Item 1. Financial Statements
Item 1. Financial Statements
BioVie Inc.
Condensed Balance Sheets
December 31,
June 30,
2020
2020
ASSETS
(Unaudited)
CURRENT ASSETS:
Cash
$ 11,876,219
$ 37,195
Other assets
27,257
375,785
Total current assets
11,903,476
412,980
OTHER ASSETS:
Intangible assets, net
1,210,538
1,325,226
Goodwill
345,711
345,711
Total other assets
1,556,249
1,670,937
TOTAL ASSETS
$ 13,459,725
$ 2,083,917
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
CURRENT LIABILITIES:
Accounts payable and accrued expenses
$ 322,428
$ 1,259,206
Derivative liability - warrants
—
16,411,504
Derivative liability - conversion option on convertible debenture
—
5,000,800
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
—
848,543
Total current liabilities
322,428
23,520,053
Loan payable
62,500
62,500
TOTAL LIABILITIES
$ 384,928
$ 23,582,553
Commitments and contingencies (Note 8)
STOCKHOLDERS' EQUITY (DEFICIT)
Preferred stock; $ 0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding
—
—
Common stock, $ 0.0001 par value; 800,000,000 shares authorized at December 31, 2020 and June 30, 2020; 13,916,164 and 5,204,392 shares issued and outstanding at December 31, 2020 and June 30, 2020, respectively
1,391
520
Additional paid in capital
103,433,515
19,538,742
Accumulated deficit
( 90,360,109 )
( 41,037,898 )
Total stockholders' equity (deficit)
13,074,797
( 21,498,636 )
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
$ 13,459,725
$ 2,083,917
See accompanying notes to unaudited condensed
financial statements
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BioVie Inc.
Condensed Statements of Operations
(Unaudited)
Three Months Ended
Three Months Ended
Six Months Ended
Six Months Ended
December 31 2020
December 31 2019
December 31 2020
December 31 2019
OPERATING EXPENSES:
Amortization expense
$ 57,344
$ 57,344
$ 114,688
$ 114,689
Research and development expenses
938,101
346,514
1,063,112
688,015
Selling, general and administrative expenses
2,067,920
306,589
2,272,320
613,961
TOTAL OPERATING EXPENSES
3,063,365
710,447
3,450,120
1,416,665
LOSS FROM OPERATIONS
( 3,063,365 )
( 710,447 )
( 3,450,120 )
( 1,416,665 )
OTHER (INCOME) EXPENSE:
Change in fair value of derivative liabilities
—
( 7,396,192 )
( 8,279,919 )
( 7,758,778 )
Interest expense
143
20,920
559,455
3,498,535
Interest income
( 5,701 )
( 213 )
( 5,765 )
( 233 )
TOTAL OTHER (INCOME) EXPENSE, NET
( 5,558 )
( 7,375,485 )
( 7,726,229 )
( 4,260,476 )
NET (LOSS) INCOME
$ ( 3,057,807 )
$ 6,665,038
$ 4,276,109
$ 2,843,811
Deemed dividends - Related Party
—
—
53,598,320
17,099,058
NET (LOSS) INCOME ATTRIBUTABLE TO COMMON STOCKHOLDERS
$ ( 3,057,807 )
$ 6,665,038
$ ( 49,322,211 )
$ ( 14,255,247 )
NET (LOSS) INCOME PER COMMON SHARE
- Basic
$ ( 0.22 )
$ 1.29
$ ( 4.95 )
$ ( 3.06 )
- Diluted
$ ( 0.22 )
$ 1.29
$ ( 4.95 )
$ ( 3.06 )
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
- Basic
13,916,164
5,183,724
9,965,599
4,661,183
- Diluted
13,916,164
5,183,724
9,965,599
4,661,183
See accompanying notes to unaudited condensed
financial statements
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BioVie Inc.
Condensed Statements of Cash Flows
(Unaudited)
Six Months Ended
Six Months Ended
December 31, 2020
December 31, 2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income
$ 4,276,109
$ 2,843,811
Adjustments to reconcile net income to net cash used in operating activities:
Amortization of intangible assets
114,688
114,689
Stock based compensation
1,536,929
11,162
Interest expense from convertible debenture
537,275
3,497,264
Change in fair value of derivative liabilities
( 8,279,919 )
( 7,758,778 )
Changes in operating assets and liabilities
Other assets
348,528
( 216,660 )
Accounts payable and accrued expenses
( 936,778 )
641,697
Net cash used in operating activities
( 2,403,168 )
( 866,815 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from issuance of common stock
15,628,010
—
Payment of convertible debenture - related party
( 1,821,818 )
—
Proceeds from loan payable - related party
—
30,000
Proceeds from convertible debenture - related party
436,000
500,000
Net cash provided by financing activities
14,242,192
530,000
Net increase (decrease) in cash
11,839,024
( 336,815 )
Cash, beginning of period
37,195
339,923
Cash, end of period
$ 11,876,219
$ 3,108
SUPPLEMENTAL CASH FLOW INFORMATION:
Cash paid for interest
$ 22,180
$ 1,272
Cash paid for taxes
$ —
$ —
SCHEDULE OF NON-CASH FINANCING ACTIVITIES:
Deemed dividends - related party
$ 53,598,320
$ 17,099,058
Stock warrants classified as derivative liability
$ —
$ 7,530,308
See accompanying notes to unaudited condensed
financial statements
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BioVie Inc.
