GridAI Technologies Corp.
For the period ended Dec 31, 2024. Filed Apr 1, 2025.
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FY2024 · Filed Apr 1, 2025
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Notes to the Consolidated Financial Statements
Notes to Consolidated Financial Statements
December 31, 2024 and 2023
Note 1 - The Company and Basis of Presentation
The Company
Entero Therapeutics, Inc. (“Entero”) and its wholly-owned subsidiaries, First Wave Bio, Inc. (“FWB”) and ImmunogenX, LLC (“IMGX”), are collectively referred to as the “Company”. The Company is engaged in the research and development of targeted, non-systemic therapies for the treatment of patients with gastrointestinal (“GI”) diseases. Non-systemic therapies are non-absorbable drugs that act locally, i.e., in the intestinal lumen, skin or mucosa, without reaching an individual’s systemic circulation.
In May 2024, the Company changed its name from First Wave Biopharma, Inc. to Entero Therapeutics, Inc.
The Company’s development pipeline consists of gut-restricted GI clinical drug candidates, including the biologic Adrulipase (formerly MS1819), a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients. The Company plans to continue development of its Adrulipase program in 2025.
In March 2024, the Company acquired ImmunogenX, Inc. (“ImmunogenX”) (the Company’s acquisition of ImmunogenX, the “Merger”), a private, clinical-stage biopharmaceutical company founded in 2013, which was developing the biologic, Latiglutenase, for celiac disease. ImmunogenX was also developing CypCel, a metabolic marker compound that can measure the state of small-intestinal recovery of celiac patients undergoing gluten-free diets (“GFDs”). The Company is seeking avenues to dispose of certain assets and liabilities of IMGX, including Latiglutenase and CypCel. As of December 31, 2024, these were classified as assets and liabilities held for sale and due to the short period of time since the close of the Merger and are reported at their fair value less cost to sell. The Company determined that the discontinued operations of IMGX represents a strategic shift that will have a major effect on the Company’s operations and financial statements. See Note 3 for additional details regarding the Merger and see Note 4 for additional details surrounding the Company’s assets and liabilities held for sale and discontinued operations.
The Company has given notice to terminate its license agreement with Sanofi for its Capeserod program, a selective 5-HT4 receptor partial agonist. The Company is also exploring strategic alternatives for its Niclosamide program, an oral small molecule with anti-viral and anti-inflammatory properties.
Risks and Uncertainties
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development and regulatory success, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, and ability to secure additional capital to fund clinical trials and operations.
Worldwide supply chain constraints and economic and capital markets uncertainty arising out of conflicts between Russia and Ukraine and conflicts in the Middle East triggered by attacks on Israel in October of 2023 have disrupted commercial and capital markets and emerged as new barriers to long-term economic recovery. Capital markets uncertainty, with public stock price decreases and volatility, could make it more difficult for us to raise capital when needed.
In addition, the Company is subject to other challenges and risks specific to its business, its ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market and its ability to execute on its strategy, as well as risks and uncertainties common to companies in the biotechnology and pharmaceutical industries with development and commercial operations, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of its drug candidates; delays or problems in the manufacture and supply of its drug candidates, loss of single source suppliers or failure to comply with manufacturing regulations; identifying, acquiring or in-licensing additional products or drug candidates; pharmaceutical product development and the inherent uncertainty of clinical success; and the challenges of protecting and enhancing our intellectual property rights; complying with applicable regulatory requirements.
Substantial Doubt about the Company’s Ability to Continue as a Going Concern
The accompanying consolidated financial statements have been prepared as if the Company will continue as a going concern. The Company has incurred significant operating losses and negative cash flows from operations since inception. On December 31, 2024, the Company had cash and cash equivalents of approximately $185,000 and an accumulated deficit of approximately $202.4 million. The Company has incurred recurring losses, has experienced recurring negative operating cash flows, and requires significant cash resources to execute its business plans. Subsequent to December 31, 2024, the Company closed on a revolving loan agreement in the principal amount of $2.0 million. Based on its cash on hand at December 31, 2024 and the available loan proceeds, the Company anticipates having sufficient cash to fund planned operations through September 2025. Historically, the Company’s major sources of cash have been comprised of proceeds from various public and private offerings of its capital stock. The Company is dependent on obtaining additional working capital funding from the sale of equity and/or debt securities in order to continue to execute its development plans and continue operations.
The Company has been, and is expected to continue, exploring various potential strategies available including but not limited to raising capital, restructuring its indebtedness and identifying and evaluating potential strategic alternatives but there can be no assurance that these efforts will be successful, that the Company will be able to raise necessary capital on acceptable terms, reach agreement with lenders, or that the strategic review process will result in the Company pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. The Company is evaluating all potential strategic options, including a merger, reverse merger, sale, wind-down, liquidation and dissolution or other strategic transaction. Additionally, there can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated or lead to increased stakeholder value or that it will make any cash distributions to stockholders. Any failure in these efforts could force the Company to delay, limit or terminate operations, make reductions in its workforce, discontinue research and development programs, liquidate all or a portion of assets or pursue other strategic alternatives, and/or seek protection under the provisions of the U.S. Bankruptcy Code.
Without adequate working capital, the Company may not be able to meet its obligations and continue as a going concern. These conditions raise substantial doubt about the Company’s ability to continue as a going concern one year from the date these financial statements are issued. If the Company is not able to obtain necessary capital, it may be required to terminate operations, liquidate all or a portion of assets and/or seek bankruptcy protection. As a result, the Company concluded that its plans at this stage do not alleviate substantial doubt about the ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis of Presentation and Principles of Consolidation
The accompanying consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) and include the accounts of Entero and its wholly owned subsidiaries, FWB and IMGX. Intercompany transactions and balances have been eliminated upon consolidation.
Note 2 - Significant Accounting Policies and Recent Accounting Pronouncements
Use of Estimates
The accompanying consolidated financial statements are prepared in conformity with GAAP and include certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements (including goodwill), and the reported amounts of revenue and expense during the reporting period, including contingencies. Accordingly, actual results may differ from those estimates.
Segment Information
The Company operates asone operating segment with a focus on research and development. The Chief Executive Officer (“CEO”), as the Company’s chief operating decision maker, manages and allocates resources to the operations of the Company on an aggregated basis. This enables the CEO to assess the Company’s overall level of available resources and determine how best to deploy these resources across functions, product and service lines, and strategic opportunities in line with the long-term Company-wide strategic goals.
Reverse Stock Split
On December 18, 2023, the Company effected a reverse stock split, whereby every twenty shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share.
On January 18, 2023, the Company effected a reverse stock split, whereby every seven shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share.
All share and per share amounts have been retroactively restated to reflect the reverse stock splits referenced above.
Cash and Cash Equivalents and Restricted Cash
The Company considers all highly liquid investments with maturities of three months or less from date of purchase to be cash equivalents. As of each of December 31, 2024 and December 31, 2023, the Company has classified approximately $22,000 as restricted cash.
Concentrations of Credit Risk
Financial instruments that potentially expose the Company to concentrations of credit risk consist of cash. The Company primarily maintains its cash balances with financial institutions in federally insured accounts in the U.S. The Company may from time to time have cash in banks in excess of FDIC insurance limits. At December 31, 2023, the Company had approximately $3.7 million in one account in the U.S. in excess of these limits. The Company has not experienced any losses to date resulting from this practice. The Company mitigates its risk by maintaining the majority of its cash and equivalents with high quality financial institutions.
Equity-Based Payments to Non-Employees
Equity-based payments to non-employees are measured at fair value on the grant date per ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting.
Fair Value Measurements
The Company follows Accounting Standards Codification (“ASC”) Topic 820-10, Fair Value Measurements and Disclosures (“ASC 820”), which among other things, defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability.
As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:
Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities;
Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and
Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions, which reflect those that a market participant would use.
In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, an instrument’s level within the fair value hierarchy is based on the lowest level of input that is significant to the overall fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the financial instrument.
The Company recognizes transfers between levels as if the transfers occurred on the last day of the reporting period.
Goodwill and Intangible Assets
Goodwill represents the excess of the purchase price of the acquired business over the fair value of amounts assigned to assets acquired and liabilities assumed. Goodwill and other intangible assets with indefinite useful lives are reviewed for impairment annually or more frequently if events or circumstances indicate impairment may be present. Any excess in carrying value over the estimated fair value is charged to results of operations. The Company hasnot recognized any impairment charges through December 31, 2024 related to goodwill.
Impairment of Long-Lived Assets
The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment*(“ASC 360”*). Potential impairment is assessed when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. Recoverability of these assets is assessed based on undiscounted expected future cash flows from the assets, considering a number of factors, including past operating results, budgets and economic projections, market trends and product development cycles. If impairments are identified, assets are written down to their estimated fair value. The Company has not recognized any impairment charges through December 31, 2024.
Income Taxes
Income taxes are recorded in accordance with ASC 740, Accounting for Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. The Company determines its deferred tax assets and liabilities based on differences between financial reporting and tax bases of assets and liabilities, which are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. At December 31, 2024 and 2023, the Company does not have any significant uncertain tax positions.
Leases
Leases are recorded on the balance sheet as right of use assets and lease obligations. Lease liabilities are recognized based on the present value of the future minimum lease payments over the least term at the commencement date. Leases with a term of 12 months or less at inception are expensed monthly over the lease term. The lease term is determined by assuming the exercise of renewal options that are reasonably certain. The implicit interest rate or the incremental borrowing rate is used in determining the present value of future payments.
Loss Per Share
Basic loss per share (“EPS”) is computed by dividing the loss attributable to common shareholders by the weighted average number of shares of Common Stock outstanding. Diluted EPS reflects the potential dilution that could occur from shares of Common Stock issuable through the exercise or conversion of stock options, restricted stock awards, warrants and convertible securities. In certain circumstances, the conversion of options is excluded from diluted EPS if the effect of such inclusion would be anti-dilutive.
The dilutive effect of stock options is determined using the treasury stock method. Stock options to purchase shares of Common Stock of the Company during fiscal 2024 and 2023 were not included in the computation of diluted EPS because the Company has incurred a loss for the years ended December 31, 2024 and 2023 and the effect would be anti-dilutive.
