Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 07, 2023 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-40925 | |
Entity Registrant Name | Xilio Therapeutics, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 85-1623397 | |
Entity Address, Address Line One | 828 Winter Street | |
Entity Address, Address Line Two | Suite 300 | |
Entity Address, City or Town | Waltham | |
Entity Address State Or Province | MA | |
Entity Address, Postal Zip Code | 02451 | |
City Area Code | 857 | |
Local Phone Number | 524-2466 | |
Title of 12(b) Security | Common stock, par value $0.0001 per share | |
Trading Symbol | XLO | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 27,542,000 | |
Entity Central Index Key | 0001840233 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 59,772 | $ 120,385 |
Prepaid expenses and other current assets | 4,708 | 4,111 |
Total current assets | 64,480 | 124,496 |
Restricted cash | 1,580 | 1,562 |
Property and equipment, net | 6,366 | 7,255 |
Operating lease right-of-use asset | 5,247 | 5,585 |
Other non-current assets | 169 | 267 |
Total assets | 77,842 | 139,165 |
Current liabilities | ||
Accounts payable | 1,486 | 3,125 |
Accrued expenses | 9,404 | 10,327 |
Operating lease liability, current portion | 1,014 | 918 |
Note payable, current portion | 4,957 | 6,667 |
Other current liabilities | 68 | 82 |
Total current liabilities | 16,929 | 21,119 |
Note payable, net of current portion | 3,165 | |
Operating lease liability, net of current portion | 8,415 | 9,189 |
Other non-current liabilities | 45 | |
Total liabilities | 25,344 | 33,518 |
Commitments and contingencies (Note 7) | ||
Stockholders' equity | ||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized, no shares issued or outstanding | ||
Common stock, $0.0001 par value; 200,000,000 shares authorized at September 30, 2023 and December 31, 2022; 27,542,000 shares issued and 27,528,926 shares outstanding at September 30, 2023; 27,471,607 shares issued and 27,425,447 shares outstanding at December 31, 2022 | 3 | 3 |
Additional paid-in capital | 360,352 | 354,752 |
Accumulated deficit | (307,857) | (249,108) |
Total stockholders' equity | 52,498 | 105,647 |
Total liabilities and stockholders' equity | $ 77,842 | $ 139,165 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 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 (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 27,542,000 | 27,471,607 |
Common stock, shares outstanding | 27,528,926 | 27,425,447 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Operating expenses | ||||
Research and development | $ 11,051 | $ 13,038 | $ 40,400 | $ 44,204 |
General and administrative | 6,310 | 7,168 | 20,603 | 21,778 |
Total operating expenses | 17,361 | 20,206 | 61,003 | 65,982 |
Loss from operations | (17,361) | (20,206) | (61,003) | (65,982) |
Other income, net | ||||
Other income, net | 613 | 416 | 2,254 | 226 |
Total other income, net | 613 | 416 | 2,254 | 226 |
Net loss | (16,748) | (19,790) | (58,749) | (65,756) |
Comprehensive loss | $ (16,748) | $ (19,790) | $ (58,749) | $ (65,756) |
Net loss per share, basic (in dollars per share) | $ (0.61) | $ (0.72) | $ (2.14) | $ (2.40) |
Net loss per share, diluted (in dollars per share) | $ (0.61) | $ (0.72) | $ (2.14) | $ (2.40) |
Weighted average common shares outstanding, basic (in shares) | 27,523,821 | 27,399,906 | 27,475,579 | 27,384,085 |
Weighted average common shares outstanding, diluted (in shares) | 27,523,821 | 27,399,906 | 27,475,579 | 27,384,085 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Beginning balance at Dec. 31, 2021 | $ 3 | $ 346,312 | $ (160,886) | $ 185,429 |
Beginning balance (in shares) at Dec. 31, 2021 | 27,358,375 | |||
Stockholders' Deficit | ||||
Vesting of restricted common stock (in shares) | 15,441 | |||
Exercise of stock options | 16 | 16 | ||
Exercise of stock options (in shares) | 2,657 | |||
Stock-based compensation expense | 2,029 | 2,029 | ||
Net loss | (21,353) | (21,353) | ||
Ending balance at Mar. 31, 2022 | $ 3 | 348,357 | (182,239) | 166,121 |
Ending balance (in shares) at Mar. 31, 2022 | 27,376,473 | |||
Beginning balance at Dec. 31, 2021 | $ 3 | 346,312 | (160,886) | 185,429 |
Beginning balance (in shares) at Dec. 31, 2021 | 27,358,375 | |||
Stockholders' Deficit | ||||
Net loss | (65,756) | |||
Ending balance at Sep. 30, 2022 | $ 3 | 352,937 | (226,642) | 126,298 |
Ending balance (in shares) at Sep. 30, 2022 | 27,407,149 | |||
Beginning balance at Mar. 31, 2022 | $ 3 | 348,357 | (182,239) | 166,121 |
Beginning balance (in shares) at Mar. 31, 2022 | 27,376,473 | |||
Stockholders' Deficit | ||||
Vesting of restricted common stock (in shares) | 15,361 | |||
Stock-based compensation expense | 2,709 | 2,709 | ||
Net loss | (24,613) | (24,613) | ||
Ending balance at Jun. 30, 2022 | $ 3 | 351,066 | (206,852) | 144,217 |
Ending balance (in shares) at Jun. 30, 2022 | 27,391,834 | |||
Stockholders' Deficit | ||||
Vesting of restricted common stock (in shares) | 15,315 | |||
Stock-based compensation expense | 1,871 | 1,871 | ||
Net loss | (19,790) | (19,790) | ||
Ending balance at Sep. 30, 2022 | $ 3 | 352,937 | (226,642) | 126,298 |
Ending balance (in shares) at Sep. 30, 2022 | 27,407,149 | |||
Beginning balance at Dec. 31, 2022 | $ 3 | 354,752 | (249,108) | 105,647 |
Beginning balance (in shares) at Dec. 31, 2022 | 27,425,447 | |||
Stockholders' Deficit | ||||
Vesting of restricted common stock (in shares) | 14,217 | |||
Exercise of stock options (in shares) | 156 | |||
Stock-based compensation expense | 1,791 | 1,791 | ||
Net loss | (22,646) | (22,646) | ||
Ending balance at Mar. 31, 2023 | $ 3 | 356,543 | (271,754) | 84,792 |
Ending balance (in shares) at Mar. 31, 2023 | 27,439,820 | |||
Beginning balance at Dec. 31, 2022 | $ 3 | 354,752 | (249,108) | $ 105,647 |
Beginning balance (in shares) at Dec. 31, 2022 | 27,425,447 | |||
Stockholders' Deficit | ||||
Exercise of stock options (in shares) | 2,757 | |||
Net loss | $ (58,749) | |||
Ending balance at Sep. 30, 2023 | $ 3 | 360,352 | (307,857) | 52,498 |
Ending balance (in shares) at Sep. 30, 2023 | 27,528,926 | |||
Beginning balance at Mar. 31, 2023 | $ 3 | 356,543 | (271,754) | 84,792 |
Beginning balance (in shares) at Mar. 31, 2023 | 27,439,820 | |||
Stockholders' Deficit | ||||
Issuance of common stock under employee stock purchase plan | 140 | 140 | ||
