10-Q 1 bivi-20240331_10q.htm FORM 10-Q FOR PERIOD ENDING MARCH 31, 2024
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended: March 31, 2024

 

  TRANSITION 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 204
Carson City, NV 89703
(Address of principal executive offices, Zip Code)
 
(775) 888-3162
(Registrant’s telephone number, including area code)

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
Class A Common Stock, par value $0.0001 per share BIVI The 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 No

 

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 No

 

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 Accelerated filer
Non-accelerated filer Smaller reporting company
    Emerging growth company

 

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 

 

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

 

Yes No

 

There were 61,018,606 shares of the Registrant’s $0.0001 par value Class A common stock outstanding as of May 10, 2024.

 

 

 

   

  

TABLE OF CONTENTS

 

PART I – FINANCIAL INFORMATION  
     
Item 1. Unaudited Financial Statements  
  Condensed Balance Sheets at March 31, 2024 and June 30, 2023 3
  Condensed Statements of Operations and Comprehensive Loss - for the three and nine months ended March 31, 2024 and 2023 4
  Condensed Statements of Cash Flows - for the nine months ended March 31, 2024 and 2023 5
  Condensed Statements of Changes in Stockholders’ Equity - for the periods from July 1, 2023 through March 31, 2024 and July 1, 2022 through March 31, 2023 6
  Notes to Unaudited Condensed Financial Statements 7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 26
Item 3. Quantitative and Qualitative Disclosures About Market Risk 31
Item 4. Controls and Procedures 32
     
PART II – OTHER INFORMATION  
     
Item 1. Legal Proceedings 33
Item 1A. Risk Factors 33
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 36
Item 3. Defaults Upon Senior Securities 36
Item 4. Mine Safety Disclosures 36
Item 5. Other Information 36
Item 6. Exhibits 37
     
SIGNATURES 38

 

FORWARD-LOOKING STATEMENTS

 

This report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. 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 requirements; and our ability to satisfy 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.

 

You are cautioned not to place undue reliance on the forward-looking statements in this report, which speak only as of the date of this report. 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, except as required by law. 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.

 

 2 

  

PART I – FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

BioVie Inc.

Condensed Balance Sheets

(Unaudited)

 

           
   March 31,   June 30, 
   2024   2023 
ASSETS          
           
CURRENT ASSETS:          
Cash and cash equivalents  $30,350,337   $19,460,883 
Investments in U.S. Treasury Bills   -    14,477,726 
Prepaids and other current assets   189,582    102,526 
Total current assets   30,539,919    34,041,135 
           
Operating lease right-of-use assets, net   422,169    80,789 
Intangible assets, net   465,062    637,095 
Goodwill   345,711    345,711 
           
TOTAL ASSETS  $31,772,861   $35,104,730 
           
LIABILITIES AND STOCKHOLDERS' EQUITY          
           
CURRENT LIABILITIES:          
Accounts payable and accrued expenses  $4,409,754   $3,476,259 
Other current liabilities   -    48,385 
Current portion of operating lease liabilities   57,143    44,909 
Current portion of note payable, net of financing cost, unearned premium and discount of $492,905 at March 31, 2024 and $894,926 at June 30, 2023   7,992,904    9,105,074 
Warrant liabilities   20,703    894,280 
Embedded derivative liability   -    925,762 
Total current liabilities   12,480,504    14,494,669 
           
Operating lease liabilities, net of current portion   366,430    42,505 
Note payable, net of current portion, financing cost, unearned premium and discount of $0 and $227,270 at March 31, 2024 and June 30, 2023, respectively.   -    5,227,270 
           
TOTAL LIABILITIES   12,846,934    19,764,444 
           
Commitments and contingencies (Note 12)          
           
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, 2024 and June 30, 2023, respectively; 61,018,606 shares issued of which 60,969,846 shares are outstanding at March 31, 2024; and 36,451,829 shares issued of which 36,428,949 shares outstanding at June 30, 2023;   6,115    3,643 
Additional paid in capital   348,211,684    316,385,759 
Accumulated other comprehensive income   -    176,591 
Accumulated deficit   (329,291,867)   (301,225,705)
Treasury stock   (5)   (2)
Total stockholders' equity   18,925,927    15,340,286 
           
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY  $31,772,861   $35,104,730 

 

See accompanying notes to unaudited condensed financial statements

 

 3 

  

BioVie Inc.

Condensed Statements of Operations and Comprehensive Loss

(Unaudited) 

 

                     
   Three Months Ended   Three Months Ended   Nine Months Ended   Nine Months Ended 
   March 31, 2024   March 31, 2023   March 31, 2024   March 31, 2023 
                 
OPERATING EXPENSES:                    
Amortization  $57,344   $57,344   $172,033   $172,033 
Research and development expenses   5,700,447    11,196,835    21,046,369    24,999,665 
Selling, general and administrative expenses   1,974,264    2,520,330    6,170,883    8,931,957 
TOTAL OPERATING EXPENSES   7,732,055    13,774,509    27,389,285    34,103,655 
                     
LOSS FROM OPERATIONS   (7,732,055)   (13,774,509)   (27,389,285)   (34,103,655)
                     
OTHER (INCOME) EXPENSE:                    
Change in fair value of derivative liabilities   (109,003)   366,093    (1,799,339)   4,154,645 
Interest expense   628,711    1,082,762    2,453,979    3,192,631 
Interest income   (183,933)   (182,201)   (864,186)   (307,055)
TOTAL OTHER (INCOME) EXPENSE, NET   335,775    1,266,654    (209,546)   7,040,221 
                     
NET LOSS  $(8,067,830)  $(15,041,163)  $(27,179,739)  $(41,143,876)
                     
Deemed dividend related to ratchet adjustment to warrants   886,423    -    886,423    - 
                     
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS  $(8,954,253)  $(15,041,163)  $(28,066,162)  $(41,143,876)
                     
NET LOSS PER COMMON SHARE                    
- Basic  $(0.20)  $(0.43)  $(0.70)  $(1.32)
- Diluted  $(0.20)  $(0.43)  $(0.70)  $(1.32)
                     
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING                    
- Basic   44,801,084    35,325,580    39,869,913    31,217,382 
- Diluted   44,801,084    35,325,580    39,869,913    31,217,382 
                     
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS  $(8,954,253)  $(15,041,163)  $(28,066,162)  $(41,143,876)
                     
Other comprehensive (loss) income                    
Unrealized gain on investments for available-for-sale   -    16,505    -    16,505 
Reclassification of unrealized gains on available-for-sale investments upon settlement   -    -    (176,591)   - 
Total other comprehensive (loss) income   -    16,505    (176,591)   16,505 
Comprehensive loss  $(8,954,253)  $(15,024,658)  $(28,242,753)  $(41,127,371)

 

See accompanying notes to unaudited condensed financial statements.

 

 4 

  

BioVie Inc.

Condensed Statements of Cash Flows

(Unaudited) 

 

           
   Nine Months Ended   Nine Months Ended 
   March 31, 2024   March 31, 2023 
         
CASH FLOWS FROM OPERATING ACTIVITIES:          
Net loss  $(27,179,739)  $(41,143,876)
Adjustments to reconcile net loss to net cash used in operating activities:          
Amortization of intangible assets   172,033    172,033 
Stock based compensation - restricted stock units   1,020,383    1,589,526 
Stock based compensation expense - stock options   2,118,649    3,480,425 
Amortization of financing costs   92,202    127,664 
Accretion of unearned loan discount   867,449    1,201,083 
Accretion of loan premium   200,909    329,267 
Realized gain on maturity of available-for sale   (223,865)   - 
Change in operating lease right-of-use assets   33,903    27,705 
Gain on termination of operating lease   (5,215)   - 
Change in fair value of derivative liabilities   (1,799,339)   4,154,645 
Changes in operating assets and liabilities:          
Prepaids and other assets   (87,056)   (111,911)
Accounts payable and accrued expenses   933,495    2,396,405 
Operating lease liabilities   (33,909   (28,519)
Other current liabilities   (48,385)   (1,159,768)
Net cash used in operating activities   (23,938,485)   (28,965,321)
           
CASH FLOWS FROM INVESTING ACTIVITIES:          
Proceeds from (purchases of) U.S. Treasury Bills   14,525,000    (12,504,943)
Net cash provided by (used in) investing activities   14,525,000    (12,504,943)
           
CASH FLOWS FROM FINANCING ACTIVITIES:          
Net proceeds from issuance of common stock   27,802,939    48,196,665 
Payment of note payable   (7,500,000)   - 
Proceeds from exercise of stock options   -    2,240 
Net proceeds from issuance of common stock - Related Party   -    5,905,840 
Net cash provided by financing activities   20,302,939    54,104,745 
           
Net increase in cash and cash equivalents   10,889,454    12,634,481 
           
Cash and cash equivalents, beginning of period   19,460,883    18,641,716 
           
Cash and cash equivalents, end of period  $30,350,337   $31,276,197 
           
SUPPLEMENTAL CASH FLOW INFORMATION:          
Cash paid for interest  $1,293,419   $62,693 
           
SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING ACTIVITIES:          
Right of use assets obtained in exchange for lease obligations  $432,192   $- 
Unrealized gain on U.S. Treasury Bills  $-   $16,505 
Reclassification of unrealized gains on available-for-sale investments upon settlement  $176,591   $- 
Deemed dividend of ratchet adjustment to warrants  $886,423   $- 

 

See accompanying notes to unaudited condensed financial statements.

 

 5 

  

BioVie Inc.

