0001410578-23-002416 | 10-Q | XBRL Viewer

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

^[1]

$ 25

860,340

860,365

^[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

Issuance of common stock related to vested restricted stock units

908,987

$ 2

(2)

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

19,359

Balance at the end at Mar. 31, 2022

(7,339,665)

$ 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

Balance at the end at Sep. 30, 2022

(21,887,761)

$ 3,553

132,432,682

(112,107,067)

20,329,168

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

35,525,689

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

Issuance of common stock related to vested restricted stock units

1,036,926

$ 5

(5)

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

54,499

Balance at the end at Jun. 30, 2022

(7,239,100)

$ 3,363

128,405,445

(104,798,071)

23,610,737

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

33,623,053

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

^[3]

$ 188

3,098,506

3,098,694

^[3]

1,876,314

Issuance of common stock related to vested restricted stock units

928,733

$ 2

(2)

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

26,322

Balance at the end at Sep. 30, 2022

(7,308,996)

$ 3,553

132,432,682

(112,107,067)

20,329,168

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

35,525,689

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 (in shares)

^[4]

$ 130

3,499,462

3,499,592

^[4]

1,299,947

Cashless exercise of stock options

$ 2

(2)

Cashless exercise of stock options (in shares)

19,530

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

819,064

3,289

Balance at the end at Mar. 31, 2023

(5,739,366)

$ 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

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

1,464,346

$ 1,738,700

Balance at the end at Sep. 30, 2023

(19,293,959)

$ 4,290

153,299,865

(137,524,422)

15,779,733

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

42,898,246

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 (in shares)

^[5]

$ 13

403,107

403,120

^[5]

121,989

Cashless exercise of stock options (in shares)

1,219

Exercise of stock options

$ 1

27,199

27,200

Exercise of stock options (in shares)

10,000

Issuance of common stock related to vested restricted stock units

493,632

$ 4

(4)

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

44,444

Balance at the end at Jun. 30, 2023

(6,215,860)

$ 3,817

140,703,819

(130,185,689)

10,521,947

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

38,169,398

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

^[6]

$ 4

97,432

97,436

^[6]

42,410

Issuance of common stock and warrants in registered direct offering

^[7],[8]

$ 420

10,885,694

10,886,114

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

^[7],[8]

4,198,633

Issuance of common stock as consideration for licensing agreement

^[9]

$ 49

999,951

1,000,000

Issuance of common stock as consideration for licensing agreement (in shares)

^[9]

487,805

612,969

Warrant modification - in issuance costs for registered direct offering

^[10]

1,738,700

^[8]

(1,738,700)

Balance at the end at Sep. 30, 2023

(7,338,733)

$ 4,290

$ 153,299,865

$ (137,524,422)

$ 15,779,733

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

42,898,246

[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 $3,194,530, less total issuance costs of $95,836.
[4]	Includes gross proceeds of $3,607,827 less total issuance costs of $108,235.
[5]	Includes gross proceeds of $415,588 less total issuance costs of $12,468
[6]	Includes gross proceeds of $100,449 less total issuance costs of $3,013.
[7]	Includes gross proceeds of $11,977,468 less total cash issuance costs of $1,091,354.
[8]	Non-cash warrant modification issuance costs related to the registered direct offering of $1,738,700 are shown on a separate line item.
[9]	Shares issued as partial consideration for License Agreement with Formosa Pharmaceuticals Inc.
[10]	Registered direct offering included modification of warrant originally granted in the March 2022 offering.

Prepaid Expenses and Other Current Assets (Details) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Prepaid Expenses and Other Current Assets
Payroll tax receivable	$ 500,684	$ 660,891
Prepaid insurance expenses	375,961	201,082
Prepaid conference expenses	345,334	97,743
Prepaid professional fees	193,750	0
Prepaid research and development expenses	155,767	2,521
Prepaid general and administrative expenses	110,659	87,982
Prepaid patent expenses	59,919	38,796
Prepaid security deposit	18,750	74,959
Other	0	26,745
Total prepaid expenses and other current assets	$ 1,760,824	$ 1,190,719

Commitments and Contingencies - Company's right-of-use assets and liabilities (Details)	9 Months Ended
	Sep. 30, 2023 USD ($)
Commitments and Contingencies
Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows used in operating activities	$ 411,266
Right-of-use assets obtained in exchange for lease obligations; Operating leases	$ 904,437
Weighted Average Remaining Lease Term (Years): Operating leases	3 years 3 months 10 days
Weighted Average Discount Rate: Operating leases	10.00%

Stockholders' Equity - Additional Information (Details) - USD ($)

1 Months Ended

3 Months Ended

9 Months Ended

Aug. 24, 2023

Jun. 16, 2023

Feb. 28, 2023

Mar. 03, 2022

Mar. 31, 2022

Sep. 30, 2023

Jun. 30, 2023

Mar. 31, 2023

Sep. 30, 2022

Jun. 30, 2022

Mar. 31, 2022

Sep. 30, 2023

Sep. 30, 2022

Aug. 31, 2023

Jun. 27, 2023

Dec. 31, 2022

Common stock, shares authorized

90,000,000

Common Stock, par value

$ 0.0001

Preferred stock, shares authorized

6,000,000

Preferred stock, par value

$ 0.0001

Net proceeds (in shares)

