0001558370-22-017583 | 10-Q | XBRL Viewer | Zynerba Pharmaceuticals INC

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Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2022	Nov. 09, 2022
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 2022
Entity File Number	001-37526
Entity Registrant Name	Zynerba Pharmaceuticals, Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	26-0389433
Entity Address, Address Line One	80 W. Lancaster Avenue
Entity Address, Address Line Two	Suite 300
Entity Address, City or Town	Devon
Entity Address, State or Province	PA
Entity Address, Postal Zip Code	19333
City Area Code	484
Local Phone Number	581-7505
Title of 12(b) Security	Common Stock, $0.001 par value per share
Trading Symbol	ZYNE
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		47,062,711
Entity Central Index Key	0001621443
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q3
Amendment Flag	false

CONSOLIDATED BALANCE SHEETS - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Current assets:
Cash and cash equivalents	$ 55,934,491	$ 67,808,000
Incentive and tax receivables	1,378,738	9,580,468
Prepaid expenses and other current assets	3,487,626	2,831,392
Total current assets	60,800,855	80,219,860
Property and equipment, net	419,863	385,833
Incentive and tax receivables	751,815
Right-of-use assets	394,205	565,814
Total assets	62,366,738	81,171,507
Current liabilities:
Accounts payable	1,619,697	1,798,813
Accrued expenses	7,598,187	7,896,598
Lease liabilities	213,428	209,068
Total current liabilities	9,431,312	9,904,479
Lease liabilities, long-term	178,672	353,694
Total liabilities	9,609,984	10,258,173
Stockholders' equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized; no shares issued or outstanding
Common stock, $0.001 par value; 200,000,000 shares authorized; 47,062,711 shares issued and outstanding at September 30, 2022 and 41,217,537 shares issued and outstanding at December 31, 2021	47,063	41,218
Additional paid-in capital	319,210,944	310,353,595
Accumulated deficit	(266,501,253)	(239,481,479)
Total stockholders' equity	52,756,754	70,913,334
Total liabilities and stockholders' equity	$ 62,366,738	$ 81,171,507

CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2022	Dec. 31, 2021
CONSOLIDATED BALANCE SHEETS
Preferred stock, par value	$ 0.001	$ 0.001
Preferred stock, shares authorized	10,000,000	10,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.001	$ 0.001
Common stock, shares authorized	200,000,000	200,000,000
Common stock, shares issued	47,062,711	41,217,537
Common stock, shares outstanding	47,062,711	41,217,537

CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	3 Months Ended		9 Months Ended
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Operating expenses:
Research and development	$ 5,039,228	$ 6,341,171	$ 15,632,150	$ 16,402,129
General and administrative	3,453,648	3,869,481	10,933,411	11,531,824
Total operating expenses	8,492,876	10,210,652	26,565,561	27,933,953
Loss from operations	(8,492,876)	(10,210,652)	(26,565,561)	(27,933,953)
Other income (expense):
Interest income	251,855	5,038	439,590	16,614
Foreign exchange loss	(435,128)	(376,637)	(893,803)	(576,619)
Total other income (expense)	(183,273)	(371,599)	(454,213)	(560,005)
Net loss	$ (8,676,149)	$ (10,582,251)	$ (27,019,774)	$ (28,493,958)
Net loss per share basic	$ (0.20)	$ (0.26)	$ (0.65)	$ (0.73)
Net loss per share diluted	$ (0.20)	$ (0.26)	$ (0.65)	$ (0.73)
Basic weighted average shares outstanding	43,746,878	40,092,128	41,831,998	38,933,209
Diluted weighted average shares outstanding	43,746,878	40,092,128	41,831,998	38,933,209

CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY - USD ($)	Common stock	Additional paid-capital	Accumulated deficit	Total
Balance at Dec. 31, 2020	$ 29,975	$ 262,286,008	$ (202,172,455)	$ 60,143,528
Balance (in shares) at Dec. 31, 2020	29,975,264
Increase (Decrease) in Stockholders' Equity (Deficit)
Issuance of common stock, net of issuance costs	$ 10,245	42,210,099		42,220,344
Issuance of common stock, net of issuance costs (in shares)	10,244,326
Issuance of restricted stock	$ 1,019	(1,019)
Issuance of restricted stock (in shares)	1,018,822
Exercise of stock options	$ 13	47,893		47,906
Exercise of stock options (in shares)	13,125
Stock-based compensation expense		1,264,837		1,264,837
Net loss			(7,961,628)	(7,961,628)
Balance at Mar. 31, 2021	$ 41,252	305,807,818	(210,134,083)	95,714,987
Balance (in shares) at Mar. 31, 2021	41,251,537
Increase (Decrease) in Stockholders' Equity (Deficit)
Stock-based compensation expense		1,934,349		1,934,349
Net loss			(9,950,079)	(9,950,079)
Balance at Jun. 30, 2021	$ 41,252	307,742,167	(220,084,162)	87,699,257
Balance (in shares) at Jun. 30, 2021	41,251,537
Increase (Decrease) in Stockholders' Equity (Deficit)
Issuance of restricted stock	$ 30	(30)
Issuance of restricted stock (in shares)	30,000
Stock-based compensation expense		1,569,993		1,569,993
Net loss			(10,582,251)	(10,582,251)
Balance at Sep. 30, 2021	$ 41,282	309,312,130	(230,666,413)	78,686,999
Balance (in shares) at Sep. 30, 2021	41,281,537
Balance at Dec. 31, 2021	$ 41,218	310,353,595	(239,481,479)	70,913,334
Balance (in shares) at Dec. 31, 2021	41,217,537
Increase (Decrease) in Stockholders' Equity (Deficit)
Issuance of common stock, net of issuance costs	$ 857	1,582,916		1,583,773
Issuance of common stock, net of issuance costs (in shares)	857,060
Issuance of restricted stock	$ 1,249	(1,249)
Issuance of restricted stock (in shares)	1,249,500
Stock-based compensation expense		1,160,482		1,160,482
Net loss			(8,490,619)	(8,490,619)
Balance at Mar. 31, 2022	$ 43,324	313,095,744	(247,972,098)	65,166,970
Balance (in shares) at Mar. 31, 2022	43,324,097
Balance at Dec. 31, 2021	$ 41,218	310,353,595	(239,481,479)	70,913,334
Balance (in shares) at Dec. 31, 2021	41,217,537
Balance at Sep. 30, 2022	$ 47,063	319,210,944	(266,501,253)	52,756,754
Balance (in shares) at Sep. 30, 2022	47,062,711
Balance at Mar. 31, 2022	$ 43,324	313,095,744	(247,972,098)	65,166,970
Balance (in shares) at Mar. 31, 2022	43,324,097
Increase (Decrease) in Stockholders' Equity (Deficit)
Issuance of common stock, net of issuance costs	$ 489	818,877		819,366
Issuance of common stock, net of issuance costs (in shares)	488,892
Issuance of restricted stock	$ 123	(123)
Issuance of restricted stock (in shares)	123,154
Stock-based compensation expense		1,108,543		1,108,543
Net loss			(9,853,006)	(9,853,006)
Balance at Jun. 30, 2022	$ 43,936	315,023,041	(257,825,104)	57,241,873
Balance (in shares) at Jun. 30, 2022	43,936,143
Increase (Decrease) in Stockholders' Equity (Deficit)
Issuance of common stock, net of issuance costs	$ 2,780	3,147,150		3,149,930
Issuance of common stock, net of issuance costs (in shares)	2,779,346
Commitment shares issued under an equity purchase agreement	$ 347	(347)
Commitment shares issued under an equity purchase agreement (in shares)	347,222
Stock-based compensation expense		1,041,100		1,041,100
Net loss			(8,676,149)	(8,676,149)
Balance at Sep. 30, 2022	$ 47,063	$ 319,210,944	$ (266,501,253)	$ 52,756,754
Balance (in shares) at Sep. 30, 2022	47,062,711

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	9 Months Ended
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	Sep. 30, 2022	Sep. 30, 2021
Cash flows from operating activities:
Net loss	$ (27,019,774)	$ (28,493,958)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	165,920	185,245
Stock-based compensation	3,310,125	4,769,179
Changes in operating assets and liabilities:
Incentive and tax receivables	7,449,915	(361,104)
Prepaid expenses and other assets	(637,578)	1,424,002
Right-of-use assets and liabilities	947	(7,858)
Accounts payable	(256,554)	113,634
Accrued expenses	(354,500)	(3,252,118)
Net cash used in operating activities	(17,341,499)	(25,622,978)
Cash flows from investing activities:
Purchases of property and equipment	(146,705)	(47,570)
Net cash used in investing activities	(146,705)	(47,570)
Cash flows from financing activities:
Proceeds from the issuance of common stock	6,059,511	43,193,660
Payment of financing fees and expenses	(444,816)	(1,085,707)
Proceeds from the exercise of stock options		47,906
Net cash provided by financing activities	5,614,695	42,155,859
Net (decrease) increase in cash and cash equivalents	(11,873,509)	16,485,311
Cash and cash equivalents at beginning of period	67,808,000	59,157,187
Cash and cash equivalents at end of period	55,934,491	75,642,498
Supplemental disclosures of cash flow information:
Financing costs included in accounts payable and accrued expenses at end of period	122,782	$ 42,500
Property and equipment acquired but unpaid at end of period	$ 53,245

Nature of Business and Liquidity

9 Months Ended

Sep. 30, 2022

Nature of Business and Liquidity

Nature of Business and Liquidity

(1) Nature of Business and Liquidity

Zynerba Pharmaceuticals, Inc., together with its subsidiary, Zynerba Pharmaceuticals Pty Ltd (collectively, “Zynerba,” the “Company,” or “we”), is a clinical stage specialty pharmaceutical company focused on the development of pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders, including Fragile X syndrome (“FXS”) and chromosome 22q11.2 deletion syndrome (“22q”). We have been granted orphan drug designations from the United States Food and Drug Administration (“FDA”) and the European Commission for the use of cannabidiol for the treatment of FXS. We have also been granted orphan drug designation from the FDA for the treatment of 22q. In addition, we have received Fast Track designation from the FDA for treatment of behavioral symptoms associated with FXS. The Company has decided to prioritize its resources on FXS and 22q, both of which have no approved products. While the data from the Company’s autism spectrum disorder (“ASD”) clinical development program to date are compelling, given the difficult financial market, the Company has decided to defer the start of the Phase 3 development program in ASD that was previously planned for the second half of 2022.

The Company has incurred losses and negative cash flows from operations since inception and has an accumulated deficit of $266.5 million as of September 30, 2022. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant revenue from its product candidates currently in development. The Company's primary source of liquidity has been the issuance of equity securities.

