Century Therapeutics Inc
For the period ended Mar 31, 2024. Filed May 9, 2024.
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Mar 31, 2024 · Filed May 9, 2024
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Notes to Unaudited Consolidated Financial Statements
NOTES TO FINANCIAL STATEMENTS
(in thousands, except share and per share amounts)
Note 1—Organization and description of the business
Century Therapeutics, Inc. (the “Company”) is an innovative biotechnology company developing transformative allogeneic cell therapies to create products for the treatment of both solid tumor and hematological malignancies and autoimmune diseases with significant unmet medical need. Since inception, the Company has devoted substantially all of its time and efforts to performing research and development activities, building infrastructure and raising capital. The Company is incorporated in the state of Delaware.
Principles of Consolidation
The consolidated financial statements include the consolidated financial position and consolidated results of operations of the Company and the Company’s subsidiary, Century Therapeutics Canada ULC (“Century Canada”). All intercompany balances and transactions have been eliminated in consolidation.
Liquidity
The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. The Company has limited operating history and its prospects are subject to risks, expenses, and uncertainties frequently encountered by companies in the biotechnology and pharmaceutical industries. These risks include, but are not limited to, the uncertainty of availability of additional financing and the uncertainty of achieving future profitability.
Since inception, the Company has incurred net losses and negative cash flows from operations. During the three months ended March 31, 2024, the Company incurred a net loss of $28,062. During the three months ended March 31, 2024, the Company used $30,248 of cash in operations. Cash and cash equivalents and investments were $249,868 at March 31, 2024. Management expects to incur additional losses in the future to fund its operations and conduct product research and preclinical and clinical development and recognizes the need to raise additional capital to fully implement its business plan. The Company believes it has adequate cash and financial resources to operate for at least the next 12 months from the date of issuance of these consolidated financial statements.
Note 2—Summary of significant accounting policies and basis of presentation
Basis of presentation
The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial information and with the interim period reporting requirements of Form 10-Q and Article 10 of Regulation S-X. The consolidated balance sheet as of March 31, 2024, and the consolidated statements of operations and comprehensive loss, consolidated statements of changes in stockholders’ equity, and the consolidated statements of cash flows for the three months ended March 31, 2024 and 2023 are unaudited, but, in the opinion of management, include all adjustments, consisting only of normal recurring adjustments, which the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for any interim period are not necessarily indicative of results for the year ending December 31, 2024 or for any other subsequent interim period. The consolidated balance sheet at December 31, 2023 has been derived from the Company’s audited consolidated financial statements.
Certain prior year information has been reclassified to conform to the fiscal year 2024 presentation.
Segment information
Operating segments are identified as components of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions on how to allocate resources and assess performance. The Company views its operations and manages the business asone operating segment.
Use of estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of expenses during the reporting period. Estimates and assumptions are primarily made in relation to the valuations supporting stock compensation, the estimation of the incremental borrowing rate for operating leases and standalone selling prices of performance obligations in collaboration agreements. If actual results differ from the Company’s estimates, or to the extent these estimates are adjusted in future periods, the Company’s results of operations could either benefit from, or be adversely affected by, any such change in estimate.
Concentration of credit risk and other risks and uncertainties
Financial instruments, which potentially subject the Company to significant concentrations of credit risk, consist of cash, cash equivalents, U.S. Treasury bills and bonds, as well as corporate bonds. Cash and cash equivalents, as well as short and long-term investments include a checking account and asset management accounts held by a limited number of financial institutions. At times, such deposits may be in excess of insured limits. As of March 31, 2024 and December 31, 2023, the Company has not experienced any losses on its deposits of cash and cash equivalents.
The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, rapid technological change, uncertainty of market acceptance of its products, competition from substitute products and larger companies, protection of proprietary technology, strategic relationships, and dependence on key individuals.
Products developed by the Company require clearances from the U.S. Food and Drug Administration (the “FDA”) or other international regulatory agencies prior to commercial sales. There can be no assurance the Company’s future products will receive the necessary clearances. If the Company was denied clearance, clearance was delayed, or if the Company was unable to maintain clearance, it could have a material adverse impact on the Company.
Fair value of financial instruments
The Company discloses and recognizes the fair value of its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The hierarchy gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements). The guidance establishes three levels of the fair value hierarchy as follows:
| Level 1 | Inputs that reflect unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date; |
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| Level 2 | Inputs other than quoted prices that are observable for the asset or liability either directly or indirectly, including inputs in markets that are not considered to be active; |
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| Level 3 | Inputs are unobservable in which there is little or no market data available, which require the reporting entity to develop its own assumptions that are unobservable. |
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Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.
Cash and cash equivalents
Management considers all highly liquid investments with an insignificant interest rate risk and original maturities of three months or less to be cash equivalents.
Restricted cash
As of March 31, 2024 and December 31, 2023, the Company had $1,979 in cash on deposit to secure certain lease commitments. Restricted cash is recorded separately in the Company’s consolidated balance sheets.
The following provides a reconciliation of the Company’s cash, cash equivalents, and restricted cash as reported in the consolidated balance sheets to the amounts reported in the consolidated statements of cash flows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · March 31, 2024 · December 31, 2023 | ||||||
| Cash and cash equivalents | | $46,812 | | $47,324 | ||
| Restricted cash | | | 1,979 | | | 1,979 |
| Cash, cash equivalents, and restricted cash | | $48,791 | | $49,303 | ||
Investments
The Company invests in fixed maturity securities including U.S. Treasury bills and bonds as well as corporate bonds. The investments are classified as available-for-sale and reported at fair value. Unrealized gains or losses are determined by comparing the fair market value of the securities with their cost or amortized cost. Realized gains and losses on investments are recorded on the trade date and are included in the statement of operations. Unrealized gains and losses on investments are recorded in other comprehensive loss on the consolidated statements of operations and comprehensive loss. The cost of securities sold is based on the specified identification method. Investment income is recognized as earned and discounts or premiums arising from the purchase of debt securities are recognized in investment income using the interest method over the remaining term of the security. Securities with an original maturity date greater than three months that mature within one year of the balance sheet date are classified as short-term, while investments with a maturity date greater than one year are classified as long-term.
Property and equipment, net
Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, which is generally five years. Leasehold improvements are amortized over the shorter of the asset’s useful life or the remaining term of the lease. Construction in progress includes direct cost related to the construction of leasehold improvements and is stated at original cost. Such costs are not depreciated until the asset is completed and placed into service. Once the asset is placed into service, these capitalized costs will be allocated to leasehold improvements and will be depreciated over the shorter of the asset’s useful life or the remaining term of the lease. Computer software and equipment includes implementation costs for cloud-based software and network equipment.
