0001558370-22-008438 | 10-Q | XBRL Viewer

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Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2022	May 11, 2022
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2022
Document Transition Report	false
Entity File Number	001-38898
Entity Registrant Name	Applied Therapeutics, Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	81-3405262
Entity Address, Address Line One	545 Fifth Avenue
Entity Address, Address Line Two	Suite 1400
Entity Address, City or Town	New York
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	10017
City Area Code	212
Local Phone Number	220-9226
Title of 12(b) Security	Common Stock
Trading Symbol	APLT
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	true
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		26,236,931
Entity Central Index Key	0001697532
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q1
Amendment Flag	false

Condensed Balance Sheets - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
CURRENT ASSETS:
Cash and cash equivalents	$ 38,214	$ 53,888
Investments	17,437	26,935
Prepaid expenses and other current assets	7,913	7,571
Total current assets	63,564	88,394
Operating lease right-of-use asset	1,190	1,298
Security deposits and leasehold improvements	199	200
TOTAL ASSETS	64,953	89,892
CURRENT LIABILITIES:
Current portion of operating lease liabilities	453	442
Accounts payable	5,922	9,461
Accrued expenses and other current liabilities	15,842	16,559
Total current liabilities	22,217	26,462
NONCURRENT LIABILITIES:
Noncurrent portion of operating lease liabilities	773	891
Total noncurrent liabilities	773	891
Total liabilities	22,990	27,353
STOCKHOLDERS' EQUITY:
Common stock, $0.0001 par value; 100,000,000 shares authorized as of March 31, 2022 and December 31, 2021; 26,215,514 shares issued and outstanding as of March 31, 2022 and December 31, 2021	3	3
Preferred stock, par value $0.0001; 10,000,000 shares authorized as of March 31, 2022 and December 31, 2021; 0 shares issued and outstanding as of March 31, 2022 and December 31, 2021.
Additional paid-in capital	331,476	328,958
Accumulated other comprehensive loss	(80)	(107)
Accumulated deficit	(289,436)	(266,315)
Total stockholders' equity	41,963	62,539
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 64,953	$ 89,892

Condensed Balance Sheets (Parenthetical) - $ / shares	Mar. 31, 2022	Dec. 31, 2021
Condensed 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	26,215,514
Common stock, outstanding (in shares)	26,215,514	26,215,514
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

Condensed Statements of Operations - USD ($) $ in Thousands	3 Months Ended
Condensed Statements of Operations - USD ($) $ in Thousands	Mar. 31, 2022	Mar. 31, 2021
OPERATING EXPENSES:
Research and development	$ 15,030	$ 14,448
General and administrative	8,071	9,751
Total operating expenses	23,101	24,199
LOSS FROM OPERATIONS	(23,101)	(24,199)
OTHER INCOME (EXPENSE), NET:
Interest income (expense), net	76	76
Other income (expense)	(96)	(56)
Total other income (expense), net	(20)	20
Net loss	(23,121)	(24,179)
Net loss attributable to common stockholders-basic	(23,121)	(24,179)
Net loss attributable to common stockholders-diluted	$ (23,121)	$ (24,179)
Net loss per share attributable to common stockholders-basic (in dollars per share)	$ (0.88)	$ (1.00)
Net loss per share attributable to common stockholders-diluted (in dollars per share)	$ (0.88)	$ (1.00)
Weighted-average common stock outstanding-basic (in shares)	26,215,514	24,135,735
Weighted-average common stock outstanding-diluted (in shares)	26,215,514	24,135,735

Condensed Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Condensed Statements of Comprehensive Income (Loss)
Net Loss	$ (23,121)	$ (24,179)
Other comprehensive income (loss)
Unrealized gain (loss) on marketable securities	27	(42)
Other comprehensive gain (loss), net of tax	27	(42)
Comprehensive income (loss), net of tax	$ (23,094)	$ (24,221)

- 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

Condensed Statement of Stockholders' Equity - USD ($) $ in Thousands	Common Stock	Additional Paid-in Capital	Accumulated Deficit	Accumulated Other Comprehensive Income (Loss)	Total
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	74,386			74,387
Issuance of common stock (in shares)	3,450,000
Exercise of options for common stock issued under equity incentive plan		67			67
Exercise of options for common stock issued under equity incentive plan (in shares)	37,400
Exercise of options for common stock not yet issued		(1)			(1)
Exercise of options for common stock not yet issued (in shares)	(465)
Restricted Stock Unit released for common stock issued under Equity Incentive Plan (in shares)	1,988
Exercise of warrants of common stock		69			69
Exercise of warrants of common stock (in shares)	27,855
Stock-based compensation expense		2,981			2,981
Net loss			(24,179)		(24,179)
Other comprehensive income (loss)				(42)	(42)
Balance at Mar. 31, 2021	$ 3	320,282	(184,910)	(154)	135,221
Balance (in shares) at Mar. 31, 2021	26,010,439
Balance at Dec. 31, 2021	$ 3	328,958	(266,315)	(107)	62,539
Balance (in shares) at Dec. 31, 2021	26,215,514
Increase (Decrease) in Stockholders' Equity
Restricted Stock Unit released for common stock issued under Equity Incentive Plan (in shares)	21,417
Restricted Stock Units released for common stock not yet issued (in shares)	(21,417)
Stock-based compensation expense		2,077			2,077
Issuance of options in-lieu of bonus		441			441
Net loss			(23,121)		(23,121)
Other comprehensive income (loss)				27	27
Balance at Mar. 31, 2022	$ 3	$ 331,476	$ (289,436)	$ (80)	$ 41,963
Balance (in shares) at Mar. 31, 2022	26,215,514

Condensed Statement of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2021	Mar. 31, 2022
Increase (Decrease) in Stockholders' Equity
Common Stock, par value (in dollars per share)		$ 0.0001
Stock issuance cost	$ 203
Common Stock
Increase (Decrease) in Stockholders' Equity
Common Stock, par value (in dollars per share)	$ 0.0001	$ 0.0001

