0001558370-23-009264 | 10-Q | XBRL Viewer

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Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2023	May 10, 2023
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2023
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		57,849,292
Entity Central Index Key	0001697532
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q1
Amendment Flag	false

Balance Sheets - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
CURRENT ASSETS:
Cash and cash equivalents	$ 22,917	$ 16,657
Investments		13,923
Prepaid expenses and other current assets	6,146	6,728
Total current assets	29,063	37,308
Operating lease right-of-use asset	743	857
Security deposits and leasehold improvements	198	198
TOTAL ASSETS	30,004	38,363
CURRENT LIABILITIES:
Current portion of operating lease liabilities	483	477
Accounts payable	5,555	4,534
Accrued expenses and other current liabilities	14,025	14,756
Warrant liability	13,188	13,657
Total current liabilities	33,251	33,424
NONCURRENT LIABILITIES:
Noncurrent portion of operating lease liabilities	291	414
Clinical holdback - long-term portion	534	464
Total noncurrent liabilities	825	878
Total liabilities	34,076	34,302
STOCKHOLDERS' EQUITY:
Common stock, $0.0001 par value; 200,000,000 shares authorized as of March 31, 2023 and December 31, 2022; 48,113,561 shares issued and outstanding as of March 31, 2023 and 48,063,358 shares issued and outstanding as of December 31, 2022	5	5
Preferred stock, par value $0.0001; 10,000,000 shares authorized as of March 31, 2023 and December 31, 2022; 0 shares issued and outstanding as of March 31, 2023 and December 31, 2022
Additional paid-in capital	354,883	352,828
Accumulated other comprehensive gain/(loss)		51
Accumulated deficit	(358,960)	(348,823)
Total stockholders' equity	(4,072)	4,061
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 30,004	$ 38,363

Balance Sheets (Parenthetical) - $ / shares	Mar. 31, 2023	Dec. 31, 2022
Balance Sheets
Common Stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common Stock, authorized (in shares)	200,000,000	200,000,000
Common Stock, issued (in shares)	48,113,561	48,063,358
Common stock, outstanding (in shares)	48,113,561	48,063,358
Preferred Stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred Stock, authorized (in shares)	10,000,000	10,000,000
Preferred Stock, issued (in shares)	0	0
Preferred Stock, outstanding (in shares)	0	0

Statements of Operations - USD ($) $ in Thousands	3 Months Ended
Statements of Operations - USD ($) $ in Thousands	Mar. 31, 2023	Mar. 31, 2022
REVENUE:
Revenue	$ 10,660
Revenue from Contract with Customer, Product and Service	us-gaap:LicenseMember
Total Revenue	$ 10,660
OPERATING EXPENSES:
Research and development	15,935	$ 15,030
General and administrative	5,583	8,071
Total operating expenses	21,518	23,101
LOSS FROM OPERATIONS	(10,858)	(23,101)
OTHER INCOME (EXPENSE), NET:
Interest income	221	76
Change in fair value of warrant liabilities	469
Other expense	31	(96)
Total other income, net	721	(20)
Net loss	(10,137)	(23,121)
Net loss attributable to common stockholders-basic	(10,137)	(23,121)
Net loss attributable to common stockholders-diluted	$ (10,137)	$ (23,121)
Net loss per share attributable to common stockholders-basic (in dollars per share)	$ (0.18)	$ (0.88)
Net loss per share attributable to common stockholders-diluted (in dollars per share)	$ (0.18)	$ (0.88)
Weighted-average common stock outstanding-basic (in shares)	56,357,983	26,215,514
Weighted-average common stock outstanding-diluted (in shares)	56,357,983	26,215,514

Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Statements of Comprehensive Income (Loss)
Net Loss	$ (10,137)	$ (23,121)
Other comprehensive income (loss)
Unrealized gain (loss) on marketable securities	(51)	27
Other comprehensive gain (loss), net of tax	(51)	27
Comprehensive income (loss), net of tax	$ (10,188)	$ (23,094)

- Definition

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

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Statements of Stockholders' Equity - USD ($) $ in Thousands	Common Stock	Additional Paid-in Capital	Accumulated Deficit	Accumulated Other Comprehensive Income (Loss)	Total
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 Units 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
Balance at Dec. 31, 2022	$ 5	352,828	(348,823)	51	4,061
Balance (in shares) at Dec. 31, 2022	48,063,358
Increase (Decrease) in Stockholders' Equity
Restricted Stock Units released for common stock issued under Equity Incentive Plan (in shares)	50,203
Stock-based compensation expense		2,055			2,055
Net loss			(10,137)		(10,137)
Other comprehensive income (loss)				$ (51)	(51)
Balance at Mar. 31, 2023	$ 5	$ 354,883	$ (358,960)		$ (4,072)
Balance (in shares) at Mar. 31, 2023	48,113,561

- Definition

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

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- Definition

Amount after tax and reclassification adjustments of other comprehensive income (loss).

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- Definition

Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity.

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+ Details

Statements of Stockholders' Equity (Parenthetical) - $ / shares	Mar. 31, 2023	Dec. 31, 2022	Mar. 31, 2022
Increase (Decrease) in Stockholders' Equity
Common Stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common Stock
Increase (Decrease) in Stockholders' Equity
Common Stock, par value (in dollars per share)	$ 0.0001		$ 0.0001

Statements of Cash Flows - USD ($) $ in Thousands	3 Months Ended
Statements of Cash Flows - USD ($) $ in Thousands	Mar. 31, 2023	Mar. 31, 2022
OPERATING ACTIVITIES:
Net loss	$ (10,137)	$ (23,121)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	2,055	2,077
Issuance of options in-lieu of bonus		441
Amortization of insurance premium	766	1,093
Amortization of operating lease right-of-use assets	114	108
Change in operating lease liability	(117)	(106)
Change in fair value of warrant liability	(469)
Changes in operating assets and liabilities:
Prepaid expenses	(184)	(1,435)
Accounts payable	1,021	(3,539)
Accrued expenses and other current liabilities	(109)	72
Other liabilities	70
Net cash used in operating activities	(6,990)	(24,410)
INVESTING ACTIVITIES:
Purchase of available-for-sale securities		(5,994)
Proceeds from sale of available-for-sale securities	4,944
Proceeds from maturities of available-for-sale securities	8,928	15,519
Net cash provided by investing activities	13,872	9,525
FINANCING ACTIVITIES:
Repayments of short-term borrowings	(622)	(789)
Net cash provided by financing activities	(622)	(789)
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	6,260	(15,674)
Cash and cash equivalents at beginning of period	16,657	53,888
Cash and cash equivalents at end of period	22,917	38,214
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Unrealized gain (loss) on marketable securities	$ (51)	$ 27

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

3 Months Ended

Mar. 31, 2023

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 (“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 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, 2023, the Company has not sold any shares of common stock pursuant to the Cowen Equity Distribution Agreement.

On June 27, 2022, the Company completed an underwritten public offering (the “June Offering”) of 20,000,000 shares of common stock, par value $0.0001 per share, 10,000,000 pre-funded warrants to purchase shares of common stock (the “Pre-Funded Warrants”), and accompanying warrants to purchase up to 30,000,000 shares of common stock (the “Common Warrants”). The shares and accompanying Common Warrants were offered at a price to the public of $1.00 per share and warrant, and the Pre-Funded Warrants and accompanying Common Warrants were offered at a price to the public of $0.9999, resulting in aggregate net proceeds of approximately $27.8 million, after deducting underwriting discounts and commissions and offering expenses. The Pre-Funded Warrants and the Common Warrants are immediately exercisable and will expire five years from the date of issuance. Holders may not exercise any Pre-Funded Warrants or Common Warrants that would cause the aggregate number of shares of common stock beneficially owned by the holder to exceed 9.99% of the Company’s outstanding common stock immediately after exercise. Holders of the Pre-Funded Warrants and/or Common Warrants (together with affiliates) who immediately prior to June 27, 2022 beneficially owned more than 9.99% of the Company’s outstanding common stock may not exercise any portion of their Pre-Funded Warrants or Common Warrants if the holder (together with affiliates) would beneficially own more than 19.99% of the Company’s outstanding common stock after exercise. The Pre-Funded Warrants and Common Warrants are subject to adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock and also upon any distributions for no consideration of assets to the Company’s stockholders. In the event of certain corporate transactions, the holders of the Pre-Funded Warrants and/or Common Warrants will be entitled to receive, upon exercise, the kind and amount of securities, cash or other property that the holders would have received had they exercised the Pre-Funded Warrants and/or Common Warrants immediately prior to such transaction. The Pre-Funded Warrants and Common Warrants do not entitle the holders thereof to any voting rights or any of the other rights or privileges to which the Company’s stockholders are entitled. The Company intends to use the net proceeds from the June Offering for general corporate purposes, which may include research and development costs, including the conduct of clinical trials and process development and manufacturing of the Company’s product candidates, expansion of the Company’s research and development capabilities, working capital and capital expenditures.

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, 2022 included in the Annual Report, filed with the SEC on March 23, 2023 (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, 2023, results of operations for the three months ended March 31, 2023 and 2022 and cash flows for the three months ended March 31, 2023 and 2022. Such adjustments are of a normal and recurring nature. The results of operations for the three months ended March 31, 2023, are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023.

