JUPITER NEUROSCIENCES INC
For the period ended Sep 30, 2024. Filed Dec 23, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Dec 23, 2024
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PART I—FINANCIAL INFORMATION Financial Statements
JUPITER NEUROSCIENCES, INC.
BALANCE SHEETS
| September 30, 2024 | December 31, 2023 | |
|---|---|---|
| (unaudited) | ||
| Assets | ||
| Current Assets: | ||
| Cash | $253 | $28,478 |
| Other current assets | 261 | 261 |
| Total current assets | 514 | 28,739 |
| Operating lease right of use asset, net | 81,249 | 116,070 |
| Other asset | 3,783 | 3,783 |
| Total assets | $85,546 | $148,592 |
| Liabilities and Stockholders’ Deficit | ||
| Current Liabilities: | ||
| Accounts payable and accrued expenses | $663,569 | $546,014 |
| Accrued compensation | 2,003,176 | 1,562,041 |
| Accrued interest | 198,475 | 88,000 |
| Current portion of operating lease liability | 49,609 | 48,213 |
| Note payable | 1,377,778 | - |
| Convertible notes payable, net of discount of $0 | 527,650 | 1,638,760 |
| Note payable, related party | 253,812 | 383,479 |
| Derivative liability | 606,787 | 1,505,398 |
| Total current liabilities | 5,680,856 | 5,771,905 |
| Convertible notes payable, net of discount of $28,275 and $43,288 | 121,725 | 106,712 |
| Operating lease liability, net of current portion | 33,961 | 71,329 |
| Total liabilities | 5,836,542 | 5,949,946 |
| Commitments and Contingencies (Note 8) | - | - |
| Stockholders’ Deficit: | ||
| Series A preferred stock, par value $0.0001; 5,000,000 shares authorized, nil shares issued and outstanding | - | - |
| Common stock, par value $0.0001; 125,000,000 shares authorized; 30,126,413 and 26,526,405 issued and outstanding | 3,012 | 2,652 |
| Additional paid in capital | 18,815,494 | 17,778,498 |
| Receivables for sale of common stock | (75,000) | - |
| Accumulated deficit | (24,494,502) | (23,582,504) |
| Total stockholders’ deficit | (5,750,996) | (5,801,354) |
| Total liabilities and stockholders’ deficit | $85,546 | $148,592 |
STATEMENTS OF OPERATIONS
| For the Three Months Ended | For the Nine Months Ended | |||
|---|---|---|---|---|
| September 30, 2024 | September 30, 2023 | September 30, 2024 | September 30, 2023 | |
| Federal contract revenue · $ · - · $ · - · $ · - · $ · - | ||||
| Expenses: | ||||
| Research and development | 91,911 | 239,458 | 291,655 | 710,063 |
| General and administrative | 401,636 | 1,202,669 | 1,341,271 | 2,625,066 |
| Total operating expenses | 493,547 | 1,442,127 | 1,632,926 | 3,335,129 |
| Operating loss | (493,547) | (1,442,127) | (1,632,926) | (3,335,129) |
| Other Income (Expenses): | ||||
| Interest income | 23 | 161 | 138 | 44,811 |
| (Loss) gain on change in fair value of derivative liability | 9,885 | (34,086) | (53,257) | (15,458) |
| Interest expense | (107,382) | (80,610) | (217,821) | (160,322) |
| Gain (Loss) on extinguishment of debt | - | (217,527) | 951,868 | (887,946) |
| Gain on forgiveness of accrued compensation | - | - | 40,000 | - |
| Total other income (expenses), net | (97,474) | (332,062) | 720,928 | (1,018,915) |
| Net loss | $(591,021) | $(1,774,189) | $(911,998) | $(4,354,044) |
| Net loss per common share: | ||||
| Basic | $(0.02) | $(0.07) | $(0.03) | $(0.16) |
| Diluted | $(0.02) | $(0.07) | $(0.03) | $(0.16) |
| Weighted average number of common stock outstanding: | ||||
| Basic | 31,065,688 | 26,402,153 | 27,829,820 | 26,396,183 |
| Diluted | 31,065,688 | 26,402,153 | 27,829,820 | 26,396,183 |
STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIT
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023
| Common Stock · Additional Paid · Receivables for Sale of Common · Accumulated · Total Stockholders’ | |||||||
|---|---|---|---|---|---|---|---|
| Shares · Amount · in Capital · Stock · Deficit · Deficit | |||||||
| December 31, 2023 | 26,526,405 | $2,652 | $17,778,498 | $ | - | $(23,582,504) | $(5,801,354) |
| Stock-based compensation | - | - | 355,317 | - | - | 355,317 | |
| Issuance of restricted stock units for forgiveness of accrued salary | - | - | 10,000 | - | - | 10,000 | |
| Issuance of stock options for forgiveness of accrued salary | 50,000 | - | - | 50,000 | |||
| Net operating loss | - | - | - | - | (634,100) | (634,100) | |
| March 31, 2024 | 26,526,405 | $2,652 | $18,193,815 | $ | - | $(24,216,604) | $(6,020,137) |
| Stock-based compensation | - | - | 276,983 | - | - | 276,983 | |
| Restricted stock issued for consulting agreements | 3,487,500 | 349 | (349) | - | - | - | |
| Sale of common stock, net of receivables of $75,000 | 112,500 | 11 | 149,989 | (75,000) | - | 75,000 | |
| Reconciling shares due to forward stock split | 8 | - | - | - | - | - | |
| Net operating income | - | - | - | - | 313,123 | 313,123 | |
| June 30, 2024 | 30,126,413 | $3,012 | $18,620,438 | $(75,000) | $(23,903,481) | $(5,355,031) | |
| Stock-based compensation | - | - | 195,056 | - | - | 195,056 | |
| Net operating loss | - | - | - | - | (591,021) | (591,021) | |
| September 30, 2024 | 30,126,413 | $3,012 | $18,815,494 | $(75,000) | $(24,494,502) | $(5,750,996) | |
| Common Stock · Additional Paid · Accumulated · Total Stockholders’ | |||||
|---|---|---|---|---|---|
| Shares | Amount | in Capital | Deficit | Deficit | |
| December 31, 2022 | 26,371,519 | $2,637 | $11,652,094 | $(18,798,815) | $(7,144,084) |
| Stock-based compensation | - | - | 381,501 | - | 381,501 |
| Purchase of common stock | 18,750 | 2 | 24,998 | - | 25,000 |
| Net operating loss | - | - | - | (1,747,250) | (1,747,250) |
| March 31, 2023 | 26,390,269 | $2,639 | $12,058,593 | $(20,546,065) | $(8,484,833) |
| Stock-based compensation | - | - | 350,862 | - | 350,862 |
| Purchase of common stock | 22,500 | 2 | 29,998 | - | 30,000 |
| Net operating loss | - | - | - | (832,605) | (832,605) |
| June 30, 2023 | 26,412,769 | $2,641 | $12,439,453 | $(21,378,670) | $(8,936,576) |
| Stock-based compensation | - | - | 253,013 | - | 253,013 |
| Issuance of restricted stock for forgiveness of accrued salary | - | - | 1,866,445 | - | 1,866,445 |
| Stock issued for amendment to convertible note | 2,323,181 | 2,323,181 | |||
| Net operating loss | - | - | - | (1,774,189) | (1,774,189) |
| September 30, 2023 | 26,412,769 | $2,641 | $16,882,092 | $(23,152,859) | $(6,268,126) |
STATEMENTS OF CASH FLOWS
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023
| September 30, 2024 · September 30, 2023 | ||||
|---|---|---|---|---|
| Cash Flows from Operating Activities: | ||||
| Net Loss | $(911,998) | $(4,354,044) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||
| Loss on change in fair value of derivative liability | 53,257 | 15,458 | ||
| Amortization of debt discounts | 15,013 | 11,671 | ||
| (Gain) Loss on extinguishment of debt | (951,868) | 887,946 | ||
| Gain on forgiveness of accrued compensation | (40,000) | - | ||
| Stock based compensation | 827,357 | 985,376 | ||
| Changes in operating assets and liabilities: | ||||
| Decrease in other current assets | 25,000 | 4,971 | ||
| (Decrease) increase in operating lease right of use asset | (1,151) | 199 | ||
| Increase in accounts payable and accrued expenses | 117,555 | 203,939 | ||
| Increase in accrued compensation | 541,135 | 1,898,095 | ||
| Increase in accrued interest | 110,475 | 26,573 | ||
| Net cash used in operating activities | (215,225) | (319,816) | ||
| Cash Flows from Financing Activities: | ||||
| Proceeds from note payable, related parties | 137,000 | 260,000 | ||
