UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
(Mark One)
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended:
| 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:
(Exact name of registrant as specified in its charter)
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or other jurisdiction of incorporation or organization) |
(I.R.S. Empl. Ident. No.) |
| (Address of principal executive offices, Zip Code) |
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| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
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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.
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).
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 | ☐ |
| ☒ | 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 ☐
There were shares of the Registrant’s $0.0001 par value Class A common stock outstanding as of May 5, 2023.
TABLE OF CONTENTS
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
| March 31 | June 30, | |||||||
| 2023 | 2022 | |||||||
| ASSETS | (Unaudited) | |||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Investments in U.S. Treasury Bills | ||||||||
| Prepaids and other assets | ||||||||
| Total current assets | ||||||||
| Operating lease right-of-use assets | ||||||||
| Intangible assets, net | ||||||||
| Goodwill | ||||||||
| Other assets, non-current | ||||||||
| TOTAL ASSETS | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accrued expenses | $ | $ | ||||||
| Current portion of other liabilities | ||||||||
| Current portion of operating lease liabilities | ||||||||
| Current portion of Note payable, net of financing cost, unearned premium and discount of $ | ||||||||
| Warrant liabilities | ||||||||
| Embedded derivative liability | ||||||||
| Total current liabilities | ||||||||
| Other liabilities, net of current portion | ||||||||
| Operating lease liabilities, net of current portion | ||||||||
| Note payable, net of current portion, financing cost, unearned premium and discount of $ | ||||||||
| TOTAL LIABILITIES | ||||||||
| Commitments and contingencies (Note 12) | ||||||||
| STOCKHOLDERS’ EQUITY : | ||||||||
| Preferred stock; $ par value; shares authorized; shares issued and outstanding | ||||||||
| Common stock, $ par value; shares authorized at March 31, 2023 and June 30, 2022, respectively; shares issued of which shares outstanding at March 31, 2023 and issued and outstanding at June 30, 2022; | ||||||||
| Additional paid in capital | ||||||||
| Accumulated other comprehensive income | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Treasury Stock | ( | ) | ||||||
| Total stockholders’ equity | ||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | $ | ||||||
See accompanying notes to unaudited condensed financial statements
-1-
BioVie Inc.
Condensed Statements of Operations and Other Comprehensive Income
(Unaudited)
| Three Months Ended | Three Months Ended | Nine Months Ended | Nine Months Ended | |||||||||||||
| March 31, 2023 | March 31, 2022 | March 31, 2023 | March 31, 2022 | |||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Amortization | $ | $ | $ | $ | ||||||||||||
| Research and development expenses | ||||||||||||||||
| Selling, general and administrative expenses | ||||||||||||||||
| TOTAL OPERATING EXPENSES | ||||||||||||||||
| LOSS FROM OPERATIONS | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| OTHER EXPENSE (INCOME): | ||||||||||||||||
| Change in fair value of derivative liabilities | ( | ) | ||||||||||||||
| Interest expense | ||||||||||||||||
| Interest income | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| TOTAL OTHER EXPENSE, NET | ||||||||||||||||
| NET LOSS | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| NET LOSS PER COMMON SHARE | ||||||||||||||||
| - Basic | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| - Diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | ||||||||||||||||
| - Basic | ||||||||||||||||
| - Diluted | ||||||||||||||||
| NET LOSS | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Other comprehensive income | ||||||||||||||||
| Unrealized gain on investments for available-for-sale | ||||||||||||||||
| Other comprehensive income | ||||||||||||||||
| Comprehensive loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
See accompanying notes to unaudited condensed financial statements
-2-
BioVie Inc.
Condensed Statements of Cash Flows
(Unaudited)
| Nine Months Ended | Nine Months Ended | |||||||
| March 31, 2023 | March 31, 2022 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Amortization of intangible assets | ||||||||
| Stock based compensation - restricted stock units | ||||||||
| Stock based compensation expense - stock options | ||||||||
| Amortization of financing costs | ||||||||
| Accretion of unearned loan discount | ||||||||
| Accretion of loan premium | ||||||||
| Change in operating lease right-of-use assets | ( | ) | ||||||
| Change in fair value of derivative liabilities | ( | ) | ||||||
| Change in operating assets and liabilities | ||||||||
| Prepaids and other assets | ( | ) | ( | ) | ||||
| Accounts payable and accrued expenses | ||||||||
| Operating lease liabilities | ( | ) | ||||||
| Other liabilities | ( | ) | ||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Purchases of U.S. Treasury Bills | ( | ) | ||||||
| Net cash used in investing activities | ( | ) | ||||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Net proceeds from issuance of common stock | ||||||||
| Proceeds from note payable net of financing costs | ||||||||
| Proceeds from exercise of stock options | ||||||||
| Net proceeds from issuance of common stock - Related Party | ||||||||
| Net cash provided by financing activities | ||||||||
| Net increase in cash and cash equivalents | ||||||||
| Cash and cash equivalents, beginning of period | ||||||||
| Cash and cash equivalents, end of period | $ | $ | ||||||
| SUPPLEMENTAL CASH FLOW INFORMATION: | ||||||||
| Cash paid for interest | $ | $ | ||||||
| SCHEDULE OF NON-CASH FINANCING AND INVESTING ACTIVITIES: | ||||||||
| Right of use assets obtained in exchange for lease obligations | $ | $ | ||||||
| Unrealized gain on U.S. Treasury Bills | $ | $ | ||||||
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 March 31, 2022
(Unaudited)
| Accumulated | ||||||||||||||||||||||||||||||||
| Additional | Other | Total | ||||||||||||||||||||||||||||||
| Common Stock | Common Stock | Paid in | Treasury Stock | Treasury Stock | Comprehensive | Accumulated | Stockholders’ | |||||||||||||||||||||||||
| Shares | Amount | Capital | Shares | Amount | Income | Deficit | Equity | |||||||||||||||||||||||||
| Balance, June 30, 2021 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
| Proceeds from issuance of common stock,net of cost of $2,224,992 | - | |||||||||||||||||||||||||||||||
| Stock-based compensation – restricted stock units | - | |||||||||||||||||||||||||||||||
| Stock option based compensation | - | - | ||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance, September 30, 2021 | ( | ) | ||||||||||||||||||||||||||||||
| Stock-based compensation – restricted stock units | - | |||||||||||||||||||||||||||||||
| Stock option based compensation | - | - | ||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance, December 31, 2021 | ( | ) | ||||||||||||||||||||||||||||||
| Stock option based compensation | - | - | ||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance, March 31, 2022 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
See accompanying notes to unaudited condensed financial statements
-4-
Condensed Statements of Changes in Stockholders’ Equity
For the periods July 1, 2022 through March 31, 2023
(Unaudited)
| Accumulated | ||||||||||||||||||||||||||||||||
| Additional | Other | Total | ||||||||||||||||||||||||||||||
| Common Stock | Common Stock | Paid in | Treasury Stock | Treasury Stock | Comprehensive | Accumulated | Stockholders’ | |||||||||||||||||||||||||
| Shares | Amount | Capital | Shares | Amount | Income | Deficit | Equity | |||||||||||||||||||||||||
| Balance, June 30, 2022 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||
| Stock option based compensation | - | - | ||||||||||||||||||||||||||||||
| Stock-based compensation – restricted stock units | - | - | ||||||||||||||||||||||||||||||
| Proceeds from issuance of common stock, net of costs of $368,370 | - | |||||||||||||||||||||||||||||||
| Proceeds from issuance of common stock, net of costs of $94,160 – Related Party | - | |||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance, September 30, 2022 | ( | ) | ||||||||||||||||||||||||||||||
| Stock-based compensation – restricted stock units | - | - | ||||||||||||||||||||||||||||||
| Stock option based compensation | - | - | ||||||||||||||||||||||||||||||
| Cashless exercise of options | ( | ) | - | |||||||||||||||||||||||||||||
| Cashless exercise of warrants | - | |||||||||||||||||||||||||||||||
| Proceeds from exercise of options | - | |||||||||||||||||||||||||||||||
| Proceeds from issuance of common stock, net of costs of $1,206,206 | - | |||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance, December 31, 2022 | ( | ) | ||||||||||||||||||||||||||||||
| Stock-based compensation – restricted stock units | - | - | ||||||||||||||||||||||||||||||
| Issuance of restricted stock units | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||
| - | ||||||||||||||||||||||||||||||||
| Stock option based compensation | - | - | ||||||||||||||||||||||||||||||
| - | ||||||||||||||||||||||||||||||||
| Proceeds from issuance of common stock, net of costs of $338,846 | - | |||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Unrealized gain on available-for-sale securities | - | - | ||||||||||||||||||||||||||||||
| Balance, March 31, 2023 | $ | $ | ( | ) | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||||
See accompanying notes to unaudited condensed financial statements
-5-
BIOVIE INC.
Notes to Condensed Financial Statements
For the Three and Nine Months Ended March 31, 2023 and 2022
(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 fourth quarter of calendar year 2023.