Condensed Statements of Cash Flows - USD ($) $ in Thousands	3 Months Ended
Condensed Statements of Cash Flows - USD ($) $ in Thousands	Mar. 31, 2022	Mar. 31, 2021
OPERATING ACTIVITIES:
Net loss	$ (23,121)	$ (24,179)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	2,077	2,981
Issuance of options in-lieu of bonus	441
Amortization of operating lease right-of-use assets	108	100
Change in operating lease liability	(106)	(97)
Changes in operating assets and liabilities:
Prepaid expenses	(1,435)	(1,573)
Accounts payable	(3,539)	2,835
Accrued expenses and other current liabilities	72	(3,270)
Amortization of insurance premium	1,093	990
Net cash used in operating activities	(24,410)	(22,213)
INVESTING ACTIVITIES:
Purchase of available-for-sale securities	(5,994)	(88,007)
Proceeds from sale of available-for-sale securities		500
Proceeds from maturities of available-for-sale securities	15,519	62,835
Net cash provided by/(used in) investing activities	9,525	(24,672)
FINANCING ACTIVITIES:
Proceeds from February Offering, net of cash issuance costs of $169		74,424
Repayments of short-term borrowings	(789)	(1,074)
Exercise of stock options for common stock under Equity Incentive Plan		67
Exercise of Warrants		69
Net cash (used in)/provided by financing activities	(789)	73,486
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	(15,674)	26,601
Cash and cash equivalents at beginning of period	53,888	57,466
Cash and cash equivalents at end of period	38,214	84,067
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Unrealized gain (loss) on marketable securities	$ 27	(42)
February Offering costs still in accrued expense		$ 38

Condensed Statements of Cash Flows (Parenthetical) $ in Thousands	3 Months Ended
	Mar. 31, 2021 USD ($)
Condensed Statements of Cash Flows
Cash issuance costs, February Offering	$ 165

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

3 Months Ended

Mar. 31, 2022

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 rare metabolic diseases such as Galactosemia, Sorbitol Dehydrogenase deficiency, (“SORD” deficiency), and diabetic complications including diabetic cardiomyopathy. 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.

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. The Goldman Equity Distribution Agreement was terminated as of January 24, 2022.

In February 2021, the Company completed an underwritten public offering of 3,450,000 shares of common stock (the “February Offering”), 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.

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. As of March 31, 2022, the Company has not sold any shares of common stock pursuant to the Cowen Equity Distribution Agreement.

The accompanying unaudited condensed financial statements have been prepared by the Company in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and, pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. These condensed financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2021 included in the Annual Report, filed with the SEC on March 10, 2022 (the “Annual Report”).

The unaudited condensed financial statements have been prepared on the same basis as the audited financial statements. In the opinion of management, the accompanying unaudited condensed financial statements contain all adjustments which are necessary for a fair presentation of the Company’s financial position as of March 31, 2022, results of operations for the three months ended March 31, 2022 and 2021 and cash flows for the three months ended March 31, 2022 and 2021. Such adjustments are of a normal and recurring nature. The results of operations for the three months ended March 31, 2022, are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2022.

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 $23.1 million for the three months ended March 31, 2022 and has an accumulated deficit of $289.4 million as of March 31, 2022. 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. While we believe that our cash and cash equivalents and investments of $55.7 million at March 31, 2022 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 at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

Significant Accounting Policies

The significant accounting policies and estimates used in preparation of the condensed financial statements are described in the Company’s audited financial statements as of and for the year ended December 31, 2021, and the notes thereto, which are included in the Annual Report. There have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2022.

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

3 Months Ended

Mar. 31, 2022

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 terms.

During the three months ended March 31, 2022, the Company recorded $0 and $13,000 in research and development expense and general and administrative expense, respectively, related to the Columbia Agreements. During the three months ended March 31, 2021, the Company recorded $0 in research and development expense and $32,000 in general and administrative expense, respectively, related to the Columbia Agreements. In aggregate, the Company has incurred $2.5 million in expense from the execution of the Columbia Agreements through March 31, 2022.

As of March 31, 2022, the Company had $36,000 due to Columbia University included in accrued expenses and $0 included in accounts payable. 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.

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 the Company 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.

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 later of 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.

During each of the three months ended March 31, 2022 and 2021 the Company recorded $25,000 in research and development expense related to the 2020 Miami License Agreement. In aggregate, the Company has incurred $2.3 million in expense from execution of the 2020 Miami License Agreement through March 31, 2022.

The Company had $0.3 million and $0.3 million due to UM included in accrued expenses as of March 31, 2022 and December 31, 2021, respectively, relating to the 2020 Miami License Agreement.

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 the Company certain option rights to access and use the research results and to obtain licenses to any associated patent rights upon the Company 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 is from December 14, 2020 through December 30, 2021, and was extended through May 31, 2022. The total consideration for the 2020 Miami Research Agreement was $0.3 million.

During the three months ended March 31, 2022 and 2021, the Company recorded $37,000 and $67,000, respectively, in research and development expense in relation to the 2020 Miami Research Agreement. The Company had $0.1 million and $0.2 million as of March 31, 2022 and December 31, 2021, respectively, in accrued expense in relation to the 2020 Miami Research Agreement.

Bayh-Dole Act

Some of the intellectual property rights the Company has licensed, including certain rights licensed in the agreements described above, may have been generated through the use of U.S. government funding. As a result, the U.S. government may have certain rights to intellectual property embodied in the Company’s current or future product candidates under the Bayh-Dole Act of 1980, or 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. To the extent any of the Company’s current or future intellectual property is generated through the use of U.S. government funding, the provisions of the Bayh-Dole Act may similarly apply.

FAIR VALUE MEASUREMENTS

3 Months Ended

Mar. 31, 2022

FAIR VALUE MEASUREMENTS

FAIR VALUE MEASUREMENTS

3. FAIR VALUE MEASUREMENTS

The following tables summarize, as of March 31, 2022, 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 in the Company’s audited financial statements as of and for the year ended December 31, 2021, and the notes thereto, which are included in the Annual Report.