1,464,346

Unrecognized stock - based compensation expense

$ 612,969

$ 928,733

$ 1,925,665

$ 2,874,646

2,841,102

$ 2,841,102

Weighted average period of recognition

1 year 9 months 18 days

Proceeds from exercise of stock options

$ 27,200

18,701

612,969

$ 493,632

$ 819,064

928,733

$ 1,036,926

$ 908,987

Granted

86,205

Net proceeds

$ 4,000,000.0

Research and Development Expense

1,738,700

^[1]

1,738,700

General and Administrative Expense

235,731

420,619

647,058

1,438,469

377,238

$ 508,114

1,278,607

$ 1,436,177

Restricted stock units

Resignation of common stock RSU

3,289

Unrecognized stock - based compensation expense

$ 203,055

Weighted average period of recognition

1 year

Warrants

Warrant to purchase common stock in period

5 years

$ 2.23

Options

Weighted average estimated grant date fair value

$ 1.22

$ 1.70

$ 1.61

Common Stock

Resignation of common stock RSU

Net proceeds (in shares)

4,198,633

^[2],[3]

3,000,000

^[4]

44,444

3,289

26,322

54,499

19,359

Cashless exercise of stock options (in shares)

4,838,709

10,000

Common Stock | Restricted stock units

$ 1.86

Number of shares delivered

44,444

Amended and Restated 2018 Omnibus Stock Incentive Plan

Number of shares of common stock reserved for further issuance

1,000,000

Pre-funded warrants

Percentage on gross sale

4.99%

3,000,000

Pre-funded warrants | Warrants

$ 1.85

Pre-funded warrants | Minimum

$ 0.01

Pre-funded warrants | Maximum

2,252,979

Percentage on gross sale

9.99%

4,198,633

Investor warrants

Equity offering august 2023

4,870,130

Equity offering august 2023 | Warrants

Equity issuance costs

$ 1,700,000

Net proceeds

10,900,000

Net proceeds

$ 1,100,000

Warrant modification

Warrant to purchase common stock in period

1,870,130

5 years

$ 3.54

Warrant modification | Minimum

$ 1,738,700

Warrant modification | Maximum

$ 2.23

Warrant Amendment | Minimum

$ 3.54

Warrant Amendment | Maximum

$ 3.54

Accrued Expenses and Other Current Liabilities

$ 2.23

[1]	Registered direct offering included modification of warrant originally granted in the March 2022 offering.
[2]	Includes gross proceeds of $11,977,468 less total cash issuance costs of $1,091,354.
[3]	Non-cash warrant modification issuance costs related to the registered direct offering of $1,738,700 are shown on a separate line item.
[4]	Includes gross proceeds of $14,981,299 less total issuance costs of $83,391

Condensed Statements of Cash Flows (unaudited) (Parenthetical) - USD ($)	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Proceeds of stock issued during period gross	$ 11,977,468	$ 14,981,299
Pre-funded warrants
Proceeds of stock issued during period gross	$ 4,168,011	$ 5,741,299

Employee Benefit Plans

9 Months Ended

Sep. 30, 2023

Employee Benefit Plans

Employee Benefit Plans

Note 10 – 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 September 30, 2023 and 2022, the Company recorded expense of $46,636 and $39,914 associated with its matching contributions, respectively. During the nine months ended September 30, 2023 and 2022, the Company recorded expense of $171,800 and $173,896 associated with its matching contributions, respectively.

Condensed Statements of Operations (unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Operating Income
Revenue	$ 1,198		$ 1,198
Cost of revenue	(1,198)		(1,198)
Operating Expenses:
Research and development	3,578,113	$ 3,876,876	8,911,124	$ 11,176,326
General and administrative	2,942,073	3,353,352	9,028,768	10,362,907
Total Operating Expenses	6,520,186	7,230,228	17,939,892	21,539,233
Loss From Operations	(6,520,186)	(7,230,228)	(17,939,892)	(21,539,233)
Other Income (Expense):
Other (expense) income, net	(348,226)	70,277	(157,783)	96,580
Interest expense	(679,222)	(177,138)	(1,691,228)	(475,811)
Interest income	208,901	28,093	494,944	30,703
Total Other Expense	(818,547)	(78,768)	(1,354,067)	(348,528)
Net Loss	$ (7,338,733)	$ (7,308,996)	$ (19,293,959)	$ (21,887,761)
Net Loss Per Share
Net Loss Per Share - Basic	$ (0.18)	$ (0.21)	$ (0.50)	$ (0.67)
Net Loss Per Share - Diluted	$ (0.18)	$ (0.21)	$ (0.50)	$ (0.67)
Weighted Average Number of Common Shares Outstanding
Shares Outstanding - Basic	40,139,697	34,631,774	38,563,074	32,778,551
Shares Outstanding - Diluted	40,139,697	34,631,774	38,563,074	32,778,551

Accrued Compensation (Details) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Accrued Compensation
Accrued bonus expenses	$ 1,048,249	$ 1,447,643
Accrued payroll expenses	327,583	299,548
Total accrued compensation	$ 1,375,832	$ 1,747,191

Accrued Expenses and Other Current Liabilities

9 Months Ended

Sep. 30, 2023

Accrued Expenses and Other Current Liabilities

Note 6 – Accrued Expenses and Other Current Liabilities

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


	September 30,		December 31,
	2023		2022
Accrued rework of clinical supply returns	$	100,000	$	—
Accrued research and development expenses		45,000		35,524
Credit card payable		53,751		50,639
Accrued consulting and professional services		46,750		320,000
Accrued franchise tax		39,300		—
Accrued leasehold improvements		—		92,528
Accrued travel and entertainment expenses		10,033		—
Other		869		4,385
Total accrued expenses and other current liabilities	$	295,703	$	503,076

Stockholders' Equity

9 Months Ended

Sep. 30, 2023

Accrued Expenses and Other Current Liabilities

Stockholders' Equity

Note 9 – 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, as amended, reserving an additional 1,000,000 shares of common stock for further issuance under such plan.

