0001410578-23-001760 | 10-Q | XBRL Viewer

Notes Payable - Schedule of notes payable (Details) - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Current portion
Notes Payable, Current portion	$ 1,038,784	$ 416,666
Debt Discount, Current portion	(91,621)	(67,770)
Net, Current portion	947,163	348,896
Note payable, Non Current portion	14,804,166	10,008,334
Debt Discount, Non-Current portion	(1,627,642)	(1,626,458)
Net, Non Current portion	13,176,524	8,381,876
D&O insurance policy loan
Current portion
Notes Payable, Current portion	205,451	0
Debt Discount, Current portion	0	0
Net, Current portion	205,451	0
Avenue - Note payable
Current portion
Notes Payable, Current portion	833,333	208,333
Debt Discount, Current portion	(91,621)	(33,885)
Net, Current portion	741,712	174,448
Note payable, Non Current portion	9,804,166	5,004,167
Debt Discount, Non-Current portion	(1,120,372)	(813,229)
Net, Non Current portion	8,683,794	4,190,938
Avenue - Convertible note payable
Current portion
Notes Payable, Current portion	0	208,333
Debt Discount, Current portion	0	(33,885)
Net, Current portion	0	174,448
Note payable, Non Current portion	5,000,000	5,004,167
Debt Discount, Non-Current portion	(507,270)	(813,229)
Net, Non Current portion	$ 4,492,730	$ 4,190,938

Notes Payable

6 Months Ended

Jun. 30, 2023

Notes Payable

Notes Payable

Note 6 – Notes Payable

As of June 30, 2023 and December 31, 2022, notes payable consisted of the following:


	June 30, 2023						December 31, 2022
	Notes Payable		Debt Discount		Net		Notes Payable		Debt Discount		Net
Current portion:
D&O insurance policy loan	$	205,451	$	—	$	205,451	$	—	$	—	$	—
Avenue - Note payable		833,333		(91,621)		741,712		208,333		(33,885)		174,448
Avenue - Convertible note payable		—		—		—		208,333		(33,885)		174,448
Total current portion	$	1,038,784	$	(91,621)	$	947,163	$	416,666	$	(67,770)	$	348,896

Non-Current portion:
Avenue - Note payable		9,804,166		(1,120,372)		8,683,794		5,004,167		(813,229)		4,190,938
Avenue - Convertible note payable		5,000,000		(507,270)		4,492,730		5,004,167		(813,229)		4,190,938
Total non-current portion	$	14,804,166	$	(1,627,642)	$	13,176,524	$	10,008,334	$	(1,626,458)	$	8,381,876

On February 24, 2023, the Company issued a note payable in the amount of $609,140 for the purchase of a directors and officers’ liability insurance policy (the “D&O Loan”). The note accrues interest at a rate of 7.11% per year and matures on August 24, 2023. The D&O Loan is payable in six monthly payments of $103,639 consisting of principal and interest. During the six months ended June 30, 2023, the Company repaid $403,689 of principal owed on the D&O Loan.

On May 22, 2023, pursuant to the Company’s Loan and Security Agreement (the “Loan and Security Agreement”) with Avenue Capital Management II, L.P., and related entities (“Avenue”), the Company received an additional tranche of non-convertible debt funding in the gross amount of $5,000,000. The Company paid approximately $126,000 of origination and legal fees connected to this debt funding. The additional funding was made under the provisions of the Loan and Security Agreement, bearing interest at an annual rate equal to the greater of (A) 7.0% and (B) the prime rate as reported in The Wall Street Journal plus 4.45%. The entire outstanding balance due under the Loan and Security Agreement has a maturity date of November 1, 2025. The additional funding triggered the extension of the interest-only period from the original 12 months to 18 months (through May 2024) for the entire outstanding balance due under the Loan and Security Agreement (initial and additional tranches). Following the interest-only period, the Company will make equal monthly payments of principal until the maturity date, plus interest.

During the three months ended June 30, 2023, the Company recorded interest expense of $558,003, of which $550,746 was related to the Loan and Security Agreement with Avenue Capital Management II, L.P. (“Avenue”) and related entities, (including amortization of debt discount of $163,956) and $7,257 was related to the D&O Loan. During the six months ended June 30, 2023, the Company recorded interest expense of $1,012,006, of which $1,001,140 was related to the Loan and Security Agreement (including amortization of debt discount of $313,446) and $10,866 was related to the D&O Loan.

Condensed Statements of Cash Flows - USD ($)	6 Months Ended
Condensed Statements of Cash Flows - USD ($)	Jun. 30, 2023	Jun. 30, 2022
Cash Flows From Operating Activities
Net Income (Loss)	$ (11,955,226)	$ (14,578,765)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	1,312,696	1,945,913
Depreciation of property and equipment	187,267	145,901
Amortization of debt discount	313,446	52,431
Non-cash rent expense	280,968
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	(1,514)	(461,761)
License fee and expense reimbursements receivables	754,780	1,095,831
Deferred clinical supply costs	(1,293,395)	(1,538,380)
Security and equipment deposits	1,750	(68,868)
Accounts payable	(115,534)	1,072,690
Accrued compensation	(734,073)	(529,534)
Accrued expenses and other current liabilities	(139,645)	(21,417)
Lease liabilities	(284,996)	2,356
Net Cash Used In Operating Activities	(11,673,476)	(12,883,603)
Cash Flows From Investing Activities
Purchases of property and equipment	(2,122,197)	(281,342)
Vendor deposits for property and equipment		(118,298)
Net Cash Used In Investing Activities	(2,122,197)	(399,640)
Cash Flows From Financing Activities
Proceeds from sale of common stock and warrants in direct offering		14,981,299
Payment of offering issuance costs		(83,391)
Proceeds from sale of common stock in At the Market offering	4,023,414	886,974
Payment of issuance costs for At the Market offering	(120,702)	(26,609)
Proceeds from exercise of stock options	27,200	18,701
Proceeds from note payable to Avenue	5,000,000
Payment of issuance costs for notes issued to Avenue	(125,982)
Repayments of notes payable	(403,689)	(448,999)
Net Cash Provided By Financing Activities	8,400,241	15,327,975
Net (Decrease) Increase in Cash and Cash Equivalents	(5,395,432)	2,044,732
Cash, cash equivalents and restricted cash - Beginning of Period	22,863,520	27,336,850
Cash, cash equivalents and restricted cash - End of Period	17,468,088	29,381,582
Cash, cash equivalents and restricted cash consisted of the following:
Cash and cash equivalents	17,468,088	21,506,582
Restricted cash		7,875,000
Total	17,468,088	29,381,582
Supplemental Disclosure of Cash Flow Information:
Interest	699,116	199,367
Supplemental Disclosure of Non-Cash Investing and Financing Activities
Purchase of insurance policy financed by note payable	609,140	675,331
Right-of-use assets and lease liabilities recognized upon lease renewal	904,437
Vendor deposits applied to purchases of property and equipment	468,376
Original issue discount on notes payable	212,500
Cashless exercise of stock options	2
Issuance of common stock related to vested restricted stock units	$ 4	$ 7

Pay vs Performance Disclosure - USD ($)	3 Months Ended				6 Months Ended
Pay vs Performance Disclosure - USD ($)	Jun. 30, 2023	Mar. 31, 2023	Jun. 30, 2022	Mar. 31, 2022	Jun. 30, 2023	Jun. 30, 2022
Pay vs Performance Disclosure
Net Income (Loss)	$ (6,215,860)	$ (5,739,366)	$ (7,239,100)	$ (7,339,665)	$ (11,955,226)	$ (14,578,765)