Condensed Statements of Changes in Stockholders’ Equity

(Unaudited)

 

                                         
                       Accumulated         
   Common Stock   Common Stock   Additional Paid in   Treasury Stock   Treasury Stock   Other Comprehensive   Accumulated   Total Stockholders' 
   Shares   Amount   Capital   Shares   Amount   Income   Deficit   Equity 
                                 
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 units   -    -    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 
                                         
Stock-based compensation - restricted stock units   -    -    1,554,453    -    -    -    -    1,554,453 
                                         
Stock option based compensation   -    -    1,712,787    -    -    -    -    1,712,787 
                                         
Cashless exercise of options   21,882    3    (3)   -    -    -    -    - 
                                         
Cashless exercise of warrants   3,590    -    -    -    -    -    -    - 
                                         
Proceeds from exercise of options   800    -    2,240    -    -    -    -    2,240 
                                         
Proceeds from issuance of common stock, net of costs of $1,206,206   4,312,741    431    32,254,230    -    -    -    -    32,524,661 
                                         
Net loss   -    -    -    -    -    -    (15,687,002)   (15,687,002)
                                         
Balance, December 31, 2022   34,504,332    3,449    303,137,216    -    -    -    (277,072,603)   26,068,062 
                                         
Stock-based compensation - restricted stock units   -    -    17,536    -    -    -    -    17,536 
                                         
Issuance of restricted stock units   134,501    13    (11)   (22,800)   (2)   -    -    - 
                                       - 
Stock option based compensation   -    -    888,998    -    -    -    -    888,998 
                                       - 
Proceeds from issuance of common stock, net of costs of $338,846   1,515,078    151    9,768,171    -    -    -    -    9,768,322 
                                         
Net loss   -    -    -    -    -    -    (15,041,163)   (15,041,163)
                                         
Unrealized gain on available-for-sale securities   -    -    -    -    -    16,505    -    16,505 
                                         
Balance, March 31, 2023   36,153,911   $3,613   $313,811,910    (22,800)  $(2)  $16,505   $(292,113,766)  $21,718,260 
                                         
Balance, June 30, 2023   36,451,829   $3,643   $316,385,759    (22,880)  $(2)  $176,591   $(301,225,705)  $15,340,286 
                                         
Stock - based compensation - stock options   -    -    808,027    -    -    -    -    808,027 
                                         
Stock-based compensation - restricted stock units   -    -    380,834    -    -    -    -    380,834 
                                         
Proceeds from issuance of common stock, net of costs of $118,891   432,201    43    1,905,793    -    -    -    -    1,905,836 
                                         
Issuance of common stock from vesting of - restricted stock units   38,730    4    (4)   -    -    -    -    - 
                                         
Net loss   -    -    -    -    -    -    (10,710,464)   (10,710,464)
                                         
Reclassification of unrealized gains on available for sale investments upon settlement   -    -    -    -    -    (176,591)   -    (176,591)
                                         
Balance, September 30, 2023   36,922,760    3,690    319,480,409    (22,880)   (2)   -    (311,936,169)   7,547,928 
                                         
Stock - based compensation - stock options   -    -    619,701    -    -    -    -    619,701 
                                         
Stock-based compensation - restricted stock units   -    -    303,173    -    -    -    -    303,173 
                                         
Proceeds from issuance of common stock, net of costs of $258,254   2,900,902    290    7,421,588    -    -    -    -    7,421,878 
                                         
Issuance of common stock from vesting of - restricted stock units   43,052    4    (4)   -    -    -    -    - 
                                         
Net loss   -    -    -    -    -    -    (8,401,445)   (8,401,445)
                                         
Balance, December 31, 2023   39,866,714    3,984    327,824,867    (22,880)   (2)   -    (320,337,614)   7,491,235 
                                         
Stock - based compensation - stock options   -    -    690,921    -    -    -    -    690,921 
                                         
Stock-based compensation - restricted stock units   -    -    336,376    -    -    -    -    336,376 
                                         
Issuance of common stock from vesting of - restricted stock units   147,508    15    (12)   (25,880)   (3)   -    -    - 
                                         
Proceeds from issuance of common stock, net of costs of $2,530,996   21,004,384    2,116    18,473,109    -    -    -    -    18,475,225 
                                         
Deemed dividend for ratchet adjustment to warrants   -    -    886,423    -    -    -    (886,423)   - 
                                         
Net loss   -    -    -    -    -    -    (8,067,830)   (8,067,830)
                                         
Balance, March 31, 2024   61,018,606   $6,115   $348,211,684    (48,760)  $(5)  $-   $(329,291,867)  $18,925,927 

 

See accompanying notes to unaudited condensed financial statements

 

 6 

  

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Nine Months Ended March 31, 2024 and 2023

(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 neurological and neuro-degenerative disorders and liver disease. 

 

The Company acquired the biopharmaceutical assets of NeurMedix, Inc. (“NeurMedix”) a privately held clinical-stage pharmaceutical company and a related party in June 2021. The acquired assets included NE3107. NE3107 is an investigational, 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 disease (“AD”) and Parkinson’s disease (“PD”), and NE3107 could, if approved by U.S. Food and Drug Administration (“FDA”), represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD and 1 million Americans suffering from PD.

 

Neurodengenerative Disease Program

 

In neurodegenerative disease, the Company’s drug candidate NE3107 inhibits activation of inflammatory actions extracellular single-regulated kinase (“ERK”) and nuclear factor kappa-light-chain-enhancer of activated B cells (“NFκB”) (including interactions with tumor necrosis factor (“TNF”) signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance. NE3107 does not interfere with their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both inflammation and insulin resistance are drivers of AD and PD.

 

Alzheimer’s Disease (NCT05083260)

 

On November 29, 2023, the Company announced the analysis of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of NE3107 in the treatment of mild to moderate AD. The study has co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive Scale (ADAS-Cog 12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Patients were randomly assigned, 1:1 versus placebo, to receive sequentially 5 mg of NE3107 orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed by 26 weeks of 20 mg orally twice daily.

 

Upon trial completion, as the Company began the process of unblinding the trial data, the Company found significant deviation from protocol and current good clinical practices (“cGCPs”) violations at 15 study sites (virtually all of which were from one geographic area). This highly unusual level of suspected improprieties led the Company to exclude all patients from these sites and to refer the sites to the FDA Office of Scientific Investigations (“OSI”) for further action. After the patient exclusions, 81 patients remained in the Modified Intent to Treat population, 57 of whom were in the Per-Protocol population which included those who completed the trial and were verified to take study drug from pharmacokinetic data.

 

The trial was originally designed to be 80% powered with 125 patients in each of the treatment and placebo arms. The unplanned exclusion of so many patients has left the trial underpowered for the primary endpoints. In the Per-Protocol population, which included those patients who completed the trial and who were further verified to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest a slowing of cognitive loss; these same patients experienced an advantage in age deceleration vs. placebo as measured by DNA epigenetic change. Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this case as measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age. This test was a non-primary/secondary endpoint, other-outcome measure, done via blood test collected at week 30 (end of study). Additional DNA methylation data continues to be collected and analyzed.

 

 7 

  

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Nine Months Ended March 31, 2024 and 2023

(unaudited)

 

1. Background Information (continued)

 

Parkinson’s Disease (NCT05083260)

 

The Phase 2 study of bezisterim (NE3107) for the treatment of PD (NCT05083260), completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and bezisterim (NE3107). Forty-five patients with a defined L-dopa “off state” were randomized 1:1 to placebo: bezisterim (NE3107) 20 mg twice daily for 28 days. This trial was launched with two design objectives: 1) the primary objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for adverse interactions of bezisterim (NE3107) with carbidopa/ levodopa; and 2) the secondary objective was to determine if preclinical indications of promotoric activity and apparent enhancement of levodopa activity could be seen in humans. Both objectives were met.

 

Long COVID Program

 

In April 2024, the Company announced the grant of a clinical trial award of up to $13.1 million from the U.S. Department of Defense (“DOD”), awarded through the Peer Reviewed Medical Research Program (“PRMRP”) of the Congressionally Directed Medical Research Programs (“CDMRP”). The award can provide up to 2 years of non-dilutive funding for a Phase 2b clinical trial that will assess bezisterim (NE3107) for the treatment of neurological symptoms that are associated with long COVID. The Company anticipates the trial to commence by early 2025.

 

Long COVID is a condition in which symptoms of COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more. The Centers for Disease Control recently reported that 6.8% of adults in the United States (more than 17 million individuals) currently or previously had long COVID. Symptoms, which include fatigue, cognitive dysfunction and sleep disturbances, are debilitating. The loss in quality of life and earnings and increased medical costs has an enormous economic impact estimated to be 3.7 trillion dollars. To date there are no therapies proven effective for treatment.

 

Chronic inflammation is one of the main hypotheses that researchers have proposed to explain the persistence of symptoms in long COVID. Specifically in individuals with “brain fog,” sustained systemic inflammation and persistent localized blood-brain-barrier (“BBB”) dysfunction are key physiological features. Bezisterim (NE3107) permeates the BBB and has been shown to modulate inflammation via the activation of NF-kB, thus representing a novel oral treatment targeting an underlying cause of long COVID symptoms.

 

Neuroinflammation, insulin resistance, and oxidative stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and Amyotrophic lateral sclerosis. Bezisterim (NE3107) is an investigational oral small molecule, blood-brain permeable, compound with potential anti-inflammatory, insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation. Bezisterim’s (NE3107) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s work testing the molecule in AD, PD, and long COVID patients. Bezisterim (NE3107) is patented in the United States, Australia, Canada, Europe and South Korea.

 

Liver Disease Program

 

In liver disease, our investigational drug candidate BIV201 (continuous infusion terlipressin), which has been granted both FDA Fast Track designation status and FDA Orphan Drug status, is being evaluated and discussed after receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis. BIV201 is administered as a patent-pending liquid formulation.

 

In June 2021, the Company initiated a Phase 2 study (NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment cycles) combined with standard-of-care (“SOC”), compared to SOC alone, for the treatment of refractory ascites. The primary endpoints of the study are the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared to a pre-treatment period.

