Inhibikase Therapeutics, Inc.
For the period ended Dec 31, 2024. Filed Mar 27, 2025.
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FY2024 · Filed Mar 27, 2025
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Notes to Consolidated Financial Statements
- Nature of Business
Inhibikase Therapeutics, Inc. is a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of cardiopulmonary and neurodegenerative diseases and other diseases that arise from aberrant signaling through the Abelson Tyrosine Kinases. The Company’s pipeline includes IkT-001, a prodrug of the anticancer agent imatinib, for the treatment of Pulmonary Arterial Hypertension. IkT-001 has completed bioequivalence dose calibration studies in preparation for a future late-stage trial in Pulmonary Arterial Hypertension (PAH).
Liquidity
As of December 31, 2024, the Company had cash, cash equivalents and marketable securities of $97,543,528.
The Company has incurred recurring losses and at December 31, 2024, had an accumulated deficit of $94,420,611.
To date, the Company has funded its operations primarily through public offerings of its common stock, private placements of its common stock and ATM sales. In December 2020, June 2021, January 2023, May 2024 and October 2024, the Company raised approximately $14.6 million, $41.1 million, $8.5 million, $3.2 million and $99.6 million, respectively, in net proceeds from its 2020 IPO, its June 2021 Offering, its January 2023 Offering, its May 2024 Offering and its October 2024 Offering, respectively and $0.5 million in ATM proceeds in 2024.
The Company is subject to a variety of risks similar to other early-stage life science companies including, but not limited to, the successful development, regulatory approval, and market acceptance of the Company’s product candidates, development by its competitors of new technological innovations, protection of proprietary technology, and raising additional working capital. The Company has incurred significant research and development expenses, general and administrative expenses related to its product candidate programs and negative cash flows from operations. The Company anticipates costs and expenses to increase in the future as the Company continues to develop its product candidates.
The Company may seek to fund its operations, particularly with respect to its pulmonary arterial hypertension programs, through additional public equity, private equity, or debt financings, as well as other sources. However, the Company may be unable to raise additional working capital, or if it is able to raise additional capital, it may be unable to do so on commercially favorable terms. In addition, potential proceeds under the Series A-1 Warrants or the Series B-1 Warrants may not be available to the Company in a timely fashion, or at all. The Company’s failure to raise capital or enter into such other arrangements if and when needed would have a negative impact on the Company’s business, results of operations and financial condition and the Company’s ability to continue to develop its product candidates.
The October 2024 Offering has mitigated the Company's substantial doubt to continue as a going concern. The Company estimates that its cash and cash equivalents and marketable securities at December 31, 2024 is sufficient to fund its normal operations for at least the next twelve months from the date of issuance of these consolidated financial statements.
The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.
- Summary of Significant Accounting Policies
Basis of Presentation
The accompanying consolidated financial statements for the years ended December 31, 2024 and 2023, have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”) and Generally Accepted Accounting Principles in the United States (“U.S. GAAP”) for financial information, which prescribes elimination of all significant inter-company accounts and transactions in the accounts of the Company and its wholly owned subsidiary, IKT Securities Corporation, which was incorporated in the Commonwealth of Massachusetts in December 2021. In the opinion of management, these consolidated financial statements reflect all adjustments which are necessary for a fair statement of the Company’s financial position and results of its operations, as of and for the periods presented. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).
On June 30, 2023, we effected a reverse stock split at the ratio of 1 post-split share for every 6 pre-split shares. All common stock, options, warrant amounts, per share information and references have been retroactively adjusted for all figures presented to reflect this split unless specifically stated otherwise.
Consolidation
The accompanying consolidated financial statements include the Company and its wholly owned subsidiary, IKT Securities Corporation. The Company has eliminated all inter-company transactions for the years presented.
Use of Estimates
The preparation of the Company’s consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company utilizes certain estimates in the determination of our liquidity and working capital adequacy, the fair value of its stock options and warrants, deferred tax valuation allowances and revenue recognition, to record expenses relating to research and development contracts and accrued expenses. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results could differ from such estimates.
Off-Balance Sheet Risk and Concentrations of Credit Risk
The Company has no significant off-balance sheet risks, such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Financial instruments that subject the Company to credit risk primarily consist of cash and cash equivalents. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash to the extent recorded on the consolidated balance sheets.
The Company has not experienced any losses in such accounts and management believes that the Company does not have significant credit risk with respect to such cash and cash equivalents and marketable securities.
No grant revenue was recognized for the year ended December 31, 2024. For the year ended December 31, 2023, the Company derived 100% of its total revenue from a single source, the United States Government, in the form of federal research grants.
Segment Information
Operating segments are defined as components of an enterprise for which separate discrete information is available for evaluation by the chief operating decision maker or decision-making group in deciding how to allocate resources and in assessing performance. The Company views is operations and manages its business as one operating and reporting segment, which is the business ofdeveloping protein kinase inhibitor therapeutics (See Note 16).
Cash and cash equivalents
The Company considers all highly liquid investments that are readily convertible to known amounts of cash with original maturities of three months or less at date of purchase to be cash equivalents. The Company had cash and cash equivalents of $56.5 million and $9.2 million at December 31, 2024 and 2023, respectively.
Accounts receivable
The Company makes judgments as to its ability to collect outstanding receivables and provides an allowance for receivables when collection becomes doubtful. Provisions are made based upon a specific review of all significant outstanding invoices and the overall quality and age of those invoices. To date, the Company has not had any provision for credit losses, and the Company didnot have any expected credit losses as of December 31, 2024 and 2023. The balance of accounts receivable as of December 31, 2022 was $39,881.
Leases
The Company accounts for its leases under ASU 2021-09, ASU 2018-10, and ASC Topic 842, Leases (“ASC 842”). ASC 842 requires a lessee to record a right-of-use asset and a corresponding lease liability for most lease arrangements on the Company's balance sheet. Under the standard, disclosure of key information about leasing arrangements to assist users of the consolidated financial statements with assessing the amount, timing and uncertainty of cash flows arising from leases is required.
Leases are classified as either finance leases or operating leases. A lease is classified as a finance lease if any one of the following criteria are met: the lease transfers ownership of the asset by the end of the lease term, the lease contains an option to purchase the asset that is reasonably certain to be exercised, the lease term is for a major part of the remaining useful life of the asset or the present value of the lease payments equals or exceeds substantially all of the fair value of the asset. A lease is classified as an operating lease if it does not meet any of these criteria.
For all leases at the lease commencement date, a right-of-use asset and a lease liability are recognized. The right-of-use asset represents the right to use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease.
The right-of-use asset is initially measured at cost, which primarily comprises the initial amount of the lease liability, plus any initial direct costs incurred if any, less any lease incentives received. All right-of-use assets are reviewed for impairment. The lease liability is initially measured at the present value of the lease payments, discounted using the interest rate implicit in the lease or, if that rate cannot be readily determined, the secured incremental borrowing rate for the same term as the underlying lease.