Research and Development
Research and development costs are charged to operations when incurred and are included in operating expenses. Research and development costs consist principally of compensation of employees and consultants that perform the Company’s research activities, payments to third parties for preclinical and non-clinical activities, expenses with clinical research organizations (“CROs”), investigative sites, consultants and contractors that conduct or provide other services relating to clinical trials, costs to acquire drug product, drug supply and clinical trial materials from contract development and manufacturing organization (“CDMOs”) and third-party contractors relating to chemistry, manufacturing and controls (“CMC”) efforts, the fees paid for and to maintain the Company’s licenses and research and development costs related to Adrulipase, Capeserod and Niclosamide. Depending upon the timing of payments to the service providers, the Company recognizes prepaid expenses or accrued expenses related to these costs. These accrued or prepaid expenses are based on management’s estimates of the work performed under service agreements, milestones achieved and experience with similar contracts. The Company monitors each of these factors and adjusts estimates accordingly.
Research and Development – Intellectual Property Acquired
The Company records intellectual property acquired in business acquisitions that has not reached technological feasibility and which has no alternative future use, as In-Process R&D (“IPR&D”) at the acquisition date. On March 13, 2024, the Company entered into an acquisition agreement with IMGX which included the intellectual property and patents for Latiglutenase and CypCel, which was accounted for as a business acquisition (see Note 3 and Note 4).
Intangible assets related to IPR&D are considered indefinite-lived intangible assets and are assessed for impairment annually or more frequently if impairment indicators exist. If the associated research and development effort is abandoned, the related assets will be written-off, and the Company will record a noncash impairment loss on its Consolidated Statements of Operations. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. The impairment test for indefinite-lived intangible assets is a one-step test that compares the fair value of the intangible asset to its carrying value. If the carrying value exceeds its fair value, an impairment loss is recognized in an amount equal to the excess. The Company has not recognized any impairment charges through December 31, 2024 related to IPR&D.
For tax purposes, intangible assets related to IPR&D are considered indefinite-lived intangible assets.
Stock-Based Compensation
The Company’s board of directors (the “Board”) and stockholders have adopted and approved the Amended and Restated 2014 Omnibus Equity Incentive Plan (the “2014 Plan”) which took effect on May 12, 2014, and the 2020 Omnibus Equity Incentive Plan, which took effect on September 11, 2020 (the “2020 Plan”). From the effective date of the 2020 Plan, no new awards have been or will be made under the 2014 Plan. On March 13, 2024, in connection with the IMGX acquisition, the Company assumed IMGX’s 2021 Stock Option Plan (the “IMGX Plan”), including all IMGX stock options immediately outstanding prior to the IMGX acquisition, with each becoming an option to purchase Common Stock, subject to adjustment. The IMGX Plan was adopted and approved by the board of directors and stockholders of IMGX in 2021. Following the assumption of the IMGX Plan by the Company, no new awards have been or will be made under the IMGX Plan. The Company accounts for its stock-based compensation awards to employees, consultants, and Board members in accordance with ASC Topic 718, Compensation-Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees, consultants, and Board members, including grants of employee stock options, to be recognized in the statements of operations by measuring the fair value of the award on the date of grant and recognizing this fair value as stock-based compensation using a straight-line method over the requisite service period, generally the vesting period.
For awards with performance conditions that affect their vesting, such as the occurrence of certain transactions or the achievement of certain operating or financial milestones, recognition of fair value of the award occurs when vesting becomes probable.
The Company estimates the grant date fair value of stock option awards using the Black-Scholes option-pricing model. The use of the Black-Scholes option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the Common Stock.
Assets Held for Sale and Discontinued Operations
Assets and liabilities are classified as held for sale when all of the following criteria for a plan of sale have been met: (1) management, having the authority to approve the action, commits to a plan to sell the assets; (2) the assets are available for immediate sale, in their present condition, subject only to terms that are usual and customary for sales of such assets; (3) an active program to locate a buyer and other actions required to complete the plan to sell the assets have been initiated; (4) the sale of the assets is probable and is expected to be completed within one year; (5) the assets are being actively marketed for a price that is reasonable in relation to their current fair value; and (6) actions required to complete the plan indicate that it is unlikely that significant changes to the plan will be made or the plan will be withdrawn. When all of these criteria have been met, the assets and liabilities are classified as held for sale in the condensed consolidated balance sheet. A newly acquired business in a business combination that has met the held for sale criteria should be measured at fair value less costs to sell. This is because the business has been recently acquired and its carrying value has been adjusted to its fair value. Depreciation and amortization of assets cease upon designation as held for sale.
Discontinued operations comprise activities that were disposed of, discontinued or held for sale at the end of the period, represent a separate major line of business that can be clearly distinguished for operational and financial reporting purposes, and represent a strategic business shift having a major effect on the Company’s operations and financial results according to ASC Topic 205, Presentation of Financial Statements.
Additional details surrounding the Company’s assets and liabilities held for sale and discontinued operations are included in Note 4.
Recent Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which modified the disclosure and presentation requirements primarily through enhanced disclosures of significant segment expenses and clarified that single reportable segment entities must apply Topic 280 in its entirety. This guidance is effective for the Company for the year beginning January 1, 2024, with early adoption permitted. The amendments should be applied retrospectively to all prior periods presented in the financial statement. The Company adopted ASU 2023-07 on January 1, 2024. The adoption of the guidance resulted in expanded disclosures in Note 19. This adoption did not have an effect on the Company’s consolidated balance sheets, results of operations, or cash flows.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which includes amendments that further enhance income tax disclosures, primarily through standardization and disaggregation of rate reconciliation categories and income taxes paid by jurisdiction. The amendments are effective for all public entities for fiscal years beginning after December 15, 2024. The Company adopted ASU 2023-09 on January 1, 2025 and the adoption is not expected to have a material effect on the Company’s financial statement disclosures.
The Company has evaluated other recently issued accounting pronouncements and has concluded that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations upon adoption.
Note 3 – Business Acquisition
On March 13, 2024, the Company acquired ImmunogenX, Inc., a Delaware corporation, in accordance with the terms of an Agreement and Plan of Merger, dated March 13, 2024 (the “Merger Agreement”), by and among the Company, IMMUNO Merger Sub I, Inc., a Delaware corporation (“First Merger Sub”), IMMUNO Merger Sub II, LLC, a Delaware limited liability company (“Second Merger Sub”), and ImmunogenX. Pursuant to the Merger Agreement, First Merger Sub merged with and into ImmunogenX, pursuant to which ImmunogenX was the surviving corporation (the “First Merger”). Immediately following the First Merger, IMGX merged with and into Second Merger Sub, pursuant to which Second Merger Sub was the surviving entity and a wholly owned subsidiary of the Company (the “Second Merger” and, together with the First Merger, the “IMGX Merger”). Second Merger Sub subsequently changed its name to ImmunogenX, LLC. The Merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes.
Under the terms of the Merger Agreement, following the consummation of the Merger (the “Closing”), in exchange for the outstanding shares of capital stock of ImmunogenX immediately prior to the effective time of the First Merger, the Company issued to the stockholders of ImmunogenX an aggregate of (A)36,830 shares of Common Stock, and (B)11,777.418 shares of Series G Preferred Stock, each share of which is convertible into 1,000 shares of Common Stock, upon shareholder approval. Following the closing of the acquisition, the Company had 2,303,135 shares of common stock issued and outstanding.
The Company incurred transaction costs of approximately $5.5 million which are included in the Company’s condensed consolidated statement of operations.
In addition, the Company assumed (i) all ImmunogenX stock options immediately outstanding prior to the First Merger, each becoming an option to purchase Common Stock subject to adjustment pursuant to the terms of the Merger Agreement (the “Assumed Options”) and (ii) all ImmunogenX warrants immediately outstanding prior to the First Merger, each becoming a warrant to purchase Common Stock subject to adjustment pursuant to the terms of the Merger Agreement (the “Assumed Warrants”). The Assumed Options are exercisable for an aggregate of 200,652 shares of Common Stock, have an exercise price of $0.81 and expire between February 1, 2031 and June 6, 2033. The Assumed Warrants are exercisable for an aggregate of 127,680 shares of Common Stock, have exercise prices ranging from $3.03 to $3.92 and expire between September 30, 2032 and September 6, 2033.
Tungsten Partners LLC (“Tungsten”) acted as financial advisor to the Company in connection with the Merger. As partial compensation for services rendered by Tungsten, the Company issued to Tungsten or its affiliates or designees an aggregate of 18,475 shares of Common Stock and 595.808 shares of Series G Preferred Stock. The fair value of the advisory fees was approximately $4.0 million which are included in the approximately $5.5 million of transaction costs noted above.
The Merger was accounted for as a business combination under the acquisition method of accounting with First Wave as the accounting acquirer. Under the acquisition method, the total purchase price of the acquisition is allocated to the net identifiable tangible and intangible assets acquired and liabilities assumed based on the fair values as of the date of such acquisition. The preliminary fair value of the consideration totaled approximately$60.1 million, summarized as follows:
| · · · | ||
|---|---|---|
| | Amount | |
| Common stock issued to ImmunogenX stockholders | | $240,500 |
| Replacement options | | 1,271,000 |
| Replacement warrants | | 789,000 |
| Preferred stock issued to ImmunogenX stockholders | | 57,790,474 |
| Total consideration paid | | $60,090,974 |
The Company has made a provisional allocation of the purchase price of the Merger to the assets acquired and the liabilities assumed as of the purchase date. The following table summarizes the provisional purchase price allocations relating to the Merger:
| · · · | ||
|---|---|---|
| Assets acquired: · | ||
| Cash and cash equivalents | | $88,169 |
| Prepaid expenses and other current assets | | 3,131,929 |
| Property and equipment, net | | 18,963 |
| Intangibles | | 63,370,000 |
| Operating lease right-of-use assets | | 4,232 |
| Total assets | | $66,613,293 |
| Liabilities assumed: | | |
| Accounts payable | | 916,209 |
| Accrued expenses and other current liabilities | | 2,131,439 |
| Long term debt | | 6,397,889 |
| Deferred tax liability | | 15,431,108 |
| Total liabilities | | $24,876,645 |
| Goodwill recorded: | | |
| Goodwill | | $18,354,326 |
| Net assets acquired | | $60,090,974 |
The fair value of IPR&D was capitalized as of the IMGX Merger date and accounted for as indefinite-lived intangible assets until completion or disposition of the assets or abandonment of the associated research and development efforts. Upon successful completion of the development efforts, the useful lives of the IPR&D assets will be determined based on the anticipated period of regulatory exclusivity and will be amortized within operating expenses. Until that time, the IPR&D assets will be subject to impairment testing and will not be amortized. The goodwill recorded related to the IMGX Merger is the excess of the fair value of the consideration transferred by the acquirer over the fair value of the net identifiable assets acquired and liabilities assumed at the date of such acquisition. The goodwill recorded is not deductible for tax purposes.
