Zentalis Pharmaceuticals Inc
For the period ended Dec 31, 2023. Filed Feb 27, 2024.
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FY2023 · Filed Feb 27, 2024
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Item 16. Form 10-K Summary
None.
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| ZENTALIS PHARMACEUTICALS, INC. | ||
| Date: February 27, 2024 | By: | /s/ Kimberly Blackwell, M.D. |
|---|---|---|
| Kimberly Blackwell, M.D. | ||
| Chief Executive Officer | ||
Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the Registrant in the capacities and on the dates indicated.
| Name | Title | Date |
|---|---|---|
| /s/ Kimberly Blackwell, M.D. | Chief Executive Officer and Director(principal executive officer) | February 27, 2024 |
| Kimberly Blackwell, M.D. | ||
| /s/ Melissa B. Epperly | Chief Financial Officer(principal financial and accounting officer) | February 27, 2024 |
| Melissa B. Epperly | ||
| /s/ David M. Johnson | Chairperson | February 27, 2024 |
| David M. Johnson | ||
| /s/ Cam S. Gallagher | President and Director | February 27, 2024 |
| Cam S. Gallagher | ||
| /s/ Enoch Kariuki | Director | February 27, 2024 |
| Enoch Kariuki | ||
| /s/ Jan Skvarka | Director | February 27, 2024 |
| Jan Skvarka | ||
| /s/ Karan S. Takhar | Director | February 27, 2024 |
| Karan S. Takhar | ||
Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of Zentalis Pharmaceuticals, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Zentalis Pharmaceuticals, Inc. (the Company) as of December 31, 2023 and 2022, the related consolidated statements of operations, comprehensive loss, changes in stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2023, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023, in conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated February 27, 2024 expressed an unqualified opinion thereon.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
| Accrued clinical trial expenses | |
| Description of the Matter | During 2023, the Company incurred $189.6 million for research and development expenses, and as of December 31, 2023, the Company accrued $36.3 million for research and development expenses, which includes clinical trial expenses and accruals. As described in Note 2 of the financial statements, the Company records accruals for estimated costs of research and development activities that include costs for clinical trials. The Company records costs based on estimates and/or representations from contract research organizations (“CROs”) and other vendors regarding work performed, level of patient enrollment, completion of patient studies and progress of the clinical trials. The Company monitors patient enrollment levels and related activities through internal reviews, correspondence with CROs and reviews of contractual terms. Auditing management's accounting for accrued clinical trial expenses was especially challenging as the evaluation is dependent upon a high volume of data received from third-party service providers and internal clinical personnel, which is tracked in spreadsheets. The accrued amounts are determined based on an evaluation of the unique terms and conditions set forth in each respective agreement. |
|---|---|
| How We Addressed the Matter in Our Audit | We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over management’s accounting for accrued clinical trial expenses.To test the adequacy of the Company’s accrued clinical trial expenses, our substantive audit procedures included, among others, testing the accuracy of data and assumptions used in management's clinical trial accrual models by inspecting invoices paid to date, agreeing terms and conditions to a sample of contracts and performing inquiries with clinical staff to corroborate progress and level of expended effort incurred by the Company's CROs and other third-party vendors. We further obtained the clinical trial agreements for a sample of active clinical sites and compared the costs and number of patient visits to the Company’s clinical trial accrual models. We also tested a sample of expenses against the related invoices and contracts and examined a sample of subsequent payments to evaluate the completeness of the accrued clinical trial expenses. |
/s/Ernst & Young LLP
We have served as the Company’s auditor since 2019.
San Diego, California
February 27, 2024
Consolidated Balance Sheets
(In thousands, except share amounts and par value)
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| ASSETS | ||
| Current assets | ||
| Cash and cash equivalents | $28,038 | $43,069 |
| Marketable securities, available for sale | 454,881 | 394,302 |
| Prepaid expenses and other current assets | 13,799 | 14,562 |
| Total current assets | 496,718 | 451,933 |
| Property and equipment, net | 5,819 | 7,705 |
| Operating lease right-of-use assets | 35,916 | 42,373 |
| Prepaid expenses and other assets | 6,818 | 9,723 |
| Goodwill | 3,736 | 3,736 |
| Investment in Zentera Therapeutics | — | 21,213 |
| Restricted cash | 2,681 | 2,627 |
| Total assets | $551,688 | $539,310 |
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||
| Current liabilities | ||
| Accounts payable | $14,926 | $11,247 |
| Accrued expenses | 54,441 | 45,400 |
| Total current liabilities | 69,367 | 56,647 |
| Deferred tax liability | — | 853 |
| Long-term lease liability | 43,150 | 45,166 |
| Other long-term liabilities | 1,780 | 2,620 |
| Total liabilities | 114,297 | 105,286 |
| Commitments and contingencies (see Note 10) | ||
| EQUITY | ||
| Preferred stock, $0.001 par value; 10,000,000 shares authorized, no shares issued and outstanding at December 31, 2023 and 2022 | — | — |
| Common stock, $0.001 par value; 250,000,000 shares authorized; 70,765,554 and 59,280,247 shares issued and outstanding at December 31, 2023 and 2022, respectively | 70 | 59 |
| Additional paid-in capital | 1,323,576 | 1,031,462 |
| Accumulated other comprehensive income/(loss) | 2,194 | (1,353) |
| Accumulated deficit | (888,556) | (596,365) |
| Total stockholders' equity | 437,284 | 433,803 |
| Noncontrolling interests | 107 | 221 |
| Total equity | 437,391 | 434,024 |
| Total liabilities and stockholders' equity | $551,688 | $539,310 |
Consolidated Statements of Operations
(In thousands, except per share amounts)
| Year endedDecember 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Operating Expenses | |||
| Research and development | $189,590 | $172,734 | $175,601 |
| Zentera in-process research and development | 45,568 | — | — |
| General and administrative | 64,351 | 54,553 | 40,941 |
| Total operating expenses | 299,509 | 227,287 | 216,542 |
| Loss from operations | (299,509) | (227,287) | (216,542) |
| Other Income (Expense) | |||
| Investment and other income, net | 22,617 | 5,987 | 401 |
| Gain on deconsolidation of Zentera | — | — | 51,582 |
| Net loss before income taxes | (276,892) | (221,300) | (164,559) |
| Income tax benefit | (601) | (469) | (297) |
| Loss on equity method investment | 16,014 | 16,282 | 1,831 |
| Net loss | (292,305) | (237,113) | (166,093) |
| Net loss attributable to noncontrolling interests | (114) | (307) | (7,368) |
| Net loss attributable to Zentalis | $(292,191) | $(236,806) | $(158,725) |
| Net loss per common share outstanding, basic and diluted | $(4.47) | $(4.48) | $(3.72) |
| Common shares used in computing net loss per share, basic and diluted | 65,409 | 52,857 | 42,688 |
Consolidated Statements of Comprehensive Loss
(In thousands)
| Year endedDecember 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Net loss | $(292,305) | $(237,113) | $(166,093) |
| Other comprehensive income (loss): | |||
| Unrealized gain (loss) on marketable securities, net | 3,547 | (1,228) | (161) |
| Total comprehensive loss | (288,758) | (238,341) | (166,254) |
| Comprehensive loss attributable to noncontrolling interests | (114) | (307) | (7,368) |
| Comprehensive loss attributable to Zentalis | $(288,644) | $(238,034) | $(158,886) |
Consolidated Statements of Stockholders' Equity
(In thousands, except per unit amounts)
| Year Ended December 31, 2021 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zentalis Stockholders | |||||||||||||
| Common · Additional Paid-In Capital · Accumulated Other Comprehensive Income · AccumulatedDeficit · NoncontrollingInterests · TotalEquity | |||||||||||||
| Shares · Amount | |||||||||||||
| Balance at December 31, 2020 | 41,040 | $41 | $509,339 | $36 | $(200,834) | $24,795 | $333,377 | ||||||
| Share-based compensation expense | — | — | 35,737 | — | — | — | 35,737 | ||||||
| Issuance of common stock in connection with an equity offering, net of underwriting discounts, commissions and offering costs | 3,691 | 4 | 171,969 | — | — | — | 171,973 | ||||||
| Issuance and withholding of common stock in connection with restricted stock unit vesting, net | 517 | — | (1,146) | — | — | — | (1,146) | ||||||
| Deconsolidation event | — | — | — | — | — | (16,899) | (16,899) | ||||||
| Issuance of common stock upon exercise of options | 232 | — | 7,149 | — | — | — | 7,149 | ||||||
