0001558370-22-003206 | 10-K | XBRL Viewer

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Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
CURRENT ASSETS:
Cash and cash equivalents	$ 53,888	$ 57,466
Investments	26,935	39,363
Prepaid expenses and other current assets	7,571	5,764
Total current assets	88,394	102,593
Operating lease right-of-use asset	1,298	1,712
Security deposits and leasehold improvements	200	201
TOTAL ASSETS	89,892	104,506
CURRENT LIABILITIES:
Current portion of operating lease liabilities	442	406
Accounts payable	9,461	640
Accrued expenses and other current liabilities	16,559	20,189
Total current liabilities	26,462	21,235
NONCURRENT LIABILITIES:
Noncurrent portion of operating lease liabilities	891	1,332
Total noncurrent liabilities	891	1,332
Total liabilities	27,353	22,567
STOCKHOLDERS' EQUITY:
Common stock, $0.0001 par value; 100,000,000 shares authorized as of December 31, 2021 and December 31, 2020; 26,215,514 shares and 22,493,661 shares issued and outstanding as of December 31, 2021 and December 31, 2020, respectively	3	2
Preferred stock, par value $0.0001; 10,000,000 shares authorized as of December 31, 2021 and December 31, 2020; 0 shares issued and outstanding as of December 31, 2021 and December 31, 2020
Additional paid-in capital	328,958	242,780
Accumulated other comprehensive loss	(107)	(112)
Accumulated deficit	(266,315)	(160,731)
Total stockholders' equity	62,539	81,939
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 89,892	$ 104,506

Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2021	Dec. 31, 2020
Balance Sheets
Common Stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common Stock, authorized (in shares)	100,000,000	100,000,000
Common Stock, issued (in shares)	26,215,514	22,493,661
Common stock, outstanding (in shares)	26,215,514	22,493,661
Preferred Stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred Stock, authorized (in shares)	10,000,000	10,000,000
Preferred Stock, issued (in shares)	0	0
Preferred Stock, outstanding (in shares)	0	0

Statements of Operations - USD ($) $ in Thousands	12 Months Ended
Statements of Operations - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
OPERATING EXPENSES:
Research and development	$ 62,570	$ 61,788
General and administrative	43,048	32,678
Total operating expenses	105,618	94,466
LOSS FROM OPERATIONS	(105,618)	(94,466)
OTHER INCOME (EXPENSE), NET:
Interest income (expense), net	555	559
Other income (expense)	(521)	(54)
Total other income (expense), net	34	505
Net loss	(105,584)	(93,961)
Net loss attributable to common stockholders-basic	(105,584)	(93,961)
Net loss attributable to common stockholders-diluted	$ (105,584)	$ (93,961)
Net loss per share attributable to common stockholders-basic	$ (4.12)	$ (4.28)
Net loss per share attributable to common stockholders-diluted	$ (4.12)	$ (4.28)
Weighted-average common stock outstanding-basic	25,598,181	21,966,326
Weighted-average common stock outstanding-diluted	25,598,181	21,966,326

Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Statements of Comprehensive Income (Loss)
Net Loss	$ (105,584)	$ (93,961)
Other comprehensive income (loss)
Unrealized gain (loss) on marketable securities	5	(110)
Other comprehensive gain (loss), net of tax	5	(110)
Comprehensive income (loss), net of tax	$ (105,579)	$ (94,071)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

Statement of Stockholders' Equity - USD ($) $ in Thousands	Common Stock Secondary Public Offering, 2020	Common Stock February Offering, 2021	Common Stock	Additional Paid-in Capital Secondary Public Offering, 2020	Additional Paid-in Capital February Offering, 2021	Additional Paid-in Capital Private Placement	Additional Paid-in Capital Shelf Registration Statement	Additional Paid-in Capital	Accumulated Deficit	Accumulated Other Comprehensive Income (Loss)	Secondary Public Offering, 2020	February Offering, 2021	Private Placement	Shelf Registration Statement	Total
Balance at Dec. 31, 2019			$ 1					$ 99,378	$ (66,770)	$ (2)					$ 32,607
Balance (in shares) at Dec. 31, 2019			18,531,560
Increase (Decrease) in Stockholders' Equity
Issuance of common stock	$ 1			$ 134,101							$ 134,102
Issuance of common stock (in shares)	3,152,712
Exercise of options for common stock issued under equity incentive plan								1,817							1,817
Exercise of options for common stock issued under equity incentive plan (in shares)			522,160
Issuance costs						$ (47)	$ (495)						$ (47)	$ (495)
Exercise of warrants of common stock (in shares)			287,229
Stock-based compensation expense								8,026							8,026
Net loss									(93,961)						(93,961)
Other comprehensive income (loss)										(110)					(110)
Balance at Dec. 31, 2020			$ 2					242,780	(160,731)	(112)					81,939
Balance (in shares) at Dec. 31, 2020			22,493,661
Increase (Decrease) in Stockholders' Equity
Issuance of common stock		$ 1			$ 74,421							$ 74,422
Issuance of common stock (in shares)		3,450,000
Exercise of options for common stock issued under equity incentive plan								511							$ 511
Exercise of options for common stock issued under equity incentive plan (in shares)			191,436												191,436
Restricted Stock Unit released for common stock issued under Equity Incentive Plan (in shares)			52,562
Exercise of warrants of common stock								69							$ 69
Exercise of warrants of common stock (in shares)			27,855
Stock-based compensation expense								11,177							11,177
Net loss									(105,584)						(105,584)
Other comprehensive income (loss)										5					5
Balance at Dec. 31, 2021			$ 3					$ 328,958	$ (266,315)	$ (107)					$ 62,539
Balance (in shares) at Dec. 31, 2021			26,215,514

Statement of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Increase (Decrease) in Stockholders' Equity
Common Stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Secondary Public Offering, 2020
Increase (Decrease) in Stockholders' Equity
Stock issuance cost		$ 739
February Offering, 2021
Increase (Decrease) in Stockholders' Equity
Stock issuance cost	$ 168
Common Stock
Increase (Decrease) in Stockholders' Equity
Common Stock, par value (in dollars per share)	$ 0.0001	$ 0.0001	$ 0.0001

Statements of Cash Flows - USD ($) $ in Thousands	12 Months Ended
Statements of Cash Flows - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
OPERATING ACTIVITIES:
Net loss	$ (105,584)	$ (93,961)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	11,177	8,026
Amortization of operating lease right-of-use assets	415	380
Payment of security deposit and leasehold improvements for long-term lease		(2)
Change in operating lease liability	(404)	(358)
Changes in operating assets and liabilities:
Financed insurance premium	(4,435)	(3,222)
Prepaid expenses	(1,654)	2,207
Accounts payable	8,821	(8,044)
Accrued expenses and other current liabilities	(3,346)	14,213
Amortization of insurance premium	4,282	2,552
Net cash used in operating activities	(90,728)	(78,209)
INVESTING ACTIVITIES:
Purchase of available-for-sale securities	(121,589)	(134,659)
Proceeds from sale of available-for-sale securities	5,538	17,109
Proceeds from maturities of available-for-sale securities	128,484	98,081
Net cash provided by/(used in) investing activities	12,433	(19,469)
FINANCING ACTIVITIES:
Proceeds from financed insurance premium	4,434	3,222
Repayments of short-term borrowings	(4,718)	(2,148)
Exercise of stock options for common stock under Equity Incentive Plan	511	1,817
Exercise of Warrants	69
Net cash provided by financing activities	74,717	136,294
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	(3,578)	38,616
Cash and cash equivalents at beginning of period	57,466	18,850
Cash and cash equivalents at end of period	53,888	57,466
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Operating lease right-of-use asset obtained in exchange for operating lease liability		57
Unrealized gain (loss) on marketable securities	5	(110)
Secondary Public Offering, 2020
FINANCING ACTIVITIES:
Proceeds from stock issuance, net of cash issuance costs		134,102
February Offering, 2021
FINANCING ACTIVITIES:
Proceeds from stock issuance, net of cash issuance costs	$ 74,421
Private Placement
FINANCING ACTIVITIES:
Payment of offering costs		(206)
Shelf Registration Statement
FINANCING ACTIVITIES:
Payment of offering costs		(493)
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Stock issuance costs in accrued expenses		$ 2

Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Secondary Public Offering, 2020
Cash issuance costs		$ 739
February Offering, 2021
Cash issuance costs	$ 169

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

12 Months Ended

Dec. 31, 2021

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Operations and Business

Applied Therapeutics, Inc. (the “Company”) is a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates against validated molecular targets in indications of high unmet medical need. In particular, the Company is currently targeting treatments for CNS rare diseases and diabetic complications. The Company was incorporated in Delaware on January 20, 2016 and is headquartered in New York, New York.

On January 28, 2020, the Company completed its secondary public offering (the “Secondary Public Offering”), pursuant to which it issued and sold 2,741,489 shares of common stock at a public offering price of $45.50 per share, with an additional 411,223 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares. The aggregate net proceeds received by the Company from the offering, after deducting underwriting discounts and commissions and offering costs, were $134.1 million.

On June 4, 2020, the Company filed a shelf registration statement on Form S-3 (the “Shelf Registration Statement”) under which the Company may, from time to time, sell securities in one or more offerings having an aggregate offering price of up to $300.0 million. The Shelf Registration Statement was declared effective as of June 15, 2020. As of the filing date of this Annual Report, the Company has sold 3,450,000 shares of common stock under the Shelf Registration.

On June 12, 2020, the Company entered into an equity distribution agreement (the “Goldman Equity Distribution Agreement”) with Goldman Sachs & Co. LLC (“Goldman”), as a sales agent to sell shares of the Company’s common stock, from time to time, having an aggregate offering price of up to $100 million. Goldman may act as an agent on the Company’s behalf or purchase shares of the Company’s common stock as a principal. As of December 31, 2021, the Company had not sold any shares of common stock pursuant to the Goldman Equity Distribution Agreement. This agreement has since been terminated as of January 24, 2022.

On February 17, 2021, the Company completed an underwritten public offering (the “February Offering”) of 3,450,000 shares of common stock, including the exercise in full of the underwriters’ option to purchase 450,000 additional shares of common stock, which option closed on February 19, 2021. The shares were offered at a price to the public of $23.00 per share, resulting in aggregate net proceeds of approximately $74.4 million, after deducting underwriting discounts and commissions and offering expenses.

Liquidity and Going Concern

The Company has incurred, and expects to continue to incur, significant operating losses for the foreseeable future as it continues to develop its drug candidates. To date, the Company has not generated any revenue, and it does not expect to generate revenue unless and until it successfully completes development and obtains regulatory approval for one of its product candidates.

Under ASC Topic 205-40, Presentation of Financial Statements - Going Concern, management is required at each reporting period to evaluate whether there are conditions and events, considered in the aggregate, that raise substantial doubt about an entity's ability to continue as a going concern within one year after the date that the financial statements are issued. We are actively pursuing several potential financing options. While we continue to explore opportunities to raise additional equity capital in the public markets, this has proven to be challenging in the biotech sector recently. Other options for structured finance which we continue to explore include a PIPE, debt, convertible debt, and synthetic royalty financing. Synthetic royalty financing, in particular, has become a favorable option for many companies for funding ongoing clinical development in late-stage and pre-approval programs. We have engaged an investment bank and we are specifically exploring this option in the near term. Additionally, we are in active dialogue with several potential partners regarding business development opportunities related to one or more of our programs.

There can be no assurances that our discussions with any of the current counterparties will be successful, and the Company expects to continue to pursue additional opportunities.

As reflected in the accompanying financial statements, the Company has a net loss of $105.6 million year ended December 31, 2021 and has an accumulated deficit of $266.3 million as of December 31, 2021. The accompanying financial statements have been prepared assuming the continuation of the Company as a going concern. The Company has not yet established an ongoing source of revenues sufficient to cover its operating costs and is dependent on debt and equity financing to fund its operations. The report of our independent registered public accounting firm on our financial statements for the year ended December 31, 2021 includes an explanatory paragraph regarding the existence of substantial doubt about our ability to continue as a going concern. While we believe that our cash and cash equivalents and investments of $80.8 million at December 31, 2021 will be sufficient to fund our operations through year end 2022, given our planned expenditures for the next several years, we have concluded and our independent registered public accounting firm has agreed with our conclusion that there is still a substantial doubt regarding our ability to continue as a going concern.

Risks and Uncertainties

The Company is subject to risks common to companies in the biotechnology industry, including but not limited to, risks of failure of preclinical studies and clinical trials, the need to obtain marketing approval for any product candidate that it may identify and develop, the need to successfully commercialize and gain market acceptance of its product candidates, dependence on key personnel, protection of proprietary technology, compliance with government regulations, development by competitors of technological innovations and reliance on third party manufacturers.

Use of Estimates

The preparation of 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 disclosure of contingent assets and liabilities and the Company's ability to continue as a going concern as of the date of the financial statements and the reported amounts of expenses during the reporting period. In preparing the financial statements, management used estimates in the following areas, among others: prepaid and accrued expenses; stock-based compensation expense; and the evaluation of the existence of conditions and events that raise substantial doubt regarding the Company’s ability to continue as a going concern. Actual results could differ from those estimates.

Significant Accounting Policies

Fair Value Measurements

Certain assets and liabilities are reported on a recurring basis at fair value. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:

Level 1—Quoted prices in active markets for identical assets or liabilities.

Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.

Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

Cash and Cash Equivalents

The Company considers all short-term, highly liquid investments, with an original maturity of three months or less, to be cash equivalents. The Company maintains its cash in bank deposit accounts which, at times, may exceed federally insured limits. The Company has not experienced any losses in these accounts and does not believe it is exposed to any significant credit risk on cash and cash equivalents.

Investments

The Company has investments in marketable debt securities. The Company determines the appropriate classification of its investments at the date of purchase and reevaluates the classifications at the balance sheet date. Marketable debt securities with maturities of 12 months or less are classified as short-term. Marketable debt securities with maturities greater than 12 months are classified as long-term. The Company’s marketable securities are accounted for as available for sale (“AFS”). AFS securities are reported at fair value. Unrealized gains and losses, after applicable income taxes, are reported in accumulated other comprehensive income/(loss). Realized gains or losses on the sale of marketable securities are determined using the specific identification method and are recorded as a component of other income (expense), net.