The Phase 2 study of NE3107 in Parkinson’s disease (“PD” (NCT05083260), completed in December was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and NE3107. 45 patients with a defined L-dopa “off state” were randomized 1:1 to placebo:NE3107 20 mg twice daily for 28 days. This 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 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 was paused in March 2023. Data from the first 15 patients treated with BIV201 plus standard of care (SOC) resulted in a 34% reduction in ascites fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment (p=0.0046). This improvement was significantly different from those treated with SOC only who experienced a mean increase in ascites fluid of 3.1% (BIV201 vs. SOC p=0.05). Patients who completed the treatment with BIV201 experienced a 53% reduction in ascites fluid (p=0.001), which was significantly different from those treated with SOC (p=0.007). This improvement was sustained in this group during the 3 months after treatment initiation as compared to the 3-month pre-treatment period (43% reduction, p=0.06). Overall treatment appeared to be well tolerated. There were no unexpected serious adverse events and overall safety was consistent with the patient population. The current trial (NCT04112199) evaluates the efficacy of BIV201 combined with SOC, compared to SOC alone, for the treatment of refractory ascites. Terlipressin was administered with a continuous low dose infusion via a portable pump in two 28-day treatment cycles. The primary endpoints are the incidence of complications of at least Grade 2 severity, and the change in cumulative ascites in the 12-week period following randomization compared to a 12-week pre-treatment period. The BIV201 trial planned to enroll 30 patients to be treated in the home care setting. 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
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| 2. | Liquidity |
The
Company’s operations are subject to a number of factors that can affect its operating results and financial conditions. Such factors
include, but are not limited to: the results of clinical testing and trial activities; 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 March 31, 2023, the Company had working capital of $
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 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.
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”).
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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 $ per share (“common stock”), outstanding during the period. Diluted net loss per common share is computed by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding and potentially outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable through stock options, warrants, and restricted stock units. For the three and nine months ended March 31, 2023, and 2022, 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, warrants and restricted stock units as of March 31, 2023 and 2022:
| March 31, 2023 | March 31, 2022 | |||||||
| Number of Shares | Number of Shares | |||||||
| Stock Options | ||||||||
| Warrants | ||||||||
| Restricted Stock Units | ||||||||
| Total | ||||||||
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.
Cash and cash equivalents
Cash and cash equivalents consisted of cash deposits and money market funds held at a bank and funds held in a brokerage account which included a U.S. treasury money market fund and U.S. Treasury Bills with original maturities of 3 months or less.
Adverse Developments Affecting the Financial Services Industry and Concentration of Risk
As of March 31, 2023 and December 31, 2022, the Company had cash deposited in certain financial institutions in excess of federally insured levels. The Company regularly monitors the financial stability of these financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents. However, in March and April 2023, certain U.S. government banking regulators took steps to intervene in the operations of certain financial institutions due to liquidity concerns, which caused general heightened uncertainties in financial markets. While these events have not had a material direct impact on the Company’s operations, if further liquidity and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, the Company’s ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of operations.
Investments in U.S. Treasury Bills
Investments in U.S. Treasury Bills with maturities greater than 3 months, are accounted for as available for sale and are recorded at fair value. Unrealized gains were included in other comprehensive income in the accompanying the statements of operations and other comprehensive income.
Fair value measurement of assets and liabilities
We determine the fair values of our financial instruments based on the fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value assumes that the transaction to sell the asset or transfer the liability occurs in the principal or most advantageous market for the asset or liability and establishes that the fair value of an asset or liability shall be determined based on the assumptions that market participants would use in pricing the asset or liability. The classification of a financial asset or liability within the hierarchy is based upon the lowest level input that is significant to the fair value measurement. The fair value hierarchy prioritizes the inputs into three levels that may be used to measure fair value:
Level 1 - Inputs are unadjusted quoted prices in active markets for identical assets or liabilities.
Level 2 - Inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument.
Level 3 - Inputs are unobservable inputs based on our assumptions.
4. Investments in U.S. Treasury Bills available for sale
The following is a summary of the U.S. Treasury Bills held at March 31, 2023:
| Total Accumulated | ||||||||||||||||||||
| Amortized Cost Basis | Gross Unrealized Gain | Gross Unrealized loss | Fair Value | Other Comprehensive Income | ||||||||||||||||
| U.S. Treasury Bills due is 3 - 6 months | $ | $ | $ | $ | $ | |||||||||||||||
| 5 | . | Intangible Assets |
The Company’s intangible assets consist of intellectual property acquired from LAT Pharma. and are amortized over their estimated useful lives.
The following is a summary of the Company’s intangible assets as of March 31, 2023 and June 30, 2022:
| March 31, 2023 | June 30, 2022 | |||||||
| Intellectual Property | $ | $ | ||||||
| Less Accumulated Amortization | ( | ) | ( | ) | ||||
| Intellectual Property, Net | $ | $ | ||||||
Amortization
expense was $
Estimated future amortization expense is as follows:
| Year ending June 30, 2023 (Remaining three months) | $ | |||
| 2024 | ||||
| 2025 | ||||
| 2026 | ||||
| Intellectual Property, Net | $ | |||
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| 6. | Related Party Transactions |
Equity Transactions with Acuitas
On July 15, 2022, the Company entered into a securities purchase agreement with Acuitas Group Holdings, LLC (Acuitas), the Company’s majority stockholder, pursuant to which Acuitas agreed to purchase from the Company, in a private placement, (i) an aggregate of 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.
| 7. | Other Liabilities |
The
current portion of other liabilities at March 31, 2023 and June 30, 2022 were $
| 8. | Notes Payable |
On
November 30, 2021 (the “Closing Date”), the Company entered into a Loan and Security Agreement and the Supplement to the
Loan and Security Agreement and Promissory Notes (together, the “Loan Agreement”) with Avenue Venture Opportunities Fund,
L.P. (“AVOPI”) and Avenue Venture Opportunities Fund II, L.P. (“AVOPII,” and together with AVOPI, “Avenue”)
for growth capital loans in an aggregate commitment amount of up to $20 million (the “Loan”). On the Closing Date, $15 million
of the Loan was funded (“Tranche 1”). The Loan provided for an additional $5 million to be available to the Company on or
prior to September 15, 2022, subject to the Company’s achievement of certain milestones with respect to certain of its ongoing
clinical trials, which were not achieved. The Loan bears interest at an annual rate equal to the greater of (a) the sum of
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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
$
The
carrying value of notes payable at March 31, 2022 was approximately $
As of March 31, 2023, 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 March 31, 2023 and June 30, 2022:
Current portion of Notes Payable
| March 31, 2023 | June 30, 2022 | |||||||
| Current portion of Notes Payable | $ | $ | ||||||
| Less debt financing costs | ( | ) | ||||||
| Less unearned discount | ( | ) | ||||||
| Plus accretion of loan premium | ||||||||
| Current portion of Notes Payable, net of financing costs, unearned premiums and discount | $ | $ | ||||||
Non-current portion of Notes Payable
| March 31, 2023 | June 30, 2022 | |||||||
| Notes Payable | $ | $ | ||||||
| Less debt financing costs | ( | ) | ( | ) | ||||
| Less unearned discount | ( | ) | ( | ) | ||||
| Plus accretion of loan premium | ||||||||
| Notes Payable, net of the current portion, financing costs, unearned premiums and discount | $ | $ | ||||||
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 3 months) | $ | $ | $ | |||||||||
| 2024 | ||||||||||||
| 2025 | ||||||||||||
| Total | $ | $ | $ | |||||||||
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| 9. | Fair Value Measurements |
At March 31, 2023 and June 30, 2022, the estimated fair value of derivative liabilities measured on a recurring basis are as follows:
| Fair Value Measurements at | ||||||||||||||||
| March 31, 2023 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Derivative liability - Warrants | $ | $ | $ | $ | ||||||||||||
| Derivative liability - Conversion option on notes payable | ||||||||||||||||
| Total derivatives | $ | $ | $ | $ | ||||||||||||
| Fair Value Measurements at | ||||||||||||||||
| June 30, 2022 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Derivative liability - Warrants | $ | $ | $ | $ | ||||||||||||
| Derivative liability - Conversion option on note payable | ||||||||||||||||
| Total derivatives | $ | $ | $ | $ | ||||||||||||
The following table presents the activity for liabilities measured at fair value using unobservable inputs for the nine months ended March 31, 2023:
| Derivative liabilities - Warrants | Derivative liability - Conversion Option on Convertible Debenture | |||||||
| Balance at July 1, 2022 | $ | $ | ||||||
| Additions to level 3 liabilities | ||||||||
| Change in in fair value of level 3 liability | ||||||||
| Transfer in and/or out of Level 3 | ||||||||
| Balance at March 31, 2023 | $ | $ | ||||||
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The following table presents the activity for liabilities measured at fair value using unobservable inputs for the nine months ended March 31, 2022:
| Derivative liabilities - Warrants | Derivative liability - Conversion Option on Convertible Debenture | |||||||
| Balance at July 1, 2021 | $ | $ | ||||||
| Additions to level 3 liabilities | ||||||||
| Change in fair value of level 3 liability | ( | ) | ( | ) | ||||
| Transfer in and/or out of Level 3 | ||||||||
| Balance at March 31, 2022 | $ | $ | ||||||
The fair values of derivative liabilities for the Avenue Warrants and conversion option at March 31, 2023 in the accompanying balance sheet, were approximately $2.0 million and approximately $2.6 million, respectively. The total change in the fair value of the derivative liabilities totaled approximately $366,000 and $4.2 million for the three and nine months ended March 31, 2023, respectively; and accordingly, was recorded in the accompanying statement of operations. The assumptions used in the Black Scholes model to value the derivative liabilities at March 31, 2023 included the closing stock price of $ per share; for the Avenue Warrants, the exercise price of $, remaining term year, risk free rate of % and volatility of %; and for the embedded derivative liability of the conversion option, the conversion price of $; remaining term years, risk free rate of % and volatility of %.
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 March 31, 2023.
The Black Scholes model was used to calculate the fair value of the warrant derivative to bifurcate the warrant derivative amount from the Avenue Loan amount funded. The Avenue Warrants are recorded at their fair values at the date of issuance and remeasured at March 31, 2023. The assumptions used for the fair value calculation at November 30, 2021 included: the closing stock price of $ per share; the exercise price of $; year term; a risk free rate of % and volatility of %.
