Cyclacel Pharmaceuticals Inc
For the period ended Dec 31, 2023. Filed Mar 21, 2024.
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FY2023 · Filed Mar 21, 2024
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Notes to Consolidated Financial Statements
- Organization of the Company and Basis of Presentation
Cyclacel Pharmaceuticals, Inc. (“Cyclacel” or “the Company”) is a clinical-stage biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and mitosis control biology. Cyclacel is a pioneer company in the field of cancer cell cycle biology with a vision to improve patient healthcare by translating insights in cancer biology into medicines that can overcome resistance and ultimately increase a patient’s overall survival.
As of December 31, 2023, substantially all efforts of the Company to date have been devoted to performing research and development, conducting clinical trials, developing and acquiring intellectual property, raising capital and recruiting and training personnel.
The Company is subject to risks and uncertainties common to early-stage companies in the biopharmaceutical industry, including, but not limited to, the fact that drug candidates developed by the Company typically will require approvals or clearances from the U.S. Food and Drug Administration, the European Medicines Agency or other similar regulatory agencies in other countries prior to commercial sales. There can be no assurance that the Company’s drug candidates will receive any of the required approvals or clearances. If any of the Company’s drug candidates are denied approval or clearance or such approval is delayed, or if the Company is unable to obtain the necessary financing to complete development and approval, there will be a material adverse impact on the Company’s financial condition and results of operations.
Through December 31, 2023, the Company has funded all of its operations and capital expenditures with proceeds from the issuance of public equity securities, private placements of securities, government grants, research and development tax credits, interest on investments, royalty income, product revenue and licensing revenue. The Company has incurred recurring losses since its inception, including net losses of$22.5 million and $21.2 million for theyears ended December 31, 2023 and 2022, respectively. As of December 31, 2023, the Company had an accumulated deficit of$428.3 million. The Company expects to continue to generate operating losses for the foreseeable future due to, among other things, costs related to the clinical development of its drug candidates, its preclinical programs and its administrative organization.
Going Concern
Pursuant to the requirements of Accounting Standard Codification (ASC) 205-40,Presentation of Financial Statements-Going Concern, management is required at each reporting period to evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about an entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effects of its plans sufficiently alleviate the substantial doubt about the Company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern for one year after the date that these financial statements are issued. In performing its analysis, management excluded certain elements of its operating plan that cannot be considered probable. Under ASC 205-40, the future receipts of potential funding from future equity or debt issuances or by entering into partnership agreements cannot be considered probable at this time because these plans are not entirely within the Company’s control nor have they been approved by the Board of Directors as of the date of these consolidated financial statements.
Based on the Company’s current operating plan, it is anticipated that cash and cash equivalents of $3.4 million as of December 31, 2023 will allow it to meet liquidity requirements into April 2024. As of March 21, 2024 the Company’s cash balance on hand is approximately $3.4 million. The Company continues to work to raise additional capital however as of the date of these financial statements there is no guarantee that the Company will be able to raise additional funds to extend operations past April 2024. The Company’s history of losses, negative cash flows from operations, liquid resources currently on hand, and dependence on the ability to obtain additional financing to fund its operations, about which there can be no certainty, have resulted in the assessment that there is substantial doubt about the Company’s ability to continue as a going concern for a period of at least twelve months from the issuance date of these financial statements. While the Company has plans in place to mitigate this risk, which primarily consist of raising additional capital through a combination of public or private equity or debt financings or by entering into partnership agreements for further development of our drug candidates, there is no guarantee that it will be successful in these mitigation efforts.The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business.
Basis of Presentation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP and include the financial statements of Cyclacel Pharmaceuticals, Inc. and all of the Company’s wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated.
Reverse Stock Split
The Company effected a 15:1 reverse stock split of the Company’s common stock on December 18, 2023 (the “Reverse Stock Split”). All share and per share information has been retroactively adjusted to give effect to the Reverse Stock Split for all periods presented, unless otherwise indicated.
- Summary of Significant Accounting Policies
Use of Estimates
The preparation of financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities and related disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Critical estimates include inputs used to determine clinical trial accruals and stock-based compensation expense. Cyclacel reviews its estimates on an ongoing basis. The estimates are based on historical experience and on various other assumptions that the Company believes to be reasonable under the circumstances. Actual results may differ from these estimates. Cyclacel believes the judgments and estimates required by the following accounting policies to be significant in the preparation of the Company’s consolidated financial statements.
Foreign Currency and Currency Translation
Transactions that are denominated in a foreign currency are remeasured into the functional currency at the current exchange rate on the date of the transaction. Any foreign currency-denominated monetary assets and liabilities are subsequently remeasured at current exchange rates, with gains or losses recognized as foreign exchange (losses) gains in the statement of operations.
The assets and liabilities of the Company’s international subsidiary are translated from its functional currency into United States dollars at exchange rates prevailing at the balance sheet date. Average rates of exchange during the period are used to translate the statement of operations, while historical rates of exchange are used to translate any equity transactions. Translation adjustments arising on consolidation due to differences between average rates and balance sheet rates, as well as unrealized foreign exchange gains or losses arising from translation of intercompany loans for which
settlement is not not planned or anticipated in the foreseeable future and that are of a long-term-investment nature, are recorded in other comprehensive loss.
Cash and Cash Equivalents
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The Company considers all highly liquid investments with an original maturity of three months or less at the time of initial purchase to be cash equivalents. The objectives of the Company’s cash management policy are to safeguard and preserve funds, to maintain liquidity sufficient to meet Cyclacel’s cash flow requirements and to attain a market rate of return. The Company deposits its cash in financial institutions that it believes have high credit quality and has not experienced any losses on such accounts and does not believe it is exposed to any significant credit risk on cash and cash equivalents.
The Company’s cash and cash equivalents balance at December 31, 2023 was $3.4 million and it maintains its cash accounts in several entities both within the United States and the United Kingdom. The cash balances for amounts held in the United States are insured by the Federal Deposit Insurance Corporation, or FDIC up to $250,000 per account. The Company has cash balances exceeding the balance insured by the FDIC that totaled approximately $2.4 million at December 31, 2023. The cash balances for amounts held in the United Kingdom are insured by the UK Government Financial Services Compensation Scheme, or FSCS up to £85,000 per account. The Company has cash balances exceeding the balance insured by the FSCS that totaled approximately $0.6 million at December 31, 2023.
Property and Equipment
The components of property and equipment are stated at cost and depreciated on a straight-line basis over the estimated useful lives of the related assets, which are generally three tofive years. Amortization of leasehold improvements is performed using the straight-line method over the shorter of the remaining lease term or the estimated useful life of the related assets. Upon sale or retirement of assets, the costs and related accumulated depreciation and amortization are removed from the balance sheet and the resulting gain or loss on sale is reflected as a component of operating income or loss. Expenditures for maintenance and repairs are charged to operating expenses as incurred.
Impairment of Long-lived Assets
The Company reviews property and equipment for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. The Company assesses the recoverability of the potentially affected long-lived assets by determining whether the carrying value of such assets can be recovered through undiscounted future operating cash flows.