All intangible assets acquired are not subject to amortization and their associated estimated acquisition date fair values are as follows:
| · · · · · | |||
|---|---|---|---|
| · Estimated · Acquisition Date | |||
| Intangible Asset · · Useful Life · · Fair Value | |||
| Patents | 2 years | | $140,000 |
| Trade names and trademarks | 6 years | | 230,000 |
| IPR&D – Latiglutenase | Indefinite | | 54,000,000 |
| IPR&D - CypCel | Indefinite | | $9,000,000 |
Net loss in the Condensed Consolidated Statement of Operations for the twelve months ended December 31, 2024 includes net losses of IMGX from the date of acquisition to December 31, 2024 of approximately $2.4 million, which is classified as discontinued operations.
The Merger is classified as held for sale as of December 31, 2024. Refer to Note 4 for further information.
Pro forma disclosure for the IMGX acquisition
The following unaudited pro forma financial information reflects the consolidated results of operations of the Company as if the Acquisition had taken place on January 1, 2024. The pro forma financial information is not necessarily indicative of the results of operations as they would have been had the transactions been effected on the assumed date:
| · · · | ||
|---|---|---|
| | | Twelve Months |
| | Ended December 31, 2024 | |
| Operating expenses | | $15,621,274 |
| Loss before discontinued operations | | (15,619,022) |
| Loss from discontinued operations | | (2,440,315) |
| Net loss applicable to common shareholders | | (18,300,301) |
| Basic and diluted weighted average shares outstanding | | 45,657 |
| Loss per share - basic and diluted | | $(400.82) |
Note 4 – Discontinued Operations and Assets and Liabilities Held for Sale
The Company has initiated a plan to dispose of certain assets and liabilities of IMGX within 12 months of the date of the Merger with IMGX. These are classified as assets and liabilities held for sale and, due to the short period of time since the close of the Merger, are reported at their fair value less cost to sell. The Company determined that the discontinued operations of IMGX represents a strategic shift that will have a major effect on the Company’s operations and financial statements.
The following table summarizes the Company’s loss from discontinued operations for the twelve months ended December 31, 2024 and 2023.
| · · · · · · | ||||
|---|---|---|---|---|
| · · Twelve Months Ended | ||||
| · · December 31, | ||||
| · 2024 · 2023 | ||||
| Operating expenses: · · | ||||
| Research and development expenses | | $1,238,786 | | $— |
| General and administrative expenses | | 157,379 | | — |
| Total operating expenses | | 1,396,165 | | — |
| Interest expense | | (979,002) | | — |
| Other (expense) income | | (65,148) | | — |
| Loss from discontinued operations | | $(2,440,315) | | $— |
The assets and liabilities associated with discontinued operations consist of the following as of December 31, 2024:
| · · · | ||
|---|---|---|
| Assets held for sale: | | |
| Prepaid expenses and other current assets | | $3,131,929 |
| Property and equipment, net | | 16,180 |
| Goodwill and intangible assets | | 80,021,900 |
| Total assets held for sale | | $83,170,009 |
| Liabilities held for sale: | | |
| Accounts payable | | $156,086 |
| Accrued expenses and other current liabilities | | 2,508,990 |
| Debt | | 6,403,737 |
| Deferred tax liability | | 13,872,684 |
| Total liabilities held for sale | | $22,941,497 |
Total assets and liabilities classified as held for sale are presented as current assets and liabilities, respectively, as they are anticipated to be sold within 12 months.
The Company recognized total depreciation and amortization of $34,381, amortization of debt discount $5,847 and a reduction in right of use asset of $4,382. There are changes in accounts payable of $760,123, accrued liabilities of $381,163, lease liability $3,611 and deferred tax liability of $112,400. These amounts are all categorized as cash used in operating activities within the Statement of Cash Flows.
Note 5 - Fair Value Disclosures
Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. GAAP establishes a hierarchical disclosure framework that prioritizes and ranks the level of observability of inputs used in measuring fair value.
The fair value of the Company’s financial instruments are as follows:
| | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · Fair Value Measured at Reporting · · · | |||||||||||||||
| · · · · · Date Using · · · | |||||||||||||||
| · · Carrying · · · · · · · · · · · · | |||||||||||||||
| | Amount | Level 1 | Level 2 | Level 3 | Fair Value | ||||||||||
| December 31, 2024: | | | | | | | | | | | | | | | |
| Money market funds | | $12,723 | | $12,723 | | $— | | $— | | $12,723 | |||||
| December 31, 2023: | | | | | | | | | | | | | | | |
| Money market funds | | | 12,131 | | | 12,131 | | | — | | | — | | | 12,131 |
| Note payable | | $612,784 | | $— | | $612,784 | | $— | | $612,784 | |||||
At December 31, 2024 and 2023, the Company had no other assets or liabilities that are subject to fair value methodology and estimation in accordance with U.S. GAAP.
Note 6 – Property, Equipment and Leasehold Improvements
Property, equipment and leasehold improvements consisted of the following:
| · · · · · · | ||||
|---|---|---|---|---|
| | December 31, | |||
| · · 2024 · 2023 | ||||
| Computer equipment and software | | $11,540 | | $11,540 |
| Office equipment | | 48,278 | | 48,278 |
| Leasehold improvements | | 28,000 | | 28,000 |
| Total property, plant, and equipment | | 87,818 | | 87,818 |
| Less accumulated depreciation | | (87,818) | | (73,253) |
| Property, plant and equipment, net | | $— | | $14,565 |
Depreciation expense was $14,565 and $29,274 for each of the years ended December 31, 2024 and December 31, 2023, respectively.
Note 7 – Goodwill
Goodwill is as follows:
| · · · | ||
|---|---|---|
| | Goodwill | |
| Balance on January 1, 2023 | | $1,684,182 |
| Balance on December 31, 2023 | | 1,684,182 |
| IMGX acquisition | | 18,354,326 |
| Goodwill reclassified as held-for-sale | | (18,354,326) |
| Balance on December 31, 2024 | | $1,684,182 |
Note 8 – Intangible Assets and In-Process R&D
Intangible assets consist of IPR&D, patents, tradenames and trademarks acquired from ImmunogenX. As of December 31, 2024, Intangible assets have been reclassified as held for sale. Intangible assets and IPR&D activity is as follows:
| | | | | | |
|---|---|---|---|---|---|
| · Estimated · December 31, | |||||
| · · Useful Life · · 2024 | |||||
| Patents | | 2 years | | $140,000 | |
| Trademarks and trade names | | 6 years | | 230,000 | |
| Less: accumulated amortization | | | | | (31,598) |
| Intangible assets, net | | | | | 338,402 |
| In-process R&D | | | | | 63,000,000 |
| Intangible assets and in-process R&D reclassified as held for sale | | | | | (60,338,402) |
| Total intangible assets and in-process R&D, net | | | | $— | |
Note 9 - Accrued Expenses
Accrued expenses consisted of the following:
| · · · · · · | ||||
|---|---|---|---|---|
| · December 31, · December 31, | ||||
| | | 2024 | | 2023 |
| Professional fees | | 186,173 | | 253,577 |
| Consulting | | 65,875 | | 75,972 |
| Payroll and benefits | | — | | 495,741 |
| Total accrued expenses | | $252,048 | | $825,290 |
Note 10 – Capital Stock
Our certificate of incorporation, as amended and restated (the “Charter”) authorized the issuance of up to 100,000,000 shares of Common Stock, par value $0.0001 per share, and 10,000,000 shares of preferred stock, par value $0.0001 per share.
On December 18, 2023, the Company effected a reverse stock split, whereby every twenty shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share.
On January 18, 2023, the Company effected a reverse stock split, whereby every seven shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share.
All share and per share amounts have been retroactively restated to reflect the reverse stock splits referenced above.
Common Stock
The Company had 4,754,038 and 1,560,998 shares of its Common Stock issued andoutstanding at December 31, 2024 and 2023, respectively.
Each holder of Common Stock is entitled to one vote for each share of Common Stock held on all matters submitted to a vote of the stockholders. The Company’s Charter and Amended and Restated Bylaws (the “Bylaws”) do not provide for cumulative voting rights.
In addition, the holders of the Company’s Common Stock will be entitled to receive ratably such dividends, if any, as may be declared by the Board out of legally available funds; however, the current policy of the Board is to retain earnings, if any, for operations and growth. Upon liquidation, dissolution or winding-up, the holders of the Company’s Common Stock will be entitled to share ratably in all assets that are legally available for distribution.
Holders of the Company’s Common Stock have no preemptive, conversion or subscription rights, and there are no redemption or sinking fund provisions applicable to the Common Stock. The rights, preferences and privileges of the holders of Common Stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of the Company’s preferred stock that it may designate and issue in the future.
Preferred Stock
The Board is authorized to divide the preferred stock into any number of series, fix the designation and number of each such series, and determine or change the designation, relative rights, preferences, and limitations of any series of preferred stock. The Board of may increase or decrease the number of shares initially fixed for any series, but no decrease may reduce the number below the shares then outstanding and duly reserved for issuance.
On July 16, 2020, the Company designated approximately 5,194.81 shares as Series B Preferred Stock. As of December 31, 2024 and 2023,475.56 and 514.96 shares of Series B Preferred Stock were issued andoutstanding, respectively. Approximately 2,282.23 shares of Series B Preferred Stock remain authorized but undesignated and unissued.