| Issuance of common stock under employee stock purchase plan | 15 | — | 545 | — | — | — | 545 | ||||||
| Cancellation of restricted stock awards | (4) | — | — | — | — | — | — | ||||||
| Other comprehensive income (loss) | — | — | — | (161) | — | — | (161) | ||||||
| Net loss attributable to non-controlling interest | — | — | — | — | — | (7,368) | (7,368) | ||||||
| Net loss attributable to Zentalis | — | — | — | — | (158,725) | — | (158,725) | ||||||
| Balance at December 31, 2021 | 45,491 | $45 | $723,593 | $(125) | $(359,559) | $528 | $364,482 | ||||||
| Year Ended December 31, 2022 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zentalis Stockholders | |||||||||||||
| Common · Additional Paid-In Capital · Accumulated Other Comprehensive Income · AccumulatedDeficit · NoncontrollingInterests · TotalEquity | |||||||||||||
| Shares · Amount | |||||||||||||
| Balance at December 31, 2021 | 45,491 | $45 | $723,593 | $(125) | $(359,559) | $528 | $364,482 | ||||||
| Share-based compensation expense | — | — | 46,840 | — | — | — | 46,840 | ||||||
| Issuance of common stock in connection with an equity offering, net of underwriting discounts, commissions and offering costs | 13,495 | 13 | 257,909 | — | — | — | 257,922 | ||||||
| Issuance of common stock in connection with restricted stock unit vesting, net | 159 | 1 | — | — | — | — | 1 | ||||||
| Issuance of common stock upon exercise of options | 122 | — | 2,246 | — | — | — | 2,246 | ||||||
| Issuance of common stock under employee stock purchase plan | 30 | — | 874 | — | — | — | 874 | ||||||
| Cancellation of restricted stock awards | (17) | — | — | — | — | — | — | ||||||
| Other comprehensive income (loss) | — | — | — | (1,228) | — | — | (1,228) | ||||||
| Net loss attributable to non-controlling interest | — | — | — | — | — | (307) | (307) | ||||||
| Net loss attributable to Zentalis | — | — | — | — | (236,806) | — | (236,806) | ||||||
| Balance at December 31, 2022 | 59,280 | $59 | $1,031,462 | $(1,353) | $(596,365) | $221 | $434,024 | ||||||
| Year Ended December 31, 2023 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zentalis Stockholders | |||||||||||||
| Common · Additional Paid-In Capital · Accumulated Other Comprehensive Income · AccumulatedDeficit · NoncontrollingInterests · TotalEquity | |||||||||||||
| Shares · Amount | |||||||||||||
| Balance at December 31, 2022 | 59,280 | $59 | $1,031,462 | $(1,353) | $(596,365) | $221 | $434,024 | ||||||
| Share-based compensation expense | — | — | 54,822 | — | — | — | 54,822 | ||||||
| Other comprehensive income (loss) | — | — | — | 3,547 | — | — | 3,547 | ||||||
| Issuance of common stock in connection with an equity offering, net of underwriting discounts, commissions and offering costs | 11,033 | 11 | 235,669 | — | — | — | 235,680 | ||||||
| Issuance and withholding of common stock in connection with restricted stock unit vesting, net | 361 | — | — | — | — | — | — | ||||||
| Issuance of common stock upon exercise of options | 54 | — | 995 | — | — | — | 995 | ||||||
| Issuance of common stock under employee stock purchase plan | 42 | — | 628 | — | — | — | 628 | ||||||
| Cancellation of restricted stock awards | (3) | — | — | — | — | — | — | ||||||
| Net loss attributable to non-controlling interest | — | — | — | — | — | (114) | (114) | ||||||
| Net loss attributable to Zentalis | — | — | — | — | (292,191) | — | (292,191) | ||||||
| Balance at December 31, 2023 | 70,767 | $70 | $1,323,576 | $2,194 | $(888,556) | $107 | $437,391 | ||||||
Consolidated Statements of Cash Flows
(in thousands)
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Operating activities: | |||
| Net loss | $(292,305) | $(237,113) | $(166,093) |
| Adjustments to reconcile net loss to net cash used in operating activities: | |||
| Depreciation and amortization | 1,389 | 1,426 | 544 |
| Operating lease right-of-use asset and fixed asset impairment | 4,953 | — | — |
| IPR&D impairment | — | — | 8,800 |
| Recognized tax gain on IPR&D impairment | — | — | (2,462) |
| Gain on deconsolidation of Zentera, net of tax | — | — | (49,930) |
| Noncash consideration portion of Zentera in-process research and development | 15,045 | — | — |
| Share-based compensation | 54,822 | 46,840 | 35,737 |
| Loss on disposal of equipment | 406 | 56 | 15 |
| (Accretion of discounts)/amortization of premiums on marketable securities, net | (13,157) | (3,725) | 908 |
| Loss on equity method investment | 16,014 | 16,282 | 1,831 |
| Deferred income taxes | (853) | (769) | (48) |
| Changes in operating assets and liabilities: | |||
| Prepaid expenses and other assets | (5,678) | (6,605) | 1,294 |
| Accounts payable and accrued liabilities | 10,919 | 15,527 | 13,964 |
| Operating lease right-of-use assets and liabilities, net | 623 | 4,330 | 1,347 |
| Net cash used in operating activities | (207,822) | (163,751) | (154,093) |
| Investing activities: | |||
| Purchases of marketable securities | (549,182) | (533,161) | (363,508) |
| Proceeds from maturities of marketable securities | 505,307 | 421,529 | 365,820 |
| Deconsolidation of Zentera cash | — | — | (14,320) |
| Purchases of property and equipment | (583) | (2,548) | (6,107) |
| Net cash used in investing activities | (44,458) | (114,180) | (18,115) |
| Financing activities: | |||
| Proceeds from issuance of common stock under equity incentive plans | 1,623 | 3,121 | 7,694 |
| Net-settlement of restricted stock unit vesting | — | — | (1,146) |
| Proceeds from issuance of common stock, net | 235,680 | 257,922 | 171,973 |
| Net cash provided by financing activities | 237,303 | 261,043 | 178,521 |
| Net (decrease) increase in cash, cash equivalents and restricted cash | (14,977) | (16,888) | 6,313 |
| Cash, cash equivalents and restricted cash at beginning of year | 45,696 | 62,584 | 56,271 |
| Cash, cash equivalents and restricted cash at end of year | $30,719 | $45,696 | $62,584 |
| Supplemental disclosure of cash flow information: | |||
| Income taxes paid | $140 | $12 | $20 |
| Supplemental disclosure of non-cash investing and financing activities: | |||
| Right-of-use assets obtained in exchange for operating lease liabilities | $602 | $— | $44,613 |
| Accrued capital expenditures | $— | $— | $(1,510) |
The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the Consolidated Statements of Cash Flows for the periods presented:
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Cash and cash equivalents | $28,038 | $43,069 | $59,714 |
| Restricted cash, current | — | — | 243 |
| Restricted cash, non-current | 2,681 | 2,627 | 2,627 |
| Total cash, cash equivalents and restricted cash reported in the Consolidated Statement of Cash Flows | $30,719 | $45,696 | $62,584 |
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
- Organization and Business
Organization
Zentalis Pharmaceuticals, Inc. (“Zentalis,” “We” or the “Company”) is a clinical-stage biopharmaceutical company discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers. The Company’s lead product candidate, azenosertib (ZN-c3), is a potentially first-in-class and best-in-class WEE1 inhibitor for advanced solid tumors and hematologic malignancies. The Company is also developing a BCL-2 inhibitor, ZN-d5, in combination with azenosertib. The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. All of the Company’s tangible assets are held in the United States.
- Summary of Significant Accounting Policies
Basis of Presentation
The consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”) and include our wholly-owned subsidiaries and a variable interest entity (“VIE”) for the periods in which we determined we were the primary beneficiary. All intercompany transactions and balances have been eliminated in consolidation.
We evaluate our ownership, contractual and other interests in entities that are not wholly-owned to determine if these entities are VIEs, and, if so, whether we are the primary beneficiary of the VIE. In determining whether we are the primary beneficiary of a VIE and therefore required to consolidate the VIE, we apply a qualitative approach that determines whether we have both (1) the power to direct the activities of the VIE that most significantly impact the VIE’s economic performance and (2) the obligation to absorb losses of, or the rights to receive benefits from, the VIE that could potentially be significant to that VIE.
We will continuously assess whether we are the primary beneficiary of a VIE, as changes to existing relationships or future transactions may result in the consolidation or deconsolidation of such VIE. During the periods presented, we have not provided any other material financial or other support to our VIE that we were not contractually required to provide.
Noncontrolling Interests
Noncontrolling interests represent interests held by third parties in our consolidated subsidiaries. We reflect noncontrolling interest attributable to the other owners in a separate line in our consolidated statements of operations and a separate line within stockholders' equity in our consolidated balance sheets.
