NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
Note
1 – Description of Business and Liquidity
Nature
of Operations
Hillstream
BioPharma, Inc. (“HBI”) was incorporated on March 28, 2017, as a Delaware C-corporation. At September 30, 2022, Hillstream
BioPharma, Inc. had two wholly-owned subsidiaries: HB Pharma Corp. (“HB”) and Farrington Therapeutics LLC (“Farrington”
and together with HBI and HB, the “Company”).
The
Company is a pre-clinical biotechnology company developing novel therapeutic candidates targeting ferroptosis, an emerging new anti-cancer
mechanism resulting in iron mediated cell death (“IMCD”) for treatment resistant cancers. The Company’s most advanced
product candidate is HSB-1216, an IMCD modulator, targeting a variety of solid tumors. The active drug in HSB-1216 was found to reduce
tumor burden in a clinical pilot study in Germany in treatment resistant cancers, including triple negative breast cancer and epithelial
carcinomas. The Company’s goal is to file an investigational new drug application (“IND”) with the U.S. Food and Drug
Administration (“FDA”) in 2023 and start a clinical study with HSB-1216 in 2023; however, no assurance can be provided that
the Company’s IND will be accepted by the FDA in 2023, if at all. If the IND is accepted by the FDA, the HSB-1216 clinical study
will focus on expanding upon the clinical pilot study conducted in Germany. If the Company is able to start the clinical study with HSB-1216
in 2023, the Company anticipates that initial data from such trial will be released either at the end of 2023 or early 2024. The Company
uses Quatramer™, the proprietary tumor targeting platform, to enhance the uptake of HSB-1216 in the tumor microenvironment with
an extended duration of action and minimal off-target toxicity. The discovery of regulated cell death processes, such as apoptosis and
autophagy, has enabled novel target discovery for drug development. Ferroptosis, a form of IMCD, is an emerging regulated cell death
process which decreases intracellular iron or the Labile Iron Pool (“LIP”). Cancer cells increase the LIP leading to unregulated
cell growth and metabolism. Decreasing the LIP, induces iron-led reactive oxygen species production and lipid peroxidation, two key hallmarks
of ferroptosis/IMCD. HSB-1216 binds iron in the cytoplasm of cancer cells and decreases the LIP, thereby inducing ferroptosis/IMCD, leading
to regulated cell death. Areas of interest for the development of HSB-1216 are as a treatment of solid tumors, including small cell lung
cancer, metastatic castration resistant prostate cancer, triple negative breast cancer, uveal melanoma, glioblastoma multiforme, head
and neck squamous cell carcinoma, and other treatment resistant cancers with high unmet need.
Liquidity
The
accompanying condensed consolidated financial statements have been prepared on the basis that the Company is a going concern, which contemplates,
among other things, the realization of assets and satisfaction of liabilities in the normal course of business. For the nine months ended
September 30, 2022, the Company incurred operating losses in the amount of approximately $5.1 million, expended approximately $5.5 million
in cash in operating activities, and had an accumulated deficit of approximately $13.6 million as of September 30, 2022. The Company
financed its working capital requirements through September 30, 2022 primarily through the issuance of common stock in its initial public
offering (“IPO”). Net proceeds to the Company from the IPO were approximately $13.0 million. See Note 5 to the condensed
consolidated financial statements for details regarding the IPO. The shares of the Company’s common stock began trading on The
Nasdaq Capital Market on January 12, 2022 under the ticker symbol “HILS”.
The Company believes its cash on hand as of September 30, 2022 is sufficient to meet its operating obligations and capital requirements
for at least 12 months from the filing date of this Quarterly Report on Form 10-Q. Thereafter, the Company may need to raise further capital
through the sale of additional equity or debt securities or other debt instruments, strategic relationships or grants or other arrangements
to support its future operations. If such funding is not available, or not available on terms acceptable to the Company, the Company’s
current development plan may be curtailed.
Other
Risks and Uncertainties
There
can be no assurance that the Company’s products, if approved, will be accepted in the marketplace, nor can there be any assurance
that any future products can be developed or manufactured at an acceptable cost and with appropriate performance characteristics, or
that such products will be successfully marketed, if at all. The Company is subject to risks common to biopharmaceutical companies including,
but not limited to, the development of new technological innovations, dependence on key personnel, protection of proprietary technology,
compliance with government regulations, product liability, uncertainty of market acceptance of products and the need to obtain additional
financing. The Company is dependent on third party suppliers. The Company’s products require approval or clearance from the FDA
prior to commencing commercial sales in the United States. Approvals or clearances are also required in foreign jurisdictions in which
the Company may license or sell its products. There can be no assurance that the Company’s products will receive all of the required
approvals or clearances.
COVID-19
Considerations
On
March 11, 2020, the World Health Organization characterized the outbreak of a novel strain of coronavirus (“COVID-19”) as
a pandemic, prompting many national, regional, and local governments to implement preventative or protective measures, such as travel
and business restrictions, temporary store closures and capacity limitations, and wide-sweeping quarantines and stay-at-home orders.
As a result, COVID-19 and the related restrictive measures have had a significant adverse impact upon many sectors of the economy.