| Proceeds from sale of common stock | 50,000 | 55,000 | ||
| Net cash provided by financing activities | 187,000 | 315,000 | ||
| Net Change in Cash | (28,225) | (4,816) | ||
| Beginning of period | 28,478 | 64,431 | ||
| End of period | $253 | $59,615 | ||
| Supplemental disclosure of cash flow information: | ||||
| Cash paid for interest | $56,891 | $28,128 | ||
| Cash paid for income taxes | $ | - | $ | - |
| Schedule of Non-Cash Investing and Financing Activities: | ||||
| Convertible note issued as a settlement of a previously accrued liability | $ | - | $150,000 | |
| Restricted stock issued for forgiveness of salary | $10,000 | $1,866,445 | ||
| Stock options issued for forgiveness of salary | $50,000 | $2,323,181 | ||
| Note payable, related party assigned to Note payable | $266,667 | $ | - | |
| Receivables from Sale of Common Stock | $75,000 | $ | - | |
Note 1 –Organization and Description of Business
Jupiter Neurosciences, Inc. (the “Company”) is a clinical stage research and development pharmaceutical company located in Jupiter, Florida. The Company incorporated in Delaware in January 2016. The Company has developed a unique resveratrol platform product primarily targeting treatment of neuro-inflammation. The product candidate, called JOTROL, has many potential indications of use for rare diseases, which of we primarily are targeting Mucopolysaccharidoses Type 1, Friedreich’s Ataxia, and MELAS. In the larger disease areas, we are primarily targeting Parkinson’s Disease and Mild Cognitive Impairment/early Alzheimer’s disease
On August 30, 2021, the Company filed a Certificate of Amendment to the Certificate of Incorporation with the State of Delaware to change its name from Jupiter Orphan Therapeutics, Inc. to Jupiter Neurosciences, Inc.
JOTROL has the potential to deliver a therapeutically effective dose of resveratrol in the blood stream, using a unique patented micellar formulation, without causing gastrointestinal side effects. We expect JOTROL, based on the results of our Phase I study, will resolve the major obstacle of resveratrol’s poor bioavailability, which has been documented in various scientific articles describing previously conducted human trials with resveratrol as well as preclinical trial results in mice and rats
The Company’s activities and operations include a project funded by the U.S. National Institute on Aging, an institute of the U.S. National Institutes of Health (“NIH”): Safety and Pharmacokinetics of JOTROL for Alzheimer’s Disease, Federal Award Identification Number R44AG067907-01A1 (the “Award”). The project encompassed a Phase 1 dose finding pharmacokinetics (“PK”) study which was completed before December 31, 2021. The award end date was May 31, 2022. This Phase 1 PK study will be homogeneous for all indications where JOTROL will be used in Phase II and Phase III clinical trials.
On January 9, 2020, the Company effected athree-for-one (3:1) forward stock split whereby the Company (i) increased the number of authorized shares of common stock, $0.0001 par value per share, to 25,000,000 from 5,000,000 and (ii) increased by a ratio of three-for-one (3:1) the number of retroactively issued and outstanding shares of common stock. Proportional adjustments for the forward stock split were made to the Company’s outstanding stock options, warrants and equity incentive plans.
On November 11, 2021, the Company increased the number of authorized shares of common stock, $0.0001 par value per share, to 45,000,000 from 25,000,000.
On January 25, 2022, the Company effected aone-for-two (1:2) reverse stock split whereby the Company (i) decreased the number of issued and outstanding shares of common stock, $0.0001 per share, from 13,076,608 to 6,538,304 and (ii) decreased by a ratio of one-for two (1:2) the number of retroactively issued and outstanding shares of common stock. Proportional adjustments for the reverse stock split were made to the Company’s outstanding stock options, warrants and equity incentive plans. All share and per-share data and amounts have been retroactively adjusted as of the earliest period presented in the financial statements to reflect the reverse stock split.
On June 14, 2024, the Company increased the number of authorized shares of common stock, $0.0001 par value per share, to 125,000,000 from 45,000,000.
On June 14, 2024, the Company effected afifteen-for-four (15:4) forward stock split whereby the Company (i) increased the number of issued and outstanding shares of common stock, $0.0001 par value per share, from 8,033,706 to 30,126,413 and (ii) increased by a ratio of fifteen-for-four (15:4) the number of retroactively issued and outstanding shares of common stock. Proportional adjustments for the forward stock split were made to the Company’s outstanding stock options, warrants and equity incentive plans. All share and per-share data and amounts have been retroactively adjusted as of the earliest period presented in the financial statements to reflect the forward stock split.
Note 2 –Significant Accounting Policies
Basis of presentation
The accompanying unaudited interim condensed financial statements reflect all adjustments (which are normal and recurring) that are necessary for a fair presentation of the financial position of the Company and its results of operations and cash flows for the periods presented. The unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2023, included in the Company’s registration Statement filed with the SEC on September 13, 2024.
The results disclosed in the statements of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for the full fiscal year 2024.
The financial statements of the Company have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). For the nine months ended September 30, 2024 and 2023, the Company hadno revenues from product sales and incurred a net loss of $911,998 and $4,354,044, respectively. Net cash used in operations for nine months ended September 30, 2024 and 2023 was $215,225 and $319,816, respectively. As of September 30, 2024, the Company had a working capital deficit and accumulated deficit of $5,680,342 and $24,494,502, respectively.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from such estimates.
Federal Contract Revenue
The Company recognizes federal contract revenue from the NIH Award in the period in which the allowable research and development expenses are incurred, and receivables associated with this revenue are included within federal contract revenue receivable on our balance sheets. This revenue is not within the scope of Accounting Standards Codification (ASC) 606 – Revenue from contracts with customers.
Federal Contract Receivable
Federal contract receivable represents amounts due to us under the NIH Award for valid expenditures expected to be reimbursed to us under the terms of the NIH contract.
Cash
The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. As of September 30, 2024 and December 31, 2023, the Company invested a portion of cash balances in a high yield savings account, which are included as cash equivalents on the balance sheets. As of September 30, 2024 and December 31, 2023, the cash balances did not exceed the FDIC limit of $250,000.
Other Current Assets and Prepaid Expenses
Other current assets and prepaid expenses generally represent payments made for goods or services to be received within one year and are expensed as the related benefit is received.