On January 5, 2021, the Company designated 75,000 shares as Series C Preferred Stock. Shares of Series C Preferred Stock converted into Common Stock (or Prefunded Warrants, as applicable) or redeemed shall be canceled and shall not be reissued. As of December 31, 2024 and 2023,0 shares of Series C Preferred Stock were issued and outstanding, with approximately 41,903 shares of Series C Preferred Stock remaining authorized but unissued.
On July 15, 2022, the Company designated 150 shares as Series D Preferred Stock and had 0 shares of Series D Preferred Stock issued and outstanding on December 31, 2024 and 2023.
On July 15, 2022, the Company designated 150 shares as Series E Preferred Stock and had 0 shares of Series E Preferred Stock issued and outstanding on December 31, 2024 and 2023.
On November 28, 2022, the Company designated 7,000 shares as Series F Preferred Stock and had 0 shares of Series F Preferred Stock issued and outstanding on December 31, 2024 and 2023.
At December 31, 2023, the Company had approximately 9,999,485.04 shares of preferred stock remaining authorized but unissued.
Mezzanine Equity
Series G Preferred Stock
The Company had 12,373.226 and 0 shares of Series G stock issued and outstanding on December 31, 2024 and 2023, respectively.
On March 13, 2024, the Company issued 12,373.226 shares of Series G Preferred stock in connection with the IMGX Merger. The following is a summary of the principal terms of the Series G Preferred Stock as set forth in the Certificate of Designation of the Series G Preferred Stock:
General; Transferability. Share of Series G Preferred Stock will be uncertificated and issued in book-entry form. Shares of Series G Preferred Stock may be transferred by the holders thereof without the consent of the Company, provided that such transfer is in compliance with applicable securities laws.
Conversion. Following stockholder approval of the conversion of the Series G Preferred Stock into Common Stock in accordance with the listing rules of the Nasdaq Stock Market (the “Conversion”), each share of Series G Preferred Stock will automatically convert into 1,000 shares of Common Stock, subject to certain limitations, including that a holder of Series G Preferred Stock is prohibited from converting shares of Series G Preferred Stock into shares of Common Stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than a specified percentage (to be established by the holder between 4.9% and 19.9%) of the total number of shares of Common Stock issued and outstanding immediately after giving effect to such conversion.
The Series G Preferred Stock is redeemable for cash at the option of the holder thereof at any time following the date that is six months after the initial issuance of the Series G Preferred Stock (without regard to the lack of obtaining the requisite stockholder approval to convert the Series G Preferred Stock into Common Stock), at a price per share equal to the then-current fair value of the Series G Preferred Stock, which shall be the last reported closing sale price of the Company’s Common Stock as reported on the Nasdaq Stock Market as of the trading day immediately prior to the conversion event. As such, Series G Preferred Stock is classified as Mezzanine Equity on the balance sheet.
Voting Rights. Except as otherwise required by law, the Series G Preferred Stock does not have voting rights. However, as long as any shares of Series G Preferred Stock are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then-outstanding shares of the Series G Preferred Stock, (i) alter or change adversely the powers, preferences or rights given to the Series G Preferred Stock or alter or amend the Certificate of Designation, amend or repeal any provision of, or add any provision to, the Charter or bylaws of the Company, or file any articles of amendment, certificate of designations, preferences, limitations and relative rights of any series of preferred stock, in each case if any such action would adversely alter or change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of the Series G Preferred Stock, regardless of whether any of the foregoing actions shall be by means of amendment to the Charter or by merger, consolidation, recapitalization, reclassification, conversion or otherwise, (ii) issue further shares of Series G Preferred Stock, (iii) prior to the earlier of stockholder approval of the Conversion or the six-month anniversary of issuance, consummate either: (A) any Fundamental Transaction (as in the Certificate of Designation) or (B) any stock sale to, or any merger, consolidation or other business combination of the Company with or into, another entity in which the stockholders of the Company immediately before such transaction do not hold at least a majority of the capital stock of the Company immediately after such transaction, or (iv) enter into any agreement with respect to any of the foregoing.
Liquidation Preference. The Series G Preferred Stock does not have a preference upon any liquidation, dissolution or winding-up of the Company.
Dividend Rights. Holders of Series G Preferred Stock are entitled to receive dividends on shares of Series G Preferred Stock equal to, on an as-if-converted-to-Common-Stock basis, and in the same form as dividends actually paid on shares of the Common Stock.
Redemption. The shares of Series G Preferred Stock shall not be redeemable at the option of the Company or the holder thereof.
Trading Market. There is no established trading market for any of the Series G Preferred Stock, and we do not expect a market to develop. We do not intend to apply for a listing for any of the Series G Preferred Stock on any securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity of the Series G Preferred Stock will be limited.
Most Favored Nations Exchange Right and Waiver Agreements
In the event the Company effects any issuance by the Company or any of its subsidiaries of Common Stock or Common Stock equivalents for cash consideration, or a combination of units thereof (a “Subsequent Financing”), each holder of the Series B Preferred Stock used to have the right, subject to certain exceptions set forth in the Series B Certificate of Designations, at its option, to exchange (in lieu of cash subscription payments) all or some of the Series B Preferred Stock then held (with a value per share of Series B Preferred Stock equal to the stated value of each share of Series B Preferred Stock, or $7,700.00, plus accrued and unpaid dividends thereon, of the Series B Preferred Stock (the “Exchange Amount”)) for any securities or units issued in a Subsequent Financing on dollar-for-dollar basis (the “Series B Exchange Right”). Effective May 12, 2022, the holders of 81.3% of the outstanding shares of the Series B Preferred Stock permanently waived for themselves and all other holders of the Series B Preferred Stock the Series B Exchange Right with respect to any Subsequent Financing occurring on or after January 1, 2022 (the “Permanent Waiver”). Holders of Series B Preferred Stock as of the April 27, 2022 record date were entitled to notice of and to consent to the Permanent Waiver.
As of December 31, 2024, (i) holders of approximately 1,839.76 shares of Series B Preferred Stock with an aggregate Exchange Amount of approximately $14.4 million had previously elected to exercise their Series B Exchange Rights into Series C Preferred Stock, convertible into an aggregate of 395 shares of Common Stock (which conversion the Company has elected to make in full), and additional Investor Warrants exercisable for up to an aggregate of 395 shares of Common Stock, (ii) holders of approximately 169.57 shares of Series B Preferred Stock with an aggregate Exchange Amount of approximately $1.6 million had previously elected to exercise their Series B Exchange Rights into 136 shares of Common Stock with no warrants, and (iii) holders of approximately 30.91 shares of Series B Preferred Stock with an aggregate Exchange Amount of approximately $265,000 had previously elected to exercise their Series B Exchange Rights into 44 shares of Common Stock, and additional Series C Warrants exercisable for up to an aggregate of 44 shares of Common Stock.
July 2024 Inducement Offering
On July 10, 2024, the Company entered into a warrant exercise inducement offer letter (the “Inducement Letter”) with a holder (the “Holder”) of warrants to purchase shares of the Company’s common stock (the “Existing Warrants”) pursuant to which the Holder agreed to exercise for cash their Existing Warrants to purchase 1,762,674 shares of the Company’s common stock (the “Existing Warrant Shares”), in the aggregate, at a reduced exercised price of $1.09 per share, in exchange for the Company’s agreement to issue new warrants (the “Inducement Warrants”) on substantially the same terms as the Existing Warrants as described below, to purchase up to 3,525,348 shares of the Company’s common stock (the “Inducement Warrant Shares”). The Inducement Warrants will be exercisable upon the receipt of stockholder approval and may be exercised until the fifth anniversary of the date on which such stockholder approval is obtained. The Company received aggregate gross proceeds of approximately $1.9 million from the exercise of the Existing Warrants by the Holder and the sale of the Inducement Warrants. The Company engaged Roth Capital Partners, LLC (“Roth”) to act as its financial advisor in connection with the transactions summarized above and paid Roth approximately $116,000 for its services and for reimbursement for certain expenses.
May 2024 Registered Direct Offering
On May 14, 2024, the Company completed a Registered Direct Offering (the “May 2024 Offering”) priced at market under Nasdaq rules, for an aggregate of (i)275,000 shares of Common Stock, (ii) pre-funded warrants (the “May 2024 Pre-Funded Warrants”) to purchase up to an aggregate of 91,000 shares of Common Stock and (iii) common warrants (the “May 2024 Warrants”) to purchase up to an aggregate of 732,000 shares of Common Stock. The public offering price for each share of Common Stock and accompanying May 2024 Warrant to purchaseone share of Common Stock was $2.95 per share. The May 2024 Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately and will expire when exercised in full. The May 2024 Warrants have an exercise price of $2.70 per share, are exercisable immediately and will expiresix years from the initial exercise date.
The Company received gross proceeds of approximately $1.1 million less placement agent’s fees and other offering expenses of approximately $182,000.
March 2024 Registered Direct Offering
On March 6, 2024, the Company completed a Registered Direct Offering (the “March 2024 Offering”) priced at market under Nasdaq rules, for an aggregate of (i)173,100 shares of Common Stock, (ii) pre-funded warrants (the “March 2024 Pre-Funded Warrants”) to purchase up to an aggregate of 352,525 shares of Common Stock and (iii) common warrants (the “March 2024 Warrants”) to purchase up to an aggregate of 525,625 shares of Common Stock. The public offering price for each share of Common Stock and accompanying March 2024 Warrant to purchaseone share of Common Stock was $7.61 per share. The March 2024 Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately and will expire when exercised in full. The March 2024 Warrants have an exercise price of $7.48 per share, are exercisable immediately and will expire five years from the initial exercise date. The Company received gross proceeds of approximately $4.0 million less placement agent’s fees and other offering expenses of approximately $393,000.