Issuance of common stock under employee stock purchase plan (in shares) | 68,929 | |||
Vesting of restricted common stock (in shares) | 9,978 | |||
Exercise of stock options (in shares) | 168 | |||
Stock-based compensation expense | 1,800 | 1,800 | ||
Net loss | (19,355) | (19,355) | ||
Ending balance at Jun. 30, 2023 | $ 3 | 358,483 | (291,109) | 67,377 |
Ending balance (in shares) at Jun. 30, 2023 | 27,518,895 | |||
Stockholders' Deficit | ||||
Vesting of restricted common stock (in shares) | 7,598 | |||
Exercise of stock options | 8 | 8 | ||
Exercise of stock options (in shares) | 2,433 | |||
Stock-based compensation expense | 1,861 | 1,861 | ||
Net loss | (16,748) | (16,748) | ||
Ending balance at Sep. 30, 2023 | $ 3 | $ 360,352 | $ (307,857) | $ 52,498 |
Ending balance (in shares) at Sep. 30, 2023 | 27,528,926 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (58,749) | $ (65,756) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,451 | 1,358 |
Non-cash interest expense | 141 | 164 |
Stock-based compensation expense | 5,452 | 6,609 |
Loss on disposal of property and equipment | 3 | 1 |
Changes in operating assets and liabilities: | ||
Prepaid and other assets | (597) | 1,283 |
Operating lease right-of-use asset | 338 | 288 |
Accounts payable | (1,625) | (972) |
Accrued expenses and other liabilities | (928) | 116 |
Operating lease liability | (679) | (591) |
Net cash used in operating activities | (55,193) | (57,500) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (486) | (1,358) |
Net cash used in investing activities | (486) | (1,358) |
Cash flows from financing activities: | ||
Repayments of debt principal | (5,000) | |
Payments of finance lease | (64) | (64) |
Proceeds from issuance of common stock under employee stock purchase plan | 140 | |
Proceeds from exercise of stock options | 8 | 16 |
Net cash used in financing activities | (4,916) | (48) |
Decrease in cash, cash equivalents and restricted cash | (60,595) | (58,906) |
Cash, cash equivalents and restricted cash, beginning of period | 121,947 | 199,606 |
Cash, cash equivalents and restricted cash, end of period | 61,352 | 140,700 |
Supplemental cash flow disclosure: | ||
Cash paid for interest | 474 | 380 |
Supplemental disclosure of non-cash activities: | ||
Capital expenditures included in accounts payable or accrued expenses | 371 | |
Reconciliation to amounts within the condensed consolidated balance sheets: | ||
Cash and cash equivalents | 59,772 | 139,143 |
Restricted cash | 1,580 | 1,557 |
Cash, cash equivalents and restricted cash, end of period | $ 61,352 | $ 140,700 |
Description of Business and Liq
Description of Business and Liquidity and Going Concern | 9 Months Ended |
Sep. 30, 2023 | |
Description of Business and Liquidity and Going Concern | |
Description of Business and Liquidity and Going Concern | 1. Description of Business and Liquidity and Going Concern Description of Business Xilio Therapeutics, Inc. (“Xilio” or the “Company”) is a clinical-stage biotechnology company dedicated to discovering and developing tumor-activated immuno-oncology (“I-O”) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The Company was incorporated in Delaware in June 2020, and its headquarters are located in Waltham, Massachusetts. Liquidity and Going Concern Since its inception, the Company has devoted substantially all of its financial resources and efforts to research and development activities. As of September 30, 2023, the Company had an accumulated deficit of $307.9 million and has incurred significant operating losses, including net losses of $58.7 million and $65.8 million for the nine months ended September 30, 2023 and 2022, respectively. The Company expects its operating losses and negative operating cash flows to continue for the foreseeable future as it continues to advance its product candidates through clinical trials, maintains the infrastructure necessary to support these activities and continues to incur costs associated with operating as a public company. The Company anticipates its existing cash and cash equivalents of $59.8 million as of September 30, 2023 will not be sufficient to enable the Company to fund its current operating plan and capital expenditure requirements for at least twelve months from the date of issuance of these condensed consolidated financial statements. These factors raise substantial doubt about the Company’s ability to continue as a going concern. To continue to fund the operations of the Company, management has developed plans, which in the near term primarily consist of raising additional capital through one or more of the following: equity or debt financings; collaborations, partnerships or licensing transactions; or other sources. However, there can be no assurance that the Company will be able to complete any such transaction on acceptable terms or otherwise, and the Company may be unable to obtain sufficient additional capital. If the Company is not able to secure sufficient additional capital in the near term, the Company will need to implement cost reduction strategies, which could include delaying, limiting, reducing or eliminating both internal and external costs related to its operations and research and development programs. In addition, if the Company’s efforts to secure sufficient additional capital in the near term are unsuccessful, the Company may in the future need to seek to engage in one or more other strategic alternatives, including without limitation, the sale or divestiture of some or all of its assets or proprietary technologies. The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of this uncertainty. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The Company’s unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASUs”) of the Financial Accounting Standards Board (“FASB”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2022 and notes thereto, included in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on March 2, 2023. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements. In the opinion of the Company’s management, the unaudited interim condensed consolidated financial statements contain all adjustments which are necessary to present fairly the Company’s financial position as of September 30, 2023 and the results of its operations for the three and nine months ended September 30, 2023 and 2022 and cash flows for the nine months ended September 30, 2023 and 2022. Such adjustments are of a normal and recurring nature. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results for the year ending December 31, 2023 or for any future period. Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: Xilio Development, Inc., a Delaware corporation and Xilio Securities Corporation, a Massachusetts security corporation. All intercompany accounts and transactions have been eliminated in consolidation. Significant Accounting Policies The significant accounting policies used in preparation of the unaudited condensed consolidated financial statements are described in Note 2, “ Summary of Significant Accounting Policies ” of the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022. There have been no material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, except as noted below. Collaboration Agreements The Company analyzes its collaboration agreements to assess whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities and therefore within the scope of ASC Topic 808, (“ASC 808”). For arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and which elements of the collaboration are more reflective of a vendor-customer relationship and therefore within the scope of ASC Topic 606, (“ASC 606”). For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently, either by analogy to authoritative accounting literature or by applying a reasonable and rational policy election. For collaboration agreements where the Company is reimbursed for a portion of its research and development expenses or participates in the cost-sharing of such research and development expenses, such reimbursements and cost-sharing arrangements are reflected as a reduction of research and development expenses in the Company’s condensed consolidated statements of operations and comprehensive loss, as the Company does not consider performing research and development services for reimbursement to be a part of its ongoing major or central operations. Concentrations of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The Company holds all cash and cash equivalents at accredited financial institutions. Bank accounts in the United States are generally insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000. Substantially all of the Company’s cash and cash equivalents are FDIC insured, including funds held through an insured cash sweep program. The Company has not experienced any losses in its cash and cash equivalents and does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Sep. 30, 2023 | |
Property and Equipment, Net | |
Property and Equipment, Net | 3. Property and Equipment, Net Property and equipment, net consists of the following as of September 30, 2023 and December 31, 2022: September 30, December 31, 2023 2022 Laboratory equipment $ 6,091 $ 5,587 Computers and software 183 228 Furniture and fixtures 681 636 Leasehold improvements 5,124 5,124 Construction in process — 98 Total property and equipment 12,079 11,673 Less: accumulated depreciation (5,713) (4,418) Property and equipment, net $ 6,366 $ 7,255 The Company recognized depreciation and amortization expense related to property and equipment of $1.4 million and $1.3 million for the nine months ended September 30, 2023 and 2022, respectively. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses | |
Accrued Expenses | 4. Accrued Expenses Accrued expenses consist of the following as of September 30, 2023 and December 31, 2022: September 30, December 31, 2023 2022 External research and development $ 4,553 $ 3,178 Personnel-related 4,051 5,413 Professional and consulting fees 627 1,536 Other 173 200 Total accrued expenses $ 9,404 $ 10,327 |
Loan and Security Agreement
Loan and Security Agreement | 9 Months Ended |
Sep. 30, 2023 | |
Loan and Security Agreement | |
Loan and Security Agreement | 5. Loan and Security Agreement In November 2019, the Company’s wholly owned subsidiary, Xilio Development, Inc. (“Borrower”), entered into a loan and security agreement (as amended and restated in May 2023, the “Loan Agreement”) with Pacific Western Bank (“PacWest”), with the Company as a guarantor. Under the Loan Agreement, in November 2019, the Borrower borrowed $10.0 million under a term loan. Interest on amounts outstanding under the Loan Agreement accrues at a variable annual rate equal to the greater of (i) the prime rate plus 0.25% or (ii) 4.75%. As of September 30, 2023, the interest rate on the term loan was 8.75%. The Borrower was required to make interest-only payments on any outstanding balances through December 31, 2022. The Borrower commenced making equal monthly payments of principal plus interest in January 2023, and it will be required to make such payments until the term loan matures on June 30, 2024. The Loan Agreement contains customary representations, warranties and covenants and also includes customary terms covering events of default, including payment defaults, breaches of covenants, a change of control provision and occurrence of a material adverse effect. As security for its obligations under the Loan Agreement, the Borrower granted PacWest a first priority security interest on substantially all of the Borrower’s assets, excluding intellectual property, subject to certain exceptions. Upon the occurrence and continuation of an event of default, a default interest rate of an additional 5% per annum may be applied to the outstanding loan balance, and the administrative agent, collateral agent, and lender may declare all outstanding obligations immediately due and payable and exercise all of their rights and remedies as set forth in the Loan Agreement and under applicable law. As of September 30, 2023, the Company and Borrower were in compliance with all covenants under the Loan Agreement. The Borrower has the following minimum aggregate future loan principal payments under the Loan Agreement as of September 30, 2023: Minimum Loan Payments 2023 (remaining three months) $ 1,667 2024 3,333 Total future principal payments 5,000 Less: unamortized discount (43) Total note payable $ 4,957 The Company recognized $0.6 million and $0.5 million of interest expense related to the Loan Agreement for the nine months ended September 30, 2023 and 2022, respectively, which is reflected in other income, net on the condensed consolidated statements of operations and comprehensive loss. |