	As of March 31, 2022
(in thousands)	Level 1		Level 2		Level 3		Total
Cash	$	3,991	$	—	$	—	$	3,991
Money market funds		34,223		—		—		34,223
Total cash and cash equivalents	$	38,214	$	—	$	—	$	38,214
U.S. government agency debt securities		—		17,437		—		17,437
Total marketable securities	$	—	$	17,437	$	—	$	17,437
Total financial assets measured at fair value on a recurring basis	$	38,214	$	17,437	$	—	$	55,651

Investments in 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 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. During the period ended March 31, 2022, there were no transfers of financial assets between Level 1 and Level 2.

INVESTMENTS

3 Months Ended

Mar. 31, 2022

INVESTMENTS

INVESTMENTS

4. INVESTMENTS

Marketable Securities

Marketable securities, which the Company classifies as available-for-sale securities, primarily consist of 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 March 31, 2022								As of December 31, 2021
			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	$	17,518	$	1	$	(82)	$	17,437	$	27,042	$	1	$	(108)	$	26,935
Total	$	17,518	$	1	$	(82)	$	17,437	$	27,042	$	1	$	(108)	$	26,935

As of March 31, 2022, the Company’s investment portfolio reported an unrealized loss of $0.1 million. Based on its 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+ or above, along with a history of no defaults. No single investment in the portfolio had an individually material unrealized loss and in the aggregate. The total amount of unrealized losses of $0.1 million as of March 31, 2022 was only 0.47% 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 three months ended March 31, 2022 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:


	As of March 31, 2022								As of December 31, 2021
			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	$	17,518	$	1	$	(82)	$	17,437	$	27,042	$	1	$	(108)	$	26,935
Due in one through two years		—		—		—		—		—		—		—		—
Total	$	17,518	$	1	$	(82)	$	17,437	$	27,042	$	1	$	(108)	$	26,935

At March 31, 2022, 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 three months ended March 31, 2022, the Company recorded gross realized losses of $80,000 and no gross realized gains of 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 March 31, 2022 are as follows:


	As of March 31, 2022
	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	$	(82)	$	14,438	$	—	$	—	$	(82)	$	14,438
Total	$	(82)	$	14,438	$	—	$	—	$	(82)	$	14,438

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

PREPAID EXPENSES AND OTHER CURRENT ASSETS

3 Months Ended

Mar. 31, 2022

PREPAID EXPENSES AND OTHER CURRENT ASSETS

PREPAID EXPENSES AND OTHER CURRENT ASSETS

5. PREPAID EXPENSES AND OTHER CURRENT ASSETS

Prepaid expenses and other current assets consisted of the following:


	March 31,		December 31,
(in thousands)	2022		2021
Prepaid research and development expenses	$	5,837	$	4,483
Insurance premium asset		522		1,616
Prepaid rent expenses		125		117
Prepaid insurance expenses		99		105
Prepaid commercial and patient advocacy		383		254
Research and development tax credit receivable		469		502
Interest receivable		23		23
Other prepaid expenses and current assets		455		471
Total prepaid expenses & other current assets	$	7,913	$	7,571

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

3 Months Ended

Mar. 31, 2022

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

6. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

Accrued expenses and other current liabilities consisted of the following:


	March 31,		December 31,
(in thousands)	2022		2021
Accrued pre-clinical and clinical expenses	$	12,217	$	9,912
Short-term insurance financing note		—		789
Accrued professional fees		533		419
Accrued compensation and benefits		707		2,779
Accrued commercial expenses		1,355		1,394
Accrued patent expenses		328		279
Other		702		987
Total accrued expenses & other current liabilities	$	15,842	$	16,559

STOCK BASED COMPENSATION

3 Months Ended

Mar. 31, 2022

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 was 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 March 31, 2022, there were 1,379,543 shares of common stock available for issuance under the 2019 Plan.

Stock-Based Compensation Expense

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


	Three Months Ended
	March 31,
(in thousands)	2022		2021
Research and development	$	856	$	799
General and administrative		1,221		2,182
Total stock-based compensation expense	$	2,077	$	2,981

Stock Option Activity

During the three months ended March 31, 2022 the Company granted 400,416 options to shares of common stock. For the three months ended March 31, 2022 and 2021, amortization of stock compensation of options amounted to $2.0 million and $2.5 million, respectively. As of March 31, 2022 and 2021, the total unrecognized stock-based compensation balance for unvested options was $13.0 million and $22.7 million, respectively, which is expected to be recognized over 2.4 years and 2.9 years, respectively. The weighted-average fair value per share of options granted during the three months ended March 31, 2022 and 2021 was $2.22 and zero, respectively.

The following table summarizes the information about options outstanding at March 31, 2022:


				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, 2021	4,704,888	$	13.29	7.7	$	10,305
Options granted	400,416		3.68
Options exercised	-		—
Forfeited	(248,222)		27.73
Expired	(5,517)		23.15
Outstanding at March 31, 2022	4,851,565	$	11.74	7.4	$	489

Exercisable at March 31, 2022	3,577,835	$	9.81	7.0	$	489
Nonvested at March 31, 2022	1,273,730	$	17.17	8.5	$	—

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 three months ended March 31, 2022 and 2021.


	Three Months Ended
	March 31,
	2022			2021
Expected term (in years)		5.5			—
Volatility		69.68	%		—	%
Risk-free interest rate		1.56	%		—	%
Dividend yield		—	%		—	%

Restricted Stock Unit Activity

During the three months ended March 31, 2022, the Company granted 248,700 RSUs to shares of common stock. For the three months ended March 31, 2022 and 2021, amortization of stock compensation of RSUs amounted to $0.1 million and $0.5 million, respectively. As of March 31, 2022 and 2021, the unamortized compensation costs associated with non-vested restricted stock awards were $5.4 million and $5.9 million, respectively, with a weighted-average remaining amortization period of 3.4 and 3.2 years, respectively.

