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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: December 31,2022

 

☐ 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 34,987,568 shares of the Registrant’s $0.0001 par value Class A common stock outstanding as of February 1, 2023.

 

 

 

 

 

TABLE OF CONTENTS

 

PART I – FINANCIAL INFORMATION  
     
Item 1. Financial Statements 1
  Condensed Balance Sheets at December 31, 2022 (unaudited) and June 30, 2022 1
  Condensed Statements of Operations (unaudited) - for the three months and six months ended December 31, 2022 and 2021 2
  Condensed Statements of Cash Flows (unaudited) - for the six months ended December 31, 2022 and 2021 3
  Condensed Statements of Changes in Stockholders’ Equity (unaudited) - for the periods from July 1, 2021 through December 31, 2021 and July 1, 2022 through December 31, 2022 4
  Notes to Unaudited Condensed Financial Statements 5
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 18
Item 3. Quantitative and Qualitative Disclosures About Market Risk 21
Item 4. Controls and Procedures 21
     
PART II – OTHER INFORMATION  
     
Item 1. Legal Proceedings 22
Item 1A. Risk Factors 22
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 27
Item 3. Defaults Upon Senior Securities 27
Item 4. Mine Safety Disclosures 27
Item 5. Other Information 27
Item 6. Exhibits 28
     
SIGNATURES 29

 

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.

 

 

 

PART I – FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

BioVie Inc.

Condensed Balance Sheets

 

           
   December 31   June 30, 
   2022   2022 
ASSETS   (Unaudited)      
           
CURRENT ASSETS:          
Cash  $45,748,591   $18,641,716 
Prepaids and other assets   241,282    137,879 
Total current assets   45,989,873    18,779,595 
           
OTHER  ASSETS:          
Operating lease right-of-use assets   100,038    118,254 
Intangible assets, net   751,784    866,472 
Goodwill   345,711    345,711 
Other assets, non-current   4,562    4,562 
Total other assets   1,202,095    1,334,999 
           
TOTAL ASSETS  $47,191,968   $20,114,594 
           
LIABILITIES AND STOCKHOLDERS' EQUITY          
           
CURRENT LIABILITIES:          
Accounts payable and accrued expenses  $3,245,414   $2,442,804 
Current portion of other liabilities   338,698    1,304,925 
Current portion of operating lease liabilities   41,788    38,884 
Warrant liabilities   1,842,560    194,531 
Embedded derivative liability   2,328,553    188,030 
Total current liabilities   7,797,013    4,169,174 
           
Other liabilities, net of current portion   -    48,385 
Operating lease liabilities, net of current portion   65,835    87,414 
Note payable, net of financing cost, unearned premium and  discount of $1,738,942 at December 31, 2022 and $2,861,314 at June 30, 2022   13,261,058    12,138,686 
TOTAL LIABILITIES   21,123,906    16,443,659 
           
Commitments and contingencies (Note 11)          
           
STOCKHOLDERS' EQUITY :          
           
Preferred stock; $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding   -    - 
Common stock, $0.0001 par value; 800,000,000 shares authorized at December 31, 2022 and June 30, 2022; 34,504,332 and 24,984,083 shares issued and outstanding at December 31, 2022 and June 30, 2022, respectively   3,449    2,496 
Additional paid in capital   303,137,216    254,638,329 
Accumulated deficit   (277,072,603)   (250,969,890)
Total stockholders' equity   26,068,062    3,670,935 
           
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY  $47,191,968   $20,114,594 

 

See accompanying notes to unaudited condensed financial statements

 

-1-

BioVie Inc.

Condensed Statements of Operations

(Unaudited)

 

                     
   Three Months Ended   Three Months Ended   Six Months Ended   Six Months Ended 
   December 31,
2022		   December 31,
2021		   December 31,
2022		   December 31,
2021		 
OPERATING EXPENSES:                    
Amortization  $57,344   $57,344   $114,688   $114,689 
Research and development expenses   7,032,898    4,713,667    13,802,830    7,808,444 
Selling, general and administrative expenses   4,404,564    1,893,999    6,411,626    4,289,161 
TOTAL OPERATING EXPENSES   11,494,806    6,665,010    20,329,144    12,212,294 
                     
LOSS FROM OPERATIONS   (11,494,806)   (6,665,010)   (20,329,144)   (12,212,294)
                     
OTHER EXPENSE (INCOME):                    
Change in fair value of derivative liabilities   3,222,010    (1,555,254)   3,788,552    (1,555,254)
Interest expense   1,053,455    316,263    2,109,871    317,378 
Interest income   (83,269)   (11,702)   (124,854)   (19,348)
TOTAL OTHER EXPENSE (INCOME), NET   4,192,196    (1,250,693)   5,773,569    (1,257,224)
                     
NET LOSS  $(15,687,002)  $(5,414,317)  $(26,102,713)  $(10,955,070)
                     
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS  $(15,687,002)  $(5,414,317)  $(26,102,713)  $(10,955,070)
                     
NET LOSS PER COMMON SHARE                    
- Basic  $(0.50)  $(0.22)  $(0.89)  $(0.45)
- Diluted  $(0.50)  $(0.22)  $(0.89)  $(0.45)
                     
WEIGHTED AVERAGE NUMBER OF COMMON  SHARES OUTSTANDING                    
- Basic   31,168,826    24,962,373    29,201,445    24,344,545 
- Diluted   31,168,826    24,962,373    29,201,445    24,344,545 

 

See accompanying notes to unaudited condensed financial statements

 

-2-

BioVie Inc.

