Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 02, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | INOZYME PHARMA, INC. | |
Entity Central Index Key | 0001693011 | |
Entity Incorporation, State or Country Code | DE | |
Entity File Number | 001-39397 | |
Entity Tax Identification Number | 38-4024528 | |
Entity Address, Address Line One | 321 Summer Street | |
Entity Address, Address Line Two | Suite 400 | |
Entity Address, City or Town | Boston | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02210 | |
City Area Code | 857 | |
Local Phone Number | 330-4340 | |
Title of 12(b) Security | Common stock, par value $0.0001 per share | |
Trading Symbol | INZY | |
Security Exchange Name | NASDAQ | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 61,855,509 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 20,618 | $ 34,588 |
Short-term investments | 145,535 | 154,001 |
Prepaid expenses and other current assets | 8,171 | 7,661 |
Total current assets | 174,324 | 196,250 |
Property and equipment, net | 1,316 | 1,466 |
Restricted cash | 311 | 311 |
Right-of-use assets | 992 | 1,126 |
Prepaid expenses, net of current portion | 0 | 1,694 |
Total assets | 176,943 | 200,847 |
Current liabilities: | ||
Accounts payable | 2,166 | 1,166 |
Accrued expenses | 9,306 | 12,610 |
Operating lease liabilities | 934 | 910 |
Total current liabilities | 12,406 | 14,686 |
Operating lease liabilities, net of current portion | 669 | 913 |
Long term debt, net | 45,032 | 44,769 |
Total liabilities | 58,107 | 60,368 |
Commitments and contingencies (Note 7) | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value - 5,000,000 shares authorized at March 31, 2023 and December 31, 2023; no shares issued and outstanding at March 31, 2023 or December 31, 2023 | 0 | 0 |
Common Stock, $0.0001 par value - 200,000,000 shares authorized at March 31, 2024 and December 31, 2023; 61,816,509 shares issued and outstanding at March 31, 2024 and 61,768,771 shares issued and outstanding at December 31, 2023 | 6 | 6 |
Additional paid in-capital | 428,212 | 426,362 |
Accumulated other comprehensive income (loss) | (105) | 41 |
Accumulated deficit | (309,277) | (285,930) |
Total stockholders’ equity | 118,836 | 140,479 |
Total liabilities and stockholders’ equity | $ 176,943 | $ 200,847 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) (Unaudited) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 61,816,509 | 61,768,771 |
Common stock, shares outstanding | 61,816,509 | 61,768,771 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating expenses: | ||
Research and development | $ 19,111 | $ 11,857 |
General and administrative | 5,234 | 6,512 |
Total operating expenses | 24,345 | 18,369 |
Loss from operations | (24,345) | (18,369) |
Other income (expense): | ||
Interest income | 2,374 | 1,327 |
Interest expense | (1,325) | (328) |
Other income (expense), net | (51) | (34) |
Other income, net | 998 | 965 |
Net loss | (23,347) | (17,404) |
Other comprehensive income (loss): | ||
Unrealized (losses) gains on available-for-sale securities | (156) | 150 |
Foreign currency translation adjustment | 10 | 19 |
Total other comprehensive income (loss) | (146) | 169 |
Comprehensive loss | (23,493) | (17,235) |
Net Income (Loss) | $ (23,347) | $ (17,404) |
Net loss per share attributable to common stockholders- basic | $ (0.38) | $ (0.4) |
Net loss per share attributable to common stockholders- diluted | $ (0.38) | $ (0.4) |
Weighted-average common shares and pre-funded warrants outstanding - basic | 61,772,279 | 43,720,578 |
Weighted-average common shares and pre-funded warrants outstanding - diluted | 61,772,279 | 43,720,578 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive (Loss) Income | Accumulated Deficit |
Balance at Dec. 31, 2022 | $ 118,394 | $ 4 | $ 333,356 | $ (205) | $ (214,761) |
Balance, shares at Dec. 31, 2022 | 40,394,363 | ||||
Stock-based compensation | 2,092 | 2,092 | |||
Exercise of pre-funded warrants, shares | 3,325,644 | ||||
Shares purchased in Employee Stock Purchase Plan | 96 | 96 | |||
Shares purchased in Employee Stock Purchase Plan, shares | 45,478 | ||||
Other comprehensive income (loss): | |||||
Unrealized gain on investments | 150 | 150 | |||
Foreign currency translation adjustment | 19 | 19 | |||
Net loss | (17,404) | (17,404) | |||
Balance at Mar. 31, 2023 | 103,347 | $ 4 | 335,544 | (36) | (232,165) |
Balance, shares at Mar. 31, 2023 | 43,765,485 | ||||
Balance at Dec. 31, 2023 | 140,479 | $ 6 | 426,362 | 41 | (285,930) |
Balance, shares at Dec. 31, 2023 | 61,768,771 | ||||
Stock-based compensation | 1,691 | 1,691 | |||
Exercise of stock options, shares | 3,206 | ||||
Shares purchased in Employee Stock Purchase Plan | 148 | 148 | |||
Shares purchased in Employee Stock Purchase Plan, shares | 44,532 | ||||
Other comprehensive income (loss): | |||||
Unrealized gain on investments | (156) | (156) | |||
Foreign currency translation adjustment | 10 | 10 | |||
Net loss | (23,347) | (23,347) | |||
Balance at Mar. 31, 2024 | $ 118,836 | $ 6 | $ 428,212 | $ (105) | $ (309,277) |
Balance, shares at Mar. 31, 2024 | 61,816,509 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating activities | ||
Net loss | $ (23,347) | $ (17,404) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 182 | 207 |
Stock-based compensation expense | 1,691 | 2,092 |
Amortization of premiums and discounts on marketable securities | (2,116) | (746) |
Reduction in the carrying value of right-of-use assets | 134 | 117 |
Non-cash interest expense and amortization of debt issuance costs | 263 | 80 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (510) | 309 |
Accounts payable | 1,000 | (729) |
Accrued expenses | (3,304) | (1,423) |
Operating lease liabilities | (220) | (197) |
Prepaid expenses, net of current portion | 1,694 | 0 |
Other long-term liabilities | 0 | (78) |
Net cash used in operating activities | (24,533) | (17,772) |
Investing activities | ||
Purchases of marketable securities | (49,324) | (46,059) |
Maturities of marketable securities | 59,750 | 60,000 |
Purchases of property and equipment | (32) | (175) |
Net cash provided by investing activities | 10,394 | 13,766 |
Financing activities | ||
Net proceeds from issuance of long-term debt | 0 | 20,000 |
Proceeds from exercise of stock options | 11 | 0 |
Proceeds from issuance of common stock for cash under Employee Stock Purchase Plan | 148 | 96 |
Net cash provided by financing activities | 159 | 20,096 |
Net (decrease) increase in cash, cash equivalents, and restricted cash | (13,980) | 16,090 |
Effect of foreign currency exchange rate in cash | 10 | 19 |
Cash, cash equivalents and restricted cash at beginning of period | 34,899 | 33,269 |
Cash, cash equivalents and restricted cash at end of period | 20,929 | 49,378 |
Supplemental cash flow information: | ||
Cash and cash equivalents | 20,618 | 49,024 |
Restricted cash | 311 | 354 |
Cash, cash equivalents and restricted cash at end of period | 20,929 | 49,378 |
Property and equipment unpaid at end of period | $ 0 | $ 5 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (23,347) | $ (17,404) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Organization and Basis of Prese