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 product revenue, and it does not expect to generate product 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. As discussed below, we recently completed a $30 million private placement, before deducting placement agent commissions and other offering expenses (see Note 16). We continue to actively pursue several potential long-term financing options, including equity capital, debt, convertible debt, and synthetic royalty financing. 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 incurred a net loss of $10.1 million for the three months ended March 31, 2023 and has an accumulated deficit of $359.0 million as of March 31, 2023. The exclusive licensing agreement with Advanz Pharma for commercialization rights to AT-007 in Europe provides a source of capital to the Company based on clinical and regulatory milestones. We received a $10.7 million upfront payment from Advanz Pharma in January 2023 in conjunction with signing the agreement. If actualization of these milestones aligns with the projected timelines, and product approvals are received in the timeframes expected, this source of capital may be sufficient to cover operating expenses through expected product approvals and potential revenues. However, there are no guarantees that this will materialize timely or at all, and delays or unexpected data could disrupt this potential liquidity. Broadly, 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. As of March 31, 2023, our cash, cash equivalents and marketable securities totaled $22.9 million. Additionally, on April 26, 2023, the Company completed a private placement that resulted in gross proceeds of $30 million, before deducting placement agent commissions and other offering expenses (see Note 16). Given our planned expenditures for the next twelve months, we have concluded there is substantial doubt regarding our ability to continue as a going concern for a year beyond the date of this Quarterly Report on Form 10-Q is issued. The accompanying financial statements have been prepared assuming the continuation of the Company 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, disclosure of contingent assets and liabilities and the Company's ability to continue as a going concern as of the date of the financial statements and the reported amounts of expenses during the reporting period. In preparing the financial statements, management used estimates in the following areas, among others: prepaid and accrued expenses; warrant liability valuation; stock-based compensation expense; and the evaluation of the existence of conditions and events that raise substantial doubt regarding the Company’s ability to continue as a going concern. Actual results could differ from those estimates.

Significant Accounting Policies

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, 2022, 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, 2023.

Clinical hold-back, long-term

As part of the regulatory approval process for taking its products to market, the Company enters into certain Clinical Trial Agreements (CTAs) which include, among other things, the compensation and payment schedule the participating medical institutions and physicians will receive for all costs in connection with the clinical trial (or study) under the terms of the CTA. As individual patients are enrolled in the study by the participating medical institution or physician, the Company pays certain per study fees according to the CTA for the duration of the trial. As invoices are received by the Company from the medical institution or physician, the Company retains an agreed upon percentage of total invoiced costs, generally ranging between 5% - 10%, that is withheld from payment until the end of the study.

These retained amounts are recorded as clinical holdback, a liability, on the accompanying balance sheets, and all expenses incurred in connection with these CTA activities are expensed as services are provided, which are included as research and development expenses on the accompanying statements of operations.

The following table shows the activity within the clinical holdback liability accounts for the three months ended March 31, 2023:



(in thousands)
Balance as of December 31,2022	$	464
Clinical holdback retained		70
Clinical holdback paid		—
Balance as of March 31,2023	$	534
Less: clinical holdback current portion		—
Clinical holdback - long-term portion	$	534

There was no clinical holdback 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, 2023

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. When we grant sublicenses under the 2016 Columbia Agreement we are 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 Advanz Agreement includes a sublicense under the 2016 Columbia Agreement.

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.

In July 2022, following regulatory changes impacting development of the class of PI3k inhibitors and the Company’s decision to discontinue its early stage preclinical PI3k program, the Company and Columbia entered into an agreement terminating the 2019 Columbia Agreement (the “2022 Columbia Termination Agreement”) as of July 25, 2022. Under the terms of the 2022 Columbia Termination Agreement, the Company assigned certain regulatory documents regarding the preclinical PI3k inhibitor AT-104 to Columbia and granted Columbia a non-exclusive royalty free license (with rights to sublicense any future Columbia licensee) under certain know-how, technical information and data relating to AT-104 that was developed by the Company during the term of the 2019 Columbia Agreement.

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, 2023, the Company recorded $0 in research and development expense; and $0.1 million in general and administrative expense, related to the Columbia Agreements. During the three months ended March 31, 2022, the Company recorded $0 in research and development expense and $13,000 in general and administrative expense related to the Columbia Agreements. In aggregate, the Company has incurred $2.7 million in expense from the execution of the Columbia Agreements through March 31, 2023.

As of March 31, 2023, the Company had $0.1 million due to Columbia University included in accrued expenses and $0 included in accounts payable. As of December 31, 2022, the Company had $0.1 million due to Columbia University included in accrued expenses and $0 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. When 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 Advanz Agreement includes a sublicense under the 2020 Miami License Agreement.

The 2020 Miami License Agreement terminates upon the expiration of all issued patents and filed patent applications or 10 years after the first commercial sale of the last product or process for which a royalty is due, unless earlier terminated. In addition, the 2020 Miami License Agreement may be terminated by the Company at any time upon 60 days prior written notice to UM, and may be terminated by either the Company or UM upon material breach of an obligation if action to cure the breach is not initiated within 60 days of receipt of written notice.

During the three months ended March 31, 2023 the company recorded $25,000 in research and development expense related to the Miami License Agreement. During the three months ended March 31, 2022 the Company recorded $25,000 in research and development expense related to the 2020 Miami License Agreement. There were no general and administrative expense related to 2020 Miami License Agreement recorded during the three months ended March 30, 2023, and 2022. In aggregate, the Company has incurred $2.4 million in expense from execution of the 2020 Miami License Agreement through March 31, 2023.

The Company had $0.3 million and $0.3 million due to UM included in accrued expenses as of March 31, 2023 and December 31, 2022, 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 us certain option rights to access and use the research results and to obtain licenses to any associated patent rights upon us making specified payments to UM within specified time limits. If the Company elects to obtain option rights the Company will be required to make payments to UM in the low-six figures to the low-seven figures, depending upon the rights the Company elects to obtain, and the Company will be obligated to make certain milestone payments in the high-six figures to mid-seven figures if UM conducts and completes certain research activities within specified time periods and the Company elects to receive rights to use the results of that research.

2020 Miami Sponsored Research Agreement

On December 14, 2020, the Company entered into a research agreement with the University of Miami (the “2020 Miami Research Agreement”), under which the University of Miami will conduct a research study relating to SORD neuropathy and deliver a final report on the study to the Company. The term of the research agreement is from December 14, 2020 through December 30, 2021, and was extended through August 31, 2022, whereby the research study was completed. The total consideration for the 2020 Miami Research Agreement was $0.3 million.

During the three months ended March 31, 2023, the Company recorded $0 in research and development expense in relation to the 2020 Miami Research Agreement. During the three months ended March 31, 2022, the Company recorded $37,000 in research and development expense in relation to the 2020 Miami Research Agreement. The Company had $0.1 million and $0.1 million as of March 31, 2023 and December 31, 2022, 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, 2023

FAIR VALUE MEASUREMENTS

FAIR VALUE MEASUREMENTS

3. FAIR VALUE MEASUREMENTS

The following tables summarize, as of March 31, 2023, 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, 2022, and the notes thereto, which are included in the Annual Report.


	As of March 31, 2023
(in thousands)	Level 1		Level 2		Level 3		Total
Cash	$	21,917	$	—	$	—	$	21,917
Money market funds		1,000		—		—		1,000
Total cash and cash equivalents	$	22,917	$	—	$	—	$	22,917
U.S. government agency debt securities		—		—		—		—
Total marketable securities	$	—	$	—	$	—	$	—
Total financial assets measured at fair value on a recurring basis	$	22,917	$	—	$	—	$	22,917
Warrant liabilities - Common Warrants		—		—		13,188		13,188
Total financial liabilities measured at fair value on a recurring basis	$	—	$	—	$	13,188	$	13,188

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, 2023, there were no transfers of financial assets between Level 1 and Level 2.

On June 27, 2022 the Company issued Common Warrants exercisable for 30,000,000 shares of common stock and Pre-Funded Warrants exercisable for 10,000,000 shares of common stock in connection with the June Offering (see note 1 and note 8 for more information on the June Offering). The Common Warrants were accounted for as liabilities under ASC 815-40, Derivatives and Hedging, Contracts in Entity’s Own Equity (“ASC 815-40”), as these warrants provide for a settlement provision that does not meet the requirements of the indexation guidance under ASC 815-40. The Pre-Funded Warrants were initially recorded at fair value as a liability as the Company could be required to settle the Pre-Funded Warrants in cash under certain circumstances. In December 2022, the Company amended the Pre-Funded Warrants to remove the potential requirement that they could be settled in cash under certain circumstances. Upon the amendment to the Pre-Funded Warrants, the Pre-funded Warrants liability was reclassified to equity, using their fair value as of the amendment date.

These Common Warrant liabilities were measured at fair value at inception and are then subsequently measured on a recurring basis, with changes in fair value recognized in other income (expense) within the Company’s statement of operations.

The Company uses a Black-Scholes option pricing model to estimate the fair value of the Common and Pre-Funded Warrants, which utilizes certain unobservable inputs and is therefore considered a Level 3 fair value measurement. Certain inputs used in this Black-Scholes pricing model may fluctuate in future periods based upon factors that are outside of the Company’s control, including a potential change in control outside of the Company’s control. A significant change in one or more of these inputs used in the calculation of the fair value may cause a significant change to the fair value of the Company’s warrant liabilities, which could also result in material non-cash gains or losses being reported in the Company’s condensed statement of operations.