Expenditures for major additions and improvements are capitalized, while minor replacements, maintenance, and repairs are charged to expense as incurred. When property is retired or otherwise disposed of, the costs and accumulated depreciation are removed from the respective accounts, with any resulting gain or loss recognized concurrently.
Research and development expenses
Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, payroll taxes, employee benefits, stock compensation, materials, supplies, rent, depreciation on and maintenance of research equipment with alternative future use, and the cost of services provided by outside contractors. All costs associated with research and development are expensed as incurred.
Clinical trial costs are a component of research and development expenses. The Company expenses costs for its clinical trial activities performed by third parties, including clinical research organizations and other service providers, as they are incurred, based upon estimates of the work completed over the life of the individual study in accordance with associated agreements. The Company uses information it receives from internal personnel and outside service providers to estimate the clinical trial costs incurred.
Stock-based compensation
Employees, consultants and members of the Board of Directors of the Company have received stock options and restricted stock of the Company. The Company recognizes the cost of the stock-based compensation incurred as its employees and board members vest in the awards. The Company accounts for stock-based compensation arrangements in accordance with provisions of Accounting Standards Codification (“ASC”) 718, Compensation—Stock Compensation. ASC 718 requires the recognition of compensation expense, using a fair-value based method, for costs related to all share-based payments including stock options. ASC 718 requires companies to estimate the fair value of share-based payment awards on the date of grant using an option-pricing model. The Company uses the Black-Scholes option-pricing model (“Black Scholes”) to determine the fair value of options granted. The Company’s stock-based awards are subject to service-based vesting conditions and performance-based vesting conditions. Compensation expense related to awards to employees and directors with service-based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term. For performance-based awards, the Company reassesses at each reporting date whether achievement of the performance condition is probable and accrues compensation expense if and when achievement of the performance condition is probable.
Black Scholes requires inputs based on certain subjective assumptions, including (i) the expected stock price volatility, (ii) the expected term of the award, (iii) the risk-free interest rate and (iv) expected dividends. The historical volatility is calculated based on a period of time commensurate with expected term assumption. The risk-free interest rate is based on U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The expected dividend yield is assumed to bezero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock. Forfeitures are recognized as they occur.
Foreign currency translation
The reporting currency of the Company is the U.S. dollar. The functional currency of Century Canada is the Canadian dollar. Assets and liabilities of Century Canada are translated into U.S. dollars based on exchange rates at the end of each reporting period. Expenses are translated at average exchange rates during the reporting period. Gains and losses arising from the translation of assets and liabilities are included as a component of accumulated other comprehensive loss or income on the Company’s consolidated balance sheets. Gains and losses resulting from foreign currency transactions are reflected within the Company’s
consolidated statements of operations and comprehensive loss. The Company has not utilized any foreign currency hedging strategies to mitigate the effect of its foreign currency exposure.
Intercompany payables and receivables are considered to be long-term in nature and any change in balance due to foreign currency fluctuation is included as a component of the Company’s consolidated comprehensive loss and accumulated other comprehensive loss within the Company’s consolidated balance sheets.
Basic and diluted net loss per common shares
Basic net loss per common share is computed by dividing net loss applicable to common shareholders by the weighted-average number of common shares outstanding during the period. The Company computes diluted net loss per common share by dividing the net loss applicable to common shareholders by the sum of the weighted-average number of common shares outstanding during the period plus the potential dilutive effects of its warrants, restricted stock and stock options to purchase common shares, but such items are excluded if their effect is anti-dilutive. Because the impact of these items is anti-dilutive during periods of net loss, there were no differences between the Company’s basic and diluted net loss per common share for the three months ended March 31, 2024 and 2023.
Collaboration revenue
The Company may enter into collaboration and licensing agreements with strategic partners for research and development, manufacturing, and commercialization of its product candidates. Payments under these arrangements may include non-refundable, upfront fees; reimbursement of certain costs; customer option fees for additional goods or services; payments upon the achievement of development, regulatory, and commercial milestones; sales of product at certain agreed-upon amounts; and royalties on product sales.
The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers, (“ASC 606”). This standard applies to all contracts with customers. When an agreement falls under the scope of other standards, such as ASC Topic 808, Collaborative Arrangements, or (“ASC 808”), the Company will apply the recognition, measurement, presentation, and disclosure guidance in ASC 606 to the performance obligations in the agreements if those performance obligations are with a customer. Revenue recognized by analogizing to ASC 606 is recorded as collaboration revenue on the statements of operations.
Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under a collaboration agreement, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations on a relative stand-alone selling price basis; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.
As part of the accounting for these arrangements, the Company must use its judgment to determine the stand-alone selling price for each performance obligation identified in the contract for the allocation of transaction price. The estimation of the stand-alone selling price may include such estimates as forecasted revenues and costs, development timelines, discount rates, and probabilities of regulatory and commercial success. The Company also applies significant judgment when evaluating whether contractual obligations represent distinct performance obligations, allocating transaction price to performance obligations within a contract, determining when performance obligations have been met, assessing the recognition and future reversal of variable consideration and determining and applying appropriate methods of measuring progress for performance obligations satisfied over time. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, current. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, non-current.
If an arrangement is determined to contain customer options that allow the customer to acquire additional goods or services, the goods and services underlying the customer options are not considered to be performance obligations at the outset of the arrangement, as they are contingent upon option exercise. The Company evaluates the customer options for material rights or options to acquire additional goods or services for free or at a discount. If the customer options are not determined to represent a material right, no transaction price is allocated to these options and the Company will account for these options at that time they are exercised. If the customer options are determined to represent a material right, the material right is recognized as a separate performance obligation at the outset of the arrangement.
The obligations under the Company’s collaboration agreements may include research and development services to be performed by the Company for or on behalf of the customer. Amounts allocated to these performance obligations are recognized as the Company performs these obligations, and revenue is measured based on an inputs method of costs incurred to date of budgeted costs. Under certain circumstances, the Company may be reimbursed for certain expenses incurred under the research and development services.
At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The Company evaluates factors such as the scientific, clinical, regulatory, commercial and other risks that must be overcome to achieve the particular milestone in making this assessment. There is considerable judgment involved in determining whether it is probable that a significant revenue reversal would not occur. At the end of each subsequent reporting period, the Company reevaluates the probability of achievement of all milestones subject to constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis in the statements of operations in the period of adjustment.