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 amounts reported in our consolidated financial statements and accompanying notes. On an ongoing basis, we evaluate our estimates and judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from management’s estimates.
Cash and Cash Equivalents
Cash equivalents are comprised of short-term, highly-liquid investments with maturities of 90 days or less at the date of purchase. As of December 31, 2023 and 2022, our cash equivalents consisted of money market funds and corporate debt securities.
Marketable Securities
Marketable securities are investments with original maturities of more than ninety days from the date of purchase that we have the ability to liquidate to fund current operations. Accordingly, those investments with contractual maturities greater than one year from the date of purchase are classified as short-term investments on the accompanying consolidated balance sheets. Marketable securities are considered available-for-sale and are carried at fair value with unrealized gains and losses recorded in other comprehensive income (loss) and included as a separate component of stockholders' equity. The cost of marketable securities is adjusted for amortization of premiums or accretion of discounts to maturity, and such amortization or accretion is included in investment and other income, net through an allowance account. We use the specific identification method for calculating realized gains and losses on marketable securities sold. Realized gains and losses on marketable securities, if any, are included in investment and other income, net in the consolidated statements of operations.
Restricted Cash
Under the terms of our office leases, we are required to maintain a letter of credit as a security deposit during the term of such leases. At December 31, 2023 and 2022, restricted cash of $2.7 million and $2.6 million, respectively, was pledged as collateral for the letters of credit.
Fair Value of Financial Instruments
The authoritative guidance defines fair value and requires us to establish a framework for measuring fair value and disclosure about fair value measurements using a three-tier approach. These tiers include: Level 1, defined as observable inputs such as quoted prices in active markets; Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions.
Our financial instruments include cash equivalents, marketable securities, prepaid expenses and other assets, accounts payable and accrued expenses. Fair value estimates of these instruments are made at a specific point in time, based on relevant market information. These estimates may be subjective in nature and involve uncertainties and matters of significant judgement and therefore cannot be determined with precision.
The fair value of marketable securities is determined using proprietary valuation models and analytical tools, which utilize market pricing or prices for similar instruments that are both objective and publicly available, such as matrix pricing or reported trades, benchmark yields, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities and bids and offers.
The carrying amount of cash equivalents, prepaid expenses and other assets, accounts payable and accrued expenses are generally considered to be representative of their respective values because of the short-term nature of those instruments.
Concentrations of Credit Risk and Sources of Supply
We are subject to credit risk from our portfolios of cash equivalents and marketable securities. We maintain our cash and cash equivalent and marketable securities balances with major commercial banks. Deposits held with the financial institutions exceed the amount of insurance provided on such deposits. We are exposed to credit risk in the event of a default by the financial institutions holding our cash and cash equivalents and marketable securities to the extent recorded on the consolidated balance sheets. We have also established guidelines to limit our exposure to credit risk by diversifying our marketable securities portfolio and placing them in investments with maturities that maintain safety and liquidity.
We rely on third-party manufacturers for the supply of active pharmaceutical ingredients.
Property and Equipment, Net
Property and equipment are recorded at cost, less accumulated depreciation and amortization. Equipment is depreciated using the straight-line method over its estimated useful life ranging from three tofive years and leasehold improvements are amortized using the straight-line method over the estimated useful life of the asset or the lease term, whichever is shorter. Repair and maintenance costs are expensed as incurred.
Leases
We have entered into operating leases for real estate. We determine if an arrangement is a lease at inception and evaluate each lease agreement to determine whether the lease is an operating or finance lease. For leases where we are the lessee, right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent an obligation to make lease payments arising from the lease. Liabilities from operating leases are included inaccrued expenses and long-term lease liabilities on our consolidated balance sheet. ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. As our leases do not provide an implicit interest rate, we use our incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The operating lease ROU asset also includes any prepaid lease payments, lease incentives received, and costs which will be incurred in exiting a lease. Our leases often include options to extend or terminate the lease. These options are included in the lease term when it is reasonably certain that we will exercise that option. As of December 31, 2023, it is not reasonably certain that these options will be exercised and they are not included within the lease term. Short-term leases with an initial term of 12 months or less are not recorded on the balance sheet. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. We have lease agreements with lease and non-lease components which are accounted for as a single lease component for all of our leases.
Impairment of Long-Lived Assets
We account for long-lived assets in accordance with authoritative guidance for impairment or disposal of long-lived assets. Long-lived assets are reviewed for events or changes in circumstances, which indicate that their carrying value may not be recoverable.
Goodwill
Our goodwill, which has an indefinite useful life, represents the excess of the cost over the fair value of net assets acquired from its business combination. The determination of the value of goodwill and intangible assets arising from business combinations and asset acquisitions requires extensive use of accounting estimates and judgments to allocate the purchase price to the fair value of the net tangible and intangible assets acquired, including capitalized in-process research and development (“IPR&D”).
Goodwill is reviewed for impairment at least annually, or more frequently if an event occurs indicating the potential for impairment. During the impairment review process, we consider qualitative factors to determine whether it is more likely than not that the fair value of the reporting unit is less than the carrying amount, including goodwill. If we determine that it is not more likely than not that the fair value of our reporting unit is less than the carrying amount, then no additional assessment is deemed necessary. Otherwise, we proceed to compare the estimated fair values of the reporting units with the carrying values, including goodwill. If the carrying amounts of the reporting units exceed the fair values, we record an impairment loss based on the difference. We completed our most recent annual evaluation for impairment for goodwill as of December 31, 2023 using the qualitative assessment and determined thatno impairment existed, and no charges were recorded.
Equity Method Accounting
We held significant influence, but not a controlling interest, in our former affiliate Zentera. From the deconsolidation of Zentera during July 2021 until the termination of our collaboration Zentera during the six-months ended June 30, 2023, this investment was accounted for using the equity method. Our share of earnings or losses of the investment entity were reported on the consolidated statement of operations, with a corresponding increase or decrease to the equity investment carried on the statement of financial position. This information was generally not received sufficiently timely for us to record our portion of earnings or loss in the current financial statements, and therefore we reported our portion of earnings or loss on a one quarter lag. The maximum exposure to loss as a result of our investment in Zentera was directly associated with the carrying amount of the equity method investment on our consolidated balance sheet, which iszero as of December 31, 2023.
Research and development expenses include salaries and benefits, facilities and other overhead expenses, external clinical trial expenses, research-related manufacturing services, contract services and other outside expenses. Research and development expenses are charged to operating expenses as incurred when these expenditures relate to our research and development efforts and have no alternative future uses. Reimbursed research and development costs under government grant arrangements are recorded as a reduction to research and development expenses and are recognized in the period in which the related costs are incurred.
We are obligated to make upfront payments upon execution of certain research and development agreements. Advance payments, including nonrefundable amounts, for goods or services that will be used or rendered for future research and development activities are deferred. Such amounts are recognized as expense as the related goods are delivered or the related services are performed, or such time when we do not expect the goods to be delivered or services to be performed.
Clinical Trial Expenses
We make payments in connection with our clinical trials under contracts with CROs that support conducting and managing clinical trials. The financial terms of these agreements are subject to negotiation and vary from contract to contract and may result in uneven payment flows. Generally, these agreements set forth the scope of work to be performed at a fixed fee, unit price or on a time and materials basis. A portion of our obligation to make payments under these contracts depends on factors such as the successful enrollment or treatment of patients or the completion of other clinical trial milestones.
Expenses related to clinical trials are accrued based on our estimates and/or representations from service providers regarding work performed, including actual level of patient enrollment, completion of patient studies and progress of the clinical trials. Other incidental costs related to patient enrollment or treatment are accrued when reasonably certain. If the amounts we are obligated to pay under our clinical trial agreements are modified (for instance, as a result of changes in the clinical trial protocol or scope of work to be performed), we adjust our accruals accordingly. Revisions to our contractual payment obligations are charged to expense in the period in which the facts that give rise to the revision become reasonably certain.
Share-Based Compensation
We record share-based compensation expense associated with equity instruments in accordance with the authoritative guidance for stock-based compensation. The cost of employee services received in exchange for an award of an equity instrument is measured at the grant date based on the estimated fair value of the award and is recognized as expense on a straight-line basis over the requisite service period of the award. Share-based compensation expense for an award with a performance condition is recognized when the achievement of such performance condition is determined to be probable. If the outcome of such performance condition is not determined to be probable or is not met, no compensation expense is recognized, and any previously recognized compensation expense is reversed. Forfeitures are recognized as a reduction of share-based compensation expense as they occur.
Income Taxes
Deferred income taxes are recognized for the tax consequences in future years of differences between the tax basis of assets and liabilities and their financial reporting amounts at each year end based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income. A provision has been made for income taxes due on taxable income and for the deferred taxes on temporary differences. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. Realization of the deferred income tax asset is dependent on gathering sufficient taxable income in future years.
Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Income tax expense is the combination of the tax payable for the period and the change during the period in deferred tax assets and liabilities. We follow the accounting guidance on accounting for uncertainty in income taxes. The guidance prescribes a recognition threshold and measurement attribute criteria for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities based on the technical merits of the position.
Accumulated Other Comprehensive Income
Accumulated other comprehensive income is the result of unrealized gains and losses on marketable securities.
Net Loss per Common Share Outstanding
Basic net loss per common share outstanding is computed by dividing net loss, after adjusting for dividends, if declared, by the weighted-average number of common shares outstanding during the period. Diluted net loss per common share outstanding is computed using the weighted-average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential common shares. Potential common shares consist of unvested restricted stock awards, unvested restricted stock units and common shares issuable upon the exercise of stock options.
Acquisitions and Contingent Consideration
The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs, which would meet the requirements of a business.
If determined to be a business combination, the Company accounts for the transaction under the acquisition method of accounting as indicated in Accounting Standards Update (ASU) 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, which requires the acquiring entity in a business combination to recognize the fair value of all assets acquired, liabilities assumed, and any non-controlling interest in the acquired entity and establishes the acquisition date as the fair value measurement point. Accordingly, the Company recognizes assets acquired and liabilities assumed in business combinations, including contingent assets and liabilities, and non-controlling interest in the acquired entity based on the fair value estimates as of the date of acquisition. In accordance with Accounting Standards Codification (ASC) 805, Business Combinations, the Company recognizes and measures goodwill as of the acquisition date, as the excess of the fair value of the consideration paid over the fair value of the identified net assets acquired.
The consideration for the Company’s business acquisitions may include future payments that are contingent upon the occurrence of a particular event or events. The obligations for such contingent consideration payments are recorded at fair value on the acquisition date. The contingent consideration obligations are then evaluated each reporting period. Changes in the fair value of contingent consideration, other than changes due to payments, are recognized as a gain or loss and recorded within change in the fair value of deferred and contingent consideration liabilities in the consolidated statements of comprehensive loss. Contingent consideration liabilities expected to be settled within 12 months after the balance sheet date are presented in current liabilities. Contingent consideration liabilities expected to be settled 12 months after the balance sheet date are presented in long-term liabilities.
If determined to be an asset acquisition, the Company accounts for the transaction under ASC 805-50, which requires the acquiring entity to recognize assets acquired and liabilities assumed based on the cost to the acquiring entity on a relative fair value basis, which includes transaction costs in addition to consideration given. No gain or loss is recognized as of the date of acquisition unless the fair value of non-cash assets given as consideration differs from the assets’ carrying amounts on the acquiring entity’s books. Consideration transferred that is non-cash will be measured based on either the cost (which shall be measured based on the fair value of the consideration given) or the fair value of the assets acquired and liabilities assumed, whichever is more reliably measurable. Goodwill is not recognized in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired is allocated to the identifiable assets based on relative fair values. If the in-licensed agreement for in-process research and development (“IPR&D”) does not meet the definition of a business and the assets have not reached technological feasibility and therefore have no alternative future use, the Company expenses payments made under such license agreements as acquired IPR&D expense in its consolidated statement of comprehensive loss. Contingent consideration payments in asset acquisitions are recognized when the contingency is resolved and the consideration is paid or becomes payable (unless the contingent consideration meets the definition of a derivative, in which case the amount becomes part of the basis in the asset acquired). Upon recognition of the contingent consideration payment, the amount is included in the cost of the acquired asset or group of assets.
- Significant Transactions
Zentera Therapeutics
On June 15, 2023, we announced that we and certain of our wholly owned subsidiaries had entered into an agreement to terminate our Collaboration and License Agreements (the “Termination Agreement”) with Zentera Therapeutics, a Shanghai-based clinical-stage biopharmaceutical company focused on developing cancer therapeutics (“Zentera”), pursuant to which such wholly owned subsidiaries had granted to Zentera certain development and commercialization rights to our product candidates, azenosertib, ZN-d5 and ZN-c5 (the “Zentera Collaboration Products”) in the People’s Republic of China, Macau, Hong Kong and Taiwan (collectively, “Greater China”). As a result of the termination of these agreements, we regained the rights from Zentera for azenosertib, ZN-d5 and ZN-c5 in Greater China, and now hold worldwide development and commercialization rights to these assets. Concurrent with the agreement to terminate the Collaboration and License Agreements, we executed a share purchase agreement (the “Share Purchase Agreement”) with Zentera to return our 40.3% equity stake in Zentera for de minimis consideration.
We assessed the Termination Agreement and Share Purchase Agreement together and determined that the transaction to reacquire the licensed intellectual property without an acquired workforce, inputs or any substantive processes capable of contributing to the ability to produce outputs, represents asset acquisitions for accounting purposes.
The total consideration transferred of $45.6 million was comprised of the following components: Fixed consideration of $30 million, representing an up-front payment. Fixed consideration of forgiveness of $9.4 million of outstanding receivables under the Collaboration and License Agreements. Fixed consideration of the return of our 40.3% equity stake in Zentera for de minimis cash consideration. Using the adjusted balance sheet method under the cost approach, the difference between the carrying value of the equity method investment at the time of the transaction and the fair value of the equity method investment after the return of the intellectual property was $13.7 million, which was recognized as a loss on the equity method investment line item in the statement of operations during the second quarter of 2023. Variable consideration of a change in control milestone payment as contingent consideration can be either zero or $15.0 million. The value of the contingent consideration of approximately $0.5 million was calculated using estimates of future discounted cash flows, and other significant estimates including estimates for probability of milestone achievement and discount rates. The value of the contingent consideration for this milestone will be remeasured at fair value at each reporting period with gains and losses reported in the statement of operations, as applicable. We also incurred $0.5 million of acquisition-related costs that were included in the total consideration for the acquired assets. Additional consideration to be paid to Zentera includes a low single digit royalty on net sales of azenosertib, ZN-d5 and ZN-c5 in the Greater China region. These additional payments are payable only after regulatory approval and commercials sales in the Greater China region and are excluded from the transaction price.
The fair value of in-process research and development assets acquired was based on the market approach, which includes significant estimates. These estimates included calibration adjustments for comparable companies, cost estimates, control and marketability discounts, as well as estimates for the probability of success and applicable discount rates. The excess of the fair value of the consideration given in exchange for the Zentera in-process research and development received was accounted for as a contract termination cost. The Company determined to recognize the full amount of $45.6 million in the condensed consolidated statement of operations and comprehensive loss during the year ended December 31, 2023.
- Business Combinations
Kalyra Pharmaceuticals, Inc.
On December 21, 2017, we acquired $4.5 million of Kalyra Pharmaceuticals, Inc.’s ("Kalyra") Series B Preferred Stock representing a 25% equity interest in Kalyra for purposes of entering the analgesics therapeutic research space. The acquisition price was paid entirely in cash.
In accordance with the authoritative guidance, we concluded that Kalyra is a business consisting of inputs, employees, intellectual property and processes capable of producing outputs. Additionally, we have concluded that Kalyra is a VIE, we are the primary beneficiary and have the power to direct the activities that most significantly affect Kalyra’s economic performance through common management and our board representation. Prior to December 21, 2017, the Company and Kalyra transacted for the delivery of research and development services and support. The financial position and results of operations of Kalyra have been included in our consolidated financial statements from the date of the initial investment.
Pursuant with authoritative guidance, we have recorded the identifiable assets, liabilities and noncontrolling interests in the VIE at their fair value upon initial consolidation. The identified goodwill is comprised of the workforce and expected synergies from combining the entities. Total assets and liabilities of Kalyra as of December 31, 2023 and 2022 are immaterial.
The liabilities recognized as a result of consolidating Kalyra do not represent additional claims on our general assets. Pursuant to the authoritative guidance, the equity interest in Kalyra not owned by Zentalis is reported as a noncontrolling interest on our consolidated balance sheets.