 

In March 2023 the company announced enrollment was paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to show at least a 30% reduction in ascites fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment. The change in ascites volume was significantly different from those patients receiving SOC treatment. Patients who completed the treatment with BIV201 experienced a 53% reduction in ascites fluid, which was sustained (43% reduction) during the three months after treatment initiation as compared to the three-month pre-treatment period.

 

In June 2023, the Company requested and subsequently received guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis. The Company is currently finalizing protocol designs for the Phase 3 study of BIV201 for the treatment of ascites due to chronic liver cirrhosis.

 

 8 

 

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Nine Months Ended March 31, 2024 and 2023

(unaudited)

 

1. Background Information (continued)

 

While the active agent, terlipressin, is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, treatment of ascites is not included in these authorizations. Patients with refractory ascites 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 FDA has not approved any drug to treat refractory ascites.

 

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 this 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. 

 

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, 2024, the Company had working capital of approximately $18.1 million, cash and cash equivalents of approximately $30.4 million, stockholders’ equity of approximately $18.9 million, and an accumulated deficit of approximately $329.3 million. The Company is in the pre-revenue stage 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 is projected to sustain operations over the next nine months from the balance sheet date. Projected cash flows could be extended beyond that period of time, if further measures are taken to delay planned expenditures in our research protocols and slow the progress in the Company’s development and launch of next phase clinical programs, the Company’s current planned operations to meet certain goals and objectives.

 

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.

 

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 condensed financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

 9 

 

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Nine Months Ended March 31, 2024 and 2023

(unaudited)

 

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, 2023 was derived from audited annual financial statements but does not contain all the footnote disclosures from the annual financial statements. These unaudited interim condensed financial statements should be read in conjunction with the Company’s audited financial statements for the fiscal years ended June 30, 2023 and 2022 in our Annual Report on Form 10-K filed with the SEC on August 16, 2023 (the “2023 Form 10-K”). A summary of significant accounting policies can also be found in those audited financial statements in the 2023 Form 10-K. 

 

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, par value $0.0001 per share (“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 restricted stock units. For the three and nine months ended March 31, 2024 and 2023, such amounts were excluded from the diluted loss since their effect was considered anti-dilutive due to the net loss for the periods.

 

The table below shows the number of outstanding stock options, warrants and restricted stock units as of March 31, 2024 and 2023:

 

        
   March 31, 2024   March 31, 2023 
   Number of Shares   Number of Shares 
Stock Options   4,022,758    3,448,997 
Warrants   19,320,285    7,770,285 
Restricted Stock Units   539,920    527,549 
Total   23,882,963    11,746,831 

 

Recent Accounting Pronouncements

 

The Company considers the applicability and impact of all Accounting Standards Updates (“ASUs”). There have been no recent ASUs that are expected to have a material impact on the Company’s balance sheets or statements of operations and comprehensive loss since the 2023 Form 10-K.

 

 10 

  

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Nine Months Ended March 31, 2024 and 2023

(unaudited)

 

3. Significant Accounting Policies (continued)

 

Cash and cash equivalents

 

Cash and cash equivalents consisted of cash deposits and money market funds held at banks and funds held in brokerage accounts which included a U.S. treasury money market fund and U.S. Treasury Bills with original maturities of three months or less.

 

Investments in U.S. Treasury Bills

 

Investments in U.S. Treasury Bills with maturities greater than three months on the date of purchase, are accounted for as available for sale and are recorded at fair value. Unrealized gains were included in other comprehensive (loss) income in the accompanying condensed statements of operations and comprehensive loss. Upon the maturity and settlement of these investments, realized gains were recorded as a component of interest income on the accompanying condensed statement of operations and comprehensive loss.

 

Concentration of Credit Risk in the Financial Service Industry

 

As of March 31, 2024, the Company had cash deposited in certain financial institutions in excess of federally insured levels. The Company regularly monitors the financial stability of these financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents. However, in March and April 2023, certain U.S. government banking regulators took steps to intervene in the operations of certain financial institutions due to liquidity concerns, which caused general heightened uncertainties in financial markets. While these and other current events have not had a material direct impact on the Company’s operations, if further liquidity and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, the Company’s ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of operations.

 

Fair value measurement of assets and liabilities

 

We determine the fair values of our financial instruments based on the fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value assumes that the transaction to sell the asset or transfer the liability occurs in the principal or most advantageous market for the asset or liability and establishes that the fair value of an asset or liability shall be determined based on the assumptions that market participants would use in pricing the asset or liability. The classification of a financial asset or liability within the hierarchy is based upon the lowest level input that is significant to the fair value measurement. The fair value hierarchy prioritizes the inputs into three levels that may be used to measure fair value:

 

Level 1 – Inputs are unadjusted quoted prices in active markets for identical assets or liabilities.

 

Level 2 – Inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument.

 

Level 3 – Inputs are unobservable inputs based on our assumptions.

 

The Company’s financial instruments include cash, accounts payable, the carrying value of the operating lease liabilities, notes payable and other derivative liabilities (see Note 9). The carrying amounts of cash and accounts payable approximate their fair value, due to the short-term nature of these items. The carrying amounts of notes payable and operating lease liabilities approximate their fair values since they bear interest at rates which approximate market rates for similar debt instruments.

 

 11 

  

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Nine Months Ended March 31, 2024 and 2023

(unaudited)

 

4. Investments in U.S. Treasury Bills Available for Sale

 

The following is a summary of the U.S. Treasury Bills held at June 30, 2023:

 

                       
    Amortized Cost Basis     Gross Unrealized Gain     Fair Value     Total Accumulated Other Comprehensive Income  
U.S. Treasury Bills due in 3 - 6 months   $ 14,301,136     $ 176,591     $ 14,477,726     $ 176,591  

 

During the fiscal year ended June 30, 2023, the Company purchased a total of approximately $46 million of U.S. Treasury Bills. All outstanding investments in U.S. Treasury Bills available for sale held at June 30, 2023 matured during the three months ended September 30, 2023 and were settled, resulting in a realized gain of $223,865 recorded as a component of interest income on the accompanying condensed statement of operations and comprehensive loss.

 

5. Intangible Assets

 

The Company’s intangible assets consist of intellectual property acquired from LAT Pharma and are amortized over their estimated useful lives.

 

The following is a summary of the Company’s intangible assets:

 

          
   March 31, 2024   June 30, 2023 
         
Intellectual Property  $2,293,770   $2,293,770 
Less Accumulated Amortization   (1,828,708)   (1,656,675)
Intellectual Property, Net  $465,062   $637,095 

 

Amortization expense was $57,344 in each of the three-month periods ended March 31, 2024 and 2023. Amortization expense was $172,033 in each of the nine-month periods ended March 31, 2024 and 2023. The Company amortizes intellectual property over the expected, original useful lives of 10 years.

 

Estimated future amortization expense is as follows:

 

     
Year ending June 30, 2024 (Remaining 3 months)  $57,344 
2025   229,377 
2026   178,341 
   $465,062 

 

 12 

  

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Nine Months Ended March 31, 2024 and 2023

(unaudited)

 

6. 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 stockholder, 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 Common Stock, at a price of $1.65 per share (the “PIPE Shares”), and (ii) a warrant to purchase 7,272,728 shares of Common Stock (“PIPE Warrant Shares”), at an exercise price of $1.82, with a term of exercise of five years. The warrant’s down round feature reduced the exercise price of the warrant to $1.00 per share on March 6, 2024 in connection with the offering further described in Note 10 as the Company sold stock at a price lower than the initial exercise price of the warrant. The Company calculated the difference in fair value of the warrants between the stated exercise price and the reduced exercise price and recorded $886,423 as a deemed dividend. The fair value of the warrants were estimated using the Black Scholes Method with the following inputs, the stock price of $1.07, exercise price of $1.82 and $1.00, remaining term 3.4 years, risk free rate of 4.4% and volatility of 95.0%.

 

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 agreement 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 PIPE Warrant Shares as Registrable Securities thereunder.

 

7. Other Liabilities

 

The current portion of other liabilities at June 30, 2023 was approximately $48,000 and represented the remaining balance of a retention bonus payable for arrangements with certain employees, which was paid in July 2023. 

 

8. 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,” and together with AVOPI, “Avenue”) for growth capital loans in an aggregate commitment amount of up to $20 million (the “Loan”). On the Closing Date, $15 million of the Loan was funded (“Tranche 1”). The Loan provided for an additional $5 million to be 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, which were not achieved. The Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.00% plus the prime rate as reported in The Wall Street Journal and (b) 10.75%. The prime rate at March 31, 2024 was 8.50%. 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.

 

The Loan Agreement required monthly interest-only payments during the first eighteen months of the term of the Loan. Following the interest-only period, on July 1, 2023, the Company pays 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, the Company will be obligated to pay a final payment equal to 4.25% of the Loan commitment amount, the sum of Tranche 1 and Tranche 2.

 

 13 

  

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Nine Months Ended March 31, 2024 and 2023

(unaudited)

 

8. Notes Payable (continued)

 

The Loan Agreement includes a conversion option to convert up to $5.0 million of the principal amount of the Loan outstanding at the option of Avenue, into shares of the Company’s Common Stock at a conversion price of $6.98 per share.

 

On the Closing Date, the Company issued to Avenue warrants to purchase 361,002 shares of Common Stock of the Company (the “Avenue Warrants”) at an exercise price per share equal to $5.82. The Avenue Warrants are exercisable until November 30, 2026.

 

The amount of the carrying value of the notes payable was determined by allocating portions of the outstanding principal of the notes; approximately $1.4 million to the fair value of the Avenue Warrants and approximately $2.2 million to the fair value of the embedded conversion option. Accordingly, the total amount of unearned discount of approximately $3.6 million, the total direct financing cost of approximately $390,000 and premium of $850,000 being recognized on an effective interest method over the term of the Loan. The adjusted effective interest rate is 25%.