Management believes that the Company’s cash and cash equivalents as of September 30, 2022 are sufficient to fund operations and capital requirements into the first quarter of 2024. Top-line results from the confirmatory pivotal Phase 3 RECONNECT trial of Zygel in patients with FXS are expected in the second half of 2023. Substantial additional financings will be needed by the Company to fund its operations, and to complete clinical development of and to commercially develop its product candidates. The Company’s ability to raise sufficient additional financing depends on many factors beyond its control, including the current and ongoing volatility in the capital markets as a result of, among other factors, the COVID-19 pandemic and geopolitical tensions or the outbreak of hostilities or war. There is no assurance that such financing will be available when needed or on acceptable terms.

The Company is subject to those risks associated with any clinical stage pharmaceutical company that has substantial expenditures for research and development. There can be no assurance that the Company's research and development projects will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will be commercially viable. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its employees and consultants.

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2022

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

(2) Summary of Significant Accounting Policies

a. Basis of Presentation

The accompanying unaudited interim consolidated financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. The interim unaudited consolidated financial statements have been prepared on the same basis as the consolidated financial statements as of and for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 (the “2021 Annual Report”), filed with the Securities and Exchange Commission (the “SEC”). In the opinion of management, the accompanying consolidated financial statements of the Company include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the consolidated financial statements) considered necessary to present fairly the Company's financial position as of September 30, 2022, its results of operations for the three and nine months ended September 30, 2022 and 2021 and cash flows for the nine months ended September 30, 2022 and 2021. Operating results for any interim period are not necessarily indicative of results for any future interim period or for the entire year. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the consolidated financial statements and related notes included in the 2021 Annual Report.

b. Use of Estimates

The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from such estimates.

c. Incentive and Tax Receivables

The Company’s subsidiary, Zynerba Pharmaceuticals Pty Ltd (the “Subsidiary”), is incorporated in Australia. The Subsidiary is eligible to participate in an Australian research and development tax incentive program. As part of this program, the Subsidiary is eligible to receive a cash refund from the Australian Taxation Office (“ATO”) for a percentage of the research and development costs expended by the Subsidiary in Australia. The cash refund is available to eligible companies with an annual aggregate revenue of less than $20.0 million (Australian) during the reimbursable period. The Company estimates the amount of cash refund it expects to receive related to the Australian research and development tax incentive program and records the incentives when it is probable (1) the Company will comply with relevant conditions of the program and (2) the incentive will be received. The Company evaluates its eligibility under tax incentive programs as of each balance sheet date based on the most current and relevant data available. If the Company is deemed to be ineligible or unable to receive the Australian research and development tax credit, or the Australian government significantly reduces or eliminates the tax credit, the actual cash refund the Company receives may materially differ from its estimates.

In December 2018, the Company submitted an Advance Overseas Finding (“AOF”) application to a division of the Australian Government’s Department of Industry, Innovation and Science (“AusIndustry”), for a portion of the Company’s research and development activities incurred outside of Australia, which was approved by AusIndustry in July 2019. During the year ended December 31, 2019, the Company recorded $8.3 million as an incentive and tax receivable and recorded a corresponding credit to research and development expense for amounts expected to be received through the AOF for the period January 1, 2018 through December 31, 2019. In June 2020, the ATO informed the Company that it may not qualify for the AOF program based on their interpretation of certain eligibility requirements and, during the three months ended June 30, 2020, the Company determined it was no longer probable that the AOF claim would be received and the Company recorded a full reserve against the AOF receivable.

During the three months ended March 31, 2022, the Company concluded its conversations with the ATO on these matters and made the decision to no longer pursue the AOF claim, resulting in the write off of both the AOF receivable and the corresponding reserve during the period. During the three months ended March 31, 2022, the Company received a payment of $8.0 million from the ATO for the non-AOF research and development incentive for the years ended December 31, 2018, 2019 and 2020.

The Subsidiary incurs Goods and Services Tax (“GST”) on services provided by Australian vendors. As an Australian entity, the Subsidiary is entitled to a refund of the GST paid. The Company’s estimate of the amount of cash refund it expects to receive related to GST incurred is included in “Incentive and tax receivables” in the accompanying consolidated balance sheets. As of September 30, 2022, incentive and tax receivables included $0.3 million for refundable GST on expenses incurred with Australian vendors during the three months ended September 30, 2022.

Current incentive and tax receivables consisted of the following as of September 30, 2022 and December 31, 2021:


	September 30,		December 31,
	2022		2021
Research and development incentive (non-AOF) for the period 1/1/18 - 12/31/18	$	—	$	3,144,152
Research and development incentive (non-AOF) for the period 1/1/19 - 12/31/19		—		2,914,931
Research and development incentive (non-AOF) for the period 1/1/20 - 12/31/20		—		1,993,038
Research and development incentive (non-AOF) for the period 1/1/21 - 12/31/21		1,095,535		1,226,688
Research and development incentive (AOF) for the period 1/1/18 - 12/31/19		—		8,566,843
Goods and services tax		283,203		301,659
Total incentive and tax receivables before reserve for AOF		1,378,738		18,147,311
Reserve for research and development incentive (AOF) for the period 1/1/18 - 12/31/19		—		(8,566,843)
Total incentive and tax receivables - current assets	$	1,378,738	$	9,580,468