The Company conducts an other-than-temporary impairment (“OTTI”) analysis on a quarterly basis or more often if a potential loss-triggering event occurs. The Company considers factors such as the duration, severity and the reason for the decline in value, the potential recovery period and whether the Company intends to sell. For AFS securities, the Company also considers whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis and (ii) the amortized cost basis cannot be recovered as a result of credit losses.

The Company adopted ASU No. 2016-13, “Financial Instruments–Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” on January 1, 2020 and applied the new modified credit impairment guidance related to available-for-sale debt securities prospectively. Under the new guidance, at each reporting date, entities must evaluate their individual available-for-sale debt securities that are in an unrealized loss position and determine whether the decline in fair value below the amortized cost basis from a credit loss or other factors. The amount of the decline related to credit losses is recorded as a credit loss expense in earnings with a corresponding allowance for credit losses and the amount of decline not related to credit losses are recorded through other comprehensive income, net of tax. Credit losses are measured in a manner similar to current generally accepted accounting standards; however, ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, will require that credit losses be presented as an allowance rather than as a write-down.

Leases

At the inception of an arrangement, the Company determines if an arrangement is, or contains, a lease based on the unique facts and circumstances present in that arrangement. Lease classification, recognition, and measurement are then determined at the lease commencement date. For arrangements that contain a lease the Company (i) identifies lease and non-lease components, (ii) determines the consideration in the contract, (iii) determines whether the lease is an operating or financing lease; and (iv) recognizes lease right-of-use (“ROU”) assets and liabilities. Lease liabilities and their corresponding ROU assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable and as such, the Company uses its incremental borrowing rate based on the information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment.

Most leases include options to renew and, or, terminate the lease, which can impact the lease term. The exercise of these options is at the Company’s discretion and the Company does not include any of these options within the expected lease term as the Company is not reasonably certain it will exercise these options. The Company has elected to combine

lease components (for example fixed payments including rent) with non-lease components (for example, non-dedicated parking and common-area maintenance costs) on our real estate asset classes.

Fixed, or in substance fixed, lease payments on operating leases are recognized over the expected term of the lease on a straight-line basis. Fixed lease expense on operating leases is recognized within operating expenses within the statements of operations. The Company has operating leases for our corporate offices. The Company has elected the short-term lease exemption and, therefore, do not recognize a ROU asset or corresponding liability for lease arrangements with an original term of 12 months or less. Leasehold improvements and assets under financing lease arrangements are amortized over the lesser of the asset’s estimated useful life or the term of the respective lease. Maintenance costs are expensed as incurred.

Operating leases are included in operating lease right-of-use asset, current portion of operating lease liabilities, and noncurrent portion of operating lease liabilities in the balance sheet as of December 31, 2021 and 2020.

Deferred Offering Costs

The Company capitalizes certain legal, professional accounting and other third party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in the statement of stockholders’ (deficit) equity as a reduction of proceeds generated as a result of the offering. Should a planned equity financing be abandoned, the deferred offering costs would be expensed immediately as a charge to operating expenses in the statement of operations.

As of December 31, 2021 and 2020, the Company did not have any deferred offering costs recorded in prepaid and other current assets.

Research and Development

The Company expenses all costs incurred in performing research and development activities. Research and development expenses include salaries and other related costs, materials and supplies, preclinical expenses, manufacturing expenses, contract services and other outside expenses. As part of the process of preparing the financial statements, the Company is required to estimate their accrued research and development expenses. The Company makes estimates of the accrued expenses as of each balance sheet date in the financial statements based on facts and circumstances known at that time. In addition, there may be instances in which payments made to the Company’s vendors will exceed the level of services provided and result in a prepayment of the expense in which case such amounts are reflected as prepaid expenses and other current assets. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company adjusts the accrual or the amount of prepaid expenses accordingly. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized in prepaid expenses and other current assets. The capitalized amounts are expensed as the related goods are delivered or the services are performed.

Research and development costs also include costs incurred in connection with certain licensing arrangements. Before a compound receives regulatory approval, the Company records upfront and milestone payments made to third parties under licensing arrangements as expense. Upfront payments are recorded when incurred, and milestone payments are recorded when the specific milestone has been achieved. Once a compound receives regulatory approval, the Company will record any milestone payments in identifiable intangible assets, less accumulated amortization and, unless the asset is determined to have an indefinite life, the Company will amortize the payments on a straight-line basis over the remaining agreement term or the expected product life cycle, whichever is shorter.

General and Administrative

General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in the Company’s executive and finance functions. General and administrative expenses also include professional fees for legal, accounting, auditing, tax and consulting services; travel expenses; and facility-related expenses, which include allocated expenses for rent and maintenance of facilities and other operating costs.

Commercial expenses consist of payroll expense for commercial personnel, as well as marketing, market research, market access, and other focused investments to support launch of drug candidates, generate evidence of commercial potential and value proposition, and maximize potential business development deal leverage. Commercial expenses are included in general and administrative expenses.

Stock-Based Compensation

The Company accounts for its stock-based compensation as expense in the statements of operations based on the awards’ grant date fair values. The Company accounts for forfeitures as they occur by reversing any expense recognized for unvested awards.

The Company estimates the fair value of options granted using the Black-Scholes option pricing model. The Black-Scholes option pricing model requires inputs based on certain subjective assumptions, including (a) the expected stock price volatility, (b) the calculation of expected term of the award, (c) the risk-free interest rate and (d) expected dividends. Due to the lack of a public market for the Company’s common stock and a lack of company-specific historical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The historical volatility is calculated based on a period of time commensurate with the expected term assumption. The computation of expected volatility is based on the historical volatility of a representative group of companies with similar characteristics to the Company, including stage of product development and life science industry focus. The Company uses the simplified method as allowed by the Securities and Exchange Commission (“SEC”) Staff Accounting Bulletin (“SAB”) No. 107, Share-Based Payment, to calculate the expected term for options granted to employees as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected term of the stock options. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock.

The fair value of stock-based payments is recognized as expense over the requisite service period which is generally the vesting period.

Stock-Based Compensation–Restricted Stock Units

The Company accounts for restricted stock units in accordance with the authoritative guidance for stock-based compensation. The fair value of restricted stock units is measured at the grant date based on the closing market price of the Company’s common stock on the date of grant, and is recognized as expense on a straight-line basis over the period of vesting. Forfeitures are recognized as a reduction of stock-based compensation expense as they occur.

Income Taxes

The Company uses the asset and liability method of accounting for deferred income taxes. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities at currently enacted tax rates. These temporary differences primarily relate to net operating loss carryforwards available to offset future taxable income. Valuation allowances are established, if necessary, to reduce a deferred tax asset to the amount that will more likely than not be realized.

The Company recognizes tax liabilities from an uncertain tax position only if it is more likely than not that the tax position will not be sustained upon examination by the taxing authorities, based on the technical merits of the tax position. There are no uncertain tax positions that have been recognized in the accompanying financial statements. The Company is required to file tax returns in the U.S. federal jurisdiction and in the states of New York, California, Massachusetts, New Jersey, and New York City. The Company’s policy is to recognize interest and penalties related to uncertain tax benefits, if any, as part of income tax expense. No such interest and penalties have been accrued as of December 31, 2021 and 2020.

In December 2019, the FASB issued ASU 2019-12, Income Taxes: Simplifying the Accounting for Income Taxes. The new standard intended to simplify the accounting for income taxes by eliminating certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The new guidance also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill. The standard is effective for annual periods beginning after December 15, 2020 and interim periods within, with early adoption permitted. Adoption of the standard requires certain changes to primarily be made prospectively, with some changes to be made retrospectively. The Company adopted the amendment on January 1, 2021, with no impact to the financial statements.

Net Loss per Share

Basic net loss per share is calculated by dividing net loss available to common stockholders by the weighted-average common stock outstanding. Diluted net loss per share is calculated similarly, except that it includes the dilutive effect of the assumed exercise of securities, including outstanding warrants and the effect of shares issuable under the Company’s stock-based compensation plan, if such effect is dilutive.

Segment Information

Operating segments are defined as components of an enterprise for which separate discrete information is available for evaluation by the chief operating decision-maker in deciding how to allocate resources and assess performance. The Company and the Company’s chief operating decision-maker, the Company’s chief executive officer, views the Company’s operations and manages its business as a single operating segment, which is the business of discovering and developing its product candidates.

Recent Accounting Pronouncements

Any recent pronouncements issued by the FASB or other authoritative standards groups with future effective dates are either not applicable or are not expected to be significant to the financial statements of the Company.

LICENSE AGREEMENT

12 Months Ended

Dec. 31, 2021

LICENSE AGREEMENT

LICENSE AGREEMENT

2. LICENSE AGREEMENT

Columbia University

In October 2016, the Company entered into a license agreement (the “ 2016 Columbia Agreement”) with the Trustees of Columbia University (“Columbia University”) to obtain an exclusive royalty-bearing sublicensable license in respect to certain patents. As part of the consideration for entering into the 2016 Columbia Agreement, the Company issued to Columbia University shares equal to 5% of its outstanding common stock on a fully diluted basis at the time of issue. The common stock had a fair value of $0.5 million at the time of issuance. The Company will be required to make further payments to Columbia University of up to an aggregate of $1.3 million for the achievement of specified development and regulatory milestones, and up to an aggregate of $1.0 million for the achievement of a specified level of aggregate annual net sales, in each case in connection with products covered by the 2016 Columbia Agreement. The Company will also be required to pay tiered royalties to Columbia University in the low- to mid-single digit percentages

on the Company’s, its affiliates’ and its sublicensees’ net sales of licensed products, subject to specified offsets and reductions. In addition, the Company is required to make specified annual minimum royalty payments to Columbia University, which is contingent upon the approval of the licensed products, in the mid six figures beginning on the 10th anniversary of the effective date of the 2016 Columbia Agreement. The Company has not granted any sublicenses under the 2016 Columbia Agreement. However, if the Company sublicenses the rights granted under the 2016 Columbia Agreement to one or more third parties, it will be required to pay Columbia University a portion of the net sublicensing revenue received from such third parties, at percentages between 10% and 20%, depending on the stage of development at the time such revenue is received from such third parties.

The 2016 Columbia Agreement will terminate upon the expiration of all the Company’s royalty payment obligations in all countries. The Company may terminate the 2016 Columbia Agreement for convenience upon 90 days’ written notice to Columbia University. At its election, Columbia University may terminate the 2016 Columbia Agreement, or convert the licenses granted to the Company into non-exclusive, non-sublicensable licenses, in the case of (a) the Company’s uncured material breach upon 30 days’ written notice (which shall be extended to 90 days if the Company is diligently attempting to cure such material breach), (b) the Company’s failure to achieve the specified development and funding milestone events, or (c) the Company’s insolvency.

In January 2019, the Company entered into a second license agreement with Columbia University (the “2019 Columbia Agreement”). Pursuant to the 2019 Columbia Agreement, Columbia University granted the Company a royalty-bearing, sublicensable license that is exclusive with respect to certain patents, and non-exclusive with respect to certain know-how, in each case to develop, manufacture and commercialize PI3k inhibitor products. The license grant is worldwide. Under the 2019 Columbia Agreement, the Company is obligated to use commercially reasonable efforts to research, discover, develop and market licensed products for commercial sale in the licensed territory, and to comply with certain obligations to meet specified development and funding milestones within defined time periods. Columbia University retains the right to conduct, and grant third parties the right to conduct, non-clinical academic research using the licensed technology; provided that such research is not funded by a commercial entity or for-profit entity or results in rights granted to a commercial or for-profit entity. As consideration for entering into the 2019 Columbia Agreement, the Company made a nominal upfront payment to Columbia University. The Company will be required to make further payments to Columbia University of up to an aggregate of $1.3 million for the achievement of specified development and regulatory milestones, and up to an aggregate of $1.0 million for the achievement of a specified level of aggregate annual net sales, in each case in connection with products covered by the 2019 Columbia Agreement. The Company will also be required to pay tiered royalties to Columbia University in the low- to mid-single digit percentages on the Company’s, its affiliates’ and its sublicensees’ net sales of licensed products, subject to specified offsets and reductions. In addition, the Company is required to make specified annual minimum royalty payments to Columbia University, which is contingent upon the approval of the licensed products, in the mid-six figures beginning on the tenth anniversary of the effective date of the 2019 Columbia Agreement.

The Company has not granted any sublicenses under the 2019 Columbia Agreement. However, if the Company sublicenses the rights granted under the 2019 Columbia Agreement to one or more third parties, it will be required to pay Columbia University a portion of the net sublicensing revenue received from such third parties, at percentages between 10% and 50%, depending on the stage of development at the time such revenue is received from such third parties. The 2019 Columbia Agreement will terminate upon the expiration of all the Company’s royalty payment obligations in all countries. The Company may terminate the 2019 Columbia Agreement for convenience upon 90 days’ written notice to Columbia University. At its election, Columbia University may terminate the 2019 Columbia Agreement, or convert the licenses granted to the Company into non-exclusive, non-sublicensable licenses, in the case of (a) the Company’s uncured material breach upon 30 days’ written notice (which shall be extended to 90 days if the Company is diligently attempting to cure such material breach), (b) the Company’s failure to achieve the specified development and funding milestone events, or (c) the Company’s insolvency.

In March 2019, and in connection with the 2016 Columbia Agreement, the Company entered into a research services agreement (the “2019 Columbia Research Agreement”) with Columbia University with the purpose of analyzing structural and functional changes in brain tissue in an animal model of Galactosemia, and the effects of certain compounds whose intellectual property rights were licensed to the Company as part of the 2016 Columbia Agreement on

any such structural and functional changes. The 2019 Columbia Research Agreement had a term of 12 months from its effective date and expired in accordance with its terms.

On October 3, 2019, and in connection with the 2019 Columbia Agreement, the Company entered into a research services agreement (the “PI3k Columbia Research Agreement” and collectively with the 2016 Columbia Agreement, 2019 Columbia Agreement and 2019 Columbia Research Agreement, the “Columbia Agreements”) with Columbia University with the purpose of analyzing PI3k inhibitors for the treatment of lymphoid malignancies. The PI3k Columbia Research Agreement had a term of 18 months from its effective date and expired in accordance with its term.

During the years ended December 31, 2021 and 2020, the Company recorded $0 and $0.3 million in research and development expense, respectively, and $0.2 million and $0.1 million, respectively, in general and administrative expense related to the Columbia Agreements. In aggregate, the Company has incurred $2.5 million in expense from the execution of the Columbia Agreements through December 31, 2021.