The following table summarizes the information about restricted stock units outstanding at March 31, 2022:


		Weighted-Average
		Grant Date		Aggregate
(in thousands, except for share data)	Shares	Fair Value		Intrinsic Value
Outstanding at December 31, 2021	469,485	$	18.05	$	4,202
Awarded	248,700		4.17
Released	(21,417)		25.69
Forfeited	(145,300)		19.48
Outstanding at March 31, 2022	551,468	$	11.12	$	1,164
Nonvested at March 31, 2022	551,468	$	11.12	$	1,164

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 March 31, 2022, 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

3 Months Ended

Mar. 31, 2022

STOCKHOLDERS' EQUITY

STOCKHOLDERS' EQUITY

8. STOCKHOLDERS’ EQUITY

As of March 31, 2022, and December 31, 2021, 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

Goldman Equity Distribution Agreement

In June 2020, the Company entered into the Goldman Equity Distribution Agreement to sell shares of the Company’s common stock, from time to time, having an aggregate offering price of up to $100.0 million. The issuance and sale of shares of common stock by the Company pursuant to the Goldman 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 the Company’s common stock sold through it as a sales agent pursuant to the Goldman Equity Distribution Agreement. The Goldman Equity Distribution Agreement was terminated as of January 24, 2022.

Cowen Equity Distribution Agreement

On January 26, 2022, the Company entered into the Cowen Equity Distribution Agreement 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. As of March 31, 2022, the Company has not sold any shares of common stock pursuant to the Cowen Equity Distribution Agreement.

- 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.

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+ Details

WARRANTS

3 Months Ended

Mar. 31, 2022

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 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 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.

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 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	%

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 vested 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.

A summary of the Company’s outstanding common stock warrants as of March 31, 2022 is as follows:


	Warrants
Outstanding as of December 31, 2021		125,618
Warrants granted and issued		—
Warrants exercised		—
Warrants exchanged		—
Balance as of March 31, 2022		125,618

LEASES

3 Months Ended

Mar. 31, 2022

LEASES

LEASES

10. LEASES

The following table summarizes the Company’s lease related costs for the three months ended March 31, 2022 and 2021:


		Operating (in thousands)
Lease Cost	Statement of Operations Location		2022		2021
Operating Lease Cost	General and administrative	$	142	$	126
Total Lease Cost		$	142	$	126

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


	Three Months Ended
	March 31,		March 31,
Other Information	2022		2021
Weighted-average remaining lease term
Operating leases		2.6 years		3.6 years
Weighted-average discount rate
Operating leases		5.69%		5.69%

The following table summarizes the maturities of lease liabilities as of March 31, 2022:


	Operating
Year	(in thousands)
2022	$	381
2023		515
2024		426
Thereafter		—
Total lease payments		1,322
Less: interest		96
Total lease liabilities	$	1,226

INCOME TAXES

3 Months Ended

Mar. 31, 2022

INCOME TAXES

INCOME TAXES

11. INCOME TAXES

On March 27, 2020, Congress enacted the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to provide certain relief as a result of the Covid-19 pandemic. The CARES Act provides numerous tax provisions and other stimulus measures, including temporary changes regarding the prior and future utilization of net operating losses, temporary changes to the prior and future limitations on interest deductions, temporary suspension of certain payment requirements for the employer portion of social security taxes, technical corrections from prior tax legislation for tax depreciation of certain qualified improvement property and the creation of certain refundable employee retention credits. The CARES Act did not have a material impact on our financial statements for the three ended March 31, 2022. The Company continues to monitor any effects that may result from the CARES Act.

During the three months ended March 31, 2022 and the year ended December 31, 2021, the Company recorded a full valuation allowance on federal and state deferred tax assets since management does not forecast the Company to be in a profitable position in the near future.

- 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

3 Months Ended

Mar. 31, 2022

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 of directors. The Company made approximately $0.2 million and $0.1 million in matching contributions to the plan during the three months ended March 31, 2022 and 2021, respectively.

- Definition

The entire disclosure for retirement benefits.

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+ Details

NET LOSS PER COMMON SHARE

3 Months Ended

Mar. 31, 2022

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 three months ended March 31, 2022 and 2021, as the inclusion of all potential common shares outstanding would have been anti-dilutive.

The following tables set forth the computation of basic and diluted net loss per common share for the three months ended March 31, 2022 and 2021:


	Three Months Ended
	March 31,
	2022		2021
Numerator:
Net loss	$	(23,121)	$	(24,179)
Denominator:
Weighted-average common stock outstanding		26,215,514		24,135,735
Net loss per share attributable to common stockholders - basic and diluted	$	(0.88)	$	(1.00)

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 for the three months ended March 31, 2022 and 2021, 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
	March 31,
	2022	2021
Options to purchase common stock	4,851,565	4,491,670
Restricted stock units	551,468	204,279
Warrants to purchase common stock	125,618	125,618

RELATED PARTIES

3 Months Ended

Mar. 31, 2022

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 three months ended March 31, 2022, and 2021, the Company made payments to Alexandria LaunchLabs of approximately $16,000, and $23,000 respectively, under the LaunchLabs Agreement, which was recognized in research and development expenses. As of March 31, 2022, there were no amounts due to Alexandria LaunchLabs under the LaunchLabs Agreement.

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	3 Months Ended
	Mar. 31, 2022
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 rare metabolic diseases such as Galactosemia, Sorbitol Dehydrogenase deficiency, (“SORD” deficiency), and diabetic complications including diabetic cardiomyopathy. 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. 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. The Goldman Equity Distribution Agreement was terminated as of January 24, 2022. In February 2021, the Company completed an underwritten public offering of 3,450,000 shares of common stock (the “February Offering”), 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. 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. As of March 31, 2022, the Company has not sold any shares of common stock pursuant to the Cowen Equity Distribution Agreement. The accompanying unaudited condensed financial statements have been prepared by the Company in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and, pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. These condensed financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2021 included in the Annual Report, filed with the SEC on March 10, 2022 (the “Annual Report”). The unaudited condensed financial statements have been prepared on the same basis as the audited financial statements. In the opinion of management, the accompanying unaudited condensed financial statements contain all adjustments which are necessary for a fair presentation of the Company’s financial position as of March 31, 2022, results of operations for the three months ended March 31, 2022 and 2021 and cash flows for the three months ended March 31, 2022 and 2021. Such adjustments are of a normal and recurring nature. The results of operations for the three months ended March 31, 2022, are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2022.
Liquidity and Going Concern	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 $23.1 million for the three months ended March 31, 2022 and has an accumulated deficit of $289.4 million as of March 31, 2022. 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. While we believe that our cash and cash equivalents and investments of $55.7 million at March 31, 2022 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.
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 at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
Significant Accounting Policies	Significant Accounting Policies The significant accounting policies and estimates used in preparation of the condensed financial statements are described in the Company’s audited financial statements as of and for the year ended December 31, 2021, and the notes thereto, which are included in the Annual Report. There have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2022.
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)