At-The-Market Offering

During the nine months ended September 30, 2023, the Company received approximately $4.0 million in net proceeds from the sale of 1,464,346 shares of its common stock pursuant to its Sales Agreement with Leerink Partners, formerly known as SVB Securities LLC (“Leerink Partners”) in an ”at-the-market” offering (the “At-the-Market Offering Program”).

Registered Direct Offering

On August 24, 2023, the Company entered into a securities purchase agreement with a certain institutional and accredited investor (the “Purchaser”), pursuant to which the Company agreed to sell, in a registered direct offering by the Company directly to the Purchaser (the “August 2023 Offering”), 4,198,633 shares of common stock, pre-funded warrants to purchase up to 2,252,979 shares of common stock (the “Pre-Funded Warrants”) and warrants to purchase up to 4,838,709 shares of common stock (the “Common Warrants” and, together with the Pre-Funded Warrants, the “Warrants”). The combined offering price for each share of common stock and accompanying Common Warrant was $1.86, and the combined offering price for each Pre-Funded Warrant and accompanying Common Warrant was $1.85.

The Common Warrants will be exercisable beginning six months following the date of issuance and may be exercised for a period of five years from the initial exercisability date at an exercise price of $2.23 per share. The Pre-Funded Warrants were immediately exercisable and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full at an exercise price of $0.01 per share. The exercise prices and numbers of shares of common stock issuable upon exercise of the Common Warrants and the Pre-Funded Warrants are subject to typical anti-dilution provisions. A holder may not exercise any portion of such holder’s Common Warrants or Pre-Funded Warrants to the extent that the holder would own more than 4.99% of the Company’s outstanding common stock immediately after exercise (unless the holder otherwise elects a limitation of 9.99%). The Company determined that the Warrants met the criteria to be classified as equity.

The net cash proceeds of the August 2023 Offering were approximately $10.9 million after deducting cash issuance costs in the aggregate amount of approximately $1.1 million. See Warrant Modification below for details about an additional $1.7 million of non-cash issuance costs. The August 2023 Offering closed on August 29, 2023.

Warrant Modification

Original Warrant Issuance - March 2022

On March 3, 2022, the Company entered into a securities purchase agreement (the “March 2022 Purchase Agreement”) with a holder (the “Holder”) relating to the issuance and sale of 3,000,000 shares of common stock, pre-funded warrants to purchase an aggregate of 1,870,130 shares of common stock and warrants to purchase an aggregate of 4,870,130 shares of common stock (the “March 2022 Investor Warrants”). The March 2022 Investor Warrants became exercisable beginning six months from the date of issuance and initially were exercisable for a period of five years at an exercise price of $3.54 per share.

Warrant Amendment

In connection with the August 2023 Offering (see “Registered Direct Offering” above), the Company entered into a warrant amendment agreement (the “Amendment”) with the Holder, whereby the Company agreed to amend the March 2022 Investor Warrants to (i) reduce the exercise price from $3.54 per share of common stock to $2.23 per share of common stock, (ii) extend the term of the March 2022 Investor Warrants until March 1, 2029, (iii) include a stockholder approval requirement in connection with a modification of the beneficial ownership limitation and (iv) prohibit exercise of the March 2022 Investor Warrants for the six-month period following the effective date of the Amendment.

The Company accounted for the modification of the March 2022 Investor Warrants as an exchange of the old warrants for new warrants. The incremental value of the new warrant (resulting from the decrease in exercise price from $3.54 to $2.23 per share and the extension of the warrant expiration date to March 1, 2029) was measured as the excess of the fair value of the modified warrants over the fair

value of the original warrants immediately before modification. The increase in the incremental value of $1,738,700 was credited to additional paid-in-capital (“APIC”) and debited to APIC as an issuance cost of the August 2023 Offering.

Warrants

A summary of the warrant activity for the nine months ended September 30, 2023 is presented below:


				Weighted
		Weighted		Average
		Average		Remaining
	Number of	Exercise		Life
	Warrants	Price		In Years
Outstanding January 1, 2023	6,087,845	$	3.37
Granted	7,091,688		1.52
Repriced - Old (1)	(4,870,130)		3.54
Repriced - New (1)	4,870,130		2.23
Outstanding September 30, 2023	13,179,533	$	1.89	4.2

Exercisable September 30, 2023	3,470,694	$	0.95	0.7

(1)	Warrants represent the reset of the exercise price of the March 2022 Investor Warrants to purchase 4,870,130 shares of common stock to a price of $2.23 per share.

The following table presents information related to warrants as of September 30, 2023:


Warrants Outstanding		Warants Exercisable
		Weighted
	Outstanding	Average	Exercisable
Exercise	Number of	Remaining Life	Number of
Price	Warrants	In Years	Warrants
$0.0100 (1)	2,252,979	N/A	2,252,979
$2.2300 (2)	9,708,839	—	—
$2.4696	909,451	1.5	909,451
$2.7240	216,380	1.5	216,380
$4.7600	91,884	7.6	91,884
	13,179,533	0.7	3,470,694

(1)These are Pre-Funded Warrants that do not expire.