As of December 31, 2021, the Company had $12,000 due to Columbia University included in accrued expenses and $0.1 million included in accounts payable. As of December 31, 2020, the Company had $0.1 million due to Columbia University included in accrued expenses and $0 included in accounts payable.

University of Miami

2020 Miami License Agreement

On October 28, 2020, the Company entered into a license agreement with the University of Miami (the “2020 Miami License Agreement”) relating to certain technology that is co-owned by the University of Miami (UM), the University of Rochester (UR) and University College London (UCL). UM was granted an exclusive agency from UR and UCL to license each of their rights in the technology. Pursuant to the 2020 Miami License Agreement, UM, on behalf of itself and UR and UCL, granted us a royalty-bearing, sublicensable license that is exclusive with respect to certain patent applications and patents that may grant from the applications, and non-exclusive with respect to certain know-how, in each case to research, develop, make, have made, use, sell and import products for use in treating and/or detecting certain inherited neuropathies, in particular those caused by mutation in the sorbitol dehydrogenase (SORD) gene. The license grant is worldwide. Under the 2020 Miami License Agreement, the Company is obligated to use commercially reasonable efforts to develop, manufacture, market and sell licensed products in the licensed territory, and to comply with certain obligations to meet specified development milestones within defined time periods. UM retains for itself UR and UCL the right to use the licensed patent rights and licensed technology for their internal non-commercial educational, research and clinical patient care purposes, including in sponsored research and collaboration with commercial entities. As the technology licensed to us under the 2020 Miami License Agreement was developed as a result of a U.S. government grant, the licenses granted to us under the agreement are subject to the terms of such grant, and to standard rights of the U.S. government under the Bayh-Dole Act, including the grant to the government of a non-exclusive, worldwide, freedom to operate license under any patents, and the requirement, absent a waiver, to manufacture products substantially in the United States.

Under the terms of the 2020 Miami License Agreement, the Company was obligated to pay UM an up-front non-refundable license fee of $1.1 million, and a second non-refundable license fee of $0.5 million due on the first anniversary of the date of the license. The Company will be required to make further payments to UM of up to an aggregate $2.2 million for the achievement of specified patenting and development milestones, and up to an aggregate of $4.1 million for achievement of late stage regulatory milestones. The Company will also be required to pay royalties ranging from 0.88% - 5% on the Company’s, the Company’s affiliates’ and the Company’s sublicensees’ net sales of licensed products. If the Company sublicenses the rights granted under the 2020 Miami License Agreement to one or more third parties, the Company will be required to pay to UM a portion of the non-royalty sublicensing revenue received from such third parties ranging from 15% – 25%.

The 2020 Miami License Agreement terminates upon the expiration of all issued patents and filed patent applications or 10 years after the first commercial sale of the last product or process for which a royalty is due, unless earlier terminated. In addition, the 2020 Miami License Agreement may be terminated by the Company at any time upon

60 days prior written notice to UM, and may be terminated by either the Company or UM upon material breach of an obligation if action to cure the breach is not initiated within 60 days of receipt of written notice.

The Company recorded $0.3 million and $0 in research and development expense and general and administrative expense, respectively, during the year-ended December 31, 2021. As of December 31, 2021, the Company had $0.3 million in accrued expenses.

The Company recorded $2.0 million and $36,000 in research and development expense and general and administrative expense, respectively, during the year-ended December 31, 2020. As of December 31, 2020, the Company had $1.6 million in accrued expenses.

2020 Miami Option Agreement

On October 28, 2020, the Company entered into an option agreement with the University of Miami (the “2020 Miami Option Agreement”) concerning certain research activities and technology relating to SORD neuropathy that may be pursued and developed by UM. Under the 2020 Miami Option Agreement, if UM conducts such research activities, then UM is obligated to grant us certain option rights to access and use the research results and to obtain licenses to any associated patent rights upon us making specified payments to UM within specified time limits. If the Company elects to obtain option rights the Company will be required to make payments to UM in the low-six figures to the low-seven figures, depending upon the rights the Company elects to obtain, and the Company will be obligated to make certain milestone payments in the high-six figures to mid-seven figures if UM conducts and completes certain research activities within specified time periods and the Company elects to receive rights to use the results of that research.

2020 Miami Sponsored Research Agreement

On December 14, 2020, the Company entered into a research agreement with the University of Miami (the “2020 Miami Research Agreement”), under which the University of Miami will conduct a research study relating to SORD neuropathy and deliver a final report on the study to the Company. The term of the research agreement was from December 14, 2020 through December 30, 2021. The consideration for the 2020 Miami Research Agreement was $0.3 million.

During the years ended December 31, 2021 and 2020, the Company recorded $0.2 million and $3,740 in research and development expenses, respectively, in relation to the 2020 Miami Research Agreement. As of December 31, 2021 and 2020, the Company had $0.2 million and $3,740, respectively, in accrued expenses.

FAIR VALUE MEASUREMENTS

12 Months Ended

Dec. 31, 2021

FAIR VALUE MEASUREMENTS

FAIR VALUE MEASUREMENTS

3. FAIR VALUE MEASUREMENTS

The following tables summarize, as of December 31, 2021 and 2020, the Company's financial assets and liabilities that are measured at fair value on a recurring basis, according to the fair value hierarchy described in the significant accounting policies section.


	As of December 31, 2021
(in thousands)	Level 1		Level 2		Level 3		Total
Cash	$	12,671	$	—	$	—	$	12,671
Money market funds		41,217		—		—		41,217
Total cash and cash equivalents	$	53,888	$	—	$	—	$	53,888
U.S. government agency debt securities		—		26,935		—		26,935
Total marketable securities	$	—	$	26,935	$	—	$	26,935
Total financial assets measured at fair value on a recurring basis	$	53,888	$	26,935	$	—	$	80,823


	As of December 31, 2020
(in thousands)	Level 1		Level 2		Level 3		Total
Cash	$	6,691	$	—	$	—	$	6,691
Money market funds		50,775		—		—		50,775
Total cash and cash equivalents	$	57,466	$	—	$	—	$	57,466
U.S. government agency debt securities		—		39,363		—		39,363
Total marketable securities	$	—	$	39,363	$	—	$	39,363
Total financial assets measured at fair value on a recurring basis	$	57,466	$	39,363	$	—	$	96,829

Investments in certificate of deposits, corporate bonds, and U.S. government agency debt securities have been classified as Level 2 as they are valued using quoted prices in less active markets or other directly or indirectly observable inputs. Fair values of corporate bonds and U.S. government agency debt securities were derived from a consensus or weighted average price based on input of market prices from multiple sources at each reporting period. With regard to commercial paper, all of the securities had high credit ratings and one year or less to maturity; therefore, fair value was derived from accretion of purchase price to face value over the term of maturity or quoted market prices for similar instruments if available. During the period ended December 31, 2021 and 2020, there were no transfers of financial assets between Level 1 and Level 2.

INVESTMENTS

12 Months Ended

Dec. 31, 2021

INVESTMENTS

INVESTMENTS

4. INVESTMENTS

Marketable Securities

Marketable securities, which the Company classifies as available-for-sale securities, primarily consist of high quality commercial paper, corporate bonds, and U.S. government debt obligations. Marketable securities with remaining effective maturities of twelve months or less from the balance sheet date are classified as short-term; otherwise, they are classified as long-term on the balance sheets.

The following tables provide the Company’s marketable securities by security type (in thousands):


	As of December 31, 2021								As of December 31, 2020
			Gross		Gross						Gross		Gross
			Unrealized		Unrealized		Estimated				Unrealized		Unrealized		Estimated
(in thousands)	Cost		Gains		Losses		Fair Value		Cost		Gains		Losses		Fair Value
US government agency debt security	$	27,042	$	1	$	(108)	$	26,935	$	39,475	$	11	$	(123)	$	39,363
Total	$	27,042	$	1	$	(108)	$	26,935	$	39,475	$	11	$	(123)	$	39,363

The Company adopted ASU No. 2016-13, “Financial Instruments–Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” on January 1, 2020 and applied the new modified credit impairment guidance related to available-for-sale debt securities prospectively. Under the new guidance, at each reporting date, entities must evaluate their individual available-for-sale debt securities that are in an unrealized loss position and determine whether the decline in fair value below the amortized cost basis is from a credit loss or other factors. The amount of the decline related to credit losses is recorded as a credit loss expense in earnings with a corresponding allowance for credit losses and the amount of decline not related to credit losses is recorded through other comprehensive income, net of tax. As of December 31, 2021, our investment portfolio reported an unrealized loss of $0.1 million. Based on our evaluations, the Company determined that a credit loss allowance is not required since the decline was not related to underlying credit issues of the counterparties. The counterparties to these investments have high credit quality with investment grade

ratings of at least AA₊ as of December 31, 2021, along with a history of no defaults. No single investment in the corporate portfolio had an individually material unrealized loss. The total amount of unrealized losses of $0.1 million as of December 31, 2021 was only 0.39% of the total amortized costs basis of the investment portfolio. In addition, the Company does not intend to sell these investments and it is not more likely than not that the Company will be required to sell these investments before recovery of their amortized cost bases. Accordingly, based on the foregoing evaluation, the Company did not record any credit losses during the year ended December 31, 2021 and the entire amount of the decline in fair value below the amortized cost basis was recorded as an unrealized loss, net of tax, in other comprehensive loss in the Statements of Comprehensive Loss. Unrealized gains are also reflected, net of tax, as other comprehensive income (loss) in the Statements of Comprehensive Loss.

Contractual maturities of the Company’s marketable securities are summarized as follows (in thousands):


	As of December 31, 2021								As of December 31, 2020
			Gross		Gross						Gross		Gross
			Unrealized		Unrealized		Estimated				Unrealized		Unrealized		Estimated
(in thousands)	Cost		Gains		Losses		Fair Value		Cost		Gains		Losses		Fair Value
Due in one year or less	$	27,042	$	1	$	(108)	$	26,935	$	39,475	$	11	$	(123)	$	39,363
Due in one through two years		—		—		—		—		—		—		—		—
Total	$	27,042	$	1	$	(108)	$	26,935	$	39,475	$	11	$	(123)	$	39,363

At December 31, 2021, the Company had $1,000 of gross unrealized gains and $0.1 million of gross unrealized losses primarily due to fluctuations in the fair value of certain U.S. government agency debt securities.

During the year ended December 31, 2021, the Company recorded gross realized losses of $0.5 million and gross realized gains of $0 from the sale of marketable securities.

The unrealized losses and fair values of available-for-sale securities that have been in an unrealized loss position for a period of less than and greater than 12 months as of December 31, 2021 are as follows:


	As of December 31, 2021
	Securities in an unrealized loss position less than 12 months				Securities in an unrealized loss position greater than 12 months				Total
	Unrealized		Estimated		Unrealized		Estimated		Unrealized		Estimated
(in thousands)	Losses		Fair Value		Losses		Fair Value		Losses		Fair Value
US government agency debt security	$	(108)	$	17,696	$	—	$	—	$	(108)	$	17,696
Total	$	(108)	$	17,696	$	—	$	—	$	(108)	$	17,696


	As of December 31, 2020
	Securities in an unrealized loss position less than 12 months				Securities in an unrealized loss position greater than 12 months				Total
	Unrealized		Estimated		Unrealized		Estimated		Unrealized		Estimated
(in thousands)	Losses		Fair Value		Losses		Fair Value		Losses		Fair Value
US government agency debt security	$	(123)	$	14,073	$	—	$	—	$	(123)	$	14,073
Total	$	(123)	$	14,073	$	—	$	—	$	(123)	$	14,073

PREPAID EXPENSES AND OTHER CURRENT ASSETS

12 Months Ended

Dec. 31, 2021

PREPAID EXPENSES AND OTHER CURRENT ASSETS

PREPAID EXPENSES AND OTHER CURRENT ASSETS

5. PREPAID EXPENSE AND OTHER CURRENT ASSETS

Prepaid expenses and other current assets consisted of the following (in thousands):


	December 31,		December 31,
(in thousands)	2021		2020
Prepaid research and development expenses	$	4,483	$	2,349
Insurance premium asset		1,616		1,463
Prepaid rent expenses		117		108
Prepaid insurance expenses		105		91
Prepaid commercial and patient advocacy		254		968
Research and development tax credit receivable		502		500
Interest receivable		23		5
Other prepaid expenses and current assets		471		280
Total prepaid expenses & other current assets	$	7,571	$	5,764

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

12 Months Ended

Dec. 31, 2021

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

6. ACCRUED EXPENSE AND OTHER CURRENT LIABILITIES

Accrued expenses and other current liabilities consisted of the following (in thousands):


	December 31,		December 31,
(in thousands)	2021		2020
Accrued pre-clinical and clinical expenses	$	9,912	$	13,742
Short-term insurance financing note		789		1,074
Accrued professional fees		419		511
Accrued compensation and benefits		2,779		2,103
Accrued commercial expenses		1,394		502
Accrued patent expenses		279		1,704
Other		987		553
Total accrued expenses & other current liabilities	$	16,559	$	20,189

STOCK BASED COMPENSATION

12 Months Ended

Dec. 31, 2021

STOCK BASED COMPENSATION

STOCK BASED COMPENSATION

7. STOCK-BASED COMPENSATION

Equity Incentive Plans

In May 2019, the Company's board of directors (the "Board") adopted its 2019 Equity Incentive Plan ("2019 Plan"), which was subsequently approved by its stockholders and became effective on May 13, 2019. As a result, no additional awards under the Company's 2016 Equity Incentive Plan, as amended (the "2016 Plan") will be granted and all outstanding stock awards granted under the 2016 Plan that are repurchased, forfeited, expired or are cancelled will become available for grant under the 2019 Plan in accordance with its terms. The 2016 Plan will continue to govern outstanding equity awards granted thereunder.

The 2019 Plan provides for the issuance of incentive stock options ("ISOs") to employees, and for the grant of nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance stock awards, performance cash awards and other forms of stock awards to the Company's employees, officers and directors, as well as non- employees, consultants and affiliates to the Company. Under the terms of the 2019 Plan, stock options may not be granted at an exercise price less than fair market value of the Company's common stock on the date of the grant. The 2019 Plan is administered by the Compensation Committee of the Company's Board.