Condensed Statements of Cash Flows

(Unaudited)

 

           
   Six Months Ended   Six Months Ended 
   December 31,
2022		   December 31,
2021		 
CASH FLOWS FROM OPERATING ACTIVITIES:          
Net loss  $(26,102,713)  $(10,955,070)
Adjustments to reconcile net loss to net cash used in operating activities:          
Amortization of intangible assets   114,688    114,689 
Stock based compensation - restricted stock units   1,571,990    384,454 
Stock based compensation expense - stock options   2,591,427    3,074,384 
Amortization of financing costs   85,110    14,185 
Accretion of unearned loan discount   800,722    133,454 
Accretion of loan premium   236,540    23,611 
Amortization of operating lease right-of-use assets   18,216    - 
Change in fair value of derivative liability   3,788,552    (1,555,254)
Changes in operating assets and liabilities:          
Other assets   (103,403)   (61,381)
Accounts payable and accrued expenses   802,610    666,715 
Operating lease liabilities   (18,675)   - 
Other liabilities   (1,014,612)   919,323 
Net cash used in operating activities   (17,229,548)   (7,240,891)
           
CASH FLOWS FROM FINANCING ACTIVITIES:          
Net proceeds from issuance of common stock   38,428,343    18,511,009 
Proceeds from note payable net of financing costs   -    14,609,915 
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   44,336,423    33,120,924 
           
Net increase in cash   27,106,875    25,880,033 
           
Cash, beginning of period   18,641,716    4,511,642 
           
Cash, end of period  $45,748,591   $30,391,675 
           
SUPPLEMENTAL CASH FLOW INFORMATION:          
Cash paid for interest  $987,498   $146,128 

 

See accompanying notes to unaudited condensed financial statements

 

-3-

BioVie Inc.

Condensed Statements of Changes in Stockholders’ Equity

For the periods July 1, 2021 through December 31, 2021 and July 1, 2022 through December 31, 2022

(Unaudited)

 

                          
   Common Stock   Common Stock   Paid in   Accumulated   Stockholders' 
   Shares   Amount   Capital   Deficit   Equity 
Balance, June 30, 2021   22,333,324   $2,232   $229,933,505   $(224,885,422)  $5,050,315 
                          
Proceeds from issuance of common stock,net of cost of $2,224,992   2,592,000    259    18,510,750    -    18,511,009 
                          
Stock-based compensation - restricted stock units   37,049    3    286,756    -    286,759 
                          
Stock option based compensation   -    -    1,926,962    -    1,926,962 
                          
Net Loss   -    -    -    (5,540,753)   (5,540,753)
                          
Balance, September 30, 2021   24,962,373    2,494    250,657,973    (230,426,175)   20,234,292 
                          
Stock-based compensation - restricted stock units   21,710    2    97,693    -    97,695 
                          
Stock option based compensation   -    -    1,147,422    -    1,147,422 
                          
Net loss   -    -    -    (5,414,317)   (5,414,317)
                          
Balance, December 31, 2021   24,984,083   $2,496   $251,903,088   $(235,840,492)  $16,065,092 
                          
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    32,524,230    -    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 

 

See accompanying notes to unaudited condensed financial statements

 

-4-

BIOVIE INC.

Notes to Condensed Financial Statements

For the Three and Six Months Ended December 31, 2022 and 2021

(unaudited)

 

  1. Background Information

 

BioVie Inc. (the “Company” or “we” or “our”) is a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including 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, in June 2021 (See Note 5 Related Party Transactions). The acquired assets included NE3107, a potentially selective inhibitor of inflammatory extracellular single-regulated kinase(“ERK”) signaling that, based on animal studies, is believed to reduce neuroinflammation. NE3107 is a novel orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel mechanism of action. There is emerging scientific consensus that both inflammation and insulin resistance may play fundamental roles in the development of Alzheimer’s Disease (AD) and Parkinson’s Disease (PD), and NE3107 could, if approved 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. In August 2021, the Company initiated the FDA authorized potentially pivotal Phase 3 randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate NE3107 in subjects who have mild to moderate AD (NCT04669028). The Company is targeting primary completion of this study in the third quarter of calendar year 2023.

 

In December 2022, the Company released topline results from its Phase 2 study assessing NE3107’s safety and tolerability and potential pro-motoric impact in Parkinson’s disease patients. The NM201 study (NCT05083260) was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and NE3107. Forty-five patients with a defined L-dopa “off state” were randomized 1:1 to placebo: NE3107 20 mg twice daily for 28 days. The trial was launched with two design objectives: 1) the primary objectives are safety and a drug-drug interaction study (as requested by the FDA) to demonstrate the absence of adverse interactions of NE3107 with levodopa; and 2) the secondary objective is to determine if preclinical indications of promotoric activity and apparent enhancement of levodopa activity can be seen in humans. Both objectives of the study were met. The Company continues to process its findings from its completed NM201 study as it prepares for the next round of clinical studies in PD.  

 

Neuroinflammation, insulin resistance, and oxidative stress are common features in the major neurodegenerative diseases, including AD, PD, frontotemporal lobar dementia, and Amyotrophic lateral sclerosis (ALS). NE3107 is an 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. NE3107’s potential to inhibit neuroinflammation and insulin resistance forms the basis for the Company’s work testing the molecule in AD and PD patients. NE3107 is patented in the United States, Australia, Canada, Europe and South Korea. 

 

The Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with FDA Fast Track status, is being evaluated in a US Phase 2b study for the treatment of refractory ascites due to liver cirrhosis with top-line results anticipated in mid-2023. BIV201 is administered as a patent-pending liquid formulation. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis.

 

The BIV201 development program was initiated by LAT Pharma LLC (“LAT Pharma”). On April 11, 2016, the Company acquired LAT Pharma 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 and NanoAntibiotics, Inc., BioVie is obligated to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin), if approved, to be shared by the members of LAT Pharma, PharmaIn Corporation and The Barrett Edge, Inc

 

-5-

 

  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; 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, if approved; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, if approved; and the Company’s ability to raise capital to support its operations. 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 December 31, 2022, the Company had working capital of approximately $38.2 million, cash of approximately $45.7 million, stockholders’ equity of approximately $26.1 million, and an accumulated deficit of approximately $277.1 million. The Company has not generated any revenue to date and no revenue is 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 may sustain operations over the next 12 months from the balance sheet date if measures are taken to delay planned expenditures in our research protocols and slow the progress in the Company’s clinical programs, the Company’s current planned operations to meet certain goals and objectives project cash flows to be depleted within that period of time.

 

Management expects that future sources of funding may include sales of equity, obtaining loans, or other strategic transactions.