Impairment, if any, is measured as the amount by which the carrying amount of a long-lived asset or asset group exceeds its fair value.
Fair Value of Financial Instruments
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Assets and liabilities measured at fair value are classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
| ● | Level 1 — Quoted prices in active markets for identical assets or liabilities. |
| ● | Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. |
| ● | Level 3 — Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. |
The carrying values of cash and cash equivalents, other receivables, accounts payable and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities.
Segments
The Company is managed and operated asone business which is focused on using cell cycle, transcriptional regulation and mitosis control biology to develop innovative, targeted medicines for cancer and other proliferative diseases. The entire business is managed by a single management team that reports to the Chief Executive Officer. The Company does not operate separate lines of business with respect to any of its products or product candidates and the Company does not prepare discrete financial information with respect to separate products or product candidates or by location. Accordingly, the Company views its business asone reportable operating segment with development operations intwo geographic areas, namely the United States and the United Kingdom.
Revenue Recognition
The Company recognizes revenue in accordance with Accounting Standards Codification (ASC) 606,Revenue from Contracts with Customers. The Company recognized $420,000 of revenue for the year ended December 31, 2023. This revenue relates to recovery of clinical manufacturing costs associated with an investigator sponsored study managed by Cedars-Sinai Medical Center. There wereno revenues recognized for the comparative period in 2022. Royalty income, if any, is recognized when the licensee sells the underlying product to which the royalty relates.
Other Income
Other income is primarily related to royalty income received under a historical Asset Purchase Agreement for activities which are not part of the Company’s ongoing operations and activities.
Research and Development Costs
Research and development expenses consist primarily of costs associated with the development of the Company’s product candidates, including upfront fees, milestones, compensation and other expenses for research and development personnel, supplies and development materials, costs for consultants and related contract research, facility costs and depreciation. Expenditures relating to research and development are expensed as incurred.
Clinical Trial Accounting
Data management and monitoring of the Company’s clinical trials are performed with the assistance of contract research organizations, or CROs or clinical research associates, or CRAs in accordance with the Company’s standard operating procedures. Typically, CROs and CRAs bill monthly for services performed, and others bill based upon milestones achieved. The Company accrues unbilled clinical trial expenses based on estimates of the level of services performed each period. Clinical trial costs related to patient enrollment are accrued as patients are entered into and progress through the trial.
Patent Costs
Patent prosecution costs are charged to general and administrative expenses as incurred as recoverability of such expenditure is uncertain.
Leases
The Company accounts for lease contracts in accordance with ASC 842. As of December 31, 2023 and 2022, all of the Company’s leases are classified as operating leases.
The Company recognizes an asset for the right to use an underlying leased asset for the lease term and records lease liabilities based on the present value of the Company’s obligation to make lease payments under the lease. As the Company’s leases do not indicate an implicit rate, the Company uses a best estimate of its incremental borrowing rate to discount the future lease payments. The Company estimates its incremental borrowing rate based on observable information about risk-free interest rates that are the same tenure as the lease term, adjusted for various factors, including the effects of assumed collateral, the nature of how a loan would be repaid (e.g., amortizing versus bullet), and the Company’s credit risk.
The Company evaluates options included in its lease agreements to extend or terminate the lease. The Company will reflect the effects of exercising those options in the lease term when it is reasonably certain that the Company will exercise that option. In assessing whether it is reasonably certain that the Company will exercise an option, the Company considers factors such as:
| ● | The lease payments due in any optional period; |
| ● | Penalties for failure to exercise (or not exercise) the option; |
| ● | Market factors, such as the availability of similar assets and current rental rates for such assets; |
| ● | The nature of the underlying leased asset and its importance to the Company’s operations; and |
| ● | The remaining useful lives of any related leasehold improvements. |
Lease expense for the Company’s operating leases is recognized on a straight-line basis over the lease term and is reported as a component of general and administrative expense. Variable lease payments, if any, are recognized in the period when the obligation to make those payments is incurred. Lease incentives received prior to lease commencement are recorded as a reduction in the right-of-use asset. Fixed lease incentives received after lease commencement reduce both the lease liability and the right-of-use asset.
The Company has elected an accounting policy to account for the lease and non-lease components as a single lease component.
Stock-based Compensation
The Company measures all stock options and other stock-based awards granted to employees and directors based on the fair value on the date of the grant and recognizes compensation expense of those awards over the requisite service period, which for the Company is the period between the grant date and the date the award vests or becomes exercisable. Many awards granted by the Company vest ratably over three orfour years. However, certain awards granted to members of the Company’s Board of Directors vest in their entirety on theone-year anniversary following the date of grant. Generally, the Company issues stock options and restricted stock awards to employees with only service-based vesting conditions and records the expense for these awards using the straight-line method. However, in certain years, the Company will grant share-based payment awards to employees that are dependent upon the fulfillment of certain clinical and financial conditions. In such instances where the performance condition must be met for the award to vest, the company only recognizes compensation expense when the award is probable of vesting (See Note 12 — Stock-Based Compensation).
The Company classifies stock-based compensation expenses in its statement of operations in the same manner in which the award recipient’s payroll costs are classified. The Company accounts for forfeitures as they occur.
The fair value of restricted stock and restricted stock units is determined based on the number of shares granted and the quoted price of the Company’s common stock on the date of grant. The determination of grant-date fair value for stock option awards is estimated using the Black-Scholes model, which includes variables such as the expected volatility of the Company’s share price, expected term of the award, interest rates, and dividend yields.
The Company relies on its historical volatility as an input to the option pricing model as management believes that this rate will be representative of future volatility over the expected term of the options.
The expected term assumption is estimated using past history of early exercise behavior and expectations about future behaviors.
The weighted average risk-free interest rate represents the interest rate for treasury constant maturities published by the Federal Reserve Board. If the term of available treasury constant maturity instruments is not equal to the expected term of an employee option, Cyclacel interpolates a discount rate based on the two Federal Reserve securities closest to the expected term of the employee option.
The expected dividend yield is zero, as the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends on common stock in the foreseeable future.
Income Taxes
The Company accounts for income taxes using the liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized.
The Company accounts for uncertainty in income taxes recognized in the financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not-to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves for unrecognized tax benefits that are considered appropriate as well as the related net interest and penalties.
The Company records research and development tax credits within income taxes. Credit is taken in the accounting period for research and development tax credits, which will be claimed from H.M. Revenue & Customs, or HMRC, the United Kingdom’s taxation and customs authority, in respect of qualifying research and development costs incurred in the same accounting period.
Net Loss Per Common Share
The Company calculates net loss per common share in accordance with ASC 260 “Earnings Per Share”. Basic and diluted net loss per common share was determined by dividing the net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period.
In periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders since potentially dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. The Company reported a net loss attributable to common stockholders for the years ended December 31, 2023 and 2022.
For the year ended December 31, 2022, the Company calculated loss per share using the two-class method. The two-class method is an allocation formula that determines loss per share for each share of common stock and redeemable common stock (see Note 11), according to dividends declared and participation rights in undistributed earnings. The
reconciliation showing the loss per share attributable to common and redeemable common stockholders is presented in Note 15.
