0001410578-24-001425 | 10-Q | XBRL Viewer

Common stock, shares authorized

300,000,000

90,000,000

300,000,000

Common stock, par value

$ 0.0001

Pursuant to the license and certain milestone achievements stock

^[1]

$ 436,809

pursuant to the Letter Agreement stock

^[2]

2,322,391

Net proceeds

$ 4,900,000

Net proceeds (in shares)

4,128,276

Unrecognized stock - based compensation expense

541,056

$ 493,632

$ 1,087,288

$ 1,312,696

$ 2,358,546

Weighted average period of recognition

1 year 9 months 18 days

Weighted average estimated grant date fair value

$ 0.44

$ 2.04

$ 0.84

$ 1.78

Research and Development Expense

General and Administrative Expense

$ 232,154

$ 36,197

$ 438,740

$ 411,327

308,902

$ 457,435

$ 648,548

$ 901,369

Restricted stock units

Weighted average period of recognition

10 months 24 days

Unrecognized stock-based compensation expense

$ 237,405

Registered Direct Offering

Number of shares of common stock

Common stock, par value

$ 0.0001

Net proceeds

$ 1,900,000

3,223,726

Share price

$ 0.6204

Proceeds from issuance of common stock

$ 2,000,000.0

License | Bausch License Agreement

Pursuant to the Letter Agreement shares

2,299,397

pursuant to the Letter Agreement stock

$ 2,300,000

Net proceeds (in shares)

2,299,397

License | Formosa Pharmaceuticals Inc

Pursuant to the license and certain milestone achievements issued

613,496

487,805

Pursuant to the license and certain milestone achievements stock

$ 400,000

[1]	Shares issued as partial consideration for License Agreement with Formosa Pharmaceuticals Inc.
[2]	Shares issued as partial consideration for reversion of License Agreement with Bausch & Lomb Ireland Limited.

Business Organization, Nature of Operations and Basis of Presentation

6 Months Ended

Jun. 30, 2024

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 a commercial-stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics based on its Optejet platform. MicroPine, its leading late-stage candidate for the multi-billion dollar pediatric progressive myopia market has been licensed to Arctic Vision (Hong Kong) Limited (“Arctic Vision”) in China and South Korea. In the United States, Eyenovia is also focused on the commercialization of its two Food and Drug Administration (“FDA”)-approved products: Mydcombi (tropicamide and phenylephrine ophthalmic HCI spray) 1%/2.5% for mydriasis, as well as clobetasol propionate ophthalmic suspension 0.05% to reduce pain and inflammation following ocular surgery.

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, 2024 and for the three and six months ended June 30, 2024 and 2023. The results of operations for the three and six months ended June 30, 2024 are not necessarily indicative of the operating results for the full year ending December 31, 2024 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, 2023 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, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 18, 2024 (the “2023 Form 10-K”), as amended by Amendment No. 1, filed with the SEC on April 26, 2024 (the “2023 Form 10-K Amendment”).

Prepaid Expenses and Other Current Assets (Details) - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Prepaid Expenses and Other Current Assets
Prepaid insurance expenses	$ 568,997	$ 167,338
Payroll tax receivable	305,981	500,684
Prepaid research and development expenses	65,769	421,056
Prepaid conference expenses	36,765	123,556
Prepaid general and administrative expenses	270,401	85,938
Prepaid patent expenses	88,483	48,409
Prepaid rent and security deposit	18,750	18,750
Prepaid professional fees	6,667	0
Prepaid board of directors fees	32,500	0
Total prepaid expenses and other current assets	$ 1,394,313	$ 1,365,731

Accrued Compensation (Tables)

6 Months Ended

Jun. 30, 2024

Accrued Compensation

Schedule of accrued compensation


	June 30,		December 31,
	2024		2023
Accrued bonus expenses	$	808,787	$	1,302,997
Accrued payroll expenses		469,391		355,616
Total accrued compensation	$	1,278,178	$	1,658,613

Accrued Expenses and Other Current Liabilities (Tables)

6 Months Ended

Jun. 30, 2024

Accrued Expenses and Other Current Liabilities

Schedule of accrued expenses and other current liabilities


	June 30,		December 31,
	2024		2023
Accrued intangible asset milestone obligation	$	2,000,000	$	—
Accrued defective clinical supply settlement, net		250,000		100,000
Accrued research and development expenses		455,520		89,872
Accrued professional services		239,201		63,028
Credit card payable		31,967		27,193
Accrued franchise tax		10,000		—
Other		1,440		7,835
Total accrued expenses and other current liabilities	$	2,988,128	$	287,928

Notes Payable and Convertible Notes Payable - Additional Information (Details) - USD ($)		1 Months Ended	3 Months Ended	6 Months Ended
	Feb. 24, 2024	Jun. 30, 2024	Jun. 30, 2024	Jun. 30, 2024	Jun. 30, 2023	Dec. 31, 2023
Notes Payable
Short term notes payable		$ 8,730,043	$ 8,730,043	$ 8,730,043		$ 5,329,419
Repayments of notes payable				1,082,439	$ 403,689
Avenue Ventures Loan
Notes Payable
Initial principal payment related to loan and security agreement		$ 833,333
Loan issuance costs				1,341,462
Interest expense			674,001	1,352,659
Interest expense related to the Loan and Security Agreement with Avenue Capital Management			666,235
D&O insurance policy loan
Notes Payable
Short term notes payable	$ 505,050
Interest rate (as a percent)	8.15%
Number of monthly payments	8 months
Debt Instrument, Periodic Payment	$ 65,076
Repayments of notes payable				249,107
Amortization of debt discount			184,207	368,414
Amortization of debt discount related to loans			$ 7,767	$ 11,197

Stockholders' (Deficiency) Equity - Summary of option activity (Details) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Stockholders' (Deficiency) Equity
Weighted Average Exercise Price, Granted \| $ / Shares	$ 0.44	$ 2.04	$ 0.84	$ 1.78
Stock Options
Stockholders' (Deficiency) Equity
Number of Options, Outstanding \| Shares			5,306,377
Number of Options, Granted \| Shares			1,926,136
Number of Options, Forfeited \| Shares			(633,124)
Number of Options, Outstanding \| Shares	6,599,389		6,599,389
Number of Options, Exercisable \| Shares	4,053,359		4,053,359
Weighted Average Exercise Price, Outstanding \| $ / Shares			$ 3.31
Weighted Average Exercise Price, Granted \| $ / Shares			1.18
Weighted Average Exercise Price, Forfeited \| $ / Shares			3.27
Weighted Average Exercise Price, Outstanding \| $ / Shares	$ 2.91		2.91
Weighted Average Exercise Price, Exercisable \| $ / Shares	$ 3.48		$ 3.48
Weighted Average Remaining Life In Years, Outstanding			7 years 3 months 18 days
Weighted Average Remaining Life In Years, Exercisable			6 years
Aggregate Intrinsic Value, Outstanding	$ 26,325		$ 26,325