Condensed Statements of Changes in Stockholders’
(Deficit) Equity
For the periods July 1, 2019 through December
31, 2019 and July 1, 2020 through December 31, 2020
(Unaudited)
Total
Additional
Stockholders'
Common Stock
Paid in
Accumulated
Equity
Shares
Amount
Capital
Deficit
(Deficit)
Balance, June 30, 2019
4,058,724
$ 406
$ 9,392,573
$ ( 7,262,072 )
$ 2,130,907
Issuance of commitment shares
1,125,000
112
10,068,638
—
10,068,750
Deemed dividend for commitment shares
—
—
—
( 17,099,058 )
( 17,099,058 )
Net loss for the three months ended September 30, 2019
—
—
—
( 3,821,227 )
( 3,821,227 )
Balance, September 30, 2019
5,183,724
518
19,461,211
( 28,182,357 )
( 8,720,628 )
Stock option compensation
—
—
11,162
—
11,162
Net income for the three months ended December 31, 2019
—
—
—
6,665,038
6,665,038
Balance, December 31, 2019
5,183,724
$ 518
$ 19,472,373
$ ( 21,517,319 )
$ ( 2,044,428 )
Balance, June 30, 2020
5,204,392
$ 520
$ 19,538,742
$ ( 41,037,898 )
$ ( 21,498,636 )
Net proceeds from issuance of common stock
1,799,980
180
15,627,830
—
15,628,010
Redemption of warrants - related party
1,549,750
155
13,132,230
—
13,132,385
Deemed dividend for purchase option - related party
5,359,832
536
53,597,784
( 53,598,320 )
—
Cashless exercise of options
2,210
—
—
—
—
Net income for the three months ended September 30, 2020
—
—
—
7,333,916
7,333,916
Balance, September 30, 2020
13,916,164
1,391
101,896,586
( 87,302,302 )
14,595,675
Stock-based compensation
—
—
1,536,929
—
1,536,929
Net loss for the three months ended December 31, 2020
—
—
—
( 3,057,807 )
( 3,057,807 )
Balance, December 31, 2020
13,916,164
$ 1,391
$ 103,433,515
$ ( 90,360,109 )
$ 13,074,797
See accompanying notes to unaudited condensed
financial statements
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BIOVIE INC.
Notes to Condensed Financial Statements
For the Six Months Ended December 31, 2020
and 2019
(unaudited)
1.
Background Information
BioVie Inc. (the “Company”) is
a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. We are currently
focused on developing and commercializing BIV201 (continuous infusion terlipressin), a novel approach to the treatment of ascites
due to chronic liver cirrhosis. Our therapy BIV201 is based on a drug that is approved in about 40 countries to treat related complications
of liver cirrhosis (part of the same disease pathway as ascites), but not yet available in the United States. BIV201’s active
agent is a potent vasoconstrictor and has shown efficacy for reducing portal hypertension in studies around the world. The goal
is for BIV201 to interrupt the ascites 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
in 2019. The Company met with representatives of the FDA in a Type C Guidance Meeting to discuss the study results and plan our
next clinical study. In September 2019, we requested a Type B Meeting and subsequently submitted an extensive pre-meeting information
package. In April 2020, the FDA provided a written response that provided new guidance regarding primary and secondary endpoints,
BIV201 dosing levels, quality of life measures and other key aspects of the clinical trial design. After further communications,
the Company completed the Phase 2 clinical trial design protocol and was cleared to begin the study. BioVie expects to commence
treating refractory ascites patients in the Phase 2 trial in the first calendar quarter of 2021. The Phase 2 study will be used
to guide the design of a pivotal Phase 3 clinical trial. We have developed a patent-pending novel liquid formulation of BIV201
for use in this study that is intended to improve convenience for outpatient administration and avoid potential formulation errors
that may occur when pharmacists reconstitute the powder version.
BIV201 has the potential to improve the health
of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, nonalcoholic steatohepatitis
(NASH), and alcoholism. It has FDA Fast-Track status and Orphan Drug designation for the most common of these complications, ascites,
which represents a significant unmet medical need. An Orphan drug that is first-to-market typically receives 7 years of market
exclusivity in the United States for the designated use(s). The FDA has never approved any drug specifically for treating ascites. In
addition, the Company has a pending patent application directed to proprietary liquid formulations of terlipressin for use in its
planned Phase 2 and Phase 3 clinical trials, subject to FDA clearance, which could eventually provide up to 20 years of patent
coverage in each country in which the Company seeks patent protection according to the patent laws of the issuing country.
The BIV201 development program began at LAT
Pharma LLC. On April 11, 2016, the Company acquired LAT Pharma LLC and the rights to its BIV201 development program. The Company
currently owns all development and marketing rights to its drug candidate. The Company and PharmaIN, Corp. (“PharmaIN”),
LAT Pharma’s former partner focused on the development of new modified drug candidates in the same therapeutic field but
not including BIV201, had agreed to pay royalties equal to less than 1% of future net sales of each company's ascites drug development
programs, or if such program is licensed to a third party, less than 5% of each company's net license revenues. On December 24,
2018, the Company returned its partial ownership rights to the PharmaIN modified terlipressin development program and simultaneously
paid the remaining balance due on a related debt. PharmaIN, Corp.’s rights to our program remain unchanged.
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BIOVIE INC.
Notes to Condensed Financial Statements
For the Six Months Ended December 31, 2020
and 2019
(unaudited)
2.
Liquidity
On September 22, 2020, the Company closed a
registered public offering (the “Offering”) issuing 1,799,980 of its Class A common stock, par value $0.0001 per share
(the “Common Stock”) at $10 per share, resulting in net proceeds to the Company of approximately $15.6 million, net
of issuance costs of approximately $2.4 million; and of which approximately $1.8 million was used to satisfy all amounts owing
in respect of a 10% OID Convertible Delayed Draw Debenture (the “Debenture”) due September 24, 2020 held by the Company’s
controlling stockholder, Acuitas Group Holdings, LLC (“Acuitas”).
On September 17, 2020, the Company’s
common stock was approved for listing on The NASDAQ Capital Market (“Nasdaq”) under the symbol “BIVI” and
began trading on September 18, 2020.
At December 31, 2020, the Company had
working capital of approximately $11.6 million and cash of $11.9 million and, stockholders’ equity was approximately $13.1
million and its accumulated deficit was approximately $90.4 million. As a development stage enterprise, the Company expects substantial
losses in future periods. These unaudited interim condensed financial statements were prepared assuming the Company will continue
as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.