(2)These warrants are not yet exercisable.

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 September 30, 2023 and 2022, the Company recorded expense of $612,969 ($235,731 of which was included within research and development expenses and $377,238 was included within general and administrative expenses on the statements of operations) and $928,733 ($420,619 of which was included within research and development expenses and $508,114 was included within general and administrative expenses on the statements of operations), respectively. For the nine months ended September 30, 2023 and 2022, the Company recorded expense of $1,925,665 ($647,058 of which was included within research and development expenses and $1,278,607 was included within general and administrative expenses on the statements of operations) and $2,874,646 ($1,438,469 of which was included within research and development expenses and $1,436,177 was included within general and administrative expenses on the statements of operations), respectively.

Restricted Stock Units

A summary of RSU activity during the nine months ended September 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 September 30, 2023	86,205	$	2.32

Vested RSUs undelivered September 30, 2023	135,745	$	2.22

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 September 30, 2023, there was $203,055 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 Nine Months Ended
	September 30,		September 30,
	2023	2022	2023		2022
Expected term (years)	N/A	5.41 - 5.85		5.50 - 10.00		0.58 - 10.00
Risk free interest rate	N/A	2.66% - 3.02%		3.44% - 4.18%		0.76% - 3.35%
Expected volatility	N/A	85% - 87%		82% - 95%		82% - 90%
Expected dividends	N/A	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.

There were no options granted in the three months ended September 30, 2023. The weighted average estimated grant date fair value of the stock options granted for the three months ended September 30, 2022 was approximately $1.22 per share. The weighted average estimated grant date fair value of the stock options granted for the nine months ended September 30, 2023 and 2022 was approximately $1.70 and $1.61 per share respectively.

A summary of the option activity during the nine months ended September 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	797,190		2.29
Exercised	(88,999)		1.83
Forfeited/ Expired	(870,058)		3.86
Outstanding September 30, 2023	5,218,686	$	3.33	7.0	$	59,408

Exercisable September 30, 2023	3,835,305	$	3.62	6.2	$	59,408

The following table presents information related to stock options as of September 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	1,493,849	5.3	1,067,990
	$2.00 - $2.99	1,450,105	6.7	841,000
	$3.00 - $3.99	898,528	6.7	717,140
	$4.00 - $4.99	333,000	7.9	224,429
	$5.00 - $5.99	50,805	4.0	50,638
	$6.00 - $6.99	843,759	6.3	785,468
	$7.00+	148,640	4.5	148,640
		5,218,686	6.2	3,835,305

As of September 30, 2023, there was $2,841,102 of unrecognized stock-based compensation expense related to stock options, which will be recognized over a weighted average period of 1.8 years.

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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+ Details

Going Concern and Summary of Significant Accounting Policies - Inventories (Details)	Sep. 30, 2023 USD ($)
Going Concern and Summary of Significant Accounting Policies
Finished goods	$ 24,506
Raw materials	25,790
Total inventory	$ 50,296

Accrued Expenses and Other Current Liabilities (Tables)

9 Months Ended

Sep. 30, 2023

Schedule of accrued expenses and other current liabilities


	September 30,		December 31,
	2023		2022
Accrued rework of clinical supply returns	$	100,000	$	—
Accrued research and development expenses		45,000		35,524
Credit card payable		53,751		50,639
Accrued consulting and professional services		46,750		320,000
Accrued franchise tax		39,300		—
Accrued leasehold improvements		—		92,528
Accrued travel and entertainment expenses		10,033		—
Other		869		4,385
Total accrued expenses and other current liabilities	$	295,703	$	503,076

Insider Trading Arrangements	9 Months Ended
Insider Trading Arrangements	Sep. 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 September 30, 2023, none of our directors or officers, or the Company, 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) promulgated under the Securities Exchange Act of 1934 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

Stockholders' Equity - Related to warrants (Details) - $ / shares	9 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Stockholders' Equity
Outstanding Number of Warrants	13,179,533	6,087,845
Weighted Average Remaining Life, Exercisable	8 months 12 days
Exercisable Number of Warrants	3,470,694
Warrants at exercise price of $0.0100
Stockholders' Equity
Outstanding Number of Warrants	2,252,979
Exercisable Number of Warrants	2,252,979
Warrants at exercise price of $2.2300
Stockholders' Equity
Outstanding Number of Warrants	9,708,839
Warrants at exercise price of $2.4696
Stockholders' Equity
Exercise price	$ 2.4696
Outstanding Number of Warrants	909,451
Weighted Average Remaining Life, Exercisable	1 year 6 months
Exercisable Number of Warrants	909,451
Warrants at exercise price of $2.7240
Stockholders' Equity
Exercise price	$ 2.7240
Outstanding Number of Warrants	216,380
Weighted Average Remaining Life, Exercisable	1 year 6 months
Exercisable Number of Warrants	216,380
Warrants at exercise price of $4.7600
Stockholders' Equity
Exercise price	$ 4.7600
Outstanding Number of Warrants	91,884
Weighted Average Remaining Life, Exercisable	7 years 7 months 6 days
Exercisable Number of Warrants	91,884