The Common and Pre-Funded Warrants were initially valued and remeasured using a Black-Scholes option pricing model with a range of assumptions as follows:


Expected term (in years)	3.2
Volatility	93.86	%
Risk-free interest rate	3.95	%
Dividend yield	0.00	%

The Company utilized a probability-weighted approach that considered the probability of a change in control at the Company in the Black-Scholes option pricing model, whereby a 10% probability of change in control was used for each of the five years in the term of the agreements.

The following table provides a roll forward of the aggregate fair values of the Company’s warrant liability, for which fair value is determined using Level 3 inputs (in thousands):


	Warrant Liability
	Common Warrant		Pre-Funded Warrant
Balance as of January 1, 2023	$	13,657	$	—
Change in fair value		(469)		—
Balance as of March 31, 2023	$	13,188	$	—

The inputs utilized by management to value the warrant liability for Common and Pre-Funded Warrants are highly subjective. The assumptions used in calculating the fair value of the warrant liability for Common and Pre-Funded 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 warrant liability for Common and Pre-Funded Warrants may be materially different in the future.

INVESTMENTS

3 Months Ended

Mar. 31, 2023

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, 2023								As of December 31, 2022
			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	$	—	$	-	$	—	$	—	$	13,873	$	50	$	—	$	13,923
Total	$	—	$	—	$	—	$	—	$	13,873	$	50	$	—	$	13,923

As of March 31, 2023, the Company had $0 in its investment portfolio.

Contractual maturities of the Company’s marketable securities are summarized as follows:


	As of March 31, 2023								As of December 31, 2022
			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	$	—	$	—	$	—	$	—	$	13,873	$	50	$	—	$	13,923
Due in one through two years		—		—		—		—		—		—		—		—
Total	$	—	$	—	$	—	$	—	$	13,873	$	50	$	—	$	13,923

At March 31, 2023, the Company had $0 of gross unrealized gains and $0 of gross unrealized losses.

During the three months ended March 31, 2023, the Company recorded no gross realized losses and no gross realized gains of from the sale of marketable securities.

There were no 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, 2023 or December 31, 2022.

PREPAID EXPENSES AND OTHER CURRENT ASSETS

3 Months Ended

Mar. 31, 2023

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)	2023		2022
Prepaid research and development expenses	$	4,493	$	4,272
Insurance premium asset		366		1,131
Prepaid rent expenses		163		99
Prepaid insurance expenses		52		71
Prepaid commercial and patient advocacy		233		206
Research and development tax credit receivable		262		252
Interest receivable		23		23
Other prepaid expenses and current assets		554		674
Total prepaid expenses & other current assets	$	6,146	$	6,728

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

3 Months Ended

Mar. 31, 2023

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)	2023		2022
Accrued pre-clinical and clinical expenses	$	11,253	$	8,877
Short-term insurance financing note		-		622
Accrued professional fees		387		1,218
Accrued compensation and benefits		707		2,301
Accrued commercial expenses		860		896
Accrued patent expenses		407		361
Other		411		481
Total accrued expenses & other current liabilities	$	14,025	$	14,756

STOCK BASED COMPENSATION

3 Months Ended

Mar. 31, 2023

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.

On August 2, 2022, the Board took action in accordance with its authority under the terms of the 2019 Plan to reset the per-share exercise price of all stock options previously granted under the 2019 Plan to $1.05 per share (the "Options Repricing"), which is equal to the closing price of a share of the Company’s common stock on August 1, 2022. The Options Repricing was deemed to be a Type I modification event under ASC 718, Compensation-Stock Compensation. No other terms of the repriced stock options were modified, and the repriced stock options will continue to vest according to their original vesting schedules and will retain their original expiration dates. As a result of the Options Repricing, 1,797,517 vested and 1,380,917 unvested stock options outstanding as of August 2, 2022, with original exercise prices ranging from $1.22 to $49.60, were repriced. The Options Repricing resulted in incremental

stock-based compensation expense of $1.4 million, of which $0.9 million related to vested stock option awards and was expensed on the repricing date, and $0.5 million of which related to unvested stock option awards and is being amortized on a ratable basis over the remaining weighted-average vesting period of those awards being approximately 2.4 years.

As of March 31, 2023, there were 968,529 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)	2023		2022
Research and development	$	862	$	856
General and administrative		1,193		1,221
Total stock-based compensation expense	$	2,055	$	2,077

Stock Option Activity

During the three months ended March 31, 2023 the Company did not grant any options to shares of common stock. For the three months ended March 31, 2023, amortization of stock compensation of options amounted to $1.6 million and for the three months ended March 31, 2022, amortization of stock compensation of options amounted to $2.1 million. As of March 31, 2023 and 2022, the total unrecognized stock-based compensation balance for unvested options was $6.4 million and $13.0 million, respectively, which is expected to be recognized over 2.1 years and 2.4 years, respectively. The weighted-average fair value per share of options granted during the three months ended March 31, 2023 and 2022 was $0 and $2.22, respectively.

The following table summarizes the information about options outstanding at March 31, 2023:


				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, 2022	4,874,047	$	1.97	6.9	$	—
Options granted	-
Options exercised	-
Forfeited	(26,902)
Expired	(8,048)
Outstanding at March 31, 2023	4,839,097	$	1.98	6.6	$	—

Exercisable at March 31, 2023	4,043,481	$	2.16	6.4	$	—
Nonvested at March 31, 2023	795,616	$	1.05	8.2	$	—

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, 2023 and 2022.


	Three Months Ended
	March 31,
	2023			2022
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, 2023, the Company granted 2,575,000 RSUs to shares of common stock. For the three months ended March 31, 2023 and 2022, amortization of stock compensation of RSUs amounted to $0.5 million and $0.1 million, respectively. As of March 31, 2023 and 2022, the unamortized compensation costs associated with non-vested restricted stock awards were $5.5 million and $5.4 million, respectively, with a weighted-average remaining amortization period of 3.6 and 3.4 years, respectively.

The following table summarizes the information about restricted stock units outstanding at March 31, 2023:


		Weighted-Average
		Grant Date		Aggregate
(in thousands, except for share data)	Shares	Fair Value		Intrinsic Value
Outstanding at December 31, 2022	815,509	$	5.96	$	$ 620
Awarded	2,575,000		0.99
Released	(50,203)		9.44
Forfeited	(6,408)		11.50
Outstanding at March 31, 2023	3,333,898	$	5.96	$	2,704
Nonvested at March 31, 2023	3,256,670	$	1.89	$	2,641

Weighted Average Remaining Recognition Period (in years)	3.6

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, 2023, 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, 2023

STOCKHOLDERS' EQUITY

STOCKHOLDERS' EQUITY

8. STOCKHOLDERS’ EQUITY

As of March 31, 2023, and December 31, 2022, the authorized capital stock of the Company consisted of 200,000,000 shares of common stock, par value $0.0001 per share and 10,000,000 shares of preferred stock, par value $0.0001 per share, respectively.

Common Stock

Goldman Equity Distribution Agreement

In June 2020, the Company entered into an equity distribution agreement ( the “Goldman Equity Distribution Agreement”) with Goldman Sachs & Co. LLC (“Goldman”) 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, 2023, the Company has not sold any shares of common stock pursuant to the Cowen Equity Distribution Agreement.

June 2022 Offering

On June 27, 2022, the Company completed the June Offering, an underwritten public offering of 20,000,000 shares of common stock, par value $0.0001 per share, 10,000,000 Pre-Funded Warrants, and accompanying Common Warrants to purchase up to 30,000,000 shares of common stock. The shares and accompanying Common Warrants were offered at a price to the public of $1.00 per share and warrant, and the Pre-Funded Warrants and accompanying Common Warrants were offered at a price to the public of $0.9999, resulting in aggregate net proceeds of approximately $27.8 million, after deducting underwriting discounts and commissions and offering expenses. The Pre-Funded Warrants and the Common Warrants are immediately exercisable and will expire five years from the date of issuance. Holders may not exercise any Pre-Funded Warrants or Common Warrants that would cause the aggregate number of shares of common stock beneficially owned by the holder to exceed 9.99% of the Company’s outstanding common stock immediately after exercise. Holders of the Pre-Funded Warrants and/or Common Warrants (together with affiliates) who immediately prior to June 27, 2022 beneficially owned more than 9.99% of the Company’s outstanding common stock may not exercise any portion of their Pre-Funded Warrants or Common Warrants if the holder (together with affiliates) would beneficially own more than 19.99% of the Company’s outstanding common stock after exercise. The Pre-Funded Warrants and Common Warrants are subject to adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock and also upon any distributions for no consideration of assets to the Company’s stockholders. In the event of certain corporate transactions, the holders of the Pre-Funded Warrants and/or Common Warrants will be entitled to receive, upon exercise, the kind and amount of securities, cash or other property that the holders would have received had they exercised the Pre-Funded Warrants and/or Common Warrants immediately prior to such transaction. The Pre-Funded Warrants and Common Warrants do not entitle the holders thereof to any voting rights or any of the other rights or privileges to which the Company’s

stockholders are entitled. The Company intends to use the net proceeds from the June Offering for general corporate purposes, which may include research and development costs, including the conduct of clinical trials and process development and manufacturing of the Company’s product candidates, expansion of the Company’s research and development capabilities, working capital and capital expenditures.