Comprehensive Income (Loss)
All components of comprehensive income (loss), including net income (loss), are reported in the financial statements in the period in which they are recognized. Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. Net income (loss) and other comprehensive income (loss), including foreign currency translation adjustments, are reported to arrive at comprehensive income (loss). There wereno reclassifications out of other comprehensive income (loss) during the years ended December 31, 2023 and 2022.
Recently Issued Accounting Pronouncements
The Financial Accounting Standards Board (“FASB”)has issued Accounting Standards Update (“ASU”)2020-04, “Reference Rate Reform (Topic 848)”. This standard provides optional expedients and exceptions for applying GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform initiatives that would replace interbank offered rates, including the London Interbank Offered Rate (LIBOR). For example, modifications of lease contracts within the scope of ASC 842 solely for changes in reference rates would be accounted for as a continuation of the existing contracts with no reassessments of the lease classification and the discount rate. Following the issuance of ASU 2022-06, “Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848”, the relief remains effective for all entities as of March 12, 2020 through December 31, 2024. The Company does not currently have any contracts affected by this guidance.
The FASB has issued ASU 2023-07, “Segment Reporting (Topic 280)”. This standard will require all public entities – even those like the Company that have a single reportable segment – to disclose additional information about the title and position of the Chief Operaing Decision Maker (“CODM”), the measure or measures of segment profit and loss used by the CODM in assessing segment performance and deciding how to allocate resources, an explanation of how the CODM uses the reported measure(s) in assessing segment performance, significant segment expenses that are regularly provided to the CODM, and a reconciliation of segment profit and loss to the closest consolidated totals prepared under United States GAAP. The amendments in ASU 2023-07 are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. ASU 2023-07 will not change the way in which reportable segments are determined. However, the Company is currently evaluating the effects of ASU 2023-07 on its financial statement presentation and disclosures.
The FASB has issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”. This standard will require all entities shall disclose the amount of income taxes paid (net of refunds received) disaggregated by federal (national), state, and foreign for each annual reporting period. The guidance in ASU 2023-09 becomes effective for annual periods beginning after December 15, 2024. The Company already discloses the amount of cash taxes received and does not anticipate that ASU 2023-09 will require significant adjustments to the presentation of that information.
- Significant Contracts
Distribution, Licensing and Research Agreements
The Company has entered into licensing and similar agreements with academic and research organizations. Under the terms of these agreements, the Company has received licenses to technology and patent applications. The Company may be required to pay royalties on future sales of products employing the technology or falling under claims of patent applications.
Under a 2003 license agreement, the Company licensed certain patent rights for sapacitabine. The Company will not be pursuing further development of sapacitabine and the license agreement was terminated effective as of March 23, 2023 for commercial reasons.
Thethree-year term of the Clinical Collaboration Agreement, or CCA with The University of Texas MD Anderson Cancer Center, or MD Anderson ended in September 2021, in accordance with its terms. The main objective of the CCA was to clinically evaluate the safety and efficacy of three Cyclacel medicines in patients with hematological malignancies, including chronic lymphocytic leukemias, acute myeloid leukemias, myelodysplastic syndromes and other advanced leukemias. Under the terms of the CCA, MD Anderson conducted four clinical studies and under the risk-sharing agreement MD Anderson assumed the patient costs for all studies and Cyclacel, who is the sponsor, provided investigational drugs and other limited support. The agreement provided that the Company would make certain payments to MD Anderson upon first commercial sale in specific indications studied in the alliance. There wereno such payments earned in 2023 or 2022.
- Cash and Cash Equivalents
The following is a summary of cash and cash equivalents at December 31, 2023 and 2022 (in thousands):
| · · · · · · | ||||
|---|---|---|---|---|
| | December 31, | |||
| · 2023 · 2022 | ||||
| Cash | | $3,303 | | $13,798 |
| Cash equivalents | | 75 | | 4,547 |
| Total cash and cash equivalents | | $3,378 | | $18,345 |
Cash equivalents are made up entirely of money market funds.
- Fair Value of Financial Assets and Liabilities
The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · Fair Value Measurements · · · | ||||||||
| · as of December 31, 2023 Using: · · · | ||||||||
| · Level 1 · Level 2 · Level 3 · Total | ||||||||
| Assets: · · · · | ||||||||
| Cash equivalents | | $75 | | $— | | $— | | $75 |
| Total Assets | | $75 | | $— | | $— | | $75 |
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · Fair Value Measurements · · · | ||||||||
| · as of December 31, 2022 Using: · · · | ||||||||
| · Level 1 · Level 2 · Level 3 · Total | ||||||||
| Assets: · · · · | ||||||||
| Cash equivalents | | $4,547 | | $— | | $— | | $4,547 |
| Total Assets | | $4,547 | | $— | | $— | | $4,547 |
- Prepaid Expenses and Other Assets
The following is a summary of prepaid expenses and other current assets at December 31, 2023 and 2022 (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · December 31, · · December 31, | ||||||
| · 2023 · 2022 | ||||||
| Research and development tax credit receivable | | $2,933 | | $4,664 | ||
| Prepayments and VAT receivable | | | 792 | | 976 | |
| Other current assets | | 341 | | | 426 | |
| | | $4,066 | | $6,066 | ||
7. Non-Current Assets
As at December 31, 2023, the Company had non-current assets of $1.3 million, which comprised clinical trial deposits held by a contract research organization in relation to the Company’s Phase 1/2 clinical trials.
- Property and Equipment
Property and equipment consisted of the following at December 31, 2023 and 2022 (in thousands):
| · · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| · · · December 31, | ||||||
| · Lives in years · 2023 · 2022 | ||||||
| Leasehold improvements | | 2 to 5 | | $6 | | $6 |
| Office equipment and furniture | 3 to 5 | | 423 | | 409 | |
| | | | | 429 | | 415 |
| Less: accumulated depreciation and amortization | | (420) | | (383) | ||
| | | | | $9 | | $32 |
- Accrued and Other Current Liabilities
Accrued and other current liabilities consisted of the following at December 31, 2023 and 2022 (in thousands):
| · · · · · · | ||||
|---|---|---|---|---|
| · December 31, · · December 31, | ||||
| · 2023 · 2022 | ||||
| Accrued research and development | | $3,668 | | $3,611 |
| Accrued legal and professional fees | | 570 | | 333 |
| Other current liabilities | | 380 | | 1,006 |
| | | $4,618 | | $4,950 |
Other current liabilities include accrued payroll costs of approximately $0 and $680,000 for the years ended December 31, 2023 and 2022 respectively.
- Commitments and Contingencies
General
Please refer toNote 3 — Significant Contracts for further discussion of certain of the Company’s commitments and contingencies.
Leases
In April 2022, the Company extended the lease for its corporate headquarters facility in Berkeley Heights, New Jersey for a further three years, expiring in July 2025.
