Inhibikase Therapeutics, Inc.
For the period ended Mar 31, 2025. Filed May 14, 2025.
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Mar 31, 2025 · Filed May 14, 2025
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Notes to Unaudited Condensed Consolidated Financial Statements
Nature of Business
Inhibikase Therapeutics, Inc. is a clinical-stage pharmaceutical company developing a protein kinase inhibitor therapeutic to modify the course of cardiopulmonary disease that arises from aberrant signaling through the Abelson Tyrosine Kinases. The Company’s lead product candidate is IKT-001, a prodrug of the anticancer agent imatinib, an FDA approved drug for certain blood and stomach cancers. The Company plans to seek approval from the FDA for IKT-001 for the treatment of Pulmonary Arterial Hypertension (“PAH”) as an orphan indication. IKT-001 is designed to improve tolerance to imatinib's active ingredient which may allow for improved safety and efficacy. The Company has completed non-human primate safety studies and a bioequivalence clinical trial in healthy volunteers to determine the doses of IKT-001 that are equivalent to imatinib mesylate and the results are being utilized to set the doses for a Phase 2b clinical study that the Company expects to initiate in the second half of 2025.
- Liquidity
As of March 31, 2025, the Company had cash, cash equivalents and marketable securities of $93,180,291.
The Company has incurred recurring losses and at March 31, 2025, had an accumulated deficit of $108,099,346.
To date, the Company has funded its operations primarily through public offerings of its common stock, private placements of its common stock (and pre-funded warrants) and sales of common stock through At-The-Market (“ATM”) offerings. 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 and $0.5 million in net 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 IKT-001.
The Company may seek to fund its operations 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 from the exercise of 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 would have a negative impact on the Company’s business, financial viability, results of operations and financial condition and the Company’s ability to continue to develop its product candidates.
The Company estimates that its cash and cash equivalents and marketable securities at March 31, 2025 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 unaudited condensed 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 unaudited condensed 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.
Basis of Presentation and Significant Accounting Policies
Basis of Presentation of Interim Financial Statements
The accompanying unaudited condensed consolidated financial statements were prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for interim financial statements and, in the opinion of management, include all normal and recurring adjustments necessary to present fairly the results of the interim periods shown. The December 31, 2024 balance sheet was derived from the December 31, 2024 audited financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles (“US GAAP”) have been condensed or omitted pursuant to such SEC rules and regulations. Management believes that the disclosures made are adequate to make the information presented not misleading. The results for the interim periods are not necessarily indicative of results to be expected for the fiscal year ending December 31, 2025. The unaudited condensed consolidated financial statements contained herein should be read in conjunction with the Company’s annual audited financial statements and notes thereto for the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K filed with the SEC.
The unaudited condensed consolidated financial statements have been prepared in conformity with US GAAP, which prescribes elimination of all significant intercompany accounts and transactions in the accounts of the Company and its wholly-owned subsidiaries, IKT Securities Corporation, Inc. and CorHepta Pharmaceuticals, Inc. Any reference in these notes to applicable guidance is meant to refer to the authoritative US GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).
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, or the 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.
Use of Estimates
The preparation of the Company’s financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company utilizes certain estimates in the determination of its liquidity and working capital adequacy, the fair value of its stock options and warrants and deferred tax valuation allowances, 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.
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 its operations and manages its business as one operating and reporting segment, which is the business of developing protein kinase inhibitor therapeutics.
New Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on its condensed consolidated financial statements and disclosures.
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 purchasesof 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.
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.
The Company didnot report any revenues for the three months ended March 31, 2025 and 2024.
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 unaudited condensed consolidated statements of operations and comprehensive loss. 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, and include salaries and benefits, stock compensation, research-related subcontractors and consultants, supplies and overhead costs and in-process research and development. 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 three months ended March 31, 2025 and March 31, 2024, the Company incurred expenses of approximately $0 and $90 thousand, respectively, with a related party vendor which were included in research and development expenses. As of the periods ended March 31, 2025 and December 31, 2024, the Company had a payable or accrued expense balance with a related party vendor of approximately $11 thousand and $109 thousand, respectively, included in accounts payable and accrued expenses.