Based on the Company’s plans, management believes it has sufficient funds to fund its operations through our next round of
clinical trials through at least February 2022.
The emergence of widespread health emergencies
or pandemics of the coronavirus ("Covid-19"), may lead to continued regional quarantines, business shutdowns, labor shortages,
disruptions to supply chains, and overall economic instability, including the duration and spread of the outbreak and restrictions
and the impact of Covid-19 on the financial markets and the overall economy, all of which are highly uncertain and cannot be predicted.
If the financial markets and/or the overall economy are impacted for an extended period, the Company’s ability to raise funds
may be materially adversely affected.
3.
Significant Accounting Policies
Basis of Presentation – Interim Financial Information
These unaudited interim condensed financial
statements and related notes have been prepared in accordance with accounting principles generally accepted in the United State
of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of
Regulation S-X of the Securities Exchange Commission for Interim Reporting. Accordingly, they do not include all of the information
and footnotes required by U.S. GAAP for complete financial statements. The unaudited interim financial statements furnished reflect
all adjustments (consisting of normal recurring accruals) that are, in the opinion of management, considered necessary for a fair
presentation of the results for the interim periods presented. Interim results are not necessarily indicative of the results for
the full year. The condensed balance sheet at June 30, 2020 was derived from audited annual financial statements but does not contain
all the footnote disclosures from the annual financial statements. These unaudited interim condensed financial statements and information
included under the heading: “Management’s Discussion and Analysis of Financial Condition and Results of Operations”
should be read in conjunction with the Company’s audited financial statements for the fiscal years ended June 30, 2020 and
2019 in our Annual Report on form 10-K filed with Securities Exchange Commission (“SEC”) on August 6, 2020, and as
amended by Amendment No. 1 on Form 10-K/A and filed with the SEC on August 7, 2020. For a summary of significant accounting policies,
see the Company’s Annual Report on Form 10K for the fiscal year ended June 30, 2020 filed with the SEC on August 6, 2020,
and as amended by Amendment No. 1 on Form 10-K/A and filed with the SEC on August 7, 2020.
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BIOVIE INC.
Notes to Condensed Financial Statements
For the Six Months Ended December 31, 2020
and 2019
(unaudited)
3.
Significant Accounting Policies (continued)
Loan Pursuant to Paycheck Protection Program
The Company received $62,500 in loan proceeds
pursuant to the Paycheck Protection Program (“PPP”), under the Coronavirus Aid Relief and Economic Security (CARES)
Act. The PPP Loan is evidenced by a loan application and payment agreement by and between the Company and Lender. The Company applied
for the loan in May 2020 and received funding for its maximum amount of $62,500 on May 21, 2020. The term of the loan is for 60
months and matures on the fifth year anniversary from the date of funding. It bears interest at an annual rate of 1%. The PPP loan
is subject to 100% forgiveness. Currently, the application process to apply forgiveness occurs 10 months after the funding date.
The Company intends to file the application for forgiveness, accordingly, unless the pending outcome of a new ruling is approved
that forgives all the PPP loans under $150,000. There can be no assurance that such forgiveness will occur. The Company is accounting
for the loan as debt and if forgiveness is granted the Company will recognize a gain on extinguishment.
Net (loss) income per Common Share
Basic net (loss) income per common
share is computed by dividing the net (loss) income attributable to common stockholders by the weighted average number of shares
of common stock outstanding during the period. Diluted net (loss) income per common share is computed by dividing the net (loss)
income attributable to common stockholders by the weighted average number of shares of common stock outstanding and potentially
outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable
through stock options, warrants, and convertible debentures. For the six months ended December 31, 2020 and 2019, all potential
securities were anti-dilutive as a result of the effect of the change in fair value of the derivative liability creating a net
loss available to common shareholders. For the three months ended December 31, 2020, such amounts were excluded from the diluted
loss since their effect was considered anti-dilutive due to net loss for the period. For the three months ended December 31, 2019,
all potential securities were anti-dilutive.
The table below shows the number of
outstanding stock options and warrants as of December 31, 2020 and 2019:
December 31, 2020
December 31, 2019
Number of Shares
Number of Shares
Stock Options
750,400
60,400
Warrants
214,665
1,374,667
Total
965,065
1,435,067
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BIOVIE INC.
Notes to Condensed Financial Statements
For the Six Months Ended December 31, 2020
and 2019
(unaudited)
3.
Significant Accounting Policies (continued)
Recent accounting pronouncements
The Company considers the applicability
and impact of all Accounting Standard Updates (“ASU’s”). ASU’s not discussed below were assessed and determined
to be either not applicable or expected to have minimal impact on our balance sheets or statement of operations.
In August 2018, the FASB issued ASU 2018-13,
“Fair value measurement (Topic 820): Disclosure Framework – Changes to the Disclosure Requirements for Fair Value Measurement”.
The new guidance modifies the disclosure requirements on fair value measurements. ASU 2018-13 is effective for fiscal years beginning
after December 15, 2019. Early adoption is permitted. This ASU was adopted as of July 1, 2020. There has been no impact to its
condensed financial statements and related disclosures.
4.
Intangible Assets
The Company’s
intangible assets consist of intellectual property acquired from LAT Pharma, Inc. and are amortized over their estimated useful
lives. The following is a summary of the intangible assets as of December 31, 2020 and June 30, 2020:
December 31, 2020
June 30, 2020
Intellectual Property
$ 2,293,770
$ 2,293,770
Less Accumulated Amortization
( 1,083,232 )
( 968,544 )
Intellectual Property, Net
$ 1,210,538
$ 1,325,226
Amortization expense
for the three-month period ended December 31, 2020 and 2019 was $57,344 and $57,344 respectively. Amortization expense for the
six-month period ended December 31, 2020 and 2019 was $114,688 and $114,689 respectively.
