Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 27, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity File Number | 001-40544 | ||
Entity Registrant Name | Aerovate Therapeutics, Inc. | ||
Entity Central Index Key | 0001798749 | ||
Entity Tax Identification Number | 83-1377888 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Address Line One | 930 Winter Street | ||
Entity Address, Address Line Two | Suite M-500 | ||
Entity Address, City or Town | Waltham | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02451 | ||
City Area Code | 617 | ||
Local Phone Number | 443-2400 | ||
Title of 12(b) Security | Common stock, par value $0.0001 per share | ||
Trading Symbol | AVTE | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 | ||
Elected Not To Use the Extended Transition Period | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 157.3 | ||
Entity Common Stock, Shares Outstanding | 24,812,418 | ||
Documents Incorporated By Reference | The registrant intends to file a definitive proxy statement pursuant to Regulation 14A relating to the 2023 Annual Meeting of Stockholders within 120 days of the end of the registrant’s fiscal year ended December 31, 2022. Portions of such definitive proxy statement are incorporated by reference into Part III of this Annual Report on Form 10-K to the extent stated herein. | ||
ICFR Auditor Attestation Flag | false | ||
Auditor Name | KPMG LLP | ||
Auditor Location | San Diego, California | ||
Auditor Firm ID | 185 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 22,397 | $ 54,197 |
Short-term investments | 106,823 | 113,178 |
Prepaid expenses and other current assets | 2,276 | 6,958 |
Total current assets | 131,496 | 174,333 |
Property and equipment, net | 242 | 186 |
Operating lease right-of-use assets | 1,003 | 542 |
Other long-term assets | 2,560 | 302 |
Total assets | 135,301 | 175,363 |
Current liabilities: | ||
Accounts payable | 2,575 | 1,208 |
Accrued and other current liabilities | 4,822 | 1,150 |
Operating lease liabilities | 385 | 192 |
Total current liabilities | 7,782 | 2,550 |
Operating lease liabilities, net of current portion | 705 | 382 |
Other liabilities | 71 | 13 |
Total liabilities | 8,558 | 2,945 |
Commitments and contingencies (Note 5) | ||
Stockholders' equity: | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized as of December 31, 2022 and December 31, 2021, respectively; no shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively | ||
Common stock, $0.0001 par value; 150,000,000 shares authorized at December 31, 2022 and December 31, 2021, respectively; 24,722,974 and 24,410,393 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively | 2 | 2 |
Additional paid-in capital | 215,110 | 208,867 |
Accumulated other comprehensive loss | (466) | (59) |
Accumulated deficit | (87,903) | (36,392) |
Total stockholders' equity | 126,743 | 172,418 |
Total liabilities and stockholders' equity | $ 135,301 | $ 175,363 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 24,722,974 | 24,410,393 |
Common stock, shares outstanding | 24,722,974 | 24,410,393 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Operating expenses: | ||
Research and development | $ 38,622 | $ 14,987 |
General and administrative | 14,615 | 8,035 |
Total operating expenses | 53,237 | 23,022 |
Loss from operations | (53,237) | (23,022) |
Other income (expense): | ||
Interest income | 1,830 | 65 |
Other expense | (79) | (3) |
Total other income | 1,751 | 62 |
Net loss before income taxes | (51,486) | (22,960) |
Provision for income taxes | 25 | 3 |
Net loss | (51,511) | (22,963) |
Comprehensive loss: | ||
Net loss | (51,511) | (22,963) |
Other comprehensive loss: | ||
Unrealized loss on securities | (407) | (59) |
Comprehensive loss | $ (51,918) | $ (23,022) |
Net loss per share, basic | $ (2.10) | $ (1.87) |
Net loss per share, diluted | $ (2.10) | $ (1.87) |
Weighted-average shares of common stock outstanding, basic | 24,472,104 | 12,293,629 |
Weighted-average shares of common stock outstanding, diluted | 24,472,104 | 12,293,629 |
CONSOLIDATED STATEMENTS OF REDE
CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Preferred Stock Series Seed Redeemable Convertible Preferred Stock | Preferred Stock Series A Redeemable Convertible Preferred Stock | Common Stock ESPP | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total |
Beginning balance, shares at Dec. 31, 2020 | 4,000,000 | 6,489,534 | ||||||
Beginning balance at Dec. 31, 2020 | $ 4,000 | $ 12,285 | ||||||
Beginning balance, shares at Dec. 31, 2020 | 243,076 | |||||||
Beginning balance at Dec. 31, 2020 | $ 63 | $ (13,407) | $ (13,344) | |||||
Issuance of Series A redeemable convertible preferred stock per share, net of issuance costs | $ 63,512 | |||||||
Issuance of Series A redeemable convertible preferred stock per share, net of issuance costs, shares | 33,562,620 | |||||||
Issuance of Series A redeemable convertible preferred stock per share, net of issuance costs | ||||||||
Accretion of Series A redeemable convertible preferred stock to redemption value | $ 22 | (22) | (22) | |||||
Conversion of redeemable convertible preferred stock to common stock upon initial public offering | $ (4,000) | $ (75,819) | $ 1 | 79,817 | 79,818 | |||
Conversion of redeemable convertible preferred stock to common stock upon initial public offering, shares | (4,000,000) | (40,052,154) | 14,182,854 | |||||
Issuance of common stock upon initial public offering, net of issuance costs | $ 1 | 126,944 | 126,945 | |||||
Issuance of common stock upon initial public offering, net of issuance costs, shares | 9,984,463 | |||||||
Unrealized loss on investments | (59) | (59) | ||||||
Stock based compensation | 2,043 | 2,043 | ||||||
Net loss | (22,963) | (22,963) | ||||||
Ending balance, shares at Dec. 31, 2021 | ||||||||
Ending balance at Dec. 31, 2021 | ||||||||
Ending balance, shares at Dec. 31, 2021 | 24,410,393 | |||||||
Ending balance at Dec. 31, 2021 | $ 2 | 208,867 | (59) | (36,392) | 172,418 | |||
Unrealized loss on investments | (407) | (407) | ||||||
Stock based compensation | 5,476 | 5,476 | ||||||
Issuance of common stock upon exercise of stock options | 617 | $ 617 | ||||||
Issuance of common stock upon exercise of stock options, shares | 298,712 | 298,712 | ||||||
Issuance of common stock under ESPP | 150 | $ 150 | ||||||
Issuance of common stock under ESPP, shares | 13,869 | |||||||
Net loss | (51,511) | (51,511) | ||||||
Ending balance, shares at Dec. 31, 2022 | ||||||||
Ending balance at Dec. 31, 2022 | ||||||||
Ending balance, shares at Dec. 31, 2022 | 24,722,974 | |||||||
Ending balance at Dec. 31, 2022 | $ 2 | $ 215,110 | $ (466) | $ (87,903) | $ 126,743 |
CONSOLIDATED STATEMENTS OF RE_2
CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) (Parenthetical) $ in Thousands | 12 Months Ended |
Dec. 31, 2021 USD ($) $ / shares | |
Accretion of Series A redeemable convertible preferred stock | $ 22 |
Preferred Stock | Series A Redeemable Convertible Preferred Stock | |
Share price | $ / shares | $ 1.893 |
Accretion of Series A redeemable convertible preferred stock | $ (22) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flow from operating activities: | ||
Net loss | $ (51,511) | $ (22,963) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 5,476 | 2,043 |
Depreciation and amortization expense | 68 | 15 |
Accretion of discounts and amortization of premiums on investments, net | (910) | 16 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 4,677 | (6,855) |
Other long-term assets | (1,872) | (302) |
Accounts payable | 1,368 | 609 |
Accrued and other liabilities | 3,672 | (6) |
Operating lease assets and liabilities, net | 43 | 32 |
Other liabilities | (133) | 12 |
Net cash used in operating activities | (39,122) | (27,399) |
Cash flow from investing activities: | ||
Purchases of short-term investments | (147,623) | (113,253) |
Sales and maturities of short-term investments | 154,744 | |
Purchases of property and equipment | (195) | (181) |
Net cash provided by (used in) investing activities | 6,926 | (113,434) |
Cash flow from financing activities: | ||
Proceeds from sale of Series A redeemable convertible preferred stock, net of issuance costs | 63,512 | |
Payments for deferred offering costs | (371) | |
Proceeds from issuance of common stock under ESPP | 150 | |
Proceeds from exercise of stock options | 617 | |
Proceeds from issuance of common stock, net of issuance costs | 126,945 | |
Net cash provided by financing activities | 396 | 190,457 |
Net (decrease) increase in cash and cash equivalents | (31,800) | 49,624 |
Cash and cash equivalents at the beginning of the year | 54,197 | 4,573 |
Cash and cash equivalents at the end of the period | 22,397 | 54,197 |
Supplemental disclosure of noncash investing and financing activities: | ||
Right-of-use asset obtained in exchange for operating lease liability | 765 | 542 |
Deferred offering costs included in accounts payable | $ 15 | |
Purchases of property and equipment in accounts payable | 21 | |
Conversion of redeemable convertible preferred stock to common stock upon initial public offering | $ 79,818 |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2022 | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | (1) (a) Organization and Nature of Operations Aerovate Therapeutics Inc. (“Aerovate” or the “Company”) was incorporated in the state of Delaware in July 2018, and is headquartered in Waltham, Massachusetts. The Company has a wholly owned subsidiary, Aerovate Securities Corporation. The Company is a clinical-stage biopharmaceutical company that is focused on the development of drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease. The Company’s initial focus is on advancing AV-101, the Company’s dry powder inhaled formulation of imatinib for the treatment of pulmonary arterial hypertension (“PAH”). The Company initiated a global Phase 2b/Phase 3 trial of AV-101 in adults with PAH in December 2021. (b) Initial Public Offering On July 2, 2021, the Company completed its initial public offering (“IPO”). The Company’s Registration Statement on Form S-1 (File No. 333-256949) relating to the IPO was declared effective by the Securities and Exchange Commission (“SEC”) on June 29, 2021. The shares began trading on The Nasdaq Global Market on June 30, 2021. The Company issued 9,984,463 shares of its common stock, including 1,302,321 shares associated with the full exercise of the underwriters’ option to purchase additional shares, at an offering price of $14.00 per share. Immediately prior to the closing of the Company’s IPO on July 2, 2021, all outstanding shares of the Company’s redeemable convertible preferred stock were converted into 14,182,854 shares of the Company’s common stock. In aggregate, the shares issued in the IPO generated approximately $126.9 million in net proceeds after deducting underwriting discounts and commissions and other offering costs. At-the-Market Offering On August 15, 2022, we entered into an Open Market Sale Agreement SM , or the Sale Agreement, with Jefferies LLC, or the Agent, pursuant to which we can sell, from time to time, at our option, up to an aggregate of $75.0 million of shares of our common stock, through the Agent, as our sales agent. As of December 31, 2022, no shares were sold under the Sale Agreement. (c) Liquidity and Management Plans Since inception, the Company has devoted substantially all of its resources to research and development activities, business planning, establishing and maintaining its intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations and has not realized revenues from its planned principal operations. The Company has incurred losses and negative cash flows from operations since inception. In addition, the Company expects to incur substantial operating losses for the next several years as it continues its research and development activities. As of December 31, 2022, the Company had cash and cash equivalents and short-term investments of $129.2 million. Management plans to continue to incur substantial costs in order to conduct research and development activities and additional capital will be needed to undertake these activities. The Company intends to raise such capital through debt or equity financings or other arrangements to fund operations. Management believes that the Company’s current cash and cash equivalents and short-term investments will provide sufficient funds to enable the Company to meet its obligations for at least twelve months from the filing date of this report. |
BASIS OF PRESENTATION AND SIGNI