Initially, subject to adjustments as provided in the 2019 Plan, the maximum number of the Company's common stock that may be issued under the 2019 Plan is 4,530,000 shares, which is the sum of (i) 1,618,841 new shares, plus (ii) the number of shares (not to exceed 2,911,159 shares) that remained available for the issuance of awards under the 2016 Plan, at the time the 2019 Plan became effective, and (iii) any shares subject to outstanding stock options or other stock awards granted under the 2016 Plan that are forfeited, expired, or reacquired. The 2019 Plan provides that the number of shares reserved and available for issuance under the 2019 Plan will automatically increase each January 1, beginning on January 1, 2020, by 5% of the outstanding number of shares of common stock on the immediately preceding December 31 or such lesser number of shares as determined by the Board. Subject to certain changes in capitalization of the Company, the aggregate maximum number of shares of common stock that may be issued pursuant to the exercise of ISOs shall be equal to 13,000,000 shares of common stock. Stock options awarded under the 2019 Plan expire 10 years after grant and typically vest over four years.

As of December 31, 2021, there were 398,744 shares of common stock available for issuance under the 2019 Plan. On January 1, 2022, there were 1,310,776 shares that became issuable for future grants subject to the adjustments provided in the 2019 Plan.

Stock-Based Compensation Expense

Total stock-based compensation expense recorded for employees, directors and non-employees (in thousands):


	Year Ended
	December 31,
(in thousands)	2021		2020
Research and development	$	2,759	$	2,580
General and administrative		8,418		5,446
Total stock-based compensation expense	$	11,177	$	8,026

Stock Option Activity

During the year ended December 31, 2021, and 2020 the Company granted options to purchase 406,752 and 1,105,604 shares of common stock, respectively. For the years ended December 31, 2021, and 2020, amortization of stock compensation of options amounted to $9.3 million and $7.1 million, respectively. As of December 31, 2021, the total unrecognized stock-based compensation balance for unvested options was $18.8 million, which is expected to be recognized over 2.4 years. The weighted-average fair value of options granted during the years ended December 31, 2021, and December 31, 2020, were $8.43 per share and $18.84 per share, respectively.

The following table summarizes the information about options outstanding at December 31, 2021:


				Weighted-Average
		Weighted-		Remaining	Aggregate
	Options	Average		Contractual	Intrinsic
(in thousands, except for share data)	Outstanding	Exercise Price		Term (in years)	Value
Outstanding at December 31, 2020	4,529,675	$	12.87	8.49	$	51,103
Options granted	406,752		13.74
Options exercised	(191,436)		2.67			2,990
Forfeited	(40,008)		21.43
Expired	(95)		44.02
Outstanding at December 31, 2021	4,704,888	$	13.29	7.7	$	10,305

Exercisable at December 31, 2021	3,168,679	$	9.83	7.3	$	10,258
Nonvested at December 31, 2021	1,536,209	$	20.40	8.6	$	48

Valuation of Stock Options Granted to Employees that Contain Service Conditions Only

The fair value of each option award granted with service-based vesting is estimated on the date of the grant using the Black-Scholes option valuation model based on the weighted average assumptions noted in the table below for those options granted in the years ended December 31, 2021 and 2020.


	Year Ended
	December 31,
	2021			2020
Expected term (in years)		5.8			6.1
Volatility		71.92	%		69.70	%
Risk-free interest rate		1.08	%		0.51	%
Dividend yield		—	%		—	%

Restricted Stock Unit Activity

During the year ended December 31, 2021, the Company granted 348,536 restricted stock units (“RSUs”). For the years ended December 31, 2021 and December 31, 2020, amortization of stock compensation of RSUs amounted to $1.9 million and $1.0 million, respectively. As of December 31, 2021, the unamortized compensation costs associated with non-vested restricted stock awards was $7.2 million with a weighted-average remaining amortization period of 3.4 years.

The following table summarizes the information about restricted stock units outstanding at December 31, 2021:


		Weighted-Average
		Grant Date		Aggregate
(in thousands, except for share data)	Shares	Fair Value		Intrinsic Value
Outstanding at December 31, 2020	206,529	$	36.08	$	4,546
Awarded	348,536		11.03
Released	(52,562)		33.52
Forfeited	(33,018)		32.07
Outstanding at December 31, 2021	469,485	$	18.05	$	4,202
Nonvested at December 31, 2021	469,485	$	18.05	$	4,202

Weighted Average Remaining Recognition Period (in years)	3.4

2019 Employee Stock Purchase Plan

In May 2019, the Company’s Board and its stockholders approved the 2019 Employee Stock Purchase Plan (the “ESPP”), which became effective as of May 13, 2019. The ESPP is intended to qualify as an “employee stock purchase plan” within the meaning of Section 423 of the U.S. Internal Revenue Code of 1986, as amended. The number of shares of common stock initially reserved for issuance under the ESPP was 180,000 shares. The ESPP provides for an annual increase on the first day of each year beginning in 2020 and ending in 2029, in each case subject to the approval of the Board, equal to the lesser of (i) 1% of the shares of common stock outstanding on the last day of the calendar month before the date of the automatic increase and (ii) 360,000 shares; provided that prior to the date of any such increase, the Board may determine that such increase will be less than the amount set forth in clauses (i) and (ii). As of December 31, 2021, no shares of common stock had been issued under the ESPP. The first offering period has not yet been decided by the Board.

STOCKHOLDERS' EQUITY

12 Months Ended

Dec. 31, 2021

STOCKHOLDERS' EQUITY

STOCKHOLDERS' EQUITY

8. STOCKHOLDERS’ EQUITY

As of December 31, 2021, and 2020, the authorized capital stock of the Company consists of 100,000,000 shares of common stock, par value $0.0001 per share and 10,000,000 shares of preferred stock, par value $0.0001 per share.

Common Stock

Voting

The holders of the common stock are entitled to one vote for each share of common stock held at all meetings of the stockholders. There is no cumulative voting.

Equity Distribution Agreement

In June 2020, the Company entered into the Equity Distribution Agreement with Goldman to sell shares of the Company’s common stock, from time to time, having and aggregate offering price of $100.0 million. The issuance and sale of shares of common stock by us pursuant to the Equity Distribution Agreement is deemed an “at-the-market” offering under the Securities Act of 1933, as amended, or the Securities Act. Goldman is entitled to compensation for its services equal to up to 3.0% of the gross offering proceeds of all shares of our common stock sold through it as a sales agent pursuant to the Equity Distribution Agreement. As of December 31, 2021, the Company has received no proceeds from the sale of shares of common stock pursuant to the Equity Distribution Agreement. This agreement has since been terminated as of January 24, 2022.

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

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-Publisher FASB
-Name Accounting Standards Codification
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+ Details

WARRANTS

12 Months Ended

Dec. 31, 2021

WARRANTS

WARRANTS

9. WARRANTS

Warrants Issued with Series A Preferred Stock

On January 26, 2017, in connection with the sale and issuance of the Series A Preferred Stock, the Company issued equity-classified warrants to purchase 309,389 shares of common stock (the “2017 Warrants”), valued at $0.2 million, and included in the issuance costs of the Series A Preferred Stock. The warrants vested immediately and have an exercise price of $2.49 per share and expire on March 13, 2027.

The fair value of warrants issued is estimated using the Black-Scholes option pricing model with the following assumptions for the 2017 Warrants.


Contractual term (in years)	10.0
Volatility	74.48	%
Risk-free interest rate	3.20	%
Dividend yield	0.00	%

On December 5, 2019, an optionholder exercised 20,000 options in a cashless exercise at net, and the Company issued 17,026 shares of common stock.

On February 21, 2020, two warrantholders exercised 185,634 options in a cashless exercise at net, and the Company issued 176,092 shares of common stock. On February 24, 2020, a warrantholder exercised 72,818 options in a cashless exercise at net, and the Company issued 69,094 shares of common stock.

On February 5, 2021, a warrantholder exercised 27,855 warrants on a cash basis and received 27,855 shares of common stock. The Company received $69,000 in cash proceeds for the exercise of these warrants.

Warrants Issued with the 2018 Notes

On January 18, 2018, the Company entered into a placement agent agreement through which it became obligated to issue common stock warrants in connection with the issuance of the Company’s convertible promissory notes issued on February 5, 2018 (the “2018 Notes”). The obligation to issue the 2018 Notes Warrants was recorded as a liability at its fair value (see Note 3), which was initially $0.1 million, and was included in the issuance costs of the 2018 Notes. On November 5, 2018, in connection with the extinguishment of the 2018 Notes into shares of Series B Preferred Stock, the Company issued the 2018 Notes Warrants, which were equity-classified warrants upon issuance, to purchase 76,847 shares of common stock, valued at $0.3 million. The 2018 Notes Warrants vested immediately upon issuance and have an exercise price of $6.59 per share and expire on November 4, 2028.

On February 24, 2020, a warrantholder exercised 386 options in a cashless exercise at net, and the Company issued 333 shares of common stock. On June 24, 2020, a warrantholder exercised 20,331 options in a cashless exercise at net, and the Company issued 17,369 shares of common stock.

Warrants Issued with Series B Preferred Stock

In November and December 2018, in connection with the sale and issuance of the Series B Preferred Stock, the Company was obligated to issue equity-classified warrants to purchase 72,261 shares of common stock (collectively the “2018 Warrants”), valued in the aggregate at $0.2 million, which was included in the issuance costs for the Series B Preferred Stock. The warrants vest immediately upon issuance, have an exercise price of $8.24 per share and expire 10 years from the date of issuance.

The fair value of the 2018 Warrants is estimated using the Black-Scholes option pricing model with the following assumptions:


Contractual term (in years)	10.0
Volatility	73.22	%
Risk-free interest rate	2.70	%
Dividend yield	0.00	%

In February 2019, in connection with the sale and issuance of the Series B Preferred Stock, the Company was obligated to issue warrants to purchase 23,867 shares of common stock (collectively the “2019 Warrants”), valued in the aggregate at $0.1 million, which was included in the issuance costs for the Series B Preferred Stock. The warrants vest immediately upon issuance, have an exercise price of $8.24 per share and expire 10 years from the date of issuance.

The fair value of the 2019 Warrants was estimated using the Black-Scholes option pricing model with the following assumptions:


Contractual term (in years)	10.0
Volatility	73.22	%
Risk-free interest rate	2.70	%
Dividend yield	0.00	%

The inputs utilized by management to value the warrants are highly subjective. The assumptions used in calculating the fair value of the warrants represent the Company’s best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and the Company uses different assumptions, the fair value of the warrants may be materially different in the future.

On January 14, 2020, a warrantholder exercised 220 options in a cashless exercise at net, and the Company issued 146 shares of common stock. On February 24, 2020, a warrantholder exercised 5,193 options in a cashless exercise at net, and the Company issued 4,313 shares of common stock. On June 24, 2020, a warrantholder exercised 24,309 options in a cashless exercise at net, and the Company issued 19,882 shares of common stock.

A summary of the Company’s outstanding common stock warrants as of December 31, 2021 is as follows:


	Warrants
Outstanding as of December 31, 2020		153,473
Warrants granted and issued		—
Warrants exercised		(27,855)
Warrants exchanged		—
Balance as of December 31, 2021		125,618

LEASES

12 Months Ended

Dec. 31, 2021

LEASES

LEASES

10. LEASES

The following table summarizes our lease assets and liabilities as of December 31, 2021 and 2020:


		Operating (in thousands)
		December 31,		December 31,
ROU Assets and Liabilities	Balance Sheet Location	2021		2020
ROU - Asset	Right-of-use assets	$	1,298	$	1,712
Lease liabilities (current)	Operating lease liabilities, current		442		406
Lease liabilities (non-current)	Operating lease liabilities, non-current		891		1,332

The following table summarizes our lease related costs for the twelve months ended December 31, 2021 and 2020:


		Operating (in thousands)
Lease Cost	Statement of Operations Location		2021		2020
Operating Lease Cost	General and administrative	$	505	$	487
Total Lease Cost		$	505	$	487

Average lease terms and discount rates for the Company’s operating leases were as follows:


	Year Ended		Year Ended
	December 31,		December 31,
Other Information	2021		2020
Weighted-average remaining lease term
Operating leases		2.8 years		3.8 years
Weighted-average discount rate
Operating leases		5.7%		5.7%

The following table summarizes the maturities of lease liabilities as of December 31, 2021:


	Operating
Year	(in thousands)
2022	$	507
2023		515
2024		424
Thereafter		—
Total lease payments		1,446
Less: interest		113
Total lease liabilities	$	1,333

INCOME TAXES

12 Months Ended

Dec. 31, 2021

INCOME TAXES

INCOME TAXES

11. INCOME TAXES

The Company’s current tax provision for the years ended December 31, 2021 and 2020 is $0 and $0, respectively. The Company’s deferred tax provision for the years ended December 31, 2021 and 2020 is $0 and $0, respectively.

A reconciliation of the Company's deferred taxes is as follows (in thousands):


	Year ended
	December 31,
	2021		2020
Deferred Tax Assets
Operating Lease Liability	$	420	$	541
Stock-based compensation		6,606		3,788
License fee		594		630
Net operating loss carryforwards		79,429		49,094
Research and development tax credits		14,940		9,037
Other		1,352		689
Total Deferred Tax Assets	$	103,341	$	63,779
Valuation Allowance	$	(102,932)	$	(63,246)
Net Deferred Tax Assets	$	409	$	533
Deferred Tax Liabilities
Right of Use Asset		(409)		(533)
Net Deferred Tax Liabilities	$	(409)	$	(533)
Net deferred tax asset (liability)	$	—	$	—

Deferred tax assets result primarily from unutilized net operating losses, research tax credits, stock-based compensation, operating lease liability, and timing differences as a result of the Company reporting its income tax returns. As of December 31, 2021, the Company had approximately $253.5 million of federal operating losses (“NOLs”) carried forward. Of this amount, approximately $3.3 million will begin to expire in 2037 and approximately $250.1 million are carried forward indefinitely. The Company had approximately $516.1 million in state and city net operating loss carryforwards available to offset future taxable income.

As of December 31, 2021, the Company had federal research tax credits (R&D) of approximately $4.8 million which may be used to offset future tax liabilities. Additionally, the Company had a federal orphan drug credit (“ODC”) related to qualifying research of $10.2 million. These tax credit carryforwards will begin to expire at various times beginning in 2037 for federal purposes.

