COVER PAGE
COVER PAGE - shares | 9 Months Ended | |
Sep. 30, 2023 | Oct. 31, 2023 | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-40675 | |
Entity Registrant Name | Immuneering Corporation | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 26-1976972 | |
Entity Address, Address Line One | 245 Main St | |
Entity Address, Address Line Two | Second Floor | |
Entity Address, City or Town | Cambridge | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02142 | |
City Area Code | 617 | |
Local Phone Number | 500-8080 | |
Title of 12(b) Security | Class A common Stock, par value $0.001 per share | |
Trading Symbol | IMRX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Central Index Key | 0001790340 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Class A Common Stock | ||
Entity Common Stock, Shares Outstanding | 29,269,121 | |
Class B Common Stock | ||
Entity Common Stock, Shares Outstanding | 0 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 68,040,264 | $ 72,636,886 |
Marketable securities, current | 29,202,248 | 32,887,970 |
Accounts receivable | 0 | 12,417 |
Prepaids and other current assets | 3,340,248 | 3,209,536 |
Total current assets | 100,582,760 | 108,746,809 |
Property and equipment, net | 1,393,173 | 1,369,608 |
Goodwill | 6,690,431 | 6,690,431 |
Intangible asset, net | 386,997 | 408,947 |
Right-of-use assets, net | 4,083,875 | 4,407,785 |
Other assets | 743,703 | 743,703 |
Total assets | 113,880,939 | 122,367,283 |
Current liabilities: | ||
Accounts payable | 1,941,099 | 3,154,557 |
Accrued expenses | 3,299,053 | 4,500,993 |
Other liabilities, current | 80,497 | 19,796 |
Lease liabilities, current | 301,633 | 378,723 |
Total current liabilities | 5,622,282 | 8,054,069 |
Long-term liabilities: | ||
Lease liabilities, non-current | 4,241,020 | 4,462,959 |
Total liabilities | 9,863,302 | 12,517,028 |
Commitments and contingencies (Note 10) | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 10,000,000 shares authorized at September 30, 2023 and December 31, 2022; 0 shares issued or outstanding at September 30, 2023 and December 31, 2022 | 0 | 0 |
Additional paid-in capital | 252,157,847 | 219,640,912 |
Accumulated other comprehensive income (loss) | 5,607 | (30,120) |
Accumulated deficit | (148,175,086) | (109,786,956) |
Total stockholders' equity | 104,017,637 | 109,850,255 |
Total liabilities and stockholders' equity | 113,880,939 | 122,367,283 |
Class A Common Stock | ||
Stockholders’ equity: | ||
Common stock | 29,269 | 26,419 |
Class B Common Stock | ||
Stockholders’ equity: | ||
Common stock | $ 0 | $ 0 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Preferred stock, par value per share (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Class A Common Stock | ||
Common stock, par value per share (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 29,269,121 | 26,418,732 |
Common stock, shares outstanding (in shares) | 29,269,121 | 26,418,732 |
Class B Common Stock | ||
Common stock, par value per share (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 20,000,000 | 20,000,000 |
Common stock, shares issued (in shares) | 0 | 0 |
Common stock, shares outstanding (in shares) | 0 | 0 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Revenue | $ 0 | $ 38,380 | $ 0 | $ 316,497 |
Cost of revenue | 0 | 19,343 | 0 | 158,122 |
Gross profit | 0 | 19,037 | 0 | 158,375 |
Operating expenses | ||||
Research and development | 10,050,198 | 9,363,838 | 29,713,835 | 26,395,355 |
General and administrative | 3,868,823 | 3,836,032 | 12,375,114 | 11,500,144 |
Amortization of intangible asset | 7,317 | 7,317 | 21,950 | 22,737 |
Total operating expenses | 13,926,338 | 13,207,187 | 42,110,899 | 37,918,236 |
Loss from operations | (13,926,338) | (13,188,150) | (42,110,899) | (37,759,861) |
Other income (expense) | ||||
Interest income | 855,532 | 222,985 | 2,852,852 | 498,288 |
Other income (expense) | 475,595 | 120,835 | 869,917 | (6,434) |
Net loss | $ (12,595,211) | $ (12,844,330) | $ (38,388,130) | $ (37,268,007) |
Net loss per share attributable to common stockholders, basic (in dollars per share) | $ (0.43) | $ (0.49) | $ (1.36) | $ (1.41) |
Net loss per share attributable to common stockholders, diluted (in dollars per share) | $ (0.43) | $ (0.49) | $ (1.36) | $ (1.41) |
Weighted-average common shares outstanding, basic (in shares) | 29,266,309 | 26,394,490 | 28,129,005 | 26,380,101 |
Weighted-average common shares outstanding, diluted (in shares) | 29,266,309 | 26,394,490 | 28,129,005 | 26,380,101 |
Other comprehensive loss: | ||||
Unrealized gains (losses) from marketable securities | $ 7,825 | $ 39,088 | $ 35,727 | $ (93,464) |
Comprehensive Loss | $ (12,587,386) | $ (12,805,242) | $ (38,352,403) | $ (37,361,471) |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (Unaudited) - USD ($) | Total | Class A Common Stock | Class B Common Stock | Common Stock Class A Common Stock | Common Stock Class B Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2021 | 26,320,199 | 0 | ||||||
Beginning balance at Dec. 31, 2021 | $ 155,980,109 | $ 26,320 | $ 0 | $ 215,276,186 | $ (49,009) | $ (59,273,388) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock upon exercise of stock options (in shares) | 63,100 | |||||||
Issuance of common stock upon exercise of stock options | 193,111 | $ 63 | 193,048 | |||||
Stock-based compensation expense | 897,650 | 897,650 | ||||||
Net loss | (12,896,374) | (12,896,374) | ||||||
Other comprehensive (loss) gain | (118,386) | (118,386) | ||||||
Ending balance (in shares) at Mar. 31, 2022 | 26,383,299 | 0 | ||||||
Ending balance at Mar. 31, 2022 | 144,056,110 | $ 26,383 | $ 0 | 216,366,884 | (167,395) | (72,169,762) | ||
Beginning balance (in shares) at Dec. 31, 2021 | 26,320,199 | 0 | ||||||
Beginning balance at Dec. 31, 2021 | 155,980,109 | $ 26,320 | $ 0 | 215,276,186 | (49,009) | (59,273,388) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Net loss | (37,268,007) | |||||||
Ending balance (in shares) at Sep. 30, 2022 | 26,404,732 | 0 | ||||||
Ending balance at Sep. 30, 2022 | 121,893,202 | $ 26,405 | $ 0 | 218,550,665 | (142,473) | (96,541,395) | ||
Beginning balance (in shares) at Mar. 31, 2022 | 26,383,299 | 0 | ||||||
Beginning balance at Mar. 31, 2022 | 144,056,110 | $ 26,383 | $ 0 | 216,366,884 | (167,395) | (72,169,762) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock upon exercise of stock options (in shares) | 9,000 | |||||||
Issuance of common stock upon exercise of stock options | 27,784 | $ 9 | 27,775 | |||||
Stock-based compensation expense | 1,052,421 | 1,052,421 | ||||||
Net loss | (11,527,303) | (11,527,303) | ||||||
Other comprehensive (loss) gain | (14,166) | (14,166) | ||||||
Ending balance (in shares) at Jun. 30, 2022 | 26,392,299 | 0 | ||||||
Ending balance at Jun. 30, 2022 | 133,594,846 | $ 26,392 | $ 0 | 217,447,080 | (181,561) | (83,697,065) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock upon exercise of stock options (in shares) | 12,433 | |||||||
Issuance of common stock upon exercise of stock options | 37,386 | $ 13 | 37,373 | |||||
Stock-based compensation expense | 1,066,212 | 1,066,212 | ||||||
Net loss | (12,844,330) | (12,844,330) | ||||||
Other comprehensive (loss) gain | 39,088 | 39,088 | ||||||
Ending balance (in shares) at Sep. 30, 2022 | 26,404,732 | 0 | ||||||
Ending balance at Sep. 30, 2022 | 121,893,202 | $ 26,405 | $ 0 | 218,550,665 | (142,473) | (96,541,395) | ||
Beginning balance (in shares) at Dec. 31, 2022 | 26,418,732 | 0 | 26,418,732 | 0 | ||||
Beginning balance at Dec. 31, 2022 | 109,850,255 | $ 26,419 | $ 0 | 219,640,912 | (30,120) | (109,786,956) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock upon exercise of stock options (in shares) | 77,065 | |||||||
Issuance of common stock upon exercise of stock options | 239,409 | $ 77 | 239,332 | |||||
Stock-based compensation expense | 1,273,505 | 1,273,505 | ||||||
Net loss | (13,604,171) | (13,604,171) | ||||||
Other comprehensive (loss) gain | 30,626 | 30,626 | ||||||
Ending balance (in shares) at Mar. 31, 2023 | 26,495,797 | 0 | ||||||
Ending balance at Mar. 31, 2023 | 97,789,624 | $ 26,496 | $ 0 | 221,153,749 | 506 | (123,391,127) | ||
Beginning balance (in shares) at Dec. 31, 2022 | 26,418,732 | 0 | 26,418,732 | 0 | ||||
Beginning balance at Dec. 31, 2022 | $ 109,850,255 | $ 26,419 | $ 0 | 219,640,912 | (30,120) | (109,786,956) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock upon exercise of stock options (in shares) | 123,116 | |||||||
Net loss | $ (38,388,130) | |||||||
Ending balance (in shares) at Sep. 30, 2023 | 29,269,121 | 0 | 29,269,121 | 0 | ||||
Ending balance at Sep. 30, 2023 | 104,017,637 | $ 29,269 | $ 0 | 252,157,847 | 5,607 | (148,175,086) | ||
Beginning balance (in shares) at Mar. 31, 2023 | 26,495,797 | 0 | ||||||
Beginning balance at Mar. 31, 2023 | 97,789,624 | $ 26,496 | $ 0 | 221,153,749 | 506 | (123,391,127) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock upon exercise of stock options (in shares) | 39,958 | |||||||
Issuance of common stock upon exercise of stock options | 176,146 | $ 40 | 176,106 | |||||
Stock-based compensation expense | 1,333,882 | 1,333,882 | ||||||
Issuance of common stock upon public offering, net of commissions, underwriting discounts and issuance costs (in shares) | 2,727,273 | |||||||
Issuance of common stock upon public offering, net of commissions, underwriting discounts and issuance costs | 27,996,235 | $ 2,727 | 27,993,508 | |||||
Net loss | (12,188,748) | (12,188,748) | ||||||
Other comprehensive (loss) gain | (2,724) | (2,724) | ||||||
Ending balance (in shares) at Jun. 30, 2023 | 29,263,028 | 0 | ||||||
Ending balance at Jun. 30, 2023 | 115,104,415 | $ 29,263 | $ 0 | 250,657,245 | (2,218) | (135,579,875) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock upon exercise of stock options (in shares) | 6,093 | |||||||
Issuance of common stock upon exercise of stock options | 21,448 | $ 6 | 21,442 | |||||
Stock-based compensation expense | 1,479,160 | 1,479,160 | ||||||
Net loss | (12,595,211) | (12,595,211) | ||||||
Other comprehensive (loss) gain | 7,825 | 7,825 | ||||||
Ending balance (in shares) at Sep. 30, 2023 | 29,269,121 | 0 | 29,269,121 | 0 | ||||
Ending balance at Sep. 30, 2023 | $ 104,017,637 | $ 29,269 | $ 0 | $ 252,157,847 | $ 5,607 | $ (148,175,086) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (Unaudited) (Parenthetical) - USD ($) | 3 Months Ended | |
Apr. 20, 2023 | Jun. 30, 2023 | |
Underwriting Offering | ||
Proceeds, before deducting offering costs payable | $ 203,768 | $ 203,768 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (38,388,130) | $ (37,268,007) |