Organization and Basis of Presentation | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Basis of Presentation | 1. Organization an d Basis of Presentation Inozyme Pharma, Inc. (the “Company”) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases impacting the vasculature, soft tissue, and skeleton. Through the Company’s in-depth understanding of a key biological pathway, the Company is pursuing the development of therapeutics that address pathologic mineralization and intimal proliferation, or smooth muscle cell overgrowth that leads to narrowing and the obstruction of blood vessels, to improve the underlying causes of these debilitating diseases. It is well established that low levels of plasma pyrophosphate ("PPi") drive pathologic mineralization and low levels of adenosine drive intimal proliferation in a number of rare diseases. The Company is initially focused on developing a novel therapy for diseases characterized by pathological calcification and intimal proliferation, including ENPP1 Deficiency and ABCC6 Deficiency as well as calciphylaxis. The Company’s lead product candidate, INZ-701, is a soluble, recombinant, or genetically engineered, fusion protein that is designed to cleave extracellular adenosine triphosphate to generate plasma PPi and adenosine monophosphate, which can be processed to phosphate and adenosine. This process is central to the regulation of calcium deposition throughout the body and is further associated with the inhibition of intimal proliferation. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles ("U.S. GAAP") for interim financial information. Accordingly, these unaudited condensed consolidated financial statements do not include all of the information and note disclosures required by U.S. GAAP for audited year-end financial statements. The accompanying unaudited condensed consolidated financial statements reflect all normal recurring adjustments that are, in the opinion of management, necessary for a fair presentation of the interim period results. The results for the three month period ended March 31, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024, any other interim periods, or any future year or period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2023 . Liquidity, Capital Resources, and Going Concern Since the Company’s incorporation in 2017 and through March 31, 2024, the Company has devoted substantially all of its efforts to raising capital, building infrastructure, developing intellectual property, and conducting res earch and development activities. The Company incurred net losses of $ 24.3 million for the three months ended March 31, 2024 and had an accumulated deficit of $ 309.3 million as of March 31, 2024. The Company had cash, cash equivalents, and short-term investments of $ 166.2 million as of March 31, 2024. The Company has incurred recurring losses and negative cash flows from operations since inception and has primarily funded its operations with proceeds from the issuance of convertible preferred stock, offerings of common stock and pre-funded warrants, and its loan and security agreement (the “Loan Agreement”) with K2 HealthVentures LLC (see Note 8). The Company expects its operating losses and negative operating cash flows to continue into the foreseeable future as it continues to expand its research and development efforts. The accompanying condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets, and the satisfaction of liabilities and commitments in the ordinary course of business. The Company believes its available cash, cash equivalents, and short-term investments as of March 31, 2024 will be sufficient to fund its cash flow requirements for at least 12 months from the filing date of this Quarterly Report on Form 10-Q. Management’s expectations with respect to its ability to fund current and long-term planned operations are based on estimates that are subject to risks and uncertainties. If actual results are different from management’s estimates, the Company may need to seek additional strategic or financing opportunities sooner than would otherwise be expected. However, there is no guarantee that any of these strategic or financing opportunities will be executed on favorable terms, or at all, and some could be dilutive to existing stockholders. If the Company is unable to obtain additional funding on a timely basis, it may be forced to delay, reduce, or eliminate some or all of its research and development programs, portfolio expansion, or commercialization efforts, which could adversely affect its business prospects. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Inozyme Securities Corp., which is a Massachusetts subsidiary created to buy, sell, and hold securities; Inozyme Ireland Limited; and Inozyme Pharma Switzerland GmbH. All intercompany transactions and balances have been eliminated. Summary of Significant Accounting Policies The significant accounting policies and estimates used in the preparation of the accompanying condensed consolidated financial statements are described in the Company’s audited consolidated financial statements for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. There have been no material changes in the Company’s significant accounting policies during the three months ended March 31, 2024 . Use of Estimates The preparation of the Company’s financial statements 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 financial statements and the reported amounts of expenses during the reporting period. Estimates and judgments are based on historical information and other market-specific or various relevant assumptions, including, in certain circumstances, future projections that management believes to be reasonable under the circumstances. Actual results could differ materially from estimates. Significant estimates and assumptions are used for, but not limited to, the accruals for research and development expenses. The Company evaluates its estimates and assumptions on an ongoing basis. All revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected. Concentration of Credit Risk and Off-Balance Sheet Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, and short-term investments and, from time to time, long-term investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits and limits its exposure to credit risk by placing its cash with high credit quality financial institutions. The Company’s investments are currently composed of U.S. Treasury securities and U.S. government agency debt securities. The Company mitigates credit risk by maintaining a diversified portfolio and limiting the amount of investment exposure as to institution, maturity, and investment type. The Company has no significant off-balance sheet risk such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. Cash and cash equivalents include cash in readily available checking accounts, money market accounts, and certain marketable securities. Cash is carried at cost, which approximates its fair value. Cash equivalents are carried at fair market value. Restricted Cash Restricted cash is composed of amounts held to collateralize the letter of credit related to the Company’s lease arrangements. Restricted cash is classified as either current or non-current based on the terms of the underlying lease arrangement. |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Changes and Error Corrections [Abstract] | |
