UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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For the quarterly period ended
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CADRENAL THERAPEUTICS, INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2024
TABLE OF CONTENTS
i
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
CADRENAL THERAPEUTICS, INC.
BALANCE SHEETS
| September 30, 2024 (unaudited) | December 31, 2023 | |||||||
| Assets: | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Prepaid expenses | ||||||||
| Deferred offering costs | ||||||||
| Total current assets | ||||||||
| Property, plant and equipment, net | ||||||||
| Right of use assets | ||||||||
| Other assets | ||||||||
| Total assets | $ | $ | ||||||
| Liabilities and Stockholders’ Equity: | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued liabilities | ||||||||
| Operating lease liability | ||||||||
| Total current liabilities | ||||||||
| Total liabilities | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $ | ||||||||
| Common stock, $ | ||||||||
| Additional paid-in capital (1) | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
| (1) |
The accompanying notes are an integral part of these financial statements.
1
CADRENAL THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| General and administrative expenses | $ | $ | $ | $ | ||||||||||||
| Research and development expenses | ||||||||||||||||
| Depreciation expense | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other (income) expense: | ||||||||||||||||
| Interest and dividend income | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Interest expense | ||||||||||||||||
| Interest expense, amortization of debt discount | ||||||||||||||||
| Change in fair value of derivative liabilities | ||||||||||||||||
| Loss on extinguishment of debt | ||||||||||||||||
| Total other (income) expense | ( | ) | ( | ) | ( | ) | ||||||||||
| Net loss and comprehensive loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net loss per common share, basic and diluted (1) | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Weighted average number of common shares used in computing net loss per common share, basic and diluted (1) | ||||||||||||||||
| (1) |
The accompanying notes are an integral part of these financial statements.
2
CADRENAL THERAPEUTICS, INC.
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(unaudited)
| For the Three Months Ended September 30, 2024 | ||||||||||||||||||||
| Common Stock (1) | Additional Paid-In | Accumulated | Total Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital (1) | Deficit | Equity | ||||||||||||||||
| Balance, June 30, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Rounding of fractional shares from reverse stock split | ( | ) | ||||||||||||||||||
| Equity-based compensation - options | - | |||||||||||||||||||
| Issuance of common stock for consulting services | ||||||||||||||||||||
| Proceeds from sale of common stock, net of fees | ||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance, September 30, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| For the Nine Months Ended September 30, 2024 | ||||||||||||||||||||
| Common Stock (1) | Additional Paid-In | Accumulated | Total Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital (1) | Deficit | Equity | ||||||||||||||||
| Balance, December 31, 2023 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Issuance of common shares from exercise of pre-funded warrants | ||||||||||||||||||||
| Rounding of fractional shares from reverse stock split | ( | ) | ||||||||||||||||||
| Equity-based compensation - options | - | |||||||||||||||||||
| Issuance of common stock for consulting services | ||||||||||||||||||||
| Proceeds from sale of common stock, net of fees | ||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance, September 30, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| For the Three Months Ended September 30, 2023 | ||||||||||||||||||||
| Common Stock (1) | Additional Paid-In | Accumulated | Total Stockholders’ | |||||||||||||||||
| Shares | Amount | Capital (1) | Deficit | Equity | ||||||||||||||||
| Balance, June 30, 2023 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Equity-based compensation - options, restricted stock and RSUs | - | |||||||||||||||||||
| Issuance of common shares, pre-funded warrants and warrants in private placement, net of fees | ||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance, September 30, 2023 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| For the Nine Months Ended September 30, 2023 | ||||||||||||||||||||
| Common Stock (1) | Additional Paid-In | Accumulated | Total Stockholders’ Equity | |||||||||||||||||
| Shares | Amount | Capital (1) | Deficit | (Deficit) | ||||||||||||||||
| Balance, December 31, 2022 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||
| Issuance of common shares in initial public offering, net of offering costs | ||||||||||||||||||||
| Issuance of common shares to settle convertible debt | ||||||||||||||||||||
| De-recognition of derivative liabilities | - | |||||||||||||||||||
| Issuance of common shares, pre-funded warrants and warrants in private placement, net of fees | ||||||||||||||||||||
| Issuance of common shares from exercise of warrants | ||||||||||||||||||||
| Issuance of common shares to settle asset purchase obligation | ||||||||||||||||||||
| Issuance of restricted common shares for prepaid consulting services | ||||||||||||||||||||
| Equity-based compensation - options, restricted stock and RSUs | ||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Balance, September 30, 2023 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| (1) |
The accompanying notes are an integral part of these financial statements.
3
CADRENAL THERAPEUTICS, INC.
STATEMENTS OF CASH FLOWS
(unaudited)
| Nine Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation expense | ||||||||
| Equity-based compensation | ||||||||
| Amortization of debt discount | ||||||||
| Change in fair value of derivative liabilities | ||||||||
| Loss on extinguishment of debt | ||||||||
| Non-cash lease expense | ( | ) | ||||||
| Issuance of shares to settle asset purchase agreement | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses | ( | ) | ( | ) | ||||
| Deferred offering costs | ( | ) | ||||||
| Other assets | ||||||||
| Accounts payable | ( | ) | ||||||
| Accrued liabilities | ( | ) | ||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows used in investing activities: | ||||||||
| Investment in property and equipment | ( | ) | ||||||
| Net cash used in investing activities | ( | ) | ||||||
| Cash flows from financing activities: | ||||||||
| Proceeds from sale of common stock, pre-funded warrants and warrants in private placement, net of fees | ||||||||
| Proceeds from sale of common stock, net of fees | ||||||||
| Proceeds from exercise of warrants | ||||||||
| Repayment of promissory notes | ( | ) | ||||||
| Proceeds from sale of common stock in initial public offering, net of offering costs | ||||||||
| Net cash provided by financing activities | ||||||||
| Net change in cash | ( | ) | ||||||
| Cash and cash equivalents – beginning of the period | ||||||||
| Cash and cash equivalents – end of the period | $ | $ | ||||||
| Supplemental disclosure of non-cash financing activity: | ||||||||
| Issuance of common shares to settle convertible debt | $ | $ | ||||||
| De-recognition of derivative liabilities | $ | $ | ||||||
| Issuance of common shares for prepaid consulting services | $ | $ | ||||||
The accompanying notes are an integral part of these financial statements.
4
CADRENAL THERAPEUTICS, INC.
Notes to Unaudited Financial Statements
Note 1. Description of Business and Summary of Significant Accounting Policies
Cadrenal Therapeutics, Inc. (the “Company” or “Cadrenal”) was incorporated on January 25, 2022 in the State of Delaware and is headquartered in Ponte Vedra, Florida. Cadrenal Therapeutics is a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to offer safer, superior chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions. Tecarfarin is anticipated to result in fewer adverse events such as strokes, heart attacks, bleeds and deaths than warfarin, the most commonly used anticoagulant for these patients despite its prevalent side effects, drug-to-drug interactions and frequent dosing changes. Tecarfarin received an orphan drug designation from the U.S. Food and Drug Administration (the “FDA”) for the prevention of thrombosis and thromboembolism (blood clots) in patients with an implanted mechanical circulatory support device, which includes implanted left ventricular assist devices (LVADs), as well as both orphan drug and fast-track status for the prevention of systemic thromboembolism of cardiac origin in end-stage kidney disease (ESKD) patients with atrial fibrillation (AFib). Cadrenal is planning pivotal clinical trials and pursuing clinical and commercial partnerships to advance tecarfarin. The Company’s plans also include studying tecarfarin in patients with mechanical heart valves experiencing anticoagulation difficulties.
Basis of Presentation
The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for the fair presentation of the Company’s financial statements for the periods presented. The Company’s fiscal year-end is December 31.
The accompanying financial statements of the Company are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2024, the results of its operations for the three and nine months ended September 30, 2024 and 2023, the statements of stockholders’ equity for the three and nine months ended September 30, 2024 and 2023, and its cash flows for the nine months ended September 30, 2024 and 2023. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2024 and 2023 are also unaudited. The results for the three and nine months ended September 30, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024, any other interim periods, or any future year or period. These interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2023, and notes thereto, which are included in the Company’s Annual Report on Form 10-K that was filed with the SEC on March 11, 2024.
Liquidity
The accompanying financial statements have been
prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and settlement of liabilities
and commitments in the normal course of business. The financial statements do not reflect any adjustments relating to the recoverability
and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. Since
inception, the Company has incurred operating losses, and negative cash flows from operations. For the nine months ended September 30,
2024, the Company had a net loss of $
During October 2024, the Company sold
On November 1, 2024, the Company entered into
a warrant inducement letter agreement (the “Warrant Inducement Agreement”) with a holder (the “Holder”) of outstanding
warrants to purchase up to
5
The Company’s cash and cash equivalents balance of approximately $
Emerging Growth Company Status
As an “emerging growth company” (“EGC”) under the Jumpstart Our Business Startups Act (“JOBS Act”), the Company may elect to take advantage of certain forms of relief from various reporting requirements that are applicable to public companies. The relief afforded under the JOBS Act includes an extended transition period for the implementation of new or revised accounting standards. The Company has elected to take advantage of this extended transition period and, as a result, the Company’s financial statements may not be comparable to those of companies that implement accounting standards as of the effective dates for public companies. The Company may take advantage of the relief afforded under the JOBS Act up until the last day of the fiscal year following the fifth anniversary of its initial offering or such earlier time that it is no longer an EGC.
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 as of the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying financial statements include but are not limited to the fair value of stock-based awards, deferred tax assets and valuation allowance, income tax uncertainties, and certain accruals. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances change. Actual results could differ from those estimates.
Concentration of Credit and Other Risks and Uncertainties
Financial instruments, which potentially subject
the Company to significant concentrations of credit risk, consist primarily of cash and cash equivalents. Cash is maintained at high credit
quality financial institutions and, at times, balances may exceed federally insured limits. All interest-bearing and non-interest-bearing
cash balances are insured up to $
The Company is subject to a number of risks common for early-stage biopharmaceutical companies including, but not limited to, dependency on the clinical and commercial success of its product candidate, ability to obtain regulatory approval of its product candidate, the need for substantial additional financing to achieve its goals, uncertainty of broad adoption of its approved products, if any, by physicians and patients, significant competition and untested manufacturing capabilities.
Segments
Operating segments are defined as components of
an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”)
in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s CODM is its Chief Executive
Officer. The Company has determined it operates in a single operating segment and has
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash and cash equivalents include cash and money market funds.
6
Derivative Financial Instruments
The Company evaluates all of its agreements to determine if such instruments have derivatives or contain features that qualify as embedded derivatives. The Company accounted for certain redemption features that were associated with convertible notes as liabilities at fair value and adjusted the instruments to their fair value at the end of each reporting period. Derivative financial liabilities are initially recorded at fair value, with gains and losses arising from changes in the fair value recognized in other (income) expense in the accompanying statements of operations and comprehensive loss for each reporting period while such instruments are outstanding. The embedded derivative liabilities were valued using a probability-weighted expected return model. If the Company repays the noteholders or if, during the next round of financing, the noteholders convert the debt into equity, the derivative financial liabilities are de-recognized and reclassified to stockholders’ equity (deficit) on that date. Derivative instrument liabilities are classified in the balance sheet as current or non-current based on whether or not net-cash settlement of the derivative instrument could be required within 12 months of the balance sheet date.
Concurrent with the closing of the initial public offering in January 2023 (the “IPO”), the note holders converted the debt into common stock, accordingly, the derivative financial liabilities were de-recognized and reclassified to stockholders’ equity (deficit) on January 24, 2023.
Stock-Based Compensation
The Company measures its stock-based awards granted to employees, consultants, and directors based on the estimated fair values of the awards and recognizes the compensation over the requisite service period. The Company uses the Black-Scholes option-pricing model to estimate the fair value of its stock option awards. Stock-based compensation is recognized using the straight-line method. As the stock compensation expense is based on awards ultimately expected to vest, it is reduced by forfeitures. The Company accounts for forfeitures as they occur.
Deferred Offering Costs
The Company capitalizes certain legal, professional, and other third-party costs that are directly associated with in-process equity financings until such financings are consummated, at which time such costs are recorded against the gross proceeds of the offering. Should an in-process equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the statements of operations and comprehensive loss.
Income Taxes
Income taxes are accounted for under the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Management makes an assessment of the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s historical operating performance and net losses, the net deferred tax assets have been fully offset by a valuation allowance.
The Company recognizes uncertain income tax positions
at the largest amount that is more likely than not to be sustained upon audit by the relevant taxing authority. An uncertain income tax
position will not be recognized if it has less than a
Net Loss Per Common Share
Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of shares of common stock and pre-funded warrants outstanding for the period, without consideration for potential dilutive shares of common stock. Diluted net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock and common stock equivalents of potentially dilutive securities outstanding for the period determined using the treasury stock or if-converted methods. Since the Company was in a loss position for all periods presented, basic net loss per common share is the same as diluted net loss per common share since the effects of potentially dilutive securities are anti-dilutive. Shares of common stock subject to repurchase are excluded from the weighted-average shares.
7
Comprehensive Loss
Comprehensive loss is defined as the change in equity during a period from transactions and other events or circumstances from non-owner sources. Net loss and comprehensive loss were the same for the periods presented in the accompanying financial statements.
Research and Development Expenses
Research and development costs are expensed as incurred and consist of fees paid to other entities that conduct certain research and development activities on the Company’s behalf. Acquired intangible assets are expensed as research and development costs if, at the time of payment, the technology is under development; is not approved by the FDA or other regulatory agencies for marketing; has not reached technical feasibility; or otherwise has no foreseeable alternative future use. Non-refundable advance payments for goods or services to be received in the future for use in research and development activities are capitalized and then expensed as the related goods are delivered or the services are performed.
On January 19, 2023, the Company issued
Patents
Patent costs are comprised primarily of external legal fees, filing fees incurred to file patent applications, and periodic renewal fees to keep the patent in force and are expensed as incurred as a component of general and administrative expenses.
Note 2. Recent Accounting Guidance
Recently Issued Accounting Pronouncements Not Yet Adopted
In November 2023, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The ASU expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly reviewed by the chief operating decision maker, or CODM, and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. The ASU also allows, in addition to the measure that is most consistent with GAAP, the disclosure of additional measures of segment profit or loss that are used by the CODM in assessing segment performance and deciding how to allocate resources. All disclosure requirements under ASU 2023-07 are also required for public entities with a single reportable segment. The ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, on a retrospective basis, with early adoption permitted. The Company is currently evaluating the impact of this standard on its disclosures.
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures. The ASU requires greater disaggregation of information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. The ASU applies to all entities subject to income taxes and is intended to help investors better understand an entity’s exposure to potential changes in jurisdictional tax legislation and assess income tax information that affects cash flow forecasts and capital allocation decisions. The ASU is effective for annual periods beginning after December 15, 2024, with early adoption permitted. The ASU should be applied on a prospective basis although retrospective application is permitted. The Company is currently evaluating the impact of this standard on its disclosures.