Recent accounting pronouncements
In December 2023, the FASB issued ASU No. 2023-09, "Income Taxes (Topic 740): Improvements to Income Tax Disclosures ("ASU 2023-09"). ASU 2023-09 requires entities to provide additional information in their tax rate reconciliation and additional disclosures about income taxes paid by jurisdiction. ASU 2023-09 is effective for annual reporting periods beginning after December 15, 2024, with early adoption permitted. The guidance should be applied prospectively, but entities have the option to apply it retrospectively for each period presented. The Company is currently evaluating the impact of adopting this new accounting guidance.
Note 3—Reduction in force
In January 2023, the Company's Board of Directors approved, and management implemented, a new portfolio prioritization and capital allocation strategy. The resulting changes included pausing investments in CNTY-103 for glioblastoma as well as a discovery program in hematologic malignancies. The Company has shifted focus to CNTY-101 and will accelerate key programs, including one follow-on candidate for lymphoma, CNTY-102, CNTY-107 for Nectin-4+ solid tumors, and CNTY-101 in moderate to severe Systemic Lupus Eythematosus (“SLE”). In addition, the Company continues its partnered programs with Bristol Myers Squibb. The restructuring plan resulted in a reduction in the Company's workforce of approximately 25%. In connection with the restructuring plan, lab operations in Seattle and Hamilton, Ontario were closed and research activities were consolidated in Philadelphia.
During the three months ended March 31, 2023, the Company incurred $2,032 of cash-based expenses related to employee severances, benefits and related costs. Of these amounts,$292 related to general and administrative expense, while $1,740 related to R&D expense. In addition, the Company recorded non-cash stock-based compensation charge of$581 related to modification of equity awards for employees impacted by the restructuring during the year ended December 31, 2023. Of these amounts,$171 related to G&A expense, while $410 related to R&D expense. There wereno remaining outstanding liabilities related to the reduction in force at March 31, 2024.
Note 4—Financial instruments and fair value measurements
The following table sets forth the Company’s assets that were measured at fair value as of March 31, 2024 by level within the fair value hierarchy:
| · · · · · · · · · · · · | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| · Level 1 · Level 2 · Level 3 · Total | ||||||||||
| Cash equivalents | | $41,492 | | | — | | | — | | $41,492 |
| U.S. Treasury | | — | | 17,838 | | — | | 17,838 | ||
| Corporate bonds | | — | | 185,218 | | — | | 185,218 | ||
| Total | | $41,492 | | $203,056 | | $— | | $244,548 | ||
The following table sets forth the Company’s assets that were measured at fair value as of December 31, 2023, by level within the fair value hierarchy:
| · · · · · · · · · · · · | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| · Level 1 · Level 2 · Level 3 · Total | ||||||||||
| Cash equivalents | | $42,263 | | | — | | | — | | $42,263 |
| U.S. Treasury | | — | | 26,114 | | — | | 26,114 | ||
| Corporate bonds | | — | | 188,396 | | — | | 188,396 | ||
| Total | | $42,263 | | $214,510 | | $— | | $256,773 | ||
There wereno transfers between levels during the period ended March 31, 2024. The Company uses the services of its investment manager, which uses widely accepted models for assumptions in valuing securities with inputs from major third-party data providers.
The Company classifies all of its investments in fixed maturity debt securities as available-for-sale and, accordingly, are carried at estimated fair value.
The amortized cost, gross unrealized gains and losses, and fair value of investments in fixed maturity securities are as follows as of March 31, 2024:
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · · Gross · Gross · · | ||||||||
| · · · · · Unrealized · · Unrealized · · · | ||||||||
| | | Amortized Cost | | Gains | | Losses | | Fair Value |
| U.S. Treasury | | $17,855 | | $— | | $(17) | | $17,838 |
| Corporate bonds | | 185,329 | | 128 | | (239) | | 185,218 |
| Total | | $203,184 | | $128 | | $(256) | | $203,056 |
The amortized cost, gross unrealized gains and losses, and fair value of investments in fixed maturity securities are as follows as of December 31, 2023:
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · · · Gross · Gross · · | ||||||||
| · · · · · Unrealized · · Unrealized · · · | ||||||||
| · Amortized Cost · · Gains · · Losses · · Fair Value | ||||||||
| U.S. Treasury | | $26,070 | | $44 | | $— | | $26,114 |
| Corporate bonds | | 188,219 | | 399 | | (222) | | 188,396 |
| Total | | $214,289 | | $443 | | $(222) | | $214,510 |
The following table provides the maturities of our fixed maturity available-for-sale securities:
| · · · · · · | ||||
|---|---|---|---|---|
| · March 31, 2024 · December 31, 2023 | ||||
| Less than one year | | $145,204 | | $125,414 |
| One to five years | | 57,852 | | 89,096 |
| | | $203,056 | | $214,510 |
The Company has evaluated the unrealized losses on the fixed maturity securities and determined that they are not attributable to credit risk factors. For fixed maturity securities, losses in fair value are viewed as temporary if the fixed maturity security can be held to maturity and it is reasonable to assume that the issuer will be able to service the debt, both as to principal and interest.
At March 31, 2024 and December 31, 2023, the Company had 52 and 25 available-for-sale investment debt securities in an unrealized loss position without an allowance for credit losses, respectively. Unrealized losses on corporate debt securities have not been recognized into income because the issuers’ bonds are of high credit quality (rated BBB+ or higher) and the decline in fair value is largely due to market conditions and or changes in interest rates. Management does not intend to sell and it is likely that management will not be required to sell the securities prior to the anticipated recovery of their amortized cost basis. The issuers continue to make timely payments on the bonds. The fair value is expected to recover as the bonds approach maturity.
As of March 31, 2024 and December 31, 2023, accrued interest receivable on available-for-sale investment debt securities totaling $1,583 and $1,570, respectively, is excluded from the estimate of credit losses and is included in prepaid expenses and other current assets.