For the years ended December 31, 2023 and December 31, 2022, the Company recognized operating lease expenses of $74,218 and $62,528 respectively, including $10,851 in 2023 relating to a short term lease for offices in Dundee, Scotland. The remaining lease term as of December 31, 2023 is approximately 1.6 years for the Berkeley Heights facility. The discount rate used by the Company in determining the lease liability was 12%.
The following is a summary of the Company’s future contractual obligations and commitments relating to its facilities lease as at December 31, 2023 (in thousands):
| | | | |
|---|---|---|---|
| · Operating Lease | |||
| · Obligation | |||
| 2024 | | $66 | |
| 2025 | | 38 | |
| Thereafter | | — | |
| Total future minimum lease obligation | | $104 | |
| Less imputed interest | | | (11) |
| Total | | $93 | |
- Stockholders’ Equity
The Company has completed the following equity issuances during the periods presented in the consolidated financial statements.
December 2023 Registered Direct Offering Securities Purchase Agreement
On December 21, 2023, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain institutional investors (“Purchasers”). Pursuant to the Securities Purchase Agreement, the Company agreed to sell in a registered direct offering (“Registered Direct Offering”)168,500 shares (“Shares”) of the Company’s common stock, $0.001 par value per share (“Common Stock”), and pre-funded warrants (“Pre-Funded Warrants”) to purchase up to 219,700 shares of Common Stock. The Pre-Funded Warrants have an exercise price of $0.001 per share and are immediately exercisable and can be exercised at any time after their original issuance until such Pre-Funded Warrants are exercised in full. Each Share is being sold at an offering price of $3.315 and each Pre-Funded Warrant is being sold at an offering price of $3.314 (equal to the purchase price per Share minus the exercise price of the Pre-Funded Warrant).
Pursuant to the Securities Purchase Agreement, in a concurrent private placement (together with the Registered Direct Offering, the “Offerings”), the Company also agreed to issue to the Purchasers unregistered warrants (“Common Warrants”) to purchase up to 388,200 shares of Common Stock. Each Common Warrant has an exercise price of $3.19 per share, is exercisable immediately following their original issuance and will expire seven years from the original issuance date. The closing of the offering occurred on December 26, 2023, and the net proceeds to the Company were approximately $1.0 million, after deducting placement agent fees and other offering expenses payable by the Company.
On December 21, 2023, in a separate concurrent insider private placement (the “Insider Private Placement”), the Company also entered into a Securities Purchase Agreement with certain of its executive officers (the “Insider Securities Purchase Agreement”) pursuant to which the Company agreed to sell in a private placement (i)6,070 shares of Common Stock and warrants to purchase 6,070 shares of Common Stock on the same terms as the Common Warrants issued to the Purchasers in the Offerings to Spiro Rombotis, the Company’s Chief Executive Officer, and (ii)1,886 shares of Common Stock and warrants to purchase 1,886 shares of Common Stock on the same terms as the Common Warrants issued to the Purchasers in the Offerings to Paul McBarron, the Company’s Executive Vice President-Finance, Chief Financial Officer and Chief Operating Officer. Each such share of Common Stock and accompanying warrant was sold at a purchase price of $3.315, which was the same purchase price for the Shares sold in the Registered Direct Offering.
Ladenburg Thalmann & Co. Inc. (the “Placement Agent”) acted as the exclusive placement agent for the Offerings, pursuant to a placement agency agreement (the “Placement Agency Agreement”), dated December 21, 2023, by and between the Company and the Placement Agent.
Pursuant to the Placement Agency Agreement, the Company paid the Placement Agent a cash placement fee equal to 8.0% of the aggregate gross proceeds raised in the Offerings from sales arranged for by the Placement Agent. Subject to certain conditions, the Company also agreed to reimburse all reasonable travel and other out-of-pocket expenses of the Placement Agent in connection with the Offerings, including but not limited to legal fees, up to a maximum of $85,000. In addition, the Placement Agent also received warrants that have substantially the same terms as the Warrants issued in the concurrent private placement to the Purchasers in the Offerings to purchase that number of shares of Common Stock equal to 6.0% of the aggregate number of shares of Common Stock and Prefunded Warrants sold in the Offerings, or an aggregate of 23,769 shares of Common Stock, at an exercise price of $4.14375 per share (the “Placement Agent Warrants”). The Placement Agent Warrants will be exercisable immediately following the date of issuance and will expire five years from issuance. The Placement Agency Agreement contains customary representations, warranties and agreements by the Company and customary conditions to closing. The Company has agreed to indemnify the Placement Agent against certain liabilities, including liabilities under the Securities Act, and liabilities arising from breaches of representations and warranties contained in the Placement Agency Agreement, or to contribute to payments that the Placement Agent may be required to make in respect of those liabilities.
Each of the instruments issued in the Offerings and the Insider Private Placement have been classified and recorded as part of shareholders’ equity. The amounts allocated to each issued security were based on their relative fair values, resulting in initial carrying values of the respective instruments as follows:
The aggregate fair value of the Placement Agent Warrants was $47,000. These have been accounted for as a direct cost of the Offerings and Inside Private Placement, resulting in no net effect to overall shareholders’ equity.
In determining the fair values of the Pre-Funded Warrants, Regular Warrants, and Placement Agent Warrants, the Company used a Black-Scholes Option Pricing model with the following assumptions:
The fair value of the common shares was determined using the closing price of the Company’s common stock as of December 26, 2023, which is the date that the Offerings and the Insider Private Placement closed.
August 2021 Controlled Equity Offering Sales Agreement
On August 12, 2021, the Company entered into a Controlled Equity Offering Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. ("Cantor"), pursuant to which the Company could issue and sell, from time to time, shares of its common stock having an aggregate offering price of up to $50.0 million through Cantor as the sales agent. Cantor could sell the Company’s common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act.
On August 12, 2022, the Company became aware that the shelf registration statement on Form S-3 (file number 333-231923) (the “Registration Statement”) associated with this Sales Agreement had expired on June 21, 2022. Prior to
becoming aware of the expiration, the Company sold an aggregate of 132,473 shares of its common stock at the market price, following the expiration of the Registration Statement and through August 12, 2022, for aggregate proceeds of approximately $2,721,187. There was no sale of shares post August 12, 2022. The sale of these shares were subject to potential rescission rights by certain shareholders. As a result of these potential rescission rights, the Company reclassified 207,807 shares (including 75,333 shares sold for which the Company did not receive any proceeds), with an aggregate purchase price of $4,494,496 of its common as stock outside stockholders’ equity as of December 31, 2022. These shares have been treated as issued and outstanding for financial reporting purposes. The rescission rights for these shares has now lapsed and the shares were reclassified back to permanent equity. As of December 31, 2023, there have been no claims or demands to exercise such rights.
On August 15, 2022, due to expiry of the Registration Statement, the Sales Agreement was mutually terminated. A total of 218,738 shares, for gross proceeds of approximately $7.6 million, had been sold pursuant to the Sales Agreement.
Warrants
December 2020 Warrants
As of December 31, 2023, warrants to purchase 44,657 shares of common stock issued pursuant to a securities purchase agreement in a December 2020 financing transaction remained outstanding. Each warrant shall be exercisable beginning on the 12-month anniversary of the date of issuance for a period offive years after the date of issuance, at an exercise price of $61.95 per warrant share. The exercise price of the warrants will be subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the warrants. The warrants may be exercised on a “cashless” basis.