Research and Development
Research and development costs are expensed as incurred. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, monitoring visits, clinical site activations, or information provided to us by our vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as the case may be. Total research and development costs for the three months ended September 30, 2024, and 2023 were $91,911 and $239,458, respectively. Total research and development costs for the nine months ended September 30, 2024, and 2023 were $291,655 and $710,063, respectively.
Income Taxes
The Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of our assets and liabilities and the expected benefits of net operating loss carryforwards. The impact of changes in tax rates and laws on deferred taxes, if any, applied during the years in which temporary differences are expected to be settled, is reflected in the financial statements in the period of enactment. The measurement of deferred tax assets is reduced, if necessary, if, based on weight of the evidence, it is more likely than not that some, or all, of the deferred tax assets will not be realized. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. As of September 30, 2024 and December 31, 2023, the Company concluded that a full valuation allowance is necessary for the net deferred tax assets. The Company had no material amounts recorded for uncertain tax positions, interest or penalties in the accompanying financial statements. The Company is subject to taxation in the U.S. Our tax years for 2021 and forward are subject to examination by tax authorities. The Company is not currently under examination by any tax authority.
Loss Per Share of Common Stock
Basic loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding during each period. Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as convertible preferred stock, convertible notes payable, warrants, stock options, and unvested restricted stock, which would result in the issuance of incremental shares of common stock, as calculated using the treasury method. In computing the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remains the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation.
As of September 30, 2024, there were 1,359,375 warrants outstanding,1,626,037 restricted stock units and 10,633,988 stock options and 13 convertible notes payable, which are convertible into restricted fully-paid and non-assessable shares of the Company’s common stock or units of common stock and warrants to purchase common stock, if units are offered in the Initial Public Offering equal to the indebtedness divided by 70% of the offering price paid per share of at which the IPO is made. Such securities are considered dilutive securities which were excluded from the computation since the effect is anti-dilutive.
As of December 31, 2023, there were 1,359,375 warrants outstanding,1,618,537 restricted stock units, and 10,336,882 stock options and 14 convertible notes payable, which are convertible into restricted fully-paid and non-assessable shares of the Company’s common stock or units of common stock and warrants to purchase common stock, if units are offered in the Initial Public Offering equal to the indebtedness divided by 70% of the offering price paid per share of at which the IPO is made.
Stock-Based Compensation
The Company accounts for stock-based compensation in accordance with the provisions of Accounting Standards Codification (“ASC”) Topic 718, Compensation—Stock Compensation, or ASC 718, which requires the recognition of expense related to the fair value of stock-based awards in the statements of operations. For stock options issued to employees, non-employees and members of our board of directors, the Company estimates the grant-date fair value of options using the Black-Scholes option pricing model. The use of the Black-Scholes option pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the expected life of the option, risk-free interest rates, and, for grants prior to our initial public offering, the value of the common stock. For awards subject to time-based vesting, the Company recognized stock-based compensation expense, on a straight-line basis over the requisite service period, which is generally the vesting term of the award.
Clinical Trial Expenses
As part of the process of preparing our financial statements, the Company is required to estimate expenses resulting from obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate trial expenses in the financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company determines accrual estimates based on estimates of services received and efforts expended that take into account discussion with applicable personnel and outside service providers as to the progress or state of consummation of trials. During the course of a clinical trial, the Company adjusts the clinical expense recognition if actual results differ from its estimates. The Company makes estimates of the accrued expenses as of each balance sheet date based on the facts and circumstances known at that time. The clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect the estimates to be materially different from amounts actually incurred, understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low for any particular period.
Fair Value of Financial Instruments and Fair Value Measurements
The Company measures its financial assets and liabilities in accordance with US GAAP. For certain financial instruments, including cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities, the carrying amounts approximate fair value due to their short maturities. Amounts recorded for notes payable, net of discount, and loans payable also approximate fair value because current interest rates available for debt with similar terms and maturities are substantially the same.
The Company follows accounting guidance for financial assets and liabilities. This standard defines fair value, provides guidance for measuring fair value and requires certain disclosures. This standard does not require any new fair value measurements, but rather applies to all other accounting pronouncements that require or permit fair value measurements. This guidance does not apply to measurements related to share-based payments. This guidance discusses valuation techniques, such as the market approach (comparable market prices), the income approach (present value of future income or cash flow), and the cost approach (cost to replace the service capacity of an asset or replacement cost).
Fair Value of Financial Instruments and Fair Value Measurements, continued
The guidance utilizes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value into six broad levels. The following is a brief description of those three levels:
Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities.
Level 2: Inputs, other than quoted prices that are observable, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.
Level 3: Unobservable inputs in which little or no market data exists, therefore developed using estimates and assumptions developed by us, which reflect those that a market participant would use.
The following table represents the Company’s financial instruments that are measured at fair value on a recurring basis at each reporting period for each fair value hierarchy level:
| Derivative Liability 09/30/2024 | Derivative Liability 12/31/2023 | |
|---|---|---|
| Level I · $ · - · $ · - | ||
| Level II · $ · - · $ · - | ||
| Level III | $606,787 | $1,505,398 |
| Total | $606,787 | $1,505,398 |
Also see Note 5 - Convertible Debt and Derivative Liability.
Derivative Instruments
ASC Topic 815, Derivatives and Hedging (“ASC Topic 815”), establishes accounting and reporting standards for derivative instruments and for hedging activities by requiring that all derivatives be recognized in the balance sheet and measured at fair value. Gains or losses resulting from changes in the fair value of derivatives are recognized in earnings. On the date of conversion or payoff of debt, the Company records the fair value of the conversion shares, removes the fair value of the related derivative liability, removes any discounts and records a net gain or loss on debt extinguishment. On January 1, 2020 the Company adopted ASU 2017-11 under which down-round Features in Financial Instruments will no longer cause derivative treatment. The Company applies the modified prospective method of adoption. There were no cumulative effects on adoption.
Convertible Notes with Embedded Derivative Liabilities
The Company has entered into convertible notes, some of which contain variable conversion options, whereby the outstanding principle and accrued interest may be converted, by the holder, into shares of common stock at a fixed discount to the price of the common stock at or around the time of conversion upon certain trigger events. The Company evaluates all its financial instruments to determine if those contracts or any potential embedded components of those contracts qualify as derivatives to be separately accounted for in accordance with ASC 815-10*– Derivative and Hedging – Contract in Entity’s Own Equity*. This accounting treatment requires that the carrying amount of any derivatives be recorded at fair value at issuance and marked-to-market at each balance sheet date. In the event that the fair value is recorded as a liability, as is the case with the Company, the change in the fair value during the period is recorded as either other income or expense. Upon conversion, exercise or repayment, the respective derivative liability is marked to fair value at the conversion, repayment, or exercise date and then the related fair value amount is reclassified to other income or expense as part of gain or loss on debt extinguishment.
Leases
In February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-02, Leases (Topic 842). The updated guidance requires lessees to recognize lease assets and lease liabilities for most operating leases. In addition, the updated guidance requires that lessors separate lease and non-lease components in a contract in accordance with the new revenue guidance in ASC 606.
Operating lease ROU assets represents the right to use the leased asset for the lease term and operating lease liabilities are recognized based on the present value of future minimum lease payments over the lease term at commencement date. As most leases do not provide an implicit rate, the Company use an incremental borrowing rate based on the information available at the adoption date in determining the present value of future payments. Lease expense for minimum lease payments is amortized on a straight-line basis over the lease term and is included in general and administrative expenses in the statements of operations.
