Aldeyra Therapeutics (ALDX) 10-K 9 Mar 23 2022 FY Annual report Financial data

Document And Entity Information

Document And Entity Information - USD ($)	12 Months Ended
	Dec. 31, 2022	Mar. 07, 2023	Jun. 30, 2022
Cover [Abstract]
Document Type	10-K
Amendment Flag	false
Document Period End Date	Dec. 31, 2022
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	FY
Trading Symbol	ALDX
Entity Registrant Name	ALDEYRA THERAPEUTICS, INC.
Entity Central Index Key	0001341235
Current Fiscal Year End Date	--12-31
Entity Filer Category	Non-accelerated Filer
Entity Well-known Seasoned Issuer	No
Entity Current Reporting Status	Yes
Entity Voluntary Filers	No
Entity Emerging Growth Company	false
Entity Small Business	true
ICFR Auditor Attestation Flag	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		58,576,350
Entity Public Float			$ 228,378,259
Entity Tax Identification Number	20-1968197
Entity Interactive Data Current	Yes
Document Annual Report	true
Document Transition Report	false
Security Exchange Name	NASDAQ
Documents Incorporated by Reference	Specified portions of the registrant’s proxy statement with respect to the registrant’s 2023 Annual Meeting of Stockholders, which is to be filed pursuant to Regulation 14A within 120 days after the end of the registrant’s fiscal year ended December 31, 2022 , are incorporated by reference into Part III of this Annual Report on Form 10-K
Entity Address, Address Line One	131 Hartwell Avenue
Entity Address, Address Line Two	Suite 320
Entity Address, City or Town	Lexington
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02421
City Area Code	781
Local Phone Number	761-4904
Entity Incorporation, State or Country Code	DE
Title of 12(b) Security	Common Stock, $0.001 par value per share
Entity File Number	001-36332
Auditor Firm ID	243
Auditor Name	BDO USA, LLP
Auditor Location	Boston, Massachusetts

Consolidated Balance Sheets

Consolidated Balance Sheets - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Current assets:
Cash and cash equivalents	$ 144,419,364	$ 104,790,989
Cash equivalent - reverse repurchase agreements	0	125,000,000
Marketable securities	29,881,520	0
Prepaid expenses and other current assets	6,722,229	2,961,781
Total current assets	181,023,113	232,752,770
Fixed assets, net	19,279	32,487
Right of use assets	249,265	351,863
Total assets	181,291,657	233,137,120
Current liabilities:
Accounts payable	133,625	1,019,702
Accrued expenses	14,065,885	10,523,353
Current portion of long-term debt	911,763
Current portion of operating lease liabilities	249,265	229,607
Total current liabilities	15,360,538	11,772,662
Operating lease liabilities, long-term	0	125,232
Long-term debt	14,923,090	15,503,703
Total liabilities	30,283,628	27,401,597
Commitments and contingencies (Note 13)
Stockholders' equity:
Preferred stock, $0.001 par value, 15,000,000 shares authorized, none issued and outstanding	0	0
Common stock, voting, $0.001 par value; 150,000,000 authorized and 58,560,078 and 58,081,215 shares issued and outstanding, respectively	58,560	58,081
Additional paid-in capital	507,770,045	500,369,444
Accumulated other comprehensive income	(103,938)	0
Accumulated deficit	(356,716,638)	(294,692,002)
Total stockholders’ equity	151,008,029	205,735,523
Total liabilities and stockholders’ equity	$ 181,291,657	$ 233,137,120

Consolidated Balance Sheets (Pa

Consolidated Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2022	Dec. 31, 2021
Statement of Financial Position [Abstract]
Preferred Stock, par value	$ 0.001	$ 0.001
Preferred Stock, shares authorized	15,000,000	15,000,000
Preferred Stock, shares issued	0	0
Preferred Stock, shares outstanding	0	0
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	150,000,000	150,000,000
Common stock, shares issued	58,560,078	58,081,215
Common stock, shares outstanding	58,560,078	58,081,215

Consolidated Statements of Oper

Consolidated Statements of Operations - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Operating expenses:
Research and development	$ 47,306,066	$ 44,936,532
General and administrative	15,373,921	11,283,004
Loss from operations	(62,679,987)	(56,219,536)
Other income (expense):
Interest income	2,349,449	185,363
Interest expense	(1,694,098)	(1,742,101)
Total other income (expense), net	655,351	(1,556,738)
Net loss	$ (62,024,636)	$ (57,776,274)
Earnings Per Share, Basic	$ (1.06)	$ (1.07)
Earnings Per Share, Diluted	$ (1.06)	$ (1.07)
Weighted Average Number of Shares Outstanding, Basic	58,405,897	54,042,103
Weighted Average Number of Shares Outstanding, Diluted	58,405,897	54,042,103

Consolidated Statements of Comp

Consolidated Statements of Comprehensive Loss - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Statement of Comprehensive Income [Abstract]
Net loss	$ (62,024,636)	$ (57,776,274)
Other comprehensive loss:
Unrealized loss on marketable securities	(103,938)	0
Total other comprehensive loss	(103,938)	0
Comprehensive loss	$ (62,128,574)	$ (57,776,274)

Consolidated Statements of Stoc

Consolidated Statements of Stockholders' Equity - USD ($)	Total	Common Voting Stock [Member]	Common Voting Stock [Member] Helio Vision, Inc [Member] Founders [Member]	Additional Paid-in Capital [Member]	Additional Paid-in Capital [Member] Helio Vision, Inc [Member] Founders [Member]	Accumulated Other Comprehensive Income (Loss), Net of Tax [Member]	Accumulated Deficit [Member]
Beginning Balance at Dec. 31, 2020	$ 59,508,558	$ 38,667		$ 296,385,619			$ (236,915,728)
Beginning Balance, Shares at Dec. 31, 2020		38,667,491
Stock-based compensation	7,006,857			7,006,857
Issuance of common stock, acquisition of Helio Vision, Inc.			$ 142	(142)
Issuance of common stock, acquisition of Helio Vision, Inc., Shares			141,965
Issuance of common stock, net of issuance costs	189,811,611	$ 18,092		189,793,519
Issuance of common stock, net of issuance costs, Shares		18,091,947
Issuance of common stock, exercise of stock options	4,623,251	$ 634		4,622,617
Issuance of common stock, exercise of stock options, Shares		634,214
Issuance of common stock, employee stock purchase plan	61,529	$ 12		61,517
Issuance of common stock, employee stock purchase plan, Shares		12,092
Issuance of common stock, vested restricted stock awards		$ 287		(287)
Issuance of common stock, vested restricted stock awards, shares		286,944
Issuance of common stock in connection with Helio Vision, Inc. acquisition milestone	2,499,991	$ 247		2,499,744
Issuance of common stock in connection with Helio Vision, Inc. acquisition milestone, Shares		246,562
Net loss	(57,776,274)						(57,776,274)
Ending Balance at Dec. 31, 2021	205,735,523	$ 58,081		500,369,444			(294,692,002)
Ending Balance, Shares at Dec. 31, 2021		58,081,215
Stock-based compensation	6,180,988			6,180,988
Issuance of common stock, acquisition of Helio Vision, Inc.			$ 11		$ (11)
Issuance of common stock, acquisition of Helio Vision, Inc., Shares			10,890
Issuance of common stock, exercise of stock options	$ 1,123,427	$ 237		1,123,190
Issuance of common stock, exercise of stock options, Shares	236,962	236,962
Issuance of common stock, employee stock purchase plan	$ 96,665	$ 29		96,636
Issuance of common stock, employee stock purchase plan, Shares		28,485
Issuance of common stock, vested restricted stock awards		$ 202		(202)
Issuance of common stock, vested restricted stock awards, shares		202,526
Other comprehensive income (loss)	(103,938)					$ (103,938)
Net loss	(62,024,636)						(62,024,636)
Ending Balance at Dec. 31, 2022	$ 151,008,029	$ 58,560		$ 507,770,045		$ (103,938)	$ (356,716,638)
Ending Balance, Shares at Dec. 31, 2022		58,560,078

Consolidated Statements of Cash

Consolidated Statements of Cash Flows - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (62,024,636)	$ (57,776,274)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	8,288,976	7,108,027
Non-cash interest expense	331,150	409,471
Net amortization of premium on marketable securities	(47,245)	0
Depreciation and amortization expense	258,707	264,180
Change in operating assets and liabilities:
Prepaid expenses and other current assets	(3,760,448)	2,239,176
Accounts payable	(886,077)	638,064
Accrued expenses and other liabilities	1,202,386	4,561,449
Net cash used in operating activities	(56,637,187)	(42,555,907)
CASH FLOWS FROM INVESTING ACTIVITIES:
Acquisitions of fixed assets	(16,317)	(7,806)
Purchases of marketable securities	(92,938,213)	0
Maturities of marketable securities	63,000,000	0
Net cash used in investing activities	(29,954,530)	(7,806)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock, net of issuance costs	0	189,811,611
Proceeds from exercise of stock options	1,123,427	4,623,251
Proceeds from employee stock purchase plan	96,665	61,529
Net cash provided by financing activities	1,220,092	194,496,391
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	(85,371,625)	151,932,678
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD	229,790,989	77,858,311
CASH AND CASH EQUIVALENTS, END OF PERIOD	144,419,364	229,790,989
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
Cash paid during the period for interest	1,338,542	1,337,083
SUPPLEMENTAL INFORMATION AND DISCLOSURES OF NONCASH ACTIVITIES:
Common stock issued in connection with Helio Vision, Inc. acquisition milestone	58,560	58,081
Helio Vision, Inc [Member]
SUPPLEMENTAL INFORMATION AND DISCLOSURES OF NONCASH ACTIVITIES:
Common stock issued in connection with Helio Vision, Inc. acquisition milestone	$ 0	$ 2,499,991

Nature of Business

Nature of Business	12 Months Ended
	Dec. 31, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Nature of Business	1. NATURE OF BUSINESS Aldeyra Therapeutics, Inc. (Aldeyra, Company, we, us and our) was incorporated in the state of Delaware on August 13, 2004 as Neuron Systems, Inc. On December 20, 2012, the Company changed its name to Aldexa Therapeutics, Inc. and, on March 17, 2014, the Company changed its name to Aldeyra Therapeutics, Inc. Aldeyra, together with its wholly-owned subsidiaries, is a clinical-stage biotechnology company discovering and developing innovative therapies designed to treat immune-mediated diseases. The Company’s principal activities to date include research and development activities along with related general business planning, including raising capital.