Condensed Statements of Cash Flows - USD ($)	6 Months Ended
Condensed Statements of Cash Flows - USD ($)	Jun. 30, 2024	Jun. 30, 2023
Cash Flows From Operating Activities
Net loss	$ (21,975,800)	$ (11,955,226)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation	1,087,288	1,312,696
Change in fair value of equity consideration payable	(1,240,800)
Depreciation of property and equipment	543,124	187,267
Amortization of debt discount	368,414	313,446
Write-off of property and equipment	85,051
Write-down of inventories to net realizable value	665,770	0.0
Reacquisition of license rights	2,864,600
Non-cash rent expense	257,719	280,968
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	417,775	(1,514)
License fee and expense reimbursement receivables	(340)	754,780
Deferred clinical supply costs	377,365	(1,293,395)
Inventories	(140,826)
Security and equipment deposits	1,506	1,750
Accounts payable	(316,508)	(115,534)
Accrued compensation	(380,435)	(734,073)
Accrued expenses and other current liabilities	(470,432)	(139,645)
Lease liabilities	(209,699)	(284,996)
Net Cash Used In Operating Activities	(18,066,228)	(11,673,476)
Cash Flows From Investing Activities
Purchases of property and equipment	(159,853)	(2,122,197)
Net Cash Used In Investing Activities	(159,853)	(2,122,197)
Cash Flows From Financing Activities
Proceeds from sale of common stock and warrants in registered direct offering	2,000,000
Payment of registered direct offering issuance costs	(111,171)
Proceeds from sale of common stock in At the Market offering	5,022,151	4,023,414
Payment of issuance costs for At the Market offering	(150,665)	(120,702)
Proceeds from exercise of stock options		27,200
Proceeds from note payable and equity issued to Avenue		5,000,000
Payment of issuance costs for notes issued to Avenue		(125,982)
Repayments of notes payable	(1,082,439)	(403,689)
Net Cash Provided By Financing Activities	5,677,876	8,400,241
Net Decrease in Cash and Cash Equivalents	(12,548,205)	(5,395,432)
Cash and Cash Equivalents - Beginning of Period	14,849,057	22,863,520
Cash and Cash Equivalents - End of Period	2,300,852	17,468,088
Supplemental Disclosure of Cash Flow Information:
Interest	984,246	699,116
Supplemental Disclosure of Non-Cash Investing and Financing Activities
Purchase of insurance policy financed by note payable	505,050	609,140
Accrual for intangible asset milestone obligation	2,000,000
Reclassification of deferred clinical supply costs to inventories	2,801,518
Right-of-use assets obtained in exchange for lease liabilities		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
Common stock issued in consideration for licensing agreement	436,809
Common stock issued in consideration for reacquisition of licensing agreement	$ 2,322,391
Issuance of common stock related to vested restricted stock units		$ 4

Summary of Significant Accounting Policies - Inventories (Details) - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Summary of Significant Accounting Policies
Finished goods	$ 286,236	$ 30,683
Raw materials	2,765,906	79,115
Total inventory	$ 3,052,142	$ 109,798

Employee Benefit Plans (Details) - USD ($)	1 Months Ended	3 Months Ended		6 Months Ended
Employee Benefit Plans (Details) - USD ($)	Apr. 30, 2019	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
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		$ 61,706	$ 46,196	$ 164,189	$ 125,164
General and Administrative Expense
Employee Benefit Plans
Defined contribution plan, maximum annual contributions per employee, amount		17,831	11,018	68,777	46,988
Research and Development Expense
Employee Benefit Plans
Defined contribution plan, maximum annual contributions per employee, amount		$ 43,875	$ 35,178	$ 95,412	$ 78,176

Commitments and Contingencies - Company's right-of-use assets and liabilities (Details) - USD ($)	6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023
Commitments and Contingencies
Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows used in operating activities	$ 209,699	$ 284,996
Right-of-use assets obtained in exchange for lease obligations: Operating leases		$ 904,437
Weighted Average Remaining Lease Term (Years): Operating leases	2 years 7 months 2 days	3 years 6 months
Weighted Average Discount Rate: Operating leases	10.00%	10.00%

Document and Entity Information - shares	6 Months Ended
Document and Entity Information - shares	Jun. 30, 2024	Aug. 09, 2024
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Jun. 30, 2024
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	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		64,059,440
Entity Central Index Key	0001682639
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q2
Amendment Flag	false

Condensed Statements of Operations - USD ($)	3 Months Ended		6 Months Ended
Condensed Statements of Operations - USD ($)	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Operating Income
Revenue	$ 22,625		$ 27,618
Cost of revenue	(490,361)		(693,388)
Gross Loss	(467,736)		(665,770)
Operating Expenses:
Research and development	4,597,173	$ 2,811,061	9,028,774	$ 5,333,011
General and administrative	3,758,835	3,149,809	7,396,024	6,086,695
Reacquisition of license rights	2,864,600		4,864,600
Total Operating Expenses	11,220,608	5,960,870	21,289,398	11,419,706
Loss From Operations	(11,688,344)	(5,960,870)	(21,955,168)	(11,419,706)
Other Income (Expense):
Other income (expense), net	2,980	119,450	(94,578)	190,443
Change in fair value of equity consideration payable	1,240,800		1,240,800
Interest expense	(674,001)	(558,003)	(1,352,659)	(1,012,006)
Interest income	64,866	183,563	185,805	286,043
Total Other Income (Expense)	634,645	(254,990)	(20,632)	(535,520)
Net Loss	$ (11,053,699)	$ (6,215,860)	$ (21,975,800)	$ (11,955,226)
Net Loss Per Share
Net Loss Per Share - Basic ( in dollars per share)	$ (0.21)	$ (0.16)	$ (0.44)	$ (0.32)
Net Loss Per Share - Diluted ( in dollars per share)	$ (0.21)	$ (0.16)	$ (0.44)	$ (0.32)
Weighted Average Number of Common Shares Outstanding
Shares Outstanding - Basic ( in shares)	53,121,760	38,093,826	49,864,275	37,753,694
Shares Outstanding - Diluted ( in shares)	53,121,760	38,093,826	49,864,275	37,753,694

