UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
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For the Quarterly Period Ended
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Acurx Pharmaceuticals, Inc.
Table of Contents
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (“Quarterly Report”) and certain information incorporated herein by reference contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In this Quarterly Report, we refer to Acurx Pharmaceuticals, Inc., together with its subsidiary, as the “Company,” “we,” “our” or “us.” All statements other than statements of historical facts contained herein, including statements regarding our future results of operations and financial position, strategy and plans, and our expectations for future operations, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect” or the negative version of these words and similar expressions are intended to identify forward-looking statements.
We have based these forward-looking statements on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, strategy, short- and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in Part II, Item 1A “Risk Factors.” In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances included herein may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Forward-looking statements include, but are not limited to, statements about:
● | our ability to obtain and maintain regulatory approval of ibezapolstat and/or our other product candidates; |
● | our ability to successfully commercialize and market ibezapolstat and/or our other product candidates, if approved; |
● | our ability to contract with third-party suppliers, manufacturers and other service providers and their ability to perform adequately; |
● | the potential market size, opportunity and growth potential for ibezapolstat and/or our other product candidates, if approved; |
● | our ability to build our own sales and marketing capabilities, or seek collaborative partners, to commercialize ibezapolstat and/or our other product candidates, if approved; |
● | our ability to obtain funding for our operations; |
● | the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; |
● | the timing of anticipated regulatory filings; |
● | the timing of availability of data from our clinical trials; |
● | the impact of the ongoing COVID-19 pandemic and our response to it; |
● | the accuracy of our estimates regarding expenses, capital requirements and needs for additional financing; |
● | our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals; |
● | our ability to advance product candidates into, and successfully complete, clinical trials; |
● | our ability to recruit and enroll suitable patients in our clinical trials and the timing of enrollment; |
● | the timing or likelihood of the accomplishment of various scientific, clinical, regulatory and other product development objectives; |
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● | the pricing and reimbursement of our product candidates, if approved; |
● | the rate and degree of market acceptance of our product candidates, if approved; |
● | the implementation of our business model and strategic plans for our business, product candidates and technology; |
● | the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology; |
● | developments relating to our competitors and our industry; |
● | the development of major public health concerns, including the novel coronavirus outbreak or other pandemics arising globally, and the future impact of it and COVID-19 on our clinical trials, business operations and funding requirements; |
● | the effects of the recent disruptions to and volatility in the credit and financial markets in the United States and worldwide from the conflict between Russia and Ukraine; |
● | the volatility of the price of our common stock; |
● | our financial performance; and |
● | other risks and uncertainties, including those listed in “Risk Factors.” |
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance or achievements. In addition, neither we nor any other person assumes responsibility for the accuracy and completeness of any of these forward-looking statements. Any forward-looking statement made by us in this Quarterly Report speaks only as of the date on which it is made. We disclaim any duty to update any of these forward-looking statements after the date of this Quarterly Report to conform these statements to actual results or revised expectations.
Other risks may be described from time to time in our filings made under applicable securities laws. New risks emerge from time to time. It is not possible for our management to predict all risks. All forward-looking statements in this Quarterly Report speak only as of the date made and are based on our current beliefs and expectations. We undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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PART I—FINANCIAL INFORMATION
ITEM 1. CONDENSED INTERIM FINANCIAL STATEMENTS.
ACURX PHARMACEUTICALS, INC.
CONDENSED INTERIM BALANCE SHEETS
September 30, |
| December 31, | ||||
| 2022 |
| 2021 | |||
(unaudited) | (Note 2) | |||||
ASSETS |
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CURRENT ASSETS |
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Cash | $ | | $ | | ||
Prepaid Expenses |
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TOTAL ASSETS | $ | | $ | | ||
LIABILITIES AND SHAREHOLDERS’ EQUITY |
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CURRENT LIABILITIES |
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Accounts Payable and Accrued Expenses | $ | | $ | | ||
TOTAL CURRENT LIABILITIES |
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TOTAL LIABILITIES |
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COMMITMENTS AND CONTINGENCIES |
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SHAREHOLDERS' EQUITY | ||||||
Common Stock; $ |
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Additional Paid-In Capital |
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Accumulated Deficit |
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TOTAL SHAREHOLDERS’ EQUITY |
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TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | | $ | |
See accompanying notes to the condensed interim financial statements.