3 Months Ended

Mar. 31, 2022

FAIR VALUE MEASUREMENTS

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


	As of March 31, 2022
(in thousands)	Level 1		Level 2		Level 3		Total
Cash	$	3,991	$	—	$	—	$	3,991
Money market funds		34,223		—		—		34,223
Total cash and cash equivalents	$	38,214	$	—	$	—	$	38,214
U.S. government agency debt securities		—		17,437		—		17,437
Total marketable securities	$	—	$	17,437	$	—	$	17,437
Total financial assets measured at fair value on a recurring basis	$	38,214	$	17,437	$	—	$	55,651

INVESTMENTS (Tables)

3 Months Ended

Mar. 31, 2022

INVESTMENTS

Schedule of marketable securities by security type


	As of March 31, 2022								As of December 31, 2021
			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	$	17,518	$	1	$	(82)	$	17,437	$	27,042	$	1	$	(108)	$	26,935
Total	$	17,518	$	1	$	(82)	$	17,437	$	27,042	$	1	$	(108)	$	26,935

Schedule of contractual maturities


	As of March 31, 2022								As of December 31, 2021
			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	$	17,518	$	1	$	(82)	$	17,437	$	27,042	$	1	$	(108)	$	26,935
Due in one through two years		—		—		—		—		—		—		—		—
Total	$	17,518	$	1	$	(82)	$	17,437	$	27,042	$	1	$	(108)	$	26,935

Unrealized Gain (Loss) on Investments


	As of March 31, 2022
	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	$	(82)	$	14,438	$	—	$	—	$	(82)	$	14,438
Total	$	(82)	$	14,438	$	—	$	—	$	(82)	$	14,438


	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

PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables)

3 Months Ended

Mar. 31, 2022

PREPAID EXPENSES AND OTHER CURRENT ASSETS

Summary of prepaid expenses and other current assets


	March 31,		December 31,
(in thousands)	2022		2021
Prepaid research and development expenses	$	5,837	$	4,483
Insurance premium asset		522		1,616
Prepaid rent expenses		125		117
Prepaid insurance expenses		99		105
Prepaid commercial and patient advocacy		383		254
Research and development tax credit receivable		469		502
Interest receivable		23		23
Other prepaid expenses and current assets		455		471
Total prepaid expenses & other current assets	$	7,913	$	7,571

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables)

3 Months Ended

Mar. 31, 2022

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

Summary of accrued expenses and other current liabilities


	March 31,		December 31,
(in thousands)	2022		2021
Accrued pre-clinical and clinical expenses	$	12,217	$	9,912
Short-term insurance financing note		—		789
Accrued professional fees		533		419
Accrued compensation and benefits		707		2,779
Accrued commercial expenses		1,355		1,394
Accrued patent expenses		328		279
Other		702		987
Total accrued expenses & other current liabilities	$	15,842	$	16,559

STOCK BASED COMPENSATION (Tables)

3 Months Ended

Mar. 31, 2022

Stock-based compensation

Schedule of stock-based compensation expenses


	Three Months Ended
	March 31,
(in thousands)	2022		2021
Research and development	$	856	$	799
General and administrative		1,221		2,182
Total stock-based compensation expense	$	2,077	$	2,981

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, 2021	4,704,888	$	13.29	7.7	$	10,305
Options granted	400,416		3.68
Options exercised	-		—
Forfeited	(248,222)		27.73
Expired	(5,517)		23.15
Outstanding at March 31, 2022	4,851,565	$	11.74	7.4	$	489

Exercisable at March 31, 2022	3,577,835	$	9.81	7.0	$	489
Nonvested at March 31, 2022	1,273,730	$	17.17	8.5	$	—

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, 2021	469,485	$	18.05	$	4,202
Awarded	248,700		4.17
Released	(21,417)		25.69
Forfeited	(145,300)		19.48
Outstanding at March 31, 2022	551,468	$	11.12	$	1,164
Nonvested at March 31, 2022	551,468	$	11.12	$	1,164

Weighted Average Remaining Recognition Period (in years)	3.4

Stock options - Service conditions only

Stock-based compensation

Schedule of valuation assumptions


	Three Months Ended
	March 31,
	2022			2021
Expected term (in years)		5.5			—
Volatility		69.68	%		—	%
Risk-free interest rate		1.56	%		—	%
Dividend yield		—	%		—	%

WARRANTS (Tables)

3 Months Ended

Mar. 31, 2022

Warrants

Schedule of warrants outstanding


	Warrants
Outstanding as of December 31, 2021		125,618
Warrants granted and issued		—
Warrants exercised		—
Warrants exchanged		—
Balance as of March 31, 2022		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)

3 Months Ended

Mar. 31, 2022

LEASES

Summary of lease related costs


		Operating (in thousands)
Lease Cost	Statement of Operations Location		2022		2021
Operating Lease Cost	General and administrative	$	142	$	126
Total Lease Cost		$	142	$	126

Summary of lease terms and discount rates


	Three Months Ended
	March 31,		March 31,
Other Information	2022		2021
Weighted-average remaining lease term
Operating leases		2.6 years		3.6 years
Weighted-average discount rate
Operating leases		5.69%		5.69%

Summary of maturities of lease liabilities


	Operating
Year	(in thousands)
2022	$	381
2023		515
2024		426
Thereafter		—
Total lease payments		1,322
Less: interest		96
Total lease liabilities	$	1,226

NET LOSS PER COMMON SHARE (Tables)