8
Note 3. Fair Value Measurements
Assets and liabilities recorded at fair value on a recurring basis in the balance sheet are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows:
| ● | Level 1 — | Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. |
| ● | Level 2 — | Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the asset or liability. 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 that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
The Company classified its embedded derivative liability as a Level 3 financial instrument and measured and reported its embedded derivatives at fair value. Concurrent with the closing of the initial public offering in January 2023, the note holders converted the debt into common stock, accordingly, the derivative financial liabilities were de-recognized and reclassified to stockholders’ equity (deficit) on January 24, 2023.
| September 30, 2024 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Fair Value | |||||||||||||
| Financial Assets: | ||||||||||||||||
| Money market funds | $ | $ | $ | $ | ||||||||||||
| Total financial liabilities | $ | $ | $ | $ | ||||||||||||
| December 31, 2023 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Fair Value | |||||||||||||
| Financial Assets: | ||||||||||||||||
| Money market funds | $ | $ | $ | $ | ||||||||||||
| Total financial liabilities | $ | $ | $ | $ | ||||||||||||
| Derivative Liabilities | ||||
| Balance at December 31, 2022 | $ | |||
| Change in fair value | ||||
| De-recognition of derivative liabilities | ( | ) | ||
| Balance at December 31, 2023 | $ | |||
9
The carrying amounts of cash and cash equivalents, prepaid expenses, deferred offering costs, accounts payable, and accrued liabilities approximate their fair values due to their short-term nature. There were no transfers of liabilities among the fair value measurement categories during any of the periods presented.
Note 4. Accrued Liabilities
| September 30, 2024 | December 31, 2023 | |||||||
| Accrued consulting fees | $ | $ | ||||||
| Accrued compensation | ||||||||
| Other | ||||||||
| Total accrued liabilities | $ | $ | ||||||
Note 5. Leases, Commitments, and Contingencies
Leases
At lease inception, the Company determines if an arrangement is an operating or capital lease. For operating leases, the Company recognizes rent expense, inclusive of rent escalation, on a straight-line basis over the lease term.
In accordance with ASC 842, Leases, the Company determines if an arrangement is or contains a lease at inception. A contract is or contains a lease if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. The Company classifies leases at the lease commencement date as operating or finance leases and records a right-of-use asset and a lease liability on the balance sheet for all leases with an initial lease term of greater than 12 months. Leases with an initial term of 12 months or less are not recorded in the balance sheet, but payments are recognized as expenses on a straight-line basis over the lease term. The Company has elected not to recognize leases with terms of 12 months or less.
A lease qualifies as a finance lease if any of the following criteria are met at the inception of the lease: (i) there is a transfer of ownership of the leased asset to the Company by the end of the lease term, (ii) the Company holds an option to purchase the leased asset that it is reasonably certain to exercise, (iii) the lease term is for a major part of the remaining economic life of the leased asset, (iv) the present value of the sum of lease payments equals or exceeds substantially all of the fair value of the leased asset, or (v) the nature of the leased asset is specialized to the point that it is expected to provide the lessor no alternative use at the end of the lease term. All other leases are recorded as operating leases.
The Company enters into contracts that contain both lease and non-lease components. Non-lease components may include maintenance, utilities, and other operating costs. The Company combines the lease and non-lease components of fixed costs in its lease arrangements as a single lease component. Variable costs, such as utilities or maintenance costs, are not included in the measurement of right-of-use (“ROU”) assets and lease liabilities but rather are expensed when the event determining the amount of variable consideration to be paid occurs.
Finance and operating lease assets and liabilities are recognized at the lease commencement date based on the present value of the lease payments over the lease term using the discount rate implicit in the lease. If the rate implicit is not readily determinable, the Company utilizes an estimate of its incremental borrowing rate based upon the available information at the lease commencement date. Operating lease assets are further adjusted for prepaid or accrued lease payments. Operating lease payments are expensed using the straight-line method as an operating expense over the lease term.
10
| September 30, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| Right of use assets | $ | $ | ||||||
| Liabilities | ||||||||
| Current | ||||||||
| Operating lease liabilities | $ | $ | ||||||
| Total operating lease liabilities | $ | $ | ||||||
Operating lease expenses were $
| 2024 | $ | |||
| Total lease payments | ||||
| Less: Imputed interest | ||||
| Total operating lease liabilities | $ |
Contingencies
In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown, because it involves claims that may be made against the Company in the future, but have not yet been made. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated.
Indemnification
In accordance with the Company’s certificate of incorporation and bylaws, the Company indemnifies its officers and directors for certain events or occurrences, subject to certain limits, while they are serving in such capacity. In addition, the Company has entered into indemnification agreements with its officers and directors. There have been no claims to date, and the Company has a directors and officers liability insurance policy that may enable it to recover a portion of any amounts paid for future claims.
Note 6. Stockholders’ Equity and Warrants
Reverse Stock Split
On July 29, 2024, the Company’s stockholders approved amendments to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of its shares of common stock, and its Board of Directors subsequently approved a final reverse stock split ratio of 1-for-15. The reverse stock split became effective on August 20, 2024. On the effective date, every 15 shares of issued and outstanding common stock were combined and converted into one issued and outstanding share of common stock. The number of authorized shares of common stock was not reduced and the par value per share of common stock remains unchanged. Fractional shares were canceled, and stockholders received cash in lieu thereof. A proportionate adjustment was also made to the maximum number of shares of common stock issuable under the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive Plan. As a result, the number of common shares, stock options, warrants, net loss per share, and exercise prices disclosed throughout these notes to the unaudited financial statements, as well as the Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 to which these unaudited financial statements and notes thereto are attached, have been retrospectively adjusted to reflect the reverse stock split.
11
Common Stock
The Company is authorized to issue a total of
Holders of common stock are entitled to
On January 24, 2023, the Company consummated its
IPO of
In connection with the IPO, on January 19, 2023,
the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Boustead Securities, LLC, as representative
of the underwriters (the “Representative”). Pursuant to the Underwriting Agreement, the Company issued to the underwriters
a five-year warrant (the “Representative’s Warrant”) to purchase an aggregate of
On July 12, 2023, the Company entered into a securities
purchase agreement with an institutional investor (the “Investor Selling Stockholder”) pursuant to which the Company sold
to the Investor Selling Stockholder in a private placement (the “Private Placement”) (i) an aggregate of
The Private Placement closed on July 14, 2023.
The Company received aggregate gross proceeds from the Private Placement of approximately $
Each Pre-Funded Warrant had an exercise price
equal to $
During the three months ended March 31, 2024,
the Company received notice of the exercise of all of the
The Common Warrants issued in the Private Placement
provide that the holder thereof has the right to participate in distributions or dividends paid on the Company’s shares of common
stock on an as-converted basis. They also provide that a holder of Common Warrants, as applicable, will not have the right to exercise
any portion of its Common Warrants if such holder, together with its affiliates, and any other party whose holdings would be aggregated
with those of the holder for purposes of Section 13(d) or Section 16 of the Exchange Act would beneficially own in excess of
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ATM Facility
During the quarter ended September 30, 2024, the
Company sold
Warrant Summary
| Exercise Price | Expiration | Outstanding as of December 31, | New | Outstanding as of September 30, | ||||||||||||||||||||
| Issue Date | Per Share | Date | 2023 | Issuance | Exercised | 2024 | ||||||||||||||||||
| Placement agent warrants | $ | |||||||||||||||||||||||
| Placement agent warrants | $ | |||||||||||||||||||||||
| Representative warrants | $ | |||||||||||||||||||||||
| Pre-funded investor warrants | $ | ( | ) | |||||||||||||||||||||
| Common warrants | $ | |||||||||||||||||||||||
| Placement agent warrants | $ | |||||||||||||||||||||||
| ( | ) | |||||||||||||||||||||||
Note 7. Equity-Based Compensation
The Company adopted the Cadrenal Therapeutics, Inc. 2022 Equity Incentive Plan (the “Initial Plan”), on July 11, 2022, which was later amended and restated on October 16, 2022, for purposes of clarifying the application of certain of the rules of the Initial Plan to awards approved before such amendment and restatement of the Initial Plan and to facilitate the transition to the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive Plan (the “Successor Plan”) for the issuance and approval of awards after consummation of the IPO. On October 16, 2022, the Board adopted and the Company’s stockholders approved the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive Plan (the “2022 Plan”), which is a successor to and continuation of the Initial Plan and became effective on January 19, 2023. Upon the effectiveness of the 2022 Plan, it replaced the Initial Plan, except with respect to awards outstanding under the Initial Plan, and no further awards will be available for grant under the Initial Plan.
Subject to certain adjustments, the maximum number
of shares of common stock that could have been issued under the Initial Plan and 2022 Plan was initially
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The Company measures its stock-based awards granted to employees, consultants and directors based on the estimated fair values of the awards and recognizes the compensation over the requisite service period. The Company uses the Black-Scholes option-pricing model to estimate the fair value of its stock option awards. Stock-based compensation is recognized using the straight-line method. As the stock compensation expense is based on awards ultimately expected to vest, it is reduced by forfeitures. The Company accounts for forfeitures as they occur.
| Three Months Ended | Nine Months Ended | |||||||
| September 30, 2024 | September 30, 2024 | |||||||
| Risk-free interest rate | % | |||||||
| Dividend yield | ||||||||
| Expected term (years) | ||||||||
| Volatility | % | |||||||
| Number Outstanding | Weighted- Average Exercise Price Per Share | Weighted- Average Remaining Contractual Life (Years) | Aggregate Intrinsic Value | |||||||||||||
| Outstanding at December 31, 2023 | $ | $ | ||||||||||||||
| Granted | ||||||||||||||||
| Exercised | - | |||||||||||||||
| Canceled/forfeited/expired | - | |||||||||||||||
| Outstanding at September 30, 2024 | $ | $ | ||||||||||||||
| Options vested and exercisable at September 30, 2024 | $ | $ | ||||||||||||||
| Options vested and expected to vest as of September 30, 2024 | $ | $ | ||||||||||||||
The weighted average grant date fair value of
options granted to date was $
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| General and administrative | $ | $ | $ | $ | ||||||||||||
| Research and development | ||||||||||||||||
| Total stock-based compensation | $ | $ | $ | $ | ||||||||||||
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Note 8. Net Loss Per Common Share
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Numerator: | ||||||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Denominator: | ||||||||||||||||
| Weighted average common shares outstanding | ||||||||||||||||
| Net loss per common share, basic and diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
Since the Company was in a loss position for the periods presented, basic net loss per share is the same as diluted net loss per share as the inclusion of all potential dilutive securities would have been anti-dilutive. For the periods presented, there were no potential dilutive securities other than convertible notes, stock options, and warrants.
| As of September 30, | ||||||||
| 2024 | 2023 | |||||||
| Anti-dilutive common stock equivalents: | ||||||||
| Stock options to purchase common stock | ||||||||
| Warrants to purchase common stock | ||||||||
| Total anti-dilutive common stock equivalents | ||||||||
Note 9. Subsequent Events
The Company has evaluated events that occurred through November 7, 2024, the date that the financial statements were issued, and determined that except than as set forth below, there have been no events that have occurred that would require adjustments to the Company’s disclosures in the financial statements.
On October 10, 2024, the Company issued
During October 2024, the Company sold
On November 1, 2024, the Company entered
into the Warrant Inducement Agreement with the Holder of the Existing Warrants pursuant to which the Holder and exercised the
Existing Warrants, purchasing
In consideration for the Holder’s exercise of
the Existing Warrants, the Company issued new unregistered Series A-1 and Series A-2 warrants (the “New Warrants”) to the Holder,
to purchase up to an additional
H.C.W. acted as the exclusive placement agent
for the warrant inducement transaction. As part of its compensation, the Company agreed to pay HCW a cash fee equal to
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following management’s discussion and analysis of our financial condition and results of operations in conjunction with our unaudited financial statements and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with our audited financial statements and notes thereto for the year ended December 31, 2023, included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed on March 11, 2024 (the “Annual Report”) with the U.S. Securities and Exchange Commission (the “SEC”). This discussion, particularly information with respect to our future results of operations or financial condition, business strategy, plans and objectives for future operations, includes forward-looking statements that involve risks and uncertainties as described under the heading “Special note regarding forward-looking statements” in this Quarterly Report on Form 10-Q. You should review the disclosure under Part 1, Item 1A of the Annual Report for a discussion of important factors that could cause our actual results to differ materially from those anticipated in these forward-looking statements. References in this Quarterly Report on Form 10-Q to “we,” “us,” “our” and similar first-person expressions refer to Cadrenal Therapeutics, Inc. (“Cadrenal”).
Special Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those discussed in the forward-looking statements. The statements contained in this report that are not purely historical are 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”). Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “seek,” “should,” “strategy,” “target,” “will,” “would” and similar expressions or variations intended to identify forward-looking statements. These statements are based on the beliefs and assumptions of our management based on information currently available to management. Such forward-looking statements are subject to risks, uncertainties and other important factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified under Part 1, Item 1A of the Annual Report. Furthermore, such forward-looking statements speak only as of the date of this report. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.
Company Overview
We are developing tecarfarin, a new Vitamin K Antagonist (VKA) chronic anticoagulant (blood thinner) to prevent heart attacks, strokes, and deaths due to thrombosis (blood clots) in patients with implanted cardiac devices or rare cardiovascular conditions. The prevailing treatment for thrombosis is an oral anticoagulant, either a VKA, like warfarin, or a direct oral anticoagulant, (“DOAC”). VKAs block the production of vitamin K-dependent blood clotting factors, such that the blood is “thinned,” preventing clots, while DOACs directly block the activity of certain of these clotting factors. Tecarfarin, like warfarin, is a VKA.
Tecarfarin, a once-daily oral and reversible anticoagulation treatment, is expected to improve outcomes and reduce overall healthcare costs for patients that are not well served by currently available VKAs and for which DOACs are contraindicated or lack clinical evidence of efficacy. This includes patients with LVADs, patients with ESKD and AFib, and patients with mechanical heart valves, among others, where the need for VKA-dependent chronic anticoagulation has been underscored by recent clinical studies.
Tecarfarin is specifically designed to provide safer and more effective anticoagulation than the most commonly prescribed VKA, warfarin.
We anticipate that tecarfarin will address many of the bleeding and other adverse events and drug-to-drug interaction challenges of warfarin because tecarfarin is metabolized using a different metabolic pathway.
Extensive data indicates that tecarfarin may avoid kidney impairment problems, which are common in these patients. Late-stage clinical trials show that tecarfarin may offer enhanced stability and time in therapeutic range (TTR) that inversely correlates with major events. Cadrenal aims to show that tecarfarin will provide less dosing variability, enhancing the quality of care for patients and reducing the time-consuming and costly hassles of dosing adjustments for healthcare providers. We believe tecarfarin is the only new anticoagulant being developed for patients with implanted cardiac devices and certain other rare cardiovascular conditions. Despite breakthrough implanted cardiac device products by leading medical device companies such as Abbott, patients still depend on 70-year-old warfarin for the indefinite future.
Tecarfarin has an orphan drug designation from the U.S. Food and Drug Administration (the “FDA”) for the prevention of thrombosis and thromboembolism (blood clots) in patients with an implanted mechanical circulatory support device, which includes left ventricular assist device (LVAD), a heart pump. Tecarfarin also has orphan drug and fast-track designations from the FDA for the prevention of systemic thromboembolism of cardiac origin in patients with end-stage kidney disease (ESKD) and atrial fibrillation (AFib).
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Tecarfarin has been evaluated in eleven (11) human clinical trials in over 1,000 individuals; (269 patients were treated for at least six months and 129 patients were treated for one year or more). In Phase 1, Phase 2 and Phase 2/3 clinical trials, tecarfarin has generally been well-tolerated in both healthy adult subjects and patients with chronic kidney disease (“CKD”). In the Phase 2/3 trial, EMBRACE-AC, the largest tecarfarin trial with 607 patients having completed it including those with mechanical heart valves, only 1.6% of the blinded tecarfarin subjects suffered from major bleeding and there were no thrombotic events.