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ACURX PHARMACEUTICALS, INC.
CONDENSED INTERIM STATEMENTS OF OPERATIONS
| Three Months Ended |
| Nine Months Ended |
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September 30, | September 30, | ||||||||||||
| 2022 |
| 2021 |
| 2022 |
| 2021 |
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(unaudited) | (unaudited) | (unaudited) | (unaudited) | ||||||||||
OPERATING EXPENSES |
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Research and Development | $ | | $ | | $ | | $ | | |||||
General and Administrative |
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TOTAL OPERATING EXPENSES |
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Gain on Forgiveness of Paycheck Protection Program Loan |
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NET LOSS | $ | ( | $ | ( | $ | ( | $ | ( | |||||
LOSS PER SHARE |
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Basic and diluted net loss per common share/units | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Weighted average common shares/units outstanding basic and diluted |
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See accompanying notes to the condensed interim financial statements.
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ACURX PHARMACEUTICALS, INC.
CONDENSED INTERIM STATEMENTS OF CHANGES IN MEMBERS’ AND SHAREHOLDERS’ EQUITY (unaudited)
Class A Membership | Class B Membership | |||||||||||||||||||||||
| Interests | Interests | Common Stock | Total | ||||||||||||||||||||
Additional | Members’ | |||||||||||||||||||||||
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Units | Amount | of Units | Amount | Shares | Amount | Capital | Deficit | Equity | ||||||||||||||||
Balance at January 1, 2021 |
| | $ | |
| | $ | |
| — | $ | — | $ | — | $ | ( | $ | | ||||||
Executive Compensation Settled with Membership Interests |
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Cancellation of Class B Issuance | — | — | ( | — | — | — | — | — | — | |||||||||||||||
Share-Based Compensation |
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Share-Based Payments to Vendors |
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Net Loss |
| — |
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| — |
| — |
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| — |
| — |
| ( |
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Balance at March 31, 2021 |
| | $ | |
| | $ | |
| — | $ | — | $ | — | $ | ( | $ | | ||||||
Share-Based Compensation |
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Share-Based Payments to Vendors |
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Corporate Conversion | ( | ( | ( | ( | | | | — | — | |||||||||||||||
Initial Public Offering, net of issuance costs | — | — | — | — | | | | — | | |||||||||||||||
Net Loss |
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| — |
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| — |
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Balance at June 30, 2021 |
| — | $ | — |
| — | $ | — |
| | $ | | $ | | $ | ( | $ | | ||||||
Share-Based Compensation | — | — | — | — | — | — | | — | | |||||||||||||||
Share-Based Payments to Vendors | — | — | — | — | | | | — | | |||||||||||||||
Net Loss | — | — | — | — | — | — | — | ( | ( | |||||||||||||||
Balance at September 30, 2021 | — | $ | — | — | $ | — | | $ | | $ | | $ | ( | $ | | |||||||||
Balance at January 1, 2022 | — | $ | — | — | $ | — | | $ | | $ | | $ | ( | $ | | |||||||||
Share-Based Compensation | — | — | — | — | — | — | | — | | |||||||||||||||
Share-Based Payments to Vendors | — | — | — | — | | | | — | | |||||||||||||||
Cashless Warrant Exercise | — | — | — | — | | | ( | — | — | |||||||||||||||
Net Loss | — | — | — | — | — | — | — | ( | ( | |||||||||||||||
Balance at March 31, 2022 | — | $ | — | — | $ | — | | $ | | $ | | $ | ( | $ | | |||||||||
Share-Based Compensation | — | — | — | — | — | — | | — | | |||||||||||||||
Net Loss | — | — | — | — | — | — | — | ( | ( | |||||||||||||||
Balance at June 30, 2022 | — | $ | — | — | $ | — | | $ | | $ | | $ | ( | $ | | |||||||||
Share-Based Compensation | — | — | — | — | — | — | | — | | |||||||||||||||
Share-Based Payments to Vendors | — | — | — | — | | | | — | | |||||||||||||||
Issuance of shares of common stock and pre-funded warrants in registered direct offering, net of $ | — | — | — | — | | | | — | | |||||||||||||||
Cashless Warrant Exercise | — | — | — | — | | | ( | — | — | |||||||||||||||
Pre-funded Warrant Exercise | — | — | — | — | | | ( | — | | |||||||||||||||
Net Loss | — | — | — | — | — | — | — | ( | ( | |||||||||||||||
Balance at September 30, 2022 | — | $ | — | — | $ | — | | $ | | $ | | $ | ( | $ | |
See accompanying notes to the condensed interim financial statements.