 

The total interest expense of approximately $629,000 and $1.1 million for the three months ended March 31, 2024 and 2023, respectively, was recognized in the accompanying condensed statements of operations and comprehensive loss. Interest expense for the three months ended March 31, 2024 and 2023 included the interest payments totaling approximately $327,000 and $547,000, the amortization of financing costs of approximately $24,000 and $43,000, unearned discount of approximately $222,000 and $400,000 and the accretion of loan premium of approximately $52,000 and $93,000, respectively. The total interest expense of approximately $2.5 million and $3.2 million for the nine months ended March 31, 2024 and 2023, respectively, was recognized in the accompanying condensed statements of operations and comprehensive loss. Interest expense for the nine months ended March 31, 2024 and 2023 included interest payments totaling approximately $1.3 million and $1.5 million, the amortization of financing costs of approximately $92,000 and $128,000, unearned discount of approximately $867,000 and $1.2 million and the accretion of loan premium of approximately $201,000 and $329,000, respectively.

 

As of March 31, 2024, the remaining principal balance of $7.5 million under the Loan is payable in 9 monthly equal installments. For the three and nine months ended March 31, 2024, the Company paid back $2.5 million and $7.5 million respectively, of the original loan of $15 million.

 

The following is a summary of the Notes Payable as of March 31, 2024 and June 30, 2023:

 

 14 

  

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Nine Months Ended March 31, 2024 and 2023

(unaudited)

 

8. Notes Payable (continued)

 

Current portion of Notes Payable

 

          
   March 31, 2024   June 30, 2023 
         
Current portion of Notes Payable  $7,500,000   $10,000,000 
Less debt financing costs   (28,369)   (108,751)
Less unearned discount   (266,908)   (1,023,145)
Plus accretion of loan premium   788,181    236,970 
Current portion of Notes Payable, net of financing costs, unearned premiums and discount  $7,992,904   $9,105,074 

 

Non-current portion of Notes Payable

 

   March 31, 2024   June 30, 2023 
         
Notes Payable  $-   $5,000,000 
Less debt financing costs   -    (11,820)
Less unearned discount   -    (111,212)
Plus accretion of loan premium   -    350,302 
Notes Payable, net of the current portion financing costs, unearned premiums and discount  $-   $5,227,270 

 

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

 

               
   Unearned Discount   Debt Financing Costs   Loan accretion Premium 
             
Year ending June 30, 2024 (Remaining 3 months)  $155,696   $16,549   $36,061 
2025   111,212    11,820    25,758 
Total  $266,908   $28,369   $61,819 

 

 15 

  

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Nine Months Ended March 31, 2024 and 2023

(unaudited)

 

9. Fair Value Measurements

 

At March 31, 2024 and June 30, 2023, the estimated fair value of derivative liabilities measured on a recurring basis are as follows:

 

                 
   Fair Value Measurements at 
   March 31, 2024 
   Level 1   Level 2   Level 3   Total 
                 
Derivative liability - Warrants  $-   $-   $20,703   $20,703 
Derivative liability - Conversion option on note payable   -    -    -    - 
Total derivatives  $-   $-   $20,703   $20,703 

 

   Fair Value Measurements at 
   June 30, 2023 
   Level 1   Level 2   Level 3   Total 
                 
Derivative liability - Warrants  $-   $-   $894,280   $894,280 
Derivative liability - Conversion option on note payable   -    -    925,762    925,762 
Total derivatives  $-   $-   $1,820,042   $1,820,042 

 

The following table presents the activity for liabilities measured at fair value using unobservable inputs for the nine months ended March 31, 2024: 

 

          
   Derivative liabilities  -
Warrants
   Derivative liability -
Conversion Option on
Convertible Debenture
 
Balance at June 30, 2023  $894,280   $925,762 
Additions to level 3 liabilities   -    - 
Change in in fair value of level 3 liabilities   (873,577)   (925,762)
Transfer in and/or out of Level 3   -    - 
Balance at March 31, 2024  $20,703   $- 

 

 16 

  

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Nine Months Ended March 31, 2024 and 2023

(unaudited)

 

9. Fair Value Measurements (continued)

 

The following table presents the activity for liabilities measured at fair value using unobservable inputs for the nine months ended March 31, 2023:

 

   Derivative liabilities -
Warrants
   Derivative liability -
Conversion Option on
Convertible Debenture
 
Balance at June 30, 2022  $194,531   $188,030 
Additions to level 3 liabilities   -    - 
Change in in fair value of level 3 liabilities   1,762,250    2,392,395 
Transfer in and/or out of Level 3   -    - 
Balance at March 31, 2023  $1,956,781   $2,580,425 

 

The fair values of derivative liabilities for the Avenue Warrants and the conversion option of the Note at March 31, 2024 in the accompanying condensed balance sheet, were approximately $21,000 and approximately zero, respectively. The total change in the fair value of the derivative liabilities totaled approximately $109,000 and $1.8 million for the three and nine months ended March 31, 2024, respectively; and accordingly, was recorded in the accompanying condensed statement of operations and comprehensive loss. The assumptions used in the Black Scholes model to value the derivative liabilities at March 31, 2024 included the closing stock price of $0.53 per share; for the Avenue Warrants, the exercise price of $5.82, remaining term 2.7 years, risk free rate of 4.5% and volatility of 93.0%; and for the embedded derivative liability of the conversion option, the conversion price of $6.98; remaining term 0.67 years, risk free rate of 5.3% and volatility of 104.0%.

 

Derivative liability – Avenue 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 for as derivative financial instruments. The Avenue Warrants 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 accompanying condensed balance sheets at March 31, 2024 and June 30, 2023.

 

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 Avenue Warrants are recorded at their fair values at the date of issuance and remeasured at March 31, 2024 and June 30, 2023.

 

Embedded derivative liability – Conversion Option

 

The embedded derivative liability represents the optional conversion feature of up to $5.0 million of the outstanding Loan, which 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.

 

Financial assets

 

As of March 31, 2024, investments in U.S. Treasury Bills were valued through use of quoted prices and are classified as Level 1.

 

 17 

  

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Nine Months Ended March 31, 2024 and 2023

(unaudited)

 

9. Fair Value Measurements (continued)

 

The following table presents information about our assets that are measured at fair value on a recurring basis.

 

                 
   Fair Value Measurements at 
   March 31, 2024 
   Level 1   Level 2   Level 3   Total 
                 
Cash  $11,279,241   $-   $-   $11,279,241 
U.S. Treasury Bills due in 3 months or less at purchase   19,071,096    -    -    19,071,096 
Total  $30,350,337   $-   $-   $30,350,337 

 

    Fair Value Measurements at  
    June 30, 2023  
    Level 1     Level 2     Level 3     Total  
                         
Cash   $ 6,304,543     $ -     $ -     $ 6,304,543  
U.S. Treasury Bills due in 3 months or less at purchase     13,156,340       -       -       13,156,340  
U.S. Treasury Bills due in 3 - 6 months at purchase     14,477,726       -       -       14,477,726  
Total   $ 33,938,609     $ -     $ -     $ 33,938,609  

 

 18 

  

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Nine Months Ended March 31, 2024 and 2023

(unaudited)

 

10. Equity Transactions

 

Issuance of common stock for cash

 

On August 31, 2022, the Company entered 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 the Company’s common stock through the Agents, subject to the terms and conditions of the Sales Agreement. On April 6, 2023, the Company and B. Riley Securities, Inc. mutually agreed to terminate B. Riley Securities, Inc.’s role as a sales agent under the Sales Agreement. During the three months ended March 31, 2024, the Company sold 4,384 shares of common stock under the Sales Agreement for total net proceeds of approximately $6,500 after 3% commissions and expenses of approximately $201. During the nine months ended March 31, 2024, the Company sold 3,337,487 shares of common stock under the Sales Agreement for total net proceeds of $9.3 million after 3% commissions and expenses of approximately $377,000.

 

During the three months ended March 31, 2023, the Company sold 1,515,078 shares of common stock under the Sales Agreement for total net proceeds of $9.8 million after 3% commissions and expenses of approximately $339,000. During the nine months ended March 31, 2023, the Company sold 7,372,691 shares of common stock under the Sales Agreement for total net proceeds of $48.2 million after 3% commissions and expenses of approximately $1.9 million. 

 

On March 6, 2024, the Company closed a best efforts public offering (the “Offering”) of 15,000,000 shares (the “Shares”) of its common stock, par value $0.0001 per share (the “Common Stock”), pre-funded warrants (the “Pre-funded Warrants”) to purchase 6,000,000 shares of Common Stock, and warrants to purchase up to 10,500,000 shares of Common Stock (the “Common Warrants”) at a combined public offering price of $1.00 per Share, or Pre-funded Warrant, and the associated Common Warrant. The Common Warrants have an exercise price of $1.50 per share and are immediately exercisable upon issuance for a period of five years following the date of issuance. The gross proceeds to the Company from the Offering were approximately $21.0 million, before deducting placement agent fees and offering expenses of approximately $2.5 million. Additionally, upon closing the Company issued the placement agent warrants (“Placement Agent’s warrants”) to purchase 1,050,000 shares of Common Stock exercisable at a per share price of $1.25, which was equal to 125% of the public offering price per share. The Placement Agent’s Warrants are exercisable during a five-year period commencing 180 days from March 6, 2024.