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 condensed and consolidated balance sheet. Under the standard, disclosure of key information about leasing arrangements to assist users of the condensed and 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 its condensed consolidated balance sheets and to recognize those lease payments on a straight-line basis in its condensed 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 Economic Life | |
| Leasehold property improvements, right-of-use assets | Lesser of lease term or useful life |
|---|---|
| Furniture and office equipment | 3-5 years |
| IT equipment | 3 years |
Fair Value Measurement
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 and financial liabilities, which include cash equivalents and marketable securities and accounts payable, have been initially valued at the transaction price, and marketable securities are 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 value.
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 condensed 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 loss. Realized gains and losses, if any, are included in other income, net in the condensed 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.
Asset Acquisitions
The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs which would meet the definition of a business. Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets.
For asset acquisitions, a cost accumulation model is used to determine the cost of an asset acquisition. Common stock issued as consideration in an asset acquisition is generally measured based on the acquisition date fair value of the equity interests issued. Direct transaction costs are recognized as part of the cost of an asset acquisition. The Company also evaluates which elements of a transaction should be accounted for as a part of an asset acquisition and which should be accounted for separately. Consideration deposited into escrow accounts are evaluated to determine whether it should be included as part of the cost of an asset acquisition or accounted for as contingent consideration.
The costs of an asset acquisition, including transaction costs, are allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis. Goodwill is not recognized in an asset acquisition. Any difference between the cost of an asset acquisition and the fair value of the net assets acquired is allocated to the non-monetary identifiable assets based on their relative fair values. However, as of the date of acquisition, if certain assets are carried at fair value under other applicable GAAP, the consideration is first allocated to those assets with the remainder allocated to the non-monetary identifiable assets based on relative fair value basis.
Contingent Consideration Liabilities
The Company recognizes contingent consideration issued in connection with asset acquisitions when it is probable that a liability has been incurred and the amount of that liability can be reasonably estimated.
The Company remeasures the contingent consideration liability to fair value at each reporting date, until the contingency is resolved or expires, with changes in the fair value of the contingent consideration liability included within operating expenses on the Company’s consolidated statement of operations and comprehensive loss.
Fair Value of Financial Instruments
The Company’s marketable securities are all classified within Level 1 of the fair value hierarchy and are valued based on quoted prices in active markets. For cash and accounts payable, the carrying amounts approximate fair value, because of the short maturity of these instruments, and therefore fair value information isnot included in the table below. Contingent consideration related to the acquisition of CorHepta (see Note 10) is classified within Level 3 of the fair value hierarchy as the determination of fair value uses considerable judgment and represents the Company’s best estimate of an amount that could be realized in a market exchange for the asset or liability.
The following table summarizes cash equivalents, marketable securities and contingent consideration measured at their fair value on a recurring basis as of March 31, 2025 and December 31, 2024:
| Fair Value Measurements as of March 31, 2025: | ||||
|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Total | |
| Cash equivalents: | ||||
| Money market funds | $32,971,380 | $— | $— | $32,971,380 |
| Total | $32,971,380 | $— | $— | $32,971,380 |
| Marketable securities, available-for-sale: | ||||
| U.S. Treasury obligations | $19,738,900 | $— | $— | $19,738,900 |
| Total | $19,738,900 | $— | $— | $19,738,900 |
| Other current liabilities | ||||
| Contingent consideration (see Note 10) | $— | $— | $3,270,579 | $3,270,579 |
| Total | $— | $— | $3,270,579 | $3,270,579 |
| 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 |
The following table provides a rollforward of the contingent consideration related to the acquisition of CorHepta (see Note 10):
| Three months ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Balance, beginning | $— | $— |
| Additions | 4,435,443 | — |
| Payments | — | — |
| Change in fair value | (1,164,864) | — |
| Balance, ending | $3,270,579 | $— |
Marketable Securities
Marketable securities consisted of the following as of:
| March 31, 2025 | Amortized Cost | Unrealized Gain | Unrealized Loss | Fair Value |
|---|---|---|---|---|
| Marketable securities, available-for-sale: | ||||
| U.S. Treasury obligations | $19,739,867 | $— | $(967) | $19,738,900 |
| Total | $19,739,867 | $— | $(967) | $19,738,900 |
| 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 |
As of March 31, 2025, the Company held two U.S. Treasury debt securities that were in an unrealized loss position totaling $967. As of December 31, 2024, the Company held seven U.S. Treasury debt securities that were in an unrealized loss position totaling
$37,248. All U.S. Treasury obligations were due to mature inless than one year for the period and year ended March 31, 2025 and December 31, 2024, respectively.