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2022 | |
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES | |
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES. | (2) (a) Basis of Presentation The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and include the Company’s wholly owned subsidiary, Aerovate Securities Corporation. All intercompany transactions and balances have been eliminated in consolidation. (b) Reverse Stock Split On June 22, 2021, the Company effected a 1-for-3 (c) Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Reported amounts and note disclosures reflect the overall economic conditions that are most likely to occur and anticipated measures management intends to take. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations, and financial condition will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat it, as well as the economic impact on local, regional, national and international markets. Actual results could differ materially from those estimates. Accounting estimates and management judgements reflected in the consolidated financial statements include: normal recurring accruals, including the accrual for research and development expenses, stock-based compensation, fair value of investments, and operating lease right-of-use assets and lease liabilities. Estimates and assumptions are reviewed quarterly. Any revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected. (d) Cash and Cash Equivalents Cash and cash equivalents include cash in readily available checking accounts, money market funds and commercial paper. The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. (e) Short-term Investments Short-term investments consist of corporate debt securities, commercial paper and U.S. Treasury bills, classified as available-for-sale securities and have maturities of greater than three months. The Company has classified all of its available-for-sale investment securities as current assets on the consolidated balance sheets because these are considered highly liquid securities and are available for use in current operations. The Company carries these securities at fair value and reports unrealized gains and losses as a separate component of accumulated other comprehensive loss. The cost of debt securities is adjusted for amortization of purchase premiums and accretion of discounts to maturity. Such amortization and accretion is included in interest income in the consolidated statements of operations and comprehensive loss. Realized gains and losses on sales of securities are determined using the specific identification method and recorded in other income (expense), net in the consolidated statement of operations and comprehensive loss. (f) Concentration of Credit Risk Financial instruments, which potentially subject the Company to concentration of credit risk, consist primarily of cash, cash equivalents and short-term investments. The Company maintains cash, cash equivalents and short-term investments with various high credit quality banks and other financial institutions in the United States. Such deposits may be in excess of federally insured limits. Management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. The Company has not experienced any losses on deposits since inception. (g) Comprehensive Loss Comprehensive loss consists of net loss and unrealized gains or losses on available-for-sale investments. The Company displays comprehensive loss and its components as part of the consolidated statements of operations and comprehensive loss. (h) Fair Value Measurements The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or non-recurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices in active markets. Level 2: Inputs, other than the quoted prices in active markets that are observable either directly or indirectly. Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. The carrying amounts of prepaid expenses and other current assets, accounts payable, accrued liabilities and other current liabilities are reasonable estimates of their fair value due to the short-term nature of these accounts. (i) Prepaid Expenses and Other Current Assets Any expenses paid prior to the related services rendered are recorded as prepaid expenses. Such prepaid expenses are expensed in the period the expense is incurred. If the expense is for a service covering multiple periods, it is expensed from the date the services begin and over the period of the service rendered (or contract service period if services rendered dates are not defined). (j) Property and Equipment, Net Property and equipment, which consist of leasehold improvements, furniture and fixtures, research equipment, computers and construction-in-progress are stated at cost less accumulated depreciation or accumulated amortization. Depreciation and amortization is calculated using the straight-line method over the estimated useful lives of the assets, which ranges from three five years (k) Impairment of Long-lived Assets The carrying value of long-lived assets, including property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the asset may not be recoverable. An impairment loss is recognized when the total of estimated future undiscounted cash flows, expected to result from the use of the asset and its eventual disposition, are less than its carrying amount. Impairment, if any, would be assessed using discounted cash flows or other appropriate measures of fair value. Through December 31, 2022, there has been no such impairment losses recorded by the Company. (l) Leases At the commencement date of a lease, the Company recognizes lease liabilities which represent its obligation to make lease payments, and right-of-use assets (“ROU assets”) which represent its right to use the underlying asset during the lease term. The lease liability is measured at the present value of lease payments over the lease term. As the Company’s leases typically do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at the lease commencement date. The ROU asset is measured at cost, which includes the initial measurement of the lease liability and initial direct costs incurred by the Company and excludes lease incentives. ROU assets are recorded in operating lease ROU assets and lease liabilities are recorded in operating lease liabilities, current and noncurrent in the consolidated balance sheets. Lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Operating lease expense is recognized on a straight-line basis over the lease term. The Company has elected not to separate lease and non-lease components and not recognize lease liabilities and ROU assets for short-term leases with terms of twelve months or less. (m) Convertible Preferred Stock The Company records convertible preferred stock at fair value on the dates of issuance, net of issuance costs. Upon the occurrence of certain events that are outside the Company’s control, including a deemed liquidation event, holders of the convertible preferred stock can cause redemption for cash. Therefore, convertible preferred stock is classified outside of stockholders’ deficit on the balance sheets as events triggering the liquidation preferences are not solely within the Company’s control. The carrying values of the convertible preferred stock are adjusted to their liquidation preferences if and when it becomes probable that such a liquidation event will occur. (n) Research and Development Expenses Research and development costs are expensed as incurred. Research and development costs consist primarily of salaries and other benefits of research and development personnel, including associated share-based compensation, costs related to research activities, preclinical studies, clinical trial, drug manufacturing and allocated overhead and facility-related expenses. The Company accounts for non-refundable advance payments for goods or services that will be used in future research and development activities as expenses when the goods have been received or when the service has been performed rather than when the payment is made. Clinical trial costs are a component of research and development expenses. The Company expenses costs for its clinical trial activities performed by third parties, including clinical research organizations and other service providers, as they are incurred, based upon estimates of the work completed over the life of the individual study in accordance with associated agreements. The Company uses information it receives from internal personnel and outside service providers to estimate the clinical trial costs incurred. (o) Stock-Based Compensation Stock-based compensation expense represents the cost of the grant-date fair value of employee, officer, director, and non-employee stock option grants and restricted stock units, estimated in accordance with the applicable accounting guidance, recognized using the straight-line method over the vesting period for service-based options and using the graded vesting method for performance-based options. The vesting period generally approximates the expected service period of the awards. Forfeitures are recognized and accounted for as they occur. The fair value of stock options is estimated using a Black-Scholes option pricing model on the date of grant. This method requires certain assumptions be used as inputs, such as the fair value of the underlying common stock, expected term of the option before exercise, expected volatility of the Company’s common stock, expected dividend yield, and a risk-free interest rate. Options and awards granted during the year have a maximum contractual term of ten years. The Company has limited historical stock option activity and therefore estimates the expected term of stock options granted using the simplified method, which represents the average of the contractual term of the stock option and its weighted-average vesting period. The expected volatility of stock options is based upon the historical volatility of a number of publicly traded companies in similar stages of clinical development. The Company has historically not declared or paid any dividends and does not currently expect to do so in the foreseeable future. The risk-free interest rates used are based on the U.S. Department of Treasury (“U.S. Treasury”) yield in effect at the time of grant for zero-coupon U.S. Treasury notes with maturities approximately equal to the expected term of the stock options. (p) Income Taxes Income taxes are accounted for using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and net operating loss (“NOL”) and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance against deferred tax assets is recorded if, based upon the weight of all available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company records uncertain tax positions on the basis of a two-step process whereby (1) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense. Any accrued interest and penalties are included within the related tax liability. (q) Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions on how to allocate resources and assess performance. The Company views its operations and manages its business as one operating segment. (r) Net Loss Per Share Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period, without consideration of potential dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the sum of the weighted average number of common shares plus the potential dilutive effects of potential dilutive securities outstanding during the period. Potential dilutive securities are excluded from diluted earnings or loss per share if the effect of such inclusion is antidilutive. The Company’s potentially dilutive securities, which include convertible preferred stock prior to the conversion of such shares to common stock and outstanding stock options under the Company’s equity incentive plan, have been excluded from the computation of diluted net loss per share as they would be anti-dilutive to the net loss per share. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. The following table summarizes the Company’s net loss per share: Year Ended December 31, 2022 2021 Numerator: Net loss $ (51,511) $ (22,963) Accretion of Series A redeemable convertible preferred stock to redemption value — (22) Net loss available to common stockholders $ (51,511) $ (22,985) Denominator: Weighted-average common stock outstanding, basic and diluted 24,472,104 12,293,629 Net loss per share, basic and diluted $ (2.10) $ (1.87) Potentially dilutive securities not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would have had an anti-dilutive effect are as follows (in common stock equivalent shares): As of December 31, 2022 2021 Options to purchase common stock 4,110,219 3,454,374 Unvested restricted stock units 28,881 — 4,139,100 3,454,374 (p) Recently Issued Accounting Pronouncements In June 2022, the FASB issued ASU No. 2022-03, Fair Value Measurement (Topic 820) - Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions. This standard clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. This standard will be effective for the Company on January 1, 2024, and is not expected to have an impact on the Company’s financial position or results of operations upon adoption. |