As
a result of the COVID-19 pandemic, the Company had to delay the start of its IND enabling studies for over a year. As the COVID-19 situation
continues to evolve, the Company intends to closely monitor the impact of the COVID-19 pandemic on all aspects of its business, including,
but not limited to, impacts on third-party contractors, suppliers, vendors and employees. The Company believes that the ultimate impact
of the COVID-19 pandemic on operating results, cash flows, and financial condition is likely to be determined by factors which are uncertain,
unpredictable, and outside of the Company’s control. The situation surrounding COVID-19 remains fluid, and if disruptions arise,
they could have a material adverse impact on the Company’s business.
Note
2 – Summary of Significant Accounting Policies
Basis
of Presentation
The
accompanying unaudited condensed consolidated interim financial statements have been prepared by the Company pursuant to the rules and
regulations of the Securities and Exchange Commission (“SEC”) for interim financial reporting. These financial statements
are unaudited and, in the opinion of management, include all adjustments (consisting of normal recurring adjustments and accruals) necessary
for a fair statement of the balance sheet, operating results, and cash flows for the periods presented in accordance with accounting
principles generally accepted in the United States of America (“U.S. GAAP”). Operating results for the three and nine months
ended September 30, 2022 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2022
or any other future period. Certain information and footnote disclosure normally included in the annual financial statements prepared
in accordance with U.S. GAAP have been omitted in accordance with the SEC’s rules and regulations for interim reporting. The Company’s
financial position, results of operations, and cash flows are presented in U.S. Dollars. These financial statements and related notes
should be read in conjunction with the audited financial statements and related notes thereto for the year ended December 31, 2021 included
in the Company’s Annual Report on Form 10-K filed with the SEC on April 1, 2022. The Company
operates in one segment.
Principles
of Consolidation
The
condensed consolidated financial statements include the accounts of HBI and its wholly-owned subsidiaries, HB and Farrington. All significant
intercompany balances and transactions have been eliminated in consolidation.
Use
of Estimates
The
preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the financial statements
and the reported amounts of revenue and expenses during the reporting period. Management bases its estimates on historical experience
and on assumptions believed to be reasonable under the circumstances. The estimation process often may yield a range of potentially reasonable
estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates.
Estimates are used in the following areas, among others: research and development expense recognition, valuation of common shares and
stock options, allowances of deferred tax assets, valuation of debt related instruments, accrued expenses and liabilities, and cash flow
assumptions regarding going concern considerations. Given the situation surrounding the COVID-19 pandemic, many estimates and assumptions
have required increased judgment and are subject to a higher degree of variability and volatility. Although management believes the estimates
that have been used are reasonable, as events continue to evolve and additional information becomes available, actual results could vary
from the estimates that were used.
Concentration
of Credit Risk
The
Company maintains cash balances with various financial institutions. Account balances at these institutions are insured by the Federal
Deposit Insurance Corporation up to $250,000 per depositor. At various times during the year, bank account balances may have been in
excess of federally insured limits. The Company has not experienced losses in such accounts. The
Company believes that it is not subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
Research
and Development
Research
and development costs are expensed as incurred. Research and development expenses include personnel costs associated with research and
development activities, including third party contractors to perform research, conduct clinical trials, and manufacture drug supplies
and materials. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical
investigators, based on its estimates of service performed and costs incurred. These estimates include the level of services performed
by third parties, patient enrollment in clinical trials, administrative costs incurred by third parties, and other indicators of the
services completed. Approximately $61,000 of prepaid expenses at September 30, 2022 and December 31, 2021 relate to a manufacturing services
agreement.
Stock
Based Compensation
The
Company recognizes compensation costs resulting from the issuance of stock-based awards to employees, non-employees and directors as
an expense in the condensed consolidated statements of operations over the requisite service period based on a measurement of fair value
for each stock-based award. The fair value of each option grant to employees, non-employees and directors is estimated as of the date
of grant using the Black-Scholes option-pricing model, net of actual forfeitures. The fair value is amortized as compensation cost on
a straight-line basis over the requisite service period of the awards, which is generally the vesting period.
The
fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. Prior to January
12, 2022, the Company was a private company and the Company’s common stock has been publicly traded since that date. As a result,
the Company has lacked company-specific historical and implied volatility information. Therefore, it has estimated its expected stock
volatility based on the historical data regarding the volatility of a publicly traded set of peer companies. The expected term of stock
options granted was between five and seven years. The risk-free interest rate was determined by reference to the U.S. Treasury yield
curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award.
Common
Stock Valuations
Prior
to the IPO, the Company was required to periodically estimate the fair value of common stock with the assistance of an independent third-party
valuation expert when issuing stock options and computing its estimated stock based compensation expense and value of shares issued in
acquiring product candidates. The assumptions underlying these valuations represented management’s best estimates, which involved
inherent uncertainties and the application of significant levels of management judgment. In order to determine the fair value, the Company
considered, among other things, contemporaneous valuations of the Company’s common stock; the Company’s business, financial
condition and results of operations, including related industry trends affecting its operations; the likelihood of achieving various
liquidity events; the lack of marketability of the Company’s common stock; the market performance of comparable publicly traded
companies; and U.S. and global economic and capital market conditions. After the closing of the Company’s IPO on January 14, 2022,
the fair value of common stock is determined by using the closing price of the Company’s common stock on The Nasdaq Capital Market.
Treasury
Stock
The
Company’s board of directors has authorized the repurchase of up to $1 million of shares of the Company’s common stock, from
time to time, in the open market or through privately-negotiated transactions, at such times and at such prices as the Company’s
management may decide. Treasury stock purchases are accounted for under the cost method whereby the entire cost of the acquired common
stock is recorded as treasury stock.
