11 unchanged sentences
Derivative liability - conversion option on convertible debenture
−Removed: Convertible debenture - related party, net of unearned discount of $0 and $462,864 and capitalized accrued interest of $0 and $48,407 at December 31, 2020 and June 30, 2020, respectively
+Added: Convertible debenture - related party, net of unearned discount of $ 0 and $ 462,864 and capitalized accrued interest of $ 0 and $ 48,407 at March 31, 2021 and June 30, 2020, respectively
Total current liabilities
7 unchanged sentences
Common stock, $ 0.0001 par value;
−Removed: 800,000,000 shares authorized at December 31, 2020 and June 30, 2020;
−Removed: 13,916,164 and 5,204,392 shares issued and outstanding at December 31, 2020 and June 30, 2020, respectively
+Added: 800,000,000 shares authorized at March 31, 2021 and June 30, 2020;
+Added: 13,957,792 and 5,204,392 shares issued and outstanding at March 31, 2021 and June 30, 2020, respectively
Additional paid in capital
9 unchanged sentences
Three Months Ended
−Removed: Three Months Ended
−Removed: Six Months Ended
−Removed: Six Months Ended
−Removed: December 31 2020
−Removed: December 31 2019
−Removed: December 31 2020
−Removed: December 31 2019
+Added: Nine Months Ended
+Added: March 31 2021
+Added: March 31 2020
+Added: March 31 2021
+Added: March 31 2020
OPERATING EXPENSES:
11 unchanged sentences
( 8,125,328 )
−Removed: ( 7,758,778 )
Interest expense
3 unchanged sentences
( 4,593,327 )
−Removed: ( 4,260,476 )
NET (LOSS) INCOME
$ ( 2,992,868 )
+Added: $ ( 366,402 )
Deemed dividends - Related Party
3 unchanged sentences
$ ( 52,315,079 )
+Added: $ ( 14,621,649 )
NET (LOSS) INCOME PER COMMON SHARE
3 unchanged sentences
Condensed Statements of Cash Flows
−Removed: Six Months Ended
−Removed: Six Months Ended
−Removed: December 31, 2020
−Removed: December 31, 2019
+Added: Nine Months Ended
+Added: March 31, 2021
+Added: March 31, 2020
CASH FLOWS FROM OPERATING ACTIVITIES:
2 unchanged sentences
Stock based compensation
+Added: Common shares issued for interest payment
+Added: Common shares issued for service
Interest expense from convertible debenture
6 unchanged sentences
( 3,444,680 )
+Added: ( 1,268,208 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from issuance of common stock
+Added: Proceeds from exercise of warrants
Payment of convertible debenture - related party
16 unchanged sentences
(Deficit) Equity
−Removed: For the periods July 1, 2019 through December
−Removed: 31, 2019 and July 1, 2020 through December 31, 2020
−Removed: Stockholders'
+Added: For the periods July 1, 2019 through March
+Added: 31, 2020 and July 1, 2020 through March 31, 2021
+Added: Additional Paid in
+Added: Total Stockholders' Equity
Balance, June 30, 2019
15 unchanged sentences
$ ( 2,044,428 )
+Added: Stock based compensation
+Added: Issuance of shares for services
+Added: Issuance of shares for interest payment
+Added: Net loss for the three months ended March 31, 2020
+Added: Balance, March 31, 2020
+Added: $ ( 21,883,721 )
+Added: $ ( 2,344,459 )
Balance, June 30, 2020
16 unchanged sentences
$ ( 90,360,109 )
+Added: Stock based compensation
+Added: Cashless exercise of warrants
+Added: Proceeds from exercise of warrants
+Added: Net loss for the three months ended March 31, 2021
+Added: ( 2,992,868 )
+Added: ( 2,992,868 )
+Added: Balance, March 31, 2021
+Added: $ 104,753,666
+Added: $ ( 93,352,977 )
See accompanying notes to unaudited condensed
1 unchanged sentence
Notes to Condensed Financial Statements
−Removed: For the Six Months Ended December 31, 2020
+Added: For the Nine Months Ended March 31, 2021
Background Information
(the “Company”) is
−Removed: a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies.
−Removed: We are currently
−Removed: focused on developing and commercializing BIV201 (continuous infusion terlipressin), a novel approach to the treatment of ascites
−Removed: due to chronic liver cirrhosis.
−Removed: Our therapy BIV201 is based on a drug that is approved in about 40 countries to treat related complications
−Removed: of liver cirrhosis (part of the same disease pathway as ascites), but not yet available in the United States.
−Removed: BIV201’s active
−Removed: agent is a potent vasoconstrictor and has shown efficacy for reducing portal hypertension in studies around the world.
−Removed: is for BIV201 to interrupt the ascites disease pathway, thereby halting the cycle of accelerating fluid generation in ascites patients.
+Added: a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including liver disease
+Added: and neurological and neuro-degenerative disorders and certain cancers.
+Added: We are currently focused on developing and commercializing
+Added: BIV201 (continuous infusion terlipressin), a novel approach to the treatment of ascites due to chronic liver cirrhosis.
+Added: BIV201 is based on a drug that is approved in about 40 countries to treat related complications of liver cirrhosis (part of the
+Added: same disease pathway as ascites), but not yet available in the United States.
+Added: BIV201’s active agent is a potent vasoconstrictor
+Added: and has shown efficacy for reducing portal hypertension in studies around the world.
+Added: The goal is for BIV201 to interrupt the ascites
+Added: disease pathway, thereby halting the cycle of accelerating fluid generation in ascites patients.
