging from $1.16
+Added: to $2.35 for a total of $205,000.
+Added: offers, sales and issuances of securities described above was deemed to be exempt from registration under the Securities Act in reliance
+Added: on either Section 4(a)(2) in that the issuance of securities to the accredited investors did not involve a public offering, or Rule 701
+Added: in that the transactions were under compensatory benefit plans and contracts relating to compensation as provided under Rule 701.
Financial Data.
−Removed: Management’s
−Removed: Discussion and Analysis of Financial Condition and Results of Operations.
−Removed: following discussion and analysis is related to our financial condition and results of operations for the two years ended December
−Removed: 31, 2020 This information should be read in conjunction with our consolidated financial statements and related notes thereto beginning
−Removed: on F-1 of this Form 10-K.
−Removed: Please also see “Special Note Regarding Forward Looking Statements”
−Removed: Risk Factors.
−Removed: have issued warrants (the “Warrants”) in August 2016, February 2017, June 2017, August 2017, April 2018, and March
−Removed: 2019 that are single compound derivatives containing both an embedded right to obtain stock upon exercise (a “Call”)
−Removed: and a series of embedded rights to settle the Warrants for cash upon the occurrence of certain events (each, a “Put”).
−Removed: Generally, the Put provisions allow the Warrant Holders liquidity protection;
−Removed: the right to receive cash in certain situations
−Removed: where the Holders would not have a means of readily selling the shares issuable upon exercise of the Warrants (e.g., where there
−Removed: would no longer be a significant public market for our common stock).
−Removed: However, because the contractual formula used to determine
−Removed: the cash settlement value of the embedded Put requires use of certain assumptions, the cash settlement value of the embedded Put
−Removed: can differ from the fair value of the unexercised embedded Call option at the time the embedded Put option is exercised.
−Removed: recompute the fair value of the Warrants at the end of each quarterly reporting period.
−Removed: Such value computation includes subjective
−Removed: input assumptions that are consistently applied each period.
−Removed: If we were to alter our assumptions or the numbers input based on
−Removed: such assumptions, the resulting fair value could be materially different.
−Removed: September 28, 2018, we entered into a $3,170,000 10% Secured Convertible Promissory Note (the “IR Note”) with Iliad
−Removed: Research and Trading, L.P.
−Removed: (the “Holder”), which was issued to the Holder in conjunction with 500,000 shares of common
−Removed: stock (the “Origination Shares”).
−Removed: We collected $3,000,000 in cash from the Holder during September 2018 and the remainder
−Removed: $170,000 was retained by the Holder for the Holder’s legal fees of $20,000 for the issuance of the IR Note and the Original
−Removed: Issue Discount of $150,000.
−Removed: We incurred $210,000 in third-party fees directly attributed to the issuance of the IR Note.
−Removed: to pay the principal amount, together with guaranteed interest at the annual rate of 10%, with principal and accrued interest
−Removed: on the IR Note due and payable on September 28, 2019, unless converted under terms and provisions as set forth within the IR Note.
−Removed: The IR Note provided the Holder with the right to convert, at any time, all or any part of the outstanding principal and accrued
−Removed: but unpaid interest into shares of our common stock at a conversion price of $0.30 per share.
−Removed: In addition, beginning on March
−Removed: 28, 2019, the IR Note also provided the Holder with the right to redeem all or any portion of the IR Note (“Redemption Amount”).
−Removed: The payments of each Redemption Amount may be made, at our option, in cash, by converting such Redemption Amount into shares of
−Removed: common stock (“Redemption Conversion Shares”), or a combination thereof.
−Removed: The number of Redemption Conversion Shares
−Removed: equals the portion of the applicable Redemption Amount being converted divided by the lesser of $0.30 or 80% of the lowest Volume
−Removed: Weighted Average Price (“VWAP”) during the ten (10) trading days immediately preceding the applicable measurement
−Removed: date (the “Market Price”).
−Removed: The Purchase Agreement required us to reserve at least 8,900,000 shares of common stock
−Removed: from our authorized and unissued common stock to provide for all issuances of common stock under the IR Note.
−Removed: However, the IR
−Removed: Note provided that the aggregate number shares of common stock issued to the Holder under the IR Note and Purchase Agreement shall
−Removed: not exceed 19.99% of the total number of shares of common stock outstanding as of the closing date unless we have obtained stockholder
−Removed: approval of the issuance.