The following is a reconciliation of equity (net assets) attributable to the noncontrolling interest (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Noncontrolling interest at beginning of period | $221 | $528 |
| Net loss attributable to noncontrolling interest | (114) | (307) |
| Noncontrolling interest at end of period | $107 | $221 |
- Fair Value Measurement
Available-for-sale marketable securities consisted of the following (in thousands):
| December 31, 2023 | ||||
|---|---|---|---|---|
| Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |
| Commercial paper | $75,227 | $60 | $(15) | $75,272 |
| Corporate debt securities | 229,896 | 2,036 | — | 231,932 |
| US government agencies | 83,025 | 100 | (78) | 83,047 |
| US Treasury securities | 64,538 | 103 | (11) | 64,630 |
| $452,686 | $2,299 | $(104) | $454,881 | |
| December 31, 2022 | ||||
|---|---|---|---|---|
| Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |
| Commercial paper | $296,309 | $71 | $(587) | $295,793 |
| Corporate debt securities | 7,472 | — | (26) | 7,446 |
| US government agencies | 23,970 | — | (182) | 23,788 |
| US Treasury securities | 67,904 | — | (629) | 67,275 |
| $395,655 | $71 | $(1,424) | $394,302 | |
As of December 31, 2023, twenty of our available-for-sale debt securities with a fair market value of $113.4 million were in a gross unrealized loss position of $0.1 million. When evaluating an investment for impairment, we review factors such as the severity of the impairment, changes in underlying credit ratings, forecasted recovery, our intent to sell or the likelihood that we would be required to sell the investment before its anticipated recovery in market value and the probability that the scheduled cash payments will continue to be made. Based on our review of these marketable securities, we believe none of the unrealized loss is as a result of a credit loss as of December 31, 2023, because we do not intend to sell these securities, and it is not more-likely-than-not that we will be required to sell these securities before the recovery of their amortized cost basis.
Contractual maturities of available-for-sale debt securities are as follows (in thousands):
| December 31, 2023 | December 31, 2022 | |
|---|---|---|
| Estimated Fair Value | ||
| Due within one year | $267,336 | $394,302 |
| After one but within five years | 187,545 | — |
| $454,881 | $394,302 | |
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 at the measurement date. Fair value should maximize the use of observable inputs and minimize the use of unobservable inputs. The Company determines the fair value of financial assets and liabilities using three levels of inputs as follows:
Level 1—Inputs which include quoted prices in active markets for identical assets or liabilities at the measurement date.
Level 2—Inputs (other than quoted market prices included in Level 1) that are either directly or indirectly observable, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the instrument’s anticipated life.
Level 3—Unobservable inputs for assets or liabilities and include little or no market activity.
A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement.
The Company had $0.5 million in contingent consideration liabilities as of December 31, 2023 related to the agreement to terminate its Collaboration and License Agreements with Zentera. The contingent consideration balance is limited toone potential milestone payment measured at fair value (See Note 3 - Significant Transactions for additional information). The fair value of the contingent consideration is estimated based on the monetary value of the milestone discounted for the probability of achieving the milestone and a present value factor based on the timing of when the milestone is expected to be achieved. The value for the contingent consideration balance is based on significant inputs not observable in the market which represents Level 3 measurement within the fair value hierarchy. This liability did not exist as of December 31, 2022.
The following table summarizes, by major security type, our cash equivalents and available-for-sale marketable securities that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy (in thousands):
| Level 1 | Level 2 | Level 3 | Total estimated fair value | |
|---|---|---|---|---|
| Cash equivalents: | ||||
| Money market funds | $4,755 | $— | $— | $4,755 |
| Total cash equivalents: | 4,755 | — | — | 4,755 |
| Available-for-sale marketable securities: | ||||
| Commercial paper | — | 75,272 | — | 75,272 |
| Corporate debt securities | — | 231,932 | — | 231,932 |
| US government agencies | — | 83,047 | — | 83,047 |
| US Treasury securities | — | 64,630 | — | 64,630 |
| Total available-for-sale marketable securities: | — | 454,881 | — | 454,881 |
| Total assets measured at fair value | $4,755 | $454,881 | $— | $459,636 |
| Financial liabilities: | ||||
| Contingent consideration | — | — | 500 | 500 |
| Total financial liabilities | $— | $— | $500 | $500 |
| December 31, 2022 | ||||
|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Total estimated fair value | |
| Cash equivalents: | ||||
| Money market funds | $26,811 | $— | $— | $26,811 |
| Commercial paper | 1,998 | — | — | 1,998 |
| Total cash equivalents: | 28,809 | — | — | 28,809 |
| Available-for-sale marketable securities: | ||||
| Commercial paper | — | 295,793 | — | 295,793 |
| Corporate debt securities | — | 7,446 | — | 7,446 |
| US government agencies | — | 23,788 | — | 23,788 |
| US Treasury securities | 67,275 | — | — | 67,275 |
| Total available-for-sale marketable securities: | 67,275 | 327,027 | — | 394,302 |
| Total assets measured at fair value | $96,084 | $327,027 | $— | $423,111 |
| Financial liabilities: | ||||
| Contingent consideration | — | — | — | — |
| Total financial liabilities | $— | $— | $— | $— |
The following significant unobservable inputs were used in the valuation of the contingent consideration payable to Zentera pursuant to the Termination Agreement at December 31, 2023:
| Contingent Consideration Liability | Fair Value as of December 31, 2023 | Valuation Technique | Unobservable Input | Range |
|---|---|---|---|---|
| (in thousands) | ||||
| Milestone payment | $500 | Discounted cash flow | Likelihood of occurrence | 1.0%- 2.4% |
| Discount rate | 40% | |||
| Expected term · Perpetuity | ||||
The following table reflects the activity for the Company’s contingent consideration, measured at fair value using Level 3 inputs (in thousands):
| Contingent consideration at December 31, 2022 | $— |
|---|---|
| Issuance of contingent consideration to Zentera | 500 |
| Changes in the fair value of contingent consideration | — |
| Contingent consideration at December 31, 2023 | $500 |
There were no transfers between Level 1 and Level 2 of the fair value hierarchy during the year ended December 31, 2023. We had 1 instrument that was classified within Level 3 as of December 31, 2023. No instruments were classified as Level 3 as of December 31, 2022. As of December 31, 2023 and December 31, 2022, no material fair value adjustments were required for non-financial assets and liabilities.
- Prepaid Expenses and Other Assets
Prepaid expenses and other assets consisted of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Prepaid insurance | $747 | $1,018 |
| Prepaid software licenses and maintenance | 691 | 958 |
| Foreign R&D credit refund | 500 | 659 |
| Prepaid research and development expenses | 13,640 | 15,002 |
| Interest receivable | 3,337 | 508 |
| Sublease assets | 1,471 | — |
| Zentera receivable | — | 5,874 |
| Other prepaid expenses | 231 | 266 |
| Total prepaid expenses and other current assets | 20,617 | 24,285 |
| Less long-term portion | 6,818 | 9,723 |
| Total prepaid expenses and other assets, current | $13,799 | $14,562 |
- Property and Equipment, net
Property and equipment, net consisted of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Lab equipment | $3,069 | $2,622 |
| Leasehold improvements | 4,235 | 4,891 |
| Office equipment and furniture | 1,340 | 2,065 |
| Computer equipment | 150 | 150 |
| Construction in process | 173 | 37 |
| Subtotal | 8,967 | 9,765 |
| Accumulated depreciation and amortization | (3,148) | (2,060) |
| Property and equipment, net | $5,819 | $7,705 |
Depreciation and amortization expense was approximately $1.4 million, $1.4 million and $0.5 million for the years ended December 31, 2023, 2022 and 2021 respectively.
- Accrued Expenses
Accrued expenses consist of the following (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Accrued research and development expenses | $36,261 | $32,310 |
| Accrued employee expenses | 14,477 | 11,246 |
| Accrued general and administrative expenses | 1,032 | 662 |
| Lease liability | 2,623 | 2,162 |
| Contingent consideration | 500 | — |
| Income taxes payable | 281 | 384 |
| Accrued legal expenses | 1,047 | 1,256 |
| Total accrued expenses | 56,221 | 48,020 |
| Less long-term portion | 1,780 | 2,620 |
| Total accrued expenses, current | $54,441 | $45,400 |
- Stockholders' Equity
Follow-on Offerings of Common Stock
On June 15, 2023, we completed a follow-on offering in which we issued and sold 11,032,656 shares of common stock at a public offering price of $22.66 per share. The total gross proceeds for the offering were approximately $250.0 million, before deducting offering expenses of $14.3 million payable by us.
On May 18, 2022, we completed a follow-on offering in which we issued and sold 10,330,000 shares of common stock at a public offering price of $19.38 per share. The total gross proceeds for the offering were approximately $200.2 million, before deducting offering expenses of $11.4 million payable by us.
Direct Offering of Common Stock
On April 29, 2022, pursuant to our Registration Statement on Form S-3 (Registration No. 333-255769), filed with the SEC on May 4, 2021, we completed a direct offering of common stock to Pfizer Inc. (“Pfizer”). We issued and sold 953,834 shares of our common stock at an offering price of $26.21 per share. The total gross proceeds for the offering were approximately $25.0 million, before deducting offering expenses of $0.3 million payable by us. The parties have entered into an agreement to collaborate to advance the clinical development of azenosertib (ZN-c3), a selective WEE1 inhibitor designed to induce synthetic lethality in cancer cells. We did not grant Pfizer any economic ownership or control of azenosertib or the rest of our pipeline. The gross offering proceeds received from Pfizer exceeded the fair value of our common stock on the date of the investment. As of December 31, 2023, $2.5 million has been recorded as accrued research and development expense on the consolidated balance sheet and will be recognized as a reduction of research and development expense over the term of the collaboration agreement.