Collaboration Agreements
Collaboration Agreements | 9 Months Ended |
Sep. 30, 2023 | |
Collaboration Agreements | |
Collaboration Agreements | 6. Collaboration Agreements In July 2023, the Company and F. Hoffmann-La Roche Ltd. (“Roche”) entered into a clinical trial collaboration (the “Roche Clinical Collaboration”) pursuant to a clinical supply agreement to evaluate XTX101 in combination with atezolizumab (Tecentriq®) in a Phase 1/2 clinical trial consisting of a Phase 1 dose escalation portion assessing the combination in patients with advanced solid tumors and a Phase 2 portion assessing the combination in patients with microsatellite stable colorectal cancer. Under the clinical supply agreement, the Company is eligible to receive specified cost-sharing payments from Roche, and each company will supply its respective anti-cancer agent to support the Phase 1/2 clinical trial. The Company will sponsor and conduct the Phase 1/2 clinical trial and retains global development and commercialization rights to XTX101. The Company concluded that the cost-sharing payments from the Roche Clinical Collaboration are not in the scope of ASC 606 because the Company does not consider performing research and development services for reimbursement to be part of its ongoing major or central operations. Therefore, the Company applied a reasonable, rational, and consistently applied accounting policy election to record the cost-sharing payments from the Roche Clinical Collaboration as a reduction of research and development expenses in the condensed consolidated statements of operations and comprehensive loss for the period in which a study development event is achieved. During the three and nine months ended September 30, 2023, the Company recognized a reduction of research and development expenses of $2.0 million. As of September 30, 2023, $2.0 million of earned but unpaid cost-sharing payments were included in prepaid expenses and other current assets of the Company’s condensed consolidated balance sheets. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies | |
Commitments and Contingencies | 7. Commitments and Contingencies The Company has an operating lease for its headquarters and a finance lease for certain lab equipment. In August 2019, the Company entered into a facility lease agreement with a landlord providing funding for tenant improvements and occupancy of approximately 27,830 square feet of office and laboratory space (the “premises”) at 828 Winter Street, Waltham, Massachusetts. The initial term of the lease expires in March 2030, unless terminated earlier in accordance with the terms of the lease. The Company has an option to extend the lease for an additional term of five years at then-market rates. The Company is obligated to pay its portion of real estate taxes and costs related to the premises, including costs of operations, maintenance, repair, replacement, and management of the leased premises, which it began paying simultaneous with the rent commencement date in March 2020. As of September 30, 2023 and December 31, 2022, the Company had a letter of credit for the benefit of its landlord in the amount of $1.6 million, collateralized by a money market account, which is recorded as restricted cash on the condensed consolidated balance sheets. |
Preferred Stock and Common Stoc
Preferred Stock and Common Stock | 9 Months Ended |
Sep. 30, 2023 | |
Preferred Stock and Common Stock | |
Preferred Stock and Common Stock | 8. Preferred Stock and Common Stock Undesignated Preferred Stock As of September 30, 2023 and December 31, 2022, the Company’s certificate of incorporation, as amended, authorized the Company to issue up to 5,000,000 shares of undesignated preferred stock at $0.0001 par value per share. As of September 30, 2023 and December 31, 2022, there were no shares of preferred stock issued or outstanding. Common Stock As of September 30, 2023 and December 31, 2022, the Company is authorized to issue up to 200,000,000 shares of common stock, $0.0001 par value per share under its certificate of incorporation, as amended. Shares Reserved for Future Issuance As of September 30, 2023 and December 31, 2022, the Company had reserved shares of common stock for future issuance under the 2020 Stock Incentive Plan (as amended, the “2020 Plan”), the 2021 Stock Incentive Plan (the “2021 Plan”), the 2022 Inducement Stock Incentive Plan (the “2022 Inducement Plan”) and the 2021 Employee Stock Purchase Plan (the “2021 ESPP”) as follows: September 30, December 31, 2023 2022 Shares of common stock reserved for exercise of a warrant 2,631 2,631 Shares of common stock reserved for exercise of outstanding stock options under the 2020 Plan, 2021 Plan and 2022 Inducement Plan 7,823,478 4,960,553 Shares of common stock reserved for future awards under the 2021 Plan 1,412,759 2,848,568 Shares of common stock reserved for future awards under the 2022 Inducement Plan 220,000 275,000 Shares of common stock reserved for purchase under the 2021 ESPP 772,507 566,720 Total shares reserved for future issuance 10,231,375 8,653,472 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Stock-Based Compensation | |
Stock-Based Compensation | 9. Stock-Based Compensation Equity Incentive Plans 2020 Stock Incentive Plan Under the 2020 Plan, the Company was authorized to issue shares of common stock to the Company’s employees, officers, directors, consultants and advisors in the form of options, restricted stock awards or other stock-based awards. 