BioVie completed a Phase 2a clinical trial
of BIV201 in patients with refractory ascites due to advanced liver cirrhosis at the McGuire Research Institute in Richmond, VA
−Removed: The Company met with representatives of the FDA in a Type C Guidance Meeting to discuss the study results and plan our
−Removed: next clinical study.
−Removed: In September 2019, we requested a Type B Meeting and subsequently submitted an extensive pre-meeting information
−Removed: In April 2020, the FDA provided a written response that provided new guidance regarding primary and secondary endpoints,
−Removed: BIV201 dosing levels, quality of life measures and other key aspects of the clinical trial design.
−Removed: After further communications,
−Removed: the Company completed the Phase 2 clinical trial design protocol and was cleared to begin the study.
−Removed: BioVie expects to commence
−Removed: treating refractory ascites patients in the Phase 2 trial in the first calendar quarter of 2021.
−Removed: The Phase 2 study will be used
−Removed: to guide the design of a pivotal Phase 3 clinical trial.
−Removed: We have developed a patent-pending novel liquid formulation of BIV201
−Removed: for use in this study that is intended to improve convenience for outpatient administration and avoid potential formulation errors
−Removed: that may occur when pharmacists reconstitute the powder version.
+Added: The Company met with representatives of the Food and Drug Administration (“FDA”) in a Type C Guidance Meeting
+Added: to discuss the study results and plan our next clinical study.
+Added: Subsequently we requested a Type B Meeting and submitted an extensive
+Added: pre-meeting information package.
+Added: In April 2020, the FDA provided a written response that provided new guidance regarding primary
+Added: and secondary endpoints, BIV201 dosing levels, quality of life measures and other key aspects of the clinical trial design.
+Added: further communications, the Company completed the clinical trial design protocol and was cleared to begin a Phase 2 clinical study.
+Added: We activated the first trial sites in the first calendar quarter of 2021 and patient screening is now underway.
+Added: The Phase 2 study
+Added: results will be used to guide the design of a pivotal Phase 3 clinical trial.
+Added: We have developed a patent-pending novel liquid formulation
+Added: of BIV201 for use in this study that is intended to improve convenience for outpatient administration and avoid potential formulation
+Added: errors that may occur when pharmacists reconstitute the powder version of terlipressin.
BIV201 has the potential to improve the health
6 unchanged sentences
The FDA has never approved any drug specifically for treating ascites.
−Removed: addition, the Company has a pending patent application directed to proprietary liquid formulations of terlipressin for use in its
−Removed: planned Phase 2 and Phase 3 clinical trials, subject to FDA clearance, which could eventually provide up to 20 years of patent
−Removed: coverage in each country in which the Company seeks patent protection according to the patent laws of the issuing country.
+Added: addition, the Company is applying for global patent coverage of a proprietary liquid formulation of terlipressin for use in the
+Added: Phase 2 and Phase 3 clinical trials, which has been cleared by the FDA.
+Added: This could eventually provide up to 20 years of patent
+Added: protection in countries where the Company seeks patent issuance according to local patent laws.
The BIV201 development program began at LAT
−Removed: On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program.
−Removed: currently owns all development and marketing rights to its drug candidate.
−Removed: The Company and PharmaIN, Corp.
−Removed: (“PharmaIN”),
−Removed: LAT Pharma’s former partner focused on the development of new modified drug candidates in the same therapeutic field but
−Removed: not including BIV201, had agreed to pay royalties equal to less than 1% of future net sales of each company's ascites drug development
−Removed: programs, or if such program is licensed to a third party, less than 5% of each company's net license revenues.
−Removed: On December 24,
−Removed: 2018, the Company returned its partial ownership rights to the PharmaIN modified terlipressin development program and simultaneously
−Removed: paid the remaining balance due on a related debt.
−Removed: PharmaIN, Corp.’s rights to our program remain unchanged.
+Added: On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to
+Added: its BIV201 development program.
+Added: The Company currently owns all development and marketing rights to its drug candidate.
+Added: and PharmaIN, Corp.
+Added: (“PharmaIN”), LAT Pharma’s former partner focused on the development of new modified drug
+Added: candidates in the same therapeutic field but not including BIV201, had agreed to pay royalties equal to less than 1% of future
+Added: net sales of each company's ascites drug development programs, or if such program is licensed to a third party, less than 5% of
+Added: each company's net license revenues.
+Added: On December 24, 2018, the Company returned its partial ownership rights to the PharmaIN modified
+Added: terlipressin development program and simultaneously paid the remaining balance due on a related debt.
+Added: PharmaIN, Corp.’s rights
+Added: to our program remain unchanged.
+Added: On April 27, 2021, the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”)
+Added: with NeurMedix, Inc.
+Added: (“NeurMedix”) and Acuitas Group Holdings, LLC (“Acuitas”), which are related party
+Added: affiliates, pursuant to which the Company has agreed to acquire certain assets from NeurMedix and assume certain liabilities of
+Added: NeurMedix, in exchange for the consideration of cash and shares of common stock.
+Added: (collectively, the “Transaction”).
+Added: The acquired assets include, among others, those related to certain drug candidates being developed by NeurMedix, including NE3107,
+Added: a small molecule orally administered inhibitor of insulin resistance and the pathological inflammatory cascade, with a novel mechanism
+Added: of action that has potential applications for treatment against Alzheimer’s Disease and Parkinson’s Disease.
+Added: 9 - Subsequent Events.