Note 5—Property and equipment, net
The following is a summary of property and equipment, net:
| | | | | | | |
|---|---|---|---|---|---|---|
| · March 31, 2024 · December 31, 2023 | ||||||
| Lab equipment | | $29,928 | | $29,597 | ||
| Leasehold improvements | | 61,136 | | 60,862 | ||
| Construction in progress | | — | | 124 | ||
| Computer software and equipment | | 2,899 | | 2,899 | ||
| Furniture and fixtures | | 1,061 | | 1,061 | ||
| Total | | | 95,024 | | | 94,543 |
| Less: Accumulated depreciation | | (26,019) | | (22,838) | ||
| Property and equipment, net | | $69,005 | | $71,705 | ||
Depreciation expense was $3,226 and $2,908 for the three months ended March 31, 2024 and 2023, respectively.
Note 6—Accrued expenses and other liabilities
The following is a summary of accrued expenses:
| | | | | | | |
|---|---|---|---|---|---|---|
| · March 31, 2024 · December 31, 2023 | ||||||
| Payroll and bonuses | | $2,868 | $6,496 | |||
| Accrued clinical trial related costs | | | 356 | | | 470 |
| Professional and legal fees | | 2,043 | | 1,642 | ||
| Operating lease liability, current | | | 2,215 | | | 1,513 |
| Other | | 50 | | 28 | ||
| Total accrued expenses and other liabilities | | $7,532 | | $10,149 | ||
Note 7—Long-term debt
On September 14, 2020, the Company entered into a $10,000 Term Loan Agreement (as amended, the “Loan Agreement”) with Hercules Capital, Inc. (“Hercules”). Pursuant to the terms of the Loan Agreement, the Company borrowed $10,000 (the “Tranche 1 Advance”) from the lenders at closing. The Company granted Hercules a lien on substantially all of the Company’s assets, excluding intellectual property.
On May 1, 2023, the Company prepaid the Loan Agreement in full. The total amount paid to Hercules in connection with the prepayment was$10,617, which included all outstanding principal, accrued and unpaid interest and end of term and prepayment charges (“the Payoff Amount”). The Payoff Amount included a prepayment charge of$100 (equal to 1.0% of the outstanding principal), and an end of term fee of $395, which is being recognized as interest expense and accreted over the term of the Loan Agreement using the effective interest method. Upon receipt by Hercules of the Payoff Amount on May 1, 2023, all obligations, covenants, debts and liabilities of the Company under the Loan Agreement were satisfied and discharged in full, and the Loan Agreement was terminated.
The Company issued to Hercules warrants to purchase up to an aggregate of 16,112 shares of common stock. The warrants are exercisable for a period often years from the date of the issuance of each warrant at a per share exercise price equal to $13.96, subject to certain adjustments as specified in the warrants. The fair value of the warrants at issuance was $46. The Company accounted for the warrants as equity, and the fair value is recorded in additional paid-in capital. The warrant value is also recorded as a debt discount and classified as a contra-liability on the consolidated balance sheet and amortized to interest expense.
Interest expense attributable to the Loan Agreement is as follows:
| · · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| · · · · · · · | ||||||
| | | | For the Three Months Ended | | For the Three Months Ended | |
| · · March 31, 2024 · March 31, 2023 · | ||||||
| Interest expense | | | $— | | $348 | |
| Amortization of debt issuance costs, including end of term fee accretion | | | — | | 56 | |
| | | | $— | | $404 | |
Note 8 – Bristol-Myers Squibb Collaboration
On January 7, 2022, the Company entered into the Collaboration Agreement with Bristol-Myers Squibb to collaborate on the research, development and commercialization of iNK and iT cell programs for hematologic malignancies and solid tumors (“Collaboration Program,” and each product candidate a “Development Candidate”). The Collaboration Agreement is within the scope of ASC 808, Collaborative Arrangements as both parties are active participants in the arrangement and are exposed to significant risks and rewards. While this arrangement is in the scope of ASC 808, the Company analogizes to ASC 606 for the accounting for the Collaboration Agreement, including for the delivery of goods and services (i.e., units of account). Revenue recognized by analogizing to ASC 606 is recorded as collaboration revenue in the statements of operations.
Pursuant to the Collaboration Agreement, the Company and Bristol-Myers Squibb will initially collaborate ontwo Collaboration Programs focused on acute myeloid leukemia (“AML”) and multiple myeloma (“MM”), and Bristol-Myers Squibb has the option to add up totwo additional Collaboration Programs for an additional fee. The Company is responsible for generating Development Candidates for each Collaboration Program, and Bristol-Myers Squibb has the option to elect to exclusively license the Development Candidates for pre-clinical development, clinical development and commercialization on a worldwide basis (“License Option”). Following Bristol-Myers Squibb’s exercise of the License Option, the Company will be responsible for performing IND-enabling studies, supporting Bristol-Myers Squibb’s preparation and submission of an IND, and manufacturing of clinical supplies until completion of a proof of concept clinical trial. Bristol-Myers Squibb will be responsible for all regulatory, clinical, manufacturing (after the proof of concept clinical trial) and commercialization activities for such Development Candidates worldwide. The Company has the option to co-promote Development Candidates generated from certain specified Collaboration Programs.
Under the terms of the Collaboration Agreement, Bristol-Myers Squibb made a non-refundable, upfront cash payment of $100,000 and will pay an exercise fee upon the exercise of the License Option (“Licensed Program” and product candidates developed under a Licensed Program, “Licensed Products”). For each Licensed Program, Bristol-Myers Squibb will pay up to $235,000 in milestone payments upon the first achievement of certain development and regulatory milestones and will pay up to $500,000 per Licensed Product in net sales-based milestone payments. Bristol-Myers Squibb will also pay the Company tiered royalties per Licensed Product as a percentage of net sales in the high-single digits to low-teens, subject to reduction for biosimilar competition, compulsory licensing and certain third party license costs. If Century exercises its co-promote option, such royalty percentage will be increased to low-teens to high-teens in respect of the sales of the co-promoted Licensed Products in the United States. The royalty term shall terminate on a Licensed Product-by-Licensed Product and country-by-country basis on the latest of (i) the 12-year anniversary of the first commercial sale of such Licensed Product in such country, (ii) the expiration of any regulatory exclusivity period that covers such Licensed Product in such country, and (iii) the expiration of the last-to-expire licensed patent of the Company or a jointly owned patent that covers such the Licensed Product in such country. After expiration of the applicable royalty term for a Licensed Product in a country, all licenses granted by the Company to Bristol-Myers Squibb for such Licensed Product in such country will be fully paid-up, royalty-free, perpetual and irrevocable.