During the year ended December 31, 2023,15,833 warrants lapsed upon conversion of the associated Series B Preferred Stock. There wereno exercises of these warrants during the year ended December 31, 2022.
April 2020 Warrants
As of December 31, 2023,146,000 warrants issued in connection with an April 2020 equity financing remained outstanding, each with an exercise price of $75.00. The common warrants are immediately exercisable and will expire on the fifth anniversary of the original issuance date. The exercise price and number of shares of common stock issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting the Company’s common stock. The common warrants were issued separately from the common stock and were eligible for transfer immediately after issuance. A common warrant to purchaseone share of common stock was issued for every share of common stock purchased in this offering.
The common warrants are exercisable, at the option of each holder, in whole or in part, by delivering to the Company a duly executed exercise notice accompanied by payment in full for the number of shares of the Company’s common stock purchased upon such exercise (except in the case of a cashless exercise). A holder (together with its affiliates) may not exercise any portion of the common warrant to the extent that the holder would own more than 4.99% of the outstanding common stock immediately after exercise, except that upon at least 61 days prior notice from the holder to the Company, the holder may increase the amount of ownership of outstanding stock after exercising the holder’s common warrants up to 9.99% of the number of shares of the Company’s common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the common warrants. No fractional shares of common stock will be issued in connection with the exercise of a common warrant. In lieu of fractional shares, the Company will round down to the next whole share.
There wereno warrants exercised during the years ended December 31, 2023 or December 31, 2022.
July 2017 Warrants
As of December 31, 2023,24,968 warrants issued in connection with a July 2017 underwritten public offering remained outstanding, each with an exercise price of $600. All such warrants were issued in connection with the
July 2017 underwritten public offering and are immediately exercisable. The warrants expire in 2024. Subject to limited exceptions, a holder of warrants will not have the right to exercise any portion of its warrants if the holder (together with such holder’s affiliates, and any persons acting as a group together with such holder or any of such holder’s affiliates) would beneficially own a number of shares of common stock in excess of 4.99% (or, at the election of the purchaser,9.99%) of the shares of our Common Stock then outstanding after giving effect to such exercise.
The exercise price and the number of shares issuable upon exercise of the warrants is subject to appropriate adjustment in the event of recapitalization events, stock dividends, stock splits, stock combinations, reclassifications, reorganizations or similar events affecting the Company’s common stock. The warrant holders must pay the exercise price in cash upon exercise of the warrants unless such warrant holders are utilizing the cashless exercise provision of the warrants. On the expiration date, unexercised warrants will automatically be exercised via the “cashless” exercise provision.
Prior to the exercise of any warrants to purchase common stock, holders of the warrants will not have any of the rights of holders of the common stock purchasable upon exercise, including the right to vote, except as set forth therein.
There wereno portion of these warrants exercised during each of the years ended December 31, 2023 and 2022.
Series B Preferred Stock
237,745 shares of the Company’s Series B Preferred Stock were issued in a December 2020 Securities Purchase Agreement. Each share of Series B Preferred Stock shall initially be convertible into one third (1/3) share of Common Stock (the “Conversion Shares”), subject to adjustment in accordance with the Certificate of Designation.
Holders of Series B Preferred Stock are entitled to receive dividends on shares of Series B Preferred Stock equal, on an as-if-converted-to-Common-Stock basis, and in the same form as dividends actually paid on shares of the Common Stock. Except as otherwise required by law, the Series B Preferred Stock does not have voting rights. However, as long as any shares of Series B Preferred Stock are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series B Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series B Preferred Stock, (b) alter or amend the Certificate of Designation, (c) amend its certificate of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series B Preferred Stock, (d) increase the number of authorized shares of Series B Preferred Stock, (e) pay certain dividends or (f) enter into any agreement with respect to any of the foregoing. The Series B Preferred Stock does not have a preference upon any liquidation, dissolution or winding-up of the Company. The Purchaser may convert shares of Series B Preferred Stock through a conversion into shares of Common Stock if and solely to the extent that such conversion would not result in the Purchaser beneficially owning in excess of 9.99% of then-outstanding Common Stock or aggregate voting power of the Company (such limitation, the “Ownership Limitation”) and any portion in excess of such limitation will remain outstanding as Series B Preferred Stock.
During the year ended December 31, 2023,118,745 shares of Series B Preferred Stock was converted, at the option of the holder, into 39,582 shares of Common Stock. As of December 31, 2023,119,000 shares of the Series B Preferred Stock remained issued andoutstanding and are convertible into 39,667 shares of common stock.
Series A Preferred Stock
8,872 shares of the Company’s Series A Preferred Stock were issued in a July 2017 Underwritten Public Offering. Each share of Series A Preferred Stock is convertible at any time at the option of the holder thereof, into a number of shares of common stock determined by dividing $1,000 by the initial conversion price of $600.00 per share, subject to a 4.99% blocker provision, or, upon election by a holder prior to the issuance of shares of Series A Preferred Stock,9.99%, and is subject to adjustment for stock splits, stock dividends, distributions, subdivisions and combinations.
As of December 31, 2023 and 2022,264 shares of the Series A Preferred Stock remain issued and outstanding. The 264 shares of Series A Preferred Stock issued and outstanding at December 31, 2023, are convertible into 440 shares of common stock.
In the event of a liquidation, the holders of shares of the Series A Preferred Stock may participate on an as-converted-to-common-stock basis in any distribution of assets of the Company. The Company shall not pay any dividends on shares of common stock (other than dividends in the form of common stock) unless and until such time as dividends on each share of Series A Preferred Stock are paid on an as-converted basis. There is no restriction on the Company’s ability to repurchase shares of Series A Preferred Stock while there is any arrearage in the payment of dividends on such shares, and there are no sinking fund provisions applicable to Series A Preferred Stock.
Subject to certain conditions, at any time following the issuance of the Series A Preferred Stock, the Company has the right to cause each holder of the Series A Preferred Stock to convert all or part of such holder’s Series A Preferred Stock in the event that (i) the volume weighted average price of our common stock for 30 consecutive trading days, or Measurement Period exceeds 300% of the initial conversion price of the Series A Preferred Stock (subject to adjustment for forward and reverse stock splits, recapitalizations, stock dividends and similar transactions), (ii) the daily trading volume on each Trading Day during such Measurement Period exceeds $500,000 per trading day and (iii) the holder is not in possession of any information that constitutes or might constitute, material non-public information which was provided by the Company. The right to cause each holder of Series A Preferred Stock to convert all or part of such holder’s Series A Preferred Stock shall be exercised ratably among the holders of the then outstanding preferred stock.
The Series A Preferred Stock has no maturity date, will carry the same dividend rights as the common stock, and with certain exceptions contains no voting rights. In the event of any liquidation or dissolution of the Company, the Series A Preferred Stock ranks senior to the common stock in the distribution of assets, to the extent legally available for distribution.