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ACURX PHARMACEUTICALS, INC.
CONDENSED INTERIM STATEMENTS OF CASH FLOWS
Nine Months Ended | ||||||
September 30, | ||||||
| 2022 |
| 2021 | |||
(unaudited) | (unaudited) | |||||
Cash Flow from Operating Activities: |
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Net Loss | $ | ( | $ | ( | ||
Adjustments to Reconcile Net Loss to Net Cash Used in Operating Activities: |
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Share-Based Compensation |
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Share-Based Payments to Vendors |
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Executive Compensation Settled with Membership Interests |
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Gain on Forgiveness of Paycheck Protection Program Loan |
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(Increase) / Decrease in: |
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Prepaid Expenses |
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Accounts Payable and Accrued Expenses | | | ||||
Net Cash Used in Operating Activities | ( | ( | ||||
Cash Flow from Financing Activities: |
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Proceeds from Initial Public Offering, net of issuance costs |
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Proceeds from Registered Direct Offering, net of issuance costs | | — | ||||
Pre-funded warrant exercise | | — | ||||
Net Cash Provided by Financing Activities | | | ||||
Net (Decrease) / Increase in Cash |
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Cash at Beginning of Period | | | ||||
Cash at End of Period | $ | | $ | | ||
SUPPLEMENTAL DISCLOSURE OF NON-CASH FINANCING ACTIVITIES |
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Warrants issued in connection with offerings | $ | | — | |||
Accrued Registered Direct Offering costs | $ | | — |
See accompanying notes to the condensed interim financial statements.
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ACURX PHARMACEUTICALS, INC.
NOTES TO THE CONDENSED INTERIM FINANCIAL STATEMENTS (UNAUDITED)
NOTE 1 – NATURE OF OPERATIONS
Business
Acurx Pharmaceuticals, Inc., a Delaware corporation, formerly Acurx Pharmaceuticals, LLC (the “Company”) is a clinical stage biopharmaceutical company formed in July 2017, with operations commencing in February 2018. The Company is focused on developing a novel class of antibiotics that address serious or life threatening bacterial infections.
In March 2020, the World Health Organization declared the outbreak of COVID-19, a novel strain of coronavirus, a global pandemic. This outbreak caused major disruptions to businesses and markets worldwide as the virus continued to spread. The COVID-19 pandemic has disrupted, and the Company expects it will continue to disrupt, its operations. The extent of the effect on the Company’s operational and financial performance will depend on future developments, including the duration, spread and intensity of the pandemic, and governmental, regulatory and private sector responses, direct and indirect economic effects as a result of inflation, supply chain disruptions and labor shortages all of which are uncertain and difficult to predict. Although the Company is unable to estimate the financial effect of the pandemic, at this time, if the pandemic continues over a long period of time, it could have a material adverse effect on the Company’s business, results of operations, financial condition, and cash flows. The financial statements do not reflect any adjustments as a result of the pandemic.
In February 2018, the Company purchased the active pharmaceutical ingredient, the intellectual property and other rights to an antibiotic product candidate known as GLS362E (renamed ACX-362E and now approved for non-proprietary name, ibezapolstat) (the “Asset”) from GLSynthesis, Inc. The Company paid $
The Company’s primary activities since inception aside from organizational activities have included performing research and development activities relating to the development of its two antibiotic candidates and raising funds through equity offerings including its initial public offering (“IPO”) consummated in June 2021. The Company has not generated any revenues since inception.