Adjustment to reconcile to net loss to net cash used in operating activities: | ||
Depreciation/amortization expense | 233,062 | 170,337 |
Reduction in carrying amount of right-of-use assets | 323,910 | 414,444 |
Intangible asset amortization | 21,950 | 22,737 |
Stock-based compensation expense | 4,086,547 | 3,016,283 |
Net amortization of premium (accretion of discount) on marketable securities | (613,952) | 47,979 |
Loss on disposal of fixed assets | 1,483 | 0 |
(Increase) decrease in: | ||
Accounts receivable | 12,417 | 175,860 |
Prepaid expenses and other current assets | (130,712) | 166,413 |
Other assets | 0 | (356,117) |
Increase (decrease) in: | ||
Accounts payable | (1,277,464) | 944,040 |
Accrued expenses | (1,224,216) | 385,536 |
Lease liabilities | (299,029) | (116,718) |
Other liabilities | 60,701 | 44,562 |
Net cash used in operating activities | (37,193,433) | (32,352,651) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (171,828) | (673,181) |
Purchases of marketable securities | (28,914,599) | (37,726,144) |
Maturities of marketable securities | 33,250,000 | 72,078,000 |
Net cash provided by investing activities | 4,163,573 | 33,678,675 |
Cash flows from financing activities: | ||
Proceeds from exercise of stock options | 437,003 | 258,281 |
Proceeds from public offering of common stock, net of commissions and underwriting | 28,200,003 | 0 |
Payment of offering costs | (203,768) | (54,600) |
Net cash provided by financing activities | 28,433,238 | 203,681 |
Net increase (decrease) in cash and cash equivalents | (4,596,622) | 1,529,705 |
Cash and cash equivalents at beginning of period | 72,636,886 | 74,888,145 |
Cash and cash equivalents at end of period | 68,040,264 | 76,417,850 |
Supplemental disclosures of noncash information: | ||
Property and equipment in accounts payable/accrued expenses | 86,282 | 0 |
Reduction of right-of-use asset and lease liability in connection with lease modification | 0 | 396,901 |
Deferred offering costs included in accounts payable/accrued expenses | $ 0 | $ 224,448 |
Organization and Nature of Busi
Organization and Nature of Business | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Nature of Business | Organization and Nature of Business Immuneering Corporation, a Delaware corporation, (“Immuneering” or the “Company”) was incorporated in 2008. Immuneering is a clinical-stage oncology company seeking to develop medicines for broad populations of cancer patients with an initial aim to therapeutically address universal-RAS. The Company aims to achieve universal activity through deep cyclic inhibition of the MAPK pathway, impacting cancer cells while sparing healthy cells. Immuneering’s lead product candidate, IMM-1-104, is in a Phase 1/2a study in patients with advanced solid tumors harboring RAS mutations. On October 30, 2019, Immuneering formed a wholly owned subsidiary, Immuneering Securities Corporation (“ISC”), a Massachusetts securities corporation, for the sole purpose of buying, selling and holding securities on the Company’s behalf. On December 22, 2021, the Company acquired all outstanding shares of capital stock of BioArkive, Inc. (“BioArkive”), a California corporation, which as a result became a wholly owned subsidiary. Immuneering, ISC and BioArkive are collectively referred to as the “Company” throughout these condensed consolidated financial statements. The Company is subject to a number of inherent risks associated with any biotechnology company that has substantial expenditures for research and development. These risks include, but are not limited to, the need to obtain adequate additional funding, possible failure of clinical trials or other events demonstrating lack of clinical safety or efficacy of its product candidates, dependence on key personnel, reliance on third-party service providers for manufacturing drug product and conducting clinical trials, the ability to successfully secure its proprietary technology, and risks related to the regulatory approval and commercialization of a product candidate. There can be no assurance that the Company’s research and development programs will be successful. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its employees, advisors, and consultants. On August 3, 2021, the Company completed its initial public offering (“IPO”) pursuant to which it issued and sold 8,625,000 shares of its Class A common stock, inclusive of 1,125,000 shares of its Class A common stock sold pursuant to the full exercise of the underwriters’ option to purchase additional shares. The aggregate net proceeds received by the Company from the IPO were $120,318,750, after deducting underwriting discounts and commissions, but before deducting offering costs payable by the Company, which were $2,124,317. Upon the closing of the IPO, all 8,528,078 shares of the Company’s convertible preferred stock then outstanding automatically converted into 11,939,281 shares of Class A common stock. Upon the conversion of the convertible preferred stock, the Company reclassified the carrying value of the convertible preferred stock to common stock (at par value) and additional paid-in capital. On April 20, 2023, the Company completed an underwritten follow-on equity offering, pursuant to which it issued and sold 2,727,273 shares of its Class A common stock $0.001 par value per share at an offering price of $11.00 per share. The aggregate net proceeds received by the Company from the offering were $28,200,003, after deducting underwriting discounts and commissions, but before deducting offering costs payable by the Company of $203,768. To date, the Company has funded its operations through service revenues (which have since ceased), and with proceeds from the sale of its capital stock and convertible notes. The Company has incurred recurring losses over the past several years and as of September 30, 2023, the Company had an accumulated deficit of $148,175,086. The Company expects to continue to generate operating losses for the foreseeable future. The future viability of the Company is dependent on its ability to raise additional capital to finance its operations. The Company’s inability to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. There can be no assurances that additional funding will be available on terms acceptable to the Company, or at all. If the Company is unable to raise additional funds when needed, it may be required to delay, reduce the scope of, or eliminate development programs, which may adversely affect its business and operations. Management considered whether or not there are conditions or events, in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern, and concluded that there are none as it estimates that its cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance date of the unaudited condensed consolidated financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation The condensed consolidated financial statements have been prepared in accordance with accounting standards set by the Financial Accounting Standards Board (“FASB”). The FASB sets generally accepted accounting principles (“GAAP”) to ensure the condensed consolidated financial statements are consistently reported. References to GAAP issued by the FASB in these footnotes are to the FASB Accounting Standards Codifications (“ASC”). The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. There have been no material changes to the accounting policies of the Company as those set forth in Note 2 to the audited consolidated financial statements contained in the Annual Report on Form 10-K for the fiscal year ended December 31, 2022. Unaudited Interim Financial Information The unaudited interim condensed consolidated financial statements of the Company have been prepared, without audit, in accordance with GAAP and in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting. Certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with GAAP have been omitted from the unaudited interim condensed consolidated financial statements, as is permitted by such rules and regulations. While we believe that the disclosures presented are adequate in order to make the information not misleading, these unaudited interim condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes for the year ended December 31, 2022. It is management’s opinion that these financial statements include all normal and recurring adjustments necessary for a fair presentation of the Company’s financial position, operating results and cash flows. Revenues and net loss for any interim period are not necessarily indicative of future or annual results. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses during the reporting periods. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgements about the carrying values of assets, liabilities and the recording of expenses that are not readily apparent from other sources. Significant estimates reflected in these condensed consolidated financial statements included, but are not limited to, the research and development expenses, determination of fair value of stock-based awards, the valuation of common stock prior to the IPO, and the right-to-use assets and operating lease liabilities. Actual results may differ materially and adversely from these estimates. Goodwill Goodwill represents the excess of the fair value of the acquiree over the recognized basis of the net identifiable assets acquired and includes the future economic benefits from other assets that could not be individually identified and separately recognized. Goodwill is not amortized, but instead is periodically reviewed for impairment and an impairment charge is recorded in the periods in which the recorded carrying value of goodwill exceeds its fair value. On a quarterly basis, the Company performs a review of its business to determine if events or changes in circumstances have occurred which could have a material adverse effect on the fair value of the Company and its goodwill. If such events or changes in circumstances were deemed to have occurred, the Company would perform an impairment test of goodwill as of the end of the quarter and record any noted impairment loss. The goodwill test is performed at least annually, or more frequently if events or changes in circumstances indicate that the asset might be impaired. The Company performs its annual impairment test during the fourth quarter of each fiscal year. There were no impairments identified for the year ended December 31, 2022 or the nine months ended September 30, 2023. Deferred Offering Costs The Company capitalizes certain legal, professional, and other third-party charges related to ongoing equity financings as deferred offering costs until fully consummated. These costs are to be recorded as a reduction of the offering’s proceeds which are recorded to additional paid-in capital within stockholders’ equity. Should the Company choose not to initiate such financing, the deferred offering costs would be immediately expensed as operating expenses. On August 10, 2022, the Company entered into an Equity Distribution Agreement (the “Sales Agreement”) with Piper Sandler & Co, (the “Sales Agent”) to sell shares of the Company’s common stock, par value $0.001 per share, with aggregate gross sales proceeds of up to $50 million, from time to time, through an “at the market” equity offering program. Deferred offering costs associated with the Sales Agreement are reclassified to additional paid-in capital on a pro-rata basis when the Company completes offerings under the Sales Agreement. Any remaining deferred costs will be expensed to the statement of operations should the planned offering be abandoned. The Company had approximately $0.3 million of deferred offering costs as of both September 30, 2023 and December 31, 2022. Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. The Company is an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, as amended (“JOBS Act”). The JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. The Company elected to avail itself of this extended transition period and, as a result, the Company will not be required to adopt certain new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies. In 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Statements. The new standard, as amended, requires that expected credit losses relating to financial assets measured on an amortized cost basis and available-for-sale debt securities be recorded through an allowance for credit losses. It also limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and also requires the reversal of previously recognized credit losses if fair value increases. The targeted transition relief standard allows filers an option to irrevocably elect the fair value option of ASC 825-10, Financial Instruments - Overall, applied on an instrument-by-instrument basis for eligible instruments. ASU 2016-13, Financial Instruments - Credit Losses (Topic 326) became effective for the Company on January 1, 2023. The Company adopted this effective January 1, 2023 and there was no impact to the condensed consolidated financial statements. In January 2017, the FASB issued ASU 2017-04, Intangibles - Goodwill and Other (Topic 350 ) , which eliminates Step 2 from the goodwill impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill. Instead, entities will record an impairment charge based on the excess of a reporting unit’s carrying amount over its fair value (i.e., measure the charge based on today’s Step 1). This update is effective for annual and interim impairment tests performed in periods beginning after December 15, 2022. Early adoption of the standard is permitted. The Company adopted this effective January 1, 2023 and there was no impact to the condensed consolidated financial statements. |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities Our marketable securities are classified as available-for-sale pursuant to ASC 320, Investments – Debt and Equity Securities and are recorded at fair value. Unrealized gains (losses) are included as a component of accumulated other comprehensive income (loss) in the condensed consolidated balance sheets and statements of stockholders’ equity and a component of total comprehensive loss in the condensed consolidated statements of comprehensive loss, until realized. The Company assesses its available-for-sale marketable securities for impairment on a quarterly basis. There were no impairments of the Company’s available-for-sale marketable securities measured and carried at fair value during the three and nine months ended September 30, 2023 or 2022. Realized gains and losses are included in other income (expense). Our marketable securities portfolio contains investments in U.S. Treasury, other U.S. government-backed securities, and commercial paper. We review our portfolio based on the underlying risk profile of the securities and we don't expect there to be a loss on these investments. We also regularly review the securities in an unrealized loss position and evaluate the current expected credit loss by considering factors such as historical experience, market data, issuer-specific factors, and current economic conditions. During the three and nine months ended September 30, 2023 and 2022, we recognized no year-to-date credit loss related to our short-term investments, and had no allowance for credit loss recorded as of September 30, 2023 or December 31, 2022. Marketable securities as of September 30, 2023 consisted of the following: September 30, 2023 Amortized Cost Unrealized Gains Unrealized Losses Fair Value Assets: Current: U.S. Treasuries $ 13,094,059 $ 666 $ (195) $ 13,094,530 Government securities $ 4,425,447 $ 3,303 $ — $ 4,428,750 Commercial paper 11,678,343 1,581 (956) 11,678,968 Total marketable securities $ 29,197,849 $ 5,550 $ (1,151) $ 29,202,248 Marketable securities as of December 31, 2022 consisted of the following: December 31, 2022 Amortized Cost Unrealized Gains Unrealized Losses Fair Value Assets: Current: U.S. Treasuries $ 12,986,424 $ — $ (25,649) $ 12,960,775 Government securities 8,084,107 1,099 (12,021) 8,073,185 Commercial paper 11,847,902 6,847 (739) 11,854,010 Total marketable securities $ 32,918,433 $ 7,946 $ (38,409) $ 32,887,970 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements We record cash equivalents and marketable securities at fair value. ASC 820, Fair Value Measurements and Disclosures, establishes a fair value hierarchy for those instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and our own assumptions (unobservable inputs). The hierarchy consists of three levels: Level 1 – Unadjusted quoted prices in active markets 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, directly or indirectly, for substantially the full term of the asset or liability. Level 3 – Unobservable inputs that reflect our own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date. The following table summarizes our cash equivalents and marketable securities measured at fair value on a recurring basis as of September 30, 2023: Level 1 Level 2 Level 3 Total Assets: Cash equivalents Money market $ 58,981,550 $ — $ — $ 58,981,550 U.S. Treasuries 6,735,957 — — 6,735,957 Commercial paper — 1,995,220 — 1,995,220 Total cash equivalents 65,717,507 1,995,220 — 67,712,727 Marketable securities: U.S. Treasuries $ 13,094,530 $ — $ — $ 13,094,530 Government securities — 4,428,750 — 4,428,750 Commercial paper — 11,678,968 — 11,678,968 Total marketable securities 13,094,530 16,107,718 — 29,202,248 Total cash equivalents and marketable securities $ 78,812,037 $ 18,102,938 $ — $ 96,914,975 There have been no changes to the valuation methods during the nine months ended September 30, 2023. There were no transfers between Level 1 and Level 2 and we had no financial assets or liabilities that were classified as Level 3 at any point during the nine months ended September 30, 2023. Cash equivalents and marketable securities have been initially valued at the transaction price and subsequently, at the end of each reporting period, valued utilizing third-party pricing services or other observable market data. The pricing services utilize industry standard valuation models, including both income and market-based approaches, and observable market inputs to determine value. After completing our valuation procedures, we did not adjust or override any fair value measurements provided by the pricing services as of September 30, 2023 and December 31, 2022. The following table summarizes our cash equivalents and marketable securities measured at fair value on a recurring basis as of December 31, 2022: Level 1 Level 2 Level 3 Total Assets: Cash equivalents Money market $ 19,118,892 $ — $ — $ 19,118,892 Commercial paper — 1,249,575 — 1,249,575 Government securities — 2,742,025 — 2,742,025 Total cash equivalents 19,118,892 3,991,600 — 23,110,492 Marketable securities: U.S. Treasuries $ 12,960,775 $ — $ — $ 12,960,775 Government securities — 8,073,185 — 8,073,185 Commercial paper — 11,854,010 — 11,854,010 Total marketable securities 12,960,775 19,927,195 — 32,887,970 Total cash equivalents and marketable securities $ 32,079,667 $ 23,918,795 $ — $ 55,998,462 |
Property and Equipment, net
Property and Equipment, net | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and Equipment, net Property and equipment, net consisted of the following: September 30, December 31, Computer equipment $ 450,751 $ 437,346 Furniture and fixtures 91,317 91,317 Lab equipment 1,113,726 970,374 Leasehold improvements 298,941 288,908 Construction in progress 86,392 — Total 2,041,127 1,787,945 Accumulated depreciation/amortization (647,954) (418,337) Property and equipment, net $ 1,393,173 $ 1,369,608 Depreciation/amortization expense totaled $78,294 and $68,075 for the three months ended September 30, 2023 and 2022, respectively. Depreciation/amortization expense totaled $233,062 and $170,337 for the nine months ended September 30, 2023 and 2022, respectively. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Liabilities, Current [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses consisted of the following: September 30, December 31, Accrued professional services $ 276,617 $ 297,234 Accrued employee expenses 2,353,981 3,631,082 Accrued research and development expenses 572,502 425,846 Accrued other 95,953 146,831 Total $ 3,299,053 $ 4,500,993 |
Common Stock
Common Stock | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