Recent Accounting Pronouncements | 3. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board ("FASB") or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. |
Short-Term Investments
Short-Term Investments | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Short-Term Investments | 4. Short-Term Investments Short-term investments consisted of the following: March 31, 2024 Description Maturity Amortized Gross Gross Estimated U.S. Treasury securities 1 year or less $ 66,767 $ 3 $ ( 38 ) $ 66,732 U.S. government agency debt securities 1 year or less 78,857 — ( 54 ) 78,803 $ 145,624 $ 3 $ ( 92 ) $ 145,535 December 31, 2023 Description Maturity Amortized Gross Gross Estimated U.S. Treasury securities 1 year or less $ 80,160 $ 59 $ ( 1 ) $ 80,218 U.S. government agency debt securities 1 year or less 73,774 17 ( 8 ) 73,783 $ 153,934 $ 76 $ ( 9 ) $ 154,001 The Company did no t have any investments in a continuous unrealized loss position for more than 12 months as of March 31, 2024. As of March 31, 2024 , the Company believes that the cost basis of its available-for-sale securities is recoverable, and the Company has the intent and ability to hold its available-for-sale securities until recovery. Therefore, no allowance for credit losses was recorded. |
Fair Value Measurement
Fair Value Measurement | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurement | 5. Fair Value Measurement Fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: • Level 1 – Unadjusted quoted prices in active markets that are accessible at the measurement date for identical assets or liabilities; • Level 2 – Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; or • Level 3 – Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). The following tables represent the Company’s financial assets measured at fair value on a recurring basis and indicate the level of fair value hierarchy utilized to determine such fair values: Fair Value Measurements at Reporting Date Description March 31, Level 1 Level 2 Level 3 Assets: Money market funds (included in cash and cash equivalents) $ 19,660 $ 19,660 $ — $ — U.S. government agency debt securities 78,803 — 78,803 — U.S. Treasury securities 66,732 66,732 — — Total assets $ 165,195 $ 86,392 $ 78,803 $ — Fair Value Measurements at Reporting Date Description December 31, Level 1 Level 2 Level 3 Assets: Money market funds (included in cash and cash equivalents) $ 33,830 $ 33,830 $ — $ — U.S. government agency debt securities 73,783 — 73,783 — U.S. Treasury securities 80,218 80,218 — — Total assets $ 187,831 $ 114,048 $ 73,783 $ — There have been no transfers between fair value levels during the three months ended March 31, 2024 . |
License Agreement
License Agreement | 3 Months Ended |
Mar. 31, 2024 | |
Research and Development [Abstract] | |
License Agreement | 6. License Agreement In January 2017, the Company entered into a license agreement with Yale University (“Yale”), which was amended in May 2020 and July 2020, under which the Company licensed certain intellectual property related to ectonucleotide pyrophosphatase/phosphodiesterase enzymes that is the basis for the Company’s INZ-701 development program. Pursuant to the license agreement, as partial upfront consideration, the Company made a payment of appro ximately $ 0.1 million to Yale, which amount reflected unreimbursed patent expenses incurred by Yale prior to the date of the license agreement. The Company is responsible for paying Yale an annual license maintenance fee in varying amounts throughout the term ranging from the low tens of thousands of dollars to the high tens of thousands of dollars. As of March 31, 2024 , the Company had incurred a life-to-date total of $ 0.4 million in license maintenance fees to Yale. The Company is required to pay Yale up to $ 3.0 million, based on the achievement of a specified net product sales milestone or specified development and commercialization milestones, for each therapeutic and prophylactic-licensed product developed. In January 2022, the Company paid Yale an approximately $ 0.3 million milestone payment following dosing of the first patient in the Company’s Phase 1/2 clinical trial of INZ-701 in adult patients with ENPP1 Deficiency in November 2021. In March 2022, the Company paid Yale an approximately $ 0.3 million milestone payment following completion of the first cohort of the Company's Phase 1/2 clinical trial of INZ-701 in adult patients with ENPP1 Deficiency in January 2022. In the three months ended March 31, 2024, the Company incurred a $ 0.5 million milestone payment following completion of dosing of the first patient in the Company’s pivotal clinical trial of INZ-701 in pediatric patients with ENPP1 Deficiency. In addition, the Company is required to pay Yale an amount in the several hundreds of thousands of dollars, based on the achievement of a specified net product sales milestone or specified development and commercialization milestones, for each diagnostic licensed product developed. While the agreement remains in effect, the Company is required to pay Yale low single-digit percentage royalties on aggregate worldwide net sales of certain licensed products, which may be subject to reductions. Yale is guaranteed a minimum royalty payment amount (ranging in dollar amounts from the mid six figures to low seven figures) for each year after the first sale of a therapeutic or prophylactic-licensed product that results in net sales. Yale is guaranteed a minimum royalty payment amount (ranging from the low tens of thousands of dollars to the mid tens of thousands of dollars) for each year after the first sale of a diagnostic licensed product that results in net sales. Such minimum royalty payment amounts are summed for each year after the first sale of both a therapeutic or prophylactic-licensed product and a diagnostic licensed product has occurred. The Company must also pay Yale a percentage in the twenties of certain types of income it receives from sublicensees. The Company is also responsible for costs relating to the prosecution and maintenance of the licensed patents. Finally, subject to certain conditions, all payments due by the Company to Yale will be tripled following any patent challenge or challenge to a claim by Yale that a product is a licensed product under the agreement, made by the Company against Yale if Yale prevails in such challenge. The Company has also agreed to pay for research support from Yale pursuant to a sponsored research agreement that the Company entered into with Yale in January 2017 and amended in February 2019, February 2022, May 2022, May 2023, and January 2024. Under the sponsored research agreement, as amended, the Company agreed to pay Yale an aggregate of $ 3.0 million over eight years, ending in December 2024. As of March 31, 2024 , the Company incurred a total of $ 2.8 million for research support under this agreement since inception. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies Operating Leases The Company held the following significant operating leases as of March 31, 2024: • 8,499 square feet of office space in Boston, Massachusetts that expires in 2025 with an option to extend the term for five years ; and • 6,244 square feet of laboratory space in Boston, Massachusetts that expires in 2025 with an option to extend the term for five years . The exercise of each option was determined not to be reasonably certain and thus neither option was included in the operating lease liability on the condensed consolidated balance sheets as of March 31, 2024 or December 31, 2023. During the three months ended March 31, 2024, cash paid for amounts included in the measurement of lease liabilities was $ 0.3 million, and the Company recorded operating lease expense of $ 0.2 million. Future lease payments under non-cancelable leases as of March 31, 2024 are as follows: Year Ending December 31, 2024 (remaining 9 months) $ 762 2025 944 $ 1,706 Indemnification Agreements In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners, and other parties with respect to certain matters arising out of the relationship between such parties and the Company. In addition, the Company has entered into indemnification agreements with members of its board of directors and senior management that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not aware of any claims under indemnification arrangements, and it has not accrued any liabilities related to such obligations as of March 31, 2024 or December 31, 2023. Legal Proceedings The Company is not currently a party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses the costs related to its legal proceedings as they are incurred. No such costs have been incurred during the three months ended March 31, 2024 and 2023 . |
Convertible Debt
Convertible Debt | 3 Months Ended |
Mar. 31, 2024 | |
Debt Disclosure [Abstract] | |
Convertible Debt | 8. Convertible Debt Loan Agreement with K2 HealthVentures LLC On July 25, 202 2, the Company, as borrower, entered into the Loan Agreement with K2 HealthVentures LLC ( together with any other lender from time to time, the “Lenders”), as administrative agent for the Lenders, and Ankura Trust Company, LLC, as collateral agent for the Lenders. The Loan Agreement provides up to $ 70.0 million principal in term loans, subject to certain customary conditions. The Company received $ 5.0 million from the first tranche commitment upon closing. The first tranche commitment contained an additional $ 20.0 million available to be drawn at the Company’s option through March 31, 2023. The Company elected to borrow the remaining $ 20.0 million in February 2023. Two subsequent tranche commitments totaling $ 20.0 million in the aggregate were available to be drawn at the Company’s option during certain availability periods, subject to the achievement of certain clinical and regulatory milestones relating to INZ-701. The Company borrowed $ 7.5 million under the second tranche commitment in June 2023 and borrowed $ 12.5 million under the third tranche commitment in December 2023. A fourth tranche commitment of $ 25.0 million may be made available to be drawn down at the Company’s option through August 31, 2025, subject to use of proceeds limitations and Lender's consent at its discretion. The fourth tranche commitment is subject to an additional 0.75 % facility fee. As of March 31, 2024 , a total of $ 25.0 million of borrowing capacity remained available under the Loan Agreement, subject to the terms and conditions set forth therein. As security for its obligations under the Loan Agreement, the Company granted the Lenders a first priority security interest on substantially all of the Company’s assets (other than intellectual property), subject to certain exceptions. The term loan matures on August 1, 2026 , and the Company is obligated to make interest only payments for the first 36 months and then interest and equal principal payments through the maturity date. The term loan bears a variable interest rate equal to the greater of (i) 7.85 %, and (ii) the sum of (A) the prime rate last quoted in The Wall Street Journal (or a comparable replacement rate if The Wall Street Journal ceases to quote such rate) and (B) 3.85 %; provided that the interest rate cannot exceed 9.60% . The interest rate as of March 31, 2024 was 9.60 %. The Company has the option to prepay all, but not less than, the outstanding principal balance and all accrued and unpaid interest with respect to the principal balance being repaid of the term loans, subject to a prepayment premium to which the Lenders are entitled. The prepayment fee is 3 % prior to the second anniversary of the July 25, 2022 funding date, 2 % after the second anniversary but prior to the third anniversary of the funding date, and 1 % thereafter if prior to the maturity date. Upon final payment or prepayment of the loans, the Company must pay a final payment equal to 6.25 % of the loans borrowed ("Final Fee"), which is being accrued as interest expense over the term of the loan using the effective interest method. The Lenders may elect, prior to the full repayment of the term loans, to convert up to $ 5.0 million of outstanding principal of the term loans into shares of the Company’s common stock, at a conversion price of $ 6.21 per share, subject to customary adjustments and 9.99 % and 19.99 % beneficial ownership limitations. The Company determined that the embedded conversion option was not required to be separated from the term loan. The embedded conversion option met the derivative accounting scope exception since the embedded conversion option is indexed to the Company’s own common stock and qualifies for classification within stockholders’ equity. The Loan Agreement contains customary representations and warranties, events of default and affirmative and negative covenants, including covenants that limit or restrict the Company’s ability to, among other things, dispose of assets, make changes to the Company’s business, management, ownership or business locations, merge or consolidate, incur additional indebtedness, incur additional liens, pay dividends or other distributions or repurchase equity, make investments, and enter into certain transactions with affiliates, in each case subject to certain exceptions. Upon the occurrence of an event of default, a default interest rate of an additional 5.00 % per annum may be applied to the outstanding loan balances, and the Lender may declare all outstanding obligations immediately due and payable and exercise all of its rights and remedies as set forth in the Loan Agreement and under applicable law. As of March 31, 2024, the Company was in compliance with all covenants under the Loan Agreement. Subject to certain conditions, the Company granted the Lenders the right, prior to repayment of the term loans, to invest up to $ 5.0 million in the aggregate in future offerings of common stock, convertible preferred stock, or other equity securities of the Company that are broadly marketed and