In connection with the Collaboration Agreement, Bristol-Myers Squibb purchased 2,160,760 shares of the Company’s common stock at a price per share of $23.14, for an aggregate purchase price of $50,000. In determining the fair value of the common stock issued to Bristol-Myers Squibb, the Company considered the closing price of the common stock on the date of the transaction and included a lack of marketability discount because the shares are subject to certain restrictions. The Company determined the common stock purchase represented a premium of$7.82 per share, or $23,187 in the aggregate (“Equity Premium”), and the remaining $26,813 was recorded as issuance of common stock in stockholders’ equity.
The Company identified the following commitments under the arrangement: (i) research and development services (“R&D Services”) under each of thetwo initial Collaboration Programs and (ii) Bristol-Myers Squibb’s License Option to elect to exclusively license the Development Candidates for each of thetwo initial Collaboration Programs. The Company determined that these four commitments represent distinct
performance obligations for purposes of recognizing revenue and will recognize revenue as the Company fulfills each performance obligation.
The Company determined that the upfront payment and Equity Premium constitute the transaction price at the inception of the Collaboration Agreement. The future potential development and regulatory milestone payments were fully constrained at contract inception as the risk of significant revenue reversal related to these amounts has not yet been resolved. The achievement of the future potential milestones is not within the Company’s control and is subject to certain research and development success and therefore carries significant uncertainty. The Company will reevaluate the likelihood of achieving these milestones at the end of each reporting period and adjust the transaction price in the period the risk is resolved. In addition, the Company will recognize any consideration related to sales-based milestones and royalties when the subsequent sales occur.
The total transaction price of $123,187 was allocated to the performance obligations based on their estimated standalone selling price on January 7, 2022. The stand-alone selling price of the research and development services was estimated using the expected cost-plus margin approach, and the stand-alone selling price of the License Options was based on a discounted cash flow approach and considered several factors including, but not limited to, discount rate, development timeline, regulatory risks, estimated market demand, and future revenue potential using an adjusted market approach. The allocated transaction price is recognized as revenue in one of two ways:
| ● | Research and development services: The Company recognizes the portion of the transaction price allocated to each of the research and development performance obligations as the research and development services are provided, using an inputs method, in proportion to costs incurred to date for each research development target as compared to total costs incurred and expected to be incurred in the future to satisfy the underlying obligation related to each research and development target. The transfer of control occurs over this period and, in management’s judgment, is the best measure of progress towards satisfying the performance obligation. |
| ● | License option rights: The transaction price allocated to the license options rights, which are considered material rights to license and commercialize the underlying research and development target, are deferred until the period that Bristol-Myers Squibb elects to exercise or elects to not exercise its option or when the option to exercise expires. |
The following table summarizes the allocation of the total transaction price to the identified performance obligations under the arrangement, and the amount of the transaction price unsatisfied as of March 31, 2024:
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · · · · Cumulative collaboration · · Deferred | |||||||||
| Performance obligations: · · Transaction price · · revenue recognized · · collaboration revenue | |||||||||
| Option rights | | $109,164 | | $ | - | | $109,164 | ||
| Research and development services | | | 14,023 | | | (8,289) | | | 5,734 |
| Total | | | 123,187 | | | (8,289) | | | 114,898 |
| Less current portion of deferred revenue | | | - | | | - | | | (4,610) |
| Total long-term deferred revenue | | $123,187 | | $(8,289) | | $110,288 | |||
The following table summarizes the allocation of the total transaction price to the identified performance obligations under the arrangement, and the amount of the transaction price unsatisfied as of December 31, 2023:
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| · · · · · Cumulative collaboration · · Deferred | |||||||||
| Performance obligations: · · Transaction price · · revenue recognized · · collaboration revenue | |||||||||
| Option rights | | $109,164 | | $ | - | | $109,164 | ||
| Research and development services | | | 14,023 | | | (7,434) | | | 6,589 |
| Total | | | 123,187 | | | (7,434) | | | 115,753 |
| Less current portion of deferred revenue | | | - | | | - | | | (4,372) |
| Total long-term deferred revenue | | $123,187 | | $(7,434) | | $111,381 | |||
Note 9—Commitments and contingencies
From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when future expenditures are probable and such expenditures can be reasonably estimated.
Distributed Bio Master Service Agreement
On July 24, 2019, the Company entered into a Master Service Agreement with Distributed Bio, Inc (“DBio”), whereby DBio will screen for protein binders that bind to specific therapeutic targets (the “Master Service Agreement”). The Company pays for such services according to a payment schedule, and if the Company brings the protein binders into the clinic for further development, DBio will receive milestone payments of up to $16,100 in total for each product as the products move through the clinical development and regulatory approval processes. No milestone payments were due since the inception of the agreement.
The Company had $58 within accounts payable as of March 31, 2024 and $106 as of December 31, 2023, in its consolidated balance sheets related to the Master Service Agreement.
iCELL Inc. Sublicense Agreement
In March 2020, the Company entered into a Sublicense Agreement with iCELL Inc (“iCELL”) whereby iCELL granted the Company a license of certain patents and technology. The Company will pay iCELL royalties in the low single digits on net sales of the licensed product. In addition to the earned royalties, the Company will pay sales milestones, not to exceed $70,000, for the sales of the licensed product. iCELL is also eligible to receive payments of up to $4,250 in development and regulatory approval milestone payments. No milestones or royalties were due in 2024 or 2023.
Note 10—Leases
The Company has commitments under operating leases for certain facilities used in its operations. The Company maintains security deposits on certain leases in the amounts of $410 and $1,260 within security deposits and non-current assets in its consolidated balance sheets at March 31, 2024 and December 31, 2023, respectively. The Company’s leases have initial lease terms ranging from 5 to 16 years. Certain lease agreements contain provisions for future rent increases.