2021 Stock Incentive Plan In 2021, the Company’s board of directors and stockholders adopted the 2021 Plan, which became effective immediately prior to the IPO in October 2021. Upon effectiveness of the 2021 Plan, the Company ceased granting awards under the 2020 Plan. The 2021 Plan provides for the grant of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock units and other stock-based awards. The number of shares of the Company’s common stock initially reserved for issuance under the 2021 Plan was the sum of (1) 2,654,828; plus (2) the number of shares (up to 3,967,038 shares) as is equal to the sum of (x) the number of shares of the Company’s common stock reserved for issuance under the 2020 Plan that remained available for grant under the 2020 Plan immediately prior to the effectiveness of the 2021 Plan and (y) the number of shares of the Company’s common stock subject to outstanding awards whether granted under the 2020 Plan or outside of the 2020 Plan which awards expire, terminate or are otherwise surrendered, canceled, forfeited or repurchased by the Company at their original issuance price pursuant to a contractual repurchase right and that, prior to the effectiveness of the 2021 Plan, would have become available for issuance under the 2020 Plan; plus (3) an annual increase, to be added on the first day of each fiscal year, beginning with the fiscal year, commencing on January 1, 2022 and continuing until, and including, January 1, 2031, equal to the lesser of (i) 5% of the number of shares of the Company’s common stock outstanding on the first day of such fiscal year and (ii) the number of shares of common stock determined by the Company’s board of directors. On January 1, 2023, the number of shares reserved for issuance under the 2021 Plan automatically increased by 1,373,580 shares. As of September 30, 2023, there were 1,412,759 shares available for future issuance under the 2021 Plan. 2022 Inducement Plan In 2022, the Company’s board of directors adopted the 2022 Inducement Plan pursuant to Nasdaq Rule 5635(c)(4). In accordance with Rule 5635(c)(4), stock-based incentive awards under the 2022 Inducement Plan may only be made to a newly hired employee who has not previously been a member of the Company’s board of directors, or an employee who is being rehired following a bona fide period of non-employment by the Company as a material inducement to the employee’s entering into employment with the Company. An aggregate of 275,000 shares of the Company’s common stock has been reserved for issuance under the 2022 Inducement Plan. The exercise price of stock options granted under the 2022 Inducement Plan will not be less than the fair market value of a share of the Company’s common stock on the grant date. Other terms of awards, including vesting requirements, are determined by the Company’s board of directors and are subject to the provisions of the 2022 Inducement Plan. As of September 30, 2023, there were 220,000 shares available for future issuance under the 2022 Inducement Plan. 2021 Employee Stock Purchase Plan In 2021, the Company’s board of directors and stockholders adopted the 2021 ESPP, which became effective immediately prior to the IPO in October 2021. The Company initially reserved 292,031 shares of common stock for issuance under the 2021 ESPP. In addition, the 2021 ESPP provides that the number of shares of common stock reserved for issuance under the 2021 ESPP will be cumulatively increased on January 1 of each calendar year by the lesser of (i) 584,062 shares of common stock, (ii) 1% of the number of shares of the Company’s common stock outstanding on such date, and (iii) a number of shares of common stock as determined by the Company’s board of directors. On January 1, 2023, the number of shares reserved for issuance under the 2021 ESPP was increased by 274,716 shares. Offering periods under the 2021 ESPP commence on each June 1 and December 1, and end on the following November 30 and May 31, respectively. During the nine months ended September 30, 2023, 68,929 shares were purchased under the 2021 ESPP. During the nine months ended September 30, 2022, no shares were purchased under the 2021 ESPP. As of September 30, 2023, there were 772,507 shares available for future issuance under the 2021 ESPP. Stock-Based Compensation Expense During the three and nine months ended September 30, 2023 and 2022, the Company recorded compensation expense related to stock options, restricted common stock and ESPP share purchases for employees and non-employees, which was allocated as follows in the condensed consolidated statements of operations and comprehensive loss: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development expense $ 548 $ 594 $ 1,670 $ 1,827 General and administrative expense 1,313 1,277 3,782 4,782 Total stock-based compensation expense $ 1,861 $ 1,871 $ 5,452 $ 6,609 Stock Options A summary of stock option activity under the Company’s 2020 Plan, 2021 Plan and 2022 Inducement Plan is as follows: Weighted Average Remaining Aggregate Weighted Contractual Intrinsic Number of Average Term Value (1) Stock Options Exercise Price (In years) (In thousands) Outstanding as of December 31, 2022 4,960,553 $ 8.04 8.59 $ 89 Granted 3,738,555 $ 2.75 Exercised (2,757) $ 2.82 Cancelled/forfeited (872,873) $ 6.77 Outstanding as of September 30, 2023 7,823,478 $ 5.66 8.54 $ - Exercisable as of September 30, 2023 2,768,685 $ 7.19 7.66 $ - (1) The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock as of the end of the period. Using the Black-Scholes option pricing model, the weighted average fair value of options granted to employees and directors during the nine months ended September 30, 2023 and 2022 was $2.02 and $5.88, respectively. The following assumptions were used in determining the fair value of options granted during the nine months ended September 30, 2023 and 2022: Nine Months Ended September 30, 2023 2022 Risk-free interest rate 3.57 - 4.40 % 1.47 – 3.63 % Expected dividend yield 0 % 0 % Expected term (in years) 5.50 - 6.08 5.27 – 6.08 Expected volatility 81.69 - 87.32 % 80.75 – 87.64 % As of September 30, 2023, the Company had unrecognized stock-based compensation expense of $14.3 million related to stock options issued to employees and directors, which is expected to be recognized over a weighted-average period of 2.3 years. Restricted Stock A summary of the Company’s restricted stock activity and related information is as follows: Number Weighted of Shares Average of Restricted Grant Date Stock Fair Value Unvested as of December 31, 2022 46,160 $ 5.51 Vested (31,793) $ 5.51 Canceled/Forfeited (1,293) $ 5.51 Unvested as of September 30, 2023 13,074 $ 5.51 In June 2020, the Company granted 552,546 shares of common stock underlying restricted stock awards, and the Company has not subsequently granted any additional restricted stock awards. The aggregate fair value of the restricted stock awards that vested during the nine months ended September 30, 2023 and 2022 was $0.1 million and $0.3 million, respectively. As of September 30, 2023, total unrecognized stock-based compensation expense related to unvested restricted stock awards was $0.1 million, which is expected to be recognized over a weighted-average period of 0.4 years. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2023 | |