Basis of Presentation and Signi

Basis of Presentation and Significant Accounting Policies	12 Months Ended
	Dec. 31, 2022
Accounting Policies [Abstract]
Basis of Presentation and Significant Accounting Policies	2. BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation and Consolidation – The accompanying consolidated financial statements were prepared in conformity with accounting principles generally accepted in the United States of America (US GAAP) and pursuant to the rules and regulations of the Securities and Exchange Commission (SEC). The Company’s consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated. Risks and Uncertainties –The ongoing research and development activities will be subject to extensive regulation by numerous governmental authorities in the United States. Prior to marketing in the United States, any drug developed by the Company must undergo rigorous preclinical and clinical testing and an extensive regulatory approval process implemented by the United States Food and Drug Administration (FDA) under the Food, Drug and Cosmetic Act. The Company has limited experience in conducting and managing the preclinical and clinical testing necessary to obtain regulatory approval. There can be no assurance that the Company will not encounter problems in the clinical trials that will cause the Company or the FDA to delay or suspend clinical trials. The Company’s success will depend in part on its ability to obtain patents and product license rights, maintain trade secrets, and operate without infringing on the property rights of others, both in the United States and other countries. There can be no assurance that patents issued to or licensed by the Company will not be challenged, invalidated, circumvented, or that the rights granted thereunder will provide proprietary protection or competitive advantages to the Company. Based on its current operating plan, the Company believes that its cash, cash equivalents, and marketable securities as of December 31, 2022, will be sufficient to fund the Company's currently projected operating expenses into the second half of 2024. As a result of the COVID-19 pandemic, clinical site availability, staffing, and patient recruitment have been negatively affected and the timelines to complete the Company’s clinical trials may be delayed. The Company’s assessment of its liquidity and capital resources includes an estimate of the financial impacts of these changes. The Company has based its projections of operating capital requirements on its current operating plan, which includes several assumptions that may prove to be incorrect, and Company may use all of its available capital resources sooner than the Company expects. The Company will need to secure additional funding in the future, from one or more equity or debt financings, collaborations, or other sources, in order to carry out all of the Company’s planned research and development activities and regulatory activities; commence or continue ongoing commercialization activities, including manufacturing, sales, marketing and distribution, for any of our product candidates for which the Company may receive marketing approval; or conduct any substantial, additional development requirements requested by the Food and Drug Administration (FDA). Additional funding may not be available to the Company on acceptable terms, or at all. If the Company is unable to secure additional funding, it will be required to significantly decrease the amount of planned expenditures and may be required to cease operations. Curtailment of operations would cause significant delays in the Company’s efforts to develop and introduce its products to market, which is critical to the realization of its business plan and the future operations of the Company. Use of Estimates – The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions, including fair value estimates for investments, that affect the reported amounts of assets, liabilities, and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. The Company evaluates its estimates and assumptions on an ongoing basis. The most significant estimates in the Company’s consolidated financial statements include, but are not limited to, clinical trial accruals, deferred and accrued research and development costs, stock-based compensation, and accounting for income taxes and related valuation allowance. Although these estimates and assumptions are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions. Segment Information – Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one segment, which is the identification and development of next-generation medicines to improve the lives of patients with immune-mediated diseases. Cash and Cash Equivalents – The Company classifies all highly liquid investments with original maturities of three months or less as cash equivalents and all highly liquid investments with original maturities of greater than three months but less than 12 months as current marketable securities. The Company has a policy of making investments only with commercial institutions that have at least an investment grade credit rating. The Company invests its cash primarily in reverse repurchase agreements (RRAs), government securities and obligations, and money market funds. RRAs are collateralized by deposits in the form of ‘Government Securities and Obligations’ for an amount not less than 102 % of their value. The Company does not record an asset or liability related to the collateral as the Company is not permitted to sell or repledge the associated collateral. The Company has a policy that the collateral has at least an A (or equivalent) credit rating. The Company utilizes a third-party custodian to manage the exchange of funds as well as the requirement that collateral received is maintained at 102% of the value of the RRAs on a daily basis. Marketable Securities – Marketable securities consist of government securities and obligations with original maturities of more than 90 days . Investments are classified as available-for-sale and are recorded on the balance sheet at fair value with unrealized gains or losses reported as a separate component of other comprehensive income/(loss). Management determines the appropriate classification of its investments at the time of purchase and re-evaluates such determination at each balance sheet date. Fair Value of Financial Instruments – Financial instruments including cash equivalents and accounts payable are carried in the financial statements at amounts that approximate their fair value based on the short maturities of those instruments. Marketable securities are carried at fair value and are more fully described in Note 6. The carrying amount of the Company’s credit facility with Hercules Capital, Inc. approximates fair value since the effective interest rate approximates market rates currently available to the Company. Concentration of Credit Risk – Financial instruments that potentially subject the Company to significant concentrations of credit risk principally consist of cash, cash equivalents and marketable securities, if any. The Company places its cash and cash equivalents and marketable securities with financial institutions which management believes have high credit ratings and may hold some amounts exceed federally insured limits. As part of its cash and investment management processes, the Company performs periodic evaluations of the credit standing of the financial institutions with whom it maintains deposits. Intellectual Property – The legal and professional costs incurred by the Company to acquire its patent rights are expensed as incurred and included in general and administrative expenses. At December 31, 2022 and 2021, the Company has determined that these expenses have not met the criteria to be capitalized since the future benefits to be derived from the patents is uncertain. Intellectual property related expenses for the years ended December 31, 2022 and 2021 were $ 1.0 million and $ 1.3 million, respectively. Income Taxes – The Company follows the provisions of Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 740, Income Taxes (ASC 740) , in reporting deferred income taxes. ASC 740 requires a company to recognize deferred tax liabilities and assets for expected future income tax consequences of events that have been recognized in the Company’s financial statements. Under this method, deferred tax assets and liabilities are determined based on temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates in the years in which the temporary differences are expected to reverse. Valuation allowances are provided if based on the weight of available evidence, it is more likely than not that some or all the deferred tax assets will not be realized. The Company accounts for uncertain tax positions pursuant to ASC 740 which prescribes a recognition threshold and measurement process for financial statement recognition of uncertain tax positions taken or expected to be taken in a tax return. If the tax position meets this threshold, the benefit to be recognized is measured as the tax benefit having the highest likelihood of being realized upon ultimate settlement with the taxing authority. The Company recognizes interest accrued related to unrecognized tax benefits and penalties in the provision for income taxes. Management is not aware of any uncertain tax positions. Research and Development Costs – Research and development (R&D) costs are charged to expense as incurred and relate to salaries, employee benefits, stock-based compensation related to employees, consulting services, other operating costs and expenses associated with preclinical and clinical trial activities. Payments made by the Company in advance for research and development services not yet provided and/or for materials not yet received are recorded as prepaid expenses. Accrued liabilities are recorded related to those expenses for which vendors have not yet billed us with respect to services provided and/or materials that we have received. Preclinical and clinical trial expenses relate to third-party services, subject-related fees at the sites where the Company’s clinical trials are being conducted, laboratory costs, analysis costs, toxicology studies and investigator fees. Costs associated with these expenses are generally payable on the passage of time or when certain milestones are achieved. Expense is recorded during the period incurred or in the period in which a milestone is achieved. In order to ensure that the Company has adequately provided for preclinical and clinical expenses during the proper period, the Company maintains an accrual to cover these expenses. These accruals are assessed on a quarterly basis and are based on such assumptions as expected total cost, the number of subjects and clinical trial sites and length of the study. Actual results may differ from these estimates and could have a material impact on the Company’s reported results. The Company’s historical accrual estimates have not been materially different from actual costs. In-process research and development – Assets purchased in an asset acquisition transaction are expensed as in-process research and development (IPR&D) unless the assets acquired are deemed to have an alternative future use, provided that the acquired asset did not also include processes or activities that would constitute a “business” as defined under GAAP, the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no established alternative future use. Acquired IPR&D payments are immediately expensed in the period in which they are incurred and include upfront payments, as well as transaction fees and subsequent pre-commercial milestone payments. Research and development costs incurred after the acquisition are expensed as incurred. Stock-Based Compensation – Stock-based payments are accounted for in accordance with the provisions of ASC 718, Compensation – Stock Compensation . For options, the fair value of stock-based payments is estimated, on the date of grant, using the Black-Scholes option pricing model. For restricted stock units, fair value is based on the fair value of the stock on the date of grant. The resulting fair value for restricted stock units and options expected to vest is recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the applicable restricted stock units or option. The Company records the effect of forfeitures and cancellations when they occur. For performance-based awards, at each reporting period we assess the probability that the performance condition(s) will be achieved. We use the accelerated attribution method to expense the awards over the continuous service period based on the probability of achieving the performance conditions. We estimate the continuous service period based on our best estimate of the period over which an award’s vesting condition(s) will be achieved. We review and evaluate these estimates on a quarterly basis. The Company has cash awards and performance cash settled bonus awards, which are awards that will be settled in cash on their vesting dates (Liability Awards), rather than in equity units. The fair value of Liability Awards is updated at each balance sheet date and changes in the fair value of the vested portions of the Liability Awards are recorded as increases or decreases to compensation expense. The Company recognizes forfeitures as they occur. Comprehensive Loss – Comprehensive loss is defined as the change in equity during a period from transactions and other events and/or circumstances from non-owner sources. For December 31, 2022, comprehensive loss is equal to the Company’s net loss of $ 62.0 million and an unrealized loss on marketable securities of $ 0.1 million. For December 31, 2021, comprehensive loss is equal to the Company's net loss of $ 57.8 million. Net Loss Per Share – The Company computes net loss per share in accordance with the two-class method. Under the two-class method, net loss is allocated between common stock and other participating securities based on their participation rights. The Company has determined that the nonvested shares issued to the Helio founders represents a participating security and as such the nonvested shares are excluded from basic earnings per share. Net losses are not allocated to the nonvested stockholders for computing net loss per share under the two-class method because nonvested stockholders do not have contractual obligations to share in the losses of the Company. Basic earnings per share is calculated by dividing net loss allocable to common stockholders by the weighted average number of common stock outstanding during the period, excluding the effects of any potentially dilutive instruments. Diluted net loss per share is computed using the more dilutive of (a) the two-class method, or (b) treasury stock method, as applicable, to the potentially dilutive instruments. The weighted-average number of common shares outstanding gives effect to all potentially dilutive common equivalent shares, including outstanding stock options and restricted stock units, warrants, if any, and nonvested shares. Recent Accounting Pronouncements – In June 2016, the FASB issued (ASU) No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (ASU 2016-13). ASU 2016-13 requires that credit losses be reported as an allowance using an expected losses model, representing the entity’s current estimate of credit losses expected to be incurred. The accounting guidance currently in effect is based on an incurred loss model. For available-for-sale debt securities with unrealized losses, this standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. The amendments under ASU 2016-13 are effective for interim and annual fiscal periods beginning after December 15, 2022. The Company does not expect this standard to have a material impact on its financial statements.

Helio vision acquisition

Helio vision acquisition	12 Months Ended
	Dec. 31, 2022
Business Combinations [Abstract]
Helio vision acquisition	3. HELIO VISION ACQUISITION On January 28, 2019 (Closing Date), the Company acquired Helio Vision, Inc. (Helio). As a result of the acquisition, the Company initially issued an aggregate of 1,160,444 shares of common stock to the former securityholders and an advisor of Helio. The founders of Helio were issued 568,627 shares and non-founders were issued 591,817 shares. The Helio founders’ shares were subject to vesting based on continued service to the Company through January 28, 2022. The Company recognized the expense associated with the founders’ restricted shares as research and development compensation expense on a straight-line basis as the shares vested over the three-year period. For the year ended December 31, 2022 and 2021 , the Company recorded $ 0.1 million and $ 1.2 million of research and development compensation expense, respectively, for the founders’ restricted shares. In January 2021, pursuant to the terms of the acquisition agreement, the Company issued 246,562 shares of its common stock to the former securityholders of Helio (January Shares). In addition, the Company, subject to the conditions of the acquisition agreement, is contingently obligated to make additional payments to the former securityholders of Helio as follows: (a) $ 10.0 million of common stock following approval by the FDA of an NDA for the prevention and/or treatment of proliferative vitreoretinopathy or a substantially similar label prior to the 10th anniversary of the Closing Date; and (b) $ 2.5 million of common stock following FDA approval of an NDA for an indication (other than proliferative vitreoretinopathy or a substantially similar label) prior to the 12th anniversary of the Closing Date (the shares of common stock issuable pursuant to the preceding clauses (a) and (b) are referred to herein as the Milestone Shares), provided that in no event shall the Company be obligated to issue more than an aggregate of 5,248,885 shares of common stock in connection with the Helio acquisition. Additionally, in the event of certain change of control or divestitures by the Company, certain former convertible noteholders of Helio will be entitled to a tax gross-up payment in an amount not to exceed $ 1.0 million in the aggregate. The Company determined that liability accounting is not required for the Milestone Shares under FASB ASC Topic 480, Distinguishing Liabilities from Equity (ASC 480). The Company also determined that the Milestone Shares meet the scope exception as a derivative under FASB ASC Topic 815, Derivatives and Hedging (ASC 815), from inception of the Milestone Shares through December 31, 2022. Accordingly, the Milestone Shares are evaluated under FASB ASC Topic 450, Contingencies (ASC 450) and the Company will record a liability related to the Milestone Shares if the milestones are achieved, and the obligation to issue the Milestone Shares becomes probable. At such time, the Company will record the cost of the Milestone Shares issued to the founders as compensation expense and to the Helio non-founders as an in-process research and development (IPR&D) expense if there is no alternative future use. At December 31, 2020, the issuance of the January Shares was considered probable and $ 2.5 million was accrued as contingent consideration payable in stock and the Company recorded $ 1.8 million to IPR&D (Milestone IPR&D), which included a $ 0.5 million income tax benefit, and $ 1.2 million of compensation expense related to the January Shares, which amounted to 246,562 shares and were issued during the quarter ended March 31, 2021. No other milestones related to the remaining Milestone Shares are considered probable of being achieved as of December 31, 2022 .

Net Loss Per Share

Net Loss Per Share	12 Months Ended
	Dec. 31, 2022
Earnings Per Share [Abstract]
Net Loss Per Share	4. NET LOSS PER SHARE For the years ended December 31, 2022 and 2021, diluted weighted-average common shares outstanding is equal to basic weighted-average common shares due to the Company’s net loss position. The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted-average shares outstanding, because such securities had an antidilutive impact: Years ended December 31, 2022 2021 Options to purchase common stock 5,403,982 4,622,870 Nonvested restricted stock units 1,184,603 501,255 Nonvested founder shares (1) — 10,891 Total of common stock equivalents 6,588,585 5,135,016 (1) Represents 10,891 shares of common stock that are issued and outstanding but that were subject to vesting based on service requirements at December 31, 2021 , and were not included in stockholders’ equity at such date.

Cash, Cash Equivalents and Mark

Cash, Cash Equivalents and Marketable Securities	12 Months Ended
	Dec. 31, 2022
Cash and Cash Equivalents [Abstract]
Schedule of Cash, and Cash Equivalents	5. CASH, CASH EQUIVALENTS, AND MARKETABLE SECURITIES At December 31, 2022, cash, cash equivalents, and marketable securities were comprised of: Carrying Unrecognized Unrecognized Estimated Fair Cash and Cash Current Cash $ 135,151,081 $ — $ — $ 135,151,081 $ 135,151,081 $ — Money market funds 9,268,283 — — 9,268,283 9,268,283 — Total cash and cash equivalents $ 144,419,364 $ — $ — $ 144,419,364 $ 144,419,364 — U.S. government agency securities $ 29,985,458 $ — $ ( 103,938 ) $ 29,881,520 $ — $ 29,881,520 Available for sale (1) 29,985,458 — ( 103,938 ) 29,881,520 — 29,881,520 Total cash, cash equivalents, and current marketable securities $ 144,419,364 $ 29,881,520 At December 31, 2021, cash, cash equivalents, and marketable securities were comprised of: Carrying Unrecognized Unrecognized Estimated Fair Cash and Cash Current Cash $ 100,364,523 $ — $ — $ 100,364,523 $ 100,364,523 $ — Money market funds 4,426,466 — — 4,426,466 4,426,466 — Reverse repurchase agreements 125,000,000 — — 125,000,000 125,000,000 — Total cash and cash equivalents $ 229,790,989 $ — $ — $ 229,790,989 $ 229,790,989 $ — Available for sale (1) — — — — — — Total cash, cash equivalents, and current marketable securities $ 229,790,989 $ — There were no marketable securities held at December 31, 2021. (1) Available for sale securities are reported at fair value with unrealized gains and losses reported net of taxes, if material, in other comprehensive loss. The contractual maturities of all available for sale securities were less than one year at December 31, 2022

Fair Value Measurements

Fair Value Measurements	12 Months Ended
	Dec. 31, 2022
Fair Value Disclosures [Abstract]
Fair Value Measurements	6. FAIR VALUE MEASUREMENTS Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value are performed in a manner to maximize the use of observable inputs and minimize the use of unobservable inputs. ASC 820, Fair Value Measurements , establishes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value, which are the following: Level 1 – Quoted prices in active markets that are accessible at the market date for identical unrestricted assets or liabilities. Level 2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs for which all significant inputs are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The following table presents information about the Company’s assets measured at fair value at December 31, 2022 and December 31, 2021: December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds (a) $ 9,268,283 $ — $ — $ 9,268,283 U.S government agency securities (b) — 29,881,520 — 29,881,520 Total assets at fair value $ 9,268,283 $ 29,881,520 $ — $ 39,149,803 December 31, 2021 Level 1 Level 2 Level 3 Total Assets: Money market funds (a) $ 4,426,466 $ — $ — $ 4,426,466 Reverse repurchase agreements (b) — 125,000,000 — 125,000,000 Total assets at fair value $ 4,426,466 $ 125,000,000 $ — $ 129,426,466 (a) Money market funds included in cash and cash equivalents in the consolidated balance sheets, are valued at quoted market prices in active markets. (b) Reverse repurchase agreements and U.S. government agency securities, are recorded at fair market value, which are determined based on the most recent observable inputs for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active or are directly or indirectly observable.