Recent Accounting Pronouncements
The Company has reviewed the FASB issued ASU accounting pronouncements and interpretations thereof that have effectiveness dates during the periods reported and in future periods. The Company has carefully considered the new pronouncements that alter previous generally accepted accounting principles and do not believe that any new or modified principles will have a material impact on the Company’s reported financial position or operations in the near term. The applicability of any standard is subject to the formal review of the Company’s financial management.
In August 2020, the FASB 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. The ASU simplifies accounting for convertible instruments by removing major separation models required under current GAAP. Consequently, more convertible debt instruments will be reported as a single liability instrument with no separate accounting for embedded conversion features. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception, which will permit more equity contracts to qualify for the exceptions. The ASU also simplifies the diluted net income per share calculation in certain areas. The new guidance is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years, and early adoption is permitted. The Company’s adoption of this standard did not have a material impact on the Company’s financial statements.
All other newly issued accounting pronouncements that are not yet effective have been deemed immaterial or nonapplicable.
Note 3 – Related Party Transactions
During the nine months ended September 30, 2024, the Company’s CEO loaned the Company an additional $137,000. The loans are due on demand and accrue interest at 3% per year.
The Company’s Chief Executive Officer (CEO) has loaned the Company working capital since inception. The balance of the loans to the CEO as of September 30, 2024 and December 31, 2023 was $228,812 and $358,479, respectively. The loan is due on demand and accrues interest at 3% per year. Accrued interest relating to the loan was $17,644 and $11,308 as of September 30, 2024 and December 31, 2023, respectively, and is included in accrued interest on the accompanying balance sheets.
During the year ended December 31, 2023, an employee loaned the Company $25,000. The balance of the loan as of September 30, 2024 and December 31, 2023, was $25,000. The loan is due on demand and accrues interest at 3% per year. Accrued interest related to the loan was $1,288 and $723 as of September 30, 2024 and December 31, 2023, respectively, and is included in accrued interest on the accompanying balance sheet.
Accrued compensation includes partially accrued salaries to executives since inception. Since inception, executive salaries have been paid in cash when the Company’s cash flow has permitted such payment. During 2020, the Company began consistently paying salaries at 50% of the salaries reflected in the respective employment agreements. As of September 2021, the Company began paying full salaries. Throughout 2022, the Company returned to paying partial salaries and by November 2022 the Company stopped paying salaries 100% in an effort to conserve cash.
On September 29, 2023, various employees and board members agreed to forgive accrued compensation in the amount of $4,189,626. In exchange of the forgiveness the Company issued an aggregate of 2,353,661 stock options with an exercise price of $1.33 and an aggregate of 1,399,834 restricted stock units with a grant date value of $1.33 in exchange for the aggregate forgiveness of compensation in the amount of $4,189,626. Additionally, the Company agreed to a bonus of $513,013 for the employees and a bonus of $70,200 to the board members, to be paid upon the occurrence of a successful IPO in exchange for the forgiveness of the afore-mentioned accrued compensation.
On December 18, 2023, various employees and board members agreed to amend the accrued compensation debt forgiveness dated September 29, 2023. Pursuant to the amendment the cash bonuses of $513,013 for the employees and a bonus of $70,200 to the board members agreed to on September 29, 2023, were forgiven, and no cash will be paid upon a successful IPO. In addition, the options issued in connection with the forgiveness dated September 29, 2023, have been amended to vest fully on the effective date of the new amendment. In addition, the restricted stock unit issued in connection with the forgiveness dated September 29, 2023, were terminated and replaced with 1,399,834 restricted stock units that vest upon the earlier occurrence of the initial public offering or a change of control of the Company. In exchange for the forgiveness of the accrued bonuses the Company issued an aggregate of 289,294 stock options with an exercise price of $1.33 and an aggregate of 218,703 restricted stock units with a grant date value of $1.33 in exchange for the aggregate forgiveness of compensation in the amount of $583,213.
On March 15, 2024, a former executive agreed to forgive $100,000 of accrued compensation in exchange for 49,605 options to purchase common stock and 7,500 restricted stock units, The options to purchase common stock have a strike price of $1.33. The option had a grant date fair value of $50,000. The Company recorded a gain on the forgiveness of accrued compensation in the amount of $40,000.
Note 3 – Related Party Transactions, continued
On April 29, 2024, the Company, the Holder of the Note II and the CEO entered into an amendment in which the CEO agrees to exchange 685,867 shares issued to the Holder in exchange for his related party notes that accrued interest at 3%that are due from the Company in an aggregate principal amount of $266,667 and the Holder agreed to forfeit all rights to all additional future shares from the Company that would of become due upon a qualified offering as well as the conversion option. Therefore, the principal amount of the note was increased to $1,377,778 and the exchange debt follows the requirements of Note II. See Note 5 – Convertible Debt and Derivative liability – Senior Secured Note – Formerly known as the Convertible Debt I for more details.
Note 4 –Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses consisted of the following:
| September 30, 2024 | December 31, 2023 | |
|---|---|---|
| Accounts payable | $205,795 | $189,495 |
| Professional fees | 219,927 | 174,053 |
| License fee | 206,250 | 150,000 |
| Credit cards | 31,597 | 32,466 |
| Total accounts payable and accrued expenses | $663,569 | $546,014 |
As of September 30, 2024 and December 31, 2023, $153,900 and $67,750, respectively, was due to a Company wholly owned by the Company’s Chief Financial Officer, who also is an option holder. The amount is included in accrued compensation on the Company’s balance sheets.
Accrued compensation of $2,003,176 and $1,562,041 as of September 30, 2024 and December 31, 2023, respectively, includes accrued salaries and health benefits to executives since inception and board fees. Since inception, executive salaries have been paid in cash when the Company’s cash flow has permitted such payment. During 2020, the Company began consistently paying salaries at 50% of the salaries reflected in the respective employment agreements. As of September 1, 2021, the Company began paying full salaries. Throughout 2022, the Company returned to paying partial salaries and by November 2022 the Company stopped paying salaries 100% in an effort to conserve cash. Starting the fourth quarter of 2023 the Company’s executives agreed to reduce their salaries with 80% until an initial public offering. See Note 3 – Related Party Transactions for details related to forgiveness of accrued compensation.
Note 5 –Convertible Debt and Derivative Liability
Convertible Debt I
Between August and December 2021, the Company executed twelve convertible promissory notes (“Notes I”) for $527,650 in proceeds with a maturity date of July 31, 2022, and interest rate of 1%. The Notes I will automatically convert into equity securities on the first business day following effectiveness of an initial public offering of common stock with the Securities and Exchange Commission (“IPO”). Upon IPO, the outstanding principle of the Notes I and all unpaid accrued interest will automatically convert into a number of restricted fully paid and non-assessable shares of common stock, or units of common stock and warrants to purchase common stock if units are offered to the public in the IPO, equal to the indebtedness divided by 70% of the offering price paid per share at which the IPO is made. For the avoidance of doubt, in the event the IPO is not declared effective prior to the maturity date, none of the indebtedness shall convert or be convertible into shares of Common Stock.
Convertible Debt I, continued
At the time of execution, the Company recorded a debt discount of $257,650 based on the fair value of the embedded conversion feature of Notes I, which was amortized into interest expense over term of Notes I, each with a maturity date of July 31, 2022. On August 6, 2022, the Notes I were amended to extend the maturity date to January 31, 2023, and increase the interest rate to 5%. All other terms remain the same as previously stated in Notes I. The impact of the amendment is prospective and increased accrued interest by $23,072 and is included in accrued interest on the accompanying balance sheet. On February 2, 2023, the Notes I were amended to extend the maturity date to December 31, 2023. During January 31, 2024, the Company and all Note I holders agreed to amend and extend the maturity date of their notes to December 31, 2024. The holders waived any default under the original notes prior to the amendment date. With the amendments the applicable interest rate to Notes I increased to 10% effective from January 1, 2024. The amendments were accounted for as a modification and not an extinguishment of debt, therefore there was no gain recorded in the statement of operations.