Lease payments included in the measurement of the lease liability comprise the following: the fixed noncancelable lease payments, payments for optional renewal periods where it is reasonably certain the renewal period will be exercised, and payments for early termination options unless it is reasonably certain the lease will not be terminated early.
Lease cost for operating leases consists of the lease payments plus any initial direct costs, primarily brokerage commissions, and is recognized on a straight-line basis over the lease term. Included in lease cost are any variable lease payments incurred in the period that are not included in the initial lease liability and lease payments incurred in the period for any leases with an initial term of 12 months or less. Lease cost for finance leases consists of the amortization of the right-of-use asset on a straight-line basis over the lease term and interest expense determined on an amortized cost basis. The lease payments are allocated between a reduction of the lease liability and interest expense.
The Company has made an accounting policy election to not recognize leases with an initial term of 12 months or less within our consolidated balance sheets and to recognize those lease payments on a straight-line basis in our consolidated statements of operations and comprehensive loss over the lease term.
Equipment and Improvements
Equipment and improvements are stated at cost, less accumulated depreciation. For financial reporting purposes, depreciation is recognized using the straight-line method, allocating the cost of the assets over their estimated usefulness from threeto five years for network equipment, office equipment, and furniture classified as fixed assets.
| Estimated Useful Econcomic Life | |
| Leasehold property improvements, right-of-use assets | Lesser of lease term or useful life |
|---|---|
| Furniture and office equipment | 5 years |
| IT equipment | 3 years |
Fair Value Measurements
The Company has certain financial assets and liabilities recorded at fair value which have been classified as Level 1, 2 or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements.
· Level 1 — Fair values are determined utilizing quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access;
· Level 2 — Fair values are determined by utilizing quoted prices for identical or similar assets and liabilities in active markets or other market observable inputs such as interest rates, yield curves and foreign currency spot rates; and
· Level 3 — Inputs are unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. Financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.
The Company’s financial assets, which include cash equivalents and marketable securities, have been initially valued at the transaction price, and subsequently revalued at the end of each reporting period, utilizing third-party pricing services. The pricing services utilize industry standard valuation models, including both income and market based approaches, to determine valueand improvements are stated at cost, less accumulated depreciation.
Marketable Securities
The Company's marketable securities consist of U.S. Treasury securities with maturities of less than one year which are classified as available-for-sale and included in current assets on the consolidated balance sheets. Available-for-sale debt securities are carried at fair value with unrealized gains and losses reported as a component of stockholders’ equity in accumulated other comprehensive income (loss). Realized gains and losses, if any, are included in other income, net in the consolidated statements of operations and comprehensive loss.
Available-for-sale securities are reviewed for possible impairment at least quarterly, or more frequently if circumstances arise that may indicate impairment. When the fair value of the securities declines below the amortized cost basis, impairment is indicated and it must be determined whether it is other than temporary. Impairment is considered to be other than temporary if the Company: (i) intends to sell the security, (ii) will more likely than not be forced to sell the security before recovering its cost, or (iii) does not expect to recover the security’s amortized cost basis. If the decline in fair value is considered other than temporary, the cost basis of the security is adjusted to its fair market value and the realized loss is reported.
Revenue Recognition
The Company generates revenue from research and development grants under contracts with third parties that do not create customer-vendor relationships. The Company’s research and development grants are non-exchange transactions and are not within the scope of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). Contribution revenue earned from activities performed pursuant to research and development grants is reported as grant revenue in the Company’s consolidated statements of operations. Revenue from these grants is recognized as the Company incurs qualifying expenses as stipulated by the terms of the respective grant. Cash received from grants in advance of incurring qualifying expenses is recorded as deferred revenue. The Company records revenue and a corresponding receivable when qualifying costs are incurred before the grants are received.
Research and Development Costs
Costs incurred in the research and development of the Company’s product candidates are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including activities associated with performing services under grant revenue contracts and include salaries and benefits, stock compensation, research-related subcontractors and consultants, supplies and overhead costs. Advance payments made to suppliers and contract research organizations are classified as prepaid research and development and are expensed as research and development as the supplies are consumed and the contract services are provided. During the years ended December 31, 2024 and 2023 the company incurred expenses of approximately $307 thousand and $76 thousand, respectively with a related party vendor included in research and development expenses. As of December 31, 2024 and 2023, the Company had a payable balance with a related party vendor of approximately $0 and $14 thousand, respectively, included in accounts payable.
Stock-Based Compensation
The Company has a stock-based compensation plan which is more fully described in Note 9. The Company records stock-based compensation for options granted to employees and to members of the board of directors for their services on the board of directors, based on the grant date fair value of awards issued, and the expense is recorded on a straight-line basis over the applicable service period, which is generally one to two years. The Company accounts for non-employee stock-based compensation arrangements based upon the fair value of the consideration received or the equity instruments issued, whichever is more reliably measurable. Stock-based compensation costs for non-employee awards are recognized as services are provided, which is generally the vesting period.
The Company uses a Monte Carlo simulation to determine the fair value of complex option structures. For all non-complex option structures, the Company uses the Black-Scholes-Merton option-pricing model to determine the fair value of stock options. The use of the Black-Scholes-Merton 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. The Company has concluded that the historical share option exercise experience does not provide a reasonable basis upon which to estimate expected term. Therefore, the expected term was determined according to the simplified method, which is the average of the vesting tranche dates and the contractual term. Due to the lack of Company specific historical and implied volatility data, we have based our estimate of expected volatility primarily on the historical volatility of a group of similar companies that are publicly traded. For these analyses, companies with comparable characteristics are selected, including enterprise value and position within the industry, and with historical share price information sufficient to meet the expected life of the stock-based awards. The Company computes the historical volatility data using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of its stock-based awards. The risk-free interest rate is determined by reference to U.S. Treasury zero-coupon issues with remaining maturities similar to the expected term of the options. The Company has not paid, and does not anticipate paying, cash dividends on shares of common stock.
Income Taxes
The Company provides for income taxes using the asset and liability method. The Company provides deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company’s financial statement carrying amounts and the tax bases of assets and liabilities using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. A valuation allowance is provided to reduce the deferred tax assets to the amount that will more likely than not be realized.
The Company does not have any material uncertain tax positions for which reserves would be required. The Company will recognize interest and penalties related to uncertain tax positions, if any, in income tax expense.
Net Loss Per Share
Basic net loss per share is calculated by dividing net loss applicable to common stockholders by the weighted-average number of shares outstanding during the period which includes Pre-Funded Warrants and shares held in abeyance from date of issuance, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method. For purposes of the diluted net loss per share calculation, warrants to purchase common stock and stock options are considered to be common stock equivalents, but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented.
Recent Accounting Standards
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and are generally adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.
The Company qualifies as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, as amended (“JOBS Act”). The JOBS Act permits an emerging growth company such as the Company to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. The Company has elected not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, the Company will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that it either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company.
In November 2023, the FASB issued Accounting Standards Update No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures which is intended to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The new guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, and early adoption is permitted. The Company adopted this standard as of January 1, 2024 and concluded it did not have a material impact on the Company's consolidated financial statements.