Estimated future amortization
expense is as follows:
Year ending June 30, 2021 (Remaining six months)
$ 114,689
2022
229,377
2023
229,377
2024
229,377
2025
229,377
2026
178,341
Intellectual Property, Net
$ 1,210,538
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BIOVIE INC.
Notes to Condensed Financial Statements
For the Six Months Ended December 31, 2020
and 2019
(unaudited)
5.
Related Party Transactions
Equity Transactions with Acuitas
On September 22, 2020, concurrent with the
closing of the Company’s Offering, approximately $1.8 million was paid to Acuitas satisfying all amounts owed on the Debenture
due September 24, 2020 held by the Company’s controlling stockholder, Acuitas.
Additionally in connection with the close of the public offering on September 22, 2020, the Company
issued an aggregate of 6,909,582 shares of Common Stock to Acuitas, representing (i) 5.4 million shares issuable pursuant to Acuitas’
rights under the Purchase Agreement dated July 3, 2018, as amended on June 24, 2019 and October 9, 2019; and the various extension
letters as more fully described below; which resulted in a deemed dividend at the close of the public offering at price of $10
per share, consistent with the Company’s accounting policy; and (ii) the automatic exercise of 1.5 million warrants issued
to Acuitas in connection with the Debenture financing at the par value of the Common Stock.
During the three months ended September 30,
2020, the Company received additional draws under the Debenture totaling $436,000. The total draws as of September 22, 2020 were
$1.7 million and the related total number of warrants issuable at $4.00 per share of common stock was 424,750 of which 328,250
warrants had been issued. In accordance with the Debenture agreements, as more fully described below; at September 22, 2020 upon
the Company’s close of its public offering, al1 the warrants issued related to the debenture totaling 1,453,250 were mandatorily
redeemed along with the additional 96,500 shares common stock issued to Acuitas.
The following paragraphs summarize the background of those financings
and arrangements which were settled and redeemed on September 22, 2020.
On July 3, 2018, we entered into a Securities
Purchase Agreement (the “Purchase Agreement”) with Acuitas and certain other purchasers identified in the Purchase
Agreement (together with Acuitas, the “Purchasers”) pursuant to which (i) the Purchasers agreed to purchase an aggregate
of 2,133,332 shares of the our Series A Convertible Preferred Stock (the “Preferred Stock”) at a price per share of
$1.50 per share of Preferred Stock (the “Initial Sale”) and (ii) we agreed to issue warrants (the “Warrants”)
to purchase 1,706,666 shares of common stock, each subject to the terms and conditions set forth in the Purchase Agreement, for
an aggregate consideration of $3.2 million. We received $160,000 of the $3.2 million in April and May 2018 as prepaid equity. Acuitas
also received an additional 6,667 Warrants in connection with the payoff of a note issued by us in favor of Acuitas. The Initial
Sale and issuance of the Warrants occurred on July 3, 2018. In addition, Acuitas had the option to purchase up to an additional
1,600,000 shares of common stock at a price per share of $1.88, and warrants on the same terms as the Warrants, within two weeks
following the one year anniversary of the closing of the Initial Sale (the “Subsequent Sale”) in the event that we
did not obtain $3,000,000 of funding through various non-dilutive grants prior to the one year anniversary of the closing of the
Initial Sale, less any federal or FDA grant funding received by the Company. Acuitas is controlled by our Chairman and Chief Executive
Officer, Terren Peizer and the Purchasers included Jonathan Adams, James Lang, Cuong Do and Michael Sherman, who are members of
our Board.
The Purchase Agreement contained customary
representations and warranties. In connection with the disclosure schedule associated with the representations and warranties,
we also disclosed customary information, including the following: (i) the existence of the Mallinckrodt petition before the U.S.
Patent Trial and Appeal Board, (ii) our capitalization, (iii) our obligation to pay a low single digit royalty on the net sales
of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma LLC members, PharmaIN Corporation and The Barrett Edge,
Inc. pursuant to the Agreement and Plan of Merger, dated April 11, 2016, by and between LAT Pharma LLC and us, (iv) our obligation
to pay a low single digit royalty on net sales of all terlipressin products covered by specified patents up to a maximum of $200,000
per year pursuant to the Technology Transfer Agreement, dated July 25, 2016, by and between us and the University of Padova (Italy),
and (v) certain recent issuances of common stock by us.
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Table of Contents
BIOVIE INC.
Notes to Condensed Financial Statements
For the Six Months Ended December 31, 2020
and 2019
(unaudited)
5.
Related Party Transactions (continued)
Each share of Preferred Stock automatically
converted into 1 share of common stock upon the filing with the Secretary of State of the State of Nevada of a Certificate of Amendment
to our Articles of Incorporation (the “Amendment”) on August 13, 2018 that increased the number of authorized shares
of common stock to 800,000,000. The Amendment was approved by the written consent of the holders of more than a majority of our
issued and outstanding common stock on July 3, 2018 and was filed with the Secretary of State of the State of Nevada 20 calendar
days following the distribution of our Definitive Information Statement on Schedule 14 that was filed with the SEC on July 13,
2018.