See Note 9 – Subsequent events – Convertible Debt I for the subsequent conversion of the Note I upon the closing of the offering.
Senior Secured Note – Formerly Known as the Convertible Debt I
The Note - On April 11, 2022, the Company entered into a securities purchase agreement with an accredited investor (the “Holder”). Pursuant to the terms of the securities purchase agreement, the Company received aggregate gross proceeds of $1,000,000, less loan origination costs of $22,667, and issued a (i)10% original issue discount senior secured convertible note (the “Note II”) in the principal amount of $1,111,111 and (ii)514,403 shares of common stock.
The Company will have the right at any time to redeem in cash all or a portion of Note II at 120% (or 125% on or after the first six months from the closing) of the principal amount thereof plus any unpaid accrued interest to the date of repayment.
Pursuant to the terms of the securities purchase agreement, the Company received aggregate gross proceeds of $1,000,000, less loan origination costs of $22,667, and issued a (i)10% original issue discount senior secured convertible note (the “Note II”) in the principle amount of $1,111,111 and (ii)514,403 shares of common stock.
Upon an Event of Default (as defined therein) interest shall accrue at 1 1/2% per month and the 125% of principal and interest through maturity shall be due and payable. At the Holder’s option the Holder shall be entitled to be paid in cash or after the Qualified Offering (as defined in the Purchase Agreement) common stock with the conversion price of the common stock equal to a 30% discount to the lowest closing price of the common stock for the 20 prior trading days.
On October 10, 2022, Note II was amended to postpone the commencement of the principal payments from October 11, 2022 to November 11, 2022. As consideration for the amendment, an additional 42,867 shares of common stock were issued to the Holder on October 10, 2022, valued at 1/12 th of the original 514,403 shares issued at commencement of Note II.
On November 10, 2022, Note II was amended to postpone the commencement of the principle from November 11, 2022 to February 11, 2023 and payable in three monthly installments. An additional 128,599 shares of common stock were issued to the Holder on November 10, 2022, value at 1/4 th of the original 514,403 shares issued at commencement of Note II.
Senior Secured Note – Formerly Known as the Convertible Debt II, continued
On February 6, 2023, Note II was amended to postpone the commencement of the principle to February 28, 2023. On March 6, 2023, Note II was amended to postpone the commencement of the principal from February 11, 2023 to May 31, 2023. The Company and the noteholder agreed to a repayment plan on past due interest. In addition, the Company agreed to prepay in cash the aggregate principal amount of the Note II of 120% (or 137.5% on or after the first six months from closing) plus any accrued interest on the sale of all the assets of the Company and its subsidiaries, upon the Change of Control, or on a Qualified Offering. Upon default of Note II, the Company agrees to pay 137.5% of the outstanding note principal, and accrued interest through maturity and all liquidation damages. As a result of the material modification, the incremental fair value of the modified derivative was classified as a debt extinguishment. Due to the extension of the maturity date of the convertible note, the fair value of the derivative liability increased. This resulted in the Company recording a loss on extinguishment of debt of $670,419.
On September 22, 2023, Note II was amended to postpone the commencement of the principle to December 31, 2023. The Company and the noteholder agreed to a repayment plan on past due interest. In addition, the Company agreed to prepay in cash the aggregate principal amount of the Note II of 120% (or 150% on or after the first six months from closing) plus any accrued interest on the sale of all the assets of the Company and its subsidiaries, upon the Change of Control, or on a Qualified Offering. Upon default of Note II, the Company agrees to pay 150% of the outstanding note principal and accrued interest through maturity and all liquidation damages. In addition, upon closing the Note Holder will receive 175% stock coverage. As a result of the material modification, the incremental fair value of the modified derivative was classified as a debt extinguishment. Due to the extension of the maturity date of the convertible note, the fair value of the derivative liability increased. This resulted in the Company recording a loss on extinguishment of debt of $217,527.
On April 29, 2024, the Company, the Holder of the Note II and the CEO entered into an amendment in which the CEO agrees to exchange 685,867 shares issued to the Holder in exchange for his related party notes that accrued interest at 3% that are due from the Company in an aggregate principal amount of $266,667 and the Holder agreed to forfeit all rights to all additional future shares from the Company that would of become due upon a qualified offering as well as the conversion option. Therefore, the principal amount of the note was increased to $1,377,778 and the exchange debt follows the requirements of Note II. In addition, the Holder agreed to extend the note maturity date to August 11, 2024. The note shall be designated as a 10% original issued discount secured note (“Senior Secured Note”) moving forward. The Senior Secured Note and interest will become due and payable upon the earliest of the maturity date or upon the occurrence of a qualified event. The note is recorded on the balance sheet under note payable. As a result of the conversion feature of the note being removed the Company recorded a one-time gain on the modification of the debt of $951,868 and a new derivative liability of $407,494 was recorded related to the Senior Secured Note.
On August 8, 2024, the Company, and the Holder of the Senior Secured Note entered into an amendment to extend the maturity date of the Senior Secured Note to October 11, 2024. See Note 9 – Subsequent Events – Senior Secured Note – Formerly Known as the Convertible Debt II for the subsequent extension and repayment of the Senior Secured Note.
Ancillary Agreements - In connection with the Company’s obligations under Note II, the Company entered into a security agreement and intellectual property security agreement with the Holder, pursuant to which the Company granted a security interest on all assets of the Company, including all intellectual property of the Company, for the benefit of the Holders, to secure the Company’s obligations under Note II and the other transaction documents.
Convertible Debt III
On March 1, 2023, the Company issued a convertible promissory note (the “Note III”) with a principal amount of $150,000 as part of a settlement agreement with an investor relations firm. Note III matures on February 28, 2026 and accrues interest at 5% annually which compounds quarterly. Note III is convertible upon election of the holder upon a qualified financing of at least $5,000,000 into shares of common stock equal to 70% of the per share price of the equity issued in the qualified financing. Note III is also convertible upon the completion of an IPO by the Company into shares of common stock equal to 70% of the per share price of the equity issued in connection with the IPO. In both cases the Holder can elect to receive the principal and accrued interest instead of converting the note.
During the three months ended September 30, 2024 and 2023, $96,924 and $36,546, respectively, are included in interest expense for the combined convertible Notes I, II and III on the accompanying statements of operations. During the nine months ended September 30, 2024 and 2023, $186,906 and $107,214, respectively, are included in interest expense for the combined convertible Notes I, II and III on the accompanying statements of operations. As of September 30, 2024 and December 31, 2023 the balance of the combined convertible promissory Note I, II and III was $649,375 and $1,745,472, respectively, net of the debt discount and loan origination costs of $28,275 and $43,288, respectively. As of September 30, 2024 the balance on the Senior Secured Debt was $1,377,778.
See Note 9 – Subsequent Events – Convertible Debt III for the subsequent repayment of the Note III.