On December 14, 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which amends the guidance in ASC 740, Income Taxes. The ASU is intended to improve the transparency of income tax disclosures by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. The ASU’s amendments are effective for public business entities for annual periods beginning after December 15, 2024. Entities are permitted to early adopt the standard “for annual financial statements that have not yet been issued or made available for issuance.” Adoption is either prospectively or retrospectively; the Company will adopt this ASU on a prospective basis. The Company is currently evaluating the impact of the ASU, but does not expect any material impact upon adoption.
On November 2024, the FASB issued ASU 2024-03 -Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. The ASU requires more detailed disclosures about the types of expenses in commonly presented expense captions such as cost of sales, selling, general and administrative expenses and research and development expenses. This includes separate footnote disclosure for expenses such as purchases of inventory, employee compensation, depreciation, and intangible asset amortization. Public business entities are required to apply the guidance prospectively and may apply it retrospectively. The ASU's amendments are effective for public business entities for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Public business entities are required to apply the guidance prospectively and may apply it retrospectively. The Company is currently evaluating the effect of adopting this ASU.
- Supplemental Balance Sheet Information
Accrued expenses and other current liabilities consist of the following:
| December 31,2024 | December 31,2023 | |
|---|---|---|
| Accrued consulting | $202,379 | $49,395 |
| Accrued compensation | 999,303 | 635,451 |
| Accrued research and development | 1,397,348 | 1,472,292 |
| Accrued other | 81,000 | 102,817 |
| Total accrued expenses and other current liabilities | $2,680,030 | $2,259,955 |
- Fair Value of Financial Instruments
The following table summarizes cash equivalents and marketable securities measured at their fair value on a recurring basis as of:
| Fair Value Measurements as of December 31, 2024: | ||||
|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Total | |
| Cash equivalents: | ||||
| Money market funds | $11,238,598 | $— | $— | $11,238,598 |
| Total | $11,238,598 | $— | $— | $11,238,598 |
| Marketable securities, available-for-sale: | ||||
| U.S. Treasury obligations | $41,052,949 | $— | $— | $41,052,949 |
| Total | $41,052,949 | $— | $— | $41,052,949 |
| Fair Value Measurements as of December 31, 2023: | ||||
|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Total | |
| Cash equivalents: | ||||
| Money market funds | $8,039,024 | $— | $— | $8,039,024 |
| Total | $8,039,024 | $— | $— | $8,039,024 |
| Marketable securities, available-for-sale: | ||||
| U.S. Treasury obligations | $4,086,873 | $— | $— | $4,086,873 |
| Total | $4,086,873 | $— | $— | $4,086,873 |
- Marketable Securities
Marketable securities consisted of the following:
| December 31, 2024 | Amortized Cost | Unrealized Gain | Unrealized Loss | Fair Value |
|---|---|---|---|---|
| Marketable securities, available-for-sale: | ||||
| U.S. Treasury obligations | $41,090,197 | $— | $(37,248) | $41,052,949 |
| Total | $41,090,197 | $— | $(37,248) | $41,052,949 |
| December 31, 2023 | Amortized Cost | Unrealized Gain | Unrealized Loss | Fair Value |
|---|---|---|---|---|
| Marketable securities, available-for-sale: | ||||
| U.S. Treasury obligations | $4,085,996 | $877 | $— | $4,086,873 |
| Total | $4,085,996 | $877 | $— | $4,086,873 |
As of December 31, 2024, the Company held seven U.S. Treasury debt securities that were in an unrealized loss position totaling $37,248. As of December 31, 2023, the Company held three U.S. Treasury debt securities that were in an unrealized gain position totaling $877. All U.S. treasury obligations were due to mature inless than one year for the years ended December 31, 2024 and 2023, respectively.
The Company received proceeds of $23.5 million from maturities of marketable securities for the year ended December 31, 2024. The Company received proceeds of $41.1 million from maturities of marketable securities for the year ended December 31, 2023.
- Equipment and Improvements
| Equipment and Improvements, net | ||
|---|---|---|
| Year ended December 31, | ||
| 2024 | 2023 | |
| Furniture and office equipment | $86,930 | $86,930 |
| IT equipment | 16,895 | 16,895 |
| 103,825 | 103,825 | |
| Less: Accumulated depreciation | 56,725 | 30,453 |
| Total | $47,100 | $73,372 |
Depreciation expense for the year ended December 31, 2024 was $26,272. Depreciation expense for the year ended December 31, 2023 was $177,398.
- Insurance Premium Financing Payable
| Year ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| AON | $— | $381,784 |
| Total insurance premium financing payable | $— | $381,784 |
Insurance premium financing Payable to AON
In December 2023, the Company entered into an insurance premium financing and security agreement with AON Premium Finance, LLC (“AON”). Under the agreement, the Company financed $381,784 of certain premiums at an 8.59% annual interest rate. As of December 31, 2024 and December 31, 2023, the outstanding principal of the loan was $0 and $381,784, respectively, and is included on the balance sheet in Insurance premium financing payable. The final payment was paid in November 2024.
- Stockholders’ Equity
Each share of common stock is entitled toone vote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and when declared by the board of directors, subject to the prior rights of holders of all classes of stock outstanding. As of December 31, 2024, a total 15,106,412 shares of common stock were reserved for issuance upon the exercise of outstanding stock options and warrants under the 2020 Equity Incentive Plan and the 2011 Equity Incentive Plan.
Share Issuances
On October 21, 2024, the Company announced the closing of a private placement of approximately $110 million from the issuance and sale of shares of the Company's common stock and accompanying warrants with potential aggregate financing of up to approximately $275 million upon the full cash exercise of the warrants issued in the private placement, before deducting placement agent fees and offering expenses (“October 2024 Offering”). The October 2024 Offering consisted of (i)58,310,000 shares of common stock sold at $1.37 per share, or, in lieu thereof, pre-funded warrants (“Pre-Funded Warrants”) to purchase up to 21,985,000 shares of common stock with an exercise price of $0.001, (ii) Series A-1 Warrants to purchase an aggregate of 40,139,474 shares of common stock with an exercise price of $1.37, or in lieu thereof, Pre-Funded Warrants to purchase the same number of shares of common stock (“Series A-1 Warrants”), and (iii) Series B-1 Warrants to purchase an aggregate of 73,813,529 shares of common stock with an exercise price of $1.37, or in lieu thereof, Pre-Funded Warrants to purchase the same number of shares of common stock (“Series B-1 Warrants”). The Pre-Funded Warrants and Pre-Funded Warrants underlying the Series A-1 Warrants and Series B-1 Warrants are exercisable at any time after their original issuance and will not expire. The Series A-1 Warrants and the Series B-1 Warrants will become exercisable at the earlier of (a) the 75th calendar day following the initial filing of the resale registration statement covering the resale of the shares of common stock issuable upon the exercise of the Series A-1 Warrants and Series B-1 Warrants, if the SEC notifies the Company that it will review such resale registration statement and (b) the 5th business day after the date the Company is notified by the SEC that such resale registration statement will not be subject to further review. Each Series A-1 Warrant will be exercisable for one share of common stock and will expire at 5:00 p.m. (New York City time) on the 30th day following the later of (a) the Company’s public announcement of the Phase 2b 12 week safety readout for IKT-001 for PAH and (b) the Company both obtaining stockholder approval for and filing an amendment to its charter to increase the number of authorized shares of common stock to a number of shares of common stock sufficient to allow for the full exercise of the warrants (“Charter Amendment”). Each Series B-1 Warrant will be exercisable for one share of common stock, will become exercisable by an investor once all of such investor’s Series A-1 Warrants have been exercised and will expire at 5:00 p.m. (New York City time) on the 30th day following the later of (a) the Company’s public announcement of its Phase 2b efficacy readout for IKT-001 with respect to PAH and (b) the Company both obtaining stockholder approval for and filing the Charter Amendment. The Series A-1 Warrants have an exercise price of $1.37 per share and the Series B-1 Warrants have an exercise price of $1.49 per share. The Company intends to use the net proceeds from the private placement to finance the initiation of a Phase 2b trial in PAH and for general corporate purposes. As of December 31, 2024, the Company had 19,815,131 pre-funded warrants outstanding.