As of September 30, 2022, the Company’s estimate of the amount of cash refund it expects to receive for 2021 eligible spending as part of this incentive program was $1.1 million and was recorded as a current asset. In October 2022, the Company received payment from the ATO for the non-AOF research and development incentive for the year ended December 31, 2021 included in the table above. The Company’s estimate of the amount of cash refund it expects to receive for 2022 eligible spending through September 30, 2022 was $0.8 million and was recorded as a non-current asset.

d. Research and Development

Research and development costs are expensed as incurred and are primarily comprised of external research and development expenses incurred under arrangements with third parties, such as contract research organizations, contract manufacturing organizations, consultants and employee-related expenses including salaries and benefits. At the end of each reporting period, the Company compares the payments made to each service provider to the estimated progress towards completion of the related project. Factors that the Company considers in preparing these estimates include the number of patients enrolled in studies, milestones achieved and other criteria related to the efforts of its vendors. These estimates will be subject to change as additional information becomes available. Depending on the timing of payments to vendors and estimated services provided, the Company will record net prepaid or accrued expenses related to these costs. Research and development expenses are recorded net of expected refunds of eligible research and development costs paid pursuant to the Australian research and development tax incentive program and GST incurred on services provided by Australian vendors.

The following table summarizes research and development expenses for the nine months ended September 30, 2022 and 2021:


	Nine months ended September 30,
	2022		2021
Research and development expenses - before R&D incentive	$	16,450,619	$	17,304,684
Research and development incentive		(818,469)		(902,555)
Total research and development expenses	$	15,632,150	$	16,402,129

e. Net Loss Per Share

Basic net loss per share is determined using the weighted average number of shares of common stock outstanding during each period. Diluted net income per share includes the effect, if any, from the potential exercise or conversion of securities, such as restricted stock and stock options, which would result in the issuance of incremental shares of common stock. Basic and dilutive computations of net loss per share are the same in periods in which a net loss exists as the dilutive effects of restricted stock and stock options would be anti-dilutive.

The following potentially dilutive securities outstanding as of September 30, 2022 and 2021 have been excluded from the computation of diluted weighted average shares outstanding, as their effects on net loss per share for the periods presented would be anti-dilutive:


	September 30,
	2022	2021
Stock options	6,276,016	5,300,538
Unvested restricted stock	2,119,512	1,053,822
	8,395,528	6,354,360

f. Recent Accounting Pronouncements

The Company does not expect any recently issued accounting pronouncements to have a significant impact on its future results of operations, financial position or cash flow.

Fair Value Measurements

9 Months Ended

Sep. 30, 2022

Fair Value Measurements

Fair Value Measurements

(3) Fair Value Measurements

The Company measures certain assets and liabilities at fair value in accordance with Accounting Standards

Codification (“ASC 820”), Fair Value Measurements and Disclosures. ASC 820 defines fair value as the price that would be received to sell an asset or paid to transfer a liability (the exit price) in an orderly transaction between market participants at the measurement date. The guidance in ASC 820 outlines a valuation framework and creates a fair value hierarchy that serves to increase the consistency and comparability of fair value measurements and the related disclosures. In determining fair value, the Company maximizes the use of quoted prices and observable inputs. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from independent sources. The fair value hierarchy is broken down into three levels based on the source of inputs as follows:

Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities.

Level 2 — Valuations based on observable inputs and quoted prices in active markets for similar assets and liabilities.

Level 3 — Valuations based on unobservable inputs and models that are supported by little or no market activity.

In accordance with the fair value hierarchy described above, the following table sets forth the Company's financial assets measured at fair value on a recurring basis as of September 30, 2022 and December 31, 2021:



			Fair Value Measurement
	Carrying amount		as of September 30, 2022
	as of September 30, 2022		Level 1		Level 2		Level 3
Cash equivalents (money market accounts)	$	50,368,948	$	50,368,948	$	—	$	—
	$	50,368,948	$	50,368,948	$	—	$	—



			Fair Value Measurement
	Carrying amount		as of December 31, 2021
	as of December 31, 2021		Level 1		Level 2		Level 3
Cash equivalents (money market accounts)	$	67,709,279	$	67,709,279	$	—	$	—
	$	67,709,279	$	67,709,279	$	—	$	—

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Prepaid Expenses and Other Current Assets

9 Months Ended

Sep. 30, 2022

Prepaid Expenses and Other Current Assets

Prepaid Expenses and Other Current Assets

(4) Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following as of September 30, 2022 and December 31, 2021:


	September 30,		December 31,
	2022		2021
Prepaid development expenses	$	634,106	$	543,897
Prepaid insurance		2,186,026		1,952,867
Deferred financing costs		156,271		137,615
Other current assets		511,223		197,013
Total prepaid expenses and other current assets	$	3,487,626	$	2,831,392

Property and Equipment

9 Months Ended

Sep. 30, 2022

Property and Equipment

Property and Equipment

(5) Property and Equipment

Property and equipment consisted of the following as of September 30, 2022 and December 31, 2021:


	Estimated
	useful life	September 30,		December 31,
	(in years)	2022		2021
Equipment	2-5	$	740,543	$	740,543
Computer equipment	3-5		30,319		30,319
Furniture and fixtures	3-5		311,356		311,356
Leasehold improvements	various		68,881		68,881
Construction in process			279,292		79,342
Total cost			1,430,391		1,230,441
Less accumulated depreciation			(1,010,528)		(844,608)
Property and equipment, net		$	419,863	$	385,833

Depreciation expense was $165,920 and $185,245 for the nine months ended September 30, 2022 and 2021 respectively.