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 $ per share; the conversion price of $; year term; risk free rate of % and volatility of %.
Financial assets
As of March 31, 2023, investments in U.S. Treasury Bills were valued through use of quoted prices and are classified as Level 1. The following table presents information about our assets that are measured at fair value on a recurring basis using the above input categories.
| Fair Value Measurements at | ||||||||||||||||
| March 31, 2023 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
Cash and cash equivalent | $ | $ | $ | $ | ||||||||||||
| U.S. Treasury Bills due in 3 months or less | ||||||||||||||||
| U.S. Treasury Bills due in 3 - 6 months | ||||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
| Fair Value Measurements at | ||||||||||||||||
| June 30, 2022 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Cash and cash equivalent | $ | $ | $ | $ | ||||||||||||
| U.S. Treasury Bills due in 3 months or less | ||||||||||||||||
| U.S. Treasury Bills due in 3 - 6 months | ||||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
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| 10. | Equity Transactions |
Stock Options
The following table summarizes the activity relating to the Company’s stock options for the nine months ended March 31, 2023:
| Options | Weighed-Average Exercise Price | Weighted Remaining Average Contractual Term | Aggregate Intrinsic Value | |||||||||||||
| Outstanding at June 30, 2022 | ||||||||||||||||
| Granted | ||||||||||||||||
| Options Expired | ( | ) | - | |||||||||||||
| Options Canceled | ( | ) | - | |||||||||||||
| Options Exercised | ( | ) | - | |||||||||||||
| Outstanding at March 31, 2023 | $ | $ | ||||||||||||||
| Exercisable at March 31, 2023 | $ | $ | ||||||||||||||
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 nine months ended March 31, 2023 and 2022:
| March 31, 2023 | March 31, 2022 | |||
| Expected life of options (In years) | ||||
| Expected volatility | % | % | ||
| Risk free interest rate | % | % | ||
| Dividend Yield | % | % |
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 March 31, 2023 and 2022 was of $ and $, respectively and for the nine months ended March 31,2023 and 2022 was $ and $, respectively.
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The following is a summary of stock options outstanding and exercisable by exercise price as of March 31, 2023:
| Exercise Price | Outstanding | Weighted Average Contract Life | Exercisable | |||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
| $ | ||||||||||||||
Issuance of common stock for cash
During
the three months ended September 30, 2021, the Company issued of its Class A common stock at $ per share in connection
with its registered public offering of approximately $
On
September 24, 2021, the Company issued 92,000 of its Class A common stock at $ per share in connection with the underwriters’
exercise of its over-allotment option in for the August 2021 registered public offering, resulting in net proceeds to the Company of
approximately $
On
August 31, 2022, the Company entered into a Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor
Fitzgerald & Co. and B. Riley Securities, Inc. (collectively, the “Agents”), pursuant to which the Company may issue
and sell from time-to-time shares of the Company’s common stock through the Agents, subject to the terms and conditions of the
Sales Agreement. On April 6, 2023, the Company and B. Riley Securities, Inc. mutually agreed to terminate B. Riley Securities,
Inc.’s role as a sales agent under the Sales Agreement. During the three months ended March 31, 2023, the Company sold
shares of common stock under the Sales Agreement for total net proceeds of $
Issuance of common stock through exercise of stock options and warrants
During
the three months ended December 31, 2022, the Company issued shares of common stock pursuant to a cashless exercise of stock options
to purchase shares at an average exercise price of $
In
November 2022, the Company issued shares of common stock pursuant to a cash exercise of stock options to purchase shares at an
average exercise price of $
In
October, the Company issued shares of common stock pursuant to a cashless exercise of warrants to purchase shares at an average
exercise price of $
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Issuance of restricted stock units for services
On
August 20, 2021, the Company awarded
On
June 21, 2022, the Company awarded
On
November 23, 2022, the Company awarded
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
-15-
Issuance of Stock Options
On August 20, 2021, the Company granted, under the 2019 Omnibus Plan, stock options to purchase 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 -year period, on the first, second, third, fourth and fifth anniversary of the grant date. The exercise price of the options is $ 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.
On February 1, 2022, the Company granted stock options to purchase 124,167 shares of common stock to a new employee. Twenty percent (%) of the shares underlying the options awarded vested on the grant date, and the remaining % vest equally over a -year period, on the first, second, third, fourth and fifth anniversary of the grant date. The exercise price is $ per share, the grant date fair value, and the options terminate on the tenth anniversary of the grant date.
During the three months ended March 31, 2022, the Company granted, stock options to purchase shares of common stock totaling 273,167 to four new employees.
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, stock options to purchase shares of common stock were granted to new employees as part of their compensation package. 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 months. The exercise price is $ per share, the grant date fair value, and the options terminate on the tenth anniversary of the grant date.
On April 4, 2023, stock options to purchase shares of common stock were granted to new employees as part of their compensation package. Twenty percent (%) of the shares underlying the options awarded vest on the one-year anniversary of the grant date, and the remaining % vest in equal monthly installments over 48 months. The exercise price is $7.36 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 nine months ended March 31, 2023:
| Number of Shares | Weighted Average Exercise Price | Weighted Average Remaining Life (Years) | Aggregate Intrinsic Value | |||||||||||||
| Outstanding and exercisable at June 30, 2022 | $ | $ | ||||||||||||||
| Granted | - | |||||||||||||||
| Expired | ( | ) | - | - | ||||||||||||
| Exercised | ( | ) | - | - | ||||||||||||
| Outstanding and exercisable at March 31, 2023 | $ | $ | ||||||||||||||
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.
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| 11. | 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 costs recognized in our statement of operations were approximately $
The following table provides balance sheet information related to leases as of March 31, 2023 and June 30, 2022:
| March 31, 2023 | June 30, 2022 | |||||||
| Assets | ||||||||
| Operating lease, right-of-use asset, net | $ | $ | ||||||
| Liabilities | ||||||||
| Current portion of operating lease liabilities | $ | $ | ||||||
| Operating lease liabilities, net of current portion | ||||||||
| Total operating lease liabilities | $ | $ | ||||||
At March 31, 2023, the future estimated minimum lease payments under non-cancelable operating leases are as follows:
| Year ending June 30, 2023 (Remaining 3 months) | $ | |||
| 2024 | ||||
| 2025 | ||||
| Total minimum lease payments | ||||
| Less amount representing interest | ( | ) | ||
| Present value of future minimum lease payments | ||||
| Less current portion of operating lease liabilities | ( | ) | ||
| Operating lease liabilities, net of current portion | $ | |||
Total
cash paid for amounts included in the measurement of lease liabilities were $
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The weighted average remaining lease term and discount rate as of March 31, 2023 and June 30, 2022 were as follows:
| March 31, 2023 | June 30, 2022 | |||||||
| Weighted average remaining lease term (Years) | ||||||||
| Operating leases | ||||||||
| Weighted average discount rate | ||||||||
| Operating leases | % | % | ||||||
| 12. | Commitments and Contingencies |
Royalty Agreements
Pursuant to the Agreement and Plan of Merger entered into on April 11, 2016, by and between our predecessor entities, LAT Pharma and NanoAntibiotics, Inc., the Company is obligated to pay a low single digit royalty on net sales of BIV201 (continuous infusion terlipressin) to be shared by the members of LAT Pharma Members, PharmaIn Corporation, and The Barrett Edge, Inc.
Pursuant to the Technology Transfer Agreement entered into on July 25, 2016, by and between the Company and the University of Padova (Italy), the Company is obligated to pay a low single digit royalty on net sales of all terlipressin products covered by US patent no. 9,655,645 and any future foreign issuances, capped at a maximum of $200,000 per year.
| 13. | Employee Benefit Plan |
On August 1, 2021, the Company began sponsoring an employee benefit plan subject to Section 401(K) of the Internal Revenue Service Code (the “401K Plan”).
Subject
to certain limitations in the Internal Revenue Code, eligible employees are permitted to make contributions to the 401K Plan on a pre-tax
salary reduction basis and the Company will match 5% of the first 5% of an employee’s contributions to the 401K Plan., The Company
made contributions of approximately $
| 14. | Subsequent Events |
Subsequent
to March 31, 2023 the Company sold
shares of common stock for net proceeds of $
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
This report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Any statements contained in this report that are not statements of historical fact may be forward-looking statements. When we use the words “intends,” “estimates,” “predicts,” “potential,” “continues,” “anticipates,” “plans,” “expects,” “believes,” “should,” “could,” “may,” “will” or the negative of these terms or other comparable terminology, we are identifying forward-looking statements. Forward-looking statements involve risks and uncertainties, which may cause our actual results, performance or achievements to be materially different from those expressed or implied by forward-looking statements. These factors include, among others: our research and development activities and distributor channel; compliance with regulatory requirements; and our ability to satisfy our capital needs Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
You are cautioned not to place undue reliance on the forward-looking statements in this report, which speak only as of the date of this report. Except as may be required by applicable law, we do not undertake or intend to update or revise our forward-looking statements, and we assume no obligation to update any forward-looking statements contained in this report as a result of new information or future events or developments, except as required by law. Thus, you should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. You should carefully review and consider the various disclosures we make in this report and our other reports filed with the Securities and Exchange Commission (the “SEC”) that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business.
The following discussion of the Company’s financial condition and the results of operations should be read in conjunction with the Financial Statements and Notes thereto appearing elsewhere in this report.
Management’s Discussion
BioVie Inc. (the “Company” or “we” or “our”) is a clinical-stage company developing innovative drug therapies to treat chronic debilitating conditions including neurological and neuro-degenerative disorders and liver disease.