- Definition

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

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-URI https://asc.fasb.org/topic&trid=2208762

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Paragraph 13
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Subparagraph (SX 210.3-04)
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

WARRANTS

3 Months Ended

Mar. 31, 2023

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 was 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	%

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 $4.48 per share as of March 31, 2023 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 $5.51 per share as of March 31, 2023 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 $5.51 per share as of March 31, 2023 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.

Warrants Issued with June 2022 Offering

On June 27, 2022, in connection with the sale and issuance common stock as part of the June Offering, the Company issued 10,000,000 Pre-Funded Warrants at an exercise price of $0.0001 per share, and 30,000,000 accompanying Common Warrants at an exercise price of $1.00 per share. Each share of common stock and accompanying Common Warrant was sold at a public offering price of $1.00, less underwriting discounts and commissions, and each Pre-Funded Warrant and accompanying Common Warrant was sold at a public offering price of $0.9999, less underwriting discounts and commissions, as described in the prospectus supplement, dated June 22, 2022, filed with the Securities and Exchange Commission on June 24, 2022.

The Pre-Funded Warrants and the Common Warrants are immediately exercisable and will expire five years from the date of issuance. Holders may not exercise any Pre-Funded Warrants or Common Warrants that would cause the aggregate number of shares of common stock beneficially owned by the holder to exceed 9.99% of the Company’s outstanding common stock immediately after exercise. Holders of the Pre-Funded Warrants and/or Common Warrants (together with affiliates) who immediately prior to June 27, 2022 beneficially owned more than 9.99% of the Company’s outstanding common stock may not exercise any portion of their Pre-Funded Warrants or Common Warrants if the holder (together with affiliates) would beneficially own more than 19.99% of the Company’s outstanding common stock after exercise. The Pre-Funded Warrants and Common Warrants are subject to adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock and also upon any distributions for no consideration of assets to the Company’s stockholders. In the event of certain corporate transactions, the holders of the Pre-Funded Warrants and/or Common Warrants will be entitled to receive, upon exercise, the kind and amount of securities, cash or other property that the holders would have received had they exercised the Pre-Funded Warrants and/or Common Warrants immediately prior to such transaction. The Pre-Funded Warrants and Common Warrants do not entitle the holders thereof to any voting rights or any of the other rights or privileges to which the Company’s stockholders are entitled.

On June 28, 2022, a warrantholder exercised 1,750,000 Pre-Funded Warrants on a cash basis and received 1,750,000 shares of common stock. The Company received $175 in cash proceeds for the exercise of these Pre-Funded Warrants.

As of March 31, 2023, the Company had 8,250,000 Pre-Funded Warrants outstanding with a weighted average exercise price of $0.0001 per share and an average contractual life of 5 years. As of March 31, 2023, the Company had 30,000,000 Common Warrants outstanding with a weighted average exercise price of $1.00 per share and an average contractual life of 5 years.

The Common Warrants were accounted for as liabilities under ASC 815-40, as these warrants provide for a settlement provision that does not meet the requirements of the indexation guidance under ASC 815-40. These warrant liabilities are measured at fair value at inception and on a recurring basis, with changes in fair value presented within the

statement of operations. The Pre-Funded Warrants were initially recorded at fair value as a liability as the Company could be required to settle the Pre-Funded Warrants in cash in the event of an acquisition of the Company under certain circumstances. In December 2022, the Company amended the Pre-Funded Warrants to remove the potential requirement that they could be settled in cash under certain circumstances. At December 31, 2022, the Pre-funded Warrants are recorded as equity, using their fair value as of the amendment date.

The fair value of the Common and Pre-Funded Warrants were estimated using the Black-Scholes option pricing model with the following assumptions:


Expected term (in years)	3.2
Volatility	93.86	%
Risk-free interest rate	3.95	%
Dividend yield	0.00	%

A summary of the Company’s outstanding common stock warrants as of March 31, 2023 is as follows:


	Warrants
Outstanding as of December 31, 2022		38,375,618
Warrants granted and issued		—
Warrants exercised		—
Warrants exchanged		—
Outstanding as of March 31, 2023		38,375,618

LEASES

3 Months Ended

Mar. 31, 2023

LEASES

LEASES

10. LEASES

The following table summarizes the Company’s lease related costs for the three months ended March 31, 2023 and 2022:


		Operating (in thousands)
Lease Cost	Statement of Operations Location		2023		2022
Operating Lease Cost	General and administrative	$	126	$	489
Total Lease Cost		$	126	$	489

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


	Three Months Ended
	March 31,		March 31,
Other Information	2023		2022
Weighted-average remaining lease term
Operating leases		1.6 years		2.6 years
Weighted-average discount rate
Operating leases		5.69%		5.69%

The following table summarizes the maturities of lease liabilities as of March 31, 2023:


	Operating
Year	(in thousands)
2023	$	514
2024		297
Thereafter		—
Total lease payments		811
Less: interest		37
Total lease liabilities	$	774

INCOME TAXES

3 Months Ended

Mar. 31, 2023

INCOME TAXES

INCOME TAXES

11. INCOME TAXES

During the three months ended March 31, 2023 and the year ended December 31, 2022, 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.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 21
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

BENEFIT PLANS

3 Months Ended

Mar. 31, 2023

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 $0.2 million in matching contributions to the plan during the three months ended March 31, 2023 and 2022, respectively.

- Definition

The entire disclosure for retirement benefits.

+ References

Reference 1: http://www.xbrl.org/2003/role/exampleRef
-Publisher FASB
-Name Accounting Standards Codification
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+ Details

NET LOSS PER COMMON SHARE

3 Months Ended

Mar. 31, 2023

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, 2023 and 2022, 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, 2023 and 2022:


	Three Months Ended
	March 31,
(in thousands, except for share data)	2023		2022
Numerator:
Net loss	$	(10,137)	$	(23,121)
Denominator:
Weighted-average common stock outstanding		56,357,983		26,215,514
Net loss per share attributable to common stockholders - basic and diluted	$	(0.18)	$	(0.88)

The Company’s potentially dilutive securities, which include restricted stock units, stock options, and common 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, 2023 and 2022,

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,
	2023	2022
Options to purchase common stock	4,839,097	4,851,565
Restricted stock units	3,333,898	551,468
Warrants to purchase common stock	38,375,618	125,618

RELATED PARTIES

3 Months Ended

Mar. 31, 2023

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, 2023, the Company made payments to Alexandria LaunchLabs of approximately $23,000 and during the three months ended March 31, 2022, the Company made the same payments of approximately $23,000 under the LaunchLabs Agreement, which was recognized in research and development expenses. As of March 31, 2023, there were no amounts due to Alexandria LaunchLabs under the LaunchLabs Agreement.

REVENUE

3 Months Ended

Mar. 31, 2023

REVENUE

REVENUE

15. REVENUE

License Agreement with Advanz Pharma

On January 3, 2023, the Company entered into an Exclusive License and Supply Agreement (the “ Advanz Agreement”) with Mercury Pharma Group Limited (trading as Advanz Pharma Holdings). Pursuant to the Advanz Agreement, the Company granted Advanz Pharma the exclusive right and license to commercialize drug products containing AT-007 (also known as govorestat), our proprietary Aldose Reductase Inhibitor (ARI) (the “Licensed Product”), for use in treatment of Sorbitol Dehydrogenase Deficiency (“SORD”) and Galactosemia (each a “Licensed Indication”) in the European Economic Area, Switzerland and the United Kingdom (the “Territory”). The Company also granted Advanz Pharma a right of negotiation and “most-favored nation” rights with respect to acquiring the European commercialization rights for any additional indications for which the Licensed Product may be developed in the future (or any other products we may develop solely to the extent used for the Licensed Indications).

Advanz Pharma is required to use commercially reasonable efforts to launch and commercialize the Licensed Products in the major markets in the Territory in each Licensed Indication following, and subject to, receipt of marketing authorization therein. Under the Advanz Agreement, Advanz Pharma agreed to pay the Company (i) an upfront payment of EUR 10 million (approx. USD $10.7 million), and certain development milestone payments upon clinical trial completions and receipt of marketing authorization in the territory, as well as certain commercial milestone payments, totaling EUR 134 million (approx. USD $142.2 million) in the aggregate, and (ii) royalties of 20% of net sales of the Licensed Product. Such royalty rate will be payable on a country-by-country basis until the later of (i) the expiration of the licensed patents covering the composition of matter of AT-007, or (ii) 10 years after the European Medicines Agency’s grant of marketing authorization for the Licensed Product. The royalties are subject to certain deductions, including certain secondary finishing costs, certain step-in establishment costs and a portion of fees for any potential third party patent licenses if applicable in the future. Following the initial term of the license, as described above, the royalty rate shall be reduced to 10% and shall continue in perpetuity unless the Advanz Agreement is terminated in various circumstances in accordance with its terms.