Common Stock | Common Stock The Company had 200,000,000 authorized shares of Class A common stock, $0.001 par value per share as of September 30, 2023 and December 31, 2022 of which 29,269,121 and 26,418,732 were issued and outstanding, respectively. The holders of Class A common stock are entitled one vote for each share of common stock. Dividends may be paid when, and if declared by the Board of Directors, subject to the limitations, powers and preferences granted to the Preferred Stockholders and on a proportionate basis with holders of Class B common stock. As of September 30, 2023 and December 31, 2022, the following number of shares of Class A common stock have been reserved: September 30, December 31, Exercise of common stock options 5,490,165 3,559,041 5,490,165 3,559,041 The Company had 20,000,000 authorized shares of Class B common stock, $0.001 par value per share as of September 30, 2023 and December 31, 2022, of which no shares have been issued nor are outstanding. The holders of Class B common stock have no voting rights. Dividends may be paid when, and if, declared by the Board of Directors, subject to the limitations, powers and preferences granted to the preferred stockholders and on a proportionate basis with holders of Class A common stock. IPO On August 3, 2021, the Company completed its initial public offering pursuant to which it issued and sold 8,625,000 shares of its Class A common stock, inclusive of 1,125,000 shares of its Class A common stock sold pursuant to the full exercise of the underwriters’ option to purchase additional shares. The aggregate net proceeds received by the Company from the IPO were $120,318,750, after deducting underwriting discounts and commissions, but before deducting offering costs payable by the Company, which were $2,124,317. Upon the closing of the IPO, all 8,528,078 shares of the Company’s convertible preferred stock then outstanding automatically converted into 11,939,281 shares of Class A common stock. Upon the conversion of the convertible preferred stock, the Company reclassified the carrying value of the convertible preferred stock to common stock (at par value) and additional paid-in capital. On August 3, 2021 in connection with the closing of the IPO, the Company filed a restated certificate of incorporation, which amended and restated the Company’s certificate of incorporation to, among other things: (i) increase the number of authorized shares of common stock to 200,000,000 shares of Class A common stock and 20,000,000 shares of Class B common stock, par value $0.001 per share; (ii) authorize 10,000,000 shares of Preferred Stock; and (iii) authorize the Board of Directors to establish the rights, preferences and restrictions on any unissued series of Preferred Stock. Equity Offerings On August 10, 2022, the Company filed a Registration Statement on Form S-3 (File No. 333-266738) (the “2022 Shelf Registration Statement”) with the SEC in relation to the registration of common stock, preferred stock, debt securities, warrants and/or units or any combination thereof in the aggregate amount of up to $200 million for a period of up to three years from the date of its effectiveness on August 19, 2022. On August 10, 2022, the Company also entered into the Sales Agreement with the Sales Agent to sell shares of the Company’s Class A common stock, par value $0.001 per share, with aggregate gross sales proceeds of up to $50 million, from time to time, through an “at the market” equity offering program (the “ATM Program”) under the 2022 Shelf Registration Statement. Subject to the terms and conditions of the Sales Agreement, the Sales Agent may sell the shares by methods deemed to be an “at the market offering” as defined in Rule 415 promulgated under the Securities Act, including sales made through the Nasdaq Global Market, on any other existing trading market for the common stock, to or through a market maker, or, if expressly authorized by the Company, in privately negotiated transactions. The Company or Sales Agent may terminate the Sales Agreement upon notice to the other party and subject to other conditions. The Company will pay the Sales Agent a commission equal to 3.0% of the gross proceeds of any Common Stock sold through the Sales Agent under the Sales Agreement and has provided the Sales Agent with customary indemnification rights. Issuance costs incurred related to the Sales Agreement are classified as long-term assets on the balance sheet at September 30, 2023. The Company had approximately $0.3 million of deferred offering costs as of both September 30, 2023 and December 31, 2022. No shares were sold pursuant to the ATM Program during the three or nine month periods ended September 30, 2023 or September 30, 2022, respectively. On April 20, 2023, the Company completed an underwritten follow-on equity offering, pursuant to which it issued and sold 2,727,273 shares of its Class A common stock, $0.001 par value per share, at an offering price of $11.00 per share under the 2022 Shelf Registration Statement. The aggregate net proceeds received by the Company from the offering were $28,200,003, after deducting underwriting discounts and commissions, but before deducting offering costs payable by the Company of $203,768. |
Net Loss Per Share Attributable
Net Loss Per Share Attributable to Common Stockholders | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share Attributable to Common Stockholders | Net Loss Per Share Attributable to Common StockholdersNet loss per share of common stock is computed using the two-class method required for multiple classes of common stock and participating securities based upon their respective rights to receive dividends as if all income for the period has been distributed. The rights, including the liquidation and dividend rights and sharing of losses, of the Class A and Class B common stock are identical, other than voting rights. As the liquidation and dividend rights and sharing of losses are identical, the undistributed earnings are allocated on a proportionate basis and the resulting net loss per share attributed to common stockholders is therefore the same for Class A and Class B common stock on an individual or combined basis. Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period, adjusted for outstanding shares that are subject to repurchase. Diluted net loss per share is computed by giving effect to all potentially dilutive securities outstanding for the period using the treasury stock method or the if-converted method based on the nature of such securities. The Company has reported net losses for all periods presented, therefore diluted net loss per common share attributable to common stockholders is the same as basic net loss per common share attributable to common stockholders, because potentially dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. Basic and diluted net loss per share attributable to common stockholders was calculated at September 30, 2023 and September 30, 2022 as follows: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Numerator: Net loss $ (12,595,211) $ (12,844,330) $ (38,388,130) $ (37,268,007) Denominator - basic and diluted: Weighted-average common shares outstanding, basic and diluted 29,266,309 26,394,490 28,129,005 26,380,101 Net loss per share - basic and diluted $ (0.43) $ (0.49) $ (1.36) $ (1.41) The following table sets forth the potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to include them would be anti-dilutive (in common stock equivalent shares) at September 30, 2023 and September 30, 2022: 2023 2022 Options to purchase common stock 5,490,165 3,598,026 Total shares of common stock equivalents 5,490,165 3,598,026 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation During 2015, the Company established the Long Term Incentive Plan (“Incentive Plan”), under which incentive stock options, nonqualified stock options, restricted stock or other awards may be awarded to employees, directors or consultants of the Company. The options typically vest over a four-year period. Upon the effectiveness of the Company’s 2021 Incentive Award Plan (the "2021 Plan"), the Company ceased granting awards under the Incentive Plan. However, the Incentive Plan continues to govern awards outstanding thereunder. On July 23, 2021, the Company’s Board of Directors adopted, and on July 23, 2021 its stockholders approved, the 2021 Plan, which became effective on July 29, 2021. The 2021 Plan provides for the grant of incentive stock options, stock appreciation rights, restricted stock awards, restricted stock units, and other stock-based awards. The number of shares reserved for issuance under the 2021 Plan was initially equal to 2,590,000 plus an annual increase on the first day of each calendar year, beginning on January 1, 2022 and ending on and including January 1, 2031, equal to the lesser of (i) 4% of the aggregate number of shares of Class A common stock outstanding on the final day of the immediately preceding calendar year and (ii) such smaller number of shares of Class A common stock as determined by the Board of Directors. No more than 15,350,000 shares of Class A common stock may be issued under the 2021 Plan upon the exercise of incentive stock options. Shares issued under the 2021 Plan may be authorized but unissued shares, shares purchased on the open market or treasury shares. If an award under the 2021 Plan expires, lapses or is terminated, exchanged for or settled in cash, surrendered, repurchased, cancelled without having been fully exercised/settled or forfeited, any unused shares subject to the award will, as applicable, become or again be available for new grants under the 2021 Plan. In addition, shares subject to stock options issued under the Incentive Plan may become available for issuance under the 2021 Plan to the extent such stock options are canceled, forfeited, exchanged, settled in cash or otherwise terminated. As of September 30, 2023, there were 1,555,719 shares available for future issuance under the 2021 Plan. On July 23, 2021, the Company’s Board of Directors adopted, and on July 23, 2021 its stockholders approved, the 2021 Employee Stock Purchase Plan (the “2021 ESPP”), which became effective on July 29, 2021. A total of 250,000 shares of Class A common stock were initially reserved for issuance under this plan. The number of shares of Class A common stock that may be issued under the 2021 ESPP will automatically increase on the first day of each calendar year, beginning on January 1, 2022 and ending on and including January 1, 2031, equal to the lesser of (i) 1% of the shares of Class A common stock outstanding on the final day of the immediately preceding calendar year and (ii) such smaller number of shares of Class A common stock as determined by the Board of Directors, provided that not more than 3,340,000 shares of Class A common stock may be issued under the 2021 ESPP. As of September 30, 2023, there were 777,389 shares of common stock reserved for future issuance under the 2021 ESPP and no shares had been granted or purchased under the 2021 ESPP. The Company recognized stock-based compensation expense of $1,479,160 and $4,086,547 during the three and nine months ended September 30, 2023, respectively. During the three and nine months ended September 30, 2022, the Company recognized stock-based compensation expense of $1,066,212 and $3,016,283, respectively. As of September 30, 2023, compensation expense remaining to be recognized for outstanding stock options was $12,450,569 and to be recognized over a weighted-average period of 2.65 years. The fair value of options granted is calculated on the grant date using the Black-Scholes option valuation model. Prior to the Company's IPO on August 3, 2021, the Company was a private company and thus lacks company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own publicly traded stock price. For the nine months ended September 30, 2023, the Company granted 2,269,610 shares of stock options at a weighted-average grant date fair value of $5.31. The Company used the following assumptions in its application of the Black-Scholes option pricing model for grants during the nine months ended September 30, 2023 and 2022: Nine Months Ended September 30, 2023 2022 Weighted-average risk-free interest rate 3.46% - 4.24% 1.35% - 3.31% Expected term (in years) 5.00 - 10.00 5.00 - 10.00 Expected dividend yield 0% 0% Expected volatility 64.86% - 70.50% 64.78% - 78.12% The following table summarizes the stock option activity during the nine months ended September 30, 2023: Number of Weighted- Weighted Aggregate Outstanding at December 31, 2022 3,559,041 $ 7.36 Granted 2,269,610 5.31 Exercised (123,116) 3.55 Cancelled (215,370) 9.39 Outstanding at September 30, 2023 5,490,165 $ 6.51 7.90 $ 12,917,120 Vested and exercisable at September 30, 2023 2,570,469 $ 5.81 6.71 $ 7,424,101 For the three and nine months ended September 30, 2023 and 2022, the Company recognized share-based compensation expense on the accompanying condensed consolidated statements of operations as follows: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Cost of revenue $ — $ 1,058 $ — $ 9,703 Research and development 657,652 507,489 1,864,462 1,445,145 General and administrative 821,508 557,665 2,222,085 1,561,435 Total $ 1,479,160 $ 1,066,212 $ 4,086,547 $ 3,016,283 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Operating Leases In October 2020, the Company entered into an office lease (“Via Frontera Lease”) in San Diego, California with a lease term of 67 months. At the lease commencement date, a right-to-use asset and lease liability was recognized by the Company for $637,863. In January 2022, the Company exercised its option to terminate the Via Frontera Lease 20 months early . T he Company subsequently entered into a sublease of the Via Frontera Lease, the term of which commenced in March 2022. The lease and sublease terminated on October 1, 2023. The lease termination was accounted for as a lease modification which reduces the term of the existing lease and the Company adjusted the value of its right-of-use asset and operating lease liability by $347,739 using an incremental borrowing rate of approximately 6%. The sublease income was accounted for as a reduction of rent expense in the statement of operations. The modification is reflected as a non-cash operating activity in the statement of cash flows for the nine months ended September 30, 2022. As part of the BioArkive acquisition, the Company assumed the obligations of three leases in San Diego, California. One is for 38,613 square feet of office and laboratory space, under a lease that terminates on April 30, 2032, the second was for a 6,100 square feet of office and laboratory space under a lease that terminated on December 31, 2022 (and that was not renewed), and the third is for a lease for 4,760 square feet of office and laboratory space under a lease that terminates on March 31, 2024. As a result, the Company recorded right-to-use assets and lease liabilities of $4,824,700 on the acquisition date of December 22, 2021. The Company currently also leases office space in Cambridge, Massachusetts and New York, New York pursuant to short-term arrangements. The Cambridge lease is on a month-to-month basis, requiring one month’s notice before termination. The New York lease is renewable on a yearly basis and the most recent renewal extended the lease term until February 28, 2024. The Company also previously leased office space in San Francisco, California, pursuant to a short-term rental arrangement with a lease term that ended on July 31, 2023 and the Company chose not to renew. These lease agreements include or included payments for lease and non-lease components. The Company has elected to not separate such components and these payments were recognized as rent expense. As of September 30, 2023, total future minimum lease payments for its short-term leases in Cambridge, Massachusetts, and New York, New York were $20,760 due in 2023 and $13,840 due in 2024. Future minimum lease payments for operating leases with initial or remaining terms in excess of one year at September 30, 2023 were as follows: Amount Remainder of 2023 $ 192,600 2024 732,546 2025 739,689 2026 761,877 2027 784,737 Thereafter 3,682,509 Total future lease payments 6,893,958 Less: Imputed interest (2,351,305) Total lease liabilities $ 4,542,653 Current portion lease liabilities $ 301,633 Lease liabilities, noncurrent 4,241,020 Total lease liabilities $ 4,542,653 Quantitative information regarding the Company’s leases for the nine months ended September 30, 2023 and 2022 is as follows: September 30, September 30, Lease costs: Operating lease cost $ 675,743 $ 777,741 Short-term lease cost 114,069 225,839 Sublease income (133,530) (149,260) Total lease costs $ 656,282 $ 854,320 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 650,863 $ 479,976 Operating cash flows from short-term leases 114,069 225,839 $ 764,932 $ 705,815 Weighted-average remaining lease term - operating leases 8.55 years 9.36 years Weighted-average discount rate - operating leases 10.0 % 9.3 % As the Company’s leases typically do not provide an implicit rate, the Company uses an estimate of its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. Litigation From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities and may be exposed to litigation in connection with its product candidates and operations. The Company’s policy is to assess the likelihood of any adverse judgments or outcomes related to legal matters, as well as ranges of probable losses. When it is probable that future expenditures will be made and can be reasonably estimated the Company will accrue a liability for such matters. Significant judgement is required to determine both probability and estimated amount. The Company is not aware of any material legal matters. Clinical Research Contracts The Company may enter into contracts in the normal course of business with contract research organizations for clinical trials, with contract manufacturing organizations for clinical supplies, and with other vendors for preclinical studies, supplies and other services for our operating purposes. These contracts generally provide for termination with a 30-day notice. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 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 | |
Pay vs Performance Disclosure | ||||||||
Net loss | $ (12,595,211) | $ (12,188,748) | $ (13,604,171) | $ (12,844,330) | $ (11,527,303) | $ (12,896,374) | $ (38,388,130) | $ (37,268,007) |
Insider Trading Arrangements
Insider Trading Arrangements | 9 Months Ended |
Sep. 30, 2023 | |
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 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The condensed consolidated financial statements have been prepared in accordance with accounting standards set by the Financial Accounting Standards Board (“FASB”). The FASB sets generally accepted accounting principles (“GAAP”) to ensure the condensed consolidated financial statements are consistently reported. References to GAAP issued by the FASB in these footnotes are to the FASB Accounting Standards Codifications (“ASC”). The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The unaudited interim condensed consolidated financial statements of the Company have been prepared, without audit, in accordance with GAAP and in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”) regarding interim financial reporting. Certain information and footnote disclosures normally included in the annual financial statements prepared in accordance with GAAP have been omitted from the unaudited interim condensed consolidated financial statements, as is permitted by such rules and regulations. While we believe that the disclosures presented are adequate in order to make the information not misleading, these unaudited interim condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes for the year ended December 31, 2022. It is management’s opinion that these financial statements include all normal and recurring adjustments necessary for a fair presentation of the Company’s financial position, operating results and cash flows. Revenues and net loss for any interim period are not necessarily indicative of future or annual results. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses during the reporting periods. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgements about the carrying values of assets, liabilities and the recording of expenses that are not readily apparent from other sources. Significant estimates reflected in these condensed consolidated financial statements included, but are not limited to, the research and development expenses, determination of fair value of stock-based awards, the valuation of common stock prior to the IPO, and the right-to-use assets and operating lease liabilities. Actual results may differ materially and adversely from these estimates. |
Goodwill | Goodwill Goodwill represents the excess of the fair value of the acquiree over the recognized basis of the net identifiable assets acquired and includes the future economic benefits from other assets that could not be individually identified and separately recognized. Goodwill is not amortized, but instead is periodically reviewed for impairment and an impairment charge is recorded in the periods in which the recorded carrying value of goodwill exceeds its fair value. On a quarterly basis, the Company performs a review of its business to determine if events or changes in circumstances have occurred which could have a material adverse effect on the fair value of the Company and its goodwill. If such events or changes in circumstances were deemed to have occurred, the Company would perform an impairment test of goodwill as of the end of the quarter and record any noted impairment loss. The goodwill test is performed at least annually, or more frequently if events or changes in circumstances indicate that the asset might be impaired. The Company performs its annual impairment test during the fourth quarter of each fiscal year. There were no impairments identified for the year ended December 31, 2022 or the nine months ended September 30, 2023. |
