UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

 

Form 10-Q

 

(Mark One)

 

xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended: March 31,September 30, 2022

 

oTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from ____________to _____________

 

Commission File Number: 001-39015

 

BIOVIE INC.

(Exact name of registrant as specified in its charter)

 

Nevada 46-2510769
(State or other jurisdiction of 
incorporation or organization)
 (I.R.S. Empl. Ident. No.)

 

680 W Nye Lane Suite 201204
Carson City, NV 89703
(Address of principal executive offices, Zip Code)
 
((775)775) 888-3162
(Registrant’s telephone number, including area code)

 

Title of each classTrading Symbol(s)Name of each exchange on which registered
Class A Common Stock, par value $0.0001 per shareBIVIThe Nasdaq Stock Market, LLC

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

 

Yes x                                          No o

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

 

Yes x                                          No o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company or emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer oAccelerated filer o
Non-accelerated filer xSmaller reporting companyx
  Emerging growth companyo

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act o

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

 

Yes o                                          No x

 

There were 24,984,08330,532,830 shares of the Registrant’s $0.0001 par value Class A common stock outstanding as of May 11,November 3, 2022.

 

 

 

 

TABLE OF CONTENTS

PART I – FINANCIAL INFORMATION
Item 1.Financial Statements1
 Condensed Balance Sheets at March 31,September 30, 2022 (unaudited) and June 30, 202120221
 Condensed Statements of Operations (unaudited) - for the three months and nine months ended March 31,September 30, 2022 and 20212
 Condensed Statements of Cash Flows (unaudited) - for the ninethree months ended March 31,September 30, 2022 and 20213
 Condensed Statements of Changes in Stockholders’ Equity (Deficit) (unaudited) - for the periods from July 1, 2020 through March 31,three months ended September 30, 2022 and September 30, 2021 and July 1, 2021 through March 31, 20224
 Notes to Unaudited Condensed Financial Statements5
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations17
Item 3.Quantitative and Qualitative Disclosures About Market Risk2120
Item 4.Controls and Procedures2120
PART II – OTHER INFORMATION
Item 1.Legal Proceedings2221
Item 1A.Risk Factors2221
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds2225
Item 3.Defaults Upon Senior Securities2225
Item 4.Mine Safety Disclosures2225
Item 5.Other Information2225
Item 6.Exhibits2326
   
SIGNATURES2427

 

FORWARD-LOOKING STATEMENTS

 

This report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, and Section 27A of the Securities Act of 1933. Any statements contained in this report that are not statements of historical fact may be forward-looking statements. When we use the words “intends,” “estimates,” “predicts,” “potential,” “continues,” “anticipates,” “plans,” “expects,” “believes,” “should,” “could,” “may,” “will” or the negative of these terms or other comparable terminology, we are identifying forward-looking statements. Forward-looking statements involve risks and uncertainties, which may cause our actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. These factors include, among others; our research and development activities and, distributor channel; compliance with regulatory impositions requirements; and our capital needs. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

 

Except as may be required by applicable law, we do not undertake or intend to update or revise our forward-looking statements, and we assume no obligation to update any forward-looking statements contained in this report as a result of new information or future events or developments. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. You should carefully review and consider the various disclosures we make in this report and our other reports filed with the Securities and Exchange Commission that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business.

 

When used in this report, the terms “BioVie”, “Company”, “we”, “our”, and “us” refer to BioVie Inc.

 

Table of Contents

PART I – FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

BioVie Inc.

Condensed Balance Sheets

 

  March 31  June 30, 
  2022  2021 
ASSETS (Unaudited)    
CURRENT ASSETS:        
Cash $24,506,813  $4,511,642 
Other assets  284,967   93,487 
Total current assets  24,791,780   4,605,129 
         
OTHER  ASSETS:        
Operating lease right-of-use assets  127,105    
Intangible assets, net  923,817   1,095,849 
Goodwill  345,711   345,711 
Total other assets  1,396,633   1,441,560 
         
TOTAL ASSETS $26,188,413  $6,046,689 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
         
CURRENT LIABILITIES:        
Accounts payable and accrued expenses $1,206,323  $996,374 
Current portion of other liabilities  580,625    
Current portion of operating lease liabilities  29,250    
Warrant liabilities  1,023,294    
Embedded derivative liability  1,477,880    
Total current liabilities  4,317,372   996,374 
         
Other liabilities, net of current portion  193,542    
Operating lease liabilities, net of current portion  97,779    
Note payable net of financing costs and unearned premium and discount ($3,375,064)  11,624,935    
         
TOTAL LIABILITIES  16,233,628   996,374 
         
Commitments and contingencies (Note 11)        
         
STOCKHOLDERS’ EQUITY :        
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 March 31, 2022 and June 30, 2021, respectively; 24,984,083 and 22,333,324 shares issued and outstanding at March 31, 2022 and June 30, 2021, respectively  2,496   2,232 
         
Additional paid in capital  252,833,422   229,933,505 
Accumulated deficit  (242,881,133)  (224,885,422)
Total stockholders’ equity  9,954,785   5,050,315 
         
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $26,188,413  $6,046,689 

See accompanying notes to unaudited condensed financial statements

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Table of Contents

BioVie Inc.

Condensed Statements of Operations

(Unaudited)

  Three Months Ended  Three Months Ended  Nine Months Ended  Nine Months Ended 
  March 31 2022  March 31 2021  March 31 2022  March 31 2021 
             
OPERATING EXPENSES:                
Amortization $57,344  $57,344  $172,032  $172,032 
Research and development expenses  3,577,142   789,577   11,385,586   2,019,557 
Selling, general and administrative expenses  2,114,348   2,154,590   6,403,508   4,260,042 
TOTAL OPERATING EXPENSES  5,748,834   3,001,511   17,961,126   6,451,631 
                 
LOSS FROM OPERATIONS  (5,748,834)  (3,001,511)  (17,961,126)  (6,451,631)
                 
OTHER (INCOME) EXPENSE:                
Change in fair value of derivative liabilities  386,450      (1,168,804)  (8,279,919)
Interest expense  918,633      1,236,010   559,455 
Interest income  (13,273)  (8,643)  (32,621)  (14,408)
TOTAL OTHER EXPENSE (INCOME), NET  1,291,810   (8,643)  34,585   (7,734,872)
                 
NET (LOSS)/INCOME $(7,040,644) $(2,992,868) $(17,995,711) $1,283,241 
                 
Deemed dividends - related party           53,598,320 
                 
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $(7,040,644) $(2,992,868) $(17,995,711) $(52,315,079)
                 
NET LOSS PER COMMON SHARE                
- Basic $(0.28) $(0.22) $(0.73) $(4.64)
- Diluted $(0.28) $(0.22) $(0.73) $(4.64)
                 
WEIGHTED AVERAGE NUMBER OF COMMON  SHARES OUTSTANDING                
- Basic  24,984,083   13,919,933   24,555,382   11,269,212 
- Diluted  24,984,083   13,919,933   24,555,382   11,269,212 
         
  September 30  June 30, 
  2022  2022 
  (Unaudited)    
ASSETS        
         
CURRENT ASSETS:        
Cash $21,230,918  $18,641,716 
Prepaids and other assets 359,123   137,879 
Total current assets 21,590,041   18,779,595 
         
OTHER ASSETS:        
Operating lease right-of-use assets  109,271   118,254 
Intangible assets, net 809,128   866,472 
Goodwill 345,711   345,711 
Other assets, non-current 4,562   4,562 
Total other assets 1,268,672   1,334,999 
         
TOTAL ASSETS $22,858,713  $20,114,594 
         
LIABILITIES AND STOCKHOLDERS’ EQUITY        
         
CURRENT LIABILITIES:        
Accounts payable and accrued expenses $2,622,334  $2,442,804 
Current portion of other liabilities 483,854   1,304,925 
Current portion of operating lease liabilities 40,317   38,884 
Warrant liabilities 442,592   194,531 
Embedded derivative liability 506,511   188,030 
Total current liabilities 4,095,608   4,169,174 
         
Other liabilities, net of current portion -   48,385 
Operating lease liabilities, net of current portion 76,768   87,414 
Note payable net of financing costs and unearned premium and discount ($2,274,586 and $2,861,314 as of September 30, 2022 and June 30, 2022, respectively) 12,725,414   12,138,686 
         
TOTAL LIABILITIES $16,897,790   16,443,659 
         
Commitments and contingencies (Note 11)        
         
STOCKHOLDERS’ EQUITY:        
         
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 September 30, 2022 and June 30, 2022, respectively; 30,165,319 and 24,984,083 shares issued and outstanding at September 30, 2022 and June 30, 2022, respectively 3,015  2,496 
Additional paid in capital 267,343,509   254,638,329 
Accumulated deficit (261,385,601)  (250,969,890)
Total stockholders’ equity 5,960,923   3,670,935 
         
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $22,858,713  $20,114,594 

 

See accompanying notes to unaudited condensed financial statements

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Table of Contents

BioVie Inc.

Condensed Statements of Cash Flows

(Unaudited) 

  Nine Months Ended  Nine Months Ended 
  March 31, 2022  March 31, 2021 
       
CASH FLOWS FROM OPERATING ACTIVITIES:        
Net (loss) income $(17,995,711) $1,283,241 
Adjustments to reconcile net (loss) income to net cash used in operating activities:        
Amortization of intangible assets  172,032   172,032 
Stock based compensation - restricted stock  384,454    
Stock based compensation expense - stock options  4,004,718   2,340,533 
Amortization of financing costs  56,740    
Accretion of unearned loan discount  533,815   537,275 
Accretion of loan premium  94,444    
Amortization of operating lease, net  (77)   
Change in fair value of derivative liabilities  (1,168,804)  (8,279,919)
Changes in operating assets and liabilities:        
Other assets  (191,480)  332,930 
Accounts payable and accrued expenses  209,949   169,228 
Other liabilities  774,167    
Net cash used in operating activities  (13,125,753)  (3,444,680)
         
CASH FLOWS FROM FINANCING ACTIVITIES:        
Net proceeds from issuance of common stock  18,511,009   15,628,010 
Payment of convertible debenture - related party     (1,821,818)
Proceeds from convertible debenture - related party     436,000 
Proceeds from exercise of warrants     516,551 
Proceeds from note payable net of financing costs  14,609,915    
Net cash provided by financing activities  33,120,924   14,758,743 
         
Net increase in cash  19,995,171   11,314,063 
         
Cash, beginning of period  4,511,642   37,195 
         
Cash, end of period $24,506,813  $11,351,258 
         
SUPPLEMENTAL CASH FLOW INFORMATION:        
  Cash paid for interest $551,011  $22,180 
  Cash paid for taxes $  $ 
         
SCHEDULE OF NON-CASH FINANCING AND INVESTING ACTIVITIES:        
   Deemed dividends - related party $  $53,598,320 
   Right of use assets obtained in exchange for lease obligations $130,039  $  

See accompanying notes to unaudited condensed financial statements 

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Table of Contents

BioVie Inc.