In accordance with the Company's ASC 606 assessment, Advanz Pharma is considered to be a customer. The Company identified two performance obligation, the exclusive license to commercialize the Product, that was satisfied on the date of the execution of the Advanz Agreement when control of the license was transferred, and the obligation to

manufacture and supply Advanz with the Product. The Company determined that the upfront license fee of EUR 10 million (approx. USD $10.7 million) is the transaction price. The performance-based milestone payments, sales-based milestone payments, sales-based royalties, and manufacture and supply of Product are each determined to be variable consideration that are constrained due to the uncertainty of achievement. The Company determined that the EUR 10 million represented the point at which the licensee was able to use and benefit from the license and recognized revenue from upfront license fees when the license was transferred to Advanz upon execution of the Advanz Agreement. The Company recognized the upfront fee as license revenue on its condensed statement of operations for the three months ended March 31, 2022.

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-URI https://asc.fasb.org/topic&trid=49130388

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

SUBSEQUENT EVENTS

3 Months Ended

Mar. 31, 2023

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

16. SUBSEQUENT EVENTS

On April 26, 2023, the Company completed its sale of a total of 9,735,731 shares of the Company’s common stock, par value $0.0001 (the “Shares”), at a purchase price of $0.946 per Share, and 22,000,000 pre-funded warrants to purchase common stock (the “Pre-Funded Warrants” and together with the Shares, the “Securities”), at a purchase price of $0.946 per Pre-Funded Warrant, in a private placement (the “Private Placement”) to a select group of accredited investors (the “Purchasers”), pursuant to a Securities Purchase Agreement (the “Securities Purchase Agreement”), dated as of April 23, 2023, by and between the Company and the Purchasers. The Private Placement resulted in gross proceeds to the Company of approximately $30 million, before deducting placement agent commissions and other offering expenses.

The Pre-Funded Warrants are immediately exercisable from the date of issuance and do not have an expiration date. They have an exercise price of $0.001. Holders may not exercise any Pre-Funded Warrants that would cause the aggregate number of shares of common stock beneficially owned by the holder to exceed 9.99% of the Company’s outstanding common stock immediately after exercise. The Pre-Funded Warrants are subject to adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock and also upon any distributions for no consideration of assets to the Company’s stockholders. In the event of certain corporate transactions, the holders of the Pre-Funded Warrants will be entitled to receive, upon exercise of the Pre-Funded Warrants, the kind and amount of securities, cash or other property that the holders would have received had they exercised the Pre-Funded Warrants immediately prior to such transaction. The Pre-Funded Warrants do not entitle the holders thereof to any voting rights or any of the other rights or privileges to which holders of common stock are entitled.

The Securities have the benefit of the Registration Rights Agreement (the “Registration Rights Agreement”), dated as of April 23, 2023, by and among the Company and the Purchasers, requiring the Company to prepare and file a registration statement with the SEC as soon as reasonably practicable, but in no event later than May 26, 2023 (the “Filing Deadline”), and to use commercially reasonable efforts to have the registration statement declared effective within 30 days of the Filing Deadline, subject to extension under the terms of the Registration Rights Agreement. The Company intends to use the net proceeds to fund research and development and registration of its pipeline candidates, and for working capital and general corporate purposes.

The Securities were issued to the Purchasers pursuant to an exemption from registration under Rule 506 of Regulation D, which is promulgated under the Securities Act. The Company relied on this exemption from registration based in part on representations made by the Purchasers.

The sale of the Securities pursuant to the Securities Purchase Agreement has not been registered under the Securities Act or any state securities laws. The Securities may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

3 Months Ended

Mar. 31, 2023

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Operations and Business

Liquidity and Going Concern

Risk and Uncertainties

Risks and Uncertainties

Use of Estimates

Significant Accounting Policies

Clinical hold-back, long-term

Clinical hold-back, long-term

The following table shows the activity within the clinical holdback liability accounts for the three months ended March 31, 2023:



(in thousands)
Balance as of December 31,2022	$	464
Clinical holdback retained		70
Clinical holdback paid		—
Balance as of March 31,2023	$	534
Less: clinical holdback current portion		—
Clinical holdback - long-term portion	$	534

There was no clinical holdback during the three months ended March 31, 2022.

Recent Accounting Pronouncements

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

3 Months Ended

Mar. 31, 2023

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Schedule of activity within the clinical holdback liability accounts



(in thousands)
Balance as of December 31,2022	$	464
Clinical holdback retained		70
Clinical holdback paid		—
Balance as of March 31,2023	$	534
Less: clinical holdback current portion		—
Clinical holdback - long-term portion	$	534

FAIR VALUE MEASUREMENTS (Tables)

3 Months Ended

Mar. 31, 2023

Fair value

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


	As of March 31, 2023
(in thousands)	Level 1		Level 2		Level 3		Total
Cash	$	21,917	$	—	$	—	$	21,917
Money market funds		1,000		—		—		1,000
Total cash and cash equivalents	$	22,917	$	—	$	—	$	22,917
U.S. government agency debt securities		—		—		—		—
Total marketable securities	$	—	$	—	$	—	$	—
Total financial assets measured at fair value on a recurring basis	$	22,917	$	—	$	—	$	22,917
Warrant liabilities - Common Warrants		—		—		13,188		13,188
Total financial liabilities measured at fair value on a recurring basis	$	—	$	—	$	13,188	$	13,188

Schedule of aggregate fair values of the Company's warrant liability

The following table provides a roll forward of the aggregate fair values of the Company’s warrant liability, for which fair value is determined using Level 3 inputs (in thousands):


	Warrant Liability
	Common Warrant		Pre-Funded Warrant
Balance as of January 1, 2023	$	13,657	$	—
Change in fair value		(469)		—
Balance as of March 31, 2023	$	13,188	$	—

Common And Pre-Funded Warrants

Fair value

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


Expected term (in years)	3.2
Volatility	93.86	%
Risk-free interest rate	3.95	%
Dividend yield	0.00	%

INVESTMENTS (Tables)

3 Months Ended

Mar. 31, 2023

INVESTMENTS

Schedule of marketable securities by security type


	As of March 31, 2023								As of December 31, 2022
			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	$	—	$	-	$	—	$	—	$	13,873	$	50	$	—	$	13,923
Total	$	—	$	—	$	—	$	—	$	13,873	$	50	$	—	$	13,923

Schedule of contractual maturities


	As of March 31, 2023								As of December 31, 2022
			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	$	—	$	—	$	—	$	—	$	13,873	$	50	$	—	$	13,923
Due in one through two years		—		—		—		—		—		—		—		—
Total	$	—	$	—	$	—	$	—	$	13,873	$	50	$	—	$	13,923

PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables)

3 Months Ended

Mar. 31, 2023

PREPAID EXPENSES AND OTHER CURRENT ASSETS

Summary of prepaid expenses and other current assets


	March 31,		December 31,
(in thousands)	2023		2022
Prepaid research and development expenses	$	4,493	$	4,272
Insurance premium asset		366		1,131
Prepaid rent expenses		163		99
Prepaid insurance expenses		52		71
Prepaid commercial and patient advocacy		233		206
Research and development tax credit receivable		262		252
Interest receivable		23		23
Other prepaid expenses and current assets		554		674
Total prepaid expenses & other current assets	$	6,146	$	6,728

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables)

3 Months Ended

Mar. 31, 2023

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

Summary of accrued expenses and other current liabilities


	March 31,		December 31,
(in thousands)	2023		2022
Accrued pre-clinical and clinical expenses	$	11,253	$	8,877
Short-term insurance financing note		-		622
Accrued professional fees		387		1,218
Accrued compensation and benefits		707		2,301
Accrued commercial expenses		860		896
Accrued patent expenses		407		361
Other		411		481
Total accrued expenses & other current liabilities	$	14,025	$	14,756

STOCK BASED COMPENSATION (Tables)

3 Months Ended

Mar. 31, 2023

Stock-based compensation

Schedule of stock-based compensation expenses


	Three Months Ended
	March 31,
(in thousands)	2023		2022
Research and development	$	862	$	856
General and administrative		1,193		1,221
Total stock-based compensation expense	$	2,055	$	2,077

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, 2022	4,874,047	$	1.97	6.9	$	—
Options granted	-
Options exercised	-
Forfeited	(26,902)
Expired	(8,048)
Outstanding at March 31, 2023	4,839,097	$	1.98	6.6	$	—

Exercisable at March 31, 2023	4,043,481	$	2.16	6.4	$	—
Nonvested at March 31, 2023	795,616	$	1.05	8.2	$	—

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, 2022	815,509	$	5.96	$	$ 620
Awarded	2,575,000		0.99
Released	(50,203)		9.44
Forfeited	(6,408)		11.50
Outstanding at March 31, 2023	3,333,898	$	5.96	$	2,704
Nonvested at March 31, 2023	3,256,670	$	1.89	$	2,641

Weighted Average Remaining Recognition Period (in years)	3.6

Stock options - Service conditions only

Stock-based compensation

Schedule of valuation assumptions


	Three Months Ended
	March 31,
	2023			2022
Expected term (in years)		—			5.5
Volatility		—	%		69.68	%
Risk-free interest rate		—	%		1.56	%
Dividend yield		—	%		—	%

WARRANTS (Tables)