 

Stock Options

 

The following table summarizes the activity relating to the Company’s stock options for the nine months ended March 31, 2024: 

 

                    
   Options   Weighted-Average
Exercise Price
   Weighted Remaining
Average Contractual
Term
   Aggregate Intrinsic
Value
 
Outstanding at June 30, 2023   3,952,864   $7.10    6.3   $1,067,966 
Granted   394,417    3.22    6.1    - 
Options Expired   (6,400)   4.61    -    - 
Options Canceled   (318,123)   5.72    -    - 
Outstanding at March 31, 2024   4,022,758   $6.83    5.3   $- 
Exercisable at March 31, 2024   2,211,392   $8.15    4.3   $- 

 

 19 

  

 BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Nine Months Ended March 31, 2024 and 2023

(unaudited)

 

10. Equity Transactions (continued)

 

The fair value of each option grant on the date of grant is estimated using the Black-Scholes option pricing model. The pricing model reflects the following weighted-average assumptions for the nine months ended March 31, 2024 and 2023:

 

          
   March 31, 2024   June 30, 2023 
Expected life of options (in years)   5    6 
Expected volatility   87.11%   81.65%
Risk free interest rate   4.80%   3.82%
Dividend Yield   0%   0%

 

The total stock based compensation expense from stock options for the three-months ended March 31, 2024 and 2023 was of $690,921 and $888,998, respectively and for nine-months ended March 31, 2024 and 2023 was of $2,118,649 and $3,480,425, respectively.

 

Issuance and modification of restricted stock units and options:

 

On November 23, 2022, the Company issued equity awards for the board of directors’ annual compensation. Four directors received restricted stock units (“RSUs”) to purchase a total of 155,636 shares of common stock at the grant date fair value of $6.12 per share, a total cost of $952,492 was recognized as stock compensation in the three months ended December 31, 2022. Three directors received stock options to purchase 195,000 shares of common stock at an exercise price of $6.12 per share. The total stock compensation cost of these stock options of $791,700 was recognized as stock compensation in the three months ended December 31, 2022. The equity awards vest quarterly over the annual service period from November 9, 2023 to the next annual shareholders’ meeting. While the agreements contain certain contractual vesting terms, there are circumstances where the vesting can be accelerated that is not within the Company’s control and as a result, for accounting purposes, the awards are assumed to have been fully vested on the grant date, accordingly, the Company recognized the total compensation cost of $1,744,192 on November 23, 2022.

 

On November 9, 2023, the Company issued equity awards for the board of directors’ annual compensation. Four directors received restricted stock units (“RSUs”) to purchase a total of 182,696 shares of common stock at the grant date fair value of $3.01 per share, a total cost of $137,479 and $215,383 was recognized as stock compensation in the three and nine months ended March 31, 2024, respectively. Two directors received stock options to purchase 183,250 shares of common stock at an exercise price of $3.01 per share. The total stock compensation cost related to these stock options of $83,837 and $118,303 was recognized in the three months and nine ended March 31, 2024 and 2023, respectively. The equity awards vest quarterly over the annual service period from November 9, 2023, on February 9, 2024, May 9, 2024, August 9, 2024 and earlier of November 9, 2024 or the next annual shareholders’ meeting.

 

 20 

  

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Nine Months Ended March 31, 2024 and 2023

(unaudited)

 

10. Equity Transactions (continued)

 

In December 2023, the Company terminated five employees and as part of their severance agreement modified their equity awards that had been granted pursuant to the 2019 Omnibus Plan. The modifications included the acceleration of certain tranche vesting of stock option awards to purchase a total of 56,233 shares of common stock (“Accelerated Options”), effective on the December Separation Date, as defined in severance agreement (“Separation Date”); and extended the expiration date for one year from the Separation Date for both the Accelerated Options and any vested and unexercised stock options held by the terminated employees as of the Separation Date. Accordingly, the Company remeasured the modified awards based on the stock price of $1.54 per share at the close on the Separation Date and a one-year life. The net adjustment for both stock option modifications was a net credit of $127,199 and was recognized as adjustment to stock compensation expense for the three months ended December 31, 2023.

 

The modification also included the acceleration of an additional tranche vesting of 10,302 Restricted Stock Units, (“RSUs”) as of the Separation date. The modified RSUs were remeasured based on the stock price of $1.54 per share at close on the Separation Date and totaled $15,865, representing an additional in stock-based compensation for the three months ended December 31, 2023. The Company canceled 171,556 unvested stock options and 10,303 unvested RSUs.

 

The following table summarizes vesting of restricted stock units:

 

          
   Number of Shares   Weighted Average Grant
Date Fair Value Per Share
 
         
Unvested at June 30, 2023   596,457   $5.24 
Issued   182,696    3.01 
Vested   (228,930)   5.50 
Canceled   (10,303)   6.12 
Unvested at March 31, 2024   539,920   $4.59 

 

The total stock-based compensation expense from restricted stock units for the three-months ended March 31, 2024 and 2023 was of $336,376 and $17,537, respectively, and for the nine-months ended March 31, 2024 and 2023 was $1,020,383 and $1,589,527, respectively. 

 

There were 45,675 RSU that vested on February 9, 2024 and the related shares of common stock were issued and delivered by March 31, 2024. There were 101,833 RSUs that vested on the second anniversary date of RSUs that were awarded on November 23, 2022 and 25,880 shares of common stock were withheld for federal income tax withholdings; and delivered on February 15, 2024.

 

 21 

  

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Nine Months Ended March 31, 2024 and 2023

(unaudited)

 

10. Equity Transactions (continued)

 

Issuance of Stock Options under the 2019 Omnibus Plan.

 

On October 3, 2023, the Company granted stock options to purchase 211,167 shares of Common Stock to new hire employees. 20% of the shares underlying the options awarded vest on the one-year anniversary of the grant date, and the remaining 80% will vest in equal monthly installments over 48 months each month thereafter. The exercise price of the options is $3.41 per share and the options terminate on the earlier of the tenth grant date anniversary or the date of which the options are fully exercised.

 

Stock Warrants

 

The following table summarizes warrant activity during the nine months ended March 31, 2024: 

 

                    
   Number of Shares   Weighted Average Exercise Price   Weighted Average Remaining Life (Years)   Aggregate Intrinsic Value 
Outstanding and exercisable at June 30, 2023   7,770,285   $2.06    4.0   $18,318,954 
Granted   11,550,000    1.48    5.0    - 
Outstanding and exercisable at March 31, 2024   19,320,285   $1.40    4.3   $- 

 

Of the above warrants, 101,380 expire in the fiscal year ending June 30, 2025, 35,175 expire in the fiscal year ending June 30, 2026, 7,633,730 expire in the fiscal year ending June 30, 2027 and 11,550,000 expire in the fiscal year ending June 30, 2029.

 

On March 6, 2024, the Company issued 11,550,000 warrants at a weighted average exercise price of $1.48 as part of the Offering (see Note 10).

 

11. Leases

 

Office Lease

 

The Company pays an annual rent of $2,200 for its headquarters at 680 W Nye Lane, Suite 201, Carson City Nevada 89703. The rental agreement was for a one-year term and commenced on October 1, 2022 and has been subsequently renewed for another year at the same rate.

 

The Company’s San Diego office lease at 5090 Shoreham Place Suite 212, San Diego, CA 92122 which commenced on March 1, 2022, was for a term of 38 months with a base rate of $4,300, and annual increases of three percent. In February 2024, the Company amended the lease agreement which allowed the Company to vacate the then current space and move to a larger space at Suite 206. The current monthly base rate for the new office space is $9,685, with an annual increase of four percent. The term for the new office lease is 60 months and commenced on February 12, 2024. The lease that was in place for the 5090 Shoreham Place Suite 212 office was effectively extinguished upon the commencement of the new office space lease on February 12, 2024, resulting in the write off of the corresponding remaining right-of-use asset and operating lease liability of $56,909 and $62,124, respectively, and a gain to selling, general and administrative expenses of $5,215 for the three months ending March 31, 2024.

 

Total operating lease expense for the three months ended March 31, 2024 and 2023 of approximately $20,000 and $13,000, respectively; and for the nine months ended March 31, 2024 and 2023, of approximately $46,000 and $37,000 respectively were included in the accompanying condensed statements of operations and comprehensive loss as a component of selling, general and administrative expenses.

 

 22 

  

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Nine Months Ended March 31, 2024 and 2023

(unaudited)

 

11. Leases (continued)

 

The right-of-use asset, net and current and non-current portion of the operating lease liabilities included in the accompany condensed balance sheets are as follows:

 

          
   March 31, 2024   June 30, 2023 
Assets          
Operating lease right-of-use asset, net  $422,169   $80,789 
           
Liabilities          
Current portion of operating lease liabilities  $57,143   $44,909 
Operating lease liabilities, net of current portion   366,430    42,505 
Total operating lease liabilities  $423,573   $87,414 

 

At March 31, 2024, the future estimated minimum lease payments under non-cancelable operating leases are as follows:

 

     
Year ending June 30, 2024 (Remaining 3 months)  $29,055 
2025   117,915 
2026   122,042 
2027   126,313 
2028   130,734 
2029   77,796 
Total minimum lease payments   603,855 
Less amount representing interest   (180,282)
Present value of future minimum lease payments   423,573 
Less current portion of operating lease liabilities   (57,143)
Operating lease liabilities, net of current portion  $366,430 

 

Total cash paid for amounts included in the measurement of operating lease liabilities for the three months ended March 31, 2024 and 2023, were $23,670 and $12,650, respectively, and for the nine months ended March 31, 2024 and 2023 were $49,470 and $37,700, respectively. 

 

 23 

 

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Nine Months Ended March 31, 2024 and 2023

(unaudited)

 

11. Leases (continued)

 

The weighted average remaining lease term and discount rate as of March 31, 2024 and June 30, 2023 were as follows:

 

          
   March 31, 2024   June 30, 2023 
         
Weighted average remaining lease term (Years)          
Operating leases   4.8    1.8 
Weighted average discount rate          
Operating leases   15.00%   10.75%

 

12. Commitments and Contingencies

 

Royalty Agreements

 

Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016, by and between our predecessor entities, LAT Pharma and NanoAntibiotics, Inc., the Company is obligated to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared by the members of LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.