Derivative Liability Pursuant to Convertible Debt
In connection with the issuance of the Notes, the Company determined that the terms of Notes contain an embedded conversion option to be accounted for as a derivative liability due to the Holder having the potential to gain value upon IPO. Accordingly, under the provisions of ASC 815-40 –Derivatives and Hedging – Contracts in an Entity’s Own Stock, the embedded conversion option contained in Notes was accounted for as derivative liability and debt discount at the date of issuance and has been adjusted to fair value through earnings at each reporting date. The fair value of the embedded conversion option was determined using the Monte Carlo valuation model.
In connection with the issuance of Notes I, on the initial measurement date of September 2021, the fair value of the embedded conversion option of $257,650 was recorded as derivative liability and debt discount to be amortized into interest expense over the terms of the Notes.
In connection with the issuance of Note II, on the initial measurement date of April 2022, the fair value of the embedded conversion option of $346,000 and the fair value of the Share True Up of $34,000 was recorded as derivative liability and a debt discount to be amortized into interest expense over the term of Note II. An additional discount of $421,111 was recorded on the initial measurement date for the 10% original issue discount of $111,111 and the relative fair value of the allocation of proceeds to the 514,403 shares of common stock issued, valued at $310,000, to be amortized into interest expense over the term of Note II.
Derivative Liability Pursuant to Convertible Debt, continued
During the three and nine months ended September 30, 2023, the derivative liabilities were revalued, and a $217,527 and $887,946, respectively, adjustment was recorded as a loss on extinguishment of debt to other expenses reflected in the accompanying statements of operations.
During the three and six months ended September 30, 2024, the derivative liability was revalued, and a $0 and $951,868, respectively, gain was recorded on the modification of the Note II, now known as the Senior Secured Note, with in other income in the accompanying statements of operations.
The Company also recorded a $9,885 and $(34,086), adjustment as a gain (loss) on the change in the fair value of the derivative liability for the three months ended September 30, 2024 and 2023. The Company also recorded a $(53,257) and $15,458,adjustment as a (loss) on the change in the fair value of the derivative liability for the nine months ended September 30, 2024 and 2023.
The fair value of the derivative liability of Notes I, Note II and Note III was estimated using the Monte Carlo Valuation model at issuance and each reporting period with the following assumptions:
| NOTE III | NOTES I, II & III | NOTES I, II & III | |
|---|---|---|---|
| March 1, 2023 (Issuance) | December 31, 2023 | September 30, 2024 | |
| Dividend Rate | - | - | - |
| Term | 0.25 | 0.25 | 0.13 |
| Volatility | 90% | 90% | 90% |
| Risk-free rate | N/A | 4.70% | 5.00% |
| Probability of IPO | 60% | 60% | 60% |
A summary of activity of the derivative liability pertaining to the Notes is presented below:
| Derivative Liability | |
|---|---|
| Balance at December 31, 2022 | $710,599 |
| Fair value at issuance March 1, 2023 | 55,604 |
| Fair value on date of amendment, net | 887,946 |
| Fair value change | (148,751) |
| Balance at December 31, 2023 | $1,505,398 |
| Fair value change | 53,257 |
| Extinguishment of derivative liability - Note II | (1,359,362) |
| Fair value at issuance on April 29, 2024 - Senior Secured Note | 407,494 |
| Balance at September 30, 2024 | $606,787 |
Note 6 –Stockholders’ Deficit
Common Stock
The Company is authorized to issue 125,000,000 shares of common stock and 5,000,000 shares of preferred stock. The Company had 30,126,413 shares of common stock issued and outstanding as of September 30, 2024. There wasno preferred stock issued and outstanding as of September 30, 2024.
On June 3, 2024, the Company entered into a three 36-month service agreement with three different entities. The Company issued an aggregate of 3,487,500 restricted shares of common stock,1,162,500 restricted shares of common stock to each entity. The shares will be registered upon an IPO as long as an IPO happens no later than March 31, 2025. In addition, each of the entities agreed to purchase 37,500 shares each of the Company’s common stock at a price of $1.33 per share prior to the occurrence of the IPO. As of September 30, 2024, the Company issued 37,500 common stock and the Company received an aggregate of $75,000 for the sale of the Company’s common stock. See Note 9 – Subsequent events for cash received subsequent to September 30, 2024 related to the sale of the Company’s common stock. These shares will also be registered upon an IPO as long as an IPO happens no later than March 31, 2025. Either party is able to terminate the respective agreement with no liability upon the occurrence of i) the Company failing to raise at least $10 million in gross proceeds from an IPO prior to May 31, 2025, ii) if either party is involved in any illegal activity or iii) at any time as long as both parties agree to it. The Company has the obligation to register the shares upon the occurrence of an IPO. Therefore, until the obligations are met the aggregate value of $4,638,375 related to the 3,487,500 restricted shares will not be recognized by the Company. Once the obligations are met the Company will recognize compensation expense from the effective date of the agreement through the date the obligations are met with the remaining expense being amortized over the remaining term of the 36-months per the services agreements. If the obligations were met as of September 30, 2024, the Company would have recorded compensation expense for services provided of $504,077.
See Note 8 – Commitment and Contingencies – Service agreements for details related to sale of common stock per the service agreements.
Stock Options
The Company grants stock awards to officers, employees, directors, and other key persons pursuant to its 2021 Equity Incentive Plan (“the Plan”).
During the three and nine months ended September 30, 2024 the Company recognized stock-based compensation of $195,056 and $827,356, respectively, related to vested stock options. There was $466,416 unvested stock options expense as of September 30, 2024.
On January 1, 2023, the Company granted a non-qualified stock option to purchase 562,500 shares of Common Stock to our Chief Financial Officer, at an exercise price of $1.33 per share. The option had a grant date fair value of $589,500.
On April 1, 2023, the Company granted non-qualified stock option to purchase an aggregate of 562,500 shares of Common Stock to an employee and consultants, at an exercise price of $1.33 per share. The options had an aggregate grant date fair value of $577,500.
On January 24, 2024, the Company granted 180,000 stock options to a consultant with an exercise price of $1.33 per share. The option had a grant date fair value of $190,560.
On April 17, 2024, the Company granted 67,500 stock options to a consultant with an exercise price of $1.33 per share. The option had a grant date fair value of $73,459.
Note 6 – Stockholders’ Deficit, continued
Stock Options, continued
See Note 3 – Related Party Transactions above for details related to options issued for forgiveness of accrued salaries.
