1 unchanged sentence
TO FINANCIAL STATEMENTS
−Removed: Report of Independent Registered Public Accounting Firm
+Added: of Independent Registered Public Accounting Firm (Marcum LLP, PCAOB ID No.
Consolidated Balance Sheets as of December 31, 2021 and 2020
1 unchanged sentence
Consolidated Statements of Comprehensive Loss for the Years Ended December 31, 2021 and 2020
−Removed: Consolidated Statements of Changes In Stockholders’
−Removed: Deficiency for the Years Ended December 31, 2020 and 2019
+Added: Consolidated Statements of Changes In Stockholders’ Deficiency for the Years Ended December 31, 2021 and 2020
Consolidated Statements of Cash Flows for the Years Ended December 31, 2021 and 2020
1 unchanged sentence
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
−Removed: the Shareholders and Board of Directors of
+Added: the Stockholders and Board of Directors of
Biopharmaceuticals, Inc.
1 unchanged sentence
have audited the accompanying consolidated balance sheets of Provectus Biopharmaceuticals, Inc.
−Removed: and Subsidiaries (the “Company”)
−Removed: as of December 31, 2020 and 2019, the related consolidated statements of operations, comprehensive loss, changes in stockholders’
−Removed: deficiency and cash flows for each of the two years in the period ended December 31, 2020, and the related notes (collectively
−Removed: referred to as the “financial statements”).
−Removed: In our opinion, the consolidated financial statements present fairly,
−Removed: in all material respects, the financial position of the Company as of December 31, 2020 and 2019, and the results of its operations
−Removed: and its cash flows for each of the two years in the period ended December 31, 2020, in conformity with accounting principles generally
−Removed: accepted in the United States of America.
−Removed: Paragraph –
−Removed: Going Concern
+Added: and Subsidiaries (the “Company”)
+Added: as of December 31, 2021 and 2020, the related consolidated statements of operations, comprehensive loss, changes in stockholders’
+Added: deficiency and cash flows for each of the two years in the period ended December 31, 2021, and the related notes (collectively referred
+Added: to as the “financial statements”).
+Added: In our opinion, the consolidated financial statements present fairly, in all material
+Added: respects, the financial position of the Company as of December 31, 2021 and 2020, and the results of its operations and its cash flows
+Added: for each of the two years in the period ended December 31, 2021, in conformity with accounting principles generally accepted in the United
+Added: States of America.
+Added: Paragraph – Going Concern
accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern.
−Removed: As more fully described in Note 2, the Company has a significant working capital deficiency, has incurred significant losses and
−Removed: needs to raise additional funds to meet its obligations and sustain its operations.
−Removed: These conditions raise substantial doubt about
−Removed: the Company's ability to continue as a going concern.
+Added: fully described in Note 2, the Company has a significant working capital deficiency, has incurred significant losses and needs to raise
+Added: additional funds to meet its obligations and sustain its operations.
+Added: These conditions raise substantial doubt about the Company’s
+Added: ability to continue as a going concern.
Management’s plans in regard to these matters are also described in Note 2.
−Removed: The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
+Added: The consolidated
+Added: financial statements do not include any adjustments that might result from the outcome of this uncertainty.
financial statements are the responsibility of the Company’s management.
1 unchanged sentence
consolidated financial statements based on our audit s .
−Removed: We are a public accounting firm registered with the Public Company
−Removed: Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Company
−Removed: in accordance with the U.S.
−Removed: federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission
−Removed: and the PCAOB.
+Added: We are a public accounting firm registered with the Public Company Accounting
+Added: Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with
+Added: federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
conducted our audits in accordance with the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audit s
−Removed: to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error
−Removed: The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial
−Removed: As part of our audits we are required to obtain an understanding of internal control over financial reporting but not
−Removed: for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting.
−Removed: we express no such opinion.
−Removed: audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to
−Removed: error or fraud, and performing procedures that respond to those risks.
−Removed: Such procedures included examining, on a test basis, evidence
−Removed: regarding the amounts and disclosures in the financial statements.
−Removed: Our audits also included evaluating the accounting principles
−Removed: used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.
−Removed: We believe that our audits provide a reasonable basis for our opinion.
+Added: Those standards require that we plan and perform the audit s to
+Added: obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
+Added: The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
+Added: of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose
+Added: of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting.
+Added: Accordingly, we express
+Added: no such opinion.
+Added: audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error
+Added: or fraud, and performing procedures that respond to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding
+Added: the amounts and disclosures in the financial statements.
+Added: Our audits also included evaluating the accounting principles used and significant
+Added: estimates made by management, as well as evaluating the overall presentation of the financial statements.
+Added: We believe that our audits
+Added: provide a reasonable basis for our opinion.
Audit Matters
−Removed: Audit Matters are matters arising from the current period audit of the financial statements that were communicated or required
−Removed: to be communicated to the audit committee and that:
−Removed: (1) relate to accounts or disclosures that are material to the financial statements
−Removed: and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: We determined that there are no critical audit
−Removed: /s/ Marcum LLP
−Removed: have served as the Company’s auditor since 2016.
+Added: Audit Matters are matters arising from the current period audit of the financial statements that were communicated or required to be
+Added: communicated to the audit committee and that:
+Added: (1) relate to accounts or disclosures that are material to the financial statements and
+Added: (2) involved our especially challenging, subjective, or complex judgments.
+Added: We determined that there are no critical audit matters.
+Added: have served as the Company’s auditor since 2016.
BIOPHARMACEUTICALS, INC.
2 unchanged sentences
Cash and cash equivalents
−Removed: Short-term receivables - legal fees, settlement and other, net
−Removed: Prepaid expenses
+Added: Restricted cash
+Added: Short-term receivables
+Added: Prepaid expenses and other current assets
Total Current Assets
−Removed: Equipment and furnishings, less accumulated depreciation of $78,313 and $64,630, respectively
+Added: Equipment and furnishings, less accumulated depreciation of $ 91,178
+Added: and $ 78,313 ,
Operating lease right-of-use asset
−Removed: Patents, net of accumulated amortization of $11,715,455 and $11,487,338, respectively
−Removed: Liabilities and Stockholders’
+Added: Liabilities and Stockholders’ Deficiency
Current Liabilities:
−Removed: Accounts payable - trade
+Added: Accounts payable
+Added: Deposit for purchase
+Added: of Series D-1 Preferred Stock
+Added: Unearned grant revenue
Other accrued expenses
−Removed: Current portion of accrued interest
−Removed: Current portion of accrued interest - related parties
−Removed: Current portion of note payable
−Removed: Current portion of convertible notes payable
−Removed: Current portion of convertible notes payable - related parties
−Removed: Current portion of operating lease liability
+Added: Accrued interest
+Added: Accrued interest - related parties
+Added: Notes payable
+Added: Convertible notes payable
+Added: Convertible notes payable - related parties
+Added: Operating lease liability
Total Current Liabilities
−Removed: Accrued interest, non-current portion
−Removed: Accrued interest, non-current portion - related parties
Note payable, non-current portion
−Removed: Convertible notes payable, non-current portion
−Removed: Convertible notes payable, non-current portion - related parties
Operating lease liability, non-current portion
Total Liabilities
−Removed: Commitments and contingencies (Note 11)
−Removed: Stockholders’
+Added: Commitments, contingencies and litigation (Note 15)
+Added: Stockholders’ Deficiency:
Preferred stock;
−Removed: par value $0.001 per share;
−Removed: 25,000,000 shares authorized;
+Added: par value $ 0.001
+Added: 25,000,000 shares
Series B Convertible Preferred Stock;
shares designated;
−Removed: 100 shares issued and outstanding at December 31, 2020 and December 31, 2019;
−Removed: aggregate liquidation preference of $3,500 at December 31, 2020 and December 31, 2019
+Added: shares issued and outstanding at December 31, 2021 and 2020, respectively;
+Added: aggregate liquidation preference of $ 0
+Added: at December 31, 2021 and 2020, respectively
+Added: D Convertible Preferred Stock;
+Added: shares designated;
+Added: shares issued and outstanding at December
+Added: 31, 2021 and 2020, respectively;
+Added: aggregate liquidation preference of $ 14,164,889
+Added: at December 31, 2021 and 2020, respectively;
+Added: Stockholders’ Deficiency – Liquidation Preference )
+Added: D-1 Convertible Preferred Stock;
+Added: shares designated;
+Added: shares issued and outstanding at December
+Added: 31, 2021 and 2020, respectively;
+Added: aggregate liquidation preference of $ 105,532,804
+Added: at December 31, 2021 and 2020, respectively;
+Added: Stockholders’ Deficiency – Liquidation Preference )
Common stock;
−Removed: par value $0.001 per share;
+Added: par value $ 0.001
+Added: 1,000,000,000
shares authorized;
−Removed: 398,807,037 and 389,889,475 shares issued and outstanding at December 31, 2020 and December 31, 2019, respectively
+Added: and 398,807,037 shares issued and
+Added: outstanding at December 31, 2021 and 2020, respectively
Additional paid-in capital
3 unchanged sentences
( 240,494,415 )
−Removed: Total Stockholders’
+Added: Total Stockholders’ Deficiency
( 4,187,280 )
( 30,206,357 )
−Removed: Total Liabilities and Stockholders’
+Added: Total Liabilities and Stockholders’ Deficiency
accompanying notes to consolidated financial statements.
7 unchanged sentences
Total Operating Loss
+Added: ( 4,672,254 )
+Added: ( 4,963,576 )
Other Income/(Expense):
−Removed: Gain on settlement of lawsuits
Research and development tax credit
Investment and interest income
+Added: Gain from forgiveness of PPP Loan and interest
Interest expense
+Added: ( 1,748,120 )
Total Other Expense, Net
1 unchanged sentence
$ ( 5,539,543 )
+Added: $ ( 6,677,587 )
Basic and Diluted Loss Per Common Share
13 unchanged sentences
BIOPHARMACEUTICALS, INC.
−Removed: STATEMENTS OF CHANGES IN STOCKHOLDERS’
+Added: STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIENCY
THE YEARS ENDED DECEMBER 31, 2021 AND 2020
−Removed: Preferred Stock
Comprehensive
−Removed: Balance at January 1, 2019
+Added: at January 1, 2020
$ 209,378,835
1 unchanged sentence
$ ( 24,072,112 )
−Removed: Common stock issued upon exercise of warrants
+Added: Common stock issued upon exercise
Stock-based compensation:
+Added: Conversion of Series B Preferred
+Added: Stock to Common Stock
+Added: Conversion of Series B Preferred
+Added: Stock to Common Stock ,shares
+Added: Conversion of PRH Notes to
+Added: Series D Preferred Stock
+Added: Conversion of PRH Notes to
+Added: Series D Preferred Stock, shares
+Added: Conversion of PRH Notes to
+Added: Series D-1 Preferred Stock
+Added: Conversion of PRH Notes to
+Added: Series D-1 Preferred Stock, shares
+Added: Conversion of PRH Notes to
+Added: Series D-1 Preferred Stock , shares
+Added: Conversion of Note to Series
+Added: D-1 Preferred Stock
+Added: Conversion of Note to Series
+Added: D-1 Preferred Stock
+Added: Conversion of Series D-1 Preferred
+Added: Stock to Common Stock
+Added: Conversion of Series D-1 Preferred
+Added: Stock to Common Stock , shares
Comprehensive loss:
−Removed: Other comprehensive loss
−Removed: Balance at December 31, 2019
( 6,677,587 )
( 6,677,587 )
+Added: comprehensive loss
+Added: at December 31, 2020
$ 209,923,347
−Removed: Common stock issued upon exercise of warrants
+Added: $ ( 240,494,415 )
+Added: $ ( 30,206,357 )
+Added: $ 209,923,347
+Added: $ ( 240,494,415 )
+Added: $ ( 30,206,357 )
+Added: Common stock issued upon exercise
Stock-based compensation:
+Added: Conversion of Series B Preferred
+Added: Stock to Common Stock
+Added: Conversion of PRH Notes to
+Added: Series D Preferred Stock
+Added: Conversion of PRH Notes to
+Added: Series D-1 Preferred Stock
+Added: Conversion of Series D-1 Preferred
+Added: Stock to Common Stock
Comprehensive loss:
−Removed: Other comprehensive loss
−Removed: Balance at December 31, 2020
( 5,539,543 )
( 5,539,543 )
+Added: comprehensive loss
+Added: at December 31, 2021
( 246,033,958 )
+Added: ( 4,187,280 )
+Added: ( 246,033,958 )
+Added: ( 4,187,280 )
accompanying notes to consolidated financial statements.
7 unchanged sentences
Stock-based compensation
−Removed: Noncash lease expense
+Added: Non-cash lease expense
Amortization of patents
+Added: Gain on forgiveness of PPP Loan and interest
Changes in operating assets and liabilities
1 unchanged sentence
Prepaid expenses
−Removed: Accounts payable - trade
+Added: Accounts payable
+Added: Unearned grant revenue
Other accrued expenses
1 unchanged sentence
Accrued interest expense
−Removed: Cash Used In Operating Activities
+Added: Net Cash Used In Operating Activities
+Added: ( 1,013,304 )
+Added: ( 4,085,795 )
Cash Flows From Financing Activities:
Proceeds from issuance of convertible notes payable
−Removed: Proceeds from issuance of convertible
−Removed: notes payable - related parties
+Added: Proceeds from issuance of convertible notes payable - related parties
Repayment of short-term note payable
Proceeds from note payable
+Added: Deposit for purchase of Series D-1 Preferred Stock
Proceeds from exercise of warrants
−Removed: Cash Provided By Financing Activities
−Removed: of Exchange Rate Changes on Cash
−Removed: Net (Decrease)/Increase
−Removed: In Cash and Cash Equivalents
−Removed: Cash and Cash Equivalents, Beginning of Period
−Removed: Cash and Cash Equivalents, End of Period
+Added: Net Cash Provided By Financing Activities
+Added: Effect of exchange rates on cash, cash equivalents,
+Added: and restricted cash
+Added: Net Increase (Decrease) In Cash, Cash Equivalents, and Restricted Cash
+Added: Cash, Cash Equivalents, and Restricted Cash, Beginning
+Added: Cash, Cash Equivalents, and Restricted Cash, End of Period
+Added: Cash, cash equivalents and restricted cash consisted of the following:
+Added: Cash and cash equivalents
+Added: Restricted cash
+Added: and cash Equivalents, restricted cash
Supplemental Disclosures of Cash Flow Information:
1 unchanged sentence
Non-cash investing and financing activities:
−Removed: Purchase of insurance policies financed by short-term note payable
−Removed: Offset of related party receivable and payable
+Added: Purchase of insurance policies financed by short-term
+Added: Conversion of non-amended 2017 Notes to Series D Preferred
+Added: Conversion of amended 2017 Notes and 2020 Notes to Series
+Added: D-1 Preferred Stock
+Added: Conversion of Series D-1 Preferred Stock to Common stock
accompanying notes to consolidated financial statements.