Prepaid expenses and other curr

Prepaid expenses and other current assets	12 Months Ended
	Dec. 31, 2022
Prepaid Expense and Other Assets, Current [Abstract]
Prepaid Expenses and Other Current Assets	7. PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets at December 31, 2022 and 2021 were: December 31, December 31, 2022 2021 Deferred research and development expenses $ 2,605,252 $ 2,404,145 Prepaid insurance expenses 432,230 435,410 Other current receivables 3,242,026 28,770 Miscellaneous prepaid expenses 442,721 93,456 Total prepaid expenses and other current assets $ 6,722,229 $ 2,961,781

Accrued Expenses

Accrued Expenses	12 Months Ended
	Dec. 31, 2022
Payables and Accruals [Abstract]
Accrued Expenses	ACCRUED EXPENSES Accrued expenses at December 31, 2022 and 2021 were: December 31, December 31, 2022 2021 Accrued compensation $ 3,821,904 $ 1,512,885 Accrued research and development expenses 8,476,422 8,415,560 Accrued other expenses 1,767,559 594,908 Total accrued expenses $ 14,065,885 $ 10,523,353

Credit Facility

Credit Facility	12 Months Ended
	Dec. 31, 2022
Debt Disclosure [Abstract]
Credit Facility	9. CREDIT FACILITY The Company’s long-term debt obligation consists of amounts the Company is obligated to repay under its credit facility with Hercules Capital, Inc. (Hercules). In March 2019, the Company entered into a Loan and Security Agreement (Loan and Security Agreement or Hercules Credit Facility) with Hercules and several banks and other financial institutions or entities, from time-to-time parties thereto (collectively, referred to herein as Lender), providing for a term loan of up to $ 60.0 million, subject to the satisfaction of certain conditions contained therein, that is secured by a lien covering all of the Company’s assets, other than the Company’s intellectual property. The Loan and Security Agreement provided for (i) an initial term loan advance of up to $ 5.0 million at the Company’s option, which expired unutilized on April 15, 2019; (ii) three additional term loan advances of up to $ 15.0 million each, at the Company’s option, available to the Company upon the occurrence of certain pre-specified funding conditions prior to September 30, 2019 (2019 Tranche), March 31, 2020 (2020 Tranche), and March 31, 2021 (2021 Tranche); and (iii) a final additional term loan advance (Fourth Loan Tranche) of up to $ 10.0 million prior to December 31, 2021, at the Company’s option, subject to approval by the Lender’s investment committee. The 2019 Tranche was drawn down in full by the Company in September 2019 and the 2020 Tranche and 2021 Tranche expired unutilized prior to the Company satisfying the funding conditions for such tranche. On April 20, 2021, the Company entered into the First Amendment to the Loan and Security Agreement (First Amendment). The First Amendment, among other things, (i) increased the Fourth Loan Tranche from $ 10.0 million to $ 20.0 million and extended the deadline for drawing down the Fourth Loan Tranche to July 1, 2022; (ii) lowered the variable per annum rate of interest on borrowings under the Loan and Security Agreement from the greater of (a) 9.10 % and (b) the prime rate (as reported in the Wall Street Journal or any successor publication thereto) plus 3.10 % to the greater of (x) the Prime Rate (as defined therein) plus 3.10% or (y) 8.60%; (iii) extended the expiration of the period in which interest-only payments on borrowings under the Loan and Security Agreement are required from May 1, 2021 to July 1, 2022; and (iv) following the satisfaction of certain conditions, which conditions were satisfied in April 2021, further extended the expiration of the interest-only period and the deadline for drawing down the Fourth Loan Tranche to May 1, 2023 . Repayment of the aggregate outstanding principal balance of the term loan, in monthly installments, commences upon expiration of the interest-only period and continues through October 1, 2023 (Maturity Date). The First Amendment was determined to be a modification in accordance with FASB ASC Topic 470, Debt and did not result in extinguishment. On December 22, 2022, the Company entered into the Second Amendment to the Loan and Security Agreement (Second Amendment), which became effective as of December 31, 2022 (Second Amendment Effective Date). The Second Amendment, among other things, (i) extended the expiration of the period in which interest-only payments on borrowings under the Loan and Security Agreement are made from May 1, 2023 to May 1, 2024; (ii) extended the Maturity Date from October 1, 2023 to October 1, 2024 ; (iii) extended the availability of the Fourth Loan Tranche commitment of $ 20 million from May 1, 2023 to May 1, 2024 ; and (iv) amended the Prepayment Charge (as defined therein) to equal 0.75 % of the amount prepaid during the 12-month period following the Second Amendment Effective Date, and 0 % thereafter. The ability to draw the Fourth Loan Tranche remains conditioned on approval by the Lenders’ investment committee. In addition, a supplemental end of term charge of $ 292,500 (Supplemental End of Term Charge) shall be due on the earlier of (A) the Maturity Date, as amended, or (B) repayment of the aggregate amount of advances under the Loan and Security Agreement. The existing end of term charge of $ 1,042,500 (End of Term Charge) remains due on the earlier of (A) October 1, 2023 or (B) repayment of the aggregate amount of advances under the Loan and Security Agreement. The Second Amendment was determined to be a modification in accordance with FASB ASC Topic, Debt and did not result in extinguishment. In connection with the Hercules Credit Facility, the Company incurred a commitment charge of $ 25,000 , transaction costs of $ 273,186 , a fee of $ 375,000 upon closing, and will be required to pay the End of Term Charge and Supplemental End of Term Charge. The fees and transaction costs are amortized to interest expense from 2019 through the Maturity Date using the effective interest method. The End of Term Charge is amortized to interest expense from 2019 through October 2023, and the Supplemental End of Term Charge is amortized to interest expense from December 2022 through the Maturity Date, both using the effective interest method. The effective interest rate was 13.2 % at December 31, 2022 . At the Company’s option, the Company may elect to prepay all, but not less than all, of the outstanding term loan by paying the entire principal balance and all accrued and unpaid interest thereon plus all fees and other amounts due under the Loan and Security Agreement as of the date of such prepayment, including a prepayment charge equal to 0.75 % of the principal amount being prepaid during the 12-month period following the Second Amendment Effective Date, and 0 % thereafter. Following the effective time of the First Amendment and the Second Amendment and as of December 31, 2022 , an aggregate of $ 35 million, subject to the terms and conditions of the Loan and Security Agreement, may be made available to the Company for borrowing, $ 15 million of which was funded prior to the date of the First Amendment. Long-term debt consisted of the following: December 31, December 31, 2022 2021 Term loan payable $ 15,000,000 $ 15,000,000 End of term charge 911,763 703,269 Unamortized debt issuance costs ( 76,910 ) ( 199,566 ) Less: current portion ( 911,763 ) — Total long-term debt $ 14,923,090 $ 15,503,703 Future principal payments, including the End of Term Charge, are as follows for the years ending December 31: 2023 $ 1,042,500 2024 15,292,500 Total $ 16,335,000 The Loan and Security Agreement also contains certain events of default, representations, warranties and non-financial covenants of the Company. As of December 31, 2022 , the Company was in compliance with all covenants of the Hercules Credit Facility in all material respects. In addition, subject to the terms of the Loan and Security Agreement, the Company granted the Lender the right to purchase up to an aggregate of $ 2.0 million of the Company’s equity securities, or instruments exercisable for or convertible into equity securities, sold to investors in financings upon the same terms and conditions afforded to such other investors.

Stockholders' Equity

Stockholders' Equity	12 Months Ended
	Dec. 31, 2022
Equity [Abstract]
Stockholders' Equity	10. STOCKHOLDERS’ EQUITY Common Stock Each share of common stock is entitled to one vote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and when declared by the board of directors, subject to the prior rights of holders of all classes of stock outstanding. As of December 31, 2022, a total of 5,403,982 , 4,625,881 , and 1,785,993 , shares of common stock were reserved for issuance upon (i) the exercise of outstanding stock options, (ii) the issuance of stock awards under the Company’s Amended 2013 Plan, and (iii) the issuance of shares under the 2016 ESPP, respectively. 2021 Jefferies Sales Agreement In March 2021, the Company entered into an Open Market Sales Agreement SM with Jefferies LLC (Jefferies), as sales agent (2021 Jefferies Sales Agreement), pursuant to the 2021 Jefferies Sales Agreement, the Company may offer and sell, from time to time through Jefferies, shares of common stock providing for aggregate sales proceeds of up to $ 100.0 million. The Company has no obligation to sell any shares under the 2021 Jefferies Sales Agreement, and could at any time suspend solicitations and offers under the 2021 Jefferies Sales Agreement. No sales had been made pursuant to the 2021 Jefferies Sales Agreement as of December 31, 2022. Underwritten Public Offerings In January 2021, the Company sold 7.9 million shares of its common stock in an underwritten public offering at $ 9.50 per share, for an aggregate gross cash purchase price of $ 74.7 million or proceeds of $ 70.0 million after deducting underwriters’ discount, commissions, and other offering expenses. In May and June 2021, the Company sold an aggregate of 10.2 million shares of its common stock at a public offering price of $ 12.50 per share, in an underwritten public offering, for an aggregate gross cash purchase price of $ 127.8 million or proceeds of $ 119.8 million after deducting underwriters’ discount, commissions, and other offering expenses, which included the partial exercise of the underwriters' option to purchase additional shares.

Income Taxes

Income Taxes	12 Months Ended
	Dec. 31, 2022
Income Tax Disclosure [Abstract]
Income Taxes	11. INCOME TAXES No current or deferred tax provision expenses for federal and state income taxes have been recorded as the Company has incurred losses since inception for tax purposes. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. In assessing the realizability of net deferred taxes in accordance with Accounting Standards Codification (ASC) 740, Income Taxes (ASC 740), the Company considers whether it is more likely than not that some portion or all the deferred tax assets will not be realized. Based on the weight of available evidence, primarily the incurrence of net losses since inception, anticipated net losses in the near future, reversals of existing temporary differences and expiration of various federal and state attributes, the Company does not consider it more likely than not that some or all of the net deferred taxes will be realized. Accordingly, a 100 % valuation allowance has been applied against net deferred tax assets. Effective January 1, 2021, the Company adopted ASU No. 2019-12, Income Taxes (Topic 740), which did not have a material impact to the Company’s financial statements. As of December 31, 2022, the Company had federal and state income tax net operating loss (NOL) carryforwards of approximately $ 239.2 million and $ 231.3 million , respectively. Federal NOL carryforwards generated through December 31, 2017 and state NOL carryforwards will expire at various dates through 2041 . The federal NOL carryforwards generated during the year ended December 31, 2018 and thereafter will carryforward indefinitely. As of December 31, 2022, the Company had federal and state research and development tax credit carryforwards of approximately $ 8.7 million and $ 2.1 million , respectively, which will expire at various dates through 2041 . Additionally, as of December 31, 2022, the Company had a federal orphan drug tax credit carryforward of approximately $ 1.7 million that expires in 2042 . On August 16, 2022 President Biden signed into law the Inflation Reduction Act (IRA). From a tax perspective, the IRA provisions includes a new corporate alternative minimum tax (CAMT) of 15% on adjusted financial statement income (AFSI) for corporations with over $1 billion in profits, a new excise tax on corporate stock buybacks and increased funding for IRS enforcement. A company’s AFSI can be reduced by net operating losses, foreign tax credits, general business credits and depreciation for property under Section 197. To determine its US federal income tax liability, a company will need to compute taxes under both systems — the regular tax system and the CAMT system. The company then will pay the larger amount as its tax liability in any given year. The Company does not expect to fall into the CAMT system. The IRA provisions have no impact on the Company’s financial statements for the period ended December 31, 2022. Significant components of the Company’s deferred tax assets and liabilities at December 31, 2022 and 2021 are as follows: Years ended December 31, 2022 2021 Deferred Tax Assets Federal & state NOL carryforward $ 64,840,595 $ 61,308,787 Federal & state R&D credit 12,110,003 9,200,758 Deferred costs 342,210 — Intangibles – net 78,378 78,378 Accounts payable and accrued 2,004,737 2,301,117 Reserves 28,396 — Stock options 4,042,117 3,906,501 Capitalized R&D expenses 11,151,910 — Other items 98,552 127,791 Gross deferred tax assets 94,696,898 76,923,332 Valuation allowance ( 94,628,799 ) ( 76,827,203 ) Deferred tax assets, net $ 68,099 $ 96,129 Deferred Tax Liabilities Right of use asset ( 68,099 ) ( 96,129 ) TOTAL $ — $ — The change in valuation allowance of $ 17.8 million from December 31, 2021 to December 31, 2022 was primarily the result of an increase in capitalized R&D expenses, net operating losses, and tax credits. The components of the income tax benefit for the years ended December 31, 2022 and 2021, are as follows: Years ended December 31, 2022 2021 Deferred Taxes Federal $ — $ — State — — Total income tax benefit $ — $ — Future changes in federal and state tax laws pertaining to net operating loss carryforwards may also cause limitations or restrictions from us claiming such net operating losses. If the net operating loss carryforwards become unavailable to us or are fully utilized, our future taxable income will not be shielded from federal and state income taxation absent certain U.S. federal and state tax credits, and the funds otherwise available for general corporate purposes would be reduced. Under Section 382 of the Internal Revenue Code of 1986, as amended, a corporation that undergoes an “ownership change” is subject to limitations on its ability to utilize its pre-change NOLs and certain other tax assets to offset future taxable income. In general, an ownership change occurs if the aggregate stock ownership of certain stockholders increases by more than 50 percentage points over such stockholders’ lowest percentage ownership during the testing period (generally three years). Transactions involving the Company’s common stock within the testing period, even those outside the Company’s control such as purchases or sales by investors, could result in an ownership change. A limitation on the Company’s ability to utilize some or all its NOLs or credits could have a material adverse effect on the Company’s results of operations and cash flows. The Company believes, prior to December 31, 2021 that four ownership changes occurred since inception. Management believes that its aggregate Section 382 limitation (including the additional limitation for recognized "built-in gains") is sufficient so that no current impairment of its pre-ownership change tax attributes is required. There were no ownership changes in 2022. Any future ownership changes, including those resulting from any recent or future financing activities, may cause our existing tax attributes to have additional limitations. As of December 31, 2022, the Company is subject to tax in the U.S. (Federal and Massachusetts). The Company is open to examination for the tax years ended December 31, 2022, 2021, 2020, and 2019. In addition, any loss years remain open to the extent that losses are available for carryover to future years. A reconciliation of the federal statutory tax rate of 21 % to the Company’s effective income tax rates are as follows: Years ended December 31, 2022 2021 Statutory tax rate 21.00 % 21.00 % State taxes, net of federal benefits 6.05 % 6.65 % Federal research and development credits 4.12 % 4.29 % Change in valuation allowance ( 28.66 ) % ( 31.35 ) % Stock-based compensation ( 2.53 ) % ( 0.73 ) % Other 0.02 % 0.14 % Effective tax rate 0.00 % ( 0.00 ) %