The NOL, R&D and ODC credits carry forwards are subject to review and possible adjustment by the U.S. and state tax authorities. NOL carry forwards and credit carry forwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders, as defined under Sections 382 and 383 Internal Revenue Code. This could limit the amount of NOLs and credits that the Company can utilize annually

to offset future taxable income or tax liabilities. As of December 31, 2021, the Company has not performed such an analysis. Subsequent ownership changes and proposed future changes to tax rules in respect of the utilization of losses carried forward may further affect the limitation in future years.

In assessing the realizability of the Company’s deferred tax assets, management considers whether or not it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income. The Company’s assessment is based on the weight of available evidence, including cumulative losses since inception and expected future losses and, as such, the Company does not believe it is more likely than not that the deferred tax assets will be realized. Accordingly, a full valuation allowance has been established and no deferred tax assets and related tax benefit have been recognized in the accompanying financial statements. At December 31, 2021 and 2020, the Company recorded valuation allowances of $102.9 million and $63.2 million, respectively. The increase in valuation allowance is primarily driven by additional net operating loss.

The Company files its income tax returns in the United States, New York State, New York City, California, Massachusetts, and New Jersey. All years remain subject to examination for federal and state purpose.

The U.S. federal statutory corporate tax rate reconciles to the Company’s effective tax rate for the years ended December 31, 2021 and 2020:


	Year Ended
	December 31,
	2021		2020
Federal statutory rate	21.0	%	21.0	%
State and local taxes net of federal tax benefit	10.7		9.9
Credits	5.6		9.6
Permanent Differences	0.5		3.9
Change in valuation allowance	(37.7)		(44.3)
Other	(0.1)		(0.1)
Total	0.0	%	0.0	%

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

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+ Details

BENEFIT PLANS

12 Months Ended

Dec. 31, 2021

BENEFIT PLANS

BENEFIT PLANS

12. BENEFIT PLANS

The Company established a defined contribution savings plan under Section 401(k) of the Internal Revenue Code in 2018. This plan covers substantially all employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. Matching contributions to the plan may be made at the discretion of the Company’s Board. The Company made approximately $0.2 million and $0.1 million in matching contributions to the plan during the year ended December 31, 2021 and 2020, respectively.

- Definition

The entire disclosure for retirement benefits.

+ References

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+ Details

NET LOSS PER COMMON SHARE

12 Months Ended

Dec. 31, 2021

NET LOSS PER COMMON SHARE

NET LOSS PER COMMON SHARE

13. NET LOSS PER COMMON SHARE

Basic net loss per common share is computed by dividing the net loss available to common stockholders by the weighted-average number of shares of common stock outstanding during the period.

Diluted net loss per common share is computed by giving the effect of all potential shares of common stock, including stock options, preferred shares, warrants and instruments convertible into common stock, to the extent dilutive. Basic and diluted net loss per common share was the same for the years ended December 2021 and 2020, as the inclusion of all potential common shares outstanding would have been anti-dilutive.

The following table sets forth the computation of basic and diluted net loss per common share (in thousands, except share and per share data):


	Years Ended
	December 31,
(in thousands, except for share data)	2021		2020
Numerator:
Net loss	$	(105,584)	$	(93,961)
Denominator:
Weighted-average common stock outstanding		25,598,181		21,966,326
Net loss per share attributable to common stockholders - basic and diluted	$	(4.12)	$	(4.28)

The Company’s potentially dilutive securities, which include restricted stock units, stock options and warrants, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at December 31, 2021 and 2020, from the computation of diluted net loss per share attributable to common stockholders because including them would have had an anti-dilutive effect:


	As of
	December 31,
	2021	2020
Options to purchase common stock	4,704,888	4,529,675
Restricted stock units	469,485	206,529
Warrants to purchase common stock	125,618	153,473

RELATED PARTIES

12 Months Ended

Dec. 31, 2021

RELATED PARTIES

RELATED PARTIES

14. RELATED PARTIES

In December 2018, the Company entered into an agreement (the “LaunchLabs Agreement”) with ARE-LaunchLabs NYC LLC (“Alexandria LaunchLabs”), a subsidiary of Alexandria Real Estate Equities, Inc. for use of specified premises within the Alexandria LaunchLabs space on a month-to-month basis. A member of the Company’s board of directors is the founder and executive chairman of Alexandria Real Estate Equities, Inc. During the years ended December 31, 2021 and 2020, the Company made payments to Alexandria LaunchLabs of approximately $0.1 million and $89,000, respectively under the LaunchLabs Agreement, which was recognized in research and development expenses. As of December 31, 2021, there were no amounts due to Alexandria LaunchLabs under the LaunchLabs Agreement.

SUBSEQUENT EVENTS

12 Months Ended

Dec. 31, 2021

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

15. SUBSEQUENT EVENTS

Cowen Equity Distribution Agreement

On January 26, 2022, the Company entered into an equity distribution agreement (the “Cowen Equity Distribution Agreement) with Cowen and Company, LLC (“Cowen”), as a sales agent, to sell shares of the Company’s common stock, from time to time, having an aggregate offering price of up to $100.0 million. Pursuant to the Cowen Equity Distribution Agreement shares of our common stock may be offered and sold through the sales agent in sales deemed “at-the-market” offerings under the Securities Act of 1933, as amended, or the Securities Act. Under the Cowen Equity Distribution Agreement, the sales agent will be entitled to compensation of up to 3% of the gross offering proceeds of all shares of our common stock sold through it pursuant to the Cowen Equity Distribution Agreement. In connection with the sale of shares of our common stock on our behalf, the sales agent may be deemed to be “underwriters” within the meaning of the Securities Act, and the compensation paid to the sales agent may be deemed to be underwriting commissions or discounts.

Extension of the 2020 Miami Sponsored Research Agreement

On February 15, 2022 and effective January 1, 2022, the Company entered into an amendment to the 2020 Miami Research Agreement, under which the University of Miami will extend the research study relating to SORD neuropathy and deliver a final report on the study to the Company. The term of the research agreement is from January 1, 2022 through May 31, 2022. The consideration for the amendment to the 2020 Miami Research Agreement is $0.3 million.

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	12 Months Ended
	Dec. 31, 2021
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Operations and Business	Operations and Business Applied Therapeutics, Inc. (the “Company”) is a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates against validated molecular targets in indications of high unmet medical need. In particular, the Company is currently targeting treatments for CNS rare diseases and diabetic complications. The Company was incorporated in Delaware on January 20, 2016 and is headquartered in New York, New York. On January 28, 2020, the Company completed its secondary public offering (the “Secondary Public Offering”), pursuant to which it issued and sold 2,741,489 shares of common stock at a public offering price of $45.50 per share, with an additional 411,223 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares. The aggregate net proceeds received by the Company from the offering, after deducting underwriting discounts and commissions and offering costs, were $134.1 million. On June 4, 2020, the Company filed a shelf registration statement on Form S-3 (the “Shelf Registration Statement”) under which the Company may, from time to time, sell securities in one or more offerings having an aggregate offering price of up to $300.0 million. The Shelf Registration Statement was declared effective as of June 15, 2020. As of the filing date of this Annual Report, the Company has sold 3,450,000 shares of common stock under the Shelf Registration. On June 12, 2020, the Company entered into an equity distribution agreement (the “Goldman Equity Distribution Agreement”) with Goldman Sachs & Co. LLC (“Goldman”), as a sales agent to sell shares of the Company’s common stock, from time to time, having an aggregate offering price of up to $100 million. Goldman may act as an agent on the Company’s behalf or purchase shares of the Company’s common stock as a principal. As of December 31, 2021, the Company had not sold any shares of common stock pursuant to the Goldman Equity Distribution Agreement. This agreement has since been terminated as of January 24, 2022. On February 17, 2021, the Company completed an underwritten public offering (the “February Offering”) of 3,450,000 shares of common stock, including the exercise in full of the underwriters’ option to purchase 450,000 additional shares of common stock, which option closed on February 19, 2021. The shares were offered at a price to the public of $23.00 per share, resulting in aggregate net proceeds of approximately $74.4 million, after deducting underwriting discounts and commissions and offering expenses.
Risk and Uncertainties	Risks and Uncertainties The Company is subject to risks common to companies in the biotechnology industry, including but not limited to, risks of failure of preclinical studies and clinical trials, the need to obtain marketing approval for any product candidate that it may identify and develop, the need to successfully commercialize and gain market acceptance of its product candidates, dependence on key personnel, protection of proprietary technology, compliance with government regulations, development by competitors of technological innovations and reliance on third party manufacturers.
Use of Estimates	Use of Estimates The preparation of 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 disclosure of contingent assets and liabilities and the Company's ability to continue as a going concern as of the date of the financial statements and the reported amounts of expenses during the reporting period. In preparing the financial statements, management used estimates in the following areas, among others: prepaid and accrued expenses; stock-based compensation expense; and the evaluation of the existence of conditions and events that raise substantial doubt regarding the Company’s ability to continue as a going concern. Actual results could differ from those estimates.
Fair Value Measurements	Fair Value Measurements Certain assets and liabilities are reported on a recurring basis at fair value. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: Level 1—Quoted prices in active markets for identical assets or liabilities. Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
Cash and Cash Equivalents	Cash and Cash Equivalents The Company considers all short-term, highly liquid investments, with an original maturity of three months or less, to be cash equivalents. The Company maintains its cash in bank deposit accounts which, at times, may exceed federally insured limits. The Company has not experienced any losses in these accounts and does not believe it is exposed to any significant credit risk on cash and cash equivalents.
Investments	Investments The Company has investments in marketable debt securities. The Company determines the appropriate classification of its investments at the date of purchase and reevaluates the classifications at the balance sheet date. Marketable debt securities with maturities of 12 months or less are classified as short-term. Marketable debt securities with maturities greater than 12 months are classified as long-term. The Company’s marketable securities are accounted for as available for sale (“AFS”). AFS securities are reported at fair value. Unrealized gains and losses, after applicable income taxes, are reported in accumulated other comprehensive income/(loss). Realized gains or losses on the sale of marketable securities are determined using the specific identification method and are recorded as a component of other income (expense), net. The Company conducts an other-than-temporary impairment (“OTTI”) analysis on a quarterly basis or more often if a potential loss-triggering event occurs. The Company considers factors such as the duration, severity and the reason for the decline in value, the potential recovery period and whether the Company intends to sell. For AFS securities, the Company also considers whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis and (ii) the amortized cost basis cannot be recovered as a result of credit losses. The Company adopted ASU No. 2016-13, “Financial Instruments–Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” on January 1, 2020 and applied the new modified credit impairment guidance related to available-for-sale debt securities prospectively. Under the new guidance, at each reporting date, entities must evaluate their individual available-for-sale debt securities that are in an unrealized loss position and determine whether the decline in fair value below the amortized cost basis from a credit loss or other factors. The amount of the decline related to credit losses is recorded as a credit loss expense in earnings with a corresponding allowance for credit losses and the amount of decline not related to credit losses are recorded through other comprehensive income, net of tax. Credit losses are measured in a manner similar to current generally accepted accounting standards; however, ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, will require that credit losses be presented as an allowance rather than as a write-down.
Leases	Leases At the inception of an arrangement, the Company determines if an arrangement is, or contains, a lease based on the unique facts and circumstances present in that arrangement. Lease classification, recognition, and measurement are then determined at the lease commencement date. For arrangements that contain a lease the Company (i) identifies lease and non-lease components, (ii) determines the consideration in the contract, (iii) determines whether the lease is an operating or financing lease; and (iv) recognizes lease right-of-use (“ROU”) assets and liabilities. Lease liabilities and their corresponding ROU assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable and as such, the Company uses its incremental borrowing rate based on the information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. Most leases include options to renew and, or, terminate the lease, which can impact the lease term. The exercise of these options is at the Company’s discretion and the Company does not include any of these options within the expected lease term as the Company is not reasonably certain it will exercise these options. The Company has elected to combine lease components (for example fixed payments including rent) with non-lease components (for example, non-dedicated parking and common-area maintenance costs) on our real estate asset classes. Fixed, or in substance fixed, lease payments on operating leases are recognized over the expected term of the lease on a straight-line basis. Fixed lease expense on operating leases is recognized within operating expenses within the statements of operations. The Company has operating leases for our corporate offices. The Company has elected the short-term lease exemption and, therefore, do not recognize a ROU asset or corresponding liability for lease arrangements with an original term of 12 months or less. Leasehold improvements and assets under financing lease arrangements are amortized over the lesser of the asset’s estimated useful life or the term of the respective lease. Maintenance costs are expensed as incurred. Operating leases are included in operating lease right-of-use asset, current portion of operating lease liabilities, and noncurrent portion of operating lease liabilities in the balance sheet as of December 31, 2021 and 2020.
Deferred Offering Costs	Deferred Offering Costs The Company capitalizes certain legal, professional accounting and other third party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in the statement of stockholders’ (deficit) equity as a reduction of proceeds generated as a result of the offering. Should a planned equity financing be abandoned, the deferred offering costs would be expensed immediately as a charge to operating expenses in the statement of operations. As of December 31, 2021 and 2020, the Company did not have any deferred offering costs recorded in prepaid and other current assets.
Research and Development	Research and Development The Company expenses all costs incurred in performing research and development activities. Research and development expenses include salaries and other related costs, materials and supplies, preclinical expenses, manufacturing expenses, contract services and other outside expenses. As part of the process of preparing the financial statements, the Company is required to estimate their accrued research and development expenses. The Company makes estimates of the accrued expenses as of each balance sheet date in the financial statements based on facts and circumstances known at that time. In addition, there may be instances in which payments made to the Company’s vendors will exceed the level of services provided and result in a prepayment of the expense in which case such amounts are reflected as prepaid expenses and other current assets. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company adjusts the accrual or the amount of prepaid expenses accordingly. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized in prepaid expenses and other current assets. The capitalized amounts are expensed as the related goods are delivered or the services are performed. Research and development costs also include costs incurred in connection with certain licensing arrangements. Before a compound receives regulatory approval, the Company records upfront and milestone payments made to third parties under licensing arrangements as expense. Upfront payments are recorded when incurred, and milestone payments are recorded when the specific milestone has been achieved. Once a compound receives regulatory approval, the Company will record any milestone payments in identifiable intangible assets, less accumulated amortization and, unless the asset is determined to have an indefinite life, the Company will amortize the payments on a straight-line basis over the remaining agreement term or the expected product life cycle, whichever is shorter.
General and Administrative	General and Administrative General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in the Company’s executive and finance functions. General and administrative expenses also include professional fees for legal, accounting, auditing, tax and consulting services; travel expenses; and facility-related expenses, which include allocated expenses for rent and maintenance of facilities and other operating costs. Commercial expenses consist of payroll expense for commercial personnel, as well as marketing, market research, market access, and other focused investments to support launch of drug candidates, generate evidence of commercial potential and value proposition, and maximize potential business development deal leverage. Commercial expenses are included in general and administrative expenses.
Stock Based Compensation-Restricted Stock Units	Stock-Based Compensation The Company accounts for its stock-based compensation as expense in the statements of operations based on the awards’ grant date fair values. The Company accounts for forfeitures as they occur by reversing any expense recognized for unvested awards. The Company estimates the fair value of options granted using the Black-Scholes option pricing model. The Black-Scholes option pricing model requires inputs based on certain subjective assumptions, including (a) the expected stock price volatility, (b) the calculation of expected term of the award, (c) the risk-free interest rate and (d) expected dividends. Due to the lack of a public market for the Company’s common stock and a lack of company-specific historical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The historical volatility is calculated based on a period of time commensurate with the expected term assumption. The computation of expected volatility is based on the historical volatility of a representative group of companies with similar characteristics to the Company, including stage of product development and life science industry focus. The Company uses the simplified method as allowed by the Securities and Exchange Commission (“SEC”) Staff Accounting Bulletin (“SAB”) No. 107, Share-Based Payment, to calculate the expected term for options granted to employees as it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected term of the stock options. The expected dividend yield is assumed to be zero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock. The fair value of stock-based payments is recognized as expense over the requisite service period which is generally the vesting period. Stock-Based Compensation–Restricted Stock Units The Company accounts for restricted stock units in accordance with the authoritative guidance for stock-based compensation. The fair value of restricted stock units is measured at the grant date based on the closing market price of the Company’s common stock on the date of grant, and is recognized as expense on a straight-line basis over the period of vesting. Forfeitures are recognized as a reduction of stock-based compensation expense as they occur.
Income Taxes	Income Taxes The Company uses the asset and liability method of accounting for deferred income taxes. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities at currently enacted tax rates. These temporary differences primarily relate to net operating loss carryforwards available to offset future taxable income. Valuation allowances are established, if necessary, to reduce a deferred tax asset to the amount that will more likely than not be realized. The Company recognizes tax liabilities from an uncertain tax position only if it is more likely than not that the tax position will not be sustained upon examination by the taxing authorities, based on the technical merits of the tax position. There are no uncertain tax positions that have been recognized in the accompanying financial statements. The Company is required to file tax returns in the U.S. federal jurisdiction and in the states of New York, California, Massachusetts, New Jersey, and New York City. The Company’s policy is to recognize interest and penalties related to uncertain tax benefits, if any, as part of income tax expense. No such interest and penalties have been accrued as of December 31, 2021 and 2020. In December 2019, the FASB issued ASU 2019-12, Income Taxes: Simplifying the Accounting for Income Taxes. The new standard intended to simplify the accounting for income taxes by eliminating certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The new guidance also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill. The standard is effective for annual periods beginning after December 15, 2020 and interim periods within, with early adoption permitted. Adoption of the standard requires certain changes to primarily be made prospectively, with some changes to be made retrospectively. The Company adopted the amendment on January 1, 2021, with no impact to the financial statements.
Net Loss per Share	Net Loss per Share Basic net loss per share is calculated by dividing net loss available to common stockholders by the weighted-average common stock outstanding. Diluted net loss per share is calculated similarly, except that it includes the dilutive effect of the assumed exercise of securities, including outstanding warrants and the effect of shares issuable under the Company’s stock-based compensation plan, if such effect is dilutive.
Segment Information	Segment Information Operating segments are defined as components of an enterprise for which separate discrete information is available for evaluation by the chief operating decision-maker in deciding how to allocate resources and assess performance. The Company and the Company’s chief operating decision-maker, the Company’s chief executive officer, views the Company’s operations and manages its business as a single operating segment, which is the business of discovering and developing its product candidates.
Recent Accounting Pronouncements	Recent Accounting Pronouncements Any recent pronouncements issued by the FASB or other authoritative standards groups with future effective dates are either not applicable or are not expected to be significant to the financial statements of the Company.