offered to multiple investors on the same terms, conditions, and pricing afforded to others participating in any such financing. The Company incurred debt issuance costs of $ 0.5 million in connection with the term loan. In addition, at the time of closing, the Company paid to the Lenders a facility fee of $ 0.4 million, as well as $ 0.1 million of other expenses incurred by the Lenders and reimbursed by the Company (“Lender Expenses”). The debt issuance costs, Lender Expenses, and the Final Fee are being amortized as additional interest expense over the term of the loan using the effective interest method. At March 31, 2024, the carrying value of the Loan Agreement approximated the fair value of the term loan, considering that it bears interest that is similar to prevailing market rates. The following table summarizes the impact of the term loan on the Company’s condensed consolidated balance sheet at March 31, 2024: March 31, Gross proceeds $ 45,000 Unamortized debt issuance costs and accretion of final payments, net 32 Carrying value $ 45,032 Future principal payments, which include the Final Fee, in connection with the Loan Agreement as of March 31, 2024 are as follows: Fiscal Year 2024 $ — 2025 $ 14,508 2026 33,305 Total $ 47,813 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
Stockholders' Equity | 9. Stockholders’ Equity July 2023 Underwritten Offering On July 27, 2023, the Company entered into an underwriting agreement with BofA Securities, Inc., Cowen and Company, LLC and Piper Sandler & Co., as representatives of the several underwriters named therein (collectively, the “Underwriters”), relating to an underwritten public offering of 14,375,000 shares of the Company's common stock, which included 1,875,000 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares (the "July 2023 Shares"). The closing of the offering took place on August 1, 2023. All of the July 2023 Shares were sold by the Company. The offering price of the July 2023 Shares was $ 4.80 per share. Net proceeds from the sale and issuance of the July 2023 Shares were approximately $ 64.4 million, after deducting underwriting discounts and commissions and offering expenses. Open Market Sale Agreement On August 11, 2021, the Company filed a universal shelf registration statement on Form S-3, which was declared effective on August 23, 2021 (the "Registration Statement"). Under the Registration Statement, the Company may offer and sell up to $ 200.0 million of a variety of securities, including common stock, preferred stock, depositary shares, debt securities, warrants, subscription rights or units from time to time pursuant to one or more offerings at prices and terms to be determined at the time of the sale. In connection with the filing of the Registration Statement, the Company entered into an Open Market Sale Agreement with Jefferies LLC, as sales agent, pursuant to which the Company may offer and sell shares of its common stock with an aggregate offering price of up to $ 50.0 million under an “at-the-market” offering program. As of December 31, 2023, the Company had sold 3,553,995 shares of its common stock pursuant to the Open Market Sale Agreement for aggregate net proceeds of $ 21.2 million. No shares of the Company's common stock were sold pursuant to the Open Market Sale Agreement during the three months ended March 31, 2024. Equity Incentive Plans On July 17, 2020, the Company’s stockholders approved the 2020 Stock Incentive Plan (the “2020 Plan”), which became effective on July 23, 2020. The 2020 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock units, and other stock-based awards. On February 27, 2023, the Company's board of directors adopted the 2023 Inducement Stock Incentive Plan (the "Inducement Plan"). The Inducement Plan provides for the grant of non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock units and other stock-based awards to persons who (a) were not previously an employee or director or (b) are commencing employment with the Company following a bona fide period of non-employment, in either case, as an inducement material to such person’s entry into employment with the Company and in accordance with the requirements of the Nasdaq Stock Market Rule 5635(c)(4). Stock Options The Company estimates the fair value of stock options using the Black-Scholes option-pricing model. The underlying assumptions used to value stock options granted to participants using the Black-Scholes option-pricing model were as follows: For the Three Months Ended March 31, 2024 2023 Risk-free interest rate range 3.78 % to 4.22 % 3.36 % to 4.15 % Dividend yield — — Expected term of options (years) 6.02 to 6.08 5.73 to 6.48 Volatility rate range 88.35 % to 88.55 % 87.68 % to 88.77 % The weighted-average grant date fair value of options granted in the three months ended March 31, 2024 was $ 4.35 per share. The total unrecognized compensation cost related to outstanding option awards as of March 31, 2024 was $ 21.6 million and is expected to be recognized over a weighted-average period of 3.09 years. Restricted Stock Units The total unrecognized compensation cost related to outstanding RSUs as of March 31, 2024 was $ 0.4 million and is expected to be recognized over a weighted-average period of 3.0 years. The total compensation cost recognized in the condensed consolidated statements of operations associated with all the stock-based compensation awards granted by the Company is as follows: Three Months Ended March 31, 2024 2023 Research and development $ 849 $ 818 General and administrative 842 1,274 Total $ 1,691 $ 2,092 |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 10. Net Loss per Share Net Loss per Share Attributable to Common Stockholders The following table sets forth the computation of basic and diluted net loss per share: Three Months Ended March 31, 2024 2023 Net loss attributable to common stockholders—basic $ ( 23,347 ) $ ( 17,404 ) Net loss per share attributable to common $ ( 0.38 ) $ ( 0.40 ) Weighted-average common shares and pre-funded warrants outstanding—basic 61,772,279 43,720,578 The Company generated a net loss in all periods presented; therefore, the basic and diluted net loss per share attributable to common stockholders are the same, as the inclusion of the potentially dilutive securities would be anti-dilutive. Since the shares underlying the pre-funded warrants were issuable for little or no consideration, they were considered outstanding for both basic and diluted loss per share from the date of issuance. The Company excluded the following potential shares of common stock, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated: Three Months Ended March 31, 2024 2023 Options to purchase common stock 9,223,135 5,505,608 Unvested RSUs 100,000 — Total 9,323,135 5,505,608 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles ("U.S. GAAP") for interim financial information. Accordingly, these unaudited condensed consolidated financial statements do not include all of the information and note disclosures required by U.S. GAAP for audited year-end financial statements. The accompanying unaudited condensed consolidated financial statements reflect all normal recurring adjustments that are, in the opinion of management, necessary for a fair presentation of the interim period results. The results for the three month period ended March 31, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024, any other interim periods, or any future year or period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2023 . |