Stock Incentive Plan

Stock Incentive Plan	12 Months Ended
	Dec. 31, 2022
Share-Based Payment Arrangement [Abstract]
Stock Incentive Plan	12. STOCK INCENTIVE PLAN The Company approved the 2010 Employee, Director and Consultant Equity Incentive Plan (2010 Plan) in September 2010 to replace the 2004 Employee, Director and Consultant Equity Incentive Plan. The 2010 Plan provided for the granting of stock options and restricted stock awards. The 2010 Plan terminated upon the Company’s initial public offering in May 2014. However, grants made under the 2010 Plan are still governed by that plan. As of December 31, 2022, options to purchase 398,547 shares of common stock at a weighted average exercise price of $ 1.52 per share remained outstanding under the 2010 Plan. The Company approved the 2013 Equity Incentive Plan in October 2013. The 2013 Equity Incentive Plan became effective immediately on adoption. The 2013 Equity Incentive Plan was amended in June 2016 and June 2018, (Amended 2013 Plan). The Amended 2013 Plan provides for the granting of stock options, restricted stock units (RSU), stock appreciation rights, and stock units to certain employees, members of the board of directors and consultants of the Company. On first business day of each year the aggregate number of common shares that may be issued under the Amended 2013 Plan shall automatically increase by a number of shares equal to the lower of (a) 6 % of the total number of shares of common stock outstanding on the last calendar day of the prior fiscal year, or (b) a number of shares of common stock determined by the Company’s board of directors. As of December 31, 2022, options to purchase 5,005,435 shares of common stock at a weighted average exercise price of $ 6.25 per share and 1,184,603 shares of common stock underlying restricted stock units remained outstanding under the Amended 2013 Plan. As of December 31, 2022, there were 4,625,881 shares of common stock available for grant under the Amended 2013 Plan. As of January 3, 2023, the number of shares of common stock that may be issued under the Amended 2013 Plan was automatically increased by 3,513,605 shares, increasing the number of shares of common stock available for issuance under the Amended 2013 Plan to 8,139,486 . In 2019, 2020, and 2022 the Company granted cash awards under its Management Cash Incentive Plan, as amended. The cash awards vest in four annual installments from the date of grant and entitle the employees to receive a cash payment, on the earlier of (i) four years from the date of grant or (ii) a change of control, equal in value to the amount by which the then value of the Company’s common stock exceeds the base value. As of December 31, 2022 , $ 1.4 million was accrued as compensation expense for vested cash awards. There was no unrecognized expense as of December 31, 2022. In 2022, the Company granted performance cash settled bonus awards (CSBUs) under its Management Cash Incentive Plan, as amended. Subject to and conditioned upon the acceptance by the FDA of the Company's submission of an NDA for reproxalap (Performance Criteria), the awards will vest in four annual installments from the date of grant and entitle the employees to receive a cash payment for each vested CSBU, on the earlier of (i) four years from the date of grant or (ii) a change of control, equal in value of the closing price per share of the Company's common stock on the Nasdaq Capital Market on the payment date. As of December 31, 2022 , $ 1.1 million was accrued as compensation expense for CSBUs as the Performance Criteria was deemed probable and was subsequently met in February 2023. There was no unrecognized expense as of December 31, 2022. The Company recognizes stock-based compensation expense over the requisite service period. The Company’s share-based awards are accounted for as equity instruments, except for cash awards and CSBUs, which are accounted for as liabilities. The amounts included in the consolidated statements of operations relating to stock-based compensation associated with the two equity incentive plans, cash awards, CSBUs, and Helio founders’ shares are as follows: Years ended December 31, 2022 2021 Research and development expenses $ 4,087,073 $ 3,562,181 General and administrative expenses 4,201,903 3,545,846 Total stock-based compensation expense $ 8,288,976 $ 7,108,027 Stock Options Terms of stock option agreements, including vesting requirements, are determined by the board of directors or its compensation committee, subject to the provisions of the respective plan from which they were granted. Options granted by the Company typically vest over a four-year period. The options are subject to acceleration of vesting in the event of certain change of control transactions. The options may be granted for a term of up to ten years from the date of grant. The exercise price for options granted under the Amended 2013 Plan must be at a price no less than 100 % of the fair market value of a common share on the date of grant. The following table summarizes option activity under the incentive plans for the year ended December 31, 2022: Number of Weighted Weighted Aggregate Outstanding at December 31, 2021 4,622,870 $ 6.73 $ 1,268,089 Granted 1,756,297 4.05 — Cancelled/Forfeited ( 738,223 ) 7.09 — Exercised ( 236,962 ) 4.74 414,682 Outstanding at December 31, 2022 5,403,982 $ 5.90 6.56 $ 10,506,953 Exercisable at December 31, 2022 3,528,792 $ 6.13 5.33 $ 6,098,269 (a) The aggregate intrinsic value in this table was calculated on the positive difference, if any, between the closing price per share of the Company’s common stock on December 31, 2022 of $ 6.96 and the per share exercise price of the underlying options. The total intrinsic value of stock options exercised was $ 0.4 million and $ 2.5 million for the years ended December 31, 2022 and 2021, respectively. The Company records stock-based compensation related to stock options granted at fair value. During the years ended December 31, 2022 and 2021, the Company used the Black-Scholes option-pricing model to estimate the fair value of stock option grants and to determine the related compensation expense. The assumptions used in calculating the fair value of stock-based payment awards represent management’s best estimates. The weighted-average fair value of options granted was $ 2.92 and $ 7.95 for the years ended December 31, 2022 and 2021 , respectively. The assumptions used in determining fair value of the employee stock options for the years ended December 31, 2022 and 2021, are as follows: December 31, December 31, Expected dividend yield 0 % 0 % Anticipated volatility 84.82 % - 85.21 % 81.73 % - 83.50 % Stock price $ 3.49 - $ 4.52 $ 8.33 - $ 12.97 Exercise price $ 3.49 - $ 4.52 $ 8.33 - $ 12.97 Expected life (years) 5.50 - 6.08 5.50 - 6.08 Risk free interest rate 1.47 % - 3.26 % 0.88 % - 1.67 % The dividend yield of zero is based on the fact that the Company has never paid cash dividends and have no present intention to pay cash dividends. Expected volatility is estimated using the historical volatility of the Company. The Company has estimated the expected life of its employee stock options using the “simplified” method, whereby, the expected life equals the average of the vesting term and the original contractual term of the option for service-based awards since the Company doesn’t have sufficient historical or implied data of its own. The risk-free interest rates for periods within the expected life of the option are based on the yields of zero-coupon United States Treasury securities. At December 31, 2022, there is approximately $ 6.1 million of unrecognized compensation cost relating to stock options outstanding, which the Company expects to recognize over a weighted average period of 2.31 years. Total unrecognized compensation cost will be adjusted for future forfeitures, if necessary. Restricted Stock Units Terms of RSUs agreements, including vesting requirements, are determined by the board of directors or its compensation committee, subject to the provisions of the Amended 2013 Plan. RSUs granted by the Company typically vest over a four year period. In the event that the employees’ employment with the Company terminates any unvested shares are forfeited and revert to the Company. RSUs are not included in issued and outstanding common stock until the shares are vested and released. The table below summarizes activity relating to RSUs for the year ended December 31, 2022 : Number Weighted-Average Grant Date Fair Value Outstanding at December 31, 2021 501,255 $ 5.94 Granted 1,055,460 4.64 Cancelled/Forfeited ( 169,586 ) 4.37 Vested/released ( 202,526 ) 6.28 Outstanding at December 31, 2022 1,184,603 $ 4.95 The weighted-average fair value of RSUs granted was $ 4.64 and $ 11.71 per share for the years ended December 31, 2022 and December 31, 2021, respectively. The total fair value of RSUs vested was $ 1.3 million and $ 1.5 million for the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022, the outstanding RSUs had unamortized stock-based compensation of $ 4.3 million with a weighted-average remaining recognition period of 3.16 years and an aggregate intrinsic value of $ 8.2 million. Employee Stock Purchase Plan In March 2016, the Company’s board of directors approved the 2016 Employee Stock Purchase Plan (2016 ESPP), which became effective in June 2016 following the approval of the Company’s stockholders. The 2016 ESPP initially authorized the issuance of up to a total of 414,639 shares of the Company’s common stock to participating employees. The number of shares reserved for issuance under the 2016 ESPP automatically increases on the first business day of each fiscal year, commencing in 2017, by a number equal to the lower of (i) 1 % of the shares of common stock outstanding on the last business day of the prior fiscal year; or (ii) the number of shares determined by the Company’s Board of Directors. Unless otherwise determined by the administrator of the 2016 ESPP, two offering periods of six months’ duration will begin each year on January 1 and July 1. Participating employees purchase stock under the 2016 ESPP at a price equal to the lower of 85 % of the closing price on the applicable offering commencement date or 85 % of the closing price on the applicable offering termination date. The fair value of the purchase rights granted under this plan was estimated on the date of grant using the Black-Scholes option-pricing model using assumptions as shown below: December 31, December 31, Expected dividend yield 0 % 0 % Anticipated volatility 84.04 % - 84.99 % 81.76 % - 82.87 % Stock price $ 3.80 - $ 4.27 $ 6.53 - $ 11.31 Exercise price $ 3.80 - $ 4.27 $ 6.53 - $ 11.31 Expected life (years) 0.50 0.50 Risk free interest rate 0.22 % - 4.76 % 0.05 % - 0.09 % At December 31, 2022, the Company has 1,785,993 shares available for issuance under the 2016 ESPP. The number of shares available for issuance under the 2016 ESPP was increased as of January 3, 2023 by 585,601 shares. A summary of the weighted-average grant-date fair value, shares issued and total stock-based compensation expense recognized related to the 2016 ESPP for the years ended December 31, 2022 and 2021 are as follows: December 31, December 31, Weighted-average grant-date fair value $ 1.57 $ 2.98 Total shares issued 28,485 12,092 Total stock-based compensation expense $ 57,413 $ 45,190