December 2023 Inducement Offering
On December 27, 2023 the Company entered into warrant exercise inducement offer letters with certain holders (the “December 2023 Holders”) of warrants to purchase shares of the Company’s Common Stock (the “December 2023 Existing Warrants”) pursuant to which the December 2023 Holders agreed to exercise for cash their December 2023 Existing Warrants to purchase 881,337 shares of the Company’s Common Stock, in the aggregate, at a reduced exercised price of $5.50 per share, in exchange for the Company’s agreement to issue new warrants (the “December 2023 Inducement Warrants”) on substantially the same terms as the December 2023 Existing Warrants to purchase up to 1,762,674 shares of the Company’s Common Stock (the “December 2023 Inducement Warrant Shares”) and a cash payment of $0.125 per December 2023 Inducement Warrant Share which was paid in full upon the exercise of the December 2023 Existing Warrants (the “December 2023 Inducement Offering”). The Company received aggregate gross proceeds of approximately $4.8 million from the exercise of the December 2023 Existing Warrants by the Holders and the sale of the December 2023 Inducement Warrants. The Company engaged Roth Capital Partners, LLC (“Roth”) to act as its financial advisor in connection with the transactions summarized above and paid Roth approximately $291,000 for its services.
September 2023 Inducement Offering
On September 14, 2023, the Company entered into warrant exercise inducement offer letters with certain holders (the “September 2023 Holders”) of warrants to purchase shares of the Company’s Common Stock (the “September 2023 Existing Warrants”) pursuant to which the September 2023 Holders agreed to exercise for cash their September 2023 Existing Warrants to purchase 294,101 shares of the Company’s Common Stock, in the aggregate, at a reduced exercised price of $8.60 per share, in exchange for the Company’s agreement to issue new warrants (the “September 2023 Inducement Warrants”) on substantially the same terms as the September 2023 Existing Warrants to purchase up to 588,204 shares of the Company’s Common Stock (the “September 2023 Inducement Warrant Shares”) and a cash payment of $2.50 per September 2023 Inducement Warrant Share which was paid in full upon the exercise of the September 2023 Existing Warrants (the “September 2023 Inducement Offering”). The Company received aggregate gross proceeds of approximately $4.0 million from the exercise of the September 2023 Existing Warrants by the Holders and the sale of the September 2023 Inducement Warrants. The Company engaged Roth to act as its financial advisor in connection with the transactions summarized above and paid Roth $220,000 for its services.
July 2023 Offering
On July 21, 2023, the Company completed an offering (the “July 2023 Offering”) for an aggregate of (i)30,500 shares of Common Stock, (ii) pre-funded warrants (the “July 2023 Pre-Funded Warrants”) to purchase up to an aggregate of 133,750 shares of Common Stock, and (iii) common warrants (the “July 2023 Warrants”) to purchase up to an aggregate of 328,500 shares of Common Stock. The public offering price for each share of Common Stock and accompanying July 2023 Warrant to purchaseone share of Common Stock was $12.80 per share. The July 2023 Pre-Funded Warrants have an exercise price of $0.002 per share, are exercisable immediately and will expire when exercised in full. To date, pre-funded warrants have been exercised to purchase 133,750 shares of Common Stock. The July 2023 Warrants have an exercise price of $12.80 per share, are exercisable immediately and will expire five years from the initial exercise date.
The Company received gross proceeds of approximately $2.1 million less placement agent’s fees and other offering expenses of approximately $250,000.
June 2023 Inducement Offering
On June 13, 2023, the Company entered into warrant exercise inducement offer letters with certain holders (the “June 2023 Holders”) of warrants to purchase shares of the Company’s Common Stock (the “June 2023 Existing Warrants”) pursuant to which the June 2023 Holders agreed to exercise for cash their June 2023 Existing Warrants to purchase 86,216 shares of the Company’s Common Stock, in the aggregate, at a reduced exercised price of $23.00 per share, in exchange for the Company’s agreement to issue new warrants (the “June 2023 Inducement Warrants”) on substantially the same terms as the June 2023 Existing Warrants to purchase up to 172,433 shares of the Company’s Common Stock (the “June 2023 Inducement Warrant Shares”) and a cash payment of $2.50 per June 2023 Inducement Warrant Share which was paid in full upon the exercise of the June 2023 Existing Warrants (the “June 2023 Inducement Offering”). The Company received aggregate gross proceeds of approximately $2.4 million from the exercise of the June 2023 Existing Warrants by the June 2023 Holders and the sale of the June 2023 Inducement Warrants. The Company engaged Roth to act as its financial advisor in connection with the transactions summarized above and paid Roth $150,000 for its services.
March 2023 Private Placement
On March 15, 2023, the Company completed a private placement offering (the “March 2023 Offering”) priced at market under Nasdaq rules, for an aggregate of (i)6,400 shares of Common Stock, (ii) pre-funded warrants (the “March 2023 Pre-Funded Warrants”) to purchase up to an aggregate of 44,751 shares of Common Stock and (iii) common warrants (the “March 2023 Warrants”) to purchase up to an aggregate of 102,302 shares of Common Stock. The public offering price for each share of Common Stock and accompanying March 2023 Warrant to purchaseone share of Common Stock was $78.20 per share. The March 2023 Pre-Funded Warrants have an exercise price of $0.002 per share, are exercisable immediately and will expire when exercised in full. The March 2023 Warrants have an exercise price of $73.20 per share, are exercisable immediately and will expire five years from the initial exercise date.
The Company received gross proceeds of approximately $4.0 million less placement agent’s fees and other offering expenses of approximately $300,000.
Common Stock Issuances
2024 Issuances
During the year ended December 31, 2024, the Company issued 173,100 and 275,000 shares of Common Stock under the March 2024 Offering and May 2024 Offering, respectively, for which the Company received net proceeds of approximately $4.5 million.
During the year ended December 31, 2024, the Company issued 1,762,674 shares of Common Stock under the July 2024 Inducement Offering for which the Company received net proceeds of approximately $1.7 million.
During the year ended December 31, 2024, the Company issued an aggregate of 36,830 shares of Common Stock with a value of $2.3 million in connection with the IMGX acquisition.
During the year ended December 31, 2024, the Company issued an aggregate of 18,475 shares of Common Stock with a value of approximately $121,000 to its financial advisors in connection with the IMGX acquisition.
During the year ended December 31, 2024, the Company issued an aggregate of 443,525 shares of Common Stock upon the exercise of pre-funded warrants issued at a par value of $0.0001 (See Note 11).
During the year ended December 31, 2024, the Company issued an aggregate of 35 shares of Common Stock upon the exchange of an aggregate of 39 shares of Series B Preferred Stock with a stated value of approximately $303,337 plus accrued dividends of approximately $94,540.
During the year ended December 31, 2024, the Company issued an aggregate of 350,000 shares of its Common Stock to consultants with a grant date fair value of approximately $1,541,995 for investor relations services provided, which was recorded as stock-based compensation and included as part of general and administrative expense.
During the year ended December 31, 2024, the Company issued an aggregate of 133,401 shares of Common Stock upon the vesting of RSUs (See Note 12).
2023 Issuances
During the year ended December 31, 2023, the Company issued 6,400 shares of Common Stock under the March 2023 Offering for which the Company received net proceeds of approximately $3.7 million.
During the year ended December 31, 2023, the Company issued 86,216 shares of Common Stock upon the exercise of an aggregate of 1,724,332 investor warrants for which the Company received net proceeds of approximately $2.2 million (See Note 10).
During the year ended December 31, 2023, the Company issued 30,500 shares of Common Stock under the July 2023 Offering for which the Company received net proceeds of approximately $1.8 million.
During the year ended December 31, 2023, the Company issued 294,101 shares of Common Stock upon the exercise of an aggregate of 294,101 investor warrants for which the Company received net proceeds of approximately $3.7 million (See Note 10).
During the year ended December 31, 2023, the Company issued 881,337 shares of Common Stock upon the exercise of an aggregate of 881,337 investor warrants for which the Company received net proceeds of approximately $4.5 million (See Note 10).
During the year ended December 31, 2023, the Company issued an aggregate of 199,974 shares of Common Stock upon the conversion of pre-funded warrants issued at a par value of $0.0001 (See Note 10).
During the year ended December 31, 2023, the Company issued an aggregate of 28 shares of Common Stock upon the exchange of an aggregate of 35.21 shares of Series B Preferred Stock with a stated value of approximately $271,000 plus accrued dividends of approximately $63,500.
During the year ended December 31, 2023, the Company issued an aggregate of 7,500 shares of its Common Stock to consultants with a grant date fair value of approximately $93,000 for investor relations services provided, which was recorded as stock-based compensation and included as part of general and administrative expense.
During the year ended December 31, 2023, the Company issued an aggregate of 5,673 shares of Common Stock upon the vesting of RSUs (See Note 11).
During the year ended December 31, 2023, the Company cancelled an aggregate of 481 shares of Common Stock in connection with the 1-for-20 reverse stock split on December 18, 2023 and the 1-for-7 reverse stock split on January 18, 2023.
Note 11 – Warrants
Warrant activity for the years ending December 31, 2024 and 2023 were as follows:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · · · Weighted · · Weighted | |||||||
| · · · · Average · · Average | |||||||
| · · Number of · · Exercise Price · · Remaining | |||||||
| · Warrants · Per Share · Term in Years | |||||||
| Warrants outstanding and exercisable on January 1, 2024 | 1,779,780 | | $19.29 | 4.99 | |||
| Issued during the period | 5,226,498 | | | 1.87 | 4.60 | ||
| Assumed from IMGX | | 127,680 | | | 3.48 | | 8.22 |
| Expired during the period | (45) | | | 52,500.00 | — | ||
| Exercised during the period | (2,206,199) | | | 3.99 | 8.12 | ||
| Warrants outstanding and exercisable on December 31, 2024 | 4,927,714 | | $6.98 | 4.71 | |||
| | | | | | | | |
| Warrants outstanding and exercisable on January 1, 2023 | 108,797 | | $383.20 | 5.50 | |||
| Issued during the period | 3,132,614 | | | 9.17 | 4.81 | ||
| Expired during the period | (3) | | | 107,100.00 | — | ||
| Exercised during the period | (1,461,628) | | | 14.84 | 4.57 | ||
| Warrants outstanding and exercisable on December 31, 2023 | 1,779,780 | | $19.29 | 4.99 | |||
The weighted average fair value of warrants granted during the years ended December 31, 2024 and 2023, was $1.87 and $22.78 per share, respectively. The grant date fair values were calculated using the Black-Scholes model with the following weighted average assumptions:
| · · · · · | |||
|---|---|---|---|
| | December 31, | ||
| · 2024 · 2023 | |||
| Expected life (in years) | 4.71 | 5.00 | |
| Volatility | 107.5 - 119.6% | 103.8 - 110.2% | |
| Risk-free interest rate | 4.17 - 4.46% | 3.60 - 4.45% | |
| Dividend yield | —% | —% | |
The outstanding warrants expire from 2025 through 2033.