Notes to Condensed Financial Statements
−Removed: For the Six Months Ended December 31, 2020
−Removed: On September 22, 2020, the Company closed a
−Removed: registered public offering (the “Offering”) issuing 1,799,980 of its Class A common stock, par value $0.0001 per share
−Removed: (the “Common Stock”) at $10 per share, resulting in net proceeds to the Company of approximately $15.6 million, net
−Removed: of issuance costs of approximately $2.4 million;
−Removed: and of which approximately $1.8 million was used to satisfy all amounts owing
−Removed: in respect of a 10% OID Convertible Delayed Draw Debenture (the “Debenture”) due September 24, 2020 held by the Company’s
−Removed: controlling stockholder, Acuitas Group Holdings, LLC (“Acuitas”).
−Removed: On September 17, 2020, the Company’s
−Removed: common stock was approved for listing on The NASDAQ Capital Market (“Nasdaq”) under the symbol “BIVI” and
−Removed: began trading on September 18, 2020.
−Removed: At December 31, 2020, the Company had
−Removed: working capital of approximately $11.6 million and cash of $11.9 million and, stockholders’ equity was approximately $13.1
−Removed: million and its accumulated deficit was approximately $90.4 million.
−Removed: As a development stage enterprise, the Company expects substantial
−Removed: losses in future periods.
−Removed: These unaudited interim condensed financial statements were prepared assuming the Company will continue
−Removed: as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
−Removed: Based on the Company’s plans, management believes it has sufficient funds to fund its operations through our next round of
−Removed: clinical trials through at least February 2022.
−Removed: The emergence of widespread health emergencies
−Removed: or pandemics of the coronavirus ("Covid-19"), may lead to continued regional quarantines, business shutdowns, labor shortages,
−Removed: disruptions to supply chains, and overall economic instability, including the duration and spread of the outbreak and restrictions
−Removed: and the impact of Covid-19 on the financial markets and the overall economy, all of which are highly uncertain and cannot be predicted.
−Removed: If the financial markets and/or the overall economy are impacted for an extended period, the Company’s ability to raise funds
−Removed: may be materially adversely affected.
+Added: For the Nine Months Ended March 31, 2021
+Added: Liquidity and Going Concern
+Added: Company’s operations are subject to a number of factors that can affect its operating results and financial conditions.
+Added: factors include, but are not limited to:
+Added: the results of clinical testing and trial activities of the Company’s products,
+Added: the Company’s ability to obtain regulatory approval to market its products, competition from products manufactured and sold
+Added: or being developed by other companies, the price of, and demand for, Company products, the Company’s ability to negotiate
+Added: favorable licensing or other manufacturing and marketing agreements for its products, and the Company’s ability to raise
+Added: The Company’s financial statements have been prepared assuming the Company will continue as a going concern, which
+Added: contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
+Added: 31, 2021, the Company had working capital of approximately $10 million and cash of $11.4 million and, stockholders’ equity
+Added: was approximately $11.4 million, and its accumulated deficit was approximately $93.4 million.
+Added: In addition, the Company has not
+Added: generated any revenues and no revenues are expected in the foreseeable future.
+Added: The Company’s future operations are dependent
+Added: on the success of the Company’s ongoing development and commercialization effort, as well as continuing to secure additional
+Added: future viability of the Company is largely dependent upon its ability to raise additional capital to finance its operations.
+Added: expects that future sources of funding may include sales of equity, obtaining loans, or other strategic transactions.
+Added: emergence of widespread health emergencies or pandemics of the coronavirus ("Covid-19"), may lead to continued regional
+Added: quarantines, business shutdowns, labor shortages, disruptions to supply chains, and overall economic instability, including the
+Added: duration and spread of the outbreak and restrictions and the impact of Covid-19 on the financial markets and the overall economy,
+Added: all of which are highly uncertain and cannot be predicted.
+Added: If the financial markets and/or the overall economy are impacted for
+Added: an extended period, the Company’s ability to raise funds may be materially adversely affected.
+Added: management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient financing
+Added: on terms acceptable to the Company, if at all, to fund continuing operations.
+Added: These circumstances raise substantial doubt on the
+Added: Company’s ability to continue as a going concern.
+Added: The financial statements do not include any adjustments that might result
+Added: from the outcome of this uncertainty.
Significant Accounting Policies
27 unchanged sentences
Notes to Condensed Financial Statements
−Removed: For the Six Months Ended December 31, 2020
+Added: For the Nine Months Ended March 31, 2021
Significant Accounting Policies (continued)
9 unchanged sentences
is subject to 100% forgiveness.
−Removed: Currently, the application process to apply forgiveness occurs 10 months after the funding date.
−Removed: The Company intends to file the application for forgiveness, accordingly, unless the pending outcome of a new ruling is approved
−Removed: that forgives all the PPP loans under $150,000.
+Added: The Company has filed the application for forgiveness, in February 2021 and is pending confirmation
+Added: of forgiveness by the SBA.
There can be no assurance that such forgiveness will occur.
−Removed: The Company is accounting
−Removed: for the loan as debt and if forgiveness is granted the Company will recognize a gain on extinguishment.
+Added: The Company is accounting for the loan as
+Added: debt and if forgiveness is granted the Company will recognize a gain on extinguishment.
Net (loss) income per Common Share
−Removed: Basic net (loss) income per common
−Removed: share is computed by dividing the net (loss) income attributable to common stockholders by the weighted average number of shares
−Removed: of common stock outstanding during the period.
−Removed: Diluted net (loss) income per common share is computed by dividing the net (loss)
−Removed: income attributable to common stockholders by the weighted average number of shares of common stock outstanding and potentially
−Removed: outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable
−Removed: through stock options, warrants, and convertible debentures.