Commitments and Contingencies

Commitments and Contingencies	12 Months Ended
	Dec. 31, 2022
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	13. COMMITMENTS AND CONTINGENCIES Guarantees and Indemnifications As permitted under Delaware law, the Company indemnifies its officers and directors for certain events or occurrences while the officer or director is, or was, serving at the Company’s request in such capacity. The term of the indemnification is for the officer’s or director’s lifetime. Through December 31, 2022 , the Company had not experienced any losses related to these indemnification obligations and no material claims were outstanding. The Company does not expect significant claims related to these indemnification obligations, and consequently, concluded that the fair value of these obligations is negligible, and no related reserves were established. In-License Agreements MEEI Agreement The Company is developing ADX-2191 pursuant to an Exclusive License Agreement with Massachusetts Eye and Ear Infirmary (MEEI) originally entered into in July 2016 between MEEI and Helio Vision, Inc., as amended, (MEEI Agreement). The Company assumed the MEEI Agreement in connection with its 2019 acquisition of Helio Vision. Pursuant and subject to the MEEI Agreement, the Company obtained an exclusive, worldwide license from MEEI to develop and commercialize ADX-2191 under certain patents and patent applications, and other licenses to intellectual property (MEEI Patent Rights). The Company has agreed to use commercially reasonable efforts, to develop ADX-2191 and to meet certain specified effort and achievement benchmarks by certain dates. In consideration for the rights licensed under the MEEI Agreement, Helio Vision issued MEEI a number of shares of its preferred stock and Helio Vision agreed to pay non-creditable non-refundable license maintenance fees to MEEI of $ 15,000 on each of the second and third anniversary of the MEEI Agreement, $ 25,000 on each of the fourth and fifth anniversary of the MEEI Agreement and $ 35,000 on the sixth and each subsequent anniversary of the MEEI Agreement during the term of such agreement. In addition, Helio Vision was obligated to make future sales-dependent milestone payments to MEEI of up to the low seven figures in the aggregate, as well as royalty payments to MEEI at a rate which, as a percentage of net sales, is in the low single digits for products that incorporate or use the MEEI Patent Rights in the United States and as a percentage in the low single digits for products that incorporate or use the MEEI Patent Rights outside the United States. The Company is also obligated under the MEEI Agreement to pay MEEI a percentage of certain sublicense revenue that it receives in connection with entering into any sublicensing arrangements with any third parties, at a percentage rate which tiers downward from low-double digits to mid-single digits based on the date of the sublicense. Following the Company’s acquisition of Helio Vision, the Company became obligated to make any future payments owed under the MEEI Agreement. There is no additional equity consideration issuable under the MEEI Agreement. The MEEI Agreement will remain in effect until the expiration date of the last to expire patent licensed under the MEEI Agreement. The Company may terminate the MEEI Agreement with timely written notice to MEEI. MEEI has the right to terminate the MEEI Agreement if it, subject to certain specified cure periods, ceases all business operations with respect to licensed products, fails to pay amounts due under the MEEI Agreement, fail to comply with certain due diligence obligations, defaults in our obligation to maintain insurance, one of our officers is convicted of a felony relating to the manufacture, use, sale or importation of licensed products, we materially breach any provisions of the MEEI Agreement or in the event of its insolvency or bankruptcy. In the event of an early termination of the MEEI Agreement, all rights licensed and developed by the Company under the MEEI Agreement may revert back to MEEI. The Company has agreed to indemnify MEEI for certain claims that may arise under the MEEI Agreement. Litigation From time to time, the Company is party to legal proceedings. There are none deemed to be material at this time. Accordingly, the Company has not accrued any liabilities in its consolidated financial statements related to proceedings.

Leases

Leases	12 Months Ended
	Dec. 31, 2022
Leases [Abstract]
Leases	14. LEASES The Company currently leases an office used to conduct business. The exercise of lease renewal options is at the Company’s discretion and the renewal to extend the lease terms are not included in the Company’s Right-Of-Use assets and lease liabilities as they are not reasonably certain of exercise. The Company regularly evaluates the renewal options and when they are reasonably certain of exercise, the Company includes the renewal period in its lease term. As the Company’s lease does not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the lease commencement date in determining the present value of the lease payments. In August 2021, the Company entered into a lease amendment extending the lease by 18 months through June 30, 2023, which had an immaterial impact to the balance sheet as of December 31, 2021. In December 2022, the Company exercised its option to extend the lease for an additional 6 months through December 31, 2023, which had an immaterial impact on the balance sheet as of December 31, 2022. For the years ended December 31, 2022 and 2021 , right of use assets obtained in exchange for lease obligations were $ 0.2 million and $ 0.3 million, respectively. As of December 31, 2022, the Company maintained an unamortized Right-Of-Use asset with a corresponding operating lease liability of approximately $ 0.2 million based on the present value of the minimum rental payments in accordance with ASC Topic 842, Leases . The weighted average discount rate used for leases as of December 31, 2022 is 9.1 %. The weighted average lease term as of December 31, 2022 is 1.0 years. The operating lease expense for the year ended December 31, 2022 was $ 0.2 million . Maturities and balance sheet presentation of our lease liabilities for all operating leases as of December 31, 2022 is as follows: 2023 remaining total lease payments $ 261,828 Less: effect of discounting ( 12,563 ) Present value of lease liabilities $ 249,265 Current operating lease liabilities $ 249,265 Total $ 249,265 The Company’s gross future minimum payments under all non-cancelable operating leases as of December 31, 2022 are: Total 2023 2024 2025 2026 Operating lease obligations $ 261,828 $ 261,828 $ — $ — $ —

Basis of Presentation and Sig_2

Basis of Presentation and Significant Accounting Policies (Policies)	12 Months Ended
	Dec. 31, 2022
Accounting Policies [Abstract]
Basis of Presentation	Basis of Presentation and Consolidation – The accompanying consolidated financial statements were prepared in conformity with accounting principles generally accepted in the United States of America (US GAAP) and pursuant to the rules and regulations of the Securities and Exchange Commission (SEC). The Company’s consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated.
Risks and Uncertainties	Risks and Uncertainties –The ongoing research and development activities will be subject to extensive regulation by numerous governmental authorities in the United States. Prior to marketing in the United States, any drug developed by the Company must undergo rigorous preclinical and clinical testing and an extensive regulatory approval process implemented by the United States Food and Drug Administration (FDA) under the Food, Drug and Cosmetic Act. The Company has limited experience in conducting and managing the preclinical and clinical testing necessary to obtain regulatory approval. There can be no assurance that the Company will not encounter problems in the clinical trials that will cause the Company or the FDA to delay or suspend clinical trials. The Company’s success will depend in part on its ability to obtain patents and product license rights, maintain trade secrets, and operate without infringing on the property rights of others, both in the United States and other countries. There can be no assurance that patents issued to or licensed by the Company will not be challenged, invalidated, circumvented, or that the rights granted thereunder will provide proprietary protection or competitive advantages to the Company. Based on its current operating plan, the Company believes that its cash, cash equivalents, and marketable securities as of December 31, 2022, will be sufficient to fund the Company's currently projected operating expenses into the second half of 2024. As a result of the COVID-19 pandemic, clinical site availability, staffing, and patient recruitment have been negatively affected and the timelines to complete the Company’s clinical trials may be delayed. The Company’s assessment of its liquidity and capital resources includes an estimate of the financial impacts of these changes. The Company has based its projections of operating capital requirements on its current operating plan, which includes several assumptions that may prove to be incorrect, and Company may use all of its available capital resources sooner than the Company expects. The Company will need to secure additional funding in the future, from one or more equity or debt financings, collaborations, or other sources, in order to carry out all of the Company’s planned research and development activities and regulatory activities; commence or continue ongoing commercialization activities, including manufacturing, sales, marketing and distribution, for any of our product candidates for which the Company may receive marketing approval; or conduct any substantial, additional development requirements requested by the Food and Drug Administration (FDA). Additional funding may not be available to the Company on acceptable terms, or at all. If the Company is unable to secure additional funding, it will be required to significantly decrease the amount of planned expenditures and may be required to cease operations. Curtailment of operations would cause significant delays in the Company’s efforts to develop and introduce its products to market, which is critical to the realization of its business plan and the future operations of the Company.
Use of Estimates	Use of Estimates – The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions, including fair value estimates for investments, that affect the reported amounts of assets, liabilities, and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. The Company evaluates its estimates and assumptions on an ongoing basis. The most significant estimates in the Company’s consolidated financial statements include, but are not limited to, clinical trial accruals, deferred and accrued research and development costs, stock-based compensation, and accounting for income taxes and related valuation allowance. Although these estimates and assumptions are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions.
Segment Information	Segment Information – Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one segment, which is the identification and development of next-generation medicines to improve the lives of patients with immune-mediated diseases.
Cash and Cash Equivalents	Cash and Cash Equivalents – The Company classifies all highly liquid investments with original maturities of three months or less as cash equivalents and all highly liquid investments with original maturities of greater than three months but less than 12 months as current marketable securities. The Company has a policy of making investments only with commercial institutions that have at least an investment grade credit rating. The Company invests its cash primarily in reverse repurchase agreements (RRAs), government securities and obligations, and money market funds. RRAs are collateralized by deposits in the form of ‘Government Securities and Obligations’ for an amount not less than 102 % of their value. The Company does not record an asset or liability related to the collateral as the Company is not permitted to sell or repledge the associated collateral. The Company has a policy that the collateral has at least an A (or equivalent) credit rating. The Company utilizes a third-party custodian to manage the exchange of funds as well as the requirement that collateral received is maintained at 102% of the value of the RRAs on a daily basis.
Marketable Securities	Marketable Securities – Marketable securities consist of government securities and obligations with original maturities of more than 90 days . Investments are classified as available-for-sale and are recorded on the balance sheet at fair value with unrealized gains or losses reported as a separate component of other comprehensive income/(loss). Management determines the appropriate classification of its investments at the time of purchase and re-evaluates such determination at each balance sheet date.
Fair Value of Financial Instruments	Fair Value of Financial Instruments – Financial instruments including cash equivalents and accounts payable are carried in the financial statements at amounts that approximate their fair value based on the short maturities of those instruments. Marketable securities are carried at fair value and are more fully described in Note 6. The carrying amount of the Company’s credit facility with Hercules Capital, Inc. approximates fair value since the effective interest rate approximates market rates currently available to the Company.
Concentration of Credit Risk	Concentration of Credit Risk – Financial instruments that potentially subject the Company to significant concentrations of credit risk principally consist of cash, cash equivalents and marketable securities, if any. The Company places its cash and cash equivalents and marketable securities with financial institutions which management believes have high credit ratings and may hold some amounts exceed federally insured limits. As part of its cash and investment management processes, the Company performs periodic evaluations of the credit standing of the financial institutions with whom it maintains deposits.
Intellectual Property	Intellectual Property – The legal and professional costs incurred by the Company to acquire its patent rights are expensed as incurred and included in general and administrative expenses. At December 31, 2022 and 2021, the Company has determined that these expenses have not met the criteria to be capitalized since the future benefits to be derived from the patents is uncertain. Intellectual property related expenses for the years ended December 31, 2022 and 2021 were $ 1.0 million and $ 1.3 million, respectively.
Income Taxes	Income Taxes – The Company follows the provisions of Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 740, Income Taxes (ASC 740) , in reporting deferred income taxes. ASC 740 requires a company to recognize deferred tax liabilities and assets for expected future income tax consequences of events that have been recognized in the Company’s financial statements. Under this method, deferred tax assets and liabilities are determined based on temporary differences between financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates in the years in which the temporary differences are expected to reverse. Valuation allowances are provided if based on the weight of available evidence, it is more likely than not that some or all the deferred tax assets will not be realized. The Company accounts for uncertain tax positions pursuant to ASC 740 which prescribes a recognition threshold and measurement process for financial statement recognition of uncertain tax positions taken or expected to be taken in a tax return. If the tax position meets this threshold, the benefit to be recognized is measured as the tax benefit having the highest likelihood of being realized upon ultimate settlement with the taxing authority. The Company recognizes interest accrued related to unrecognized tax benefits and penalties in the provision for income taxes. Management is not aware of any uncertain tax positions.
Research and Development Costs	Research and Development Costs – Research and development (R&D) costs are charged to expense as incurred and relate to salaries, employee benefits, stock-based compensation related to employees, consulting services, other operating costs and expenses associated with preclinical and clinical trial activities. Payments made by the Company in advance for research and development services not yet provided and/or for materials not yet received are recorded as prepaid expenses. Accrued liabilities are recorded related to those expenses for which vendors have not yet billed us with respect to services provided and/or materials that we have received. Preclinical and clinical trial expenses relate to third-party services, subject-related fees at the sites where the Company’s clinical trials are being conducted, laboratory costs, analysis costs, toxicology studies and investigator fees. Costs associated with these expenses are generally payable on the passage of time or when certain milestones are achieved. Expense is recorded during the period incurred or in the period in which a milestone is achieved. In order to ensure that the Company has adequately provided for preclinical and clinical expenses during the proper period, the Company maintains an accrual to cover these expenses. These accruals are assessed on a quarterly basis and are based on such assumptions as expected total cost, the number of subjects and clinical trial sites and length of the study. Actual results may differ from these estimates and could have a material impact on the Company’s reported results. The Company’s historical accrual estimates have not been materially different from actual costs.
In Process Research and Development	In-process research and development – Assets purchased in an asset acquisition transaction are expensed as in-process research and development (IPR&D) unless the assets acquired are deemed to have an alternative future use, provided that the acquired asset did not also include processes or activities that would constitute a “business” as defined under GAAP, the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no established alternative future use. Acquired IPR&D payments are immediately expensed in the period in which they are incurred and include upfront payments, as well as transaction fees and subsequent pre-commercial milestone payments. Research and development costs incurred after the acquisition are expensed as incurred.
Stock-Based Compensation	Stock-Based Compensation – Stock-based payments are accounted for in accordance with the provisions of ASC 718, Compensation – Stock Compensation . For options, the fair value of stock-based payments is estimated, on the date of grant, using the Black-Scholes option pricing model. For restricted stock units, fair value is based on the fair value of the stock on the date of grant. The resulting fair value for restricted stock units and options expected to vest is recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the applicable restricted stock units or option. The Company records the effect of forfeitures and cancellations when they occur. For performance-based awards, at each reporting period we assess the probability that the performance condition(s) will be achieved. We use the accelerated attribution method to expense the awards over the continuous service period based on the probability of achieving the performance conditions. We estimate the continuous service period based on our best estimate of the period over which an award’s vesting condition(s) will be achieved. We review and evaluate these estimates on a quarterly basis. The Company has cash awards and performance cash settled bonus awards, which are awards that will be settled in cash on their vesting dates (Liability Awards), rather than in equity units. The fair value of Liability Awards is updated at each balance sheet date and changes in the fair value of the vested portions of the Liability Awards are recorded as increases or decreases to compensation expense. The Company recognizes forfeitures as they occur.
Comprehensive Loss	Comprehensive Loss – Comprehensive loss is defined as the change in equity during a period from transactions and other events and/or circumstances from non-owner sources. For December 31, 2022, comprehensive loss is equal to the Company’s net loss of $ 62.0 million and an unrealized loss on marketable securities of $ 0.1 million. For December 31, 2021, comprehensive loss is equal to the Company's net loss of $ 57.8 million.
Net Loss Per Share	Net Loss Per Share – The Company computes net loss per share in accordance with the two-class method. Under the two-class method, net loss is allocated between common stock and other participating securities based on their participation rights. The Company has determined that the nonvested shares issued to the Helio founders represents a participating security and as such the nonvested shares are excluded from basic earnings per share. Net losses are not allocated to the nonvested stockholders for computing net loss per share under the two-class method because nonvested stockholders do not have contractual obligations to share in the losses of the Company. Basic earnings per share is calculated by dividing net loss allocable to common stockholders by the weighted average number of common stock outstanding during the period, excluding the effects of any potentially dilutive instruments. Diluted net loss per share is computed using the more dilutive of (a) the two-class method, or (b) treasury stock method, as applicable, to the potentially dilutive instruments. The weighted-average number of common shares outstanding gives effect to all potentially dilutive common equivalent shares, including outstanding stock options and restricted stock units, warrants, if any, and nonvested shares.
Recent Accounting Pronouncements	Recent Accounting Pronouncements – In June 2016, the FASB issued (ASU) No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (ASU 2016-13). ASU 2016-13 requires that credit losses be reported as an allowance using an expected losses model, representing the entity’s current estimate of credit losses expected to be incurred. The accounting guidance currently in effect is based on an incurred loss model. For available-for-sale debt securities with unrealized losses, this standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. The amendments under ASU 2016-13 are effective for interim and annual fiscal periods beginning after December 15, 2022. The Company does not expect this standard to have a material impact on its financial statements.