Accrued Expenses

9 Months Ended

Sep. 30, 2022

Accrued Expenses

Accrued Expenses

(6) Accrued Expenses

Accrued expenses consisted of the following as of September 30, 2022 and December 31, 2021:


	September 30,		December 31,
	2022		2021
Accrued compensation	$	2,006,537	$	2,412,291
Accrued research and development		4,731,308		5,125,010
Other		860,342		359,297
Total accrued expenses	$	7,598,187	$	7,896,598

Common Stock

9 Months Ended

Sep. 30, 2022

Common Stock

Common Stock

(7) Common Stock

a. At The Market Financing

On May 11, 2021, the Company entered into a Controlled Equity Offering^SM Sales Agreement (the “2021 Sales Agreement”) with Cantor Fitzgerald & Co., Canaccord Genuity, LLC, H.C. Wainwright & Co. LLC and Ladenburg Thalmann & Co. Inc., as sales agents (collectively, the “2021 Sales Agents”), pursuant to which, under a prospectus filed by the Company in May 2022, the Company may sell, from time to time, up to $75.0 million of its common stock. During the nine months ended September 30, 2022, the Company sold and issued 3,925,298 shares of common stock under the 2021 Sales Agreement in the open market at a weighted average selling price of $1.49 per share, resulting in gross proceeds of $5.8 million. Net proceeds after deducting commissions and offering expenses were $5.4 million.

In August 2019, the Company entered into a Controlled Equity Offering^SM Sales Agreement (the “2019 Sales Agreement”) with Cantor Fitzgerald & Co., Canaccord Genuity, LLC, H.C. Wainwright & Co. LLC and Ladenburg Thalmann & Co. Inc., as sales agents (collectively, the “2019 Sales Agents”), pursuant to which the Company sold $75.0 million of its common stock. In the first quarter of 2021, the Company sold and issued 10,244,326 shares of common stock under the 2019 Sales Agreement in the open market at a weighted average selling price of $4.22 per share, resulting in gross proceeds of $43.2 million. Net proceeds after deducting commissions and offering expenses were $42.2 million. As of February 9, 2021, the Company had utilized the entire $75.0 million under the 2019 Sales Agreement.

b. Equity Purchase Agreement

On July 21, 2022 (the “Effective Date”), the Company entered into a Purchase Agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”) pursuant to which Lincoln Park committed to purchase up to $20.0 million of the Company’s common stock. Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $20.0 million of the Company’s common stock. Such sales of common stock will be subject to certain limitations, and may occur from time to time, at the Company’s sole discretion, over the 36-month period commencing on the Effective Date. The number of shares the Company may sell to Lincoln Park on any single business day in a regular purchase is 150,000, but that amount may be increased up to 300,000 shares, depending upon the market price of the Company’s common stock at the time of sale and subject to a maximum limit of $2.0 million per regular purchase. The purchase price per share for each such regular purchase will be based on prevailing market prices of the Company’s common stock immediately preceding the time of sale as computed under the Purchase Agreement. In addition to regular purchases, the Company may also direct Lincoln Park to purchase other amounts as accelerated purchases or as additional accelerated purchases.

Pursuant to the terms of the Purchase Agreement, the Company issued 347,222 shares of its common stock to Lincoln Park as consideration for its commitment to purchase shares of the Company’s common stock under the Purchase Agreement.

During the three months ended September 30, 2022, the Company sold and issued 200,000 shares of common stock under the Purchase Agreement at a weighted average selling price of $1.15 per share, resulting in gross of $0.2 million and net proceeds, after deducting offering expenses, of $0.1 million.

- Definition

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

+ References

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

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 14
-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 14
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.3-04)
-URI https://asc.fasb.org/extlink&oid=120397183&loc=d3e187085-122770

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 18
-Subparagraph (d)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496189-112644

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (g)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 18
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496189-112644

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (h)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 14
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 18
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496189-112644

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 16
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496180-112644

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (i)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(e)(1))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 815
-SubTopic 40
-Section 50
-Paragraph 6
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126731327&loc=SL126733271-114008

+ Details

Stock-Based Compensation

9 Months Ended

Sep. 30, 2022

Stock-Based Compensation

Stock-Based Compensation

(8) Stock-Based Compensation

The Company maintains the Amended and Restated 2014 Omnibus Incentive Compensation Plan, as amended (the “2014 Plan”), which allows for the granting of incentive stock options, nonqualified stock options, stock appreciation rights, stock awards, stock units, performance units and other stock-based awards to employees, officers, non-employee directors, consultants, and advisors. In addition, the 2014 Plan provides selected executive employees with the opportunity to receive bonus awards that are considered qualified performance-based compensation. The 2014 Plan is subject to automatic annual increases in the number of shares authorized for issuance under the 2014 Plan on the first trading day of January each year equal to the lesser of 1.5 million shares or 10% of the number of shares of common stock outstanding on the last trading day of December of the preceding year. As of January 1, 2022, the number of shares of common stock that may be issued under the 2014 Plan was automatically increased by 1.5 million shares, increasing the total number of shares of common stock available for issuance under the 2014 Plan to 10,804,869 shares. As of September 30, 2022, 1,442,876 shares were available for future issuance under the 2014 Plan.