- Definition

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

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+ Details

Notes Payable - Additional Information (Details) - USD ($)			3 Months Ended		6 Months Ended
	May 22, 2023	Feb. 24, 2022	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022	Aug. 24, 2023	Feb. 24, 2023	Dec. 31, 2022
Notes Payable
Short term notes payable			$ 947,163		$ 947,163				$ 174,448
Repayments of notes payable					$ 403,689	$ 448,999
Amount pledged to establish and maintain a collateralized money market account				$ 7,875,000		$ 7,875,000
Expected volatility				88.00%
Risk free interest rate				2.79%
Payment of origination and legal fees	$ 126,000
Prime Rate
Notes Payable
SVB loan cash flow	4.45%
Debt instrument interest rate	4.45%
Maximum
Notes Payable
Expected term (years)			10 years	5 years 6 months	10 years	10 years
Expected volatility			94.00%		95.00%	90.00%
Risk free interest rate			4.02%		4.18%	2.79%
Minimum
Notes Payable
Expected term (years)			5 years 6 months	5 years 1 month 2 days	5 years 6 months	6 months 29 days
Expected volatility			82.00%		82.00%	82.00%
Risk free interest rate			3.44%		3.44%	0.76%
Avenue Ventures Loan
Notes Payable
Interest expense			$ 558,003
Interest expense related to the Loan and Security Agreement with Avenue Capital Management			550,746
D&O insurance policy loan
Notes Payable
Short term notes payable								$ 609,140
Interest rate (as a percent)							7.11%
Number of monthly payments		6 months
Debt Instrument, Periodic Payment					$ 103,639
Amortization of debt discount			163,956		313,446
Amortization of debt discount related to loans			$ 7,257		10,866
Loan and Security Agreement
Notes Payable
Loan issuance costs					1,001,140
Interest expense					$ 1,012,006
SVB loan cash flow	7.00%
Debt instrument interest rate	7.00%
Loan and Security Agreement \| Avenue Capital Management II, L.P
Notes Payable
Debt gross amount	$ 5,000,000
Loan and Security Agreement \| Maximum
Notes Payable
Extension of interest period	18 months
Loan and Security Agreement \| Minimum
Notes Payable
Extension of interest period	12 months

Stockholders' Equity - Black Scholes option (Details)	3 Months Ended		6 Months Ended
Stockholders' Equity - Black Scholes option (Details)	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Stockholders' Equity
Risk free interest rate		2.79%
Expected volatility		88.00%
Expected dividends	0.00%	0.00%	0.00%	0.00%
Minimum
Stockholders' Equity
Expected term (years)	5 years 6 months	5 years 1 month 2 days	5 years 6 months	6 months 29 days
Risk free interest rate	3.44%		3.44%	0.76%
Expected volatility	82.00%		82.00%	82.00%
Maximum
Stockholders' Equity
Expected term (years)	10 years	5 years 6 months	10 years	10 years
Risk free interest rate	4.02%		4.18%	2.79%
Expected volatility	94.00%		95.00%	90.00%

Stockholders' Equity

6 Months Ended

Jun. 30, 2023

Stockholders' Equity

Stockholders' Equity

Note 8 – Stockholders’ Equity

Equity Incentive Plan

On June 27, 2023, the Company’s stockholders approved an amendment to the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan, reserving an additional 1,000,000 shares of common stock for further issuance under such plan.

At-The-Market Offering

During the six months ended June 30, 2023, the Company received approximately $3.9 million in net proceeds from the sale of 1,421,936 shares of its common stock pursuant to its Sales Agreement with SVB Securities LLC (“SVB Securities”) in an ”at-the-market” offering (the “At-the-Market Offering Program”).

Stock-Based Compensation Expense

The Company records stock-based compensation expense related to stock options and restricted stock units (“RSUs”). For the three months ended June 30, 2023 and 2022, the Company recorded expense of $493,632 ($36,197 of which was included within research and development expenses and $457,435 was included within general and administrative expenses on the statements of operations) and $1,036,926 ($516,669 of which was included within research and development expenses and $520,257 was included within general and administrative expenses on the statements of operations), respectively. For the six months ended June 30, 2023 and 2022, the Company recorded expense of $1,312,696 ($411,327 of which was included within research and development expenses and $901,369 was included within general and administrative expenses on the statements of operations) and $1,945,913 ($1,017,850 of which was included within research and development expenses and $928,063 was included within general and administrative expenses on the statements of operations), respectively.

Restricted Stock Units

A summary of RSU activity during the six months ended June 30, 2023 is presented below:


		Weighted
		Average
	Number of	Grant Date Value
	RSUs	Per Share
RSUs non-vested January 1, 2023	172,800	$	1.80
Granted	86,205		2.32
Vested	(150,578)		1.80
Forfeited	(22,222)		1.80
RSUs non-vested June 30, 2023	86,205	$	2.32

Vested RSUs undelivered June 30, 2023	29,611	$	3.68

To date, RSUs have only been granted to directors in accordance with the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan. The Company’s policy is to defer settlement of such RSUs until the termination of such director’s service on the Company’s board of directors. On February 28, 2023, the Company delivered 3,289 shares of common stock in respect of RSUs upon the resignation of a director. On June 16, 2023, the Company delivered 44,444 shares of common stock in respect of RSUs based on the prior resignation of two directors.

As of June 30, 2023, there was $200,000 of unrecognized stock-based compensation expense related to RSUs which will be recognized over a weighted average period of 1.0 years.

Stock Options

In applying the Black-Scholes option pricing model to stock options granted, the Company used the following approximate assumptions:


	For the Three Months Ended		For the Six Months Ended
	June 30,		June 30,
	2023	2022	2023		2022
Expected term (years)	5.50 - 10.00	5.09 - 5.50		5.50 - 10.00		0.58 - 10.00
Risk free interest rate	3.44% - 4.02%	2.79%		3.44% - 4.18%		0.76% - 2.79%
Expected volatility	82% - 94%	88%		82% - 95%		82% - 90%
Expected dividends	0.00%	0.00%		0.00%		0.00%

The Company has computed the fair value of stock options granted using the Black-Scholes option pricing model. Option forfeitures are accounted for at the time of occurrence. The expected term is the estimated period of time that options granted are expected to be outstanding. The Company utilizes the “simplified” method to develop an estimate of the expected term of “plain vanilla” employee option grants. The Company uses a blended volatility calculation, the components of which are the Company’s historical volatility for the period from its initial public offering through the valuation date and the average peer-group data of six comparable entities to supplement the Company’s own historical data for the preceding years in computing the expected volatility. Accordingly, the Company is utilizing an expected volatility figure based on a review of the historical volatility of comparable entities over a period of time equivalent to the expected life of the instrument being valued. The risk-free interest rate was determined from the implied yields from U.S. Treasury zero-coupon bonds with a remaining term consistent with the expected term of the instrument being valued. The Company has not declared dividends, is currently in the development stage and has no plan to declare future dividends at this time.

The weighted average estimated grant date fair value of the stock options granted for the three months ended June 30, 2023 and 2022 was approximately $2.04 and $1.37 per share, respectively. The weighted average estimated grant date fair value of the stock options granted for the six months ended June 30, 2023 and 2022 was approximately $1.78 and $2.02 per share, respectively.