2 unchanged sentences
Business Organization and Nature of Operations
−Removed: Biopharmaceuticals, Inc., a Delaware corporation (together with its subsidiaries, “Provectus”
−Removed: or the “Company”),
−Removed: is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases, with the aim of maximizing
−Removed: the curative impact of these medicines and achieving immunity from treated disease.
−Removed: These investigational drugs are based on an
−Removed: entire, wholly-owned, family of small molecules called halogenated xanthenes (“HXs”);
−Removed: our lead HX molecule
−Removed: is named rose bengal disodium (“RBD”).
−Removed: , an investigational autolytic cancer immunotherapy administered
−Removed: by intralesional (“IL”) injection and an injectable formulation of cGMP RBD,
−Removed: is undergoing clinical study for adult solid tumor cancers, such as melanoma and gastrointestinal
−Removed: (“GI”) tumors (including hepatocellular carcinoma (“HCC”), colorectal
−Removed: cancer metastatic to the liver (“mCRC”), neuroendocrine tumors (“NET”)
−Removed: metastatic to the liver (“mNET”), and uveal melanoma metastatic to the liver
−Removed: (“mUM”), among others).
−Removed: Orphan drug designation (“ODD”)
−Removed: status has been granted to IL PV-10 by the U.S.
−Removed: Food and Drug Administration (the “FDA”)
−Removed: for metastatic melanoma in 2006, HCC in 2011, and ocular melanoma (including uveal melanoma)
−Removed: formulations of cGMP RBD are also undergoing preclinical study as prophylactic and therapeutic treatments for high-risk
−Removed: adult solid tumor cancers, such as head and neck, breast, pancreatic, liver, and colorectal cancers.
−Removed: IL PV-10 is also undergoing preclinical study for pediatric solid tumor cancers (including neuroblastoma, Ewing
−Removed: sarcoma, rhabdomyosarcoma, and osteosarcoma).
−Removed: ODD status has been granted to IL PV-10 by the FDA for neuroblastoma
−Removed: Oral formulations of cGMP RBD are undergoing preclinical study for pediatric blood cancers (including leukemia).
−Removed: Systemically-administered formulations of cGMP RBD are undergoing preclinical study for the novel strain of coronavirus
−Removed: (“CoV”), severe acute respiratory syndrome (“SARS”) CoV 2 (“SARS-CoV-2”).
+Added: Biopharmaceuticals, Inc., a Delaware corporation (together with its subsidiaries, “Provectus” or the “Company”),
+Added: is a clinical-stage biotechnology company developing immunotherapy medicines for different diseases, with the aim of maximizing the curative
+Added: impact of these medicines and achieving immunity from treated disease.
+Added: These investigational drugs are based on a wholly owned class
+Added: of small molecules called halogenated xanthenes (“HXs”).
+Added: Our lead HX molecule is named rose bengal sodium (“RBS”).
+Added: PV-10 ® , an investigational cancer immunotherapy administered by intralesional (“IL”) injection and
+Added: an injectable formulation of cGMP (“current Good Manufacturing Practice”) RBS, is undergoing clinical study for adult
+Added: solid tumor cancers, such as melanoma and gastrointestinal (“GI”) tumors (including hepatocellular carcinoma (“HCC”),
+Added: colorectal cancer metastatic to the liver (“mCRC”), neuroendocrine tumors (“NET”) metastatic to the liver
+Added: (“mNET”), and uveal melanoma metastatic to the liver (“mUM”), among others).
+Added: Orphan drug designation (“ODD”)
+Added: status was granted to PV-10 by the FDA for metastatic melanoma in 2006, HCC
+Added: in 2011, and ocular melanoma (including uveal melanoma) in 2019.
+Added: formulations of cGMP RBS are also undergoing preclinical study as prophylactic and therapeutic treatments for high-risk and refractory
+Added: adult solid tumor cancers, such as head and neck, breast, colorectal, and testicular cancers.
+Added: In vivo data of a colorectal
+Added: tumor murine model that continuously promotes abnormal cell proliferation and transformation into cancer indicate increased survival
+Added: in both prophylactic and therapeutic settings.
+Added: IL PV-10 is also undergoing preclinical study for pediatric solid tumor cancers (including neuroblastoma, Ewing sarcoma,
+Added: rhabdomyosarcoma, and osteosarcoma).
+Added: ODD status was granted to PV-10 by the FDA for neuroblastoma in 2018.
+Added: Oral formulations of cGMP RBS are undergoing preclinical study for refractory and relapsed pediatric blood cancers (including
+Added: In vivo data of an acute lymphoblastic leukemia murine model indicated increased survival.
+Added: Systemically administered formulations of cGMP RBS are undergoing preclinical study for the novel strain of coronavirus (“CoV”):
+Added: severe acute respiratory syndrome (“SARS”) CoV 2 (“SARS-CoV-2”).
+Added: In silico data indicate docking-based
+Added: binding affinity to SARS-CoV-2’s main protease, spike protein, and different variants of the spike protein.
+Added: data indicate activity against SARS-CoV-2 in African green monkey kidney cell (Vero) and human lung epithelial cell (Calu-3) models,
+Added: and synergistic activity with remdesivir in a Vero cell model.
Microbiology:
−Removed: Different formulations of cGMP RBD are undergoing preclinical study as potential treatments for multi-drug resistant (“MDR”)
−Removed: bacteria, such as Gram-negative bacteria.
+Added: Different formulations of cGMP RBS are undergoing preclinical study as potential treatments for multi-drug resistant (“MDR”)
+Added: bacteria, such as gram-positive and gram-negative.
Ophthalmology:
−Removed: Topical formulations of cGMP RBD are undergoing preclinical study as potential treatments for diseases of the eye, such
−Removed: as infectious keratitis.
−Removed: , an investigational immuno-dermatology agent administered as a topical gel and formulation of cGMP
−Removed: RBD, is undergoing clinical study for inflammatory dermatoses (including psoriasis and atopic dermatitis).
+Added: Topical formulations of cGMP RBS are undergoing preclinical study as potential treatments for diseases of the eye, such as infectious
+Added: PH-10 ® , an investigational immuno-dermatology agent administered as a topical gel and formulation of cGMP RBS,
+Added: is undergoing monotherapy clinical study and preclinical study of combination therapy with approved drugs for inflammatory dermatoses
+Added: (including psoriasis and atopic dermatitis).
+Added: Different formulations of cGMP RBS are undergoing development as potential treatments for animal cancers and dermatological
date, the Company has not generated any revenues or profits from planned principal operations.
−Removed: The Company’s activities
−Removed: are subject to significant risks and uncertainties, including failing to successfully develop and license or commercialize the
−Removed: Company’s prescription drug candidates.
+Added: The Company’s activities are subject
+Added: to significant risks and uncertainties, including failing to successfully develop and license or commercialize the Company’s prescription
+Added: drug candidates.
was reportedly first identified in late-2019 and subsequently declared a global pandemic by the World Health Organization on March 11,
−Removed: As a result of the SARS-CoV-2 pandemic, many companies have experienced disruptions of their operations and the markets
−Removed: The Company has taken several temporary precautionary measures intended to help ensure the well-being of its employees
−Removed: and contractors and to minimize business disruption.
−Removed: The Company considered the impact of SARS-CoV-2 pandemic on its business
−Removed: and operational assumptions and estimates, and determined there were no material adverse impacts on the Company’s results
−Removed: of operations and financial position at December 31, 2020.
−Removed: full extent of the SARS-CoV-2 pandemic impacts on the Company’s operations and financial condition is uncertain.
−Removed: has experienced slower than normal enrollment and treatment of patients, and a prolonged SARS-CoV-2 pandemic could have a material
−Removed: adverse impact on the Company’s business and financial results, including the timing and ability of the Company to raise
−Removed: capital, initiate and/or complete current and/or future preclinical studies and/or clinical trials;
−Removed: disrupt the Company’s
−Removed: regulatory activities;
−Removed: and/or have other adverse effects on the Company’s clinical development.
+Added: As a result of the SARS-CoV-2 pandemic, many companies have experienced disruptions of their operations and the markets they serve.
+Added: The Company has taken several temporary precautionary measures intended to help ensure the well-being of its employees and contractors
+Added: and to minimize business disruption.
+Added: The Company considered the impact of SARS-CoV-2 pandemic on its business and operational assumptions
+Added: and estimates, and determined there were no material adverse impacts on the Company’s results of operations and financial position
+Added: at December 31, 2021.
+Added: full extent of the SARS-CoV-2 pandemic impacts on the Company’s operations and financial condition is still uncertain.
+Added: Company has experienced slower than normal enrollment and treatment of patients, and a prolonged SARS-CoV-2 pandemic could have a material
+Added: adverse impact on the Company’s business and financial results, including the timing and ability of the Company to raise capital,
+Added: initiate and/or complete current and/or future preclinical studies and/or clinical trials;
+Added: disrupt the Company’s regulatory activities;
+Added: and/or have other adverse effects on the Company’s clinical development.
Liquidity and Going Concern
−Removed: Company’s cash and cash equivalents were $97,231 at December 31, 2020, compared with $590,706 at December 31, 2019.
−Removed: Company continues to incur significant operating losses and management expects that significant on-going operating expenditures
−Removed: will be necessary to successfully implement the Company’s business plan and develop and market its products.
−Removed: These circumstances
−Removed: raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the
−Removed: consolidated financial statements are issued.
−Removed: Implementation of the Company’s plans and its ability to continue as a going
−Removed: concern will depend upon the Company’s ability to develop PV-10 and PH-10 and raise additional capital.
−Removed: Company plans to access capital resources through possible public or private equity offerings, including the 2020 Financing (as
−Removed: defined in Note 4), exchange offers, debt financings, corporate collaborations or other means.
−Removed: In addition, the Company continues
−Removed: to explore opportunities to strategically monetize its lead drug candidates, PV-10 and PH-10, through potential co-development
−Removed: and licensing transactions, although there can be no assurance that the Company will be successful with such plans.
−Removed: has historically been able to raise capital through equity offerings, although no assurance can be provided that it will continue
−Removed: to be successful in the future.
−Removed: If the Company is unable to raise sufficient capital through the 2020 Financing or otherwise,
−Removed: it will not be able to pay its obligations as they become due.
−Removed: Subsequent to December 31, 2020, the Company received an aggregate
−Removed: $1,200,000 in connection with the 2020 Financing.
−Removed: In addition, holders of 4,500,000 warrants to purchase the common stock of the
−Removed: Company at $0.0533 per share, have exercised these warrants, resulting in aggregate proceeds to the Company in the amount of $239,850.
−Removed: See Note 14 –
−Removed: Subsequent Events.
+Added: Company’s cash, cash equivalents, and restricted cash were $ 3,106,942
+Added: at December 31, 2021 which includes the $ 2,423,958
+Added: of restricted cash resulting from a grant
+Added: received from the State of Tennessee.
+Added: The Company’s working capital deficiency was $ 4,258,679
+Added: and $ 30,288,035
+Added: as of December 31, 2021 and 2020, respectively.
+Added: The improvement in working capital is primarily driven by the conversion of the 2017 and 2020 Notes into Series D and D-1 Preferred Stock.
+Added: The Company continues to incur significant operating losses.
+Added: Management expects that significant on-going operating expenditures will
+Added: be necessary to successfully implement the Company’s business plan and develop and market its products.
+Added: These circumstances raise
+Added: substantial doubt about the Company’s ability to continue as a going concern within one year after the date that these consolidated
+Added: financial statements are issued.
+Added: Implementation of the Company’s plans and its ability to continue as a going concern will depend
+Added: upon the Company’s ability to develop PV-10, PH-10, and/or any other halogenated xanthene-based drug products, and to raise additional
+Added: Company plans to access capital resources through possible public or private equity offerings, including the 2021 Financing (as defined
+Added: in Note 5), exchange offers, debt financings, corporate collaborations, or other means.
+Added: In addition, the Company continues to explore
+Added: opportunities to strategically monetize its lead drug candidates, PV-10 and PH-10, through potential co-development and licensing transactions,
+Added: although there can be no assurance that the Company will be successful with such plans.
+Added: The Company has historically been able to raise
+Added: capital through equity and debt offerings, although no assurance can be provided that it will continue to be successful in the future.
+Added: If the Company is unable to raise sufficient capital, it will not be able to pay its obligations as they become due.
primary business objective of management is to build the Company into a commercial-stage biotechnology company;
2 unchanged sentences
xanthene-based drug candidate developed by the Company or entering into any financial transaction.
−Removed: Moreover, even if the Company
−Removed: is successful in improving its current cash flow position, the Company nonetheless plans to seek additional funds to meet its
−Removed: long-term requirements in 2021 and beyond.
−Removed: The Company anticipates that these funds will otherwise come from the proceeds of private
−Removed: placement transactions, including the 2020 Financing, the exercise of existing warrants and outstanding stock options, or public
−Removed: offerings of debt or equity securities.
−Removed: While the Company believes that it has a reasonable basis for its expectation that it
−Removed: will be able to raise additional funds, the Company cannot provide assurance that it will be able to complete additional financing
−Removed: in a timely manner.
−Removed: In addition, any such financing may result in significant dilution to stockholders.
+Added: Moreover, even if the Company is successful
+Added: in improving its current cash flow position, the Company nonetheless plans to seek additional funds to meet its long-term requirements
+Added: in 2022 and beyond.
+Added: The Company anticipates that these funds will otherwise come from the proceeds of private placement transactions,
+Added: the exercise of existing warrants and outstanding stock options, or public offerings of debt or equity securities.
+Added: While the Company
+Added: believes that it has a reasonable basis for its expectation that it will be able to raise additional funds, the Company cannot provide
+Added: assurance that it will be able to complete additional financing in a timely manner.
+Added: In addition, any such financing may result in significant
+Added: dilution to stockholders.
Significant Accounting Policies
1 unchanged sentence
balances and transactions have been eliminated in consolidation.
−Removed: preparation of financial statements in conformity with accounting principles generally accepted in the United States (“GAAP”)
−Removed: requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and
−Removed: disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and
−Removed: expenses during the reporting period.
−Removed: The Company’s significant estimates and assumptions include the collectability of
−Removed: receivables, the recoverability and useful lives of long-lived assets, stock-based compensation, accrued liabilities and the valuation
−Removed: allowance related to the Company’s deferred tax assets.
+Added: preparation of financial statements in conformity with accounting principles generally accepted in the United States (“GAAP”)
+Added: requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosure
+Added: of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during
+Added: the reporting period.
+Added: The Company’s significant estimates and assumptions include the recoverability
+Added: and useful lives of long-lived assets, stock-based compensation, accrued liabilities and the valuation allowance related to the Company’s
+Added: deferred tax assets.
and Cash Equivalents
Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents.