−Removed: The Origination Shares were to be returned to us in the event that we could provide within 30 days of
−Removed: the closing of the transaction certain requested assets as security for repayment of the IR Note.
−Removed: The security was not provided
−Removed: so the Origination Shares remained with the Holder.
−Removed: determined the IR Note should be recorded at fair value with subsequent changes in fair value recorded in earnings.
−Removed: This conclusion
−Removed: is based on the redemption conversion feature, which allows the Holder to trigger the redemption of the IR Note for cash or conversion
−Removed: of the IR Note for common shares prior to its maturity date at a price of the lesser of $0.30 per share or the Market Price as
−Removed: defined within the IR Note.
−Removed: The choice of cash redemption or conversion of the IR Note for common shares was at our option.
−Removed: feature may require us to issue a variable number of common shares to settle the IR Note which was determined to have a predominantly
−Removed: fixed monetary value at inception.
−Removed: On March 13, 2019, we amended the Purchase Agreement pursuant to which we issued the Convertible
−Removed: IR Note (the “Amendment”).
−Removed: The Amendment extended the maturity of the IR Note to September 28, 2020.
−Removed: the redemption conversion rates were revised to a price to be determined by mutual agreement between us and the Holder.
−Removed: event that we and the Holder were unable to reach a mutually agreeable price, we would be required to pay the applicable redemption
−Removed: amount in cash.
−Removed: The maximum amount of the IR Note the Holder will be able to redeem in any given calendar month was $300,000.
−Removed: evaluated the Amendment in accordance with ASC 470, Debt (“ASC 470”) and determined the Amendment was considered
−Removed: an extinguishment of the existing debt and issuance of net debt.
−Removed: As a result, we derecognized the liability and recorded a loss
−Removed: on the extinguishment of debt of $345,000 in 2019 which was equal to the difference between the reacquisition price of the debt
−Removed: and the net carrying amount (amount due at maturity, adjusted for unamortized discounts) of the extinguished debt.
−Removed: Subsequently,
−Removed: the amended note was recorded in accordance with ASC 480 at the fair value that the note was issued with changes in fair value
−Removed: recorded through earnings at each reporting period.
−Removed: were a series of debt conversions during 2019 which partially converted $1,400,000 of the $3,408,000 convertible debt, as amended,
−Removed: into stockholders’
−Removed: equity, adding approximately $1,400,000 to stockholders’
−Removed: The number of shares issued in
−Removed: these conversions were 204,246 shares.
−Removed: In October 2019 and November 2019 respectively, the Holder redeemed $300,000 pursuant to
−Removed: the terms of the modification.
−Removed: In connection with the IR Note, we recorded a gain equal to $127,000 for the year-end December
−Removed: See Note 14 Convertible Note Payable.
−Removed: August 5, 2019, we issued a Secured Promissory Note (the “CV Note”) with Chicago Venture Partners, L.P.
−Removed: (“CV”).
−Removed: The Note had an original principal amount of $2,635,000, bore interest at a rate of 10% per annum and was to mature in 24 months,
−Removed: unless earlier paid in accordance with its terms.
−Removed: We received proceeds of $1,900,000 after an original issue discount and payment
−Removed: of CV’s legal fees.
−Removed: Pursuant to a Security Agreement between us and CV, repayment of the Convertible Note is secured by
−Removed: substantially all of our assets other than our intellectual property.
−Removed: the quarter ending June 30, 2020, CV made redemptions of $650,000 reducing the principal to $1,985,000.
−Removed: On May 29, 2020, we paid
−Removed: off the outstanding CV Note which consisted of principal of $1,985,000, and accrued interest payable of $220,000.
−Removed: The net payment
−Removed: of $1,795,000, less the write off of the origination discount of $369,000 and issuance costs of $6,000, resulted in a gain on
−Removed: extinguishment of $66,000.
−Removed: December 5, 2019, we issued a secured Promissory Note (the “AS Note”) to Atlas Sciences L.P.
−Removed: (“AS”).
−Removed: AS Note has an original principal amount of $2,175,000, bears interest at a rate of 10% per annum and will mature in 24 months,
−Removed: unless earlier paid in accordance with its term.
−Removed: In conjunction with the AS Note, we utilized $1,650,000 of the net proceeds from
−Removed: the AS Note to pay off in full our obligation to Iliad, an entity with affiliations to AS, pursuant to the IR Note We evaluated
−Removed: the IR Note in accordance with ASC 470, Debt (“ASC 470”) and determined the exchange is considered an extinguishment
−Removed: of the existing debt and issuance of new debt.