Deferred Offering Costs | Deferred Offering Costs The Company capitalizes certain legal, professional, and other third-party charges related to ongoing equity financings as deferred offering costs until fully consummated. These costs are to be recorded as a reduction of the offering’s proceeds which are recorded to additional paid-in capital within stockholders’ equity. Should the Company choose not to initiate such financing, the deferred offering costs would be immediately expensed as operating expenses. On August 10, 2022, the Company entered into an Equity Distribution Agreement (the “Sales Agreement”) with Piper Sandler & Co, (the “Sales Agent”) to sell shares of the Company’s common stock, par value $0.001 per share, with aggregate gross sales proceeds of up to $50 million, from time to time, through an “at the market” equity offering program. Deferred offering costs associated with the Sales Agreement are reclassified to additional paid-in capital on a pro-rata basis when the Company completes offerings under the Sales Agreement. Any remaining deferred costs will be expensed to the statement of operations should the planned offering be abandoned. The Company had approximately $0.3 million of deferred offering costs as of both September 30, 2023 and December 31, 2022. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. The Company is an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, as amended (“JOBS Act”). The JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. The Company elected to avail itself of this extended transition period and, as a result, the Company will not be required to adopt certain new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies. In 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Statements. The new standard, as amended, requires that expected credit losses relating to financial assets measured on an amortized cost basis and available-for-sale debt securities be recorded through an allowance for credit losses. It also limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value and also requires the reversal of previously recognized credit losses if fair value increases. The targeted transition relief standard allows filers an option to irrevocably elect the fair value option of ASC 825-10, Financial Instruments - Overall, applied on an instrument-by-instrument basis for eligible instruments. ASU 2016-13, Financial Instruments - Credit Losses (Topic 326) became effective for the Company on January 1, 2023. The Company adopted this effective January 1, 2023 and there was no impact to the condensed consolidated financial statements. In January 2017, the FASB issued ASU 2017-04, Intangibles - Goodwill and Other (Topic 350 ) , which eliminates Step 2 from the goodwill impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill. Instead, entities will record an impairment charge based on the excess of a reporting unit’s carrying amount over its fair value (i.e., measure the charge based on today’s Step 1). This update is effective for annual and interim impairment tests performed in periods beginning after December 15, 2022. Early adoption of the standard is permitted. The Company adopted this effective January 1, 2023 and there was no impact to the condensed consolidated financial statements. |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Marketable Securities | Marketable securities as of September 30, 2023 consisted of the following: September 30, 2023 Amortized Cost Unrealized Gains Unrealized Losses Fair Value Assets: Current: U.S. Treasuries $ 13,094,059 $ 666 $ (195) $ 13,094,530 Government securities $ 4,425,447 $ 3,303 $ — $ 4,428,750 Commercial paper 11,678,343 1,581 (956) 11,678,968 Total marketable securities $ 29,197,849 $ 5,550 $ (1,151) $ 29,202,248 Marketable securities as of December 31, 2022 consisted of the following: December 31, 2022 Amortized Cost Unrealized Gains Unrealized Losses Fair Value Assets: Current: U.S. Treasuries $ 12,986,424 $ — $ (25,649) $ 12,960,775 Government securities 8,084,107 1,099 (12,021) 8,073,185 Commercial paper 11,847,902 6,847 (739) 11,854,010 Total marketable securities $ 32,918,433 $ 7,946 $ (38,409) $ 32,887,970 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Cash Equivalents and Marketable Securities | The following table summarizes our cash equivalents and marketable securities measured at fair value on a recurring basis as of September 30, 2023: Level 1 Level 2 Level 3 Total Assets: Cash equivalents Money market $ 58,981,550 $ — $ — $ 58,981,550 U.S. Treasuries 6,735,957 — — 6,735,957 Commercial paper — 1,995,220 — 1,995,220 Total cash equivalents 65,717,507 1,995,220 — 67,712,727 Marketable securities: U.S. Treasuries $ 13,094,530 $ — $ — $ 13,094,530 Government securities — 4,428,750 — 4,428,750 Commercial paper — 11,678,968 — 11,678,968 Total marketable securities 13,094,530 16,107,718 — 29,202,248 Total cash equivalents and marketable securities $ 78,812,037 $ 18,102,938 $ — $ 96,914,975 The following table summarizes our cash equivalents and marketable securities measured at fair value on a recurring basis as of December 31, 2022: Level 1 Level 2 Level 3 Total Assets: Cash equivalents Money market $ 19,118,892 $ — $ — $ 19,118,892 Commercial paper — 1,249,575 — 1,249,575 Government securities — 2,742,025 — 2,742,025 Total cash equivalents 19,118,892 3,991,600 — 23,110,492 Marketable securities: U.S. Treasuries $ 12,960,775 $ — $ — $ 12,960,775 Government securities — 8,073,185 — 8,073,185 Commercial paper — 11,854,010 — 11,854,010 Total marketable securities 12,960,775 19,927,195 — 32,887,970 Total cash equivalents and marketable securities $ 32,079,667 $ 23,918,795 $ — $ 55,998,462 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consisted of the following: September 30, December 31, Computer equipment $ 450,751 $ 437,346 Furniture and fixtures 91,317 91,317 Lab equipment 1,113,726 970,374 Leasehold improvements 298,941 288,908 Construction in progress 86,392 — Total 2,041,127 1,787,945 Accumulated depreciation/amortization (647,954) (418,337) Property and equipment, net $ 1,393,173 $ 1,369,608 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Liabilities, Current [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following: September 30, December 31, Accrued professional services $ 276,617 $ 297,234 Accrued employee expenses 2,353,981 3,631,082 Accrued research and development expenses 572,502 425,846 Accrued other 95,953 146,831 Total $ 3,299,053 $ 4,500,993 |
Common Stock (Tables)
Common Stock (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Common Stock for Conversion of Preferred Stock, Exercise of Warrants and Exercise of Stock Options | As of September 30, 2023 and December 31, 2022, the following number of shares of Class A common stock have been reserved: September 30, December 31, Exercise of common stock options 5,490,165 3,559,041 5,490,165 3,559,041 |
Net Loss Per Share Attributab_2
Net Loss Per Share Attributable to Common Stockholders (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Net Loss Per Share Attributable to Common Stockholders | Basic and diluted net loss per share attributable to common stockholders was calculated at September 30, 2023 and September 30, 2022 as follows: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Numerator: Net loss $ (12,595,211) $ (12,844,330) $ (38,388,130) $ (37,268,007) Denominator - basic and diluted: Weighted-average common shares outstanding, basic and diluted 29,266,309 26,394,490 28,129,005 26,380,101 Net loss per share - basic and diluted $ (0.43) $ (0.49) $ (1.36) $ (1.41) |
Schedule of Potentially Dilutive Securities that have been Excluded from the Calculation of Diluted Net Loss Per Share | The following table sets forth the potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to include them would be anti-dilutive (in common stock equivalent shares) at September 30, 2023 and September 30, 2022: 2023 2022 Options to purchase common stock 5,490,165 3,598,026 Total shares of common stock equivalents 5,490,165 3,598,026 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Assumptions in its Application of the Black-scholes Option Pricing Model for Grants | The Company used the following assumptions in its application of the Black-Scholes option pricing model for grants during the nine months ended September 30, 2023 and 2022: Nine Months Ended September 30, 2023 2022 Weighted-average risk-free interest rate 3.46% - 4.24% 1.35% - 3.31% Expected term (in years) 5.00 - 10.00 5.00 - 10.00 Expected dividend yield 0% 0% Expected volatility 64.86% - 70.50% 64.78% - 78.12% |
Summary of Stock Option Activity | The following table summarizes the stock option activity during the nine months ended September 30, 2023: Number of Weighted- Weighted Aggregate Outstanding at December 31, 2022 3,559,041 $ 7.36 Granted 2,269,610 5.31 Exercised (123,116) 3.55 Cancelled (215,370) 9.39 Outstanding at September 30, 2023 5,490,165 $ 6.51 7.90 $ 12,917,120 Vested and exercisable at September 30, 2023 2,570,469 $ 5.81 6.71 $ 7,424,101 |
Summary of Recognized Share-based Compensation Expense Recognized | For the three and nine months ended September 30, 2023 and 2022, the Company recognized share-based compensation expense on the accompanying condensed consolidated statements of operations as follows: Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Cost of revenue $ — $ 1,058 $ — $ 9,703 Research and development 657,652 507,489 1,864,462 1,445,145 General and administrative 821,508 557,665 2,222,085 1,561,435 Total $ 1,479,160 $ 1,066,212 $ 4,086,547 $ 3,016,283 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Maturities of the Lease Liabilities Due | Future minimum lease payments for operating leases with initial or remaining terms in excess of one year at September 30, 2023 were as follows: Amount Remainder of 2023 $ 192,600 2024 732,546 2025 739,689 2026 761,877 2027 784,737 Thereafter 3,682,509 Total future lease payments 6,893,958 Less: Imputed interest (2,351,305) Total lease liabilities $ 4,542,653 Current portion lease liabilities $ 301,633 Lease liabilities, noncurrent 4,241,020 Total lease liabilities $ 4,542,653 |