−Removed: As of December 31, 2020 and 2019, the Company’s cash equivalent consists of Treasury bills.
+Added: December 31, 2021 and 2020, the Company’s cash equivalents consist of Treasury bills.
+Added: cash consists of a grant award of $ 2,500,000
+Added: received in cash from the State of Tennessee less payments
+Added: to vendors for expenses and deposits in the amount of $ 76,042 .
Concentrations
−Removed: and cash equivalents are maintained at financial institutions and, at times, balances may exceed federally insured limits of $250,000,
−Removed: although the Company seeks to minimize this through treasury management.
−Removed: The Company has never experienced any losses related
−Removed: to these balances although no assurance can be provided that it will not experience any losses in the future.
+Added: cash equivalents, and restricted cash are
+Added: maintained at financial institutions and, at times, balances may exceed federally insured limits of $250,000, although the Company seeks
+Added: to minimize this through treasury management.
+Added: The Company has never experienced any losses related to these balances although no assurance
+Added: can be provided that it will not experience any losses in the future.
+Added: As of December 31, 2021 and 2020, the Company had cash,
+Added: cash equivalent, and restricted cash balances in excess of FDIC insurance limits of $ 2,856,942
+Added: respectively.
and Furnishings, net
and furnishings are stated at cost less accumulated depreciation.
−Removed: Depreciation of equipment is provided for using the straight-line
−Removed: method over the estimated useful lives of the assets.
−Removed: Computers, leasehold improvements and office equipment are being depreciated
−Removed: over five years;
−Removed: furniture and fixtures are being depreciated over ten years.
−Removed: Maintenance and repairs are charged to operations
−Removed: The Company capitalizes cost attributable to the betterment of property and equipment when such betterment extends
−Removed: the useful life of the assets.
−Removed: Company reviews the carrying values of its long-lived assets for possible impairment whenever an event or change in circumstances
−Removed: indicates that the carrying amount of the assets may not be recoverable.
−Removed: Any long-lived assets held for disposal are reported
−Removed: at the lower of their carrying amounts or fair value less cost to sell.
−Removed: Management has determined there to be no impairment during
−Removed: the years ended December 31, 2020 and 2019.
+Added: Depreciation of equipment is provided for using the straight-line method
+Added: over the estimated useful lives of the assets.
+Added: Computers and office equipment are being depreciated over five years;
+Added: furniture and fixtures
+Added: are being depreciated over ten years.
+Added: Leasehold improvements are amortized over the lesser of (a) the useful life of the asset;
+Added: the remaining lease term.
+Added: Maintenance and repairs are charged to operations as incurred.
+Added: The Company capitalizes cost attributable to
+Added: the betterment of property and equipment when such betterment extends the useful life of the assets.
+Added: Company reviews the carrying values of its long-lived assets for possible impairment whenever an event or change in circumstances indicates
+Added: that the carrying amount of the assets may not be recoverable.
+Added: Any long-lived assets held for disposal are reported at the lower of their
+Added: carrying amounts or fair value less cost to sell.
+Added: Management has determined there to be no impairment during the years ended December
+Added: 31, 2021 and 2020.
patent costs are expensed in the period incurred.
−Removed: Patents purchased are capitalized and amortized over the remaining estimated
−Removed: useful life of the patent.
−Removed: patents are fully amortized.
−Removed: Annual amortization of the patents was $228,000 in 2020.
+Added: Patents purchased are capitalized and amortized over the remaining estimated useful
+Added: life of the patent.
+Added: patents are fully amortized as of December 31, 2021 and 2020.
+Added: Patent amortization was $ 0 and $ 228,107
+Added: during the years ended December 31, 2021 and
+Added: 2020, respectively.
Party Receivables
−Removed: estimates the reserve for uncollectibility based on existing economic conditions, the financial conditions of the current and
−Removed: former employees, and the amount and age of past due receivables.
−Removed: Receivables are considered past due if full payment is not received
−Removed: by the contractual due date.
−Removed: Past due amounts are generally written off against the reserve for uncollectibility only after all
−Removed: collection attempts have been exhausted.
−Removed: See Note 7 –
−Removed: Short-term Receivables.
+Added: estimates the reserve for uncollectibility based on existing economic conditions, the financial conditions of the current and former
+Added: employees, and the amount and age of past due receivables.
+Added: Receivables are considered past due if full payment is not received by the
+Added: contractual due date.
+Added: Past due amounts are generally written off against the reserve for uncollectibility only after all collection attempts
+Added: have been exhausted.
+Added: See Note 8 – Short-term Receivables.
+Added: income is recognized when qualifying costs are incurred and there is reasonable assurance that conditions of the grant have been met.
+Added: Cash received from grants in advance of incurring qualifying costs is recorded as unearned grant revenue and recognized as other income
+Added: when qualifying costs are incurred.
and Development
and development costs are charged to expense when incurred.
−Removed: An allocation of payroll expenses to research and development is made
−Removed: based on a percentage estimate of time spent.
+Added: An allocation of payroll expenses to research and development is made based
+Added: on a percentage estimate of time spent.
The research and development costs include the following:
−Removed: payroll, consulting and
−Removed: contract labor, lab supplies and pharmaceutical preparations, insurance, rent and utilities, and depreciation and amortization.
−Removed: February 2016, the Financial Accounting Standards Board (“FASB”) issued a new standard related to leases to increase
−Removed: transparency and comparability among organizations by requiring the recognition of operating lease right-of-use (“ROU”)
−Removed: assets and lease liabilities on the balance sheet (“ASC 842”) with amendments issued in 2018.
−Removed: Most prominent among
−Removed: the changes in the standard is the recognition of ROU assets and lease liabilities by lessees for those leases classified as operating
−Removed: Under the standard, disclosures are required to meet the objective of enabling users of financial statements to assess
−Removed: the amount, timing, and uncertainty of cash flows arising from leases.
−Removed: The Company is also required to recognize and measure new
−Removed: leases at the adoption date and recognize a cumulative-effect adjustment in the period of adoption using a modified retrospective
−Removed: approach, with certain practical expedients available.
+Added: payroll, consulting and contract labor,
+Added: lab supplies and pharmaceutical preparations, insurance, rent and utilities, and depreciation and amortization.
+Added: February 2016, the Financial Accounting Standards Board (“FASB”) issued a new standard related to leases to increase transparency
+Added: and comparability among organizations by requiring the recognition of operating lease right-of-use (“ROU”) assets and lease
+Added: liabilities on the balance sheet (“ASC 842”) with amendments issued in 2018.
+Added: Most prominent among the changes in the standard
+Added: is the recognition of ROU assets and lease liabilities by lessees for those leases classified as operating leases.
+Added: Under the standard,
+Added: disclosures are required to meet the objective of enabling users of financial statements to assess the amount, timing, and uncertainty
+Added: of cash flows arising from leases.
+Added: The Company is also required to recognize and measure new leases at the adoption date and recognize
+Added: a cumulative-effect adjustment in the period of adoption using a modified retrospective approach, with certain practical expedients available.
Company adopted ASC 842 effective January 1, 2019 and elected to apply the available practical expedients.
−Removed: The standard had an
−Removed: impact on the Company’s consolidated balance sheets but did not have a material impact on the Company’s consolidated
−Removed: statements of operations or cash flows upon adoption.
−Removed: The most significant impact was the recognition of ROU assets and lease
−Removed: liabilities for operating leases.
−Removed: Company accounts for income taxes under the liability method in accordance with Accounting Standards Codification (“ASC”)
−Removed: 740 “Income Taxes”.
−Removed: Under this method, deferred income tax assets and liabilities are determined based on differences
−Removed: between financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that
−Removed: will be in effect when the differences are expected to reverse.
−Removed: A valuation allowance is established if it is more likely than
−Removed: not that all, or some portion, of deferred income tax assets will not be realized.
−Removed: The Company has recorded a full valuation allowance
−Removed: to reduce its net deferred income tax assets to zero.
−Removed: In the event the Company were to determine that it would be able to realize
−Removed: some or all its deferred income tax assets in the future, an adjustment to the deferred income tax asset would increase income
−Removed: in the period such determination was made.
−Removed: Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained upon
−Removed: an examination.
−Removed: Any recognized income tax positions would be measured at the largest amount that is greater than 50% likely of
−Removed: being realized.
−Removed: Changes in recognition or measurement would be reflected in the period in which the change in judgment occurs.
−Removed: The Company would recognize any corresponding interest and penalties associated with its income tax positions in income tax expense.
−Removed: There were no income taxes, interest or penalties incurred in 2020 or 2019.
+Added: The standard had an impact
+Added: on the Company’s consolidated balance sheets but did not have a material impact on the Company’s consolidated statements
+Added: of operations or cash flows upon adoption.
+Added: The most significant impact was the recognition of ROU assets and lease liabilities for operating
+Added: Company accounts for income taxes under the liability method in accordance with Accounting Standards Codification (“ASC”)
+Added: 740 “Income Taxes”.
+Added: Under this method, deferred income tax assets and liabilities are determined based on differences between
+Added: financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect
+Added: when the differences are expected to reverse.
+Added: A valuation allowance is established if it is more likely than not that all, or some portion,
+Added: of deferred income tax assets will not be realized.
+Added: The Company has recorded a full valuation allowance to reduce its net deferred income
+Added: tax assets to zero.
+Added: In the event the Company were to determine that it would be able to realize some or all its deferred income tax assets
+Added: in the future, an adjustment to the deferred income tax asset would increase income in the period such determination was made.
+Added: Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained upon an examination.
+Added: Any recognized income tax positions would be measured at the largest amount that is greater than 50 % likely of being realized.
+Added: in recognition or measurement would be reflected in the period in which the change in judgment occurs.
+Added: The Company would recognize any
+Added: corresponding interest and penalties associated with its income tax positions in income tax expense.
+Added: There were no income taxes, interest
+Added: or penalties incurred in 2021 or 2020.
+Added: Company evaluates its convertible instruments to determine if those contracts or embedded components of those contracts qualify as derivative
+Added: financial instruments to be separately accounted for in accordance with ASC Topic 815:
+Added: Derivatives and Hedging .
+Added: The accounting
+Added: treatment of derivative financial instruments requires that the Company record qualifying embedded conversion options and any related
+Added: freestanding instruments at their fair values as of the inception date of the agreement and at fair value as of each subsequent balance
+Added: Any change in fair value is recorded as non-operating, non-cash income or expense for each reporting period at each balance
+Added: The Company reassesses the classification of its derivative instruments at each balance sheet date.
+Added: If the classification
+Added: changes as a result of events during the period, the contract is reclassified as of the date of the event that caused the reclassification.
+Added: Embedded conversion options classified as derivative liabilities and any related equity classified freestanding instruments are recorded
+Added: as a discount to the host instrument.
+Added: the instrument is determined to not be a derivative liability, the Company then evaluates for the existence of a beneficial conversion
+Added: feature by comparing the commitment date fair value to the effective conversion price of the instrument.
+Added: Company applies the accounting standards for distinguishing liabilities from equity when determining the classification and measurement
+Added: of its preferred stock.
+Added: Preferred shares subject to mandatory redemption are classified as liability instruments and are measured at
+Added: Conditionally redeemable preferred shares (including preferred shares that feature redemption rights that are either within
+Added: the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control)
+Added: are classified as temporary equity.
+Added: At all other times, preferred shares are classified as stockholders’ deficiency.
and Diluted Loss Per Common Share
−Removed: loss per common share is computed by dividing net loss by the weighted average number of vested common shares outstanding during
−Removed: Diluted earnings per share reflects the potential dilution that could occur if securities or other instruments to
−Removed: issue common stock were exercised or converted into common stock.
−Removed: The following securities are excluded from the calculation of
−Removed: weighted average dilutive common shares because their inclusion would have been anti-dilutive:
+Added: loss per common share is computed by dividing net loss by the weighted average number of vested common shares outstanding during the
+Added: Diluted earnings per share reflects the potential dilution that could occur if securities or other instruments to issue common
+Added: stock were exercised or converted into common stock.
+Added: The following securities are excluded from the calculation of weighted average dilutive
+Added: common shares because their inclusion would have been anti-dilutive:
+Added: Schedule of Securities Excluded from Calculation of Weighted Average Dilutive Common Shares
Convertible preferred stock
Total potentially dilutive shares
−Removed: potential dilutive effect of the conversion of the Company’s convertible notes payable has been excluded from this table
−Removed: since the Company’s Series D Preferred Stock has yet to be designated by the Board.
Value of Financial Instruments
−Removed: Company measures the fair value of financial assets and liabilities based on the guidance of ASC 820 “Fair Value Measurements
−Removed: and Disclosures”
−Removed: (“ASC 820”) which defines fair value, establishes a framework for measuring fair value, and
−Removed: expands disclosures about fair value measurements.
−Removed: The Company determines the estimated fair value of amounts presented in these
−Removed: consolidated financial statements using available market information and appropriate methodologies.
−Removed: However, considerable judgment
−Removed: is required in interpreting market data to develop the estimates of fair value.
−Removed: The estimates presented in the financial statements
−Removed: are not necessarily indicative of the amounts that could be realized in a current exchange between buyer and seller.
−Removed: different market assumptions and/or estimation methodologies may have a material effect on the estimated fair value amounts.
−Removed: fair value estimates were based upon pertinent information available as of December 31, 2020 and 2019.
−Removed: The carrying amounts of
−Removed: the Company’s financial assets and liabilities, such as cash and cash equivalents, receivables, other current assets, accounts
−Removed: payable, and accrued expenses approximate fair values due to the short-term nature of these instruments.
−Removed: carrying amounts of our credit obligations approximate fair value because the effective yields on these obligations, which include
−Removed: contractual interest rates are comparable to rates of returns for instruments of similar credit risk.
−Removed: 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price)
−Removed: in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants
−Removed: on the measurement date.
−Removed: ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable
−Removed: inputs and minimize the use of unobservable inputs when measuring fair value.
−Removed: ASC 820 describes three levels of inputs that may
−Removed: be used to measure fair value:
+Added: Company measures the fair value of financial assets and liabilities based on the guidance of ASC 820 “Fair Value Measurements and
+Added: Disclosures” (“ASC 820”) which defines fair value, establishes a framework for measuring fair value, and expands disclosures
+Added: about fair value measurements.
+Added: The Company determines the estimated fair value of amounts presented in these consolidated financial statements
+Added: using available market information and appropriate methodologies.
+Added: However, considerable judgment is required in interpreting market data
+Added: to develop the estimates of fair value.
+Added: The estimates presented in the financial statements are not necessarily indicative of the amounts
+Added: that could be realized in a current exchange between buyer and seller.
+Added: The use of different market assumptions and/or estimation methodologies
+Added: may have a material effect on the estimated fair value amounts.