A summary of the option activity during the six months ended June 30, 2023 is presented below:




		Average		Remaining	Aggregate
	Number of	Exercise		Life	Intrinsic
	Options	Price		In Years	Value
Outstanding, January 1, 2023	5,380,553	$	3.55
Granted	677,190		2.39
Exercised	(88,999)		1.83
Forfeited/ Expired	(783,666)		3.88
Outstanding June 30, 2023	5,185,078	$	3.37	7.1	$	962,979

Exercisable June 30, 2023	3,582,370	$	3.69	6.2	$	501,462

The following table presents information related to stock options as of June 30, 2023:


Options Outstanding			Options Exercisable
			Weighted
		Outstanding	Average	Exercisable
Exercise		Number of	Remaining Life	Number of
Price		Options	In Years	Options
	$1.00 - $1.99	1,407,183	4.7	884,183
	$2.00 - $2.99	1,473,663	6.9	844,473
	$3.00 - $3.99	908,528	6.8	694,510
	$4.00 - $4.99	350,500	8.1	216,178
	$5.00 - $5.99	50,805	4.3	50,638
	$6.00 - $6.99	843,759	6.5	741,748
	$7.00+	150,640	4.8	150,640
		5,185,078	6.2	3,582,370

As of June 30, 2023, there was $2,868,023 of unrecognized stock-based compensation expense related to stock options, which will be recognized over a weighted average period of 1.7 years.

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-14

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 235
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481062/946-235-50-2

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 235
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481062/946-235-50-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 505
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481004/946-505-50-6

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 40
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480237/815-40-50-6

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.3-04)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480008/505-10-S99-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(e)(1))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 505
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org//505/tableOfContent

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (i)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-14

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 14
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-14

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 16
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-16

Reference 17: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18

Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 18
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18

+ Details

Accrued Expenses and Other Current Liabilities (Tables)

6 Months Ended

Jun. 30, 2023

Accrued Expenses and Other Current Liabilities

Schedule of accrued expenses and other current liabilities


	June 30,		December 31,
	2023		2022
Accrued consulting and professional services	$	142,915	$	320,000
Accrued research and development expenses		117,983		35,524
Accrued leasehold improvements		—		92,528
Credit card payable		58,549		50,639
Accrued franchise tax		26,201		—
Accrued travel and entertainment expenses		13,784		—
Other		3,999		4,385
Total accrued expenses and other current liabilities	$	363,431	$	503,076

Prepaid Expenses and Other Current Assets

6 Months Ended

Jun. 30, 2023

Prepaid Expenses and Other Current Assets

Prepaid Expenses and Other Current Assets

Note 3 – Prepaid Expenses and Other Current Assets

As of June 30, 2023 and December 31, 2022, prepaid expenses and other current assets consisted of the following:


	June 30,		December 31,
	2023		2022
Payroll tax receivable	$	645,566	$	660,891
Prepaid insurance expenses		600,607		201,082
Prepaid general and administrative expenses		310,701		87,982
Prepaid research and development expenses		83,192		2,521
Prepaid patent expenses		73,157		38,796
Prepaid conference expenses		69,400		97,743
Prepaid rent and security deposit		18,750		74,959
Other		—		26,745
Total prepaid expenses and other current assets	$	1,801,373	$	1,190,719

Going Concern and Summary of Significant Accounting Policies

6 Months Ended

Jun. 30, 2023

Going Concern and Summary of Significant Accounting Policies

Going Concern and Summary of Significant Accounting Policies

Note 2 – Going Concern and Summary of Significant Accounting Policies

Since the date of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, there have been no material changes to the Company’s significant accounting policies, except as disclosed below.

Going Concern

As of June 30, 2023, the Company had cash and cash equivalents in the aggregate amount of approximately $17.5 million. For the six months ended June 30, 2023 and 2022, the Company incurred net losses of approximately $12.0 million and $14.6 million, respectively, and used cash in operations of approximately $11.7 million and $12.9 million, respectively. The Company does not have recurring revenue, has not yet achieved profitability and may never become profitable. The Company expects to continue to incur cash outflows from operations. Research and development and general and administrative expenses will continue to be incurred by the Company and, as a result, the Company will eventually need to generate significant product revenues to achieve profitability. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern for at least one year from the date that these financial statements are issued. Implementation of the Company’s plans and its ability to continue as a going concern will depend upon the Company’s ability to raise further capital through licensing transactions, the sale of additional equity or debt securities, or otherwise, to support its future operations.

The Company’s operating needs include the planned costs to operate its business, including amounts required to fund working capital and capital expenditures. The Company’s future capital requirements and the adequacy of its available funds will depend on many factors, including the Company’s ability to successfully commercialize its products and services, competing technological and market developments, and the need to enter into collaborations with other companies or acquire other companies or technologies to enhance or complement its product and service offerings. If the Company is unable to secure additional capital, it may be required to curtail its research and development initiatives and/or take additional measures to reduce general and administrative and sales and marketing costs in order to conserve its cash.

Reclassifications

Certain prior period amounts presented on the Company’s financial statements have been reclassified in order to conform to current period presentation. These reclassifications have no effect on previously reported results of operations or loss per share.

Cash and Cash Equivalents

The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents in the financial statements.As of June 30, 2023, the Company had Treasury bills with original maturity dates of three months or less in the amount of $4,493,766.

The Company has cash deposits in a financial institution that, at times, may be in excess of Federal Deposit Insurance Corporation (“FDIC”) insurance limits. The Company has not experienced losses in such accounts and periodically evaluates the creditworthiness of its financial institutions. As of June 30, 2023 and December 31, 2022, the Company had cash balances in excess of FDIC insurance limits of $12,474,323 and $22,613,520, respectively.

Net Loss Per Common Share

Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the period plus fully vested shares that are subject to issuance for little or no monetary consideration. Diluted earnings per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock.

The following table presents the computation of basic and diluted net loss per common share:


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Numerator:
Net loss attributable to common stockholders	$	(6,215,860)	$	(7,239,100)	$	(11,955,226)	$	(14,578,765)

Denominator (weighted average quantities):
Common shares issued		38,064,215		31,669,431		37,724,083		31,089,811
Add: Prefunded warrants		—		1,870,130		—		671,594
Add: Undelivered vested restricted shares		29,611		105,306		29,611		75,177
Denominator for basic and diluted net loss per share		38,093,826		33,644,867		37,753,694		31,836,582

Basic and diluted net loss per common share	$	(0.16)	$	(0.22)	$	(0.32)	$	(0.46)

The following securities are excluded from the calculation of weighted average diluted common shares because their inclusion would have been anti-dilutive:


	June 30,
	2023	2022
Options	5,185,078	4,926,750
Warrants	6,087,845	6,087,845
Convertible notes	2,327,747	—
Restricted stock units	86,205	111,110
Total potentially dilutive shares	13,686,875	11,125,705

Clinical Supply Arrangements

Bausch + Lomb, Inc. (“B+L”) and Arctic Vision (Hong Kong) Limited (“Arctic Vision”) have contracted with the Company to manufacture and supply them with the appropriate drug-device combination products to conduct their clinical trials on a cost plus 10% mark-up basis. The Company’s licensing agreements with Bausch + Lomb and Arctic Vision represent collaborative arrangements and they are not a customer with respect to the clinical supply arrangements. The Company’s policy is to (a) defer the materials and manufacturing costs in order to properly match them up against the income from the clinical supply arrangements; and (b) to report the net income from the clinical supply arrangements as other income.

Recently Adopted Accounting Standards

In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments - Credit Losses (Topic 326)” and also issued subsequent amendments to the initial guidance under ASU 2018-19, ASU 2019-04 and ASU 2019-05 (collectively, “Topic 326”). Topic 326 requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. This replaces the existing incurred loss model with an expected loss model and requires the use of forward-looking information to calculate credit loss estimates. The Company adopted ASU 2016-13 on January 1, 2023. The adoption of ASU 2016-13 did not have a material impact on the Company’s financial position, results of operations or cash flows.