Schedule of Quantitative Information Regarding the Company's Leases | Quantitative information regarding the Company’s leases for the nine months ended September 30, 2023 and 2022 is as follows: September 30, September 30, Lease costs: Operating lease cost $ 675,743 $ 777,741 Short-term lease cost 114,069 225,839 Sublease income (133,530) (149,260) Total lease costs $ 656,282 $ 854,320 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 650,863 $ 479,976 Operating cash flows from short-term leases 114,069 225,839 $ 764,932 $ 705,815 Weighted-average remaining lease term - operating leases 8.55 years 9.36 years Weighted-average discount rate - operating leases 10.0 % 9.3 % |
Organization and Nature of Bu_2
Organization and Nature of Business (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Apr. 20, 2023 | Aug. 03, 2021 | Jun. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Organization and Nature of Business | ||||||
Aggregate net proceeds | $ 28,200,003 | $ 0 | ||||
Accumulated deficit | $ (148,175,086) | $ (109,786,956) | ||||
IPO | ||||||
Organization and Nature of Business | ||||||
Aggregate net proceeds | $ 120,318,750 | |||||
Offering costs | $ 2,124,317 | |||||
Convertible preferred stock, outstanding (in shares) | 8,528,078 | |||||
Underwriting Offering | ||||||
Organization and Nature of Business | ||||||
Shares sold (in shares) | 2,727,273 | |||||
Sale of stock (in dollars per share) | $ 11 | |||||
Proceeds from company offering | $ 28,200,003 | |||||
Proceeds, before deducting offering costs payable | $ 203,768 | $ 203,768 | ||||
Class A Common Stock | ||||||
Organization and Nature of Business | ||||||
Shares issued (in shares) | 1,125,000 | |||||
Convertible preferred stock, outstanding (in shares) | 11,939,281 | |||||
Common stock, par value per share (in dollars per share) | $ 0.001 | $ 0.001 | ||||
Class A Common Stock | IPO | ||||||
Organization and Nature of Business | ||||||
Shares issued (in shares) | 8,625,000 | |||||
Class A Common Stock | Underwriting Offering | ||||||
Organization and Nature of Business | ||||||
Common stock, par value per share (in dollars per share) | $ 0.001 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) - USD ($) | 9 Months Ended | 12 Months Ended | ||
Aug. 10, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Class of Stock [Line Items] | ||||
Goodwill impairments | $ 0 | $ 0 | ||
Aggregate net proceeds | 28,200,003 | $ 0 | ||
Equity Distribution Agreement | Sandler and Co | ||||
Class of Stock [Line Items] | ||||
Common stock, par value per share (in dollars per share) | $ 0.001 | |||
Aggregate net proceeds | $ 50,000,000 | |||
Deferred offering costs | $ 300,000 | $ 300,000 |
Marketable Securities - Narrati
Marketable Securities - Narrative (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |||||
Credit loss related to short-term investments | $ 0 | $ 0 | $ 0 | $ 0 | |
Allowance for credit loss | $ 0 | $ 0 | $ 0 |
Marketable Securities - Schedul
Marketable Securities - Schedule of Marketable Securities (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Marketable securities, current | ||
Amortized Cost | $ 29,197,849 | $ 32,918,433 |
Unrealized Gains | 5,550 | 7,946 |
Unrealized Losses | (1,151) | (38,409) |
Fair Value | 29,202,248 | 32,887,970 |
U.S. Treasuries | ||
Marketable securities, current | ||
Amortized Cost | 13,094,059 | 12,986,424 |
Unrealized Gains | 666 | 0 |
Unrealized Losses | (195) | (25,649) |
Fair Value | 13,094,530 | 12,960,775 |
Government securities | ||
Marketable securities, current | ||
Amortized Cost | 4,425,447 | 8,084,107 |
Unrealized Gains | 3,303 | 1,099 |
Unrealized Losses | 0 | (12,021) |
Fair Value | 4,428,750 | 8,073,185 |
Commercial paper | ||
Marketable securities, current | ||
Amortized Cost | 11,678,343 | 11,847,902 |
Unrealized Gains | 1,581 | 6,847 |
Unrealized Losses | (956) | (739) |
Fair Value | $ 11,678,968 | $ 11,854,010 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Cash Equivalents and Marketable Securities (Details) - Recurring - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Assets: | ||
Total cash equivalents | $ 67,712,727 | $ 23,110,492 |
Total marketable securities | 29,202,248 | 32,887,970 |
Total cash equivalents and marketable securities | 96,914,975 | 55,998,462 |
Money market | ||
Assets: | ||
Total cash equivalents | 58,981,550 | 19,118,892 |
U.S. Treasuries | ||
Assets: | ||
Total cash equivalents | 6,735,957 | |
Total marketable securities | 13,094,530 | 12,960,775 |
Commercial paper | ||
Assets: | ||
Total cash equivalents | 1,995,220 | 1,249,575 |
Total marketable securities | 11,678,968 | 11,854,010 |
Government securities | ||
Assets: | ||
Total cash equivalents | 2,742,025 | |
Total marketable securities | 4,428,750 | 8,073,185 |
Level 1 | ||
Assets: | ||
Total cash equivalents | 65,717,507 | 19,118,892 |
Total marketable securities | 13,094,530 | 12,960,775 |
Total cash equivalents and marketable securities | 78,812,037 | 32,079,667 |
Level 1 | Money market | ||
Assets: | ||
Total cash equivalents | 58,981,550 | 19,118,892 |
Level 1 | U.S. Treasuries | ||
Assets: | ||
Total cash equivalents | 6,735,957 | |
Total marketable securities | 13,094,530 | 12,960,775 |
Level 1 | Commercial paper | ||
Assets: | ||
Total cash equivalents | 0 | 0 |
Total marketable securities | 0 | 0 |
Level 1 | Government securities | ||
Assets: | ||
Total cash equivalents | 0 | |
Total marketable securities | 0 | 0 |
Level 2 | ||
Assets: | ||
Total cash equivalents | 1,995,220 | 3,991,600 |
Total marketable securities | 16,107,718 | 19,927,195 |
Total cash equivalents and marketable securities | 18,102,938 | 23,918,795 |
Level 2 | Money market | ||
Assets: | ||
Total cash equivalents | 0 | 0 |
Level 2 | U.S. Treasuries | ||
Assets: | ||
Total cash equivalents | 0 | |
Total marketable securities | 0 | 0 |
Level 2 | Commercial paper | ||
Assets: | ||
Total cash equivalents | 1,995,220 | 1,249,575 |
Total marketable securities | 11,678,968 | 11,854,010 |
Level 2 | Government securities | ||
Assets: | ||
Total cash equivalents | 2,742,025 | |
Total marketable securities | 4,428,750 | 8,073,185 |
Level 3 | ||
Assets: | ||
Total cash equivalents | 0 | 0 |
Total marketable securities | 0 | 0 |
Total cash equivalents and marketable securities | 0 | 0 |
Level 3 | Money market | ||
Assets: | ||
Total cash equivalents | 0 | 0 |
Level 3 | U.S. Treasuries | ||
Assets: | ||
Total cash equivalents | 0 | |
Total marketable securities | 0 | 0 |
Level 3 | Commercial paper | ||
Assets: | ||
Total cash equivalents | 0 | 0 |
Total marketable securities | 0 | 0 |
Level 3 | Government securities | ||
Assets: | ||
Total cash equivalents | 0 | |
Total marketable securities | $ 0 | $ 0 |
Fair Value Measurements - Narra
Fair Value Measurements - Narrative (Details) | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Fair Value Disclosures [Abstract] | |
Financial assets classified as Level 3 | $ 0 |
Financial liabilities classified as Level 3 | $ 0 |
Property and Equipment, net - S
Property and Equipment, net - Schedule of Property and Equipment, Net (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Property and Equipment, net | ||
Property and equipment, gross | $ 2,041,127 | $ 1,787,945 |
Accumulated depreciation/amortization | (647,954) | (418,337) |
Property and equipment, net | 1,393,173 | 1,369,608 |
Computer equipment | ||
Property and Equipment, net | ||
Property and equipment, gross | 450,751 | 437,346 |
Furniture and fixtures | ||
Property and Equipment, net | ||
Property and equipment, gross | 91,317 | 91,317 |
Lab equipment | ||
Property and Equipment, net | ||
Property and equipment, gross | 1,113,726 | 970,374 |
Leasehold improvements | ||
Property and Equipment, net | ||
Property and equipment, gross | 298,941 | 288,908 |
Construction in progress | ||
Property and Equipment, net | ||
Property and equipment, gross | $ 86,392 | $ 0 |
Property and Equipment, net - N
Property and Equipment, net - Narrative (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation/amortization expense | $ 78,294 | $ 68,075 | $ 233,062 | $ 170,337 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Liabilities, Current [Abstract] | ||
Accrued professional services | $ 276,617 | $ 297,234 |
Accrued employee expenses | 2,353,981 | 3,631,082 |
Accrued research and development expenses | 572,502 | 425,846 |
Accrued other | 95,953 | 146,831 |
Total | $ 3,299,053 | $ 4,500,993 |
Common Stock - Class A Common S
Common Stock - Class A Common Stock (Details) - Class A Common Stock | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 Vote $ / shares shares | Dec. 31, 2022 Vote $ / shares shares | |
Class of Stock [Line Items] | ||
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, par value per share (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 |
Common stock, shares issued (in shares) | 29,269,121 | 26,418,732 |
Common stock, shares outstanding (in shares) | 29,269,121 | 26,418,732 |
Number of votes | Vote | 1 | 1 |
Common Stock - Schedule of Comm
Common Stock - Schedule of Common Stock (Details) - shares | Sep. 30, 2023 | Dec. 31, 2022 |
Class of Stock [Line Items] | ||
Shares reserved for future issuance (in shares) | 5,490,165 | 3,559,041 |
Exercise of common stock options | ||
Class of Stock [Line Items] | ||
Shares reserved for future issuance (in shares) | 5,490,165 | 3,559,041 |
Common Stock - Class B Common S
Common Stock - Class B Common Stock (Details) - Class B Common Stock | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 Vote $ / shares shares | Dec. 31, 2022 Vote $ / shares shares | |
Class of Stock [Line Items] | ||
Common stock, shares authorized (in shares) | 20,000,000 | 20,000,000 |
Common stock, par value per share (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 |
Common stock, shares issued (in shares) | 0 | 0 |
Common stock, shares outstanding (in shares) | 0 | 0 |
Number of votes | Vote | 0 | 0 |
Common Stock - IPO (Details)
Common Stock - IPO (Details) - USD ($) | Aug. 03, 2021 | Sep. 30, 2023 | Dec. 31, 2022 |
Class of Stock [Line Items] | |||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | |
Class A Common Stock | |||
Class of Stock [Line Items] | |||
Shares issued (in shares) | 1,125,000 | ||
Convertible preferred stock, outstanding (in shares) | 11,939,281 | ||
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 | |
Common stock, par value per share (in dollars per share) | $ 0.001 | $ 0.001 | |
Class B Common Stock | |||
Class of Stock [Line Items] | |||
Common stock, shares authorized (in shares) | 20,000,000 | 20,000,000 | |
Common stock, par value per share (in dollars per share) | $ 0.001 | $ 0.001 | |
IPO | |||
Class of Stock [Line Items] | |||
Proceeds from stock issued | $ 120,318,750 | ||
Offering costs | $ 2,124,317 | ||