−Removed: For the six months ended December 31, 2020 and 2019, all potential
−Removed: securities were anti-dilutive as a result of the effect of the change in fair value of the derivative liability creating a net
−Removed: loss available to common shareholders.
−Removed: For the three months ended December 31, 2020, such amounts were excluded from the diluted
−Removed: loss since their effect was considered anti-dilutive due to net loss for the period.
−Removed: For the three months ended December 31, 2019,
−Removed: all potential securities were anti-dilutive.
+Added: Basic net (loss) income per common share
+Added: is computed by dividing the net (loss) income attributable to common stockholders by the weighted average number of shares of common
+Added: stock outstanding during the period.
+Added: Diluted net (loss) income per common share is computed by dividing the net (loss) income attributable
+Added: to common stockholders by the weighted average number of shares of common stock outstanding and potentially outstanding shares
+Added: of common stock during the period to reflect the potential dilution that could occur from common shares issuable through stock
+Added: options, warrants, and convertible debentures.
+Added: For the nine months ended March 31, 2021 and 2020, all potential securities were
+Added: anti-dilutive as a result of the effect of the change in fair value of the derivative liability creating a net loss available to
+Added: common shareholders.
+Added: For the three months ended March 31, 2021 and 2020, such amounts were excluded from the diluted loss since
+Added: their effect was considered anti-dilutive due to net loss for the period.
The table below shows the number of
−Removed: outstanding stock options and warrants as of December 31, 2020 and 2019:
−Removed: December 31, 2020
−Removed: December 31, 2019
+Added: outstanding stock options and warrants as of March 31, 2021 and 2020:
+Added: March 31, 2021
+Added: March 31, 2020
Number of Shares
1 unchanged sentence
Stock Options
−Removed: Notes to Condensed Financial Statements
−Removed: For the Six Months Ended December 31, 2020
−Removed: Significant Accounting Policies (continued)
Recent accounting pronouncements
13 unchanged sentences
condensed financial statements and related disclosures.
+Added: Notes to Condensed Financial Statements
+Added: For the Nine Months Ended March 31, 2021
Intangible Assets
−Removed: The Company’s
−Removed: intangible assets consist of intellectual property acquired from LAT Pharma, Inc.
−Removed: and are amortized over their estimated useful
−Removed: The following is a summary of the intangible assets as of December 31, 2020 and June 30, 2020:
−Removed: December 31, 2020
+Added: The Company’s intangible assets consist
+Added: of intellectual property acquired from LAT Pharma, Inc.
+Added: and are amortized over their estimated useful lives.
+Added: The following is a
+Added: summary of the intangible assets as of March 31, 2021 and June 30, 2020:
+Added: Summary of the intangible assets
+Added: March 31, 2021
June 30, 2020
3 unchanged sentences
Intellectual Property, Net
−Removed: Amortization expense
−Removed: for the three-month period ended December 31, 2020 and 2019 was $57,344 and $57,344 respectively.
−Removed: Amortization expense for the
−Removed: six-month period ended December 31, 2020 and 2019 was $114,688 and $114,689 respectively.
−Removed: Estimated future amortization
−Removed: expense is as follows:
−Removed: Year ending June 30, 2021 (Remaining six months)
+Added: Amortization expense for the three-month period
+Added: ended March 31, 2021 and 2020 was $57,344 and $57,344 respectively.
+Added: Amortization expense for the nine-month period ended March
+Added: 31, 2021 and 2020 was $172,032 and $172,032 respectively.
+Added: Estimated future amortization expense is as
+Added: Year ending June 30, 2021 (Remaining three months)
Intellectual Property, Net
Notes to Condensed Financial Statements
−Removed: For the Six Months Ended December 31, 2020
+Added: For the Nine Months Ended March 31, 2021
Related Party Transactions
3 unchanged sentences
due September 24, 2020 held by the Company’s controlling stockholder, Acuitas.
−Removed: Additionally in connection with the close of the public offering on September 22, 2020, the Company
−Removed: issued an aggregate of 6,909,582 shares of Common Stock to Acuitas, representing (i) 5.4 million shares issuable pursuant to Acuitas’
−Removed: rights under the Purchase Agreement dated July 3, 2018, as amended on June 24, 2019 and October 9, 2019;
−Removed: and the various extension
−Removed: letters as more fully described below;
−Removed: which resulted in a deemed dividend at the close of the public offering at price of $10
−Removed: per share, consistent with the Company’s accounting policy;
−Removed: and (ii) the automatic exercise of 1.5 million warrants issued
−Removed: to Acuitas in connection with the Debenture financing at the par value of the Common Stock.
+Added: Additionally in connection with the close of
+Added: the public offering on September 22, 2020, the Company issued an aggregate of 6,909,582 shares of Common Stock to Acuitas, representing
+Added: (i) 5.4 million shares issuable pursuant to Acuitas’ rights under the Purchase Agreement dated July 3, 2018, as amended on
+Added: June 24, 2019 and October 9, 2019;
+Added: and the various extension letters as more fully described below;
+Added: which resulted in a deemed
+Added: dividend at the close of the public offering at price of $10 per share, consistent with the Company’s accounting policy;
+Added: and (ii) the automatic exercise of 1.5 million warrants issued to Acuitas in connection with the Debenture financing at the par
+Added: value of the Common Stock.
During the three months ended September 30,
38 unchanged sentences
Notes to Condensed Financial Statements
−Removed: For the Six Months Ended December 31, 2020
+Added: For the Nine Months Ended March 31, 2021
Related Party Transactions (continued)
24 unchanged sentences
Notes to Condensed Financial Statements
−Removed: For the Six Months Ended December 31, 2020
+Added: For the Nine Months Ended March 31, 2021
Related Party Transactions (continued)
26 unchanged sentences
stock equaling 60%.