In August 2020, the FASB issued ASU 2020-06, “Debt—Debt with Conversion and Other Options (Subtopic 470-20)” and “Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity”, to clarify the accounting for certain financial instruments with characteristics of liabilities and equity. The amendments in this update reduce the number of accounting models for convertible debt instruments and convertible preferred stock by removing the cash conversion model and the beneficial conversion feature model. Limiting the accounting models will result in fewer embedded conversion features being separately recognized from the host contract. Convertible instruments that continue to be subject to separation models are (1) those with embedded conversion features that are not clearly and closely related to the host contract, that meet the definition of a derivative, and that do not qualify for a scope exception from derivative accounting and (2) convertible debt instruments issued with substantial premiums for which the premiums are recorded as paid-in-capital. In addition, ASU 2020-06 improves disclosure requirements for convertible instruments and earnings-per-share guidance. ASU 2020-06 also revises the derivative scope exception guidance to reduce form-over-substance-based accounting conclusions driven by remote contingent events. The amendments in this update are effective for the Company in fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted. The Company early adopted ASU 2020-06 effective January 1, 2023 which eliminates the need to assess whether a beneficial conversion feature needs to be recognized upon the issuance of new convertible instruments. The adoption of ASU 2020-06 did not have a material impact on the Company’s financial position, results of operations or cash flows.

Accrued Compensation (Details) - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Accrued Compensation
Accrued bonus expenses	$ 695,450	$ 1,447,643
Accrued payroll expenses	317,668	299,548
Total accrued compensation	$ 1,013,118	$ 1,747,191

Condensed Statements of Cash Flows (Parenthetical)	3 Months Ended
Condensed Statements of Cash Flows (Parenthetical)	Mar. 31, 2022 USD ($)
IPO
Proceeds of stock issued during period gross	$ 14,981,299
IPO \| Pre-funded warrants
Proceeds of stock issued during period gross	5,741,299
At Market Offering
Proceeds of stock issued during period gross	$ 886,974

Condensed Statements of Changes in Stockholders' Equity (Parenthetical) - USD ($)	3 Months Ended
	Jun. 30, 2023	Mar. 31, 2023	Mar. 31, 2022
IPO
Proceeds of stock issued during period gross			$ 14,981,299
Adjustments to additional paid in capital upon stock issuance costs			83,391
At Market Offering
Proceeds of stock issued during period gross	$ 415,588	$ 3,607,827	886,974
Adjustments to additional paid in capital upon stock issuance costs	$ 12,468	$ 108,235	$ 26,609

Going Concern and Summary of Significant Accounting Policies (Policies)

6 Months Ended

Jun. 30, 2023

Going Concern and Summary of Significant Accounting Policies

Going Concern

Reclassifications

Cash and Cash Equivalents

Net Loss Per Common Share

The following table presents the computation of basic and diluted net loss per common share:


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Numerator:
Net loss attributable to common stockholders	$	(6,215,860)	$	(7,239,100)	$	(11,955,226)	$	(14,578,765)

Denominator (weighted average quantities):
Common shares issued		38,064,215		31,669,431		37,724,083		31,089,811
Add: Prefunded warrants		—		1,870,130		—		671,594
Add: Undelivered vested restricted shares		29,611		105,306		29,611		75,177
Denominator for basic and diluted net loss per share		38,093,826		33,644,867		37,753,694		31,836,582

Basic and diluted net loss per common share	$	(0.16)	$	(0.22)	$	(0.32)	$	(0.46)

The following securities are excluded from the calculation of weighted average diluted common shares because their inclusion would have been anti-dilutive:


	June 30,
	2023	2022
Options	5,185,078	4,926,750
Warrants	6,087,845	6,087,845
Convertible notes	2,327,747	—
Restricted stock units	86,205	111,110
Total potentially dilutive shares	13,686,875	11,125,705

Clinical Supply Arrangements

Recently Adopted Accounting Standards

Stockholders' Equity - Additional Information (Details) - USD ($)			3 Months Ended				6 Months Ended
	Jun. 16, 2023	Feb. 28, 2023	Jun. 30, 2023	Mar. 31, 2023	Jun. 30, 2022	Mar. 31, 2022	Jun. 30, 2023	Jun. 30, 2022	Jun. 27, 2023	Dec. 31, 2022
Stockholders' Equity
Common stock, shares authorized			90,000,000				90,000,000			90,000,000
Common Stock, par value			$ 0.0001				$ 0.0001			$ 0.0001
Preferred stock, shares authorized			6,000,000				6,000,000			6,000,000
Preferred stock, par value			$ 0.0001				$ 0.0001			$ 0.0001
Net proceeds (in shares)							1,421,936
Stock-based compensation			$ 493,632		$ 1,036,926		$ 1,312,696	$ 1,945,913
Unrecognized stock - based compensation expense			2,868,023				$ 2,868,023
Weighted average period of recognition							1 year 8 months 12 days
Proceeds from Stock Options Exercised							$ 27,200	18,701
Stock-based compensation			493,632	$ 819,064	1,036,926	$ 908,987
Granted							86,205
Net proceeds							$ 3,900,000
Research and Development Expense.
Stockholders' Equity
Stock-based compensation			36,197		516,669			1,017,850
Stock-based compensation							411,327
General and Administrative Expense
Stockholders' Equity
Stock-based compensation			457,435		$ 520,257		901,369	$ 928,063
Restricted stock units
Stockholders' Equity
Resignation of common stock RSU		3,289
Unrecognized stock - based compensation expense			$ 200,000				$ 200,000
Weighted average period of recognition							1 year
Options
Stockholders' Equity
Weighted average estimated grant date fair value			$ 2.04		$ 1.37		$ 1.78	$ 2.02
Common Stock
Stockholders' Equity
Resignation of common stock RSU			44,444	3,289	54,499	19,359
Cashless exercise of stock options (in shares)			10,000
Common Stock \| Restricted stock units
Stockholders' Equity
Number of shares delivered	44,444
Amended and Restated 2018 Omnibus Stock Incentive Plan
Stockholders' Equity
Number of shares of common stock reserved for further issuance									1,000,000

Notes Payable (Tables)

6 Months Ended

Jun. 30, 2023

Notes Payable

Schedule of notes payable


	June 30, 2023						December 31, 2022
	Notes Payable		Debt Discount		Net		Notes Payable		Debt Discount		Net
Current portion:
D&O insurance policy loan	$	205,451	$	—	$	205,451	$	—	$	—	$	—
Avenue - Note payable		833,333		(91,621)		741,712		208,333		(33,885)		174,448
Avenue - Convertible note payable		—		—		—		208,333		(33,885)		174,448
Total current portion	$	1,038,784	$	(91,621)	$	947,163	$	416,666	$	(67,770)	$	348,896

Non-Current portion:
Avenue - Note payable		9,804,166		(1,120,372)		8,683,794		5,004,167		(813,229)		4,190,938
Avenue - Convertible note payable		5,000,000		(507,270)		4,492,730		5,004,167		(813,229)		4,190,938
Total non-current portion	$	14,804,166	$	(1,627,642)	$	13,176,524	$	10,008,334	$	(1,626,458)	$	8,381,876

Accrued Compensation

6 Months Ended

Jun. 30, 2023

Accrued Compensation

Accrued Compensation

Note 4 – Accrued Compensation

As of June 30, 2023 and December 31, 2022, accrued compensation consisted of the following:


	June 30,		December 31,
	2023		2022
Accrued bonus expenses	$	695,450	$	1,447,643
Accrued payroll expenses		317,668		299,548
Total accrued compensation	$	1,013,118	$	1,747,191