The Company acquired the biopharmaceutical assets of NeurMedix, Inc. (“NeurMedix”), a privately held clinical-stage pharmaceutical company, 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 fourth quarter of calendar year 2023.
The Phase 2 study of NE3107 in Parkinson’s disease (“PD” (NCT05083260), completed in December was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and NE3107. 45 patients with a defined L-dopa “off state” were randomized 1:1 to placebo:NE3107 20 mg twice daily for 28 days. This 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 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, that is being evaluated in a US Phase 2b study for the treatment of refractory ascites due to liver cirrhosis was paused in March 2023. Data from the first 15 patients treated with BIV201 plus standard of care (SOC) resulted in a 34% reduction in ascites fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment (p=0.0046). This improvement was significantly different from those treated with SOC only who experienced a mean increase in ascites fluid of 3.1% (BIV201 vs. SOC p=0.05). Patients who completed the treatment with BIV201 experienced a 53% reduction in ascites fluid (p=0.001), which was significantly different from those treated with SOC (p=0.007). This improvement was sustained in this group during the 3 months after treatment initiation as compared to the 3-month pre-treatment period (43% reduction, p=0.06). Overall treatment appeared to be well tolerated. There were no unexpected serious adverse events and overall safety was consistent with the patient population. The current trial (NCT04112199) evaluates the efficacy of BIV201 combined with SOC, compared to SOC alone, for the treatment of refractory ascites. Terlipressin was administered with a continuous low dose infusion via a portable pump in two 28-day treatment cycles. The primary endpoints are the incidence of complications of at least Grade 2 severity, and the change in cumulative ascites in the 12-week period following randomization compared to a 12-week pre-treatment period. The BIV201 trial planned to enroll 30 patients to be treated in the home care setting. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis.
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Comparison of the three months ended March 31, 2023 to the three months ended March 31, 2022
Net loss
The net loss for the three months ended March 31, 2023, was approximately $15.0 million as compared to $7.0 million for the three months ended March 31, 2022. The increase in net loss of approximately $8.0 million was primarily due to increased operating expenses primarily attributed to increased clinical activities.
Total operating expenses for the three months ended March 31, 2023, were approximately $13.8 million as compared to $5.7 million for the three months ended March 31, 2022. The net increase of approximately $8.1 million for the three months ended March 31, 2023 was due to an increase in research and development expenses of approximately $7.6 million due to increased clinical activities and an increase in selling general and administrative expenses of approximately $406,000.
Research and Development Expenses
Research and development expenses were approximately $11.2 million and $3.6 million for the three months ended March 31, 2023, and 2022, respectively. The net increase of approximately $7.6 million, was comprised of an increase in clinical study activities of approximately $7.1 million, and an increase in the clinical team and consultants’ compensation expense of approximately $676,000 to support such increased clinical activities over the three months ended March 31, 2022, offset by Chemistry, Manufacturing and Control expenses of approximately $188,000 and other research of $122,000.
The increase in research and development expenses of approximately $6.7 million was primarily due to the Neuroscience NE3107 studies, which were significantly more active during the three months ended March 31, 2023, compared to the three months ended March 31, 2022. The Parkinson’s Phase 2 study initiated in January 2022 reported top results and the Alzheimer Phase 3 study reached full enrollment. Our Orphan drug candidate BIV201’s Phase 2b study, which was initiated in June 2021, accounted for approximately $124,000 of the net increase in research and development expenses for three months ended March 31, 2023.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were approximately $2.5 million and $2.1 million for the three months ended March 31, 2023, and 2022, respectively. The net increase of approximately $400,000 was primarily attributed to increased legal fees of $156,000 and other business development and promotions of approximately $100,000 and an increase in compensation expense of approximately $129,000.
Other Income and Expense
Other expense, net was $1.3 million for the three months ended March 31, 2023 was comparable to other expense, net of $1.3 million for the three months ended March 31, 2022. Other expense, net was comprised of the change in fair value of the derivative liabilities which totaled $366,000 and $386,000 and net interest expense of approximately $1.1 million and $918,000 for the three months ended March 31, 2023, and 2022, respectively.
Comparison of the nine months ended March 31, 2023, to the nine months ended March 31, 2022
Net loss
The net loss for the nine months ended March 31, 2023, was approximately $41.1 million as compared to $18.0 million for the nine months ended March 31, 2022. The increase in net loss of approximately $23.1 million was primarily due to increased administrative expenses of approximately $2.5 million, increased clinical activities of approximately $13.5 million, an increase in other expense of approximately $7.0 million primarily attributed to the change in fair value of derivative liabilities of approximately $5.3 million.
Total operating expenses for the nine months ended March 31, 2023, were approximately $34.1 million as compared to $18.0 million for the nine months ended March 31, 2022. The net increase of approximately $16.1 million during the nine months ended March 31, 2023, was due to an increase in research and development expenses of approximately $13.6 million due to our increased clinical activities, and an increase in selling general and administrative expenses of approximately $2.5 million.
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Research and Development Expenses
Research and development expenses were approximately $25.0 million and $11.4 million for the nine months ended March 31, 2023, and 2022, respectively. The net increase of approximately $13.6 million, was comprised of a net increase of $12.3 million from increased clinical activities, offset by a decline in other development activities of approximately $354,000 an increase in Chemistry, Manufacturing and Control expense of approximately $237,000, and an increase in clinical promotion and publications of approximately $237,000 and an increase compensation expense of approximately $557,000 for the clinical team and consultants.
The increase in research and development expenses of approximately $12.3 million was primarily due to the Neuroscience NE3107 studies, which were significantly more active during the nine months ended March 31, 2023 compared to the nine months ended March 31, 2022. The Parkinson’s Phase 2 study initiated in January 2022, reported its top-line data results, and the Alzheimer Phase 3 study is reached full enrollment. Our Orphan drug candidate BIV201’s Phase 2b study, which was initiated in June 2021, accounted for approximately $63,000 of the net increase in research and development expenses for nine months ended March 31, 2023.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were approximately $8.9 million and $6.4 million for the nine months ended March 31, 2023, and 2022, respectively. The net increase of approximately $2.5 million was primarily attributed to increased stock compensation expense of approximately $2.0 million related to the board of directors’ annual compensation; a net increase in legal, investor relations and other professional fees totaling approximately $787,000, offset by decreased management compensation expense of approximately $198,000.
Other Income and Expense
Other expense, net was $7.0 million compared to other expense, net of $35,000, for the nine months ended March 31, 2023 and 2022, respectively. The net increase in other expenses of $7.0 million represented an increase in interest expense of approximately $2.0 million and the change in fair value of the related derivative liabilities of approximately $5.3 million.
Capital Resources and Liquidity
As of March 31, 2023, the Company had cash and cash equivalents and US treasury bills totaling of approximately $43.8 million, working capital of approximately $28.0 million, stockholders’ equity of approximately $21.7 million, and an accumulated deficit of approximately $292.1 million. In the three months ended March 31, 2023, the Company sold approximately 1.5 million shares of its common stock under its Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co for total net proceeds of approximately $9.8 million after 3% commissions and cost totaling approximately $339,000.
The Company has not generated any revenue and no revenues are expected in the foreseeable future. The Company’s future operations are dependent on the success of the Company’s ongoing development and commercialization efforts, as well as its ability to secure additional financing. Management expects that future sources of funding may include sales of equity, obtaining loans, or other strategic transactions.
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 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.
Although management continues to pursue the Company’s strategic plans, there is no assurance that the Company will be successful in obtaining sufficient financing on terms acceptable to the Company, if at all, to fund continuing operations. These circumstances raise substantial doubt on the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Critical Accounting Policies and Estimates
For the nine-month period ended March 31, 2023, 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.
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New Accounting Pronouncements
The Company considered the applicability and impact of recent accounting pronouncements and determined those to be either not applicable or expected to have minimal impact on our balance sheets or statement of operations.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not applicable to smaller reporting companies.
Item 4. Controls and Procedures
We maintain “disclosure controls and procedures.” Such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in Securities and Exchange Commission rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Office and Chief Financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Our disclosure controls and procedures have been designed to meet reasonable assurance standards. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgement in evaluating the cost-benefit relationship of possible disclosure and procedures. The design of and disclosure controls and procedures also are based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
Based on their evaluation as of the end of the period covered by this Quarterly Report on Form 10-Q, our Chief Executive Officer and Chief Financial Officer have concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rule 13a-15f and 15d-15(f) under the Exchange Act) that occurred during the quarter ended March 31, 2023, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings
To our knowledge, neither the Company nor any of its officers or directors is a party to any material legal proceeding or litigation and such persons know of no material legal proceeding or contemplated or threatened litigation. There are no judgments against us or our officers or directors. None of our officers or directors has been convicted of a felony or misdemeanor relating to securities or performance in corporate office.
Item 1A. Risk Factors
Except as described below, there have been no material changes to the Risk Factors previously disclosed in our Form 10-K. The risks described in our Form 10-K and below are not the only risks facing our company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, and/or operating results.
Adverse Developments Affecting the Financial Services Industry and Concentration of Risk
As of March 31, 2023 and December 31, 2022, the Company had cash deposited in certain financial institutions in excess of federally insured levels. The Company regularly monitors the financial stability of these financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents. However, in March and April 2023, certain U.S. government banking regulators took steps to intervene in the operations of certain financial institutions due to liquidity concerns, which caused general heightened uncertainties in financial markets. While these events have not had a material direct impact on the Company’s operations, if further liquidity and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, the Company’s ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of operations.
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Risks Relating To Our Common Stock
You may experience future dilution as a result of future equity offerings or if we issue shares subject to options, warrants, stock awards or other arrangements.