Pursuant to a letter agreement dated June 24,
2019, Acuitas agreed to modify its existing rights under the Purchase Agreement so that:
-
Acuitas agreed to immediately exchange its
existing 1,606,667 Warrants for common stock such that it will have effectively exercised its Warrants in full pursuant to a cashless
exercise thereof at an assumed current market price of $45.00 per share and, as a result received an aggregate of 95% of the shares
covered thereby, or 1,526,094 shares of common stock;
-
Acuitas agreed to (i) waive its rights to a
50% adjustment of the purchase price of the Preferred Stock in the Initial Sale, the exercise price of the Warrants and the price
per share in the Subsequent Sale in the event of certain reductions in the useful life of our current intellectual property rights,
and (ii) effectively exercise its rights to purchase securities in a Subsequent Sale pursuant to a “cashless purchase”
at an assumed current market price of approximately $11.25 per share, conditioned in each case on the listing of our common stock
on Nasdaq or the raising of $2.0 million in additional funds in the form of another securities offering, in either case not later
than November 30, 2019, which will result Acuitas having irrevocably waived its rights to an adjustment in the purchase price of
the Preferred Stock in the Initial Sale and the exercise price of the Warrants and the purchase price of per share in the Subsequent
Sale upon the issuance by us of an aggregate of 1,339,958 shares of common stock (the “Subsequent Sale Shares”) to
Acuitas, which is expected to occur concurrently with the closing of our potential public offering and listing on Nasdaq;
-
Acuitas shall in exchange for the foregoing agreements and waivers have the option to purchase additional shares of common stock and warrants to purchase one share of common stock for each share of common stock purchased during the period from September 1, 2019 to November 30, 2019 at the then-effective purchase price of the Preferred Stock in the Initial Sale (the “Funding Option”), provided that any shares issued pursuant to any exercise of the Funding Option will reduce share-for-share the amount of shares issued pursuant to the deemed exercise of its rights to purchase securities in a Subsequent Sale mentioned above.
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Table of Contents
BIOVIE INC.
Notes to Condensed Financial Statements
For the Six Months Ended December 31, 2020
and 2019
(unaudited)
5.
Related Party Transactions (continued)
Convertible Debenture Transaction with Acuitas
On September 24, 2019, the Company entered
into a Securities Purchase Agreement (the “2019 Purchase Agreement”) with Acuitas pursuant to which (i) Acuitas agreed
to purchase a 10% OID Convertible Delayed Draw Debenture due September 24, 2020 for an aggregate commitment amount of up to $2.0
million, and (ii) the Company issued 1,125,000 shares (the “Commitment Shares”) of the Company’s common stock
and warrants (the “Commitment Warrants”) to purchase an equal number of shares, each subject to the terms and conditions
set forth in the 2019 Purchase Agreement. The Debenture accrues additional principal at the rate of 6% per annum and interest at
the rate of 10% per annum, is convertible into shares of common stock at $4.00 per share prior to the completion of the company’s
planned public offering of units (the “Public Offering”) or, subsequent to the closing of the Public Offering, the
lower of $4.00 or 80% of the offering price per unit to the public in the Public Offering and are mandatorily redeemable upon such
closing at 100% of the accrued principal amount and unpaid interest to the date of redemption. The Commitment Warrants are five-year
warrants, exercisable upon the earlier of the effectiveness of the Company’s current reverse stock split or December 1, 2019,
at an amount equal to the lower of $4.00 or 80% of the offering price per unit to the public in the Public Offering. Upon entering
into the 2019 Purchase Agreement, the Company drew an initial $500,000 under the Debenture and in accordance with the 2019 Purchase
Agreement, Acuitas received an additional 125,000 warrants (the “Bridge Warrants”) having the same terms as the Commitment
Warrants.
Any future draws under the Debenture, which
may be made from and after October 15, 2019, November 15, 2019 and December 15, 2019 in equal tranches of $500,000 each, will entitle
Acuitas to receive additional Bridge Warrants in equal amount upon such funding. In addition, the 2019 Purchase Agreement provides
that, should the underwriters in the Public 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 shall 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%.
The issuance of 1,125,000 shares of the Company’s commons stock and warrants to purchase an equal
amount number of shares, to its controlling stockholder for the Bridge Financing was accounted for as a deemed dividend due to
its related party nature and $17.1 million representing the excess of the fair value of the consideration given for the financing,
net of debt discount; was recorded in accumulated deficit for the year ended June 30, 2020, accordingly. A debt discount of $500,000
against the debenture was recorded which will be amortized over the term of the debenture using the effective interest method.
The Company recognized amortization of the unearned discount for the three month period ended December 31, 2020 and 2019 of $0
and $20,061, respectively, and for the six months period ended December 31, 2020 and 2019 of $21,336 and $21,595, respectively.
The Company received draws under
the Debenture that totaled approximately $1.3 million during the year ended June 30, 2020. The total interest expense related
to the draws under the Debenture was approximately $99,000 for the year ended June 30, 2020. On April 1, 2020, the Company
entered an amendment to modify the payment of accrued interest amounts under the original terms of the Debenture to
capitalize all such amounts as would otherwise accrue on the Debenture. On January 4, 2020, payment of $13,487 accrued
interest due was paid through the issuance of 4,422 shares of the Company’s common stock. Acuitas and the Company
continue to discuss the need and timing for some or all the remaining draws under the Debenture Agreement.
Subsequent to the initial $500,000 draw on September 24, 2019, the Company received draws that totaled $813,000 as July 13,
2020, and accordingly; the Company issued additional Bridge Warrants to purchase 203,250 shares of common stock to its
controlling stockholder under the terms of the Bridge Financing. Accordingly, on April 16, 2020, the Company recorded the
warrants to purchase 125,000 common stock related to the second $500,000 draw under the debenture as a derivative warrant
liability as of June 30, 2020. The Company recorded the warrants related to the draws totaling $313,000 to purchase 78,250
common shares as derivative liabilities.
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Table of Contents
BIOVIE
INC.
Notes to Condensed Financial Statements
For the Six Months Ended December 31, 2020
and 2019
(unaudited)
5.
Related Party Transactions (Continued)
Pursuant to the 2019 Purchase Agreement, Acuitas
agreed to further modify its existing rights under the Purchase Agreement dated July 3, 2018 with the Company so that Acuitas’
previous agreement in June 2019 to waive its rights to a 50% adjustment of the purchase price of the Preferred Stock in the July
2018 transaction, the exercise price of the warrants in such transaction and the price per share in a Subsequent Sale in the event
of certain reductions in the useful life of our current intellectual property rights, and effectively exercise its rights to purchase
securities in a Subsequent Sale pursuant to a “cashless purchase” at an assumed current market price of approximately
$11.25 per share, conditioned in each case on the listing of the Company’s common stock on Nasdaq or the raising of $2.0
million in additional funds in the form of another securities offering, in either case not later than November 30, 2019, such that
Acuitas will have irrevocably waived its rights to an adjustment in the purchase price of the Preferred Stock in the Initial Sale
and the exercise price of the Warrants and the purchase price of per share in the Subsequent Sale upon the issuance by us of an
aggregate of 2,679,916 shares of common stock and 2,679,916 warrants having the same terms as the Commitment Warrants to Acuitas,
upon the closing of the Public Offering.