ATM Program
In May 2021, the Company entered into a sales agreement (the “Sales Agreement”), with Leerink Partners LLC, as sales agent, pursuant to which the Company may, from time to time, issue and sell common stock with an aggregate value of up to $200.0 million in “at-the-market” offerings (the “ATM”), under the Company's Registration Statement on Form S-3 (File No. 333-255769). Sales of common stock, if any, pursuant to the Sales Agreement, may be made in sales deemed to be an “at the market offering” as defined in Rule 415(a) of the Securities Act, including sales made directly through The Nasdaq Global Market or any other existing trading market for the Company's common stock. During the quarter ended December 31, 2023, we didnot sell any shares of common stock under the Sales Agreement. As of December 31, 2023 there was $140.3 million of common stock remaining available for sale under the Sales Agreement.
Share-based Compensation
Effective April 2020, the Company’s Board of Directors adopted, and the Company’s stockholders approved the 2020 Incentive Award Plan (the "2020 Plan"), which allows for grants to selected employees, consultants and non-employee members of the Board of Directors. We currently grant stock options and restricted stock units (“RSUs”), under the 2020 Plan. Awards may be made under the 2020 Plan covering up to the sum of (1)5,600,000 shares of common stock; plus (2) any shares forfeited from the unvested restricted shares of our common stock issued upon conversion of unvested Class B common units (up to 1,250,000 shares); plus (3) an annual increase on the first day of each fiscal year beginning with the fiscal year ending December 31, 2021 and continuing to, and including, the fiscal year ending December 31, 2030, equal to the lesser of (a)5% of the shares of common stock outstanding on the final day of the immediately preceding calendar year and (b) such smaller number of shares as determined by our Board of Directors.
In July 2022, the Company’s Board of Directors approved the Zentalis Pharmaceuticals, Inc. 2022 Employment Inducement Incentive Award Plan (the “2022 Inducement Plan”), which is used exclusively for the grant of equity awards to new employees as an inducement material to the employees’ entering into employment with the Company. As of December 31, 2023, the Board of Directors reserved 2,275,000 shares of the Company’s common stock for issuance pursuant to awards granted under the 2022 Inducement Plan.
As of December 31, 2023,9,240,394 shares were subject to outstanding awards under the 2020 Plan and 1,836,357 shares were available for future grants of share-based awards under the 2020 Plan. As of December 31, 2023,1,995,856 shares were subject to outstanding awards under the 2022 Inducement Plan and 254,144 shares were available for future grants of share-based awards under the 2022 Inducement Plan.
During 2023, we issued an aggregate of 54,324 shares of common stock in connection with the exercises of stock options for cash in the aggregate amount of approximately $1.0 million. We did not issue any shares of common stock in connection with grants of restricted stock awards ("RSA's"). We issued 360,555 shares of common stock, upon vesting of RSU's.
Total share-based compensation expense related to share-based awards was comprised of the following (in thousands):
| Year ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Research and development expense | $24,519 | $20,439 | $14,879 |
| General and administrative expense | 30,303 | 26,401 | 20,858 |
| Total share-based compensation expense | $54,822 | $46,840 | $35,737 |
Share-based compensation expense by type of share-based award (in thousands):
| Year ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Stock options | $41,642 | $36,338 | $20,773 |
| RSAs and RSUs | 12,816 | 10,075 | 14,643 |
| Employee Stock Purchase Plan | 364 | 427 | 321 |
| $54,822 | $46,840 | $35,737 | |
Prior to the deconsolidation of Zentera during the third quarter of 2021, total share-based compensation expense includes $138 thousand of share-based compensation expense for employees, consultants and directors of Zentera, for the year ended December 31, 2021.
Total unrecognized estimated compensation cost by type of award and the weighted average requisite service period over which such expense is expected to be recognized (in thousands, unless otherwise noted):
| December 31, 2023 | ||
|---|---|---|
| UnrecognizedExpense | Remaining Weighted-Average Recognition Period(Years) | |
| Stock options | $92,129 | 2.7 |
| RSAs | $1 | 0.0 |
| RSUs | $20,699 | 2.5 |
Stock Options: The following table summarizes option activity for the year ended December 31, 2023. The amounts include stock options granted to both employees and non-employees:
| Number of Shares | Weighted AverageExercise Price | Weighted Average Remaining Contractual Term (Years) | Aggregate Intrinsic Value (in thousands) | |
|---|---|---|---|---|
| Outstanding at December 31, 2022 | 8,051,459 | $29.97 | ||
| Granted | 3,772,345 | $22.17 | ||
| Exercised | (54,324) | $18.31 | ||
| Cancelled | (1,752,045) | $32.82 | ||
| Outstanding at December 31, 2023 | 10,017,435 | $26.59 | 7.8 | $160 |
| Vested and expected to vest at December 31, 2023 | 10,017,435 | $26.59 | 7.8 | $160 |
| Exercisable at December 31, 2023 | 4,086,661 | $27.91 | 6.6 | $— |
The weighted average grant date fair value of stock options granted during the years ended December 31, 2023, 2022 and 2021 was $15.48 per share, $20.45 per share and $33.27 respectively. The total intrinsic value of options exercised during the years ended December 31, 2023, 2022 and 2021 was approximately $0.3 million, $2.0 million and $8.8 million, respectively.
The exercise price of stock options granted is equal to the closing price of the Company's common stock on the date of grant. The fair value of each option award is estimated on the date of grant using the Black-Scholes model. Due to the Company’s limited operating history and a lack of company specific historical and implied volatility data, the Company estimates expected volatility based on the historical volatility of a group of similar companies that are publicly traded. The historical volatility data was computed using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock-based awards. The Company uses the “simplified method” for estimating the expected term of employee options, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option (generally 10 years). The risk-free interest rate is based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. The Company has not issued any dividends and does not expect to issue dividends over the life of the options. As a result, the Company has estimated the dividend yield to bezero. The fair value of the stock options granted during the year ended December 31, 2023 was determined with the following assumptions:
| Year ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Expected volatility | 73.5% - 80.8% | 73.6% - 80.5% | 73.2% - 76.6% |
| Average expected term (in years) | 5.5 - 6.1 | 6.0 - 6.5 | 5.2 - 6.1 |
| Risk-free interest rate | 3.4% - 4.7% | 1.5% - 4.2% | 0.5% - 1.3% |
| Expected dividend yield | —% | —% | —% |
Restricted Stock Awards: RSAs are shares of our common stock subject to forfeiture restrictions that lapse based on the awardee's continued employment or service. The shares covered by a RSA cannot be sold, pledged or otherwise disposed of until the awards vest, and any unvested shares will be forfeited following the awardee's termination of service.
The following table summarizes RSA activity for the year ending December 31, 2023. The amounts include RSAs granted to both employees and non-employees:
| Number of Shares | Weighted Average Grant DateFair Value | |
|---|---|---|
| Outstanding at December 31, 2022 | 125,506 | $5.45 |
| Vested | (120,102) | $5.53 |
| Forfeited | (4,455) | $3.30 |
| Outstanding at December 31, 2023 | 949 | $4.61 |
The fair value of RSAs issued upon conversion of the unvested profit interest award units was based on a Black-Scholes pricing model. The estimated fair value of the RSAs for any future grants will be based on the closing market value of our common stock on the date of grant. The total grant date fair value of RSAs vested during the years ended December 31, 2023, 2022 and 2021 was approximately $0.7 million, $1.0 million and $1.7 million, respectively. The fair value of RSAs vested during the years ended December 31, 2023, 2022 and 2021, was approximately $2.7 million, $8.3 million and $21.0 million, respectively.
Restricted Stock Units: An RSU is a promise by us to issue a share of our common stock upon vesting of the unit.
The following table summarizes RSU activity for the year ending December 31, 2023. The amounts include RSUs granted to both employees and non-employees:
| Number of Shares | Weighted Average Grant DateFair Value | |
|---|---|---|
| Outstanding at December 31, 2022 | 922,901 | $27.48 |
| Granted | 968,823 | $22.94 |
| Vested | (360,555) | $27.02 |
| Forfeited | (312,354) | $25.88 |
| Outstanding at December 31, 2023 | 1,218,815 | $24.56 |
The estimated fair value of the RSUs was based on the closing market value of our common stock on the date of grant. The total grant date fair value of RSUs vested during the years ended December 31, 2023, 2022 and 2021 was approximately $9.7 million $4.6 million and $12.7 million, respectively. The fair value of RSUs vested during the years ended December 31, 2023, 2022 and 2021 was approximately $7.7 million, $7.3 million and $26.4 million, respectively.