 

The duration and spread of the COVID-19 pandemic and the long-term impact of COVID-19 and any variants on the financial markets and the overall economy continue to be highly uncertain and cannot be predicted at this time. If the financial markets and/or the overall economy are impacted for an extended period, the Company’s ability to raise funds may be materially adversely affected. In addition, the COVID-19 pandemic has created a widespread labor shortage, including a shortage of medical professionals, and has impacted and may continue to impact the potential patient participation in our studies, which may adversely impact our ability to continue or complete our clinical trials on the Company’s planned timeline.

 

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

 

  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, 2022 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, 2022 and 2021 in our Annual Report on Form 10-K filed with the SEC on September 27, 2022. For a summary of significant accounting policies, see the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2022, filed with the SEC on September 27, 2022 (the “2022 Form 10-K”).

 

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

 

-6-

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 Class A 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 convertible debentures. For the three and six months ended December 31, 2022 and 2021, such amounts were excluded from the diluted loss since their effect was considered anti-dilutive due to the net loss for the period.

 

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

 

          
   December 31,
2022		   December 31,
2021		 
   Number of Shares   Number of Shares 
Stock Options   3,448,797    2,047,910 
Warrants   7,770,285    519,763 
Total   11,219,082    2,567,673 

 

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 since the 2022 Form 10-K.

 

  4. 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 as of December 31, 2022 and June 30, 2022:

 

          
   December 31,
2022		   June 30,
2022		 
Intellectual Property  $2,293,770   $2,293,770 
Less Accumulated Amortization   (1,541,986)   (1,427,298)
Intellectual Property, Net  $751,784   $866,472 

 

Amortization expense was $57,344 in each of the three-month periods ended December 31, 2022 and 2021. Amortization expense was $114,688 and $114,689 in each of the six-month periods ended December 31, 2022 and 2021, respectively. 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, 2023 (Remaining six months)  $114,689 
2024   229,377 
2025   229,377 
2026   178,341 
Intellectual Property, Net   $751,784 

 

-7-

 

  5. Related Party Transactions

 

Equity Transactions with Acuitas

 

On July 15, 2022, the Company entered into a securities purchase agreement with Acuitas Group Holdings, LLC (Acuitas), the Company’s majority 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 has a down round feature that reduces the exercise price of the warrant if the Company sells stock at a price lower than the exercise price of the warrant. 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.

 

Asset Acquisition with NeurMedix

 

On April 27, 2021, the Company entered into an Asset Purchase Agreement (“APA”) with NeurMedix and Acuitas, which are related party affiliates, pursuant to which the Company acquired certain assets from NeurMedix and assumed certain liabilities of NeurMedix,. The acquired assets include, among others, certain assets related to the drug candidates then being developed by NeurMedix, including NE3107. On June 10, 2021, and pursuant to the terms of the APA, the Company issued to Acuitas (as NeurMedix’s assignee) 8,361,308 shares of the Company’s common stock and made a cash payment to Acuitas of approximately $2.3 million. Since the transaction was between entities under common control, there were no fair value adjustments of the purchased assets, and the historical cost basis of the purchased assets was zero. The total consideration paid was expensed as in process research and development expense in the year ended June 30, 2021. 

 

Previously, the Company was obligated to deliver contingent stock consideration to NeurMedix (or its successor) consisting of shares of the Company’s common stock having an aggregate value of up to $3.0 billion, subject to the achievement of certain clinical, regulatory and commercial milestones related to the drug candidates to be acquired by the Company from NeurMedix, and subject to a cap limiting each issuance of shares if such issuance would result in the beneficial ownership of NeurMedix and its affiliates exceeding 89.9999% of the Company’s issued and outstanding common stock. Subject to the terms and conditions of the APA, as amended, the Company may now be obligated to deliver contingent stock consideration to NeurMedix (or its successor) consisting of up to 18 million shares of the Company’s common stock, with 4.5 million shares issuable upon the achievement of each of the four milestones set forth in the APA, subject to a cap limiting the issuance of shares if such issuance would result in the beneficial ownership of NeurMedix and its affiliates exceeding 87.5% of the Company’s issued and outstanding common stock.

 

  6. Other Liabilities

 

The current portion of other liabilities at December 31, 2022 were $338,698 and at June 30, 2022 was $1.3 million, including $338,698 and $580,614, respectively, of retention bonus payable for arrangements with certain employees. The payment terms of the total retention bonus arrangements of $1,161,000 recognized in August 2021 provided for equal monthly installments over a 24-month period and began in August 2021.

 

  7. Notes Payable

 

On November 30, 2021 (the “Closing Date”), the Company entered into a Loan and Security Agreement and the Supplement to the Loan and Security Agreement and Promissory Notes (together, the “Loan Agreement”) with Avenue Venture Opportunities Fund, L.P. (“AVOPI”) and Avenue Venture Opportunities Fund II, L.P. (“AVOPII,” 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 December 31, 2022 was 7.5%. The Loan is secured by a lien upon and security interest in all of the Company’s assets, including intellectual property, subject to agreed exceptions. The maturity date of the Loan is December 1, 2024.

 

-8-

The Loan Agreement requires monthly interest-only payments during the first eighteen months of the term of the Loan. Following the interest-only period, the Company will make equal monthly payments of principal, plus accrued interest, until the Loan’s maturity date when all remaining principal and accrued interest is due. If the Company prepays the Loan, it will be required to pay (a) a prepayment fee in an amount equal to 3.0% of the principal amount of the Loan that is prepaid during the interest-only period; and (b) a prepayment fee in an amount equal to 1.0% of the principal amount of the Loan that is prepaid after the interest-only period. At the Loan’s maturity date, or on the date of the prepayment of the Loan, 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.

 

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 $3.7 million, the total direct financing cost of approximately $390,000 and premium of $850,000 are 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 $1.1 million for the three months ended December 31, 2022, was recognized in the accompanying statements of operations and included the interest only payments totaling approximately $518,000, the amortization of financing costs of approximately $43,000, unearned discount of approximately $400,000 and the accretion of loan premium of approximately $93,000. The total interest expense of approximately $2.1 million for the six- months ended December 31, 2022, was recognized in the accompanying statements of operations and included interest only payments totaling approximately $987,000, the amortization of financing costs of approximately $85,000, unearned discount of approximately $800,000 and the accretion of loan premium of approximately $237,000.