The Company received proceedsof $21.5 million from maturities of marketable securities for the three months ended March 31, 2025. The Company received proceeds of $23.5 million from maturities of marketable securities for the year ended December 31, 2024. The Company didnot realize any gains or losses from maturities of marketable securities for the period ended March 31, 2025 or the year ended December 31, 2024.
Equipment and Improvements
| Equipment and Improvements, net | ||
|---|---|---|
| March 31,2025 | December 31,2024 | |
| Furniture and office equipment | $100,329 | $86,930 |
| IT equipment | 16,895 | 16,895 |
| 117,224 | 103,825 | |
| Less: Accumulated depreciation | 69,379 | 56,725 |
| Total | $47,845 | $47,100 |
Depreciation expense for the three months ended March 31, 2025 was$12,654 and for the year ended December 31, 2024 was and $26,272, respectively.
Supplemental Condensed Consolidated Balance Sheet Information
Accrued expenses and other current liabilities consist of the following:
| March 31,2025 | December 31,2024 | |
|---|---|---|
| Accrued consulting | $391,628 | $202,379 |
| Accrued compensation | 948,712 | 999,303 |
| Accrued research and development | 2,045,205 | 1,397,348 |
| Accrued other | 127,703 | 81,000 |
| Total accrued expenses and other current liabilities | $3,513,248 | $2,680,030 |
- ATM Program
On February 1, 2024, the Company entered into an 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. The Company sold 315,338 shares of common stock pursuant to the ATM Agreement for an aggregate gross sales price of $849,187. On May 20, 2024, the Company filed with the SEC 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, which such termination was effective December 11, 2024 in accordance with the terms of the ATM Agreement.
- 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 March 31, 2025, a total of 11,854,788 shares of common stock were reserved for issuance upon the exercise of outstanding stock options and warrants under the 2020 Equity Incentive Plan (the "2020 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”) and together with the Series A-1 Warrants, the “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 became exercisable at the 5th business day after the date the Company was notified by the SEC that the initial 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 was not subject to further review. Each Series A-1 Warrant is 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. Under the terms of the Warrants, an investor may not exercise Warrants (other than a Pre-Funded Warrant), to the extent such exercise would cause such investor, together with its affiliates and attribution parties, to beneficially own a number of shares of our common stock which would exceed 4.99% or 9.99%, as applicable, of our then outstanding shares of common stock following such exercise, excluding for purposes of such determination the shares of our common stock issuable upon exercise of the Warrants which have not been exercised. 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 March 31, 2025, 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 August 5, 2025, 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 August 5, 2029. All of the warrants in the May 2024 Offering were issued to a single investor. All Pre-Funded Common Warrants have been exercised as at March 31, 2025. 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 has 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 August 5, 2025 and the Series D Common Warrants will expire on August 5, 2029. The shares held in abeyance were issued to the investor on October 9, 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 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.