Condensed Statements of Changes in Stockholders’ Equity (Deficit)

For the periods July 1, 2020 though March 31, 2021 and July 1, 2021 through March 31, 2022Operations

(Unaudited)

        Additional     Total 
  Common Stock  Common Stock  Paid in  Accumulated  Stockholders’ 
  Shares  Amount  Capital  Deficit  Equity (Deficit) 
                
           
Balance, June 30, 2020  5,204,392  $520  $19,538,742  $(41,037,898) $(21,498,636)
                     
Proceeds from issuance of common stock,net of cost of $2,371,790  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           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           (3,057,807)    
                     
Balance, December 31, 2020  13,916,164   1,391   103,433,515   (90,360,109)  13,074,797 
                     
Stock based compensation        803,604      803,604 
                     
Cashless exercise of warrants  304             
                     
Proceeds from exercise of warrants  41,324   4   516,547      516,551 
                     
Net loss           (2,992,868)  (2,992,868)
                     
Balance, March 31, 2021  13,957,792  $1,395  $104,753,666  $(93,352,977) $11,402,084 
                     
                     
Balance June, 30, 2021  22,333,324  $2,232  $229,933,505  $(224,885,422) $5,050,315 
                     
Proceeds from issuance of common stock, net cost of  $2,224,992  2,592,000   259   18,510,750      18,511,009 
                     
Stock based compensation - restricted stock  37,049   3   286,756      286,759 
                     
Stock option based compensation        1,926,962      1,926,962 
                     
Net loss           (5,540,753)  (5,540,753)
                     
Balance, September 30, 2021  24,962,373   2,494   250,657,973   (230,426,175)  20,234,292 
                     
Stock based compensation - restricted stock  21,710   2   97,693      97,695 
                     
Stock option based compensation        1,147,422      1,147,422 
                     
Net loss           (5,414,317)  (5,414,317)
                     
Balance, December 31, 2021  24,984,083   2,496   251,903,088   (235,840,489)  16,065,095 
                     
Stock option based compensation        930,334      930,334 
                     
Net loss           (7,040,644)  (7,040,644)
                     
Balance, March 31, 2022  24,984,083  $2,496  $252,833,422  $(242,881,133) $9,954,785 
         
  Three Months Ended  Three Months Ended 
  September 30,
2022
  September 30,
2021
 
       
OPERATING EXPENSES:        
Amortization $57,344  $57,344 
Research and development expenses  6,769,932   3,094,778 
Selling, general and administrative expenses  2,007,062   2,395,162 
TOTAL OPERATING EXPENSES  8,834,338   5,547,284 
         
LOSS FROM OPERATIONS  (8,834,338)  (5,547,284)
         
OTHER EXPENSE (INCOME):        
Change in fair value of derivative liabilities  566,542   - 
Interest expense  1,056,416   1,114 
Interest income  (41,585)  (7,645)
TOTAL OTHER EXPENSE (INCOME), NET  1,581,373   (6,531)
         
         
NET LOSS $(10,415,711) $(5,540,753)
         
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $(10,415,711) $(5,540,753)
         
NET LOSS PER COMMON SHARE        
- Basic $(0.38) $(0.23)
- Diluted $(0.38) $(0.23)
         
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING        
- Basic  27,212,445   23,719,927 
- Diluted  27,212,445   23,719,927 

 

See accompanying notes to unaudited condensed financial statements

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Table of Contents

BioVie Inc.

Condensed Statements of Cash Flows

(Unaudited)

       
  Three Months Ended  Three Months Ended 
  September 30,
2022
  September 30,
2021
 
       
CASH FLOWS FROM OPERATING ACTIVITIES:        
Net loss $(10,415,711) $(5,540,753)
Adjustments to reconcile net loss to net cash used in operating activities:        
Amortization of intangible assets  57,344   57,344 
Stock based compensation - restricted stock  17,537   286,759 
Stock based compensation expense - stock options  878,640   1,926,962 
Amortization of financing costs  42,554   - 
Accretion of unearned loan discount  400,361   - 
Accretion of loan premium  143,813   - 
Amortization of operating lease right-of-use assets  8,983   - 
Change in fair value of derivative liability  566,542   - 
Changes in operating assets and liabilities:        
Other assets  (221,244)  (12,436)
Accounts payable and accrued expenses  179,530   (316,981)
Operating lease liabilities  (9,213)  - 
Other liabilities  (869,456)  1,064,479 
Net cash used in operating activities  (9,220,320)  (2,534,626)
         
CASH FLOWS FROM FINANCING ACTIVITIES:        
Net proceeds from issuance of common stock  5,903,682   18,511,009 
Net proceeds from issuance of common stock - Related Party  5,905,840   - 
Net cash provided by financing activities  11,809,522   18,511,009 
         
Net increase in cash  2,589,202   15,976,383 
         
Cash, beginning of period  18,641,716   4,511,642 
         
Cash, end of period $21,230,918  $20,488,025 
         
SUPPLEMENTAL CASH FLOW INFORMATION:        
Cash paid for interest $469,687  $1,114 

See accompanying notes to unaudited condensed financial statements

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Table of Contents

BioVie Inc.

Condensed Statements of Changes in Stockholders’ Equity

For the Three Months Ended September 30, 2022 and September 30, 2021

(Unaudited)

                     
  Common
Stock
  Common
Stock
  Additional
Paid in
  Accumulated  Total
Stockholders’
 
  Shares  Amount  Capital  Deficit  Equity 
                
Balance, June 30, 2021  22,333,324  $2,232  $229,933,505  $(224,885,422) $5,050,315 
                     
Proceeds from issuance of common stock, net of cost of $2,224,992  2,592,000   259   18,510,750   -   18,511,009 
                     
Stock-based compensation - restricted stock  37,049   3   286,756   -   286,759 
                     
Stock option based compensation  -   -   1,926,962   -   1,926,962 
                     
Net Loss  -   -   -   (5,540,753)  (5,540,753)
                     
Balance, September 30, 2021  24,962,373  $2,494  $250,657,973  $(230,426,175) $20,234,292 
                     
                     
Balance, June 30, 2022  24,984,083  $2,496  $254,638,329  $(250,969,890) $3,670,935 
                     
Stock option based compensation  -   -   878,640   -   878,640 
                     
Stock-based compensation - restricted stock  -   -   17,537   -   17,537 
                     
Proceeds from issuance of common stock, net of costs of  $368,370  1,544,872   155   5,903,527   -   5,903,682 
                     
Proceeds from issuance of common stock, net of costs of  $94,160 - Related Party  3,636,364   364   5,905,476   -   5,905,840 
                     
Net loss  -   -   -   (10,415,711)  (10,415,711)
                     
Balance, September 30, 2022  30,165,319  $3,015  $267,343,509  $(261,385,601) $5,960,923 

See accompanying notes to unaudited condensed financial statements

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BIOVIE INC.

Notes to Condensed Financial Statements

March 31,For the Three Months Ended September 30, 2022 and 2021

(unaudited)

1.Background Information

BioVie Inc. (the “Company” or “we” or “our”) is a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including liver disease and neurological and neuro-degenerative disorders and certain cancers.

In liver disease, our Orphan Drug candidate BIV201 (continuous infusion terlipressin) is being developed as a future treatment option for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by NASH, hepatitis, and alcoholism. The initial target for BIV201 therapy is refractory ascites. These patients suffer from frequent life-threatening complications, generate more than $5 billion in annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months. The US Food and Drug Administration (FDA) has not approved any drug to treat refractory ascites. A Phase 2a clinical trial of BIV201 was completed in 2019, and a multi-center, randomized 30-patient Phase 2b trial is currently underway. As of March 31, 2022, ten of the thirteen planned US study centers had been activated and are actively screening and enrolling patients in the study. Top-line results from this trial are expected in early 2023.

The BIV201 development program was initiated by 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. 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.disease. 

 

In neurodegenerative disease, BioVie acquired the biopharmaceutical assets of NeurMedix, Inc. (“NeurMedix”), a privately held clinical-stage pharmaceutical company, in June 2021 (See Note 5 Related Party Transactions). The acquired assets included NE3107, a potentially selective inhibitor of inflammatory ERKextracellular single-regulated kinase(“ERK”) signaling that, based on animal studies, is believed to reduce neuroinflammation. NE3107 is a novel orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel mechanism of action. There is emerging scientific consensus that both inflammation and insulin resistance may play fundamental roles in the development of Alzheimer’s and Parkinson’s Disease, and NE3107 could, if approved represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering from Alzheimer’s and 1 million from Parkinson’s. The FDA has authorized a potentially pivotal Phase 3 randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate NE3107 in subjects who have mild to moderate Alzheimer’s disease (NCT04669028). In August 2021, the study was initiated and the Company is anticipating top line results in the first half ofmid-calendar year 2023.

 

On January 20, 2022, the Company initiated a study by treating the first patient, in it’s Phase 2 study assessing NE3107’s safety and tolerability and potential pro-motoric impact in Parkinson’s disease patients. The NM201 study (NCT05083260) is a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in Parkinson’s Disease (PD). Participants will be treated with carbidopa/levodopa and NE3107 or placebo. Forty patients with a defined PD medication “off state” will be randomized 1:1 placebo to: active NE3107 20 mg twice daily for 28 days. Safety assessments will look at standard measures of patient health and potential for drug-drug interactions affecting L-dopa pharmacokinetics and activity. Exploratory efficacy assessments will use the Motor Disease Society Unified Parkinson’s Disease Rating (MDS-UPDRS) parts 1-3, ON/OFF Diary, and Non-Motor Symptom Scale. Topline results are expected for the NM201 study in mid-2022.December 2022.

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Inflammation-driven insulin resistance is believed to be implicated in a broad range of serious diseases, including multiple myeloma and prostate cancer, and we plan to begin exploring these opportunities in the coming months using NE3107 or related compounds acquired in the NeurMedix asset purchase. NE3107 is patented in the United States, Australia, Canada, Europe and South Korea.

 

In liver disease, our Orphan Drug candidate BIV201 (continuous infusion terlipressin) is being developed as a future treatment option for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by NASH, hepatitis, and alcoholism. The initial target for BIV201 therapy is refractory ascites. These patients suffer from frequent life-threatening complications, generate more than $5 billion in annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months. The US Food and Drug Administration (FDA) has not approved any drug to treat refractory ascites. A Phase 2a clinical trial of BIV201 was completed in 2019, and a multi-center, randomized 30-patient Phase 2b trial is currently underway. Top-line results from this trial are expected in mid-calendar year 2023.

The BIV201 development program was initiated by 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. 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.

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2.Liquidity

The Company’s operations are subject to a number of factors that can affect its operating results and financial conditions. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s products, the Company’s ability to obtain regulatory approval to market its products; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, Company products; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; and the Company’s ability to raise capital. The Company’s financial statements have been 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. As of March 31,September 30, 2022, the Company had working capital of approximately $20.517.5 million,, cash of approximately $24.5$21.2 21,230,918 million, stockholders’ equity of approximately $10.0$6.0 5,960,923 million, and an accumulated deficit of approximately $242.9$261.4 261,385,601 million. In addition, the Company has not generated any revenues to date and no revenues are expected in the foreseeable future. The Company’s future operations are dependent on the success of the Company’s ongoing development and commercialization efforts, as well as its ability to secure additional financing as needed. Although our cash balance couldmay possibly sustain operations over the next 12 months from the balance sheet date if measures are taken to delay planned expenditures in our research protocols and slow the progress in the Company’s clinical programs, the Company’s current planned operations to meet certain goals and objectives, project cash flows to be depleted within that period of time.

 

The future viability of the Company is largely dependent upon its ability to raise additional capital to finance its operations. Management expects that future sources of funding may include sales of equity, obtaining loans, or other strategic transactions.

 

The continual widespread health emergencies or pandemics such as the coronavirus (“COVID-19”) pandemic (and its related variants), has led to continued regional quarantines, business shutdowns, labor shortages, disruptions to supply chains, and overall economic instability. Although some jurisdictions have relaxed these measures, others have not or have reinstated them as COVID-19 cases and its variants continue to emerge. The duration and spread of the COVID-19 pandemic and the long-term impact of COVID-19 and its variants on the financial markets and the overall economy are highly uncertain and cannot be predicted at this time. 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. In addition, the COVID-19 pandemic has created a widespread labor shortage, including a shortage of medical professionals, and has impacted and may continue to impact the potential patient participation in our studies, which may adversely impact our ability to continue or complete our clinical trials in the planned timeline.

 

Although management continues to pursue the Company’s strategic plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company, if at all, to fund continuing operations. These circumstances raise substantial doubt on the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

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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 and Exchange Commission (the “SEC”) 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 condensed 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, 20212022 was derived from audited annual financial statements for the year ended June 30, 2021 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, 20212022 and 20202021 in our Annual Report on Form 10-K filed with the SEC on August 30, 2021.September 27, 2022. For a summary of significant accounting policies, see the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2022 and 2021, filed with the SEC on August 30, 2021.September 27, 2022.

 

Certain prior period amounts have been reclassified for consistency with the current period presentation.

 

Leases

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The Company determines whether an arrangement contains a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, current portionTable of operating lease liabilities, and net of current portion of operating lease liabilities on our balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent an obligation to make lease payments arising from the lease. Lease ROU assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. As the Company’s leases do not provide an implicit rate, an incremental borrowing rate is used based on the information available at the commencement date in determining the present value of lease payments. The Company does not include options to extend or terminate the lease term unless it is reasonably certain that the Company will exercise any such options. Rent expense is recognized under the operating leases on a straight-line basis. The Company does not recognize right of-use assets or lease liabilities for short-term leases, which have a lease term of twelve months or less, and instead will recognize lease payments as expense on a straight-line basis over the lease termContents

Fair Value of Financial Instruments

Fair value is defined as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value for applicable assets and liabilities, we consider the principal or most advantageous market in which we would transact and we consider assumptions. market participants would use when pricing the asset or liability, such as inherent risk, transfer restrictions, and risk of nonperformance. This guidance also establishes a fair value hierarchy to prioritize inputs used in measuring fair value as follows:

Level 1: Observable inputs such as quoted prices in active markets;

Level 2: Inputs, other than quoted prices in active markets, that are observable either directly or indirectly; and

Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions

Net loss per Common Share

 

Basic net loss per common share is computed by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per common share is computed by dividing the net loss 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 three and nine months ended March 31,September 30, 2022 and 2021, such amounts were excluded from the diluted loss since their effect was considered anti-dilutive due to the net loss for the period.