+Added: These fair value estimates were based upon pertinent information available
+Added: as of December 31, 2021 and 2020.
+Added: The carrying amounts of the Company’s financial assets and liabilities, such as cash and cash
+Added: equivalents, restricted cash, receivables, other current assets, accounts payable, unearned grant income, and accrued expenses approximate
+Added: fair values due to the short-term nature of these instruments.
+Added: carrying amounts of our credit obligations approximate fair value because the effective yields on these obligations, which include contractual
+Added: interest rates are comparable to rates of returns for instruments of similar credit risk.
+Added: 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the
+Added: principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement
+Added: ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize
+Added: the use of unobservable inputs when measuring fair value.
+Added: ASC 820 describes three levels of inputs that may be used to measure fair value:
use quoted prices in active markets for identical assets or liabilities that the Company has the ability to access.
use directly or indirectly observable inputs.
−Removed: These inputs include quoted prices for similar assets and liabilities in active
−Removed: markets as well as other inputs such as interest rates and yield curves that are observable at commonly quoted intervals.
−Removed: are unobservable inputs, including inputs that are available in situations where there is little, if any, market activity
−Removed: for the related asset or liability.
+Added: These inputs include quoted prices for similar assets and liabilities in active markets
+Added: as well as other inputs such as interest rates and yield curves that are observable at commonly quoted intervals.
+Added: are unobservable inputs, including inputs that are available in situations where there is little, if any, market activity for the
+Added: related asset or liability.
instances where inputs used to measure fair value fall into different levels in the above fair value hierarchy, fair value measurements
in their entirety are categorized based on the lowest level input that is significant to the valuation.
−Removed: The Company’s assessment
−Removed: of the significance of particular inputs to these fair value measurements requires judgment and considers factors specific to
−Removed: each asset or liability.
−Removed: observable and unobservable inputs may be used to determine the fair value of positions that are classified within the Level 3
−Removed: As a result, the unrealized gains and losses for assets within the Level 3 category may include changes in fair value
−Removed: that were attributable to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in historical
−Removed: company data) inputs.
−Removed: Financial assets are considered Level 3 when their fair values are determined using pricing models, discounted
−Removed: cash flow methodologies or similar techniques and at least one significant model assumption or input is unobservable.
+Added: The Company’s assessment
+Added: of the significance of particular inputs to these fair value measurements requires judgment and considers factors specific to each asset
+Added: or liability.
+Added: observable and unobservable inputs may be used to determine the fair value of positions that are classified within the Level 3 category.
+Added: As a result, the unrealized gains and losses for assets within the Level 3 category may include changes in fair value that were attributable
+Added: to both observable (e.g., changes in market interest rates) and unobservable (e.g., changes in historical company data) inputs.
+Added: assets are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies or similar
+Added: techniques and at least one significant model assumption or input is unobservable.
Currency Translation
−Removed: Company’s reporting currency is the United States Dollar.
−Removed: The functional currencies of the Company’s operating subsidiaries
+Added: Company’s reporting currency is the United States Dollar.
+Added: The functional currencies of the Company’s operating subsidiaries
are their local currencies (United States Dollar and Australian Dollar).
−Removed: Australian Dollar denominated assets and liabilities
−Removed: are translated into the United States Dollar at the balance sheet date ($10,552 and $332,446 at December 31, 2020 and $61,380
−Removed: and $308,915 at December 31, 2019, respectively), and expense and other income accounts are translated at a weighted average
−Removed: exchange rate for the years then ended ($44,994 and $53,210 for the years ended December 31, 2020 and 2019, respectively).
−Removed: is translated at historical rates and the resulting foreign currency translation adjustments are included as a component of accumulated
−Removed: other comprehensive loss (“AOCL”), which is a separate component of shareholders’
+Added: Australian Dollar denominated assets and liabilities are translated
+Added: into the United States Dollar at the balance sheet date ($ 22,053
+Added: and $ 407,851
+Added: at December 31, 2021 and $ 10,552
+Added: and $ 332,446
+Added: at December 31, 2020, respectively), and expense
+Added: and other income accounts are translated at a weighted average exchange rate for the years then ended ($ 85,052
+Added: for the years ended December 31, 2021 and 2020,
+Added: respectively).
+Added: Equity is translated at historical rates and the resulting foreign currency translation adjustments are included as a
+Added: component of accumulated other comprehensive loss (“AOCL”), which is a separate component of stockholders’ deficiency.
Therefore, the U.S.
−Removed: dollar value of the non-equity translated items in the Company’s consolidated financial statements will fluctuate from period
−Removed: to period, depending on the changing value of the U.S.
+Added: dollar value of the non-equity translated items in the Company’s consolidated financial statements will
+Added: fluctuate from period to period, depending on the changing value of the U.S.
dollar versus these currencies.
−Removed: Company engages in foreign currency denomination transactions with its Australian subsidiary.
−Removed: At the date that the transaction
−Removed: is recognized, each asset, liability, revenue, expense, gain or loss arising from the transaction is measured and recorded in
−Removed: the functional currency of the recording entity using the exchange rate in effect at that date.
−Removed: At each balance sheet date, recorded
−Removed: monetary balances denominated in a currency other than the functional currency are adjusted using the exchange rate at the balance
−Removed: sheet date, with gains or losses recorded in other income or other expense.
+Added: Company engages in foreign currency denominated transactions with its Australian subsidiary.
+Added: At the date that the transaction is recognized,
+Added: each asset, liability, revenue, expense, gain or loss arising from the transaction is measured and recorded in the functional currency
+Added: of the recording entity using the exchange rate in effect at that date.
+Added: At each balance sheet date, recorded monetary balances denominated
+Added: in a currency other than the functional currency are adjusted using the exchange rate at the balance sheet date, with gains or losses
+Added: recorded in other income or other expense.
Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award.
−Removed: The fair value of the award is measured on the grant date and then is recognized over the period during which services are required
−Removed: to be provided in exchange for the award, usually the vesting period.
−Removed: The Company computes the fair value of equity-classified
−Removed: warrants and options granted using the Black-Scholes option pricing model.
−Removed: Option valuation models require the input of highly
−Removed: subjective assumptions including the expected volatility factor of the market price of the Company’s common stock which
−Removed: is determined by reviewing its historical public market closing prices.
+Added: fair value of the award is measured on the grant date and then is recognized over the period during which services are required to be
+Added: provided in exchange for the award, usually the vesting period.
+Added: The Company computes the fair value of equity-classified warrants and
+Added: options granted using the Black-Scholes option pricing model.
+Added: Option valuation models require the input of highly subjective assumptions
+Added: including the expected volatility factor of the market price of the Company’s common stock which is determined by reviewing its
+Added: historical public market closing prices.
Issued Accounting Pronouncements
−Removed: December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes.
−Removed: The amendments in ASU 2019-12
−Removed: simplify the accounting for income taxes by removing certain exceptions to the general principles in Accounting Standards Codification
−Removed: (“ASC”) Topic 740, Income Taxes .
−Removed: The amendments also improve consistent application of and simplify GAAP for
−Removed: other areas of Topic 740 by clarifying and amending existing guidance.
−Removed: ASU 2019-12 will be effective for the Company’s fiscal
−Removed: year beginning after December 15, 2020, with early adoption permitted.
−Removed: The transition requirements are dependent upon each
−Removed: amendment within this update and will be applied either prospectively or retrospectively.
−Removed: The Company does not expect this ASU
−Removed: to have a material impact on its consolidated financial statements.
−Removed: January 2020, the FASB issued ASU 2020-01, “Investments-Equity Securities (Topic 321), Investments-Equity Method and Joint
−Removed: Ventures (Topic 323), and Derivatives and Hedging (Topic 815).”
−Removed: ASU 2020-01 states any equity security transitioning from
−Removed: the alternative method of accounting under Topic 321 to the equity method, or vice versa, due to an observable transaction will
−Removed: be remeasured immediately before the transition.
−Removed: In addition, the ASU clarifies the accounting for certain non-derivative forward
−Removed: contracts or purchased call options to acquire equity securities stating such instruments will be measured using the fair value
−Removed: principles of Topic 321 before settlement or exercise.
−Removed: The ASU is effective for fiscal years beginning after December 15, 2020,
−Removed: and will be applied on a prospective basis.
−Removed: Early adoption is permitted.
−Removed: The Company is still evaluating the impact this standard
−Removed: will have on its consolidated financial statements and related disclosures.
−Removed: March 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”)
−Removed: 2020-03, “Codification Improvements to Financial Instruments”
−Removed: (“ASU 2020-03”).
−Removed: There are seven issues
−Removed: addressed in this update.
−Removed: Issues 1 –
−Removed: 5 were clarifications and codifications of previous updates.
−Removed: Issue 3 relates only to
−Removed: depository and lending institutions and therefore would not be applicable to the Company.
−Removed: Issue 6 was a clarification on determining
−Removed: the contractual term of a net investment in a lease for purposes of measuring expected credit losses, an issue not applicable
−Removed: to the Company.
−Removed: Issue 7 relates to the regaining control of financial assets sold and the recordation of an allowance for credit
−Removed: The amendment related to issues 1, 2, 4 and 5 became effective immediately upon adoption of the update.
−Removed: Issue 3 becomes
−Removed: effective for fiscal years beginning after December 15, 2019.
−Removed: Issues 6 and 7 become effective on varying dates that relate to
−Removed: the dates of adoption of other updates.
−Removed: Management’s initial analysis is that it does not believe the new guidance will
−Removed: substantially impact the Company’s consolidated financial statements.
−Removed: The Company adopted certain provisions which have
−Removed: become effective during fiscal 2020 within ASU 2020-03 and its adoption did not have a material impact on the Company’s
−Removed: condensed consolidated financial statements and financial statement disclosures.
−Removed: The Company is currently evaluating the effect
−Removed: that adopting the remaining new accounting guidance will have on its consolidated financial statements and related disclosures.
−Removed: August 2020, FASB issued ASU No.
−Removed: 2020-06, “Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives
−Removed: and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40):
−Removed: Accounting for Convertible Instruments and Contracts
−Removed: in an Entity’s Own Equity”
−Removed: (“ASU 2020-06”).
−Removed: Under ASU 2020-06, the embedded conversion features are no
−Removed: longer separated from the host contract for convertible instruments with conversion features that are not required to be accounted
−Removed: for as derivatives under Topic 815, or that do not result in substantial premiums accounted for as paid-in capital.
−Removed: Consequently,
−Removed: a convertible debt instrument will be accounted for as a single liability measured at its amortized cost, as long as no other
−Removed: features require bifurcation and recognition as derivatives.
−Removed: The new guidance also requires the if-converted method to be applied
−Removed: for all convertible instruments.
−Removed: ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, including interim
−Removed: periods within those fiscal years, with early adoption permitted.
+Added: August 2020, FASB issued Accounting Standards Update (“ASU”) No.
+Added: 2020-06, “Debt—Debt with Conversion
+Added: and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40):
+Added: for Convertible Instruments and Contracts in an Entity’s Own Equity” (“ASU 2020-06”).
+Added: Under ASU 2020-06,
+Added: the embedded conversion features are no longer separated from the host contract for convertible instruments with conversion features
+Added: that are not required to be accounted for as derivatives under Topic 815, or that do not result in substantial premiums accounted for
+Added: as paid-in capital.
+Added: Consequently, a convertible debt instrument will be accounted for as a single liability measured at its amortized
+Added: cost, as long as no other features require bifurcation and recognition as derivatives.
+Added: The new guidance also requires the if-converted
+Added: method to be applied for all convertible instruments.
+Added: ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, including
+Added: interim periods within those fiscal years, with early adoption permitted.
Adoption of the standard requires using either a modified retrospective
or a full retrospective approach.
−Removed: The Company is currently evaluating the effect of the adoption of ASU 2020-06 will have on its
−Removed: consolidated financial statements and related disclosures.
−Removed: October 2020, the FASB issued ASU 2020-10 “Codification Improvements”, which improves consistency by amending the
+Added: The Company is currently evaluating the effect of the adoption of ASU 2020-06 will have on its consolidated
+Added: financial statements and related disclosures.
+Added: October 2020, the FASB issued ASU 2020-10 “Codification Improvements” , which improves consistency by amending the
Codification to include all disclosure guidance in the appropriate disclosure sections and clarifies application of various provisions
1 unchanged sentence
The guidance is effective for the Company beginning in the first quarter of fiscal year 2022 with early adoption permitted.
−Removed: Company is currently assessing the impact that this pronouncement will have on its consolidated financial statements.
+Added: adopted this standard on January 1, 2022 and it did not have a material effect on its consolidated financial statements.
+Added: May 3, 2021, the FASB issued ASU
+Added: 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock
+Added: Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40):
+Added: Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options.
+Added: This new standard provides
+Added: clarification and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified
+Added: written call options (such as warrants) that remain equity classified after modification or exchange.
+Added: This standard is effective for
+Added: fiscal years beginning after December 15, 2021, including interim periods within those fiscal years.
+Added: Issuers should apply the new standard
+Added: prospectively to modifications or exchanges occurring after the effective date of the new standard.
+Added: Early adoption is permitted, including
+Added: adoption in an interim period.
+Added: If an issuer elects to early adopt the new standard in an interim period, the guidance should be applied
+Added: as of the beginning of the fiscal year that includes that interim period.
+Added: The Company adopted this standard on January 1, 2022 and
+Added: it did not have a material effect on its consolidated financial statements.
Adopted Accounting Pronouncements
−Removed: August 2018, the FASB issued ASU No.
−Removed: 2018-13, “Fair Value Measurement (Topic 820):
−Removed: Disclosure Framework—Changes to
−Removed: the Disclosure Requirements for Fair Value Measurement”
−Removed: (“ASU 2018-13”).
−Removed: The amendments in ASU 2018-13 modify
−Removed: the disclosure requirements on fair value measurements based on the concepts in the Concepts Statement, including the consideration
−Removed: of costs and benefits.
−Removed: The amendments on changes in unrealized gains and losses, the range and weighted average of significant
−Removed: unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty
−Removed: should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption.
−Removed: All other amendments should be applied retrospectively to all periods presented upon their effective date.
−Removed: The amendments are
−Removed: effective for all entities for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years.
−Removed: Early adoption is permitted, including adoption in an interim period.
−Removed: The Company adopted ASU
−Removed: effective January 1, 2020 and it did not have a material impact on the Company’s consolidated
−Removed: financial statements.
−Removed: Reclassifications
−Removed: Certain prior period amounts have been
−Removed: reclassified for comparative purposes to conform with the fiscal 2020 presentation.
−Removed: These reclassifications have no impact on
−Removed: the previously reported net loss.
+Added: December 2019, the FASB issued ASU 2019-12,
+Added: Simplifying the Accounting for Income Taxes.