3 Months Ended

Mar. 31, 2023

Warrants

Schedule of warrants outstanding


	Warrants
Outstanding as of December 31, 2022		38,375,618
Warrants granted and issued		—
Warrants exercised		—
Warrants exchanged		—
Outstanding as of March 31, 2023		38,375,618

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	%

Common And Pre-Funded Warrants

Warrants

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


Expected term (in years)	3.2
Volatility	93.86	%
Risk-free interest rate	3.95	%
Dividend yield	0.00	%

LEASES (Tables)

3 Months Ended

Mar. 31, 2023

LEASES

Summary of lease related costs


		Operating (in thousands)
Lease Cost	Statement of Operations Location		2023		2022
Operating Lease Cost	General and administrative	$	126	$	489
Total Lease Cost		$	126	$	489

Summary of lease terms and discount rates


	Three Months Ended
	March 31,		March 31,
Other Information	2023		2022
Weighted-average remaining lease term
Operating leases		1.6 years		2.6 years
Weighted-average discount rate
Operating leases		5.69%		5.69%

Summary of maturities of lease liabilities


	Operating
Year	(in thousands)
2023	$	514
2024		297
Thereafter		—
Total lease payments		811
Less: interest		37
Total lease liabilities	$	774

NET LOSS PER COMMON SHARE (Tables)

3 Months Ended

Mar. 31, 2023

NET LOSS PER COMMON SHARE

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


	Three Months Ended
	March 31,
(in thousands, except for share data)	2023		2022
Numerator:
Net loss	$	(10,137)	$	(23,121)
Denominator:
Weighted-average common stock outstanding		56,357,983		26,215,514
Net loss per share attributable to common stockholders - basic and diluted	$	(0.18)	$	(0.88)

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


	As of
	March 31,
	2023	2022
Options to purchase common stock	4,839,097	4,851,565
Restricted stock units	3,333,898	551,468
Warrants to purchase common stock	38,375,618	125,618

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Operations and Business (Details) - USD ($) $ / shares in Units, $ in Millions			3 Months Ended
	Jun. 27, 2022	Jan. 26, 2022	Mar. 31, 2023	Dec. 31, 2022	Mar. 31, 2022
Sale of stock
Common Stock, par value (in dollars per share)			$ 0.0001	$ 0.0001
Common And Pre-Funded Warrants
Sale of stock
Warrants term	5 years
Common Stock
Sale of stock
Common Stock, par value (in dollars per share)			$ 0.0001		$ 0.0001
Cowen Equity Distribution Agreement
Sale of stock
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%
Cowen Equity Distribution Agreement \| Common Stock
Sale of stock
Issuance of common stock (in shares)			0
June Offering
Sale of stock
Common Stock, par value (in dollars per share)	$ 0.0001
Offering price per share and accompanying warrant (in dollars per share)	1.00
Offering price per pre-funded warrant and accompanying warrant (in dollars per share)	$ 0.9999
Proceeds from issuance of shares and warrants, net	$ 27.8
June Offering \| Common And Pre-Funded Warrants
Sale of stock
Warrants term	5 years
Threshold percentage of aggregate beneficial ownership of holder for exercising warrants	9.99%
Threshold percentage of aggregate beneficial ownership of holder (together with affiliates) for exercising warrants	19.99%
June Offering \| Pre-Funded Warrants
Sale of stock
Issuance of warrants (in shares)	10,000,000
Warrants term	5 years
June Offering \| Common Warrants
Sale of stock
Issuance of warrants (in shares)	30,000,000
Warrants term	5 years
June Offering \| Common Stock
Sale of stock
Issuance of common stock (in shares)	20,000,000

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Liquidity and Going Concern (Details) $ in Thousands, € in Millions				1 Months Ended	3 Months Ended
	Apr. 26, 2023 USD ($)	Jan. 03, 2023 USD ($)	Jan. 03, 2023 EUR (€)	Jan. 31, 2023 USD ($)	Mar. 31, 2023 USD ($)	Mar. 31, 2022 USD ($)	Dec. 31, 2022 USD ($)
Cash and cash equivalents
Net loss					$ (10,137)	$ (23,121)
Accumulated deficit					(358,960)		$ (348,823)
Cash and cash equivalents and investments					$ 22,900
Substantial Doubt about Going Concern, within One Year					true
ADVANZ PHARMA \| Exclusive License and Supply Agreement
Cash and cash equivalents
Upfront payment received		$ 10,700	€ 10	$ 10,700
Private Placement, April 2023 \| Subsequent Event.
Cash and cash equivalents
Gross proceeds from sale of stock	$ 30,000

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Clinical hold-back, long-term (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022	Dec. 31, 2022
Agreements
Clinical holdback, Balance as of beginning of period	$ 464
Clinical holdback retained	70	$ 0
Clinical holdback, Balance as of end of period	534
Clinical holdback - long-term portion	$ 534		$ 464
Minimum
Agreements
Clinical holdback, Total invoiced costs withheld from payment (as a percent)	5.00%
Maximum
Agreements
Clinical holdback, Total invoiced costs withheld from payment (as a percent)	10.00%

LICENSE AGREEMENT - Columbia (Details) - USD ($) $ in Thousands		1 Months Ended			3 Months Ended		78 Months Ended
	Oct. 03, 2019	Mar. 31, 2019	Jan. 31, 2019	Oct. 31, 2016	Mar. 31, 2023	Mar. 31, 2022	Mar. 31, 2023	Dec. 31, 2022
Agreements
Research and development					$ 15,935	$ 15,030
General and administrative					5,583	8,071
Operating expenses					21,518	23,101
Accrued expenses and other current liabilities					14,025		$ 14,025	$ 14,756
Accounts payable					5,555		5,555	4,534
Columbia University
Agreements
Research and development					0	0
General and administrative					100	$ 13
Operating expenses							2,700
Accrued expenses and other current liabilities					100		100	100
Accounts payable					$ 0		$ 0	$ 0
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 \| 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
2019 research agreement \| Columbia University
Agreements
Agreement term		12 months
PI3k Research agreement \| Columbia University
Agreements
Agreement term	18 months

LICENSE AGREEMENT - Miami University (Details) - USD ($) $ in Thousands			3 Months Ended		29 Months Ended
	Dec. 14, 2020	Oct. 28, 2020	Mar. 31, 2023	Mar. 31, 2022	Mar. 31, 2023	Dec. 31, 2022
Agreements
Research and development			$ 15,935	$ 15,030
General and administrative			5,583	8,071
Operating expenses			21,518	23,101
Accrued expenses and other current liabilities			14,025		$ 14,025	$ 14,756
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
General and administrative			0	0
Operating expenses					2,400
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			0	$ 37
Accrued expenses and other current liabilities			$ 100		$ 100	$ 100

FAIR VALUE MEASUREMENTS - FV hierarchy (Details) - Fair Value, Recurring $ in Thousands	Mar. 31, 2023 USD ($)
Financial assets or liabilities measured at fair value on a recurring basis
Cash and cash equivalents	$ 22,917
Total financial assets measured at fair value on a recurring basis	22,917
Warrant liabilities - Common Warrants	13,188
Total financial liabilities measured at fair value on a recurring basis	13,188
Level 1
Financial assets or liabilities measured at fair value on a recurring basis
Cash and cash equivalents	22,917
Total financial assets measured at fair value on a recurring basis	22,917
Level 3
Financial assets or liabilities measured at fair value on a recurring basis
Warrant liabilities - Common Warrants	13,188
Total financial liabilities measured at fair value on a recurring basis	13,188
Cash
Financial assets or liabilities measured at fair value on a recurring basis
Cash and cash equivalents	21,917
Cash \| Level 1
Financial assets or liabilities measured at fair value on a recurring basis
Cash and cash equivalents	21,917
Money market funds
Financial assets or liabilities measured at fair value on a recurring basis
Cash and cash equivalents	1,000
Money market funds \| Level 1
Financial assets or liabilities measured at fair value on a recurring basis
Cash and cash equivalents	$ 1,000

FAIR VALUE MEASUREMENTS - Transfers (Details) $ in Thousands	Mar. 31, 2023 USD ($)
FAIR VALUE MEASUREMENTS
Assets, transfer from level 1 to level 2	$ 0
Assets, transfer from level 2 to level 1	$ 0

FAIR VALUE MEASUREMENTS - Warrants (Details) - June Offering	Jun. 27, 2022 shares
Common Warrants
Warrants
Issuance of warrants (in shares)	30,000,000
Pre-Funded Warrants
Warrants
Issuance of warrants (in shares)	10,000,000

FAIR VALUE MEASUREMENTS - Warrants Valuation (Details) - Common And Pre-Funded Warrants	Jun. 27, 2022	Mar. 31, 2023 Y
Fair value
Warrants term	5 years
Expected term (in years)
Fair value
Measurement input		3.2
Volatility
Fair value
Measurement input		0.9386
Risk-free interest rate
Fair value
Measurement input		0.0395
Dividend yield
Fair value
Measurement input		0.0000
Probability of change in control
Fair value
Measurement input		10

FAIR VALUE MEASUREMENTS - Fair Values of Company's Warrant Liability (Details) - Common Warrants $ in Thousands	3 Months Ended
	Mar. 31, 2023 USD ($)
Fair Value
Beginning Balance	$ 13,657
Change in fair value	(469)
Ending Balance	$ 13,188