Tecarfarin was developed by researchers using a small molecule “retrometabolic” drug design process which targets a different metabolic pathway than the most commonly prescribed drugs for the treatment of thrombosis and AFib. “Drug metabolism” refers to the process by which a drug is inactivated by the body and rendered easier to eliminate or to be cleared by the body. Most approved drugs, including warfarin, the only FDA-approved VKA, which is a prescribed drug for the treatment of thrombosis, are metabolized in the liver through a pathway known as the Cytochrome CYP450 system, or CYP450, by the enzymes known as CYP2C9 and CYP3A4.
By using a different metabolic pathway, tecarfarin eliminates or minimizes the CYP450 metabolism in the liver. Patients taking multiple medications that interact with CYP2C9, or CYP3A4, or those with impaired kidney function, can experience an overload in the pathway, creating a bottleneck that often leads to insufficient clearance, which results in a toxic build-up of one or more drugs. In some instances, patients taking multiple medications metabolized by the same CYP450 pathway may experience decreased efficacy of one or more of the medications due to rapid metabolism or increased drug effect and/or toxicity due to enzyme induction. Patient-specific genetic differences can also hinder drug clearance in the CYP450 pathway. Our product candidate tecarfarin was designed to follow a metabolic pathway distinct from the CYP450 pathway and is metabolized by both CYP450 and non-CYP450 pathways. We believe this may allow elimination by large capacity and non-saturable tissue esterase pathways that exist throughout the body rather than just in the liver.
There are approximately 15,000 patients in the U.S. with LVADs, and recent randomized controlled trials in LVAD patients have documented that currently available VKAs yield poor quality anticoagulation despite the tight management of anticoagulation in the clinical trial setting. Implantable LVAD therapy is used to improve quality of life, alleviate symptoms, and extend survival rates in patients with advanced heart failure, irrespective of eligibility for cardiac transplant. Patients with LVADs require chronic anticoagulation to reduce the risk of thromboembolic complications, and under the currently available anticoagulants, they commonly experience bleeding events. Recent data reveals that the current standard of care anticoagulant, warfarin, yields suboptimal levels of anticoagulation, leading to excess bleeding complications. LVAD patients require life-long anticoagulant therapy to reduce the risk of pump thrombosis and anticoagulation management in patients with LVADs continues to be a challenge. Patients and their clinicians are faced with the daily challenge of balancing the need for adequate anticoagulation versus the bleeding risks that are associated with excess anticoagulation. Warfarin is the only available oral anticoagulant for all currently available LVAD devices, however, warfarin is known to be a difficult medication to manage due to its labile metabolism, and its many drug-drug interactions which also impacts the stability of anticoagulation.
In patients with LVADs, recent data also highlights the need for a next generation VKA anticoagulant. The ARIES-HM3 study was designed to evaluate the need for chronic aspirin treatment in patients with the newest LVAD, the HeartMate3. The use of aspirin in LVAD patients was standard but had never been proven to be beneficial. The ARIES study randomized LVAD patients to continue aspirin, along with warfarin, versus warfarin alone. The main finding of the study revealed that aspirin is not helpful in LVAD patients; however, since all patients were receiving warfarin and had careful monitoring of the quality of anticoagulation, the study also provided the opportunity to determine if the quality of anticoagulation provided by warfarin, had an impact on patient outcomes. The analysis of this carefully controlled and monitored study showed that the average time in the therapeutic range was only 56% with warfarin, far below the target of 70%, and that, despite the superior design of the HM3 device, poor quality anticoagulation was associated with excess thrombotic and bleeding events.
Initial Public Offering
On January 24, 2023, we consummated our initial public offering (the “IPO”) of 93,333 shares of our common stock, par value $0.001 per share (the “common stock”) at a public offering price of $75.00 per share, generating gross proceeds of $7,000,000. Our shares of common stock commenced trading on the Nasdaq on January 20, 2023 under the symbol “CVKD.”
Private Placement
On July 12, 2023, we entered into a securities purchase agreement (the “Purchase Agreement”) with an institutional investor (the “Investor”) pursuant to which we sold to the Investor in a private placement priced at-the-market (the “Private Placement”) consistent with the rules of the Nasdaq), (i) an aggregate of 86,667 shares of common stock, (ii) in lieu of additional share of common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to an aggregate of 199,047 shares of common stock, and (iii) accompanying common warrants (the “Common Warrants”) to purchase up to an aggregate of 285,715 shares of common stock. The combined purchase price of each share and accompanying Common Warrants was $26.25. The combined purchase price of each Pre-Funded Warrant and accompanying Common Warrants was $26.25.
The Private Placement closed on July 14, 2023. We received aggregate gross proceeds from the Private Placement of approximately $7.5 million before deducting the placement agent commissions and estimated offering expenses payable by us. We intend to use the net proceeds from the Private Placement for working capital purposes. H.C. Wainwright & Co., LLC (“H.C.W.”) acted as the placement agent in the Private Placement, and as part of its compensation, we issued to designees of H.C.W. Placement Agent Warrants to purchase up to 18,571 shares of common stock.
17
ATM Facility
During the quarter ended September 30, 2024, we sold 154,144 shares of our common stock through our at-the-market (ATM) facility with H.C.W., generating gross proceeds of $1,635,777 and net proceeds of $1,527,946.
During October 2024, we sold 237,099 shares of our common stock through our ATM facility. These sales were made at a weighted average price of $14.79 per share, resulting in additional gross proceeds of $3,507,817.
Warrant Inducement
On November 1, 2024, the Company entered into a warrant inducement letter agreement (the “Warrant Inducement Agreement”) with a holder (the “Holder”) of outstanding warrants to purchase up to 285,715 shares of common stock issued in a private placement offering on July 14, 2023 (the “Existing Warrants”) pursuant to which such holder exercised the Existing Warrants at a reduced exercise price of $16.50 generating approximately $4.7 million in gross proceeds. See Note 9-Subsequent Events for a more detailed discussion of the warrant inducement transaction.
Results of Operations
Results of Operations for the Three Months Ended September 30, 2024 and Three Months Ended September 30, 2023
The following table summarizes our results of operations for the three months ended September 30, 2024 and September 30, 2023.
| Three Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses: | ||||||||
| General and administrative expenses | $ | 1,674,905 | $ | 898,051 | ||||
| Research and development expenses | 784,646 | 243,948 | ||||||
| Depreciation expense | 470 | 597 | ||||||
| Total operating expenses | 2,459,958 | 1,142,596 | ||||||
| Loss from operations | (2,459,958 | ) | (1,142,596 | ) | ||||
| Other (income) expense: | ||||||||
| Interest and dividend income | (52,129 | ) | (106,145 | ) | ||||
| Total other (income) expense | (52,129 | ) | (106,145 | ) | ||||
| Net loss and comprehensive loss | $ | (2,407,829 | ) | $ | (1,036,451 | ) | ||
General and administrative expenses
General and administrative expenses were $1,674,905 for the three months ended September 30, 2024 compared to $898,051 for the three months ended September 30, 2023. The $776,854, or 87%, increase can be primarily attributed to a $192,948 increase in personnel-related expenses as a result of the hiring of a Chief Operating Officer in February 2024 as well as annual pay raises for management in January 2024, a $422,147 increase in public company expenses, a $141,304 increase in stock-based compensation, and a $77,456 increase in professional fees and other expenses. These increases were partially offset by a $45,535 decrease in consulting expenses.
Research and development expenses
Research and development expenses were $784,646 for the three months ended September 30, 2024, compared to $243,948 for the three months ended September 30, 2023. The $540,698, or 222%, increase can be primarily attributed to a $291,155 increase in expenses associated with chemistry, manufacturing and controls (“CMC”), a $213,078 increase in consulting fees, and a $19,102 increase in personnel-related expenses.
Interest and dividend income
Interest and dividend income was $52,129 for the three months ended September 30, 2024. This represents the interest and dividend income earned from our investments in money market funds from the proceeds of our IPO and July 2023 Private Placement. Interest and dividend income was $106,145 for the three months ended September 30, 2023. The decrease in interest and dividend income in the current quarter can be attributed to lower balances in money market funds.
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Results of Operations for the Nine Months Ended September 30, 2024 and Nine Months Ended September 30, 2023
The following table summarizes our results of operations for the nine months ended September 30, 2024 and September 30, 2023.
| Nine Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Operating expenses: | ||||||||
| General and administrative expenses | $ | 4,013,336 | $ | 2,647,407 | ||||
| Research and development expenses | 2,667,382 | 3,720,222 | ||||||
| Depreciation expense | 1,473 | 1,383 | ||||||
| Total operating expenses | 6,682,191 | 6,369,012 | ||||||
| Loss from operations | (6,682,191 | ) | (6,369,012 | ) | ||||
| Other (income) expense: | ||||||||
| Interest and dividend income | (218,092 | ) | (129,321 | ) | ||||
| Interest expense | - | 3,534 | ||||||
| Interest expense, amortization of debt discount | - | 13,567 | ||||||
| Change in fair value of derivative liabilities | - | 216,095 | ||||||
| Loss on extinguishment of debt | - | 740,139 | ||||||
| Total other (income) expense | (218,092 | ) | 844,014 | |||||
| Net loss and comprehensive loss | $ | (6,464,099 | ) | $ | (7,213,026 | ) | ||
General and administrative expenses
General and administrative expenses were $4,013,336 for the nine months ended September 30, 2024 compared to $2,647,407 for the nine months ended September 30, 2023. The $1,365,929, or 52%, increase can be primarily attributed to a $588,693 increase in personnel-related expenses as we hired a Chief Operating Officer in February 2024 as well as annual pay raises for management in January 2024, a $636,669 increase in public company expenses, and a $61,139 increase in professional fees. These increases were partially offset by a $93,788 decrease in consulting expenses.
Research and development expenses
Research and development expenses were $2,667,382 for the nine months ended September 30, 2024 compared to $3,720,222 for the nine months ended September 30, 2023. The prior period included a $3.0 million expense for the issuance of 40,000 shares of common stock (valued at $3.0 million) in January 2023 to HESP LLC, pursuant to the terms of an Amendment to the Asset Purchase Agreement. This $3.0 million decrease was partially offset by a $1,094,419 increase in expenses associated with chemistry, manufacturing and controls (“CMC”), a $666,033 increase in consulting fees, a $105,073 increase in personnel-related expenses, and a $69,120 increase in professional fees.
Change in fair value of derivative liabilities
Concurrent with the closing of the IPO in January 2023, the note holders converted the debt into common stock, accordingly, the derivative financial liabilities were de-recognized and reclassified to stockholders’ equity (deficit) on January 24, 2023.
The derivative liabilities were considered a level 3 fair value financial instrument and were remeasured up to January 24, 2023 which was the date of derecognition. We recorded a non-cash charge of $216,095 in January 2023. This charge represented the increase in the fair value of the derivative liabilities since the previous measurement date of December 31, 2022. We did not have such activity during the nine months ended September 30, 2024.
Loss on extinguishment of debt
We recorded a $740,139 loss on the extinguishment of debt during the nine months ended September 30, 2023. This loss represented the unamortized debt discount associated with the convertible notes and the November promissory notes, which were settled concurrent with the IPO. We did not have such activity during the nine months ended September 30, 2024.
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Liquidity and Capital Resources
Since inception, we have incurred losses and negative cash flows from operations. To date, we have funded our operations from the proceeds of the sale of convertible notes, and the nonconvertible notes and warrants issued in November 2022, as well as our IPO completed in January 2023, our Private Placement consummated in July 2023, and the sale of common stock through our ATM facility. We had a net loss of $6,464,099 for the nine months ended September 30, 2024 which included $656,987 of non-cash expenses. Cash used in operating activities for the nine months ended September 30, 2024 totaled $5,566,844. As of November 7, 2024, we had cash and cash equivalents of approximately $11.3 million, which is expected to be sufficient to fund our operations for at least the next twelve months from the date of the filing of this Quarterly Report on Form 10-Q, however, we will require additional funding to complete our planned Phase 3 clinical trial and submit our New Drug Application.
Cash Flows
The following table summarizes our cash flows for the periods presented:
| Nine Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Cash used in operating activities | $ | (5,566,844 | ) | $ | (2,835,878 | ) | ||
| Cash used in investing activities | - | (3,254 | ) | |||||
| Cash provided by financing activities | 1,528,244 | 11,915,991 | ||||||
| Net (decrease) increase in cash | (4,038,600 | ) | 9,076,859 | |||||
| Cash and cash equivalents, beginning of period | 8,402,500 | 32,586 | ||||||
| Cash and cash equivalents, end of period | $ | 4,363,900 | $ | 9,109,445 | ||||
Operating activities
During the nine months ended September 30, 2024, cash used in operating activities was $5,566,844. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $5,807,112 in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, provided $240,268 in cash primarily from a $329,504 increase in accounts payable partially offset by a $116,884 increase in deferred offering costs, and a $102,033 increase in prepaid expenses.
During the nine months ended September 30, 2023, cash used in operating activities was $2,835,878. Net loss adjusted for the non-cash items as detailed on the statement of cash flows, used $2,634,308 in cash, and the changes in operating assets and liabilities, as detailed on the statement of cash flows, used $201,570 in cash primarily from a decrease in accrued liabilities of $466,935 and a decrease in accounts payable of $263,239, partially offset by a $672,295 decrease in deferred equity offering costs.
Financing activities
During the nine months ended September 30, 2024, net cash provided by financing activities totaled $1,528,244. During the period, we utilized our ATM facility, which generated proceeds of $1,527,946, net of fees. In addition, we had proceeds of $298 from the exercise of Pre-Funded Warrants.
During the nine months ended September 30, 2023, net cash provided by financing activities totaled $11,915,991 as we completed our IPO in January 2023, generating net proceeds of $5,408,575, and we completed a private placement financing in July 2023, generating net proceeds of $6,507,416. We also received $250,000 from the exercise of warrants that we issued in November 2022, which proceeds were used to repay the notes that were issued in November, with accrued interest on the notes being paid in cash.
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Critical Accounting Estimates
This discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses incurred during the reporting periods. Significant estimates and assumptions made in the accompanying financial statements include but are not limited to the fair value of financial instruments, the fair value of stock-based awards, deferred tax assets and valuation allowance, income tax uncertainties, and certain accruals. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimated under different assumption or conditions.
Derivative Financial Instruments
We evaluate all of our agreements to determine if such instruments have derivatives or contain features that qualify as embedded derivatives. We account for certain redemption features that are associated with convertible notes as liabilities at fair value and adjust the instruments to their fair value at the end of each reporting period. Derivative financial liabilities are initially recorded at fair value, with gains and losses arising from changes in the fair value recognized in other income (expense) in the accompanying statements of operations and comprehensive loss for each reporting period while such instruments are outstanding. The embedded derivative liability is valued using a probability-weighted expected return model. If we repay the note holders or if, during the next round of financing, the note holders convert the debt into equity, the derivative financial liability will be de-recognized on that date. Derivative instrument liabilities are classified in the balance sheet as current or non-current based on whether or not net-cash settlement of the derivative instrument could be required within 12 months of the balance sheet date.
Stock-Based Compensation
We measure our stock-based awards granted to employees, consultants and directors based on the estimated fair values of the awards and recognize the compensation over the requisite service period. We use the Black-Scholes option-pricing model to estimate the fair value of our stock option awards. Stock-based compensation is recognized using the straight-line method. As the stock compensation expense is based on awards ultimately expected to vest, it is reduced by forfeitures. We account for forfeitures as they occur.