- Acquisition of CorHepta
On February 21, 2025, 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”) and CorHepta Pharmaceuticals, Inc. a Delaware corporation (“CorHepta”). Pursuant to the Merger Agreement, on the closing date, Merger Sub merged with and into CorHepta, with CorHepta surviving as a wholly-owned subsidiary of the Company. The Company agreed to issue 4,979,101 shares of the Company’s common stock to the shareholders of CorHepta, of which (i)829,849 shares were fully vested on the acquisition date, (ii)2,489,030 shares represented contingent consideration and will vest later than February 21, 2026, subject to the achievement of certain milestones, and (iii)1,660,222 shares represented post-merger compensation expense, subject to both service- and performance-based vesting conditions (see Note 11). As of the acquisition date, the achievement of the only service condition included in 1,493,415 of the unvested in category (ii) was deemed probable, and the fair value of the related shares was included in the purchase price of the acquisition as contingent consideration of $4,435,443. The Company will recognize a contingent consideration liability and corresponding expense for the remaining contingent consideration shares in future periods when it is probable that a liability has been incurred and the amount of that liability can be reasonably estimated.
The Company remeasures the initial contingent consideration recognized at acquisition shown below to fair value at each reporting date and recorded a change in fair value of $1,164,864 for the period ended March 31, 2025 which is included within operating expenses. The holders of a total of 4,149,252 unvested shares (those issued inconnection with the acquisition outlined in (ii) and (iii) above, unless and until forfeited in accordance with the terms of the Merger Agreement) shall be entitled to exercise all voting rights with respect to such shares, and receive all dividends payable in respect of such shares. The Company does not forecast paying any dividends in the foreseeable future. The 4,149,252 unvested shares are excluded from the weighted average number of shares outstanding used in the calculation of basic loss per share for the three months ended March 31, 2025, since they are held by the Company and not considered “outstanding” until vested. The 4,149,252 unvested shares will be treated as “contingently issuable” shares as that term is defined in ASC 260-10-45-54 for purposes of any diluted earnings per share calculations in periods those apply.
The Company determined that the transaction represented an asset acquisition as defined by ASC 805 as substantially all of the value was attributed to a single intangible asset, in-process research and development (“IPR&D”). As a result, the consideration transferred was allocated to the identifiable tangible and intangible assets acquired and liabilities assumed based on their relative fair values resulting in approximately $7.4 million being assigned to the IPR&D asset.
The fair value of consideration transferred was determined as follows:
| Shares · Share Price at Closing · Fair Value at AcquisitionFebruary 21, 2025 | ||||
|---|---|---|---|---|
| Fully vested shares | 829,849 | $2.97 | $2,464,652 | |
| Contingent consideration | 1,493,415 | 2.97 | 4,435,443 | |
| Transaction costs incurred by the Company | 438,624 | |||
| Fair value of consideration | $7,338,719 | |||
The allocation of consideration transferred is as follows:
| Acquired IPR&D | $7,357,294 |
|---|---|
| Cash | 49,633 |
| Current liabilities | (68,208) |
| Fair value of consideration | $7,338,719 |
The IPR&D had not reached technological feasibility and had no alternative future use at the acquisition date, and therefore, the acquired IPR&D asset of $7,357,294 was written-off as research and development expense in the Company’s condensed consolidated statement of operations and comprehensive loss immediately following the acquisition in accordance with ASC 730.
- Stock-Based Compensation
2020 Equity Incentive Plan
The Company’s 2020 Plan was established for granting stock incentive awards to directors, officers, employees and consultants to the Company. On June 7, 2024, 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 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.
Restricted Stock
In connection with the acquisition of CorHepta in February 2025 (see Note 10), the Company issued a combined 1,660,222 shares of restricted common stock to two selling shareholders who were subsequently employed by the Company, which are subject to a combination of post-acquisition service- and performance-based vesting conditions, as follows: (i)996,133 shares shall vest on the first anniversary of the closing of the acquisition, (ii)166,023 shares shall vest upon the achievement of a certain milestone specified in the Merger Agreement, and (iii)498,066 shares shall vest on the first anniversary of the closing of the acquisition, provided that the performance milestone has been achieved by such date, and in all cases, provided that both employees have been continuously providing services to the Company during the one year period following the acquisition date.