Notes Payable - Schedule of notes payable (Details) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Current portion
Notes Payable, Current portion	$ 3,333,333	$ 416,666
Debt Discount, Current portion	(327,217)	(67,770)
Net, Current portion	3,006,116	348,896
Note payable, Non Current portion	12,304,167	10,008,334
Debt Discount, Non-Current portion	(1,207,839)	(1,626,458)
Net, Non Current portion	11,096,328	8,381,876
Avenue - Note payable
Current portion
Notes Payable, Current portion	3,333,333	208,333
Debt Discount, Current portion	(327,217)	(33,885)
Net, Current portion	3,006,116	174,448
Note payable, Non Current portion	7,304,167	5,004,167
Debt Discount, Non-Current portion	(754,919)	(813,229)
Net, Non Current portion	6,549,248	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	(452,920)	(813,229)
Net, Non Current portion	$ 4,547,080	$ 4,190,938

Pay vs Performance Disclosure - USD ($)	3 Months Ended						9 Months Ended
Pay vs Performance Disclosure - USD ($)	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2023	Sep. 30, 2022
Pay vs Performance Disclosure
Net Income (Loss)	$ (7,338,733)	$ (6,215,860)	$ (5,739,366)	$ (7,308,996)	$ (7,239,100)	$ (7,339,665)	$ (19,293,959)	$ (21,887,761)

- 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 (Tables)

9 Months Ended

Sep. 30, 2023

Notes Payable

Schedule of notes payable


	September 30, 2023						December 31, 2022
	Notes Payable		Debt Discount		Net		Notes Payable		Debt Discount		Net
Current portion:
Avenue - Note payable	$	3,333,333	$	(327,217)	$	3,006,116	$	208,333	$	(33,885)	$	174,448
Avenue - Convertible note payable		—		—		—		208,333		(33,885)		174,448
Total current portion	$	3,333,333	$	(327,217)	$	3,006,116	$	416,666	$	(67,770)	$	348,896

Non-Current portion:
Avenue - Note payable	$	7,304,167	$	(754,919)	$	6,549,248	$	5,004,167	$	(813,229)	$	4,190,938
Avenue - Convertible note payable		5,000,000		(452,920)		4,547,080		5,004,167		(813,229)		4,190,938
Total non-current portion	$	12,304,167	$	(1,207,839)	$	11,096,328	$	10,008,334	$	(1,626,458)	$	8,381,876

Employee Benefit Plans (Details) - USD ($)	1 Months Ended	3 Months Ended		9 Months Ended
Employee Benefit Plans (Details) - USD ($)	Apr. 30, 2019	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 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		$ 46,636	$ 39,914	$ 171,800	$ 173,896

Going Concern and Summary of Significant Accounting Policies - Anti-dilutive weighted average diluted common shares (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Going Concern and Summary of Significant Accounting Policies
Total potentially dilutive shares			18,559,192	11,745,332
Numerator:
Net loss attributable to common stockholders	$ (7,338,733)	$ (7,308,996)	$ (19,293,959)	$ (21,887,761)
Denominator (weighted average quantities):
Common shares issued	39,107,338	34,564,366	38,192,414	32,260,723
Add: Prefunded warrants	926,225		305,349	445,269
Add: Undelivered vested restricted shares	106,134	67,408	65,311	72,559
Shares Outstanding - Basic	40,139,697	34,631,774	38,563,074	32,778,551
Shares Outstanding - Diluted	40,139,697	34,631,774	38,563,074	32,778,551
Basic net loss per share of common stock	$ (0.18)	$ (0.21)	$ (0.50)	$ (0.67)
Diluted net loss per share of common stock	$ (0.18)	$ (0.21)	$ (0.50)	$ (0.67)
Options
Going Concern and Summary of Significant Accounting Policies
Total potentially dilutive shares			5,218,686	5,484,687
Warrants
Going Concern and Summary of Significant Accounting Policies
Total potentially dilutive shares			10,926,554	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	172,800

Property and Equipment, Net - Property and Equipment (Details) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Property and Equipment, Net
Property and equipment, gross	$ 4,672,887	$ 1,930,953
Less: accumulated depreciation and amortization	(1,141,522)	(635,838)
Property and equipment, net	3,531,365	1,295,115
Equipment
Property and Equipment, Net
Property and equipment, gross	3,621,033	1,271,372
Equipment not yet placed in service
Property and Equipment, Net
Property and equipment, gross	4,430	90,411
Leasehold improvements
Property and Equipment, Net
Property and equipment, gross	$ 1,047,424	$ 569,170

Commitments and Contingencies (Tables)

9 Months Ended

Sep. 30, 2023

Commitments and Contingencies

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


	For the Nine Months Ended
	September 30, 2023

Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows used in operating activities	$	411,266

Right-of-use assets and lease liabilities recognized upon lease renewal
Operating leases	$	904,437

Weighted Average Remaining Lease Term (Years)
Operating leases		3.28 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	$	137,838
2024		660,923
2025		675,400
2026		560,996
2027		214,619
Total future minimum lease payments		2,249,776
Less: amount representing imputed interest		(364,079)
Present value of lease liabilities		1,885,697
Less: current portion		(444,616)
Lease liabilities, non current portion	$	1,441,081

Prepaid Expenses and Other Current Assets (Tables)