During the year ended December 31, 2024, the Company issued warrants to purchase 525,625 shares of the Company’s Common Stock and pre-funded warrants to purchase 352,525 shares of the Company’s Common Stock in connection with the March 2024 Offering, warrants to purchase 732,000 shares of the Company’s Common Stock and pre-funded warrants to purchase 91,000 shares of the Company’s Common Stock in connection with the May 2024 Offering, and warrants to purchase 3,525,348 shares of the Company’s Common Stock in connection with the July Inducement Offering (See Note 10). Additionally, the Company assumed warrants to purchase 127,680 shares of the Company’s Common Stock in connection with the IMGX acquisition.
During the year ended December 31, 2024, an investor exercised pre-funded warrants to purchase 443,525 shares of the Company’s Common Stock and common stock warrants to purchase 1,762,674 shares of the Company’s Common Stock in connection with previous offerings.
During the year ended December 31, 2023, the Company issued warrants and pre - funded warrants to purchase 147,053 shares of the Company’s Common Stock in connection with the March 2023 Offering, warrants to purchase 172,433 shares of the Company’s Common Stock in connection with the June 2023 Inducement Offering, warrants and pre - funded warrants to purchase 462,250 shares of the Company’s Common Stock in connection with the July 2023 Offering, warrants to purchase 588,204 shares of the Company’s Common Stock in connection with the September 2023 Inducement Offering, and warrants to purchase 1,762,674 shares of the Company’s Common Stock in connection with the December 2023 Inducement Offering (See Note 9).
During the year ended December 31, 2023, an investor exercised pre - funded warrants to purchase 199,974 shares of the Company’s Common Stock in connection with previous offerings. During the year ended December 31, 2023, an investor exercised warrants to purchase 1,261,654 shares of the Company’s Common Stock in connection with previous offerings as a result of the June 2023, September 2023, and December 2023 Inducement Offerings (see Note 9).
Note 12 – Equity Incentive Plan
The Company’s Board and stockholders adopted and approved the Amended and Restated 2014 Omnibus Equity Incentive Plan (the “2014 Plan”), which took effect on May 12, 2014. The Company’s Board and stockholders adopted and approved the 2020 Omnibus Equity Incentive Plan (the “2020 Plan”), which took effect on September 11, 2020. From the adoption and approval of the 2020 Plan, no new awards have been or will be made under the 2014 Plan.
The 2020 Plan allows for the issuance of securities, including stock options to employees, Board members and consultants. The initial number of shares of Common Stock available for issuance under the 2020 Plan was 238 shares, which will, on January 1 of each calendar year, unless the Board decides otherwise, automatically increase to equal ten percent (10%) of the total number of shares of Common Stock outstanding on December 31 of the immediately preceding calendar year, calculated on an As Converted Basis. As Converted Shares include all outstanding shares of Common Stock and all shares of Common Stock issuable upon the conversion of outstanding preferred stock, warrants and other convertible securities, but will not include any shares of Common Stock issuable upon the exercise of options and other convertible securities issued pursuant to either the 2014 Plan or the 2020 Plan. The number of shares permitted to be issued as “incentive stock options” (“ISOs”) is 357 under the 2020 Plan.
As of December 31, 2024, there were an aggregate of 73 total shares available (but un-issuable) under the 2014 Plan, of which 9 are issued and outstanding, and 4 shares are reserved subject to issuance of restricted stock and RSUs.
As of December 31, 2024,334,078 total shares were authorized under the 2020 Plan, of which 156,073 were issued and outstanding and 178,005 shares were available for potential issuances.
As of January 1, 2025, the number of shares of Common Stock available for issuance under the 2020 Plan automatically increased to 969,356 under the 2020 Plan’s evergreen provision.
The following table summarizes the Company’s stock option activity:
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| · · · · Weighted · · Remaining · · · | ||||||||||
| · · · · Average · · Contract · · · | ||||||||||
| · · Number · · Exercise · · Life · · Intrinsic | ||||||||||
| · of Shares · Price · (Years) · Value | ||||||||||
| Outstanding as of January 1, 2024 | 426 | | $6,103.81 | | 8.53 | | $— | |||
| Acquired from IMGX | 200,652 | | 0.81 | | 6.80 | | — | |||
| Cancelled | | (111,229) | | | 14.80 | | — | | | — |
| Outstanding as of December 31, 2024 | 89,849 | | $10.43 | | 7.06 | | $— | |||
| Exercisable as of December 31, 2024 | 89,838 | | $9.82 | | 7.06 | | $— | |||
| | | | | | | | | | | |
| Outstanding as of January 1, 2023 | 179 | | $15,956.72 | | 8.22 | | $— | |||
| Granted | 250 | | 74.60 | | 9.40 | | — | |||
| Expired | (3) | | 91,560.00 | | — | | — | |||
| Outstanding as of December 31, 2023 | | 426 | | $6,103.81 | | 8.53 | | $— | ||
| Exercisable as of December 31, 2023 | 384 | | $5,651.52 | | 8.60 | | $— | |||
There wereno grant of options during the year ended December 31, 2024, however, the Company assumed fully vested options to purchase 200,652 shares of the Company’s Common Stock issued under the IMGX 2021 Plan. During the year ended December 31, 2023, the Board approved the grant of options to purchase 250 shares of the Company’s Common Stock pursuant to the 2020 Plan. In general, options granted under the 2020 Plan vest monthly over a 36-month period. The fair values were estimated on the grant dates using the Black-Scholes option-pricing model with the following weighted-average assumptions:
| · · · · · | ||||
|---|---|---|---|---|
| | December 31, | |||
| | | 2024 | 2023 | |
| Contractual term (in years) | — | | 6.5 | |
| Volatility | —% | 98.8% | ||
| Risk-free interest rate | —% | 4.08% | ||
| Dividend yield | —% | —% | ||
The expected term of the options is based on expected future employee exercise behavior. Volatility is based on the historical volatility of the Company’s Common Stock if available or of several public entities that are similar to the Company. The Company bases volatility this way because it may not have sufficient historical transactions in its own shares on which to solely base expected volatility. The risk-free interest rate is based on the U.S. Treasury rates at the date of grant with maturity dates approximately equal to the expected term at the grant date. The Company has not historically declared any dividends and does not expect to in the future.
The weighted average fair value of stock options granted during the year ended December 31, 2023 was $61.00 per share.
The total fair value of the stock options vested, subject to service-based milestone vesting conditions, during the years ended December 31, 2024 and 2023 was approximately $7,000 and $112,000, respectively.
The total fair value of the stock options vested, subject to performance-based milestone vesting conditions, during each of the years ended December 31, 2024 and 2023 was $0.
Restricted Stock and Restricted Stock Units
Restricted stock refers to shares of Common Stock subject to vesting based on certain service, performance, and market conditions. Restricted stock unit awards (“RSUs”) refer to an award under the 2014 Plan, which constitutes a promise to grant shares of Common Stock at the end of a specified restriction period.
As of each December 31, 2024 and December 31, 2023, under the 2014 Plan, the Company had an aggregate unrecognized restricted Common Stock expense of approximately $157,500 and $269,500 respectively, which will be recognized when vesting of certain milestones become probable.
During the years ended December 31, 2024 and 2023, RSU activity under the 2020 Plan was as follows:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · Weighted- · Weighted-Average | |||||||
| · · · · Average · · Remaining | |||||||
| · · Number · · Grant Date · · Recognition | |||||||
| · of Shares · Fair Value · Period (Years) | |||||||
| Non-vested Outstanding at January 1, 2024 | 52,271 | | $4.31 | 9.96 | |||
| Awarded | 150,421 | | 3.57 | — | |||
| Vested | (145,092) | | 3.91 | — | |||
| Cancelled | (52,600) | | 3.33 | — | |||
| Non-vested Outstanding at December 31, 2024 | | 5,000 | | $3.96 | | 2.24 | |
| | | | | | | | |
| Non-vested Outstanding at January 1, 2023 | | — | | $— | | — | |
| Awarded | | 58,460 | | | 16.98 | | — |
| Vested | | (5,673) | | | 124.00 | | — |
| Cancelled | | (516) | | | 124.00 | | — |
| Non-vested Outstanding at December 31, 2023 | 52,271 | | $4.31 | 9.96 | |||
During the year ended December 31, 2024, the Board approved the grant of 150,421 RSUs pursuant to the 2020 Plan, which vest quarterly over aone - year period. During the year ended December 31, 2024,145,092 RSUs vested of which 11,691 were issued in January 2025.
During the year ended December 31, 2023, the Board approved the grant of 58,460 RSUs pursuant to the 2020 Plan. Of the RSUs granted,50,455 vest upon a performance milestone and 8,005 vest quarterly over aone - year period. During the year ended December 31, 2023,5,673 RSUs vested.
Stock - based Compensation Expense
The total stock-based compensation expense for employees and non-employees is included in the accompanying condensed consolidated statements of operations and as follows:
| · · · · · · | ||||
|---|---|---|---|---|
| · · Year Ending December 31, | ||||
| · 2024 · 2023 | ||||
| Research and development | | $60,045 | | $123,146 |
| General and administrative | | 571,510 | | 917,326 |
| Total stock-based compensation expense | | $631,555 | | $1,040,472 |
As of December 31, 2024, the Company had unrecognized stock - based compensation expense of approximately $21,000. Approximately $7,000 of this unrecognized expense will be recognized over the average remaining vesting term of the stock options of 0.16 years.