 

Pursuant to the Technology Transfer Agreement entered into on July 25, 2016, by and between the Company and the University of Padova (Italy), the Company 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.

 

Shareholder class action complaint

 

On January 19, 2024, a purported shareholder class action complaint, captioned Eric Olmstead v. BioVie Inc. et al., No. 3:24-cv-00035, was filed in the U.S. District Court for the District of Nevada, naming the Company and certain of its officers and/or directors as defendants. On April 15, 2024 the court ordered the motion to consolidate the six pending motions, appointed the lead plaintiff and approved selection of the lead counsel, now captioned Olmstead v. BioVie Inc., et al., Case 3:24-cv-0035 LRH-CSD and Way v. BioVie Inc., et al., Case No. 2:24-cv-00361-LRH-CSD. The lawsuit alleges that the Company made material misrepresentations and/or omissions of material fact relating to the Company’s business, operations, compliance, and prospects, including information related to the study and trial of bezisterim (NE3107), in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder. The class action is on behalf of purchasers of the Company’s securities during the period from August 5, 2021 through November 29, 2023 and seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees. 

 

The Company believes the lawsuit is without merit and intends to defend the case vigorously. At this early stage of the proceedings, the Company is unable to make any prediction regarding the outcome of the litigation. No adjustment or accruals have been reflected in the accompanying condensed financial statements.

 

 24 

  

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Nine Months Ended March 31, 2024 and 2023

(unaudited)

 

13. 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., The Company made contributions for the three months ended March 31, 2024 and 2023 of approximately $53,915 and $16,000, respectively; and for the nine months ended March 31, 2024 and 2023 of approximately $105,000 and $80,100, respectively. 

 

 25 

  

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, as amended, and Section 27A of the Securities Act of 1933, as amended. 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 requirements; and our ability to satisfy 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. 

 

You are cautioned not to place undue reliance on the forward-looking statements in this report, which speak only as of the date of this report. 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, except as required by law. 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. (the “Company” or “we” or “our”) is a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including neurological and neuro-degenerative disorders and liver disease. 

 

The Company acquired the biopharmaceutical assets of NeurMedix, Inc. (“NeurMedix”) a privately held clinical-stage pharmaceutical company and a related party in June 2021. The acquired assets included NE3107. In April 2024, the Company announced that the United States Adopted Names (“USAN”) Council, and the World Health Organization (“WHO”) International Nonproprietary Names (INN) expert committee had approved “bezisterim” as the non-proprietary (generic) name for NE3107. Bezisterim (NE3107) is an investigational, 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 AD and PD, and bezisterim (NE3107) could, if approved by FDA, represent an entirely new medical approach to treating these devastating conditions affecting an estimated 6 million Americans suffering from AD and 1 million Americans suffering from PD.

 

Neurodengenerative Disease Program

 

In neurodegenerative disease, the Company’s drug candidate NE3107 inhibits activation of inflammatory actions extracellular single-regulated kinase (“ERK”) and nuclear factor kappa-light-chain-enhancer of activated B cells (“NFκB”) (including interactions with tumor necrosis factor (“TNF”) signaling and other relevant inflammatory pathways) that lead to neuroinflammation and insulin resistance. NE3107 does not interfere with their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both inflammation and insulin resistance are drivers of AD and PD.

 

 26 

  

Alzheimer’s Disease (NCT05083260)

 

On November 29, 2023, the Company announced the analysis of its unblinded, topline efficacy data from its Phase 3 clinical trial (NCT04669028) of bezisterim (NE3107) in the treatment of mild to moderate AD. The study has co-primary endpoints looking at cognition using the Alzheimer’s Disease Assessment Scale-Cognitive Scale (ADAS-Cog 12) and function using the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Patients were randomly assigned, 1:1 versus placebo, to receive sequentially 5 mg of bezisterim (NE3107) orally twice a day for 14 days, then 10 mg orally twice a day for 14 days, followed by 26 weeks of 20 mg orally twice daily.

 

Upon trial completion, as the Company began the process of unblinding the trial data, the Company found significant deviation from protocol and current good clinical practices (“cGCPs”) violations at 15 study sites (virtually all of which were from one geographic area). This highly unusual level of suspected improprieties led the Company to exclude all patients from these sites and to refer the sites to the FDA Office of Scientific Investigations (“OSI”) for further action. After the patient exclusions, 81 patients remained in the Modified Intent to Treat population, 57 of whom were in the Per-Protocol population which included those who completed the trial and were verified to take study drug from pharmacokinetic data. 

 

The trial was originally designed to be 80% powered with 125 patients in each of the treatment and placebo arms. The unplanned exclusion of so many patients has left the trial underpowered for the primary endpoints. In the Per-Protocol population, which included those patients who completed the trial and who were further verified to have taken the study drug (based on pharmacokinetic data), an observed descriptive change from baseline appeared to suggest a slowing of cognitive loss; these same patients experienced an advantage in age deceleration vs. placebo as measured by DNA epigenetic change. Age deceleration is used by longevity researchers to measure the difference between the patient’s biological age, in this case as measured by the Horvath DNA methylation Skin Blood Clock, relative to the patient’s actual chronological age. This test was a non-primary/secondary endpoint, other-outcome measure, done via blood test collected at week 30 (end of study). Additional DNA methylation data continues to be collected and analyzed.

 

Based on the efficacy signal seen in this trial, the Company is exploring (1) a discussion with the FDA to potentially employ the adaptive trial feature of the protocol to continue enrolling patients to achieve statistical significance; and/or (2) designing a new Phase 3 study of bezisterim (NE3107) that leverages the most recent data and understanding of the potential effect bezisterim (NE3107) may have in helping persons with AD. 

 

Parkinson’s Disease (NCT05083260)

 

The Phase 2 study of bezisterim (NE3107) for the treatment of PD (NCT05083260), completed in December 2022, was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and bezisterim (NE3107). Forty-five patients with a defined L-dopa “off state” were randomized 1:1 to placebo: bezisterim (NE3107) 20 mg twice daily for 28 days. This trial was launched with two design objectives: 1) the primary objective was safety and a drug-drug interaction study as requested by the FDA to measure the potential for adverse interactions of bezisterim (NE3107) with carbidopa/ levodopa; and 2) the secondary objective was to determine if preclinical indications of promotoric activity and apparent enhancement of levodopa activity could be seen in humans. Both objectives were met. The initiation of trial design for a Phase 3 study of bezisterim (NE3107) for the treatment of PD is currently on hold, pending additional funding.

 

 27 

  

Long COVID Program

 

In April 2024, the Company announced the grant of a clinical trial award of up to $13.1 million from the U.S. Department of Defense (“DOD”), awarded through the Peer Reviewed Medical Research Program (“PRMRP”) of the Congressionally Directed Medical Research Programs (“CDMRP”). The award can provide up to 2 years of non-dilutive funding for a Phase 2b clinical trial that will assess bezisterim (NE3107) for the treatment of neurological symptoms that are associated with long COVID. The Company anticipates the trial to commence by early 2025.

 

Long COVID is a condition in which symptoms of COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more. The Centers for Disease Control recently reported that 6.8% of adults in the United States (more than 17 million individuals) currently or previously had long COVID. Symptoms, which include fatigue, cognitive dysfunction and sleep disturbances, are debilitating. The loss in quality of life and earnings and increased medical costs has an enormous economic impact estimated to be 3.7 trillion dollars. To date there are no therapies proven effective for treatment.

 

Chronic inflammation is one of the main hypotheses that researchers have proposed to explain the persistence of symptoms in long COVID. Specifically in individuals with “brain fog,” sustained systemic inflammation and persistent localized blood-brain-barrier (“BBB”) dysfunction are key physiological features. Bezisterim (NE3107) permeates the BBB and has been shown to modulate inflammation via the activation of NF-kB, thus representing a novel oral treatment targeting an underlying cause of long COVID symptoms.

 

Neuroinflammation, insulin resistance, and oxidative stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and Amyotrophic lateral sclerosis. Bezisterim (NE3107) is an investigational oral small molecule, blood-brain permeable, compound with potential anti-inflammatory, insulin sensitizing, and ERK-binding properties that may allow it to selectively inhibit ERK-, NFκB- and TNF-stimulated inflammation. Bezisterim’s (NE3107) potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s work testing the molecule in AD, PD, and long COVID patients. Bezisterim (NE3107) is patented in the United States, Australia, Canada, Europe and South Korea.

 

Liver Disease Program

 

In liver disease, our investigational drug candidate BIV201 (continuous infusion terlipressin), which has been granted both FDA Fast Track designation status and FDA Orphan Drug status, is being evaluated and discussed after receiving guidance from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis. BIV201 is administered as a patent-pending liquid formulation.

 

In June 2021, the Company initiated a Phase 2 study (NCT04112199) designed to evaluate the efficacy of BIV201 (terlipressin, administered by continuous infusion for two 28-day treatment cycles) combined with standard-of-care (“SOC”), compared to SOC alone, for the treatment of refractory ascites. The primary endpoints of the study are the incidence of ascites-related complications and change in ascites fluid accumulation during treatment compared to a pre-treatment period.

 

In March 2023 the company announced enrollment was paused and that data from the first 15 patients treated with BIV201 plus SOC appeared to show at least a 30% reduction in ascites fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment. The change in ascites volume was significantly different from those patients receiving SOC treatment. Patients who completed the treatment with BIV201 experienced a 53% reduction in ascites fluid, which was sustained (43% reduction) during the three months after treatment initiation as compared to the three-month pre-treatment period.