−Removed: The issuance of 1,125,000 shares of the Company’s commons stock and warrants to purchase an equal
−Removed: amount number of shares, to its controlling stockholder for the Bridge Financing was accounted for as a deemed dividend due to
−Removed: its related party nature and $17.1 million representing the excess of the fair value of the consideration given for the financing,
−Removed: net of debt discount;
−Removed: was recorded in accumulated deficit for the year ended June 30, 2020, accordingly.
−Removed: A debt discount of $500,000
−Removed: against the debenture was recorded which will be amortized over the term of the debenture using the effective interest method.
−Removed: The Company recognized amortization of the unearned discount for the three month period ended December 31, 2020 and 2019 of $0
−Removed: and $20,061, respectively, and for the six months period ended December 31, 2020 and 2019 of $21,336 and $21,595, respectively.
−Removed: The Company received draws under
−Removed: the Debenture that totaled approximately $1.3 million during the year ended June 30, 2020.
−Removed: The total interest expense related
−Removed: to the draws under the Debenture was approximately $99,000 for the year ended June 30, 2020.
−Removed: On April 1, 2020, the Company
−Removed: entered an amendment to modify the payment of accrued interest amounts under the original terms of the Debenture to
−Removed: capitalize all such amounts as would otherwise accrue on the Debenture.
−Removed: On January 4, 2020, payment of $13,487 accrued
−Removed: interest due was paid through the issuance of 4,422 shares of the Company’s common stock.
−Removed: Acuitas and the Company
−Removed: continue to discuss the need and timing for some or all the remaining draws under the Debenture Agreement.
−Removed: Subsequent to the initial $500,000 draw on September 24, 2019, the Company received draws that totaled $813,000 as July 13,
−Removed: 2020, and accordingly;
−Removed: the Company issued additional Bridge Warrants to purchase 203,250 shares of common stock to its
−Removed: controlling stockholder under the terms of the Bridge Financing.
−Removed: Accordingly, on April 16, 2020, the Company recorded the
−Removed: warrants to purchase 125,000 common stock related to the second $500,000 draw under the debenture as a derivative warrant
−Removed: liability as of June 30, 2020.
+Added: The issuance of 1,125,000 shares of the Company’s
+Added: commons stock and warrants to purchase an equal amount number of shares, to its controlling stockholder for the Bridge Financing
+Added: was accounted for as a deemed dividend due to its related party nature and $17.1 million representing the excess of the fair value
+Added: of the consideration given for the financing, net of debt discount;
+Added: was recorded in accumulated deficit for the year ended June
+Added: 30, 2020, accordingly.
+Added: A debt discount of $500,000 against the debenture was recorded which will be amortized over the term of
+Added: the debenture using the effective interest method.
+Added: The Company recognized amortization of the unearned discount for the three-month
+Added: period ended March 31, 2021 and 2020 of $0 and $20,307, respectively, and for the nine months period ended March 31, 2021 and 2020
+Added: of $21,336 and $41,902, respectively.
+Added: The Company received draws under the Debenture
+Added: that totaled approximately $1.3 million during the year ended June 30, 2020.
+Added: The total interest expense related to the draws under
+Added: the Debenture was approximately $99,000 for the year ended June 30, 2020.
+Added: On April 1, 2020, the Company entered an amendment to
+Added: modify the payment of accrued interest amounts under the original terms of the Debenture to capitalize all such amounts as would
+Added: otherwise accrue on the Debenture.
+Added: On January 4, 2020, payment of $13,487 accrued interest due was paid through the issuance of
+Added: 4,422 shares of the Company’s common stock.
+Added: Acuitas and the Company continue to discuss the need and timing for some or all the
+Added: remaining draws under the Debenture Agreement.
+Added: Subsequent to the initial $500,000 draw on September 24, 2019, the Company received
+Added: draws that totaled $813,000 as July 13, 2020, and accordingly;
+Added: the Company issued additional Bridge Warrants to purchase 203,250
+Added: shares of common stock to its controlling stockholder under the terms of the Bridge Financing.
+Added: Accordingly, on April 16, 2020,
+Added: the Company recorded the warrants to purchase 125,000 common stock related to the second $500,000 draw under the debenture as a
+Added: derivative warrant liability as of June 30, 2020.
The Company recorded the warrants related to the draws totaling $313,000 to purchase
1 unchanged sentence
Notes to Condensed Financial Statements
−Removed: For the Six Months Ended December 31, 2020
+Added: For the Nine Months Ended March 31, 2021
Related Party Transactions (continued)
16 unchanged sentences
The provisions of the 2019 Purchase Agreement providing that, should the underwriters in the offering exercise their option to purchase additional securities during the 45 days following closing and the issuance of such securities would result in Acuitas’ beneficial ownership (on a fully diluted basis) of shares of common stock being below 60%, Acuitas will be issued a number of additional shares of common stock and warrants having the same terms as the Commitment Warrants to result in its beneficial ownership (on a fully diluted basis) of shares of common stock equaling 60% have been modified such that, upon the exercise of such option by the underwriters, the Company will issue to Acuitas a number of securities that will result in Acuitas’ fully diluted beneficial ownership after the exercise of such option being the same as prior thereto.