−Removed: As a result, we derecognized the liability and recorded a loss on the extinguishment
−Removed: of debt of $250,000 which was equal to the difference between the reacquisition price of the debt and the net carrying amount
−Removed: (amount due at maturity, adjusted for unamortized discounts) of the extinguished debt.
−Removed: Subsequently, the AS Note will be recorded
−Removed: in accordance with ASC 470 whereby we will record a liability equal to the proceeds received on December 5, 2019.
−Removed: June 19, 2020, we paid off the outstanding AS note consisting of the original principal of $2,175,000 and accrued interest payable
−Removed: of $122,000 less origination discount of $376,000 and issuance costs of $7,000, with a net note payable of $1,838,000, including
−Removed: a gain on extinguishment of $76,000.
−Removed: OF OPERATIONS
−Removed: ended December 31, 2020 versus year ended December 31, 2019
−Removed: net loss was approximately $14,400,000 and $9,404,000 for the years ended December 31, 2020 and 2019, respectively, representing
−Removed: an increase in loss of approximately $4,996,000 or 53% when compared to the same period in 2019.
−Removed: This increase in loss
−Removed: for the year ended December 31, 2020 was primarily due to the following:
−Removed: increase in the loss of the quarterly revaluation of certain redeemable warrants of $1,633,000 which resulted in a non cash
−Removed: loss of $123,000 in the year-ended December 31, 2020 compared to a non-cash gain of $1,510,000 in the year ended December
−Removed: increase in research and development expenses of $1,069,000 or 23%;
−Removed: increase in general and administrative expenses of $1,615,000 or 23%;
−Removed: increase in other assets impairment losses of $135,000;
−Removed: increase in interest expense and finance costs of $245,000;
−Removed: decrease in the gain resulting from a settlement with as insurance claim of $1,217,000 in 2019 which did not occur in 2020;
−Removed: decrease of $90,000 in the gain for the fair value adjustment for the convertible note which was paid in full in 2019;
−Removed: decrease in the extinguishment of debt of $487,000 which resulted in a gain of $142,000 for the year ended December 31, 2020
−Removed: compared to a loss of $345,000 in the year-ended December 31, 2019:
−Removed: decrease in production costs of $87,000 or 10%;
−Removed: increase in interest/other income of $130,000;
−Removed: increase in revenue from cost recovery of $23,000.
−Removed: loss per share was $ (0.45) and $(2.58) for the years ended December 31, 2020 and 2019, respectively.
−Removed: The weighted average
−Removed: number of shares of our common stock outstanding as of December 31, 2020 was 31,842,799 as compared to 3,642,717 as of December
−Removed: from our Ampligen®
−Removed: Cost Recovery Program were $163,000 and $140,000 for the years ended December 31, 2020 and 2019, respectively.
−Removed: The increase in revenues of $23,000, or 16%, between periods was primarily due to the clinical sites usage.
−Removed: the years ended December 31, 2020 and 2019, we had no Alferon N Injection®
−Removed: Finished Good product to commercially sell and
−Removed: all revenue was generated from the EAP and our FDA approved open-label treatment protocol, (“AMP 511”), that allows
−Removed: patient access to Ampligen®
−Removed: for treatment in an open-label safety study.
−Removed: costs were approximately $806,000 and $893,000, respectively, for the years ended December 31, 2020 and 2019, representing a decrease
−Removed: of $87,000 related to repairs and maintenance in the current period.
−Removed: and Development Costs
−Removed: Research and Development (“R&D”) costs for the year ended December 31, 2020 were approximately $5,720,000 as compared
−Removed: to $4,651,000 for the same period a year ago, reflecting an increase of approximately $1,069,000.
−Removed: The primary reason for the increase
−Removed: in research and development costs was due to increases in Scrap from expired material of $1,095,000, clinical trials of $197,000,
−Removed: outside labs $194,000, patent and trademark abandonments of $113,000 offset by decreases in wages and benefits of $401,000 and
−Removed: outside contractors $123,000.
−Removed: and Administrative Expenses
−Removed: and Administrative (“G&A”) expenses for the years ended December 31, 2020 and 2019, were approximately $8,654,000
−Removed: and $7,039,000, respectively, reflecting an increase of approximately $1,615,000 or 23%.