 

As of December 31, 2022, the remaining principal balance of $15 million under the Loan is payable in 18 monthly equal installments beginning July 1, 2023; for a total of $10.0 million and $5.0 million in the fiscal years ended June 30, 2024 and 2025 respectively.

 

The following is a summary of the Notes Payable as of December 31, 2022 and June 30, 2022:

 

          
   December 31,
2022		   June 30,
2022		 
Notes Payable  $15,000,000   $15,000,000 
Less debt financing costs   (205,680)   (290,790)
Less unearned discount   (1,935,080)   (2,735,802)
Plus accretion of loan premium   401,818    165,278 
Notes Payable, net of financing costs, unearned premiums and discount  $13,261,058   $12,138,686 

 

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

 

               
   Unearned Discount   Debt Financing Costs   Loan accretion Premium 
Year ending June 30, 2023 (Remaining 6 months)  $800,723   $85,111   $185,455 
2024   1,023,145    108,751    236,970 
2025   111,212    11,820    25,755 
Total  $1,935,080   $205,682   $448,180 

 

-9-

 

8. Fair Value Measurements

 

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

 

                    
   December 31, 2022 
   Level 1   Level 2   Level 3   Total 
Derivative liability – Warrants  $-   $-   $1,842,560   $1,842,560 
Derivative liability – Conversion option on notes payable   -    -    2,328,553    2,328,553 
Total derivatives  $-   $-   $4,171,113   $4,171,113 

 

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

 

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

 

          
   Derivative liabilities – Avenue Warrants   Derivative liability – Conversion Option on Convertible Debenture 
Balance at July 1, 2022  $194,531   $188,030 
Additions to level 3 liabilities   -    - 
Change in in fair value of level 3 liability   1,648,029    2,140,523 
Transfer in and/or out of Level 3   -    - 
Balance at December 31, 2022  $1,842,560   $2,328,553 

 

-10-

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

 

   Derivative liabilities – Avenue Warrants   Derivative liability – Conversion Option on Convertible Debenture 
Balance at July 1, 2021  $-   $- 
Additions to level 3 liabilities   1,456,512    2,213,466 
Change in fair value of level 3 liability   (559,553)   (995,701)
Transfer in and/or out of Level 3   -    - 
Balance at December 31, 2021  $896,959   $1,217,765 

 

The fair values of derivative liabilities for the Avenue Warrants and conversion option at December 31, 2022 in the accompanying balance sheet, were approximately $1.8 million and approximately $2.3 million, respectively. The total change in the fair value of the derivative liabilities totaled approximately $3.2 million and $3.8 million for the three and six months ended December 31, 2022, respectively; and accordingly, was recorded in the accompanying statement of operations. The assumptions used in the Black Scholes model to value the derivative liabilities at December 31, 2022 included the closing stock price of $7.77 per share; for the Avenue Warrants, the exercise price of $5.82, 4-year term, risk free rate of 4.11% and volatility of 78.5%; and for the embedded derivative liability of the conversion option, the conversion price of $6.98; 2-year term, risk free rate of 4.41% and volatility of 66.9%.

 

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 accompany balance sheet at December 31, 2022.

 

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

 

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 Loan amount funded. The assumption used for the fair value calculation at November 30, 2021 included: the closing stock price of $6.44 per share; the conversion price of $6.98; 3 year term; risk free rate of 0.81% and volatility of 76.85%.

 

-11-

 

9. Equity Transactions

 

Stock Options

 

The following table summarizes the activity relating to the Company’s stock options for the six months ended December 31, 2022:

 

                    
   Options   Weighed-Average Exercise Price   Weighted Remaining Average Contractual Term   Aggregate Intrinsic Value 
Outstanding at June 30, 2022   3,398,764    7.42    6.8    - 
Granted   205,000    6.08    5.2    347,350 
Options Expired   (5,200)   28.69    -    - 
Options Canceled   (49,667)   7.74    -    - 
Options Exercised   (100,100)   7.60    -    - 
Outstanding at December 31, 2022   3,448,797   $7.29    6.2   $5,601,237 
Exercisable at December 31, 2022   1,008,808   $9.19    5.8   $703,756 

 

The fair value of each option grant on the date of grant is estimated using the Black-Scholes option. The pricing model reflects the following weighted-average assumptions for the six months ended December 31, 2022 and 2021:

 

      
   December 31,
2022		  December 31,
2021
Expected life of options (In years)  5.2  5
Expected volatility  79.52%  74.96%
Risk free interest rate  3.61%  0.80%
Dividend Yield  0%  0%

 

Expected volatility is based on the historical volatilities of the daily closing price of the common stock of three comparable companies and the expected life of options is based on historical data with respect to employee exercise periods. The Company accounts for forfeitures as they are incurred.

 

The total stock option-based compensation expense for three-month ended December 31, 2022 and 2021 was of $1,712,787 and $1,147,422, respectively and for the six months ended December 31,2022 and 2021 was $2,591,427 and $3,074,384, respectively.

  

-12-

The following is a summary of stock options outstanding and exercisable by exercise price as of December 31, 2022:

 

                 
Exercise Price   Outstanding   Weighted Average Contract Life   Exercisable 
$1.69    124,520    4.5    - 
$1.81    10,000    4.4    - 
$1.98    72,000    4.4    2,000 
$2.74    124,167    9.1    - 
$2.80    5,600    2.1    5,600 
$3.20    248,167    9.1    24,833 
$3.24    25,000    9.1    - 
$3.75    4,800    1.1    4,800 
$5.04    755,000    4.6    188,750 
$5.21    10,000    9.9    - 
$6.12    195,000    4.9    - 
$6.25    1,600    0.8    1,600 
$7.50    1,600    1.0    1,600 
$7.74    1,241,668    8.6    447,000 
$8.75    1,600    1.0    1,600 
$9.54    800    2.8    800 
$9.90    800    2.8    800 
$12.50    4,000    0.1    4,000 
$13.91    618,475    3.0    321,425 
$42.09    4,000    3.1    4,000 
      3,448,797         1,008,808 

 

Issuance of common stock for cash

 

During the three months ended September 30, 2021, the Company issued 2,592,000 of its Class A common stock at $8.00 per share in connection with its registered public offering of approximately $18.5 million, net of issuance costs of approximately $2.2 million.