Condensed Statements of Operations - USD ($)	3 Months Ended		6 Months Ended
Condensed Statements of Operations - USD ($)	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Operating Expenses:
Research and development	$ 2,811,061	$ 3,586,866	$ 5,333,011	$ 7,299,450
General and administrative	3,149,809	3,534,590	6,086,695	7,009,555
Total Operating Expenses	5,960,870	7,121,456	11,419,706	14,309,005
Loss From Operations	(5,960,870)	(7,121,456)	(11,419,706)	(14,309,005)
Other Income (Expense):
Other income, net	119,450	33,376	190,443	26,303
Interest expense	(558,003)	(153,436)	(1,012,006)	(298,673)
Interest income	183,563	2,416	286,043	2,610
Net Loss	$ (6,215,860)	$ (7,239,100)	$ (11,955,226)	$ (14,578,765)
Net Loss Per Share
Net Loss Per Share - Basic	$ (0.16)	$ (0.22)	$ (0.32)	$ (0.46)
Net Loss Per Share - Diluted	$ (0.16)	$ (0.22)	$ (0.32)	$ (0.46)
Weighted Average Number of Common Shares Outstanding
Weighted Average Number of Common Shares Outstanding - Basic	38,093,826	33,644,867	37,753,694	31,836,582
Weighted Average Number of Common Shares Outstanding - Diluted	38,093,826	33,644,867	37,753,694	31,836,582

Employee Benefit Plans (Details) - USD ($)	1 Months Ended	3 Months Ended		6 Months Ended
Employee Benefit Plans (Details) - USD ($)	Apr. 30, 2019	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Employee Benefit Plans
Defined contribution plan, employer matching contribution, percent of match	100.00%
Defined contribution plan, employers matching contribution, annual vesting percentage	4.00%
Defined contribution plan, maximum annual contributions per employee, amount		$ 46,196	$ 47,883	$ 125,164	$ 133,982

Commitments and Contingencies (Tables)

6 Months Ended

Jun. 30, 2023

Commitments and Contingencies

Summary of company's right-of-use assets and liabilities


	For the Six Months Ended
	June 30, 2023

Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows used in operating activities	$	284,996

Right-of-use assets obtained in exchange for lease obligations
Operating leases	$	904,437


Weighted Average Remaining Lease Term (Years)
Operating leases		3.5 years

Weighted Average Discount Rate
Operating leases		10.0	%

Schedule of future minimum operating lease payments


For the Year Ending December 31,	Minimum Lease Payments
2023	$	445,025
2024		660,923
2025		675,400
2026		560,996
2027		214,619
Total future minimum lease payments		2,556,963
Less: amount representing imputed interest		(544,996)
Present value of lease liabilities		2,011,967
Less: current portion		(427,749)
Lease liabilities, non current portion	$	1,584,218

Stockholders' Equity - Summary of option activity (Details) - Stock Options - USD ($)	6 Months Ended
	Jun. 30, 2023
Stockholders' Equity
Number of Options, Outstanding \| Shares	5,380,553
Number of Options, Granted \| Shares	677,190
Number of Options, Exercised \| Shares	(88,999)
Number of Options, Forfeited \| Shares	(783,666)
Number of Options, Outstanding \| Shares	5,185,078
Number of Options, Exercisable \| Shares	3,582,370
Weighted Average Exercise Price, Outstanding \| $ / Shares	$ 3.55
Weighted Average Exercise Price, Granted \| $ / Shares	2.39
Weighted Average Exercise Price, Exercised \| $ / Shares	1.83
Weighted Average Exercise Price, Forfeited \| $ / Shares	3.88
Weighted Average Exercise Price, Outstanding \| $ / Shares	3.37
Weighted Average Exercise Price, Exercisable \| $ / Shares	$ 3.69
Remaining Life In Years, Outstanding	7 years 1 month 6 days
Remaining Life In Years, Exercisable	6 years 2 months 12 days
Aggregate Intrinsic Value, Outstanding \| $	$ 962,979
Aggregate Intrinsic Value, Exercisable	$ 501,462

Stockholders' Equity - Summary of information related to stock options (Details)	6 Months Ended
	Jun. 30, 2023 $ / shares shares
Stockholders' Equity
Options Outstanding, Outstanding Number of Options	5,185,078
Options Exercisable, Weighted Average Remaining Life In Years	6 years 2 months 12 days
Options Exercisable, Exercisable Number of Options	3,582,370
Exercise Price $1.00 - $1.99
Stockholders' Equity
Options Outstanding, Outstanding Number of Options	1,407,183
Options Exercisable, Weighted Average Remaining Life In Years	4 years 8 months 12 days
Options Exercisable, Exercisable Number of Options	884,183
Exercise Price $1.00 - $1.99 \| Minimum
Stockholders' Equity
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 1.00
Exercise Price $1.00 - $1.99 \| Maximum
Stockholders' Equity
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 1.99
Exercise Price $2.00 - $2.99
Stockholders' Equity
Options Outstanding, Outstanding Number of Options	1,473,663
Options Exercisable, Weighted Average Remaining Life In Years	6 years 10 months 24 days
Options Exercisable, Exercisable Number of Options	844,473
Exercise Price $2.00 - $2.99 \| Minimum
Stockholders' Equity
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 2.00
Exercise Price $2.00 - $2.99 \| Maximum
Stockholders' Equity
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 2.99
Exercise Price $3.00 - $3.99
Stockholders' Equity
Options Outstanding, Outstanding Number of Options	908,528
Options Exercisable, Weighted Average Remaining Life In Years	6 years 9 months 18 days
Options Exercisable, Exercisable Number of Options	694,510
Exercise Price $3.00 - $3.99 \| Minimum
Stockholders' Equity
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 3.00
Exercise Price $3.00 - $3.99 \| Maximum
Stockholders' Equity
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 3.99
Exercise Price $4.00 - $4.99
Stockholders' Equity
Options Outstanding, Outstanding Number of Options	350,500
Options Exercisable, Weighted Average Remaining Life In Years	8 years 1 month 6 days
Options Exercisable, Exercisable Number of Options	216,178
Exercise Price $4.00 - $4.99 \| Minimum
Stockholders' Equity
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 4.00
Exercise Price $4.00 - $4.99 \| Maximum
Stockholders' Equity
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 4.99
Exercise Price $5.00 - $5.99
Stockholders' Equity
Options Outstanding, Outstanding Number of Options	50,805
Options Exercisable, Weighted Average Remaining Life In Years	4 years 3 months 18 days
Options Exercisable, Exercisable Number of Options	50,638
Exercise Price $5.00 - $5.99 \| Minimum
Stockholders' Equity
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 5.00
Exercise Price $5.00 - $5.99 \| Maximum
Stockholders' Equity
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 5.99
Exercise Price $6.00 - $6.99
Stockholders' Equity
Options Outstanding, Outstanding Number of Options	843,759
Options Exercisable, Weighted Average Remaining Life In Years	6 years 6 months
Options Exercisable, Exercisable Number of Options	741,748
Exercise Price $6.00 - $6.99 \| Minimum
Stockholders' Equity
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 6.00
Exercise Price $6.00 - $6.99 \| Maximum
Stockholders' Equity
Options Outstanding, Outstanding Exercise Price \| $ / shares	6.99
Exercise Price $7.00+
Stockholders' Equity
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 7.00
Options Outstanding, Outstanding Number of Options	150,640
Options Exercisable, Weighted Average Remaining Life In Years	4 years 9 months 18 days
Options Exercisable, Exercisable Number of Options	150,640

Accrued Expenses and Other Current Liabilities (Details) - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Accrued Expenses and Other Current Liabilities
Accrued consulting and professional services	$ 142,915	$ 320,000
Accrued research and development expenses	117,983	35,524
Accrued leasehold improvements	0	92,528
Credit card payable	58,549	50,639
Accrued franchise tax	26,201	0
Accrued travel and entertainment expenses	13,784	0
Other	3,999	4,385
Total accrued expenses and other current liabilities	$ 363,431	$ 503,076