 

The table below shows the number of outstanding stock options and warrants as of March 31,September 30, 2022 and 2021:

Schedule of Dilutive securities were excluded from the computation of diluted loss per share 

     
Schedule of Dilutive securities were excluded from the computation of diluted loss per share        
 March 31, 2022 March 31, 2021  September 30,
2022
  September 30,
2021
 
 Number of Shares  Number of Shares  Number of Shares  Number of Shares 
Stock Options  2,438,044   755,200   3,348,330   2,047,910 
Warrants  511,463   173,021   7,779,194   158,761 
Total  2,949,507   928,221   11,127,524   2,206,671 

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Recent Accounting Pronouncements

 

The Company considers the applicability and impact of all Accounting Standards Updates (“ASU’s”). There were no recent ASUs that are expected to have a material impact on the Company’s balance sheets or statements of operations.

 

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 March 31,September 30, 2022 and June 30, 2021:2022:

 

Schedule of intangible assets       
 March 31, 2022  June 30, 2021  September 30,
2022
  June 30,
2022
 
            
Intellectual Property $2,293,770  $2,293,770  $2,293,770  $2,293,770 
Less Accumulated Amortization  (1,369,953)  (1,197,921)  (1,484,642)  (1,427,298)
Intellectual Property, Net $923,817  $1,095,849  $809,128  $866,472 

Amortization expense was $57,344 in each of the three-month periods ended March 31,September 30, 2022 and 2021. Amortization expense for the nine-month period ended March 31, 2022 and 2021 was $172,032 and $172,032 respectively. The Company amortizes intellectual property over the expected original useful lives of 10 years. years.

 

Estimated future amortization expense is as follows:

Schedule of Future expected Amortization of intangible assets 

Year ending June 30, 2022 (Remaining three months) $57,346 
2023  229,377 
Schedule of future amortization expense    
Year ending June 30, 2023 (Remaining nine months) $172,033 
2024  229,377   229,377 
2025  229,377   229,377 
2026  178,340   178,341 
Intellectual Property, Net $923,817 
 $809,128 

 

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5.Related Party Transactions

Equity Transactions with Acuitas

On July 15, 2022, the Company entered into a securities purchase agreement with Acuitas Group Holdings, LLC, (Acuitas), the company’s majority shareholder, pursuant to which Acuitas agreed to purchase from the Company, in a private placement (i) an aggregate of 3,636,364 shares of the Company’s Class A common stock, par value $0.0001 per share at a price of $1.65 per share (“PIPE Shares”), and (ii) a warrant to purchase 7,272,728 shares of Common Stock (“Warrant Shares”), at an exercise price of $1.82, with a term of exercise of five years; (collectively, the “Securities”). The warrant has a down round feature that reduces the exercise price if the Company sells stock for lower price. On August 15, 2022, the Company received net proceeds of approximately $5.9 million net of costs of approximately $94,000 and entered into an amended and restated registration statement with Acuitas, which amended and restated that certain Registration Rights Agreement, dated as of June 10, 2021, by and between the Company and Acuitas (the “Existing Registration Rights Agreement”), to amend the definition of “Registrable Securities” in the Existing Registration Rights Agreement to include the PIPE Shares and the Warrant Shares as Registrable Securities thereunder.

Asset Acquisition with NeurMedix

On April 27, 2021, the Company entered into an Asset Purchase Agreement (“APA”) with NeurMedix and Acuitas, Group Holdings, LLC (“Acuitas”), which are related party affiliates, pursuant to which the Company acquired certain assets from NeurMedix and assumed certain liabilities of NeurMedix, in exchange for consideration of cash and shares of common stock. The acquired assets include, among others, those related to certain drug candidates being developed by NeurMedix, including NE3107, a small molecule orally administered inhibitor of insulin resistance and the pathological inflammatory cascade, with a novel mechanism of action that has potential applications for treatment against Alzheimer’s Disease and Parkinson’s Disease. On June 10, 2021, and pursuant to the APA, the Company issued to Acuitas (as NeurMedix’s assignee) 8,361,308 shares of the Company’s common stock and made a cash payment of approximately $2.3 million. Since the transaction was between entities under common control, there were no fair value adjustments of the purchased assets, and the historical cost basis of the purchased assets was zero. The total consideration paid was expensed as in process research and development expense in the year ended June 30, 2021. 

 

Subject to the terms and conditions of the APA,Asset Purchase Agreement, following the closing, the Company was potentiallymay be obligated to deliver contingent stock consideration to NeurMedix (or its successor). Previously, the Company was obligated to deliver contingent stock consideration to NeurMedix (or its successor) consisting of shares of the Company’s common stock having an aggregate value of up to $3.0 billion, subject to the Company’s achievement of certain clinical, regulatory and commercial milestones related to the drug candidates to be acquired by the Company from NeurMedix, and subject to a cap limiting each issuance of shares if such issuance would result in the beneficial ownership of NeurMedix and its affiliates exceeding 89.9999% of the Company’s issued and outstanding common stock. Pursuant to Amendment No. 1 to the APA, dated May 9, 2021, the Company ismay now be obligated to deliver contingent stock consideration to NeurMedix (or its successor) consisting of up to 18 million shares of BioVie’s common stock, with 4.5 million shares issuable upon the achievement of each of the four milestones set forth in the APA, for an aggregate of up to 18 million shares, subject to a cap limiting the issuance of shares if such issuance would result in the beneficial ownership of NeurMedix and its affiliates exceeding 87.5% of the Company’s issued and outstanding common stock.

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On June 10, 2021, and pursuant to the APA, the Company issued to Acuitas (as NeurMedix’s assignee) 8,361,308 shares of the Company’s common stock and made a cash payment of approximately $2.3 million, representing NeurMedix’s direct and documented cash expenditures to advance certain programs from March 1, 2021 through the closing date and cash payments to other third parties for expenses totaling approximately $4.0 million for due diligence, legal fees, transaction fees and the fairness opinion. Since the transaction was between entities under common control, there were no fair value adjustments of the purchased assets, and the historical cost basis of the purchased assets was zero. The total consideration paid was expensed as research and development expense at the time of the transaction.

Equity Transactions with Acuitas 

On September 22, 2020, concurrent with the closing of the Company’s registered public 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; 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 year ended June 30, 2021, 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, at September 22, 2020 upon the Company’s close of its public offering, all 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.

 

6.Other Liabilities

OtherThe current portion of other liabilities representat September 30, 2022 of $483,854 and $724,330 of the $1.3 1,304,925 million of the current portion of other liabilities at June 30, 2022, represented retention bonus arrangements with certain employees that waswere recognized in August 2021 totaling $1,161,000 and included in the accompanying statement of operations for the nine months ended March 31, 2022.. The payment terms of the retention bonus arrangement are equal monthly installments over a 24-month period and began in August 2021. The current portion of the liability was $580,625 and the non-current portion was $193,542 in the accompanying balance sheet at March 31, 2022.

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7.Notes Payable

 

On November 30, 2021, (the “Closing Date”) the Company entered into a Loan and Security Agreement and the Supplement to the Loan and Security Agreement and Promissory Notes (together, the “Loan Agreement”) with Avenue Venture Opportunities Fund, L.P. (“AVOPI” and Avenue Venture Opportunities Fund II, L.P. (“AVOPII”) together (“Avenue”) for growth capital loans in an aggregate commitment amount of up to $20 million (the “Loan”). On the closing date, $15 million funded (“Tranche 1”) and. The Loan had the additional capacity of up to $5 million will be made available to the Company on or prior to September 15, 2022, subject to the Company’s achievement of certain milestones with respect to certain of its ongoing clinical trials (“Tranche 2”).which were not achieved. The Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.00%7.00% plus the prime rate as reported in The Wall Street Journal and (b) 10.75%. The prime rate at September 30, 2022 was 5.5%. The Loan is secured by a lien upon and security interest in all of the Company’s assets, including intellectual property, subject to agreed exceptions. The maturity date of the Loan is December 1, 2024. An additional growth capital loan in an amount equal to $5 million may be available (i) upon the Company’s achievement of additional milestones with respect to certain of its ongoing clinical trials (ii) upon the mutual written agreement of the Company and the Lenders each acting in its sole discretion, and (iii) subject to execution and delivery by the Company and the Lenders of amendments to the loan documents and the Warrant (as defined below) to reflect such additional loan and approval of each Lender’s investment committee (“Tranche 3”).

 

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The Loan Agreement requires monthly interest-only payments during the first eighteen months of the term of the Loan, which may be increased up to an additional six months from the end of such eighteen-month period prior to receipt of the Tranche 2 Loan.. Following the interest-only period, the Company will make equal monthly payments of principal, plus accrued interest, until the Loan’s maturity date when all remaining principal and accrued interest is due. If the Company prepays the Loan, it will be required to pay (a) a prepayment fee in an amount equal to 3.0% of the principal amount of the Loan that is prepaid during the interest-only period; and (b) a prepayment fee in an amount equal to 1.0% of the principal amount of the Loan that is prepaid after the interest-only period. At the Loan’s maturity date, or on the date of the prepayment of the Loan, a final payment equal to 4.25% of the sum of (a) the Loan commitment amount under Tranche 1 and Tranche 2, plus (b) the aggregate principal amount of additional growth capital loans borrowed under Tranche 3.1.

 

The Loan Agreement includes a conversion option to convert up to $5$5.0 million of the principal amount of the Loan outstanding at the option of the Lenders, into shares of the Company’s Class A common stock at a conversion price of $6.98 per share.

 

On the Closing Date, the Company issued to the Lenders warrants to purchase 361,002 shares of Class A common stock of the Company (the “Warrants”) at an exercise price per share equal to $5.82, (the “Stock Purchase Price”).the stock purchase price. The warrants are exercisable until November 30, 2026, (the “Expiration Date”).the expiration date.

 

The amount of the carrying value of the notes payable were determined by allocating portions of the outstanding principal of the notes to the fair value of the warrants of approximately $1.4$1.4 million and the fair value of the embedded conversion option of approximately $2.2$2.2 million. Accordingly, the total amount of unearned discount of approximately $3.7 million, the total direct financing cost of approximately $390,000$390,000 and premium of $850,000$850,000 are recognized on an effective interest method over term of the Loan. The adjusted effective interest rate is 25%. The carrying value of notes payable at March 31, 2022 was approximately $11.6 million, net of unearned discount of approximately $3.1 million, unamortized direct costs of approximately $333,000 and accreted premium of approximately $94,000 in the accompanying balance sheets. The total interest expense of approximately $919,000 and $1.2$1.1 million for the three and nine months ended March 31, 2022, respectively;September 30, 2022; was recognized in the accompanying statements of operations. Theoperations and included the interest only payments totaling approximately $470,000, the amortization of financing costs wasof approximately $43,000$43,000, unearned discount of approximately $400,000 and $57,000 for the three and nine months ended March 31, 2022, respectively. The accretion of loan premium wastotaled of approximately $71,000 and $94,000 for the three and nine months ended March 31, 2022, respectively. The accretion of unearned loan discount was approximately $400,000 and $534,000 for the three and nine months ended March 31, 2022, respectively.$144,000. As of March 31,September 30, 2022, the outstanding principal balance of $15 million would be paid in 18 monthly equal installments beginning July 1, 2023; a total of $10$10.0 million and $5$5.0 million in the fiscal years ended June 30, 2024 and 2025 respectively.