As of December 31, 2023, the Company had unrecognized stock - based compensation expense of approximately $505,000. Approximately $96,000 of this unrecognized expense will be recognized over the average remaining vesting term of the stock options of 1.05 years. Approximately $409,000 of this unrecognized expense will vest upon achieving certain clinical and/or corporate milestones.
Note 13 – Agreements
License Agreement with Sanofi
On September 13, 2023, the Company entered into a License Agreement with Sanofi, pursuant to which the Company received a license to obtain certain exclusive worldwide rights to develop and commercialize Capeserod, a selective 5-HT4 receptor partial agonist which the Company intended to repurpose and develop for gastrointestinal indications.
The Company paid Sanofi an upfront payment of $500,000 in October 2023 and Sanofi was eligible to receive up to $46.0 million in potential development and regulatory milestone payments and up to $235.0 million in potential commercial milestone payments. Sanofi was also eligible to receive mid-to-high single-digit royalties on net sales, as well as a percentage of sublicense and transfer revenues with respect to Capeserod. Sanofi also had a right of first refusal with respect to Capeserod out-licensing transactions.
The upfront payment of $500,000 was recorded as research and development expense in the year ended December 31, 2023. Depending on the status of development at the time a contingent payment is recognized, the Company may determine that the payment should be expensed as research and development or be capitalized as an intangible asset. This determination will be based on the facts and circumstances that exist at the time a contingent payment is recognized.
The License Agreement was to expire on a country-by-country basis upon the later of: (i) the expiration of the last to expire valid claim of an applicable patent in such country covering such licensed product, (ii) the expiration of the regulatory exclusivity for such licensed product in the applicable country and (iii) the tenth anniversary of the date of first commercial sale of a licensed product in such country. Each party may terminate the License Agreement if the other party materially breaches its obligations under the License Agreement and fails to cure such material breach within 60 days from the date of such notice of breach, except in the case of payment breach, as to which the breaching party will have only aten-day cure period. Sanofi may terminate the License Agreement upon any bankruptcy proceedings by the Company. The Company may terminate the License Agreement by providing Sanofi with at least 60 days prior written notice; provided, however, that Sanofi shall be entitled to any and all payments due and owed to Sanofi prior to the effective date of termination. On February 26, 2025, the Company provided notice to Sanofi to terminate the License Agreement. No payments are due to Sanofi and the Company expects the termination to be effective in April 2025.
Note 14 – Leases
The Company leases its office under an operating lease which is subject to various rent provisions and escalation clauses.
The Company is a party toone real property operating lease for the rental of office space. The Company has office space of 3,472 square feet in Boca Raton, Florida that is used for its corporate headquarters with a term through August 31, 2026. The Company previously had office space in Newport Beach, California with a term through April 30, 2025, which was terminated in November 2024. The Company also previously had office space in Brooklyn, New York on a month-to-month basis, which was terminated in June 2023.
The Company’s lease expires in 2026. The escalation clause is indeterminable and considered not material and has been excluded from minimum future annual rental payments.
Lease expense amounted to approximately $156,000 and $154,000 for the years ended December 31, 2024 and 2023, respectively.
The weighted-average remaining lease term and weighted-average discount rate under operating leases at December 31, 2024 were:
| · · · | |
|---|---|
| · · December 31, | |
| | 2024 |
| Lease term and discount rate | |
| Weighted-average remaining lease term · 1.7 years · | |
| Weighted-average discount rate | 7.00% |
Maturities of operating lease liabilities at December 31, 2024 were as follows:
| · · · | ||
|---|---|---|
| 2025 | | $88,788 |
| 2026 | | 60,593 |
| Total lease payments | | 149,381 |
| Less imputed interest | | (8,847) |
| Present value of lease liabilities | | $140,534 |
Note 15 – Debt
Debt consists of the following:
| · · · · · · · · · · · · · · · | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · Related · · · · · Directors · · · | ||||||||||
| · · · · · party · · · · · and Officer’s · · · | ||||||||||
| · · Revolving · · promissory · · · · · Liability · · · | ||||||||||
| · line of credit · notes · EIDL loan · Insurance · Total | ||||||||||
| Principal balance as of January 1, 2024 | | $— | | $— | | $— | | $612,784 | | $612,784 |
| Additions | | 5,359,860 | | 1,000,000 | | 500,000 | | 31,798 | | 6,891,658 |
| Payments | | — | | — | | — | | (644,582) | | (644,582) |
| Debt discount | | — | | — | | (456,123) | | — | | (456,123) |
| Reclassification to liabilities held for sale | | (5,359,860) | | (1,000,000) | | (43,877) | | — | | (6,403,737) |
| Total debt as of December 31, 2024 | | $— | | $— | | $— | | $— | | $— |
Revolving line of credit
In connection with the IMGX acquisition, the Company assumed a revolving line of credit. In October 2022, ImmunogenX entered into a credit agreement, which allowed for a revolving line of credit (the “Revolver”) for borrowings up to $6.0 million, initially maturing on October 1, 2024, and bearing interest per annum of theprime rate plus 4.5%. The credit agreement was amended in September 2023 (the “First Amendment”) to increase the maximum borrowings of the Revolver to $7.5 million. The credit agreement was amended and restated on March 13, 2024 (the “Second Amendment”). Terms under the Second Amendment include an extended maturity date of September 13, 2025, interest per annum of theprime rate plus 6.0%, and no further draws on the line of credit after March 13, 2024. As of September 30, 2024, the Revolver and accrued interest has been reclassified to liabilities of disposal group held for sale (see Note 4).
Promissory notes
In connection with the IMGX acquisition, the Company assumedtwo promissory notes, one of which is with a related party. The notes are each in the amount of $500,000, accrue interest at a rate of theprime rate plus 4.5% per annum, and have a maturity date of September 30, 2025. As of December 31, 2024, the promissory notes and all accrued interest has been reclassified to liabilities of disposal group held for sale.
EIDL** **loan
In connection with the IMGX acquisition, the Company assumed an Economic Injury Disaster Loan (“EIDL”) loan with a principal balance of $0.5 million bearing interest of 3.75% per annum, with interest payable monthly in arrears. The Company determined the loan has a fair value as of the assumption date of March 13, 2024 of $38,000, resulting in a discount of $462,000 which is amortized over the remaining life of the loan. All unpaid principal and interest are due at maturity on June 30, 2050. As of December 31, 2024, the EIDL loan and all accrued interest has been reclassified to liabilities of disposal group held for sale.
Directors and Officer**’**s Liability Insurance
On November 30, 2023, the Company entered into 9-month financing agreements for its directors and officer’s liability insurance, as well as other corporate insurances, in the amount of approximately $683,000 that bears interest at an annual rate of 7.90%. In June 2024, approximately $32,000 was added to the financing agreement. The balance due under these financing agreements was $0 at December 31, 2024 and approximately $613,000 at December 31, 2023.
Note 16 - Income Taxes
The Company is subject to taxation at the federal and state levels in the United States. At December 31, 2024 and 2023, the Company hadno tax provision.
At December 31, 2024 and 2023, the Company had gross deferred tax assets of approximately$23.7 million and$33.4 million, respectively. As the Company cannot determine that it is more likely than not that the Company will realize the benefit of the deferred tax asset, a valuation allowance of approximately$37.6 million and$33.4 million has been established at December 31, 2024 and 2023, respectively. The change in the valuation allowance was approximately$4.2 million and$4.0 million in 2024 and 2023, respectively.
The significant components of the Company’s net deferred tax assets and liabilities consisted of:
| | | | | | | |
|---|---|---|---|---|---|---|
| | December 31, | |||||
| · 2024 · 2023 | ||||||
| Gross deferred tax assets: · · | ||||||
| Net operating loss carry-forwards | | $29,616,000 | | $23,080,000 | ||
| Stock compensation | | 280,000 | | 234,000 | ||
| Intangible assets | | 5,013,000 | | 5,399,000 | ||
| Capitalized research and development | | 2,299,000 | | 2,586,000 | ||
| Research and development credits | | 2,239,000 | | 2,087,000 | ||
| Other | | 105,000 | | 87,000 | ||
| Deferred tax assets before valuation allowance | | $39,552,000 | | $33,473,000 | ||
| Valuation allowance | | (37,649,000) | | (33,425,000) | ||
| Deferred tax assets net of valuation allowance | | $1,903,000 | | $48,000 | ||
| Gross deferred tax liabilities: | | | ||||
| Right of use asset | | (32,000) | | (48,000) | ||
| Indefinite loved intangibles | | | (15,744,000) | | | — |
| Total deferred tax liability | | $(15,776,000) | | $(48,000) | ||
| Total deferred tax asset, net | | $(13,873,000) | | $— | ||
Income taxes computed using the federal statutory income tax rate differs from the Company’s effective tax rate primarily due to the following:
| · · · · · | ||||
|---|---|---|---|---|
| | December 31, | |||
| · 2024 · 2023 | ||||
| Income tax benefit at statutory rate | 21.0% | 21.0% | ||
| State income tax | 5.8 | | 2.8 | |
| Non-deductible expense | (0.3) | | (0.6) | |
| Change in valuation allowance | (23.6) | | (25.2) | |
| Prior year adjustments | — | | (0.5) | |
| Non-deductible transaction costs | (5.6) | | — | |
| Other | 2.7 | | 2.5 | |
| Total income tax benefit | 0.0% | 0.0% | ||
As of December 31, 2024, the Company has federal and state net operating loss carryforwards of approximately $120.0 million and $97.8 million, respectively, to offset future federal and state taxable income. Of the approximately $120.0 million of federal net operating loss carryforwards, approximately $14.8 million will begin to expire starting in 2034. The remaining federal net operating loss carryforwards do not expire, but their utilization is limited to 80% of taxable income. The state net operating loss carryforwards of approximately $97.8 million will begin to expire in 2034. As of December 31, 2024, the Company also has federal research and development tax credit carryforwards of approximately $2.2 million to offset future income taxes, which expire beginning in 2040.