 

In June 2023, the Company requested and subsequently received guidance from the FDA regarding the design and endpoints for definitive clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis. The Company is currently finalizing protocol designs for the Phase 3 study of BIV201 for the treatment of ascites due to chronic liver cirrhosis.

 

While the active agent, terlipressin, is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, treatment of ascites is not included in these authorizations. Patients with refractory ascites 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 U.S. FDA has not approved any drug to treat refractory ascites.

 

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 this 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. 

 

 28 

  

Comparison of the three months ended March 31, 2024 to the three months ended March 31, 2023

 

Net loss

 

The net loss for the three months ended March 31, 2024 and 2023, was approximately $8.1 million compared to a net loss of $15.0 million, respectively. The net decrease in net loss of approximately $6.9 million was due to reduced research and development expenses of approximately $5.5 million, a decrease in selling, general and administrative expenses of approximately $546,000, a reduction in interest expense of approximately $454,000 and the change in the fair value of derivative liabilities of approximately $475,000.

 

Total operating expenses for the three months ended March 31, 2024, were approximately $7.7 million as compared to $13.8 million for the three months ended March 31, 2023. The net decrease of approximately $6.1 million for the three months ended March 31, 2024, represented a net decrease in research and development expenses of approximately $5.5 million due to the completion of clinical trials and a decrease in selling general and administrative expenses of approximately $546,000 from a decline in investor relations expense of approximately $365,000 and a decline in legal expenses of $129,000.

 

Research and Development Expenses

 

Research and development expenses were approximately $5.7 million and $11.2 million for the three months ended March 31, 2024, and 2023, respectively. The net decrease of approximately $5.5 million for three months ended March 31, 2024, was primarily attributed to reduction in expenses totaling approximately $6.0 million due to completion of clinical studies and offset by increased expenses in CMC and clinical team compensation totaling approximately $520,000. The decreased expenses from completed clinical studies were comprised of approximately $868,000 from Ascites BIV201 Phase 2b study which was paused in March 2023; approximately $577,000 from completing PD Phase 2 study during the three months ended March 31, 2023; approximately $160,000 from the Investigator-Initiated Trial in MCI and Mild Alzheimer’s Disease, approximately $3.8 million from the completing AD pivotal Phase 3 clinical study and approximately $581,000 for the development of a new PD study which launch was delayed. The net decrease in clinical study expenses were offset by increased net expenses totaling approximately $520,000 and was comprised of increased expense in CMC for drug production and development of approximately $336,000; the increased clinical team compensation of $285,000 from the expansion of the clinical team subsequent to March 31, 2023; reduced by approximately $51,000 for consultancy expenses and approximately $50,000 from less travel and publications in the three months ended March 31, 2024.

 

Selling, General and Administrative Expenses

 

Selling, general and administrative expenses were approximately $2.0 million and $2.5 million for the three months ended March 31, 2024, and 2023, respectively. The net decrease of approximately $546,000 was primarily attributed from a decline in investor relations expense of approximately $365,000 and decline in legal expenses of $129,000.

 

Other Income and Expense

 

Other expense, net was approximately $336,000 compared to other expense, net of $1.3 million, for the three months ended March 31, 2024 and 2023, respectively. The net decrease in other expense of approximately $931,000 represented a change in fair value of the related derivative liabilities of approximately $475,000 and a decrease in interest expense of approximately $454,000 as the principal payments of the debt balance began July 1, 2023.

 

 29 

  

Comparison of the nine months ended March 31, 2024 to the nine months ended March 31, 2023

 

Net loss

 

The net loss for the nine months ended March 31, 2024, was approximately $27.2 million compared to a net loss of $41.1 million for the nine months ended March 31, 2023. The decrease in net loss of approximately $13.9 million was comprised of a net decrease in research and development expenses of approximately $4.0 million and selling, general and administrative expenses of approximately $2.8 million, and further reduced by an increase in interest income of approximately $557,000, a reduction in interest expense of approximately $739,000 and the change in the fair value of derivative liabilities of $6.0 million.

 

Total operating expenses for the nine months ended March 31, 2024, were approximately $27.4 million as compared to $34.1 million for the nine months ended March 31, 2023. The net decrease of approximately $6.7 million for the nine months ended March 31, 2024, was comprised of a decrease in research and development expenses of approximately $4.0 million and a decrease in selling general and administrative expenses of approximately $2.8 million.

 

Research and Development Expenses

 

Research and development expenses were approximately $21.0 million and $25.0 million for the nine months ended March 31, 2024, and 2023, respectively. The net decrease of approximately $4.0 million for the nine months ended March 31, 2024, was primarily attributed to a reduction in expenses totaling approximately $8.0 million due to completion of clinical studies and increased expenses in development of new studies, CMC and clinical team expansion and offset by the use of consultants totaling approximately $4.1 million. The decreased expenses totaling approximately $8.0 million from completed clinical studies were comprised of approximately $2.3 million from Ascites BIV201 Phase 2b study which was paused in March 2023, approximately $1.9 million from completing PD Phase 2 study during the three months ended March 31, 2023 , approximately $195,000 from the Investigator-Initiated Trial in MCI and Mild Alzheimer’s Disease, approximately $3.6 million from the completing AD pivotal Phase 3 clinical study of approximately $3.8 million. The increased expenses totaling approximately $4.1 million was comprised of the planning and development of new studies of approximately $822,000, increases from the expansion of the clinical team employees and consultants of $1.3 million and $835,000, respectively; and other increases in regulatory and other consultants of approximately $412,000 and publications and travel of approximately $133,000.

 

Selling, General and Administrative Expenses

 

Selling, general and administrative expenses were approximately $6.2 million and $8.9 million for the nine months ended March 31, 2024, and 2023, respectively. The net decrease of approximately $2.7 million was primarily attributed to decreases in directors stock compensation of approximately $2.3 million, investor relations fees of $517,000 offset by insurance expenses of approximately $181,000.

 

Other Income and Expense

 

Other income, net was approximately $210,000 compared to other expense, net of $7.0 million, for the nine months ended March 31, 2024 and 2023, respectively. The net increase in other income of approximately $7.2 million was primarily driven by the change in fair value of the derivative liabilities of approximately $6.0 million, as well as an increase in interest income of approximately $557,000 which was primarily from the investments in U.S. Treasury Bills and a reduction in interest expense of approximately $739,000 due to amortization and accretion of the financing costs, unearned discount, and premium relating to the note payable.

 

 30 

  

Capital Resources and Liquidity

 

As of March 31, 2024 the Company had working capital of approximately $18.1 million, cash and cash equivalents totaling approximately $30.4 million, stockholders’ equity of approximately $18.9 million, and an accumulated deficit of approximately $329.3 million.

 

During the nine months ended March 31, 2024, the Company sold approximately 3.3 million shares of its Common Stock under its Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co for total net proceeds of approximately $9.3 million after 3% commissions and offering costs totaling approximately $377,000.

 

On March 6, 2024, the Company closed a best efforts public offering (the “Offering”) of 15,000,000 shares (the “Shares”) of its class A common stock, par value $0.0001 per share (the “Common Stock”), pre-funded warrants (the “Pre-funded Warrants”) to purchase 6,000,000 shares of Common Stock, and warrants to purchase up to 10,500,000 shares of Common Stock (the “Common Warrants”) at a combined public offering price of $1.00 per Share, or Pre-funded Warrant, and the associated Common Warrant. The gross proceeds to the Company from the Offering were approximately $21.0 million, before deducting placement agent fees and offering expenses of approximately $2.5 million. Additionally, upon closing the Company issued the placement agent warrants (“Placement Agent’s warrants”) to purchase 1,050,000 shares of Common Stock exercisable at a per share price of $1.25, which was equal to 125% of the public offering price per share. The Placement Agent’s Warrants are exercisable during a five-year period commencing 180 days from March 6, 2024.

 

The Company has not generated any revenue 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. Management expects that future sources of funding may include sales of equity, obtaining loans, or other strategic transactions.

 

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.

 

Critical Accounting Policies and Estimates

 

For the nine-month period ended March 31, 2024, 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, 2023. 

 

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 and comprehensive loss.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

Not applicable to smaller reporting companies.

 

 31 

  

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, 2024, 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

 

On January 19, 2024, a purported shareholder class action complaint, captioned Eric Olmstead v. BioVie Inc. et al., No. 3:24-cv-00035, was filed in the U.S. District Court for the District of Nevada, naming the Company and certain of its officers and/or directors as defendants. On April 15, 2024 the court ordered the motion to consolidate the six pending motions, appointed the lead plaintiff and approved selection of the lead counsel, now captioned Olmstead v. BioVie Inc., et al., Case 3:24-cv-0035 LRH-CSD and Way v. BioVie Inc., et al., Case No. 2:24-cv-00361-LRH-CSD. The lawsuit alleges that the Company made material misrepresentations and/or omissions of material fact relating to the Company’s business, operations, compliance, and prospects, including information related to the study and trial of NE3107, in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder. The class action is on behalf of purchasers of the Company’s securities during the period from August 5, 2021 through November 29, 2023 and seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees.

 

The Company believes the lawsuit is without merit and intends to defend the case vigorously. At this early stage of the proceedings, the Company is unable to make any prediction regarding the outcome of the litigation.

 

There are no other 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

 

We rely and will continue to rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines or do not successfully perform and comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize our product candidates.