Going Concern and Summary of Significant Accounting Policies - Additional Information (Details) - USD ($)	3 Months Ended				6 Months Ended
	Jun. 30, 2023	Mar. 31, 2023	Jun. 30, 2022	Mar. 31, 2022	Jun. 30, 2023	Jun. 30, 2022	Dec. 31, 2022
Going Concern and Summary of Significant Accounting Policies
Cash and cash equivalents	$ 17,468,088		$ 21,506,582		$ 17,468,088	$ 21,506,582	$ 22,863,520
Net Income (Loss)	(6,215,860)	$ (5,739,366)	$ (7,239,100)	$ (7,339,665)	(11,955,226)	(14,578,765)
Cash used in operations					(11,673,476)	$ (12,883,603)
Treasury bills	4,493,766				4,493,766
Cash, uninsured amount	$ 12,474,323				$ 12,474,323		$ 22,613,520
Clinical Supply Arrangements
Going Concern and Summary of Significant Accounting Policies
Clinical trials, percentage of additional mark-up on cost					10.00%

- Definition

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

+ References

+ Details

Commitments and Contingencies - Company's right-of-use assets and liabilities (Details)	6 Months Ended
	Jun. 30, 2023 USD ($)
Commitments and Contingencies
Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows used in operating activities	$ 284,996
Right-of-use assets obtained in exchange for lease obligations; Operating leases	$ 904,437
Weighted Average Remaining Lease Term (Years): Operating leases	3 years 6 months
Weighted Average Discount Rate: Operating leases	10.00%

Condensed Balance Sheets - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Current Assets
Cash and cash equivalents	$ 17,468,088	$ 22,863,520
Deferred clinical supply costs	3,578,326	2,284,931
License fee and expense reimbursements receivable	429,006	1,183,786
Security deposits, current		119,550
Prepaid expenses and other current assets	1,801,373	1,190,719
Total Current Assets	23,276,793	27,642,506
Property and equipment, net	3,698,421	1,295,115
Security deposits, non-current	198,674	80,874
Operating lease right-of-use asset	1,915,061	1,291,592
Equipment deposits	257,950	726,326
Total Assets	29,346,899	31,036,413
Current Liabilities:
Accounts payable	1,312,749	1,428,283
Accrued compensation	1,013,118	1,747,191
Accrued expenses and other current liabilities	363,431	503,076
Operating lease liabilities - current portion	427,749	484,882
Notes payable - current portion, net of debt discount of $91,621 and $33,885 as of June 30, 2023 and December 31, 2022, respectively	947,163	174,448
Convertible notes payable - current portoin, net of dedt discount of $0 and $33,885 as of June 30, 2023 and December 31, 2022, respectively		174,448
Total Current Liabilities	4,064,210	4,512,328
Operating lease liabilities - non-current portion	1,584,218	907,644
Notes payable - non-current portion, net of debt discount of $1,120,372 and $813,229 as of June 30, 2023 and December 31, 2022, respectively	8,683,794	4,190,938
Convertible notes payable - non-current portion, net of debt discount of $507,270 and $813,229 as of June 30, 2023 and December 31, 2022, respectively	4,492,730	4,190,938
Total Liabilities	18,824,952	13,801,848
Commitments and contingencies
Stockholders' Equity:
Preferred stock, $0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of June 30, 2023 and December 31, 2022
Common stock, $0.0001 par value, 90,000,000 shares authorized; 38,169,398 and 36,668,980 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively	3,817	3,667
Additional paid-in capital	140,703,819	135,461,361
Accumulated deficit	130,185,689	118,230,463
Total Stockholders' Equity	10,521,947	17,234,565
Total Liabilities and Stockholders' Equity	$ 29,346,899	$ 31,036,413

Accrued Expenses and Other Current Liabilities

6 Months Ended

Jun. 30, 2023

Accrued Expenses and Other Current Liabilities

Accrued Expenses and Other Current Liabilities

Note 5 – Accrued Expenses and Other Current Liabilities

As of June 30, 2023 and December 31, 2022, accrued expenses and other current liabilities consisted of the following:


	June 30,		December 31,
	2023		2022
Accrued consulting and professional services	$	142,915	$	320,000
Accrued research and development expenses		117,983		35,524
Accrued leasehold improvements		—		92,528
Credit card payable		58,549		50,639
Accrued franchise tax		26,201		—
Accrued travel and entertainment expenses		13,784		—
Other		3,999		4,385
Total accrued expenses and other current liabilities	$	363,431	$	503,076

Prepaid Expenses and Other Current Assets (Tables)

6 Months Ended

Jun. 30, 2023

Prepaid Expenses and Other Current Assets

Schedule of prepaid expenses and other current assets


	June 30,		December 31,
	2023		2022
Payroll tax receivable	$	645,566	$	660,891
Prepaid insurance expenses		600,607		201,082
Prepaid general and administrative expenses		310,701		87,982
Prepaid research and development expenses		83,192		2,521
Prepaid patent expenses		73,157		38,796
Prepaid conference expenses		69,400		97,743
Prepaid rent and security deposit		18,750		74,959
Other		—		26,745
Total prepaid expenses and other current assets	$	1,801,373	$	1,190,719

Prepaid Expenses and Other Current Assets (Details) - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Prepaid Expenses and Other Current Assets
Payroll tax receivable	$ 645,566	$ 660,891
Prepaid insurance expenses	600,607	201,082
Prepaid general and administrative expenses	310,701	87,982
Prepaid research and development expenses	83,192	2,521
Prepaid patent expenses	73,157	38,796
Prepaid conference expenses	69,400	97,743
Prepaid rent and security deposit	18,750	74,959
Other	0	26,745
Total prepaid expenses and other current assets	$ 1,801,373	$ 1,190,719

Insider Trading Arrangements	6 Months Ended
Insider Trading Arrangements	Jun. 30, 2023
Trading Arrangements, by Individual
Material Terms of Trading Arrangement	Item 5. Other Information. Securities Trading Plans of Directors and Executive Officers During the three months ended June 30, 2023, none of our directors or officers adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement.”
Rule 10b5-1 Arrangement Adopted	false
Non-Rule 10b5-1 Arrangement Adopted	false
Rule 10b5-1 Arrangement Terminated	false
Non-Rule 10b5-1 Arrangement Terminated	false

Commitments and Contingencies

6 Months Ended

Jun. 30, 2023

Commitments and Contingencies

Commitments and Contingencies

Note 7 – Commitments and Contingencies

Operating Leases

In June 2023, the Company entered into an extension agreement to renew its lease for approximately 3,800 square feet of office space in New York, NY. The lease was due to expire on October 31, 2023. The lease was extended from November 1, 2023 to December 31, 2026.

In February 2023, the Company exercised its options to renew its three leases in Redwood City, California, for a total of approximately 6,700 square feet. The leases were due to expire on August 31, 2023. The leases were extended from September 1, 2023 to August 31, 2025.

A summary of the Company’s right-of-use assets and liabilities as follows:


	For the Six Months Ended
	June 30, 2023

Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows used in operating activities	$	284,996

Right-of-use assets obtained in exchange for lease obligations
Operating leases	$	904,437


Weighted Average Remaining Lease Term (Years)
Operating leases		3.5 years

Weighted Average Discount Rate
Operating leases		10.0	%

Future minimum payments under all of the Company’s operating lease agreements are as follows:


For the Year Ending December 31,	Minimum Lease Payments
2023	$	445,025
2024		660,923
2025		675,400
2026		560,996
2027		214,619
Total future minimum lease payments		2,556,963
Less: amount representing imputed interest		(544,996)
Present value of lease liabilities		2,011,967
Less: current portion		(427,749)
Lease liabilities, non current portion	$	1,584,218

Litigations, Claims and Assessments

The Company may be involved in legal proceedings, claims and assessments arising in the ordinary course of business. The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements.