Pursuant to an amendment to the 2019 Purchase
Agreement dated October 9, 2019, Acuitas agreed to modify its existing rights under the 2019 Purchase Agreement so that:
-
The Commitment Warrants (and related warrants issued upon the first draw under the Debenture) were replaced with warrants having similar terms, but which are automatically exercised upon the closing of the offering at an exercise price equal to the par value of the common stock;
-
Acuitas' existing rights under the Purchase Agreement dated July 3, 2018 with the Company were further amended so that the number of Subsequent Sale Shares would be multiplied by four (in lieu of the changes to the Purchase Agreement originally provided for in the 2019 Purchase Agreement); and
-
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.
On July 14, 2020, the Company, entered
into a further extension of its letter agreements dated April 8, 2020, that furthered extended its letter agreement dated
February 10, 2020 with Acuitas regarding Acuitas’ previous agreement to modify its existing rights under the Purchase
Agreement dated 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 its initial investment in the Company and the exercise price of the warrants received in such transaction
and the price per share should it exercise certain rights to purchase additional securities in the event of certain
reductions in the useful life of the Company’s intellectual property rights and commitment to purchase such securities
upon the closing of the Offering and commitment to purchase such additional securities would remain effective until October
31, 2020, and accordingly Acuitas was entitled to receive an aggregate of 5,359,832 shares of Common Stock at such closing.
In addition, the parties agreed that certain draws under the Company’s current bridge financing with Acuitas were to be
made based with respect to the Company’s ongoing capital requirements and current market conditions, notwithstanding
certain scheduled availability dates set forth in the 10% OID Convertible Delayed Draw Debenture issued in connection
therewith. The letter agreement of July 14, 2020 also confirmed the understanding between the Company and Acuitas regarding
certain amounts funded to BioVie that were intended as “partial draws” of credit available under the Debenture
which, as of July 14, 2020 hereof aggregated $813,000 in aggregate principal amount in additional to amounts initial funded
under the Debenture. Accordingly, such “partial draws” accrued additional principal as amounts otherwise funded
pursuant to the original schedule of draws included in the Debenture (as modified by the letter agreement between BioVie and
Acuitas dated April 1, 2020 regarding the capitalization of interest otherwise payable) and shall entitle Acuitas to receive
a pro rata amount of Bridge Warrants.
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Table of Contents
BIOVIE
INC.
Notes to Condensed Financial Statements
For the Six Months Ended December 31, 2020
and 2019
(unaudited)
6.
Fair Value Measurements
On September 22, 2020, concurrent with the
closing of the Offering; the warrants related to derivative liabilities were automatically exercised in full and the convertible
Debenture was paid off in cash expiring the conversion option. The fair value of the derivative liabilities - warrants and derivative
liability - conversion option on convertible Debenture prior to redemption at September 22, 2020 was $13.1 million, and the change
in the fair value of $8.3 million from June 30, 2020 was recorded in the accompanying condensed Statements of Operations. At September
22, 2020, the derivative liabilities, both the warrants and expired conversion option totaling $ 13.1 million were then recorded
as additional paid in capital upon automatic exercise of the warrants and payoff of the Debenture.
At December 31, 2020 and June 30, 2020, the estimated fair value
of derivative liabilities measured on a recurring basis are as follows:
Fair Value Measurements at
December 31, 2020
Level 1
Level 2
Level 3
Total
Derivative liability - Warrants
$ —
$ —
$ —
$ —
Derivative liability -Conversion option on convertible debenture
—
—
—
—
Total derivatives
$ —
$ —
$ —
$ —
Fair Value Measurements at
June 30, 2020
Level 1
Level 2
Level 3
Total
Derivative liability - Warrants
$ —
$ —
$ 16,411,504
$ 16,411,504
Derivative liability -Conversion option on convertible debenture
—
—
5,000,800
5,000,800
Total derivatives
$ —
$ —
$ 21,412,304
$ 21,412,304
The following table presents the activity for liabilities measured
at fair value using unobservable inputs for the six months ended December 31, 2020:
Derivative liabilities - Warrants
Derivative liability - Conversion Option on Convertible Debenture
Beginning balance at July 1, 2020
$ 16,411,504
$ 5,000,800
Additions to level 3 liabilities
—
—
Change in in fair value of level 3 liability
( 6,054,121 )
( 2,225,798 )
Transfer in and/or out of Level 3
( 10,357,383 )
( 2,775,002 )
Balance at December 31, 2020
$ —
$ —
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Table of Contents
BIOVIE
INC.
Notes to Condensed Financial Statements
For the Six Months Ended December 31, 2020
and 2019
(unaudited)
6.
Fair Value Measurements (Continued)
Derivative liability – Warrants
The Company accounts for stock purchase warrants
as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreements. Under applicable
accounting guidance, stock warrants that are precluded from being indexed to the Company’s own stock because of full-rachet
anti-dilution provisions or the adjustments to the strike price due to an occurrence of a future event; are accounted for as derivative
financial instruments. The stock warrants issued September 24, 2019 were not considered indexed to the Company’s own stock because
of the adjustment to strike price, an occurrence of a future event such as the Company’s pending capital raise.
The warrants associated with the level 3 liability
were issued on September 24, 2019 and were valued using the Black-Scholes-Merton model. The valuation at June 30, 2020 used the
following assumptions: stock price of $ 14 , exercise price of $ 4.00 , term of 5 year expiring April 2025, volatility of 76.61 % , dividend
yield of 0 % , and risk-free interest rate of 0.29 % .