Options issued under the 2014 Plan have a contractual life of 10 years and may be exercisable in cash or as otherwise determined by the board of directors. The Company has granted options to employees and non-employee directors. Stock options granted to employees primarily vest 25% upon the first anniversary of the grant date and the balance of unvested options vests in quarterly installments over the remaining three years. Stock options granted annually to non-employee directors vest on the earlier of the one-year anniversary of the grant date, or the date of the Company’s next annual stockholders’ meeting that occurs after the grant date. The Company’s non-employee director compensation policy enables directors to receive stock options in lieu of quarterly cash payments. Any option granted to the directors in lieu of cash compensation vests in full on the grant date. The Company records forfeitures as they occur.

Stock-based compensation expense for performance-based grants are recorded when management estimates that the vesting of these shares is probable based on the status of the Company’s research and development programs and other relevant factors, which were established by the Company’s board of directors. The Company’s board of directors determines if the performance conditions have been met.

During the nine months ended September 30, 2021, the Company granted 506,911 time-based restricted stock awards to employees with two-year cliff vesting of which 469,911 restricted stock awards remained outstanding as of September 30, 2022. In addition, during the nine months ended September 30, 2021, the Company granted 506,911 performance-based restricted stock awards to employees of which 187,964 restricted stock awards have fully vested and 281,947 restricted stock awards remained outstanding as of September 30, 2022. The performance-based conditions for these performance-based grants were deemed probable of achievement during the six months ended June 30, 2021 and, as of September 30, 2022, the Company has recorded $1.6 million in stock-based compensation expense related to these grants. As of September 30, 2022, there was $40,696 of unrecognized stock-based compensation expense related to these performance-based awards, which will be expensed over the estimated service period related to each performance condition.

During the nine months ended September 30, 2022, the Company granted 841,654 time-based restricted stock awards to employees, non-employee directors and consultants of which 804,654 restricted stock awards remained outstanding as of September 30, 2022. In addition, during the nine months ended September 30, 2022, the Company granted 556,500 performance-based restricted stock awards to employees of which 548,000 restricted stock awards remained outstanding as of September 30, 2022. As of September 30, 2022, satisfaction of the related performance conditions has not been deemed probable of being achieved and there was $1.1 million of unrecognized stock-based compensation expense related to these performance-based awards, which will be expensed over the estimated service period related to each performance condition once the performance conditions have been deemed probable.

For the nine months ended September 30, 2022 and 2021, the Company recorded stock-based compensation expense related to its stock option grants and restricted stock awards, as follows:


	Stock Option Grants				Restricted stock awards				Total
	2022		2021		2022		2021		2022			2021
Research and development	$	776,809	$	1,198,492	$	723,638	$	1,245,175	$	1,500,447	$	2,443,667
General and administrative		941,321		1,307,844		868,357		1,017,668		1,809,678		2,325,512
	$	1,718,130	$	2,506,336	$	1,591,995	$	2,262,843	$	3,310,125	$	4,769,179

The following table summarizes the Company’s stock option activity for the nine months ended September 30, 2022:


		Weighted-		Weighted-
		Average		Average	Aggregate
	Number	Exercise		Contractual	Intrinsic
	of Shares	Price		Life (in Years)	Value
Outstanding as of December 31, 2021	5,224,913	$	8.74
Granted	1,136,728		2.17
Forfeited	(85,625)		10.97
Outstanding as of September 30, 2022	6,276,016		7.52	6.17	$	—
Exercisable as of September 30, 2022	4,303,603		9.58	5.00	$	—
Vested and expected to vest as of September 30, 2022	6,276,016	$	7.52

The weighted-average grant date fair values of options granted during the nine months ended September 30, 2022 and 2021 were $1.74 and $2.84, respectively.

The fair values of stock options granted were calculated using the Black-Scholes option pricing model with the following weighted-average assumptions:


	Nine months ended September 30,
	2022	2021
Weighted-average risk-free interest rate	2.02%	0.37%
Expected term of options (in years)	6.11	6.21
Expected stock price volatility	100.23%	95.60%
Expected dividend yield	0%	0%

As of September 30, 2022, there was $3.9 million of unrecognized stock-based compensation expense related to stock options, which is expected to be recognized over a weighted-average period of 2.40 years. During the nine months ended September 30, 2021, the Company received $47,906 in cash from the exercise of employee stock options.

The following table summarizes the Company’s restricted stock award activity under the 2014 Plan for the nine months ended September 30, 2022:


		Weighted
		Average		Aggregate
		Grant Date		Intrinsic
	Shares	Fair Value		Value
Unvested as of December 31, 2021	989,822	$	3.62
Granted	1,398,154		2.17
Forfeited	(25,500)		2.41
Vested	(242,964)		3.60
Unvested as of September 30, 2022	2,119,512	$	2.86	$	1,551,483
Expected to vest as of September 30, 2022	1,566,512	$	2.85	$	1,146,687

As of September 30, 2022, excluding performance-based restricted stock awards that have not been deemed probable, there was $1.5 million of unrecognized stock-based compensation expense related to unvested restricted stock awards, which is expected to be recognized over a weighted-average period of 0.62 years.