9 Months Ended

Sep. 30, 2023

Prepaid Expenses and Other Current Assets

Schedule of prepaid expenses and other current assets


	September 30,		December 31,
	2023		2022
Payroll tax receivable	$	500,684	$	660,891
Prepaid insurance expenses		375,961		201,082
Prepaid conference expenses		345,334		97,743
Prepaid professional fees		193,750		—
Prepaid research and development expenses		155,767		2,521
Prepaid general and administrative expenses		110,659		87,982
Prepaid patent expenses		59,919		38,796
Prepaid security deposit		18,750		74,959
Other		—		26,745
Total prepaid expenses and other current assets	$	1,760,824	$	1,190,719

Accrued Compensation (Tables)

9 Months Ended

Sep. 30, 2023

Accrued Compensation

Schedule of accrued compensation


	September 30,		December 31,
	2023		2022
Accrued bonus expenses	$	1,048,249	$	1,447,643
Accrued payroll expenses		327,583		299,548
Total accrued compensation	$	1,375,832	$	1,747,191

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

3 Months Ended

Sep. 30, 2023

Jun. 30, 2023

Mar. 31, 2023

Sep. 30, 2022

Jun. 30, 2022

Mar. 31, 2022

Adjustments to additional paid in capital upon stock issuance costs

^[1]

$ 1,738,700

At Market Offering

Proceeds of stock issued during period gross

100,449

$ 415,588

$ 3,607,827

$ 3,194,530

$ 886,974

Adjustments to additional paid in capital upon stock issuance costs

3,013

$ 12,468

$ 108,235

$ 95,836

$ 26,609

Registered direct offering

Proceeds of stock issued during period gross

11,977,468

$ 14,981,299

Adjustments to additional paid in capital upon stock issuance costs

1,091,354

$ 83,391

Non-cash warrant modification issuance costs

$ 1,738,700

[1]	Non-cash warrant modification issuance costs related to the registered direct offering of $1,738,700 are shown on a separate line item.

Condensed Balance Sheets (Parenthetical) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Condensed Balance Sheets
Notes payable - current portion, net of debt discount	$ 327,217	$ 33,885
Convertible notes payable - current portion, net of debt discount	0	33,885
Notes payable - non-current portion, net of debt discount	754,919	813,229
Convertible notes payable - non-current portion, net of debt discount	$ 452,920	$ 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	42,898,246	36,668,980
Common stock, shares outstanding	42,898,246	36,668,980

Subsequent Events

9 Months Ended

Sep. 30, 2023

Subsequent Events

Subsequent Events

Note 11 - Subsequent Events

Exercise of Pre-Funded Warrants

On November 2, 2023, the Purchaser exercised a portion of its Pre-Funded Warrants in order to purchase 1,223,979 of the Company’s common stock at the exercise price of $0.01 per share. The total proceeds of the transaction were $12,240 (see “Registered Direct Offering” in Note 9 – Stockholders’ Equity).

Notes Payable

9 Months Ended

Sep. 30, 2023

Notes Payable

Notes Payable

Note 7 – Notes Payable

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


	September 30, 2023						December 31, 2022
	Notes Payable		Debt Discount		Net		Notes Payable		Debt Discount		Net
Current portion:
Avenue - Note payable	$	3,333,333	$	(327,217)	$	3,006,116	$	208,333	$	(33,885)	$	174,448
Avenue - Convertible note payable		—		—		—		208,333		(33,885)		174,448
Total current portion	$	3,333,333	$	(327,217)	$	3,006,116	$	416,666	$	(67,770)	$	348,896

Non-Current portion:
Avenue - Note payable	$	7,304,167	$	(754,919)	$	6,549,248	$	5,004,167	$	(813,229)	$	4,190,938
Avenue - Convertible note payable		5,000,000		(452,920)		4,547,080		5,004,167		(813,229)		4,190,938
Total non-current portion	$	12,304,167	$	(1,207,839)	$	11,096,328	$	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 accrued interest at a rate of 7.11% per year and matured on August 24, 2023. The D&O Loan was payable in six monthly payments of $103,639 consisting of principal and interest. During the nine months ended September 30, 2023, the Company fully repaid the $609,140 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 $5,250,000 (which includes a $250,000 final payment, or 5% of the debt funding). 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 September 30, 2023, the Company recorded interest expense of $679,222, of which $677,394 (which includes amortization of debt discount of $184,208) was related to the Loan and Security Agreement with Avenue and $1,828 was related to the D&O Loan. During the nine months ended September 30, 2023, the Company recorded interest expense of $1,691,228, of which $1,678,534 was related to the Loan and Security Agreement (including amortization of debt discount of $497,654) and $12,694 was related to the D&O Loan.