 

The following is a summary of the NoteNotes Payable as of March 31,September 30, 2022 and June 30, 2021:2022:

 

Schedule of note payable       
      September 30,
2022
  June 30,
2022
 
 March 31, 2022  June 30, 2021       
      
Note Payable $15,000,000  $ 
Notes Payable $15,000,000  $15,000,000 
Less debt financing costs  (333,345)      (248,236)  (290,790)
Less unearned discount  (3,136,163)      (2,335,441)  (2,735,802)
Plus accretion of loan premium  94,444      309,091   165,278 
Note Payable, net of financing costs and premiums $11,624,935  $ 
Notes Payable, net of financing costs, unearned premiums and discount $12,725,414  $12,138,686 

 

Estimated future amortization expense and accretion of premium is as follows:

 

Schedule of Estimated future amortization expense and accretion of premium            
   Unearned Discount   Debt Financing Costs  Loan accretion Premium 
             
Year ending June 30, 2023 (Remaining 9 months) $1,201,084  $127,665  $278,182 
2024  1,023,145   108,751   236,970 
2025  111,212   11,820   25,757 
Total $2,335,441  $248,236  $540,909 

Schedule of Estimated future amortization expense and accretion of premium

   Unearned Discount  Debt Financing  Loan accretion Premium 
           
Year ending June 30, 2022 (Remaining three months)  $400,361  $42,555  $70,834 
2023   1,601,445   170,219   283,333 
2024   1,023,145   108,751   283,333 
2025   111,212   11,820   118,056 
Total  $3,136,163  $333,345  $755,556 

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8.Fair Value Measurements

 

At March 31,2022September 30, 2022 and June 30, 2021,2022, the estimated fair value of derivative liabilities measured on a recurring basis are as follows:

 

          
Schedule of derivative liabilities at fair value          
 Fair Value Measurements at  Fair Value Measurements at 
 March 31, 2022  September 30, 2022 
 Level 1 Level 2 Level 3 Total  Level 1 Level 2 Level 3 Total 
                  
Derivative liability - Warrants $  $  $1,023,294  $1,023,294  $-  $-  $442,592  $442,592 
Derivative liability -Conversion option on notes payable        1,477,880   1,477,880 
Derivative liability - Conversion option on notes payable  -   -   506,511   506,511 
Total derivatives $  $  $2,501,174  $2,501,174  $-  $-  $949,103  $949,103 

  Fair Value Measurements at 
  June 30, 2022 
  Level 1  Level 2  Level 3  Total 
             
Derivative liability - Warrants $-  $-  $194,531  $194,531 
Derivative liability - Conversion option on note payable  -   -   188,030   188,030 
Total derivatives $-  $-  $382,561  $382,561 

The following table presents the activity for liabilities measured at fair value using unobservable inputs for the three months ended September 30, 2022 and 2021:

Fair value, liabilities measured on recurring basis       
  Derivative liabilities - Warrants  Derivative liability - Conversion Option on Convertible Debenture 
       
Balance at July 1, 2022 $194,531  $188,030 
Additions to level 3 liabilities  -   - 
Change in in fair value of level 3 liability  248,061   318,481 
Transfer in and/or out of Level 3  -   - 
Balance at September 30, 2022 $442,592  $506,511 

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  Fair Value Measurements at
June 30, 2021
Level 1Derivative liabilities - Warrants  Level 2Level 3Total Derivative liability - Conversion Option on Convertible Debenture 
         
Balance at July 1, 2021 $-$-
Additions to level 3 liabilities-   -
Change in fair value of level 3 liability-   -
Derivative liability Transfer in and/or out of Level 3- Warrants-
Balance at September 30, 2021 $-  $$$
Derivative liability -Conversion option on note payable
   Total derivatives$$$$- 

The following table presents the activity for liabilities measured at fair value unobservable inputs for the nine months ended March 31, 2022:

 

  Derivative liabilities -
Warrants
  Derivative liability -
Conversion Option
on Convertible
Debenture
 
       
Balance at July 1, 2021 $  $ 
Additions to level 3 liabilities  1,456,512   2,213,466 
Change in in fair value of level 3 liability  (433,218)  (735,586)
Transfer in and/or out of Level 3      
Balance at March 31, 2022 $1,023,294  $1,477,880 

The following table presents the activity for liabilities measured at fair value unobservable inputs for the nine months ended March 31, 2021:

  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 March 31, 2021 $  $ 

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The fair values of derivative liabilities for the warrants and conversion option at March 31,September 30, 2022 in the accompanying balance sheet, were approximately $1 million$443,000 and approximately $1.5 million,$507,000, respectively. The total change in the fair value of the derivative liabilities totaled approximately $386,000 and $1.2 million$567,000 for the three and nine months ended March 31,September 30, 2022, respectively, and accordingly, was recorded in the accompanying statement of operations. The assumptions used in the Black Scholes model to value the derivative liabilities at March 31,September 30, 2022 included the closing stock price of $4.502.49 per share, and for the warrants the exercise price of $5.82, 5-year5-year term, risk free rate of 1.26%4.06% and volatility of 74.796%79.9%. and for the embedded derivative liability of the conversion option, the conversion price of $6.98; 3-year3-year term, risk free rate of 0.97%4.3% and volatility of 76.15%83.9%.

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 and anti-dilution provisions or adjustments to the strike price due to an occurrence of a future event; are accounted as derivative financial instruments. The warrants issued on November 30, 2021 in connection with the Avenue loan financing were not considered to be indexed to the Company’s own stock, and accordingly, were recorded as a derivative liability at fair value in the accompany balance sheet at March 31,September 30, 2022.

 

The Black Scholes model was used to calculate the fair value of the warrant derivative to bifurcate the warrant derivative amount from the Avenue loan amount funded. The warrants are recorded at their fair values at the date of issuance and remeasured at March 31,September 30, 2022. The assumptions used for the fair value calculation at November 30, 2021 follows: the closing stock price of $6.44 per share; the exercise price of $5.82; 5 year term; a risk free rate of 1.14%1.14% and volatility of 74.4%74.4%.

 

Embedded derivative liability – Conversion Option

 

The embedded derivative represents the optional conversion feature of up to $5.0 million of the outstanding Avenue note amounts meets the definition of a derivative and requires bifurcation from the loan amount.

 

The Black Scholes model was used to calculate the fair value of the embedded derivative to bifurcate the embedded derivative amount representing the conversion option from the Avenue loan amount funded. The assumption used for the fair value calculation at November 30, 2021 follows: the closing stock price of $6.44 per share; the conversion price of $6.98; 3 year term; risk free rate of 0.81%0.81% and volatility of 76.85%76.85%.

 

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9.Equity Transactions

Stock Options

 

The following table summarizes the activity relating to the Company’s stock options for the ninethree months ended March 31,September 30, 2022:

 

  Options  Weighed-
Average
Exercise
Price
  Weighted
Remaining
Average
Contractual
Term
  Aggregate
Intrinsic
Value
 
Outstanding at June 30, 2021  755,200  $4.34   4.4  $2,569,232 
Granted  1,763,169   6.69   9.5    
Options Expired  (7,200)  29.17   0.0     
Options Forfeited  (73,125)  (13.91)      
Outstanding at March 31, 2022  2,438,044  $8.63   7.9  $678,545 
Exercisable at March 31, 2022  675,825  $10.84   6.2  $18,480 

Schedule of summarizes the activity relating to the Company’s stock options                
  Options  Weighed-
Average Exercise Price
  Weighted Remaining Average Contractual Term  Aggregate Intrinsic Value 
Outstanding at June 30, 2022  3,398,764   7.42   6.8   - 
Granted  -   -   -   - 
Options Expired  (25,600)  4.71   -   - 
Options Canceled  (24,834)  7.74   -   - 
Options Forfeited  -   -   -   - 
Outstanding at September 30, 2022  3,348,330  $7.40   6.4  $143,136 
Exercisable at September 30, 2022  1,113,341  $9.11   5.6  $39,440 

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The fair value of each option grant on the date of grant is estimated using the Black-Scholes option. The pricing model reflects the following weighted-average assumptions for the ninethree months ended March 31, 2022September 30, 2021 and 2021:no stock options were issued for the three months ended September 30, 2022:

 

  March 31, 2022 March 31, 2021
Expected life of options (In years) 5 5
Expected volatility 75.12% 77.05%
Risk free interest rate 1.6% 0.5%
Dividend Yield 0% 0%
Schedule of assumptions used
September 30, 2021
Expected life of options (In years)5
Expected volatility74.96%
Risk free interest rate0.80%
Dividend Yield0%

Expected volatility is based on the historical volatilities of the daily closing price of the common stock of three comparable companies 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 option-based compensation expense of approximately $930,000$878,640 and $804,000$1,926,962 for three-month periods ended March 31, 2022 and 2021, respectively; and of approximately $4.0 million and $2.3 million for nine-month periods ended March 31,September 30, 2022 and 2021, respectively.

 

As of March 31, 2022, there was approximately $7.1 million of unrecognized compensation cost related to non-vested stock options granted to Directors and Officers and other employees, which is expected to be recognized over a weighted-average period of approximately 4.1 years.

The following is a summary of stock options listed by exercise price, the number options outstanding and exercisable as of March 31, 2022:

 Exercise Price  Outstanding  Weighted Average Contract Life  Exercisable 
$2.74   124,167   5.0    
$2.80   7,200   2.8   7,200 
$3.20   248,167   5.0   24,833 
$3.24   25,000   5.0    
$3.75   4,800   1.8   4,800 
$6.25   1,600   1.6   1,600 
$7.50   25,600   4.0   25,600 
$7.74   1,365,835   4.4   273,167 
$8.75   1,600   2.0   1,600 
$9.54   800   3.5   800 
$9.90   800   3.5   800 
$12.50   4,000   0.8   4,000 
$13.91   618,475   3.7   321,425 
$25.00   1,600   0.5   1,600 
$26.25   2,000   0.2   2,000 
$27.50          
$28.75   1,600   0.3   1,600 
$31.25          
$42.09   4,800   3.8   4,800 
     2,438,044       675,825 

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Stock Warrants

The following table summarizes warrant activity during the nine months ended March 31,is a summary of stock options outstanding and exercisable by exercise price as of September 30, 2022:

 

  Number of
Shares
  Weighted
Average
Exercise
Price
  Weighted
Average
Remaining
Life (Years)
  Aggregate
Intrinsic
Value
 
Outstanding and exercisable at June 30, 2021  158,761  $10.37   3.1  $1,765,437 
Granted  361,002   5.82   5.0    
Expired  (8,300)  62.50       
Exercised            
Outstanding and exercisable at March 31, 2022  511,463  $6.31   4.0  $271,187 

Of the above warrants, 1,091 expire in the fiscal year ending June 30, 2022, 4,815 expire in the fiscal year ending June 30, 2023, 2,714 expire in the fiscal year ending June 30, 2025, and 502,843 expire in the fiscal year ending June 30, 2026.

 Schedule of summary of stock options outstanding and exercisable             
Exercise Price  Outstanding  Weighted Average Contract Life  Exercisable 
$1.69   124,520   4.8   - 
$1.81   10,000   4.7   - 
$1.98   72,000   4.7   2,000 
$2.74   124,167   9.4   - 
$2.80   7,200   2.4   7,200 
$3.20   248,167   9.4   24,833 
$3.24   25,000   9.5   - 
$3.75   4,800   1.4   4,800 
$5.04   755,000   4.6   188,750 
$6.25   1,600   1.1   1,600 
$7.50   1,600   3.4   1,600 
$7.74   1,341,001   8.3   546,333 
$8.75   1,600   1.5   1,600 
$9.54   800   3.1   800 
$9.90   800   3.1   800 
$12.50   4,000   0.4   4,000 
$13.91   618,475   3.3   321,425 
$25.00   800   0.1   800 
$26.25   2,000   0.1   2,000 
$28.75   800   0.2   800 
$42.09   4,000   3.4   4,000 
     3,348,330       1,113,341 

 

Issuance of common stock for cash

 

On August 11, 2021,During the 3 months ended September 30,2021, the Company closed a registered public offering issuing 2,500,000issued 2,592,000 of its Class A common stock at $8.00$8.00 per share resulting in net proceeds to the Companyconnection with its registered public offering of approximately $17.8$18.5 million, net of issuance costs of approximately $2.2$2.2 million.

 

On September 24, 2021,August 31, 2022, the Company issued 92,000entered into a Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. and B. Riley Securities, Inc. (collectively, the “Agents”), pursuant to which the Company may issue and sell from time-to-time shares of itsCompany’s Class A common stock, at $8.00par value $0.0001 per share, in connection withthrough the underwriters’ exerciseAgents, subject to the terms and conditions of its over-allotment option inthe Sales Agreement. As of September 30, 2022, the Company has issued 1,544,872 shares under the Sales Agreement for the August 2021 registered public offering, resulting ina total net proceeds to the Companyof $ 5.9 million after commissions and expenses of approximately $707,000, net of issuance cost of approximately $29,000.$400,000.