 

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. During the three months ended December 31, 2022, the Company sold 4,312,741 shares of common stock under the Sales Agreement for total net proceeds of $32.5 million after 3% commissions and expenses of approximately $1.2 million. During the six months ended December 31, 2022, the Company sold 5,857,613 shares of common stock under the Sales Agreement for total net proceeds of $38.4 million after 3% commissions and expenses of approximately $1.6 million.

 

Issuance of common stock through exercise of stock options and warrants

 

During the three months ended December 31, 2022, the Company issued 21,882 shares of common stock pursuant to a cashless exercise of stock options to purchase 99,300 shares at an average exercise price of $7.64

 

In November 2022, the Company issued 800 shares of common stock pursuant to a cash exercise of stock options to purchase 800 shares at an average exercise price of $2.80 per share.

 

In October, the Company issued 3,590 shares of common stock pursuant to a cashless exercise of warrants to purchase 8,000 shares at an average exercise price of $2.25.

 

-13-

Issuance of restricted stock units for services

 

On August 20, 2021, the Company awarded 58,759 restricted stock units (“RSUs”) to the Company’s President and CEO under the Company’s 2019 Omnibus Incentive Equity Plan (the “2019 Omnibus Plan”) as his salary for the period from April 27, 2021, the date of his appointment, through December 31, 2021. The number of RSUs awarded was based on a prorated annual base salary of $600,000 at a 10% discount to the grant date fair value of $7.74 per share of the Company’s common stock. Each RSU awarded to the CEO entitled him to receive one share of common stock upon vesting. A total of 15,339 RSUs (representing the pro rata portion of the RSU award for the period from April 27, 2021 to June 30, 2021) vested at the grant date, 21,710 vested at September 30, 2021 and remaining 21,710 vested at December 31, 2021. Accordingly, the CEO was issued an aggregate of 58,759 shares of common stock over the vesting period of the RSUs. The stock-based compensation expense related to these RSUs was $384,456.

 

On June 21, 2022, the Company awarded 124,520 RSUs to the President and CEO under the Company’s 2019 Omnibus Plan. Each RSU awarded to the CEO entitles him to receive one share of common stock upon vesting. The RSUs vest in three equal annual installments over three years on the anniversary grant date. The grant date fair value was $1.69 per share of the Company’s common stock. The stock-based compensation expense related to these RSUs was $17,537 and $35,074 for the three and six months ended December 31, 2022, respectively.

 

On November 23, 2022, the Company awarded 506,496 RSUs to certain employees and a consultant, with a grant date fair value of $6.12 per share. Twenty-five percent of these RSU vested on the grant date and the remaining RSUs vest in three equal installments over three years beginning on the first anniversary of the grant date. For the three months ended December 31, 2022, the stock-based compensation expense related to these RSUs was $584,424.

 

On November 23, 2022, the Company issued equity awards for the board of directors’ annual compensation. Four directors received 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 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 grant date fair value. The total stock compensation cost of stock options of $791,700 was recognized in the three months ended December 31, 2022. The equity awards vest every three months beginning from the last annual shareholders’ meeting on November 9, 2022 on February 9, 2023, May 9, 2023, August 9, 2023 and the earlier of November 9, 2023 or 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.

  

-14-

Issuance of Stock Options

 

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

 

Pursuant to a former employee Separation Agreement, dated April 11, 2022, the Company modified a former employee’s stock option award granted on August 20, 2021 pursuant to the 2019 Omnibus Plan (“2021 Options Grant”). Pursuant to the terms of the Separation Agreement, effective on July 8, 2022 (“the Separation Date”), the Company accelerated the vesting of options scheduled to vest on the first and second anniversary of the grant date as deemed vested (“Accelerated Options”) and after giving effect to the Accelerated Options, extended the exercise period of the total vested outstanding and unexercised options (totaling 74,500 options) to one year following the Separation Date. The unvested portion of the 2021 Option Grant (totaling 49,667 options) was canceled. The modification was remeasured as of July 8, 2022 and the incremental difference totaled $181,154, net credit, due to the original exercise price of $7.74 being greater than the stock price of $1.80 on the remeasurement date, and accordingly was recognized on July 8, 2022.

 

On December 6, 2022, the Company granted stock options to purchase 10,000 shares of common stock to a new employee. Twenty percent (20%) of the shares underlying the options awarded vest on the one year anniversary of the grant date, and the remaining 80% vest in equal monthly installments over 48 month. The exercise price is $5.21 per share, the grant date fair value, and the options terminate on the tenth anniversary of the grant date.

 

Stock Warrants

 

The following table summarizes warrant activity during the six months ended December 31, 2022:

 

                    
   Number of Shares   Weighted Average Exercise Price   Weighted Average Remaining Life (Years)   Aggregate Intrinsic Value 
Outstanding and exercisable at June 30, 2022   510,372   $6.17    3.8   $- 
Granted   7,272,728    1.82    4.9    - 
Expired   (4,815)   75.00    -    - 
Exercised   (8,000)   2.25    -    - 
Outstanding and exercisable at December 31, 2022   7,770,285   $2.06    4.5   $44,537,323 

 

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, and 7,633,730 expire in the fiscal year ending June 30, 2027.

 

-15-

 

10. Leases

 

Office Lease

 

The Company paid an annual rent of $2,200 for its headquarters at 680 W Nye Lane, Suite 201, Carson City Nevada 897603. The rental agreement is for a one year term.

 

On February 26, 2022, the Company’s San Diego office relocated to 5090 Shoreham Place, San Diego, CA 92122. The term for the new office lease is 38 months and commenced on March 1, 2022. The monthly base rate of $4,175 begins June 1, 2022, with annual increases of three percent.