Employee Stock Purchase Plan
Effective April 2020, the Company’s Board of Directors adopted, and the Company’s stockholders approved the 2020 Employee Stock Purchase Plan (the “2020 ESPP”), which was subsequently amended and restated effective March 15, 2021 to provide for a share reserve of 2,000,000 shares. As of December 31, 2023,1,913,160 shares were available for issuance under the 2020 ESPP.
The weighted average assumptions used to estimate the fair value of stock purchase rights under the 2020 ESPP are as follows:
| Year ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| ESPP | |||
| Volatility | 85.8% | 74.0% | 48.2% |
| Expected term (years) | 0.5 | 0.5 | 0.5 |
| Risk free rate | 4.8% | 1.6% | 0.1% |
| Expected dividend yield | —% | —% | —% |
Under the terms of the 2020 ESPP, the Company’s employees may elect to have up to 20% of their compensation, up to a maximum of $21,250 per calendar year, withheld to purchase shares of the Company’s common stock for a purchase price equal to 85% of the lower of the fair market value per share (at closing) of the Company’s common stock on (i) the first trading day of asix-month offering period, or (ii) the applicable purchase date, defined as the last trading day of thesix-month offering period.
- Commitments and Contingencies
Legal Contingencies
From time to time, we may be involved in various disputes, including lawsuits and claims arising in the ordinary course of business, including actions with respect to intellectual property, employment, and contractual matters. Any of these claims could subject us to costly legal expenses. The Company records a liability in its consolidated financial statements for these matters when a loss is known or considered probable and the amount can be reasonably estimated. The Company reviews these estimates each accounting period as additional information is known and adjusts the loss provision when appropriate. If a matter is both probable to result in a liability and the amounts of loss can be reasonably estimated, the Company estimates and discloses the possible loss or range of loss to the extent necessary to make the consolidated financial statements not misleading. If the loss is not probable or cannot be reasonably estimated, a liability is not recorded in our consolidated financial statements. While we do generally believe that we have adequate insurance to cover many different types of liabilities, our insurance carriers may deny coverage, or our policy limits may be inadequate to fully satisfy any damage awards or settlement. If this were to happen, the payment of any such awards could have a material adverse effect on our consolidated results of operations and financial position. Additionally, any such claims, whether or not successful, could damage our reputation and business. We are currently not a party to any legal proceedings that require a loss liability to be recorded.
Operating Leases
In September 2020, we entered into a lease for approximately 117,900 square feet of laboratory and office space in San Diego. This lease was partially terminated and amended during September 2021. This amendment reduced the rentable square feet by approximately 43,200. The lease commenced in December 2021 and continues through September 2032. The lease also included access to a temporary space of 13,200 square feet of laboratory and office space in San Diego. This lease component commenced in November 2020 and continued through January 2022. The lease is subject to approximately 3.0% annual increases throughout the lease term. We also pay for various operating costs, including utilities and real property taxes. The agreement includestwo options to extend the lease for a period offive years each. When we determined our lease term for our operating lease right-of-use assets and lease liabilities for these leases, we did not include the extension options for this lease.
In March 2021, we entered into a lease for approximately 31,362 square feet of office space at 1359 Broadway, Suites 1710 and 1800 in New York, New York. The lease commenced in December 2021 and continues through November 2032. The lease is subject to one increase in per annum rent of approximately 8.1% commencing on thesixth anniversary of the commencement date. We received lease incentives under the agreement , including tenant allowances and free rent periods. We also pay for various operating costs, including utilities and real property taxes. The agreement containsone option to extend the lease for a period offive years. When we determined our lease term for our operating lease right-of-use assets and lease liabilities, we did not include the extension options for the lease.
In December 2023, we entered into a lease for approximately 4,115 square feet of office space in New York, New York. The lease commenced in December 2023 and continues through August 2027. The lease is subject to approximately 2.5% annual increases through the lease term. We received lease incentives under the agreement, including free rent periods. We also pay for various operating costs, including utilities and real property taxes. The agreement does not contain any option to extend.
On March 6, 2023, we entered into a sublease agreement pursuant to which we sublet the office space located at 1359 Broadway, Suites 1710 and 1800 in New York, New York to a subtenant. As a result of certain triggering events, we performed an interim impairment test by comparing the carrying value of the long-lived asset group to its estimated fair value, which was determined based on the income approach using a discounted cash flow model. Estimates and assumptions used in the model included projected cash flows and a discount rate. As a result, we recorded an impairment expense of $5.0 million within our operating expenses against our operating lease right-of-use asset and fixed assets associated with our New York lease during the year ended December 31, 2023. For the year ended December 31, 2023, we recorded lease income of $0.9 million relating to this sublease, presented as other income in the statement of operations.
Rent expense recorded by the Company under the leases was approximately $6.9 million, $7.0 million and $2.7 million for the years ended December 31, 2023, 2022 and 2021 respectively. We paid approximately $6.4 million, $2.5 million and $1.3 million of lease payments, respectively, during the years ended December 31, 2023, 2022 and 2021.
The following table presents the weighted average remaining lease term and weighted average discount rates related to our operating leases as of December 31, 2023:
| Weighted average remaining lease term (in years) | 8.7 |
|---|---|
| Weighted average discount rate | 9.0% |
Approximate annual future minimum operating lease payments as of December 31, 2023 are as follows (in thousands):
| Year | Amount |
|---|---|
| 2024 | $6,643 |
| 2025 | 7,002 |
| 2026 | 7,487 |
| 2027 | 7,606 |
| 2028 | 7,760 |
| Thereafter | 31,018 |
| Total minimum lease payments: | 67,516 |
| Less: imputed interest | 21,743 |
| Total operating lease liabilities | 45,773 |
| Less: current portion | 2,623 |
| Lease liability, net of current portion | $43,150 |
- Income Taxes
Zentalis Pharmaceuticals, Inc. is a corporation for tax purposes and is subject to income taxes which have been included in the consolidated financial statements.
The amount of net loss before income taxes and loss on equity method investment for the years ended December 31, 2023, 2022 and 2021 is as follows (in thousands):
| Year ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| U.S. net loss before income taxes | $(293,284) | $(237,926) | $(171,053) |
| Foreign net income (loss) before income taxes | 378 | 344 | 4,663 |
| Net loss before income taxes, including loss on equity method investment | $(292,906) | $(237,582) | $(166,390) |
The following table presents the current and deferred income tax provision (benefit) for federal, state and foreign income taxes (in thousands):
| Year ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Current tax provision: | |||
| Federal | $— | $— | $— |
| State | 41 | 11 | 11 |
| Foreign | 249 | 298 | 550 |
| Total current tax provision | 290 | 309 | 561 |
| Deferred tax provision: | |||
| Federal | (891) | (683) | (120) |
| State | — | (41) | (736) |
| Foreign | — | (54) | (2) |
| Total deferred tax provision | (891) | (778) | (858) |
| Total provision for income taxes: | $(601) | $(469) | $(297) |
The following table is a reconciliation of the expected tax computed at the U.S. statutory federal income tax rate to the total provision for income taxes (in thousands):
| Year ended December 31, | ||||||
|---|---|---|---|---|---|---|
| 2023 · 2022 · 2021 | ||||||
| Expected tax at 21% | $(61,509) | 21.0% | $(49,892) | 21.0% | $(34,941) | 21.0% |
| State income tax, net of federal tax | (2,384) | 0.8% | (4,222) | 1.8% | (931) | 0.6% |
| Research credits | (2,031) | 0.7% | (12,558) | 5.3% | (6,938) | 4.2% |
| Share-based compensation | 3,008 | (1.0)% | 1,245 | (0.5)% | (3,307) | 2.0% |
| Deemed royalty | 8,263 | (2.8)% | — | —% | — | —% |
| Other | 586 | (0.2)% | (2,799) | 1.2% | 939 | (0.6)% |
| Section 162(m) limitations | 5,028 | (1.7)% | 3,950 | (1.7)% | 3,982 | (2.4)% |
| Effective Tax Rate Change | (10,420) | 3.6% | — | —% | — | —% |
| Change in valuation allowance | 58,858 | (20.1)% | 63,807 | (26.9)% | 40,899 | (24.6)% |
| Provision for income taxes | $(601) | 0.2% | $(469) | 0.2% | $(297) | 0.2% |
Deferred income taxes as of each of the following periods reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes.