FAIR VALUE OF FINANCIAL INSTRUM
FAIR VALUE OF FINANCIAL INSTRUMENTS | 12 Months Ended |
Dec. 31, 2022 | |
FAIR VALUE OF FINANCIAL INSTRUMENTS. | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | (3) FAIR VALUE OF FINANCIAL INSTRUMENTS The following tables summarize the Company’s financial assets measured at fair value on a recurring basis and their respective input levels based on the fair value hierarchy (in thousands): Fair Value Measurements Using Quoted Prices in Active Markets Significant Other Significant for Identical Observable Unobservable December 31, Assets Inputs Inputs 2022 (Level 1) (Level 2) (level 3) Assets: Cash equivalents Money market funds $ 18,436 $ 18,436 $ — $ — Total cash equivalents 18,436 18,436 — — Short-term investments Commercial paper 55,577 — 55,577 — U.S. Treasury bills 26,841 26,841 — — Agency bonds 24,405 — 24,405 — Total short-term investments 106,823 26,841 79,982 — Total fair value of assets $ 125,259 $ 45,277 $ 79,982 $ — Fair Value Measurements Using Quoted Prices in Active Markets Significant Other Significant for Identical Observable Unobservable December 31, Assets Inputs Inputs 2021 (Level 1) (Level 2) (level 3) Assets: Cash equivalents Money market funds $ 39,653 $ 39,653 $ — $ — Commercial paper 14,448 — 14,448 — Total cash equivalents 54,101 39,653 14,448 — Short-term investments U.S. Treasury bills 25,135 25,135 — — Corporate debt securities 10,715 — 10,715 — Commercial paper 77,328 — 77,328 — Total short-term investments 113,178 25,135 88,043 — Total fair value of assets $ 167,279 $ 64,788 $ 102,491 $ — Cash Equivalents and Short-Term Investments Financial assets measured at fair value on a recurring basis consist of the Company’s cash equivalents and short-term investments. Cash equivalents consisted of cash, money market funds and commercial paper, and short-term investments consisted of U.S. Treasury bills, agency bonds, corporate debt securities and commercial paper. The Company obtains pricing information from its investment manager and generally determines the fair value of investment securities using standard observable inputs, including reported trades, broker/dealer quotes, and bids and/or offers. The following tables summarize the Company’s short-term investments (in thousands): As of December 31, 2022 Gross Gross Amortized unrealized unrealized Estimated fair Maturity cost gains losses value Commercial paper 1 year or less 55,645 16 (84) 55,577 U.S. Treasury bills 2 years or less 27,108 — (267) 26,841 Agency bond 2 years or less 24,536 2 (133) 24,405 $ 107,289 $ 18 $ (484) $ 106,823 As of December 31, 2021 Gross Gross Amortized unrealized unrealized Estimated fair Maturity cost gains losses value Corporate debt securities 1 year or less $ 10,726 $ — $ (11) $ 10,715 Commercial paper 1 year or less 77,328 9 (9) 77,328 U.S. Treasury bills 2 years or less 25,183 — (48) 25,135 $ 113,237 $ 9 $ (68) $ 113,178 The following tables summarize the Company’s short-term investments with unrealized losses for less than 12 months and 12 months or greater: As of December 31, 2022 Less than 12 months 12 months or Greater Unrealized Unrealized Total Total Unrealized Fair Value Losses Fair Value Losses Fair Value Losses Commercial paper $ 34,928 $ (84) $ — $ — $ 34,928 $ (84) U.S. Treasury bills 1,971 (6) 24,833 (261) 26,804 (267) Agency bond 22,964 (133) — — 22,964 (133) $ 59,863 $ (223) $ 24,833 $ (261) $ 84,696 $ (484) As of December 31, 2021 Less than 12 months 12 months or Greater Unrealized Unrealized Total Total Unrealized Fair Value Losses Fair Value Losses Fair Value Losses Corporate debt securities $ 10,757 $ (11) $ — $ — $ 10,757 $ (11) Commercial paper 33,204 (9) — — 33,204 (9) U.S. Treasury bills 25,194 (48) — — 25,194 (48) $ 69,155 $ (68) $ — $ — $ 69,155 $ (68) The Company considers whether unrealized losses have resulted from a credit loss or other factors. The unrealized losses on the Company’s available-for-sale securities as of December 31, 2022 were caused by fluctuations in market value and interest rates as a result of the economic environment and not credit risk. The Company concluded that an allowance for credit losses was unnecessary as of December 31, 2022. It is neither management’s intention to sell nor is it more likely than not that the Company will be required to sell these investments prior to recovery of their cost basis or recovery of fair value. Unrealized gains and losses are included in accumulated other comprehensive loss. Accrued interest receivable is written off through net realized investment gains (losses) at the time the issuer of the bond defaults or is expected to default on payment. Accrued interest receivable |
BALANCE SHEET COMPONENTS
BALANCE SHEET COMPONENTS | 12 Months Ended |
Dec. 31, 2022 | |
BALANCE SHEET COMPONENTS | |
BALANCE SHEET COMPONENTS | (4) BALANCE SHEET COMPONENTS Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): As of December 31, 2022 2021 Prepaid expenses $ 1,503 $ 1,485 Prepaid research and development 478 5,233 Other current assets 295 240 Total prepaid expenses and other current assets $ 2,276 $ 6,958 Accrued and Other Current Liabilities Accrued and other current liabilities consisted of the following (in thousands): As of December 31, 2022 2021 Accrued research and development $ 2,751 $ 217 Accrued payroll and other employee benefits 1,691 790 Other 380 143 Total accrued and other current liabilities $ 4,822 $ 1,150 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2022 | |
COMMITMENTS AND CONTINGENCIES. | |
COMMITMENTS AND CONTINGENCIES | (5) COMMITMENTS AND CONTINGENCIES In August 2021, the Company entered into a lease agreement (the “Waltham Lease”) for approximately 5,000 square feet of office space in Waltham, Massachusetts for the Company’s corporate headquarters. The Waltham Lease has a term of thirty-nine months (“Lease Term”), unless extended or earlier terminated. The Company has the option to extend the Waltham Lease for one additional period of three years. The Lease Term had an initial abatement period, and the initial base rent payable is approximately $18,000 per month following the abatement period. The initial base rent payable will increase by approximately 2% per year over the Lease Term. The Waltham Lease commencement date was September 1, 2021. In April 2022, the Company entered into a lease agreement (the “Foster City Lease”) for approximately 3,500 square feet of office space in Foster City, California. The Foster City Lease has a term of thirty-nine months, unless extended or earlier terminated. The Company has the option to extend the Foster City Lease for on additional period of one year. The base rent payable under the Lease Term will be $22,600 per month and will be subject to annual increase of 3% on each anniversary. As of December 31, 2022, the consolidated balance sheet includes an operating lease right-of-use asset of $1.0 million and operating lease liability of $1.1 million. The total operating lease expense was $0.4 million and $0.1 million, for the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022, the future minimum annual lease payments under the operating leases were as follows (in thousands): Total Minimum Lease Payments 2023 $ 426 2024 508 2025 242 Total operating lease payments 1,176 Less: Amount representing interest (86) Present value of net minimum lease payments $ 1,090 The components of operating leases for the years ended December 31, 2022 and December 31, 2021 were as follows (in thousands except lease term and discount rate): As of December 31, Operating lease liabilities: 2022 2021 Current 385 192 Non-current 705 382 Total lease liabilities $ 1,090 $ 574 Weighted-average remaining lease term (in years) 2.4 3.0 Weighted-average incremental borrowing rate 6 % 6 % Legal Proceedings The Company may from time to time be party to litigation arising in the ordinary course of business. The Company was not subject to any material legal proceedings during the years ended December 31, 2022 and 2021, and no material legal proceedings are currently pending or, to the best of its knowledge, threatened. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2022 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | (6) STOCKHOLDERS’ EQUITY Under the Company’s Amended and Restated Certificates of Incorporation dated August 3, 2020, the Company had a total of 94,052,154 shares of capital stock authorized for issuance, consisting of 50,000,000 shares of common stock, par value of $0.0001 per share, and 44,052,154 shares of convertible preferred stock, par value of $0.0001 per share. Shares of authorized convertible preferred stock were designated as 4,000,000 shares of Series Seed redeemable convertible preferred stock and 40,052,154 shares of Series A redeemable convertible preferred stock. Following the Reverse Stock Split, the Company filed a Second Amended and Restated Certificate of Incorporation, which provided for 150,000,000 authorized shares of common stock with a par value of $0.0001 per share and 10,000,000 authorized shares of undesignated preferred stock with a par value of $0.0001 per share, effective upon completion of the Company’s IPO. (a) Redeemable Convertible Preferred Stock In August 2018, the Company sold to RA Capital Health Care Fund, L.P. an aggregate of 4,000,000 shares of Series Seed redeemable preferred stock at a purchase price of $1.00 per share, for net proceeds of $4.0 million. On August 5, 2020, the Company entered into the Stock Purchase Agreement. The Company’s initial closing of its Series A redeemable convertible preferred stock occurred on this date. The Company issued 3,468,536 shares of Series A redeemable convertible preferred shares for gross proceeds of $6.6 million at a price per share of $1.893. In addition to the cash proceeds, 3,020,998 shares of Series A redeemable convertible preferred stock were issued in connection with the conversion of the 2019 Notes and the 2020 Notes. The Stock Purchase Agreement contained provisions that potentially obligate the Company to sell, outside of its control, an additional 33,562,620 shares of Series A redeemable convertible preferred stock at $1.893 per share for expected gross proceeds of $63.5 million, upon the occurrence of three subsequent Milestone Closings or earlier, at the option of any holder of the Series A redeemable convertible preferred stock. If the defined milestones were not achieved prior to the Company’s initial public offering, the holders had the right to purchase these shares prior to the completion of the initial public offering. If the shares were not purchased prior to the completion of the initial public offering, then this right to purchase these shares would have automatically expired. On February 1, 2021, upon the completion of the First Milestone Closing, the Company sold 4,224,274 shares of Series A redeemable convertible preferred stock at the Series A Original Issue Price for aggregate gross proceeds of $8.0 million. On June 4, 2021, upon the completion of the Second Milestone Closing and the Third Milestone Closing, the Company sold 29,338,346 shares of Series A redeemable convertible preferred stock at the Series A Original Issue Price for aggregate gross proceeds of $55.5 million. Immediately prior to the closing of the Company’s IPO on July 2, 2021, all outstanding shares of the Company’s redeemable convertible preferred stock converted into 14,182,854 shares of the Company’s common stock. (b) Common Stock In August 2018, the Company issued 241,467 shares of common stock to RA Capital Healthcare Fund, L.P. at a price of $0.0012 per share. On July 2, 2021, in conjunction with the Company’s IPO, the Company issued 9,984,463 shares of its common stock and all outstanding shares of the Company’s redeemable convertible preferred stock were converted into 14,182,854 shares of the Company’s common stock. The holders of the common stock are entitled to one vote for each share of common stock held at all meetings of stockholders. As of December 31, 2022, the Company had reserved the following shares of common stock for future issuance: December 31, 2022 Common stock options granted and outstanding 4,110,219 Shares reserved for issuance under the 2021 Plan 1,077,557 Reserved for vesting of outstanding restricted stock units 28,881 Reserved for future ESPP issuances 216,131 Total 5,432,788 |