Stockholders' Equity - Restricted stock units activity (Details)	6 Months Ended
	Jun. 30, 2023 $ / shares shares
Number of RSUs
RSUs non-vested at beginning of period \| shares	172,800
Granted \| shares	86,205
Vested \| shares	(150,578)
Forfeited \| shares	(22,222)
RSUs non-vested at end of the period \| shares	86,205
Vested RSUs undelivered \| shares	29,611
Weighted Average Grant Date Value Per Share
RSUs non-vested January 1, 2023 \| $ / shares	$ 1.80
Granted \| $ / shares	2.32
Vested \| $ / shares	1.80
Forfeited \| $ / shares	1.80
RSUs non-vested December 31, 2023 \| $ / shares	2.32
Vested RSUs undelivered September 30, 2023 \| $ / shares	$ 3.68

Business Organization, Nature of Operations and Basis of Presentation

6 Months Ended

Jun. 30, 2023

Business Organization, Nature of Operations and Basis of Presentation

Business Organization, Nature of Operations and Basis of Presentation

Note 1 – Business Organization, Nature of Operations and Basis of Presentation

Eyenovia, Inc. (“Eyenovia” or the “Company”) is an ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs in mydriasis (pupil dilation), presbyopia and pediatric progressive myopia as well as out-licensing for additional indications. The Company’s investigational products are classified by the Food and Drug Administration (“FDA”) as drug-device combination products with drug primary mode of action, meaning that the Center for Drug Evaluation and Research, or CDER, is designated as the lead center with primary jurisdictional oversight. Accordingly, the product candidates are submitted to the FDA and CDER for premarket review and approval under new drug applications, or NDAs.

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the condensed financial statements of the Company as of June 30, 2023 and for the three and six months ended June 30, 2023 and 2022. The results of operations for the six months ended June 30, 2023 are not necessarily indicative of the operating results for the full year ending December 31, 2023 or any other period. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and related disclosures of the Company as of December 31, 2022 and for the year then ended, which were included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 31, 2023, as amended by Amendment No. 1, filed with the SEC on May 1, 2023.

Accrued Compensation (Tables)

6 Months Ended

Jun. 30, 2023

Accrued Compensation

Schedule of accrued compensation


	June 30,		December 31,
	2023		2022
Accrued bonus expenses	$	695,450	$	1,447,643
Accrued payroll expenses		317,668		299,548
Total accrued compensation	$	1,013,118	$	1,747,191

Commitments and Contingencies - Future Minimum Payments under Operating Lease Agreement (Details) - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Minimum Lease Payments
2023	$ 445,025
2024	660,923
2025	675,400
2026	560,996
2027	214,619
Total future minimum lease payments	2,556,963
Less: amount representing imputed interest	(544,996)
Present value of lease liabilities	2,011,967
Less: current portion	(427,749)	$ (484,882)
Lease liabilities, non current portion	$ 1,584,218	$ 907,644

Going Concern and Summary of Significant Accounting Policies (Tables)

6 Months Ended

Jun. 30, 2023

Going Concern and Summary of Significant Accounting Policies

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


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Numerator:
Net loss attributable to common stockholders	$	(6,215,860)	$	(7,239,100)	$	(11,955,226)	$	(14,578,765)

Denominator (weighted average quantities):
Common shares issued		38,064,215		31,669,431		37,724,083		31,089,811
Add: Prefunded warrants		—		1,870,130		—		671,594
Add: Undelivered vested restricted shares		29,611		105,306		29,611		75,177
Denominator for basic and diluted net loss per share		38,093,826		33,644,867		37,753,694		31,836,582

Basic and diluted net loss per common share	$	(0.16)	$	(0.22)	$	(0.32)	$	(0.46)

Schedule of weighted average diluted common shares


	June 30,
	2023	2022
Options	5,185,078	4,926,750
Warrants	6,087,845	6,087,845
Convertible notes	2,327,747	—
Restricted stock units	86,205	111,110
Total potentially dilutive shares	13,686,875	11,125,705

Going Concern and Summary of Significant Accounting Policies - Anti-dilutive weighted average diluted common shares (Details) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Going Concern and Summary of Significant Accounting Policies
Total potentially dilutive shares			13,686,875	11,125,705
Numerator:
Net loss attributable to common stockholders	$ (6,215,860)	$ (7,239,100)	$ (11,955,226)	$ (14,578,765)
Denominator (weighted average quantities):
Common shares issued	38,064,215	31,669,431	37,724,083	31,089,811
Add: Prefunded warrants		1,870,130		671,594
Add: Undelivered vested restricted shares	29,611	105,306	29,611	75,177
Denominator for basic net loss per share	38,093,826	33,644,867	37,753,694	31,836,582
Denominator for diluted net loss per share	38,093,826	33,644,867	37,753,694	31,836,582
Basic net loss per share of common stock	$ (0.16)	$ (0.22)	$ (0.32)	$ (0.46)
Diluted net loss per share of common stock	$ (0.16)	$ (0.22)	$ (0.32)	$ (0.46)
Options
Going Concern and Summary of Significant Accounting Policies
Total potentially dilutive shares			5,185,078	4,926,750
Warrants
Going Concern and Summary of Significant Accounting Policies
Total potentially dilutive shares			6,087,845	6,087,845
Convertible notes
Going Concern and Summary of Significant Accounting Policies
Total potentially dilutive shares			2,327,747	0
Restricted stock units
Going Concern and Summary of Significant Accounting Policies
Total potentially dilutive shares			86,205	111,110

Condensed Statements of Changes in Stockholders' Equity - USD ($)

Common Stock

Additional Paid-In Capital

Accumulated Deficit

Total

Balance at the beginning at Dec. 31, 2021

$ 2,844

$ 110,683,077

$ (90,219,306)

$ 20,466,615

Balance at the beginning (in shares) at Dec. 31, 2021

28,426,616

Issuance of common stock in At the Market offering

^[1]

$ 25

860,340

860,365

Issuance of common stock in At the Market offering (in shares)

^[1]

252,449

Issuance of common stock and warrants in registered direct offering

^[2]

$ 300

14,897,608

14,897,908

Issuance of common stock and warrants in registered direct offering (in shares)

^[2]

3,000,000

Stock-based compensation

908,987

Issuance of common stock related to vested restricted stock units

$ 2

(2)

Issuance of common stock related to vested restricted stock units (in shares)

19,359

Net Income (Loss)

(7,339,665)

Balance at the end at Mar. 31, 2022

$ 3,171

127,350,010

(97,558,971)

29,794,210

Balance at the end (in shares) at Mar. 31, 2022

31,698,424

Balance at the beginning at Dec. 31, 2021

$ 2,844

110,683,077

(90,219,306)

20,466,615

Balance at the beginning (in shares) at Dec. 31, 2021

28,426,616

Net Income (Loss)

(14,578,765)

Balance at the end at Jun. 30, 2022

$ 3,363

128,405,445

(104,798,071)

23,610,737

Balance at the end (in shares) at Jun. 30, 2022

33,623,053

Balance at the beginning at Mar. 31, 2022

$ 3,171

127,350,010

(97,558,971)

29,794,210

Balance at the beginning (in shares) at Mar. 31, 2022

31,698,424

Exercise of stock warrants

$ 187

18,514

18,701

Exercise of stock warrants (in shares)

1,870,130

Stock-based compensation

1,036,926

Issuance of common stock related to vested restricted stock units

$ 5

(5)

Issuance of common stock related to vested restricted stock units (in shares)

54,499

Net Income (Loss)

(7,239,100)