−Removed: On July 14, 2020, the Company, entered
−Removed: into a further extension of its letter agreements dated April 8, 2020, that furthered extended its letter agreement dated
−Removed: February 10, 2020 with Acuitas regarding Acuitas’ previous agreement to modify its existing rights under the Purchase
−Removed: Agreement dated July 3, 2018 with the Company so that its June 2019 waiver of its rights to a 50% adjustment of the purchase
−Removed: price applicable to its initial investment in the Company and the exercise price of the warrants received in such transaction
−Removed: and the price per share should it exercise certain rights to purchase additional securities in the event of certain
−Removed: reductions in the useful life of the Company’s intellectual property rights and commitment to purchase such securities
−Removed: upon the closing of the Offering and commitment to purchase such additional securities would remain effective until October
−Removed: 31, 2020, and accordingly Acuitas was entitled to receive an aggregate of 5,359,832 shares of Common Stock at such closing.
−Removed: In addition, the parties agreed that certain draws under the Company’s current bridge financing with Acuitas were to be
−Removed: made based with respect to the Company’s ongoing capital requirements and current market conditions, notwithstanding
−Removed: certain scheduled availability dates set forth in the 10% OID Convertible Delayed Draw Debenture issued in connection
−Removed: The letter agreement of July 14, 2020 also confirmed the understanding between the Company and Acuitas regarding
−Removed: certain amounts funded to BioVie that were intended as “partial draws” of credit available under the Debenture
−Removed: which, as of July 14, 2020 hereof aggregated $813,000 in aggregate principal amount in additional to amounts initial funded
−Removed: under the Debenture.
−Removed: Accordingly, such “partial draws” accrued additional principal as amounts otherwise funded
−Removed: pursuant to the original schedule of draws included in the Debenture (as modified by the letter agreement between BioVie and
−Removed: Acuitas dated April 1, 2020 regarding the capitalization of interest otherwise payable) and shall entitle Acuitas to receive
−Removed: a pro rata amount of Bridge Warrants.
+Added: On July 14, 2020, the Company, entered into
+Added: a further extension of its letter agreements dated April 8, 2020, that furthered extended its letter agreement dated February 10,
+Added: 2020 with Acuitas regarding Acuitas’ previous agreement to modify its existing rights under the Purchase Agreement dated
+Added: July 3, 2018 with the Company so that its June 2019 waiver of its rights to a 50% adjustment of the purchase price applicable to
+Added: its initial investment in the Company and the exercise price of the warrants received in such transaction and the price per share
+Added: should it exercise certain rights to purchase additional securities in the event of certain reductions in the useful life of the
+Added: Company’s intellectual property rights and commitment to purchase such securities upon the closing of the Offering and commitment
+Added: to purchase such additional securities would remain effective until October 31, 2020, and accordingly Acuitas was entitled to receive
+Added: an aggregate of 5,359,832 shares of Common Stock at such closing.
+Added: In addition, the parties agreed that certain draws under the
+Added: Company’s current bridge financing with Acuitas were to be made based with respect to the Company’s ongoing capital
+Added: requirements and current market conditions, notwithstanding certain scheduled availability dates set forth in the 10% OID Convertible
+Added: Delayed Draw Debenture issued in connection therewith.
+Added: The letter agreement of July 14, 2020 also confirmed the understanding between
+Added: the Company and Acuitas regarding certain amounts funded to BioVie that were intended as “partial draws” of credit
+Added: available under the Debenture which, as of July 14, 2020 hereof aggregated $813,000 in aggregate principal amount in additional
+Added: to amounts initial funded under the Debenture.
+Added: Accordingly, such “partial draws” accrued additional principal as amounts
+Added: otherwise funded pursuant to the original schedule of draws included in the Debenture (as modified by the letter agreement between
+Added: BioVie and Acuitas dated April 1, 2020 regarding the capitalization of interest otherwise payable) and shall entitle Acuitas to
+Added: receive a pro rata amount of Bridge Warrants.
Notes to Condensed Financial Statements
−Removed: For the Six Months Ended December 31, 2020
+Added: For the Nine Months Ended March 31, 2021
Fair Value Measurements
8 unchanged sentences
as additional paid in capital upon automatic exercise of the warrants and payoff of the Debenture.
−Removed: At December 31, 2020 and June 30, 2020, the estimated fair value
−Removed: of derivative liabilities measured on a recurring basis are as follows:
+Added: At March 31, 2021 and June 30, 2020, the estimated fair value of
+Added: derivative liabilities measured on a recurring basis are as follows:
Fair Value Measurements at
−Removed: December 31, 2020
Derivative liability - Warrants
7 unchanged sentences
The following table presents the activity for liabilities measured
−Removed: at fair value using unobservable inputs for the six months ended December 31, 2020:
+Added: at fair value using unobservable inputs for the nine months ended March 31, 2021:
Derivative liabilities - Warrants
8 unchanged sentences
( 2,775,002 )
−Removed: Balance at December 31, 2020
+Added: Balance at March 31, 2021
Notes to Condensed Financial Statements
−Removed: For the Six Months Ended December 31, 2020
+Added: For the Nine Months Ended March 31, 2021
Fair Value Measurements (continued)
39 unchanged sentences
(See note 5 “Related Party Transactions ” )
+Added: Notes to Condensed Financial Statements
+Added: For the Nine Months Ended March 31, 2021
Equity Transactions
1 unchanged sentence
The following table summarizes the activity
−Removed: relating to the Company’s stock options for the six months ended December 31, 2020:
+Added: relating to the Company’s stock options for the nine months ended March 31, 2021:
Weighted-Average Exercise Price
3 unchanged sentences
Options Exercised or Forfeited
−Removed: Outstanding at December 31, 2020
−Removed: Exercisable at December 31, 2020
−Removed: Notes to Condensed Financial Statements
−Removed: For the Six Months Ended December 31, 2020
−Removed: Equity Transactions (Continued)
−Removed: The fair value of each option grant
−Removed: on the date of grant is estimated using the Black-Scholes option.