 

Issuance of Shares for Services

 

On August 20, 2021, the Company awarded 58,759 restricted stock units (“RSUs”) to the President and CEO under the Company’s 2019 Omnibus Incentive Equity Plan (the “2019 Omnibus Plan”) as his salary for the period from April 27, 2021, the date of his appointment, through December 31, 2021. The number of RSUs awarded was based on a prorated annual base salary of $600,000 at a 10% discount to the grant date fair value of $7.74$7.74 per share of the Company’s common stock. Each RSU awarded to the CEO entitles him to receive one share of common stock upon vesting. A total of 15,339 RSUs (representing the pro rata portion of the RSU award for the period from April 27, 2021 to June 30, 2021) vested at the grant date, 21,710 vested at September 30, 2021 and 21,710 vested at December 31, 2021. Accordingly, the common stock was issued to the CEO at each of the quarter end vesting dates.

 

On June 21, 2022, the Company awarded 124,520 RSUs to the President and CEO under the Company’s 2019 Omnibus. Each RSU awarded to the CEO entitles him to receive one share of common stock upon vesting. The RSUs vest in equal installments over three years on the anniversary Grant date. The grant date fair value was $1.69 per share of the Company’s common stock. The stock-based compensation expense related to these RSUs totaled $97,695 for the fiscal year ended June 30, 2021 and $384,454 for the nine month period ended March 31, 2022, respectively. There were no stock-based compensation expense related to these RSUs$17,537 for the three month periodmonths ended March 31, 2022 and 2021.September 30, 2022.

 

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Issuance of Stock Options

 

On August 20, 2021, the Company granted, under the 2019 Omnibus Plan, stock options to purchase 1,365,835 shares of common stock to the executive management team. Twenty percent (20%) of the shares underlying the options awarded vested on the grant date, and the remaining 80% vest equally over a 5-year5-year period, on the first, second, third, fourth and fifth anniversary of the grant date. The exercise price of the options is $7.74$7.74 per share, the grant date fair value of the stock, and the options terminate on the earlier of the tenth anniversary of the grant date or the date as of which the options were fully exercised.

 

On February 1,

Pursuant to a former employee Separation Agreement, dated April 11, 2022, the Company modified a former employee’s stock option award granted stockon August 20, 2021 pursuant to the 2019 Omnibus Plan (“2021 Options Grant”). Pursuant to the terms of the Separation Agreement of the employee, effective on July 8, 2022, (“the Separation Date”), the Company accelerated the vesting of options to purchase 124,16774,500 shares of common stock as deemed vested, (“Accelerated Options”) and after giving effect to a new employee. Twenty percent (20%)the Accelerated Options, extended the exercise period of the shares underlyingtotal vested outstanding and unexercised options totaling 99,333 of the options awarded vested2021 Options Grant as of July 8, 2022 to one year following the Separation Date. The unvested portion of the 2021 option grant of 24,834 was canceled. The modification were remeasured as of the July 8, 2022 and the incremental difference totaled $181,154, net credit; due to the original exercise price of $7.74 is greater than the stock price of $1.80 on the grantremeasurement date and the remaining 80% vest equally over a 5-year period,accordingly was recognized on the first, second, third, fourth and fifth anniversary of the grant date. The exercise price is $3.20 per share, the grant date fair value, and the options terminate on the tenth anniversary of the grant date.July 8, 2022.

 

During the three months ended March 31, 2022, the Company granted, stock options to purchase shares of common stock totaling 273,167 to four new employees.

Stock Warrants

 

The exercise prices per share are $3.20; $2.74 and $3.24, which were fair values offollowing table summarizes warrant activity during the Company’s common stock on the respective grant dates. Twenty percent (20%) of the shares underlying the options awarded vest on the one year anniversary of the grant date, and the remaining 80% vest in equal monthly installments over 48 month. options terminate on the tenth anniversary of the grant date or date as of which the options were fulling exercised.three months ended September 30, 2022:

 

Forfeiture of Stock Options

Summary of warrants activity                
  Number of Shares  Weighted Average Exercise Price  Weighted Average Remaining Life (Years)  Aggregate Intrinsic Value 
Outstanding and exercisable at June 30, 2022  510,372  $6.17   3.8  $- 
Granted  7,272,728   1.82   4.9   - 
Expired  (3,906)  75.00   -   - 
Exercised  -   -   -   - 
Outstanding and exercisable at September 30, 2022  7,779,194  $2.07   4.8  $4,899,997 

 

On August 27, 2021,Of the Chief Executive Officer forfeited unvested stock options to purchase up to 73,125 shares of common stock that were previously granted to him as compensation as an independent director ofabove warrants, 909 expire in the board.fiscal year ending June 30, 2023, 109,380 expire in the fiscal year ending June 30, 2025, 35,175 expire in the fiscal year ending June 30, 2026, and 7,633,730 expire in the fiscal year ending June 30, 2027.

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10.Leases

Office Leases Lease

 

From July 1, 2019 to October 31, 2021, the Company paid monthly rent of $1,000 to Acuitas for its headquarter office at 2120 Colorado Avenue Suite 230, Santa Monica, CA 90404. Effective November 1, 2021, the Company relocated its headquarters to Nevada. The Company paid an annual rent of $2,200 for the address at 680 W Nye Lane, Suite 201, Carson City Nevada 897603. The Nevada leaserental agreement is an annual lease.for a one year term.

 

On June 1, 2021, the Company assumed a NeurMedix office lease that was extended to February 2022 at 6165 Greenwich Dr Suite 150, San Diego, CA 92122. The lease agreement required monthly payments of $8,782. On February 26, 2022, the Company’s San Diego office relocated to 5090 Shoreham Place, San Diego, CA 92122. (the “New Office”). The New Officeoffice lease term for 38 months, commenced on March 1, 2022 with a 2 month rent abatement.2022. The monthly base rate payment of $4,175 begins June 1, 2022, with annual increases of three percent.

 

The operating lease cost recognized in in our statement of operations was approximately $23,000$12,800 and $76,500$25,400 for the three and nine months ended March 31,September 30, 2022 and approximately $3,000 and $9,000 for the three and nine months ended March 31, 2021.2021, respectively.

 

The following table provides balance sheet information related to leases as of March 31,September 30, 2022 and June 30, 2021:2022:

 

Schedule of balance sheet information related to leases        
 March 31, 2022  June 30, 2021  September 30, 2022  June 30, 2022 
Assets              
Operating lease, right-of-use asset, net $127,105  $  $109,271  $118,254 
                
Liabilities                
Current portion of operating lease liabilities $29,250  $  $40,317  $38,884 
Operating lease liabilities, net of current portion  97,779      76,768   87,414 
Total operating lease liabilities $127,029  $  $117,085  $126,298 

At March 31,September 30, 2022, the future estimated minimum lease payments under non-cancelable operating leases are as follows:

 

Year ending June 30:    
2022 (remaining 3 months) $4,175 
2023  50,600 
Schedule of future estimated minimum lease payments under non-cancelable operating leases    
Year ending June 30, 2023 (Remaining 9 months) $38,075 
2024  52,156   52,156 
2025  44,636   44,636 
Total minimum lease payments  151,567   134,867 
Less amount representing interest  (24,538)  (17,782)
Present value of future minimum lease payments  127,029   117,085 
Less current portion of operating lease liabilities  (29,250)  (40,317)
Operating lease liabilities, net of current portion $97,779  $76,768 

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The weighted average remaining lease term and discount rate as of March 31,September 30, 2022 and 2021June 30, 2022 were as follows:

 

March 31, 2022June 30, 2021
Weighted average remaining lease term (Years)
Operating leases3.1
Weighted average discount rate
Operating leases10.75%

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Schedule of weighted average remaining lease term and discount rate        
  September 30, 2022  June 30, 2022 
       
Weighted average remaining lease term (Years)        
Operating leases  2.5   2.8 
Weighted average discount rate        
Operating leases  10.75%  10.75%

 

11.Commitments and Contingencies

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 (“IPR”) of our U.S. Patent No. 9,655,945 titled “Treatment of Ascites” (the “’945 patent”). On November 13, 2019, the Patent Trial and Appeal Board of USPTO issued a written decision in the IPR from which no appeal was taken. The decision revoked all of the claims of the patent as lacking novelty or as obvious.

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 review and authorization, 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 count.

 

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.

 

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.

 

12.Employee Benefit Plan

On August 1, 2021, the Company began sponsoring an employee benefit plan subject to Section 401(K) of the Internal Revenue Service Code (the “401K Plan”) pursuant to which, all employees meeting eligibility requirements are able to participate.

 

Subject to certain limitations in the Internal Revenue Code, eligible employees are permitted to make contributions to the 401K Plan on a pre-tax salary reduction basis and the Company will match 5% of the first 5% of an employee’s contributions to the 401K Plan. For the three and nine months ended March 31,September 30, 2022 and 2021, the Company’sCompany made contributions to the 401K Plan totaledof approximately $28,70045,479 and $$75,10023,613, respectively.

 

13.Subsequent Events

On April 5,November 4, 2022, the Company granted stock options to purchase 755,000issued 367,511 shares of common stock for net proceeds of $1.2 million net of cost of approximately $26,000 under the Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. and B. Riley Securities, Inc. (collectively, the “Agents”), pursuant to which the Company may issue and sell from time-to-time shares of Company’s Class A common stock, par value $0.0001 per share, through the Agents, subject to the independent directorsterms and conditions of the board as compensation for services at an exercise price of $5.04 per share, the grant date fair value. Twenty-five percent (25%) of the shares underlying the options awarded vested on the grant date, and the remaining 75% vest ratably over three years on the first, second, and third anniversary of the grant date. The options terminate on the earlier of the fifth anniversary of the grant date or the date as of which the options are fully exercised.Sales Agreement.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

This report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, and Section 27A of the Securities Act of 1933. Any statements contained in this report that are not statements of historical fact may be forward-looking statements. When we use the words “intends,” “estimates,” “predicts,” “potential,” “continues,” “anticipates,” “plans,” “expects,” “believes,” “should,” “could,” “may,” “will” or the negative of these terms or other comparable terminology, we are identifying forward-looking statements. Forward-looking statements involve risks and uncertainties, which may cause our actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. These factors among others, include our; research and development activities and, distributor channel; compliance with regulatory impositions requirements; and our capital needs Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. 

 

Except as may be required by applicable law, we do not undertake or intend to update or revise our forward-looking statements, and we assume no obligation to update any forward-looking statements contained in this report as a result of new information or future events or developments. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. You should carefully review and consider the various disclosures we make in this report and our other reports filed with the Securities and Exchange Commission (the “SEC”) that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business. 

 

The following discussion of the Company’s financial condition and the results of operations should be read in conjunction with the Financial Statements and Notes thereto appearing elsewhere in this report. 

 

Management’s Discussion

 

BioVie Inc. is a clinical-stage company developing innovative drug therapies to overcome unmet medical needs in chronic debilitating conditions.

 

In liver disease, our Orphan Drug candidate BIV201 (continuous infusion terlipressin) is being developed as a future treatment option for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by NASH, hepatitis, and alcoholism. The initial target for BIV201 therapy is refractory ascites. These patients suffer from frequent life-threatening complications, generate more than $5 billion in annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months. The US Food and Drug Administration (FDA) has not approved any drug to treat refractory ascites. A Phase 2a clinical trial of BIV201 was completed in 2019, and a multi-center, randomized and controlled Phase 2b trial is currently underway at ten of thirteen planned US medical centers including Vanderbilt University, the Mayo Clinic, and the University of Pennsylvania (NCT04112199). Top-line results from this trial are expected in early 2023, to be followed by a proposed single pivotal Phase 3 clinical trial, subject to favorable FDA review.

In neurodegenerative disease, BioVie acquired the biopharmaceutical assets of NeurMedix, Inc., a related party privately held clinical-stage pharmaceutical company and related party affiliate, in June 2021. The acquired assets include NE3107, a potentially selective inhibitor of inflammatory ERK signaling that, based on animal studies, is believed to reduce neuroinflammation. NE3107isNE3107 is a novel orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel mechanism of action. There is emerging scientific consensus that both inflammation and insulin resistance may play fundamental roles in the development of Alzheimer’s and Parkinson’s Disease, and NE3107 could, if approved, represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering from Alzheimer’s and 1 million from Parkinson’s. The FDA has authorized a potentially pivotal Phase 3 randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate NE3107 in subjects who have mild to moderate Alzheimer’s disease (NCT04669028). We initiated this trial on August 5, 2021 and are targeting primary completion in mid-calendar year 2023.