The Company’s ability to use its NOL carryforwards may be limited if it experiences an “ownership change” as defined in Section 382 of the Internal Revenue Code of 1986, as amended. An ownership change generally occurs if certain stockholders increase their aggregate percentage ownership of a corporation’s stock by more than 50 percentage points over their lowest percentage ownership at any time during the testing period, which is generally the three-year period preceding any potential ownership change. The Company has not completed a study to determine whether transactions that have occurred over the past three years may have triggered an ownership change limitation. Any 382 limitations on net operating loss carryforwards would not have an impact on the financial statements due to the full valuation allowance.
The Company had takenno uncertain tax positions that would require disclosure under ASC 740, Accounting for Income Taxes, at December 31, 2024 and 2023, respectively. None are expected in the next twelve months.
Note 17 - Net Loss per Common Share
Basic net loss per share is computed by dividing net loss available to Common Stockholders by the weighted average number of common shares outstanding during the period. Diluted earnings per share reflect, in periods in which they have a dilutive effect, the impact of common shares issuable upon exercise of stock options and warrants and conversion of convertible debt that are not deemed to be anti-dilutive. The dilutive effect of the outstanding stock options and warrants, if applicable, is computed using the treasury stock method.
All shares of Common Stock that may potentially be issued in the future are as follows:
| | | | | |
|---|---|---|---|---|
| · · | ||||
| | | December 31, 2024 | | December 31, 2023 |
| Series G convertible preferred stock | | 12,373,226 | | — |
| Common stock warrants | 4,927,714 | 1,779,780 | ||
| Stock options | 89,849 | 426 | ||
| RSUs not yet issued | 5,000 | 52,271 | ||
| Convertible preferred stock (1) | 136 | 141 | ||
| Restricted stock not yet issued | 4 | 4 | ||
| Total shares of common stock issuable | 17,395,929 | 1,832,622 | ||
(1)Convertible preferred stock is assumed to be converted at the rate of $32,340 per common share, which is the conversion price as of December 31, 2024.
Note 18 - Employee Benefit Plans
401(k) Plan
Since 2015, the Company has sponsored a multiple employer defined contribution benefit plan, which complies with Section 401(k) of the Internal Revenue Code covering substantially all employees of the Company.
All employees are eligible to participate in the plan. Employees may contribute from 1% to 100% of their compensation and the Company matches an amount equal to 100% on the first 6% of the employee contribution and may also make discretionary profit-sharing contributions.
Employer contributions under this 401(k) plan amounted to approximately $95,000 and $87,000 for the years ended December 31, 2024 and 2023, respectively.
Note 19 – Segments
FASB ASC 280-10-50 requires use of the “management approach” model for segment reporting. The management approach is based on the way a company’s management organizes segments within the company for making operating decisions and assessing performance. Reportable segments are based on products and services, geography, legal structure, management structure, or any other way management disaggregates a company.
The Company has historically determined that its reportable segment is drug development for the treatment of GI diseases. The Company identified its reporting segment based on the business activities of the Company and the financial information used by its chief operating decision maker, the CEO, to make decisions regarding the allocation of resources to and the financial performance of the reporting segment. During the years ended December 31, 2024, and 2023, the Company has only engaged in business activities in a single operating segment.
Asset information by operating segment is not presented below since the chief operating decision maker does not review this information by segment. The reporting segment follows the same accounting policies used in the preparation of the Company’s financial statements.
The following represents selected information for the Company’s reportable segments:
| · · · · · · | ||||
|---|---|---|---|---|
| · December 31, 2024 · December 31, 2023 | ||||
| Operating loss by segment: · · | ||||
| Drug development | | $(2,114,643) | | $(4,869,278) |
| Total operating loss by segment | | $(2,114,643) | | $(4,869,278) |
The table below reconciles the Company’s operating income by segment to income before income taxes as reported in the Company’s condensed consolidated statements of operations:
| · · · · · · | ||||
|---|---|---|---|---|
| · December 31, 2024 · December 31, 2023 | ||||
| Operating loss by segment | | $(2,114,643) | | $(4,869,278) |
| Corporate unallocated costs | | (8,849,233) | | (9,831,803) |
| Depreciation expense | | (14,565) | | (29,274) |
| Stock-based compensation | | (631,555) | | (1,040,472) |
| Non-cash financial advisor fees | | (4,011,274) | | — |
| Interest income (expense), net | | 875 | | (19,932) |
| Other income (expense), net | | 1,374 | | (4,224) |
| Loss from discontinued operations | | (2,440,315) | | — |
| Net loss | | $(18,059,336) | | $(15,794,983) |
Note 20 - Subsequent Events
Effective January 31, 2025, we entered into a Revolving Loan Agreement dated January 27, 2025 (the “Revolving Loan Agreement”), with a Lender pursuant to which the Lender agreed to make loans to us. Pursuant to and under the terms of the Revolving Loan Agreement, we issued to the Lender a revolving note dated January 27, 2025 in the principal amount of $2,000,000 (the “Revolving Note” and such amount, the “Total Outstanding Amount”). This transaction is referred to as the “Financing”. The Company shall use the proceeds from the Financing for general corporate purposes, including but not limited to finance the expense of a Qualified Public Equity Offering (as defined below) and payment of certain items. Out of the Total Outstanding Amount, the Lender disbursed an initial loan amount of $550,000 to the Company on January 31, 2025.
The Revolving Note bears interest at the rate of 18% per annum calculated on the basis of a 360-day year, consisting of twelve 30 calendar day periods, and shall accrue daily commencing on January 31, 2025 until paid in full. The outstanding principal balance of all outstanding loans under the Financing, all accrued and unpaid interest and all other amounts, costs, expenses and/or liquidated damages are due in full on January 31, 2026. The Revolving Loan Agreement contains customary events of default. If an event of default occurs, the Lender may accelerate the indebtedness under the Revolving Loan Agreement, and an amount equal to 120% of the of the outstanding
principal amount and accrued and unpaid interest plus liquidated damages and other amounts, costs, expenses and/or liquidated damages due under or in respect of the Loan Documents (as defined under the Revolving Loan Agreement) for the Financing, if any.
The Revolving Loan Agreement provides that it is a condition of the closing of the Financing that not less than three of the current members of our Board of Directors resign and that three nominees designated by the Lender (“Lender Board Member Candidates”) be appointed to the Board of Directors by the remaining members of the Board of Directors. The Revolving Loan Agreement also provides that we will use our reasonable best efforts to consummate an underwritten or “best efforts” public offering of not less than $5,000,000 by us of our common stock and/or any convertible security or warrant, option or other right to subscribe for or purchase any additional shares of our common stock (“Qualified Public Equity Offering”) as soon as practicable, and the Lender shall cooperate with us in connection therewith. If, despite the reasonable best efforts of the Borrower, (x) a registration statement with respect to securities to be offered in a Qualified Public Equity Offering (the “QPEO S-1”) is not filed within 45 days following the initial Closing Date, or (y) a Qualified Public Equity Offering is not consummated within the earlier of (A)120 days from the initial filing of the QPEO S-1 and (B)30 days of a QPEO S-1 being declared effective by the SEC, then the Lender Board Member Candidates shall, upon the written request of the remaining members of the Board of Directors, resign from all of their respective positions on the Board of Directors.
Rescission Agreement with ImmunogenX
In* *March 2025, the Company announced that it entered into a rescission agreement (the “Rescission Agreement”), by and among the Company, IMGX and the former shareholders of IMGX (the “IMGX Shareholders”).
Under the terms of the Rescission Agreement, the parties have amicably determined that it is in their collective best interest to: (i) rescind the issuances of the of the shares of Common Stock and Series G Preferred Stock that the Company has issued to the IMGX Shareholders as part of the Merger, (ii) convey to the IMGX Shareholders all of the issued and outstanding membership interests (the “Membership Interests”) of IMGX currently held by the Company, (iii) cancel the Assumed Options and Assumed Warrants; and (iv) provide for such additional agreements as are set forth therein.
Pursuant to the terms of the Rescission Agreement (i) each Shareholder agreed to cancel, waive, relinquish and disclaim in all respects any and all claims and/or rights to record or beneficial ownership in and to the shares of Common Stock and Series G Preferred Stock that the Company has issued to the IMGX Shareholders as part of the Merger, as set forth in the Rescission Agreement, (ii) each Shareholder agreed to cancel, waive, relinquish and disclaim in all respects any and all claims and/or rights to record or beneficial ownership in and to the Assumed Options and Assumed Warrants as set forth in the Rescission Agreement, including any Common Stock into which such Assumed Options and Assumed Warrants are not or ever have been converted or are convertible, (iii) the Company agreed to cancel, waive, relinquish and disclaim in all respects any and all claims and/or rights to record or beneficial ownership in and to the Membership Interests of IMGX, and (iv) the Company will retain up to approximately $695,000 of IMGX’s accounts payable, and IMGX will remain responsible for approximately $9,278,400 of IMGX’s secured debt.
In addition, under the terms of the Rescission Agreement, the Company shall have no obligation and will released from any and all obligations with respect to the assets or business of IMGX incurred after the Closing Date, as defined in the Rescission Agreement, or prior to the Closing Date, except as provided in the Rescission Agreement, unless approved in writing by the Company.
The obligations of each party to the Rescission Agreement to consummate the transactions contemplated by the Rescission Agreement are subject to the fulfillment, at or prior to the Closing, as defined in the Rescission Agreement, of each of the conditions set forth in the Rescission Agreement, and among others, that (i) the Company shall have obtained approval of its shareholders for the transfer of the Membership Interests to the Shareholders, and the other consents, authorizations or approvals from the parties as set forth in the Rescission Agreement to consummate the transactions contemplated by this Agreement, (ii) the Shareholders shall have delivered a mutually satisfactory voting agreement agreeing to, including other things, vote the Shares held by them in favor of the transactions contemplated by the Rescission Agreement, and (iii) the Company shall have received a resignation letter from Jack Syage resigning from all positions with the Company.
The Rescission Agreement may be terminated and the transactions contemplated thereby may be abandoned by the Company or the Shareholder Representative, as defined in the Rescission Agreement, if the transactions contemplated thereby shall not have been consummated by June 30, 2025, unless the Company and Shareholder Representative shall have consented to a subsequent date.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.