OFF-BALANCE SHEET ARRANGEMENTS
We did not have during the period presented, and we do not currently have, any off-balance sheet arrangements, as defined under the SEC rules.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2024. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. We have adopted and maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) that are designed to provide reasonable assurance that information required to be disclosed in the reports filed under the Exchange Act, such as this Quarterly Report on Form 10-Q, is collected, recorded, processed, summarized, and reported within the time periods specified in the rules of the SEC. Our disclosure controls and procedures are also designed to ensure that such information is accumulated and communicated to management to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of September 30, 2024, our Chief Executive Officer and Chief Financial Officer concluded that, as of such a date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
During the quarter ended September 30, 2024, there were no changes in our internal control over financial reporting (as defined in Rules 13a 15(f) and 15d 15(f) of the Exchange Act) that occurred that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
21
PART II: OTHER INFORMATION
Item 1. Legal Proceedings
We are not currently subject to any material legal proceedings.
Item 1A. Risk Factors
Investing in our securities involves a high degree of risk. Please refer to Part I, Item 1A, “Risk Factors,” contained in our Annual Report for a description of certain significant risks and uncertainties to which our business, financial condition and results of operations are subject. Except as set forth below, there have been no material changes from these risk factors as of the date of filing of this Quarterly Report on Form 10-Q.
We cannot be assured that we will be able to maintain our listing on the Nasdaq Capital Market.
Our securities are listed on The Nasdaq Capital Market, a national securities exchange. We cannot be assured that we will continue to comply with the rules, regulations or requirements governing the listing of our common stock on Nasdaq Capital Market or that our securities will continue to be listed on Nasdaq Capital Market in the future. If Nasdaq should determine at any time that we fail to meet Nasdaq requirements, we may be subject to a delisting action by Nasdaq.
On September 6, 2023, we received a letter from Nasdaq stating that we were not in compliance with Nasdaq Listing Rule 5550(a)(2) (the “Rule”), requiring listed securities to maintain a minimum bid price of $1.00 per share because our closing bid price for the last 30 consecutive business days was below $1.00 per share. Pursuant to the Rule, we initially had 180 calendar days (until March 4, 2024), to regain compliance with the Nasdaq Listing Rules (the “Compliance Period”). On February 16, 2024, we requested an additional 180 calendar days to comply with the Rule. On March 5, 2024, we received written notification from Nasdaq granting our request for a 180-day extension or until September 3, 2024 to regain compliance with the Rule. On August 20, 2024, we effected a 1-for-15 reverse stock split. On September 5, 2024, we received a letter from Nasdaq stating that we had regained compliance with the Rule. However, there can be no assurance that we will continue to comply with the Rule or any other Nasdaq continued listing requirements.
If Nasdaq delists our securities from trading on its exchange at some future date, we could face significant material adverse consequences, including:
| ● | a limited availability of market quotations for our securities; |
| ● | reduced liquidity with respect to our securities; |
| ● | a determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our common stock; |
| ● | a limited amount of news and analyst coverage for our company; and |
| ● | a decreased ability to issue additional securities or obtain additional financing in the future. |
We will also need to raise additional capital to meet our long-term business objectives.
We had an accumulated deficit of $21,535,514 as of September 30, 2024 and a net loss of approximately $6,464,099 for the nine months ended September 30, 2024, having incurred significant losses from operations to date. We expect to incur significant expenses and continued losses from operations for the foreseeable future. We believe that our existing cash and cash equivalents will be sufficient to meet our anticipated cash requirements for the next twelve months, however, we will require additional financing as we continue to execute our business strategy, including additional funds for the initiation of enrollment of patients and completion of the planned pivotal Phase 3 trial for tecarfarin. Our unaudited financial statement for the nine months ended September 30, 2024 were prepared under the assumption that we will continue as a going concern; however, we expect our expenses to increase in connection with the initiation of enrollment of patients and completion of the planned pivotal Phase 3 trial for tecarfarin. Our liquidity may be negatively impacted as a result of research and development cost increases in addition to general economic and industry factors. In order to meet our expected obligations, we intend to raise additional funds through partnering and equity and debt financings or a combination of these potential sources of liquidity. There can be no assurance that funding will be available on acceptable terms on a timely basis, or at all. The various ways that we could raise capital carry potential risks. Any additional sources of financing will likely involve the issuance of our equity securities, which will have a dilutive effect on our stockholders. Any debt financing, if available, may involve restrictive covenants that may impact our ability to conduct our business. If we raise funds through partnering such as collaborations and licensing arrangements, we might be required to relinquish significant rights to our technologies or grant licenses on terms that are not favorable to us. If we do not succeed in raising additional funds on acceptable terms or at all, we may be unable to complete the planned Phase 3 trial.
22
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
(a) Unregistered Sales of Equity Securities
We did not sell any equity securities during the quarter ended September 30, 2024 and up to the date of the filing of this Quarterly Report on Form 10-Q in transactions that were not registered under the Securities Act other than as set forth below and as previously disclosed in our filings with the SEC.
On September 11, 2024, we issued 13,333 shares of restricted common stock to a consultant as partial compensation for services.
On October 10, 2024, we issued 25,000 shares of restricted common stock to a consultant as partial compensation for services.
(b) Use of Proceeds
Not applicable.
(c) Issuer Purchases of Equity Securities
Not applicable.
Item 3. Defaults Upon Senior Securities.
Not applicable.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
During the three months ended September 30, 2024,
no director or officer of the Company
23
Item 6. Exhibits.
The exhibits filed or furnished as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index, which Exhibit Index is incorporated herein by reference.
| * | Filed herewith. |
| # | Management contract or compensatory plan or arrangement required to be identified pursuant to Item 15(a)(3) of this Quarterly Report on Form 10-Q. |
24
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| CADRENAL THERAPEUTICS, INC. | ||
| (Registrant) | ||
| Date: November 7, 2024 | By: | /s/ Quang Pham |
| Quang Pham | ||
| Chief Executive Officer | ||
| (Principal Executive Officer) | ||
| CADRENAL THERAPEUTICS, INC. | ||
| (Registrant) | ||
| Date: November 7, 2024 | By: | /s/ Matthew Szot |
| Matthew Szot | ||
| Chief Financial Officer | ||
| (Principal Financial Officer and Principal Accounting Officer) | ||
25
Exhibit 31.1
Certification of Chief Executive Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Quang Pham, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q of Cadrenal Therapeutics, Inc. |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| a. | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| b. | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| c. | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| d. | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| a. | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| b. | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: November 7, 2024 | |||
| By: | /s/ Quang Pham | ||
| Name: | Quang Pham | ||
| Title: | Chief Executive Officer | ||
| (Principal Executive Officer) | |||
Exhibit 31.2
Certification of Chief Financial Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Matthew Szot, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q of Cadrenal Therapeutics, Inc. |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| a. | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| b. | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| c. | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| d. | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| a. | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| b. | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: November 7, 2024 | |||
| By: | /s/ Matthew Szot | ||
| Name: | Matthew Szot | ||
| Title: | Chief Financial Officer | ||
| (Principal Financial Officer and | |||
| Principal Accounting Officer) | |||
Exhibit 32.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
I, Quang Pham, Chief Executive Officer (Principal Executive Officer) of Cadrenal Therapeutics, Inc. (the “Company”), do hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:
| 1. | The Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2024 (the “Form 10-Q”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended; and |
| 2. | The information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company for the periods presented. |
| Dated: November 7, 2024 | ||
| By: | /s/ Quang Pham | |
| Name: | Quang Pham | |
| Title: | Chief Executive Officer | |
| (Principal Executive Officer) |
Exhibit 32.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
I, Matthew Szot, Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) of Cadrenal Therapeutics, Inc. (the “Company”), do hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:
| 1. | The Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2024 (the “Form 10-Q”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended; and |
| 2. | The information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company for the periods presented. |
| Dated: November 7, 2024 | ||
| By: | /s/ Matthew Szot | |
| Name: | Matthew Szot | |
| Title: | Chief Financial Officer | |
| (Principal Financial Officer and | ||
| Principal Accounting Officer) |
Balance Sheets (Parentheticals) - $ / shares |
Sep. 30, 2024 |
Dec. 31, 2023 |
||
|---|---|---|---|---|
| Statement of Financial Position [Abstract] | ||||
| Preferred stock par value (in Dollars per share) | $ 0.001 | $ 0.001 | ||
| Preferred stock, shares authorized | 7,500,000 | 7,500,000 | ||
| Preferred stock, shares issued | ||||
| Preferred stock, shares outstanding | ||||
| Common stock, par value (in Dollars per share) | [1] | $ 0.001 | $ 0.001 | |
| Common stock, shares authorized | [1] | 75,000,000 | 75,000,000 | |
| Common stock, shares issued | [1] | 1,234,672 | 868,184 | |
| Common stock, shares outstanding | [1] | 1,234,672 | 868,184 | |
| ||||
Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) |
3 Months Ended | 9 Months Ended | ||||
|---|---|---|---|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
|||
| Operating expenses: | ||||||
| General and administrative expenses | $ 1,674,905 | $ 898,051 | $ 4,013,336 | $ 2,647,407 | ||
| Research and development expenses | 784,646 | 243,948 | 2,667,382 | 3,720,222 | ||
| Depreciation expense | 407 | 597 | 1,473 | 1,383 | ||
| Total operating expenses | 2,459,958 | 1,142,596 | 6,682,191 | 6,369,012 | ||
| Loss from operations | (2,459,958) | (1,142,596) | (6,682,191) | (6,369,012) | ||
| Other (income) expense: | ||||||
| Interest and dividend income | (52,129) | (106,145) | (218,092) | (129,321) | ||
| Interest expense | 3,534 | |||||
| Interest expense, amortization of debt discount | 13,567 | |||||
| Change in fair value of derivative liabilities | 216,095 | |||||
| Loss on extinguishment of debt | 740,139 | |||||
| Total other (income) expense | (52,129) | (106,145) | (218,092) | 844,014 | ||
| Net loss and comprehensive loss | $ (2,407,829) | $ (1,036,451) | $ (6,464,099) | $ (7,213,026) | ||
| Net loss per common share, basic (in Dollars per share) | [1] | $ (2.18) | $ (1.01) | $ (5.99) | $ (8.56) | |
| Net loss per common share, diluted (in Dollars per share) | [1] | $ (2.18) | $ (1.01) | $ (5.99) | $ (8.56) | |
| Weighted average number of common shares used in computing net loss per common share, basic (in Shares) | [1] | 1,104,005 | 1,026,415 | 1,079,489 | 842,721 | |
| Weighted average number of common shares used in computing net loss per common share, diluted (in Shares) | [1] | 1,104,005 | 1,026,415 | 1,079,489 | 842,721 | |
| ||||||
Statements of Changes in Stockholders’ Equity (Unaudited) - USD ($) |
Common Stock |
Additional Paid-In Capital |
Accumulated Deficit |
Total |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Balance at Dec. 31, 2022 | $ 546 | [1] | $ 1,162,633 | [1] | $ (6,714,329) | $ (5,551,150) | |||||
| Balance (in Shares) at Dec. 31, 2022 | [1] | 546,258 | |||||||||
| Equity-based compensation - options, restricted stock and RSUs | $ 4 | [1] | 498,986 | [1] | 498,990 | ||||||
| Equity-based compensation - options, restricted stock and RSUs (in Shares) | [1] | 4,056 | |||||||||
| Issuance of common shares in initial public offering, net of offering costs | $ 93 | [1] | 5,408,482 | [1] | 5,408,575 | ||||||
| Issuance of common shares in initial public offering, net of offering costs (in Shares) | [1] | 93,333 | |||||||||
| Issuance of common shares to settle convertible debt | $ 76 | [1] | 1,140,624 | [1] | 1,140,700 | ||||||
| Issuance of common shares to settle convertible debt (in Shares) | [1] | 76,047 | |||||||||
| De-recognition of derivative liabilities | 4,596,039 | [1] | 4,596,039 | ||||||||
| Issuance of common shares, pre-funded warrants and warrants in private placement, net of fees | $ 87 | [1] | 6,507,329 | [1] | 6,507,416 | ||||||
| Issuance of common shares, pre-funded warrants and warrants in private placement, net of fees (in Shares) | [1] | 86,667 | |||||||||
| Issuance of common shares from exercise of warrants | $ 17 | [1] | 249,983 | [1] | 250,000 | ||||||
| Issuance of common shares from exercise of warrants (in Shares) | [1] | 16,667 | |||||||||
| Issuance of common shares to settle asset purchase obligation | $ 40 | [1] | 2,999,960 | [1] | 3,000,000 | ||||||
| Issuance of common shares to settle asset purchase obligation (in Shares) | [1] | 40,000 | |||||||||
| Issuance of restricted common shares for prepaid consulting services | $ 5 | [1] | 108,271 | [1] | 108,276 | ||||||
| Issuance of restricted common shares for prepaid consulting services (in Shares) | [1] | 5,156 | |||||||||
| Net loss | (7,213,026) | (7,213,026) | |||||||||
| Balance at Sep. 30, 2023 | $ 868 | [1] | 22,672,307 | [1] | (13,927,355) | 8,745,820 | |||||
| Balance (in Shares) at Sep. 30, 2023 | [1] | 868,184 | |||||||||
| Balance at Jun. 30, 2023 | $ 781 | [1] | 16,066,045 | [1] | (12,890,904) | 3,175,922 | |||||
| Balance (in Shares) at Jun. 30, 2023 | [1] | 781,517 | |||||||||
| Equity-based compensation - options, restricted stock and RSUs | 98,933 | [1] | 98,933 | ||||||||
| Issuance of common shares, pre-funded warrants and warrants in private placement, net of fees | $ 87 | [1] | 6,507,329 | [1] | 6,507,416 | ||||||
| Issuance of common shares, pre-funded warrants and warrants in private placement, net of fees (in Shares) | [1] | 86,667 | |||||||||
| Net loss | (1,036,451) | (1,036,451) | |||||||||
| Balance at Sep. 30, 2023 | $ 868 | [1] | 22,672,307 | [1] | (13,927,355) | 8,745,820 | |||||
| Balance (in Shares) at Sep. 30, 2023 | [1] | 868,184 | |||||||||
| Balance at Dec. 31, 2023 | $ 868 | [1] | 22,762,922 | [1] | (15,071,415) | $ 7,692,375 | |||||
| Balance (in Shares) at Dec. 31, 2023 | 868,184 | [1] | 868,184 | [2] | |||||||
| Issuance of common shares from exercise of pre-funded warrants | $ 199 | [1] | 99 | [1] | $ 298 | ||||||
| Issuance of common shares from exercise of pre-funded warrants (in Shares) | [1] | 199,047 | |||||||||
| Rounding of fractional shares from reverse stock split | |||||||||||
| Rounding of fractional shares from reverse stock split (in Shares) | [1] | (36) | |||||||||
| Equity-based compensation - options | 551,434 | [1] | 551,434 | ||||||||
| Issuance of common stock for consulting services | $ 13 | [1] | 104,384 | [1] | 104,397 | ||||||
| Issuance of common stock for consulting services (in Shares) | [1] | 13,333 | |||||||||
| Proceeds from sale of common stock, net of fees | $ 154 | [1] | 1,527,792 | [1] | $ 1,527,946 | ||||||
| Proceeds from sale of common stock, net of fees (in Shares) | [1] | 154,144 | |||||||||
| Issuance of common shares from exercise of warrants (in Shares) | |||||||||||
| Net loss | (6,464,099) | $ (6,464,099) | |||||||||
| Balance at Sep. 30, 2024 | $ 1,234 | [1] | 24,946,631 | [1] | (21,535,514) | $ 3,412,351 | |||||
| Balance (in Shares) at Sep. 30, 2024 | 1,234,672 | [1] | 1,234,672 | [2] | |||||||
| Balance at Jun. 30, 2024 | $ 1,067 | [1] | 23,118,872 | [1] | (19,127,685) | $ 3,992,254 | |||||
| Balance (in Shares) at Jun. 30, 2024 | [1] | 1,067,231 | |||||||||
| Rounding of fractional shares from reverse stock split | |||||||||||
| Rounding of fractional shares from reverse stock split (in Shares) | [1] | (36) | |||||||||
| Equity-based compensation - options | 195,583 | [1] | 195,583 | ||||||||
| Issuance of common stock for consulting services | $ 13 | [1] | 104,384 | [1] | 104,397 | ||||||
| Issuance of common stock for consulting services (in Shares) | [1] | 13,333 | |||||||||
| Proceeds from sale of common stock, net of fees | $ 154 | [1] | 1,527,792 | [1] | 1,527,946 | ||||||
| Proceeds from sale of common stock, net of fees (in Shares) | [1] | 154,144 | |||||||||
| Net loss | (2,407,829) | (2,407,829) | |||||||||
| Balance at Sep. 30, 2024 | $ 1,234 | [1] | $ 24,946,631 | [1] | $ (21,535,514) | $ 3,412,351 | |||||
| Balance (in Shares) at Sep. 30, 2024 | 1,234,672 | [1] | 1,234,672 | [2] | |||||||
| |||||||||||
Statements of Cash Flows (Unaudited) - USD ($) |
9 Months Ended | |
|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
|
| Cash flows from operating activities: | ||
| Net loss | $ (6,464,099) | $ (7,213,026) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||
| Depreciation expense | 1,473 | 1,383 |
| Equity-based compensation | 655,831 | 607,266 |
| Amortization of debt discount | 13,567 | |
| Change in fair value of derivative liabilities | 216,095 | |
| Loss on extinguishment of debt | 740,139 | |
| Non-cash lease expense | (317) | 268 |
| Issuance of shares to settle asset purchase agreement | 3,000,000 | |
| Changes in operating assets and liabilities: | ||