Prepaid Expenses and Other Current Assets

6 Months Ended

Jun. 30, 2024

Prepaid Expenses and Other Current Assets

Prepaid Expenses and Other Current Assets

Note 3 – Prepaid Expenses and Other Current Assets

As of June 30, 2024 and December 31, 2023, prepaid expenses and other current assets consisted of the following:


	June 30,		December 31,
	2024		2023
Prepaid insurance expenses	$	568,997	$	167,338
Payroll tax receivable		305,981		500,684
Prepaid research and development expenses		65,769		421,056
Prepaid conference expenses		36,765		123,556
Prepaid general and administrative expenses		270,401		85,938
Prepaid patent expenses		88,483		48,409
Prepaid rent and security deposit		18,750		18,750
Prepaid professional fees		6,667		—
Prepaid board of directors fees		32,500		—
Total prepaid expenses and other current assets	$	1,394,313	$	1,365,731

Prepaid Expenses and Other Current Assets (Tables)

6 Months Ended

Jun. 30, 2024

Prepaid Expenses and Other Current Assets

Schedule of prepaid expenses and other current assets


	June 30,		December 31,
	2024		2023
Prepaid insurance expenses	$	568,997	$	167,338
Payroll tax receivable		305,981		500,684
Prepaid research and development expenses		65,769		421,056
Prepaid conference expenses		36,765		123,556
Prepaid general and administrative expenses		270,401		85,938
Prepaid patent expenses		88,483		48,409
Prepaid rent and security deposit		18,750		18,750
Prepaid professional fees		6,667		—
Prepaid board of directors fees		32,500		—
Total prepaid expenses and other current assets	$	1,394,313	$	1,365,731

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

3 Months Ended

6 Months Ended

Jul. 01, 2024

Apr. 08, 2024

Jun. 30, 2024

Mar. 31, 2024

Jun. 30, 2023

Mar. 31, 2023

Jun. 30, 2024

Jun. 30, 2023

Dec. 31, 2023

Cash and cash equivalents

$ 2,300,852

$ 14,849,057

Accumulated deficit

167,467,359

145,491,559

Net Income (Loss)

(11,053,699)

$ (10,922,101)

$ (6,215,860)

$ (5,739,366)

(21,975,800)

$ (11,955,226)

Cash used in operations

(18,066,228)

(11,673,476)

Proceeds from offerings

2,000,000

Treasury bills

5,450,118

Cash, uninsured amount

1,573,044

14,243,870

Deferred clinical supply costs

412,140

4,256,793

Write-down of inventories to net realizable value

500,000

$ 0.0

$ 665,770

$ 0.0

Inventory write down of adjustments

$ 200,000

Inventory to net realizable value

500,000

Issuance of common stock as consideration for licensing agreement

^[1]

436,809

Clinical Supply Arrangements

Clinical trials, percentage of additional mark-up on cost

10.00%

Deferred clinical supply costs

$ 400,000

$ 4,300,000

Registered Direct Offering

Subsequent Events | Registered Direct Offering

Gross proceeds

$ 2,000,000.0

Share price

$ 0.6204

Subsequent Events | At Market Offering

Proceeds from offerings

$ 5,000,000.0

Accrued Expenses and Other Current Liabilities

Gross proceeds

$ 800,000

[1]	Shares issued as partial consideration for License Agreement with Formosa Pharmaceuticals Inc.

Stockholders' (Deficiency) Equity - Black Scholes option (Details)	3 Months Ended		6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Stockholders' (Deficiency) Equity
Expected dividends	0.00%	0.00%	0.00%	0.00%
Minimum
Stockholders' (Deficiency) Equity
Expected term (years)	5 years 6 months	5 years 6 months	5 years 6 months	5 years 6 months
Risk free interest rate	4.32%	3.44%	4.04%	3.44%
Expected volatility	83.00%	82.00%	80.00%	82.00%
Maximum
Stockholders' (Deficiency) Equity
Expected term (years)	5 years 10 months 6 days	10 years	10 years	10 years
Risk free interest rate	4.72%	4.02%	4.72%	4.18%
Expected volatility	86.00%	94.00%	86.00%	95.00%

Accrued Compensation (Details) - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Accrued Compensation
Accrued bonus expenses	$ 808,787	$ 1,302,997
Accrued payroll expenses	469,391	355,616
Total accrued compensation	$ 1,278,178	$ 1,658,613

Commitments and Contingencies - Additional Information (Details) - USD ($)					3 Months Ended	6 Months Ended	12 Months Ended
	May 03, 2024	Apr. 11, 2024	Jan. 22, 2024	Oct. 09, 2020	Jun. 30, 2024	Jun. 30, 2024	Dec. 31, 2023	Apr. 23, 2024
Commitments and Contingencies
Net proceeds (in shares)						4,128,276
Change in fair value of equity consideration payable					$ 1,240,800	$ 1,240,800
Written notice period				90 days
Bausch License Agreement [Member] \| License
Commitments and Contingencies
Net proceeds (in shares)	2,299,397
Common stock value	$ 2,300,000	$ 3,000,000.0
Change in fair value of equity consideration payable						700,000
Current estimated loss								$ 500,000
Current estimated net payable amount								250,000
Receivable upon completion of milestone								250,000
Purchased upon completion of milestone								500,000
Issue of common stock			$ 2,000,000.0
Upfront payment received			$ 3,000,000.0
Defective clinical supply returns
Commitments and Contingencies
Current estimated loss								$ 500,000
Loss recorded					$ 0	$ 100,000	$ 400,000

Accrued Expenses and Other Current Liabilities

6 Months Ended

Jun. 30, 2024

Accrued Expenses and Other Current Liabilities

Note 6 – Accrued Expenses and Other Current Liabilities

As of June 30, 2024 and December 31, 2023, accrued expenses and other current liabilities consisted of the following:


	June 30,		December 31,
	2024		2023
Accrued intangible asset milestone obligation	$	2,000,000	$	—
Accrued defective clinical supply settlement, net		250,000		100,000
Accrued research and development expenses		455,520		89,872
Accrued professional services		239,201		63,028
Credit card payable		31,967		27,193
Accrued franchise tax		10,000		—
Other		1,440		7,835
Total accrued expenses and other current liabilities	$	2,988,128	$	287,928