Principles of Consolidation | Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Inozyme Securities Corp., which is a Massachusetts subsidiary created to buy, sell, and hold securities; Inozyme Ireland Limited; and Inozyme Pharma Switzerland GmbH. All intercompany transactions and balances have been eliminated. Summary of Significant Accounting Policies The significant accounting policies and estimates used in the preparation of the accompanying condensed consolidated financial statements are described in the Company’s audited consolidated financial statements for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. There have been no material changes in the Company’s significant accounting policies during the three months ended March 31, 2024 . |
Use of Estimates | Use of Estimates The preparation of the Company’s financial statements 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 financial statements and the reported amounts of expenses during the reporting period. Estimates and judgments are based on historical information and other market-specific or various relevant assumptions, including, in certain circumstances, future projections that management believes to be reasonable under the circumstances. Actual results could differ materially from estimates. Significant estimates and assumptions are used for, but not limited to, the accruals for research and development expenses. The Company evaluates its estimates and assumptions on an ongoing basis. All revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected. |
Concentration of Credit Risk and Off-Balance Sheet Risk | Concentration of Credit Risk and Off-Balance Sheet Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, and short-term investments and, from time to time, long-term investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits and limits its exposure to credit risk by placing its cash with high credit quality financial institutions. The Company’s investments are currently composed of U.S. Treasury securities and U.S. government agency debt securities. The Company mitigates credit risk by maintaining a diversified portfolio and limiting the amount of investment exposure as to institution, maturity, and investment type. The Company has no significant off-balance sheet risk such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. Cash and cash equivalents include cash in readily available checking accounts, money market accounts, and certain marketable securities. Cash is carried at cost, which approximates its fair value. Cash equivalents are carried at fair market value. |
Restricted Cash | Restricted Cash Restricted cash is composed of amounts held to collateralize the letter of credit related to the Company’s lease arrangements. Restricted cash is classified as either current or non-current based on the terms of the underlying lease arrangement. |
Short-Term Investments (Tables)
Short-Term Investments (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Short-Term Investments | Short-term investments consisted of the following: March 31, 2024 Description Maturity Amortized Gross Gross Estimated U.S. Treasury securities 1 year or less $ 66,767 $ 3 $ ( 38 ) $ 66,732 U.S. government agency debt securities 1 year or less 78,857 — ( 54 ) 78,803 $ 145,624 $ 3 $ ( 92 ) $ 145,535 December 31, 2023 Description Maturity Amortized Gross Gross Estimated U.S. Treasury securities 1 year or less $ 80,160 $ 59 $ ( 1 ) $ 80,218 U.S. government agency debt securities 1 year or less 73,774 17 ( 8 ) 73,783 $ 153,934 $ 76 $ ( 9 ) $ 154,001 |
Fair Value Measurement (Tables)
Fair Value Measurement (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Assets Measured at Fair Value | The following tables represent the Company’s financial assets measured at fair value on a recurring basis and indicate the level of fair value hierarchy utilized to determine such fair values: Fair Value Measurements at Reporting Date Description March 31, Level 1 Level 2 Level 3 Assets: Money market funds (included in cash and cash equivalents) $ 19,660 $ 19,660 $ — $ — U.S. government agency debt securities 78,803 — 78,803 — U.S. Treasury securities 66,732 66,732 — — Total assets $ 165,195 $ 86,392 $ 78,803 $ — Fair Value Measurements at Reporting Date Description December 31, Level 1 Level 2 Level 3 Assets: Money market funds (included in cash and cash equivalents) $ 33,830 $ 33,830 $ — $ — U.S. government agency debt securities 73,783 — 73,783 — U.S. Treasury securities 80,218 80,218 — — Total assets $ 187,831 $ 114,048 $ 73,783 $ — |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Lease Payments Under Non-Cancelable Leases | Future lease payments under non-cancelable leases as of March 31, 2024 are as follows: Year Ending December 31, 2024 (remaining 9 months) $ 762 2025 944 $ 1,706 |
Convertible Debt (Tables)
Convertible Debt (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Debt Disclosure [Abstract] | |
Summarizes of impact Term Loan | The following table summarizes the impact of the term loan on the Company’s condensed consolidated balance sheet at March 31, 2024: March 31, Gross proceeds $ 45,000 Unamortized debt issuance costs and accretion of final payments, net 32 Carrying value $ 45,032 |
Future principal payment of Loan Agreement | Future principal payments, which include the Final Fee, in connection with the Loan Agreement as of March 31, 2024 are as follows: Fiscal Year 2024 $ — 2025 $ 14,508 2026 33,305 Total $ 47,813 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Summary of Assumptions Used to Value Stock Options Granted Using Black-Scholes Option-Pricing | The underlying assumptions used to value stock options granted to participants using the Black-Scholes option-pricing model were as follows: For the Three Months Ended March 31, 2024 2023 Risk-free interest rate range 3.78 % to 4.22 % 3.36 % to 4.15 % Dividend yield — — Expected term of options (years) 6.02 to 6.08 5.73 to 6.48 Volatility rate range 88.35 % to 88.55 % 87.68 % to 88.77 % |
Summary of Total Compensation Cost Recognized in Statements of Operations | The total compensation cost recognized in the condensed consolidated statements of operations associated with all the stock-based compensation awards granted by the Company is as follows: Three Months Ended March 31, 2024 2023 Research and development $ 849 $ 818 General and administrative 842 1,274 Total $ 1,691 $ 2,092 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Schedule of Net Loss Per Share, Basic and Diluted | The following table sets forth the computation of basic and diluted net loss per share: Three Months Ended March 31, 2024 2023 Net loss attributable to common stockholders—basic $ ( 23,347 ) $ ( 17,404 ) Net loss per share attributable to common $ ( 0.38 ) $ ( 0.40 ) Weighted-average common shares and pre-funded warrants outstanding—basic 61,772,279 43,720,578 |