Condensed Balance Sheets - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Current Assets
Cash and cash equivalents	$ 20,702,212	$ 22,863,520
Inventories	50,296
Deferred clinical supply costs	3,622,687	2,284,931
License fee and expense reimbursements receivable	397,014	1,183,786
Security deposits, current		119,550
Prepaid expenses and other current assets	1,760,824	1,190,719
Total Current Assets	26,533,033	27,642,506
Property and equipment, net	3,531,365	1,295,115
Security deposits, non-current	198,674	80,874
Intangible assets	2,122,945
Operating lease right-of-use asset	1,792,667	1,291,592
Equipment deposits	686,753	726,326
Total Assets	34,865,437	31,036,413
Current Liabilities:
Accounts payable	1,426,028	1,428,283
Accrued compensation	1,375,832	1,747,191
Accrued expenses and other current liabilities	295,703	503,076
Operating lease liabilities - current portion	444,616	484,882
Notes payable - current portion, net of debt discount of $327,217 and $33,885 as of September 30, 2023 and December 31, 2022, respectively	3,006,116	174,448
Convertible notes payable - current portion, net of debt discount of $0 and $33,885 as of September 30, 2023 and December 31, 2022, respectively		174,448
Total Current Liabilities	6,548,295	4,512,328
Operating lease liabilities - non-current portion	1,441,081	907,644
Notes payable - non-current portion, net of debt discount of $754,919 and $813,229 as of September 30, 2023 and December 31, 2022, respectively	6,549,248	4,190,938
Convertible notes payable - non-current portion, net of debt discount of $452,920 and $813,229 as of September 30, 2023 and December 31, 2022, respectively	4,547,080	4,190,938
Total Liabilities	19,085,704	13,801,848
Commitments and contingencies (Note 8)
Stockholders' Equity:
Preferred stock, $0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022
Common stock, $0.0001 par value, 90,000,000 shares authorized; 42,898,246 and 36,668,980 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively	4,290	3,667
Additional paid-in capital	153,299,865	135,461,361
Accumulated deficit	137,524,422	118,230,463
Total Stockholders' Equity	15,779,733	17,234,565
Total Liabilities and Stockholders' Equity	$ 34,865,437	$ 31,036,413

Subsequent Events (Details) - USD ($)		9 Months Ended
Subsequent Events (Details) - USD ($)	Nov. 02, 2023	Sep. 30, 2023	Aug. 24, 2023	Mar. 03, 2022
Subsequent Events
Total proceeds		$ 4,000,000.0
Pre-funded warrants
Subsequent Events
Number of warrants issued				3,000,000
Exercise price of warrants			$ 1.85
Subsequent Event \| Pre-funded warrants
Subsequent Events
Number of warrants issued	1,223,979
Total proceeds	$ 12,240
Exercise price of warrants	$ 0.01

Stockholders' Equity - Summary of information related to stock options (Details)	9 Months Ended
	Sep. 30, 2023 $ / shares shares
Stockholders' Equity
Options Outstanding, Outstanding Number of Options	5,218,686
Options Exercisable, Weighted Average Remaining Life In Years	6 years 2 months 12 days
Options Exercisable, Exercisable Number of Options	3,835,305
Exercise Price $1.00 - $1.99
Stockholders' Equity
Options Outstanding, Outstanding Number of Options	1,493,849
Options Exercisable, Weighted Average Remaining Life In Years	5 years 3 months 18 days
Options Exercisable, Exercisable Number of Options	1,067,990
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	1,450,105
Options Exercisable, Weighted Average Remaining Life In Years	6 years 8 months 12 days
Options Exercisable, Exercisable Number of Options	841,000
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	898,528
Options Exercisable, Weighted Average Remaining Life In Years	6 years 8 months 12 days
Options Exercisable, Exercisable Number of Options	717,140
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	333,000
Options Exercisable, Weighted Average Remaining Life In Years	7 years 10 months 24 days
Options Exercisable, Exercisable Number of Options	224,429
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
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 3 months 18 days
Options Exercisable, Exercisable Number of Options	785,468
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	148,640
Options Exercisable, Weighted Average Remaining Life In Years	4 years 6 months
Options Exercisable, Exercisable Number of Options	148,640

Property and Equipment, Net

9 Months Ended

Sep. 30, 2023

Property and Equipment, Net

Property and Equipment, Net

Note 4 - Property and Equipment, Net

As of September 30, 2023 and December 31, 2022, property and equipment consisted of the following:


	September 30,		December 31,
	2023		2022
Equipment	$	3,621,033	$	1,271,372
Equipment not yet placed in service		4,430		90,411
Leasehold improvements		1,047,424		569,170
		4,672,887		1,930,953
Less: accumulated depreciation and amortization		(1,141,522)		(635,838)
Property and equipment, net	$	3,531,365	$	1,295,115

Depreciation expense was $318,417 and $82,997 for the three months ended September 30, 2023 and 2022, respectively, of which $316,673 and $80,212, respectively, was included within research and development expenses and $1,744 and $2,785, respectively, was included in general and administrative expenses in the accompanying statements of operations. Depreciation expense was $505,684 and $228,898 for the nine months ended September 30, 2023 and 2022, respectively, of which $499,535 and $221,031, respectively, was included within research and development expenses and $6,149 and $7,867, respectively, was included in general and administrative expenses in the accompanying statements of operations.

As of September 30, 2023 and December 31, 2022, the Company had $686,753 and $726,326, respectively, of outstanding deposits for equipment purchases.

Business Organization, Nature of Operations and Basis of Presentation

9 Months Ended

Sep. 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 (“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 (“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 September 30, 2023 and for the three and nine months ended September 30, 2023 and 2022. The results of operations for the nine months ended September 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 for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 31, 2023 (the “2022 Form 10-K”), as amended by Amendment No. 1, filed with the SEC on May 1, 2023 (the “2022 Form 10-K Amendment”).