Net Loss Per Share (Tables)

Net Loss Per Share (Tables)	12 Months Ended
	Dec. 31, 2022
Earnings Per Share [Abstract]
Computation of Diluted Weighted-Average Shares Outstanding	The following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted-average shares outstanding, because such securities had an antidilutive impact: Years ended December 31, 2022 2021 Options to purchase common stock 5,403,982 4,622,870 Nonvested restricted stock units 1,184,603 501,255 Nonvested founder shares (1) — 10,891 Total of common stock equivalents 6,588,585 5,135,016 (1) Represents 10,891 shares of common stock that are issued and outstanding but that were subject to vesting based on service requirements at December 31, 2021 , and were not included in stockholders’ equity at such date.

Cash, Cash Equivalents and Ma_2

Cash, Cash Equivalents and Marketable Securities (Tables)	12 Months Ended
	Dec. 31, 2022
Cash and Cash Equivalents [Abstract]
Schedule of Cash, Cash Equivalents and Marketable Securities	At December 31, 2022, cash, cash equivalents, and marketable securities were comprised of: Carrying Unrecognized Unrecognized Estimated Fair Cash and Cash Current Cash $ 135,151,081 $ — $ — $ 135,151,081 $ 135,151,081 $ — Money market funds 9,268,283 — — 9,268,283 9,268,283 — Total cash and cash equivalents $ 144,419,364 $ — $ — $ 144,419,364 $ 144,419,364 — U.S. government agency securities $ 29,985,458 $ — $ ( 103,938 ) $ 29,881,520 $ — $ 29,881,520 Available for sale (1) 29,985,458 — ( 103,938 ) 29,881,520 — 29,881,520 Total cash, cash equivalents, and current marketable securities $ 144,419,364 $ 29,881,520 At December 31, 2021, cash, cash equivalents, and marketable securities were comprised of: Carrying Unrecognized Unrecognized Estimated Fair Cash and Cash Current Cash $ 100,364,523 $ — $ — $ 100,364,523 $ 100,364,523 $ — Money market funds 4,426,466 — — 4,426,466 4,426,466 — Reverse repurchase agreements 125,000,000 — — 125,000,000 125,000,000 — Total cash and cash equivalents $ 229,790,989 $ — $ — $ 229,790,989 $ 229,790,989 $ — Available for sale (1) — — — — — — Total cash, cash equivalents, and current marketable securities $ 229,790,989 $ — There were no marketable securities held at December 31, 2021. (1) Available for sale securities are reported at fair value with unrealized gains and losses reported net of taxes, if material, in other comprehensive loss.

Fair Value Measurements (Tables

Fair Value Measurements (Tables)	12 Months Ended
	Dec. 31, 2022
Fair Value Disclosures [Abstract]
Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis	The following table presents information about the Company’s assets measured at fair value at December 31, 2022 and December 31, 2021: December 31, 2022 Level 1 Level 2 Level 3 Total Assets: Money market funds (a) $ 9,268,283 $ — $ — $ 9,268,283 U.S government agency securities (b) — 29,881,520 — 29,881,520 Total assets at fair value $ 9,268,283 $ 29,881,520 $ — $ 39,149,803 December 31, 2021 Level 1 Level 2 Level 3 Total Assets: Money market funds (a) $ 4,426,466 $ — $ — $ 4,426,466 Reverse repurchase agreements (b) — 125,000,000 — 125,000,000 Total assets at fair value $ 4,426,466 $ 125,000,000 $ — $ 129,426,466 (a) Money market funds included in cash and cash equivalents in the consolidated balance sheets, are valued at quoted market prices in active markets. Reverse repurchase agreements and U.S. government agency securities, are recorded at fair market value, which are determined based on the most recent observable inputs for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active or are directly or indirectly observable.

Prepaid expenses and other cu_2

Prepaid expenses and other current assets (Tables)	12 Months Ended
	Dec. 31, 2022
Prepaid Expense and Other Assets, Current [Abstract]
Schedule of Prepaid Expenses and Other Current Assets	Prepaid expenses and other current assets at December 31, 2022 and 2021 were: December 31, December 31, 2022 2021 Deferred research and development expenses $ 2,605,252 $ 2,404,145 Prepaid insurance expenses 432,230 435,410 Other current receivables 3,242,026 28,770 Miscellaneous prepaid expenses 442,721 93,456 Total prepaid expenses and other current assets $ 6,722,229 $ 2,961,781

Accrued Expenses (Tables)

Accrued Expenses (Tables)	12 Months Ended
	Dec. 31, 2022
Payables and Accruals [Abstract]
Schedule of Accrued Expenses	Accrued expenses at December 31, 2022 and 2021 were: December 31, December 31, 2022 2021 Accrued compensation $ 3,821,904 $ 1,512,885 Accrued research and development expenses 8,476,422 8,415,560 Accrued other expenses 1,767,559 594,908 Total accrued expenses $ 14,065,885 $ 10,523,353

Credit Facility (Tables)

Credit Facility (Tables)	12 Months Ended
	Dec. 31, 2022
Debt Disclosure [Abstract]
Schedule of Long-Term Debt	Long-term debt consisted of the following: December 31, December 31, 2022 2021 Term loan payable $ 15,000,000 $ 15,000,000 End of term charge 911,763 703,269 Unamortized debt issuance costs ( 76,910 ) ( 199,566 ) Less: current portion ( 911,763 ) — Total long-term debt $ 14,923,090 $ 15,503,703
Schedule of Principal Payments Including End of Term Charges	Future principal payments, including the End of Term Charge, are as follows for the years ending December 31: 2023 $ 1,042,500 2024 15,292,500 Total $ 16,335,000

Income Taxes (Tables)

Income Taxes (Tables)	12 Months Ended
	Dec. 31, 2022
Income Tax Disclosure [Abstract]
Components of Deferred Tax Assets and Liabilities	Significant components of the Company’s deferred tax assets and liabilities at December 31, 2022 and 2021 are as follows: Years ended December 31, 2022 2021 Deferred Tax Assets Federal & state NOL carryforward $ 64,840,595 $ 61,308,787 Federal & state R&D credit 12,110,003 9,200,758 Deferred costs 342,210 — Intangibles – net 78,378 78,378 Accounts payable and accrued 2,004,737 2,301,117 Reserves 28,396 — Stock options 4,042,117 3,906,501 Capitalized R&D expenses 11,151,910 — Other items 98,552 127,791 Gross deferred tax assets 94,696,898 76,923,332 Valuation allowance ( 94,628,799 ) ( 76,827,203 ) Deferred tax assets, net $ 68,099 $ 96,129 Deferred Tax Liabilities Right of use asset ( 68,099 ) ( 96,129 ) TOTAL $ — $ —
Components of Income Tax Benefit	The components of the income tax benefit for the years ended December 31, 2022 and 2021, are as follows: Years ended December 31, 2022 2021 Deferred Taxes Federal $ — $ — State — — Total income tax benefit $ — $ —
Summary of Statutory Tax Rates and Effective Tax Rates	A reconciliation of the federal statutory tax rate of 21 % to the Company’s effective income tax rates are as follows: Years ended December 31, 2022 2021 Statutory tax rate 21.00 % 21.00 % State taxes, net of federal benefits 6.05 % 6.65 % Federal research and development credits 4.12 % 4.29 % Change in valuation allowance ( 28.66 ) % ( 31.35 ) % Stock-based compensation ( 2.53 ) % ( 0.73 ) % Other 0.02 % 0.14 % Effective tax rate 0.00 % ( 0.00 ) %

Stock Incentive Plan (Tables)

Stock Incentive Plan (Tables)	12 Months Ended
	Dec. 31, 2022
Schedule of Stock-Based Compensation Expense	The amounts included in the consolidated statements of operations relating to stock-based compensation associated with the two equity incentive plans, cash awards, CSBUs, and Helio founders’ shares are as follows: Years ended December 31, 2022 2021 Research and development expenses $ 4,087,073 $ 3,562,181 General and administrative expenses 4,201,903 3,545,846 Total stock-based compensation expense $ 8,288,976 $ 7,108,027
Summary of Activity Relating to Stock Options	The following table summarizes option activity under the incentive plans for the year ended December 31, 2022: Number of Weighted Weighted Aggregate Outstanding at December 31, 2021 4,622,870 $ 6.73 $ 1,268,089 Granted 1,756,297 4.05 — Cancelled/Forfeited ( 738,223 ) 7.09 — Exercised ( 236,962 ) 4.74 414,682 Outstanding at December 31, 2022 5,403,982 $ 5.90 6.56 $ 10,506,953 Exercisable at December 31, 2022 3,528,792 $ 6.13 5.33 $ 6,098,269
Summary of Activity Relating to Restricted Stock Units	The table below summarizes activity relating to RSUs for the year ended December 31, 2022 : Number Weighted-Average Grant Date Fair Value Outstanding at December 31, 2021 501,255 $ 5.94 Granted 1,055,460 4.64 Cancelled/Forfeited ( 169,586 ) 4.37 Vested/released ( 202,526 ) 6.28 Outstanding at December 31, 2022 1,184,603 $ 4.95
Schedule of Fair Value of Employee Stock Purchase Plan Assumptions	The fair value of the purchase rights granted under this plan was estimated on the date of grant using the Black-Scholes option-pricing model using assumptions as shown below: December 31, December 31, Expected dividend yield 0 % 0 % Anticipated volatility 84.04 % - 84.99 % 81.76 % - 82.87 % Stock price $ 3.80 - $ 4.27 $ 6.53 - $ 11.31 Exercise price $ 3.80 - $ 4.27 $ 6.53 - $ 11.31 Expected life (years) 0.50 0.50 Risk free interest rate 0.22 % - 4.76 % 0.05 % - 0.09 %
Summary of Employee Stock Purchase Plan Activity	A summary of the weighted-average grant-date fair value, shares issued and total stock-based compensation expense recognized related to the 2016 ESPP for the years ended December 31, 2022 and 2021 are as follows: December 31, December 31, Weighted-average grant-date fair value $ 1.57 $ 2.98 Total shares issued 28,485 12,092 Total stock-based compensation expense $ 57,413 $ 45,190
Employee Stock Options [Member]
Schedule of Fair Value of Stock Option Assumptions	The assumptions used in determining fair value of the employee stock options for the years ended December 31, 2022 and 2021, are as follows: December 31, December 31, Expected dividend yield 0 % 0 % Anticipated volatility 84.82 % - 85.21 % 81.73 % - 83.50 % Stock price $ 3.49 - $ 4.52 $ 8.33 - $ 12.97 Exercise price $ 3.49 - $ 4.52 $ 8.33 - $ 12.97 Expected life (years) 5.50 - 6.08 5.50 - 6.08 Risk free interest rate 1.47 % - 3.26 % 0.88 % - 1.67 %

Leases (Tables)

Leases (Tables)	12 Months Ended
	Dec. 31, 2022
Leases [Abstract]
Schedule of Maturities and Balance Sheet Presentation of Lease Liabilities	Maturities and balance sheet presentation of our lease liabilities for all operating leases as of December 31, 2022 is as follows: 2023 remaining total lease payments $ 261,828 Less: effect of discounting ( 12,563 ) Present value of lease liabilities $ 249,265 Current operating lease liabilities $ 249,265 Total $ 249,265 The Company’s gross future minimum payments under all non-cancelable operating leases as of December 31, 2022 are: Total 2023 2024 2025 2026 Operating lease obligations $ 261,828 $ 261,828 $ — $ — $ —

Basis of Presentation and Sig_3

Basis of Presentation and Significant Accounting Policies - Additional Information (Detail)	12 Months Ended
	Dec. 31, 2022 USD ($) Segment	Dec. 31, 2021 USD ($)
Basis Of Presentation And Significant Accounting Policies [Line Items]
Number of segment | Segment	1
Investment maturity period	three months or less
Marketable securities maturity period	90 days
Unrealized gain on marketable securities	$ (103,938)	$ 0
Net loss	62,024,636	57,776,274
Intellectual Property [Member]
Basis Of Presentation And Significant Accounting Policies [Line Items]
Legal expense	$ 1,000,000	$ 1,300,000
Minimum [Member]
Basis Of Presentation And Significant Accounting Policies [Line Items]
Percentage of Collateral Deposits under Reverse Repurchase Agreement	102%