Schedule of Potential Dilutive Securities Excluded from Computation of Earning Per Share | The Company excluded the following potential shares of common stock, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated: Three Months Ended March 31, 2024 2023 Options to purchase common stock 9,223,135 5,505,608 Unvested RSUs 100,000 — Total 9,323,135 5,505,608 |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Subsidiary, Sale of Stock [Line Items] | |||
Net loss | $ (23,347) | $ (17,404) | |
Operating Expenses | 24,345 | $ 18,369 | |
Accumulated deficit | (309,277) | $ (285,930) | |
Cash and cash equivalents and short term investments | $ 166,200 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Accounting Policies [Abstract] | |
Off-balance sheet concentrations of credit risk description | The Company has no significant off-balance sheet risk such as foreign exchange contracts, option contracts, or other foreign hedging arrangements. |
Off-balance sheet concentrations of credit risk | $ 0 |
Short-Term Investments - Schedu
Short-Term Investments - Schedule of Short-Term Investments (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2024 | Dec. 31, 2023 | |
Schedule Of Available For Sale Securities [Line Items] | ||
Amortized Costs | $ 145,624 | $ 153,934 |
Gross Unrealized Gains | 3 | 76 |
Gross Unrealized Losses | (92) | (9) |
Estimated Fair Value | $ 145,535 | $ 154,001 |
U.S. Treasury Securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity | 1 year or less | 1 year or less |
Amortized Costs | $ 66,767 | $ 80,160 |
Gross Unrealized Gains | 3 | 59 |
Gross Unrealized Losses | (38) | (1) |
Estimated Fair Value | $ 66,732 | $ 80,218 |
U.S. government agency debt securities | ||
Schedule Of Available For Sale Securities [Line Items] | ||
Maturity | 1 year or less | 1 year or less |
Amortized Costs | $ 78,857 | $ 73,774 |
Gross Unrealized Gains | 0 | 17 |
Gross Unrealized Losses | (54) | (8) |
Estimated Fair Value | $ 78,803 | $ 73,783 |
Short-Term Investments - Additi
Short-Term Investments - Additional Information (Details) $ in Thousands | Mar. 31, 2024 USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Investments in a continuous unrealized loss position, 12 months or longer | $ 0 |
Debt securities, available for sale, allowance for credit loss | $ 0 |
Short-Term Investments - Sche_2
Short-Term Investments - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Payables and Accruals [Abstract] | ||
Total | $ 9,306 | $ 12,610 |
Fair Value Measurement - Summar
Fair Value Measurement - Summary of Financial Assets Measured at Fair Value (Details) - Recurring - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | $ 165,195 | $ 187,831 |
Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents fair value disclosure | 19,660 | 33,830 |
Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 86,392 | 114,048 |
Level 1 | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents fair value disclosure | 19,660 | 33,830 |
Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 78,803 | 73,783 |
Level 2 | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents fair value disclosure | 0 | 0 |
Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 0 | 0 |
Level 3 | Money Market Funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents fair value disclosure | 0 | 0 |
U.S. Treasury Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 66,732 | 80,218 |
U.S. Treasury Securities | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 66,732 | 80,218 |
U.S. Treasury Securities | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 0 | 0 |
U.S. Treasury Securities | Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 0 | 0 |
U.S. Government Agency Debt Securities | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 78,803 | 73,783 |
U.S. Government Agency Debt Securities | Level 1 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 0 | 0 |
U.S. Government Agency Debt Securities | Level 2 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | 78,803 | 73,783 |
U.S. Government Agency Debt Securities | Level 3 | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value disclosure | $ 0 | $ 0 |
Fair Value Measurement - Additi
Fair Value Measurement - Additional Information (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Fair Value Disclosures [Abstract] | |
Fair value measurement with unobservable inputs reconciliation recurring basis asset transfers into level 3 | $ 0 |
License and Sponsored Research
License and Sponsored Research Agreements - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |||
Mar. 31, 2024 | Mar. 31, 2023 | Mar. 31, 2022 | Nov. 30, 2021 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Research and development | $ 19,111 | $ 11,857 | ||
Yale University [Member] | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Partial upfront consideration payment under license agreement | 100 | |||
Milestone payment upon achievement of certain milestones | 3,000 | $ 300 | $ 300 | |
Yale University [Member] | Sponsored Research Agreement | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Research and development | 3,000 | |||
Research support funding amount | 2,800 | |||
Yale University [Member] | Clinical Trial[Member] | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Milestone payment upon achievement of certain milestones | 500 | |||
Yale University [Member] | License [Member] | ||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||
Maintenance fees | $ 400 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 USD ($) ft² | Mar. 31, 2023 USD ($) | |
Lessee Lease Description [Line Items] | ||
Operating lease liabilities | $ 300 | |
Operating lease expense | 200 | |
Costs related to legal proceedings | $ 0 | $ 0 |
Office Space | Boston, Massachusetts | ||
Lessee Lease Description [Line Items] | ||
Area of leased space | ft² | 8,499 | |
Lessee operating lease expiration year | 2025 | |
Lessee, Operating Lease, Existence of Option to Extend [true false] | true | true |
Lessee operating lease option to extend description | option to extend the term for five years | |
Operating lease renewal term | 5 years | |
Laboratory Space | Boston, Massachusetts | ||
Lessee Lease Description [Line Items] | ||
Area of leased space | ft² | 6,244 | |
Lessee operating lease expiration year | 2025 | |
Lessee, Operating Lease, Existence of Option to Extend [true false] | true | |
Lessee operating lease option to extend description | option to extend the term for five years |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Future Lease Payments Under Non-Cancelable Leases (Details) $ in Thousands | Mar. 31, 2024 USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2024 (remaining 9 months) | $ 762 |
2025 | 944 |
Operating lease liability | $ 1,706 |
Convertible Debt (Additional In
Convertible Debt (Additional Information) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |||
Jul. 25, 2022 | Mar. 31, 2024 | Dec. 31, 2023 | Jun. 30, 2023 | |
Debt Instrument [Line Items] | ||||
Loan amount | $ 45,032 | $ 44,769 | ||