In order to raise additional capital, we may in the future offer additional shares of our common stock or other securities convertible into or exchangeable for our common stock, including under the Controlled Equity Offering Sales Agreement (the “Sales Agreement”), dated as of August 31, 2022, with Cantor Fitzgerald & Co. and B. (the “Agent”), pursuant to which the Company may issue and sell from time to time shares of common stock through the Agent. We may sell shares or other securities in any other offering at a price per share that is less than the current market price of our securities, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders. The sale of additional shares of common stock or other securities convertible into or exchangeable for our common stock would dilute all of our stockholders, and if such sales of convertible securities into or exchangeable into our common stock occur at a deemed issuance price that is lower than the current exercise price of our outstanding warrants sold to Acuitas Group Holdings, LLC (“Acuitas”) in August 2022, the exercise price for those warrants would adjust downward to the deemed issuance price pursuant to price adjustment protection contained within those warrants.
In addition, as of March 31, 2023, 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 3,443,997 shares issuable upon exercise of outstanding options at exercise prices ranging from $1.69 to $42.09 per share and restricted stock units totaling 527,549. Our Loan Agreement entered into on November 30, 2021 contains a conversion feature whereby at the option of lender, up to $5 million of the outstanding loan amount may be converted into shares of common stock at a conversion price of $6.98 per share. We may grant additional options, warrants or equity awards. To the extent such shares are issued, the interest of holders of our common stock will be diluted.
Moreover, we are obligated to issue shares of common stock upon achievement of certain clinical, regulatory and commercial milestones with respect to certain of our drug candidates (i.e., NE3107, NE3291, NE3413, and NE3789) pursuant to the asset purchase agreement, dated April 27, 2021, by and among the Company, NeurMedix, Inc. and Acuitas, as amended on May 9, 2021. The achievement of these milestones could result in the issuance of up to 18 million shares of our common stock, further diluting the interest of holders of our common stock.
Certain stockholders who are also officers and directors of the Company may have significant control over our management.
As of March 31, 2023, our directors and executive officers and affiliate currently own an aggregate 24,431,826 shares of our common stock, which currently constitutes 65% 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 majority shareholder, 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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We may, in the future, issue additional common stock, which would reduce investors’ percent of ownership and may dilute our share value.
As of March 31, 2023, our Articles of Incorporation, as amended, authorize the issuance of 800,000,000 shares of common stock, and we had 36,153,911 shares of common stock issued and 36,131,311 issued and outstanding. Accordingly, we may issue up to an additional 752,147,919 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
| * | Filed herewith. |
| ** | Furnished herewith. This certification is being furnished solely to accompany this report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filings of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. |
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
BioVie Inc.,
| Signature | Titles | Date | ||
| /s/ Cuong V Do | ||||
| Cuong V Do | Chairman and Chief Executive Officer (Principal Executive Officer) | May 12, 2023 | ||
| /s/ Joanne Wendy Kim | ||||
| Joanne Wendy Kim | Chief Financial Officer (Principal Financial and Accounting Officer) | May 12, 2023 |
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Exhibit 31.1
CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES OXLEY ACT OF 2002
AND RULE 13-A14 OF THE EXCHANGE ACT OF 1934
CERTIFICATION
| I, Cuong V Do, certify that: | ||
| 1. | I have reviewed this quarterly report on Form 10-Q of BioVie Inc.; | |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; | |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | |
| 4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a – 15(f) and 15d – 15(f)) for the registrant and have: | |
| a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of the annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and | |
| 5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): | |
| a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |
| b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. | |
Date: May 12, 2023
| /s/ Cuong V Do | ||||||||
Cuong V Do Chief Executive Officer (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION PURSUANT TO SECTION 302 OF THE SARBANES OXLEY ACT OF 2002
AND RULE 13-A14 OF THE EXCHANGE ACT OF 1934
CERTIFICATION
| I, Joanne Wendy Kim, certify that: | ||
| 1. | I have reviewed this quarterly report on Form 10-Q of BioVie Inc.; | |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; | |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | |
| 4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a – 15(f) and 15d – 15(f)) for the registrant and have: | |
| a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of the annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and | |
| 5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): | |
| a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |
| b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. | |
Date: May 12, 2023
| /s/ Joanne Wendy Kim | ||||||||
|
Joanne Wendy Kim Chief Financial Officer |
Exhibit 32.1
CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER PURSUANT TO 18 U.S. C. SECTION 1350 AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of BioVie Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Cuong V Do, Chief Executive Officer of the Company certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002, that, to my knowledge:
| (1) | The Report fully complies with the requirements of Section 13 (a) or 15 (d) of the Securities Exchange Act of 1934; and |
| (2) | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: May 12, 2023
| /s/ Cuong V Do | ||||||||
|
Cuong V Do Chief Executive Officer (Principal Executive Officer) |
Exhibit 32.2
CERTIFICATION OF THE CHIEF FINANCIAL OFFICER PURSUANT TO 18 U.S. C. SECTION 1350 AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of BioVie Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Joanne Wendy Kim, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002, that, to my knowledge:
| (1) | The Report fully complies with the requirements of Section 13 (a) or 15 (d) of the Securities Exchange Act of 1934; and |
| (2) | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: May 12, 2023
| /s/ Joanne Wendy Kim | |||||||||
|
Joanne Wendy Kim Chief Financial Officer |
Condensed Balance Sheets (Unaudited) (Parenthetical) - USD ($) |
Mar. 31, 2023 |
Jun. 30, 2022 |
|---|---|---|
| Statement of Financial Position [Abstract] | ||
| Unearned premium and discount current | $ 1,108,932 | |
| Unearned premium and discount | $ 94,368 | $ 2,861,314 |
| Preferred Stock, Par Value | $ 0.001 | $ 0.001 |
| Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 |
| Preferred Stock, Shares Issued | 0 | 0 |
| Preferred Stock, Shares Outstanding | 0 | 0 |
| Common Stock, Par Value | $ 0.0001 | $ 0.0001 |
| Common Stock, Shares Authorized | 800,000,000 | 800,000,000 |
| Common Stock, Shares Issued | 36,153,911 | 24,984,083 |
| Common Stock, Shares Outstanding | 36,131,311 | 24,984,083 |
Condensed Statements of Operations and other comprehensive income (Unaudited) - USD ($) |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
Mar. 31, 2023 |
Mar. 31, 2022 |
|
| OPERATING EXPENSES: | ||||
| Amortization | $ 57,344 | $ 57,344 | $ 172,033 | $ 172,032 |
| Research and development expenses | 11,196,835 | 3,577,142 | 24,999,665 | 11,385,586 |
| Selling, general and administrative expenses | 2,520,330 | 2,114,348 | 8,931,957 | 6,403,508 |
| TOTAL OPERATING EXPENSES | 13,774,509 | 5,748,834 | 34,103,655 | 17,961,126 |
| LOSS FROM OPERATIONS | (13,774,509) | (5,748,834) | (34,103,655) | (17,961,126) |
| OTHER EXPENSE (INCOME): | ||||
| Change in fair value of derivative liabilities | 366,093 | 386,450 | 4,154,645 | (1,168,804) |
| Interest expense | 1,082,762 | 918,633 | 3,192,631 | 1,236,010 |
| Interest income | (182,201) | (13,273) | (307,055) | (32,621) |
| TOTAL OTHER EXPENSE, NET | 1,266,654 | 1,291,810 | 7,040,221 | 34,585 |
| NET LOSS | (15,041,163) | (7,040,644) | (41,143,876) | (17,995,711) |
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ (15,041,163) | $ (7,040,644) | $ (41,143,876) | $ (17,995,711) |
| NET LOSS PER COMMON SHARE | ||||
| - Basic | $ (0.43) | $ (0.28) | $ (1.32) | $ (0.73) |
| - Diluted | $ (0.43) | $ (0.28) | $ (1.32) | $ (0.73) |
| WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | ||||
| - Basic | 35,325,580 | 24,984,083 | 31,217,382 | 24,555,382 |
| - Diluted | 35,325,580 | 24,984,083 | 31,217,382 | 24,555,382 |
| NET LOSS | $ 15,041,163 | $ 7,040,644 | $ 41,143,876 | $ 17,995,711 |
| Other comprehensive income | ||||
| Unrealized gain on investments for available-for-sale | 16,505 | 16,505 | ||
| Other comprehensive income | 16,505 | 16,505 | ||
| Comprehensive loss | $ (15,024,658) | $ (7,040,644) | $ (41,127,371) | $ (17,995,711) |
Background Information |
9 Months Ended | ||
|---|---|---|---|
Mar. 31, 2023 | |||
| Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
| 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 fourth quarter of calendar year 2023.
The Phase 2 study of NE3107 in Parkinson’s disease (“PD” (NCT05083260), completed in December was a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in PD participants treated with carbidopa/levodopa and NE3107. 45 patients with a defined L-dopa “off state” were randomized 1:1 to placebo:NE3107 20 mg twice daily for 28 days. This 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 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 was paused in March 2023. Data from the first 15 patients treated with BIV201 plus standard of care (SOC) resulted in a 34% reduction in ascites fluid during the 28 days after treatment initiation compared to the 28 days prior to treatment (p=0.0046). This improvement was significantly different from those treated with SOC only who experienced a mean increase in ascites fluid of 3.1% (BIV201 vs. SOC p=0.05). Patients who completed the treatment with BIV201 experienced a 53% reduction in ascites fluid (p=0.001), which was significantly different from those treated with SOC (p=0.007). This improvement was sustained in this group during the 3 months after treatment initiation as compared to the 3-month pre-treatment period (43% reduction, p=0.06). Overall treatment appeared to be well tolerated. There were no unexpected serious adverse events and overall safety was consistent with the patient population. The current trial (NCT04112199) evaluates the efficacy of BIV201 combined with SOC, compared to SOC alone, for the treatment of refractory ascites. Terlipressin was administered with a continuous low dose infusion via a portable pump in two 28-day treatment cycles. The primary endpoints are the incidence of complications of at least Grade 2 severity, and the change in cumulative ascites in the 12-week period following randomization compared to a 12-week pre-treatment period. The BIV201 trial planned to enroll 30 patients to be treated in the home care setting. 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
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Liquidity |
9 Months Ended | ||
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Mar. 31, 2023 | |||
| Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
| 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 March 31, 2023, the Company had working capital of $28.0 million, cash and cash equivalents and US treasury bills totaling approximately $43.8 million, stockholders’ equity of approximately $21.7 million, and an accumulated deficit of approximately $292 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 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.