SHARE-BASED COMPENSATION
SHARE-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2022 | |
SHARE-BASED COMPENSATION | |
SHARE-BASED COMPENSATION | (7) SHARE-BASED COMPENSATION (a) Stock Option Plan The Company’s 2021 Stock Option and Incentive Plan (the “2021 Plan”) was adopted by the Company’s board of directors and approved by the Company’s stockholders in June 2021 and became effective as of June 29, 2021. Upon the effectiveness of the 2021 Plan, the Company’s 2018 Equity Incentive Plan (the “2018 Plan”) was terminated and no further grants may be made thereunder. The Company’s 2021 Plan allows for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, stock bonuses, restricted stock, stock units and other forms of awards including cash awards to its officers, directors, employees, consultants and advisors. As of December 31, 2022, a total of 3,576,415 shares of the Company’s common stock were authorized for issuance with respect to awards granted under the 2021 Plan. The share limit will automatically increase on the first trading day in January of each year (commencing with 2022) by an amount equal to the lesser of (1) 4% of the total number of outstanding shares of the Company’s common stock on the last trading day in December in the prior year, or (2) such lesser number as determined by the Company’s board of directors. The number of shares available under the 2021 Plan increased by 976,415 and 988,918 shares, effective January 1, 2022 and January 1, 2023, respectively, as determined by the Company’s board of directors. Any shares subject to awards granted under the 2021 Plan or the 2018 Plan that are not paid, delivered or exercised before they expire or are canceled or terminated, or otherwise fail to vest, as well as shares used to pay the purchase or exercise price of such awards or related tax withholding obligations, will become available for new award grants under the 2021 Plan. As of December 31, 2022, 2,467,977 options had been granted and 28,881 restricted stock units awarded under the 2021 Plan, with 1,077,557 shares authorized for future issuance. As of December 31, 2022, a total of 1,642,242 options had been granted and were outstanding under the 2018 Plan. The options that are granted under the 2021 Plan and the 2018 Plan are exercisable at various dates as determined upon grant and terminate within 10 years of the date of grant. The vesting period generally occurs over three The following table summarizes the option activity under the 2021 Plan and 2018 Plan for the year ended December 31, 2022: Weighted- Average Remaining Aggregate Weighted-Average Contractual Term Intrinsic Value Options Exercise Price (in years) (in thousands) Vested and expected to vest at December 31, 2021 3,454,374 $ 6.85 9.42 $ 19,378 Granted 954,557 15.62 Exercised (298,712) 2.09 Cancelled/Forfeited — — Outstanding at December 31, 2022 4,110,219 $ 9.23 9.23 82,490 Vested and exercisable at December 31, 2022 1,044,465 7.58 8.11 22,682 Vested and expected to vest at December 31, 2022 4,110,219 9.23 8.46 82,490 The weighted-average grant date fair value of stock option grants was $10.48 and $4.46 per share for the years ended December 31, 2022 and December 31, 2021, respectively. All exercisable options are vested and all outstanding options are vested or expected to vest. As of December 31, 2022 there was approximately $17.2 million of unrecognized stock-based compensation expense related to nonvested stock-based compensation arrangements granted under the 2021 Plan and 2018 Plan, which is expected to be recognized over a weighted-average period of 2.7 years (b) Employee Stock Purchase Plan The Company’s Employee Stock Purchase Plan (the “ESPP”) was adopted by the Company’s board of directors and stockholders in June 2021 and became effective upon the consummation of the IPO. A total of 230,000 shares of the Company’s common stock is initially available for issuance under the ESPP. The share limit will automatically increase on the first trading day in January of each year (commencing with 2022) by an amount equal to the lesser of (1) 1% of the total number of outstanding shares of the Company’s common stock on the last trading day in December in the prior year, or (2) such lesser number as determined by the Company’s board of directors. The number of shares available under the 2021 Plan increased by 247,229 shares effective January 1, 2023 as determined by the Company’s board of directors. The ESPP allows eligible employees to purchase shares of the Company’s common stock at a discount through payroll deductions of up to 15% of their eligible compensation, subject to any plan limitations. The ESPP provides for six-month offering periods, and at the end of each offering period, employees are able to purchase shares at 85% of the lower of the fair market value of the Company’s common stock on the first trading day of the offering period or on the last trading day of the offering period. As of December 31, 2022, 13,869 shares had been issued under the ESPP, and 216,131 shares authorized under the ESPP Plan were available for issuance. (c) Restricted Stock Units As of December 31, 2022, 28,881 restricted stock units had been awarded under the 2021 Plan. A summary of the status of and changes in unvested restricted stock unit activity under the Company’s equity award plans for the nine months ended December 31, 2022 was as follows: Weighted- Average Grant Date Fair Value Units Per Unit Unvested restricted stock units as of December 31, 2021 — — Granted 28,881 $ 21.62 Vested — — Forfeited — — Unvested restricted stock units as of December 31, 2022 28,881 $ 21.62 Stock-based compensation of restricted stock units is based on the fair value of the Company’s common stock on the date of grant and recognized over the vesting period. The vesting period generally occurs over one As of December 31, 2022, the Company had unrecognized stock-based compensation expense related to its unvested restricted stock units of $0.6 million, which is expected to be recognized over the remaining weighted-average vesting period of 3.3 years. The Company did not incur or have any unrecognized stock-based compensation related to restricted stock units as of December 31, 2021. (d) Stock-Based Compensation Expense The Company estimated the fair value of stock options using the Black-Scholes valuation model. The Company accounts for any forfeitures of options when they occur. Previously recognized compensation expense for an award is reversed in the period that the award is forfeited. The fair value of stock options was estimated using the following assumptions: Year Ended December 31, 2022 2021 Expected term (in years) 5.5 - 6.1 5.2 - 6.1 Expected volatility 73.5 - 76.5 % 68.7 - 69.8 % Risk-free interest rate 1.6 - 4.3 % 0.9 - 1.4 % Expected dividend — — Stock-based compensation expense recognized for stock option grants has been reported in the statements of operations and comprehensive loss as follows (in thousands): Year Ended December 31, 2022 2021 General and administrative $ 3,347 $ 1,673 Research and development 2,129 370 Total $ 5,476 $ 2,043 Stock-based compensation expense by type of award included within the consolidated statements of operations and comprehensive (loss) income was as follows: Year Ended December 31, 2022 2021 Stock options $ 5,316 $ 2,043 Employee stock purchase plan awards 98 — Restricted stock awards and units 63 — Total $ 5,476 $ 2,043 |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2022 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | (8) RELATED PARTY TRANSACTIONS Services Agreement In August 2018, the Company entered into a services agreement (“Services Agreement”) with Carnot, LLC (“Carnot”), an entity owned and controlled by RA Capital Management, L.P. under which Carnot provides research and other services to the Company. RA Capital Management, L.P. is a related party due to its equity ownership of the Company. The Company pays Carnot for services performed and costs incurred. The Services Agreement is for a term of two years. The Company may terminate the Services Agreement by giving 30 days’ prior notice and either party can terminate the services agreement for a material breach, if not cured within 30 days following notice by the nonbreaching party. In July 2019, the Services Agreement with Carnot was amended whereby research and other services are now performed by Carnot Pharma, LLC (“Carnot Pharma”), an entity owned and controlled by RA Capital Management, L.P., and the term was updated to the later of (i) two years from July 15, 2019 and (ii) completion of services under the agreement. Expenses incurred by the Company under the Services Agreement with Carnot Pharma totaled less than $0.1 million and $0.1 million for the years ended December 31, 2022 and December 31, 2021, respectively, and are presented in the statement of operations and comprehensive loss as research and development and general and administrative expenses. As of December 31, 2021, $2,000 was due to Carnot Pharma, LLC by the Company for services rendered under the agreement, and no amount was due to Carnot Pharma, LLC as of December 31, 2022. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2022 | |
INCOME TAXES | |
INCOME TAXES | (9) INCOME TAXES Significant components of the Company’s net deferred tax assets are as follows (in thousands): December 31, 2022 2021 Deferred income tax assets: NOL carryforwards $ 11,781 $ 7,498 Research credit carryforwards 1,601 530 Capitalized R&D 8,490 — Other 1,713 615 Gross deferred tax assets 23,585 8,643 Less: valuation allowance (23,283) (8,517) Total deferred tax assets 302 126 Deferred income tax liabilities: Other (302) (126) Total deferred tax liabilities (302) (126) Net deferred tax assets (liabilities) $ — $ — A reconciliation between the provision for income taxes and income taxes computed using the U.S. federal statutory corporate tax rate is as follows (in thousands): Years ended December 31, 2022 2021 U.S. Federal statutory income tax rate $ (10,829) $ (4,821) State taxes (2,828) (520) Permanent and other differences 563 3 Stock-based compensation (787) 115 Research and development credits (757) (392) Change in valuation allowance 14,663 5,618 Total tax provision $ 25 $ 3 The Company had federal NOL carryforwards available of $46.6 million and $32.6 million as of December 31, 2022 and December 31, 2021, respectively, before consideration of limitations under Section 382 of the Internal Revenue Code or Section 382, as further described below. The NOL generated from 2018 onwards of $46.6 million will carryforward indefinitely and be available to offset up to 80% of future taxable income each year. Additionally, the Company had state NOL carryforwards available of $34.4 million and $20.3 million as of December 31, 2022 and December 31, 2021, respectively. The state NOLs may be used to offset future taxable income and will begin to expire in 2038. At December 31, 2022 the Company had federal and state research and development credit carryforwards available of $1.8 million and $0.6 million, respectively. The federal credit carryforwards will begin to expire in 2038, unless previously utilized. The Massachusetts credit carryforwards will begin expiring in 2036, unless previously utilized. The California credits carry forward indefinitely. The Company has established a full valuation allowance for its deferred tax assets due to uncertainties that preclude it from determining that it is more likely than not that the Company will be able to generate sufficient taxable income to realize such assets. Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to utilize the existing deferred tax assets. A significant piece of objective negative evidence evaluated was the cumulative loss incurred since inception. Such objective evidence limits the ability to consider other subjective evidence such as the Company’s projections for future growth. Based on this evaluation, as of December 31, 2022 and December 31, 2021, a valuation allowance of $23.3 million and $8.5 million, respectively, has been recorded against all of the Company’s net deferred tax assets, as the Company has determined that none of the Company’s balance of net deferred tax assets is more likely than not to be realized. The amount of the deferred tax assets considered realizable, however, could be adjusted in the future if objective negative evidence in the form of cumulative losses is no longer present and additional weight may be given to subjective evidence, such as estimates of future taxable income during carryforward periods and the Company’s projections for growth. The future utilization of the Company’s NOL and tax credit carryforwards to offset future taxable income may be subject to a substantial annual limitation as a result of changes in ownership by stockholders that hold 5% or more of the Company’s common stock. An assessment of such ownership changes under Section 382 and 383 was not completed through December 31, 2022. Utilization of our net operating loss and income tax credit carryforwards may be subject to a substantial annual limitation due to ownership changes that may have occurred or that could occur in the future. These ownership changes may limit the amount of the net operating loss and income tax credit carryover that can be utilized annually to offset future taxable income. The Company will examine the impact of any potential ownership changes in the future. The following table summarizes the activity related to the Company’s gross unrecognized tax benefits at the beginning and end of the years ended December 31, 2022 and December 31, 2021 (in thousands): Years ended December 31, 2022 2021 Beginning balance of unrecognized tax benefits $ 529 $ 276 Additions based on tax positions related to the current year 461 253 Additions based on tax positions related to the prior year 3 — Ending balance of unrecognized tax benefits $ 993 $ 529 The unrecognized tax benefit amounts are reflected in the determination of the Company’s deferred tax assets. If recognized, none of these amounts would affect the Company’s effective tax rate, since it would be offset by an equal corresponding adjustment in the deferred tax asset valuation allowance. The Company does not foresee material changes to its liability for uncertain tax benefits within the next twelve months. The Company is subject to taxation in the United States and various states. The Company’s Federal and state returns are subject to examination, as 2018 was the first year of operations for the Company. |
BASIS OF PRESENTATION AND SIG_2
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES | |
Basis of Presentation | (a) Basis of Presentation The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and include the Company’s wholly owned subsidiary, Aerovate Securities Corporation. All intercompany transactions and balances have been eliminated in consolidation. |
Reverse Stock Split | (b) Reverse Stock Split On June 22, 2021, the Company effected a 1-for-3 |
Use of Estimates | (c) Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Reported amounts and note disclosures reflect the overall economic conditions that are most likely to occur and anticipated measures management intends to take. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations, and financial condition will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat it, as well as the economic impact on local, regional, national and international markets. Actual results could differ materially from those estimates. Accounting estimates and management judgements reflected in the consolidated financial statements include: normal recurring accruals, including the accrual for research and development expenses, stock-based compensation, fair value of investments, and operating lease right-of-use assets and lease liabilities. Estimates and assumptions are reviewed quarterly. Any revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected. |
Cash and Cash Equivalents | (d) Cash and Cash Equivalents Cash and cash equivalents include cash in readily available checking accounts, money market funds and commercial paper. The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. |
Short-term Investments | (e) Short-term Investments Short-term investments consist of corporate debt securities, commercial paper and U.S. Treasury bills, classified as available-for-sale securities and have maturities of greater than three months. The Company has classified all of its available-for-sale investment securities as current assets on the consolidated balance sheets because these are considered highly liquid securities and are available for use in current operations. The Company carries these securities at fair value and reports unrealized gains and losses as a separate component of accumulated other comprehensive loss. The cost of debt securities is adjusted for amortization of purchase premiums and accretion of discounts to maturity. Such amortization and accretion is included in interest income in the consolidated statements of operations and comprehensive loss. Realized gains and losses on sales of securities are determined using the specific identification method and recorded in other income (expense), net in the consolidated statement of operations and comprehensive loss. |
Concentration of Credit Risk | (f) Concentration of Credit Risk Financial instruments, which potentially subject the Company to concentration of credit risk, consist primarily of cash, cash equivalents and short-term investments. The Company maintains cash, cash equivalents and short-term investments with various high credit quality banks and other financial institutions in the United States. Such deposits may be in excess of federally insured limits. Management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. The Company has not experienced any losses on deposits since inception. |
Comprehensive Loss | (g) Comprehensive Loss Comprehensive loss consists of net loss and unrealized gains or losses on available-for-sale investments. The Company displays comprehensive loss and its components as part of the consolidated statements of operations and comprehensive loss. |
Fair Value Measurements | (h) Fair Value Measurements The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or non-recurring basis. Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices in active markets. Level 2: Inputs, other than the quoted prices in active markets that are observable either directly or indirectly. Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. The carrying amounts of prepaid expenses and other current assets, accounts payable, accrued liabilities and other current liabilities are reasonable estimates of their fair value due to the short-term nature of these accounts. |
Prepaid Expenses and Other Current Assets | (i) Prepaid Expenses and Other Current Assets Any expenses paid prior to the related services rendered are recorded as prepaid expenses. Such prepaid expenses are expensed in the period the expense is incurred. If the expense is for a service covering multiple periods, it is expensed from the date the services begin and over the period of the service rendered (or contract service period if services rendered dates are not defined). |
Property and Equipment, Net | (j) Property and Equipment, Net Property and equipment, which consist of leasehold improvements, furniture and fixtures, research equipment, computers and construction-in-progress are stated at cost less accumulated depreciation or accumulated amortization. Depreciation and amortization is calculated using the straight-line method over the estimated useful lives of the assets, which ranges from three five years |
Impairment of Long-lived Assets | (k) Impairment of Long-lived Assets The carrying value of long-lived assets, including property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the asset may not be recoverable. An impairment loss is recognized when the total of estimated future undiscounted cash flows, expected to result from the use of the asset and its eventual disposition, are less than its carrying amount. Impairment, if any, would be assessed using discounted cash flows or other appropriate measures of fair value. Through December 31, 2022, there has been no such impairment losses recorded by the Company. |
Leases | (l) Leases At the commencement date of a lease, the Company recognizes lease liabilities which represent its obligation to make lease payments, and right-of-use assets (“ROU assets”) which represent its right to use the underlying asset during the lease term. The lease liability is measured at the present value of lease payments over the lease term. As the Company’s leases typically do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at the lease commencement date. The ROU asset is measured at cost, which includes the initial measurement of the lease liability and initial direct costs incurred by the Company and excludes lease incentives. ROU assets are recorded in operating lease ROU assets and lease liabilities are recorded in operating lease liabilities, current and noncurrent in the consolidated balance sheets. Lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Operating lease expense is recognized on a straight-line basis over the lease term. The Company has elected not to separate lease and non-lease components and not recognize lease liabilities and ROU assets for short-term leases with terms of twelve months or less. |
Convertible Preferred Stock | (m) Convertible Preferred Stock The Company records convertible preferred stock at fair value on the dates of issuance, net of issuance costs. Upon the occurrence of certain events that are outside the Company’s control, including a deemed liquidation event, holders of the convertible preferred stock can cause redemption for cash. Therefore, convertible preferred stock is classified outside of stockholders’ deficit on the balance sheets as events triggering the liquidation preferences are not solely within the Company’s control. The carrying values of the convertible preferred stock are adjusted to their liquidation preferences if and when it becomes probable that such a liquidation event will occur. |
Research and Development Expenses | (n) Research and Development Expenses Research and development costs are expensed as incurred. Research and development costs consist primarily of salaries and other benefits of research and development personnel, including associated share-based compensation, costs related to research activities, preclinical studies, clinical trial, drug manufacturing and allocated overhead and facility-related expenses. The Company accounts for non-refundable advance payments for goods or services that will be used in future research and development activities as expenses when the goods have been received or when the service has been performed rather than when the payment is made. Clinical trial costs are a component of research and development expenses. The Company expenses costs for its clinical trial activities performed by third parties, including clinical research organizations and other service providers, as they are incurred, based upon estimates of the work completed over the life of the individual study in accordance with associated agreements. The Company uses information it receives from internal personnel and outside service providers to estimate the clinical trial costs incurred. |
Stock-Based Compensation | (o) Stock-Based Compensation Stock-based compensation expense represents the cost of the grant-date fair value of employee, officer, director, and non-employee stock option grants and restricted stock units, estimated in accordance with the applicable accounting guidance, recognized using the straight-line method over the vesting period for service-based options and using the graded vesting method for performance-based options. The vesting period generally approximates the expected service period of the awards. Forfeitures are recognized and accounted for as they occur. The fair value of stock options is estimated using a Black-Scholes option pricing model on the date of grant. This method requires certain assumptions be used as inputs, such as the fair value of the underlying common stock, expected term of the option before exercise, expected volatility of the Company’s common stock, expected dividend yield, and a risk-free interest rate. Options and awards granted during the year have a maximum contractual term of ten years. The Company has limited historical stock option activity and therefore estimates the expected term of stock options granted using the simplified method, which represents the average of the contractual term of the stock option and its weighted-average vesting period. The expected volatility of stock options is based upon the historical volatility of a number of publicly traded companies in similar stages of clinical development. The Company has historically not declared or paid any dividends and does not currently expect to do so in the foreseeable future. The risk-free interest rates used are based on the U.S. Department of Treasury (“U.S. Treasury”) yield in effect at the time of grant for zero-coupon U.S. Treasury notes with maturities approximately equal to the expected term of the stock options. |