| Prepaid expenses | (102,033) | (145,887) |
| Deferred offering costs | (116,884) | 672,295 |
| Other assets | 2,196 | |
| Accounts payable | 329,504 | (263,239) |
| Accrued liabilities | 129,681 | (466,935) |
| Net cash used in operating activities | (5,566,844) | (2,835,878) |
| Cash flows used in investing activities: | ||
| Investment in property and equipment | (3,254) | |
| Net cash used in investing activities | (3,254) | |
| Cash flows from financing activities: | ||
| Proceeds from sale of common stock, pre-funded warrants and warrants in private placement, net of fees | 6,507,416 | |
| Proceeds from sale of common stock, net of fees | 1,527,946 | |
| Proceeds from exercise of warrants | 298 | 250,000 |
| Repayment of promissory notes | (250,000) | |
| Proceeds from sale of common stock in initial public offering, net of offering costs | 5,408,575 | |
| Net cash provided by financing activities | 1,528,244 | 11,915,991 |
| Net change in cash | (4,038,600) | 9,076,859 |
| Cash and cash equivalents – beginning of the period | 8,402,500 | 32,586 |
| Cash and cash equivalents – end of the period | 4,363,900 | 9,109,445 |
| Supplemental disclosure of non-cash financing activity: | ||
| Issuance of common shares to settle convertible debt | 1,140,700 | |
| De-recognition of derivative liabilities | 4,596,039 | |
| Issuance of common shares for prepaid consulting services | $ 108,276 | |
Description of Business and Summary of Significant Accounting Policies |
9 Months Ended |
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Sep. 30, 2024 | |
| Description of Business and Summary of Significant Accounting Policies [Abstract] | |
| Description of Business and Summary of Significant Accounting Policies | Note 1. Description of Business and Summary of Significant Accounting Policies
Cadrenal Therapeutics, Inc. (the “Company” or “Cadrenal”) was incorporated on January 25, 2022 in the State of Delaware and is headquartered in Ponte Vedra, Florida. Cadrenal Therapeutics is a late-stage biopharmaceutical company developing tecarfarin, a new vitamin K antagonist (VKA) designed to offer safer, superior chronic anticoagulation for patients with implanted cardiac devices or rare cardiovascular conditions. Tecarfarin is anticipated to result in fewer adverse events such as strokes, heart attacks, bleeds and deaths than warfarin, the most commonly used anticoagulant for these patients despite its prevalent side effects, drug-to-drug interactions and frequent dosing changes. Tecarfarin received an orphan drug designation from the U.S. Food and Drug Administration (the “FDA”) for the prevention of thrombosis and thromboembolism (blood clots) in patients with an implanted mechanical circulatory support device, which includes implanted left ventricular assist devices (LVADs), as well as both orphan drug and fast-track status for the prevention of systemic thromboembolism of cardiac origin in end-stage kidney disease (ESKD) patients with atrial fibrillation (AFib). Cadrenal is planning pivotal clinical trials and pursuing clinical and commercial partnerships to advance tecarfarin. The Company’s plans also include studying tecarfarin in patients with mechanical heart valves experiencing anticoagulation difficulties.
Basis of Presentation
The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for the fair presentation of the Company’s financial statements for the periods presented. The Company’s fiscal year-end is December 31.
The accompanying financial statements of the Company are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2024, the results of its operations for the three and nine months ended September 30, 2024 and 2023, the statements of stockholders’ equity for the three and nine months ended September 30, 2024 and 2023, and its cash flows for the nine months ended September 30, 2024 and 2023. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2024 and 2023 are also unaudited. The results for the three and nine months ended September 30, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024, any other interim periods, or any future year or period. These interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2023, and notes thereto, which are included in the Company’s Annual Report on Form 10-K that was filed with the SEC on March 11, 2024.
Liquidity
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and settlement of liabilities and commitments in the normal course of business. The financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. Since inception, the Company has incurred operating losses, and negative cash flows from operations. For the nine months ended September 30, 2024, the Company had a net loss of $6,464,099, which included $656,987 of non-cash expenses. Cash used in operations for the nine months ended September 30, 2024 totaled $5,566,844. As of September 30, 2024, the Company had cash and cash equivalents of $4,363,900, net working capital of $3,405,548, and an accumulated deficit of $21,535,514.
During October 2024, the Company sold 237,099 shares of its common stock through its at-the-market (ATM) facility with H.C. Wainwright & Co. These sales were made at a weighted average price of $14.79 per share, resulting in total gross proceeds of $3,507,817 and net proceeds of $3,390,933
On November 1, 2024, the Company entered into a warrant inducement letter agreement (the “Warrant Inducement Agreement”) with a holder (the “Holder”) of outstanding warrants to purchase up to 285,715 shares of common stock issued in a private placement offering on July 14, 2023 (the “Existing Warrants”) pursuant to which such holder exercised the Existing Warrants at a reduced exercise price of $16.50 generating approximately $4.7 million in gross proceeds. See Note 9-Subsequent Events for a more detailed discussion of the warrant inducement transaction.
The Company’s cash and cash equivalents balance of approximately $11.3 million as of November 7, 2024 is expected to be sufficient to fund its operations for at least the next twelve months from the date of the filing of its Quarterly Report on Form 10-Q, however, the Company will require additional funding to complete its planned Phase 3 clinical trial and submit its New Drug Application.
Emerging Growth Company Status
As an “emerging growth company” (“EGC”) under the Jumpstart Our Business Startups Act (“JOBS Act”), the Company may elect to take advantage of certain forms of relief from various reporting requirements that are applicable to public companies. The relief afforded under the JOBS Act includes an extended transition period for the implementation of new or revised accounting standards. The Company has elected to take advantage of this extended transition period and, as a result, the Company’s financial statements may not be comparable to those of companies that implement accounting standards as of the effective dates for public companies. The Company may take advantage of the relief afforded under the JOBS Act up until the last day of the fiscal year following the fifth anniversary of its initial offering or such earlier time that it is no longer an EGC.
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 as of the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying financial statements include but are not limited to the fair value of stock-based awards, deferred tax assets and valuation allowance, income tax uncertainties, and certain accruals. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances change. Actual results could differ from those estimates.
Concentration of Credit and Other Risks and Uncertainties
Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist primarily of cash and cash equivalents. Cash is maintained at high credit quality financial institutions and, at times, balances may exceed federally insured limits. All interest-bearing and non-interest-bearing cash balances are insured up to $250,000 at each financial institution. Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial condition, results of operations, and cash flows.
The Company is subject to a number of risks common for early-stage biopharmaceutical companies including, but not limited to, dependency on the clinical and commercial success of its product candidate, ability to obtain regulatory approval of its product candidate, the need for substantial additional financing to achieve its goals, uncertainty of broad adoption of its approved products, if any, by physicians and patients, significant competition and untested manufacturing capabilities.
Segments
Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company has determined it operates in a single operating segment and has one reportable segment.
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash and cash equivalents include cash and money market funds.
Derivative Financial Instruments
The Company evaluates all of its agreements to determine if such instruments have derivatives or contain features that qualify as embedded derivatives. The Company accounted for certain redemption features that were associated with convertible notes as liabilities at fair value and adjusted the instruments to their fair value at the end of each reporting period. Derivative financial liabilities are initially recorded at fair value, with gains and losses arising from changes in the fair value recognized in other (income) expense in the accompanying statements of operations and comprehensive loss for each reporting period while such instruments are outstanding. The embedded derivative liabilities were valued using a probability-weighted expected return model. If the Company repays the noteholders or if, during the next round of financing, the noteholders convert the debt into equity, the derivative financial liabilities are de-recognized and reclassified to stockholders’ equity (deficit) on that date. Derivative instrument liabilities are classified in the balance sheet as current or non-current based on whether or not net-cash settlement of the derivative instrument could be required within 12 months of the balance sheet date.
Concurrent with the closing of the initial public offering in January 2023 (the “IPO”), the note holders converted the debt into common stock, accordingly, the derivative financial liabilities were de-recognized and reclassified to stockholders’ equity (deficit) on January 24, 2023.
Stock-Based Compensation
The Company measures its stock-based awards granted to employees, consultants, and directors based on the estimated fair values of the awards and recognizes the compensation over the requisite service period. The Company uses the Black-Scholes option-pricing model to estimate the fair value of its stock option awards. Stock-based compensation is recognized using the straight-line method. As the stock compensation expense is based on awards ultimately expected to vest, it is reduced by forfeitures. The Company accounts for forfeitures as they occur.
Deferred Offering Costs
The Company capitalizes certain legal, professional, and other third-party costs that are directly associated with in-process equity financings until such financings are consummated, at which time such costs are recorded against the gross proceeds of the offering. Should an in-process equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the statements of operations and comprehensive loss.
Income Taxes
Income taxes are accounted for under the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Management makes an assessment of the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s historical operating performance and net losses, the net deferred tax assets have been fully offset by a valuation allowance.
The Company recognizes uncertain income tax positions at the largest amount that is more likely than not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. Changes in recognition or measurement are reflected in the period in which judgment occurs. The Company’s policy is to recognize interest and penalties related to the underpayment of income taxes as a component of the provision for income taxes.
Net Loss Per Common Share
Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of shares of common stock and pre-funded warrants outstanding for the period, without consideration for potential dilutive shares of common stock. Diluted net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock and common stock equivalents of potentially dilutive securities outstanding for the period determined using the treasury stock or if-converted methods. Since the Company was in a loss position for all periods presented, basic net loss per common share is the same as diluted net loss per common share since the effects of potentially dilutive securities are anti-dilutive. Shares of common stock subject to repurchase are excluded from the weighted-average shares.
Comprehensive Loss
Comprehensive loss is defined as the change in equity during a period from transactions and other events or circumstances from non-owner sources. Net loss and comprehensive loss were the same for the periods presented in the accompanying financial statements.
Research and Development Expenses
Research and development costs are expensed as incurred and consist of fees paid to other entities that conduct certain research and development activities on the Company’s behalf. Acquired intangible assets are expensed as research and development costs if, at the time of payment, the technology is under development; is not approved by the FDA or other regulatory agencies for marketing; has not reached technical feasibility; or otherwise has no foreseeable alternative future use. Non-refundable advance payments for goods or services to be received in the future for use in research and development activities are capitalized and then expensed as the related goods are delivered or the services are performed.
On January 19, 2023, the Company issued 40,000 shares of common stock to HESP LLC, pursuant to the terms of an Amendment to the Asset Purchase Agreement, dated August 18, 2022, between the Company and HESP LLC. This payment was determined to be IPR&D with no alternative use. Accordingly, the Company recorded the common stock payment of $3.0 million as research and development expense on January 19, 2023. This payment settled all obligations under the Amendment to the Asset Purchase Agreement.
Patents
Patent costs are comprised primarily of external legal fees, filing fees incurred to file patent applications, and periodic renewal fees to keep the patent in force and are expensed as incurred as a component of general and administrative expenses. |
Recent Accounting Guidance |
9 Months Ended |
|---|---|
Sep. 30, 2024 | |
| Recent Accounting Guidance [Abstract] | |
| Recent Accounting Guidance | Note 2. Recent Accounting Guidance
Recently Issued Accounting Pronouncements Not Yet Adopted
In November 2023, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The ASU expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly reviewed by the chief operating decision maker, or CODM, and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. The ASU also allows, in addition to the measure that is most consistent with GAAP, the disclosure of additional measures of segment profit or loss that are used by the CODM in assessing segment performance and deciding how to allocate resources. All disclosure requirements under ASU 2023-07 are also required for public entities with a single reportable segment. The ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, on a retrospective basis, with early adoption permitted. The Company is currently evaluating the impact of this standard on its disclosures.
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures. The ASU requires greater disaggregation of information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. The ASU applies to all entities subject to income taxes and is intended to help investors better understand an entity’s exposure to potential changes in jurisdictional tax legislation and assess income tax information that affects cash flow forecasts and capital allocation decisions. The ASU is effective for annual periods beginning after December 15, 2024, with early adoption permitted. The ASU should be applied on a prospective basis although retrospective application is permitted. The Company is currently evaluating the impact of this standard on its disclosures. |
Fair Value Measurements |
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| Fair Value Measurements [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Fair Value Measurements | Note 3. Fair Value Measurements
Assets and liabilities recorded at fair value on a recurring basis in the balance sheet are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows:
The Company classified its embedded derivative liability as a Level 3 financial instrument and measured and reported its embedded derivatives at fair value. Concurrent with the closing of the initial public offering in January 2023, the note holders converted the debt into common stock, accordingly, the derivative financial liabilities were de-recognized and reclassified to stockholders’ equity (deficit) on January 24, 2023.
Financial assets and liabilities subject to fair value measurements on a recurring basis and the level of inputs used in such measurements by major security type are presented in the following table:
The following table summarizes the changes in the fair value of the derivative liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3)
The carrying amounts of cash and cash equivalents, prepaid expenses, deferred offering costs, accounts payable, and accrued liabilities approximate their fair values due to their short-term nature. There were no transfers of liabilities among the fair value measurement categories during any of the periods presented. |
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Accrued Liabilities |
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| Accrued Liabilities | Note 4. Accrued Liabilities
Accrued liabilities consist of the following:
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Leases, Commitments, and Contingencies |
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| Leases, Commitments, and Contingencies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Leases, Commitments, and Contingencies | Note 5. Leases, Commitments, and Contingencies
Leases
At lease inception, the Company determines if an arrangement is an operating or capital lease. For operating leases, the Company recognizes rent expense, inclusive of rent escalation, on a straight-line basis over the lease term.
In accordance with ASC 842, Leases, the Company determines if an arrangement is or contains a lease at inception. A contract is or contains a lease if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. The Company classifies leases at the lease commencement date as operating or finance leases and records a right-of-use asset and a lease liability on the balance sheet for all leases with an initial lease term of greater than 12 months. Leases with an initial term of 12 months or less are not recorded in the balance sheet, but payments are recognized as expenses on a straight-line basis over the lease term. The Company has elected not to recognize leases with terms of 12 months or less.