Debt
Discount and Derivative Instruments
The
initial fair value of the redemption feature relating to the convertible debt instruments was treated as a debt discount and was amortized
over the term of the related debt using the straight-line method, which approximates the interest method. Amortization of debt discount
is recorded as a component of interest expense. If a loan is paid in full, any unamortized debt discounts will be removed from the related
accounts and charged to operations. As the convertible debt was converted into common stock at the date of the IPO, the unamortized debt
discount was charged to interest expense. In accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards
Update (“ASU”) 2015-03, Interest - Imputation of Interest, the unamortized debt discount at December 31, 2021 was
presented in the accompanying condensed consolidated balance sheet as a direct deduction from the carrying amount of the related debt.
The
Company accounts for derivative instruments in accordance with FASB Accounting Standards Codification (“ASC”) 815, Derivative
and Hedging, which establishes accounting and reporting standards for derivative instruments, including certain derivative instruments
embedded in other financial instruments or contracts and requires recognition of all derivatives on the balance sheet at fair value.
The Company’s derivative financial instrument consisted of an embedded feature contained in the Company’s convertible debt
that was bifurcated and accounted for separately. See Note 3 to the condensed consolidated financial statements for further details.
Fair
Value Measurements
The
Company applies FASB ASC 820, Fair Value Measurement (“ASC 820”), which establishes a framework for measuring fair
value and clarifies the definition of fair value within that framework. ASC 820 defines fair value as an exit price, which is the price
that would be received for an asset or paid to transfer a liability in the Company’s principal or most advantageous market in an
orderly transaction between market participants on the measurement date. The fair value hierarchy established in ASC 820 generally requires
an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Observable
inputs reflect the assumptions that market participants would use in pricing the asset or liability and are developed based on market
data obtained from sources independent of the reporting entity. Unobservable inputs reflect the entity’s own assumptions based
on market data and the entity’s judgments about the assumptions that market participants would use in pricing the asset or liability
and are to be developed based on the best information available in the circumstances.
The
carrying value of the Company’s prepaid expenses, accounts payable, and accrued expenses approximate fair value because of the
short-term maturity of these financial instruments. The redemption feature of the debt instruments is recorded at fair value. See Note
4 to the condensed consolidated financial statements for further details.
The
valuation hierarchy is composed of three levels. The classification within the valuation hierarchy is based on the lowest level of input
that is significant to the fair value measurement. The levels within the valuation hierarchy are described below:
Level
1 Inputs: Observable inputs such as quoted prices (unadjusted) in active markets that are accessible at the measurement date for
identical, unrestricted assets or liabilities.
Level
2 Inputs: Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include
quoted prices for assets or liabilities recently traded in active markets, with similar underlying terms, as well as direct or indirect
observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals, as well as quoted prices
for identical or similar assets or liabilities in markets that are not active.
Level
3 Inputs: Unobservable inputs, such as estimates, assumptions, and valuation techniques when little or no market data exists for
the assets or liabilities, that reflect the reporting entity’s own assumptions.
Deferred
Offering Costs
Deferred
offering costs consisted of legal, accounting, printing, and filing fees that the Company capitalized which were offset against the proceeds
from the IPO.
Income
Taxes
The
Company accounts for income taxes using the asset-and-liability method in accordance with FASB ASC 740, Income Taxes (“ASC
740”). Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the
financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit
carryforwards.
Deferred
income taxes are recognized for the tax effect of temporary differences between the financial statement carrying amount of assets and
liabilities and the amounts used for income tax purposes and for certain changes in valuation allowances. Valuation allowances are recorded
to reduce certain deferred tax assets when, in management’s estimation, it is more-likely-than-not that a tax benefit will not
be realized. A valuation allowance has been recognized for all periods since it is more-likely-than-not that some portion or all of the
deferred tax assets will not be realized in future periods.
The
Company follows the guidance in FASB ASC Topic 740-10 in assessing uncertain tax positions. The standard applies to all tax positions
and clarifies the recognition of tax benefits in the financial statements by providing for a two-step approach of recognition and measurement.
The first step involves assessing whether the tax position is more-likely-than-not to be sustained upon examination based upon its technical
merits. The second step involves measurement of the amount to be recognized. Tax positions that meet the more-likely-than-not threshold
are measured at the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate finalization with the
taxing authority. The Company recognizes the impact of an uncertain income tax position in the financial statements if it believes that
the position is more likely than not to be sustained by the relevant taxing authority. The Company will recognize interest and penalties
related to tax positions in income tax expense. At September 30, 2022 and December 31, 2021, the Company had no unrecognized uncertain
income tax positions, and therefore no amounts have been recognized in the condensed consolidated financial statements.
Net
Loss per Share
The
Company reports loss per share in accordance with FASB ASC 260-10, Earnings Per Share, which provides for calculation of basic
and diluted earnings per share. Basic earnings per share includes no dilution and is computed by dividing net income or loss available
to common stockholders by the weighted average common shares outstanding for the period. Diluted earnings per share reflect the potential
dilution of securities that could share in the earnings of an entity. The calculation of diluted net earnings (loss) per share gives
effect to common stock equivalents; however, potential common shares are excluded if their effect is anti-dilutive.