−Removed: The pricing model reflected the following weighted-average assumptions
−Removed: for the six months ended December 31, 2020:
−Removed: December 31, 2020
−Removed: December 31, 2019
+Added: Outstanding at March 31, 2021
+Added: Exercisable at March 31, 2021
+Added: The fair value of each option grant on the date of grant is estimated
+Added: using the Black-Scholes option.
+Added: The pricing model reflected the following weighted-average assumptions for the nine months ended
+Added: March 31, 2021 and 2020:
+Added: March 31, 2021
+Added: March 31, 2020
Expected life of options (In years)
8 unchanged sentences
The Company recorded stock-based compensation
−Removed: expense of $ 1,536,929 and $ 1,536,929 for the three- and six- month periods ended December 31, 2020, respectively, and $ 11,162 and $ 11,162
−Removed: for the three- and six- month periods ended December 31, 2019, respectively.
−Removed: As of December 31, 2020, there was approximately
−Removed: $ 4,400,886 of unrecognized compensation cost related to non-vested options granted to Directors, which is expected to be recognized
−Removed: over a weighted-average period of approximately 3 years .
+Added: expense of $ 803,604 and $ 2,340,533 for the three- and nine- month periods ended March 31, 2021, respectively, and $ 13,684 and $ 24,846
+Added: for the three- and nine- month periods ended March 31, 2020, respectively.
+Added: As of March 31, 2021, unrecognized stock-based
+Added: compensation cost was $ 3,721,620 which is expected to be recognized over a weighted-average period of approximately 3 years .
+Added: Notes to Condensed Financial Statements
+Added: For the Nine Months Ended March 31, 2021
+Added: Equity Transactions (continued)
The following is a summary of stock
−Removed: options outstanding and exercisable by exercise price as of December 31, 2020:
+Added: options outstanding and exercisable by exercise price as of March 31, 2021:
Exercise Price
Weighted Average Contract Life
−Removed: Notes to Condensed Financial Statements
−Removed: For the Six Months Ended December 31, 2020
−Removed: Equity Transactions (Continued)
Stock Warrants
The following table summarizes the warrants
−Removed: activity during the six months ended December 31, 2020:
+Added: activity during the nine months ended March 31, 2021:
Number of Shares
5 unchanged sentences
( 1,453,250 )
−Removed: Outstanding and exercisable at December 31, 2020
+Added: Outstanding and exercisable at March 31, 2020
Of the above warrants, 9,391 expire in fiscal
1 unchanged sentence
and 48,675 expire in fiscal year ending June 30, 2026.
+Added: Notes to Condensed Financial Statements
+Added: For the Nine Months Ended March 31, 2021
+Added: Equity Transactions (continued)
Issuance of common stock through
−Removed: exercise of Stock Options
+Added: exercise of Stock Options and Warrants
On July 28, 2020, the Company issued 2,210
1 unchanged sentence
$ 4.76 per share.
+Added: On January 27, 2021, the Company issued 304
+Added: shares of common stock pursuant to a cashless exercise of warrants to purchase 320 shares at an average exercise price of $ 1.88
+Added: On March 23, 2021, the Company issued 27,000
+Added: shares of common stock pursuant to a cash exercise of warrants to purchase 27,000 shares at an average exercise price of $ 12.50
+Added: On March 24, 2021, the Company issued 14,324
+Added: shares of common stock pursuant to a cash exercise of warrants to purchase 14,324 shares at an average exercise price of $ 12.50
Issuance of warrants
23 unchanged sentences
from date of issuance and expire 5 years from the date of issuance.
+Added: The amortization for the quarter ended March 31, 2021 was $679,276.
+Added: The remaining amortization over the next 5 years is $3,721,610.
+Added: On January 19, 2021, the Company issued stock
+Added: option grants to purchase a total of 4,800 shares of common stock, granting 800 shares each to the Chief Operations Officer, the
+Added: Chief Scientific Officer and to four of its key consultants as part of their annual compensation.
+Added: The stock options were issued
+Added: and are exercisable at $ 42.09 at any time from date of issuance and expire 5 years from the date of issuance.
Notes to Condensed Financial Statements
−Removed: For the Six Months Ended December 31, 2020
+Added: For the Nine Months Ended March 31, 2021
Commitments and Contingencies
43 unchanged sentences
Notes to Condensed Financial Statements
−Removed: For the Six Months Ended December 31, 2020
+Added: For the Nine Months Ended March 31, 2021
Commitments and Contingencies (continued)
−Removed: The Company and PharmaIN Corporation, LAT
−Removed: Pharma’s former partner focused on the development of new modified drug candidates in the same therapeutic field but
−Removed: not including BIV201, had agreed to pay royalties equal to less than 1% of future net sales of each company's ascites drug
−Removed: development programs, or if such program is licensed to a third party, less than 5% of each company's net license revenues.
−Removed: On December 24, 2018, the Company returned its partial ownership rights to the PharmaIN modified terlipressin development
−Removed: program and simultaneously paid the remaining balance due on a related debt.
+Added: The Company and PharmaIN Corporation, LAT Pharma’s
+Added: former partner focused on the development of new modified drug candidates in the same therapeutic field but not including BIV201,
+Added: had agreed to pay royalties equal to less than 1% of future net sales of each company's ascites drug development programs, or if
+Added: such program is licensed to a third party, less than 5% of each company's net license revenues.