Net Loss Per Share | |
Net Loss Per Share | 10. Net Loss Per Share The following table sets forth the outstanding shares of common stock equivalents, presented based on amounts outstanding at each period end, that were excluded from the calculation of diluted net loss per share attributable to common stockholders during each period because including them would have been anti-dilutive: Nine Months Ended September 30, 2023 2022 Unvested restricted common stock 13,074 64,458 Outstanding stock options 7,823,478 4,999,256 Warrants 2,631 2,631 Unvested employee stock purchase plan shares 60,488 — Total common stock equivalents 7,899,671 5,066,345 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The Company’s unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASUs”) of the Financial Accounting Standards Board (“FASB”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2022 and notes thereto, included in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on March 2, 2023. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited financial statements. In the opinion of the Company’s management, the unaudited interim condensed consolidated financial statements contain all adjustments which are necessary to present fairly the Company’s financial position as of September 30, 2023 and the results of its operations for the three and nine months ended September 30, 2023 and 2022 and cash flows for the nine months ended September 30, 2023 and 2022. Such adjustments are of a normal and recurring nature. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results for the year ending December 31, 2023 or for any future period. |
Principles of Consolidation | Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: Xilio Development, Inc., a Delaware corporation and Xilio Securities Corporation, a Massachusetts security corporation. All intercompany accounts and transactions have been eliminated in consolidation. |
Collaboration Agreements | Collaboration Agreements The Company analyzes its collaboration agreements to assess whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities and therefore within the scope of ASC Topic 808, (“ASC 808”). For arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and which elements of the collaboration are more reflective of a vendor-customer relationship and therefore within the scope of ASC Topic 606, (“ASC 606”). For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently, either by analogy to authoritative accounting literature or by applying a reasonable and rational policy election. For collaboration agreements where the Company is reimbursed for a portion of its research and development expenses or participates in the cost-sharing of such research and development expenses, such reimbursements and cost-sharing arrangements are reflected as a reduction of research and development expenses in the Company’s condensed consolidated statements of operations and comprehensive loss, as the Company does not consider performing research and development services for reimbursement to be a part of its ongoing major or central operations. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. The Company holds all cash and cash equivalents at accredited financial institutions. Bank accounts in the United States are generally insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000. Substantially all of the Company’s cash and cash equivalents are FDIC insured, including funds held through an insured cash sweep program. The Company has not experienced any losses in its cash and cash equivalents and does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property and Equipment, Net | |
Summary of property and equipment, net | September 30, December 31, 2023 2022 Laboratory equipment $ 6,091 $ 5,587 Computers and software 183 228 Furniture and fixtures 681 636 Leasehold improvements 5,124 5,124 Construction in process — 98 Total property and equipment 12,079 11,673 Less: accumulated depreciation (5,713) (4,418) Property and equipment, net $ 6,366 $ 7,255 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses | |
Summary of accrued expenses | September 30, December 31, 2023 2022 External research and development $ 4,553 $ 3,178 Personnel-related 4,051 5,413 Professional and consulting fees 627 1,536 Other 173 200 Total accrued expenses $ 9,404 $ 10,327 |
Loan and Security Agreement (Ta
Loan and Security Agreement (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Loan and Security Agreement | |
Schedule of minimum aggregate future loan principal payments | Minimum Loan Payments 2023 (remaining three months) $ 1,667 2024 3,333 Total future principal payments 5,000 Less: unamortized discount (43) Total note payable $ 4,957 |
Preferred Stock and Common St_2
Preferred Stock and Common Stock (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Preferred Stock and Common Stock | |
Schedule of Shares Reserved for Future Issuance | September 30, December 31, 2023 2022 Shares of common stock reserved for exercise of a warrant 2,631 2,631 Shares of common stock reserved for exercise of outstanding stock options under the 2020 Plan, 2021 Plan and 2022 Inducement Plan 7,823,478 4,960,553 Shares of common stock reserved for future awards under the 2021 Plan 1,412,759 2,848,568 Shares of common stock reserved for future awards under the 2022 Inducement Plan 220,000 275,000 Shares of common stock reserved for purchase under the 2021 ESPP 772,507 566,720 Total shares reserved for future issuance 10,231,375 8,653,472 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Stock-Based Compensation | |
Schedule of stock-based compensation expense | Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Research and development expense $ 548 $ 594 $ 1,670 $ 1,827 General and administrative expense 1,313 1,277 3,782 4,782 Total stock-based compensation expense $ 1,861 $ 1,871 $ 5,452 $ 6,609 |