Condensed Statements of Changes in Stockholders' Equity (Parenthetical) - USD ($)	3 Months Ended
	Jun. 30, 2024	Mar. 31, 2024	Jun. 30, 2023	Mar. 31, 2023
At Market Offering
Proceeds of stock issued during period gross	$ 1,728,804	$ 3,293,347	$ 415,588	$ 3,607,827
Adjustments to additional paid in capital upon stock issuance costs	51,865	$ 98,800	$ 12,468	$ 108,235
Registered direct offering
Proceeds of stock issued during period gross	2,000,000
Adjustments to additional paid in capital upon stock issuance costs	$ 111,171

Accrued Expenses and Other Current Liabilities (Details) - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Accrued Expenses and Other Current Liabilities
Accrued intangible asset milestone obligation	$ 2,000,000
Accrued defective clinical supply settlement, net	250,000	$ 100,000
Accrued research and development expenses	455,520	89,872
Accrued professional services	239,201	63,028
Credit card payable	31,967	27,193
Accrued franchise tax	10,000
Other	1,440	7,835
Total accrued expenses and other current liabilities	$ 2,988,128	$ 287,928

Notes Payable and Convertible Notes Payable (Tables)

6 Months Ended

Jun. 30, 2024

Notes Payable and Convertible Notes Payable

Schedule of notes payable and convertible notes payable


	June 30, 2024						December 31, 2023
	Notes Payable		Debt Discount		Net		Notes Payable		Debt Discount		Net
Current portion:
D&O insurance policy loan	$	255,943	$	—	$	255,943	$	—	$	—	$	—
Avenue - Note payable		9,166,667		(692,567)		8,474,100		5,833,333		(503,914)		5,329,419
Avenue - Convertible note payable		833,333		(18,117)		815,216		—		—		—
Total current portion	$	10,255,943	$	(710,684)	$	9,545,259	$	5,833,333	$	(503,914)	$	5,329,419

Non-Current portion:
Avenue - Note payable	$	637,500	$	—	$	637,500	$	4,804,167	$	(448,367)	$	4,355,800
Avenue - Convertible note payable		4,166,667		(271,752)		3,894,915		5,000,000		(398,569)		4,601,431
Total non-current portion	$	4,804,167	$	(271,752)	$	4,532,415	$	9,804,167	$	(846,936)	$	8,957,231

Summary of Significant Accounting Policies (Tables)

6 Months Ended

Jun. 30, 2024

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

Schedule of inventory


	June 30,		December 31,
	2024		2023
Finished goods	$	286,236	$	30,683
Raw materials		2,765,906		79,115
Total inventory	$	3,052,142	$	109,798


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2024		2023		2024		2023
Numerator:
Net loss attributable to common stockholders	$	(11,053,699)	$	(6,215,860)	$	(21,975,800)	$	(11,955,226)

Denominator (weighted average quantities):
Common shares issued		52,965,044		38,064,215		49,718,045		37,724,083
Add: Undelivered vested restricted shares		156,716		29,611		146,230		29,611
Denominator for basic and diluted net loss per share		53,121,760		38,093,826		49,864,275		37,753,694

Basic and diluted net loss per common share	$	(0.21)	$	(0.16)	$	(0.44)	$	(0.32)

Schedule of weighted average diluted shares of common stock


	June 30,
	2024	2023
Warrants	10,926,554	5,185,078
Options	6,599,389	6,087,845
Convertible notes	2,327,747	2,327,747
Restricted stock units	368,886	86,205
Total potentially dilutive shares	20,222,576	13,686,875

Pay vs Performance Disclosure - USD ($)	3 Months Ended				6 Months Ended
Pay vs Performance Disclosure - USD ($)	Jun. 30, 2024	Mar. 31, 2024	Jun. 30, 2023	Mar. 31, 2023	Jun. 30, 2024	Jun. 30, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (11,053,699)	$ (10,922,101)	$ (6,215,860)	$ (5,739,366)	$ (21,975,800)	$ (11,955,226)

- Definition

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

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-6

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 9
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-9

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 805
-SubTopic 60
-Name Accounting Standards Codification
-Section 65
-Paragraph 1
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147476176/805-60-65-1

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 323
-Name Accounting Standards Codification
-Section 65
-Paragraph 2
-Subparagraph (g)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478666/740-323-65-2

Reference 5: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 2
-Subparagraph (SX 210.5-03(20))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483621/220-10-S99-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(g)(1)(ii))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480678/235-10-S99-1

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 323
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147481687/323-10-50-3

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 825
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 28
-Subparagraph (f)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482907/825-10-50-28

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482765/220-10-50-6

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 3
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-3

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (b)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-1

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 815
-SubTopic 40
-Name Accounting Standards Codification
-Section 65
-Paragraph 1
-Subparagraph (f)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480175/815-40-65-1

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 8
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-8

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 11
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-11

Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 11
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-11

Reference 16: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 4
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483443/250-10-50-4

Reference 17: http://www.xbrl.org/2003/role/exampleRef
-Topic 946
-SubTopic 830
-Name Accounting Standards Codification
-Section 55
-Paragraph 10
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479168/946-830-55-10

Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 220
-Name Accounting Standards Codification
-Section 45
-Paragraph 7
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479105/946-220-45-7

Reference 19: http://www.xbrl.org/2003/role/disclosureRef
-Topic 944
-SubTopic 220
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.7-04(18))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147477250/944-220-S99-1

Reference 20: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 220
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.6-07(9))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479134/946-220-S99-1

Reference 21: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 220
-Name Accounting Standards Codification
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-Paragraph 3
-Subparagraph (SX 210.6-09(1)(d))
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-URI https://asc.fasb.org/1943274/2147479134/946-220-S99-3

Reference 22: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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Reference 23: http://www.xbrl.org/2009/role/commonPracticeRef
-Topic 470
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Reference 24: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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Reference 25: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1A
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Reference 26: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1A
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Reference 27: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1B
-Subparagraph (SX 210.13-02(a)(4)(i))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480097/470-10-S99-1B

Reference 28: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1B
-Subparagraph (SX 210.13-02(a)(4)(iii)(A))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480097/470-10-S99-1B

Reference 29: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1B
-Subparagraph (SX 210.13-02(a)(4)(iii)(B))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480097/470-10-S99-1B

Reference 30: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1B
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Reference 31: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org/1943274/2147480097/470-10-S99-1B

Reference 32: http://www.xbrl.org/2003/role/disclosureRef
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-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 60B
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482689/260-10-45-60B

Reference 33: http://www.xbrl.org/2003/role/disclosureRef
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-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 7
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483499/205-20-50-7

Reference 34: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 230
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 28
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482740/230-10-45-28

Reference 35: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 1A
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482790/220-10-45-1A

Reference 36: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 1B
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482790/220-10-45-1B

Reference 37: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 942
-SubTopic 220
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-04(22))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478524/942-220-S99-1

+ Details

Intangible Assets

6 Months Ended

Jun. 30, 2024

Intangible Assets.