On January 20, 2022, the Company initiated a study by treating the first half of 2023.

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In addition to Alzheimer’s disease, the FDA has authorized apatient, in its Phase 2 study assessing NE3107’s safety and tolerability and potential pro-motoric impact in Parkinson’s disease patients, and to assess its safety and tolerability.patients. The NM201 study (NCT05083260) Initiated by the Company on January 20, 2022; is a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in Parkinson’s Disease (PD). Participants will be treated with carbidopa/levodopa and NE3107 or placebo. Forty (40) patients with a defined L-dopaPD medication “off state” will be randomized 1:1placebo:1 placebo to active NE3107 20 mg twice daily for 28 days. Safety assessments will look at standard measures of patient health and potential for drug-drug interactions affecting L-dopa PKpharmacokinetics and activity. EfficacyExploratory efficacy assessments will use the Motor Disease Society Unified Parkinson’s Disease Rating (MDS-UPDRS) parts 1-4, Hauser1-3, ON/OFF Diary, and Non-Motor Symptom Scale. The study was initiated on January 20, 2022 and toplineTopline results are expected for the NM201 study in midDecember 2022. Inflammation-driven insulin resistance is believed to be implicated in a broad range of serious diseases, including multiple myeloma and prostate cancer, and we plan to begin exploring these opportunities in the coming months using NE3107 or related compounds acquired in the NeurMedix asset purchase.

 

In liver disease, our Orphan Drug candidate BIV201 (continuous infusion terlipressin) is being developed as a future treatment option for patients suffering from ascites and other life-threatening complications of advanced liver cirrhosis caused by NASH, hepatitis, and alcoholism. The initial target for BIV201 therapy is refractory ascites. These patients suffer from frequent life-threatening complications, generate more than $5 billion in annual treatment costs, and have an estimated 50% mortality rate within 6 to 12 months. The US Food and Drug Administration (FDA) has not approved any drug to treat refractory ascites. A Phase 2a clinical trial of BIV201 was completed in 2019, and a multi-center, randomized 30-patient Phase 2b trial is currently underway. Top-line results from this trial are expected in mid-calendar year 2023.

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Comparison of the three months ended March 31,September 30, 2022 to the three months ended March 31,September 30, 2021

 

Net lossincome (loss)

 

The net loss for the three months ended March 31,September 30, 2022 was approximately $7.0$10.4 million as compared to net loss of $3.0$5.5 million for the three months ended March 31,September 30, 2021. The increase in net loss increase of $4.0approximately $4.9 million for the three month period ended March 31, 2022 resulted from anwas primarily due to increased losslosses from operations of $2.7$3.3 million primarily attributed tofrom increased research and development activities $919,000in our clinical studies, increase in interest expense related toof $1.1 million from the new debtnotes payable financing that funded onobtained in November 30, 2021 and $ 386,000 increase ina change in fair value of the derivative liabilities.liabilities of approximately $567,000.

 

Total operating expenses for the three months ended March 31,September 30, 2022 and 2021 were approximately $5.7$8.8 million and $3.0as compared to $5.5 million respectively.for the three months ended September 30, 2021.  The net increase of approximately $2.7$3.3 million during the three months ended March 31,September 30, 2022 was comprised of a netprimarily due to an increase in research and development expenses of approximately $2.8$3.7 million and net decrease infrom the increased activities of our clinical studies; offset by decline selling general and administrationadministrative expenses of approximately $40,000. Approximately $1.0 million in selling, general and administration included expense related to the neuroscience operations and development of the biopharmaceutical assets purchased in June 2021. The increase in research and development related to the Alzheimer pivotal Phase 3 clinical trial that was initiated in August 2021, the initiation of the Phase 2 Parkinson study in January 2022, and the continuation of our Orphan Drug candidate BIV201’s Phase 2b clinical trial, which was initiated in the 2021 calendar year.$388,000.

 

Research and Development Expenses

 

Research and development expenses were approximately $3.6$6.8 million and $790,000$3.1 million for the three months ended March 31,September 30, 2022 and 2021, respectively. The net increase of approximately $2.8$3.7 million, for the three months period ended March 31, 2022 was comprisedconsisted of Neuroscience operational expenses of approximately $1.7 million attributed to increased activity in the Alzheimer pivotal Phase 3 clinical trial and the initiation of the Parkinson’s Phase 2 clinical trial in January 2022; an increase of $300,000 relatedapproximately $4.1 million primarily attributed to the continuation of Orphan Drug candidate BIV201’s Phase 2bincreased activities in our clinical trial initiatedstudies offset by $446,000 from a net decrease in June 2021; and increases in salary and employee benefit expenses of $522,000 and stock-basedthe clinical team’s compensation expense of $258,000. expense.

The Company expanded clinical team personnel by the hiringNeuroscience NE3107 studies accounted for approximately $3.9 million of the neuroscience personnel to oversee thenet increase in research and development of the biopharmaceutical assets purchased in June 2021, our CMO who came on board on November 1, 2021 and other related clinical personnelexpenses as both studies were significantly more active during the three months ended March 31,September 30, 2022 over the three months ended September 30, 2021, as the Parkinson’s Phase 2 study initiated in January 2022, became fully enrolled and with the top-line data read expected in December 2022 and the Alzheimer Phase 3 study nears full enrollment. Our Orphan Drug candidates BIV201’s Phase 2b study initiated in June 2021 accounted for approximately $159,000 of the net increase for three months ended September 30, 2022.

The total increase in the clinical studies expenses of $4.1 million was offset by a net decline in clinical team’s total compensation expense of approximately $446,000. The net decline in the clinical team’s compensation consisted of an increase of approximately $1.1 million in the clinical team’s compensation from expansion of the clinical team, offset by $1.6 million representing declines in stock compensation expense of approximately $578,000 from stock options awarded and the retention compensation of $1.0 million accrued in the three months ended September 30, 2021.

 

Selling, General and Administrative Expenses

 

Selling, general and administrative expenses were approximately $2.1$2.0 million and $2.2$2.4 million for the three month periodsmonths ended March 31, 2022September 30, 2021 and 2021,2020, respectively. The components of the approximate $100,000 net decrease of approximately $388,000 was comprisedprimarily attributed to decline in compensation expense of increases in salary and employee benefit expenses of $250,000 andapproximately $641,000, representing a decline stock-based compensation expense of $364,000; an increase in investor relationsapproximately $828,000 representing restricted stock units and advisory fees of $527,000, and an increase in legal and other consultants, office and insurance expenses totaling $347,000; offset by $518,000 of directors’ stock-based compensation decline from 2021 and approximately $1 million relatedstock options awarded to the purchase of Neuroscience biopharmaceutical assets which closed on June 10, 2021 recognizedexecutive management team in the three months ended March 31, 2021.September 30, 2021 and increase of approximately $187,000 related to increase in staff from two to four and annual salary increases. The remaining net increase of approximately $239,000 was attributed to increased expenses related to being listed on a national exchange including listing fees and investor relations and advisory $197,000, increase in directors stock compensation of approximately $162,000 stock options awarded and other net increases totaling approximately $54,000 representing insurance and office and website development expenses offset by a decline in other legal and professional fees of approximately $174,000.

 

Other Income/Income and Expense

Other expense, net was $1.6 million for the three months ended March 31,September 30, 2022 was $1.3 million compared to approximately $35,000nearly nil for the three months ended March 31,September 30, 2021. The increase forInterest expense of $1.1 million recognized during the three months ended March 31,September 30, 2022 was comprised ofattributed to the $15 million debt financing obtained in November 2021 and the change in fair value of the related derivative liabilities of approximately $386,000 and interest expense of approximately $918,000. Inrecognized for the three month periodmonths ended March 31, 2021 there were no derivative liabilities or debt outstanding.September 30, 2022 was approximately $567,000.

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Comparison of the nine months ended March 31, 2022 to the nine months ended March 31, 2021

Net (loss)/Income

The net loss for the nine months ended March 31, 2022 was approximately $18.0 million as compared to net income of $1.3 million for the nine months ended March 31, 2021. The decline from net income to net loss of approximately $19.3 million was attributed to an increase in the loss from operations of approximately $11.5 million and the change in the fair value of derivative liabilities of $7.1 million and an increase in interest expense of approximately $677,000.

Total operating expenses for the nine months ended March 31, 2022 were approximately $18 million as compared to $6.5 million for the nine months ended March 31, 2021.  The net increase of approximately $11.5 million during the nine months ended March 31, 2022 was primarily attributed to the expanded operations of the Company from the purchase of the Neuroscience pharmaceutical assets that was completed in June 2021. The net increase was comprised of increased research and development expenses of approximately $9.4 million, attributed to the Alzheimer pivotal Phase 3 clinical trial that was initiated in August 2021 and the continuation of our Orphan Drug candidate BIV201’s Phase 2b clinical trial, which was initiated earlier in the 2021 calendar year, and an increase in selling, general and administrative expenses of $2.1 million.

Research and Development Expenses

Research and development expenses were approximately $11.4 million and $2.0 million for the nine months ended March 31, 2022, and 2021, respectively. The net increase of approximately $9.4 million, was comprised of the Neuroscience clinical operations of approximately $4.9 million for the activities in the Alzheimer pivotal Phase 3 clinical trial and the preparations for the initiation of the Parkinson’s Phase 2 clinical that launched in January 2022; an increase of approximately $1.3 million for the ongoing Orphan Drug candidate BIV201’s Phase 2b clinical trial; and increases in salary and employee benefit expenses of $2.1 million and stock based compensation expense of $1.0 million. The Company expanded the clinical team personnel by the hiring of the neuroscience personnel to oversee the development of the biopharmaceutical assets purchased in June 2021, our CMO who came on board on November 1, 2021 and other related clinical personnel during the three months ended March 31, 2022.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were approximately $6.4 million and $4.3 million for the nine months ended March 31, 2022 and 2021, respectively. The net increase of approximately $2.1 million was primarily comprised of increased salary and employee benefit expenses of approximately $546,000, stock based compensation expense of $2.0 million ; increased legal expense of $620,000; investor relations and advisory of $729,000; and approximately $442,000 of increased expenses related to other consulting fees, insurance premiums, office and website development expenses, as the Company operations were expanded during the nine months ended March 31, 2022 with the addition of Neuroscience operations in June 2021. These increases were offset by $1.1 million of directors’ stock-based compensation and $1.1 million related to the purchase of Neuroscience biopharmaceutical assets which closed on June 10, 2021.

Other Expense/(Income)

Other expense, net for the nine months ended March 31, 2022 was a nominal amount and comprised of net interest expense of $1.2 million offset by the change in fair valued of the derivative liabilities of $1.2 million compared to other income, net of $7.7 million for the nine months ended March 31, 2021 which was comprised of net interest expense of $545,000 offset by the change in fair value of $8.3 million. The increase in net interest expense and change in fair value of the derivative liabilities is related to debt financing that was funded in November 30, 2021.

Capital Resources and Liquidity

 

As of March 31,September 30, 2022, the Company had working capital of approximately $20.5$17.5 million, cash of approximately $24.5$21.2 million, stockholders’ equity of approximately $10.0$6.0 million, and an accumulated deficit of approximately $242.9$261.4 million. In addition, the Company has not generated any revenues to date and no revenues are expected in the foreseeable future. The Company’s future operations are dependent on the success of the Company’s ongoing development and commercialization efforts, as well as its ability to secure additional financing as needed.

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In November 2021, the Company closed a debt financing, pursuant to which it received a loan in the aggregate principal amount of $15 million and incurred direct financing costs of approximately $390,000. Although the increase in the Company’s cash balance could possibly sustain operations over the next 12 months if measures are taken to delay planned expenditures in our research protocols and slow the progress in the Company’s clinical programs, given the Company’s current planned operations to meet certain goals and objectives, we expect projected cash flows to be depleted within that period of time.

  

The future viability of the Company is largely dependent upon its ability to raise additional capital to finance its operations. We cannot assure youManagement expects that our drug candidate will be developed, work,future sources of funding may include sales of equity, obtaining loans, or receive regulatory approval; that we will ever earn revenues sufficient to support our operations or that we will ever be profitable. Furthermore, since we have no committed source of sufficient financing, we cannot assure that we will be able to raise money as and when we need it to continue our operations. If we cannot raise funds as and when we need them, we may be required to severely curtail, or even to cease, our operations.other strategic transactions.