The valuation at September 22, 2020 of the
warrants associated with equity financing prior to their automatic exercise in full used were the following assumptions: stock
price of $ 9.55 , exercise price of $ 4.00 , term of 4 year expiring September 2024, volatility of 79.69 % , dividend yield of 0 % , and
risk-free interest rate of 0.21 % . (See note 5 “Related Party Transactions”)
Derivative liability – Conversion
option in convertible debenture
The Company recognized a derivative liability
for the conversion option of the $2 million 10% OID Convertible Delayed Draw Debenture; which may be convertible into shares of
common stock at $4.00 per share prior to the completion of an offering or, subsequent to the closing of the offering, the lower
of $4.00 or 80% of the offering price per unit to the public in such offering and are mandatorily redeemable upon such closing
at 100% of the accrued principal amount and unpaid interest to the date of redemption. The valuation at June 30, 2020 used the
following assumptions: stock price of $ 14 , conversion price of $ 4.00 , term of 0.25 year expiring September 2020, volatility of
62.47 % , dividend yield of 0 % , and risk-free interest rate of 0.16 % .
The valuation at September 22, 2020 used the
following assumptions: stock price of $ 9.55 , conversion price of $ 4.00 , term of 0.008 year expiring September 2020, volatility
of 45.49 % , dividend yield of 0 % , and risk-free interest rate of 0.01 % .
The related Debenture was paid off in cash
on September 22, 2020, expiring the conversion option. (See note 5 “Related Party Transactions ” )
7.
Equity Transactions
Stock Options
The following table summarizes the activity
relating to the Company’s stock options for the six months ended December 31, 2020:
Options
Weighted-Average Exercise Price
Weighted Remaining Average Contractual Term
Aggregate Intrinsic Value
Outstanding at June 30, 2020
60,400
$ 11.06
4.2
$ 352,600
Granted
693,200
13.87
5.0
585,671
Options Exercised or Forfeited
( 3,200 )
4.76
—
—
Outstanding at December 31, 2020
750,400
$ 13.25
4.6
$ 704,927
Exercisable at December 31, 2020
230,100
$ 13.25
4.6
$ 704,927
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Table of Contents
BIOVIE INC.
Notes to Condensed Financial Statements
For the Six Months Ended December 31, 2020
and 2019
(unaudited)
7.
Equity Transactions (Continued)
The fair value of each option grant
on the date of grant is estimated using the Black-Scholes option. The pricing model reflected the following weighted-average assumptions
for the six months ended December 31, 2020:
December 31, 2020
December 31, 2019
Expected life of options (In years)
5
5
Expected volatility
77.29 %
71.55 %
Risk free interest rate
0.4 %
1.61 %
Dividend Yield
0 %
0 %
Expected volatility is based on the
historical volatilities of three comparable companies of the daily closing price of their respective common stock and the expected
life of options is based on historical data with respect to employee exercise periods. The Company accounts for forfeitures as
they are incurred.
The Company recorded stock-based compensation
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
for the three- and six- month periods ended December 31, 2019, respectively.
As of December 31, 2020, there was approximately
$ 4,400,886 of unrecognized compensation cost related to non-vested options granted to Directors, which is expected to be recognized
over a weighted-average period of approximately 3 years .
The following is a summary of stock
options outstanding and exercisable by exercise price as of December 31, 2020:
Exercise Price
Outstanding
Weighted Average Contract Life
Exercisable
$ 2.80
7,200
4.1
7,200
$ 3.75
4,800
3.1
4,800
$ 6.25
1,600
2.8
1,600
$ 7.50
25,600
5.1
25,600
$ 8.75
1,600
3.3
1,600
$ 9.54
800
4.8
800
$ 9.90
800
4.8
800
$ 12.50
4,000
2.1
4,000
$ 13.91
691,600
5.0
172,900
$ 25.00
1,600
1.8
1,600
$ 26.25
4,400
1.3
4,400
$ 27.50
800
1.2
800
$ 28.75
1,600
1.6
1,600
$ 31.25
4,000
0.9
4,000
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Table of Contents
BIOVIE INC.
Notes to Condensed Financial Statements
For the Six Months Ended December 31, 2020
and 2019
(unaudited)
7.
Equity Transactions (Continued)
Stock Warrants
The following table summarizes the warrants
activity during the six months ended December 31, 2020:
Number of Shares
Weighted Average Exercise Price
Weighted Average Remaining Life (Years)
Aggregate Intrinsic Value
Outstanding and exercisable at June 30, 2020
1,374,667
$ 7.72
4.2
$ 13,799,331
Granted
293,248
6.61
5.0
—
Expired
—
—
—
—
Exercised - Acuitas
( 1,453,250 )
$ 4.00
—
$ —
Outstanding and exercisable at December 31, 2020
214,665
$ 10.87
3.9
$ 2,099,854
Of the above warrants, 9,391 expire in fiscal
year ending June 30, 2022, 4,815 expire in fiscal year ending June 30, 2023, 110,460 expire in fiscal year ending June 30, 2025
and 89,999 expire in fiscal year ending June 30, 2026.
Issuance of common stock through
exercise of Stock Options
On July 28, 2020, the Company issued 2,210
shares of common stock pursuant to a cashless exercise of stock options to purchase 3,200 shares at an average exercise price of
$ 4.76 per share.
Issuance of warrants
On July 13, 2020, the Company issued
Warrants to purchase 203,250 shares of common stock to its controlling stockholder under the terms of the Bridge Financing. The
warrants were exercisable at an exercise price of $ 4 at any time from the date of issuance until 5 years from the date of issuance.
(See Note 5 Related Party Transactions.)
On September 22, 2020, the Company issued
warrants to purchase 89,998 shares of common stock to the underwriters of the Offering in connection with the close of the Offering
of registered Common Stock The warrants are exercisable at an exercise price of $ 12.50 at any time from date of issuance until
5 years from the date of issuance.