Intangible Assets

Note 4 - Intangible Assets

On August 15, 2023 (the “Effective Date”), the Company entered into a license agreement (the “License”) with Formosa Pharmaceuticals Inc. (“Formosa”), whereby the Company acquired the exclusive U.S. rights to commercialize any product related to a novel formulation of clobetasol propionate ophthalmic suspension, 0.05% (the “Licensed Product”), which was approved by the FDA for ophthalmic use for inflammation and pain after ocular surgery and supplemental disease indications, if any, associated with the New Drug Application for the Licensed Product. The License will remain in effect for ten years from the date of the first commercial sale of a Licensed Product, unless earlier terminated. The Company paid Formosa the aggregate amount of $2.0 million (the “Upfront Payment”), consisting of (a) cash in the amount of $1.0 million and (b) 487,805 shares of common stock, which is included in Intangible Assets on the accompanying balance sheet. The Company also capitalized $122,945 of transaction costs, which were primarily legal expenses. In addition to the Upfront Payment, the Company must pay Formosa up to $4.0 million upon the achievement of certain development milestones and up to $80.0 million upon the achievement of certain sales milestones. The trigger for the initial $2.0 million development milestone payments was FDA approval of the Licensed Product and the effective date of the acceptance by the Company of the transfer and assignment of the FDA approval. This occurred on March 14, 2024. Under the provisions of the License, the Company had 45 days from the effective date of acceptance of the transfer and assignment of FDA approval to make the payment half in cash and half in common stock, otherwise the payment due would revert to be fully in cash. The Company paid Formosa the aggregate amount of $2.0 million, consisting of (a) cash in the amount of $1.0 million on April 26, 2024 and (b) 613,496 shares of common stock on April 29, 2024 (calculated pursuant to the License using a five-day volume-weighted average price on March 14, 2024, but valued at $0.4 million on the April 29, 2024 settlement date, resulting in a $0.6 million change in fair value of the equity consideration payable), which is included in Intangible Assets on the accompanying balance sheet as of June 30, 2024. The second $2.0 million development milestone (to be fully paid in cash) was earned upon FDA approval of the Licensed Product and payment was triggered on the earlier of twelve months after FDA approval or six months following the first commercial sale of the Licensed Product. Because the payment became probable and estimable, the Company recorded an additional $2.0 million increase in the intangible asset and the related accrual on March 14, 2024.

Commitments and Contingencies (Tables)

6 Months Ended

Jun. 30, 2024

Commitments and Contingencies

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


	For the Six Months Ended June 30,
	2024			2023
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows used in operating activities	$	209,699		$	284,996

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

Weighted Average Remaining Lease Term (Years)
Operating leases		2.59	years		3.50	years

Weighted Average Discount Rate
Operating leases		10.0	%		10.0	%

Schedule of future minimum payments under the company's operating lease agreements


For the Years Ending December 31,	Minimum Lease Payments
2024	$	364,928
2025		675,400
2026		560,996
2027		214,618
Total future minimum lease payments		1,815,942
Less: Imputed interest		(231,724)
Present value of lease liabilities		1,584,218
Less: current portion		(600,379)
Lease liabilities, non-current portion	$	983,839

Stockholders' (Deficiency) Equity (Tables)

6 Months Ended

Jun. 30, 2024

Summary of restricted stock units ("RSUs") activity


		Weighted
		Average
	Number of	Exercise
	RSUs	Price
RSUs non-vested January 1, 2024	106,019	$	2.12
Granted	368,886		0.65
Vested	(106,019)		2.12
Forfeited	—		—
RSUs non-vested June 30, 2024	368,886	$	0.65

Vested RSUs undelivered June 30, 2024	241,764	$	2.17

Summary of the option activity


				Weighted
		Weighted		Average
		Average		Remaining	Aggregate
	Number of	Exercise		Life	Intrinsic
	Options	Price		In Years	Value
Outstanding, January 1, 2024	5,306,377	$	3.31
Granted	1,926,136		1.18
Exercised	—		—
Forfeited	(633,124)		3.27
Outstanding, June 30, 2024	6,599,389	$	2.91	7.3	$	26,325

Exercisable, June 30, 2024	4,053,359	$	3.48	6.0	$	—

Schedule of information related to stock options

The following table presents information related to stock options as of June 30, 2024:


Options Outstanding		Options Exercisable
		Weighted
		Average
Exercise	Number of	Remaining Life	Number of
Price	Options	In Years	Options
$0.01 - $0.99	1,053,136	—	—
$1.00 - $1.99	2,263,037	5.6	1,145,297
$2.00 - $2.99	1,279,099	6.8	1,014,401
$3.00 - $3.99	819,018	6.1	733,022
$4.00 - $4.99	303,027	7.2	278,567
$5.00 - $5.99	35,805	2.9	35,805
$6.00 - $6.99	695,627	5.5	695,627
$7.00+	150,640	3.8	150,640
	6,599,389	6.0	4,053,359

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,
	2024	2023	2024		2023
Expected term (years)	5.50 - 5.85	5.50 - 10.00		5.50 - 10.00		5.50 - 10.00
Risk free interest rate	4.32% - 4.72%	3.44% - 4.02%		4.04% - 4.72%		3.44% - 4.18%
Expected volatility	83% - 86%	82% - 94%		80% - 86%		82% - 95%
Expected dividends	0.00%	0.00%		0.00%		0.00%

Condensed Balance Sheets (Parenthetical) - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Condensed Balance Sheets
Notes payable - current portion, net of debt discount	$ 692,567	$ 503,914
Convertible notes payable - current portion, net of debt discount	18,117	0
Notes payable - non-current portion, net of debt discount	0	448,367
Convertible notes payable - non-current portion, net of debt discount	$ 271,752	$ 398,569
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	300,000,000	300,000,000
Common stock, shares issued	55,817,921	45,553,026
Common stock, shares outstanding	55,817,921	45,553,026

Stockholders' (Deficiency) Equity - Restricted stock units activity (Details)	6 Months Ended
	Jun. 30, 2024 $ / shares shares
Number of RSUs
RSUs non-vested January 1, 2024 \| shares	106,019
Granted \| shares	368,886
Vested \| shares	(106,019)
RSUs non-vested June 30, 2024 \| shares	368,886
Vested RSUs undelivered June 30, 2024 \| shares	241,764
Weighted Average Grant Date Value Per Share
RSUs non-vested January 1, 2024 \| $ / shares	$ 2.12
Granted \| $ / shares	0.65
Vested \| $ / shares	2.12
RSUs non-vested June 30, 2024 \| $ / shares	0.65
Vested RSUs undelivered June 30, 2024 \| $ / shares	$ 2.17