−Removed: The increase in G&A expenses during
−Removed: the current period was mainly due to increases in salaries and benefits of $973,000, accounting, professional and legal fees of
−Removed: $349,000, stock compensation of $184,000, taxes and licenses of $163,000, scientific advisory board of $159,000, offset
−Removed: by decreases in public relations of $90,000 and investment bank fees of $135,000, and travel of $31,000.
−Removed: and Other Income
−Removed: and other income for the years ended December 31, 2020 and 2019 was approximately $219,000 and $89,000, respectively, representing
−Removed: an increase of approximately $130,000 or 146%.
−Removed: The primary cause for the increase in investment income during the current
−Removed: period was primarily due to higher balances available to invest in the current period as compared to the prior period.
−Removed: of other assets
−Removed: the year ended December 31, 2020 there was a loss of $135,000 related to the impairment of other assets consisting of the loss
−Removed: of a deposit to a supplier for use of technology which we are no longer utilizing and was written off.
−Removed: Expense and Finance Costs
−Removed: and finance costs for the year ended December 31, 2020 was $672,000 compared to $427,000 in the prior year, an increase
−Removed: of $245,000 or 57%.
−Removed: The increase is mainly attributed to the interest and amortization of costs of the Chicago Ventures and Atlas
−Removed: notes which were extinguished in the second quarter of 2020.
−Removed: Extinguishment
−Removed: extinguishment costs decreased $487,000.
−Removed: There was a gain of $142,000 for the year ended December 31, 2020 compared to a loss
−Removed: of $345,000 in the year-ended December 31, 2019.
−Removed: quarterly revaluation of certain redeemable warrants resulted in a non-cash adjustment to the redeemable warrants liability amounted
−Removed: to a loss of $123,000 for the year ended December 31, 2020 compared to a gain of approximately $1,510,000 in December 31, 2019
−Removed: which represents a decrease of $1,633,000 or 108% (see “Financial Statements:
−Removed: Fair Value”
−Removed: for the various
−Removed: factors considered in the valuation of redeemable warrants).
−Removed: from sale of income tax operating losses
−Removed: December 2020, we effectively sold $11,000,000 New Jersey state net operating loss for approximately $1,090,000 and recorded a
−Removed: deferred tax asset of 96,000.
−Removed: In December 2019, we effectively sold $10,000,000 New Jersey state net operating loss for approximately
−Removed: $776,000 and recorded a deferred tax asset of $129,000.
−Removed: quarterly revaluation of the convertible note resulted in a non-cash adjustment in 2020 of zero and in 2019 amounted to a gain
−Removed: the year ended December 31, 2020 there were no gains or losses from insurance claims, however, in 2019 there was a gain from the
−Removed: insurance loss claim of $1,217,000.
−Removed: and Capital Resources
−Removed: September 2019, we raised approximately $8,000,000 in a public offering underwritten by A.G.P./Alliance Global Partners, LLC (“AGP”)
−Removed: pursuant to which we issued (i) 1,740,550 shares of our common stock;
−Removed: (ii) pre-funded warrants exercisable for 7,148,310 shares
−Removed: of common stock (the “Prefunded Warrants”), (iii) warrants to purchase up to an aggregate of 8,887,860 shares of common
−Removed: stock (the “Warrants”);
−Removed: and (iv) a Representative’s Warrant to purchase up to an aggregate of 266,665 shares
−Removed: of common stock (the “Representative’s Warrant”).
−Removed: During 2020, an aggregate of 8,874,000 shares of common stock
−Removed: were issued upon exercise of the Prefunded Warrants.
−Removed: the first quarter of 2020 an aggregate of 8,746,990 shares were issued upon exercise of the Warrants for gross proceeds of approximately
−Removed: $8,658,000 and an aggregate of 1,870,000 shares were issued upon exercise of the Prefunded Warrants.
−Removed: In addition, on March 25,
−Removed: 2020, the Representative’s Warrant was amended to permit exercise of such warrant to commence on March 30, 2020.
−Removed: the first quarter of 2020, the amended warrants were exercised and an aggregate of 266,665 shares are being issued
−Removed: upon exercise of the warrant for gross proceeds of approximately of $264,000.
−Removed: entered into an Equity Distribution Agreement (the “2019 EDA”) with Maxim Group LLC (“Maxim”), pursuant
−Removed: to which we could sell from time to time, shares of our Common Stock through Maxim, as agent (the “Offering”).