Going Concern and Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 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 Nine Months Ended
	September 30,				September 30,
	2023		2022		2023		2022
Numerator:
Net loss attributable to common stockholders	$	(7,338,733)	$	(7,308,996)	$	(19,293,959)	$	(21,887,761)

Denominator (weighted average quantities):
Common shares issued		39,107,338		34,564,366		38,192,414		32,260,723
Add: Prefunded warrants		926,225		—		305,349		445,269
Add: Undelivered vested restricted shares		106,134		67,408		65,311		72,559
Denominator for basic and diluted net loss per share		40,139,697		34,631,774		38,563,074		32,778,551

Basic and diluted net loss per common share	$	(0.18)	$	(0.21)	$	(0.50)	$	(0.67)

Schedule of weighted average diluted common shares


	September 30,
	2023	2022
Options	5,218,686	5,484,687
Warrants	10,926,554	6,087,845
Convertible notes	2,327,747	—
Restricted stock units	86,205	172,800
Total potentially dilutive shares	18,559,192	11,745,332

Schedule of inventory


	September 30,
	2023
Finished goods	$	24,506
Work-in-process		—
Raw materials		25,790
Total inventory	$	50,296

Stockholders' Equity - Restricted stock units activity (Details)	9 Months Ended
	Sep. 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	135,745
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	$ 2.22

Stockholders' Equity - Black Scholes option (Details)	3 Months Ended	9 Months Ended
Stockholders' Equity - Black Scholes option (Details)	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Stockholders' Equity
Expected dividends	0.00%	0.00%	0.00%
Minimum
Stockholders' Equity
Expected term (years)	5 years 4 months 28 days	5 years 6 months	6 months 29 days
Risk free interest rate	2.66%	3.44%	0.76%
Expected volatility	85.00%	82.00%	82.00%
Maximum
Stockholders' Equity
Expected term (years)	5 years 10 months 6 days	10 years	10 years
Risk free interest rate	3.02%	4.18%	3.35%
Expected volatility	87.00%	95.00%	90.00%

Condensed Statements of Cash Flows (unaudited) - USD ($)

9 Months Ended

Sep. 30, 2023

Sep. 30, 2022

Cash Flows From Operating Activities

Net loss

$ (19,293,959)

$ (21,887,761)

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation of property and equipment

1,925,665

2,874,646

505,684

228,898

Amortization of debt discount

497,654

78,645

Write-off of property and equipment

209,040

Write-down of inventories to net realizable value

12,218

Provision for returned deferred clinical supplies

400,000

Non-cash rent expense

403,362

Changes in operating assets and liabilities:

Prepaid expenses and other current assets

39,035

(66,250)

License fee and expense reimbursements receivables

786,772

995,635

Deferred clinical supply costs

(1,637,756)

(1,871,096)

Inventories

(62,514)

Security and equipment deposits

1,750

(67,614)

Accounts payable

(2,255)

(509,145)

Accrued compensation

(371,359)

(275,609)

Accrued expenses and other current liabilities

(307,373)

539,084

Lease liabilities

(411,266)

50,905

Net Cash Used In Operating Activities

(17,514,342)

(19,700,622)

Cash Flows From Investing Activities

Purchases of property and equipment

(2,702,361)

(509,370)

Vendor deposits for property and equipment

(53,589)

Investment in intangible asset

(1,122,945)

Net Cash Used In Investing Activities

(3,825,306)

(562,959)

Cash Flows From Financing Activities

Proceeds from sale of common stock and warrants in direct offering

^[1],[2]

11,977,468

14,981,299

Payment of offering issuance costs

(1,091,354)

(83,391)

Proceeds from sale of common stock in At the Market offering

4,123,864

4,081,504

Payment of issuance costs for At the Market offering

(123,716)

(122,445)

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

(609,140)

(675,332)

Net Cash Provided By Financing Activities

19,178,340

18,200,336

Net Decrease in Cash and Cash Equivalents

(2,161,308)

(2,063,245)

Cash, cash equivalents and restricted cash - Beginning of Period

22,863,520

27,336,850

Cash, cash equivalents and restricted cash - End of Period

20,702,212

25,273,605

Cash, cash equivalents and restricted cash consisted of the following:

Cash and cash equivalents

20,702,212

17,398,605

Restricted cash

7,875,000

Total

20,702,212

25,273,605

Supplemental Disclosure of Cash Flow Information:

Interest

1,194,132

315,550

Supplemental Disclosure of Non-Cash Investing and Financing Activities

Purchase of insurance policy financed by note payable

609,140

675,332

Right-of-use assets and lease liabilities recognized upon lease renewal

904,437

Vendor deposits applied to purchases of property and equipment

39,573

Original issue discount on notes payable

212,500

Issuance of common stock in consideration of licensing agreement

1,738,700

1,000,000

Cashless exercise of stock options

Issuance of common stock related to vested restricted stock units

$ 4

$ 9

[1]	For 2022, includes gross proceeds of $14,981,299, of which $5,741,299 is pre-funded warrants.
[2]	For 2023, includes gross proceeds of $11,977,468, of which $4,168,011 is pre-funded warrants.

Going Concern and Summary of Significant Accounting Policies - Additional Information (Details) - USD ($)

3 Months Ended

9 Months Ended

Aug. 15, 2023

Sep. 30, 2023

Jun. 30, 2023

Mar. 31, 2023

Sep. 30, 2022

Jun. 30, 2022

Mar. 31, 2022

Sep. 30, 2023

Sep. 30, 2022

Dec. 31, 2022

Going Concern and Summary of Significant Accounting Policies

Cash and cash equivalents

$ 20,702,212

$ 17,398,605

$ 20,702,212

$ 17,398,605

$ 22,863,520