Potentially
dilutive securities not included in the computation of loss per share for the three and nine months ended September 30, 2022 and 2021
included options to purchase 1,628,813 and 903,468 shares of common stock, respectively. All common share amounts as of September 30,
2022 and December 31, 2021 and per share amounts for the three and nine months ended September 30, 2022 and 2021 have been adjusted to
reflect a 1-for-26.4 reverse stock split of the Company’s common stock effectuated on September 16, 2021. Other potentially dilutive
securities also not included in the computation of loss per share for the three and nine months ended September 30, 2022 included warrants
to purchase 187,500 shares of the Company’s common stock.
Recently
Adopted Accounting Pronouncements
The
Company has evaluated all recent accounting pronouncements and believes that none of them will have a material effect on the
Company’s financial position, results of operations, or cash flows, except as described below.
Earnings
per Share
In
May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic
470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity
(Subtopic 815-40). This ASU addresses an issuer’s accounting for certain modifications or exchanges of freestanding equity-classified
written call options. This amendment is effective for fiscal years beginning after December 15, 2021, including interim periods within
those fiscal years, and was effective for the Company beginning January 1, 2022. This ASU did not have a material impact on the Company’s
consolidated financial statement presentation.
Recent
Accounting Pronouncements Not Yet Adopted
Debt
with Conversion and Other Options and Derivatives and Hedging
The
FASB recently issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470- 20) and Derivatives and Hedging
- Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s
Own Equity (“ASU 2020-06”), to reduce complexity in applying U.S. GAAP to certain financial instruments with characteristics
of liabilities and equity. The guidance in ASU 2020-06 simplifies the accounting for convertible debt instruments and convertible preferred
stock by removing the existing guidance that requires entities to account for beneficial conversion features and cash conversion features
in equity, separately from the host convertible debt or preferred stock. The guidance in FASB ASC Subtopic 470-20 applies to convertible
instruments for which the embedded conversion features are not required to be bifurcated from the host contract and accounted for as
derivatives. In addition, the amendments revise the scope exception from derivative accounting in FASB ASC Subtopic 815-40 for freestanding
financial instruments and embedded features that are both indexed to the issuer’s own stock and classified in stockholders’
equity, by removing certain criteria required for equity classification. These amendments are expected to result in more freestanding
financial instruments qualifying for equity classification (and, therefore, not accounted for as derivatives), as well as fewer embedded
features requiring separate accounting from the host contract. The amendments in ASU 2020-06 further revise the guidance in FASB ASC
260, Earnings Per Share, to require entities to calculate diluted earnings per share (“EPS”) for convertible instruments
by using the if-converted method. In addition, entities must presume share settlement for purposes of calculating diluted EPS when an
instrument may be settled in cash or shares. The amendments in ASU 2020-06 are effective for public entities that meet the definition
of an SEC filer, excluding smaller reporting companies as defined by the SEC for fiscal years beginning after December 15, 2021. For
all other entities, including the Company, the amendments are effective for fiscal years beginning after December 15, 2023. Early adoption
is permitted. The Company is currently evaluating the impact this standard will have on its consolidated financial statements.
Codification
Improvements
In
October 2020, the FASB issued ASU 2020-10, Codification Improvements. The guidance contains improvements to the codification by
ensuring that all guidance that requires or provides an option for an entity to provide information in the notes to financial statements
is codified in the disclosure section of the codification. The guidance also contains codifications that are varied in nature and may
affect the application of the guidance in cases in which the original guidance may have been unclear. This
ASU is effective for fiscal years beginning after December 15, 2021, and interim periods within annual periods beginning after December
15, 2022. The Company does not expect the adoption of ASU 2020-10 to have a material impact on
its consolidated financial statements.
Note
3 – Convertible Notes - Related Parties
Commencing
in May 2017, the Company entered into Subordinated Convertible Promissory Note Agreements (the “Agreements”) with certain
lenders (together, the “Holders” or individually, the “Holder”), pursuant to which the Company issued Subordinated
Convertible Promissory Notes (individually the “Note” or together, the “Notes”) to the Holders, principally all
to the Chief Executive Officer (“CEO”) and founder of the Company, a member of the Company’s board of directors and
third parties that are family members of the founder and CEO. Interest on the unpaid principal balance accrued at a rate of 5% per annum,
computed on the basis of the actual number of days elapsed and a year of 365 days. Unless earlier converted into shares of the Company’s
common stock or preferred stock (collectively, the “Equity Securities”), the principal and accrued interest was to be due
and payable by the Company on demand by the Holders at any time after the earlier of (i) the Maturity Date (as defined in each Agreement)
and (ii) the closing of the Next Equity Financing. “Next Equity Financing” means the next sale, or series of related sales,
by the Company of its Equity Securities pursuant to which the Company received gross proceeds of not less than $5.0 million for Notes
issued in 2017 and through November 2020 and $7.5 million for Notes issued after November 2020 (including the aggregate amount of debt
securities converted into Equity Securities upon conversion or cancellation of the Notes). The Company’s IPO qualified as a Next
Equity Financing.
In
general, the stated maturity date was two years from the date of issuance, except for the Notes issued in December 2020 and thereafter
(in the aggregate principal amount of approximately $2.1 million) which had a stated maturity date of three years. For Notes issued in
2017 and through September 2018, the default interest rate of 20% was added to the Notes for the period after the stated maturity date.
The
Notes were to automatically convert into the type of Equity Securities issued in the Next Equity Financing upon closing. The number of
shares of such Equity Securities to be issued was equal to the quotient obtained by dividing the outstanding principal and unpaid accrued
interest due on the Note on the date of conversion by the lesser of (i) 80% of the price paid per share for Equity Securities by the
investors in the Next Equity Financing, or (ii) an equity valuation of $25 million ($50 million for Notes issued after December 2020).