Issuance of stock options
On October 1, 2020, the Company issued stock
options to purchase 800 shares of common stock to the Chief Financial Officer as part of her compensation. The stock options were
issued and are exercisable at an exercise price of $ 9.54 at any time from date of issuance and expire 5 years from the date of
issuance.
On October 13, 2020, the Company issued stock
options to purchase 800 shares of common stock as part of the annual board of director compensation. The stock options were issued
and are exercisable at $ 9.90 at any time from date of issuance and expire 5 years from the date of issuance.
On December 18, 2020, the Company issued stock
options to purchase 691,600 shares of common stock as part of the annual board of director compensation. The stock options have
a vesting period, where 25% of the stock options vest on the grant date, and the remaining 75% vest over a 3 year period, on the
first, second, and third anniversary of the grant date. The stock options were issued and are exercisable at $ 13.91 at any time
from date of issuance and expire 5 years from the date of issuance.
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Table of Contents
BIOVIE INC.
Notes to Condensed Financial Statements
For the Six Months Ended December 31, 2020
and 2019
(unaudited)
8.
Commitments and Contingencies
Office Lease
On July 1, 2019, the Company’s
office moved with Acuitas’ new offices to 2120 Colorado Avenue Ste 230, Santa Monica, CA 90404. There is no lease agreement
for the new premises and the Company continues to accrue monthly lease payments of $ 1,000 for the new office under the terms of
the previous month-to-month lease for the previous premises which may be cancelled upon 30 days’ written notice.
Challenge to US Patent
On April 30, 2018, we received notice that
Mallinckrodt had petitioned the U.S. Patent and Trademark Office (“USPTO”) to institute an Inter Partes Review of our
U.S. Patent No. 9,655,945 titled “Treatment of Ascites” (the “’945 patent”). Inter Partes Review
is a trial proceeding conducted with the USPTO Patent Trial and Appeal Board (PTAB) to review the patentability of one or more
claims of a patent. Such review is limited to grounds of novelty and obviousness on the basis of prior art consisting of patents
and printed publications.
On November 13, 2019, the Patent Trial and
Appeal Board of the United States Patent and Trademark Office (the “Board”) issued a written decision in the inter
partes review (“IPR”) action that was brought by Mallinckrodt Pharmaceuticals Ireland Limited (“Mallinckrodt”)
against BioVie Inc. (“BioVie” or “Company”). In that action, Mallinckrodt sought to invalidate BioVie’s
patent (U.S. Pat. No. 9,655,945, “Treatment of Ascites”) (the “’945 Patent”). In its decision, the
Board determined that all claims of the ‘945 Patent were not patentable because they were either anticipated or obvious in
light of prior art. The Board also denied BioVie’s Motion to Amend the claims on similar grounds. The result of the Board’s
decision is that the ‘945 patent is no longer valid or enforceable. Acuitas Group Holdings, LLC was aware of this patent
challenge when it purchased a majority ownership interest in the company in July 2018.
This ruling is unrelated to the Company’s
Orphan drug designations for ascites and hepatorenal syndrome (“HRS”), which remain unchanged. An Orphan drug that
is first-to-market typically receives 7 years of market exclusivity in the United States for the designated use(s). In addition,
the ruling does not affect the Company’s rights in its pending patent application directed to proprietary liquid formulations
of terlipressin for use in its planned Phase 2 and Phase 3 trials, subject to FDA clearance, which could eventually provide up
to 20 years of patent coverage in each country in which the Company seeks patent protection, such as the United States, if a patent
issues from a patent application according to the patent laws of each issuing country.
Royalty Agreements
Pursuant to the Agreement and Plan of Merger
entered into on April 11, 2016 between our predecessor entities, LAT Pharma LLC and NanoAntibiotics, Inc., BioVie is obligated
to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared among LAT Pharma Members,
PharmaIn Corporation, and The Barrett Edge, Inc.
- 17 -
Table of Contents
BIOVIE INC.
Notes to Condensed Financial Statements
For the Six Months Ended December 31, 2020
and 2019
(unaudited)
8.
Commitments and Contingencies (continued)
The Company and PharmaIN Corporation, LAT
Pharma’s former partner focused on the development of new modified drug candidates in the same therapeutic field but
not including BIV201, had agreed to pay royalties equal to less than 1% of future net sales of each company's ascites drug
development programs, or if such program is licensed to a third party, less than 5% of each company's net license revenues.
On December 24, 2018, the Company returned its partial ownership rights to the PharmaIN modified terlipressin development
program and simultaneously paid the remaining balance due on a related debt. PharmaIN, Corp. rights to our program remain
unchanged. Additionally the Company obligation to pay a low single digit royalty on the net sales of BIV201 (continuous
infusion terlipressin) to be shared among LAT Pharma LLC members, and The Barrett Edge, Inc. pursuant to the Agreement and
Plan of Merger, dated April 11, 2016, by and between LAT Pharma LLC. The Company has an obligation to pay a low single digit
royalty on net sales of all terlipressin products covered by specified patents up to a maximum of $200,000 per year pursuant
to the Technology Transfer Agreement, dated July 25, 2016, by and between us and the University of Padova (Italy).
Pursuant to the Technology Transfer Agreement entered into on July
25, 2016 between BioVie and the University of Padova (Italy), BioVie is obligated to pay a low single digit royalty on net sales
of all terlipressin products covered by US patent no. 9,655,645 and any future foreign issuances capped at a maximum of $200,000
per year.
9.
Subsequent Events
On January 19, 2021, the Company issued stock option grants to purchase a total of 4,800
shares of common stock, granting 800 shares each to the Chief Operations Officer, the Chief Scientific Officer and to four of its
key consultants as part of their annual compensation. The stock options were issued and are exercisable at $ 42.09 at any time from
date of issuance and expire 5 years from the date of issuance.
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Table of Contents
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.