Operating Lease Obligations

9 Months Ended

Sep. 30, 2022

Operating Lease Obligations

Operating Lease Obligations

(9) Operating Lease Obligations

The Company adopted Accounting Standards Update No. 2016-02, Leases (Topic 842), Accounting Standards Codification 842 prospectively using the modified-retrospective method and elected the package of transition practical expedients that does not require reassessment of: (1) whether any existing or expired contracts are or contain leases, (2) lease classification and (3) initial direct costs. In addition, the Company has elected other available practical expedients to not separate lease and nonlease components, which consist principally of common area maintenance charges, and to exclude leases with an initial term of 12 months or less.

The Company leases its headquarters where it occupies 10,877 square feet of office space. On March 1, 2021, the Company extended its lease for three additional years until May 31, 2024. The Company’s lease contains variable lease costs that do not depend on a rate or index and consist primarily of common area maintenance, taxes, and insurance charges. As the implicit rate was not readily determinable for the Company’s lease, the Company used an estimated incremental borrowing rate, or discount rate, to determine the initial present value of the lease payments. The discount rate for the lease was calculated using a synthetic credit rating model.

As of March 1, 2021, the effective date of the lease modification, the Company remeasured the lease liability for the remaining portion of the lease and adjusted the lease liability to $755,085 and right-of-use assets to $752,391, which was recorded net of a deferred rent liability of $2,694. As of September 30, 2022, the Company’s right-of-use asset, net of amortization, was $394,205.

Other operating lease information as of September 30, 2022:


Weighted-average remaining lease term - operating leases	1.7	years
Weighted-average discount rate - operating leases	2.76	%

The following is a maturity analysis of the annual undiscounted cash flows of the operating lease liabilities as of September 30, 2022:


	September 30,
Year ending:	2022
December 31, 2022	$	60,105
December 31, 2023		240,421
December 31, 2024		100,175
Total minimum lease payments		400,701
Less: imputed lease interest		(8,601)
Total lease liabilities	$	392,100

Lease expense for the nine months ended September 30, 2022 was comprised of the following:


	Nine months ended September 30,
		2022		2021
Operating lease expense	$	181,262	$	183,788
Variable lease expense		46,951		46,190
Total lease expense	$	228,213	$	229,978

Total cash payments related to leases were $227,266 and $237,835 for the nine months ended September 30, 2022 and 2021, respectively.

Summary of Significant Accounting Policies (Policies)

9 Months Ended

Sep. 30, 2022

Summary of Significant Accounting Policies

Basis of Presentation

a. Basis of Presentation

Use of Estimates

b. Use of Estimates

Incentive and Tax Receivables

c. Incentive and Tax Receivables

Current incentive and tax receivables consisted of the following as of September 30, 2022 and December 31, 2021:


	September 30,		December 31,
	2022		2021
Research and development incentive (non-AOF) for the period 1/1/18 - 12/31/18	$	—	$	3,144,152
Research and development incentive (non-AOF) for the period 1/1/19 - 12/31/19		—		2,914,931
Research and development incentive (non-AOF) for the period 1/1/20 - 12/31/20		—		1,993,038
Research and development incentive (non-AOF) for the period 1/1/21 - 12/31/21		1,095,535		1,226,688
Research and development incentive (AOF) for the period 1/1/18 - 12/31/19		—		8,566,843
Goods and services tax		283,203		301,659
Total incentive and tax receivables before reserve for AOF		1,378,738		18,147,311
Reserve for research and development incentive (AOF) for the period 1/1/18 - 12/31/19		—		(8,566,843)
Total incentive and tax receivables - current assets	$	1,378,738	$	9,580,468

Research and Development

d. Research and Development

The following table summarizes research and development expenses for the nine months ended September 30, 2022 and 2021:


	Nine months ended September 30,
	2022		2021
Research and development expenses - before R&D incentive	$	16,450,619	$	17,304,684
Research and development incentive		(818,469)		(902,555)
Total research and development expenses	$	15,632,150	$	16,402,129

Net Loss Per Share

e. Net Loss Per Share


	September 30,
	2022	2021
Stock options	6,276,016	5,300,538
Unvested restricted stock	2,119,512	1,053,822
	8,395,528	6,354,360

Recent Accounting Pronouncements

f. Recent Accounting Pronouncements

The Company does not expect any recently issued accounting pronouncements to have a significant impact on its future results of operations, financial position or cash flow.

Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2022

Summary of Significant Accounting Policies

Schedule of incentive and tax receivables


	September 30,		December 31,
	2022		2021
Research and development incentive (non-AOF) for the period 1/1/18 - 12/31/18	$	—	$	3,144,152
Research and development incentive (non-AOF) for the period 1/1/19 - 12/31/19		—		2,914,931
Research and development incentive (non-AOF) for the period 1/1/20 - 12/31/20		—		1,993,038
Research and development incentive (non-AOF) for the period 1/1/21 - 12/31/21		1,095,535		1,226,688
Research and development incentive (AOF) for the period 1/1/18 - 12/31/19		—		8,566,843
Goods and services tax		283,203		301,659
Total incentive and tax receivables before reserve for AOF		1,378,738		18,147,311
Reserve for research and development incentive (AOF) for the period 1/1/18 - 12/31/19		—		(8,566,843)
Total incentive and tax receivables - current assets	$	1,378,738	$	9,580,468

Schedule of research and development expenses


	Nine months ended September 30,
	2022		2021
Research and development expenses - before R&D incentive	$	16,450,619	$	17,304,684
Research and development incentive		(818,469)		(902,555)
Total research and development expenses	$	15,632,150	$	16,402,129