Significant components of our net deferred tax asset or liability are as follows (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Deferred tax assets | ||
| Net operating loss | $96,676 | $95,392 |
| Compensation | 2,451 | 1,937 |
| Share-based compensation | 11,486 | 7,735 |
| ASC 842 lease liability | 11,131 | 9,967 |
| Intangibles | 11,185 | 1,745 |
| Capitalized research and experimental expenditures | 66,500 | 30,776 |
| Accrued liabilities | 1,163 | 476 |
| Research credits | 29,055 | 27,024 |
| Other | 22 | 62 |
| Total gross deferred tax assets | 229,669 | 175,114 |
| Valuation allowance | (219,292) | (160,967) |
| Net deferred tax assets | 10,377 | 14,147 |
| Deferred tax liabilities | ||
| Depreciable assets | (1,108) | (1,609) |
| ASC 842 right of use asset | (8,734) | (8,924) |
| Equity method investment | — | (4,467) |
| Other | (497) | — |
| Deferred tax liabilities | (10,339) | (15,000) |
| Net deferred tax assets (liabilities) | $38 | $(853) |
Realization of a portion of the Company's deferred tax assets is dependent upon the Company generating sufficient taxable income in future years to obtain benefit from the reversal of temporary differences. Management considered all available evidence under existing tax law and anticipated expiration of tax statutes and determined that a valuation allowance of $219.3 million and $161.0 million was required as of December 31, 2023 and 2022, for those deferred tax assets that are not expected to provide future tax benefits. The increase in valuation allowance was primarily related to intangibles and the capitalized research expenditures during the period ended December 31, 2023.
At December 31, 2023, we have federal and state net operating loss ("NOL") carryforwards of approximately $396.1 million and $193.0 million, respectively. The federal NOL carryforwards generated in taxable years beginning prior to January 1, 2018 begin to expire in 2033. The federal NOL carryforwards generated in taxable years beginning after December 31, 2017 of $375.2 million can be carried forward indefinitely but may only be used to offset up to 80% of taxable income in future periods. The state NOL carryforwards begin to expire in 2033.
At December 31, 2023, we have federal and state research tax credit carryforwards, net of reserves, of approximately $23.0 million and $7.1 million, respectively. The federal credit carryforwards begin to expire in 2033, and the state credit carryforwards do not expire and can be carried forward indefinitely until utilized.
Pursuant to Internal Revenue Code ("Code") Sections 382 and 383, annual use of the Company’s federal and California NOL and research and development credit carryforwards may be limited in the event a cumulative change in ownership of more than fifty percentage points by certain stockholders or groups of stockholders occurs within a three-year period. The Company has completed a Code Section 382 analysis through June 30, 2023 regarding the limitation of NOL carryforwards and other tax attributes. Under the Section 382 rules, the Company experienced ownership changes in 2015, 2019 and 2022. Additionally, several of the subsidiaries experienced an ownership change in 2020 based on the Section 382 rules for the time period prior to when the Company was a consolidated group for tax purposes. The Company’s attributes are subject to annual limitations, however, the federal NOL's of $375.2 million carryforward indefinitely and the remaining $20.9 million begin to expire in 2033. There is a risk that additional ownership changes may occur in the future. If a future change in ownership occurs, the NOL carryforwards and other tax attributes could be limited or restricted. Additionally, the Company’s NOLs prior to the tax consolidation are also subject to the separate return loss year (“SRLY”) rules. The SRLY rules may limit one member from offsetting taxable income with losses generated from another member prior to joining the consolidated group.
Uncertain Tax Positions
In accordance with authoritative guidance, the impact of an uncertain income tax position on the income tax return must be recognized at the largest amount that is more-likely-than-not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of being sustained.
The following table reconciles the beginning and ending amount of unrecognized tax benefits for the fiscal years ended December 31 2023, and 2022 (in thousands):
| December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Gross unrecognized tax benefits at the beginning of the year | $4,297 | $2,835 | $1,932 |
| Increase related to current year tax positions | 857 | 1,112 | 969 |
| Increase related to prior year tax positions | — | 350 | — |
| Decrease related to prior year tax positions | (940) | — | (66) |
| Gross unrecognized tax benefits at end of the year | $4,214 | $4,297 | $2,835 |
Included in the balance of unrecognized tax benefits at December 31, 2023 is $3.9 million that, if recognized, would not impact the Company's income tax benefit or effective tax rate as long as our deferred tax asset remains subject to a valuation allowance. The Company does not expect any significant increases or decreases to our unrecognized tax benefits within the next 12 months.
The Company recognizes interest and penalties related to unrecognized tax positions within the income tax expense line in the accompanying consolidated statements of operations. There wereno accrued interest and penalties associated with uncertain tax positions as of December 31, 2023 and 2022.
The Company files federal and state income tax returns in the United States as well as income tax returns in Australia. Due to the Company's unutilized NOLs and credits, all years remain subject to income tax examination by authorities. The Company is not currently under examination by federal, state or foreign jurisdictions.
- Net Loss Per Common Share
Basic and diluted net loss per common share were calculated as follows (in thousands except per share amounts):
| Year ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Numerator: | |||
| Net loss attributable to Zentalis | $(292,191) | $(236,806) | $(158,725) |
| Denominator: | |||
| Weighted average number of common shares outstanding, basic and diluted | 65,409 | 52,857 | 42,688 |
| Net loss per common share | $(4.47) | $(4.48) | $(3.72) |
Our potential and dilutive securities, which include outstanding stock options, unvested RSAs and unvested RSUs have been excluded from the computation of diluted net loss per common share as the effect would be anti-dilutive.
The following common stock equivalents have been excluded from the calculations of diluted net loss per common share because their inclusion would be antidilutive (in thousands):
| Year ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Outstanding stock options | 10,017 | 8,051 | 3,121 |
| Unvested RSAs | 1 | 126 | 742 |
| Unvested RSUs | 1,219 | 923 | 675 |
| 11,237 | 9,100 | 4,538 | |
- Employee Savings Plan
We have an employee savings plan pursuant to Section 401(k) of the Internal Revenue Code. All employees are eligible to participate provided that they meet the requirements of the plan. The Company began making matching contributions under the plan during 2021. The Company has recorded as expense $1.5 million, $1.4 million and $1.0 million in matching contributions for the years ended December 31, 2023, 2022 and 2021 respectively.
- Related Party Disclosures
Tempus
Kimberly Blackwell, M.D., our Chief Executive Officer and a member of our Board of Directors, was previously employed by Tempus Labs, Inc. ("Tempus") and served as an advisor of Tempus until June 2023, at which time Tempus ceased to be a related party of Zentalis. The Company entered into a Master Services Agreement with Tempus in December 2020 to provide data licensing and research services. There were $0.5 million, $0.2 million and $1.0 million incurred for services performed by Tempus for the period in which Tempus was a related party in 2023 and for the years ended December 31, 2022 and 2021, respectively.
Zentera
Kevin D. Bunker, Ph.D., our former Chief Scientific Officer, served as a member of the Board of Directors of Zentera until June 2023, when Dr. Bunker resigned in connection with the termination of our Collaboration and License Agreements with Zentera and the sale of our 40.3% equity stake in Zentera back to Zentera. For additional information, please see Note 3. Accordingly, the Company identified Zentera as a related party up until the date of termination.
In May 2020, each of our wholly owned subsidiaries, Zeno Alpha, Inc., K-Group Alpha, Inc. and K-Group Beta, Inc., entered into Collaboration and License Agreements, pursuant to which we collaborated with Zentera on the development and comm ercialization of the Zentera Collaboration Products, in Greater China. Under the terms of the Collaboration and License Agreements with Zentera, Zentera was responsible for the costs of developing the Zentera Collaboration Products in Greater China, and we were responsible for the costs of developing the Zentera Collaboration Products outside Greater China, provided that Zentera was obligated to reimburse us for a portion of its costs for global data management, pharmacovigilance, safety database management, and chemistry, manufacturing and controls activities with respect to each Zentera Collaboration Product.
For the periods in which Zentera was a related party in 2023 and for the years ended December 31, 2022 and 2021, the amounts incurred under this arrangement totaled $3.5 million, $11.0 million, and $5.3 million, respectively and are presented as contra-research and development expense in the consolidated statement of operations. As disclosed above, these Collaboration and License Agreements were terminated in June 2023 at which time Zentera ceased to be a related party of Zentalis.
- Subsequent Events
On January 5, 2024, we entered into an exclusive, worldwide license agreement with Immunome, Inc. ("Immunome"), under which Immunome licensed from us ZPC-21 (now known as IM-1021), a preclinical ROR1 antibody-drug conjugate ("ADC") with best-in-class potential, and our proprietary ADC platform technology. Under the terms of the deal, we received an up-front payment of $35 million in cash and Immunome common stock. We are eligible to receive up to $275 million of milestone payments for ZPC-21 and other products that utilize the platform technology in addition to mid-to-high single-digit royalties.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.