Helio vision acquisition - Addi

Helio vision acquisition - Additional Information (Detail) - USD ($)		1 Months Ended	3 Months Ended	12 Months Ended
	Jan. 28, 2019	Jan. 31, 2021	Mar. 31, 2021	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2018
Business Acquisition [Line Items]
Share-based compensation award, vesting period							4 years
Allocated Share Based Compensation Expense				$ 8,288,976	$ 7,108,027
Income tax benefit				0	0
Helio Vision, Inc [Member]
Business Acquisition [Line Items]
Business combination, stock issued	1,160,444	246,562
Contingent consideration payable in stock						$ 2,500,000
Income tax benefit						500,000
Common Stock after FDA Approval prior to 10th Anniversary [Member] | Helio Vision, Inc [Member]
Business Acquisition [Line Items]
Business Combination Contingent Consideration Liability	$ 10,000,000
Common Stock after FDA Approval Prior to 12th Anniversary [Member] | Helio Vision, Inc [Member]
Business Acquisition [Line Items]
Business Combination Contingent Consideration Liability	$ 2,500,000
Common Stock after FDA Approval Prior to 12th Anniversary [Member] | Maximum [Member] | Helio Vision, Inc [Member]
Business Acquisition [Line Items]
Business combination, contingent consideration stock to be issued	5,248,885
Tax Gross-up Payment in Event of Change of Control or Divesture [Member] | Maximum [Member] | Helio Vision, Inc [Member]
Business Acquisition [Line Items]
Business Combination Contingent Consideration Liability	$ 1,000,000
Research and Development Expenses [Member]
Business Acquisition [Line Items]
Allocated Share Based Compensation Expense				4,087,073	3,562,181
Founders [Member] | Helio Vision, Inc [Member]
Business Acquisition [Line Items]
Business combination, stock issued	568,627
Founders [Member] | Restricted Stock [Member] | Helio Vision, Inc [Member]
Business Acquisition [Line Items]
Share-based compensation award, vesting period	3 years
Founders [Member] | Restricted Stock [Member] | Research and Development Expenses [Member] | Helio Vision, Inc [Member]
Business Acquisition [Line Items]
Allocated Share Based Compensation Expense				$ 100,000	$ 1,200,000
Non Founders [Member] | Helio Vision, Inc [Member]
Business Acquisition [Line Items]
Business combination, stock issued	591,817
Milestone [Member] | Helio Vision, Inc [Member]
Business Acquisition [Line Items]
Business combination, stock issued			246,562
Milestone [Member] | Restricted Stock [Member] | Research and Development Expenses [Member] | Helio Vision, Inc [Member]
Business Acquisition [Line Items]
Allocated Share Based Compensation Expense						1,200,000
Expense related to the Milestone IPR&D						$ 1,800,000

Net Loss Per Share - Computatio

Net Loss Per Share - Computation of Diluted Weighted-Average Shares Outstanding (Detail) - shares		12 Months Ended
		Dec. 31, 2022	Dec. 31, 2021
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total of common stock equivalents		6,588,585	5,135,016
Options to Purchase Common Stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total of common stock equivalents		5,403,982	4,622,870
Nonvested restricted stock units [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total of common stock equivalents		1,184,603	501,255
Nonvested Founder Shares [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Total of common stock equivalents	[1]	0	10,891
[1] Represents 10,891 shares of common stock that are issued and outstanding but that were subject to vesting based on service requirements at December 31, 2021 , and were not included in stockholders’ equity at such date.

Net Loss Per Share - Computat_2

Net Loss Per Share - Computation of Diluted Weighted-Average Shares Outstanding (Parenthetical) (Detail)	Dec. 31, 2021 shares
Restricted Stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Number of common stock shares issued and outstanding subject of vesting shares based on service requirements	10,891

Cash, Cash Equivalents and Ma_3

Cash, Cash Equivalents and Marketable Securities - Schedule of Cash and Cash Equivalents (Detail) - USD ($)		12 Months Ended
		Dec. 31, 2022	Dec. 31, 2021
Cash Cash Equivalents And Marketable Securities [Line Items]
Reverse repurchase agreements		$ 0	$ 125,000,000
Total Cash and cash equivalents		144,419,364	229,790,989
Current Marketable Securities		29,881,520
Cash and Cash Equivalents		29,881,520	0
Cash [Member]
Cash Cash Equivalents And Marketable Securities [Line Items]
Cash		135,151,081	100,364,523
Estimated Fair Value		135,151,081	100,364,523
Cash and Cash Equivalents		135,151,081	100,364,523
Money Market Funds [Member]
Cash Cash Equivalents And Marketable Securities [Line Items]
Money market funds		9,268,283	4,426,466
Estimated Fair Value		9,268,283	4,426,466
Cash and Cash Equivalents		9,268,283	4,426,466
Reverse Repurchase Agreements [Member]
Cash Cash Equivalents And Marketable Securities [Line Items]
Reverse repurchase agreements			125,000,000
Estimated Fair Value			125,000,000
Cash and Cash Equivalents			125,000,000
Total Cash and cash equivalents [Member]
Cash Cash Equivalents And Marketable Securities [Line Items]
Total Cash and cash equivalents		144,419,364	229,790,989
Estimated Fair Value		144,419,364	229,790,989
Cash and Cash Equivalents		144,419,364	$ 229,790,989
U.S. Government Agencies Securities [Member]
Cash Cash Equivalents And Marketable Securities [Line Items]
Available for sales carrying amount		29,985,458
Available for sale unrecognized loss		(103,938)
Available for sale fair value disclosure		29,881,520
Current Marketable Securities		29,881,520
Available-for-Sale Securities [Member]
Cash Cash Equivalents And Marketable Securities [Line Items]
Available for sales carrying amount	[1]	29,985,458
Available for sale unrecognized loss	[1]	(103,938)
Available for sale fair value disclosure	[1]	29,881,520
Current Marketable Securities		$ 29,881,520
[1] Available for sale securities are reported at fair value with unrealized gains and losses reported net of taxes, if material, in other comprehensive loss.

Cash, Cash Equivalents and Ma_4

Cash, Cash Equivalents and Marketable Securities - Additional Information (Detail)	Dec. 31, 2021 USD ($)
Cash and Cash Equivalents [Abstract]
Marketable Securities	$ 0

Fair Value Measurements - Sched

Fair Value Measurements - Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($)		Dec. 31, 2022	Dec. 31, 2021
Assets:
Total assets at fair value		$ 39,149,803	$ 129,426,466
Level 1 [Member]
Assets:
Total assets at fair value		9,268,283	4,426,466
Level 2 [Member]
Assets:
Total assets at fair value		29,881,520	125,000,000
Level 3 [Member]
Assets:
Total assets at fair value		0	0
Money Market Funds [Member]
Assets:
Total assets at fair value	[1]	9,268,283	4,426,466
Money Market Funds [Member] | Level 1 [Member]
Assets:
Total assets at fair value	[1]	9,268,283	4,426,466
Money Market Funds [Member] | Level 2 [Member]
Assets:
Total assets at fair value	[1]	0	0
Money Market Funds [Member] | Level 3 [Member]
Assets:
Total assets at fair value	[1]	0	0
Reverse Repurchase Agreements [Member]
Assets:
Total assets at fair value	[2]		125,000,000
Reverse Repurchase Agreements [Member] | Level 1 [Member]
Assets:
Total assets at fair value	[2]		0
Reverse Repurchase Agreements [Member] | Level 2 [Member]
Assets:
Total assets at fair value	[2]		125,000,000
Reverse Repurchase Agreements [Member] | Level 3 [Member]
Assets:
Total assets at fair value	[2]		$ 0
U.S. Government Agencies Securities [Member]
Assets:
Total assets at fair value	[2]	29,881,520
U.S. Government Agencies Securities [Member] | Level 1 [Member]
Assets:
Total assets at fair value	[2]	0
U.S. Government Agencies Securities [Member] | Level 2 [Member]
Assets:
Total assets at fair value	[2]	29,881,520
U.S. Government Agencies Securities [Member] | Level 3 [Member]
Assets:
Total assets at fair value	[2]	$ 0
[1] Money market funds included in cash and cash equivalents in the consolidated balance sheets, are valued at quoted market prices in active markets. Reverse repurchase agreements and U.S. government agency securities, are recorded at fair market value, which are determined based on the most recent observable inputs for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active or are directly or indirectly observable.

Prepaid Expenses and Other Cu_3

Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Prepaid Expense and Other Assets, Current [Abstract]
Deferred research and development expenses	$ 2,605,252	$ 2,404,145
Prepaid insurance expenses	432,230	435,410
Other current receivables	3,242,026	28,770
Miscellaneous prepaid expenses	442,721	93,456
Total prepaid expenses and other current assets	$ 6,722,229	$ 2,961,781

Accrued Expenses - Schedule of

Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Payables and Accruals [Abstract]
Accrued compensation	$ 3,821,904	$ 1,512,885
Accrued research and development expenses	8,476,422	8,415,560
Accrued other expenses	1,767,559	594,908
Accrued expenses	$ 14,065,885	$ 10,523,353

Credit Facility - Additional In

Credit Facility - Additional Information (Detail) - USD ($)		1 Months Ended	12 Months Ended
	Apr. 20, 2021	Dec. 22, 2022	Dec. 31, 2022
Line Of Credit Facility [Line Items]
Proceeds from Long-term lines of credit			$ 16,335,000
Hercules Credit Facility [Member]
Line Of Credit Facility [Line Items]
Credit facility amount	$ 35,000,000		$ 60,000,000
Debt instrument annual interest rate			9.10%
Interest payment period			May 01, 2021
Interest payment extension period		Oct. 01, 2024	May 01, 2023
Commitment charge			$ 25,000
Transaction costs			273,186
Credit facility fee			$ 375,000
Credit facility prepayment fee percentage		0.75%	0.75%
Credit facility, interest rate			13.20%
Loan funded prior to the date of amendment			$ 15,000,000
Long term debt maturity		extended the Maturity Date from October 1, 2023 to October 1, 2024; (iii) extended the availability of the Fourth Loan Tranche commitment of $20 million from May 1, 2023 to May 1, 2024
Long term debt percentage		0%	0%
Supplemental term charge		$ 292,500
Existing term charge		1,042,500
Hercules Credit Facility [Member] | Maximum [Member]
Line Of Credit Facility [Line Items]
Loan agreement right to purchase aggregate amount of equity securities			$ 2,000,000
Hercules Credit Facility [Member] | Prime Rate [Member]
Line Of Credit Facility [Line Items]
Debt instrument variable annual interest rate			3.10%
Hercules Credit Facility [Member] | Term Loan Advance One [Member]
Line Of Credit Facility [Line Items]
Credit facility amount			$ 5,000,000
Hercules Credit Facility [Member] | Term Loan Advance Four [Member]
Line Of Credit Facility [Line Items]
Proceeds from Long-term lines of credit		$ 20	15,000,000
Hercules Credit Facility [Member] | Term Loan Advance Five [Member]
Line Of Credit Facility [Line Items]
Proceeds from Long-term lines of credit	10,000,000		$ 10,000,000
Debt instrument, increase amount	$ 20,000,000

Credit Facility - Schedule of L

Credit Facility - Schedule of Long-Term Debt (Detail) - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Line of Credit Facility [Abstract]
Term loan payable	$ 15,000,000	$ 15,000,000
End of term charge	911,763	703,269
Unamortized debt issuance costs	(76,910)	(199,566)
Less: current portion	(911,763)	0
Total long-term debt	$ 14,923,090	$ 15,503,703

Credit Facility - Schedule of P

Credit Facility - Schedule of Principal Payments Incuding End of Term Charges (Detail)	Dec. 31, 2022 USD ($)
Line of Credit Facility [Abstract]
2023	$ 1,042,500
2024	15,292,500
Total	$ 16,335,000

Stockholders' Equity - Addition

Stockholders' Equity - Additional Information (Detail) - USD ($)	1 Months Ended			2 Months Ended	12 Months Ended
	Jun. 30, 2021	Mar. 31, 2021	Jan. 31, 2021	Jun. 30, 2021	Dec. 31, 2022	Dec. 31, 2021
Class Of Stock [Line Items]
Common stock, voting rights					Each share of common stock is entitled to one vote.
Issuance of common stock, net of issuance costs						$ 189,811,611
Proceeds from issuance of common stock, net of issuance costs					$ 0	$ 189,811,611
Common Voting Stock [Member]
Class Of Stock [Line Items]
Issuance of common stock, net of issuance costs, Shares						18,091,947
Issuance of common stock, net of issuance costs						$ 18,092
2021 Jefferies Sales Agreement [Member] | Maximum [Member]
Class Of Stock [Line Items]
Proceeds from issuance of common stock, net of issuance costs		$ 100,000,000
Underwritten Public Offering [Member]
Class Of Stock [Line Items]
Proceeds from issuance of common stock, net of issuance costs			$ 70,000,000	$ 119,800,000
Underwritten Public Offering [Member] | Common Voting Stock [Member]
Class Of Stock [Line Items]
Issuance of common stock, net of issuance costs, Shares			7,900,000	10,200,000
Shares issued, price per share	$ 12.50		$ 9.50	$ 12.50
Issuance of common stock, net of issuance costs	$ 127,800,000		$ 74,700,000
Employee Stock Options [Member]
Class Of Stock [Line Items]
Common stock reserved for issuance of shares					5,403,982
Two Thousand And Thirteen Incentive Plan [Member]
Class Of Stock [Line Items]
Common stock reserved for issuance of shares					4,625,881
2016 Employee Stock Purchase Plan [Member]
Class Of Stock [Line Items]
Common stock reserved for issuance of shares					1,785,993