Subsequent Events (Details) - USD ($)				6 Months Ended
Subsequent Events (Details) - USD ($)	Jul. 01, 2024	Jun. 30, 2024	Apr. 08, 2024	Jun. 30, 2024
Subsequent Events
Net proceeds (in shares)				4,128,276
Proceeds from sale of common stock and warrants in registered direct offering				$ 2,000,000
Registered Direct Offering
Subsequent Events
Gross proceeds			$ 2,000,000.0
Registered Direct Offering \| Prior Warrants
Subsequent Events
Exercise price of warrants		$ 2.23		$ 2.23
Exercise price 2		$ 2.21
Subsequent Events \| Registered Direct Offering
Subsequent Events
Proceeds from sale of common stock and warrants in registered direct offering	$ 5,000,000.0
Payment of issuance costs in registered direct offering	$ 700,000
Subsequent Events \| Registered Direct Offering \| Investor warrants
Subsequent Events
Net proceeds (in shares)	7,575,757
Shares Issued, Price Per Share	$ 0.66
Subsequent Events \| Registered Direct Offering \| Investor warrants \| Maximum
Subsequent Events
Common stock issued from exercise of warrants	7,575,757
Subsequent Events \| Registered Direct Offering \| Prior Warrants
Subsequent Events
Exercise price of warrants	$ 0.69
Subsequent Events \| Registered Direct Offering \| Prior Warrants \| Maximum
Subsequent Events
Common stock issued from exercise of warrants	10,386,269
Subsequent Events \| Registered Direct Offering \| New warrants
Subsequent Events
Common stock issued from exercise of warrants	1,749,780
Exercise price of warrants	$ 0.69
Warrants exercisable term	6 months
Subsequent Events \| At Market Offering
Subsequent Events
Net proceeds (in shares)	665,762
Gross proceeds	$ 800,000

Summary of Significant Accounting Policies - Net loss per share of common stock (Details) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Numerator:
Net loss attributable to common stockholders	$ (11,053,699)	$ (6,215,860)	$ (21,975,800)	$ (11,955,226)
Denominator (weighted average quantities):
Common shares issued	52,965,044	38,064,215	49,718,045	37,724,083
Add: Undelivered vested restricted shares	156,716	29,611	146,230	29,611
Denominator for basic net loss per share (in shares)	53,121,760	38,093,826	49,864,275	37,753,694
Denominator for diluted net loss per share (in shares)	53,121,760	38,093,826	49,864,275	37,753,694
Basic net loss per common share (in dollars per share)	$ (0.21)	$ (0.16)	$ (0.44)	$ (0.32)
Diluted net loss per common share (in dollars per share)	$ (0.21)	$ (0.16)	$ (0.44)	$ (0.32)
Total potentially dilutive shares			20,222,576	13,686,875
Warrants
Denominator (weighted average quantities):
Total potentially dilutive shares			10,926,554	5,185,078
Options
Denominator (weighted average quantities):
Total potentially dilutive shares			6,599,389	6,087,845
Convertible notes
Denominator (weighted average quantities):
Total potentially dilutive shares			2,327,747	2,327,747
Restricted stock units
Denominator (weighted average quantities):
Total potentially dilutive shares			368,886	86,205

Notes Payable and Convertible Notes Payable - Schedule of notes payable (Details) - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Current portion
Notes Payable, Current portion	$ 10,255,943	$ 5,833,333
Debt Discount, Current portion	(710,684)	(503,914)
Net, Current portion	9,545,259	5,329,419
Note payable, Non Current portion	4,804,167	9,804,167
Debt Discount, Non-Current portion	(271,752)	(846,936)
Net, Non Current portion	4,532,415	8,957,231
D&O insurance policy loan
Current portion
Notes Payables	255,943	0
Notes Payable, Net Of Debt Discount, Total	255,943	0
Debt Instrument, Unamortized Discount	0	0
Avenue - Note payable
Current portion
Notes Payable, Current portion	9,166,667	5,833,333
Debt Discount, Current portion	(692,567)	(503,914)
Net, Current portion	8,474,100	5,329,419
Note payable, Non Current portion	637,500	4,804,167
Debt Discount, Non-Current portion	0	(448,367)
Net, Non Current portion	637,500	4,355,800
Avenue - Convertible note payable
Current portion
Notes Payable, Current portion	833,333	0
Debt Discount, Current portion	(18,117)	0
Net, Current portion	815,216	0
Note payable, Non Current portion	4,166,667	5,000,000
Debt Discount, Non-Current portion	(271,752)	(398,569)
Net, Non Current portion	$ 3,894,915	$ 4,601,431

Summary of Significant Accounting Policies

6 Months Ended

Jun. 30, 2024

Summary of Significant Accounting Policies

Note 2 – Summary of Significant Accounting Policies

The Company disclosed its significant accounting policies in Note 2 – Summary of Significant Accounting Policies included in the 2023 Form 10-K. There have been no material changes to the Company’s significant accounting policies during the six months ended June 30, 2024, except as disclosed below.

Liquidity and Going Concern

As of June 30, 2024, the Company had unrestricted cash and cash equivalents of approximately $2.3 million and an accumulated deficit of approximately $167.5 million. For the six months ended June 30, 2024 and 2023, the Company incurred net losses of approximately $22.0 million and $12.0 million, respectively, and used cash in operations of approximately $18.1 million and $11.7 million, respectively. The Company does not have recurring revenue and has not yet achieved profitability. The Company expects to continue to incur cash outflows from operations for the near future. The Company expects that its research and development and general and administrative expenses will continue to increase and, as a result, it 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 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. Additionally, the Company will need to raise further capital, through the sale of additional equity or debt securities. On July 1, 2024, the Company raised $5.0 million of gross proceeds from a registered direct offering of equity securities. Also, subsequent to June 30, 2024, the Company raised $0.8 million of gross proceeds from its ongoing “at-the-market” offering. See Note 11 – Subsequent Events for additional details. If the Company is unable to generate sufficient recurring revenues or secure additional capital, it may be required to curtail its research and development initiatives and take additional measures to reduce costs in order to conserve its cash.

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, 2024 and December 31, 2023, the Company had Treasury bills with original maturity dates of three months or less in the amounts of $0 and $5,450,118, respectively.