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. |
Significant Accounting Policies |
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| Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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”).
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 $ per share (“common stock”), outstanding during the period. Diluted net loss per common share is computed by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding and potentially outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable through stock options, warrants, and restricted stock units. For the three and nine months ended March 31, 2023, and 2022, 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, warrants and restricted stock units as of March 31, 2023 and 2022:
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.
Cash and cash equivalents
Cash and cash equivalents consisted of cash deposits and money market funds held at a bank and funds held in a brokerage account which included a U.S. treasury money market fund and U.S. Treasury Bills with original maturities of 3 months or less.
Adverse Developments Affecting the Financial Services Industry and Concentration of Risk
As of March 31, 2023 and December 31, 2022, the Company had cash deposited in certain financial institutions in excess of federally insured levels. The Company regularly monitors the financial stability of these financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents. However, in March and April 2023, certain U.S. government banking regulators took steps to intervene in the operations of certain financial institutions due to liquidity concerns, which caused general heightened uncertainties in financial markets. While these events have not had a material direct impact on the Company’s operations, if further liquidity and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, the Company’s ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of operations.
Investments in U.S. Treasury Bills
Investments in U.S. Treasury Bills with maturities greater than 3 months, are accounted for as available for sale and are recorded at fair value. Unrealized gains were included in other comprehensive income in the accompanying the statements of operations and other comprehensive income.
Fair value measurement of assets and liabilities
We determine the fair values of our financial instruments based on the fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value assumes that the transaction to sell the asset or transfer the liability occurs in the principal or most advantageous market for the asset or liability and establishes that the fair value of an asset or liability shall be determined based on the assumptions that market participants would use in pricing the asset or liability. The classification of a financial asset or liability within the hierarchy is based upon the lowest level input that is significant to the fair value measurement. The fair value hierarchy prioritizes the inputs into three levels that may be used to measure fair value:
Level 1 - Inputs are unadjusted quoted prices in active markets for identical assets or liabilities.
Level 2 - Inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument.
Level 3 - Inputs are unobservable inputs based on our assumptions.
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Investments in U.S. Treasury Bills available for sale |
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| Investments in U.S. Treasury Bills available for sale | 4. Investments in U.S. Treasury Bills available for sale
The following is a summary of the U.S. Treasury Bills held at March 31, 2023:
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Intangible Assets |
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| Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 March 31, 2023 and June 30, 2022:
Amortization expense was $57,344 in each of the three-month periods ended March 31, 2023 and 2022. Amortization expense was $172,033 and $172,032 in each of the nine-month periods ended March 31, 2023 and 2022, respectively. The Company amortizes intellectual property over the expected, original useful lives of 10 years.
Estimated future amortization expense is as follows:
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Related Party Transactions |
9 Months Ended | ||
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Mar. 31, 2023 | |||
| Related Party Transactions [Abstract] | |||
| 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 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. |
Other Liabilities |
9 Months Ended | ||
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Mar. 31, 2023 | |||
| Other Liabilities Disclosure [Abstract] | |||
| Other Liabilities |
The current portion of other liabilities at March 31, 2023 and June 30, 2022 were $193,542 and $1.3 million, and included $193,542 and $580,614, respectively, of a 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. |
Notes Payable |
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| Notes Payable |
On November 30, 2021 (the “Closing Date”), the Company entered into a Loan and Security Agreement and the Supplement to the Loan and Security Agreement and Promissory Notes (together, the “Loan Agreement”) with Avenue Venture Opportunities Fund, L.P. (“AVOPI”) and Avenue Venture Opportunities Fund II, L.P. (“AVOPII,” and together with AVOPI, “Avenue”) for growth capital loans in an aggregate commitment amount of up to $20 million (the “Loan”). On the Closing Date, $15 million of the Loan was funded (“Tranche 1”). The Loan provided for an additional $5 million to be available to the Company on or prior to September 15, 2022, subject to the Company’s achievement of certain milestones with respect to certain of its ongoing clinical trials, which were not achieved. The Loan bears interest at an annual rate equal to the greater of (a) the sum of 7.00% plus the prime rate as reported in The Wall Street Journal and (b) 10.75%. The prime rate at March 31, 2023 was 8.0%. The Loan is secured by a lien upon and security interest in all of the Company’s assets, including intellectual property, subject to agreed exceptions. The maturity date of the Loan is December 1, 2024.
The Loan Agreement 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 March 31, 2023, was recognized in the accompanying statements of operations and included the interest only payments totaling approximately $547,000, 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 $3.2 million for the nine- months ended March 31, 2023, was recognized in the accompanying statements of operations and included interest only payments totaling approximately $1.5 million, the amortization of financing costs of approximately $128,000, unearned discount of approximately $1.2 million and the accretion of loan premium of approximately $329,000.
The carrying value of notes payable at March 31, 2022 was approximately $11.6 million, net of unearned discount of approximately $3.1 million, unamortized direct costs of approximately $333,000 and accreted premium of approximately $94,000 in the accompanying balance sheets. The total interest expense of approximately $919,000 and $1.2 million for the three and nine months ended March 31, 2022, respectively; was recognized in the accompanying statements of operations. The amortization of financing costs was approximately $43,000 and $57,000 for the three and nine months ended March 31, 2022, respectively. The accretion of loan premium was approximately $71,000 and $94,000 for the three and nine months ended March 31, 2022, respectively.
As of March 31, 2023, 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 March 31, 2023 and June 30, 2022:
Current portion of Notes Payable
Non-current portion of Notes Payable
Estimated future amortization expense and accretion of premium is as follows:
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| Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fair Value Measurements |
At March 31, 2023 and June 30, 2022, the estimated fair value of derivative liabilities measured on a recurring basis are as follows:
The following table presents the activity for liabilities measured at fair value using unobservable inputs for the nine months ended March 31, 2023:
The following table presents the activity for liabilities measured at fair value using unobservable inputs for the nine months ended March 31, 2022:
The fair values of derivative liabilities for the Avenue Warrants and conversion option at March 31, 2023 in the accompanying balance sheet, were approximately $2.0 million and approximately $2.6 million, respectively. The total change in the fair value of the derivative liabilities totaled approximately $366,000 and $4.2 million for the three and nine months ended March 31, 2023, respectively; and accordingly, was recorded in the accompanying statement of operations. The assumptions used in the Black Scholes model to value the derivative liabilities at March 31, 2023 included the closing stock price of $ per share; for the Avenue Warrants, the exercise price of $, remaining term year, risk free rate of % and volatility of %; and for the embedded derivative liability of the conversion option, the conversion price of $; remaining term years, risk free rate of % and volatility of %.
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 March 31, 2023.
The Black Scholes model was used to calculate the fair value of the warrant derivative to bifurcate the warrant derivative amount from the Avenue Loan amount funded. The Avenue Warrants are recorded at their fair values at the date of issuance and remeasured at March 31, 2023. The assumptions used for the fair value calculation at November 30, 2021 included: the closing stock price of $ per share; the exercise price of $; year term; a risk free rate of % and volatility of %.
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 $ per share; the conversion price of $; year term; risk free rate of % and volatility of %.
Financial assets
As of March 31, 2023, investments in U.S. Treasury Bills were valued through use of quoted prices and are classified as Level 1. The following table presents information about our assets that are measured at fair value on a recurring basis using the above input categories.
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Equity Transactions |
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| Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Equity Transactions |
Stock Options
The following table summarizes the activity relating to the Company’s stock options for the nine months ended March 31, 2023:
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 nine months ended March 31, 2023 and 2022:
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 March 31, 2023 and 2022 was of $ and $, respectively and for the nine months ended March 31,2023 and 2022 was $ and $, respectively.
The following is a summary of stock options outstanding and exercisable by exercise price as of March 31, 2023:
Issuance of common stock for cash
During the three months ended September 30, 2021, the Company issued of its Class A common stock at $ per share in connection with its registered public offering of approximately $18.5 million, net of issuance costs of approximately $2.2 million.
On September 24, 2021, the Company issued 92,000 of its Class A common stock at $ per share in connection with the underwriters’ exercise of its over-allotment option in for the August 2021 registered public offering, resulting in net proceeds to the Company of approximately $707,000, net of issuance cost of approximately $29,000.
On August 31, 2022, the Company entered into a Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. and B. Riley Securities, Inc. (collectively, the “Agents”), pursuant to which the Company may issue and sell from time-to-time shares of the Company’s common stock through the Agents, subject to the terms and conditions of the Sales Agreement. On April 6, 2023, the Company and B. Riley Securities, Inc. mutually agreed to terminate B. Riley Securities, Inc.’s role as a sales agent under the Sales Agreement. During the three months ended March 31, 2023, the Company sold shares of common stock under the Sales Agreement for total net proceeds of $9.8 million after 3% commissions and expenses of approximately $339,000. During the nine months ended March 31, 2023, the Company sold shares of common stock under the Sales Agreement for total net proceeds of $48.2 million after 3% commissions and expenses of approximately $1.9 million.