A lease qualifies as a finance lease if any of the following criteria are met at the inception of the lease: (i) there is a transfer of ownership of the leased asset to the Company by the end of the lease term, (ii) the Company holds an option to purchase the leased asset that it is reasonably certain to exercise, (iii) the lease term is for a major part of the remaining economic life of the leased asset, (iv) the present value of the sum of lease payments equals or exceeds substantially all of the fair value of the leased asset, or (v) the nature of the leased asset is specialized to the point that it is expected to provide the lessor no alternative use at the end of the lease term. All other leases are recorded as operating leases.
The Company enters into contracts that contain both lease and non-lease components. Non-lease components may include maintenance, utilities, and other operating costs. The Company combines the lease and non-lease components of fixed costs in its lease arrangements as a single lease component. Variable costs, such as utilities or maintenance costs, are not included in the measurement of right-of-use (“ROU”) assets and lease liabilities but rather are expensed when the event determining the amount of variable consideration to be paid occurs.
Finance and operating lease assets and liabilities are recognized at the lease commencement date based on the present value of the lease payments over the lease term using the discount rate implicit in the lease. If the rate implicit is not readily determinable, the Company utilizes an estimate of its incremental borrowing rate based upon the available information at the lease commencement date. Operating lease assets are further adjusted for prepaid or accrued lease payments. Operating lease payments are expensed using the straight-line method as an operating expense over the lease term.
The Company’s operating lease ROU assets and liabilities as of September 30, 2024 and December 31, 2023 are as follows:
Operating lease expenses were $6,472 and $6,618 for the three months ended September 30, 2024 and 2023, respectively. Operating lease expenses were $19,866 and $19,892 for the nine months ended September 30, 2024 and 2023, respectively. Cash paid for amounts included in the measurement of operating lease liabilities included in operating cash flows was $20,087 and $19,502 for the nine months ended September 30, 2024 and 2023, respectively. The remaining operating lease term is one month, and the operating lease discount rate was 12% as of September 30, 2024.
Future annual lease payments under non-cancellable operating leases as of September 30, 2024 were as follows:
Contingencies
In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown, because it involves claims that may be made against the Company in the future, but have not yet been made. The Company accrues a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated.
Indemnification
In accordance with the Company’s certificate of incorporation and bylaws, the Company indemnifies its officers and directors for certain events or occurrences, subject to certain limits, while they are serving in such capacity. In addition, the Company has entered into indemnification agreements with its officers and directors. There have been no claims to date, and the Company has a directors and officers liability insurance policy that may enable it to recover a portion of any amounts paid for future claims. |
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Stockholders' Equity and Warrants |
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| Stockholders' Equity and Warrants | Note 6. Stockholders’ Equity and Warrants
Reverse Stock Split
On July 29, 2024, the Company’s stockholders approved amendments to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of its shares of common stock, and its Board of Directors subsequently approved a final reverse stock split ratio of 1-for-15. The reverse stock split became effective on August 20, 2024. On the effective date, every 15 shares of issued and outstanding common stock were combined and converted into one issued and outstanding share of common stock. The number of authorized shares of common stock was not reduced and the par value per share of common stock remains unchanged. Fractional shares were canceled, and stockholders received cash in lieu thereof. A proportionate adjustment was also made to the maximum number of shares of common stock issuable under the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive Plan. As a result, the number of common shares, stock options, warrants, net loss per share, and exercise prices disclosed throughout these notes to the unaudited financial statements, as well as the Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 to which these unaudited financial statements and notes thereto are attached, have been retrospectively adjusted to reflect the reverse stock split.
Common Stock
The Company is authorized to issue a total of 75,000,000 shares of common stock with a par value of $0.001 per share and 7,500,000 shares of preferred stock, par value $0.001 per share.
Holders of common stock are entitled to one vote for each share of common stock held of record for the election of the Company’s directors and all other matters requiring stockholder action. Holders of common stock will be entitled to receive such dividends, if any, as may be declared from time to time by the Company’s Board in its discretion out of funds legally available therefor.
On January 24, 2023, the Company consummated its IPO of 93,333 shares of its common stock at a public offering price of $75.00 per share, generating gross proceeds of $7,000,000 and net proceeds of $5,408,575. The Company’s shares of common stock commenced trading on the Nasdaq Capital Market on January 20, 2023, under the symbol “CVKD.”
In connection with the IPO, on January 19, 2023, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Boustead Securities, LLC, as representative of the underwriters (the “Representative”). Pursuant to the Underwriting Agreement, the Company issued to the underwriters a five-year warrant (the “Representative’s Warrant”) to purchase an aggregate of 5,600 shares of the Company’s common stock, which was equal to six percent (6%) of the shares of common stock sold in the IPO. The Representative’s Warrant has an exercise price of $90.00, which was equal to 120% of the public offering price of the common stock in the IPO.
On July 12, 2023, the Company entered into a securities purchase agreement with an institutional investor (the “Investor Selling Stockholder”) pursuant to which the Company sold to the Investor Selling Stockholder in a private placement (the “Private Placement”) (i) an aggregate of 86,667 shares of common stock (the “Shares”), (ii) in lieu of additional Shares, pre-funded warrants to purchase up to an aggregate of 199,047 shares of Common Stock (the “Pre-Funded Warrants”), and (iii) accompanying common warrants to purchase up to an aggregate of 285,715 shares of common stock (the “Common Warrants”). The combined purchase price of each Share and accompanying Common Warrants was $26.25. The combined purchase price of each Pre-Funded Warrant and accompanying Common Warrants was $26.25.
The Private Placement closed on July 14, 2023. The Company received aggregate gross proceeds from the Private Placement of approximately $7.5 million before deducting the placement agent commissions and offering expenses payable by the Company. H.C. Wainwright & Co., LLC (“H.C.W.”) acted as the placement agent in the Private Placement, and as part of its compensation, the Company issued to designees of H.C.W. Placement Agent Warrants to purchase up to 18,571 shares of common stock at an exercise price of $32.81.
Each Pre-Funded Warrant had an exercise price equal to $0.0015 per share. The Pre-Funded Warrants were exercisable at any time after their original issuance and would not expire until exercised in full. Each Common Warrant has an exercise price equal to $26.25 per share. The Common Warrants are exercisable at any time after their original issuance and will expire on January 16, 2029. The exercise price and number of shares of common stock issuable upon exercise of the Common Warrant and Pre-Funded Warrant are subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events.
During the three months ended March 31, 2024, the Company received notice of the exercise of all of the 199,047 Pre-Funded Warrants. As a result of the respective Pre-Funded Warrant exercises, the Company issued 199,047 shares of common stock. As of September 30, 2024, there are no Pre-Funded Warrants outstanding.
The Common Warrants issued in the Private Placement provide that the holder thereof has the right to participate in distributions or dividends paid on the Company’s shares of common stock on an as-converted basis. They also provide that a holder of Common Warrants, as applicable, will not have the right to exercise any portion of its Common Warrants if such holder, together with its affiliates, and any other party whose holdings would be aggregated with those of the holder for purposes of Section 13(d) or Section 16 of the Exchange Act would beneficially own in excess of 4.99% of the number of shares of Common Stock outstanding immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”); provided, however, that the holder may increase or decrease the Beneficial Ownership Limitation by giving notice to the Company, with any such increase not taking effect until the sixty-first day after such notice is delivered to the Company but not to any percentage in excess of 9.99%. The Common Warrants may be exercised on a cashless basis if a registration statement registering the shares of common stock underlying the Common Warrants is not effective at the time of exercise.
ATM Facility
During the quarter ended September 30, 2024, the Company sold 154,144 shares of its common stock through its at-the-market (ATM) facility with H.C. Wainwright & Co., generating gross proceeds of $1,635,777 and net proceeds of $1,527,946.
Warrant Summary
The following table summarizes the total warrants outstanding at September 30, 2024:
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Equity-Based Compensation |
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| Equity-Based Compensation [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Equity-Based Compensation | Note 7. Equity-Based Compensation
The Company adopted the Cadrenal Therapeutics, Inc. 2022 Equity Incentive Plan (the “Initial Plan”), on July 11, 2022, which was later amended and restated on October 16, 2022, for purposes of clarifying the application of certain of the rules of the Initial Plan to awards approved before such amendment and restatement of the Initial Plan and to facilitate the transition to the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive Plan (the “Successor Plan”) for the issuance and approval of awards after consummation of the IPO. On October 16, 2022, the Board adopted and the Company’s stockholders approved the Cadrenal Therapeutics, Inc. 2022 Successor Equity Incentive Plan (the “2022 Plan”), which is a successor to and continuation of the Initial Plan and became effective on January 19, 2023. Upon the effectiveness of the 2022 Plan, it replaced the Initial Plan, except with respect to awards outstanding under the Initial Plan, and no further awards will be available for grant under the Initial Plan.
Subject to certain adjustments, the maximum number of shares of common stock that could have been issued under the Initial Plan and 2022 Plan was initially 133,333 shares. The maximum number of shares of common stock that may be issued under the 2022 Plan will automatically increase on January 1 of each calendar year for a period of ten years commencing on January 1, 2024 and ending on (and including) January 1, 2033, to a number of shares of common stock equal to 20% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year; provided, however that the board of directors, or the compensation committee, may act prior to January 1 of a given calendar year to provide that the increase for such year will be a lesser number of shares of common stock. On January 1, 2024, the maximum number of shares of common stock that may be issued under the 2022 Plan increased to 173,636. On July 29, 2024, the Company held its 2024 Annual Meeting of Stockholders (the “2024 Annual Meeting”). At the 2024 Annual Meeting, the Company’s stockholders approved an amendment to the 2022 Plan to increase the number of shares of the Company’s common stock that will be available for awards under the 2022 Plan by 133,333 shares to 306,969 shares and to amend the “evergreen provision” such that the number of reserved shares of Common Stock available for issuance each year will be 20% of: (i) the shares of Common Stock outstanding at December 31; plus (ii) the shares of Common Stock issuable upon exercise of warrants and pre-funded warrants outstanding at December 31. As of September 30, 2024, 141,303 remained available for future issuance. All available shares may be utilized toward the grant of any type of award under the 2022 Plan.
The Company measures its stock-based awards granted to employees, consultants and directors based on the estimated fair values of the awards and recognizes the compensation over the requisite service period. The Company uses the Black-Scholes option-pricing model to estimate the fair value of its stock option awards. Stock-based compensation is recognized using the straight-line method. As the stock compensation expense is based on awards ultimately expected to vest, it is reduced by forfeitures. The Company accounts for forfeitures as they occur.
Weighted average assumptions used in the Black-Scholes model are set forth below:
Activity under the Plans for the period from December 31, 2023 to September 30, 2024 is set forth below:
The weighted average grant date fair value of options granted to date was $12.67. At September 30, 2024, the Company had $824,647 of unrecognized stock-based compensation expense related to stock options which will be recognized over the weighted average remaining requisite service period of 1.6 years. The Company settles employee stock option exercises with newly issued shares of common stock.
Total stock-based compensation expense and the allocation of stock-based compensation for the periods presented below were as follows:
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Net Loss Per Common Share |
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| Net Loss Per Common Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss Per Common Share | Note 8. Net Loss Per Common Share
The following table sets forth the computation of the basic and diluted net loss per common share:
Since the Company was in a loss position for the periods presented, basic net loss per share is the same as diluted net loss per share as the inclusion of all potential dilutive securities would have been anti-dilutive. For the periods presented, there were no potential dilutive securities other than convertible notes, stock options, and warrants.
The following common stock equivalents were excluded from the calculation of diluted net loss per share applicable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:
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Subsequent Events |
9 Months Ended |
|---|---|
Sep. 30, 2024 | |
| Subsequent Events [Abstract] | |
| Subsequent Events | Note 9. Subsequent Events
The Company has evaluated events that occurred through November 7, 2024, the date that the financial statements were issued, and determined that except than as set forth below, there have been no events that have occurred that would require adjustments to the Company’s disclosures in the financial statements.
On October 10, 2024, the Company issued 25,000 shares of restricted common stock to a consultant as partial compensation for services.
During October 2024, the Company sold 237,099 shares of its common stock through its at-the-market (ATM) facility with H.C. Wainwright & Co. These sales were made at a weighted average price of $14.79 per share, resulting in total gross proceeds of $3,507,817.
On November 1, 2024, the Company entered into the Warrant Inducement Agreement with the Holder of the Existing Warrants pursuant to which the Holder and exercised the Existing Warrants, purchasing 285,715 shares of the Company’s common stock at a reduced exercise price of $16.50 per share, generating gross proceeds to the Company of approximately $4.7 million, before placement agent fees and other expenses. The proceeds are expected to support the Company’s pivotal Phase 3 trial and related partnering activities.
In consideration for the Holder’s exercise of the Existing Warrants, the Company issued new unregistered Series A-1 and Series A-2 warrants (the “New Warrants”) to the Holder, to purchase up to an additional 285,715 shares of common stock each (for a total of 571,430 shares of common stock) at an exercise price of $16.50 per share. The New Warrants are exercisable immediately. The Series A-1 Warrants expire five years after issuance, while the Series A-2 Warrants expire 18 months from the date that the registration statement covering the shares of common stock issuable upon exercise of the Series A-2 Warrants becomes effective.
H.C.W. acted as the exclusive placement agent for the warrant inducement transaction. As part of its compensation, the Company agreed to pay HCW a cash fee equal to 7% of the gross proceeds and to issue HCW warrants to purchase up to 18,571 shares of common stock at an exercise price of $20.625 per share, which represents 125% of the New Warrants’ exercise price. |
Pay vs Performance Disclosure - USD ($) |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
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| Pay vs Performance Disclosure | ||||
| Net Income (Loss) | $ (2,407,829) | $ (1,036,451) | $ (6,464,099) | $ (7,213,026) |
Insider Trading Arrangements |
3 Months Ended |
|---|---|
Sep. 30, 2024 | |
| Trading Arrangements, by Individual | |
| Rule 10b5-1 Arrangement Adopted | false |
| Non-Rule 10b5-1 Arrangement Adopted | false |
| Rule 10b5-1 Arrangement Terminated | false |
| Non-Rule 10b5-1 Arrangement Terminated | false |
Accounting Policies, by Policy (Policies) |
9 Months Ended |
|---|---|
Sep. 30, 2024 | |
| Description of Business and Summary of Significant Accounting Policies [Abstract] | |
| Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for the fair presentation of the Company’s financial statements for the periods presented. The Company’s fiscal year-end is December 31. The accompanying financial statements of the Company are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2024, the results of its operations for the three and nine months ended September 30, 2024 and 2023, the statements of stockholders’ equity for the three and nine months ended September 30, 2024 and 2023, and its cash flows for the nine months ended September 30, 2024 and 2023. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2024 and 2023 are also unaudited. The results for the three and nine months ended September 30, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024, any other interim periods, or any future year or period. These interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2023, and notes thereto, which are included in the Company’s Annual Report on Form 10-K that was filed with the SEC on March 11, 2024. |
| Liquidity | Liquidity The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and settlement of liabilities and commitments in the normal course of business. The financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. Since inception, the Company has incurred operating losses, and negative cash flows from operations. For the nine months ended September 30, 2024, the Company had a net loss of $6,464,099, which included $656,987 of non-cash expenses. Cash used in operations for the nine months ended September 30, 2024 totaled $5,566,844. As of September 30, 2024, the Company had cash and cash equivalents of $4,363,900, net working capital of $3,405,548, and an accumulated deficit of $21,535,514. During October 2024, the Company sold 237,099 shares of its common stock through its at-the-market (ATM) facility with H.C. Wainwright & Co. These sales were made at a weighted average price of $14.79 per share, resulting in total gross proceeds of $3,507,817 and net proceeds of $3,390,933 On November 1, 2024, the Company entered into a warrant inducement letter agreement (the “Warrant Inducement Agreement”) with a holder (the “Holder”) of outstanding warrants to purchase up to 285,715 shares of common stock issued in a private placement offering on July 14, 2023 (the “Existing Warrants”) pursuant to which such holder exercised the Existing Warrants at a reduced exercise price of $16.50 generating approximately $4.7 million in gross proceeds. See Note 9-Subsequent Events for a more detailed discussion of the warrant inducement transaction.