 

Although management continues to pursue its strategic plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company, if at all, to fund continuing operations. Management intends to attempt to secure additional required funding primarily through additional equity or debt financings.  We may also seek to secure required funding through sales or out-licensing of intellectual property assets, seeking partnerships with other pharmaceutical companies or third parties to co-develop and fund research and development efforts, or similar transactions.  However, there can be no assurance that we will be able to obtain required funding.  If we are unsuccessful in securing funding from any of these sources, we will defer, reduce or eliminate certain planned expenditures in our research protocols.  If we do not have sufficient funds to continue operations, we could be required to seek bankruptcy protection or other alternatives that could result in our stockholders losing some or all of their investment in us.

The continual widespread health emergencies or pandemics such as the coronavirus (“COVID-19”) pandemic (and its related variants), has lead to continued regional quarantines, business shutdowns, labor shortages, disruptions to supply chains, and overall economic instability. Although some jurisdictions have relaxed these measures, others have not or have reinstated them as COVID-19 cases and its variants continue to emergeThe duration and spread of the COVID-19 pandemic and the long-term impact of COVID-19 and its variants on the financial markets and the overall economy are highly uncertain and cannot be predicted at this time. 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. In addition, the COVID-19 pandemic has created a widespread labor shortage, including a shortage of medical professionals, and has impacted and may possiblycontinue to impact the potential patient participation in our studies, of which may adversely impact our ability to continue or complete our clinical trials in the planned timeline.

 

Although management continues to pursue the Company’s strategic plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company, if at all, to fund continuing operations. These circumstances raise substantial doubt on ourthe Company’s ability to continue as a going concern. The financial statements included in this report do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts and classification of liabilities that might result from the outcome of this uncertainty.

 

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Off-Balance Sheet Arrangements

 

The Company has no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect or change on the Company’s financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors. The term “off-balance sheet arrangement” generally means any transaction, agreement or other contractual arrangement to which an entity unconsolidated with the Company is a party, under which the Company has (i) any obligation arising under a guarantee contract, derivative instrument or variable interest; or (ii) a retained or contingent interest in assets transferred to such entity or similar arrangement that serves as credit, liquidity or market risk support for such assets.

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Critical Accounting Policies and Estimates

 

For the three-month and nine month periodsperiod ended March 31,September 30, 2022, there were no significant changes to the Company’s critical accounting policies as identified in the Annual Report Form 10-K for the fiscal year ended June 30, 2021.2022.

 

New Accounting Pronouncements

 

The Company considered the applicability and impact of recent accounting pronouncements and determined those to be either not applicable or expected to have minimal impact on our balance sheets or statement of operations.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

Not applicable to smaller reporting companies.

 

Item 4. Controls and Procedures

 

We maintain “disclosure controls and procedures.” Such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in Securities and Exchange Commission rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Office and Chief Financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Our disclosure controls and procedures have been designed to meet reasonable assurance standards. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgement in evaluating the cost-benefit relationship of possible disclosure and procedures. The design of and disclosure controls and procedures also are based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

 

Based on their evaluation as of the end of the period covered by this Quarterly Report on Form 10-Q, our Chief Executive Officer and Chief Financial Officer have concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level, as appropriate, to allow timely decisions regarding required disclosure.

 

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting (as defined in Rule 13a-15f and 15d-15(f) under the Exchange Act) that occurred during the quarter ended March 31,September 30, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings

 

To our knowledge, neither the Company nor any of its officers or directors is a party to any material legal proceeding or litigation and such persons know of no material legal proceeding or contemplated or threatened litigation. There are no judgments against us or our officers or directors. None of our officers or directors has been convicted of a felony or misdemeanor relating to securities or performance in corporate office.

 

Item 1A. Risk Factors

Except as described below, there have been no material changes to the Risk Factors previously disclosed in our Form 10-K. The risks described in our Form 10-K and below are not the only risks facing our company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, and/or operating results.

Risks Relating to Our Business and Industry

If the FDA or comparable foreign regulatory authorities approve generic versions of any of our product candidates that receive marketing approval, or such authorities do not grant our products sufficient, or any, periods of exclusivity before approving generic versions of our products, the sales of our products could be adversely affected.

Once a new drug application (“NDA”) is approved, the product covered thereby becomes a “reference listed drug” or RLD, in the FDA’s publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book. Other manufacturers may seek approval of generic versions of reference listed drugs through submission of abbreviated new drug applications (“ANDAs”) in the United States. In support of an ANDA, a generic manufacturer need not conduct clinical trials. Rather, the applicant generally must show that its product has the same active ingredient(s), dosage form, strength, route of administration and conditions of use or labeling as the reference listed drug and that the generic version is bioequivalent to the reference listed drug, meaning it is absorbed in the body at the same rate and to the same extent as the RLD. Generic products may be significantly less costly to bring to market than the reference listed drug and companies that produce generic products are generally able to offer them at lower prices. Moreover, generic versions of RLDs are often automatically substituted for the RLD by pharmacies when dispensing a prescription written for the RLD. Thus, following the introduction of a generic drug, a significant percentage of the sales of any branded product or reference listed drug is typically lost to the generic product.

The FDA may not approve an ANDA for a generic product until any applicable period of non-patent exclusivity for the RLD has expired. The U.S. federal Food, Drug, and Cosmetic Act (“FDCA”) provides a period of five years of non-patent exclusivity for a new drug containing a new chemical entity (“NCE”). An NCE is an active ingredient that has not previously been approved by FDA alone or in combination with other substances. Specifically, in cases where such exclusivity has been granted, an ANDA may not be submitted to the FDA until the expiration of five years unless the submission is accompanied by a Paragraph IV Certification that a patent covering the reference listed drug is either invalid or will not be infringed by the generic product, in which case the applicant may submit its application four years following approval of the reference listed drug. If an ANDA is submitted to FDA with a Paragraph IV Certification, the generic applicant must also provide a Paragraph IV Notification to the holder of the NDA for the RLD and to the owner of the listed patent(s) being challenged by the ANDA applicant, providing a detailed written statement of the basis for the ANDA applicant’s position that the relevant patent(s) is invalid or would not be infringed. If the patent owner brings a patent infringement lawsuit against the ANDA applicant within 45 days of the Paragraph IV Notification, FDA approval of the ANDA will be automatically stayed for 30 months, or until 7-1/2 years after the NDA approval if the generic application was filed between 4 years and 5 years after the NDA approval. Any such stay will be terminated earlier if the court rules that the patent is invalid or would not be infringed.

Competition that our products may face from generic versions of our products could materially and adversely impact our future revenue, profitability and cash flows and substantially limit our ability to obtain a return on the investments we have made in those product candidates.

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If we fail to obtain or maintain Orphan Drug exclusivity for BIV201, we will have to rely on other potential marketing exclusivity, and on our intellectual property rights, which may reduce the length of time that we can prevent competitors from selling generic versions of BIV201.

We have obtained Orphan Drug Designation for BIV201 (terlipressin) in the U.S. for the treatment of hepatorenal syndrome (received November 21, 2018) and treatment of ascites due to all etiologies except cancer (received September 8, 2016). Under the Orphan Drug Act, the FDA may designate a product as an Orphan Drug if it is a drug intended to treat a rare disease or condition, defined, in part, as a patient population of fewer than 200,000 in the U.S. In the EU, Orphan Drug designation may be granted to drugs intended to treat, diagnose or prevent a life-threatening or chronically debilitating disease having a prevalence of no more than five in 10,000 people in the EU, and which meet other specified criteria. The company that first obtains FDA approval for a designated Orphan Drug for the associated rare disease may receive a seven-year period of marketing exclusivity during which time FDA may not approve another application for the same drug for the same orphan disease or condition. Orphan Drug Exclusivity does not prevent FDA approval of another application for the same drug for a different disease or condition, or of an application for a different drug for the same rare disease or condition. Orphan Drug exclusive marketing rights may be lost under several circumstances, including a later determination by the FDA that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug. Similar regulations are available in the EU with a ten-year period of market exclusivity.

Even though BioVie has obtained two Orphan Drug Designations for its lead product candidate, terlipressin, for treatment of ascites and for treatment of HRS, and may seek other Orphan Drug Designations for BIV201, and Orphan Drug Designation for other product candidates, there is no assurance that BioVie will be the first to obtain marketing approval for any particular rare indication. Further, even though BioVie has obtained Orphan Drug Designations for its lead product candidate, or even if BioVie obtains Orphan Drug Designation for other potential product candidates, such designation may not effectively protect BioVie from competition because different drugs can be approved for the same condition and the same drug can be approved for different conditions and potentially used off-label in the Orphan indication. Even after an Orphan Drug is approved, the FDA can subsequently approve another competing drug with the same active ingredient for the same condition for several reasons, including, if the FDA concludes that the later drug is clinically superior due to being safer or more effective or because it makes a major contribution to patient care. Orphan Drug Designation neither shortens the development time or regulatory review time of a drug, nor gives the drug any advantage in the regulatory review or approval process.

In fact, Mallinckrodt recently received an NDA approval for its terlipressin product for the hepatorenal syndrome (“HRS”) indication in September 2022, which is the same indication for which we had received an Orphan Designation. FDA granted Mallinckrodt and its approved drug a new chemical entity exclusivity. Similarly, if another company with an Orphan Drug designation for the same drug as ours for the same proposed disease or condition receives FDA approval and orphan drug exclusivity before our product is approved, approval of our drug(s) for the orphan indication may be blocked for seven years by the other company’s orphan drug exclusivity and they may obtain a competitive advantage even after the exclusivity period expires associated with being the first to market.  

We may face business disruption and related risks resulting from the outbreak of the novel coronavirus 2019 (COVID-19)if there is another surge ofCOVID-19 or if there is another pandemic caused by other bacteria or viruses, which could have a material adverse effect on our business plan.

The continual widespread healthHealth emergencies or pandemics, such as the coronavirus (“COVID-19”) pandemic (and its related variants), has ledwhether from COVID-19 or other viruses or bacteria, may lead to continued regional quarantines, business shutdowns, labor shortages, disruptions to supply chains, and overall economic instability, which could materially and adversely affect the clinical trials, supply chain, financial condition and financial performance of our company. Although some jurisdictions have relaxed these measures, others have not or have reinstated them as COVID-19 cases surge and its variants continue to emerge. The duration and spread of the COVID-19a pandemic and theits long-term impact of COVID-19 and its variants on the financial markets and the overall economy are highly uncertain and cannot be predicted at this time.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. In addition, the COVID-19 pandemic has createdsuch health emergencies or pandemics may create a widespread labor shortage, including a shortage of medical professionals, and has impacted and may continue to impact the potential patient participation in our studies of which may adversely impact our ability to continue or complete our clinical trials in the planned timeline.

We can provide no assurance that our product candidates will obtain regulatory approval or that the results of clinical studies will be favorable.

The business plan we have developed through June 2024 for the liver disease program is to complete the Phase 2b clinical development program for our lead new product candidate BIV201 for treatment of ascites, conduct a single pivotal Phase 3 trial of BIV201 for ascites, and to pursue other key milestones such as additional patent issuances. For NE3107, we have commenced a potentially pivotal 18-month Phase 3 trial in Alzheimer’s disease, commenced a Phase 2 study of NE3017 in Parkinson’s disease. Due to our financial constraints, we do not have the resources necessary to complete all of these clinical studies. Subject to FDA guidance, we plan to commence additional Phase 2 and potentially Phase 3 clinical trials upon receipt of a successful capital raise. There is no guarantee the FDA will approve the commencement of a Phase 3 trial for BIV201, and even if it does, our financial constraints may prevent us from undertaking clinical trials.

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We may be unable to obtain or protect intellectual property rights relating to our product candidates, and we may be liable for infringing upon the intellectual property rights of others, which could have a materially adverse effect on our business.

Our ability to compete effectively will depend on our ability to maintain the proprietary nature of our technologies. We cannot assure investors that we will continue to innovate and file new patent applications, or that if filed any future patent applications will result in granted patents with respect to the technology owned by us or licensed to us. Further, we cannot predict how long it will take for such patents to issue, if at all. The patent position of pharmaceutical or biotechnology companies, including ours, is generally uncertain and involves complex legal and factual considerations and, therefore, validity and enforceability cannot be predicted with certainty. Patents may be challenged, deemed unenforceable, invalidated or circumvented.