+Added: The amendments in ASU 2019-12 simplify the accounting for income taxes by removing
+Added: certain exceptions to the general principles in Accounting Standards Codification (“ASC”) Topic 740, Income Taxes .
+Added: The amendments also improve consistent application of and simplify GAAP for other areas of Topic 740 by clarifying and amending existing
+Added: The Company adopted ASU 2019-12 on January 1, 2021 and there was no material impact on the Company’s consolidated
+Added: financial statements or disclosures.
+Added: January 2020, the FASB issued ASU 2020-01, “Investments-Equity Securities (Topic 321), Investments-Equity Method and Joint Ventures
+Added: (Topic 323), and Derivatives and Hedging (Topic 815).” ASU 2020-01 states any equity security transitioning from the alternative
+Added: method of accounting under Topic 321 to the equity method, or vice versa, due to an observable transaction will be remeasured immediately
+Added: before the transition.
+Added: In addition, the ASU clarifies the accounting for certain non-derivative forward contracts or purchased call options
+Added: to acquire equity securities stating such instruments will be measured using the fair value principles of Topic 321 before settlement
+Added: 20 The Company adopted ASU 2020-01 on a prospective basis on January 1, 2021 and there was no material impact on the Company’s
+Added: consolidated financial statements or disclosures.
+Added: March 2020, the FASB issued ASU No.
+Added: 2020-03, “Codification Improvements to Financial Instruments” (“ASU 2020-03”).
+Added: There are seven issues
+Added: addressed in this update.
+Added: Issues 1 – 5 were clarifications and codifications of previous updates.
+Added: Issue 3 relates only to depository
+Added: and lending institutions and therefore would not be applicable to the Company.
+Added: Issue 6 was a clarification on determining the contractual
+Added: term of a net investment in a lease for purposes of measuring expected credit losses, an issue not applicable to the Company.
+Added: relates to the regaining control of financial assets sold and the recordation of an allowance for credit losses.
+Added: The amendment related
+Added: to issues 1, 2, 4 and 5 became effective immediately upon adoption of the update.
+Added: Issue 3 becomes effective for fiscal years beginning
+Added: after December 15, 2019.
+Added: Issues 6 and 7 become effective on varying dates that relate to the dates of adoption of other updates.
+Added: Company adopted the applicable provisions within ASU 2020-03 which became effective during fiscal 2020 and 2021 and this adoption did
+Added: not have a material impact on the Company’s consolidated financial statements and financial statement disclosures.
+Added: Other Accrued Expenses
+Added: following table summarizes the other accrued expenses at December 31, 2021 and 2020:
+Added: of Other Accrued Expenses
+Added: For The Years Ended
+Added: Accrued payroll and taxes
+Added: Accrued vacation
+Added: Accrued directors’ fees
+Added: Accrued PPP interest
+Added: Accrued other expenses
+Added: Total Other Accrued Expenses
Convertible Notes Payable
−Removed: March 23, 2017, the Company entered into an exclusive Definitive Financing Commitment Term Sheet with a group of the Company’s
−Removed: stockholders (the “PRH Group”), which was amended and restated effective as of March 19, 2017 (the “2017 Term
−Removed: Sheet”) that set forth the terms on which the PRH Group would use their best efforts to arrange for a financing of a minimum
−Removed: of $10,000,000 and maximum of $20,000,000 (the “2017 Financing”).
−Removed: of December 31, 2020, the Company had received aggregate 1st Loans, as defined below, of $20,067,000 in connection with
−Removed: the 2017 Financing.
−Removed: 2017 Financing is in the form of a secured convertible loan (the “1 st Loan”) from the PRH Group or other
−Removed: investors in the 2017 Financing (the “1 st Loan Investors”).
−Removed: The 1 st Loan is evidenced by secured
−Removed: convertible promissory notes (individually a “2017 Note”
−Removed: and collectively, the “2017 Notes”) from the
−Removed: Company to the PRH Group or the 1 st Loan Investors.
−Removed: In addition to the customary provisions, the 2017 Notes contains
+Added: following summarizes convertible note activity during the years ended December 31, 2021 and 2020:
+Added: of Convertible Notes Payable
+Added: Balance at January 1, 2020
+Added: Balance at December 31, 2020
+Added: ( 20,067,000 )
+Added: ( 5,025,000 )
+Added: ( 25,092,000 )
+Added: Balance at December 31, 2021
+Added: August 13, 2021, the Board approved a Financing Term Sheet (the “2021 Term Sheet”), which set forth the terms under which
+Added: the Company will use its best efforts to arrange for financing of a maximum of $ 5,000,000 (the “2021 Financing”), which amounts
+Added: will be obtained in several tranches.
+Added: to the 2021 Term Sheet, the 2021 Notes will either be paid back, convert into shares of the Company’s Series D-1 Preferred Stock,
+Added: or convert into Company equity securities and/or debt instruments of certain future financings on or before twelve months after the issue
+Added: date of a 2021 Note, subject to certain exceptions.
+Added: 2021 Financing is in the form of unsecured convertible loans from the investors and evidenced by convertible promissory notes (individually,
+Added: a “2021 Note” and collectively, the “2021 Notes”).
+Added: In addition to customary provisions, the 2021 Notes will contain
the following provisions:
−Removed: is secured by a first priority security interest on the Company’s IP,
−Removed: 1 st Loan bears interest at the rate of 8% per annum on the outstanding principal amount of the 2017 Notes that
−Removed: has been funded to the Company,
−Removed: 1 st Loan proceeds are held in one or more accounts (the “Escrow”) pending the funding of the tranches
−Removed: of the 2017 Financing pursuant to borrowing requests made by the Company,
−Removed: 2017 Notes, including interest and principal, are due and payable in full on the earlier of:
−Removed: (i) on such date upon which the
−Removed: Company defaults under the 2017 Notes, (ii) upon a change of control of the Company, or (iii) dates ranging from May 15, 2021
−Removed: to the 18-month anniversary of the funding of the Final Tranche.
−Removed: In the event there is a change of control of the Company’s
−Removed: Board as proposed by any person or group other than the 1 st Loan Investors,
−Removed: the term of the 2017 Notes will be accelerated and all amounts due under the 2017 Notes will be immediately due and payable,
−Removed: plus interest at the rate of 8% per annum, plus a penalty in the amount equal to 10 times the outstanding principal amount
−Removed: of the 1 st Loan that has been funded to the Company,
−Removed: outstanding principal amount and interest payable under the 1 st Loan will become convertible at the sole discretion
−Removed: of the 1 st Loan Investors into shares of the Company’s Series
−Removed: D Preferred Stock, a new series of preferred stock, that the Company’s Board may designate in the future, at a price
−Removed: per share equal to $0.2862, and
−Removed: Notwithstanding
−Removed: (v) above, the principal amount of the 2017 Notes and the interest payable under the 1 st Loan will automatically
−Removed: convert into shares of the Company’s Series D Preferred Stock at a price per share equal to $0.2862 effective on the
−Removed: 18-month anniversary of the funding of the final tranche of the 2017 Financing subject to certain exceptions if the Company’s
−Removed: Board designates such series of preferred stock in the future.
−Removed: to the 2017 Term Sheet, the PRH Group concluded its best-efforts activity to arrange for a financing of $20,000,000, which amounts
−Removed: were provided in a number of tranches, between the first tranche on April 4, 2017 and the Final Tranche, on December 20, 2019.
−Removed: As a result, the 2017 Notes under the 1 st Loan will convert into shares of Series D Preferred Stock (once designated)
−Removed: of the Company on or before June 20, 2021, which is the 18-month anniversary of the funding of the Final Tranche of the 2017 Financing,
−Removed: subject to certain exceptions.
−Removed: conversion of the 2017 Notes, the 1 st Loan Investors will release their first lien on the Company’s IP.
−Removed: December 31, 2019, the Board approved a Definitive Financing Term Sheet (the “2020 Term Sheet”), which sets forth
−Removed: the terms under which the Company will use its best efforts to arrange for financing of a maximum of $20,000,000 (the “2020
−Removed: Financing”).
−Removed: The 2020 Financing will be in the form of secured convertible loans from investors that
−Removed: will be evidenced by convertible promissory notes (the “2020 Notes”).
−Removed: The 2020 Term Sheet is similar to the 2017 Term
−Removed: Subject to the terms and conditions of the 2020 Term Sheet, the Company will use its best efforts to arrange for the 2020
−Removed: Financing, which amounts will be obtained in several tranches.
−Removed: The proceeds from the 2020 Financing will be used to fund the Company’s
−Removed: clinical development program, as currently constituted and envisioned, and to fund the Company’s general and administrative
−Removed: to the 2020 Term Sheet, the 2020 Notes (defined below) will convert into shares of the Company’s Series D Preferred Stock
−Removed: on or before June 20, 2021, subject to certain exceptions.
−Removed: As of December 31, 2019, and through the date of filing, the Series
−Removed: D Preferred Stock had not been designated by the Board.
−Removed: 2020 Financing will be in the form of a secured convertible loan (the “2 nd Loan”) from the Investors (the
−Removed: “2 nd Loan Investors”) that will be evidenced by convertible promissory notes (individually, a “2020
−Removed: and collectively, the “2020 Notes”) subordinate to the 2017 Notes in right of payment and to the security
−Removed: interests granted to holders of the 2017 Notes.
−Removed: In addition to customary provisions, the 2020 Notes contains the following provisions:
−Removed: It will be secured by a second priority security interest on the Company’s IP subordinate to the first priority security
−Removed: interest of the 2017 Notes;
−Removed: The 2 nd Loan will bear interest at the rate of eight percent (8%) per annum on the outstanding principal amount of
−Removed: the 2 nd Loan that has been funded to the Company;
−Removed: In the event there is a change of control of the Company’s Board, the term of the 2020 Notes will be accelerated and all
−Removed: amounts due under the 2020 Notes will be immediately due and payable, plus interest at the rate of eight percent (8%) per annum,
−Removed: plus a penalty in the amount equal to ten times (10x) the outstanding principal amount of the 2 nd Loan that has been
+Added: 2021 Notes will bear interest at the rate of eight percent ( 8 %) per annum on the outstanding principal amount of the loan that has been
funded to the Company;
−Removed: The outstanding principal amount and interest payable under the 2 nd Loan will become convertible at the sole discretion
−Removed: of the 2 nd Loan Investors into shares of the Company’s Series D Preferred Stock, a series of preferred stock
−Removed: to be designated by the Board, at a price per share equal to $2.8620;
−Removed: Notwithstanding (iv) above, the principal amount of the 2020 Notes and the interest payable under the 2 nd Loan will
−Removed: automatically convert into shares of the Company’s Series D Preferred Stock at a price per share equal to $2.8620 effective
+Added: the event there is a change of control of the Board, the term of the 2021 Notes will be accelerated and all amounts due under the
+Added: 2021 Notes may be immediately due and payable at the investors’ option;
+Added: outstanding principal amount and interest payment under the 2021 Notes may be paid back at maturity at the investors’ option;
+Added: outstanding principal amount and interest payable under the 2021 Notes may be convertible at the investors’ option into shares
+Added: of Series D-1 Preferred Stock at a price per share equal to $ 2.8620 .
+Added: The Series D-1 Preferred Stock is convertible into ten ( 10 )
+Added: shares of common stock;
+Added: the event the Company conducts a qualified equity or debt financing and the Company receives gross proceeds in the aggregate amount
+Added: of $ 20 million, the 2021 Notes may be converted into the equity securities and/or debt instruments of such financing at the same
+Added: terms as those investors.
+Added: embedded conversion options associated with the 2021 Notes do not require bifurcation and treatment as a derivative liability and they
+Added: do not represent a beneficial conversion feature because the effective conversion price is not at a discount to the commitment date market
+Added: of December 31, 2021, the Company had received 2021 Notes (defined above) proceeds of $ 1,460,000 , of which $ 200,000
+Added: is from a related party investor (an officer
+Added: of the Company).
+Added: On December 31, 2019, the Board approved a Definitive
+Added: Financing Term Sheet (the “2020 Term Sheet”), which sets forth the terms of a financing in the form of secured convertible
+Added: loans from investors that were evidenced by convertible promissory notes (the “2020 Notes”), which bear interest at the rate
+Added: of eight percent ( 8 %) per annum.
+Added: outstanding principal amount and interest payable under the 2020 was convertible into shares of a new series of preferred stock
+Added: at a price per share equal to $ 2.8620 ,
+Added: either (a) at any time after the new series of preferred stock is designated, at the sole discretion of the investors;
+Added: or (b) automatically
on June 20, 2021, subject to certain exceptions.
−Removed: conversion of the 2 nd Loan, the 2 nd Loan Investors will release their second lien on the IP.
−Removed: Loan Investors in the 2020 Financing will hold Series D Preferred Stock pari passu with the Series D Preferred Stock of
−Removed: 1 st Loan Investors in the 2017 Financing.
−Removed: the 2020 Financing was launched and through December 31, 2020, the Company had received aggregate 2 nd Loans
−Removed: of $3,325,000.
−Removed: Notes Payable –
−Removed: Related Parties
−Removed: the year ended December 31, 2019, the Company entered into 2017 Notes with related parties in the aggregate principal amount of
−Removed: $50,000 offset by the application of the 2017 Note in the principal amount of $250,000 that the Company entered into with Timothy
−Removed: Scott (former President) and Leigh Anne Scott on February 28, 2018 that was applied to Dr.
−Removed: Scott’s Kleba Settlement agreement.
−Removed: As of December 31, 2020 and 2019, the Company had borrowed $6,670,000 of 2017 Notes from related parties which
−Removed: were outstanding.
−Removed: the year ended December 31, 2020, the Company entered into 2020 Notes with related parties in the aggregate principal amount of
−Removed: As of December 31, 2020, the Company had borrowed $100,000 of 2020 Notes from related parties which were outstanding.
−Removed: Notes Payable –
−Removed: Non-Related Parties
−Removed: the year ended December 31, 2019, the Company entered into 2017 Notes with accredited investors in the aggregate principal amount
−Removed: of $6,335,000.
−Removed: As of December 31, 2020 and 2019, the Company had borrowed $13,397,000 under these notes, all of which
−Removed: were outstanding as of that date.
−Removed: During the year ended December 31, 2019, the Company entered into a 2020 Note with an accredited
−Removed: investor in the principal amount of $100,000.
−Removed: As of December 31, 2019, the Company had borrowed $100,000 under this note.
−Removed: the year ended December 31, 2020, the Company entered into 2020 Notes with accredited investors in the aggregate principal amount
−Removed: of $3,125,000.
−Removed: As of December 31, 2020, the Company had borrowed $3,225,000 under these notes, all of which were outstanding
−Removed: as of that date.
−Removed: Series D Preferred Stock
−Removed: of December 31, 2020, and through the date of filing, the Series D Preferred Stock had not been designated by the Board.