On May 20, 2024, the Company entered into a securities purchase agreement with a single institutional investor in connection with a registered direct offering and concurrent private placement with the same institutional investor (collectively the "May 2024 Offering”). The May 2024 Offering consisted of (i)714,527 shares of the Company's common stock sold at $1.68 per share, (ii) Pre-Funded Common Warrants to purchase up to 957,925 shares of common stock with an exercise price of $0.0001 which are immediately exercisable after the issuance until exercised in full, (iii) Series A Common Warrants to purchase 1,672,452 shares of common stock with an exercise price of $1.68 per share which expire on the one-year anniversary from the date of stockholder approval, and (iv) Series B Common Warrants to purchase 1,672,452 shares of common stock with an exercise price of $1.68 per share which expire on the five-year anniversary from the date of stockholder approval. All of the warrants in the May 2024 Offering were issued to a single investor. During the third quarter 2024, the investor exercised 247,925 Pre-Funded Common Warrants and exercised the remaining 710,000 Pre-Funded Common Warrants as of the date of this report. The Company received net proceeds from the May 2024 Offering of approximately $2.2 million.
On May 20, 2024, the Company also entered into a warrant inducement agreement with the same investor to exercise certain outstanding warrants that the Company issued in January 2023 (“January 2023 Existing Warrants”). Pursuant to the warrant inducement agreement, the investor agreed to exercise outstanding warrants to purchase an aggregate of 708,500 shares of the Company's common stock at an amended exercise price of $1.68 per share. These shares are held in abeyance and not considered outstanding. The shares held in abeyance will be held in abeyance until notice from the investor that the balance, or portion thereof, may be issued in compliance with a beneficial ownership limitation provision in the warrants. The Company also agreed to reduce the exercise price of the remaining unexercised portion of such warrants to purchase 1,229,484 shares of common stock to $1.68 per share and to issue the investor Series C Common Warrants to purchase 708,500 shares of the Company's common stock and Series D Common Warrants to purchase 708,500 shares of the Company's common stock (“January 2023 New Warrants”). Each will have an exercise price of $1.68 per share and will be exercisable beginning on the effective date of stockholder approval. The Series C Common Warrants will expire on the one-year anniversary from the date of stockholder approval and the Series D Common Warrants will expire on the five-year anniversary from the date of stockholder approval. The shares held in abeyance were all issued to the investor in 2024.
Therepricing of the January 2023 Existing Warrants and issuance of the Series C Common Warrants and the Series D Common Warrants is considered a modification of the January 2023 Existing Warrants under the guidance of ASU 2021-04. The modification is consistent with the "Equity Issuance" classification under that guidance as the reason for the modification was to induce the holder to cash exercise their warrants, resulting in the imminent exercise of the January 2023 Existing Warrants, which raised equity capital and generatednet proceeds for the Company of approximately $1.0 million. The total fair value of the consideration of the modification includes the incremental fair value of the January 2023 Existing Warrants (determined by comparing the fair values immediately prior to and immediately after the modification) and the initial fair value of the January 2023 New Warrants. The fair values were calculated using the Black-Scholes model and the Company determined that the total fair value of the consideration related to the modification of the January 2023 Existing Warrants, including the initial fair value of the January 2023 New Warrants was $1.8 million.
On January 25, 2023, the Company entered into a securities purchase agreement in connection with a registered direct offering and concurrent private placement with an institutional investor. The Company also entered into a securities purchase agreement and a registration rights agreement in connection with a concurrent private placement with the same institutional investor(collectively the "January 2023 Offering”). The January 2023 Offering consisted of (i)466,799 shares of Common Stock sold at $5.16 per share, (ii) Common Warrants to purchase up to 1,937,985 shares of Common Stock with an exercise price of $5.16, and (iii) Pre-Funded Warrants to purchase up to 1,471,187 shares of Common Stock with an exercise price of $0.06, all issued to Armistice Capital Master Fund Ltd (“Armistice”). The warrants will expire on January 27, 2028. As part of the January 2023 Offering, the Company further issued warrants to H.C. Wainwright & Co., LLC (“Placement Agent Warrants”) to purchase up to 67,830 shares of Common Stock with an exercise price of $6.45 and an expiration date of January 25, 2028. As of December 31, 2023 the institutional investor has exercised all 1,471,187 Pre-Funded Warrants.
The Company received net proceeds from the January 2023 Offering of approximately $8.5 million. Effective January 25, 2023, the Company terminated the Equity Distribution Agreement with Piper Sandler & Co. by providing a notice of termination in accordance with the terms of the Equity Distribution Agreement (see Note 10).
In September 2023 and December 2023, the Company issued 12,000 shares respectively of its stock in exchange for digital media consulting services. The fair value of the stock was $17,280 and $14,280 respectively based upon the closing price of the shares on the date of the transaction. Issuance costs were not material. No additional rights or options were granted to this accredited investor in connection with this issuance. This issuance is exempt from registration pursuant to Section 4(a)(2) of the Securities Act as transactions by an issuer not involving any public offering.
- Stock-Based Compensation
2020 Equity Incentive Plan
On July 21, 2020, the Company’s board of directors and its stockholders approved the 2020 Equity Incentive Plan (“2020 Plan”). The 2020 Plan became effective immediately prior to the closing of the Company’s December 2020 IPO. The 2020 Plan provides for the granting of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock or restricted stock units to any of its employees, directors, consultants and other service providers or those of its affiliates. The board of directors has initially designated the compensation committee to administer the 2020 Plan. The compensation committee has broad authority to administer the plan and to determine the vesting conditions for awards. Neither the compensation committee nor the board of directors are authorized to reprice outstanding options or stock appreciation rights without shareholder consent. In addition, any amendments to increase the total number of shares reserved for issuance under the 2020 Plan or modification of the classes of participants eligible to awards requires ratification by the stockholders. On June 7, 2024, the stockholders of Registrant approved an amendment to the 2020 Plan, pursuant to which the number of shares of Common Stock reserved and available for issuance under the 2020 Plan increased by 2,500,000 shares. On January 3, 2025, the stockholders of the Company approved an amendment to the 2020 Plan, pursuant to which the number of shares of Common Stock reserved and available for issuance under the 2020 Plan increased by 27,453,993 shares. Subject to certain adjustments, the maximum number of shares of common stock that may be issued under the 2020 Plan after the stockholder's approval on January 3, 2025 in connection with awards is limited to 31,417,517 shares.