BioVie has also filed a PCT (“Patent Cooperation Treaty”) application covering our novel liquid formulations of terlipressin (international patent application PCT/US2020/034269 published as WO2020/237170) and we are seeking patent protection in the United States, Europe, China, Japan and eight other jurisdictions. As of August 22, 2022, we have fifteen (15) issued U.S. patents, one (1) pending U.S. patent application, one (1) pending PCT application and six (6) issued foreign patents directed to protecting NE3107 and related compounds and methods of making and using thereof. However, there can be no assurance that our pending patent applications will result in issued patents, or that any issued patent claims from pending or future patent applications will be sufficiently broad to protect BIV201, NE3107, or any other product candidates or to provide us with competitive advantages. 

Any patents we do obtain may be challenged by re-examination or otherwise invalidated or eventually found unenforceable. Both the patent application process and the process of managing patent disputes can be time consuming and expensive. If we were to initiate legal proceedings against a third party to enforce a patent related to one of our products, the defendant in such litigation could counterclaim that our patent is invalid and/or unenforceable. In patent litigation in the U.S., defendant counterclaims alleging invalidity and/or unenforceability are commonplace, as are validity challenges by the defendant against the subject patent or other patents before the United States Patent and Trademark Office (the “USPTO”). Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness or non-enablement, failure to meet the written description requirement, indefiniteness, and/or failure to claim patent eligible subject matter. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent intentionally withheld material information from the USPTO, or made a misleading statement, during prosecution. Additional grounds for an unenforceability assertion include an allegation of misuse or anticompetitive use of patent rights, and an allegation of incorrect inventorship with deceptive intent. Third parties may also raise similar claims before the USPTO even outside the context of litigation. The outcome is unpredictable following legal assertions of invalidity and unenforceability. With respect to the validity question, for example, we cannot be certain that no invalidating prior art existed of which we and the patent examiner were unaware during prosecution. These assertions may also be based on information known to us or the Patent Office. If a defendant or third party were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the claims of the challenged patent. Such a loss of patent protection would or could have a material adverse impact on our business.

The standards that the United States Patent and Trademark Office (and foreign countries) use to grant patents are not always applied predictably or uniformly and can change. There is also no uniform, worldwide policy regarding the subject matter and scope of claims granted or allowable in pharmaceutical or biotechnology patents. Accordingly, we do not know the degree of future protection for our proprietary rights or the breadth of claims that will be allowed in any patents issued to us or to others.

Further, we rely on a combination of trade secrets, know-how, technology and nondisclosure, and other contractual agreements and technical measures to protect our rights in the technology. If any trade secret, know-how or other technology not protected by a patent were to be disclosed to or independently developed by a competitor, our business and financial condition could be materially adversely affected. The laws of some foreign countries do not protect our proprietary rights to the same extent as the laws of the U.S., and we may encounter significant problems in protecting our proprietary rights in these countries.

We do not believe that either BIV201 or NE3107, the product candidates we are currently developing, infringe upon the rights of any third parties nor are they infringed upon by third parties. However, there can be no assurance that our technology will not be found in the future to infringe upon the rights of others or be infringed upon by others. Moreover, patent applications are in some cases maintained in secrecy until patents are issued. The publication of discoveries in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were made and patent applications were filed. Because patents can take many years to issue, there may be currently pending applications of which we are unaware that may later result in issued patents that our products or product candidates infringe. For example, pending applications may exist that provide support or can be amended to provide support for a claim that results in an issued patent that our product infringes. In such a case, others may assert infringement claims against us, and should we be found to infringe upon their patents, or otherwise impermissibly utilize their intellectual property, we might be forced to pay damages, potentially including treble damages, if we are found to have willfully infringed on such parties’ patent rights. In addition to any damages we might have to pay, we may be required to obtain licenses from the holders of this intellectual property. We may fail to obtain any of these licenses or intellectual property rights on commercially reasonable terms. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. In that event, we may be required to expend significant time and resources to develop or license replacement technology. If we are unable to do so, we may be unable to develop or commercialize the affected products, which could materially harm our business and the third parties owning such intellectual property rights could seek either an injunction prohibiting our sales, or, with respect to our sales, an obligation on our part to pay royalties and/or other forms of compensation. Conversely, we may not always be able to successfully pursue our claims against others that infringe upon our technology. Thus, the proprietary nature of our technology or technology licensed by us may not provide adequate protection against competitors.

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The pharmaceutical industry is characterized by extensive litigation regarding patents and other intellectual property rights. Moreover, the cost to us of any litigation or other proceeding relating to our patents and other intellectual property rights, even if resolved in our favor, could be substantial, and the litigation would divert our management’s efforts. We may not have sufficient resources to bring any such action to a successful conclusion. Uncertainties resulting from the initiation and continuation of any litigation could limit our ability to continue our operations and you could lose all of your investment.

There may be conflicts of interest among our officers, directors and stockholders.

Certain of our executive officers and directors and their affiliates are engaged in other activities and have interests in other entities on their own behalf or on behalf of other persons. Neither we nor any of our stockholders will have any rights in these ventures or their income or profits. In particular, our executive officers or directors or their affiliates may have an economic interest in or other business relationship with partner companies that invest in us or are engaged in competing drug development. Our executive officers or directors may have conflicting fiduciary duties to us and third parties. The terms of transactions with third parties may not be subject to arm’s length negotiations and therefore may be on terms less favorable to us than those that could be procured through arm’s length negotiations.

Risks Relating To Our Common Stock

You may experience future dilution as a result of future equity offerings or if we issue shares subject to options, warrants, stock awards or other arrangements.

In order to raise additional capital, we may in the future offer additional shares of our common stock or other securities convertible into or exchangeable for our common stock, at prices thatincluding under the Controlled Equity Offering Sales Agreement (the “Sales Agreement”), dated as of August 31, 2022, by and among the Company, Cantor Fitzgerald & Co. and B. Riley Securities, Inc. (collectively, the “Agents”), pursuant to which the Company may not beissue and sell from time to time shares of common stock through the same as the price per share in this offering.Agents. We may sell shares or other securities in any other offering at a price per share that is less than the current market price per share paid by investors in this offering,of our securities, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders. The price per share at which we sellsale of additional shares of common stock or other securities convertible into or exchangeable for our common stock orwould dilute all of our stockholders, and if such sales of convertible securities convertibleinto or exchangeable into our common stock in future transactions may be higher oroccur at a deemed issuance price that is lower than the current exercise price per share paid by investorsof our outstanding warrants sold to Acuitas Group Holdings, LLC (“Acuitas”) in this offering.August 2022, the exercise price for those warrants would adjust downward to the deemed issuance price pursuant to price adjustment protection contained within those warrants.

In addition, as of March 31,November 3, 2022, there were warrants outstanding to purchase an aggregate of 511,4637,778,285 shares of common stock at exercise prices ranging from $1.88$1.82 to $75.00$12.50 per share and 2,438,0443,345,530 shares issuable upon exercise of outstanding options at exercise prices ranging from $2.74$1.69 to $42.09 per share. Our Loan Agreement entered into on November 30, 2021 contains a conversion feature whereby at the option of lender, up to $5 million of the outstanding loan amount maybe converted to shares of common stock at a conversion price of $6.98 per share. We may grant additional options, warrants or stock awards. To the extent such shares are issued, the interest of holders of our common stock will be diluted.

Moreover, we are obligated to issue shares of common stock upon achievement of certain clinical, regulatory and commercial milestones with respect to certain of our drug candidates (i.e., NE3107, NE3291, NE3413, and NE3789) pursuant to the asset purchase agreement, dated April 27, 2021, by and among the Company, NeurMedix, Inc. and Acuitas, Group Holdings, LLC, as amended on May 9, 2021.2021 (the “Asset Purchase Agreement”). The achievement of these milestones could result in the issuance of up to 18 million shares of our common stock, further diluting the interest of holders of our common stock.

Certain stockholders who are also officers and directors of the Company may have significant control over our management.

As of November 3, 2022, our directors and executive officers currently own an aggregate              shares of our common stock, which currently constitutes 76.7% of our issued and outstanding common stock. As a result, directors and executive officers may have a significant influence on our affairs and management, as well as on all matters requiring member approval, including electing and removing members of our board of directors, causing us to engage in transactions with affiliated entities, causing or restricting our sale or merger, and certain other matters. Our Chairman, Mr. Terren Peizer, may be deemed to beneficially own the shares held by Acuitas. Such concentration of ownership and control could have the effect of delaying, deferring or preventing a change in control of us even when such a change of control would be in the best interests of our stockholders.

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There is a limited trading market for our common stock, which could make it difficult to liquidate an investment in our common stock, in a timely manner.

Our common stock is currently traded on the Nasdaq Capital Market. Because there is a limited public market for our common stock, investors may not be able to liquidate their investment whenever desired. We cannot assure that there will be an active trading market for our common stock and the lack of an active public trading market could mean that investors may be exposed to increased risk. In addition, if we failed to meet the criteria set forth in SEC regulations, various requirements would be imposed by law on broker dealers who sell our securities to persons other than established customers and accredited investors. Consequently, such regulations may deter broker-dealers from recommending or selling our common stock, which may further affect its liquidity.

We may, in the future, issue additional common stock, which would reduce investors’ percent of ownership and may dilute our share value.

As of November 3, 2022 our Articles of Incorporation, as amended, authorize the issuance of 800,000,000 shares of common stock, and we had 30,532,830 shares of common stock outstanding. Accordingly, we may issue up to an additional 769,467,170 shares of common stock. The future issuance of common stock may result in substantial dilution in the percentage of our common stock held by our then existing stockholders. We may value any common stock in the future on an arbitrary basis. The issuance of common stock for future services or acquisitions or other corporate actions may have the effect of diluting the value of the shares held by our investors, might have an adverse effect on any trading market for our common stock and could impair our ability to raise capital in the future through the sale of equity securities.

 

Item 2. Unregistered Salessales of Equity Securitiesequity securities

 

None Other than equity securities issued in transactions disclosed on our Current Report on Form 8-K/A filed with the SEC on July 18, 2022, there were no unregistered sales of equity securities during the period.

 

Item 3. Defaults Upon Senior Securities

 

None

 

Item 4. Mine Safety Disclosures

 

Not applicableNone

 

Item 5. Other Information

 

None

On August 15, 2022, in connection with the consummation of the Private Placement, the Company entered into an amended and restated registration statement with Acuitas, which amended and restated that certain Registration Rights Agreement, dated as of June 10, 2021, by and between the Company and Acuitas (the “Existing Registration Rights Agreement”), to amend the definition of “Registrable Securities” in the Existing Registration Rights Agreement to include the PIPE Shares and the Warrant Shares as Registrable Securities thereunder.

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Item 6. Exhibits

 

(a) Exhibit index

Exhibit
4.1Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K/A (File No. 001-39015) filed on July 18, 2022).
10.1Securities Purchase Agreement, dated July 15, 2022, by and between the Company and Acuitas Group Holdings, LLC (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K/A (File No. 001-39015) filed on July 18, 2022).
10.2*Amended and Restated Registration Rights Agreement, dated August 15, 2022, by and between BioVie Inc. and Acuitas Group Holdings, LLC.
10.3Controlled Equity OfferingSM Sales Agreement, dated August 31, 2022, by and among BioVie Inc. Cantor Fitzgerald & Co. and B. Riley Securities, Inc. (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K (File No. 001-39015) filed on August 31, 2022).

31.1* Certification of Chief Executive Officer (Principal Executive Officer) required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.
   
31.2* Certification of Chief Financial Officer (Principal Financial Officer) required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.
   
32.1** Certifications of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
   
32.2** Certification of Chief Financial Officer (Principal Financial Officer) pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
   
101.INS XBRL Instance Document
   
101.SCH XBRL Taxonomy Extension Schema Document
   
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document
   
101.LAB XBRL Taxonomy Extension Label Linkbase Document
   
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document
   
101.DEF XBRL Taxonomy Extension Definition Linkbase Document

*Filed herewith.

**Furnished herewith. This certification is being furnished solely to accompany this report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filings of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

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SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

BioVie Inc.,

     
Signature Titles Date
     
/s/ Cuong V Do    
     Cuong V Do Chairman and Chief Executive Officer (Principal Executive Officer) May 11,November 4, 2022
     
/s/ Joanne Wendy Kim    
     Joanne Wendy Kim Chief Financial Officer (Principal Financial and Accounting Officer) May 11,November 4, 2022

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