The following table reflects the components of lease expense:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · For the · · For the · | |||||||
| · · Three Months Ended · · Three Months Ended · | |||||||
| · · March 31, 2024 · · March 31, 2023 · | |||||||
| Operating lease expense: · · · · · | |||||||
| Fixed lease cost | | $1,085 | | $1,395 | | ||
| Variable lease cost | | 450 | | 125 | | ||
| Short term lease expense | | | — | | | 594 | |
| Total operating lease expense | | $1,535 | | $2,114 | | ||
The following table reflects supplemental balance sheet information related to leases:
| · · · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| | | | As of | | As of | |
| · · March 31, · December 31, · | ||||||
| · · Location in Balance Sheet · · 2024 · · 2023 · | ||||||
| · · · · · · · · · | ||||||
| Operating lease right-of-use asset, net | Operating lease right-of-use assets | | $19,314 | | $20,376 | |
| Operating lease liability, current | Accrued expenses and other liabilities | | $2,215 | | $1,513 | |
| Operating lease liability, long-term | Operating lease liability, long-term | | 44,251 | | 46,658 | |
| Total operating lease liability | | $46,466 | | $48,171 | | |
The following table reflects supplement lease term and discount rate information related to leases:
| · · · · · | ||
|---|---|---|
| | As of March 31, 2024 | As of December 31, 2023 |
| Weighted-average remaining lease terms - operating leases · 7.3 years · · 7.6 years · | ||
| Weighted-average discount rate - operating leases | 9.9% | 9.9% |
The following table reflects supplemental cash flow information related to leases as of the periods indicated:
| · · · · · · · | |||||
|---|---|---|---|---|---|
| | | For the Three Months Ended | | For the Three Months Ended | |
| · March 31, 2024 · March 31, 2023 · | |||||
| Cash paid for amounts included in the measurement of lease liabilities · · · | |||||
| Operating cash flows from operating leases | | $(2,186) | | $(31) | |
| Right-of-use assets obtained in exchange for lease obligations: | | $— | | $— | |
The following table reflects future minimum lease payments under noncancelable leases as of March 31, 2024:
| | | | |
|---|---|---|---|
| · Operating Leases | |||
| 2024 | | $5,900 | |
| 2025 | | 8,421 | |
| 2026 | | 7,931 | |
| 2027 | | 8,125 | |
| 2028 | | 8,325 | |
| Thereafter | | 43,163 | |
| Total lease payments | | 81,865 | |
| Less: Imputed interest | | (27,423) | |
| Less: Tenant incentive receivable | | | (7,976) |
| Total | | $46,466 | |
Note 11—Income taxes
During the three months ended March 31, 2024, the Company recordedno income tax benefits for the net operating losses incurred or for the research and development tax credits generated in the U.S. due to its uncertainty of realizing a benefit from those items. During the three months ended March 31, 2023, the Company recorded a tax provision of$1.2 million, due primarily to revenue recognition for tax purposes from the Company's Research Collaboration and Collaboration Agreement entered into with Bristol-Myers Squibb Company in 2022.
Note 12—Basic and diluted net loss per common share
The Company’s potentially dilutive securities, which include RSUs (“Restricted Stock Units”), restricted stock, warrants, early exercised stock options and stock options to purchase shares of the Company’s common stock, have been excluded from the computation of dilutive net loss per share as the effect would be antidilutive. Therefore, the weighted-average number of shares of common stock outstanding used to calculate both basic and diluted net loss per share is the same. The Company excluded the following potential shares of common stock presented based on amounts outstanding at each stated period end, from the computation of diluted net loss per share for the three months ended March 31, 2024 and 2023 because including them would have had an anti-dilutive effect.
| | | | | | |
|---|---|---|---|---|---|
| | | Three Months Ended | | Three Months Ended | |
| | | March 31, | | March 31, | |
| · 2024 · 2023 · | |||||
| Stock options to purchase common stock | | 4,739,854 | 10,370,402 | | |
| Early exercised stock options subject to future vesting | | 84,380 | 385,655 | | |
| Restricted stock awards subject to future vesting | | 24,731 | 49,465 | | |
| Unvested restricted stock units | 3,941,432 | 544,650 | | ||
| Warrants | | 32,009 | | 32,009 | |
| Total | 8,822,406 | 11,382,181 | | ||
Note 13—Stock-based compensation
On June 17, 2021, the Company adopted the Century Therapeutics, Inc. 2021 Equity Incentive Plan (the “2021 Incentive Plan”) which superseded the 2018 Incentive Plan and from that date forward all issuances of incentive awards will be governed by the 2021 Incentive Plan.
The 2021 Incentive Plan provides for the Company to sell or issue common stock or restricted common stock, RSUs, or to grant incentive stock options or nonqualified stock options for the purchase of common stock, to employees, members of the Board of Directors, and consultants of the Company under terms and provisions established by the Board of Directors. Under the terms of the 2021 Incentive Plan, options may be granted at an exercise price not less than fair market value.
Upon adoption of the 2021 Incentive Plan, the Company was authorized to issue 5,481,735 shares of Common Stock under the 2021 Incentive Plan (which represents 5,640,711 shares of Common Stock initially available for grant under the 2021 Incentive Plan less 158,976 shares of Common Stock reserved for issuance upon the exercise of previously granted stock options that remain outstanding under the 2018 Incentive Plan). The number of shares of common stock initially reserved for issuance under the 2021 Incentive Plan shall be increased, upon approval by the Board of Directors, on January 1, 2022 and each January 1 thereafter, in an amount equal to the least of, (i) five percent (5%) of the outstanding common stock on the immediately preceding December 31, or (ii) such number of common stock determined by the Board of Directors no later than the immediately preceding December 31. For 2023, the 2021 Incentive Plan reserved shares were increased under clause (i) by 2,954,788 shares, effective as of January 1, 2023. For 2024, the 2021 Incentive Plan reserved shares were increased under clause (i) by 3,025,220 shares, effective as of January 1, 2024. As of March 31, 2024, there were 4,905,295 shares available for issuance under the 2021 Incentive Plan.
The Company’s stock-based awards are subject to service-based vesting conditions. Compensation expense related to awards to employees and directors with service-based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term. Stock awards granted typically vest over afour-year period but may be granted with different vesting terms. The Company may also issue awards with performance-based vesting conditions. For performance-based awards, the Company would reassess at each reporting date whether achievement of the performance condition is probable and accrue compensation expense if and when the achievement of the performance condition is probable. During the quarter ended June 30, 2023, the Company issued performance based RSUs that represent a contingent right to receiveone share of the Company’s common stock. The RSUs shall vest 50% on November 1, 2023, with the remaining 50% vesting upon the earlier of: (i) November 1, 2024; and (ii) satisfaction of certain performance criteria. The Company is currently recording expense for these RSUs on the straight-line basis.
The Company recognizes the costs of the stock-based payments as the employees vest in the awards.