Income Taxes - Additional Infor

Income Taxes - Additional Information (Detail) - USD ($)	1 Months Ended	12 Months Ended
	Aug. 16, 2022	Dec. 31, 2022	Dec. 31, 2021
Income Tax Contingency [Line Items]
Income tax benefit		$ 0	$ 0
Deferred tax assets valuation allowance		100%
Net operating loss carryforwards expire period		2041
Increasing in research activities expire period		2041	2042
Statutory tax rate		21%	21%
Change in valuation allowance		$ 17,800,000
Income Tax Perspective, Description	the IRA provisions includes a new corporate alternative minimum tax (CAMT) of 15% on adjusted financial statement income (AFSI) for corporations with over $1 billion in profits, a new excise tax on corporate stock buybacks and increased funding for IRS enforcement.
Federal orphan drug tax credit carryforward		$ 1,700,000
Maximum [Member]
Income Tax Contingency [Line Items]
Statutory tax rate		50%
State and Federal [Member]
Income Tax Contingency [Line Items]
Income tax benefit		$ 0
Federal [Member]
Income Tax Contingency [Line Items]
Net operating loss carryforwards		239,200,000
Increasing in research activities		8,700,000
State [Member]
Income Tax Contingency [Line Items]
Net operating loss carryforwards		231,300,000
Increasing in research activities		$ 2,100,000

Income Taxes - Components of De

Income Taxes - Components of Deferred Tax Assets and Liabilities (Detail) - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Deferred Tax Assets
Federal & state NOL carryforward	$ 64,840,595	$ 61,308,787
Federal & state R&D credit carryforward	12,110,003	9,200,758
Deferred costs	342,210	0
Intangibles – net	78,378	78,378
Accounts payable and accrued expenses	2,004,737	2,301,117
Reserves	28,396	0
Stock options	4,042,117	3,906,501
Capitalized R&D expenses	11,151,910	0
Other items	98,552	127,791
Gross deferred tax assets	94,696,898	76,923,332
Valuation allowance	(94,628,799)	(76,827,203)
Deferred tax assets, net	68,099	96,129
Deferred Tax Liabilities
Right of use asset	(68,099)	(96,129)
TOTAL	$ 0	$ 0

Income Taxes - Components of In

Income Taxes - Components of Income Tax Benefit (Detail) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Deferred Taxes
Federal	$ 0	$ 0
State	0	0
Total income tax benefit	$ 0	$ 0

Income Taxes - Summary of Statu

Income Taxes - Summary of Statutory Tax Rates and Effective Tax Rates (Detail)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Income Tax Disclosure [Abstract]
Statutory tax rate	21%	21%
State taxes, net of federal benefits	6.05%	6.65%
Federal research and development credits	4.12%	4.29%
Change in valuation allowance	(28.66%)	(31.35%)
Stock-based compensation	(2.53%)	(0.73%)
Other	0.02%	0.14%
Effective tax rate	0%	(0.00%)

Stock Incentive Plan - Addition

Stock Incentive Plan - Additional Information (Detail) - USD ($)			12 Months Ended
	Jan. 01, 2023	Jan. 02, 2016	Dec. 31, 2022	Dec. 31, 2021	Dec. 31, 2018
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options to purchase of shares of common stock			5,403,982	4,622,870
Exercise price per share of common stock			$ 5.90	$ 6.73
Unrecognized Tax Benefits, Interest on Income Taxes Expense			$ 0
Number of shares outstandig	1,184,603
Share-based compensation award, vesting period					4 years
Fair value of a common stock percentage			100%
Aggregate Intrinsic Value, Exercisable			$ 6,098,269
Granted period			4 years
Share based compensation expense			$ 1,400,000
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock options granted in term years					10 years
Restricted Stock Units (RSUs)
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of shares outstandig			1,184,603	501,255
Share-based compensation award, vesting period			4 years
Weighted average grant date fair value of shares			$ 2.92	$ 7.95
Unamortized stock-based compensation			$ 4,300,000
Aggregate Intrinsic Value, Exercisable			$ 8,200,000
Weighted average grant date fair value, Granted			$ 4.64	$ 11.71
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested in Period, Fair Value			$ 1,300,000	$ 1,500,000
Weighted average remaining recognition period			3 years 1 month 28 days
Employee Stock Options [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected dividend yield			0%	0%
Cash dividend paid			$ 0
Unamortized stock-based compensation			$ 6,100,000
Weighted average recognition period			2 years 3 months 21 days
CSBU [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Unrecognized Tax Benefits, Interest on Income Taxes Expense			$ 0
Share based compensation expense			$ 1,100,000
2010 Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options to purchase of shares of common stock			398,547
Exercise price per share of common stock			$ 1.52
2013 Equity Incentive Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Options to purchase of shares of common stock			5,005,435
Exercise price per share of common stock			$ 6.25
Common stock available for issuance	8,139,486		4,625,881
Common stock issued	3,513,605
Amended 2013 Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Percentage of increase in common stock outstanding		6%
2016 Employee Stock Purchase Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common stock available for issuance	585,601		1,785,993
Expected dividend yield			0%	0%
Weighted average grant date fair value, Granted			$ 1.57	$ 2.98
Issuance of common stock authorized			414,639
Percentage increase in number of shares of common stock reserved for issuance			1%
Share-based compensation arrangement by share-based payment award, closing price on the applicable offering commencement			85%
Share-based compensation arrangement by share-based payment award, closing price on the applicable offering termination date			85%
Share-based compensation arrangement by share-based payment award, description			In March 2016, the Company’s board of directors approved the 2016 Employee Stock Purchase Plan (2016 ESPP), which became effective in June 2016 following the approval of the Company’s stockholders. The 2016 ESPP initially authorized the issuance of up to a total of 414,639 shares of the Company’s common stock to participating employees. The number of shares reserved for issuance under the 2016 ESPP automatically increases on the first business day of each fiscal year, commencing in 2017, by a number equal to the lower of (i) 1% of the shares of common stock outstanding on the last business day of the prior fiscal year; or (ii) the number of shares determined by the Company’s Board of Directors. Unless otherwise determined by the administrator of the 2016 ESPP, two offering periods of six months’ duration will begin each year on January 1 and July 1. Participating employees purchase stock under the 2016 ESPP at a price equal to the lower of 85% of the closing price on the applicable offering commencement date or 85% of the closing price on the applicable offering termination date.

Stock Incentive Plan - Schedule

Stock Incentive Plan - Schedule of Stock-Based Compensation Expense (Detail) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Total stock-based compensation expense	$ 8,288,976	$ 7,108,027
Research and Development Expenses [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Total stock-based compensation expense	4,087,073	3,562,181
General and Administrative Expenses [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Total stock-based compensation expense	$ 4,201,903	$ 3,545,846

Stock Incentive Plan - Summary

Stock Incentive Plan - Summary of Stock Option Activity (Detail)	12 Months Ended
	Dec. 31, 2022 USD ($) $ / shares shares
Share-Based Payment Arrangement [Abstract]
Number of Shares Outstanding, Beginning Balance | shares	4,622,870
Number of Shares, Granted | shares	1,756,297
Number of Shares,Cancelled/Forfeited | shares	(738,223)
Number of Shares, Exercised | shares	(236,962)
Number of Shares Outstanding, Ending Balance | shares	5,403,982
Number of Shares Exercisable, Ending Balance | shares	3,528,792
Weighted Average Exercise Price, Beginning Balance | $ / shares	$ 6.73
Weighted Average Exercise Price, Granted | $ / shares	4.05
Weighted Average Exercise Price, Cancelled/Forfeited | $ / shares	7.09
Weighted Average Exercise Price, Exercised | $ / shares	4.74
Weighted Average Exercise Price, Ending Balance | $ / shares	5.90
Weighted Average Exercise Price Exercisable, Ending Balance | $ / shares	$ 6.13
Weighted Average Contractual Term, Outstanding	6 years 6 months 21 days
Weighted Average Contractual Term, Exercisable	5 years 3 months 29 days
Aggregate Intrinsic Value, Outstanding | $	$ 1,268,089
Aggregate Intrinsic Value, Excercised | $	414,682
Aggregate Intrinsic Value, Outstanding | $	10,506,953
Aggregate Intrinsic Value, Exercisable | $	$ 6,098,269

Stock Incentive Plan - Summar_2

Stock Incentive Plan - Summary of Stock Option Activity (Parenthetical) (Detail) - USD ($) $ / shares in Units, $ in Millions	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Share-Based Payment Arrangement [Abstract]
Closing market value of common stock	$ 6.96
Stock Issued, Value, Stock Options Exercised, Net of Tax Benefit (Expense)	$ 0.4	$ 2.5

Stock Incentive Plan - Schedu_2

Stock Incentive Plan - Schedule of Fair Value of Stock Option Assumptions (Detail) - $ / shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock price	$ 6.96
Employee Stock Options [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected dividend yield	0%	0%
Employee Stock Options [Member] | Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Anticipated volatility	84.82%	81.73%
Stock price	$ 3.49	$ 8.33
Exercise price	$ 3.49	$ 8.33
Expected life (years)	5 years 6 months	5 years 6 months
Risk free interest rate	1.47%	0.88%
Employee Stock Options [Member] | Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Anticipated volatility	85.21%	83.50%
Stock price	$ 4.52	$ 12.97
Exercise price	$ 4.52	$ 12.97
Expected life (years)	6 years 29 days	6 years 29 days
Risk free interest rate	3.26%	1.67%

Stock Incentive Plan - Summar_3

Stock Incentive Plan - Summary of Activity Relating to Restricted Stock Units (Detail) - Restricted Stock Units (RSUs) - $ / shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of Shares Outstanding, Beginning Balance	501,255
Granted	1,055,460
Cancelled/Forfeited	(169,586)
Vested/released	(202,526)
Number of Shares Outstanding, Ending Balance	1,184,603	501,255
Weighted-Average Grant Date Fair Value, Beginning Balance	$ 5.94
Weighted average grant date fair value, Granted	4.64	$ 11.71
Weighted-Average Grant Date Fair Value, Cancelled/Forfeited	4.37
Weighted-Average Grant Date Fair Value, Vested/released	6.28
Weighted-Average Grant Date Fair Value, Ending Balance	$ 4.95	$ 5.94

Stock Incentive Plan - Schedu_3

Stock Incentive Plan - Schedule of Fair Value of Employee Stock Purchase Plan Assumptions (Detail) - $ / shares	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock price	$ 6.96
2016 Employee Stock Purchase Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected dividend yield	0%	0%
Expected life (years)	6 months	6 months
2016 Employee Stock Purchase Plan [Member] | Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Anticipated volatility	84.04%	81.76%
Stock price	$ 3.80	$ 6.53
Exercise price	$ 3.80	$ 6.53
Risk free interest rate	0.22%	0.05%
2016 Employee Stock Purchase Plan [Member] | Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Anticipated volatility	84.99%	82.87%
Stock price	$ 4.27	$ 11.31
Exercise price	$ 4.27	$ 11.31
Risk free interest rate	4.76%	0.09%

Stock Incentive Plan - Summar_4

Stock Incentive Plan - Summary of Employee Stock Purchase Plan Activity (Detail) - USD ($)	12 Months Ended
	Dec. 31, 2022	Dec. 31, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total stock-based compensation expense	$ 8,288,976	$ 7,108,027
2016 Employee Stock Purchase Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Weighted-average grant-date fair value per share	$ 1.57	$ 2.98
Issuance of common stock, employee stock purchase plan, Shares	28,485	12,092
Total stock-based compensation expense	$ 57,413	$ 45,190

Commitments and Contingencies -

Commitments and Contingencies - Additional Information (Detail)	12 Months Ended
	Dec. 31, 2022 USD ($)
Commitments And Contingencies [Line Items]
Outstanding material claims	$ 0
Reserve for indemnification	0
MEEI Agreement [Member]
Commitments And Contingencies [Line Items]
Additional equity consideration issuable	0
MEEI Agreement [Member] | Second and Third Anniversary [Member]
Commitments And Contingencies [Line Items]
Non-creditable non-refundable license maintenance fees	15,000
MEEI Agreement [Member] | Fourth and Fifth Anniversary [Member]
Commitments And Contingencies [Line Items]
Non-creditable non-refundable license maintenance fees	25,000
MEEI Agreement [Member] | Sixth and Subsequent Anniversary [Member]
Commitments And Contingencies [Line Items]
Non-creditable non-refundable license maintenance fees	$ 35,000

Leases - Additional Information

Leases - Additional Information (Detail) - USD ($)	1 Months Ended		12 Months Ended
	Dec. 31, 2022	Aug. 31, 2021	Dec. 31, 2022	Dec. 31, 2021
Leases [Abstract]
Lease extended term	6 months	18 months
Operating lease liability	$ 249,265		$ 249,265
Operating leases, weighted average remaining lease term (years)	1 year		1 year
Right of use assets obtained in exchange for lease obligations			$ 200,000	$ 300,000
Operating leases, weighted average discount rate	9.10%		9.10%
Operating lease, expense			$ 200,000

Leases - Schedule of Maturities

Leases - Schedule of Maturities and Balance Sheet Presentation of Lease Liabilities (Detail) - USD ($)	Dec. 31, 2022	Dec. 31, 2021
Leases [Abstract]
2022 remaining total lease payments	$ 261,828
Less: effect of discounting	(12,563)
Present value of lease liabilities	249,265
Current operating lease liabilities	249,265	$ 229,607
Non-current operating lease liabilities	0	$ 125,232
Present value of lease liabilities	$ 249,265

Leases - Schedule of Future Min

Leases - Schedule of Future Minimum Payments Under Non-Cancelable Operating Leases (Detail)	Dec. 31, 2022 USD ($)
Leases [Abstract]
2022 remaining total lease payments	$ 261,828
Operating lease obligations, 2023	261,828
Operating lease obligations, 2024	0
Operating lease obligations, 2025	0
Operating lease obligations, 2026	$ 0