3 Months Ended

Mar. 31, 2022

NET LOSS PER COMMON SHARE

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


	Three Months Ended
	March 31,
	2022		2021
Numerator:
Net loss	$	(23,121)	$	(24,179)
Denominator:
Weighted-average common stock outstanding		26,215,514		24,135,735
Net loss per share attributable to common stockholders - basic and diluted	$	(0.88)	$	(1.00)

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


	As of
	March 31,
	2022	2021
Options to purchase common stock	4,851,565	4,491,670
Restricted stock units	551,468	204,279
Warrants to purchase common stock	125,618	125,618

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Stock issued (Details) - USD ($) $ / shares in Units, $ in Thousands					1 Months Ended		3 Months Ended
	Jan. 26, 2022	Jun. 12, 2020	Jun. 04, 2020	Jan. 28, 2020	Feb. 28, 2021	Jun. 30, 2020	Mar. 31, 2022	Mar. 31, 2021
Sale of stock
Proceeds from stock issuance, net of cash issuance costs								$ 74,424
Secondary Public Offering, 2020
Sale of stock
Issue price (in dollars per share)				$ 45.50
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
Proceeds from stock issuance, net of cash issuance costs				$ 134,100
Shelf Registration Statement
Sale of stock
Maximum value of shares authorized to be sold in stock offering			$ 300,000
Goldman Equity Distribution Agreement
Sale of stock
Maximum value of shares authorized to be sold in stock offering		$ 100,000				$ 100,000
Maximum amount to be paid to sales agent (as a percent)						3.00%
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
February Offering Underwriters' Option
Sale of stock
Issuance of common stock (in shares)					450,000
Cowen 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
Maximum amount to be paid to sales agent (as a percent)	3.00%

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Liquidity and Going Concern (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Net loss	$ (23,121)	$ (24,179)
Accumulated deficit	(289,436)		$ (266,315)
Cash and cash equivalents and investments	$ 55,700
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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-Publisher FASB
-Name Accounting Standards Codification
-Topic 810
-SubTopic 10
-Section 55
-Paragraph 4K
-URI http://asc.fasb.org/extlink&oid=120409616&loc=SL4591552-111686

Reference 33: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 250
-SubTopic 10
-Section 50
-Paragraph 8
-URI http://asc.fasb.org/extlink&oid=124431687&loc=d3e22658-107794

+ Details

- Definition

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

+ References + Details

LICENSE AGREEMENT - Columbia (Details) - USD ($) $ in Thousands		1 Months Ended			3 Months Ended		66 Months Ended
	Oct. 03, 2019	Mar. 31, 2019	Jan. 31, 2019	Oct. 31, 2016	Mar. 31, 2022	Mar. 31, 2021	Mar. 31, 2022	Dec. 31, 2021
Agreements
Research and development					$ 15,030	$ 14,448
General and administrative					8,071	9,751
Operating expenses					23,101	24,199
Accrued expenses and other current liabilities					15,842		$ 15,842	$ 16,559
Accounts payable					5,922		5,922	9,461
Columbia University
Agreements
Research and development					0	0
General and administrative					13	$ 32
Operating expenses							2,500
Accrued expenses and other current liabilities					36		36	12
Accounts payable					$ 0		$ 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 ($) $ in Thousands			3 Months Ended		17 Months Ended
	Dec. 14, 2020	Oct. 28, 2020	Mar. 31, 2022	Mar. 31, 2021	Mar. 31, 2022	Dec. 31, 2021
Agreements
Research and development			$ 15,030	$ 14,448
Operating expenses			23,101	24,199
General and administrative			8,071	9,751
Accrued expenses and other current liabilities			15,842		$ 15,842	$ 16,559
Accounts payable			5,922		5,922	9,461
2020 license agreement \| University of Miami
Agreements
Amount of first payment to be made for license issue fee		$ 1,100
Amount of second payment to be made for license issue fee, due on first anniversary of the date of license		500
Payment to be made on achievement of specified patenting and development milestones		2,200
Payment to be made on achievement of late stage regulatory milestones		$ 4,100
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			25	25
Operating expenses					2,300
Accrued expenses and other current liabilities			300		300	$ 300
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
Research and development			37	67
Accrued expenses and other current liabilities			$ 100	$ 200	$ 100

FAIR VALUE MEASUREMENTS - FV hierarchy (Details) - Fair Value, Recurring $ in Thousands	Mar. 31, 2022 USD ($)
Financial assets or liabilities measured at fair value on a recurring basis
Cash and cash equivalents	$ 38,214
Marketable securities	17,437
Total financial assets measured at fair value on a recurring basis	55,651
Level 1
Financial assets or liabilities measured at fair value on a recurring basis
Cash and cash equivalents	38,214
Total financial assets measured at fair value on a recurring basis	38,214
Level 2
Financial assets or liabilities measured at fair value on a recurring basis
Marketable securities	17,437
Total financial assets measured at fair value on a recurring basis	17,437
Cash
Financial assets or liabilities measured at fair value on a recurring basis
Cash and cash equivalents	3,991
Cash \| Level 1
Financial assets or liabilities measured at fair value on a recurring basis
Cash and cash equivalents	3,991
Money market funds
Financial assets or liabilities measured at fair value on a recurring basis
Cash and cash equivalents	34,223
Money market funds \| Level 1
Financial assets or liabilities measured at fair value on a recurring basis
Cash and cash equivalents	34,223
U.S. government agency debt securities
Financial assets or liabilities measured at fair value on a recurring basis
Marketable securities	17,437
U.S. government agency debt securities \| Level 2
Financial assets or liabilities measured at fair value on a recurring basis
Marketable securities	$ 17,437

FAIR VALUE MEASUREMENTS - Transfers (Details) $ in Thousands	Mar. 31, 2022 USD ($)
FAIR VALUE MEASUREMENTS
Assets, transfer from level 1 to level 2	$ 0
Assets, transfer from level 2 to level 1	$ 0