−Removed: terms of the notes issued in connection with the 2017 and 2020 Financings, if the Company has not designated the Series D Preferred
−Removed: Stock or if an insufficient number of Series D Preferred shares exist upon a conversion by a note holder, then the outstanding
−Removed: loans will continue to accrue interest at a rate of 8% per annum until which time the Company has designated a sufficient number
−Removed: of Series D Preferred shares.
−Removed: As a result, the Company did not analyze the notes for a potential beneficial conversion feature
−Removed: as the definition of a firm commitment has not been met since the notes were not convertible as of their respective dates of issuance
−Removed: or as of December 31, 2020.
+Added: See 2021 Conversions of Notes into Preferred Stock below.
+Added: time, the Company received 2020 Notes proceeds of $ 5,025,000 , of which $ 100,000 is from a related party investor, an officer of the Company.
+Added: March 23, 2017, the Company entered into an exclusive Definitive Financing Commitment Term Sheet with a group of the Company’s
+Added: stockholders (the “PRH Group”), which was amended and restated effective as of March 19, 2017 (the “2017 Term Sheet”)
+Added: that set forth the terms of a financing in the form of secured convertible loans from the PRH Group or other investors that were evidenced
+Added: by convertible promissory notes (the “2017 Notes”), which bore interest at the rate of eight percent ( 8 %)
+Added: outstanding principal amount and interest payable under the 2017 Notes were convertible into shares of a new series of preferred
+Added: stock at a price per share equal to $ 0.2862 ,
+Added: either (a) at any time after the new series of preferred stock is designated, at the sole discretion of the investors;
+Added: or (b) automatically
+Added: at the eighteen-month anniversary of the funding of the final tranche of 2017 Notes, subject to certain exceptions.
+Added: See 2021 Conversions
+Added: of Notes into Preferred Stock below.
+Added: time, the Company received 2017 Notes proceeds of $ 20,067,000 , of which $ 6,670,000 is from related party investors.
+Added: Officers of the Company
+Added: invested $ 3,050,000 and Board of Director members invested $ 3,620,000 .
+Added: the Company had not designated the new series of preferred stock into which the 2017 Notes and the 2020 Notes (collectively the “Notes”)
+Added: were convertible into.
+Added: As a result, the Company did not analyze the Notes for a potential beneficial conversion feature, as the definition
+Added: of a firm commitment had not been met since the Notes were not yet convertible.
+Added: On June 17, 2021, the required Certificates of Designation
+Added: were filed with the Delaware Secretary of State.
+Added: Accordingly, a firm commitment was achieved.
+Added: The Company analyzed the Notes for a beneficial
+Added: conversion feature and determined that there was none because the Notes have an effective conversion price of $ 0.2862 per share of underlying
+Added: common stock, which exceeds the $ 0.07 per share commitment date closing market price of the common stock.
+Added: Conversions of Notes into Preferred Stock
+Added: following summarizes the conversion activity during the year ended December 31, 2021:
+Added: of Conversion of Notes into Preferred Stock
+Added: 2021 Conversions Into Preferred
+Added: Principal converted
+Added: Accrued interest converted
+Added: Total converted
+Added: Conversion price
+Added: fractional shares issuable pursuant to the formula were rounded up to the next whole share of Series D and Series D-1 Preferred Shares.
+Added: 2017 Notes originally provided that they were convertible into a new series of preferred stock at a price per share equal to $ 0.2862
+Added: (the “Original Conversion Price”).
+Added: order to ensure that the Company had sufficient authorized shares of preferred stock into which the 2017 Notes would convert, yet keep
+Added: the economic terms of the 2017 Notes substantially equivalent, on February 26, 2019, the Company entered into amendments (the
+Added: “Amendments”) to the 2017 Notes (as amended, the “Amended 2017 Notes”) with a large majority of the holders of
+Added: 2017 Notes to increase the conversion price by 10 times from $ 0.2862
+Added: (the “New Conversion Price”) and
+Added: to change the conversion ratio by providing that one share of Preferred Stock would be convertible into 10 shares of common stock (the
+Added: “New Conversion Ratio”).
+Added: The impact of the Amendments was to reduce by 10 times the number of shares of preferred stock into
+Added: which the 2017 Notes would convert, while keeping the economic terms the same.
+Added: The 2020 Notes had substantially similar terms to the
+Added: Amended 2017 Notes, including being convertible into preferred stock at the New Conversion Price, with the Preferred Stock being convertible
+Added: into Common Stock at the New Conversion Ratio.
+Added: order to (i) address the fact that a small minority of the holders of 2017 Notes did not execute the Amendments and (ii) ensure economic
+Added: fairness for all of the holders of the 2017 Notes and 2020 Notes, on June 17, 2021, the Company designated two separate series
+Added: of preferred stock into which the 2017 Notes and 2020 Notes would convert:
+Added: (i) the Company’s Series D Convertible Preferred Stock,
+Added: par value $ 0.001
+Added: per share was designated for the holders of 2017
+Added: Notes who did not execute the Amendments and (ii) the Company’s Series D-1 Convertible Preferred Stock, par value $ 0.001
+Added: per share was designated for the holders of Amended
+Added: 2017 Notes and the holders of the 2020 Notes.
+Added: June 20, 2021, principal and interest in the aggregate amount of $ 3,541,222 ,
+Added: representing all of the outstanding non-amended 2017 Notes, was converted into 12,373,247
+Added: shares of Series D Convertible Preferred Stock
+Added: at the Original Conversion Price of $ 0.2862 .
+Added: Further on June 20, 2021, principal and interest in the aggregate amount of $ 27,031,858 ,
+Added: representing all of the outstanding Amended 2017 Notes and outstanding 2020 Notes was converted into 9,440,594
+Added: shares of Series D-1 Convertible Preferred Stock
+Added: at the New Conversion Price of $ 2.862 .
+Added: Any fractional shares issuable pursuant to the formula were rounded up to the next whole share of Series D and Series D-1 Preferred
+Added: Stockholders’ Deficiency for additional information on the Series D and Series D-1 Convertible Preferred
+Added: a result of the conversion of the 2017 Notes and 2020 Notes into convertible preferred stock, all the security interests of these Notes
+Added: in the Company’s intellectual property were released.
Notes Payable
−Removed: April 20, 2020, the Company received a $62,500 loan under the CARES Act PPP (the “PPP Loan”).
−Removed: The PPP provides for
−Removed: loans to qualifying businesses for amounts of up to 2.5 times certain of the borrower’s average monthly payroll expenses.
−Removed: The loan principal and accrued interest are forgivable, as long as the borrower uses loan proceeds for eligible uses during a
−Removed: specified period following disbursement, such as payroll, benefits, rent, and utilities, and maintains specified headcount and
−Removed: payroll thresholds.
−Removed: If any portion of a PPP Loan is not forgiven, the unforgiven portion is payable over two years at an interest
−Removed: rate of 1%, with a deferral of payments for the first seven months.
−Removed: The Company intends to use PPP Loan proceeds in a manner that
−Removed: it believes presently qualifies for full forgiveness.
−Removed: We cannot provide assurance that the PPP Loan will be forgiven in full.
−Removed: As of December 31, 2020, the Company had not applied for forgiveness of the PPP Loan.
−Removed: Once an amount is forgiven under the PPP
−Removed: Loan, the Company will recognize a gain on forgiveness of note payable in the period in which it obtained forgiveness.
+Added: On April 20, 2020, the
+Added: Company received a $ 62,500
+Added: loan under the CARES Act PPP (the “PPP Loan”).
+Added: PPP provides for loans to qualifying businesses for amounts of up to 2.5 times certain of the borrower’s average monthly payroll
+Added: On May 20, 2021, the Company applied for forgiveness of the PPP Loan.
+Added: On June 2, 2021, the Company was awarded full
+Added: forgiveness of the PPP Loan and accrued interest.
+Added: During the year ended December 31, 2021, the Company recognized a gain on forgiveness
+Added: of the PPP loan of $ 62,500
+Added: and interest of $ 594 .
Company obtained short-term financing from AFCO Insurance Premium Finance for our commercial insurance policies.
As of December 31, 2021
−Removed: 31, 2020 and 2019, the balance of the note payable was $212,790 and $228,424, respectively.
+Added: and December 31, 2020, the balance of the note payable was $ 238,452 and $ 212,790 , respectively.
Related Party Transactions
1 unchanged sentence
Bruce Horowitz (Capital Strategists) consulting fees of $ 169,600
−Removed: and $277,200, respectively, for services rendered.
+Added: and $ 254,400 ,
+Added: respectively, for services rendered.
+Added: Director fees for Mr.
+Added: Horowitz for the year ending December 31, 2021 and 2020 were
+Added: and $ 75,000 ,
+Added: respectively.
Accrued director fees for Mr.
Horowitz as of December 31, 2021 and 2020 were $ 281,250
−Removed: $75,000 and $75,000, respectively.
−Removed: Horowitz serves as both COO and a Director.
+Added: and $ 206,250 ,
+Added: respectively.
+Added: Total amount owed to Capital Strategist as of December 31, 2021 and 2020 were $ 127,200
+Added: and $ 42,400 ,
+Added: respectively.
+Added: Horowitz serves as both COO and
Note 5 and Note 8 for details of other related party transactions.
fees during the years ended December 31, 2021 and 2020 were $ 385,000 and $ 383,065 , respectively.
−Removed: Accrued directors’
−Removed: as of December 31, 2020 and 2019 were $1,175,589 and $792,524, respectively.
+Added: Accrued directors’ fees as of
+Added: December 31, 2021 and 2020 were $ 1,560,589 and $ 1,175,589 , respectively.
Short-term Receivables
−Removed: following table summarizes the receivables at December 31, 2020 and 2019:
−Removed: December 31, 2020
−Removed: Provectus Australia tax credit
−Removed: Gross receivable
−Removed: Reserve for uncollectibility
−Removed: Net receivable
−Removed: December 31, 2019
−Removed: Provectus Australia tax credit
−Removed: Gross receivable
−Removed: Reserve for uncollectibility
−Removed: Net receivable
−Removed: the year ended December 31, 2019, officers of the Company offset their settlement amounts owed to the Company against accrued
−Removed: payroll and other payables totaling $535,361.
−Removed: This offset reduced the amount of the settlement and was approved by the Company’s
−Removed: Stockholders’
−Removed: of December 31, 2020, the Company was authorized to issue 1,000,000,000 shares of common stock, $0.001 par value, and 25,000,000
−Removed: shares of preferred stock, $0.001 par value.
−Removed: The holders of the Company’s common stock are entitled to one vote per share.
−Removed: The preferred stock is designated as follows:
−Removed: 240,000 shares to Series B Convertible Preferred Stock (the “Series B Preferred
−Removed: Stock”) and 24,760,000 shares undesignated.
−Removed: B Convertible Preferred Stock
+Added: at December 31, 2021 and 2020, include the Australian VAT tax credit and approximately $ 2,100,000
+Added: is owed from Peter Culpepper.
+Added: The Company has established a reserve of approximately $ 2,100,000
+Added: as of December 31, 2021 and 2020,
+Added: which represents the amount Culpepper owes to the Company under the Derivative Lawsuit Settlement (excluding the amount of attorneys’
+Added: fees incurred in enforcing the terms of the Derivative Lawsuit Settlement).
+Added: Stockholders’ Deficiency
+Added: of December 31, 2021, the Company was authorized to issue 1,000,000,000 shares of common stock, $ 0.001 par value, and 25,000,000 shares
+Added: of preferred stock, $ 0.001 par value.
+Added: The holders of the Company’s common stock are entitled to one vote per share .
+Added: The preferred
+Added: stock is designated as follows:
+Added: 240,000 shares to Series B Convertible Preferred Stock (the “Series B Preferred Stock”),
+Added: 12,374,000 shares to Series D Convertible Preferred Stock (the “Series D Preferred Stock”), and 9,441,000 shares of Series
+Added: D-1 Convertible Preferred Stock (the “Series D-1 Preferred Stock”) and 2,945,000 shares undesignated.
+Added: B Preferred Stock
August 25, 2016, the Company filed the Series B Certificate of Designation with the Delaware Secretary of State.
−Removed: Certificate of Designation provides for the issuance of the Series B Preferred Stock, par value $0.001 per share.
−Removed: of the Company’s liquidation, dissolution, or winding up, holders of Series B Preferred Stock will be entitled to receive
−Removed: the amount of cash, securities or other property to which such holder would be entitled to receive with respect to such shares
−Removed: of Series B Preferred Stock if such shares had been converted to common stock immediately prior to such event (without giving
−Removed: effect for such purposes to any beneficial ownership limitation), subject to the preferential rights of holders of any class or
−Removed: series of the Company’s capital stock specifically ranking by its terms senior to the Series B Preferred Stock as to distributions
−Removed: of assets upon such event, whether voluntarily or involuntarily.
+Added: The Series B Certificate
+Added: of Designation provides for the issuance of the Series B Preferred Stock with a par value $ 0.001 per share and a stated value of $ 25.00
The Series B Preferred Stock has no voting rights.
−Removed: holders of Series B Preferred Stock will be entitled to receive cumulative dividends at the rate per share of 8% per annum of
−Removed: the stated value per share, until the fifth anniversary of the date of issuance of the Series B Preferred Stock.
−Removed: The dividends
−Removed: become payable, at the Company’s option in either cash, out of any funds legally available for such purpose, or in shares
−Removed: of common stock, (i) upon any conversion of the Series B Preferred Stock, (ii) on each such other date as the Board may determine,
−Removed: subject to written consent of the holders of Series B Preferred Stock holding a majority of the then issued and outstanding Series
−Removed: B Preferred Stock, (iii) upon the Company’s liquidation, dissolution or winding up, and (iv) upon occurrence of a fundamental
−Removed: transaction, which includes any merger or consolidation, sale of all or substantially all of the Company’s assets, exchange
−Removed: or conversion of all of the common stock by tender offer, exchange offer or reclassification;
−Removed: provided, however, that if Series
−Removed: B Preferred Stock is converted into shares of common stock at any time prior to the fifth anniversary of the date of issuance
−Removed: of the Series B Preferred Stock, the holder will receive a make-whole payment in an amount equal to all of the dividends that,
−Removed: but for the early conversion, would have otherwise accrued on the applicable shares of Series B Preferred Stock being converted
−Removed: for the period commencing on the conversion date and ending on the fifth anniversary of the date of issuance, less the amount
−Removed: of all prior dividends paid on such converted Series B Preferred Stock before the date of conversion.
−Removed: Make-whole payments are
−Removed: payable at the Company’s option in either cash, out of any funds legally available for such purpose, or in shares of common
−Removed: With respect to any dividend payments and make-whole payments paid in shares of common stock, the number of shares of common
−Removed: stock to be issued to a holder of Series B Preferred Stock will be an amount equal to the quotient of (a) the amount of the dividend
−Removed: payable to such holder divided by (b) the conversion price then in effect.