For the restricted shares with service-based vesting conditions, stock-based compensation expense is recognized on a straight-line basis over the service period, which is generally the vesting term. For restricted shares with performance-based vesting conditions, stock-based compensation expense is recognized over the requisite service period when it is probable that the performance condition will be achieved.
The weighted-average grant date fair value of the restricted shares issued in connection with the asset acquisition was $4.9 million. During the three months ended March 31, 2025, the Company recognized stock-based compensation expense of $0.3 million related to the restricted shares with service-based vesting conditions. No stock-based compensation expense was recognized related to the restricted shares with performance-based vesting conditions during the three months ended March 31, 2025, as it was not considered probable that the performance conditions would be achieved. As of March 31, 2025, there was $4.6 million of unrecognized compensation expense related to the restricted shares issued in connection with the acquisition of CorHepta.
Stock Options
During the three months ended March 31, 2025, the Company granted 21,329,195 options with a weighted average strike price of $2.52 to purchase common stock to certain employees that either (i) vest annually in three equal parts over three years, (ii) vest on the first anniversary of the grant of such option in the amount of one-third of such grant, and the remaining portion will vest in 36 equal monthly installments thereafter, (iii) vest in 48 equal monthly installments, (iv) vest annually over two years, or (v) vest annually over four years. The Company also granted 2,056,049 performance-based options with a weighted average strike price of $2.35 to purc hase common stock to certain employees. These options are subject to performance vesting and will vest and become exercisable once the performance conditions are probable of being met. There is no assurance that the performance conditions will be met and therefore some or all of these options may never vest or become exercisable. The total aggregate grant date fair value of all options granted was $43,113,397. During the three months ended March 31, 2025, certain performance conditions were met.
During the three months ended March 31, 2024, the Company granted 18,039 options with a weighted average strike price of $2.55 to purchase common stock to certain employees that will vest annually in three equal parts over three years. The total aggregate grant date fair value of all options granted was $34,494. On January 3, 2025, the above options were repriced to $1.26 with the incremental fair value of the reprice being de minimis.
For awards with performance conditions in which the award does not vest unless the performance condition is met, the Company recognizes expense if, and to the extent that, the Company estimates that achievement of the performance condition is probable. If the Company concludes that vesting is probable, the Company recognizes expense from the date the Company reaches this conclusion through the estimated vesting date.
Stock-Based Compensation Expense
The following table summarizes the stock-based compensation expense for stock options granted to employees and non-employees:
| Three months ended March 31, | |||
|---|---|---|---|
| 2025 · 2024 | |||
| Research and development | $453,186 | * | $17,931 |
| Selling, general and administrative | 1,589,010 | 35,503 | |
| Total stock-based compensation expense | $2,042,196 | $53,434 | |
*Includes $0.3 million related to the restricted stock awards issued in connection with the acquisition of CorHepta.
- Warrants
In January 2025, in connection with the October 2024 Offering, the Company issued 702,625 warrants to a non-financial investor pursuant to a pre-existing brokerage agreement. These warrants have an exercise price of $1.7125 and an expiration date of January 25, 2028.
- 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 incl udes 19,815,131 of Pre-Funded Warrants and shares held in abeyance from date of issuance.