Convertible preferred stock, outstanding (in shares) | 8,528,078 | ||
Preferred stock, shares authorized (in shares) | 10,000,000 | ||
IPO | Class A Common Stock | |||
Class of Stock [Line Items] | |||
Shares issued (in shares) | 8,625,000 | ||
Common stock, shares authorized (in shares) | 200,000,000 | ||
IPO | Class B Common Stock | |||
Class of Stock [Line Items] | |||
Common stock, shares authorized (in shares) | 20,000,000 | ||
Common stock, par value per share (in dollars per share) | $ 0.001 |
Common Stock - Equity Offerings
Common Stock - Equity Offerings (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
Apr. 20, 2023 | Aug. 10, 2022 | Sep. 30, 2023 | Jun. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Class A Common Stock | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock, par value per share (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |||||
At the market offering | ||||||||
Class of Stock [Line Items] | ||||||||
Percentage on gross proceeds from common stock sold for sales agent commission | 3% | |||||||
Deferred offering costs | $ 300,000 | $ 300,000 | $ 300,000 | |||||
Shares sold (in shares) | 0 | 0 | 0 | 0 | ||||
At the market offering | Class A Common Stock | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock, par value per share (in dollars per share) | $ 0.001 | |||||||
Aggregate gross sales proceeds | $ 50,000,000 | |||||||
Underwriting Offering | ||||||||
Class of Stock [Line Items] | ||||||||
Shares sold (in shares) | 2,727,273 | |||||||
Sale of stock (in dollars per share) | $ 11 | |||||||
Proceeds from company offering | $ 28,200,003 | |||||||
Proceeds, before deducting offering costs payable | $ 203,768 | $ 203,768 | ||||||
Underwriting Offering | Class A Common Stock | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock, par value per share (in dollars per share) | $ 0.001 | |||||||
Maximum | ||||||||
Class of Stock [Line Items] | ||||||||
Aggregate amount | $ 200,000,000 | |||||||
Date of effective period | 3 years |
Net Loss Per Share Attributab_3
Net Loss Per Share Attributable to Common Stockholders - Basic and diluted net loss per share attributable to common stockholders (Details) - USD ($) | 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 | |
Numerator: | ||||||||
Net loss | $ (12,595,211) | $ (12,188,748) | $ (13,604,171) | $ (12,844,330) | $ (11,527,303) | $ (12,896,374) | $ (38,388,130) | $ (37,268,007) |
Denominator - basic and diluted: | ||||||||
Weighted-average common shares outstanding, basic (in shares) | 29,266,309 | 26,394,490 | 28,129,005 | 26,380,101 | ||||
Weighted-average common shares outstanding, diluted (in shares) | 29,266,309 | 26,394,490 | 28,129,005 | 26,380,101 | ||||
Earnings per share: | ||||||||
Net loss per share, basic (in dollars per share) | $ (0.43) | $ (0.49) | $ (1.36) | $ (1.41) | ||||
Net loss per share, diluted (in dollars per share) | $ (0.43) | $ (0.49) | $ (1.36) | $ (1.41) |
Net Loss Per Share Attributab_4
Net Loss Per Share Attributable to Common Stockholders - Antidilutive effect (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares of common stock equivalents (in shares) | 5,490,165 | 3,598,026 |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total shares of common stock equivalents (in shares) | 5,490,165 | 3,598,026 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Jul. 23, 2021 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares reserved for future issuance (in shares) | 5,490,165 | 5,490,165 | 3,559,041 | |||
Granted (in shares) | 2,269,610 | |||||
Stock-based compensation expense | $ 1,479,160 | $ 1,066,212 | $ 4,086,547 | $ 3,016,283 | ||
Grant date weighted average fair value (in dollars per share) | $ 5.31 | |||||
Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period | 4 years | |||||
Stock-based compensation expense | 1,479,160 | $ 1,066,212 | $ 4,086,547 | $ 3,016,283 | ||
Compensation expense remaining to be recognized | $ 12,450,569 | $ 12,450,569 | ||||
Compensation expense recognized over a weighted-average period | 2 years 7 months 24 days | |||||
2021 Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares reserved for future issuance (in shares) | 1,555,719 | 1,555,719 | ||||
2021 Plan | Maximum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares reserved for future issuance (in shares) | 2,590,000 | |||||
Aggregate number of shares outstanding (as a percent) | 4% | |||||
2021 Plan | Maximum | Class A Common Stock | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Granted (in shares) | 15,350,000 | |||||
2021 ESPP | Class A Common Stock | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares reserved for future issuance (in shares) | 250,000 | 777,389 | 777,389 | |||
Aggregate number of shares outstanding (as a percent) | 1% | |||||
Granted (in shares) | 0 | |||||
2021 ESPP | Maximum | Class A Common Stock | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Granted (in shares) | 3,340,000 |
Stock-Based Compensation - Assu
Stock-Based Compensation - Assumptions (Details) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted-average risk-free interest rate, minimum | 3.46% | 1.35% |
Weighted-average risk-free interest rate, maximum | 4.24% | 3.31% |
Expected dividend yield | 0% | 0% |
Expected volatility, minimum | 64.86% | 64.78% |
Expected volatility, maximum | 70.50% | 78.12% |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 5 years | 5 years |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 10 years | 10 years |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock option activity (Details) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | Dec. 31, 2022 $ / shares shares | |
Number of Options | ||
Outstanding at the beginning (in shares) | shares | 3,559,041 | |
Granted (in shares) | shares | 2,269,610 | |
Exercised (in shares) | shares | (123,116) | |
Cancelled (in shares) | shares | (215,370) | |
Outstanding at the ending (in shares) | shares | 5,490,165 | 3,559,041 |
Vested and exercisable (in shares) | shares | 2,570,469 | |
Weighted- Average Exercise Price per Share | ||
Weighted Average Exercise Price per Share Outstanding at the beginning (in dollars per share) | $ / shares | $ 7.36 | |
Weighted Average Exercise Price per Share Granted (in dollars per share) | $ / shares | 5.31 | |
Weighted Average Exercise Price per Share Exercised (in dollars per share) | $ / shares | 3.55 | |
Weighted Average Exercise Price per Share Cancelled (in dollars per share) | $ / shares | 9.39 | |
Weighted Average Exercise Price per Share Outstanding at the ending (in dollars per share) | $ / shares | 6.51 | $ 7.36 |
Weighted Average Exercise Price per Share Vested and exercisable (in dollars per share) | $ / shares | $ 5.81 | |
Weighted Average Remaining Contractual Term (in Years) | ||
Weighted Average Remaining Contractual Term (in Years) | 7 years 10 months 24 days | |
Weighted Average Remaining Contractual Term, Vested and exercisable (in Years) | 6 years 8 months 15 days | |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value Outstanding | $ | $ 12,917,120 | |
Aggregate Intrinsic Value Vested and exercisable | $ | $ 7,424,101 |
Stock-Based Compensation - Shar
Stock-Based Compensation - Share-based compensation expense (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 1,479,160 | $ 1,066,212 | $ 4,086,547 | $ 3,016,283 |
Cost of revenue | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | 0 | 1,058 | 0 | 9,703 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | 657,652 | 507,489 | 1,864,462 | 1,445,145 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 821,508 | $ 557,665 | $ 2,222,085 | $ 1,561,435 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) | 1 Months Ended | 9 Months Ended | |||
Jan. 31, 2022 USD ($) | Sep. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 22, 2021 USD ($) ft² agreement | Oct. 31, 2020 USD ($) | |
Lessee, Lease, Description [Line Items] | |||||
Right-of-use assets, net | $ 4,083,875 | $ 4,407,785 | |||
Increase (decrease) in right of use asset | $ 347,739 | ||||
Incremental borrowing rate | 6% | ||||
Lease liability | 4,542,653 | ||||
Remainder of 2023 | 192,600 | ||||
Liability, to be paid 2024 | $ 732,546 | ||||
Notice period for contract termination | 30 days | ||||
Lease Termination on April 30, 2032 | |||||
Lessee, Lease, Description [Line Items] | |||||
Area of property under lease | ft² | 38,613 | ||||
Lease Termination on December 31, 2022 | |||||
Lessee, Lease, Description [Line Items] | |||||
Area of property under lease | ft² | 6,100 | ||||
Lease Termination on March 31, 2024 | |||||
Lessee, Lease, Description [Line Items] | |||||
Area of property under lease | ft² | 4,760 | ||||
BioArkive Inc | |||||
Lessee, Lease, Description [Line Items] | |||||
Right-of-use assets, net | $ 4,824,700 | ||||
Number of lease obligations acquired | agreement | 3 | ||||
Lease liability | $ 4,824,700 | ||||
2020 San Diego Lease | |||||
Lessee, Lease, Description [Line Items] | |||||
Lease term | 67 months | ||||
Right-of-use assets, net | $ 637,863 | ||||
Office and Laboratory Space in San Diego California | |||||
Lessee, Lease, Description [Line Items] | |||||
Period of lease modification | 20 months | ||||
Office Space In Cambridge, Massachusetts, New York | |||||
Lessee, Lease, Description [Line Items] | |||||
Remainder of 2023 | $ 20,760 | ||||
Liability, to be paid 2024 | $ 13,840 |
Commitments and Contingencies_2
Commitments and Contingencies - Maturities of the lease liabilities due (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] | ||
Remainder of 2023 | $ 192,600 | |
2024 | 732,546 | |
2025 | 739,689 | |
2026 | 761,877 | |
2027 | 784,737 | |
Thereafter | 3,682,509 | |
Total future lease payments | 6,893,958 | |
Less: Imputed interest | (2,351,305) | |
Total lease liabilities | 4,542,653 | |
Current portion lease liabilities | 301,633 | $ 378,723 |
Lease liabilities, noncurrent | $ 4,241,020 | $ 4,462,959 |
Commitments and Contingencies_3
Commitments and Contingencies - Lease cost and contract termination (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Lease costs: | ||
Operating lease cost | $ 675,743 | $ 777,741 |
Short-term lease cost | 114,069 | 225,839 |
Sublease income | (133,530) | (149,260) |
Total lease costs | 656,282 | 854,320 |
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash flows from operating leases | 650,863 | 479,976 |
Operating cash flows from short-term leases | 114,069 | 225,839 |
Total lease Payment | $ 764,932 | $ 705,815 |
Weighted-average remaining lease term - operating leases | 8 years 6 months 18 days | 9 years 4 months 9 days |
Weighted-average discount rate - operating leases | 10% | 9.30% |