On January 14, 2022, all outstanding Notes and accrued interest were converted into an aggregate of 1,225,384 shares of the Company’s
common stock as the IPO qualified as a Next Equity Financing.
Certain
embedded features contained in the Notes in the aggregate were embedded derivative instruments, which were recorded as a debt discount
and derivative liability at the issuance date at their estimated fair value for all Notes of approximately $2.4 million. Amortization
of debt discount for the Notes recorded as interest expense was approximately $1.6 million for the nine months ended September 30, 2022,
and approximately $192,000 and approximately $455,000 for the three and nine months ended September 30, 2021, respectively. The amount
for the nine months ended September 30, 2022 contains amortization charged to interest expense of approximately $34,000 up to the date
of the IPO and the full amount of the unamortized debt discount of approximately $1.5 million charged to interest expense on the date
of the IPO.
Accrued
interest expense associated with the Notes at December 31, 2021 was approximately $180,000. Accrued interest at the date of the IPO was
approximately $187,000 and was converted into common stock as the IPO qualified as a Next Equity Financing. Total interest expense, including
accrued interest and amortization of the debt discount, amounted to approximately $1.6 million for the nine months ended September 30,
2022, and $236,000 and $573,000 for the three and nine months ended September 30, 2021, respectively.
The
carrying value of the outstanding related-party convertible notes at December 31, 2021 was as follows:
Schedule
of Convertible Debt
| |
| | |
Principal amount outstanding | |
$ | 3,734,446 | |
Less: debt discount, net of amortization | |
| (1,569,003 | ) |
Carrying value | |
$ | 2,165,443 | |
Current portion | |
$ | 1,392,544 | |
Long-term portion | |
| 772,899 | |
Total carrying value | |
$ | 2,165,443 | |
Roll-over
Notes
Effective
October 1, 2020, all Notes which matured, and were not repaid or converted, were rolled over, including the default interest rate of
20% as disclosed above. Approximately $805,000 of such Notes were rolled over through December 31, 2021, of which approximately $166,000
occurred prior to December 31, 2020 and approximately $639,000 occurred between January 1, 2021 and December 31, 2021. Since the terms
of the new notes were not substantially different from the Notes, this was not accounted for as a debt modification or debt extinguishment.
Note
4 – Redemption Liability
The
fair value of the redemption liability is calculated under Level 3 of the fair value hierarchy, determined based upon a probability-weighted
expected returns method (“PWERM”). This PWERM was determined to be the most appropriate method of estimating the value of
possible redemption or conversion outcomes over time, since the Company had not entered into a priced equity round through December 31,
2021. The significant assumptions utilized in these calculations are the possible exit scenarios (either a conversion of the principal
and accrued interest of the Notes in the event of a Next Equity Financing (see Note 3 to the condensed consolidated financial statements),
a repayment of the Notes and accrued interest in the event of a corporate transaction (as defined in the Notes) or a repayment of the
Notes and accrued interest at maturity), the pre-money valuation of the Company’s common stock, the probabilities of such exit
events occurring, and discounts/premiums available to the Holders at such measurement dates. The calculation of the redemption liability
at December 31, 2021 was based upon the actual incremental value derived by the Holders at the IPO date. The fair value of the redemption
liability is re-measured at each period and is summarized as of December 31, 2021 as follows:
Schedule
of Fair Value of Redemption Liability
| |
| | |
December 31, 2020 | |
$ | 1,325,288 | |
Beginning balance as of December 31, 2020 | |
$ | 1,325,288 | |
Initial embedded redemption value | |
| 1,487,596 | |
Change in fair value | |
| (1,832,651 | ) |
December 31, 2021 | |
$ | 980,233 | |
Ending balance as of
December 31, 2021 | |
$ | 980,233 | |
The
change in fair value of a loss of approximately $76,000
and approximately $980,000 for the three and nine months ended September 30, 2021, respectively,
was recorded as a component of other expense in the accompanying condensed consolidated statements of operations. The balance of approximately
$980,000 as of December 31, 2021 and as of the date of the IPO was converted into common stock
in connection with the related-party convertible debt to which it related.
Note
5 – Common Stock
Pursuant
to an amendment to the Company’s Certificate of Incorporation filed in April 2019, the Company increased the number of authorized
shares of common stock to 250,000,000 shares. See the Net Loss Per Share section of Note 2 to the condensed consolidated financial statements
for a discussion of the reverse stock split effectuated on September 16, 2021.
On
January 14, 2022, the Company closed the IPO pursuant to which it issued 3,750,000 shares of its common stock at a public offering price
of $4.00 per share. The gross proceeds to the Company from the IPO were $15.0 million, prior to deducting underwriting discounts of approximately
$1.1 million and commissions and other offering expenses of approximately $1.0 million. Other offering expenses include deferred offering
costs of approximately $547,000 that were capitalized prior to December 31, 2021 and additional costs incurred prior to the date of the
IPO. The net proceeds to the Company from the IPO were approximately $13.0 million. The Company granted the underwriters a 45-day option
to purchase up to an additional 562,500 shares of common stock at the public offering price less discounts and commissions, to cover
over-allotments; however, this option expired unexercised. Additionally, and as a result of the completion of the IPO, all of the Company’s
convertible debt and accrued interest was converted into an aggregate of 1,225,384 shares of the Company’s common stock pursuant
to the terms of the Notes. Outstanding principal of approximately $3.7 million, accrued interest of approximately $187,000, and a redemption
liability of approximately $980,000 were converted to common stock as the IPO qualified as a Next Equity Financing. In addition, the
Company issued warrants in connection with the IPO. See Note 6 to the condensed consolidated financial statements for a discussion of
the warrants issued.