Issuance of common stock through exercise of stock options and warrants
During the three months ended December 31, 2022, the Company issued shares of common stock pursuant to a cashless exercise of stock options to purchase shares at an average exercise price of $7.64.
In November 2022, the Company issued shares of common stock pursuant to a cash exercise of stock options to purchase shares at an average exercise price of $2.80 per share.
In October, the Company issued shares of common stock pursuant to a cashless exercise of warrants to purchase shares at an average exercise price of $2.25.
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 $ 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 the remaining 21,710 vested at December 31, 2021. Accordingly, the CEO was issued an aggregate of shares of common stock over the vesting period of the RSUs. The stock-based compensation expense related to these RSUs was $.
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 $ per share of the Company’s common stock. The stock-based compensation expense related to these RSUs was $ and $ for the three and nine months ended March 31, 2023, respectively.
On November 23, 2022, the Company awarded 506,496 RSUs to certain employees and a consultant, with a grant date fair value of $ 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 $. On February 16, 2023, the Company delivered the vested portion of the RSU’s and issued shares of common stock net of % withholding. shares issued to employees were withheld in Treasury stock in exchange for payment of withholding tax on behalf of the employees.
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 $ per share, a total cost of $ 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 $ per share, the grant date fair value. The total stock compensation cost of stock options of $ 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 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. On February 9, 2023, the Company delivered the vested portion and issued shares of common stock.
Issuance of Stock Options
On August 20, 2021, the Company granted, under the 2019 Omnibus Plan, stock options to purchase 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 -year period, on the first, second, third, fourth and fifth anniversary of the grant date. The exercise price of the options is $ 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.
On February 1, 2022, the Company granted stock options to purchase 124,167 shares of common stock to a new employee. Twenty percent (%) of the shares underlying the options awarded vested on the grant date, and the remaining % vest equally over a -year period, on the first, second, third, fourth and fifth anniversary of the grant date. The exercise price is $ per share, the grant date fair value, and the options terminate on the tenth anniversary of the grant date.
During the three months ended March 31, 2022, the Company granted, stock options to purchase shares of common stock totaling 273,167 to four new employees.
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, stock options to purchase shares of common stock were granted to new employees as part of their compensation package. 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 months. The exercise price is $ per share, the grant date fair value, and the options terminate on the tenth anniversary of the grant date.
On April 4, 2023, stock options to purchase shares of common stock were granted to new employees as part of their compensation package. Twenty percent (%) of the shares underlying the options awarded vest on the one-year anniversary of the grant date, and the remaining % vest in equal monthly installments over 48 months. The exercise price is $7.36 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 nine months ended March 31, 2023:
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.
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Leases |
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| 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 costs recognized in our statement of operations were approximately $13,000 and $23,000 for the three months ended March 31, 2023, and 2022, respectively; and approximately $36,900 and $76,500 for the nine months ended March 31, 2023 and 2022, respectively.
The following table provides balance sheet information related to leases as of March 31, 2023 and June 30, 2022:
At March 31, 2023, the future estimated minimum lease payments under non-cancelable operating leases are as follows:
Total cash paid for amounts included in the measurement of lease liabilities were $12,650 and $37,700 for the three and nine months ended March 31, 2023, respectively.
The weighted average remaining lease term and discount rate as of March 31, 2023 and June 30, 2022 were as follows:
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Commitments and Contingencies |
9 Months Ended | ||
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Mar. 31, 2023 | |||
| Commitments and Contingencies Disclosure [Abstract] | |||
| 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. |
Employee Benefit Plan |
9 Months Ended | ||
|---|---|---|---|
Mar. 31, 2023 | |||
| Employee Benefit Plan | |||
| 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., The Company made contributions of approximately $16,000 and $28,700, for the three months ended March 31, 2023 and 2022, respectively and approximately $80,100 and $75,100, for the nine months ended March 31, 2023 and 2022, respectively. |
Subsequent Events |
9 Months Ended | ||
|---|---|---|---|
Mar. 31, 2023 | |||
| Subsequent Events [Abstract] | |||
| Subsequent Events |
Subsequent to March 31, 2023 the Company sold shares of common stock for net proceeds of $1.3 million net of 3% commission and expenses totaling approximately $40,000 under the Sales Agreement with the Agent. |
Significant Accounting Policies (Policies) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Basis of Presentation – Interim Financial Information | 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”).
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| 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 $ per share (“common stock”), outstanding during the period. Diluted net loss per common share is computed by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding and potentially outstanding shares of common stock during the period to reflect the potential dilution that could occur from common shares issuable through stock options, warrants, and restricted stock units. For the three and nine months ended March 31, 2023, and 2022, 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, warrants and restricted stock units as of March 31, 2023 and 2022:
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| Recent Accounting Pronouncements | 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.
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| Cash and cash equivalents | Cash and cash equivalents
Cash and cash equivalents consisted of cash deposits and money market funds held at a bank and funds held in a brokerage account which included a U.S. treasury money market fund and U.S. Treasury Bills with original maturities of 3 months or less.
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| Adverse Developments Affecting the Financial Services Industry and Concentration of Risk | Adverse Developments Affecting the Financial Services Industry and Concentration of Risk
As of March 31, 2023 and December 31, 2022, the Company had cash deposited in certain financial institutions in excess of federally insured levels. The Company regularly monitors the financial stability of these financial institutions and believes that it is not exposed to any significant credit risk in cash and cash equivalents. However, in March and April 2023, certain U.S. government banking regulators took steps to intervene in the operations of certain financial institutions due to liquidity concerns, which caused general heightened uncertainties in financial markets. While these events have not had a material direct impact on the Company’s operations, if further liquidity and financial stability concerns arise with respect to banks and financial institutions, either nationally or in specific regions, the Company’s ability to access cash or enter into new financing arrangements may be threatened, which could have a material adverse effect on its business, financial condition and results of operations.
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| Investments in U.S. Treasury Bills | Investments in U.S. Treasury Bills
Investments in U.S. Treasury Bills with maturities greater than 3 months, are accounted for as available for sale and are recorded at fair value. Unrealized gains were included in other comprehensive income in the accompanying the statements of operations and other comprehensive income.
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| Fair value measurement of assets and liabilities | Fair value measurement of assets and liabilities
We determine the fair values of our financial instruments based on the fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value assumes that the transaction to sell the asset or transfer the liability occurs in the principal or most advantageous market for the asset or liability and establishes that the fair value of an asset or liability shall be determined based on the assumptions that market participants would use in pricing the asset or liability. The classification of a financial asset or liability within the hierarchy is based upon the lowest level input that is significant to the fair value measurement. The fair value hierarchy prioritizes the inputs into three levels that may be used to measure fair value:
Level 1 - Inputs are unadjusted quoted prices in active markets for identical assets or liabilities.
Level 2 - Inputs are quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument.
Level 3 - Inputs are unobservable inputs based on our assumptions.