FAIR VALUE MEASUREMENTS (Tables)

12 Months Ended

Dec. 31, 2021

FAIR VALUE MEASUREMENTS

Schedule of financial assets or liabilities measured at fair value on a recurring basis


	As of December 31, 2021
(in thousands)	Level 1		Level 2		Level 3		Total
Cash	$	12,671	$	—	$	—	$	12,671
Money market funds		41,217		—		—		41,217
Total cash and cash equivalents	$	53,888	$	—	$	—	$	53,888
U.S. government agency debt securities		—		26,935		—		26,935
Total marketable securities	$	—	$	26,935	$	—	$	26,935
Total financial assets measured at fair value on a recurring basis	$	53,888	$	26,935	$	—	$	80,823


	As of December 31, 2020
(in thousands)	Level 1		Level 2		Level 3		Total
Cash	$	6,691	$	—	$	—	$	6,691
Money market funds		50,775		—		—		50,775
Total cash and cash equivalents	$	57,466	$	—	$	—	$	57,466
U.S. government agency debt securities		—		39,363		—		39,363
Total marketable securities	$	—	$	39,363	$	—	$	39,363
Total financial assets measured at fair value on a recurring basis	$	57,466	$	39,363	$	—	$	96,829

INVESTMENTS (Tables)

12 Months Ended

Dec. 31, 2021

INVESTMENTS

Schedule of marketable securities by security type

The following tables provide the Company’s marketable securities by security type (in thousands):


	As of December 31, 2021								As of December 31, 2020
			Gross		Gross						Gross		Gross
			Unrealized		Unrealized		Estimated				Unrealized		Unrealized		Estimated
(in thousands)	Cost		Gains		Losses		Fair Value		Cost		Gains		Losses		Fair Value
US government agency debt security	$	27,042	$	1	$	(108)	$	26,935	$	39,475	$	11	$	(123)	$	39,363
Total	$	27,042	$	1	$	(108)	$	26,935	$	39,475	$	11	$	(123)	$	39,363

Schedule of contractual maturities

Contractual maturities of the Company’s marketable securities are summarized as follows (in thousands):


	As of December 31, 2021								As of December 31, 2020
			Gross		Gross						Gross		Gross
			Unrealized		Unrealized		Estimated				Unrealized		Unrealized		Estimated
(in thousands)	Cost		Gains		Losses		Fair Value		Cost		Gains		Losses		Fair Value
Due in one year or less	$	27,042	$	1	$	(108)	$	26,935	$	39,475	$	11	$	(123)	$	39,363
Due in one through two years		—		—		—		—		—		—		—		—
Total	$	27,042	$	1	$	(108)	$	26,935	$	39,475	$	11	$	(123)	$	39,363

Unrealized Gain (Loss) on Investments


	As of December 31, 2021
	Securities in an unrealized loss position less than 12 months				Securities in an unrealized loss position greater than 12 months				Total
	Unrealized		Estimated		Unrealized		Estimated		Unrealized		Estimated
(in thousands)	Losses		Fair Value		Losses		Fair Value		Losses		Fair Value
US government agency debt security	$	(108)	$	17,696	$	—	$	—	$	(108)	$	17,696
Total	$	(108)	$	17,696	$	—	$	—	$	(108)	$	17,696


	As of December 31, 2020
	Securities in an unrealized loss position less than 12 months				Securities in an unrealized loss position greater than 12 months				Total
	Unrealized		Estimated		Unrealized		Estimated		Unrealized		Estimated
(in thousands)	Losses		Fair Value		Losses		Fair Value		Losses		Fair Value
US government agency debt security	$	(123)	$	14,073	$	—	$	—	$	(123)	$	14,073
Total	$	(123)	$	14,073	$	—	$	—	$	(123)	$	14,073

PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables)

12 Months Ended

Dec. 31, 2021

PREPAID EXPENSES AND OTHER CURRENT ASSETS

Summary of prepaid expenses and other current assets

Prepaid expenses and other current assets consisted of the following (in thousands):


	December 31,		December 31,
(in thousands)	2021		2020
Prepaid research and development expenses	$	4,483	$	2,349
Insurance premium asset		1,616		1,463
Prepaid rent expenses		117		108
Prepaid insurance expenses		105		91
Prepaid commercial and patient advocacy		254		968
Research and development tax credit receivable		502		500
Interest receivable		23		5
Other prepaid expenses and current assets		471		280
Total prepaid expenses & other current assets	$	7,571	$	5,764

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables)

12 Months Ended

Dec. 31, 2021

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

Summary of accrued expenses and other current liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):


	December 31,		December 31,
(in thousands)	2021		2020
Accrued pre-clinical and clinical expenses	$	9,912	$	13,742
Short-term insurance financing note		789		1,074
Accrued professional fees		419		511
Accrued compensation and benefits		2,779		2,103
Accrued commercial expenses		1,394		502
Accrued patent expenses		279		1,704
Other		987		553
Total accrued expenses & other current liabilities	$	16,559	$	20,189

STOCK BASED COMPENSATION (Tables)

12 Months Ended

Dec. 31, 2021

Stock-based compensation

Schedule of stock-based compensation expenses

Total stock-based compensation expense recorded for employees, directors and non-employees (in thousands):


	Year Ended
	December 31,
(in thousands)	2021		2020
Research and development	$	2,759	$	2,580
General and administrative		8,418		5,446
Total stock-based compensation expense	$	11,177	$	8,026

Schedule of options outstanding


				Weighted-Average
		Weighted-		Remaining	Aggregate
	Options	Average		Contractual	Intrinsic
(in thousands, except for share data)	Outstanding	Exercise Price		Term (in years)	Value
Outstanding at December 31, 2020	4,529,675	$	12.87	8.49	$	51,103
Options granted	406,752		13.74
Options exercised	(191,436)		2.67			2,990
Forfeited	(40,008)		21.43
Expired	(95)		44.02
Outstanding at December 31, 2021	4,704,888	$	13.29	7.7	$	10,305

Exercisable at December 31, 2021	3,168,679	$	9.83	7.3	$	10,258
Nonvested at December 31, 2021	1,536,209	$	20.40	8.6	$	48

Schedule of restricted stock units outstanding


		Weighted-Average
		Grant Date		Aggregate
(in thousands, except for share data)	Shares	Fair Value		Intrinsic Value
Outstanding at December 31, 2020	206,529	$	36.08	$	4,546
Awarded	348,536		11.03
Released	(52,562)		33.52
Forfeited	(33,018)		32.07
Outstanding at December 31, 2021	469,485	$	18.05	$	4,202
Nonvested at December 31, 2021	469,485	$	18.05	$	4,202

Weighted Average Remaining Recognition Period (in years)	3.4

Stock options - Service conditions only

Stock-based compensation

Schedule of valuation assumptions


	Year Ended
	December 31,
	2021			2020
Expected term (in years)		5.8			6.1
Volatility		71.92	%		69.70	%
Risk-free interest rate		1.08	%		0.51	%
Dividend yield		—	%		—	%

WARRANTS (Tables)

12 Months Ended

Dec. 31, 2021

Warrants

Schedule of warrants outstanding


	Warrants
Outstanding as of December 31, 2020		153,473
Warrants granted and issued		—
Warrants exercised		(27,855)
Warrants exchanged		—
Balance as of December 31, 2021		125,618

Warrants Issued with Series A Preferred Stock | 2017 Warrants

Warrants

Schedule of fair value of warrants using the Black Scholes option pricing model


Contractual term (in years)	10.0
Volatility	74.48	%
Risk-free interest rate	3.20	%
Dividend yield	0.00	%

Warrants Issued with Series B Preferred Stock | 2018 Warrants

Warrants

Schedule of fair value of warrants using the Black Scholes option pricing model


Contractual term (in years)	10.0
Volatility	73.22	%
Risk-free interest rate	2.70	%
Dividend yield	0.00	%

Warrants Issued with Series B Preferred Stock | 2019 Warrants

Warrants

Schedule of fair value of warrants using the Black Scholes option pricing model


Contractual term (in years)	10.0
Volatility	73.22	%
Risk-free interest rate	2.70	%
Dividend yield	0.00	%

LEASES (Tables)

12 Months Ended

Dec. 31, 2021

LEASES

Summary of lease assets and liabilities


		Operating (in thousands)
		December 31,		December 31,
ROU Assets and Liabilities	Balance Sheet Location	2021		2020
ROU - Asset	Right-of-use assets	$	1,298	$	1,712
Lease liabilities (current)	Operating lease liabilities, current		442		406
Lease liabilities (non-current)	Operating lease liabilities, non-current		891		1,332

Summary of lease related costs


		Operating (in thousands)
Lease Cost	Statement of Operations Location		2021		2020
Operating Lease Cost	General and administrative	$	505	$	487
Total Lease Cost		$	505	$	487

Summary of lease terms and discount rates


	Year Ended		Year Ended
	December 31,		December 31,
Other Information	2021		2020
Weighted-average remaining lease term
Operating leases		2.8 years		3.8 years
Weighted-average discount rate
Operating leases		5.7%		5.7%

Summary of maturities of lease liabilities


	Operating
Year	(in thousands)
2022	$	507
2023		515
2024		424
Thereafter		—
Total lease payments		1,446
Less: interest		113
Total lease liabilities	$	1,333

INCOME TAXES (Tables)

12 Months Ended

Dec. 31, 2021

INCOME TAXES

Schedule of reconciliation of deferred taxes

A reconciliation of the Company's deferred taxes is as follows (in thousands):


	Year ended
	December 31,
	2021		2020
Deferred Tax Assets
Operating Lease Liability	$	420	$	541
Stock-based compensation		6,606		3,788
License fee		594		630
Net operating loss carryforwards		79,429		49,094
Research and development tax credits		14,940		9,037
Other		1,352		689
Total Deferred Tax Assets	$	103,341	$	63,779
Valuation Allowance	$	(102,932)	$	(63,246)
Net Deferred Tax Assets	$	409	$	533
Deferred Tax Liabilities
Right of Use Asset		(409)		(533)
Net Deferred Tax Liabilities	$	(409)	$	(533)
Net deferred tax asset (liability)	$	—	$	—