 

The operating lease cost recognized in our statement of operations was approximately $13,000 and $27,700 for the three months ended December 31, 2022 and 2021, respectively. The operating lease cost recognized in our statement of operations was approximately $25,900 and $53,100 for the six months ended December 31, 2022 and 2021, respectively.

 

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

 

         
   December 31,
2022		   June 30,
2022		 
Assets        
Operating lease, right-of-use asset, net  $100,038   $118,254 
           
Liabilities          
Current portion of operating lease liabilities  $41,788   $38,884 
Operating lease liabilities, net of current portion   65,835    87,414 
Total operating lease liabilities  $107,623   $126,298 

 

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

 

     
Year ending June 30, 2023 (Remaining 6 months)  $25,550 
2024   52,156 
2025   44,636 
Toal minimum lease payments   122,342 
Less amount representing interest   (14,719)
Present value of future minimum lease payments   107,623 
Less currrent portion of operating lease liabilities   (41,788)
Operating lease liabilities, net of current portion  $65,835 

 

-16-

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

 

          
   December 31,
2022		   June 30,
2022		 
Weighted average remaining lease term (Years)          
Operating leases   2.3    2.8 
Weighted average discount rate          
Operating leases   10.75%   10.75%

 

 

11. 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.

 

12. Employee Benefit Plan

 

On August 1, 2021, the Company began sponsoring an employee benefit plan subject to Section 401(K) of the Internal Revenue Service Code (the “401K Plan”).

 

Subject to certain limitations in the Internal Revenue Code, eligible employees are permitted to make contributions to the 401K Plan on a pre-tax salary reduction basis and the Company will match 5% of the first 5% of an employee’s contributions to the 401K Plan. For the three months ended December 31, 2022 and 2021, the Company made contributions of approximately $19,000 and $23,000, respectively. For the six months ended December 31, 2022 and 2021, the Company made contributions of approximately $64,192 and $46,600, respectively.

 

13. Subsequent Events

 

In January 2023, the Company sold 483,036 shares of common stock for net proceeds of $2.9 million net of 3% commission and expenses totaling approximately $90,000 under the Sales Agreement with the Agents.

 

-17-

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. 

 

In neurodegenerative disease, the Company acquired the biopharmaceutical assets of NeurMedix, Inc. (“NeurMedix”), a privately held clinical-stage pharmaceutical company, in June 2021 (See Note 5 Related Party Transactions). The acquired assets included NE3107, a potentially selective inhibitor of inflammatory extracellular single-regulated kinase (“ERK”) signaling that, based on animal studies, is believed to reduce neuroinflammation. NE3107 is a novel orally administered small molecule that is thought to inhibit inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel mechanism of action. There is emerging scientific consensus that both inflammation and insulin resistance may play fundamental roles in the development of Alzheimer’s Disease (AD) and Parkinson’s Disease (PD), and NE3107 could, if approved, 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. In August 2021, the Company initiated the FDA authorized potentially pivotal Phase 3 randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate NE3107 in subjects who have mild to moderate Alzheimer’s disease (NCT04669028). The Company is targeting primary completion of this study in the third quarter of calendar year 2023.

 

In December 2022, the Company released topline results from its Phase 2 study assessing NE3107’s safety and tolerability and potential pro-motoric impact in PD patients. The NM201 study (NCT05083260) was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and NE3107. Forty-five patients with a defined L-dopa “off state” were randomized 1:1 to placebo:NE3107 20 mg twice daily for 28 days. The trial was launched with two design objectives: 1) the primary objectives are safety and a drug-drug interaction study (as requested by the FDA) to demonstrate the absence of adverse interactions of NE3107 with levodopa; and 2) the secondary objective is to determine if preclinical indications of promotoric activity and apparent enhancement of levodopa activity can be seen in humans. Both objectives of the study were met. The Company continues to process its findings from its completed NM201 study as it prepares for the next round of clinical studies in PD.

 

 In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with FDA Fast Track status, is being evaluated in a US Phase 2b study for the treatment of refractory ascites due to liver cirrhosis with top-line results anticipated in mid-2023. BIV201 is administered as a patent-pending liquid formulation. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis.

 

-18-

Comparison of the three months ended December 31, 2022 to the three months ended December 31, 2021

 

Net loss

 

The net loss for the three months ended December 31, 2022 was approximately $15.7 million as compared $5.4 million for the three months ended December 31, 2021. The increase in net loss of approximately $10.3 million was primarily due to increased losses from operations of $4.8 million due to increased clinical activities, an increase in interest expense of approximately $737,000 million from the notes payable financing obtained in November 2021 and a change in fair value of derivative liabilities of approximately $4.8 million.

 

Total operating expenses for the three months ended December 31, 2022 were approximately $11.5 million as compared to $6.7 million for the three months ended December 31, 2021.  The net increase of approximately $4.8 million for the three months ended December 31, 2022 was due to an increase in research and development expenses of approximately $2.3 million due to increased clinical activities and an increase in selling general and administrative expenses of approximately $2.5 million.

 

Research and Development Expenses

 

Research and development expenses were approximately $7.0 million and $4.7 million for the three months ended December 31, 2022 and 2021, respectively. The net increase of approximately $2.3 million, was comprised of a net increase in clinical study activities of approximately $1.4 million, offset by a decline in other development activities of approximately $526,000 ; and increase in Chemistry, Manufacturing and Control of approximately $542,000, and an increase in compensation expense of approximately $973,000 related to the Company’s expansion of the clinical team and consultants supporting its increased clinical activities over the three months ended December 31, 2021.

 

The increase in research and development expenses of $1.3 million was primarily due to the Neuroscience NE3107 studies, which were significantly more active during the three months ended December 31, 2022 compared to the three months ended December 31, 2021. The Parkinson’s Phase 2 study initiated in January 2022, became fully enrolled with the top-line data read reported in December 2022 and the Alzheimer Phase 3 study is approaching full enrollment. Our Orphan drug candidate BIV201’s Phase 2b study, which was initiated in June 2021, accounted for approximately $100,000 of the net increase in research and development expenses for three months ended December 31, 2022.