The Company has cash deposits in financial institutions 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, 2024 and December 31, 2023, the Company had cash and cash equivalent balances in excess of FDIC insurance limits of $1,573,044 and $14,243,870, respectively.

Clinical Supply Arrangements

Bausch + Lomb Ireland Limited (“Bausch + Lomb”) and Arctic Vision had 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. Pursuant to the Letter Agreement (as defined below) with Bausch + Lomb, as referenced in Note 8 – Commitments and Contingencies – Bausch License Agreements, the arrangement with Bausch + Lomb has been terminated, and all rights have been repurchased by Eyenovia. The arrangement with Arctic Vision is still in place. The Company’s licensing agreement with Arctic Vision represents a collaborative arrangement and Arctic Vision is 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) report the net income from the clinical supply arrangements as other income. Deferred clinical supply costs were $0.4 million and $4.3 million at June 30, 2024 and December 31, 2023, respectively. See Note 8 – Commitments and Contingencies –Defective Clinical Supply for additional information.

Inventories

Inventories are stated at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method. The cost of inventory that is sold to third parties is included within cost of sales. The Company will periodically review for slow-moving, excess or obsolete inventories.

Inventory is primarily comprised of drug-device combination products, which are available for commercial sale, as follows:


	June 30,		December 31,
	2024		2023
Finished goods	$	286,236	$	30,683
Raw materials		2,765,906		79,115
Total inventory	$	3,052,142	$	109,798

The Company has evaluated the net realizable value of the commercial inventory. The write-down of commercial inventory to net realizable value for the three months ended June 30, 2024 and 2023 was $0.5 million and $0.0 million, respectively. The write-down of commercial inventory for the six months ended June 30, 2024 and 2023 was $0.7 million and $0.0 million, respectively, which consisted of $0.2 million of inventory write down of adjustments to list price for the first quarter of 2024 and $0.5 million for the write-down of short dated inventory to net realizable value for the second quarter of 2024. The Company recorded the write-downs to cost of revenue as it relates to goods that were part of commercial inventory during 2024.

Net Loss Per Share of Common Stock

Basic net loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period, plus fully vested shares that are subject to issuance for little or no monetary consideration. Diluted loss 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,
	2024		2023		2024		2023
Numerator:
Net loss attributable to common stockholders	$	(11,053,699)	$	(6,215,860)	$	(21,975,800)	$	(11,955,226)

Denominator (weighted average quantities):
Common shares issued		52,965,044		38,064,215		49,718,045		37,724,083
Add: Undelivered vested restricted shares		156,716		29,611		146,230		29,611
Denominator for basic and diluted net loss per share		53,121,760		38,093,826		49,864,275		37,753,694

Basic and diluted net loss per common share	$	(0.21)	$	(0.16)	$	(0.44)	$	(0.32)

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


	June 30,
	2024	2023
Warrants	10,926,554	5,185,078
Options	6,599,389	6,087,845
Convertible notes	2,327,747	2,327,747
Restricted stock units	368,886	86,205
Total potentially dilutive shares	20,222,576	13,686,875

Subsequent Events

The Company has evaluated subsequent events through the date which the financial statements were issued. Based upon the evaluation, the Company did not identify any recognized or non-recognized subsequent events that would have required adjustment or disclosure in the financial statements, except as disclosed.

Recently Issued Accounting Standards

In November 2023, the FASB issued ASU 2023-07, Improvements to Reportable Segments Disclosures (Topic 280), which updates reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses on both an annual and interim basis. The guidance becomes effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. Since this new ASU addresses only disclosures, the Company does not expect the adoption of this ASU to have any material effects on its financial condition, results of operations or cash flows. The Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2023-07.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The amendments in this update address investor requests for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. This update also includes certain other amendments to improve the effectiveness of income tax disclosures. The amendments in ASU 2023-09 are effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of this standard, but does not expect it to have a material impact on its financial statements.

Insider Trading Arrangements	3 Months Ended
Insider Trading Arrangements	Jun. 30, 2024	Mar. 31, 2024
Trading Arrangements, by Individual
Rule 10b5-1 Arrangement Adopted	false	false
Non-Rule 10b5-1 Arrangement Adopted	false	false
Rule 10b5-1 Arrangement Terminated	false	false
Non-Rule 10b5-1 Arrangement Terminated	false	false

Summary of Significant Accounting Policies (Policies)

6 Months Ended

Jun. 30, 2024

Liquidity and Going Concern

Cash and Cash Equivalents

Clinical Supply Arrangements

Inventories

Inventory is primarily comprised of drug-device combination products, which are available for commercial sale, as follows:


	June 30,		December 31,
	2024		2023
Finished goods	$	286,236	$	30,683
Raw materials		2,765,906		79,115
Total inventory	$	3,052,142	$	109,798

Net Loss Per Share of Common Stock


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2024		2023		2024		2023
Numerator:
Net loss attributable to common stockholders	$	(11,053,699)	$	(6,215,860)	$	(21,975,800)	$	(11,955,226)

Denominator (weighted average quantities):
Common shares issued		52,965,044		38,064,215		49,718,045		37,724,083
Add: Undelivered vested restricted shares		156,716		29,611		146,230		29,611
Denominator for basic and diluted net loss per share		53,121,760		38,093,826		49,864,275		37,753,694

Basic and diluted net loss per common share	$	(0.21)	$	(0.16)	$	(0.44)	$	(0.32)

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


	June 30,
	2024	2023
Warrants	10,926,554	5,185,078
Options	6,599,389	6,087,845
Convertible notes	2,327,747	2,327,747
Restricted stock units	368,886	86,205
Total potentially dilutive shares	20,222,576	13,686,875

Subsequent Events

Recently Issued Accounting Standards

- Definition

Disclosure of inventory accounting policy for inventory classes, including, but not limited to, basis for determining inventory amounts, methods by which amounts are added and removed from inventory classes, loss recognition on impairment of inventories, and situations in which inventories are stated above cost.

+ References + Details

Stockholders' (Deficiency) Equity

6 Months Ended

Jun. 30, 2024

Stockholders' (Deficiency) Equity

Note 9 – Stockholders’ (Deficiency) Equity

Increase in Authorized Number of Shares of Common Stock

On June 12, 2024, at the Annual Shareholders’ Meeting, the Company proposed and the shareholders approved an increase in authorized number of shares of common stock from 90,000,000 to 300,000,000 at the same par value of $0.0001 per share.

Common Stock Issuances

Pursuant to the License and certain milestone achievements, the Company issued 613,496 shares of common stock valued at $0.4 million on April 29, 2024 to Formosa (see Note 4 – Intangible Assets).