A summary of activity for the nine months ended September 30, 2024 is presented below:
| Number of Options | Weighted Average Exercise Price | Weighted Average Contractual Term (Years) | Aggregate Intrinsic Value | |
|---|---|---|---|---|
| Outstanding as of December 31, 2023 | 10,336,883 | $1.00 | 7.41 | $3,316,119 |
| Granted | 297,105 | 1.33 | ||
| Exercised | - | - | ||
| Forfeited | - | - | ||
| Outstanding as of September 30, 2024 | 10,633,988 | $1.02 | 6.25 | $3,316,141 |
| Exercisable as of September 30, 2024 | 10,186,012 | $1.01 | 6.15 | $3,316,141 |
The following table summarized information about employee stock options outstanding as of September 30, 2024:
| Outstanding Options · Vested Options | ||||
|---|---|---|---|---|
| Exercise Price | Number Outstanding at September 30, 2024 | Weighted Average Remaining Life | Number Exercisable at September 30, 2024 | Weighted Average Remaining Life |
| $0.01 | 675,000 | 1.25 | 675,000 | 1.25 |
| $0.74 | 1,657,560 | 4.32 | 1,657,562 | 4.32 |
| $0.80 | 2,783,243 | 4.54 | 2,783,238 | 4.54 |
| $1.33 | 5,461,935 | 8.33 | 5,013,962 | 8.31 |
| $2.16 | 56,250 | 6.71 | 56,250 | 6.71 |
| 10,633,988 | 6.25 | 10,186,012 | 6.15 | |
Warrants
The following is a summary of the Company’s warrant activity for the nine months ended September 30, 2024:
| Number of Shares | Weighted Average Exercise Price per Share | Weighted Average Remaining Life (Years) | |
|---|---|---|---|
| Outstanding as of December 31, 2022 | 1,359,375 | $0.80 | 2.93 |
| Granted | - | - | - |
| Forfeited | - | - | - |
| Outstanding as of December 31, 2023 | 1,359,375 | $0.80 | 1.93 |
| Granted | - | - | - |
| Forfeited | - | - | - |
| Outstanding as of September 30, 2024 | 1,359,375 | $0.80 | 1.18 |
Note 6 – Stockholders’ Deficit, continued
Restricted Stock Units
On September 29, 2023, the Company issued an aggregate of 1,399,834 restricted stock units with a grant date value of $1.33 per unit in exchange for the forgiveness of accrued compensation. Pursuant to the amendment dated December 18, 2023, the restricted stock units shall vest on the on earlier event of either the occurrence of an initial public offering or in the event of change of control of the Company. The restricted stock units have an aggregate grant date fair value of $1,866,445.
On December 18, 2023, the Company terminated 1,399,384 restricted stock units and issued an aggregate of 1,618,537 restricted stock units with a grant date value of $1.33 in exchange for the forgiveness of accrued compensation. The restricted stock units shall vest on the earlier event of either the occurrence of an initial public offering or in the event of change of control of the Company. The restricted stock units have an aggregate grant date fair value of $2,158,050.
On March 15, 2024, the Company issued 7,500 restricted stock units with a grant date value of $1.33 per unit in exchange for the forgiveness of accrued compensation. The restricted stock units shall vest on the earlier event of either the occurrence of an initial public offering or in the event of change of control of the Company.
As of September 30, 2024, the Company had an aggregate of 1,626,037 restricted stock units outstanding with an aggregate fair value of $2,195,550.
Note 7 –Concentrations
The Company’s grant revenues and grant receivables are from the NIH Award. The Company expects to maintain the relationship with the NIH.
Note 8 –Commitments and Contingencies
Legal Matters
From time to time, claims are made against the Company in the ordinary course of business, which could result in litigation. Claims and associated litigation are subject to inherent uncertainties and unfavorable outcomes could occur, such as monetary damages, fines, penalties or injunctions prohibiting the Company from selling one or more products or engaging in other activities. The occurrence of an unfavorable outcome in any specific period could have a material adverse effect on the Company’s results of operations for that period or future periods.
On July 19, 2022, Tiberend Strategic Advisors (“Tiberend”), an entity that the Company had previously engaged as a communications and investor relations firm, filed a summons for civil action in the District Court of Southern Florida against the Company alleging non-payment by the Company under a services agreement (the “Services Agreement”) with Tiberend in the amount of $130,400. The Company and Tiberend entered into a full settlement and release agreement in exchange for a $150,000 convertible promissory note in March 2023. See Note 5 – Convertible Debt and Derivative Liability – Convertible Debt III for details associated with the note issuance.
Office Lease
On May 1, 2021 the Company entered into an 61 month operating lease for office space for a base rent of $3,783 subject to a 3% yearly escalation. The Company adopted ASC Topic 842, Leases upon inception of the lease. As of September 30, 2024, the Company’s Operating lease right-of-use asset, net (ROU) is $81,249 and total lease liability is $83,570 based on an incremental borrowing rate of 0.81% at lease inception. As of December 31, 2023, the Company’s Operating lease right-of-use asset, net (ROU) is $116,070 and total lease liability is $119,542 based on an incremental borrowing rate of 0.81% at lease inception.
** Office Lease, continued**
| September 30, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| Operating lease right-of-use asset (“ROU”) is summarized below: | ||
| Office lease ROU | $236,009 | $236,009 |
| Less accumulated reduction | (154,760) | (119,939) |
| Balance of ROU, net | $81,249 | $116,070 |
| Operating lease liability related to the ROU asset is summarized below: | ||
| Office lease liability | $236,009 | $236,009 |
| Reduction of lease liability | (152,439) | (116,467) |
| Total | $83,570 | $119,542 |
Future minimum lease liability payments under non-cancelable operating lease at September 30, 2024 and December 31, 2023 are as follows:
| 2024 | 12,402 | 49,004 |
| 2025 | 50,476 | 50,476 |
| 2026 | 21,290 | 21,290 |
| Total lease payments | 84,168 | 120,770 |
| Less: imputed interest | (598) | (1,228) |
| Total lease liabilities | $83,570 | $119,542 |
| Current operating lease liabilities | 49,609 | 48,213 |
| Non-current operating lease liabilities | 33,961 | 71,329 |
| Total lease liabilities | $83,570 | $119,542 |
On October 1, 2021, the Company entered into a month-to-month lease for office space in Charlestown, MA.
Rental expenses of $2,332 and $4,295 for the three months ended September 30, 2024 and 2023, respectively, are included in general and administrative expenses on the accompanying statement of operations. Rental expenses of $15,407 and $15,121 for the nine months ended September 30, 2024 and 2023, respectively, are included in general and administrative expenses on the accompanying statement of operations.
Consulting Agreements
The Company utilizes various consultants and advisors for clinical research, scientific advisory services and business strategies. Each consultant has an executed agreement in place defining term, compensation, duties, confidentiality, intellectual property. The majority of the agreements have a 2-year term. Agreements are evaluated for renewal upon expiration. Bonus provisions are at the discretion of the Company’s Board of Directors and are granted on an individual agreement basis.
Executive Employment Agreements
The Company’s standard executive employment agreements have a stated term of six years. Per the agreements, employees are eligible for a discretionary annual performance bonus, determined by the Board of Directors. If the Company terminates an employee without cause, the employee is entitled to a pro-rated pay out of the annual performance bonus based on days worked in the fiscal year, severance of twelve months of the base salary, and automatic vesting of unvested equity grants. If the employee terminates with good reason, as defined in the employment contract, the employee is entitled to automatic vesting of unvested equity grants.
During 2020, the Company began consistently paying salaries at 50% of the salaries reflected in the respective employment agreements. As of September 2021, the Company began paying full salaries. Throughout 2022, the Company returned to paying partial salaries and by October 2023 the company stopped paying 100% in an effort to conserve cash. See Note 3 – Related Party Transactions for details related to forgiveness of accrued compensation during the year ended December 31, 2023.
On December 18, 2023, various employees agreed to reduce their annual base salary to 20% of their original base salary effective October 1, 2023 until the time the Company raises additional capital from securities in the amount of $1,500,000 (the “Reduction Period”). Upon the expiration of the Reduction Period, the bases salaries shall adjust to be 105% of their original base salary as set forth in their original agreements.