Following the effectiveness of the 2020 Plan, the Company ceased making grants under the 2011 Plan. However, the 2011 Plan continues to govern the terms and conditions of the outstanding awards granted under the 2011 Plan. Shares of common stock subject to awards granted under the 2011 Plan that cease to be subject to such awards by forfeiture or otherwise after the effective date of the 2020 Plan will become available for issuance under the 2020 Plan.
2011 Equity Incentive Plan
Prior to the closing of its IPO, the Company maintained the 2011 Plan, pursuant to which the Company made grants of non-qualified stock options to eligible employees and other service providers.
Stock Options
On October 9, 2024, the Company modified only the exercise price on all outstanding previously issued stock options. A total of 31 grantees were affected resulting in approximately $0.2 million of total incremental fair value expense recognized. The Company determined that the modification of the stock options, both vested and unvested, was a probable to probable (Type 1) modification. The Company recognized the grant date fair value and any incremental fair value on the modification date. For all options previously vested, all prior expense had been recognized and only the incremental fair value will be recognized. For the options not fully vested, any remaining grant date fair value plus the incremental fair value will be recognized ratably over the remaining vesting term.
The following is a summary of option activity under the 2011 Plan and the 2020 Plan:
| Number ofShares · Weighted-AverageExercisePricePer Share · Weighted-AverageRemainingContractualTerm(In Years) | ||||||
|---|---|---|---|---|---|---|
| Outstanding at December 31, 2022 | 732,395 | $13.14 | 6.20 | |||
| Granted | 111,668 | 3.03 | — | |||
| Exercised | — | — | — | |||
| Forfeited | (4,540) | 10.74 | — | |||
| Cancelled | — | — | — | |||
| Outstanding at December 31, 2023 | 839,523 | 11.90 | 5.30 | |||
| Granted | 17,219,692 | 1.42 | ||||
| Exercised | — | — | — | |||
| Forfeited | (1,140,595) | 9.11 | — | |||
| Cancelled | (14,570) | 12.15 | — | |||
| Outstanding at December 31, 2024 | 16,904,050 | 1.41 | 9.48 | |||
| Exercisable at December 31, 2024 | 7,962,036 | 1.26 | 9.31 | |||
As of December 31, 2024, the intrinsic value of options outstanding was $31.1 million and $15.8 million of the intrinsic value of options was exercisable. Intrinsic value is calculated based on the aggregate difference between the closing price of the Company’s common stock on the last trading day of 2024 and the exercise price of each in the money stock option award. We adjust for actual forfeitures as they occur.
During the year ended December 31, 2024, certain performance conditions were met. There wereno options to purchase stock that vested upon the achievement of performance conditions at December 31, 2023.
The weighted-average fair values of options granted in the years ended December 31, 2024 and 2023 were $0.62 and $3.03, per share, respectively, and were calculated using the following estimated assumptions:
| Year ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Weighted-average risk-free interest rate | 4.11% | 4.27% |
| Expected dividend yield | 0.00% | 0.00% |
| Expected volatility | 98.77% | 98.45% |
| Expected terms | 9.50 years | 4.38 years |
The total fair values of stock options that vested during the years ended December 31, 2024 and 2023 were $7,863,021 and $608,539, respectively.
As of December 31, 2024, there was $2,763,814 of total unrecognized compensation cost related to non-vested stock options granted under the 2011 Plan and the 2020 Plan. The Company expects to recognize that cost over a remaining weighted-average period of 1.57 years as of December 31, 2024.
Restricted Stock Units
During the years ended December 31, 2024 and 2023, there wereno restricted stock units issued or outstanding.
Stock-Based Compensation Expense
The following table summarizes the stock-based compensation expense for stock options granted to employees and non-employees:
| Year ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Research and development | $4,692,169 | $160,080 |
| Selling, general and administrative | 3,448,448 | 340,068 |
| Total stock-based compensation expense | $8,140,617 | $500,148 |
- ATM Program
On May 16, 2022, the Company entered into an Equity Distribution Agreement (“Piper Agreement”) with Piper Sandler & Co. as sales agent (“Agent”), pursuant to which the Company may, from time to time, issue and sell shares of its common stock, at an aggregate offering price of up to $9.8 million (“Shares”) through the Agent. Under the terms of the Agreement, the Agent may sell the Shares at market prices by any method that is deemed to be an “ATM” as defined in Rule 415 under the Securities Act, as amended.
Subject to the terms and conditions of the Agreement, the Agent will use its commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions. The Company has no obligation to sell any of the Shares, and may at any time suspend sales under the Agreement or terminate the Agreement in accordance with its terms. The Company has provided the Agent with customary indemnification rights, and the Agent will be entitled to a fixed commission of 3.0% of the aggregate gross proceeds from the Shares sold. The Agreement contains customary representations and warranties, and the Company is required to deliver customary closing documents and certificates in connection with sales of the Shares.
Effective January 25, 2023, the Company terminated the Piper Agreement by providing a notice of termination to the Agent in accordance with the terms of the Equity Distribution Agreement. No shares were sold under the Piper Agreement prior to termination.
On February 1, 2024, the Company entered into an At the Market Offering Agreement (“ATM”) with H.C. Wainwright & Co., LLC, as sales agent (“Agent”), pursuant to which the Company may, from time to time, issue and sell shares of its common stock, in an aggregate offering price of up to $5,659,255, through or to the Agent. Under the terms of the ATM Agreement with the Agent (“ATM Agreement”), the Agent may sell the shares of the Company’s common stock at market prices by any method that is deemed to be an “at the market offering” as defined in Rule 415 under the Securities Act of 1933, as amended.315,338 shares of the Company’s common stock were sold pursuant to the ATM Agreement for an aggregate gross sales price of $849,187. On May 20, 2024, the Company filed with the Securities and Exchange Commission a prospectus supplement to reduce the maximum aggregate gross sales price of its common stock that may be offered, issued and sold under the ATM Agreement from and after May 20, 2024 to $50,000, not including the shares of the Company’s common stock previously sold. No sales of the Company’s common stock pursuant to the ATM Agreement have occurred since this date. On December 2, 2024, the Company provided to the Agent a notice of termination of the ATM Agreement, with such termination to be effective December 11, 2024 in accordance with the terms of the ATM Agreement.