Income Taxes | (p) Income Taxes Income taxes are accounted for using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and net operating loss (“NOL”) and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance against deferred tax assets is recorded if, based upon the weight of all available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company records uncertain tax positions on the basis of a two-step process whereby (1) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense. Any accrued interest and penalties are included within the related tax liability. |
Segment Reporting | (q) Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions on how to allocate resources and assess performance. The Company views its operations and manages its business as one operating segment. |
Net Loss Per Share | (r) Net Loss Per Share Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period, without consideration of potential dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the sum of the weighted average number of common shares plus the potential dilutive effects of potential dilutive securities outstanding during the period. Potential dilutive securities are excluded from diluted earnings or loss per share if the effect of such inclusion is antidilutive. The Company’s potentially dilutive securities, which include convertible preferred stock prior to the conversion of such shares to common stock and outstanding stock options under the Company’s equity incentive plan, have been excluded from the computation of diluted net loss per share as they would be anti-dilutive to the net loss per share. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. The following table summarizes the Company’s net loss per share: Year Ended December 31, 2022 2021 Numerator: Net loss $ (51,511) $ (22,963) Accretion of Series A redeemable convertible preferred stock to redemption value — (22) Net loss available to common stockholders $ (51,511) $ (22,985) Denominator: Weighted-average common stock outstanding, basic and diluted 24,472,104 12,293,629 Net loss per share, basic and diluted $ (2.10) $ (1.87) Potentially dilutive securities not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would have had an anti-dilutive effect are as follows (in common stock equivalent shares): As of December 31, 2022 2021 Options to purchase common stock 4,110,219 3,454,374 Unvested restricted stock units 28,881 — 4,139,100 3,454,374 |
Recently Issued Accounting Pronouncements | (p) Recently Issued Accounting Pronouncements In June 2022, the FASB issued ASU No. 2022-03, Fair Value Measurement (Topic 820) - Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions. This standard clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. This standard will be effective for the Company on January 1, 2024, and is not expected to have an impact on the Company’s financial position or results of operations upon adoption. |
BASIS OF PRESENTATION AND SIG_3
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES | |
SCHEDULE OF NET LOSS PER SHARE | The following table summarizes the Company’s net loss per share: Year Ended December 31, 2022 2021 Numerator: Net loss $ (51,511) $ (22,963) Accretion of Series A redeemable convertible preferred stock to redemption value — (22) Net loss available to common stockholders $ (51,511) $ (22,985) Denominator: Weighted-average common stock outstanding, basic and diluted 24,472,104 12,293,629 Net loss per share, basic and diluted $ (2.10) $ (1.87) |
SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES NOT INCLUDED IN THE CALCULATION OF DILUTED NET LOSS PER SHARE | Potentially dilutive securities not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would have had an anti-dilutive effect are as follows (in common stock equivalent shares): As of December 31, 2022 2021 Options to purchase common stock 4,110,219 3,454,374 Unvested restricted stock units 28,881 — 4,139,100 3,454,374 |
FAIR VALUE OF FINANCIAL INSTR_2
FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
FAIR VALUE OF FINANCIAL INSTRUMENTS. | |
SCHEDULE OF FAIR VALUE INSTRUMENTS | The following tables summarize the Company’s financial assets measured at fair value on a recurring basis and their respective input levels based on the fair value hierarchy (in thousands): Fair Value Measurements Using Quoted Prices in Active Markets Significant Other Significant for Identical Observable Unobservable December 31, Assets Inputs Inputs 2022 (Level 1) (Level 2) (level 3) Assets: Cash equivalents Money market funds $ 18,436 $ 18,436 $ — $ — Total cash equivalents 18,436 18,436 — — Short-term investments Commercial paper 55,577 — 55,577 — U.S. Treasury bills 26,841 26,841 — — Agency bonds 24,405 — 24,405 — Total short-term investments 106,823 26,841 79,982 — Total fair value of assets $ 125,259 $ 45,277 $ 79,982 $ — Fair Value Measurements Using Quoted Prices in Active Markets Significant Other Significant for Identical Observable Unobservable December 31, Assets Inputs Inputs 2021 (Level 1) (Level 2) (level 3) Assets: Cash equivalents Money market funds $ 39,653 $ 39,653 $ — $ — Commercial paper 14,448 — 14,448 — Total cash equivalents 54,101 39,653 14,448 — Short-term investments U.S. Treasury bills 25,135 25,135 — — Corporate debt securities 10,715 — 10,715 — Commercial paper 77,328 — 77,328 — Total short-term investments 113,178 25,135 88,043 — Total fair value of assets $ 167,279 $ 64,788 $ 102,491 $ — |
SUMMARY OF SHORT TERM INVESTMENT | The following tables summarize the Company’s short-term investments (in thousands): As of December 31, 2022 Gross Gross Amortized unrealized unrealized Estimated fair Maturity cost gains losses value Commercial paper 1 year or less 55,645 16 (84) 55,577 U.S. Treasury bills 2 years or less 27,108 — (267) 26,841 Agency bond 2 years or less 24,536 2 (133) 24,405 $ 107,289 $ 18 $ (484) $ 106,823 As of December 31, 2021 Gross Gross Amortized unrealized unrealized Estimated fair Maturity cost gains losses value Corporate debt securities 1 year or less $ 10,726 $ — $ (11) $ 10,715 Commercial paper 1 year or less 77,328 9 (9) 77,328 U.S. Treasury bills 2 years or less 25,183 — (48) 25,135 $ 113,237 $ 9 $ (68) $ 113,178 |
SCHEDULE OF SHORT-TERM INVESTMENTS WITH UNREALIZED LOSSES | As of December 31, 2022 Less than 12 months 12 months or Greater Unrealized Unrealized Total Total Unrealized Fair Value Losses Fair Value Losses Fair Value Losses Commercial paper $ 34,928 $ (84) $ — $ — $ 34,928 $ (84) U.S. Treasury bills 1,971 (6) 24,833 (261) 26,804 (267) Agency bond 22,964 (133) — — 22,964 (133) $ 59,863 $ (223) $ 24,833 $ (261) $ 84,696 $ (484) As of December 31, 2021 Less than 12 months 12 months or Greater Unrealized Unrealized Total Total Unrealized Fair Value Losses Fair Value Losses Fair Value Losses Corporate debt securities $ 10,757 $ (11) $ — $ — $ 10,757 $ (11) Commercial paper 33,204 (9) — — 33,204 (9) U.S. Treasury bills 25,194 (48) — — 25,194 (48) $ 69,155 $ (68) $ — $ — $ 69,155 $ (68) |
BALANCE SHEET COMPONENTS (Table
BALANCE SHEET COMPONENTS (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
BALANCE SHEET COMPONENTS | |
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS | Prepaid expenses and other current assets consisted of the following (in thousands): As of December 31, 2022 2021 Prepaid expenses $ 1,503 $ 1,485 Prepaid research and development 478 5,233 Other current assets 295 240 Total prepaid expenses and other current assets $ 2,276 $ 6,958 |
SCHEDULE OF ACCRUED AND OTHER CURRENT LIABILITIES | Accrued and other current liabilities consisted of the following (in thousands): As of December 31, 2022 2021 Accrued research and development $ 2,751 $ 217 Accrued payroll and other employee benefits 1,691 790 Other 380 143 Total accrued and other current liabilities $ 4,822 $ 1,150 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
COMMITMENTS AND CONTINGENCIES. | |
SCHEDULE OF FUTURE MINIMUM ANNUAL LEASE PAYMENTS FOR OPERATING LEASES | As of December 31, 2022, the future minimum annual lease payments under the operating leases were as follows (in thousands): Total Minimum Lease Payments 2023 $ 426 2024 508 2025 242 Total operating lease payments 1,176 Less: Amount representing interest (86) Present value of net minimum lease payments $ 1,090 The components of operating leases for the years ended December 31, 2022 and December 31, 2021 were as follows (in thousands except lease term and discount rate): As of December 31, Operating lease liabilities: 2022 2021 Current 385 192 Non-current 705 382 Total lease liabilities $ 1,090 $ 574 Weighted-average remaining lease term (in years) 2.4 3.0 Weighted-average incremental borrowing rate 6 % 6 % |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
STOCKHOLDERS' EQUITY | |
SCHEDULE OF COMMON STOCK SHARES RESERVED FOR ON AND AS-CONVERTED BASIS, FOR FUTURE ISSUANCE | As of December 31, 2022, the Company had reserved the following shares of common stock for future issuance: December 31, 2022 Common stock options granted and outstanding 4,110,219 Shares reserved for issuance under the 2021 Plan 1,077,557 Reserved for vesting of outstanding restricted stock units 28,881 Reserved for future ESPP issuances 216,131 Total 5,432,788 |
SHARE-BASED COMPENSATION (Table
SHARE-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
SHARE-BASED COMPENSATION | |
SUMMARY OF OPTION ACTIVITY UNDER 2021 PLAN AND 2018 PLAN | The following table summarizes the option activity under the 2021 Plan and 2018 Plan for the year ended December 31, 2022: Weighted- Average Remaining Aggregate Weighted-Average Contractual Term Intrinsic Value Options Exercise Price (in years) (in thousands) Vested and expected to vest at December 31, 2021 3,454,374 $ 6.85 9.42 $ 19,378 Granted 954,557 15.62 Exercised (298,712) 2.09 Cancelled/Forfeited — — Outstanding at December 31, 2022 4,110,219 $ 9.23 9.23 82,490 Vested and exercisable at December 31, 2022 1,044,465 7.58 8.11 22,682 Vested and expected to vest at December 31, 2022 4,110,219 9.23 8.46 82,490 |
SCHEDULE OF UNVESTED STOCK UNIT ACTIVITY | Weighted- Average Grant Date Fair Value Units Per Unit Unvested restricted stock units as of December 31, 2021 — — Granted 28,881 $ 21.62 Vested — — Forfeited — — Unvested restricted stock units as of December 31, 2022 28,881 $ 21.62 |
SUMMARY OF FAIR VALUE OF STOCK OPTIONS ASSUMPTIONS | Year Ended December 31, 2022 2021 Expected term (in years) 5.5 - 6.1 5.2 - 6.1 Expected volatility 73.5 - 76.5 % 68.7 - 69.8 % Risk-free interest rate 1.6 - 4.3 % 0.9 - 1.4 % Expected dividend — — |
SUMMARY OF STOCK-BASED COMPENSATION EXPENSE RECOGNIZED AND EXPENSE BY AWARD TYPE | Stock-based compensation expense recognized for stock option grants has been reported in the statements of operations and comprehensive loss as follows (in thousands): Year Ended December 31, 2022 2021 General and administrative $ 3,347 $ 1,673 Research and development 2,129 370 Total $ 5,476 $ 2,043 Stock-based compensation expense by type of award included within the consolidated statements of operations and comprehensive (loss) income was as follows: Year Ended December 31, 2022 2021 Stock options $ 5,316 $ 2,043 Employee stock purchase plan awards 98 — Restricted stock awards and units 63 — Total $ 5,476 $ 2,043 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
INCOME TAXES | |
SUMMARY OF COMPONENTS OF NET DEFERRED TAX ASSETS | Significant components of the Company’s net deferred tax assets are as follows (in thousands): December 31, 2022 2021 Deferred income tax assets: NOL carryforwards $ 11,781 $ 7,498 Research credit carryforwards 1,601 530 Capitalized R&D 8,490 — Other 1,713 615 Gross deferred tax assets 23,585 8,643 Less: valuation allowance (23,283) (8,517) Total deferred tax assets 302 126 Deferred income tax liabilities: Other (302) (126) Total deferred tax liabilities (302) (126) Net deferred tax assets (liabilities) $ — $ — |