INVESTMENTS - By type (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Marketable securities by type
Cost		$ 13,873
Gross Unrealized Gains	$ 0	50
Gross Unrealized Losses	0
Estimated Fair Value	$ 0	13,923
U.S. government agency debt securities
Marketable securities by type
Cost		13,873
Gross Unrealized Gains		50
Estimated Fair Value		$ 13,923

INVESTMENTS - By contractual maturity (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
INVESTMENTS
Due in one year or less - Cost		$ 13,873
Due in on year or less - Gross Unrealized Gains		50
Due in one year or less - Estimated Fair Value		13,923
Cost		13,873
Gross Unrealized Gains	$ 0	50
Gross Unrealized Losses	0
Estimated Fair Value	$ 0	$ 13,923

INVESTMENTS - Realized gains and losses (Details) $ in Thousands	3 Months Ended
	Mar. 31, 2023 USD ($)
Marketable securities realized gain (loss) recorded
Gross realized losses from redemption of marketable securities	$ 0
Gross realized gains from redemption of marketable securities	$ 0

INVESTMENTS - Unrealized losses and fair values of available-for-sale securities (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Securities in an unrealized loss position greater than 12 months
Unrealized Losses Greater Than 12 months	$ 0	$ 0

PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid research and development expenses	$ 4,493	$ 4,272
Insurance premium asset	366	1,131
Prepaid rent expenses	163	99
Prepaid insurance expenses	52	71
Prepaid commercial and patient advocacy	233	206
Research and development tax credit receivable	262	252
Interest receivable	23	23
Other prepaid expenses and current assets	554	674
Total prepaid expenses & other current assets	$ 6,146	$ 6,728

ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
Accrued pre-clinical and clinical expenses	$ 11,253	$ 8,877
Short-term insurance financing note		622
Accrued professional fees	387	1,218
Accrued compensation and benefits	707	2,301
Accrued commercial expenses	860	896
Accrued patent expenses	407	361
Other	411	481
Total accrued expenses & other current liabilities	$ 14,025	$ 14,756

STOCK BASED COMPENSATION - Plans (Details) - USD ($) $ / shares in Units, $ in Millions		1 Months Ended	3 Months Ended
	Aug. 02, 2022	May 31, 2019	Mar. 31, 2023	Mar. 31, 2022	Aug. 01, 2022
Options
Stock-based compensation
Weighted Average Remaining Recognition Period (in years)			2 years 1 month 6 days	2 years 4 months 24 days
2019 Plan
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%
Option exercise price upon option repricing (in dollars per share)	$ 1.05
Options vested upon option repricing (in Shares)	1,797,517
Options non-vested upon option repricing (in Shares)	1,380,917
Incremental stock based compensation expense	$ 1.4
Weighted Average Remaining Recognition Period (in years)	2 years 4 months 24 days
Number of shares available for future issuance			968,529
2019 Plan \| Minimum
Stock-based compensation
Original exercise price (in dollars per share)					$ 1.22
2019 Plan \| Maximum
Stock-based compensation
Original exercise price (in dollars per share)					$ 49.60
2019 Plan \| Options
Stock-based compensation
Maximum number of shares authorized for issuance		13,000,000
Expiration period		10 years
Vesting period		4 years
2019 Plan \| Vested stock option
Stock-based compensation
Incremental stock based compensation expense	$ 0.9
2019 Plan \| Non-vested stock option
Stock-based compensation
Incremental stock based compensation expense	$ 0.5

STOCK BASED COMPENSATION - Stock-based compensation expense (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Stock-based compensation
Total stock-based compensation expense	$ 2,055	$ 2,077
Research and development
Stock-based compensation
Total stock-based compensation expense	862	856
General and administrative
Stock-based compensation
Total stock-based compensation expense	$ 1,193	$ 1,221

STOCK BASED COMPENSATION - Options (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Stock-based compensation
Options granted (in shares)	0
Stock-based compensation expense	$ 2,055	$ 2,077
Unrecognized stock-based compensation balance for unvested options	$ 6,400	$ 13,000
Weighted-average fair value of options granted (in dollars per share)	$ 0	$ 2.22
Options
Stock-based compensation
Stock-based compensation expense	$ 1,600	$ 2,100
Weighted Average Remaining Recognition Period (in years)	2 years 1 month 6 days	2 years 4 months 24 days

STOCK BASED COMPENSATION - Options activity (Details) - $ / shares	3 Months Ended	12 Months Ended
	Mar. 31, 2023	Dec. 31, 2022
Options Outstanding
Outstanding at beginning of period (in shares)	4,874,047
Options granted (in shares)	0
Forfeited (in shares)	(26,902)
Expired (in shares)	(8,048)
Outstanding at end of period (in shares)	4,839,097	4,874,047
Exercisable at end of period (in shares)	4,043,481
Nonvested at end of period (in shares)	795,616
Weighted-Average Exercise Price
Outstanding at beginning of period (in dollars per share)	$ 1.97
Outstanding at end of period (in dollars per share)	1.98	$ 1.97
Exercisable at end of period (in dollars per share)	2.16
Nonvested at end of period (in dollars per share)	$ 1.05
Weighted-Average Remaining Contractual Term-in years
Outstanding	6 years 7 months 6 days	6 years 10 months 24 days
Exercisable	6 years 4 months 24 days
Nonvested	8 years 2 months 12 days

STOCK BASED COMPENSATION - Valuation assumptions (Details) - Stock options - Service conditions only	3 Months Ended
	Mar. 31, 2022
Valuation Assumptions
Expected term (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, 2023	Mar. 31, 2022	Dec. 31, 2022
Stock-based compensation
Stock-based compensation expense	$ 2,055	$ 2,077
Restricted Stock Units (RSUs)
Stock-based compensation
Stock-based compensation expense	500	100
Unamortized stock-based compensation costs for unvested awards	$ 5,500	$ 5,400
Summary of restricted stock units outstanding
Outstanding at beginning of period ( in shares)	815,509
Awarded (in shares)	2,575,000
Released (in shares)	(50,203)
Forfeited (in shares)	(6,408)
Outstanding at end of period ( in shares)	3,333,898
Nonvested at end of period (in shares)	3,256,670
Weighted-Average Grant Date Fair Value
Outstanding at beginning of period (in dollars per share)	$ 5.96
Awarded (in dollars per share)	0.99
Released (in dollars per share)	9.44
Forfeited (in dollars per share)	11.50
Outstanding at end of period (in dollars per share)	5.96
Nonvested at end of period (in dollars per share)	$ 1.89
Aggregate Intrinsic Value
Outstanding at end of period (in dollars)	$ 2,704		$ 620
Nonvested at end of period (in dollars)	$ 2,641
Weighted Average Remaining Recognition Period (in years)	3 years 7 months 6 days	3 years 4 months 24 days

STOCK BASED COMPENSATION - 2019 Employee Stock Purchase Plan (Details) - 2019 ESPP - shares	1 Months Ended	47 Months Ended
	May 31, 2019	Mar. 31, 2023
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, 2023	Dec. 31, 2022
STOCKHOLDERS' EQUITY
Common Stock, authorized (in shares)	200,000,000	200,000,000
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 - Equity Distribution Agreements (Details) - USD ($) $ in Millions		1 Months Ended	3 Months Ended
	Jan. 26, 2022	Jun. 30, 2020	Mar. 31, 2023
Goldman 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%
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%
Cowen Equity Distribution Agreement \| Common Stock
STOCKHOLDERS' EQUITY
Issuance of common stock (in shares)			0

STOCKHOLDERS' EQUITY - June 2022 Offering (Details) - USD ($) $ / shares in Units, $ in Millions	Jun. 27, 2022	Mar. 31, 2023	Dec. 31, 2022	Mar. 31, 2022
Equity
Common Stock, par value (in dollars per share)		$ 0.0001	$ 0.0001
Common And Pre-Funded Warrants
Equity
Warrants term	5 years
Common Stock
Equity
Common Stock, par value (in dollars per share)		$ 0.0001		$ 0.0001
June Offering
Equity
Common Stock, par value (in dollars per share)	$ 0.0001
Offering price per share and accompanying warrant (in dollars per share)	1.00
Offering price per pre-funded warrant and accompanying warrant (in dollars per share)	$ 0.9999
Proceeds from issuance of shares and warrants, net	$ 27.8
June Offering \| Common And Pre-Funded Warrants
Equity
Warrants term	5 years
Threshold percentage of aggregate beneficial ownership of holder for exercising warrants	9.99%
Threshold percentage of aggregate beneficial ownership of holder (together with affiliates) for exercising warrants	19.99%
June Offering \| Pre-Funded Warrants
Equity
Issuance of warrants (in shares)	10,000,000
Warrants term	5 years
June Offering \| Common Warrants
Equity
Issuance of warrants (in shares)	30,000,000
Warrants term	5 years
June Offering \| Common Stock
Equity
Issuance of common stock (in shares)	20,000,000