Annual rate of interest for the debt | 7.85 | 9.60 | ||
Additional Interest rate for debt instrument | 3.85% | |||
Payment Description for Debt | the Company is obligated to make interest only payments for the first 36 months and then interest and equal principal payments through the maturity date. The term loan bears a variable interest rate equal to the greater of (i) 7.85%, and (ii) the sum of (A) the prime rate last quoted in The Wall Street Journal (or a comparable replacement rate if The Wall Street Journal ceases to quote such rate) and (B) 3.85%; provided that the interest rate cannot exceed 9.60% | |||
Prepayment of Loans | 6.25% | |||
Additional facility fee | 5% | |||
K2HV [Member] | ||||
Debt Instrument [Line Items] | ||||
Loan amount | $ 70,000 | $ 25,000 | ||
Loan Maturity Date | Aug. 01, 2026 | |||
Debt instrument conversion price | $ 6.21 | |||
Customary percentage | 9.99% | |||
Beneficial ownership limitation percentage | 19.99% | |||
Maximum [Member] | K2HV [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, Amount converted to common stock upon lender's choice | $ 5,000 | |||
Future offerings of common stock | $ 5,000 | |||
Share Based Compensation Award Tranche One [Member] | ||||
Debt Instrument [Line Items] | ||||
Prepayment fee percentage | 3% | |||
Share Based Compensation Award Tranche One [Member] | K2HV [Member] | ||||
Debt Instrument [Line Items] | ||||
Loan amount | $ 5,000 | |||
Additional loan amount | $ 20,000 | |||
Share Based Compensation Award Tranche Two [Member] | ||||
Debt Instrument [Line Items] | ||||
Prepayment fee percentage | 2% | |||
Share Based Compensation Award Tranche Two [Member] | K2HV [Member] | ||||
Debt Instrument [Line Items] | ||||
Loan amount | $ 20,000 | $ 7,500 | $ 12,500 | |
Share Based Compensation Award Tranche Four [Member] | ||||
Debt Instrument [Line Items] | ||||
Prepayment fee percentage | 1% | |||
Share Based Compensation Award Tranche Four [Member] | K2HV [Member] | ||||
Debt Instrument [Line Items] | ||||
Loan amount | $ 25,000 | |||
Additional facility fee | 0.75% | |||
Term Loan [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt issuance cost | $ 500 | |||
Lenders facility fee | 400 | |||
Lenders reimbursed amount | $ 100 |
Convertible Debt - Summarizes o
Convertible Debt - Summarizes of impact Term Loan (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Debt Disclosure [Abstract] | ||
Gross Proceeds | $ 45,000 | |
Unamortized debt issuance costs and accretion of final payments, net | 32 | |
Total | $ 45,032 | $ 44,769 |
Convertible Debt - Future princ
Convertible Debt - Future principal payments (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Fiscal Year | ||
Total | $ 45,032 | $ 44,769 |
K2 Loan Agreement [Member] | ||
Fiscal Year | ||
2024 | 0 | |
2025 | 14,508 | |
2026 | 33,305 | |
Total | $ 47,813 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | |||
Jul. 27, 2023 | Mar. 31, 2024 | Dec. 31, 2023 | Aug. 11, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Common Stock, Par or Stated Value Per Share | $ 0.0001 | $ 0.0001 | ||
Plan description | On July 17, 2020, the Company’s stockholders approved the 2020 Stock Incentive Plan (the “2020 Plan”), which became effective on July 23, 2020. The 2020 Plan provides for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock units, and other stock-based awards. | |||
Additional shares issued | 1,875,000 | |||
Employee Stock Option | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Weighted-average grant date fair value of options granted | $ 4.35 | |||
Total unrecognized compensation cost related to outstanding employee awards | $ 21.6 | |||
Total unrecognized compensation cost related to outstanding employee awards, expected to be recognized over a weighted-average period | 3 years 1 month 2 days | |||
Restricted Stock Units (RSUs) [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total unrecognized compensation cost related to outstanding employee awards | $ 0.4 | |||
Employee Service ShareBased Compensation Nonvested Awards Total Compensation Cost Not Yet Recognized Period ForRecognition 2 | 3 years | |||
Jefferies LLC | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Proceeds from issuance or sale of equity | $ 21.2 | |||
Sale of Stock, Number of Shares Issued in Transaction | 3,553,995 | |||
Aggregate offering price | $ 50 | |||
BofA Securities, Inc [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Offering price | $ 4.8 | |||
Net proceeds from the offering | $ 64.4 | |||
Underwriting Agreement [Member] | BofA Securities, Inc [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Proceeds from issuance of common stock, Shares | 14,375,000 | |||
Maximum [Member] | Jefferies LLC | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Offer and sell | $ 200 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Assumptions Used to Value Stock Options Granted to Employees using Black-Scholes Option-Pricing (Details) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate range, minimum | 3.78% | 3.36% |
Risk-free interest rate range, maximum | 4.22% | 4.15% |
Dividend yield | 0% | 0% |
Volatility rate range, minimum | 88.35% | 87.68% |
Volatility rate range, maximum | 88.55% | 88.77% |
Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term of options (years) | 6 years 7 days | 5 years 8 months 23 days |
Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term of options (years) | 6 years 29 days | 6 years 5 months 23 days |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Total Compensation Cost Recognized in Statements of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total | $ 1,691 | $ 2,092 |
Research and Development | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total | 849 | 818 |
General and Administrative | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total | $ 842 | $ 1,274 |
Net Loss per Share - Schedule o
Net Loss per Share - Schedule of Earnings Per Share, Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Earnings Per Share [Abstract] | ||
Net Income (Loss) | $ (23,347) | $ (17,404) |
Net loss per share attributable to common stockholders- basic | $ (0.38) | $ (0.4) |
Net loss per share attributable to common stockholders- diluted | $ (0.38) | $ (0.4) |
Weighted-average common shares and pre-funded warrants outstanding - basic | 61,772,279 | 43,720,578 |
Weighted-average common shares and pre-funded warrants outstanding - diluted | 61,772,279 | 43,720,578 |
Net Loss per Share - Schedule_2
Net Loss per Share - Schedule of Potential Dilutive Securities Excluded from Computation of Earning Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 9,323,135 | 5,505,608 |
Employee Stock Option | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 9,223,135 | 5,505,608 |
Unvested RSUs [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities | 100,000 | 0 |
Subsequent Event (Additional In
Subsequent Event (Additional Information) (Details) - Jefferies, LLC [Member] $ in Millions | 3 Months Ended |
Mar. 31, 2024 USD ($) shares | |
Subsequent Event [Line Items] | |
Number of shares issued or sold | shares | 3,553,995 |
Proceeds from issuance or sale of equity | $ | $ 21.2 |