Licensing and Royalty Agreements - Aquanova AG
On September 15, 2016 the Company entered into a Development, Collaboration and License Agreement (“License Agreement”) with Aquanova AG, a German company in the field of development, manufacturing and selling of colloidal formulas. The License Agreement resulted in the creation of the pharmaceutic product, JOTROL. The License Agreement is in effect until product launch, which is undeterminable at this time. The Chief Scientific Officer of the Company and the CEO of Aquanova are the joint inventors of JOTROL. Aquanova is assignee on the patents in the United States, the European Union, China and Japan whereas the Company is obligated to maintain the patents. The agreement grants ownership to the Company for regulatory approvals and the sole and exclusive worldwide right to develop, manufacture and commercialize all products, including JOTROL. Aquanova is granted the exclusive license to conduct formulation development and manufacturing. The agreement also defines fees owed to Aquanova for product and formulation development and licensing of the products. The Company is required to pay Aquanova an annual license fee of $75,000 upon acceptance of the product formulation by both parties, with the license fee requirement ending in the year of marketing authorization approval (“MMA”) in a single territory. MMA has not yet been received as of the period ended September 30, 2024. As of September 30, 2024 and December 31, 2023, $206,250 and $150,000 of accrued license fees are included in accounts payable and accrued expenses on the balance sheet, respectively. Upon receipt of approval of the MMA in each territory (e.g United States, European Union, China, Japan), the Company will pay $200,000 to Aquanova per territory an MMA approval is received, up to a max of $600,000. The Company shall pay Aquanova a royalty of 5% of net sales in each territory through the later of ten years after the first commercial sale, the first date there is no valid claim within the Aquanova patent rights, or the date of expiration of the MMA in each territory.
Upon mutual agreement, the Company can pay a one-time royalty of $3,000,000 within 180 days of United States marketing approval, with subsequent royalty payments reduced to 1.25%, in accordance with the terms set forth above.
Murdoch Children’s Research Institute
On September 1, 2015 the Company entered into a Global Development and License Agreement (“License Agreement II”) with Murdoch Children’s Research Institute (“MCRI”), an Australian Institute at the Royal Children’s Hospital in Australia, with the know-how in the process of using pharmaceutical grade Resveratrol for the treatment of Freidreich’s ataxia. The License Agreement II is for both parties to work jointly to develop an appropriate delivery system and conduct clinical trials for the purpose of product approval in the treatment of Friedreich’s ataxia and worldwide commercialization by the Company. The License Agreement II grants an exclusive worldwide license to the Company to use the MCRI know-how for developing, manufacturing and commercializing the product for proposed treatment for Friedreich’s ataxia. MCRI is granted an irrevocable, royalty free, worldwide license to use the product inventions and patent rights for internal research and development. Upon receipt of approval of the MMA in each territory (e.g United States, European Union, China, Japan), the Company will pay $100,000 to MCRI per each territory up to a maximum of $300,000. MMA has not yet been received as of September 30, 2024. The Company shall pay MCRI a royalty of 1.5% of net sales in each territory until the product is no longer sold in the respective territory.
Research and Development Service Providers
In addition to the services received under the licensing agreements noted above, a substantial portion of the research and development (“R&D”) expense included in the statement of operations is incurred pursuant to short term service and consulting agreements with third party providers for research, development, testing and manufacturing services. The agreements generally provide termination, at any time by either party without cause, upon a 30-day written notice, unless otherwise disclosed below. There are no pending milestone payments due as of September 30, 2024.
Service Agreements
On June 3, 2024, the Company entered into a three 36-month service agreement with three different entities. The Company issued an aggregate of 3,487,500 restricted shares of common stock,1,162,500 restricted shares of common stock to each entity. The shares will be registered upon an IPO as long as an IPO happens no later than March 31, 2025. In addition, each of the entities agreed to purchase 37,500 shares each of the Company’s common stock at a price of $1.33 per share prior to the occurrence of the IPO. As of September 30, 2024, the Company issued the 37,500 common stock and the Company received an aggregate of $50,000 for the sale of the Company’s common stock. See Note 9 – Subsequent events for cash received subsequent to September 30, 2024 related to the sale of the Company’s common stock. These shares will also be registered upon an IPO as long as an IPO happens no later than March 31, 2025. Either party is able to terminate the respective agreement with no liability upon the occurrence of i) the Company failing to raise at least $10 million in gross proceeds from an IPO prior to May 31, 2025, ii) if either party is involved in any illegal activity or iii) at any time as long as both parties agree to it. The Company has the obligation to register the shares upon the occurrence of an IPO. Therefore, until the obligations are met the aggregate value of $4,638,375 related to the 3,487,500 restricted shares will not be recognized by the Company. Once the obligations are met the Company will recognize compensation expense from the effective date of the agreement through the date the obligations are met with the remaining expense being amortized over the remaining term of the 36-months per the services agreements. If the obligations were met as of September 30, 2024, the Company would have recorded compensation expense for services provided of $504,077.
Note 9 –Subsequent Events
The Company evaluated events that have occurred after the balance sheet date but before the financial statements are issued. Based upon the evaluation and transactions, the Company did not identify any subsequent events that would have required adjustment or disclosure in the Financial Statements.
Subsequent to September 30, 2024, the Company’s CEO loaned the Company an additional $1,500. The loan is due on demand and accrues interest at 3% per year.
Subsequent to the September 30, 2024, the Company received the remaining balance related to the sale of the Company’s common stock per the service agreements.
Closing Offering
On December 2, 2024, the Company entered into an Underwriting Agreement (the “Underwriting Agreement”) with Dominari Securities LLC relating to the Company’s firm commitment underwritten initial public offering (the “Offering”) of common stock, par value $0.0001 per share (the “Common Stock”). Pursuant to the Underwriting Agreement, the Company agreed to sell 2,750,000 shares of Common Stock to the underwriters at a public offering price of $4.00 per share (the “Offering Price”), pursuant to the Company’s registration statement on Form S-1, as amended (File No. 333-260183) (the “Registration Statement”), under the Securities Act of 1933, as amended (the “Securities Act”).
Note 9 – Subsequent Events, continued
The Company intends to use the proceeds primarily to fund the Phase II clinical trial of its product candidate JOTROL™ in patients with Parkinson’s Disease, Strategic Service Agreements to accelerate business activities in South-East Asia, research and development activities regarding evaluation of new product opportunities, payment of the outstanding annual license fees due to Aquanova AG, the repayment of debt, working capital and other general corporate purposes.
The Underwriting Agreement includes customary representations, warranties and covenants by the Company. It also provides that the Company will indemnify the underwriters against certain liabilities, including liabilities under the Securities Act, or contribute to payments the underwriters may be required to make because of any of those liabilities. In exchange for the underwriters’ services, the Company agreed to (i) sell the Common Stock to the underwriters at a purchase price of $3.72 per share representing a 7% underwriting discount, (ii) pay a non-accountable expense allowance to the underwriter equal to 1% of the gross proceeds received at the closing of the offering, and (iii) pay the underwriter’s actual out-of-pocket expenses relating to the offering, not to exceed $175,000.
The Offering closed on December 4, 2024, and the Company sold 2,750,000 shares of Common Stock to the underwriters for total gross proceeds of $11,000,000. After deducting the underwriting commissions, discounts, and offering expenses payable by the Company, the Company received net proceeds of approximately $9.5 million.
Convertible Debt I
Upon the closing of the offering on December 4, 2024, the outstanding principle and all unpaid accrued interest, totaling $109,216, of the Notes I converted into an aggregate of 227,447 share of common stock of the Company at $2.80, which is 70% of the offering price of $4.00.
Senior Secured Note – Formerly Known as the Convertible Debt I
On November 15, 2024, the Company, and the Holder of the Senior Secured Note entered into an amendment to extend the maturity date of the Senior Secured Note to December 10, 2024. During December 2024, the Company fully repaid the Senior Secured Note pursuant to the terms in the amount of $2,102,797.
Convertible Debt III
During December 2024, the Company fully repaid the Convertible Debt III pursuant to the terms in the amount of $178,386.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.