WARRANTS - Issued with Series A Preferred Stock (Details) - 2017 Warrants - Warrants Issued with Series A Preferred Stock $ / shares in Units, $ in Millions	Jan. 26, 2017 USD ($) $ / shares shares	Mar. 31, 2023 Y
Warrants
Issuance of warrants (in shares) \| shares	309,389
Warrants to purchase common stock (in dollars) \| $	$ 0.2
Exercise price (in dollars per share) \| $ / shares	$ 2.49
Contractual term (in years)
Warrants
Measurement input \| Y		10.0
Volatility
Warrants
Measurement input		0.7448
Risk-free interest rate
Warrants
Measurement input		0.0320
Dividend yield
Warrants
Measurement input		0.0000

WARRANTS - Issued with the 2018 Notes (Details) - Warrants Issued with the 2018 Notes - USD ($) $ / shares in Units, $ in Millions	Nov. 05, 2018	Mar. 31, 2023	Jan. 18, 2018
Warrants
Initial fair value recorded as debt discount (in dollars)			$ 0.1
Issuance of warrants (in shares)	76,847
Warrants to purchase common stock (in dollars)	$ 0.3
Exercise price (in dollars per share)		$ 4.48

WARRANTS - Issued with Series B Preferred Stock (Details) - Warrants Issued with Series B Preferred Stock $ / shares in Units, $ in Millions	1 Months Ended	2 Months Ended
	Feb. 28, 2019 USD ($) shares	Dec. 31, 2018 USD ($) shares	Mar. 31, 2023 Y $ / shares
2018 Warrants
Warrants
Issuance of warrants (in shares) \| shares		72,261
Warrants to purchase common stock (in dollars) \| $		$ 0.2
Exercise price (in dollars per share) \| $ / shares			$ 5.51
Expiration term		10 years
2018 Warrants \| Contractual term (in years)
Warrants
Measurement input \| Y			10.0
2018 Warrants \| Volatility
Warrants
Measurement input			0.7322
2018 Warrants \| Risk-free interest rate
Warrants
Measurement input			0.0270
2018 Warrants \| Dividend yield
Warrants
Measurement input			0.0000
2019 Warrants
Warrants
Issuance of warrants (in shares) \| shares	23,867
Warrants to purchase common stock (in dollars) \| $	$ 0.1
Exercise price (in dollars per share) \| $ / shares			$ 5.51
Expiration term	10 years
2019 Warrants \| Contractual term (in years)
Warrants
Measurement input \| Y			10.0
2019 Warrants \| Volatility
Warrants
Measurement input			0.7322
2019 Warrants \| Risk-free interest rate
Warrants
Measurement input			0.0270
2019 Warrants \| Dividend yield
Warrants
Measurement input			0.0000

WARRANTS - Issued with June 2022 Offering (Details)			3 Months Ended
WARRANTS - Issued with June 2022 Offering (Details)	Jun. 28, 2022 USD ($) shares	Jun. 27, 2022 $ / shares shares	Mar. 31, 2023 Y $ / shares shares	Dec. 31, 2022 shares
Common And Pre-Funded Warrants
Warrants
Warrants term		5 years
Warrants exercised (in shares)			0
Warrants outstanding (in shares)			38,375,618	38,375,618
Common And Pre-Funded Warrants \| Contractual term (in years)
Warrants
Measurement input \| Y			3.2
Common And Pre-Funded Warrants \| Volatility
Warrants
Measurement input			0.9386
Common And Pre-Funded Warrants \| Risk-free interest rate
Warrants
Measurement input			0.0395
Common And Pre-Funded Warrants \| Dividend yield
Warrants
Measurement input			0.0000
June Offering
Warrants
Offering price per share and accompanying warrant (in dollars per share) \| $ / shares		$ 1.00
Offering price per pre-funded warrant and accompanying warrant (in dollars per share) \| $ / shares		$ 0.9999
June Offering \| Common And Pre-Funded Warrants
Warrants
Warrants term		5 years
Threshold percentage of aggregate beneficial ownership of holder for exercising warrants		9.99%
Threshold percentage of aggregate beneficial ownership of holder (together with affiliates) for exercising warrants		19.99%
June Offering \| Pre-Funded Warrants
Warrants
Issuance of warrants (in shares)		10,000,000
Exercise price (in dollars per share) \| $ / shares		$ 0.0001	$ 0.0001
Warrants term		5 years
Warrants exercised (in shares)	1,750,000
Exercise of prefunded warrants for common stock (in shares)	1,750,000
Proceeds from exercise of warrants \| $	$ 175
Warrants outstanding (in shares)			8,250,000
June Offering \| Common Warrants
Warrants
Issuance of warrants (in shares)		30,000,000
Exercise price (in dollars per share) \| $ / shares		$ 1.00	$ 1.00
Warrants term		5 years
Warrants outstanding (in shares)			30,000,000

WARRANTS - Warrant Activity (Details) - Common And Pre-Funded Warrants	3 Months Ended
	Mar. 31, 2023 shares
Warrants
Outstanding as of beginning of period	38,375,618
Warrants granted and issued	0
Warrants exercised	0
Outstanding as of end of period	38,375,618

LEASES - Lease Cost (Details) - USD ($) $ in Thousands	3 Months Ended
LEASES - Lease Cost (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Mar. 31, 2022
Leases
Operating Lease Cost	$ 126	$ 489
General and administrative
Leases
Operating Lease Cost	$ 126	$ 489

LEASES - Lease terms and discount rates (Details)	Mar. 31, 2023	Mar. 31, 2022
LEASES
Weighted-average remaining lease term - operating leases	1 year 7 months 6 days	2 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, 2023 USD ($)
LEASES
2023	$ 514
2024	297
Total lease payments	811
Less: interest	37
Total lease liabilities	$ 774
Operating Lease, Liability, Statement of Financial Position	Current portion of operating lease liabilities, Noncurrent portion of operating lease liabilities

BENEFIT PLANS (Details) - USD ($) $ in Millions	3 Months Ended
BENEFIT PLANS (Details) - USD ($) $ in Millions	Mar. 31, 2023	Mar. 31, 2022
BENEFIT PLANS
Employer matching contributions to the plan	$ 0.2	$ 0.2

NET LOSS PER COMMON SHARE - EPS (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Numerator:
Net loss attributable to common stockholders-basic	$ (10,137)	$ (23,121)
Net loss attributable to common stockholders-diluted	$ (10,137)	$ (23,121)
Denominator:
Weighted-average common stock outstanding-basic (in shares)	56,357,983	26,215,514
Weighted-average common stock outstanding-diluted (in shares)	56,357,983	26,215,514
Net loss per share attributable to common stockholders-basic (in dollars per share)	$ (0.18)	$ (0.88)
Net loss per share attributable to common stockholders-diluted (in dollars per share)	$ (0.18)	$ (0.88)

- Definition

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

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

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Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities; of income (loss) available to common shareholders.

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Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities, and addition from assumption of issuance of common shares for dilutive potential common shares; of income (loss) available to common shareholders.

+ References + Details

NET LOSS PER COMMON SHARE - Anti-dilutive securities (Details) - shares	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Options to purchase common stock
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	4,839,097	4,851,565
Restricted stock units
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	3,333,898	551,468
Warrants to purchase common stock
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	38,375,618	125,618

RELATED PARTIES (Details) - LaunchLabs Agreement - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Related Party Transactions
Payments to related party	$ 23	$ 23
Due to related parties	$ 0

- Definition

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

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+ Details

REVENUE (Details) $ in Thousands, € in Millions			1 Months Ended	3 Months Ended
REVENUE (Details) $ in Thousands, € in Millions	Jan. 03, 2023 USD ($) item	Jan. 03, 2023 EUR (€) item	Jan. 31, 2023 USD ($)	Mar. 31, 2023 USD ($)	Mar. 31, 2023 EUR (€)	Jan. 03, 2023 EUR (€)
Revenue
Revenue \| $				$ 10,660
Exclusive License and Supply Agreement \| ADVANZ PHARMA
Revenue
Upfront payment received	$ 10,700	€ 10	$ 10,700
Potential milestone payments to be received	$ 142,200					€ 134
Royalties as a percent of sales	20.00%					20.00%
Initial term	10 years	10 years
Royalties as a percent of sales following initial term	10.00%					10.00%
Number of performance obligations \| item	2	2
Revenue \| €					€ 10

SUBSEQUENT EVENTS (Details) - USD ($) $ / shares in Units, $ in Millions	Apr. 26, 2023	Mar. 31, 2023	Dec. 31, 2022	Mar. 31, 2022
Subsequent event
Common Stock, par value (in dollars per share)		$ 0.0001	$ 0.0001
Common Stock
Subsequent event
Common Stock, par value (in dollars per share)		$ 0.0001		$ 0.0001
Subsequent Event. \| Private Placement, April 2023
Subsequent event
Common Stock, par value (in dollars per share)	$ 0.0001
Gross proceeds from sale of stock	$ 30
Registration statement, period to be declared effective	30 days
Subsequent Event. \| Private Placement, April 2023 \| Pre-Funded Warrants
Subsequent event
Issuance of warrants (in shares)	22,000,000
Purchase price (in dollars per share)	$ 0.946
Exercise price (in dollars per share)	$ 0.001
Threshold percentage of aggregate beneficial ownership of holder for exercising warrants	9.99%
Subsequent Event. \| Private Placement, April 2023 \| Common Stock
Subsequent event
Issuance of common stock (in shares)	9,735,731
Purchase price (in dollars per share)	$ 0.946