The Company’s cash and cash equivalents balance of approximately $11.3 million as of November 7, 2024 is expected to be sufficient to fund its operations for at least the next twelve months from the date of the filing of its Quarterly Report on Form 10-Q, however, the Company will require additional funding to complete its planned Phase 3 clinical trial and submit its New Drug Application. |
| Emerging Growth Company Status | Emerging Growth Company Status As an “emerging growth company” (“EGC”) under the Jumpstart Our Business Startups Act (“JOBS Act”), the Company may elect to take advantage of certain forms of relief from various reporting requirements that are applicable to public companies. The relief afforded under the JOBS Act includes an extended transition period for the implementation of new or revised accounting standards. The Company has elected to take advantage of this extended transition period and, as a result, the Company’s financial statements may not be comparable to those of companies that implement accounting standards as of the effective dates for public companies. The Company may take advantage of the relief afforded under the JOBS Act up until the last day of the fiscal year following the fifth anniversary of its initial offering or such earlier time that it is no longer an EGC. |
| Use of Estimates | 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 as of the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying financial statements include but are not limited to the fair value of stock-based awards, deferred tax assets and valuation allowance, income tax uncertainties, and certain accruals. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances change. Actual results could differ from those estimates. |
| Concentration of Credit and Other Risks and Uncertainties | Concentration of Credit and Other Risks and Uncertainties Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist primarily of cash and cash equivalents. Cash is maintained at high credit quality financial institutions and, at times, balances may exceed federally insured limits. All interest-bearing and non-interest-bearing cash balances are insured up to $250,000 at each financial institution. Any loss incurred or a lack of access to such funds could have a significant adverse impact on the Company’s financial condition, results of operations, and cash flows. The Company is subject to a number of risks common for early-stage biopharmaceutical companies including, but not limited to, dependency on the clinical and commercial success of its product candidate, ability to obtain regulatory approval of its product candidate, the need for substantial additional financing to achieve its goals, uncertainty of broad adoption of its approved products, if any, by physicians and patients, significant competition and untested manufacturing capabilities. |
| Segments | Segments Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company has determined it operates in a single operating segment and has one reportable segment. |
| Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments purchased with original maturities of three months or less from the purchase date to be cash equivalents. Cash and cash equivalents include cash and money market funds.
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| Derivative Financial Instruments | Derivative Financial Instruments The Company evaluates all of its agreements to determine if such instruments have derivatives or contain features that qualify as embedded derivatives. The Company accounted for certain redemption features that were associated with convertible notes as liabilities at fair value and adjusted the instruments to their fair value at the end of each reporting period. Derivative financial liabilities are initially recorded at fair value, with gains and losses arising from changes in the fair value recognized in other (income) expense in the accompanying statements of operations and comprehensive loss for each reporting period while such instruments are outstanding. The embedded derivative liabilities were valued using a probability-weighted expected return model. If the Company repays the noteholders or if, during the next round of financing, the noteholders convert the debt into equity, the derivative financial liabilities are de-recognized and reclassified to stockholders’ equity (deficit) on that date. Derivative instrument liabilities are classified in the balance sheet as current or non-current based on whether or not net-cash settlement of the derivative instrument could be required within 12 months of the balance sheet date. Concurrent with the closing of the initial public offering in January 2023 (the “IPO”), the note holders converted the debt into common stock, accordingly, the derivative financial liabilities were de-recognized and reclassified to stockholders’ equity (deficit) on January 24, 2023. |
| Stock-Based Compensation | Stock-Based Compensation The Company measures its stock-based awards granted to employees, consultants, and directors based on the estimated fair values of the awards and recognizes the compensation over the requisite service period. The Company uses the Black-Scholes option-pricing model to estimate the fair value of its stock option awards. Stock-based compensation is recognized using the straight-line method. As the stock compensation expense is based on awards ultimately expected to vest, it is reduced by forfeitures. The Company accounts for forfeitures as they occur. |
| Deferred Offering Costs | Deferred Offering Costs The Company capitalizes certain legal, professional, and other third-party costs that are directly associated with in-process equity financings until such financings are consummated, at which time such costs are recorded against the gross proceeds of the offering. Should an in-process equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the statements of operations and comprehensive loss. |
| Income Taxes | Income Taxes Income taxes are accounted for under the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Management makes an assessment of the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to the Company’s historical operating performance and net losses, the net deferred tax assets have been fully offset by a valuation allowance. The Company recognizes uncertain income tax positions at the largest amount that is more likely than not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained. Changes in recognition or measurement are reflected in the period in which judgment occurs. The Company’s policy is to recognize interest and penalties related to the underpayment of income taxes as a component of the provision for income taxes. |
| Net Loss Per Common Share | Net Loss Per Common Share Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of shares of common stock and pre-funded warrants outstanding for the period, without consideration for potential dilutive shares of common stock. Diluted net loss per common share is computed by dividing net loss by the weighted average number of shares of common stock and common stock equivalents of potentially dilutive securities outstanding for the period determined using the treasury stock or if-converted methods. Since the Company was in a loss position for all periods presented, basic net loss per common share is the same as diluted net loss per common share since the effects of potentially dilutive securities are anti-dilutive. Shares of common stock subject to repurchase are excluded from the weighted-average shares.
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| Comprehensive Loss | Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions and other events or circumstances from non-owner sources. Net loss and comprehensive loss were the same for the periods presented in the accompanying financial statements. |
| Research and Development Expenses | Research and Development Expenses Research and development costs are expensed as incurred and consist of fees paid to other entities that conduct certain research and development activities on the Company’s behalf. Acquired intangible assets are expensed as research and development costs if, at the time of payment, the technology is under development; is not approved by the FDA or other regulatory agencies for marketing; has not reached technical feasibility; or otherwise has no foreseeable alternative future use. Non-refundable advance payments for goods or services to be received in the future for use in research and development activities are capitalized and then expensed as the related goods are delivered or the services are performed. On January 19, 2023, the Company issued 40,000 shares of common stock to HESP LLC, pursuant to the terms of an Amendment to the Asset Purchase Agreement, dated August 18, 2022, between the Company and HESP LLC. This payment was determined to be IPR&D with no alternative use. Accordingly, the Company recorded the common stock payment of $3.0 million as research and development expense on January 19, 2023. This payment settled all obligations under the Amendment to the Asset Purchase Agreement. |
| Patents | Patents Patent costs are comprised primarily of external legal fees, filing fees incurred to file patent applications, and periodic renewal fees to keep the patent in force and are expensed as incurred as a component of general and administrative expenses. |
Fair Value Measurements (Tables) |
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| Fair Value Measurements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Financial Assets and Liabilities Subject to Fair Value Measurements | Financial assets and liabilities subject to fair
value measurements on a recurring basis and the level of inputs used in such measurements by major security type are presented in the
following table:
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| Schedule of Derivative Liabilities Measured at Fair Value | The following table summarizes the changes in
the fair value of the derivative liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level
3)
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Accrued Liabilities (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Accrued Liabilities [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Accrued Liabilities | Accrued liabilities consist of the following:
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Leases, Commitments, and Contingencies (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Leases, Commitments, and Contingencies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Operating Lease ROU Assets and Liabilities | The Company’s operating lease ROU assets
and liabilities as of September 30, 2024 and December 31, 2023 are as follows:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Future Annual Lease Payments Under Non-Cancellable Operating Leases | Future annual lease payments under non-cancellable
operating leases as of September 30, 2024 were as follows:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders' Equity and Warrants (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stockholders' Equity and Warrants [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Total Warrants Outstanding | The following table summarizes the total warrants outstanding at September
30, 2024:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity-Based Compensation (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Equity-Based Compensation [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Weighted Average Assumptions Used in the Black-Scholes Model | Weighted average assumptions used in the Black-Scholes
model are set forth below:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Activity Under the Plans | Activity under the Plans for the period from December 31,
2023 to September 30, 2024 is set forth below:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Stock-Based Compensation Expense | Total stock-based compensation expense and the
allocation of stock-based compensation for the periods presented below were as follows:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss Per Common Share (Tables) |
9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss Per Common Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Basic and Diluted Net Loss Per Common Share | The following table sets forth the computation
of the basic and diluted net loss per common share:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Common Stock Equivalents | The following common stock equivalents were excluded
from the calculation of diluted net loss per share applicable to common stockholders for the periods indicated because including them
would have had an anti-dilutive effect:
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Description of Business and Summary of Significant Accounting Policies (Details) |
3 Months Ended | 9 Months Ended | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|
Nov. 01, 2024
USD ($)
$ / shares
shares
|
Oct. 31, 2024
USD ($)
$ / shares
shares
|
Jan. 19, 2023
$ / shares
shares
|
Jan. 19, 2023
USD ($)
$ / shares
|
Sep. 30, 2024
USD ($)
$ / shares
|
Sep. 30, 2023
USD ($)
|
Sep. 30, 2024
USD ($)
$ / shares
shares
|
Sep. 30, 2023
USD ($)
|
Nov. 07, 2024
USD ($)
|
Dec. 31, 2023
USD ($)
|
|
| Description of Business and Summary of Significant Accounting Policies [Line Items] | ||||||||||
| Net loss | $ (2,407,829) | $ (1,036,451) | $ (6,464,099) | $ (7,213,026) | ||||||
| Non-cash expenses | 656,987 | |||||||||
| Cash used in operations | (5,566,844) | (2,835,878) | ||||||||
| Cash and cash equivalents | 4,363,900 | 4,363,900 | ||||||||
| Net working capital | 3,405,548 | 3,405,548 | ||||||||
| Accumulated deficit | $ (21,535,514) | (21,535,514) | $ (15,071,415) | |||||||
| Gross proceeds | $ 1,527,946 | |||||||||
| warrants exercise price (in Dollars per share) | $ / shares | $ 20.625 | $ 20.625 | ||||||||
| Cash balances insured amount | $ 250,000 | $ 250,000 | ||||||||
| Operating segment | 1 | |||||||||
| Uncertain income tax position rate | 50.00% | |||||||||
| Research and development expense | $ 3,000,000 | $ 784,646 | $ 243,948 | $ 2,667,382 | $ 3,720,222 | |||||
| HESP LLC [Member] | ||||||||||
| Description of Business and Summary of Significant Accounting Policies [Line Items] | ||||||||||
| Shares of common stock issued (in Shares) | shares | 40,000 | |||||||||
| H.C. Wainwright & Co. [Member] | ||||||||||
| Description of Business and Summary of Significant Accounting Policies [Line Items] | ||||||||||
| Gross proceeds | 1,635,777 | |||||||||
| Net proceeds | $ 1,527,946 | |||||||||
| Shares of common stock issued (in Shares) | shares | 154,144 | |||||||||
| Warrant [Member] | ||||||||||
| Description of Business and Summary of Significant Accounting Policies [Line Items] | ||||||||||
| warrants exercise price (in Dollars per share) | $ / shares | $ 90 | $ 90 | $ 16.5 | $ 16.5 | ||||||
| Subsequent Event [Member] | ||||||||||
| Description of Business and Summary of Significant Accounting Policies [Line Items] | ||||||||||
| Cash and cash equivalents | $ 11,300,000 | |||||||||
| Net proceeds | $ 3,390,933 | |||||||||
| Subsequent Event [Member] | H.C. Wainwright & Co. [Member] | ||||||||||
| Description of Business and Summary of Significant Accounting Policies [Line Items] | ||||||||||
| Shares of common stock sold (in Shares) | shares | 237,099 | |||||||||
| Weighted average price per share (in Dollars per share) | $ / shares | $ 14.79 | |||||||||
| Gross proceeds | $ 3,507,817 | |||||||||
| Subsequent Event [Member] | Warrant [Member] | ||||||||||
| Description of Business and Summary of Significant Accounting Policies [Line Items] | ||||||||||
| Warrants purchase shares of common stock (in Shares) | shares | 285,715 | |||||||||
| warrants exercise price (in Dollars per share) | $ / shares | $ 16.5 | |||||||||
| Gross proceeds | $ 4,700,000 | |||||||||