Schedule of the U.S. federal statutory corporate tax rate reconciles to the Company's effective tax rate


	Year Ended
	December 31,
	2021		2020
Federal statutory rate	21.0	%	21.0	%
State and local taxes net of federal tax benefit	10.7		9.9
Credits	5.6		9.6
Permanent Differences	0.5		3.9
Change in valuation allowance	(37.7)		(44.3)
Other	(0.1)		(0.1)
Total	0.0	%	0.0	%

NET LOSS PER COMMON SHARE (Tables)

12 Months Ended

Dec. 31, 2021

NET LOSS PER COMMON SHARE

Schedule of computation of basic and diluted net loss per common share

The following table sets forth the computation of basic and diluted net loss per common share (in thousands, except share and per share data):


	Years Ended
	December 31,
(in thousands, except for share data)	2021		2020
Numerator:
Net loss	$	(105,584)	$	(93,961)
Denominator:
Weighted-average common stock outstanding		25,598,181		21,966,326
Net loss per share attributable to common stockholders - basic and diluted	$	(4.12)	$	(4.28)

Schedule of potential dilutive securities excluded from the computation of diluted net loss per share attributable to common stockholders


	As of
	December 31,
	2021	2020
Options to purchase common stock	4,704,888	4,529,675
Restricted stock units	469,485	206,529
Warrants to purchase common stock	125,618	153,473

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Stock issued (Details) - USD ($) $ / shares in Units, $ in Thousands					1 Months Ended	12 Months Ended		19 Months Ended
	Feb. 19, 2021	Jun. 12, 2020	Jun. 04, 2020	Jan. 28, 2020	Jun. 30, 2020	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2021
Secondary Public Offering, 2020
Sale of stock
Issue price (in dollars per share)				$ 45.50
Proceeds from stock issuance, net of cash issuance costs				$ 134,100			$ 134,102
Secondary Public Offering, Excluding Underwriters' Option
Sale of stock
Issuance of common stock (in shares)				2,741,489
Secondary Public Offering, Underwriters' Option
Sale of stock
Issuance of common stock (in shares)				411,223
February Offering, 2021
Sale of stock
Issuance of common stock (in shares)	3,450,000
Issue price (in dollars per share)	$ 23.00
Proceeds from stock issuance, net of cash issuance costs	$ 74,400					$ 74,421
February Offering Underwriters' Option
Sale of stock
Issuance of common stock (in shares)	450,000
Shelf Registration Statement
Sale of stock
Issuance of common stock (in shares)								3,450,000
Maximum value of shares authorized to be sold in stock offering			$ 300,000
Goldman Equity Distribution Agreement
Sale of stock
Issuance of common stock (in shares)						0
Maximum value of shares authorized to be sold in stock offering		$ 100,000			$ 100,000

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Liquidity and Going Concern (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Net loss	$ (105,584)	$ (93,961)
Accumulated deficit	(266,315)	$ (160,731)
Cash and cash equivalents and investments	$ 80,800
Substantial Doubt about Going Concern, within One Year	true

- Definition

The consolidated profit or loss for the period, net of income taxes, including the portion attributable to the noncontrolling interest.

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+ Details

- Definition

The cumulative amount of the reporting entity's undistributed earnings or deficit.

+ References + Details

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Deferred Offering Costs (Details) - USD ($) $ in Millions	Dec. 31, 2021	Dec. 31, 2020
Deferred offering cost
Deferred offering costs	$ 0.0	$ 0.0

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Stock-based compensation (Details)	12 Months Ended
	Dec. 31, 2021
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Dividend yield (as a percent)	0.00%

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Income Taxes (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Uncertain tax positions	$ 0	$ 0
Accrued interest and penalties	$ 0	$ 0

LICENSE AGREEMENT - Columbia (Details) - USD ($) $ in Thousands		1 Months Ended			12 Months Ended		63 Months Ended
	Oct. 03, 2019	Mar. 31, 2019	Jan. 31, 2019	Oct. 31, 2016	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2021
Agreements
Research and development					$ 62,570	$ 61,788
General and administrative					43,048	32,678
Operating expenses					105,618	94,466
Accrued expenses and other current liabilities					16,559	20,189	$ 16,559
Accounts payable					9,461	640	9,461
Columbia University
Agreements
Research and development					0	300
General and administrative					200	100
Operating expenses							2,500
Accrued expenses and other current liabilities					12	100	12
Accounts payable					$ 100	$ 0	$ 100
2016 license agreement \| Columbia University
Agreements
Percentage of outstanding common stock issued				5.00%
Fair value of stock issued				$ 500
Written notice period for termination of agreement				90 days
Written notice period for termination of agreement, uncured material breach				30 days
Extended written notice period for termination of agreement, attempt to cure material breach				90 days
2016 license agreement \| Columbia University \| Minimum
Agreements
Percentage of sublicensing revenue, if sublicenses rights granted				10.00%
2016 license agreement \| Columbia University \| Maximum
Agreements
Payment on achievement of specified development and regulatory milestones				$ 1,300
Payment on achievement of specified level of aggregate annual net sales				$ 1,000
Percentage of sublicensing revenue, if sublicenses rights granted				20.00%
2019 license agreement \| Columbia University
Agreements
Written notice period for termination of agreement			90 days
Written notice period for termination of agreement, uncured material breach			30 days
Extended written notice period for termination of agreement, attempt to cure material breach			90 days
2019 license agreement \| Columbia University \| Minimum
Agreements
Percentage of sublicensing revenue, if sublicenses rights granted			10.00%
2019 license agreement \| Columbia University \| Maximum
Agreements
Payment on achievement of specified development and regulatory milestones			$ 1,300
Payment on achievement of specified level of aggregate annual net sales			$ 1,000
Percentage of sublicensing revenue, if sublicenses rights granted			50.00%
2019 research agreement \| Columbia University
Agreements
Agreement term		12 months
P13k Research agreement \| Columbia University
Agreements
Agreement term	18 months

LICENSE AGREEMENT - Miami University (Details) - USD ($)			12 Months Ended
	Dec. 14, 2020	Oct. 28, 2020	Dec. 31, 2021	Dec. 31, 2020
Agreements
Research and development			$ 62,570,000	$ 61,788,000
Operating expenses			105,618,000	94,466,000
General and administrative			43,048,000	32,678,000
Accrued expenses and other current liabilities			16,559,000	20,189,000
Accounts payable			9,461,000	640,000
2020 license agreement \| University of Miami
Agreements
Amount of first payment to be made for license issue fee		$ 1,100,000
Amount of second payment to be made for license issue fee, due on first anniversary of the date of license		500,000
Payment to be made on achievement of specified patenting and development milestones		2,200,000
Payment to be made on achievement of late stage regulatory milestones		$ 4,100,000
Agreement term		10 years
Written notice period for termination of agreement		60 days
Written notice period of material breach leading to termination		60 days
Research and development			300,000	2,000,000.0
General and administrative			0	36,000
Accrued expenses and other current liabilities			300,000	1,600,000
2020 license agreement \| University of Miami \| Minimum
Agreements
Royalties payment (as a percent)		0.88%
Non-royalty sublicensing revenue payment (as a percent)		15.00%
2020 license agreement \| University of Miami \| Maximum
Agreements
Royalties payment (as a percent)		5.00%
Non-royalty sublicensing revenue payment (as a percent)		25.00%
2020 research agreement and amendment \| University of Miami
Agreements
Consideration	$ 300,000
Research and development			200,000	3,740
Accrued expenses and other current liabilities			$ 200,000	$ 3,740

FAIR VALUE MEASUREMENTS - FV hierarchy (Details) - Fair Value, Recurring - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Financial assets or liabilities measured at fair value on a recurring basis
Cash and cash equivalents	$ 53,888	$ 57,466
Marketable securities	26,935	39,363
Total financial assets measured at fair value on a recurring basis	80,823	96,829
Level 1
Financial assets or liabilities measured at fair value on a recurring basis
Cash and cash equivalents	53,888	57,466
Total financial assets measured at fair value on a recurring basis	53,888	57,466
Level 2
Financial assets or liabilities measured at fair value on a recurring basis
Marketable securities	26,935	39,363
Total financial assets measured at fair value on a recurring basis	26,935	39,363
Cash
Financial assets or liabilities measured at fair value on a recurring basis
Cash and cash equivalents	12,671	6,691
Cash \| Level 1
Financial assets or liabilities measured at fair value on a recurring basis
Cash and cash equivalents	12,671	6,691
Money market funds
Financial assets or liabilities measured at fair value on a recurring basis
Cash and cash equivalents	41,217	50,775
Money market funds \| Level 1
Financial assets or liabilities measured at fair value on a recurring basis
Cash and cash equivalents	41,217	50,775
U.S. government agency debt securities
Financial assets or liabilities measured at fair value on a recurring basis
Marketable securities	26,935	39,363
U.S. government agency debt securities \| Level 2
Financial assets or liabilities measured at fair value on a recurring basis
Marketable securities	$ 26,935	$ 39,363

FAIR VALUE MEASUREMENTS - Transfers (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
FAIR VALUE MEASUREMENTS
Assets, transfer from level 1 to level 2	$ 0	$ 0
Assets, transfer from level 2 to level 1	$ 0	$ 0

INVESTMENTS - By type (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Marketable securities by type
Cost	$ 27,042	$ 39,475
Gross Unrealized Gains	1	11
Gross Unrealized Losses	(108)	(123)
Estimated Fair Value	26,935	39,363
U.S. government agency debt securities
Marketable securities by type
Cost	27,042	39,475
Gross Unrealized Gains	1	11
Gross Unrealized Losses	(108)	(123)
Estimated Fair Value	$ 26,935	$ 39,363

INVESTMENTS - Additional Information (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
INVESTMENTS
Gross unrealized loss	$ 108	$ 123
Unrealized loss as a percentage of total amortized costs basis of corporate bond portfolio	0.39%

INVESTMENTS - By contractual maturity (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
INVESTMENTS
Due in one year or less - Cost	$ 27,042	$ 39,475
Due in on year or less - Gross Unrealized Gains	1	11
Due in one through two years - Gross Unrealized Losses	(108)	(123)
Due in one year or less - Estimated Fair Value	26,935	39,363
Cost	27,042	39,475
Gross Unrealized Gains	1	11
Gross Unrealized Losses	(108)	(123)
Estimated Fair Value	$ 26,935	$ 39,363

INVESTMENTS - Realized gains and losses (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2021 USD ($)
Marketable securities realized gain (loss) recorded
Gross realized gain from sale of marketable securities	$ 0
Gross realized loss from sale of marketable securities	$ 500

INVESTMENTS - Unrealized losses and fair values of available-for-sale securities (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Securities in an unrealized loss position less than 12 months
Unrealized Losses Less Than 12 months	$ (108)	$ (123)
Estimated Fair Value Less Than 12 Months	17,696	14,073
Total Unrealized Losses	(108)	(123)
Total Estimated Fair Value	17,696	14,073
U.S. government agency debt securities
Securities in an unrealized loss position less than 12 months
Unrealized Losses Less Than 12 months	(108)	(123)
Estimated Fair Value Less Than 12 Months	17,696	14,073
Total Unrealized Losses	(108)	(123)
Total Estimated Fair Value	$ 17,696	$ 14,073

PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid research and development expenses	$ 4,483	$ 2,349
Insurance premium asset	1,616	1,463
Prepaid rent expenses	117	108
Prepaid insurance expenses	105	91
Prepaid commercial and patient advocacy	254	968
Research and development tax credit receivable	502	500
Interest receivable	23	5
Other prepaid expenses and current assets	471	280
Total prepaid expenses & other current assets	$ 7,571	$ 5,764

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
Accrued pre-clinical and clinical expenses	$ 9,912	$ 13,742
Short-term insurance financing note	789	1,074
Accrued professional fees	419	511
Accrued compensation and benefits	2,779	2,103
Accrued commercial expenses	1,394	502
Accrued patent expenses	279	1,704
Other	987	553
Total accrued expenses & other current liabilities	$ 16,559	$ 20,189

STOCK BASED COMPENSATION - Plans (Details) - 2019 Plan - shares	1 Months Ended
	May 31, 2019	Jan. 01, 2022	Dec. 31, 2021
Stock-based compensation
Shares reserved (in shares)	4,530,000
New shares reserved (in shares)	1,618,841
Reserved shares available from 2016 Plan (in shares)	2,911,159
Increase in number of shares reserved and available for issuance (as a percent)	5.00%
Number of shares available for future issuance			398,744
Subsequent Event.
Stock-based compensation
Number of shares available for future issuance		1,310,776
Options
Stock-based compensation
Maximum number of shares authorized for issuance	13,000,000
Expiration period	10 years
Vesting period	4 years

STOCK BASED COMPENSATION - Stock-based compensation expense (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Stock-based compensation
Total stock-based compensation expense	$ 11,177	$ 8,026
Research and development
Stock-based compensation
Total stock-based compensation expense	2,759	2,580
General and administrative
Stock-based compensation
Total stock-based compensation expense	$ 8,418	$ 5,446

STOCK BASED COMPENSATION - Options (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Stock-based compensation
Options granted (in shares)	406,752	1,105,604
Stock-based compensation expense	$ 11,177	$ 8,026
Unrecognized stock-based compensation balance for unvested options	$ 18,800
Weighted-average fair value of options granted (in dollars per share)	$ 8.43	$ 18.84
Options
Stock-based compensation
Stock-based compensation expense	$ 9,300	$ 7,100
Unrecognized stock-based compensation balance for unvested options expected to be recognized (in years)	2 years 4 months 24 days

STOCK BASED COMPENSATION - Options activity (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Options Outstanding
Outstanding at beginning of period (in shares)	4,529,675
Options granted (in shares)	406,752	1,105,604
Options exercised (in shares)	(191,436)
Forfeited (in shares)	(40,008)
Expired (in shares)	(95)
Outstanding at end of period (in shares)	4,704,888	4,529,675
Exercisable at end of period (in shares)	3,168,679
Nonvested at end of period (in shares)	1,536,209
Weighted-Average Exercise Price
Outstanding at beginning of period (in dollars per share)	$ 12.87
Options granted (in dollars per share)	13.74
Options exercised (in dollars per share)	2.67
Options forfeited (in dollars per share)	21.43
Options expired (in dollars per share)	44.02
Outstanding at end of period (in dollars per share)	13.29	$ 12.87
Exercisable at end of period (in dollars per share)	9.83
Nonvested at end of period (in dollars per share)	$ 20.40
Weighted-Average Remaining Contractual Term-in years
Outstanding	7 years 8 months 12 days	8 years 5 months 26 days
Exercisable	7 years 3 months 18 days
Nonvested	8 years 7 months 6 days
Aggregate Intrinsic Value
Options exercised (in dollars)	$ 2,990
Outstanding (in dollars)	10,305	$ 51,103
Exercisable (in dollars)	10,258
Nonvested (in dollars)	$ 48