+Added: The holders of Series B Preferred Stock are entitled to receive cumulative
+Added: dividends at the rate of 8 % per annum of the stated value per share, until the fifth anniversary of the date of issuance of the Series
+Added: B Preferred Stock, at which time the Series B Preferred Stock automatically converts into common stock at the adjusted conversion price
+Added: of $ 0.0533 .
+Added: the year ended December 31, 2021, 100
+Added: shares of outstanding Series B Preferred Stock
+Added: automatically converted, at the fifth-year anniversary of their issuance, into 65,666
+Added: shares of common stock, which represents $ 3,500
+Added: of stated value plus $ 1,000
+Added: of cumulative dividends) divided by the adjusted
+Added: conversion price.
+Added: D and Series D-1 Preferred Stock
+Added: rights, preferences and privileges of the Series D Preferred Stock and Series D-1 Preferred Stock (collectively, the “D-Series
+Added: Preferred Stock”) are set forth in their respective Certificates of Designation.
+Added: The Board of Directors of the Company approved
+Added: each of the Certificates of Designation on June 14, 2021, and each Certificate of Designation was filed with the Delaware Secretary
+Added: of State on June 17, 2021.
+Added: The Series D Certificate of Designation established and designated 12,374,000
+Added: shares of Series D Preferred Stock.
+Added: D-1 Certificate of Designation established and designated 9,441,000
+Added: shares of Series D-1 Preferred Stock.
+Added: June 20, 2021, the Company issued 12,373,247
+Added: shares of Series D Preferred Stock upon the conversion
+Added: of all of the outstanding 2017 Notes at the Original Conversion Price of $ 0.2862
+Added: issued 9,440,594
+Added: shares of Series D-1 Preferred Stock upon the
+Added: conversion of all outstanding Amended 2017 Notes and 2020 Notes at the New Conversion Price of $ 2.862 .
+Added: Convertible Notes Payable for additional information on the conversion.
+Added: the year ended December 31, 2021, the Company received consideration of $ 150,000
+Added: from an investor in exchange for an aggregate
+Added: shares of restricted Series D-1 Preferred Stock
+Added: that have not yet been issued.
+Added: the year ended December 31, 2021, a holder of 222,145 shares of Series D-1 Preferred Stock voluntarily converted the Preferred Stock
+Added: into 2,221,450 shares of common stock.
+Added: Series D Preferred Stock and the Series D-1 Preferred Stock rank pari passu with each other.
+Added: The D-Series Preferred Stock rank
+Added: senior to the Common Stock and any other class or series of the Company’s capital stock, the terms of which do not provide that
+Added: shares of such class rank senior to, or pari passu with, the D-Series Preferred as to dividends and distributions upon a change
+Added: of control transaction, or the liquidation, winding-up and dissolution of the Company.
+Added: D-Series Preferred Stock does not have any dividend preference but are entitled to receive, on a pari passu basis, dividends,
+Added: if any, that are declared and paid on the common stock and any other class of the Company’s capital stock that ranks junior or
+Added: on par to the D-Series Preferred Stock.
+Added: the occurrence of the liquidation, winding-up or dissolution of the Company or certain mergers, corporate reorganizations or sales of
+Added: the Company’s assets (each, a “Company Event”), holders of D-Series Preferred Stock will be entitled to receive a liquidation
+Added: preference before any distributions are made to holders of any other class or series of the Company’s capital stock junior to the
+Added: D-Series Preferred Stock.
+Added: If a Company Event occurs within two years of June 20, 2021 (the “Date of Issuance”), the holders
+Added: of D-Series D Preferred Stock will receive, for each share of D-Series Preferred Stock, an amount in cash equal to the Original Issue
+Added: Price (as defined in the respective Certificates of Designation) multiplied by four.
+Added: If a Company Event occurs from and after the second
+Added: anniversary of the Date of Issuance, the holders of D-Series Preferred Stock will receive, for each share of D-Series Preferred Stock,
+Added: an amount in cash equal to the Original Issue Price multiplied by six.
+Added: The Original Issue Price for the Series D Preferred Stock is $ 0.2862 ,
+Added: and the Original Issue Price for the Series D-1 Preferred Stock is $ 2.862 .
+Added: of shares of D-Series Preferred Stock will vote together with the holders of common stock as a single class.
+Added: Each share of Series D Preferred
+Added: Stock carries the right to one vote per share.
+Added: Each share of Series D-1 Preferred Stock carries the right to ten votes per share.
+Added: Company is not permitted to amend, alter or repeal its Certificate of Incorporation or Bylaws in a manner adverse to the relative rights,
+Added: preferences, qualifications, limitations or restrictions of the D-Series Preferred Stock without the affirmative vote of a majority of
+Added: the votes entitled to be cast by holders of outstanding shares of D-Series Preferred Stock, voting together as a single class with each
+Added: share of D-Series Convertible Preferred Stock having a number of votes equal to the number of shares of common stock then issuable upon
+Added: conversion of such share of D-Series Preferred Stock.
+Added: Series D Preferred Stock is convertible at the option of the holders thereof into shares of common stock based on a one-for-one conversion
+Added: The Series D-1 Preferred Stock is convertible at the option of the holders thereof into shares of common stock based on a one-for-ten
+Added: conversion ratio.
+Added: The conversion ratio of the D-Series Preferred Stock is subject to adjustment for stock splits and combinations, recapitalizations,
+Added: reclassifications, reorganizations, mergers, and consolidations.
+Added: The D-Series Preferred Stock will automatically convert into shares
+Added: of common stock upon the fifth anniversary of the date of issuance.
Stock Issuances
−Removed: the year ended December 31, 2019, the Company issued 229,090 shares of immediately vested restricted common stock as payment of
−Removed: services, with an aggregate issuance date fair value of $11,538, which was recognized immediately as stock compensation within
−Removed: general and administrative expenses on the accompanying consolidated statement of operations.
−Removed: the year ended December 31, 2020, the Company issued 1,062,500 shares of immediately vested restricted common stock with an aggregate
−Removed: issuance date value of $69,088, which was recognized immediately as stock compensation within general and administrative
−Removed: expenses on the accompanying consolidated statement of operations.
+Added: the year ended December 31, 2020, the Company issued 1,062,500
+Added: shares of immediately vested restricted common
+Added: stock with an aggregate issuance date value of $ 69,088 ,
+Added: which was recognized immediately as stock compensation within general and administrative expenses on the accompanying consolidated statements
+Added: of operations.
+Added: following summarizes the Common Stock Issuances activity during the year ended December 31, 2020:
+Added: of Common Stock Issuance Activity
+Added: Stock Issuance
+Added: Grant Date Value
+Added: Advisory Board Member
+Added: Advisory Board Member
+Added: Advisory Board Member
+Added: Board of Director
+Added: Board of Director/Officer
+Added: the year ended December 31, 2021, the Company issued an aggregate of 300,000
+Added: shares of immediately vested restricted common
+Added: stock with a grant date fair value of $ 23,199
+Added: for services.
+Added: the year ended December 31, 2021, the Company issued 2,221,450 shares of common stock upon the voluntary conversion of Series D-1 Convertible
+Added: Preferred Stock.
Stock Incentive Plan and Warrants
2017 Amendment and Restatement of the Provectus Biopharmaceuticals, Inc.
−Removed: 2014 Equity Compensation Plan (the “2017
−Removed: Equity Compensation Plan”) provides for the issuance of up to 20,000,000 shares of common stock pursuant to stock options
−Removed: for the benefit of eligible employees and directors of the Company.
−Removed: Options granted under the 2017 Equity Compensation
−Removed: Plan are either “incentive stock options”
−Removed: within the meaning of Section 422 of the Internal Revenue Code or options
−Removed: which are not incentive stock options.
−Removed: The stock options are exercisable over a period determined by the Board of Directors (through
−Removed: its Compensation Committee), but generally no longer than 10 years after the date they are granted.
−Removed: As of December 31, 2020, there
−Removed: were 15,312,500 shares available for issuance under the 2017 Equity Compensation Plan.
+Added: 2014 Equity Compensation Plan (the “2017 Equity Compensation
+Added: Plan”) provides for the issuance of up to 20,000,000 shares of common stock pursuant to stock options for the benefit of eligible
+Added: employees and directors of the Company.
+Added: Options granted under the 2017 Equity Compensation Plan are either “incentive stock options”
+Added: within the meaning of Section 422 of the Internal Revenue Code or options which are not incentive stock options.
+Added: The stock options are
+Added: exercisable over a period determined by the Board of Directors (through its Compensation Committee), but generally no longer than 10
+Added: years after the date they are granted.
+Added: As of December 31, 2021, there were 16,437,500 shares available for issuance under the 2017 Equity
+Added: Compensation Plan.
were no stock options granted during the year ended December 31, 2021.
−Removed: the year ended December 31, 2020, the Company issued 2,425,000 five-year immediately vested stock options to an officer/director
−Removed: to purchase an aggregate of 2,425,000 shares of common stock with exercise price of $0.12 per share.
−Removed: The stock options had an
−Removed: aggregate grant date fair value of $62,880, which was recognized immediately as stock compensation within general and administrative
−Removed: expenses on the accompanying statement of operations.
−Removed: the year ended December 31, 2020, the Company issued 100,000 five-year immediately vested stock options to a director to purchase
−Removed: an aggregate of 100,000 shares of common stock with an exercise price of $0.2862 per share.
+Added: the year ended December 31, 2020, the Company issued 2,425,000
+Added: immediately vested stock options to an officer/director to purchase an aggregate of 2,425,000
+Added: shares of common stock with an exercise price
The stock options had an aggregate
−Removed: grant date fair value of $1,414, which was recognized immediately as stock compensation within general and administrative expenses
−Removed: on the accompanying statement of operations.
−Removed: Options granted during the year ended December 31, 2020 were valued using the Black Scholes Model, with the following assumptions
−Removed: For the Years Ended
+Added: grant date fair value of $ 62,880 ,
+Added: which was recognized immediately as stock compensation within general and administrative expenses on the accompanying consolidated
+Added: statements of operations.
+Added: the year ended December 31, 2020, the Company issued 100,000
+Added: immediately vested stock options to a director to purchase an aggregate of 100,000
+Added: shares of common stock with an exercise price
+Added: The stock options had an aggregate
+Added: grant date fair value of $ 1,414 ,
+Added: which was recognized immediately as stock compensation within general and administrative expenses on the accompanying consolidated
+Added: statements of operations.
+Added: options granted during the year ended December 31, 2020 were valued using the Black Scholes Model, with the following assumptions used:
+Added: Schedule of Stock Options Granted Valued Using Black Scholes Model
Expected terms (years)
3 unchanged sentences
following table summarizes option activity during the year ended December 31, 2021 and 2020:
+Added: Summary of Option Activity
Weighted Average
2 unchanged sentences
Outstanding and exercisable at December 31, 2020
+Added: ( 1,175,000 )
Outstanding and exercisable at December 31, 2021
+Added: of December 31, 2021, the intrinsic value of outstanding and exercisable options was $ 0 .
following table summarizes information about stock options outstanding at December 31, 2021:
−Removed: Number Outstanding
−Removed: Weighted Average
−Removed: Remaining Contractual
−Removed: Number Exercisable
+Added: Summary of Stock Options Outstanding
+Added: Options Outstanding
+Added: Options Exercisable
Exercise Price
−Removed: at December 31, 2020
−Removed: at December 31, 2020
−Removed: of December 31, 2020, the intrinsic value of outstanding and exercisable options was $0.
−Removed: the year-ended December 31, 2019, holders of warrants exercised warrants to purchase 5,045,857 shares of common stock at a price
−Removed: of $0.053 per share.
−Removed: In connection with the exercises, the Company received cash proceeds of $268,943 and issued 5,045,857 shares
−Removed: of common stock.
−Removed: the year ended December 31, 2020, holders of warrants exercised warrants to purchase 7,855,062 shares of common stock at a price
−Removed: of $0.053 per share.
−Removed: In connection with the exercises, the Company received cash proceeds of $418,676 and issued 7,855,062
−Removed: shares of common stock.
−Removed: the year ended December 31, 2020, the Company issued 62,500 three-year immediately vested warrants to board members to purchase
−Removed: an aggregate of 62,500 shares of common stock with an exercise price of $0.2862 per share.
+Added: Outstanding Number of Options
+Added: Weighted Average Remaining Life In Years
+Added: Exercisable Number of Options
+Added: the year ended December 31, 2020, holders of warrants exercised warrants to purchase 7,855,062 shares of common stock at a price of $ 0.053
+Added: In connection with the exercises, the Company received cash proceeds of $ 418,677 and issued 7,855,062 shares of common stock.
+Added: the year ended December 31, 2021, holders of warrants exercised warrants to purchase 18,052,966 shares of common stock at a price of
+Added: $ 0.053 per share.
+Added: In connection with the exercises, the Company received cash proceeds of $ 962,223 and issued 18,052,966 shares of common
+Added: On August 30, 2021, a total of 68,723,698 of August 2016 warrants expired.
+Added: the year ended December 31, 2020, the Company issued 62,500
+Added: three-year immediately vested warrants to board
+Added: members to purchase an aggregate of 62,500
+Added: shares of common stock with an exercise price
The warrants had an aggregate grant
−Removed: date fair value of $1,372, which was recognized immediately as stock compensation within general and administrative expenses on
−Removed: the accompanying statement of operations.
+Added: date fair value of $ 1,372 ,
+Added: which was recognized immediately as stock compensation within general and administrative expenses on the accompanying consolidated
+Added: statements of operations.