Balance at the end at Jun. 30, 2022

$ 3,363

128,405,445

(104,798,071)

23,610,737

Balance at the end (in shares) at Jun. 30, 2022

33,623,053

Balance at the beginning at Dec. 31, 2022

$ 3,667

135,461,361

(118,230,463)

17,234,565

Balance at the beginning (in shares) at Dec. 31, 2022

36,668,980

Issuance of common stock in At the Market offering

^[3]

$ 130

3,499,462

3,499,592

Issuance of common stock in At the Market offering (in shares)

^[3]

1,299,947

Cashless exercise of stock options

$ 2

(2)

Cashless exercise of stock options (in shares)

19,530

Stock-based compensation

819,064

Issuance of common stock related to vested restricted stock units (in shares)

3,289

Net Income (Loss)

(5,739,366)

Balance at the end at Mar. 31, 2023

$ 3,799

139,779,885

(123,969,829)

15,813,855

Balance at the end (in shares) at Mar. 31, 2023

37,991,746

Balance at the beginning at Dec. 31, 2022

$ 3,667

135,461,361

(118,230,463)

17,234,565

Balance at the beginning (in shares) at Dec. 31, 2022

36,668,980

Net Income (Loss)

(11,955,226)

Balance at the end at Jun. 30, 2023

$ 3,817

140,703,819

(130,185,689)

10,521,947

Balance at the end (in shares) at Jun. 30, 2023

38,169,398

Balance at the beginning at Mar. 31, 2023

$ 3,799

139,779,885

(123,969,829)

15,813,855

Balance at the beginning (in shares) at Mar. 31, 2023

37,991,746

Issuance of common stock in At the Market offering

^[4]

$ 13

403,107

403,120

Issuance of common stock in At the Market offering (in shares)

^[4]

121,989

Cashless exercise of stock options (in shares)

1,219

Exercise of stock options (in shares)

10,000

Exercise of stock options

$ 1

27,199

27,200

Stock-based compensation

493,632

Issuance of common stock related to vested restricted stock units

$ 4

(4)

Issuance of common stock related to vested restricted stock units (in shares)

44,444

Net Income (Loss)

(6,215,860)

Balance at the end at Jun. 30, 2023

$ 3,817

$ 140,703,819

$ (130,185,689)

$ 10,521,947

Balance at the end (in shares) at Jun. 30, 2023

38,169,398

[1]	Includes gross proceeds of $886,974, less total issuance costs of $26,609
[2]	Includes gross proceeds of $14,981,299 less total issuance costs of $83,391
[3]	Includes gross proceeds of $3,607,827 less total issuance costs of $108,235
[4]	Includes gross proceeds of $415,588 less total issuance costs of $12,468

Stockholders' Equity (Tables)

6 Months Ended

Jun. 30, 2023

Stockholders' Equity

Schedule of Restricted Stock Units activity


		Weighted
		Average
	Number of	Grant Date Value
	RSUs	Per Share
RSUs non-vested January 1, 2023	172,800	$	1.80
Granted	86,205		2.32
Vested	(150,578)		1.80
Forfeited	(22,222)		1.80
RSUs non-vested June 30, 2023	86,205	$	2.32

Vested RSUs undelivered June 30, 2023	29,611	$	3.68

Schedule of Black-Scholes option pricing model to stock options granted


	For the Three Months Ended		For the Six Months Ended
	June 30,		June 30,
	2023	2022	2023		2022
Expected term (years)	5.50 - 10.00	5.09 - 5.50		5.50 - 10.00		0.58 - 10.00
Risk free interest rate	3.44% - 4.02%	2.79%		3.44% - 4.18%		0.76% - 2.79%
Expected volatility	82% - 94%	88%		82% - 95%		82% - 90%
Expected dividends	0.00%	0.00%		0.00%		0.00%

Summary of the option activity




		Average		Remaining	Aggregate
	Number of	Exercise		Life	Intrinsic
	Options	Price		In Years	Value
Outstanding, January 1, 2023	5,380,553	$	3.55
Granted	677,190		2.39
Exercised	(88,999)		1.83
Forfeited/ Expired	(783,666)		3.88
Outstanding June 30, 2023	5,185,078	$	3.37	7.1	$	962,979

Exercisable June 30, 2023	3,582,370	$	3.69	6.2	$	501,462

Schedule of information related to stock options

The following table presents information related to stock options as of June 30, 2023:


Options Outstanding			Options Exercisable
			Weighted
		Outstanding	Average	Exercisable
Exercise		Number of	Remaining Life	Number of
Price		Options	In Years	Options
	$1.00 - $1.99	1,407,183	4.7	884,183
	$2.00 - $2.99	1,473,663	6.9	844,473
	$3.00 - $3.99	908,528	6.8	694,510
	$4.00 - $4.99	350,500	8.1	216,178
	$5.00 - $5.99	50,805	4.3	50,638
	$6.00 - $6.99	843,759	6.5	741,748
	$7.00+	150,640	4.8	150,640
		5,185,078	6.2	3,582,370

Document and Entity Information - shares	6 Months Ended
Document and Entity Information - shares	Jun. 30, 2023	Aug. 08, 2023
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Jun. 30, 2023
Document Transition Report	false
Entity File Number	001-38365
Entity Registrant Name	EYENOVIA, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	47-1178401
Entity Address, Postal Zip Code	10017
Entity Address, Address Line One	295 Madison Avenue, Suite 2400
Entity Address, City or Town	NEW YORK
Entity Address, State or Province	NY
City Area Code	833
Local Phone Number	393-6684
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Trading Symbol	EYEN
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		0
Entity Central Index Key	0001682639
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q2
Amendment Flag	false

Condensed Balance Sheets (Parenthetical) - USD ($)	Jun. 30, 2023	Dec. 31, 2022
Condensed Balance Sheets
Notes payable - current portion, net of debt discount	$ 91,621	$ 33,885
Convertible notes payable - current portion, net of debt discount	0	33,885
Notes payable - non-current portion, net of debt discount	1,120,372	813,229
Convertible notes payable - non-current portion, net of debt discount	$ 507,270	$ 813,229
Preferred stock, par value	$ 0.0001	$ 0.0001
Preferred stock, shares authorized	6,000,000	6,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common Stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	90,000,000	90,000,000
Common stock, shares issued	38,169,398	36,668,980
Common stock, shares outstanding	38,169,398	36,668,980

Commitments and Contingencies - Additional Information (Details) - Lease Agreement For Office Located In Redwood City, California [Member] - ft²	1 Months Ended
	Feb. 28, 2023	Jun. 30, 2023
Commitments and Contingencies
Net rentable area	6,700	3,800
Lease expiration date	Aug. 31, 2023

Employee Benefit Plans

6 Months Ended

Jun. 30, 2023

Employee Benefit Plans

Employee Benefit Plans

Note 9 – Employee Benefit Plans

401(k) Plan

In April 2019, the Company adopted the Eyenovia 401(k) Plan (the “Plan”), which went into effect in May 2019. All Company employees are able to participate in the Plan, subject to eligibility requirements as outlined in the Plan documents. Under the terms of the Plan, eligible employees are able to defer a percentage of their pay every pay period up to annual limitations set by Congress and the Internal Revenue Service under Section 401(k) of the Internal Revenue Code. For 2023 and 2022, the Company’s Board of Directors approved a matching contribution equal to 100% of elective deferrals up to 4% of eligible earnings with the matching contribution subject to certain vesting requirements as outlined in the Plan documents. During the three months ended June 30, 2023 and 2022, the Company recorded expense of $46,196 and $47,883 associated with its matching contributions, respectively. During the six months ended June 30, 2023 and 2022, the Company recorded expense of $125,164 and $133,982 associated with its matching contributions, respectively.