−Removed: the year ended December 31, 2020, we sold 20,444,807 shares under the 2019 EDA for total gross proceeds of $53,936,615, which
−Removed: included a 3.5% fee to Maxim of $1,888,727.
−Removed: During 2021, we sold 5,655,731 shares under the 2019 EDA for total gross proceeds
−Removed: of $13,301,526, which includes a 3.5% fee to Maxim of $465,553.
−Removed: The 2019 EDA was terminated in early February 2021.
−Removed: used in operating activities for the year ended December 31, 2020 was approximately $10,368,000 compared to approximately
−Removed: $9,067,000 for the same period in 2019, an increase of $1,301,000.
−Removed: The primary reasons for this increase in cash used in
−Removed: operations in 2020 was related production cost of 2 Ampligen batches in the amount of $664,000, increase in New
−Removed: Jersey NOL of $314,000, and decrease in accounts payable of $89,000.
−Removed: used in investing activities for the year ended December 31, 2020 was approximately $9,164,000 compared to $6,147,000 for
−Removed: the same period in 2019, representing a change of $3,017,000.
−Removed: The primary reason for the increase in cash used in investing
−Removed: activities resulted from the purchase of marketable securities of approximately $12,831,000 offset by the sale of marketable securities
−Removed: provided by financing activities for the year ended December 31, 2020 was approximately $56,563,000 compared to approximately
−Removed: $16,385,000 for the same period in 2019, an increase of $40,178,000.
−Removed: The primary reasons for this increase was our receipt
−Removed: of $61,216,000 in net proceeds from the sale of shares compared to $15,303,000 from the sale of shares in 2019.
−Removed: of December 31, 2020, we had approximately $54,378,000 in cash, cash equivalents and marketable securities, inclusive of approximately
−Removed: $15,877,000 in Marketable Securities, representing an increase of approximately $45,600,000 from December 31, 2019.
−Removed: are committed to a focused business plan oriented toward finding senior co-development partners with the capital and expertise
−Removed: needed to commercialize the many potential therapeutic aspects of our experimental drugs and our FDA approved drug Alferon.
−Removed: development of our products requires the commitment of substantial resources to conduct the time-consuming research, preclinical
−Removed: development, and clinical trials that are necessary to bring pharmaceutical products to market.
−Removed: We believe, based on our current
−Removed: financial condition, that we have adequate funds to meet our anticipated operational cash needs and fund current clinical trials
−Removed: over approximately the next twenty-four months.
−Removed: At present we do not generate any material revenues from operations and
−Removed: we do not anticipate doing so in the near future.
−Removed: We may need to obtain additional funding in the future for new studies and/or
−Removed: if current studies do not yield positive results, require unanticipated changes and/or additional studies.
−Removed: If we are unable to
−Removed: commercialize and sell Ampligen and/or recommence material sales of Alferon N Injection, our operations, financial position and
−Removed: liquidity may be adversely impacted, and additional financing may be required.
−Removed: There can be no assurances that, if needed, we
−Removed: will be able to raise adequate funds or enter into licensing, partnering or other arrangements to advance our business goals.
−Removed: We may seek to access the public equity market whenever conditions are favorable, even if we do not have an immediate need for
−Removed: additional capital at that time.
−Removed: We are unable to estimate the amount, timing or nature of future sales of outstanding common
−Removed: stock or instruments convertible into or exercisable for our common stock.
−Removed: Any additional funding may result in significant dilution
−Removed: and could involve the issuance of securities with rights, which are senior to those of existing stockholders.
−Removed: See Part I, Item
−Removed: 1A - “Risk Factors;
−Removed: We may require additional financing which may not be available ”.
−Removed: Relationships and Related Transactions
−Removed: to PART III, ITEM 13 - “Certain Relationships and Related Transactions, and Director Independence.”
−Removed: Accounting Pronouncements
−Removed: to “Note 2(h) –
−Removed: Recent Accounting Standards and Pronouncements”
−Removed: under Notes to Consolidated Financial Statements.
−Removed: about Off-Balance Sheet Arrangements
−Removed: Accounting Policies
−Removed: Reporting Release No.
−Removed: 60 requires all companies to include a discussion of critical accounting policies or methods used in the
−Removed: preparation of financial statements.