On
February 16, 2022, the Company entered into an agreement for marketing and investor related consulting services. Pursuant to the agreement,
compensation includes a monthly fee and an upfront issuance of shares of the Company’s common stock. On the effective date of February
16, 2022, the Company issued 31,746 shares of common stock with a per share value of $3.15 and a total value of $100,000 as compensation
expense.
On
June 9, 2022, the Company’s Board of Directors authorized the repurchase of up to $1.0 million of shares of the Company’s
common stock until December 31, 2022. On June 10, 2022, the Company entered into a Repurchase Agreement (the “Repurchase Agreement”)
with a financial institution pursuant to which such financial institution may purchase shares of the Company’s common stock upon
the terms and conditions set forth in such agreement, including in accordance with the guidelines specified in Rules
10b5-1 and 10b-8 under the Securities Exchange Act of 1934, as amended. Shares of
the Company’s common stock may be repurchased in open market or through privately-negotiated transactions. Pursuant to the
Repurchase Agreement, the financial institution shall cease purchasing shares of the Company’s common stock upon the earlier of
(i) the close of trading on December 31, 2022, (ii) the completion of repurchases up to the approved
amount and (iii) the date upon which the Company gives notice of termination of the Repurchase Agreement to the financial institution.
The Company will determine the timing and amount of any repurchases based upon its evaluation of market conditions, applicable SEC guidelines
and regulations, and other factors.
During
the three and nine months ended September 30, 2022, the Company purchased 45,109 and 75,109 shares of its common stock, respectively,
for a total purchase cost of approximately $37,000 and $62,000, respectively.
Note
6 – Stock Based Compensation
Incentive
Plans and Options
Under
the Company’s 2017 Stock Incentive Plan (the “2017 Stock Incentive Plan”) the Company may grant incentive stock options,
non-statutory stock options, rights to purchase common stock, stock appreciation rights, restricted stock, performance shares, and performance
units to employees, directors, and consultants of the Company and its affiliates. Up to 94,696 shares of the Company’s common stock
may be issued pursuant to the 2017 Stock Incentive Plan.
The
Company has granted options to acquire 92,801 shares of common stock at $13.20 per share under the 2017 Stock Incentive Plan, and 1,895
shares remain available for issuance. At both September 30, 2022 and December 31, 2021, there were options outstanding to acquire 92,801
shares of common stock. As of both September 30, 2022 and December 31, 2021, all such options were fully vested, and the weighted average
remaining contractual life for such options was approximately 5.4 and 6.2 years, respectively.
In
July 2019, the Company authorized a new plan (the “2019 Stock Incentive Plan”). The Company initially reserved 284,090 shares
of its common stock for issuance pursuant to the 2019 Stock Incentive Plan in the form of incentive stock options, non-statutory stock
options, rights to purchase common stock, stock appreciation rights, restricted stock, performance shares, and performance units to employees,
directors, and consultants of the Company and its affiliates. On August 30, 2019, the Company approved an increase in the number of shares
authorized for issuance under the 2019 Stock Incentive Plan by 2,575,757 shares. In January 2021, the Company approved an increase in
the number of shares reserved for issuance under the 2019 Stock Incentive Plan by 574,494 shares. On May 31, 2021, the Company approved
an increase in the number of shares reserved for issuance under the 2019 Stock Incentive Plan by 467,171 shares. At both September 30,
2022 and December 31, 2021, a total of 3,901,512 shares were authorized for issuance under the 2019 Stock Incentive Plan.
The
Company has granted options to acquire 3,386,385 and 2,420,514 shares of common stock under the 2019 Stock Incentive Plan, and 515,127
and 1,480,998 shares of common stock remain available for issuance under the 2019 Stock Incentive Plan at September 30, 2022 and December
31, 2021, respectively. There are stock options outstanding to acquire 1,536,012 and 810,667 shares of common stock with weighted average
exercise prices of $3.80 and $3.25 and weighted average contractual terms of 8.7 years and 8.0 years at September 30, 2022 and December
31, 2021, respectively.
The
following table summarizes stock-based activities under the 2017 Stock Incentive Plan and 2019 Stock Incentive Plans:
Schedule of Stock Option Activity
| |
| | |
Weighted | | |
Weighted | |
| |
Shares | | |
Average | | |
Average | |
| |
Underlying | | |
Exercise | | |
Contractual | |
| |
Options | | |
Price | | |
Terms | |
| |
| | |
| | |
| |
Outstanding at December 31, 2021 | |
| 903,468 | | |
$ | 4.27 | | |
| 7.9 years | |
Granted | |
| 980,075 | | |
$ | 3.38 | | |
| | |
Exercised | |
| (240,526 | ) | |
$ | 0.10 | | |
| | |
Forfeited /cancelled | |
| (14,204 | ) | |
$ | 5.28 | | |
| | |
Outstanding at September 30, 2022 | |
| 1,628,813 | | |
$ | 4.34 | | |
| 8.5 years | |
| |
| | | |
| | | |
| | |
Exercisable options at September 30, 2022 | |
| 881,952 | | |
$ | 4.91 | | |
| 7.9 years | |
| |
| | | |
| | | |
| | |
Vested and expected to vest at September 30, 2022 | |
| 1,628,813 | | |
$ | 4.34 | | |
| 8.5 years | |
The
fair value of stock option awards is estimated at the date of grant using the Black-Scholes option-pricing model. The estimated fair
value of each stock option is then expensed over the requisite service period, which is generally the vesting period (ranging between
immediate vesting and four years). The determination of fair value using the Black-Scholes model is affected by the Company’s share
price as well as assumptions regarding a number of complex and subjective variables, including expected price volatility, expected life,
risk-free interest rate and forfeitures.