INVESTMENTS - By type (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
Marketable securities by type
Cost	$ 17,518	$ 27,042
Gross Unrealized Gains	1	1
Gross Unrealized Losses	(82)	(108)
Estimated Fair Value	17,437	26,935
U.S. government agency debt securities
Marketable securities by type
Cost	17,518	27,042
Gross Unrealized Gains	1	1
Gross Unrealized Losses	(82)	(108)
Estimated Fair Value	$ 17,437	$ 26,935

INVESTMENTS - Additional Information (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Dec. 31, 2021
INVESTMENTS
Gross unrealized loss	$ 82	$ 108
Unrealized loss as a percentage of total amortized costs basis of corporate bond portfolio	0.47%

INVESTMENTS - By contractual maturity (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
INVESTMENTS
Due in one year or less - Cost	$ 17,518	$ 27,042
Due in on year or less - Gross Unrealized Gains	1	1
Due in one year or less - Gross Unrealized Losses	(82)	(108)
Due in one year or less - Estimated Fair Value	17,437	26,935
Cost	17,518	27,042
Gross Unrealized Gains	1	1
Gross Unrealized Losses	(82)	(108)
Estimated Fair Value	$ 17,437	$ 26,935

INVESTMENTS - Realized gains and losses (Details) $ in Thousands	3 Months Ended
	Mar. 31, 2022 USD ($)
Marketable securities realized gain (loss) recorded
Gross realized loss from sale of marketable securities	$ 80
Gross realized gain from sale of marketable securities	$ 0

INVESTMENTS - Unrealized losses and fair values of available-for-sale securities (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
Securities in an unrealized loss position less than 12 months
Unrealized Losses Less Than 12 months	$ (82)	$ (108)
Estimated Fair Value Less Than 12 Months	14,438	17,696
Total Unrealized Losses	(82)	(108)
Total Estimated Fair Value	14,438	17,696
U.S. government agency debt securities
Securities in an unrealized loss position less than 12 months
Unrealized Losses Less Than 12 months	(82)	(108)
Estimated Fair Value Less Than 12 Months	14,438	17,696
Total Unrealized Losses	(82)	(108)
Total Estimated Fair Value	$ 14,438	$ 17,696

PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid research and development expenses	$ 5,837	$ 4,483
Insurance premium asset	522	1,616
Prepaid rent expenses	125	117
Prepaid insurance expenses	99	105
Prepaid commercial and patient advocacy	383	254
Research and development tax credit receivable	469	502
Interest receivable	23	23
Other prepaid expenses and current assets	455	471
Total prepaid expenses & other current assets	$ 7,913	$ 7,571

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Dec. 31, 2021
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
Accrued pre-clinical and clinical expenses	$ 12,217	$ 9,912
Short-term insurance financing note		789
Accrued professional fees	533	419
Accrued compensation and benefits	707	2,779
Accrued commercial expenses	1,355	1,394
Accrued patent expenses	328	279
Other	702	987
Total accrued expenses & other current liabilities	$ 15,842	$ 16,559

STOCK BASED COMPENSATION - Plans (Details) - 2019 Plan - shares	1 Months Ended
	May 31, 2019	Mar. 31, 2022
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		1,379,543
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	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Stock-based compensation
Total stock-based compensation expense	$ 2,077	$ 2,981
Research and development
Stock-based compensation
Total stock-based compensation expense	856	799
General and administrative
Stock-based compensation
Total stock-based compensation expense	$ 1,221	$ 2,182

STOCK BASED COMPENSATION - Options (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Stock-based compensation
Options granted (in shares)	400,416
Stock-based compensation expense	$ 2,077	$ 2,981
Unrecognized stock-based compensation balance for unvested options	$ 13,000	$ 22,700
Weighted-average fair value of options granted (in dollars per share)	$ 2.22	$ 0
Options
Stock-based compensation
Stock-based compensation expense	$ 2,000	$ 2,500
Weighted Average Remaining Recognition Period (in years)	2 years 4 months 24 days	2 years 10 months 24 days

STOCK BASED COMPENSATION - Options activity (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended	12 Months Ended
	Mar. 31, 2022	Dec. 31, 2021
Options Outstanding
Outstanding at beginning of period (in shares)	4,704,888
Options granted (in shares)	400,416
Forfeited (in shares)	(248,222)
Expired (in shares)	(5,517)
Outstanding at end of period (in shares)	4,851,565	4,704,888
Exercisable at end of period (in shares)	3,577,835
Nonvested at end of period (in shares)	1,273,730
Weighted-Average Exercise Price
Outstanding at beginning of period (in dollars per share)	$ 13.29
Options granted (in dollars per share)	3.68
Options forfeited (in dollars per share)	27.73
Options expired (in dollars per share)	23.15
Outstanding at end of period (in dollars per share)	11.74	$ 13.29
Exercisable at end of period (in dollars per share)	9.81
Nonvested at end of period (in dollars per share)	$ 17.17
Weighted-Average Remaining Contractual Term-in years
Outstanding	7 years 4 months 24 days	7 years 8 months 12 days
Exercisable	7 years
Nonvested	8 years 6 months
Aggregate Intrinsic Value
Outstanding (in dollars)	$ 489	$ 10,305
Exercisable (in dollars)	$ 489

STOCK BASED COMPENSATION - Valuation assumptions (Details) - Stock options - Service conditions only	3 Months Ended
	Mar. 31, 2022
Valuation Assumptions
Expected term/Time to expiration (in years)	5 years 6 months
Volatility (as a percent)	69.68%
Risk-free interest rate (as a percent)	1.56%

STOCK BASED COMPENSATION - RSUs (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021
Stock-based compensation
Stock-based compensation expense	$ 2,077	$ 2,981
Restricted Stock Units (RSUs)
Stock-based compensation
Stock-based compensation expense	100	500
Unamortized stock-based compensation costs for unvested awards	$ 5,400	$ 5,900
Summary of restricted stock units outstanding
Outstanding at beginning of period ( in shares)	469,485
Awarded (in shares)	248,700
Released (in shares)	(21,417)
Forfeited (in shares)	(145,300)
Outstanding at end of period ( in shares)	551,468
Nonvested at end of period (in shares)	551,468
Weighted-Average Grant Date Fair Value
Outstanding at beginning of period (in dollars per share)	$ 18.05
Awarded (in dollars per share)	4.17
Released (in dollars per share)	25.69
Forfeited (in dollars per share)	19.48
Outstanding at end of period (in dollars per share)	11.12
Nonvested at end of period (in dollars per share)	$ 11.12
Aggregate Intrinsic Value
Outstanding at end of period (in dollars)	$ 1,164		$ 4,202
Nonvested at end of period (in dollars)	$ 1,164
Weighted Average Remaining Recognition Period (in years)	3 years 4 months 24 days	3 years 2 months 12 days