As of March 31, 2024, the Company had reserved shares of common stock for issuance as follows:
| | | |
|---|---|---|
| · Shares | ||
| Options and RSUs issued and outstanding | | 8,681,286 |
| Shares available for future stock option and RSU grants | | 4,905,295 |
| Shares available for employee stock purchase plan | | 954,522 |
| Total | | 14,541,103 |
The shares of Common Stock available under the 2021 Incentive Plan as of March 31, 2024 are as follows:
| | | |
|---|---|---|
| · Shares | ||
| Balance December 31, 2023 | | 3,128,244 |
| Shares reserved for issuance | | 2,954,788 |
| Options granted | | (1,433,838) |
| RSU’s granted | | (350,379) |
| Options and RSUs forfeited / cancelled | | 606,480 |
| Balance March 31, 2024 | | 4,905,295 |
Stock Options
The following table summarizes stock option activity for the three month period ended March 31, 2024:
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| · · · · Weighted Average · · · | ||||||||||
| | | | | | | | Remaining | | | Aggregate |
| | | | | | | | Contractual | | | Intrinsic |
| | | | | | | | Term | | | Value |
| · Shares · Exercise Price · (years) · · · (in thousands) | ||||||||||
| Outstanding January 1, 2024 | 3,938,006 | | $7.11 | 5.66 | | $2,923 | ||||
| Granted | 1,433,838 | | 5.29 | — | | — | ||||
| Exercised | (155,928) | | 1.25 | — | | — | ||||
| Forfeited | (380,899) | | 6.46 | — | | — | ||||
| Cancelled | | (95,163) | | | 12.76 | | — | | | — |
| Outstanding, March 31, 2024 | 4,739,854 | | $5.60 | 4.53 | | $6,066 | ||||
| Exercisable at March 31, 2024 | | 4,441,321 | | $7.07 | | 5.52 | | $3,619 | ||
The weighted average grant date fair value of awards for options granted during the three months ended March 31, 2024 was $3.73. As of March 31, 2024, there was $18,525 of total unrecognized compensation expense related to unvested stock options with time-based vesting terms, which is expected to be recognized over a weighted average period of 3.02 years. The aggregate intrinsic value of options vested and exercisable as of March 31, 2024 and 2023 is calculated based on the difference between the exercise price and the fair value of our common stock. The intrinsic value of options exercised in 2024 and 2023 was$3,619 and $3,262, respectively.
The Company estimates the fair value of its option awards to employees and directors using Black-Scholes, which requires inputs and subjective assumptions, including (i) the expected stock price volatility, (ii) the calculation of the expected term of the award, (iii) the risk-free interest rate and (iv)expected dividends. Due to the lack of substantial company-specific historical and implied volatility data of its common stock, the Company has based its estimate of expected volatility on the historical volatility of a group of similar public companies. Starting in June of 2023 the Company had sufficient historical information regarding stock trading history, and started to use the Company’s own stock volatility. The Company has never paid dividends and does not expect to in the foreseeable future. The expected term of the options granted to employees is derived from the “simplified” method as described in Staff Accounting Bulletin 107 relating to stock-based compensation. The risk-free interest rates for periods within expected term of the option are based on the U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The Company will account for actual forfeitures as they occur.
The weighted-average assumptions used to calculate the fair value of stock options granted are as follows:
| · · · · · | ||||
|---|---|---|---|---|
| | | March 31, 2024 | | December 31, 2023 |
| Expected dividend rate | | — | — | |
| Expected option term (years) | | 6.08 | 6.04 | |
| Expected volatility | | 77.86% | 77.87% | |
| Risk-free interest rate | | 4.38% | 3.68% | |
Stock-based compensation expense recorded under ASC 718 related to stock options granted and common stock issued under the 2021 Employee Stock Purchase Plan (the “ESPP”) were allocated to research and development and general and administrative expense as follows:
| | | | | | |
|---|---|---|---|---|---|
| · Three Months Ended · · Three Months Ended | |||||
| · March 31, · · March 31, | |||||
| · 2024 · · 2023 | |||||
| Research and development | $1,748 | | $2,112 | ||
| General and administrative | | 1,459 | | | 1,685 |
| Total stock-based compensation | $3,207 | | $3,797 | ||
Stock-based compensation expense by award type included within the condensed consolidated statements of operations is as follows:
| | | | | | |
|---|---|---|---|---|---|
| · Three Months Ended · · Three Months Ended | |||||
| · March 31, · · March 31, | |||||
| · 2024 · · 2023 | |||||
| Stock options | $2,091 | | $3,546 | ||
| Restricted stock units | | 1,014 | | | 97 |
| Restricted stock awards | | 45 | | | 93 |
| Employee stock purchase plan | | 57 | | | 61 |
| Total stock-based compensation | $3,207 | | $3,797 | ||
Restricted Stock Units
The following table summarizes RSU activity for the three months ended March 31, 2024:
| | | | | | |
|---|---|---|---|---|---|
| · · Weighted Average | |||||
| · · Shares · · Grant Date Fair Value | |||||
| Total Unvested December 31, 2023 | 3,721,471 | | $2.69 | ||
| Granted | | 350,379 | | | 5.31 |
| Forfeited | | (130,418) | | | 3.65 |
| Total Unvested March 31, 2024 | 3,941,432 | | $2.84 | ||
As of March 31, 2024, there was $6,774 of total unrecognized compensation expense related to the unvested restricted stock with time-based vesting terms, which is expected to be recognized over a weighted average period of 2.84 years.
Restricted Stock Awards
The following table summarizes restricted stock activity as of March 31, 2024 and December 31, 2023:
| | | | | | |
|---|---|---|---|---|---|
| · · Weighted Average | |||||
| · · Shares · · Grant Date Fair Value | |||||
| Total Unvested December 31, 2023 | 49,416 | | $7.27 | ||
| Granted | | — | | | — |
| Forfeited | | — | | | — |
| Vested | (24,685) | | 7.27 | ||
| Total Unvested March 31, 2024 | 24,731 | | $7.27 | ||
As of March 31, 2024, there was $311 of total unrecognized compensation expense related to the unvested restricted stock with time-based vesting terms, which is expected to be recognized over a weighted average period of 0.98 years. All restricted stock vests over afour-year period.
Early-Exercise of Unvested Equity Awards
Certain equity award holders early exercised unvested equity awards. The cash received upon early exercise of options of $491 was recorded as a deposit liability on the Company’s balance sheet as of March 31, 2024.
Employee Stock Purchase Plan
The Employee Stock Purchase Plan (“ESPP”) was adopted by the Board of Directors in May 2021. A total of 564,071 shares of common stock were initially reserved for issuance under this plan, which shall be increased, upon approval by the Board of Directors, on January 1, 2022 and each January 1 thereafter, to the lesser of (i) one percent (1%) of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (ii) an amount determined by the Board of Directors no later than the last day of the immediately preceding fiscal year. For 2022, the ESPP reserved shares were increased under clause (i) by 550,055 shares, effective as of January 1, 2022. For 2023 and 2024, the board waived the annual increase to the shares reserved under the ESPP. As of March 31, 2024, there were 954,522 shares available for issuance, under the ESPP.