+Added: the year ended December 31, 2021, the Company issued 25,000
+Added: three-year immediately vested warrants to an
+Added: advisory board member to purchase an aggregate of 25,000
+Added: shares of common stock with exercise price of
+Added: The warrants had an aggregate
+Added: grant date fair value of $ 488 ,
+Added: which was recognized immediately within stock compensation in general and administrative expenses.
applying the Black-Scholes option pricing model to warrants granted, the Company used the following assumptions:
+Added: Schedule of Assumptions of Warrants
For the Years Ended
2 unchanged sentences
Risk-free interest rate
+Added: .011 %- 0.18 %
Expected dividend
following table summarizes warrant activity during the year ended December 31, 2021 and 2020:
+Added: Summary of Warrant Activity
Weighted Average
1 unchanged sentence
Outstanding and exercisable at January 1, 2020
+Added: ( 7,855,062 )
+Added: ( 31,052,806 )
Outstanding and exercisable at December 31, 2020
( 18,052,966 )
+Added: ( 68,723,698 )
Outstanding and exercisable at December 31, 2021
+Added: As of December 31, 2021, the intrinsic value of
+Added: outstanding and exercisable warrants was $ 0 .
following table summarizes information about warrants outstanding at December 31, 2021:
−Removed: Number Outstanding
−Removed: Weighted Average
−Removed: Number Exercisable
−Removed: Intrinsic Value
−Removed: at December 31,
−Removed: Remaining Contractual
−Removed: at December 31,
−Removed: at December 31,
+Added: Summary of Warrants Outstanding
+Added: Warrants Outstanding
+Added: Warrants Exercisable
Exercise Price
+Added: Outstanding Number of Warrant
+Added: Weighted Average Remaining Life In Years
+Added: Exercisable Number of Warrants
of the outstanding warrants are not entitled to vote and the exercise prices of such warrants are subject to customary anti-dilution
−Removed: domestic and foreign components of loss before income taxes from operations for the years ended December 31, 2020 and 2019 are
−Removed: Year ended December 31
+Added: domestic and foreign components of loss before income taxes from operations for the years ended December 31, 2021 and 2020 are as follows:
+Added: Schedule of Domestic and Foreign Loss Before Income Taxes
+Added: Years ended December 31
+Added: $ ( 5,454,489 )
+Added: $ ( 6,632,593 )
Net Pre-Tax Loss
+Added: $ ( 5,539,542 )
+Added: $ ( 6,677,587 )
income tax provision (benefit) consists of the following:
−Removed: Year ended December 31
+Added: Summary of Income Tax Provision (Benefit)
+Added: Years ended December 31
State and local:
1 unchanged sentence
Income tax provision (benefit)
−Removed: reconciliations between the statutory federal income tax rate and the Company’s effective tax rate are as follows:
−Removed: Year Ended December 31
+Added: reconciliations between the statutory federal income tax rate and the Company’s effective tax rate are as follows:
+Added: Schedule of Statutory Federal Income Tax Rate and Effective Tax Rate
+Added: Years Ended December 31
Tax benefit at federal statutory rate
5 unchanged sentences
Expiration of warrants and options
+Added: Conversion of accrued interest to preferred stock
Miscellaneous
Effective income tax rate
−Removed: components of the Company’s deferred income taxes are summarized below:
+Added: components of the Company’s deferred income taxes are summarized below:
+Added: Schedule of Components of Deferred Income Taxes
Deferred Tax Assets:
1 unchanged sentence
Stock-based compensation
+Added: Intangible assets
Research and development credit carryovers
Contribution carryovers
−Removed: Intangible assets
Accrued liabilities
9 unchanged sentences
Change in valuation allowance
−Removed: $ (1,694,521 )
−Removed: valuation allowance against deferred tax assets is required if, based on the weight of available evidence, it is more likely than
−Removed: not that some or all of the deferred tax assets may not be realized.
−Removed: The Company is in the early stages of development and realization
−Removed: of the deferred tax assets is not considered more likely than not.
−Removed: As a result, the Company has recorded a full valuation allowance
−Removed: for the net deferred tax asset.
−Removed: inception of the Company on January 17, 2002, the Company has generated federal, state and Australian tax net operating
−Removed: losses of approximately $166 million, $153 million, and $326 thousand.
−Removed: Under the Tax Cuts and Jobs Act, net
−Removed: operating loss incurred after December 31, 2017 may be carried forward indefinitely.
−Removed: The tax loss carry-forwards of the
−Removed: Company may be subject to limitation by Section 382 of the Internal Revenue Code with respect to the amount utilizable each
−Removed: This limitation reduces the Company’s ability to utilize net operating loss carry-forwards.
−Removed: operating losses (“NOL”) totaling $151.4 million expire in various amounts between 2022 and 2037.
−Removed: Federal NOL totaling
−Removed: $14.5 million do not expire.
+Added: valuation allowance against deferred tax assets is required if, based on the weight of available evidence, it is more likely than not
+Added: that some or all of the deferred tax assets may not be realized.
+Added: The Company is in the early stages of development and realization of
+Added: the deferred tax assets is not considered more likely than not.
+Added: As a result, the Company has recorded a full valuation allowance for
+Added: the net deferred tax asset.
+Added: inception of the Company on January 17, 2002, the Company has generated federal, state, and Australian tax net operating losses
+Added: of approximately $ 170
+Added: million, $ 150
+Added: million, and $ 139
+Added: respectively.
+Added: Under the Tax Cuts and Jobs Act, federal net operating losses incurred after December 31, 2017 may be carried forward
+Added: indefinitely.
+Added: The tax loss carryforwards of the Company may be subject to limitation by Section 382 of the Internal Revenue Code
+Added: with respect to the amount utilizable each year.
+Added: This limitation could reduce the Company’s ability to utilize net operating loss
+Added: carryforwards.
+Added: Federal net operating losses (“NOLS”) totaling $ 151.4
+Added: million expire in various amounts between 2022
+Added: Federal NOLS totaling $ 18.6 million
+Added: do not expire.
+Added: Schedule of Net Operating Loss
$ 170,074,959
−Removed: NOL totaling $153 million expire in various years between 2021 and 2035.
+Added: NOLS totaling $ 150 million expire in various years between 2022 and 2036.
$ 149,793,556
−Removed: NOL totaling $326,000 do not expire.
+Added: NOLS totaling $ 138,540
+Added: do not expire.
+Added: Year Generated
+Added: Year of Expiration
Company has determined that there are no uncertain tax positions as of December 31, 2021 or 2020.
1 unchanged sentence
federal jurisdiction and the state of Tennessee.
−Removed: The Company intends to permanently
−Removed: reinvest earnings in its foreign subsidiary.
−Removed: date, the Company’s operations conducted by its Australian subsidiary consist primarily of research and development activities.
−Removed: As of December 31, 2020, there were no accumulated earnings and profits in the Company’s foreign subsidiary.
−Removed: tax rates, no additional Federal income taxes (net of available tax credits) would be payable if such earnings were to be repatriated.
−Removed: The Company currently leases 4,500 square
−Removed: feet of corporate office space in Knoxville, Tennessee through an operating lease agreement for a term of five years ending on
−Removed: June 30, 2022.
−Removed: Payments are approximately $7,900 per month.
−Removed: expense for operating leases for the year ended December 31, 2020 was $90,821, of which, $60,547 was included within
−Removed: research and development and $30,274 was included within general and administrative expenses on the consolidated statement of
−Removed: Total expense for operating leases for the year ended December 31, 2019 was $102,378, of which, $68,252 was included
−Removed: within research and development and $34,126 was included within general and administrative expenses on the consolidated statement
−Removed: of operations.
+Added: The Company intends to permanently reinvest
+Added: earnings in its foreign subsidiary.
+Added: date, the Company’s operations conducted by its Australian subsidiary consist primarily of research and development activities.
+Added: As of December 31, 2021, there were no accumulated earnings and profits in the Company’s foreign subsidiary.
+Added: At current tax rates,
+Added: no additional Federal income taxes (net of available tax credits) would be payable if such earnings were to be repatriated.
+Added: Company currently leases 4,500
+Added: square feet of corporate office space in Knoxville,
+Added: Tennessee through an operating lease agreement for a term of five
+Added: years ending on June
+Added: Payments are approximately $ 6,100
+Added: August 13, 2021, the Company negotiated a reduced rent from July 1, 2021 through December 31, 2021 in the amount of $ 6,100 per month.
+Added: expense for operating leases for the year ended December 31, 2021 was $ 86,545 ,
+Added: of which, $ 57,697
+Added: was included within research and development
+Added: was included within general and administrative
+Added: expenses on the consolidated statements of operations.
+Added: Total expense for operating leases for the year ended December 31, 2020
+Added: was $ 90,821 ,
+Added: of which, $ 60,547
+Added: was included within research and development
+Added: was included within general and administrative
+Added: expenses on the consolidated statements of operations.
of December 31, 2021, the Company had no leases that were classified as a financing lease.
−Removed: As of December 31, 2020, the Company
−Removed: did not have additional operating and financing leases that have not yet commenced. 
−Removed: summary of the Company’s right-of-use assets and liabilities is as follows:
+Added: As of December 31, 2021, the Company did not
+Added: have additional operating and financing leases that have not yet commenced.
+Added: summary of the Company’s right-of-use assets and liabilities is as follows:
+Added: Schedule of Right-of-use Assets and Liabilities
For The Years Ended
8 unchanged sentences
minimum payments under non-cancellable lease as of December 31, 2021 were as follows:
+Added: Schedule of Future Minimum Payments Under Non-cancellable Lease
Total future minimum lease payments
2 unchanged sentences
Company maintains a retirement plan under Section 401(k) of the Internal Revenue Code, which covers all eligible employees.
−Removed: employees with U.S.
+Added: All employees
source income are eligible to participate in the plan immediately upon employment.
−Removed: There was no contribution
−Removed: made by the Company in 2020 or 2019.
−Removed: Travel Expenses and Related Collection Efforts
−Removed: December 27, 2016, the then-Board of Directors (the “then-Board”) unanimously voted to terminate then-interim Chief
−Removed: Executive Officer, then-Chief Operating Officer, and former Chief Financial Officer, Peter Culpepper (“Culpepper”),
−Removed: effective immediately, from all positions he held with the Company and each of its subsidiaries, “for cause,”
−Removed: in accordance
−Removed: with the terms of the Amended and Restated Executive Employment Agreement entered into by Culpepper and the Company on April 28,
−Removed: 2014 (the “Culpepper Employment Agreement”), based on the results of the investigation conducted by the Audit Committee
−Removed: of the then-Board regarding improper expense reimbursements to Culpepper.
−Removed: Company took the position that under the terms of the Culpepper Employment Agreement, Culpepper is owed no severance payments
−Removed: as a result of his termination “for cause”
−Removed: as that term is defined in the Culpepper Employment Agreement.
−Removed: Culpepper is no longer entitled to the 2:1 credit under the Stipulated Settlement Agreement and Mutual Release in the Kleba Derivative
−Removed: Lawsuit Settlement (the “Derivative Lawsuit Settlement”) such that the total $2,240,000 owed by Culpepper pursuant
−Removed: to the Derivative Lawsuit Settlement plus Culpepper’s proportionate share of the litigation cost in the amount of $227,750,
−Removed: less the amount that he repaid as of December 31, 2016, is immediately due and payable.
−Removed: The Company sent Culpepper a notice of
−Removed: default in January 2017 for the total amount he owes the Company and is in the process of pursuing these claims in accordance
−Removed: with the alternative dispute resolution provision of the Culpepper Employment Agreement.
−Removed: The Company has established a reserve
−Removed: of $2,104,543 as of December 31, 2020 and December 31, 2019, which amount represents the amount the Company currently believes
−Removed: Culpepper owes to the Company under the Derivative Lawsuit Settlement (excluding the amount of attorneys’
−Removed: fees incurred
−Removed: in enforcing the terms of the Derivative Lawsuit Settlement), while the Company pursues collection of this amount.
−Removed: disputed that he was terminated “for cause”
−Removed: under the Culpepper Employment Agreement.
−Removed: On June 28, 2017, pursuant to
−Removed: the alternative dispute resolution provisions of that agreement, the Company and Culpepper participated in a mediation of their
−Removed: Having reached no resolution during the mediation, the parties participated in arbitration under the commercial rules
−Removed: of the American Arbitration Association, arbitrating Culpepper’s claim against the Company for severance and the Company’s
−Removed: claims against Culpepper for improper expense reimbursements and amounts Culpepper owed the Company under the Derivative Lawsuit
−Removed: On September 12, 2018, the arbitrator issued his final award in favor of the Company.
−Removed: October 4, 2018, the Company filed a petition with the Chancery Court for Davidson County, Tennessee to confirm the arbitration
−Removed: On January 23, 2019, the Chancery Court entered an order confirming the arbitrator’s award.
−Removed: On February 20, 2019,
−Removed: Culpepper filed a motion to alter or amend the Chancery Court’s judgment.
−Removed: On March 22, 2019, the Chancery Court upheld the
−Removed: arbitration award in favor of the Company.
−Removed: April 16, 2019, Culpepper filed a Notice of Appeal with the Tennessee Court of Appeals regarding the Chancery Court’s judgment.
−Removed: The Company and Culpepper submitted their respective court of appeal briefs on November 12, 2019 and December 3, 2019, respectively.
−Removed: Oral arguments were held on January 7, 2020.
−Removed: On April 14, 2020, the Court of Appeals affirmed the Chancery Court’s judgment
−Removed: and awarded court costs to the Company.
−Removed: June 16, 2020, Culpepper filed an application to the Supreme Court of Tennessee for permission to appeal the Court of Appeals’
−Removed: final decision.
−Removed: On June 30, 2020, the Company filed an answer to the Supreme Court in opposition to Culpepper’s application
−Removed: for permission to appeal.
−Removed: On August 5, 2020, the Supreme Court of Tennessee denied Culpepper’s application.
−Removed: November 3, 2020, Culpepper filed a petition for writ of certiorari to the Supreme Court of the United States “SCOTUS”).
−Removed: The petition for writ of certiorari was denied by the Supreme Court on January 11, 2021.
−Removed: There are no further avenues for
−Removed: appeal for Culpepper.
+Added: There was no contribution made by the Company
+Added: in 2021 or 2020.
+Added: October 25, 2021, the Company received a grant award of $ 2,500,000
+Added: from the State of Tennessee for the study of
+Added: animal cancers and dermatological disorders for the period October 15, 2021 to June 30, 2022.
+Added: As of December 31, 2021, the grant award is recorded as unearned grant revenue liability on the accompanying consolidated balance sheets.
+Added: Commitments, Contingencies and Litigation
+Added: Company may, from time to time, be involved in litigation arising in the ordinary course of business or which may be expected to be covered
+Added: by insurance.
+Added: The Company is not aware of any pending or threatened litigation that, if resolved against the Company, would have a material
+Added: adverse effect on the Company’s consolidated financial position, results of operations or cash flows.
Subsequent Events
−Removed: Notes Payable
−Removed: to December 31, 2020, the Company entered into a 2020 Note with a non-related party accredited investor in the aggregate principal
−Removed: amount of $1,200,000 in connection with 2 nd Loans received by the Company for the same amount.
−Removed: None of the proceeds
−Removed: were received from a related party.
−Removed: addition, holders of 4,500,000 warrants to purchase the common stock of the Company at $0.0533 per share, have exercised these
−Removed: The Company has received proceeds in the aggregate amount of $239,850.
+Added: Company has evaluated events that have occurred after the balance sheet date and through the date the financial statements were
+Added: Based upon the evaluation, the Company did not identify any recognized or non-recognized subsequent events that would have required
+Added: adjustment or disclosure in the financial statements, except as disclosed below.
+Added: On February 23,
+Added: 2022, the Company negotiated a continued reduced rent from January 1, 2022 through June 30, 2022 in the amount of $ 6,100 per month.
IN AND DISAGREEMENTS WITH ACCOUNTANTS 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.