STOCK BASED COMPENSATION - 2019 Employee Stock Purchase Plan (Details) - 2019 ESPP - shares	1 Months Ended	3 Months Ended
	May 31, 2019	Mar. 31, 2022
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	Mar. 31, 2022	Dec. 31, 2021
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) - USD ($) $ in Millions			1 Months Ended	3 Months Ended
	Jan. 26, 2022	Jun. 12, 2020	Jun. 30, 2020	Mar. 31, 2022	Mar. 31, 2021
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%
Cowen Equity Distribution Agreement
STOCKHOLDERS' EQUITY
Maximum value of shares authorized to be sold in stock offering.	$ 100.0
Maximum amount to be paid to sales agent (as a percent)	3.00%
Issuance of common stock (in shares)				0
Common Stock
STOCKHOLDERS' EQUITY
Issuance of common stock (in shares)					3,450,000

WARRANTS - Issued with Series A Preferred Stock (Details) $ / shares in Units, $ in Thousands			3 Months Ended
	Feb. 05, 2021 USD ($) shares	Jan. 26, 2017 USD ($) $ / shares shares	Mar. 31, 2022 Y shares	Mar. 31, 2021 USD ($)
Warrants
Warrants exercised (in shares)			0
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
Warrants exercised (in shares)	27,855
Stock issued in exercise of warrants (in shares)	27,855
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			0.7448
2017 Warrants \| Warrants Issued with Series A Preferred Stock \| Risk-free interest rate
Warrants
Measurement input			0.0320
2017 Warrants \| Warrants Issued with Series A Preferred Stock \| Dividend yield
Warrants
Measurement input			0.0000

WARRANTS - Issued with the 2018 Notes (Details) - USD ($) $ / shares in Units, $ in Millions		3 Months Ended
	Nov. 05, 2018	Mar. 31, 2022	Jan. 18, 2018
Warrants
Warrants exercised (in shares)		0
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 - Issued with Series B Preferred Stock (Details) $ / shares in Units, $ in Millions	1 Months Ended	2 Months Ended	3 Months Ended
	Feb. 28, 2019 USD ($) $ / shares shares	Dec. 31, 2018 USD ($) $ / shares shares	Mar. 31, 2022 Rate Y shares
Warrants
Warrants exercised (in shares) \| shares			0
Warrants Issued with Series B Preferred Stock \| 2018 Warrants
Warrants
Warrants to purchase common stock (in shares) \| 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			0.7322
Warrants Issued with Series B Preferred Stock \| 2018 Warrants \| Risk-free interest rate
Warrants
Measurement input			0.0270
Warrants Issued with Series B Preferred Stock \| 2018 Warrants \| Dividend yield
Warrants
Measurement input			0.0000
Warrants Issued with Series B Preferred Stock \| 2019 Warrants
Warrants
Warrants to purchase common stock (in shares) \| 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)	3 Months Ended
WARRANTS - Warrant Activity (Details)	Mar. 31, 2022 USD ($) shares
WARRANTS
Outstanding as of beginning of period	125,618
Warrants granted and issued \| $	$ 0
Warrants exercised	0
Warrants exchanged	0
Outstanding as of end of period	125,618

LEASES - Lease Cost (Details) - USD ($) $ in Thousands	3 Months Ended
LEASES - Lease Cost (Details) - USD ($) $ in Thousands	Mar. 31, 2022	Mar. 31, 2021
Leases
Operating Lease Cost	$ 142	$ 126
General and administrative
Leases
Operating Lease Cost	$ 142	$ 126

LEASES - Lease terms and discount rates (Details)	Mar. 31, 2022	Mar. 31, 2021
LEASES
Weighted-average remaining lease term - operating leases	2 years 7 months 6 days	3 years 7 months 6 days
Weighted-average discount rate - operating leases	5.69%	5.69%

LEASES - Maturities of Lease Liabilities (Details) $ in Thousands	Mar. 31, 2022 USD ($)
LEASES
2022	$ 381
2023	515
2024	426
Total lease payments	1,322
Less: interest	96
Total lease liabilities	$ 1,226

BENEFIT PLANS (Details) - USD ($) $ in Millions	3 Months Ended
BENEFIT PLANS (Details) - USD ($) $ in Millions	Mar. 31, 2022	Mar. 31, 2021
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	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Numerator:
Net loss attributable to common stockholders-basic	$ (23,121)	$ (24,179)
Net loss attributable to common stockholders-diluted	$ (23,121)	$ (24,179)
Denominator:
Weighted-average common stock outstanding-basic (in shares)	26,215,514	24,135,735
Weighted-average common stock outstanding-diluted (in shares)	26,215,514	24,135,735
Net loss per share attributable to common stockholders-basic (in dollars per share)	$ (0.88)	$ (1.00)
Net loss per share attributable to common stockholders-diluted (in dollars per share)	$ (0.88)	$ (1.00)

- Definition

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

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 815
-SubTopic 40
-Section 65
-Paragraph 1
-Subparagraph (e)(4)
-URI http://asc.fasb.org/extlink&oid=123482062&loc=SL123482106-238011

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 250
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-Name Accounting Standards Codification
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-Name Accounting Standards Codification
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NET LOSS PER COMMON SHARE - Anti-dilutive securities (Details) - shares	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
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	4,851,565	4,491,670
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	551,468	204,279
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	125,618

RELATED PARTIES (Details) - LaunchLabs Agreement - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Related Party Transaction [Line Items]
Payments to related party	$ 16	$ 23
Due to related parties	$ 0

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