 

Selling, General and Administrative Expenses

 

Selling, general and administrative expenses were approximately $4.4 million and $1.9 million for the three months ended December 31, 2022 and 2021, respectively. The net increase of approximately $2.5 million was primarily attributed to increased stock compensation expense of approximately $1.7 million related to the board of directors’ annual compensation, a net increase in management compensation expenses of approximately $342,000, due to an increase in staff from 2 to 4 persons, and equity awards granted in the three months ended December 31, 2022, and increased legal, investor advisory and other professional fees totaling approximately $478,000.

 

Other Income and Expense

 

Other expense, net was $4.2 million for the three months ended December 31, 2022 compared to other income of $1.3 million for the three months ended December 31, 2021. The net increase in other expense of $5.5 million was due to an increase in interest expense of approximately $737,000, which was attributed to the $15 million debt financing obtained in November 2021 and the change in fair value of the related derivative liabilities recognized for the three months ended December 31, 2022 was approximately $4.8 million.

 

Comparison of the six months ended December 31, 2022 to the six months ended December 31, 2021

 

Net loss

 

The net loss for the six months ended December 31, 2022 was approximately $26.1 million as compared to $11.0 million for the six months ended December 31, 2021. The increase in net loss of approximately $15.1 million was primarily due to increased losses from operations of $8.1 million due to increased clinical activities, an increase in interest expense of approximately $1.8 million from the notes payable financing obtained in November 2021, and a change in fair value of derivative liabilities of approximately $5.3 million.

 

Total operating expenses for the six months ended December 31, 2022 were approximately $20.3 million as compared to $12.2 million for the six months ended December 31, 2021.  The net increase of approximately $8.1 million during the six months ended December 31, 2022 was due to an increase in research and development expenses of approximately $6.0 million due to our increased clinical activities, and an increase in selling general and administrative expenses of approximately $2.0 million.

 

Research and Development Expenses

 

Research and development expenses were approximately $13.8 million and $7.8 million for the six months ended December 31, 2022 and 2021, respectively. The net increase of approximately $6.0 million, was comprised of a net increase of $5.4 million from increased clinical activities, offset by a decline in other development activities of approximately $543,000, an increase in Chemistry, Manufacturing and Control expense of approximately $542,000, and an increase in compensation expense of approximately $537,000 due to the Company’s expansion of the clinical team and consultants supporting our increased clinical activities over the six months ended December 31, 2021.

 

The increase in research and development expenses of $5.3 million was primarily due to the Neuroscience NE3107 studies, which were significantly more active during the six months ended December 31, 2022 compared to the six months ended December 31, 2021. The Parkinson’s Phase 2 study initiated in January 2022, became fully enrolled, with the top-line data read reported in December 2022, and the Alzheimer Phase 3 study is approaching full enrollment. Our Orphan drug candidate BIV201’s Phase 2b study, which was initiated in June 2021, accounted for approximately $100,000 of the net increase in research and development expenses for six months ended December 31, 2022.

 

Selling, General and Administrative Expenses

 

Selling, general and administrative expenses were approximately $6.4 million and $4.3 million for the six months ended December 31, 2022 and 2021, respectively. The net increase of approximately $2.1 million was primarily attributed to increased stock compensation expense of approximately $1.8 million related to the board of directors’ annual compensation; a net increase in legal, investor relations and other professional fees totaling approximately $462,000, an increase in management compensation expense of approximately $477,000 due to an increase in staff from two to four persons, offset by stock compensation expense of approximately $758,000.

 

Other Income and Expense

 

Other expense, net was $5.8 million for the six months ended December 31, 2022 compared to other income of $1.3 million. The net increase in other expense of $7.1 million represented an increase in interest expense of approximately $1.8 million attributed to the $15 million debt financing obtained in November 2021 and the change in fair value of the related derivative liabilities recognized for the six months ended December 31, 2022 of approximately $5.3 million.

 

-19-

Capital Resources and Liquidity

 

As of December 31, 2022, the Company had cash of approximately $45.7 million, working capital of approximately $38.2 million, stockholders’ equity of approximately $26.1 million, and an accumulated deficit of approximately $277.1 million. In the three months ended December 31, 2022, the Company sold 4.3 million shares of its common stock under its Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co and B. Riley Securities, Inc. for total net proceeds of $32.5 million after 3% commissions and cost totaling approximately $1.2 million.

 

The Company has not generated any revenues 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.

 

The duration and spread of the COVID-19 pandemic and the long-term impact of COVID-19 and its variants on the financial markets and the overall economy continue to be highly uncertain and cannot be predicted at this time. If the financial markets and/or the overall economy are impacted for an extended period, the Company’s ability to raise funds may be materially adversely affected. In addition, the COVID-19 pandemic has created a widespread labor shortage, including a shortage of medical professionals, and has impacted and may continue to impact the potential patient participation in our studies, which may adversely impact our ability to continue or complete our clinical trials in the planned timeline.

 

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

 

-20-

Critical Accounting Policies and Estimates

 

For the six-month period ended December 31, 2022, there were no significant changes to the Company’s critical accounting policies as identified in the Annual Report Form 10-K for the fiscal year ended June 30, 2022.

 

New Accounting Pronouncements

 

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

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

Not applicable to smaller reporting companies.

 

Item 4. Controls and Procedures

 

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

 

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

 

Changes in Internal Control over Financial Reporting

 

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

 

-21-

PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings

 

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

 

Item 1A. Risk Factors

 

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

 

Risks Relating to Our Business and Industry

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

We may face business disruption and related risks if there is another surge ofCOVID-19 or if there is another pandemic caused by other bacteria or viruses, which could have a material adverse effect on our business plan.