- Warrants
On October 27, 2018, the Company granted a warrant to purchase 4.9% of its issued and outstanding shares of common stock at the time of the issuance of the warrant, or 66,811 shares. The warrant has a term of 7 years and is exercisable at $28.76 per share.
On January 1, 2019, the Company issued aseven-year warrant to a service provider to purchase 3,423 shares of the Company’s common stock with an exercise price of $28.76 per share. The warrants vested immediately. The Company received legal services, as needed, during 2019 under an unwritten agreement with the service provider.
On March 31, 2020, the Company issued a warrant to purchase up to 4,371 shares of its stock to one of its consultants in exchange for legal services, as needed, during 2020. The warrant contains a strike price of $34.04 per share and has aseven-year contractual term.
On August 25, 2020, the Company granted a fully vested warrant to purchase up to 3,643 shares of its common stock to one of its consultants. The warrant is exercisable at a strike price of $35.42 per share and has a contractual term ofseven years.
On August 25, 2020, the Company granted a warrant to purchase up to 25,000 shares of its common stock to one of its consultants. The warrant is exercisable at a strike price of $35.42 per share and has a contractual term ofseven years.
On December 28, 2020, the Company issued aseven-year warrant to purchase up to a total of 17,073 shares of the Company’s common stock with an exercise price of $60.00 per share to certain 2018 investors in consideration for completing the IPO later than March 2019 (“Late IPO Warrants”).
The Company issued and sold to its underwriters warrants to purchase up to 15,000 shares of its common stock and up to 125,000 shares of its common stock in connection with its December 2020 IPO and its June 2021 Offering, respectively. The warrants were sold for an aggregate purchase price of $100 for each set of warrants and have five-year terms. The IPO warrant is exercisable beginning June 20, 2021 at an initial exercise price of $75.00 per share of common stock. The June 2021 Offering warrant is exercisable beginning June 15, 2022 at an initial exercise price of $22.50 per share of common stock.
On June 15, 2021, the Company issued a warrantto purchase an aggregate of 125,000 shares of common stock for an aggregate purchase price of $100. The warrant has an initial exercise price of $22.50 per share of common stock and expires June 15, 2026.
On January 25, 2023, the Company issued warrants to purchase up to 1,937,985 shares of Common Stock with an exercise price of $5.16, and pre-funded warrants to purchase up to 1,471,187 shares of Common Stock with an exercise price of $0.06. The warrants will expire on January 27, 2028. The Company further issued warrants to purchase up to 67,830 shares of common stock with an exercise price of $1.68 and an expiration date of January 25, 2028. As of December 31, 20242,179,687 warrants were exercised.
On May 20, 2024, the Company issued pre-funded warrants to purchase up to 957,925 shares of common stock with an exercise price of $0.0001 which are immediately exercisable after the issuance until exercised in full, series A common warrants to purchase 1,672,452 shares of common stock with an exercise price of $1.68 per share which expire on the one-year anniversary from the date of stockholder approval, and series B common warrants to purchase 1,672,452 shares of common stock with an exercise price of $1.68 per share which expire on the five-year anniversary from the date of stockholder approval. All of the warrants in the May 2024 Offering were issued to a single investor. All of the pre-funded warrants were exercised in 2024.
On May 20, 2024, the Company also entered into a warrant inducement agreement with the same investor to exercise certain outstanding warrants that the Company issued in January 2023 (“January 2023 Existing Warrants”). Pursuant to the warrant inducement agreement, the investor agreed to exercise outstanding warrants to purchase an aggregate of 708,500 shares of the Company's common stock at an amended exercise price of $1.68 per share. These shares are held in abeyance and not considered outstanding. The shares held in abeyance will be held in abeyance until notice from the investor that the balance, or portion thereof, may be issued in compliance with a beneficial ownership limitation provision in the warrants. The Company also agreed to reduce the exercise price of the remaining unexercised portion of such warrants to purchase 1,229,484 shares of common stock to $1.68 per share and to issue the investor Series C Common Warrants to purchase 708,500 shares of the Company's common stock and Series D Common Warrants to purchase 708,500 shares of the Company's common stock (“January 2023 New Warrants”). Each will have an exercise price of $1.68 per share and will be exercisable beginning on the effective date of stockholder approval. The Series C Common Warrants will expire on the one-year anniversary from the date of stockholder approval and the Series D Common Warrants will expire on the five-year anniversary from the date of stockholder approval. As of December 2024,708,500 abeyance shares were exercised.
On October 21, 2024, the Company issued pre-funded warrants to purchase up to 21,985,000 shares of common stock with an exercise price of $0.001, series A-1 warrants to purchase an aggregate of 40,139,474 shares of common stock with an exercise price of $1.37, or in lieu thereof, pre-funded warrants to purchase the same number of shares of common stock, and series B-1 warrants to purchase an aggregate of 73,813,529 shares of common stock with an exercise price of $1.37, or in lieu thereof, pre-funded warrants to purchase the same number of shares of common stock. The pre-funded warrants and pre-funded warrants underlying the series A-1 warrants and series B-1 warrants are exercisable at any time after their original issuance and will not expire. The series A-1 warrants and the series B-1 warrants will become exercisable at the earlier of (a) the 75th calendar day following the initial filing of the resale registration statement covering the resale of the shares of common stock issuable upon the exercise of the series A-1 warrants and series B-1 warrants, if the SEC notifies the Company that it will review such resale registration statement and (b) the 5th business day after the date the Company is notified by the SEC that such resale registration statement will not be subject to further review. Each series A-1 warrant will be exercisable for one share of common stock and will expire at 5:00 p.m. (New York City time) on the 30th day following the later of (a) the Company’s public announcement of the Phase 2b 12 week safety readout for IKT-001 for PAH and (b) the Company both obtaining stockholder approval for and filing an amendment to its charter to increase the number of authorized shares of common stock to a number of shares of common stock sufficient to allow for the full exercise of the warrants (“Charter Amendment”). Each series B-1 warrant will be exercisable for one share of common stock, will become exercisable by an investor once all of such investor’s series A-1 warrants have been exercised and will expire at 5:00 p.m. (New York City time) on the 30th day following the later of (a) the Company’s public announcement of its Phase 2b efficacy readout for IKT-001 with respect to PAH and
(b)the Company both obtaining stockholder approval for and filing the Charter Amendment. The series A-1 warrants have an exercise price of $1.37 per share and the series B-1 warrants have an exercise price of $1.49 per share. As of December 31, 2024,2,169,869 pre-funded warrants were exercised.