On May 3, 2024, the Company issued Bausch + Lomb 2,299,397 shares of the Company’s common stock, valued at $2.3 million, in satisfaction of its obligations pursuant to the Letter Agreement (see Note 8 – Commitments and Contingencies).

At-The-Market Offering

During the six months ended June 30, 2024, the Company received approximately $4.9 million in net proceeds from the sale of 4,128,276 shares of its common stock pursuant to a sales agreement (the “Sales Agreement”) with Leerink Partners, LLC, formerly known as SVB Securities LLC (“Leerink Partners”) in an ”at-the-market” offering.

Registered Direct Offering

On April 8, 2024, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with a single fundamentals-based healthcare investor (the “Purchaser”), pursuant to which the Company agreed to sell, in a registered direct offering by the Company directly to the Purchaser (the “Offering”), 3,223,726 shares of common stock, par value $0.0001 per share. The price per share in the Offering was $0.6204. The aggregate gross proceeds to the Company from the Offering were $2.0 million, and net proceeds after offering costs were approximately $1.9 million.

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, 2024 and 2023, the Company recorded stock-based compensation expense of $541,056 ($232,154 of which was included within research and development expenses and $308,902 was included within general and administrative expenses on the statements of operations) and $493,632 ($36,197 of which was included within research and development expenses and $457,435 of which was included within general and administrative expenses on the statements of operations), respectively. For the six months ended June 30, 2024 and 2023, the Company recorded stock-based compensation expense of $1,087,288 ($438,740 of which was included within research and development expenses and $648,548 of which was included within general and administrative expenses on the statements of operations) and $1,312,696 ($411,327 of which was included within research and development expenses and $901,369 of which was included within general and administrative expenses on the statements of operations), respectively.

Restricted Stock Units

A summary of the restricted stock units (“RSUs”) activity during the six months ended June 30, 2024 is presented below:


		Weighted
		Average
	Number of	Exercise
	RSUs	Price
RSUs non-vested January 1, 2024	106,019	$	2.12
Granted	368,886		0.65
Vested	(106,019)		2.12
Forfeited	—		—
RSUs non-vested June 30, 2024	368,886	$	0.65

Vested RSUs undelivered June 30, 2024	241,764	$	2.17

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 not to deliver shares underlying the RSUs until the termination of service.

As of June 30, 2024, there was $237,405 of unrecognized stock-based compensation expense related to RSUs which will be recognized over a weighted average period of 0.9 years.

Stock Options

A summary of the option activity during the six months ended June 30, 2024 is presented below:


				Weighted
		Weighted		Average
		Average		Remaining	Aggregate
	Number of	Exercise		Life	Intrinsic
	Options	Price		In Years	Value
Outstanding, January 1, 2024	5,306,377	$	3.31
Granted	1,926,136		1.18
Exercised	—		—
Forfeited	(633,124)		3.27
Outstanding, June 30, 2024	6,599,389	$	2.91	7.3	$	26,325

Exercisable, June 30, 2024	4,053,359	$	3.48	6.0	$	—

The following table presents information related to stock options as of June 30, 2024:


Options Outstanding		Options Exercisable
		Weighted
		Average
Exercise	Number of	Remaining Life	Number of
Price	Options	In Years	Options
$0.01 - $0.99	1,053,136	—	—
$1.00 - $1.99	2,263,037	5.6	1,145,297
$2.00 - $2.99	1,279,099	6.8	1,014,401
$3.00 - $3.99	819,018	6.1	733,022
$4.00 - $4.99	303,027	7.2	278,567
$5.00 - $5.99	35,805	2.9	35,805
$6.00 - $6.99	695,627	5.5	695,627
$7.00+	150,640	3.8	150,640
	6,599,389	6.0	4,053,359

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,
	2024	2023	2024		2023
Expected term (years)	5.50 - 5.85	5.50 - 10.00		5.50 - 10.00		5.50 - 10.00
Risk free interest rate	4.32% - 4.72%	3.44% - 4.02%		4.04% - 4.72%		3.44% - 4.18%
Expected volatility	83% - 86%	82% - 94%		80% - 86%		82% - 95%
Expected dividends	0.00%	0.00%		0.00%		0.00%

As of June 30, 2024, there was $2,358,546 of unrecognized stock-based compensation expense related to stock options which will be recognized over a weighted average period of 1.8 years.

The weighted average estimated grant date fair value of the stock options granted for the three months ended June 30, 2024 and 2023 was approximately $0.44 and $2.04 per share, respectively. The weighted average estimated grant date fair value of the stock options granted for the six months ended June 30, 2024 and 2023 was approximately $0.84 and $1.78 per share, respectively.

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

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

Common Stock

Additional Paid-In Capital

Accumulated Deficit

Total

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)

^[1]

$ 130

3,499,462

3,499,592

^[1]

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

Balance at the end at Jun. 30, 2023

(11,955,226)

$ 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 (in shares)

^[2]

$ 13

403,107

403,120

^[2]

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

Balance at the beginning at Dec. 31, 2023

$ 4,555

154,486,098

(145,491,559)

8,999,094

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

45,553,026

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

^[3]

$ 183

3,194,364

3,194,547

^[3]

1,833,323

546,232

Balance at the end at Mar. 31, 2024

(10,922,101)

$ 4,738

158,226,694

(156,413,660)

1,817,772

Balance at the end (in shares) at Mar. 31, 2024

47,386,349

Balance at the beginning at Dec. 31, 2023

$ 4,555

154,486,098

(145,491,559)

$ 8,999,094

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

45,553,026

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

4,128,276

Balance at the end at Jun. 30, 2024

$ (21,975,800)

$ 5,582

165,091,874

(167,467,359)

(2,369,903)

Balance at the end (in shares) at Jun. 30, 2024

55,817,921

Balance at the beginning at Mar. 31, 2024

$ 4,738

158,226,694

(156,413,660)

1,817,772

Balance at the beginning (in shares) at Mar. 31, 2024

47,386,349

Issuance of common stock in registered direct offering

^[4]

$ 322

1,888,507

1,888,829

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

^[4]

3,223,726

Issuance of common stock as consideration for licensing agreement

^[5]

$ 62

436,747

436,809

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

^[5]

613,496

Issuance of common stock as consideration for reacquisition of licensing agreement

^[6]

$ 230

2,322,161

2,322,391

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

^[6]

2,299,397

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

^[7]

$ 230

1,676,709

1,676,939

^[7]

2,294,953

541,056