The Company has experienced net losses and negative cash flows from operations since inception and expects these conditions to continue for the foreseeable future. The Company has needed to raise capital from sales of its securities to sustain operations. On June 29, 2021, the Company completed the IPO, issuing
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NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying unaudited condensed interim financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and in accordance with the rules and regulations of the United States Securities Exchange Commission for interim reporting. In the opinion of management, these unaudited interim financial statements include all adjustments, consisting only of normal, recurring adjustments, necessary for a fair statement of the Company’s financial position, results of operations, and cash flows. The unaudited interim results of operations are not necessarily indicative of the results that may occur for the full fiscal year. The year-end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. Management believes that the disclosures provided herein are adequate when these unaudited condensed interim financial statements are read in conjunction with the audited financial statements and notes thereto as of December 31, 2021 filed in Form 10-K.
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 expenses during the reporting period. Actual results could differ from those estimates.
Income Taxes
The Company estimates an annual effective tax rate of
Based on the Company’s history of generating operating losses and its anticipation of operating losses for the foreseeable future, the Company has determined that it is more likely than not that the tax benefits from those net operating losses would not be realized and a full valuation allowance against all deferred tax assets has been recorded. Should the Company’s assessment change, tax benefits associated with the historic net operating loss carryforwards could be limited due to future ownership changes.
Prior to the Company’s corporate conversion in June 2021, the Company was organized as a limited liability company. As such, the Company was not a tax paying entity for federal income tax purposes and, therefore,
Concentration of Credit Risk
The Company maintains its cash balance in one financial institution. The balance is insured up to the maximum allowable by the Federal Deposit Insurance Corporation (“FDIC”). The Company has not experienced any losses in such accounts and does not believe it is exposed to any significant risk of loss on cash. At times, the cash balance may exceed the maximum insured limit of the FDIC. As of September 30, 2022, the Company had cash of approximately $
Research and Development
The Company expenses research and development costs when incurred. At times, the Company may make cash advances for future research and development services. These amounts are deferred and expensed in the period the service is provided. The Company incurred research and development expenses in the amount of $
10
Share-Based Compensation
The Company accounts for the cost of services performed by officers and directors received in exchange for an award of Company membership interests, common stock or stock options, based on the grant-date fair value of the award. The Company recognizes compensation expense based on the requisite service period.
Compensation expense associated with stock option awards is recognized over the requisite service period based on the fair value of the option at the grant date determined based on the Black-Scholes option pricing model. Option valuation models require the input of highly subjective assumptions including the expected price volatility. The Company’s employee stock options have characteristics significantly different from those of traded options, and changes in the subjective input assumptions can materially affect the fair value computation using the Black-Scholes option pricing model. Because there is no public market for the Company’s stock options and very little historical experience with the Company’s stock, similar public companies were used for the comparison of volatility and the dividend yield. The risk-free rate of return was derived from U.S. Treasury notes with comparable maturities.
Share-Based Payments to Vendors
The Company accounts for the cost of services performed by vendors in exchange for an award of Company membership interests, common stock, or stock options, based on the grant-date fair value of the award or the fair value of the services rendered; whichever is more readily determinable. Such fair value is measured as of the date the services or the date performance by the other party is complete. The Company recognizes the expense in the same period and in the same manner as if the Company had paid cash for the services.