Stock
options granted during the three and nine months ended September 30, 2022 and 2021 were valued using the Black-Scholes option-pricing
model with the following weighted average assumptions:
Schedule of Options Weighted Average Assumptions
| |
For the three months ended | | |
For the nine months ended | |
| |
September 30, | | |
September 30, | | |
September 30, | | |
September 30, | |
| |
2022 | | |
2021* | | |
2022 | | |
2021 | |
| |
| | |
| | |
| | |
| |
Expected volatility | |
| 104.0 | % | |
| N/A | | |
| 94.5% - 104.0 | % | |
| 111.3 | % |
Risk-free interest rate | |
| 3.39 | % | |
| N/A | | |
| 1.69% - 3.39 | % | |
| 0.42% - 0.86 | % |
Expected dividend yield | |
| 0 | % | |
| N/A | | |
| 0 | % | |
| 0 | % |
Expected life of options in years | |
| 5.0 | | |
| N/A | | |
| 5.0 - 7.0 | | |
| 5.0 | |
Estimated fair value of options granted | |
$ | 0.78 | | |
| N/A | | |
$ | 0.78 - $3.20 | | |
$ | 5.46 - $5.56 | |
* | No stock options
were granted during the three months ended September 30, 2021. |
The
weighted average grant date fair value of stock options granted during the three months ended September 30, 2022 was approximately $0.78.
The weighted average grant date fair value of stock options granted during the nine months ended September 30, 2022 and 2021 was approximately
$2.70 and $5.47, respectively. The weighted average fair value of stock options vested during the three and nine months ended September
30, 2022 was approximately $1.60 and $1.10, respectively, and during the three and nine months ended September 30, 2021 was approximately
$0.53 and $5.46, respectively.
Included
in the above table are stock options granted in 2019 to purchase 231,058 shares of the Company’s common stock at an exercise price
of $0.08 per share, which vest upon a specified performance condition. These stock options vested at the date of the Company’s
IPO, which was the specified performance condition.
Total
stock based compensation expense included in the accompanying condensed consolidated statements of operations was as follows:
Schedule
of Stock Based Compensation Expense
| |
September 30, 2022 | | |
September 30, 2021 | | |
September 30, 2022 | | |
September 30, 2021 | |
| |
For the three months ended | | |
For the nine months ended | |
| |
September 30, 2022 | | |
September 30, 2021 | | |
September 30, 2022 | | |
September 30, 2021 | |
Research and development | |
$ | 87,829 | | |
$ | 66 | | |
$ | 253,561 | | |
$ | 516,328 | |
General and administrative | |
| 152,933 | | |
| 4,369 | | |
| 345,133 | | |
| 716,199 | |
Total stock based compensation | |
$ | 240,762 | | |
$ | 4,435 | | |
$ | 598,694 | | |
$ | 1,232,527 | |
At
September 30, 2022, the total unrecognized compensation expense related to non-vested options was approximately $2.1 million and is expected
to be recognized over the remaining weighted average service period of approximately 2.9 years.
In
March 2021, the Company modified the stock option exercise price for stock options granted during 2020, increasing the exercise price
of such stock options (after adjusting for the 1-for-26.4 reverse stock split) from $0.18 or $2.60 to $0.31 or $3.82 per share, respectively.
The increase in the stock option exercise price was accounted for as a modification of the stock grant in 2021; however, the impact on
the Company’s condensed consolidated statements of operations was immaterial.
Warrants
In
connection with the IPO, the Company issued warrants to purchase such number of shares of the Company’s common stock equal to 5%
of the total shares of common stock issued in the IPO. The warrants are exercisable at $5.00 per
share, were not exercisable within the first six months after issuance, and may, under certain circumstances, be exercised on a cashless
basis. The exercise price of the warrants is subject to standard antidilutive provision adjustments for stock splits, stock combinations,
or similar events affecting the Company’s common stock. The Company has determined that these warrants should be classified as
equity instruments since they do not require the Company to repurchase the underlying common stock and do not require the Company to
issue a variable amount of common stock. In addition, these warrants are indexed to common stock and do not have any unusual antidilution
rights. Terms of the warrants outstanding at September 30, 2022 are as follows:
Schedule
of Warrants
| |
Initial | | |
| |
Exercise | | |
Warrants | | |
Warrants | | |
Warrants | |
Issuance Date | |
Exercise Date | | |
Expiration Date | |
Price | | |
Issued | | |
Exercised | | |
Outstanding | |
| |
| | | |
| |
| | | |
| | | |
| | | |
| | |
January 14, 2022 | |
| July 10, 2022 | | |
January 11, 2027 | |
$ | 5.00 | | |
| 187,500 | | |
| 0 | | |
| 187,500 | |
Note
7 – Related-party Transactions
As
described in Note 3 to the condensed consolidated financial statements, the Company entered into the Notes with the Holders commencing
in May 2017. The Holders of substantially all of the Notes were the Company’s founder and CEO, a member of the Company’s
board of directors, and third parties that are family members of the founder and CEO. The Notes
were converted into shares of the Company’s common stock on January 14, 2022 in connection with the closing of the IPO.