| Three months ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Numerator: | ||
| Net loss | $(13,678,735) | $(4,649,635) |
| Denominator: | ||
| Weighted-average number of shares outstanding – basic and diluted | 89,537,171 | 6,340,697 |
| Net loss per share applicable to common stockholders – basic and diluted | $(0.15) | $(0.73) |
The Company’s potentially dilutive securities have been excluded from the computation 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 antidilutive for the periods presented. Therefore the weighted average number of shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The potentially dilutive securities that have been excluded from the computation of diluted net loss per share include stock options and warrants to purchase common stock, restricted common stock and shares of common stock issued as contingent consideration in connection with the acquisition of CorHepta, for which the vesting conditions have not been met. The Company excluded the following potential shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share for the periods indicated:
| Three months ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Options to purchase shares of stock | 33,899,741 | 846,666 |
| Warrants to purchase shares of stock | 140,790,299 | 2,266,136 |
| Contingently issuable shares (see Note 10): | ||
| Restricted common stock | 1,660,222 | — |
| Contingent consideration | 2,489,030 | — |
| Total | 178,839,292 | 3,112,802 |
- Income Taxes
During the three months ended March 31, 2025 and 2024, there wasno provision for income taxes as the Company incurred losses during those periods. Deferred tax assets and liabilities reflect the net tax effect of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The Company recorded a full valuation allowance against its deferred tax assets as the Company believes it is more likely than not the deferred tax assets will not be realized.
- Commitments and Contingencies
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. The Company is not currently a party to any material litigation or legal proceedings.
Lease
On April 18, 2022, the Company entered into an operating lease agreement for office space located in Lexington, Massachusetts (the "Office Lease"). On August 8, 2022, the Company commenced occupancy of the leased space. The lease runs through September 30, 2025 and the Company does not expect to continue occupancy of this premises.
The Company accounts for the Office Lease under the provisions of ASC 842. The Company recorded a right-of-use asset and a corresponding operating lease liability on the Company's condensed consolidated balance sheets upon the accounting commencement date in August 2022. The lease liability was measured at the accounting commencement date utilizing a 12% discount rate. The right-of-use asset had a balance of $68,719 at March 31, 2025. The operating lease obligations totaled $74,772 at March 31, 2025, all of which is included under current liabilities. The Company recorded lease expense related to the Office Lease of $35,296 and other short-term payments of $5,132 for thethree months ended March 31, 2025, respectively, in selling, general and administrative expenses and lease expense of $35,296 and other short-term payments of $5,653 for thethree months ended March 31, 2024, respectively, 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 March 31, 2025, a security deposit of approximately $25,000 was included in prepaid expenses and other current assets on the Company’s condensed consolidated balance sheet related to the Office Lease.
Future minimum lease payments under this lease at March 31, 2025, are presented by calendar year as follows:
| Year | |
|---|---|
| 2025 | $76,644 |
| Total lease payments | 76,644 |
| Less: imputed interest | (1,872) |
| Present value of operating lease liabilities | $74,772 |
- Segment Information
The Company views its operations and manages its business asone 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 information is regularly reviewed and used by the CODM to evaluate performance, set operational targets, forecast future financial results, and allocate resources.
| Three months ended March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Costs and expenses: | ||
| Research and development (excluding share-based compensation) expense: | ||
| PAH | $9,330,844 | $— |
| Parkinson's disease | 142,420 | 2,343,896 |
| Other programs | 587,128 | 389,453 |
| Selling, general and administrative (excluding share-based compensation) | 3,660,282 | 1,995,577 |
| Change in fair value contingent consideration | (1,164,864) | — |
| Share-based compensation expense | 2,042,196 | 53,434 |
| Total costs and expenses | 14,598,006 | 4,782,360 |
| Loss from operations | (14,598,006) | (4,782,360) |
| Interest income | 919,271 | 132,725 |
| Net loss | $(13,678,735) | $(4,649,635) |
- Subsequent Event
On May 5, 2025, the Company entered into a license agreement (the “License Agreement”) with ABLi Therapeutics, Inc. (“ABLi”), pursuant to which the Company granted ABLi an exclusive license to develop, manufacture and commercialize certain abelson tyrosine kinase inhibitors, including risvodetinib (IkT-148009). If ABLi does not meet certain milestones with respect to the Licensed Material within 18 months, then the License Agreement will automatically terminate.
Under the terms of the License Agreement, the Company received a nominal upfront payment and will be eligible to receive up to $47.5 million in development and regulatory milestone payments, along with tiered royalties based on net sales.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.