Summary of potentially dilutive securities excluded from the computation of diluted weighted average shares outstanding


	September 30,
	2022	2021
Stock options	6,276,016	5,300,538
Unvested restricted stock	2,119,512	1,053,822
	8,395,528	6,354,360

Fair Value Measurements (Tables)

9 Months Ended

Sep. 30, 2022

Fair Value Measurements

Summary of financial assets measured at fair value on a recurring basis



			Fair Value Measurement
	Carrying amount		as of September 30, 2022
	as of September 30, 2022		Level 1		Level 2		Level 3
Cash equivalents (money market accounts)	$	50,368,948	$	50,368,948	$	—	$	—
	$	50,368,948	$	50,368,948	$	—	$	—



			Fair Value Measurement
	Carrying amount		as of December 31, 2021
	as of December 31, 2021		Level 1		Level 2		Level 3
Cash equivalents (money market accounts)	$	67,709,279	$	67,709,279	$	—	$	—
	$	67,709,279	$	67,709,279	$	—	$	—

Prepaid Expenses and Other Current Assets (Tables)

9 Months Ended

Sep. 30, 2022

Prepaid Expenses and Other Current Assets

Schedule of prepaid expenses and other current assets


	September 30,		December 31,
	2022		2021
Prepaid development expenses	$	634,106	$	543,897
Prepaid insurance		2,186,026		1,952,867
Deferred financing costs		156,271		137,615
Other current assets		511,223		197,013
Total prepaid expenses and other current assets	$	3,487,626	$	2,831,392

Property and Equipment (Tables)

9 Months Ended

Sep. 30, 2022

Property and Equipment

Schedule of property and equipment


	Estimated
	useful life	September 30,		December 31,
	(in years)	2022		2021
Equipment	2-5	$	740,543	$	740,543
Computer equipment	3-5		30,319		30,319
Furniture and fixtures	3-5		311,356		311,356
Leasehold improvements	various		68,881		68,881
Construction in process			279,292		79,342
Total cost			1,430,391		1,230,441
Less accumulated depreciation			(1,010,528)		(844,608)
Property and equipment, net		$	419,863	$	385,833

Accrued Expenses (Tables)

9 Months Ended

Sep. 30, 2022

Accrued Expenses

Schedule of accrued expenses


	September 30,		December 31,
	2022		2021
Accrued compensation	$	2,006,537	$	2,412,291
Accrued research and development		4,731,308		5,125,010
Other		860,342		359,297
Total accrued expenses	$	7,598,187	$	7,896,598

Stock-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2022

Stock-Based Compensation

Schedule of stock-based compensation expense


	Stock Option Grants				Restricted stock awards				Total
	2022		2021		2022		2021		2022			2021
Research and development	$	776,809	$	1,198,492	$	723,638	$	1,245,175	$	1,500,447	$	2,443,667
General and administrative		941,321		1,307,844		868,357		1,017,668		1,809,678		2,325,512
	$	1,718,130	$	2,506,336	$	1,591,995	$	2,262,843	$	3,310,125	$	4,769,179

Summary of stock option activity


		Weighted-		Weighted-
		Average		Average	Aggregate
	Number	Exercise		Contractual	Intrinsic
	of Shares	Price		Life (in Years)	Value
Outstanding as of December 31, 2021	5,224,913	$	8.74
Granted	1,136,728		2.17
Forfeited	(85,625)		10.97
Outstanding as of September 30, 2022	6,276,016		7.52	6.17	$	—
Exercisable as of September 30, 2022	4,303,603		9.58	5.00	$	—
Vested and expected to vest as of September 30, 2022	6,276,016	$	7.52

Schedule of weighted-average assumptions used to calculate fair values of stock options


	Nine months ended September 30,
	2022	2021
Weighted-average risk-free interest rate	2.02%	0.37%
Expected term of options (in years)	6.11	6.21
Expected stock price volatility	100.23%	95.60%
Expected dividend yield	0%	0%

Summary of restricted stock activity


		Weighted
		Average		Aggregate
		Grant Date		Intrinsic
	Shares	Fair Value		Value
Unvested as of December 31, 2021	989,822	$	3.62
Granted	1,398,154		2.17
Forfeited	(25,500)		2.41
Vested	(242,964)		3.60
Unvested as of September 30, 2022	2,119,512	$	2.86	$	1,551,483
Expected to vest as of September 30, 2022	1,566,512	$	2.85	$	1,146,687

Operating Lease Obligations (Tables)

9 Months Ended

Sep. 30, 2022

Operating Lease Obligations

Schedule of other operating lease information


Weighted-average remaining lease term - operating leases	1.7	years
Weighted-average discount rate - operating leases	2.76	%

Schedule of operating lease liabilities maturity analysis


	September 30,
Year ending:	2022
December 31, 2022	$	60,105
December 31, 2023		240,421
December 31, 2024		100,175
Total minimum lease payments		400,701
Less: imputed lease interest		(8,601)
Total lease liabilities	$	392,100

Schedule of lease expense


	Nine months ended September 30,
		2022		2021
Operating lease expense	$	181,262	$	183,788
Variable lease expense		46,951		46,190
Total lease expense	$	228,213	$	229,978

Nature of Business and Liquidity (Details) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Nature of Business and Liquidity
Accumulated deficit	$ 266,501,253	$ 239,481,479