- Net Loss Per Share
The following table presents the calculation of basic and diluted net loss per share applicable to common stockholders. Basic net loss per share is calculated by dividing net loss attributable to common shareholders by the weighted-average number of shares outstanding during the period which includes Pre-Funded Warrants and shares held in abeyance from date of issuance.
| Year ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Numerator: | ||
| Net loss | $(27,519,886) | $(19,028,883) |
| Denominator: | ||
| Weighted-average number of common shares outstanding – basic and diluted | 23,712,220 | 6,028,210 |
| Net loss per share applicable to common stockholders – basic and diluted | $(1.16) | $(3.16) |
The following shares were excluded from the calculation of diluted net loss per share applicable to common stockholders, prior to the application of the treasury stock method, because their effect would have been anti-dilutive for the periods presented:
| Year ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Options to purchase shares of stock | 16,904,050 | 839,523 |
| Warrants to purchase shares of stock | 26,134,671 | 2,266,133 |
| Total | 43,038,721 | 3,105,656 |
- Income Taxes
No provision or benefit for federal or state income taxes has been recorded, as the Company has incurred a net loss for all of the periods presented, and the Company has provided a full valuation allowance against its deferred tax assets.
At December 31, 2024, the Company had federal net operating loss carryforwards of approximately $1.6 million which will begin to expire in varying amounts annually beginning in 2030 and $46.5 million of federal net operating losses with no expiration. At December 31, 2024, the Company had state net operating loss carryforwards of approximately $36.1 million which will begin to expire in varying amounts annually beginning in 2030. Utilization of net operating losses may be subject to substantial annual limitations due to the “change in ownership” provisions of the Internal Revenue Code, and similar state provisions. The Company is in the process of completing a Section 382 study through December 31, 2024, and preliminarily determined there were likely ownership changes on June 5, 2021 and October 21, 2024, which will result in annual base limitations. The limitations are still being finalized, though the analysis determined there will be sufficient annual limitation to allow for the absorption of pre-change NOLs, and therefore, the Company will not write them off. Conversely, the analysis provides that the Company's federal R&D credits will expire unutilized, and as a result, the Company has written off the deferred tax assets related to these credits.
The reconciliation of the U.S. federal statutory rate to the Company’s effective tax rate is as follows:
| Year ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Tax at statutory rate | 21.00% | 21.00% |
| State income taxes | 2.98% | 5.54% |
| Tax law change | (1.40)% | 1.37% |
| Stock-based compensation | (2.42)% | (0.11)% |
| R&D Tax Credits | 2.59% | 5.75% |
| Other | 0.02% | (0.05)% |
| Limitation on tax attributes | (6.56)% | 0.00% |
| Change in valuation Allowance | (16.21)% | (33.50)% |
| Effective tax rate | 0.00% | 0.00% |
On December 4, 2023, Massachusetts enacted supplemental tax law changes modifying the adoption of a single sales apportionment factor effective on January 1, 2025 to use the property and payroll factors if no sales factor exits. As required under ASC 740, the Company has accounted for the deferred tax impacts of this tax law change in the period the tax law was enacted, which has the impact of decreasing its state deferred tax assets. The impact of the tax law change is offset by a change in valuation allowance.
The significant components of the Company’s deferred tax assets (liabilities) consist of the following at December 31, 2024 and 2023:
| 2024 | 2023 | |
|---|---|---|
| Deferred tax assets: | ||
| Net operating loss carryforwards | $12,320,874 | $9,179,115 |
| Capitalized research and development | 6,895,747 | 5,669,202 |
| Stock-based compensation | 3,780,237 | 2,629,771 |
| R&D tax credits carryforwards | — | 1,093,839 |
| Accrued expenses | 218,802 | 187,393 |
| Fixed assets | 447 | (1,966) |
| Other | 1,728 | 1,827 |
| Total deferred tax assets | 23,217,835 | 18,759,181 |
| Deferred tax asset valuation allowance | (23,217,835) | (18,759,181) |
| Net deferred tax asset | $— | $— |
The Company has maintained a full valuation allowance against its deferred tax assets in all periods presented. A valuation allowance is required to be recorded when it is not more likely than not that some portion or all of the net deferred tax assets will be realized. Since the Company cannot determine that it is more likely than not that it will generate taxable income, and thereby realize the net deferred tax assets, a full valuation allowance has been provided. The valuation allowance increased $4.5 million and $6.4 million for the years ended December 31,2024 and 2023, respectively. The increases in 2024 and 2023 are primarily related to each year’s taxable loss as well as the increase in stock-based compensation in 2024. The Company hasno uncertain tax positions at December 31,2024 and 2023 that would affect its effective tax rate. Since the Company is in a loss carryforward position, the Company is generally subject to U.S. federal and state income tax examinations by tax authorities for all years for which a loss carryforward is available.
The Tax Cuts and Jobs Act (“TCJA”) resulted in significant changes to the treatment of research and developmental (R&D) expenditures under Section 174. For tax years beginning after December 31, 2021, taxpayers are required to capitalize and amortize all R&D expenditures that are paid or incurred in connection with their trade or business. Specifically, costs for U.S.-based R&D activities must be amortized over five years and costs for foreign R&D activities must be amortized over 15 years- both using a midyear convention. During the year ended December 31, 2024, the Company capitalized for tax purp oses $11.3 million and $0.7 million of domestic and foreign R&D expenses, respectively.
- Commitments and Contingencies
Operating Leases
On April 18, 2022, the Company entered into an operating lease agreement for office space at its new location in Lexington, Massachusetts (“Office Lease”). On August 8, 2022, the Company commenced occupancy of the leased space. The lease runs through September 30, 2025 or a remaining lease period of 9 months. We have an option to extend the lease term for an additional three (3) years thereafter.
The Company accounts for the Office Lease under the provisions of ASU No. 2021-09, ASU 2018-10, and ASC 842. We recorded a right-of-use asset and a corresponding operating lease liability on the Company's consolidated balance sheets upon the accounting commencement date in August 2022. The lease liability was measured at the accounting commencement date utilizing 12% which is the Company's incremental borrowing rate. The right-of-use asset had a balance of $101,437 at December 31, 2024. The operating lease obligations totaled $110,517 at December 31, 2024, all of which is included under current liabilities. The Company recorded lease expense relating to the Office Lease of $141,182 and short-term payments of $21,959 for the year ended December 31, 2024 and lease expense relating to the Office Lease of $141,182 and short-term payments of $22,209 for the year ended December 31, 2023 included in selling, general and administrative expenses.
The Office Lease contains escalating payments during the lease period. Upon execution of the Office Lease, the Company prepaid one month of rent and a security deposit, one of which will be held in escrow and credited at the termination of the lease and the other of which will be applied to the first month’s rent. As of December 31, 2024, a security deposit of approximately $25,000 was included in prepaid expenses and other current assets on the Company’s consolidated balance sheets related to the Office Lease.
Future minimum lease payments under these leases at December 31, 2024, are presented by calendar year as follows:
| Year | |
|---|---|
| 2025 | $114,966 |
| Total lease payments | 114,966 |
| Less: imputed interest | (4,449) |
| Present value of operating lease liabilities | $110,517 |
Guarantees
As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while the officer or director is, or was, serving at the Company’s request in such capacity. The term of the indemnification is for the officer’s or director’s lifetime. The maximum potential amount of future payments the Company could be required to make is unlimited; however, the Company has directors’ and officers’ insurance coverage that limits its exposure and enables it to recover a portion of any future amounts paid.