6% Convertible Exchangeable Preferred Stock
As of December 31, 2023, there were 335,273 shares of the Company’s 6% Convertible Exchangeable, or Preferred Stock issued andoutstanding at an issue price of $10.00 per share. Dividends on the Preferred Stock are cumulative from the date of original issuance at the annual rate of 6% of the liquidation preference of the Preferred Stock, and if declared, payable quarterly on the first day of February, May, August and November, commencing February 1, 2005. Any dividends must be declared by the Company’s Board of Directors and must come from funds that are legally available for dividend payments. The Preferred Stock has a liquidation preference of $10.00 per share, plus accrued and unpaid dividends.
The Company’s Board of Directors considers numerous factors in determining whether to declare the quarterly dividend pursuant to the Certificate of Designations governing the terms of the Company’s Preferred Stock, including the requisite financial analysis and determination of a surplus. Accumulated but unpaid dividends in arrears on preferred stock were $0.7 million, or $1.95 per share, of preferred stock, as of December 31, 2023.
The Preferred Stock is convertible at the option of the holder at any time into the Company’s shares of common stock at a conversion rate of approximately 0.0000167 shares of common stock for each share of Preferred Stock based on a price of $592,200. The Company has reserved 6 shares of common stock for issuance upon conversion of the remaining shares of Preferred Stock outstanding at December 31, 2023. The shares of previously converted Preferred Stock have been retired, cancelled and restored to the status of authorized but unissued shares of preferred stock, subject to reissuance by the Board of Directors as shares of Preferred Stock of one or more series.
The Company may automatically convert the Preferred Stock into common stock if the closing price of the Company’s common stock has exceeded $888,300, which is 150% of the conversion price of the Preferred Stock, for at least 20 trading days during any 30-day trading period, ending within five trading days prior to notice of automatic conversion.
The Certificate of Designations governing the Preferred Stock provides that if the Company fails to pay dividends on its Preferred Stock forsix quarterly periods, holders of Preferred Stock are entitled to nominate and elect two directors to the Company’s Board of Directors. This right accrued to the holders of Preferred Stock as of August 2, 2010 and two directors were nominated and elected at the annual meeting held on May 24, 2011.
The Preferred Stock has no maturity date and no voting rights prior to conversion into common stock, except under limited circumstances.
The Company may, at its option, redeem the Preferred Stock in whole or in part, out of funds legally available at the redemption price of $10.00 per share.
The Preferred Stock is exchangeable, in whole but not in part, at the option of the Company on any dividend payment date beginning on November 1, 2005, or Exchange Date for the Company’s 6% Convertible Subordinated Debentures, or Debentures at the rate of $10.00 principal amount of Debentures for each share of Preferred Stock. The Debentures, if issued, will mature 25 years after the Exchange Date and have terms substantially similar to those of the Preferred Stock. No such exchanges have taken place as of December 31, 2023.
For the year ended December 31, 2023, the company declared dividends of $0.15 per share quarterly on its 6% Convertible Exchangeable Preferred Stock. These dividends were paid on May 1, August 1 and November 1, 2023, and February 1, 2024, respectively.
- Stock-Based Compensation
Stock based compensation has been reported within expense line items on the consolidated statement of operations for the years ended 2023 and 2022 as shown in the following table (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| | Year Ended | |||||
| | December 31, | |||||
| · · 2023 · 2022 | ||||||
| General and administrative | | $1,039 | | $1,051 | ||
| Research and development | | | 434 | | | 455 |
| Stock-based compensation costs before income taxes | | $1,473 | | $1,506 | ||
2018 Plan
In May 2018, the Company’s stockholders approved the 2018 Equity Incentive Plan (the “2018 Plan”), under which Cyclacel may make equity incentive grants to its officers, employees, directors and consultants. The 2018 Plan replaced the 2015 Equity Incentive Plan (the “2015 Plan”).
The 2018 Plan allows for various types of award grants, including stock options and restricted stock units.
On June 13, 2023, the Company’s stockholders approved an additional 60,000 shares of common stock that may be issued under the 2018 Plan. On June 14, 2022, the Company’s stockholders approved an additional 33,333 shares of common stock that may be issued under the 2018 Plan. As of December 31, 2023, the Company has reserved 25,415 shares of the Company’s common stock under the 2018 Plan for future issuances. Stock option awards granted under the Company’s equity incentive plans have a maximum life of 10 years and generally vest over aone tofour-year period from the date of grant.
2020 Inducement Equity Incentive Plan
In October 2020, the Inducement Equity Incentive Plan (the “Inducement Plan”), became effective. Under the Inducement Plan, Cyclacel may make equity incentive grants to new senior level Employees (persons to whom the Company may issue securities without stockholder approval). The Inducement Plan allows for the issuance of up to 13,333 shares of the Company’s common stock (or the equivalent of such number). As of December 31, 2023,8,000 shares under the Inducement Plan have been issued, leaving a remaining reserve of 5,333 shares.
Option Grants and Exercises
There were 43,342 options granted during the year ended December 31, 2023, all issued under the 2018 Plan. These options had a grant date fair value ranging between $6.32-$10.98 per option. There were 34,822 options granted during the year ended December 31, 2022. These options had a grant date fair value ranging between $12.45-$43.50 per option.
Of the options granted during the year ended December 31, 2023,25,633 shall vest on the third anniversary of their date of grant, or earlier if either of the certain performance conditions are met relating to enrollment goals for various clinical studies. The Company has assumed that these awards will vest after three years as satisfaction of the performance conditions is not probable at this time.
As of December 31, 2023, the total remaining unrecognized compensation cost related to the non-vested stock options with service conditions amounted to approximately $1.0 million, which will be amortized over the weighted-average remaining requisite service period of 1.53 years.
Outstanding Options
A summary of the share option activity and related information is as follows:
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| · · · · Weighted · · | ||||||||||
| · · Weighted · Average · · | ||||||||||
| · Number of · Average · Remaining · Aggregate | ||||||||||
| · · Options · Exercise · Contractual · · Intrinsic | ||||||||||
| · · Outstanding · · Price Per Share · Term (Years) · · Value ($000) | ||||||||||
| Options outstanding at December 31, 2021 | 73,291 | | $112.90 | 8.99 | | $189 | ||||
| Granted | | 34,822 | | $36.16 | — | | $— | |||
| Cancelled/forfeited | | (740) | | $157.33 | — | | $— | |||
| Options outstanding at December 31, 2022 | 107,373 | | $87.70 | 8.34 | | $— | ||||
| | | | | | | | | | | |
| Granted | 43,342 | | $8.82 | — | | — | ||||
| Cancelled/forfeited | (7,919) | | $332.24 | — | | — | ||||
| Options outstanding at December 31, 2023 | 142,796 | | $50.20 | 7.96 | | $— | ||||
| Unvested at December 31, 2023 | 59,126 | | $19.81 | 9.10 | | $— | ||||
| Vested and exercisable at December 31, 2023 | 83,670 | | $71.68 | 7.16 | | $— | ||||
The fair value of the stock options granted is calculated using the Black-Scholes option-pricing model as prescribed by ASC 718 using the following assumptions:
| · · · · | |||
|---|---|---|---|
| · · · · | |||
| · · Year ended · · Year ended | |||
| · December 31, 2023 · December 31, 2022 | |||
| Expected term (years) | 5-6 | 5-6 | |
| Risk free interest rate | 3.660% – 4.160% | | 1.370% – 3.605% |
| Volatility | 89% – 92% | | 86% – 93% |
| Expected dividend yield over expected term | 0.00% | | 0.00% |
| Resulting weighted average grant date fair value | $6.63 | | $26.44 |
There wereno stock options exercised during each of the years ended December 31, 2022 and 2023, respectively. The Company does not expect to be able to benefit from the deduction for stock option exercises that may occur because the company has tax loss carryforwards from prior periods that would be expected to offset any potential taxable income.