Major Vendor
The Company had a major vendor that accounted for approximately
NOTE 3 - ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses as of September 30, 2022 and December 31, 2021 were as follows:
| September 30, 2022 |
| December 31, 2021 | |||
Accrued compensation expenses | $ | | $ | | ||
Accrued research and development |
| |
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Accrued professional fees |
| |
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Other accounts payable and accrued expenses |
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Total | $ | | $ | |
NOTE 4 – EXECUTIVE COMPENSATION
In January 2021, the Company issued
The board of directors also approved certain grants to members of management as a component of their 2020 year-end compensation, authorizing the issuance of
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The Company is currently managed by
NOTE 5 – ISSUANCE OF EQUITY INTERESTS
On June 23, 2021, Acurx Pharmaceuticals, LLC was converted into a corporation and renamed Acurx Pharmaceuticals, Inc. The Company’s certificate of incorporation authorizes
On June 29, 2021, the Company completed an IPO issuing
In connection with the IPO, the Company issued
On July 25, 2022, the Company entered into securities purchase agreements (the “Purchase Agreements”) with two of the Company’s executives and a member of the Company’s board of directors (collectively, the “Affiliate Investors”), and a single U.S. institutional investor (the “Investor”) pursuant to which the Company issued and sold in a registered direct offering an aggregate of
The gross proceeds to the Company from the registered direct offering were $
On July 25, 2022, the Company entered into a co-placement agent agreement (the “Placement Agent Agreement”), with two placement agents in connection with the registered direct offering pursuant to which the Company paid the Placement Agents a cash fee of $
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The following table summarizes information with respect to outstanding warrants to purchase common stock of the Company at September 30, 2022:
Weighted Average | ||||||
| Number of Warrants |
| Exercise Price | |||
Balance, December 31, 2021 | | $ | | |||
Issued |
| | $ | | ||
Exercised |
| ( | $ | | ||
Balance, September 30, 2022 |
| | $ | |
The weighted average contractual life of the outstanding warrants is
NOTE 6 – SHARE-BASED COMPENSATION
While the Company was a limited liability company in its pre-IPO phase of corporate development, the Company granted performance-based awards of restricted Class A Membership Interests to board members and corporate advisory council members in exchange for services. All of these awards of membership interests became fully vested upon consummation of the Company’s corporate conversion from a Delaware limited liability company to a Delaware corporation immediately prior to the Company’s IPO in June 2021, with the Company recognizing all previously unrecognized compensation expense. The fair value of the membership interests granted during 2020 and 2019 was equal to the per-membership interest value of the most recent private placement. Total share-based compensation associated with these awards had been recorded as general and administrative expenses in the amount of $
In April 2021, the board of directors approved the creation of the 2021 Equity Incentive Plan (the “Plan”). The Plan became effective as of the completion of the corporate conversion, with an annual evergreen provision pursuant to the Plan. The Plan currently reserves an aggregate of
In June 2021, the Company granted stock options to purchase a total of
In the second quarter of 2021, the Company entered into a number of agreements with vendors pursuant to which the Company granted a total of
In July 2021, the Company granted stock options to purchase a total of
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In January 2022, the Company granted stock options to purchase a total of
In April 2022, the Company granted stock options to purchase a total of
Compensation expense associated with these awards is recognized over the vesting period based on the fair value of the option at the grant date determined based on the Black-Scholes model. Option valuation models require the input of highly subjective assumptions including the expected price volatility. The Company’s employee stock options have characteristics significantly different from those of traded options, and changes in the subjective input assumptions can materially affect the fair value computation using the Black-Scholes option pricing model. Because there is no public market for the Company’s stock options and very little historical experience with the Company’s stock, similar public companies were used for the comparison of volatility and the dividend yield. The risk-free rate of return was derived from U.S. Treasury notes with comparable maturities.
The Company determined the fair value of the option awards using the Black-Scholes option pricing model using the following weighted average assumptions:
Nine Months Ended |
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| September 30, 2022 |
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Expected term |
| | years | |
Volatility |
| | % | |
Dividend yield |
| — | % | |
Risk-free interest rate |
| | % | |
Weighted average grant date fair value | $ | |
A summary of the Company’s stock option activity is as follows:
Nine Months Ended |
| Weighted Average | |||
| September 30, 2022 |
| Exercise Price | ||
Outstanding at the beginning of the period |
| |
| $ | |
Granted |
| | $ | | |
Vested |
| ( | $ | | |
Outstanding and expected to vest |
| | $ | |
The total compensation expense not yet recognized as of September 30, 2022 was $
NOTE 7 – SHARE-BASED PAYMENTS TO VENDORS
While the Company was a limited liability company in its pre-IPO phase of corporate development, the Company granted Class A Membership Interests to certain vendors in the ordinary course of business in exchange for consulting services relating to research and development activities and investor relations. The Company granted