The Company leases office space on a month-to-month basis. The Company has standard indemnification arrangements under the lease that require it to indemnify the landlord against all costs, expenses, fines, suits, claims, demands, liabilities, and actions directly resulting from any breach, violation or nonperformance of any covenant or condition of the Company’s lease.
In the ordinary course of business, the Company enters into indemnification agreements with certain suppliers and business partners where the Company has certain indemnification obligations limited to the costs, expenses, fines, suits, claims, demands, liabilities and actions directly resulting from the Company’s gross negligence or willful misconduct, and in certain instances, breaches, violations or nonperformance of covenants or conditions under the agreements.
As of December 31, 2024, and 2023, the Company had not experienced any material losses related to these indemnification obligations, and no material claims with respect thereto were outstanding. The Company does not expect significant claims related to these indemnification obligations and, consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established.
License Agreements
Sphaera Pharma Pte. Ltd.
On March 2, 2012, we entered into a collaborative research and development agreement, (“Sphaera Agreement”), with Sphaera Pharma Pte. Ltd. (“Sphaera”), to collaborate on the development of the prodrug technology to be applied to protein kinase inhibitors for oncology and non-oncology indications. Under the terms of the Sphaera Agreement, each party would retain its preexisting intellectual property, but any intellectual property conceived or reduced to practice under and certain results arising from the Sphaera Agreement would be assigned to us. On October 5, 2012, we and Sphaera amended the Sphaera Agreement to reflect joint patent applications in the U.S. and India by us and Sphaera for a series of novel compounds. While the underlying intellectual property would be jointly owned, we have the exclusive right to commercialize thirteen of the twenty-four linkers detailed in the filed patent applications (“Company Compounds”), including the linker attached to imatinib that comprises IKT-001 with the remaining nine linkers owned by Sphaera (“Sphaera Compounds”). Sphaera has the right to develop the Company Compounds for oncology indications but may not commercialize the Company Compounds unless we abandon the Company Compounds. We have notified Sphaera that we do not intend to abandon the Company Compounds. We do not currently have the right to develop the Sphaera Compounds. Additionally, if either party files an IND for a Company Compound that has been abandoned by the other party for an oncology indication in humans, the non-filing party is prohibited from developing such Company Compound. In 2023, Sphaera liquidated and transferred its interests to Pivot Holding LLC, a U.S. entity (“Pivot”). On September 30, 2024, the Company and Pivot agreed to amend the agreement and for the Company to pay $500,000 upon signing as well as payment of the following milestones by the Company. A one-time payment of $4.4 million upon FDA Approval (as described in the Sphaera Agreement) and a single low digit royalty on net sales of an FDA approved drug. The parties agreed that no further FDA Approval milestone payment(s) shall be due to Pivot in the event that the Company receives additional FDA Approval(s).
The prosecution of patents related to the Company Compounds, which includes the prodrug technology, is the responsibility of the Company.
Litigation
From time to time, the Company may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. When the Company is aware of a claim or potential claim, it assesses the likelihood of any loss or exposure. If it is probable that a loss will result and the amount of the loss can be reasonably estimated, the Company will record a liability for the loss. In addition to the estimated loss, the recorded liability would include probable and estimable legal costs associated with the claim or potential claim. Litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm the Company’s business. We are not currently a party to any material litigation or legal proceedings.
- Simple Retirement Account for Employees (“Simple IRA”)
The Company established an individual retirement plan for employees effective January 1, 2013 under Section 408(p) of the Internal Revenue Code. The Simple IRA covers substantially all employees of the Company who received at least $5,000 in compensation from the Company during any two preceding years and are reasonably expected to receive at least $5,000 in compensation from the Company in the current year of participation. Subject to certain overall statutory limitations, the Company must match employee contributions up to 3% of employees’ qualified compensation for the year. Company contributions under the Simple IRA were $59,905 and $59,511 for the years ended December 31, 2024 and 2023, respectively.
- Segment Information
The Company views its operations and manages its business as one operating and reportable segment, which is the business of developing protein kinase inhibitor therapeutics. Consistent with the operational structure, the Chief Executive Officer, as the chief operating decision maker (“CODM”), manages and allocates resources on a consolidated basis using consolidated net income (loss) as a measure of profit/loss for the single reportable segment. This decision making process reflects the way in which the financial informationis regularly reviewed and used by the CODM to evaluate performance, set operational targets, forecast future financial results, and allocate resources.
| Year ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Revenues and other income | ||
| Grant income | $— | $260,501 |
| Costs and expenses: | ||
| Research and development (excluding share-based compensation) expense: | ||
| PAH | 1,672,869 | — |
| PD | 9,333,359 | 9,036,750 |
| Other programs | 1,512,151 | 4,421,520 |
| Selling, general and administrative (excluding share-based compensation) | 7,930,072 | 6,391,875 |
| Share-based compensation expense | 8,140,617 | 500,148 |
| Total costs and expenses | 28,589,068 | 20,350,293 |
| Loss from operations | (28,589,068) | (20,089,792) |
| Interest income | 1,069,182 | 1,060,909 |
| Net loss | $(27,519,886) | $(19,028,883) |
- Subsequent Events
On February 21, 2025 (“Closing Date”), the Company entered into an Agreement and Plan of Merger and Reorganization (“Merger Agreement”) with Project IKT Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of the Company (“Merger Sub”), CorHepta Pharmaceuticals, Inc., a Delaware corporation (“CorHepta”), and Preston S. Klassen, solely in his capacity as sellers’ representative. Pursuant to the Merger Agreement, on the Closing Date, Merger Sub merged with and into CorHepta (“Merger”), with CorHepta surviving the Merger as a wholly-owned subsidiary of the Company. On the Closing Date, the Company paid consideration for CorHepta of $15.0 million, subject to a customary purchase price adjustment mechanism. The Company paid the purchase price pursuant to the issuance of an aggregate of 4,979,101 shares (“Consideration Shares”) of the Company’s common stock, par value $0.001 per share (“Common Stock”), to the former stockholders of CorHepta (“CorHepta Stockholders”), of which 3,319,397 were issued as upfront consideration (“Upfront Consideration”).82,979 Consideration Shares of the Upfront Consideration were deposited in a twelve-month escrow for purposes of satisfying potential indemnity obligations of the CorHepta Stockholders under the Merger Agreement. The remaining Consideration Shares were issued as contingent consideration (“Contingent Consideration”), which will vest upon achievement of a certain milestone. If the vesting condition is not satisfied as of the first anniversary of the Closing Date, then the Contingent Consideration will be forfeited. The Company is currently evaluating the accounting implications for the Merger Agreement.
In January 2025, in connection with the October 2024 Offering, the Company issued 702,625 warrants with an exercise price of $1.7125 and an expiration date of January 25, 2028.
On January 3, 2025, the number of the Company's authorized shares of common stock was increased from 100,000,000 shares to 500,000,000 shares. Also, the number of authorized shares of common stock reserved for issue under the Company's 2020 Equity Incentive plan was increased by 27,453,993 shares.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.