Note 14—Related party transactions
License Agreements and Collaborative Agreements with Shareholder
The Company owns licenses and other contracts with FUJIFILM Cellular Dynamics, Inc. (“FCDI”). FCDI is a shareholder of Century. The acquired licenses and other contracts with FCDI are as follows:
FCDI Agreements
The Company owns a non-exclusive license agreement with FCDI. The license provides the Company with certain patents and know-how related to the reprogramming of human somatic cells to induce pluripotent stem cells (“iPSCs”) (“Reprogramming License Agreement”). Under this agreement, the Company is required to make certain developmental and regulatory milestone payments as well as royalty payments upon commercialization. Royalties are in the low single digits on the sale of all licensed products.
The Company also owns an exclusive license agreement with FCDI (“Differentiation Licenses Agreement”). The Differentiation Licenses Agreement provides the Company with patents and know-how related to human iPSC exclusively manufactured by FCDI.
In October 2019, the Company entered into the Master Collaboration Agreement with FCDI (“Collaboration Agreement”), whereby FCDI provides certain services to the Company to develop and manufacture iPSCs and immune cells derived therefrom. FCDI provides services in accordance with the approved research plan and related research budget. The initial research plan covered the period from October 2019 through March 31, 2022. In July, 2022 the Company amended the Collaboration Agreement to extend the term through September 30, 2025, and in September 2023, the Company amended the Collaboration Agreement in connection with the Autoimmune License (as defined below).
In March, 2021, the Company entered into a Manufacturing Agreement with FCDI, (“Manufacturing Agreement”), pursuant to which FCDI will provide certain agreed upon technology transfer, process development, analytical testing and cGMP manufacturing services to the Company.
In January, 2022, the Company and FCDI entered into a letter agreement (the “Letter Agreement”), which amended the Reprogramming License Agreement, Differentiation License Agreement and Manufacturing Agreement (the “FCDI Agreements”) pursuant to the Company’s Research Collaboration and License Agreement with Bristol-Myers Squibb. Pursuant to the Letter Agreement, and in consideration for amending
the FCDI Agreements, the Company paid to FCDI an upfront payment of$10,000, and will pay FCDI (i) a percentage of any milestone payments received by the Company under the FCDI Collaboration Agreement in respect of achievement of development or regulatory milestones specific to Japan, and (ii) a percentage of all royalties received by the Company under the FCDI Collaboration Agreement in respect of sales of products in Japan.
In September, 2023 the Company and FCDI entered into a worldwide license agreement whereby FCDI will grant non-exclusive licenses to the Company for certain patent rights and know-how related to cell differentiation and reprogramming for the development and commercialization of iPSC-derived therapies for the treatment of inflammatory and autoimmune diseases (the “Autoimmune License”). In addition, the Company and FCDI entered into an amendment to each of the Reprogramming License and the Differentiation License to expand the licenses related to the development and commercialization of iPSC-derived cancer immunotherapeutic to also include inflammatory and autoimmune diseases. Under the terms of these agreements, FCDI will be eligible to receive certain development and regulatory milestone payments as well as low single-digit royalties related to products developed in connection with such agreements.
During the three months ended March 31, 2024 and 2023, the Company made payments of $2,707 and $12 and incurred research and development expenses of $2,666 and $32, and legal fees of $35 and $33, in each case related to these agreements, and recorded within general and administrative expenses in its consolidated statements of operations and comprehensive loss, respectively.
Bayer Option Agreement
Bayer Health, LLC (“Bayer”) has the right of first refusal to acquire certain products researched and developed by the Company. Subject to certain exceptions, Bayer’s right of first refusal is exercisable with respect to up to four products and may only exercise these option rights in a non-sequential and alternating manner, and such rights are subject to additional limitations.
Note 15 – Common Stock
The Company has a Sales Agreement (“Sales Agreement”), with Cowen and Company, LLC, or (“Cowen”) to provide for the offering, issuance and sale of up to an aggregate amount of $150,000 of common stock from time to time in “at-the-market” offerings (the “ATM Program”) pursuant to its shelf registration statement on Form S-3 (File No. 333-265975) and subject to the limitations thereof. During the three months ended March 31, 2024, the Company sold 4,084,502 shares pursuant to the ATM Program for net proceeds of $17,829, after deducting commissions of $551. Subsequent to March 31, 2024 through the date of the filing of these financial statements, the Company did not have any sales in the ATM Program.
Note 16—Subsequent Events
Private Placement Offering
In April, 2024, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain institutional accredited investors (the “Investors”), pursuant to which the Company agreed to issue and sell to the Investors in a private placement an aggregate of 15,873,011 shares of the Company’s common stock (the “Private Placement Shares”), at a price of$3.78 per share (the “Private Placement”).
The Private Placement closed on April 15, 2024. The Company received aggregate net proceeds from the Private Placement of approximately$56,700, after deducting placement agent fees and offering expenses. The Company intends to use the net proceeds from the private placement to support the expansion of CNTY-101 in autoimmune indications and for working capital and general corporate purposes.
Clade Therapeutics, Inc. Acquisition
In April 2024, the Company acquired Clade, a privately-held biotechnology company focused on discovering and delivering engineerable, off-the-shelf, scalable, and consistent stem cell-based medicines, with a focus on iPSC-derived αβ T cells. The aggregate upfront consideration consists of (i) approximately$15,000 in cash and (ii)4,535,333 shares of the Company’s common stock, par value$0.0001 per share. The cash portion of the upfront consideration is subject to customary adjustments for indebtedness, cash, and transaction expenses.
Following the closing, one potential clinical development milestone payment of$10,000 (which may be paid by the Company in cash, shares of its common stock or a combination thereof) will be made to Clade securityholders upon the achievement of the milestone.
In connection with the closing, the Company entered into customary lock-up agreements with certain of Clade’s stockholders providing that such holders will not transfer, subject to limited exceptions, any of the shares of the Company’s common stock received for 180 days after the closing.
The Company is currently in process of completing its accounting analysis of the acquisition, including assessing whether or not the acquisition qualifies as either an asset acquisition or a business combination for US GAAP reporting purposes.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.