 

We depend, and will continue to depend, on third parties, including, but not limited to, CROs, clinical trial sites and clinical trial principal investigators, contract laboratories, IRBs, manufacturers, suppliers, and other third parties to conduct our clinical trials, including those for our drug candidates bezisterim (NE3107) and BIV201. We rely heavily on these third parties over the course of our clinical trials, and we control only certain aspects of their activities. Nevertheless, we retain ultimate responsibility for ensuring that each of our studies is conducted in accordance with the protocol and applicable legal, regulatory, and scientific standards and regulations, and our reliance on third parties does not relieve us of our regulatory responsibilities. We and these third parties are required to comply with cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for the conduct of clinical trials on product candidates in clinical development. Regulatory authorities enforce cGCPs through periodic inspections and for-cause inspections of clinical trial principal investigators and trial sites. If, due to the failure of either the Company or a third party, a clinical trial fails to comply with applicable cGCPs, FDA’s Investigational New Drug (“IND”) requirements, other applicable regulatory requirements, or requirements set forth in the applicable IRB-approved protocol, including failure to enroll a sufficient number of patients, the Company may be required to conduct additional clinical trials to support our marketing applications, which would delay the regulatory approval process. Moreover, our business may be implicated if any of these third parties violates applicable federal, state, or foreign laws and/or regulations, including but not limited to FDA’s IND regulations, fraud and abuse or false claims laws, healthcare privacy and data security laws, or provide us or government agencies with inaccurate, misleading, or incomplete data. For example, during routine monitoring of blinded data from our Phase 3 study (NCT04669028) of bezisterim (NE3107), we uncovered what appears to be potential scientific misconduct and significant deviation from study protocol and GCP violations at fifteen sites, which resulted in the Company excluding all patients from these sites and referring them to the FDA’s OSI for further action. The unplanned exclusion of so many patients left our Phase 3 study underpowered for the primary endpoints. These findings of potential scientific misconduct, significant deviation from protocol and GCP violations may call into question the rigor, robustness and validity of the entire data set for this study (NCT04669028).

 

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Although we design the clinical trials for our product candidates, our CROs are tasked with facilitating and monitoring our clinical trials. As a result, many important aspects of our clinical development programs, including site and investigator selection, and the conduct, timing, and monitoring of the study, is often outside our direct control, either partially or in whole. Our reliance on third parties to conduct clinical trials also results in less direct control over the collection, management, and quality of data developed through clinical trials than would be the case if we were relying entirely upon our own employees. Communicating with third parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities.

 

Successful development of biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our control.

 

Product candidates that appear promising in the early phases of development may fail to reach the market for several reasons. Pre-clinical study results may show the product candidate to be less effective than desired (e.g., the study failed to meet its primary endpoints) or to have harmful or problematic side effects. Product candidates may fail to receive the necessary regulatory approvals or may be delayed in receiving such approvals. Among other things, such delays may be caused by slow enrollment in clinical studies; length of time to achieve study endpoints; additional time requirements for data analysis; IND and later NDA preparation; discussions with the FDA; an FDA request for additional pre-clinical or clinical data; unexpected safety or manufacturing issues; manufacturing costs; pricing or reimbursement issues; clinical sites deviating from the trial protocol, committing scientific misconduct, or other violations of regulatory requirements – which can render data from those sites unusable in support of regulatory approval; or other factors that make the product not economical. Proprietary rights of others and their competing products and technologies may also prevent the product from being commercialized.

 

Success in pre-clinical and early clinical studies does not ensure that large-scale clinical studies will be successful. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. The length of time necessary to complete clinical studies and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one product to the next, and may be difficult to predict. There can be no assurance that any of our products will develop successfully, and the failure to develop our products will have a materially adverse effect on our business and will cause you to lose all of your investment.

 

Adverse Developments Affecting the Financial Services Industry and Concentration of Risk

 

As of March 31, 2024, the Company had cash deposited in certain financial institutions in excess of federally insured levels. The Company regularly monitors the financial stability of these financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents. However, in March and April 2023, certain U.S. government banking regulators took steps to intervene in the operations of certain financial institutions due to liquidity concerns, which caused general heightened uncertainties in financial markets. While these and other current events have not had a material direct impact on the Company’s operations, if further liquidity and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, the Company’s ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of operations.

 

We are currently subject to securities class action litigation and may be subject to similar or other litigation in the future, all of which will require significant management time and attention, result in significant legal expenses and may result in unfavorable outcomes, which may have a material adverse effect on our business, operating results and financial condition, and negatively affect the price of our common stock.

 

We are, and may in the future become, subject to various legal proceedings and claims that arise in or outside the ordinary course of business. For example, On January 19, 2024, a purported shareholder class action complaint, captioned Eric Olmstead v. BioVie Inc. et al., No. 3:24-cv-00035, was filed in the U.S. District Court for the District of Nevada, naming the Company and certain of its officers and/or directors as defendants. On April 15, 2024 the court ordered the motion to consolidate the six pending motions, appointed the lead plaintiff and approved selection of the lead counsel, now captioned Olmstead v. BioVie Inc., et al., Case 3:24-cv-0035 LRH-CSD and Way v. BioVie Inc., et al., Case No. 2:24-cv-00361-LRH-CSD. The lawsuit alleges that the Company made material misrepresentations and/or omissions of material fact relating to the Company’s business, operations, compliance, and prospects, including information related to the study and trial of bezisterim (NE3107), in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder. The class action is on behalf of purchasers of the Company’s securities during the period from August 5, 2021 through November 29, 2023 and seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees. See Part II, Item 1 of this Quarterly Report on Form 10-Q, entitled “Legal Proceedings” for more information regarding this litigation.

 

It is possible that additional lawsuits will be filed, or allegations received from stockholders, with respect to these same or other matters and also naming us and/or our officers and directors as defendants. Such lawsuits and any other related lawsuits are subject to inherent uncertainties, and the actual defense and disposition costs will depend upon many unknown factors. The outcome of such lawsuits is necessarily uncertain. We could be forced to expend significant resources in the defense of the pending lawsuit and any additional lawsuits, and we may not prevail. In addition, we may incur substantial legal fees and costs in connection with such lawsuits. We currently are not able to estimate the possible cost to us from this matter, as the pending lawsuit is currently at an early stage, and we cannot be certain how long it may take to resolve the pending lawsuit or the possible amount of any damages that we may be required to pay. Monitoring, initiating and defending against legal actions is time-consuming for our management, is likely to be expensive and may detract from our ability to fully focus our internal resources on our business activities. We could be forced to expend significant resources in the settlement or defense of the pending lawsuit and any potential future lawsuits, and we may not prevail in such lawsuits.

 

Although we have insurance coverage that we believe applies to these actions, the coverage is subject to a $2 million deductible. That means that we are responsible for the first $2 million of loss arising from these actions, which includes both defense costs and damages, before any insurance coverage will apply. Furthermore, our insurance coverage may be insufficient, and our assets may be insufficient to cover any amounts that exceed our insurance coverage, and we may have to pay damage awards or otherwise may enter into a settlement arrangement in connection with such claim. A decision adverse to our interests in the pending lawsuit, or in similar or related litigation, could result in the payment of substantial damages, or possibly fines, and could have a material adverse effect on our business, our stock price, cash flow, results of operations and financial condition. We have not established any reserve for any potential liability relating to the pending lawsuit or any potential future lawsuits. Any such payments or settlement arrangements in current or future litigation could have a material adverse effect on our business, operating results or financial condition. In addition, such lawsuits may make it more difficult to finance our operations and affect our ability to make payments for damages. 

 

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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, including under the Controlled Equity Offering Sales Agreement (the “Sales Agreement”), dated as of August 31, 2022, with Cantor Fitzgerald & Co. (the “Agent”), pursuant to which the Company may issue and sell from time to time shares of common stock through the Agent. We may sell shares or other securities in any other offering at a price per share that is less than the current market price of our securities, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders. The sale of additional shares of common stock or other securities convertible into or exchangeable for our common stock would dilute all of our stockholders, and if such sales of convertible securities into or exchangeable into our common stock occur at a deemed issuance price that is lower than the current exercise price of our outstanding warrants sold to Acuitas Group Holdings, LLC (“Acuitas”) in 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, 2024, there were warrants outstanding to purchase an aggregate of 19,320,285 shares of common stock at exercise prices ranging from $1.25 to $12.50 per share and 4,022,758 shares issuable upon exercise of outstanding options at exercise prices ranging from $1.69 to $42.09 per share and restricted stock units totaling 539,920. 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 may be converted into shares of common stock at a conversion price of $6.98 per share. We may grant additional options, warrants or equity 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., bezisterim (NE3107), NE3291, NE3413, and NE3789) pursuant to the asset purchase agreement, dated April 27, 2021, by and among the Company, NeurMedix, Inc. and Acuitas, as amended on May 9, 2021. 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 March 31, 2024, our directors and executive officers and affiliates currently own aggregate 23,631,735 shares of our Common Stock, which currently constitutes 38.8% of our issued and outstanding Common Stock. As a result, directors and executive officers and affiliates 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 affiliates entities, causing or restricting our sale or merger, and certain other matters. Our majority shareholder, Mr. Terren Peizer, may be deemed to beneficially own the 23,166,210 shares of Common Stock held by Acuitas, which constitutes 38.0% of our issued and outstanding Common Stock 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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We may, in the future, issue additional common stock, which would reduce investors’ percent of ownership and may dilute our share value.

 

As of March 31, 2024, our Articles of Incorporation, as amended, authorize the issuance of 800,000,000 shares of Common Stock, and we had 61,018,606 shares of Common Stock issued and 60,969,846 issued and outstanding. Accordingly, we may issue up to an additional 738,981,394 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 sales of equity securities

 

None.

 

Item 3. Defaults Upon Senior Securities

 

None

 

Item 4. Mine Safety Disclosures

 

None

 

Item 5. Other Information

 

None 

 

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Item 6. Exhibits

 

(a) Exhibit index

 

Exhibit

 

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 14, 2024
         
/s/ Joanne Wendy Kim        
Joanne Wendy Kim   Chief Financial Officer (Principal Financial and Accounting Officer)   May 14, 2024

 

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