Restricted Stock Units
The Company issued 25,621 restricted stock units during the year ended December 31, 2023.
8,488 restricted stock units issued in June 2023 vest on the first anniversary of the date of grant. Each of these restricted stock units were valued at $8.84 at the date of grant, which was equivalent to the market price of a share of the Company’s common stock on that date.
17,133 restricted stock units issued in January 2023 vest on the third anniversary of their date of grant, or earlier if certain defined clinical trial related performance targets are met. Athree-year vesting assumption was applied to these restricted stock units as satisfaction of the performance conditions is not probable at this time. Each restricted stock unit was valued at $13.50 at the date of grant, which was equivalent to the market price of a share of the Company’s common stock on that date. As of December 31, 2023,300 of these restricted stock units have been forfeited as the recipient’s employment was voluntarily terminated by the Company.
The Company issued 7,911 restricted stock units during the year ended December 31, 2022. These restricted stock units vest over a period of one year for awards granted to directors andthree years for grants to employees. Each restricted stock unit was valued at $16.65 based on their fair value at the date of grant, which is equivalent to the market price of a share of the Company’s common stock.
Summarized information for restricted stock units as of December 31, 2023 is as follows:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · Weighted · · Weighted | |||||||
| · · Average · · Average | |||||||
| · · Restricted · Grant Date · · Remaining | |||||||
| · · Stock Units · · Value Per Share · · Term | |||||||
| Restricted Stock Units outstanding at December 31, 2021 | 1,266 | | $100.35 | | | ||
| Granted | 7,911 | | | 16.65 | | | |
| Restricted Stock Units outstanding at December 31, 2022 | 9,177 | | $28.20 | | | ||
| | | | | | | | |
| Granted | | 25,621 | | | 11.96 | | |
| Cancelled/forfeited | | (300) | | | 13.50 | | |
| | | | | | | | |
| Restricted Stock Units outstanding at December 31, 2023 | | 34,498 | | $16.26 | | 8.96 years | |
| Unvested at December 31, 2023 | 26,428 | | $12.30 | | 9.20 years | ||
| Vested and exercisable at December 31, 2023 | 8,070 | | $29.24 | | 8.17 years | ||
- Employee Benefit Plans
Pension Plan
The Company operates a defined contribution group personal pension plan for all of its UK based employees. Company contributions to the plan totaled approximately $52,000 and $44,000 for the years ended December 31, 2023 and 2022, respectively.
401(k) Plan
The 401(k) Plan provides for matching contributions by the Company in an amount equal to the lesser of 100% of the employee’s deferral or 6% of the U.S. employee’s qualifying compensation. The 401(k) Plan is intended to qualify under Section 401(k) of the Internal Revenue Code, so that contributions to the 401(k) Plan by employees or by the Company, and the investment earnings thereon, are not taxable to the employees until withdrawn. Company matching contributions are tax deductible by the Company when made. In 2023, Company employees could elect to reduce their current compensation by up to the statutorily prescribed annual limit of $22,500 if under 50 years old and $30,000 if over 50 years old and to have those funds contributed to the 401(k) Plan. The Company made contributions of approximately $103,000 and $95,000 to the 401(k) Plan for the years ended December 31, 2023 and 2022, respectively.
- Taxes
(Loss) income from continuing operations before taxes is comprised of the following components for the years ended December 31, 2023 and 2022 (in thousands):
| · · · · · · | ||||
|---|---|---|---|---|
| | Year Ended December 31, | |||
| · 2023 · 2022 | ||||
| Domestic | | $(806) | | $(1,981) |
| Foreign | | (24,745) | | (23,934) |
| Loss from continuing operations before taxes | | $(25,551) | | $(25,915) |
The benefit (provision) for income taxes from continuing operations consists of the following (in thousands):
| · · · · · · | ||||
|---|---|---|---|---|
| | Year Ended December 31, | |||
| · 2023 · 2022 | ||||
| Current – domestic | | $(2) | | $(2) |
| Current – foreign | | 2,998 | | 4,719 |
| Current – total | | 2,996 | | 4,717 |
| Deferred – domestic | | — | | — |
| Income tax benefit | | $2,996 | | $4,717 |
The Company has incurred a taxable loss in each of the operating periods since incorporation. The income tax credits of $3.0 million and $4.7 million for the years ended December 31, 2023 and 2022, respectively, represent UK research and development (“R&D”) tax credits for expenditures in the United Kingdom that are refundable.
A reconciliation of the (benefit) provision for income taxes from continuing operations with the amount computed by applying the statutory federal tax rate to loss from continuing operations before income taxes is as follows (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| | Year Ended December 31, | |||||
| · 2023 · 2022 | ||||||
| Loss from continuing operations before taxes | | $(25,551) | | $(25,915) | ||
| Income tax expense computed at statutory federal tax rate | | (5,366) | | (5,442) | ||
| Additional research and development tax relief | | (5,409) | | (4,719) | ||
| Loss surrendered to generate R&D credit | | 4,865 | | 6,169 | ||
| Change in valuation allowance | | 1,261 | | 2,310 | ||
| Other foreign items | | 809 | | (3,487) | ||
| Disallowed expenses and non-taxable income | | 782 | | 369 | ||
| Stock Compensation | | | 62 | | | 105 |
| Foreign items, including change in tax rates, and other | | — | | (20) | ||
| Change in UK Tax Rate | | — | | (2) | ||
| | | $(2,996) | | $(4,717) | ||
Significant components of the Company’s deferred tax assets are shown below (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| | Year Ended December 31, | |||||
| · 2023 · 2022 | ||||||
| Net operating loss and tax credit carryforwards | | $57,074 | | $53,092 | ||
| Depreciation, amortization and impairment of property and equipment | | 39 | | 61 | ||
| Stock options | | 210 | | 153 | ||
| Right of use asset | | | (26) | | | (40) |
| Lease liability | | | 26 | | | 40 |
| Total deferred tax assets | | 57,323 | | 53,306 | ||
| Valuation allowance for deferred tax assets | | (57,323) | | (53,306) | ||
| Net deferred tax assets | | $— | | $— | ||
A valuation allowance has been established, as realization of such assets is uncertain. The Company’s management evaluated the positive and negative evidence bearing upon the realizability of its deferred assets, and has determined that, at present, the Company may not be able to recognize the benefits of the deferred tax assets under the more likely than not criteria. Accordingly, a valuation allowance of approximately $57.3 million has been established at December 31, 2023. The valuation allowance has increased by approximately $4.0 million in 2023.