STOCK BASED COMPENSATION - Valuation assumptions (Details)	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Valuation Assumptions
Dividend yield (as a percent)	0.00%
Stock options - Service conditions only
Valuation Assumptions
Expected term/Time to expiration (in years)	5 years 9 months 18 days	6 years 1 month 6 days
Volatility	71.92%	69.70%
Risk-free interest rate	1.08%	0.51%

STOCK BASED COMPENSATION - RSUs (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Stock-based compensation
Stock-based compensation expense	$ 11,177	$ 8,026
Restricted Stock Units (RSUs)
Stock-based compensation
Stock-based compensation expense	1,900	$ 1,000
Unamortized stock-based compensation costs for unvested awards	$ 7,200
Summary of restricted stock units outstanding
Outstanding at beginning of period ( in shares)	206,529
Awarded (in shares)	348,536
Released (in shares)	(52,562)
Forfeited (in shares)	(33,018)
Outstanding at end of period ( in shares)	469,485	206,529
Nonvested at end of period (in shares)	469,485
Weighted-Average Grant Date Fair Value
Outstanding at beginning of period (in dollars per share)	$ 36.08
Awarded (in dollars per share)	11.03
Released (in dollars per share)	33.52
Forfeited (in dollars per share)	32.07
Outstanding at end of period (in dollars per share)	$ 18.05	$ 36.08
Aggregate Intrinsic Value
Outstanding at end of period (in dollars)	$ 4,202	$ 4,546
Nonvested at end of period (in dollars)	$ 4,202
Unrecognized stock-based compensation balance for unvested options expected to be recognized (in years)	3 years 4 months 24 days

STOCK BASED COMPENSATION - 2019 Employee Stock Purchase Plan (Details) - 2019 ESPP - shares	1 Months Ended	12 Months Ended
	May 31, 2019	Dec. 31, 2021
Stock-based compensation
Shares authorized (in shares)	180,000
Shares issued under ESPP		0
Maximum
Stock-based compensation
Increase in number of shares reserved and available for issuance (as a percent)	1.00%
Increase in number of shares reserved and available for issuance (in shares)	360,000

STOCKHOLDERS' EQUITY - Authorized stock (Details) - $ / shares	Dec. 31, 2021	Dec. 31, 2020
STOCKHOLDERS' EQUITY
Common Stock, authorized (in shares)	100,000,000	100,000,000
Common Stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred Stock, authorized (in shares)	10,000,000	10,000,000
Preferred Stock, par value (in dollars per share)	$ 0.0001	$ 0.0001

STOCKHOLDERS' EQUITY - Common Stock and Equity Distribution Agreement (Details) $ in Millions		1 Months Ended	12 Months Ended
	Jun. 12, 2020 USD ($)	Jun. 30, 2020 USD ($)	Dec. 31, 2021 USD ($) Vote
STOCKHOLDERS' EQUITY
Number of votes per common stock \| Vote			1
Goldman Equity Distribution Agreement
STOCKHOLDERS' EQUITY
Maximum value of shares authorized to be sold in stock offering.	$ 100.0	$ 100.0
Maximum amount to be paid to sales agent (as a percent)		3.00%
Proceeds from stock issuance			$ 0.0

WARRANTS - Issued with Series A Preferred Stock (Details) $ / shares in Units, $ in Thousands						12 Months Ended
	Feb. 05, 2021 USD ($) shares	Feb. 24, 2020 shares	Feb. 21, 2020 item shares	Dec. 05, 2019 shares	Jan. 26, 2017 USD ($) $ / shares shares	Dec. 31, 2021 USD ($) Rate Y shares
Warrants
Warrants exercised (in shares)						27,855
Proceeds from exercise of warrants \| $						$ 69
2017 Warrants \| Warrants Issued with Series A Preferred Stock
Warrants
Warrants to purchase common stock (in shares)					309,389
Warrants to purchase common stock (in dollars) \| $					$ 200
Exercise price (in dollars per share) \| $ / shares					$ 2.49
Number of warrant holders that exercised options \| item			2
Warrants exercised (in shares)	27,855	72,818	185,634	20,000
Stock issued in exercise of warrants (in shares)	27,855	69,094	176,092	17,026
Proceeds from exercise of warrants \| $	$ 69
2017 Warrants \| Warrants Issued with Series A Preferred Stock \| Contractual term (in years)
Warrants
Measurement input \| Y						10.0
2017 Warrants \| Warrants Issued with Series A Preferred Stock \| Volatility
Warrants
Measurement input \| Rate						0.7448
2017 Warrants \| Warrants Issued with Series A Preferred Stock \| Risk-free interest rate
Warrants
Measurement input \| Rate						0.0320
2017 Warrants \| Warrants Issued with Series A Preferred Stock \| Dividend yield
Warrants
Measurement input \| Rate						0.0000

WARRANTS - Issued with the 2018 Notes (Details) - USD ($) $ / shares in Units, $ in Millions				12 Months Ended
	Jun. 24, 2020	Feb. 24, 2020	Nov. 05, 2018	Dec. 31, 2021	Jan. 18, 2018
Warrants
Warrants exercised (in shares)				27,855
Warrants Issued with the 2018 Notes
Warrants
Initial fair value recorded as debt discount (in dollars)					$ 0.1
Warrants to purchase common stock (in shares)			76,847
Warrants to purchase common stock (in dollars)			$ 0.3
Exercise price (in dollars per share)			$ 6.59
Warrants exercised (in shares)	20,331	386
Stock issued in exercise of warrants (in shares)	17,369	333

WARRANTS - Issued with Series B Preferred Stock (Details) $ / shares in Units, $ in Millions				1 Months Ended	2 Months Ended	12 Months Ended
	Jun. 24, 2020 shares	Feb. 24, 2020 shares	Jan. 14, 2020 shares	Feb. 28, 2019 USD ($) $ / shares shares	Dec. 31, 2018 USD ($) $ / shares shares	Dec. 31, 2021 Rate Y shares
Warrants
Warrants exercised (in shares)						27,855
Warrants Issued with Series B Preferred Stock
Warrants
Warrants exercised (in shares)	24,309	5,193	220
Stock issued in exercise of warrants (in shares)	19,882	4,313	146
Warrants Issued with Series B Preferred Stock \| 2018 Warrants
Warrants
Warrants to purchase common stock (in shares)					72,261
Warrants to purchase common stock (in dollars) \| $					$ 0.2
Exercise price (in dollars per share) \| $ / shares					$ 8.24
Expiration term					10 years
Warrants Issued with Series B Preferred Stock \| 2018 Warrants \| Contractual term (in years)
Warrants
Measurement input \| Y						10.0
Warrants Issued with Series B Preferred Stock \| 2018 Warrants \| Volatility
Warrants
Measurement input \| Rate						0.7322
Warrants Issued with Series B Preferred Stock \| 2018 Warrants \| Risk-free interest rate
Warrants
Measurement input \| Rate						0.0270
Warrants Issued with Series B Preferred Stock \| 2018 Warrants \| Dividend yield
Warrants
Measurement input \| Rate						0.0000
Warrants Issued with Series B Preferred Stock \| 2019 Warrants
Warrants
Warrants to purchase common stock (in shares)				23,867
Warrants to purchase common stock (in dollars) \| $				$ 0.1
Exercise price (in dollars per share) \| $ / shares				$ 8.24
Expiration term				10 years
Warrants Issued with Series B Preferred Stock \| 2019 Warrants \| Contractual term (in years)
Warrants
Measurement input \| Y						10.0
Warrants Issued with Series B Preferred Stock \| 2019 Warrants \| Volatility
Warrants
Measurement input						0.7322
Warrants Issued with Series B Preferred Stock \| 2019 Warrants \| Risk-free interest rate
Warrants
Measurement input						0.0270
Warrants Issued with Series B Preferred Stock \| 2019 Warrants \| Dividend yield
Warrants
Measurement input						0.0000

WARRANTS - Warrant Activity (Details)	12 Months Ended
WARRANTS - Warrant Activity (Details)	Dec. 31, 2021 shares
WARRANTS
Outstanding as of beginning of period	153,473
Warrants exercised	(27,855)
Outstanding as of end of period	125,618

LEASES - ROU Assets and Liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
ROU Assets and Liabilities
ROU - Asset	$ 1,298	$ 1,712
Lease liabilities (current)	442	406
Lease liabilities (non-current)	$ 891	$ 1,332

LEASES - Lease Cost (Details) - USD ($) $ in Thousands	12 Months Ended
LEASES - Lease Cost (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Leases
Operating Lease Cost	$ 505	$ 487
General and administrative
Leases
Operating Lease Cost	$ 505	$ 487

LEASES - Lease terms and discount rates (Details)	Dec. 31, 2021	Dec. 31, 2020
LEASES
Weighted-average remaining lease term - operating leases	2 years 9 months 18 days	3 years 9 months 18 days
Weighted-average discount rate - operating leases	5.70%	5.70%

LEASES - Maturities of Lease Liabilities (Details) $ in Thousands	Dec. 31, 2021 USD ($)
LEASES
2022	$ 507
2023	515
2024	424
Total lease payments	1,446
Less: interest	113
Total lease liabilities	$ 1,333

INCOME TAXES - Provision (Details) - USD ($) $ in Thousands	12 Months Ended
INCOME TAXES - Provision (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
INCOME TAXES
Current tax provision	$ 0	$ 0
Deferred tax provision	$ 0	$ 0

INCOME TAXES - Deferred taxes (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Deferred Tax Assets
Operating lease liability	$ 420	$ 541
Stock-based compensation	6,606	3,788
License fee	594	630
Net operating loss carryforwards	79,429	49,094
Research and development tax credits	14,940	9,037
Other	1,352	689
Total Deferred Tax Assets	103,341	63,779
Valuation Allowance	(102,932)	(63,246)
Net Deferred Tax Assets	409	533
Deferred Tax Liabilities
Right of Use Asset	(409)	(533)
Net Deferred Tax Liabilities	(409)	(533)
Net deferred tax asset (liability)	$ 0	$ 0

INCOME TAXES - NOLs (Details) $ in Millions	Dec. 31, 2021 USD ($)
Federal
Income taxes
NOLs	$ 253.5
NOLs expiring through 2037	3.3
NOLs not subject expiration	250.1
State
Income taxes
NOLs	$ 516.1

INCOME TAXES - Tax credit carryforward (Details) $ in Millions	Dec. 31, 2021 USD ($)
Research tax credit carryforward
Tax Credit Carryforward [Line Items]
Tax credit carryforward	$ 4.8
Orphan drug credit carryforward
Tax Credit Carryforward [Line Items]
Tax credit carryforward	$ 10.2

INCOME TAXES - Valuation allowance (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
INCOME TAXES
Net deferred tax asset (liability)	$ 0	$ 0
Valuation Allowance	$ (102,932)	$ (63,246)

INCOME TAXES - Income tax rate reconciliation (Details)	12 Months Ended
INCOME TAXES - Income tax rate reconciliation (Details)	Dec. 31, 2021	Dec. 31, 2020
Tax rate reconciliation
Federal statutory rate (as a percent)	21.00%	21.00%
State and local taxes net of federal tax benefit (as a percent)	10.70%	9.90%
Credits (as a percent)	5.60%	9.60%
Permanent Differences (as a percent)	0.50%	3.90%
Change in valuation allowance (as a percent)	(37.70%)	(44.30%)
Other (as a percent)	(0.10%)	(0.10%)
Total (as a percent)	0.00%	0.00%

BENEFIT PLANS (Details) - USD ($) $ in Millions	12 Months Ended
BENEFIT PLANS (Details) - USD ($) $ in Millions	Dec. 31, 2021	Dec. 31, 2020
BENEFIT PLANS
Employer matching contributions to the plan	$ 0.2	$ 0.1

NET LOSS PER COMMON SHARE - EPS (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Numerator:
Net loss attributable to common stockholders-basic	$ (105,584)	$ (93,961)
Net loss attributable to common stockholders-diluted	$ (105,584)	$ (93,961)
Denominator:
Weighted-average common stock outstanding-basic	25,598,181	21,966,326
Weighted-average common stock outstanding-diluted	25,598,181	21,966,326
Net loss per share attributable to common stockholders-basic	$ (4.12)	$ (4.28)
Net loss per share attributable to common stockholders-diluted	$ (4.12)	$ (4.28)

- Definition

The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

+ References

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+ Details

- Definition

The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.

+ References

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NET LOSS PER COMMON SHARE - Anti-dilutive securities (Details) - shares	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Options
Antidilutive securities excluded from computation of loss per share
Potential dilutive securities excluded from the computation of diluted net loss per share attributable to common stockholders	4,704,888	4,529,675
Restricted Stock Units (RSUs)
Antidilutive securities excluded from computation of loss per share
Potential dilutive securities excluded from the computation of diluted net loss per share attributable to common stockholders	469,485	206,529
Warrants Liability
Antidilutive securities excluded from computation of loss per share
Potential dilutive securities excluded from the computation of diluted net loss per share attributable to common stockholders	125,618	153,473

RELATED PARTIES (Details) - LaunchLabs Agreement - USD ($)	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Related Party Transaction [Line Items]
Payments to related party	$ 100,000	$ 89,000
Due to related parties	$ 0

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Carrying amount as of the balance sheet date of obligations due all related parties.

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SUBSEQUENT EVENTS (Details) - USD ($) $ in Millions	Feb. 15, 2022	Jan. 26, 2022	Dec. 14, 2020
University of Miami \| 2020 research agreement and amendment
Subsequent event
Consideration			$ 0.3
Subsequent Event. \| University of Miami \| 2020 research agreement and amendment
Subsequent event
Consideration	$ 0.3
Subsequent Event. \| Cowen Equity Distribution Agreement
Subsequent event
Maximum value of shares authorized to be sold in stock offering		$ 100.0
Maximum amount to be paid to sale agent (as a percent)		3.00%