−Removed: Our significant accounting policies are described in the Notes to Consolidated Financial
−Removed: The significant accounting policies that we believe are most critical to aid in fully understanding our reported financial
−Removed: results are the following:
−Removed: assess long-lived assets for impairment when events or changes in circumstances indicate that the carrying value of the assets
−Removed: or the asset grouping may not be recoverable.
−Removed: Factors that we consider in deciding when to perform an impairment review include
−Removed: significant under-performance of a business or product line in relation to expectations, significant negative industry or economic
−Removed: trends, and significant changes or planned changes in its use of the assets.
−Removed: We measure the recoverability of assets that it will
−Removed: continue to use in its operations by comparing the carrying value of the asset grouping to our estimate of the related total future
−Removed: undiscounted net cash flows.
−Removed: If an asset grouping’s carrying value is not recoverable through the related undiscounted cash
−Removed: flows, the asset grouping is considered to be impaired.
−Removed: measure the impairment by comparing the difference between the asset grouping’s carrying value and its fair value.
−Removed: assets are considered a non-financial asset and are recorded at fair value only if an impairment charge is recognized.
−Removed: are determined for groups of assets related to the lowest level of identifiable independent cash flows.
−Removed: We make subjective judgments
−Removed: in determining the independent cash flows that can be related to specific asset groupings.
−Removed: In addition, as we review our manufacturing
−Removed: process and other manufacturing planning decisions, we must make subjective judgments regarding the remaining useful lives of
−Removed: When we determine that the useful lives of assets are shorter than originally estimated, we accelerate the rate of depreciation
−Removed: over the assets’
−Removed: new, shorter useful lives.
−Removed: utilize the guidance contained in ASC 480 in the determination of whether to record warrants and options as Equity and/or Liability.
−Removed: If the guidance of ASC 480 is deemed inconclusive, we continue our analysis utilizing ASC 815.
−Removed: method of recording the related value is consistent with the standards as defined by the Financial Accounting Standards
−Removed: Board utilizing the concept of “Fair Value”
−Removed: from ASC 820-10-55-1 that states that any fair value measurement requires
−Removed: that the reporting entity, to determine the valuation technique(s) appropriate for the measurement, consider the availability
−Removed: of data with which to develop inputs that represent the assumptions that market participants would use in pricing the asset or
−Removed: liability and the level in the fair value hierarchy within which the inputs fall.
−Removed: recomputed the value of the redeemable warrants at the end of each quarterly period.
−Removed: We use the Monte Carlo Simulation approach
−Removed: which includes subjective input assumptions that are consistently applied each quarter.
−Removed: If we were to alter our assumptions or
−Removed: the numbers input based on such assumptions, the resulting fair value could be materially different.
−Removed: As discussed in greater detail
−Removed: in “Fair Value”
−Removed: at the beginning of this ITEM 7, the significant assumptions using this model are:
−Removed: (i) Risk-Free Interest
−Removed: (ii) Expected Holding Period;
−Removed: (iii) Expected Volatility;
−Removed: (iv) Expected Dividend Yield;
−Removed: (v) Expected Probability of a Fundamental
−Removed: (vi) Expected Timing of Announcement of a Fundamental Transaction;
−Removed: (vii) Expected 100 Day Volatility at Announcement
−Removed: of a Fundamental Transaction;
−Removed: (viii) Expected Risk-Free Interest Rate at Announcement of a Fundamental Transaction;
−Removed: and (ix) Expected
−Removed: Time Between Announcement and Consummation of a Fundamental Transaction.
−Removed: Concentration
−Removed: of Credit Risk
−Removed: policy is to limit the amount of credit exposure to any one financial institution and place investments with financial institutions
−Removed: evaluated as being credit worthy, or in short-term money markets, which are exposed to minimal interest rate and credit risks.
−Removed: We have had bank deposits and overnight repurchase agreements that exceed federally insured limits.
−Removed: Concentration
−Removed: of credit risk, with respect to receivables, is limited through our credit evaluation process.
−Removed: We do not require collateral on
−Removed: our receivables.
−Removed: Our receivables historically consisted principally of amounts due from wholesale drug companies.
−Removed: and Qualitative Disclosures About Market Risk.
−Removed: Statements and Supplementary Data.
−Removed: see the “Index to Financial Statements and Financial Statement Schedule”
−Removed: in and Disagreements with Accountants on Accounting and Financial Disclosures.
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.