As specified in the Tax Reform Act of 1986, due to ownership changes, the Company’s ability to utilize its net operating loss (“NOL”) carryforwards may be limited. Utilization of the NOLs may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986 due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. The Company completed a Section 382 study and has concluded that an ownership change occurred on March 4, 2015 and July 21, 2017. As a result of the ownership changes, the NOLs are limited.
As of December 31, 2023 and 2022, the Company has federal NOLs of $3.9 million and $3.6 million, respectively. The federal NOLs have an indefinite life. As of December 31, 2023 and 2022, the Company has state NOLs of $17.3 million and $22.1 million, respectively, which will begin to expire in 2028. As of December 31, 2023 and 2022, the Company had foreign NOLs of $220.1 million and $203.0 million, respectively. The Company’s foreign NOL’s do not expire under UK tax law however the use of these NOLs is restricted to an annual £5.0 million allowance in each standalone company or group and above this allowance, there will be a 50% restriction in the profits that can be covered by losses brought forward.
Management has evaluated all significant tax positions at December 31, 2023 and 2022 and concluded that there are no material uncertain tax positions. The Company would recognize both interest and penalties related to unrecognized benefits in income tax expense. The Company has not recorded any interest and penalties on any unrecognized tax benefits since its inception.
Tax years 2020 - 2022 remain open to examination by major taxing jurisdictions to which the Company is subject, which are primarily in the United Kingdom and the United States, as carryforward attributes generated in years past may still be adjusted upon examination by the United Kingdom’s H.M. Revenue & Customs, the Internal Revenue Service (“IRS”) or state tax authorities. The Company is currently not under examination by the IRS or any other jurisdictions for any tax years.
We have not provided a deferred tax liability on the cumulative amount of unremitted foreign earnings of international subsidiaries because it is our intent to permanently reinvest such earnings outside of the United States.
The Company has an aggregate deficit in foreign earnings and therefore has not provided any deferred tax liability on its outside book-tax basis difference in its foreign subsidiaries and because it is also our intent to permanently reinvest any earnings outside of the United States. We would recognize this deferred tax liability if we were to experience a change in circumstances producing a change in that intention. As a result of the repeal of Section 902 foreign tax credit under the Tax Act, future distributions would not be offset by a foreign tax credit.
Effective for tax years beginning after December 31, 2021, taxpayers are required to capitalize any expenses incurred that are considered incidental to research and experimentation (R&E) activities under IRC Section 174. While taxpayers historically had the option of deducting these expenses under IRC Section 174, the December 2017 Tax Cuts and Jobs Act mandates capitalization and amortization of R&E expenses for tax years tax years beginning after December 31, 2021. Expenses incurred in connection with R&E activities in the US must be amortized over a 5-year period if incurred, and R&E expenses incurred outside the US must be amortized over a 15-year period. R&E activities are broader in scope than qualified research activities that are considered under IRC Section 41 (relating to the research tax credit). For the year ended December 31, 2023, the Company performed an analysis based on available guidance and determined that the company does not have any R&E expenses in the US. The company will continue to monitor this issue for future developments, but it does not expect R&E capitalization and amortization to require it to pay cash taxes now or in the near future.
- Net Loss Per Share
Basic and diluted net loss per share attributable to common stockholders was calculated as follows:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Years ended December 31, · · · · · · | ||||||||||||
| | | 2023 | | 2022 | | | ||||||
| Numerator: | | | | | | | | | | | | |
| Net loss | | $(22,555) | | $(21,198) | | | | | | | ||
| Dividend on convertible exchangeable preferred shares | | | (201) | | | (201) | | | | | | |
| Net loss attributable to common shareholders | | $(22,756) | | $(21,399) | | | | | | | ||
| Deemed dividend on accretion of redeemable common stock | | | | | | (135) | | | | | | |
| Remaining undistributed loss | | | (22,756) | | | (21,534) | | | | | | |
| | | | | | | | | | | | | |
| | | Years ended December 31, 2023 | | Years ended December 31, 2022 | ||||||||
| | | Common Shareholders | | Redeemable Common Shareholders | | Common Shareholders | Redeemable Common Shareholders | |||||
| Allocation of undistributed loss | | $(22,756) | | $— | | $(18,872) | | $(2,662) | ||||
| Deemed dividend on accretion of redeemable common stock | | | — | | | — | | | | | | 135 |
| Net loss attributable to common shareholders | | | (22,756) | | | — | | | (18,872) | | | (2,527) |
| | | | | | | | | | | | | |
| Denominator: | | | | | | | | | | | | |
| Weighted-average number of common shares used in loss per share – basic and diluted | | | 850,815 | | | — | | | 657,620 | | | 92,759 |
| Loss per share - basic and diluted | | $(26.75) | | $— | | $(28.70) | | $(27.24) | ||||
| Distributed earnings | | | — | | | — | | | — | | | 1.46 |
| Undistributed loss | | | (26.75) | | | — | | | (28.70) | | | (28.70) |
| Net loss per share | | $(26.75) | | $— | | $(28.70) | | $(27.24) | ||||
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Potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:
| · · · · | ||
|---|---|---|
| · December 31, · · December 31, | ||
| | 2023 | 2022 |
| Stock options | 142,796 | 107,373 |
| Restricted Stock Units | 34,498 | 9,177 |
| 6% convertible exchangeable preferred stock | 6 | 6 |
| Series A preferred stock | 440 | 440 |
| Series B preferred stock | 39,667 | 79,248 |
| Common stock warrants | 635,550 | 215,625 |
| Total shares excluded from calculation | 852,957 | 411,869 |
- Geographic Information
Geographic information for the years ended December 31, 2023 and 2022 is as follows (in thousands):
| · · · · · · | ||||
|---|---|---|---|---|
| | Year Ended December 31, | |||
| · 2023 · 2022 | ||||
| Revenue · · | ||||
| United Kingdom | | $420 | | $— |
| Total Revenue | | $420 | | $— |
| Net loss | | | ||
| United States | | $(808) | | $(1,983) |
| United Kingdom | | (21,747) | | (19,215) |
| Total Net Loss | | $(22,555) | | $(21,198) |
| · · · · · · | ||||
|---|---|---|---|---|
| | December 31, | |||
| · 2023 · 2022 | ||||
| Total Assets · · | ||||
| United States | | $2,938 | | $18,220 |
| United Kingdom | | 5,867 | | 9,830 |
| Total Assets | | $8,805 | | $28,050 |
| Long Lived Assets, net | | | ||
| United States | | $— | | $— |
| United Kingdom | | 9 | | 32 |
| Total Long Lived Assets, net | | $9 | | $32 |
- Subsequent Events
On January 12, 2024, the Board of Directors declared a quarterly cash dividend in the amount of $0.15 per share on the Company’s Preferred Stock. The cash dividend waspaid on February 1, 2024 to the holders of record of the Preferred Stock as of the close of business on January 22, 2024.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.