+Added: On December 24, 2018, the Company
+Added: returned its partial ownership rights to the PharmaIN modified terlipressin development program and simultaneously paid the remaining
+Added: balance due on a related debt.
PharmaIN, Corp.
−Removed: rights to our program remain
−Removed: Additionally the Company obligation to pay a low single digit royalty on the net sales of BIV201 (continuous
−Removed: infusion terlipressin) to be shared among LAT Pharma LLC members, and The Barrett Edge, Inc.
−Removed: pursuant to the Agreement and
−Removed: Plan of Merger, dated April 11, 2016, by and between LAT Pharma LLC.
−Removed: The Company has an obligation to pay a low single digit
−Removed: royalty on net sales of all terlipressin products covered by specified patents up to a maximum of $200,000 per year pursuant
−Removed: to the Technology Transfer Agreement, dated July 25, 2016, by and between us and the University of Padova (Italy).
+Added: rights to our program remain unchanged.
+Added: Additionally, the Company obligation to
+Added: pay a low single digit royalty on the net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma LLC
+Added: members, and The Barrett Edge, Inc.
+Added: pursuant to the Agreement and Plan of Merger, dated April 11, 2016, by and between LAT Pharma
+Added: The Company has an obligation to pay a low single digit royalty on net sales of all terlipressin products covered by specified
+Added: patents up to a maximum of $200,000 per year pursuant to the Technology Transfer Agreement, dated July 25, 2016, by and between
+Added: us and the University of Padova (Italy).
Pursuant to the Technology Transfer Agreement entered into on July
3 unchanged sentences
Subsequent Events
−Removed: On January 19, 2021, the Company issued stock option grants to purchase a total of 4,800
−Removed: shares of common stock, granting 800 shares each to the Chief Operations Officer, the Chief Scientific Officer and to four of its
−Removed: key consultants as part of their annual compensation.
−Removed: The stock options were issued and are exercisable at $ 42.09 at any time from
−Removed: date of issuance and expire 5 years from the date of issuance.
+Added: On April 19, 2021, the Company issued
+Added: 724 shares of common stock pursuant to a cashless exercise of warrants to purchase 760 shares at an average exercise price of $ 1.88
+Added: On April 30, 2021, the Company issued 13,500
+Added: shares of common stock pursuant a cash exercise of warrants at $ 12.50 per share.
+Added: On April 27, 2021, the Company entered into a Purchase Agreement with NeurMedix, and Acuitas,
+Added: which are related party affiliates, pursuant to which the Company has agreed to acquire certain assets from NeurMedix and assume
+Added: certain liabilities of NeurMedix, in exchange for the consideration described below.
+Added: The acquired assets include, among others,
+Added: those related to certain drug candidates being developed by NeurMedix, including NE3107, a small molecule orally administered inhibitor
+Added: of insulin resistance and the pathological inflammatory cascade, with a novel mechanism of action that has potential applications
+Added: for treatment against Alzheimer’s Disease and Parkinson’s Disease.
+Added: At the closing of the Transaction, BioVie will
+Added: issue to NeurMedix 8,361,308 shares of the Company’s common stock and make a cash payment equal to the aggregate amount of
+Added: NeurMedix’s direct and documented cash expenditures to advance certain clinical programs from March 1, 2021 through the closing,
+Added: which cash payment is estimated to be approximately $3.0 million.
+Added: Subject to the terms and conditions of the Purchase Agreement,
+Added: following the closing, BioVie will also be obligated to deliver contingent consideration to NeurMedix (or its successor) consisting
+Added: of (i) a cash payment of approximately $7.3 million, subject to a pivotal clinical trial for NE3107 meeting its primary endpoint(s)
+Added: and BioVie having successfully raised at least $50 million in new capital, and (ii) shares of BioVie’s common stock having
+Added: an aggregate value of up to $3.0 billion, subject to the achievement of certain clinical, regulatory and commercial milestones
+Added: related to the drug candidates to be acquired by the Company from NeurMedix, as more fully set forth in the Purchase Agreement.
+Added: May 9, 2021, the Company, NeurMedix and Acuitas entered into Amendment No.
+Added: 1 to the APA (the Amendment and the APA as so
+Added: amended, the Purchase Agreement), pursuant to which the parties agreed, among other things, to modify the contingent stock
+Added: consideration that BioVie may be obligated to deliver to NeurMedix (or its successor) pursuant to the Purchase Agreement.
+Added: BioVie was obligated to deliver contingent stock consideration to NeurMedix (or its successor) consisting of shares of BioVies
+Added: common stock having an aggregate value of up to $3.0 billion, subject to the achievement of certain clinical, regulatory and commercial
+Added: milestones related to the drug candidates to be acquired by BioVie from NeurMedix, and subject to a cap limiting each issuance of shares
+Added: if such issuance would result in the beneficial ownership of NeurMedix and its affiliates exceeding 89.9999% of BioVies issued
+Added: and outstanding common stock.
+Added: Pursuant to the Amendment, BioVie will be obligated to deliver contingent stock consideration to NeurMedix
+Added: (or its successor) consisting of up to 18.0 million shares of BioVies common stock, with 4.5 million shares issuable upon the
+Added: achievement of each of the four milestones set forth in the Purchase Agreement, subject to a cap limiting the issuance of shares if such
+Added: issuance would result in the beneficial ownership of NeurMedix and its affiliates exceeding 87.5% of BioVies issued and outstanding
+Added: common stock.
+Added: The Transaction is expected to close twenty
+Added: calendar days after a related definitive information statement on Schedule 14C is mailed to the Company’s stockholders and
+Added: is anticipated to close in the second calendar quarter of 2021.
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.