In
addition to the above Notes, the Company had amounts due to the founder and CEO that totaled $200,000 at December 31, 2021 for accrued
compensation. See Note 8 to the condensed consolidated financial statements. On April 1, 2022, the founder and CEO received the full
amount of $200,000.
On
January 4, 2022 and January 6, 2022, the Company issued unsecured promissory notes in the aggregate principal amount of approximately
$139,000 (including an original issuance discount of an aggregate of approximately $14,000)
to three related-party investors. The notes were to accrue interest at a rate of 12% per annum and mature upon the earlier of (i) June
30, 2022, and (ii) the closing of a subsequent equity financing. “Subsequent Equity Financing” means the next sale (or series
of related sales) by the Company of its equity securities following the date of the notes pursuant to which the Company receives gross
proceeds of not less than $5.0 million. The notes were repaid in full on January 21, 2022 following the Company’s IPO on January
14, 2022 as the IPO was considered a Subsequent Equity Financing.
Additionally,
on April 18, 2022, the founder and CEO exercised options to purchase up to 240,526 shares of the Company’s common stock at a weighted
average exercise price of $0.10 per share for a total of approximately $24,000.
Note
8 – Commitments and Contingencies
Small
Molecule Analogues
On
December 30, 2019, the Company acquired a series of small molecule analogues pursuant to an Asset Purchase Agreement (“APA”).
Pursuant to the APA, the Company is required to make a payment of $50,000 upon raising of at least $2.0 million in funding, and up to
$1.75 million based upon successfully meeting clinical and sales milestones. As of September 30, 2022 and December 31, 2021, such fund-raising
requirement was not met and no payments were made pursuant to the APA. The Company included, in accounts payable at both September 30,
2022 and December 31, 2021, the $50,000 required initial payment. Milestone based payments, if any, will be expensed as incurred.
Employment
Agreement
In
January 2019, the Company entered into a three-year employment agreement with its CEO which provides a specified base salary and bonus.
The employment agreement also provides the CEO with certain benefits while employed and if employment ceases. The Company accrued $200,000
in 2019 related to the CEO’s base salary as per the employment agreement, which was included in due to founder as of December 31,
2021, which was paid in full on April 1, 2022. No bonus was approved by the board of directors of the Company for any period through
September 30, 2022.
In
January 2020, the Company amended the employment agreement pursuant to which, in lieu of a cash base salary, the CEO was to be compensated
with stock options to purchase 7,575 shares of the Company’s common stock per month (at an exercise price based upon the Company’s
most recent 409A valuation at the date of the grant) effective January 1, 2020 until the Company received a minimum of $3.0 million of
gross proceeds from the sale of its securities, after which time, cash compensation, pursuant to the employment agreement, would be paid.
Effective
January 1, 2021, the Company amended the employment agreement with its CEO to provide a revised base salary pre-funding (as defined in
the employment agreement). In lieu of cash base salary, the CEO was to be compensated with stock options to purchase 18,939 shares of
the Company’s common stock per month at an exercise price of $7.82 per share effective January 1, 2021 until funding meets or exceeds
$5.0 million, after which time, cash compensation, pursuant to his employment agreement, would be paid. The amended employment agreement
also provides for a future base salary for the CEO after the Company receives funding greater than $5.0 million or completes an initial
public offering or similar transaction as set forth in the employment agreement. In addition, if the CEO acts as the “finder”
of an investor who purchases more than $5.0 million of the Company’s equity, he will receive a grant of stock options to acquire
757,575 shares of common stock of the Company at an exercise price equal to the most recent fair value of the Company’s common
stock at the time of grant.
On
June 1, 2021, the Company entered into an Amended and Restated Employment Agreement, as amended on September 24, 2021 (the “Amended
and Restated Employment Agreement”) with the Company’s CEO. The term of the Amended and Restated Employment Agreement commenced
upon the closing of the Company’s IPO and continues for a period of five years and automatically renews for successive one-year
periods at the end of each term unless either party provides written notice of their intent not to renew at least 60 days prior to the
expiration of the then effective term. Pursuant to the Amended and Restated Employment Agreement, the CEO will receive an annual base
salary of $485,000, which may be increased from time to time, and shall be eligible to receive an annual cash bonus equal to 55% of his
then base salary based upon the achievement of Company and individual performance targets established by the Company’s board of
directors. In addition, in the first year in which the Company’s market capitalization (as defined in the Amended and Restated
Employment Agreement) equals or exceeds (i) $250 million, the CEO shall receive a cash payment of $150,000; (ii) $500 million, the CEO
shall receive a cash payment of $350,000; and (iii) $1.0 billion, the CEO shall receive a cash payment of $750,000. Furthermore, following
the date of the Company’s IPO, the CEO was issued an option to purchase 757,575 shares of the Company’s common stock at an
exercise price of $4.00 per share, which options shall vest over a 48-month period commencing 12 months after the date of grant. This
shall be in addition to any additional equity-based compensation awards the Company may grant the CEO from time to time.
Note
9 – Subsequent Events
There
were no material subsequent events that required recognition or additional disclosure in these condensed consolidated financial statements.