 

Health emergencies or pandemics, whether from COVID-19 or other viruses or bacteria, may lead to regional quarantines, business shutdowns, labor shortages, disruptions to supply chains, and overall economic instability, which could materially and adversely affect the clinical trials, supply chain, financial condition and financial performance of our company. The duration and spread of a pandemic and its long-term impact on the financial markets and the overall economy are highly uncertain and cannot be predicted. If the financial markets and/or the overall economy are impacted for an extended period, the Company’s ability to raise funds may be materially adversely affected. In addition, such health emergencies or pandemics may create a widespread labor shortage, including a shortage of medical professionals, and may impact potential patient participation in our studies which may adversely impact our ability to continue or complete our clinical trials in the planned timeline.

 

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

 

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

 

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We 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, we may not be able to obtain regulatory approval of or commercialize our product candidates.

 

We depend, and will continue to depend, on contract research organizations (“CROs”), clinical trial sites and clinical trial principal investigators, contract laboratories, and other third parties to conduct our clinical trials. 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 are responsible 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 current good clinical practices (“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 we or any of these third parties fail to comply with applicable cGCPs or fail to enroll a sufficient number of patients, we 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 federal, state, or foreign fraud and abuse or false claims laws and regulations or healthcare privacy and security laws, or provide us or government agencies with inaccurate, misleading, or incomplete data.

 

Although we design the clinical trials for our product candidates, our CROs will facilitate and monitor our clinical trials. As a result, many important aspects of our clinical development programs, including site and investigator selection, and the conduct and timing and monitoring of the study, will be partly or completely outside our direct control. Our reliance on third parties to conduct clinical trials will also result 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.

 

Any third parties conducting our clinical trials are not, and will not be, our employees and, except for remedies available to us under our agreements with these third parties, we cannot control whether they devote sufficient time and resources to our ongoing preclinical, clinical, and nonclinical programs. These third parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other drug development activities, which could affect their performance on our behalf. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements, or if there are other difficulties with such third parties, such as staffing difficulties, changes in priorities, or financial distress, our clinical trials may be extended, delayed, or terminated. As a result, we may not be able to complete development of, obtain regulatory approval of, or successfully commercialize our product candidates. As a result, our financial results and the commercial prospects for our product candidates will be harmed, our costs could increase, and our ability to generate revenue could be delayed.

 

If any of our relationships with trial sites, or any CRO that we may use in the future, terminates, we may not be able to timely enter into arrangements with alternative trial sites or CROs, or do so on commercially reasonable terms. Switching or adding clinical trial sites or CROs to conduct our clinical trials involves substantial cost and requires extensive management time, training, and focus. In addition, there is a natural transition lag when a new third party must learn about our product candidates and protocols, which can result in delays that may materially impact our ability to meet our desired clinical development timelines.

  

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

 

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

 

BioVie has also filed a PCT (“Patent Cooperation Treaty”) application covering our novel liquid formulations of terlipressin (international patent application PCT/US2020/034269 published as WO2020/237170) and we are seeking patent protection in the United States, Europe, China, Japan and eight other jurisdictions. As of December 31, 2022, we have fifteen (15) issued U.S. patents, one (1) pending U.S. patent application, one (1) pending PCT application and six (6) issued foreign patents directed to protecting NE3107 and related compounds and methods of making and using thereof. However, there can be no assurance that our pending patent applications will result in issued patents, or that any issued patent claims from pending or future patent applications will be sufficiently broad to protect BIV201, NE3107, or any other product candidates or to provide us with competitive advantages. 

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

Risks Relating To Our Common Stock

 

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

 

In order to raise additional capital, we may in the future offer additional shares of our common stock or other securities convertible into or exchangeable for our common stock, including under the Controlled Equity Offering Sales Agreement (the “Sales Agreement”), dated as of August 31, 2022, by and among the Company, Cantor Fitzgerald & Co. and B. Riley Securities, Inc. (collectively, the “Agents”), pursuant to which the Company may issue and sell from time to time shares of common stock through the Agents. We may sell shares or other securities in any other offering at a price per share that is less than the current market price 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 December 31, 2022, there were warrants outstanding to purchase an aggregate of 7,770,285 shares of common stock at exercise prices ranging from $1.82 to $12.50 per share and 3,448,797 shares issuable upon exercise of outstanding options at exercise prices ranging from $1.69 to $42.09 per share. Our Loan Agreement entered into on November 30, 2021 contains a conversion feature whereby at the option of lender, up to $5 million of the outstanding loan amount may be converted into shares of common stock at a conversion price of $6.98 per share. We may grant additional options, warrants or stock awards. To the extent such shares are issued, the interest of holders of our common stock will be diluted.

 

Moreover, we are obligated to issue shares of common stock upon achievement of certain clinical, regulatory and commercial milestones with respect to certain of our drug candidates (i.e., NE3107, NE3291, NE3413, and NE3789) pursuant to the asset purchase agreement, dated April 27, 2021, by and among the Company, NeurMedix, Inc. and Acuitas, 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 December 31, 2022, our directors and executive officers currently own an aggregate 24,431,826 shares of our common stock, which currently constitutes 67.9% of our issued and outstanding common stock. As a result, directors and executive officers may have a significant influence on our affairs and management, as well as on all matters requiring member approval, including electing and removing members of our board of directors, causing us to engage in transactions with affiliated entities, causing or restricting our sale or merger, and certain other matters. Our Chairman, Mr. Terren Peizer, may be deemed to beneficially own the shares held by Acuitas. Such concentration of ownership and control could have the effect of delaying, deferring or preventing a change in control of us even when such a change of control would be in the best interests of our stockholders.

 

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

 

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

 

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

 

As of December 31, 2022 our Articles of Incorporation, as amended, authorize the issuance of 800,000,000 shares of common stock, and we had 34,504,332 shares of common stock outstanding. Accordingly, we may issue up to an additional 753,719,062 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
 
4.1   Form of Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K/A (File No. 001-39015) filed on July 18, 2022).
     
10.1*   Amendment No. 2 to Asset Purchase Agreement, dated January 13, 2023, by and between BioVie Inc. and Acuitas Group Holdings, LLC, and Acuitas Group Holdings, LLC, solely for purposes of Section 10.16 of the Agreement

 

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)   February 10, 2023
         
/s/ Joanne Wendy Kim        
     Joanne Wendy Kim   Chief Financial Officer (Principal Financial and Accounting Officer)   February 10, 2023

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