Fair Value Measurements (Details) - Schedule of Financial Assets and Liabilities Subject to Fair Value Measurements - USD ($) |
Sep. 30, 2024 |
Dec. 31, 2023 |
|---|---|---|
| Financial Assets: | ||
| Money market funds | $ 3,380,029 | $ 8,287,843 |
| Total financial liabilities | 3,380,029 | 8,287,843 |
| Level 1 [Member] | ||
| Financial Assets: | ||
| Money market funds | 3,380,029 | 8,287,843 |
| Total financial liabilities | 3,380,029 | 8,287,843 |
| Level 2 [Member] | ||
| Financial Assets: | ||
| Money market funds | ||
| Total financial liabilities | ||
| Level 3 [Member] | ||
| Financial Assets: | ||
| Money market funds | ||
| Total financial liabilities |
Fair Value Measurements (Details) - Schedule of Derivative Liabilities Measured at Fair Value - Level 3 [Member] |
12 Months Ended |
|---|---|
|
Dec. 31, 2023
USD ($)
| |
| Schedule of Derivative Liabilities Measured at Fair Value [Line Items] | |
| Balance at beginning | $ 4,379,944 |
| Change in fair value | 216,095 |
| De-recognition of derivative liabilities | (4,596,039) |
| Balance at ending |
Accrued Liabilities (Details) - Schedule of Accrued Liabilities - USD ($) |
Sep. 30, 2024 |
Dec. 31, 2023 |
|---|---|---|
| Schedule of Accrued Liabilities [Abstract] | ||
| Accrued consulting fees | $ 108,409 | $ 4,000 |
| Accrued compensation | 613,238 | 596,131 |
| Other | 46,240 | 38,075 |
| Total accrued liabilities | $ 767,887 | $ 638,206 |
Leases, Commitments, and Contingencies (Details) - USD ($) |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
|
| Leases, Commitments, and Contingencies [Abstract] | ||||
| Operating lease expense | $ 6,472 | $ 6,618 | $ 19,866 | $ 19,892 |
| Operating lease liabilities | $ 20,087 | $ 19,502 | ||
| Remaining operating lease term | 1 month | 1 month | ||
| Operating lease discount rate | 12.00% | 12.00% | ||
Leases, Commitments, and Contingencies (Details) - Schedule of Operating Lease ROU Assets and Liabilities - USD ($) |
Sep. 30, 2024 |
Dec. 31, 2023 |
|---|---|---|
| Assets | ||
| Right of use assets | $ 2,197 | $ 20,998 |
| Liabilities | ||
| Operating lease liabilities | 2,232 | 21,350 |
| Total operating lease liabilities | $ 2,232 | $ 21,350 |
Leases, Commitments, and Contingencies (Details) - Schedule of Future Annual Lease Payments Under Non-Cancellable Operating Leases - USD ($) |
Sep. 30, 2024 |
Dec. 31, 2023 |
|---|---|---|
| Schedule of Future Annual Lease Payments Under Non-Cancellable Operating Leases [Abstract] | ||
| 2024 | $ 2,232 | |
| Total lease payments | 2,232 | |
| Less: Imputed interest | ||
| Total operating lease liabilities | $ 2,232 | $ 21,350 |
Stockholders' Equity and Warrants (Details) - USD ($) |
9 Months Ended | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2024 |
Jul. 14, 2023 |
Jul. 12, 2023 |
Jan. 24, 2023 |
Jan. 19, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
|||
| Stockholders’ Equity and Warrants [Line Items] | ||||||||||
| Common stock shares, authorized | [1] | 75,000,000 | 75,000,000 | |||||||
| Common stock par value (in Dollars per share) | [1] | $ 0.001 | $ 0.001 | |||||||
| Preferred stock, shares authorized | 7,500,000 | 7,500,000 | ||||||||
| Preferred stock par value (in Dollars per share) | $ 0.001 | $ 0.001 | ||||||||
| Common stock vote held | one | |||||||||
| Gross proceeds (in Dollars) | $ 5,408,575 | |||||||||
| Purchase an aggregate | 18,571 | |||||||||
| Common warrant price per share (in Dollars per share) | $ 20.625 | |||||||||
| Gross proceeds from private placement (in Dollars) | $ 7,500,000 | |||||||||
| Excess warrants own percentage | 9.99% | |||||||||
| Generating gross proceeds (in Dollars) | $ 1,527,946 | |||||||||
| H.C. Wainwright & Co. [Member] | ||||||||||
| Stockholders’ Equity and Warrants [Line Items] | ||||||||||
| Consummated common unit | 154,144 | |||||||||
| Net proceeds (in Dollars) | $ 1,527,946 | |||||||||
| Generating gross proceeds (in Dollars) | $ 1,635,777 | |||||||||
| Warrants [Member] | ||||||||||
| Stockholders’ Equity and Warrants [Line Items] | ||||||||||
| Purchase an aggregate | 5,600 | 285,715 | ||||||||
| Common warrant price per share (in Dollars per share) | $ 90 | $ 16.5 | ||||||||
| Pre-Funded Warrant [Member] | ||||||||||
| Stockholders’ Equity and Warrants [Line Items] | ||||||||||
| Consummated common unit | 199,047 | 199,047 | ||||||||
| Common warrant price per share (in Dollars per share) | 0.0015 | |||||||||
| Exercise warrants | 199,047 | |||||||||
| Common Warrants [Member] | ||||||||||
| Stockholders’ Equity and Warrants [Line Items] | ||||||||||
| Consummated common unit | 285,715 | |||||||||
| Common warrant price per share (in Dollars per share) | $ 26.25 | $ 26.25 | ||||||||
| Combined purchase price of warrants (in Dollars per share) | $ 26.25 | |||||||||
| Excess warrants own percentage | 4.99% | |||||||||
| Common Stock [Member] | ||||||||||
| Stockholders’ Equity and Warrants [Line Items] | ||||||||||
| Common stock shares, authorized | 75,000,000 | |||||||||
| Common stock par value (in Dollars per share) | $ 0.001 | |||||||||
| Purchase an aggregate | 571,430 | |||||||||
| Preferred Stock [Member] | ||||||||||
| Stockholders’ Equity and Warrants [Line Items] | ||||||||||
| Preferred stock, shares authorized | 7,500,000 | |||||||||
| Preferred stock par value (in Dollars per share) | $ 0.001 | |||||||||
| IPO [Member] | ||||||||||
| Stockholders’ Equity and Warrants [Line Items] | ||||||||||
| Consummated common unit | 93,333 | |||||||||
| Public offering price (in Dollars per share) | $ 75 | |||||||||
| Gross proceeds (in Dollars) | $ 7,000,000 | |||||||||
| Net proceeds (in Dollars) | $ 5,408,575 | |||||||||
| Sale of stock percentage | 6.00% | |||||||||
| Percentage of public offering price | 120.00% | |||||||||
| Private Placement [Member] | ||||||||||
| Stockholders’ Equity and Warrants [Line Items] | ||||||||||
| Consummated common unit | 86,667 | |||||||||
| H.C.W. Placement Agent Warrant [Member] | ||||||||||
| Stockholders’ Equity and Warrants [Line Items] | ||||||||||
| Purchase an aggregate | 18,571 | |||||||||
| Common warrant price per share (in Dollars per share) | $ 32.81 | |||||||||
| ||||||||||
Stockholders' Equity and Warrants (Details) - Schedule of Total Warrants Outstanding |
9 Months Ended |
|---|---|
|
Sep. 30, 2024
$ / shares
shares
| |
| Schedule of Total Warrants Outstanding [Line Items] | |
| Exercise Price Per Share (in Dollars per share) | $ / shares | $ 20.625 |
| Outstanding, Beginning | 510,700 |
| New Issuance | |
| Exercised | (199,047) |
| Outstanding, Ending | 311,653 |
| Placement Agent Warrants [Member] | |
| Schedule of Total Warrants Outstanding [Line Items] | |
| Issue Date | July - Sept 2022 |
| Exercise Price Per Share (in Dollars per share) | $ / shares | $ 45 |
| Expiration Date | July - Sept 2027 |
| Outstanding, Beginning | 767 |
| New Issuance | |
| Exercised | |
| Outstanding, Ending | 767 |
| Placement Agent Warrants One [Member] | |
| Schedule of Total Warrants Outstanding [Line Items] | |
| Issue Date | Nov 2022 |
| Exercise Price Per Share (in Dollars per share) | $ / shares | $ 15 |
| Expiration Date | Nov 2027 |
| Outstanding, Beginning | 1,000 |
| New Issuance | |
| Exercised | |
| Outstanding, Ending | 1,000 |
| Representative Warrants [Member] | |
| Schedule of Total Warrants Outstanding [Line Items] | |
| Issue Date | Jan 2023 |
| Exercise Price Per Share (in Dollars per share) | $ / shares | $ 90 |
| Expiration Date | Jan 2028 |
| Outstanding, Beginning | 5,600 |
| New Issuance | |
| Exercised | |
| Outstanding, Ending | 5,600 |
| Pre-funded Investor Warrants [Member] | |
| Schedule of Total Warrants Outstanding [Line Items] | |
| Issue Date | July 2023 |
| Exercise Price Per Share (in Dollars per share) | $ / shares | $ 0.0015 |
| Expiration Date | Once exercised |
| Outstanding, Beginning | 199,047 |
| New Issuance | |
| Exercised | (199,047) |
| Outstanding, Ending | |
| Common Warrants [Member] | |
| Schedule of Total Warrants Outstanding [Line Items] | |
| Issue Date | July 2023 |
| Exercise Price Per Share (in Dollars per share) | $ / shares | $ 26.25 |
| Expiration Date | Jan 2029 |
| Outstanding, Beginning | 285,715 |
| New Issuance | |
| Exercised | |
| Outstanding, Ending | 285,715 |
| Placement Agent Warrants [Member] | |
| Schedule of Total Warrants Outstanding [Line Items] | |
| Issue Date | July 2023 |
| Exercise Price Per Share (in Dollars per share) | $ / shares | $ 32.81 |
| Expiration Date | Jan 2029 |
| Outstanding, Beginning | 18,571 |
| New Issuance | |
| Exercised | |
| Outstanding, Ending | 18,571 |
Equity-Based Compensation (Details) - USD ($) |
9 Months Ended | ||
|---|---|---|---|
Jul. 29, 2024 |
Sep. 30, 2024 |
Jan. 01, 2024 |
|
| Equity-Based Compensation [Line Items] | |||
| Common stock outstanding percentage | 20.00% | ||
| Remained available for future issuance | 141,303 | ||
| Increase the number of common stock award | 306,969 | ||
| Reserved shares of common stock available for issuance | 20.00% | ||
| Options granted (in Dollars per share) | $ 12.67 | ||
| Unrecognized stock-based compensation expense (in Dollars) | $ 824,647 | ||
| Service period | 1 year 7 months 6 days | ||
| 2022 Plan [Member] | |||
| Equity-Based Compensation [Line Items] | |||
| Increase the number of common stock award | 133,333 | ||
| Common Stock [Member] | |||
| Equity-Based Compensation [Line Items] | |||
| Remained available for future issuance | 173,636 | ||
| 2022 Plan [Member] | |||
| Equity-Based Compensation [Line Items] | |||
| Maximum number of shares of common stock | 133,333 |
Equity-Based Compensation (Details) - Schedule of Weighted Average Assumptions Used in the Black-Scholes Model |
3 Months Ended | 9 Months Ended |
|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2024 |
|
| Schedule of Weighted Average Assumptions Used in the Black-Scholes Model [Line Items] | ||
| Risk-free interest rate | ||
| Dividend yield | ||
| Expected term (years) | ||
| Volatility | ||
| Minimum [Member] | ||
| Schedule of Weighted Average Assumptions Used in the Black-Scholes Model [Line Items] | ||
| Risk-free interest rate | 4.09% | |
| Expected term (years) | 5 years 3 months 7 days | |
| Volatility | 76.40% | |
| Maximum [Member] | ||
| Schedule of Weighted Average Assumptions Used in the Black-Scholes Model [Line Items] | ||
| Risk-free interest rate | 4.83% | |
| Expected term (years) | 5 years 3 months 21 days | |
| Volatility | 77.70% |
Equity-Based Compensation (Details) - Schedule of Activity Under the Plans - USD ($) |
9 Months Ended | |
|---|---|---|
Dec. 31, 2023 |
Sep. 30, 2024 |
|
| Schedule of Activity Under the Plans [Abstract] | ||
| Number Outstanding, Ending Balance | 78,333 | 156,334 |
| Weighted- Average Exercise Price Per Share, Ending Balance | $ 12.92 | $ 13.2 |
| Weighted- Average Remaining Contractual Life (Years), Ending Balance | 8 years 7 months 20 days | 8 years 7 months 6 days |
| Aggregate Intrinsic Value, Ending Balance | $ 105,000 | $ 327,000 |
| Number Outstanding, Options vested and exercisable | 70,036 | |
| Weighted- Average Exercise Price Per Share, Options vested and exercisable | $ 12.64 | |
| Weighted- Average Remaining Contractual Life (Years), Options vested and exercisable | 8 years 1 month 20 days | |
| Aggregate Intrinsic Value, Options vested and exercisable | $ 24,681 | |
| Number Outstanding Options vested and expected to vest | 156,334 | |
| Weighted- Average Exercise Price Per Share Options vested and expected to vest | $ 13.2 | |
| Weighted- Average Remaining Contractual Life (Years) Options vested and expected to vest | 8 years 7 months 6 days | |
| Aggregate Intrinsic Value Options vested and expected to vest | $ 327,000 | |
| Number Outstanding, Granted | 78,001 | |
| Weighted- Average Exercise Price Per Share, Granted | $ 13.48 | |
| Weighted- Average Remaining Contractual Life (Years), Granted | 9 years 3 months 25 days | |
| Aggregate Intrinsic Value, Granted | $ 43,500 | |
| Number Outstanding, Exercised | ||
| Weighted- Average Exercise Price Per Share, Exercised | ||
| Aggregate Intrinsic Value, Exercised | ||
| Number Outstanding, Canceled/forfeited/expired | ||
| Weighted- Average Exercise Price Per Share, Canceled/forfeited/expired | ||
| Aggregate Intrinsic Value, Canceled/forfeited/expired |
Equity-Based Compensation (Details) - Schedule of Stock-Based Compensation Expense - USD ($) |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
|
| Schedule of Stock-Based Compensation Expense [Line Items] | ||||
| Total stock-based compensation | $ 299,980 | $ 153,072 | $ 655,831 | $ 607,266 |
| General and administrative [Member] | ||||
| Schedule of Stock-Based Compensation Expense [Line Items] | ||||
| Total stock-based compensation | 202,066 | 60,763 | 365,368 | 329,420 |
| Research and development [Member] | ||||
| Schedule of Stock-Based Compensation Expense [Line Items] | ||||
| Total stock-based compensation | $ 97,914 | $ 92,309 | $ 290,463 | $ 277,846 |
Net Loss Per Common Share (Details) - Schedule of Basic and Diluted Net Loss Per Common Share - USD ($) |
3 Months Ended | 9 Months Ended | ||||
|---|---|---|---|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
|||
| Numerator: | ||||||
| Net loss | $ (2,407,829) | $ (1,036,451) | $ (6,464,099) | $ (7,213,026) | ||
| Denominator: | ||||||
| Weighted average common shares outstanding, basic | [1] | 1,104,005 | 1,026,415 | 1,079,489 | 842,721 | |
| Weighted average common shares outstanding, diluted | [1] | 1,104,005 | 1,026,415 | 1,079,489 | 842,721 | |
| Net loss per common share, basic | [1] | $ (2.18) | $ (1.01) | $ (5.99) | $ (8.56) | |
| Net loss per common share, diluted | [1] | $ (2.18) | $ (1.01) | $ (5.99) | $ (8.56) | |
| ||||||
Net Loss Per Common Share (Details) - Schedule of Common Stock Equivalents - shares |
9 Months Ended | |
|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
|
| Anti-dilutive common stock equivalents: | ||
| Total anti-dilutive common stock equivalents | 467,986 | 589,033 |
| Stock options to purchase common stock [Member] | ||
| Anti-dilutive common stock equivalents: | ||
| Total anti-dilutive common stock equivalents | 156,334 | 78,333 |
| Warrants to purchase common stock [Member] | ||
| Anti-dilutive common stock equivalents: | ||
| Total anti-dilutive common stock equivalents | 311,652 | 510,700 |
Subsequent Events (Details) - USD ($) |
9 Months Ended | |||||
|---|---|---|---|---|---|---|
Nov. 01, 2024 |
Oct. 31, 2024 |
Oct. 10, 2024 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Jan. 19, 2023 |
|
| Subsequent Events [Line Items] | ||||||
| Total gross proceeds (in Dollars) | $ 1,527,946 | |||||
| Warrants issued | 18,571 | |||||
| Exercise price (in Dollars per share) | $ 20.625 | |||||
| Percentage of gross proceeds | 7.00% | |||||
| Percentage of warrants exercise price | 125.00% | |||||
| H.C. Wainwright & Co. [Member] | ||||||
| Subsequent Events [Line Items] | ||||||
| Total gross proceeds (in Dollars) | $ 1,635,777 | |||||
| Warrant [Member] | ||||||
| Subsequent Events [Line Items] | ||||||
| Warrants issued | 285,715 | 5,600 | ||||
| Exercise price (in Dollars per share) | $ 16.5 | $ 90 | ||||
| Warrants expire | 5 years | |||||
| Subsequent Event [Member] | ||||||
| Subsequent Events [Line Items] | ||||||
| Restricted common stock | 25,000 | |||||
| Subsequent Event [Member] | H.C. Wainwright & Co. [Member] | ||||||
| Subsequent Events [Line Items] | ||||||
| Shares issued | 237,099 | |||||
| Weighted average price per share (in Dollars per share) | $ 14.79 | |||||
| Total gross proceeds (in Dollars) | $ 3,507,817 | |||||
| Subsequent Event [Member] | Warrant [Member] | ||||||
| Subsequent Events [Line Items] | ||||||
| Warrants issued | 285,715 | |||||
| Exercise price (in Dollars per share) | $ 16.5 | |||||
| Gross proceeds (in Dollars) | $ 4,700,000 | |||||
| Exercise price (in Dollars per share) | $ 16.5 | |||||
| Common Stock [Member] | ||||||
| Subsequent Events [Line Items] | ||||||
| Warrants issued | 571,430 | |||||
| Warrants expire | 18 months | |||||