Summary of stock option activity | Weighted Average Remaining Aggregate Weighted Contractual Intrinsic Number of Average Term Value (1) Stock Options Exercise Price (In years) (In thousands) Outstanding as of December 31, 2022 4,960,553 $ 8.04 8.59 $ 89 Granted 3,738,555 $ 2.75 Exercised (2,757) $ 2.82 Cancelled/forfeited (872,873) $ 6.77 Outstanding as of September 30, 2023 7,823,478 $ 5.66 8.54 $ - Exercisable as of September 30, 2023 2,768,685 $ 7.19 7.66 $ - |
Schedule of assumptions used in determining fair value of options granted | Nine Months Ended September 30, 2023 2022 Risk-free interest rate 3.57 - 4.40 % 1.47 – 3.63 % Expected dividend yield 0 % 0 % Expected term (in years) 5.50 - 6.08 5.27 – 6.08 Expected volatility 81.69 - 87.32 % 80.75 – 87.64 % |
Summary of restricted stock activity | Number Weighted of Shares Average of Restricted Grant Date Stock Fair Value Unvested as of December 31, 2022 46,160 $ 5.51 Vested (31,793) $ 5.51 Canceled/Forfeited (1,293) $ 5.51 Unvested as of September 30, 2023 13,074 $ 5.51 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Net Loss Per Share | |
Schedule of antidilutive securities excluded from computation of diluted net loss per share | Nine Months Ended September 30, 2023 2022 Unvested restricted common stock 13,074 64,458 Outstanding stock options 7,823,478 4,999,256 Warrants 2,631 2,631 Unvested employee stock purchase plan shares 60,488 — Total common stock equivalents 7,899,671 5,066,345 |
Description of Business and L_2
Description of Business and Liquidity and Going Concern - Liquidity and Going Concern (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Description of Business and Liquidity and Going Concern | |||||||||
Accumulated deficit | $ 307,857 | $ 307,857 | $ 249,108 | ||||||
Net loss | 16,748 | $ 19,355 | $ 22,646 | $ 19,790 | $ 24,613 | $ 21,353 | 58,749 | $ 65,756 | |
Cash and cash equivalents | $ 59,772 | $ 139,143 | $ 59,772 | $ 139,143 | $ 120,385 | ||||
Substantial doubt about going concern within one year | true |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) $ in Thousands | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Property and Equipment | |||
Property and equipment | $ 12,079 | $ 11,673 | |
Less accumulated depreciation | (5,713) | (4,418) | |
Property and equipment, net | 6,366 | 7,255 | |
Depreciation | 1,400 | $ 1,300 | |
Laboratory equipment | |||
Property and Equipment | |||
Property and equipment | 6,091 | 5,587 | |
Computers and software | |||
Property and Equipment | |||
Property and equipment | 183 | 228 | |
Furniture & fixtures | |||
Property and Equipment | |||
Property and equipment | 681 | 636 | |
Leasehold improvements | |||
Property and Equipment | |||
Property and equipment | $ 5,124 | 5,124 | |
Construction in process | |||
Property and Equipment | |||
Property and equipment | $ 98 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Expenses | ||
External research and development | $ 4,553 | $ 3,178 |
Personnel related | 4,051 | 5,413 |
Professional and consulting services | 627 | 1,536 |
Other | 173 | 200 |
Total accrued expenses | $ 9,404 | $ 10,327 |
Loan and Security Agreement - D
Loan and Security Agreement - Description (Details) - Loan Agreement - USD ($) $ in Millions | 1 Months Ended | |
Nov. 30, 2019 | Sep. 30, 2023 | |
Loan and security agreement | ||
Borrowed amount | $ 10 | |
Interest rate at end of period (as a percent) | 8.75% | |
Additional interest rate upon event of default (as a percent) | 5% | |
Minimum | ||
Loan and security agreement | ||
Stated interest rate | 4.75% | |
Prime rate | ||
Loan and security agreement | ||
Basis spread (as percent) | 0.25% |
Loan and Security Agreement - M
Loan and Security Agreement - Maturities (Details) - Loan Agreement - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Minimum aggregate future loan payments | ||
2023 (remaining three months) | $ 1,667 | |
2024 | 3,333 | |
Total future principal payments | 5,000 | |
Less: unamortized discount | (43) | |
Total notes payable | 4,957 | |
Interest expense | $ 600 | $ 500 |
Collaboration Agreements (Detai
Collaboration Agreements (Details) - Clinical Supply Agreement - F. Hoffmann-La Roche Ltd. $ in Millions | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 USD ($) | Sep. 30, 2023 USD ($) | |
Prepaid expenses and other current assets | ||
Collaboration Agreements | ||
Earned but unpaid cost-sharing payments | $ 2 | $ 2 |
Research and development | ||
Collaboration Agreements | ||
Reduction in research and development expenses | $ 2 | $ 2 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | 1 Months Ended | ||
Aug. 31, 2019 ft² | Sep. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Commitments and Contingencies | |||
Area leased (in square feet) | ft² | 27,830 | ||
Option to extend | true | ||
Term of option to extend | 5 years | ||
Letter of credit for the benefit of landlord | $ | $ 1.6 | $ 1.6 |
Preferred Stock and Common St_3
Preferred Stock and Common Stock - Authorized (Details) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Preferred Stock and Common Stock | ||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred Stock and Common St_4
Preferred Stock and Common Stock - Shares Reserved for Future Issuance (Details) - shares | Sep. 30, 2023 | Dec. 31, 2022 | Oct. 31, 2021 |
Shares for future issuance | |||
Shares reserved for future issuance (in shares) | 10,231,375 | 8,653,472 | |
2020 Plan, 2021 Plan and 2022 Inducement Plan | Outstanding stock options | |||
Shares for future issuance | |||
Shares reserved for future issuance (in shares) | 7,823,478 | 4,960,553 | |
2021 Plan | Future Awards | |||
Shares for future issuance | |||
Shares reserved for future issuance (in shares) | 1,412,759 | 2,848,568 | |
2022 Inducement Plan | Future Awards | |||
Shares for future issuance | |||
Shares reserved for future issuance (in shares) | 220,000 | 275,000 | |
2021 ESPP | |||
Shares for future issuance | |||
Shares reserved for future issuance (in shares) | 772,507 | 566,720 | 292,031 |
Warrants | |||
Shares for future issuance | |||
Shares reserved for future issuance (in shares) | 2,631 | 2,631 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Incentive Plans (Details) - shares | 1 Months Ended | |||
Jan. 01, 2023 | Oct. 31, 2021 | Sep. 30, 2023 | Dec. 31, 2022 | |
Stock-Based Compensation | ||||
Common stock reserved for issuance (in shares) | 10,231,375 | 8,653,472 | ||
2021 Plan | ||||