SUMMARY OF RECONCILIATION OF FEDERAL INCOME TAX RATE | A reconciliation between the provision for income taxes and income taxes computed using the U.S. federal statutory corporate tax rate is as follows (in thousands): Years ended December 31, 2022 2021 U.S. Federal statutory income tax rate $ (10,829) $ (4,821) State taxes (2,828) (520) Permanent and other differences 563 3 Stock-based compensation (787) 115 Research and development credits (757) (392) Change in valuation allowance 14,663 5,618 Total tax provision $ 25 $ 3 |
SUMMARY OF GROSS UNRECOGNIZED TAX BENEFITS | The following table summarizes the activity related to the Company’s gross unrecognized tax benefits at the beginning and end of the years ended December 31, 2022 and December 31, 2021 (in thousands): Years ended December 31, 2022 2021 Beginning balance of unrecognized tax benefits $ 529 $ 276 Additions based on tax positions related to the current year 461 253 Additions based on tax positions related to the prior year 3 — Ending balance of unrecognized tax benefits $ 993 $ 529 |
ORGANIZATION AND SUMMARY OF S_2
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) | 12 Months Ended | ||
Aug. 15, 2022 | Jul. 02, 2021 | Dec. 31, 2022 | |
Subsidiary, Sale of Stock [Line Items] | |||
Cash and cash equivalents and short term investment | $ 129,200,000 | ||
Jefferies | |||
Subsidiary, Sale of Stock [Line Items] | |||
Aggregate amount of shares | $ 75,000,000 | ||
Shares sold | 0 | ||
IPO | |||
Subsidiary, Sale of Stock [Line Items] | |||
Number of shares issued | 9,984,463 | ||
Number of shares conversion securities | 14,182,854 | ||
Proceeds from issuance of public offering | $ 126,900,000 | ||
Over-Allotment Option | |||
Subsidiary, Sale of Stock [Line Items] | |||
Number of shares issued | 1,302,321 | ||
Sale of price per share | $ 14 |
BASIS OF PRESENTATION AND SIG_4
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES (Details) | 12 Months Ended | |
Jun. 22, 2021 | Dec. 31, 2022 USD ($) segment | |
Stockholders' equity, reverse stock split | 0.321956 | |
Impairment losses | $ | $ 0 | |
Number of Operating Segments | segment | 1 | |
Minimum | ||
Leasehold improvements are amortized over the remaining life | 3 years | |
Maximum | ||
Leasehold improvements are amortized over the remaining life | 5 years | |
Expiration period | 10 years |
BASIS OF PRESENTATION AND SIG_5
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES - SCHEDULE OF NET LOSS PER SHARE (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Net loss | $ (51,511) | $ (22,963) |
Accretion of Series A redeemable convertible preferred stock to redemption value | (22) | |
Net loss available to common stockholders | $ (51,511) | $ (22,985) |
Weighted-average common stock outstanding, basic | 24,472,104 | 12,293,629 |
Weighted-average common stock outstanding, diluted | 24,472,104 | 12,293,629 |
Net loss per share, basic | $ (2.10) | $ (1.87) |
Net loss per share, diluted | $ (2.10) | $ (1.87) |
Series A Redeemable Convertible Preferred Stock | ||
Accretion of Series A redeemable convertible preferred stock to redemption value | $ (22) |
BASIS OF PRESENTATION AND SIG_6
BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES - SCHEDULE OF POTENTIALLY DILUTIVE SECURITIES NOT INCLUDED IN THE CALCULATION OF DILUTED NET LOSS PER SHARE (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities | 4,139,100 | 3,454,374 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities | 4,110,219 | 3,454,374 |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities | 28,881 |
FAIR VALUE OF FINANCIAL INSTR_3
FAIR VALUE OF FINANCIAL INSTRUMENTS - SCHEDULE OF FAIR VALUE INSTRUMENTS (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total short-term investments | $ 106,823 | $ 113,178 |
Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 18,436 | 54,101 |
Total short-term investments | 106,823 | 113,178 |
Total fair value of assets | 125,259 | 167,279 |
Fair Value, Recurring | Fair Value, Inputs, Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 18,436 | 39,653 |
Total short-term investments | 26,841 | 25,135 |
Total fair value of assets | 45,277 | 64,788 |
Fair Value, Recurring | Fair Value, Inputs, Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 14,448 | |
Total short-term investments | 79,982 | 88,043 |
Total fair value of assets | 79,982 | 102,491 |
Money market funds | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 18,436 | 39,653 |
Money market funds | Fair Value, Recurring | Fair Value, Inputs, Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 18,436 | 39,653 |
Commercial paper | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 14,448 | |
Total short-term investments | 55,577 | 77,328 |
Commercial paper | Fair Value, Recurring | Fair Value, Inputs, Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash equivalents | 14,448 | |
Total short-term investments | 55,577 | 77,328 |
U.S. Treasury bills | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total short-term investments | 26,841 | 25,135 |
U.S. Treasury bills | Fair Value, Recurring | Fair Value, Inputs, Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total short-term investments | 26,841 | 25,135 |
Corporate Debt Securities | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total short-term investments | 10,715 | |
Corporate Debt Securities | Fair Value, Recurring | Fair Value, Inputs, Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total short-term investments | $ 10,715 | |
Agency bond | Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total short-term investments | 24,405 | |
Agency bond | Fair Value, Recurring | Fair Value, Inputs, Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total short-term investments | $ 24,405 |
FAIR VALUE OF FINANCIAL INSTR_4
FAIR VALUE OF FINANCIAL INSTRUMENTS - SCHEDULE OF SHORT TERM INVESTMENT (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Amortized cost | $ 107,289 | $ 113,237 |
Gross unrealized gains | 18 | 9 |
Gross unrealized loss | (484) | (68) |
Estimated fair value | $ 106,823 | 113,178 |
Debt Securities, Available-for-Sale, Accrued Interest, after Allowance for Credit Loss, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other long-term assets | |
Short-Term Investments | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Accrued interest receivable | $ 300 | 100 |
Corporate Debt Securities | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Amortized cost | 10,726 | |
Gross unrealized loss | (11) | |
Estimated fair value | 10,715 | |
Commercial paper | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Amortized cost | 55,645 | 77,328 |
Gross unrealized gains | 16 | 9 |
Gross unrealized loss | (84) | (9) |
Estimated fair value | 55,577 | 77,328 |
U.S. Treasury bills | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Amortized cost | 27,108 | 25,183 |
Gross unrealized gains | ||
Gross unrealized loss | (267) | (48) |
Estimated fair value | 26,841 | $ 25,135 |
Agency bond | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Amortized cost | 24,536 | |
Gross unrealized gains | 2 | |
Gross unrealized loss | (133) | |
Estimated fair value | $ 24,405 | |
Maximum | Corporate Debt Securities | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Maturity term | 1 year | |
Maximum | Commercial paper | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Maturity term | 1 year | 1 year |
Maximum | U.S. Treasury bills | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Maturity term | 2 years | 2 years |
Maximum | Agency bond | ||
Fair Value, Off-balance Sheet Risks, Disclosure Information [Line Items] | ||
Maturity term | 2 years |
FAIR VALUE OF FINANCIAL INSTR_5
FAIR VALUE OF FINANCIAL INSTRUMENTS - SCHEDULE OF SHORT-TERM INVESTMENTS WITH UNREALIZED LOSSES (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-Sale, Unrealized Loss Position [Line Items] | ||
Short-term investments, Less than 12 months, Fair Value | $ 59,863 | $ 69,155 |
Short-term investments, Less than 12 months, Unrealized Losses | (223) | (68) |
Short-term investments, 12 months or Greater, Fair Value | 24,833 | |
Short-term investments, 12 months or Greater, Unrealized Losses | (261) | |
Short-term investments, Total Fair Value | 84,696 | 69,155 |
Short-term investments, Total Unrealized Losses | (484) | (68) |
Corporate Debt Securities | ||
Debt Securities, Available-for-Sale, Unrealized Loss Position [Line Items] | ||
Short-term investments, Less than 12 months, Fair Value | 10,757 | |
Short-term investments, Less than 12 months, Unrealized Losses | (11) | |
Short-term investments, Total Fair Value | 10,757 | |
Short-term investments, Total Unrealized Losses | (11) | |
Commercial paper | ||
Debt Securities, Available-for-Sale, Unrealized Loss Position [Line Items] | ||
Short-term investments, Less than 12 months, Fair Value | 34,928 | 33,204 |
Short-term investments, Less than 12 months, Unrealized Losses | (84) | (9) |
Short-term investments, Total Fair Value | 34,928 | 33,204 |
Short-term investments, Total Unrealized Losses | (84) | (9) |
U.S. Treasury bills | ||
Debt Securities, Available-for-Sale, Unrealized Loss Position [Line Items] | ||
Short-term investments, Less than 12 months, Fair Value | 1,971 | 25,194 |
Short-term investments, Less than 12 months, Unrealized Losses | (6) | (48) |
Short-term investments, 12 months or Greater, Fair Value | 24,833 | |
Short-term investments, 12 months or Greater, Unrealized Losses | (261) | |
Short-term investments, Total Fair Value | 26,804 | 25,194 |
Short-term investments, Total Unrealized Losses | (267) | $ (48) |
Agency bond | ||
Debt Securities, Available-for-Sale, Unrealized Loss Position [Line Items] | ||
Short-term investments, Less than 12 months, Fair Value | 22,964 | |
Short-term investments, Less than 12 months, Unrealized Losses | (133) | |
Short-term investments, Total Fair Value | 22,964 | |
Short-term investments, Total Unrealized Losses | $ (133) |
BALANCE SHEET COMPONENTS - SCHE
BALANCE SHEET COMPONENTS - SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
BALANCE SHEET COMPONENTS | ||
Prepaid expenses | $ 1,503 | $ 1,485 |
Prepaid research and development | 478 | 5,233 |
Other current assets | 295 | 240 |
Total prepaid expenses and other current assets | $ 2,276 | $ 6,958 |
BALANCE SHEET COMPONENTS - SC_2
BALANCE SHEET COMPONENTS - SCHEDULE OF ACCRUED AND OTHER CURRENT LIABILITIES - (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
BALANCE SHEET COMPONENTS | ||
Accrued research and development | $ 2,751 | $ 217 |
Accrued payroll and other employee benefits | 1,691 | 790 |
Other | 380 | 143 |
Total accrued and other current liabilities | $ 4,822 | $ 1,150 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details) | 1 Months Ended | 12 Months Ended | ||
Apr. 30, 2022 USD ($) ft² | Aug. 31, 2021 USD ($) ft² | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Lessee, Lease, Description [Line Items] | ||||
Lease, option to extend | true | |||
Operating lease right-of-use assets | $ 1,003,000 | $ 542,000 | ||
Operating lease liability | 1,090,000 | 574,000 | ||
Total operating lease expenses | $ 400,000 | $ 100,000 | ||
Waltham Lease | ||||
Lessee, Lease, Description [Line Items] | ||||
Area of land | ft² | 5,000 | |||
Operating lease term | 39 months | |||
Renewal term | 3 years | |||
Payment for rent | $ 18,000 | |||
Lease rent percentage | 2% | |||
Foster City Lease | ||||
Lessee, Lease, Description [Line Items] | ||||
Area of land | ft² | 3,500 | |||
Operating lease term | 39 months | |||
Renewal term | 1 year | |||
Payment for rent | $ 22,600 | |||
Lease rent percentage | 3% |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - SCHEDULE OF FUTURE MINIMUM ANNUAL LEASE PAYMENTS FOR OPERATING LEASES (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
COMMITMENTS AND CONTINGENCIES. | ||
2023 | $ 426 | |
2024 | 508 | |
2025 | 242 | |
Total operating lease payments | 1,176 | |
Less: Amount representing interest | (86) | |
Present value of net minimum lease payments | 1,090 | $ 574 |
Operating lease liabilities: | ||
Current | 385 | 192 |
Non-current | $ 705 | $ 382 |
Weighted-average remaining lease term (in years) | 2 years 4 months 24 days | 3 years |
Weighted-average incremental borrowing rate | 6% | 6% |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) $ / shares in Units, $ in Millions | 1 Months Ended | ||||||||
Jul. 02, 2021 shares | Jun. 04, 2021 USD ($) shares | Feb. 01, 2021 USD ($) shares | Aug. 05, 2020 USD ($) $ / shares shares | Aug. 31, 2018 USD ($) $ / shares shares | Dec. 31, 2022 Vote $ / shares shares | Dec. 31, 2021 $ / shares shares | Jun. 22, 2021 $ / shares shares | Aug. 03, 2020 $ / shares shares | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||