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Significant Accounting Policies (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Dilutive securities were excluded from the computation of diluted loss per share |
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Investments in U.S. Treasury Bills available for sale (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Investments In U.s. Treasury Bills Available For Sale | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of U.S. treasury bills held |
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Intangible Assets (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Goodwill and Intangible Assets Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of intangible assets |
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| Schedule of future amortization expense |
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Notes Payable (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Debt Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of note payable |
Non-current portion of Notes Payable
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| Schedule of Estimated future amortization expense and accretion of premium |
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Fair Value Measurements (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of derivative liabilities at fair value |
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| Fair value, liabilities measured on recurring basis |
The following table presents the activity for liabilities measured at fair value using unobservable inputs for the nine months ended March 31, 2022:
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| Measured at fair value on a recurring basis |
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Equity Transactions (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of summarizes the activity relating to the Company’s stock options |
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| Schedule of assumptions used |
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| Schedule of summary of stock options outstanding and exercisable |
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| Summary of warrants activity |
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Leases (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Leases | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of balance sheet information related to leases |
|
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| Schedule of future estimated minimum lease payments under non-cancelable operating leases |
|
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| Schedule of weighted average remaining lease term and discount rate |
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Liquidity (Details Narrative) |
Mar. 31, 2023
USD ($)
|
|---|---|
| Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
| Working capital | $ 28,000,000 |
| Cash and cash equivalent | 43,800,000 |
| Stockholders' equity | 21,700,000 |
| Accumulated deficit | $ 292,000,000 |
Significant Accounting Policies (Details) - shares |
9 Months Ended | |
|---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
| Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
| Total | 11,741,831 | 2,949,507 |
| Equity Option [Member] | ||
| Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
| Total | 3,443,997 | 2,438,044 |
| Warrant [Member] | ||
| Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
| Total | 7,770,285 | 511,463 |
| Restricted Stock Units (RSUs) [Member] | ||
| Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
| Total | 527,549 | |
Significant Accounting Policies (Details Narrative) - $ / shares |
Mar. 31, 2023 |
Jun. 30, 2022 |
|---|---|---|
| Common stock, par value | $ 0.0001 | $ 0.0001 |
| Common Class A [Member] | ||
| Common stock, par value | $ 0.0001 |
Investments in U.S. Treasury Bills available for sale (Details) |
Mar. 31, 2023
USD ($)
|
|---|---|
| Schedule of Investments [Line Items] | |
| Total Accumulated Other Comprehensive Income | $ 16,505 |
| US Treasury Bill Securities [Member] | |
| Schedule of Investments [Line Items] | |
| Amortized Cost Basis | 12,504,943 |
| Gross Unrealized Gain | 16,505 |
| Gross Unrealized loss | |
| Fair Value | 12,521,448 |
| Total Accumulated Other Comprehensive Income | $ 16,505 |
Intangible Assets (Details) - USD ($) |
Mar. 31, 2023 |
Jun. 30, 2022 |
|---|---|---|
| Goodwill and Intangible Assets Disclosure [Abstract] | ||
| Intellectual Property | $ 2,293,770 | $ 2,293,770 |
| Less Accumulated Amortization | (1,599,331) | (1,427,298) |
| Intellectual Property, Net | $ 694,439 | $ 866,472 |
Intangible Assets (Details 1) - USD ($) |
Mar. 31, 2023 |
Jun. 30, 2022 |
|---|---|---|
| Goodwill and Intangible Assets Disclosure [Abstract] | ||
| Year ending June 30, 2023 (Remaining three months) | $ 57,344 | |
| 2024 | 229,377 | |
| 2025 | 229,377 | |
| 2026 | 178,341 | |
| Intellectual Property, Net | $ 694,439 | $ 866,472 |
Intangible Assets (Details Narrative) - USD ($) |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
Mar. 31, 2023 |
Mar. 31, 2022 |
|
| Goodwill and Intangible Assets Disclosure [Abstract] | ||||
| Amortization expenses | $ 57,344 | $ 57,344 | $ 172,033 | $ 172,032 |
| Useful Life | 10 years | 10 years | ||
Related Party Transactions (Details Narrative) - shares |
Mar. 31, 2023 |
Aug. 15, 2022 |
Jun. 30, 2022 |
|---|---|---|---|
| Related Party Transaction [Line Items] | |||
| Common Stock, shares issued | 36,153,911 | 24,984,083 | |
| Acuitas Group Holdings L L C [Member] | |||
| Related Party Transaction [Line Items] | |||
| Common Stock, shares issued | 3,636,364 |
Other Liabilities (Details Narrative) - USD ($) |
Mar. 31, 2023 |
Jun. 30, 2022 |
Aug. 31, 2021 |
|---|---|---|---|
| Other Liabilities Disclosure [Abstract] | |||
| Other liabilities | $ 193,542 | $ 1,300,000 | |
| Accrued Bonuses, Current | $ 193,542 | $ 580,614 | $ 1,161,000 |
Notes Payable (Details) - USD ($) |
Mar. 31, 2023 |
Jun. 30, 2022 |
|---|---|---|
| Debt Disclosure [Abstract] | ||
| Current portion of Notes Payable | $ 7,500,000 | |
| Less debt financing costs | (134,757) | |
| Less unearned discount | (1,267,811) | |
| Plus accretion of loan premium | 293,636 | |
| Current portion of Notes Payable, net of financing costs, unearned premiums and discount | 6,391,068 | |
| Notes Payable | 7,500,000 | 15,000,000 |
| Less debt financing costs | (28,369) | (290,790) |
| Less unearned discount | (266,908) | (2,735,802) |
| Plus accretion of loan premium | 200,909 | 165,278 |
| Notes Payable, net of the current portion, financing costs, unearned premiums and discount | $ 7,405,632 | $ 12,138,686 |
Notes Payable (Details 1) |
Mar. 31, 2023
USD ($)
|
|---|---|
| Unearned Discount [Member] | |
| Accounts, Notes, Loans and Financing Receivable [Line Items] | |
| Year ending June 30, 2023 (Remaining 3 months) | $ 400,362 |
| 2024 | 1,023,145 |
| 2025 | 111,212 |
| Total | 1,534,719 |
| Financing Receivable [Member] | |
| Accounts, Notes, Loans and Financing Receivable [Line Items] | |
| Year ending June 30, 2023 (Remaining 3 months) | 42,555 |
| 2024 | 108,751 |
| 2025 | 11,820 |
| Total | 163,126 |
| Loan Accretion Premium [Member] | |
| Accounts, Notes, Loans and Financing Receivable [Line Items] | |
| Year ending June 30, 2023 (Remaining 3 months) | 92,727 |
| 2024 | 236,970 |
| 2025 | 25,758 |
| Total | $ 355,455 |
Notes Payable (Details Narrative) - USD ($) |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
Mar. 31, 2023 |
Mar. 31, 2022 |
|
| Debt Instrument [Line Items] | ||||
| Interest rate | 8.00% | |||
| Fair value of warrants | $ 1,400,000 | |||
| Fair value of embedded conversion option | 2,200,000 | |||
| Unearned discount | $ 400,000 | 3,700,000 | $ 3,100,000 | |
| Direct financing cost | 390,000 | |||
| Unamortized premium recognized | 850,000 | 850,000 | ||
| Interest expense | 1,100,000 | $ 919,000 | 3,200,000 | 1,200,000 |
| Interest payment | 547,000 | $ 1,500,000 | ||
| Amortization of financing costs | 43,000 | 43,000 | 57,000 | |
| Accretion of loan premium | $ 329,000 | 71,000 | 94,000 | |
| Notes payable | 11,600,000 | 11,600,000 | ||
| Unamortized direct costs | 333,000 | 333,000 | ||
| Unamortized accreted premium | $ 94,000 | $ 94,000 | ||
| Prime Rate [Member] | ||||
| Debt Instrument [Line Items] | ||||
| Interest rate | 7.00% | |||
Fair Value Measurements (Details Narrative) - $ / shares |
1 Months Ended | 9 Months Ended | |
|---|---|---|---|
Nov. 30, 2021 |
Mar. 31, 2023 |
Mar. 31, 2022 |
|
| Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
| Term | 5 years | 5 years | |
| Risk Free Interest Rate | 3.61% | 1.60% | |
| Volatility Rate | 79.52% | 75.12% | |
| Derivative Liability Warrants [Member] | Fair Value, Inputs, Level 3 [Member] | |||
| Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
| Share Price | $ 6.44 | $ 8.08 | |
| Exercise Price | $ 5.82 | $ 5.82 | |
| Term | 5 years | 3 years 8 months 12 days | |
| Risk Free Interest Rate | 1.14% | 3.70% | |
| Volatility Rate | 74.40% | 83.70% | |
| Derivative Liability Conversion Option On Convertible Debenture [Member] | Fair Value, Inputs, Level 3 [Member] | |||
| Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
| Share Price | $ 6.44 | $ 6.98 | |
| Exercise Price | $ 6.98 | ||
| Term | 3 years | 1 year 8 months 12 days | |
| Risk Free Interest Rate | 0.81% | 4.35% | |
| Volatility Rate | 76.85% | 76.24% | |
Equity Transactions (Details 1) |
9 Months Ended | |
|---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
| Equity [Abstract] | ||
| Expected life of options (In years) | 5 years | 5 years |
| Expected volatility | 79.52% | 75.12% |
| Risk free interest rate | 3.61% | 1.60% |
| Dividend Yield | 0.00% | 0.00% |
Leases (Details) - USD ($) |
Mar. 31, 2023 |
Jun. 30, 2022 |
|---|---|---|
| Leases | ||
| Operating lease, right-of-use asset, net | $ 90,549 | $ 118,254 |
| Current portion of operating lease liabilities | 43,314 | 38,884 |
| Operating lease liabilities, net of current portion | 54,465 | 87,414 |
| Total operating lease liabilities | $ 97,779 | $ 126,298 |
Leases (Details 1) - USD ($) |
Mar. 31, 2023 |
Jun. 30, 2022 |
|---|---|---|
| Leases | ||
| Year ending June 30, 2023 (Remaining 3 months) | $ 12,900 | |
| 2024 | 52,156 | |
| 2025 | 44,636 | |
| Total minimum lease payments | 109,692 | |
| Less amount representing interest | 11,913 | |
| Present value of future minimum lease payments | 97,779 | $ 126,298 |
| Less current portion of operating lease liabilities | (43,314) | (38,884) |
| Operating lease liabilities, net of current portion | $ 54,465 | $ 87,414 |
Leases (Details 2) |
Mar. 31, 2023 |
Jun. 30, 2022 |
|---|---|---|
| Leases | ||
| Weighted average remaining lease term (Years) Operating leases | 2 years | 2 years 9 months 18 days |
| Weighted average discount rate Operating leases | 10.75% | 10.75% |
Leases (Details Narrative) - USD ($) |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
Mar. 31, 2023 |
Mar. 31, 2022 |
|
| Leases | ||||
| Operating lease cost | $ 13,000 | $ 23,000 | $ 36,900 | $ 76,500 |
| Cash paid for amounts included in measurement of lease liabilities | $ 12,650 | $ 37,700 | ||
Employee Benefit Plan (Details Narrative) - USD ($) |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
Mar. 31, 2023 |
Mar. 31, 2022 |
|
| Employee Benefit Plan | ||||
| Employee Benefit Plan | $ 16,000 | $ 28,700 | $ 80,100 | $ 75,100 |
Subsequent Events (Details Narrative) - Common Class A [Member] - USD ($) |
1 Months Ended | 3 Months Ended | 9 Months Ended | |
|---|---|---|---|---|
May 12, 2023 |
Mar. 31, 2023 |
Mar. 31, 2023 |
Mar. 31, 2022 |
|
| Subsequent Event [Line Items] | ||||
| Issuance of common stock for cash, shares | 2,592,000 | |||
| Proceeds from issuance of common stock | $ 18,500,000 | |||
| Sales Agreement [Member] | ||||
| Subsequent Event [Line Items] | ||||
| Issuance of common stock for cash, shares | 1,515,078 | 7,372,691 | ||
| Proceeds from issuance of common stock | $ 9,800,000 | $ 48,200,000 | ||
| Subsequent Event [Member] | Sales Agreement [Member] | ||||
| Subsequent Event [Line Items] | ||||
| Issuance of common stock for cash, shares | 162,767 | |||
| Proceeds from issuance of common stock | $ 1,300,000,000 | |||
| Issuance costs | $ 40,000 | |||
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