Stock-Based Compensation | ||||
Additional common stock reserved under the plan (in shares) | 1,373,580 | |||
Shares available for future issuance (in shares) | 1,412,759 | |||
2021 Plan | Minimum | ||||
Stock-Based Compensation | ||||
Common stock reserved for issuance (in shares) | 2,654,828 | |||
2021 Plan | Maximum | ||||
Stock-Based Compensation | ||||
Additional common stock to be reserved for issuance (in shares) | 3,967,038 | |||
Annual increase in number of shares reserved for issuance (as a percent) | 5% |
Stock-Based Compensation - 2022
Stock-Based Compensation - 2022 Inducement Plan (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | |
Stock-Based Compensation | ||
Common stock reserved for issuance (in shares) | 10,231,375 | 8,653,472 |
Stock options granted during the period (in shares) | 3,738,555 | |
2022 Inducement Plan | ||
Stock-Based Compensation | ||
Shares available for future issuance (in shares) | 220,000 | |
2022 Inducement Plan | Future Awards | ||
Stock-Based Compensation | ||
Common stock reserved for issuance (in shares) | 220,000 | 275,000 |
Stock-Based Compensation - Empl
Stock-Based Compensation - Employee Stock Purchase Plan (Details) - shares | 1 Months Ended | 9 Months Ended | |||
Jan. 01, 2023 | Oct. 31, 2021 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Stock-Based Compensation | |||||
Common stock reserved for issuance (in shares) | 10,231,375 | 8,653,472 | |||
2021 ESPP | |||||
Stock-Based Compensation | |||||
Common stock reserved for issuance (in shares) | 292,031 | 772,507 | 566,720 | ||
Additional common stock reserved under the plan (in shares) | 274,716 | ||||
Shares issued under plan (in shares) | 68,929 | 0 | |||
Shares available for future issuance (in shares) | 772,507 | ||||
2021 ESPP | Maximum | |||||
Stock-Based Compensation | |||||
Annual increase in number of shares reserved and available for issuance (in shares) | 584,062 | ||||
Annual increase in number of shares reserved for issuance (as a percent) | 1% |
Stock-Based Compensation - St_2
Stock-Based Compensation - Stock-based compensation expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Stock-Based Compensation | ||||
Total compensation expense | $ 1,861 | $ 1,871 | $ 5,452 | $ 6,609 |
Research and development expense | ||||
Stock-Based Compensation | ||||
Total compensation expense | 548 | 594 | 1,670 | 1,827 |
General and administrative expense | ||||
Stock-Based Compensation | ||||
Total compensation expense | $ 1,313 | $ 1,277 | $ 3,782 | $ 4,782 |
Stock-Based Compensation - St_3
Stock-Based Compensation - Stock option activity (Details) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | |
Options Outstanding | ||
Outstanding at beginning of period (in shares) | 4,960,553 | |
Granted (in shares) | 3,738,555 | |
Exercised (in shares) | (2,757) | |
Cancelled/forfeited (in shares) | (872,873) | |
Outstanding at end of period (in shares) | 7,823,478 | 4,960,553 |
Exercisable at end of period (in shares) | 2,768,685 | |
Weighted Average Exercise Price | ||
Outstanding (in dollars per share) | $ / shares | $ 5.66 | $ 8.04 |
Granted (in dollars per share) | $ / shares | 2.75 | |
Exercised (in dollars per share) | $ / shares | 2.82 | |
Cancelled/forfeited (in dollars per share) | $ / shares | 6.77 | |
Exercisable at end of period (in dollars per share) | $ / shares | $ 7.19 | |
Weighted Average Remaining Contractual Term (In years) | ||
Outstanding (in years) | 8 years 6 months 14 days | 8 years 7 months 2 days |
Exercisable at end of period (in years) | 7 years 7 months 28 days | |
Aggregate Intrinsic Value | ||
Outstanding (in dollars) | $ | $ 89 |
Stock-Based Compensation - St_4
Stock-Based Compensation - Stock options, fair value assumptions (Details) - USD ($) $ / shares in Units, $ in Millions | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Stock-Based Compensation | ||
Fair value of options granted (in dollars per share) | $ 2.02 | $ 5.88 |
Stock options | ||
Stock-Based Compensation | ||
Risk-free interest rate, minimum (as a percent) | 3.57% | 1.47% |
Risk-free interest rate, maximum (as a percent) | 4.40% | 3.63% |
Expected dividend yield (as a percent) | 0% | 0% |
Expected volatility, minimum (as percentage) | 81.69% | 80.75% |
Expected volatility, maximum (as percentage) | 87.32% | 87.64% |
Unrecognized stock-based compensation expense | $ 14.3 | |
Weighted-average period for unrecognized compensation expense to be recognized | 2 years 3 months 18 days | |
Stock options | Minimum | ||
Stock-Based Compensation | ||
Expected term (in years) | 5 years 6 months | 5 years 3 months 7 days |
Stock options | Maximum | ||
Stock-Based Compensation | ||
Expected term (in years) | 6 years 29 days | 6 years 29 days |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2020 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Weighted Average Grant Date Fair Value | |||||
Stock-based compensation expense | $ 1,861 | $ 1,871 | $ 5,452 | $ 6,609 | |
Restricted stock | |||||
Equity Based Compensation | |||||
Outstanding at beginning of period (in shares) | 46,160 | ||||
Vested (in shares) | (31,793) | ||||
Canceled/Forfeited (in shares) | (1,293) | ||||
Outstanding at end of period (in shares) | 13,074 | 13,074 | |||
Weighted Average Grant Date Fair Value | |||||
Outstanding at beginning of period (in dollars per share) | $ 5.51 | ||||
Vested (in dollars per share) | 5.51 | ||||
Cancelled/forfeited (in dollars per share) | 5.51 | ||||
Outstanding at end of period (in dollars per share) | $ 5.51 | $ 5.51 | |||
Granted (in shares) | 552,546 | ||||
Aggregate fair value of restricted stock awards that vested | $ 100 | $ 300 | |||
Total unrecognized stock-based compensation expense | $ 100 | $ 100 | |||
Weighted-average period for unrecognized compensation expense to be recognized | 4 months 24 days |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Net Loss Per Share | ||
Total common stock equivalents | 7,899,671 | 5,066,345 |
Restricted stock | ||
Net Loss Per Share | ||
Total common stock equivalents | 13,074 | 64,458 |
Stock options | ||
Net Loss Per Share | ||
Total common stock equivalents | 7,823,478 | 4,999,256 |
Warrants | ||
Net Loss Per Share | ||
Total common stock equivalents | 2,631 | 2,631 |
Employee stock purchase plan | ||
Net Loss Per Share | ||
Total common stock equivalents | 60,488 |