Capital stock shares authorized | 94,052,154 | ||||||||
Common Stock, Shares Authorized | 150,000,000 | 150,000,000 | 150,000,000 | 50,000,000 | |||||
Common Stock, Par or Stated Value Per Share | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||
Preferred stock, shares authorized | 10,000,000 | 10,000,000 | |||||||
Preferred stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | |||||||
Temporary Equity, Shares Authorized | 10,000,000 | 44,052,154 | |||||||
Temporary Equity, Par or Stated Value Per Share | $ / shares | $ 0.0001 | $ 0.0001 | |||||||
Common stock issued | 24,722,974 | 24,410,393 | |||||||
IPO | |||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||
Number of shares issued | 9,984,463 | ||||||||
RA Capital Healthcare Fund, L.P | |||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||
Share price | $ / shares | $ 0.0012 | ||||||||
Conversion of stock shares issued | 14,182,854 | ||||||||
Common stock issued | 241,467 | ||||||||
Number of votes for each share of common stock | Vote | 1 | ||||||||
Series Seed Redeemable Convertible Preferred Stock | |||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||
Temporary Equity, Shares Authorized | 4,000,000 | ||||||||
Series Seed Redeemable Convertible Preferred Stock | RA Capital Healthcare Fund, L.P | |||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||
Temporary Equity, Shares Authorized | 4,000,000 | ||||||||
Temporary Equity, Par or Stated Value Per Share | $ / shares | $ 1 | ||||||||
Temporary equity shares issued .value | $ | $ 4 | ||||||||
Series A Redeemable Convertible Preferred Stock | |||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||
Temporary Equity, Shares Authorized | 40,052,154 | ||||||||
Temporary equity shares issued .value | $ | $ 6.6 | ||||||||
Temporary equity, shares issued | 3,468,536 | ||||||||
Shares issued, price per share | $ / shares | $ 1.893 | ||||||||
Temporary equity shares issued | 3,020,998 | ||||||||
Series A Redeemable Convertible Preferred Stock | Stock Purchase Agreement | |||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||
Temporary equity shares issued .value | $ | $ 63.5 | ||||||||
Temporary equity, shares issued | 33,562,620 | ||||||||
Share price | $ / shares | $ 1.893 | ||||||||
Series A Redeemable Convertible Preferred Stock | Stock Purchase Agreement | First Milestone | |||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||
Temporary equity shares issued .value | $ | $ 8 | ||||||||
Temporary equity, shares issued | 4,224,274 | ||||||||
Series A Redeemable Convertible Preferred Stock | Stock Purchase Agreement | Second and Third Milestone | |||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||||
Temporary equity shares issued .value | $ | $ 55.5 | ||||||||
Temporary equity, shares issued | 29,338,346 |
STOCKHOLDERS' EQUITY - SCHEDULE
STOCKHOLDERS' EQUITY - SCHEDULE OF COMMON STOCK SHARES RESERVED FOR ON AND AS-CONVERTED BASIS, FOR FUTURE ISSUANCE (Details) | Dec. 31, 2022 shares |
Subsidiary, Sale of Stock [Line Items] | |
Common stock reserved for future issuance | 5,432,788 |
2021 Plan | |
Subsidiary, Sale of Stock [Line Items] | |
Common stock reserved for future issuance | 1,077,557 |
Common Stock | |
Subsidiary, Sale of Stock [Line Items] | |
Common stock reserved for future issuance | 4,110,219 |
Restricted stock units | |
Subsidiary, Sale of Stock [Line Items] | |
Common stock reserved for future issuance | 28,881 |
ESPP | |
Subsidiary, Sale of Stock [Line Items] | |
Common stock reserved for future issuance | 216,131 |
SHARE-BASED COMPENSATION (Detai
SHARE-BASED COMPENSATION (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | |||
Jan. 01, 2023 | Jun. 30, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Jan. 01, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Restricted stock units award | 28,881 | ||||
Unrecognized stock based compensation | $ 17.2 | ||||
Unrecognized stock-based compensation weighted-average period | 2 years 8 months 12 days | ||||
2021 Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Percentage of outstanding common stock | 4% | ||||
Common stock available for issuance | 988,918 | 3,576,415 | 976,415 | ||
Common stock available for issuance, awards granted | 2,467,977 | ||||
Maximum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Expiration period | 10 years | ||||
Stock options | 2021 Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock available for issuance | 1,077,557 | ||||
Stock options | 2018 Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock available for issuance, awards granted | 1,642,242 | ||||
Stock options | 2021 Plan and 2018 Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Expiration period | 10 years | ||||
Stock options | Minimum | 2021 Plan and 2018 Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vested term | 3 years | ||||
Stock options | Maximum | 2021 Plan and 2018 Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vested term | 4 years | ||||
Restricted stock units | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized stock based compensation | $ 0.6 | ||||
Unrecognized stock-based compensation weighted-average period | 3 years 3 months 18 days | ||||
Restricted stock units | 2021 Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Restricted stock units award | 28,881 | ||||
Restricted stock units | Minimum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vested term | 1 year | ||||
Restricted stock units | Maximum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vested term | 4 years | ||||
ESPP | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock available for issuance | 230,000 | 216,131 | |||
Additional common stock available for issuance | 247,229 | ||||
Percentage of common stock purchase price | 15% | 1% | |||
Offering period | 6 months | ||||
Discount percentage on marker price | 85% | ||||
Shares issued | 13,869 |
SHARE-BASED COMPENSATION - SCHE
SHARE-BASED COMPENSATION - SCHEDULE OF OPTION ACTIVITY UNDER 2021 PLAN AND 2018 PLAN (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
SHARE-BASED COMPENSATION | ||
Options Outstanding, beginning balance | 3,454,374 | |
Weighted-Average Exercise Price Outstanding, beginning balance | $ 6.85 | |
Weighted- Average Remaining Contractual Term, Outstanding | 9 years 2 months 23 days | 9 years 5 months 1 day |
Aggregate Intrinsic Value Outstanding, beginning balance | $ 19,378 | |
Options Granted | 954,557 | |
Weighted-Average Exercise Price, Granted | $ 15.62 | |
Options Exercised | (298,712) | |
Weighted-Average Exercise Price, Exercised | $ 2.09 | |
Options Outstanding, ending balance | 4,110,219 | 3,454,374 |
Weighted-Average Exercise Price Outstanding, ending balance | $ 9.23 | $ 6.85 |
Aggregate Intrinsic Value Outstanding, ending balance | $ 82,490 | $ 19,378 |
Options, Vested and exercisable | 1,044,465 | |
Weighted-Average Exercise Price, Vested and exercisable | $ 7.58 | |
Weighted- Average Remaining Contractual Term, Vested and exercisable | 8 years 1 month 9 days | |
Aggregate Intrinsic Value, Vested and exercisable | $ 22,682 | |
Options, Vested and expected to vest | 4,110,219 | |
Weighted-Average Exercise Price, Vested and expected to vest | $ 9.23 | |
Weighted- Average Remaining Contractual Term, Vested and expected to vest | 8 years 5 months 15 days | |
Aggregate Intrinsic Value, Vested and expected to vest | $ 82,490 | |
weighted-average grant date fair value of stock option grants | $ 10.48 | $ 4.46 |
Unrecognized stock based compensation | $ 17,200 | |
Unrecognized stock-based compensation weighted-average period | 2 years 8 months 12 days |
SHARE-BASED COMPENSATION - SC_2
SHARE-BASED COMPENSATION - SCHEDULE OF UNVESTED RESTRICTED STOCK UNIT ACTIVITY (Details) | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of units, Granted | shares | 28,881 |
Weighted Average Grant date fair value, Granted | $ / shares | $ 21.62 |
Number of units, Ending | shares | 28,881 |
Weighted Average Grant date fair value, Ending | $ / shares | $ 21.62 |
SHARE-BASED COMPENSATION - SC_3
SHARE-BASED COMPENSATION - SCHEDULE OF FAIR VALUE OF STOCK OPTIONS ASSUMPTIONS (Details) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility, minimum | 73.50% | 68.70% |
Expected volatility, maximum | 76.50% | 69.80% |
Risk-free interest rate, minimum | 1.60% | 0.90% |
Risk-free interest rate, maximum | 4.30% | 1.40% |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 5 years 6 months | 5 years 2 months 12 days |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days |
SHARE-BASED COMPENSATION - SC_4
SHARE-BASED COMPENSATION - SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE RECOGNIZED FOR STOCK OPTION GRANTS (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total | $ 5,476 | $ 2,043 |
Research and Development Expense | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total | 2,129 | 370 |
General and Administrative Expense | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total | $ 3,347 | $ 1,673 |
SHARE-BASED COMPENSATION - SC_5
SHARE-BASED COMPENSATION - SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE BY TYPE OF AWARDS (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 5,476 | $ 2,043 |
Stock options | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | 5,316 | $ 2,043 |
Employee stock purchase plan awards | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | 98 | |
Restricted stock awards and units | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Stock-based compensation expense | $ 63 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - Service agreement with carnot LLC - USD ($) | 1 Months Ended | 12 Months Ended | ||
Jul. 31, 2019 | Aug. 31, 2018 | Dec. 31, 2022 | Dec. 31, 2021 | |
Related Party Transaction [Line Items] | ||||
Term of service agreement | 2 years | 2 years | ||
Termination notice period | 30 days | |||
Material breach correction period | 30 days | |||
Amount payable to related parties | $ 0 | $ 2,000 | ||
Research and development and general and administrative expenses | ||||
Related Party Transaction [Line Items] | ||||
Expenses from transactions with related party | $ 100,000 | |||
Research and development and general and administrative expenses | Maximum | ||||
Related Party Transaction [Line Items] | ||||
Expenses from transactions with related party | $ 100,000 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Operating Loss Carryforwards [Line Items] | ||
Deferred tax assets valuation allowance | $ 23,283 | $ 8,517 |
Domestic Tax Authority | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | 46,600 | 32,600 |
Domestic Tax Authority | Research Tax Credit Carryforward | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | 1,800 | |
State and Local Jurisdiction | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 34,400 | 20,300 |
State and Local Jurisdiction | Research Tax Credit Carryforward | ||
Operating Loss Carryforwards [Line Items] | ||
Operating loss carryforwards | $ 600 |
INCOME TAXES - SUMMARY OF COMPO
INCOME TAXES - SUMMARY OF COMPONENTS OF NET DEFERRED TAX ASSETS (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
INCOME TAXES | ||
NOL carryforwards | $ 11,781 | $ 7,498 |
Research credit carryforwards | 1,601 | 530 |
Capitalized R&D | 8,490 | |
Other | 1,713 | 615 |
Gross deferred tax assets | 23,585 | 8,643 |
Less: valuation allowance | (23,283) | (8,517) |
Total deferred tax assets | 302 | 126 |
Other | (302) | (126) |
Total deferred tax liabilities | $ (302) | (126) |
Net deferred tax assets (liabilities) |
INCOME TAXES - SUMMARY OF RECON
INCOME TAXES - SUMMARY OF RECONCILIATION OF FEDERAL INCOME TAX RATE (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
INCOME TAXES | ||
U.S. Federal statutory income tax rate | $ (10,829) | $ (4,821) |
State taxes | (2,828) | (520) |
Permanent and other differences | 563 | 3 |
Stock-based compensation | (787) | 115 |
Research and development credits | (757) | (392) |
Change in valuation allowance | 14,663 | 5,618 |
Total tax provision | $ 25 | $ 3 |
INCOME TAXES - SUMMARY OF GROSS
INCOME TAXES - SUMMARY OF GROSS UNRECOGNIZED TAX BENEFITS (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
INCOME TAXES | ||
Beginning balance of unrecognized tax benefits | $ 529 | $ 276 |
Additions based on tax positions related to the current year | 461 | 253 |
Additions based on tax positions related to the prior year | 3 | |
Ending balance of unrecognized tax benefits | $ 993 | $ 529 |