Form 10-Q - Quarterly report [Sections 13 or 15(d)]

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended: June 30, 2023

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

COMMISSION FILE NUMBER: 001-38365

EYENOVIA, INC.

(Exact name of Registrant as Specified in Its Charter)

DELAWARE		47-1178401
(State or Other Jurisdiction of Incorporation or Organization)		(I.R.S. Employer Identification No.)

295 Madison Avenue, Suite 2400 NEW YORK, NY		10017
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: (833) 393-6684

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.0001 per share	EYEN	Nasdaq Capital Market

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐

Non-accelerated filer	☒	Smaller reporting company	☒

		Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any news or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

The number of outstanding shares of the registrant’s common stock was 38,211,808 as of August 8, 2023.

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EYENOVIA, INC.

FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2023

TABLE OF CONTENTS


PART I - FINANCIAL INFORMATION

Item 1. Financial Statements.		2

Condensed Balance Sheets as of June 30, 2023 (Unaudited) and December 31, 2022		2

Unaudited Condensed Statements of Operations for the Three and Six Months Ended June 30, 2023 and 2022		3

Unaudited Condensed Statements of Changes in Stockholders’ Equity for the Three and Six Months Ended June 30, 2023 and 2022		4

Unaudited Condensed Statements of Cash Flows for the Six Months Ended June 30, 2023 and 2022		5

Notes to Unaudited Condensed Financial Statements		6

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.		14

Item 3. Quantitative and Qualitative Disclosures About Market Risk.		20

Item 4. Controls and Procedures.		21

PART II - OTHER INFORMATION

Item 1. Legal Proceedings.		22

Item 1A. Risk Factors.		22

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.		22

Item 3. Defaults Upon Senior Securities.		22

Item 4. Mine Safety Disclosures.		22

Item 5. Other Information.		22

Item 6. Exhibits.		23

SIGNATURES		24

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PART I – FINANCIAL INFORMATION

Item 1. Financial Statements.

EYENOVIA, INC.

Condensed Balance Sheets


	June 30,		December 31,
	2023		2022
	(unaudited)
Assets

Current Assets
Cash and cash equivalents	$	17,468,088	$	22,863,520
Deferred clinical supply costs		3,578,326		2,284,931
License fee and expense reimbursements receivable		429,006		1,183,786
Security deposits, current		—		119,550
Prepaid expenses and other current assets		1,801,373		1,190,719
Total Current Assets		23,276,793		27,642,506

Property and equipment, net		3,698,421		1,295,115
Security deposits, non-current		198,674		80,874
Operating lease right-of-use asset		1,915,061		1,291,592
Equipment deposits		257,950		726,326
Total Assets	$	29,346,899	$	31,036,413

Liabilities and Stockholders’ Equity

Current Liabilities:
Accounts payable	$	1,312,749	$	1,428,283
Accrued compensation		1,013,118		1,747,191
Accrued expenses and other current liabilities		363,431		503,076
Operating lease liabilities - current portion		427,749		484,882
Notes payable - current portion, net of debt discount of $91,621 and $33,885 as of June 30, 2023 and December 31, 2022, respectively		947,163		174,448
Convertible notes payable - current portion, net of dedt discount of $0 and $33,885 as of June 30, 2023 and December 31, 2022, respectively		—		174,448
Total Current Liabilities		4,064,210		4,512,328

Operating lease liabilities - non-current portion		1,584,218		907,644
Notes payable - non-current portion, net of debt discount of $1,120,372 and $813,229 as of June 30, 2023 and December 31, 2022, respectively		8,683,794		4,190,938
Convertible notes payable - non-current portion, net of debt discount of $507,270 and $813,229 as of June 30, 2023 and December 31, 2022, respectively		4,492,730		4,190,938
Total Liabilities		18,824,952		13,801,848

Commitments and contingencies (Note 7)

Stockholders’ Equity:
Preferred stock, $0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of June 30, 2023 and December 31, 2022		—		—
Common stock, $0.0001 par value, 90,000,000 shares authorized; 38,169,398 and 36,668,980 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively		3,817		3,667
Additional paid-in capital		140,703,819		135,461,361
Accumulated deficit		(130,185,689)		(118,230,463)
Total Stockholders’ Equity		10,521,947		17,234,565
Total Liabilities and Stockholders’ Equity	$	29,346,899	$	31,036,413

The accompanying notes are an integral part of these condensed financial statements.

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EYENOVIA, INC.

Condensed Statements of Operations

(unaudited)


	For the Three Months Ended				For the Six Months Ended
	June 30,				June 30,
	2023		2022		2023		2022
Operating Expenses:
Research and development	$	2,811,061	$	3,586,866	$	5,333,011	$	7,299,450
General and administrative		3,149,809		3,534,590		6,086,695		7,009,555
Total Operating Expenses		5,960,870		7,121,456		11,419,706		14,309,005
Loss From Operations		(5,960,870)		(7,121,456)		(11,419,706)		(14,309,005)

Other Income (Expense):
Other income, net		119,450		33,376		190,443		26,303
Interest expense		(558,003)		(153,436)		(1,012,006)		(298,673)
Interest income		183,563		2,416		286,043		2,610
Net Loss	$	(6,215,860)	$	(7,239,100)	$	(11,955,226)	$	(14,578,765)

Net Loss Per Share - Basic and Diluted	$	(0.16)	$	(0.22)	$	(0.32)	$	(0.46)

Weighted Average Number of Common Shares Outstanding - Basic and Diluted		38,093,826		33,644,867		37,753,694		31,836,582

The accompanying notes are an integral part of these condensed financial statements.

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EYENOVIA, INC.

Condensed Statements of Changes in Stockholders’ Equity

(unaudited)


	For the Three and Six Months Ended June 30, 2023
				Additional				Total
	Common Stock			Paid-In		Accumulated		Stockholders’
	Shares	Amount		Capital		Deficit		Equity
Balance - January 1, 2023	36,668,980	$	3,667	$	135,461,361	$	(118,230,463)	$	17,234,565
Issuance of common stock in At the Market offering [1]	1,299,947		130		3,499,462		—		3,499,592
Cashless exercise of stock options	19,530		2		(2)		—		—
Stock-based compensation	—		—		819,064		—		819,064
Issuance of common stock related to vested restricted stock units	3,289		—		—		—		—
Net loss	—		—		—		(5,739,366)		(5,739,366)
Balance - March 31, 2023	37,991,746	$	3,799	$	139,779,885	$	(123,969,829)	$	15,813,855
Issuance of common stock in At the Market offering [2]	121,989		13		403,107		—		403,120
Cashless exercise of stock options	1,219		—		—		—		—
Exercise of stock options	10,000		1		27,199		—		27,200
Stock-based compensation	—		—		493,632		—		493,632
Issuance of common stock related to vested restricted stock units	44,444		4		(4)		—		—
Net loss	—		—		—		(6,215,860)		(6,215,860)
Balance - June 30, 2023	38,169,398	$	3,817	$	140,703,819	$	(130,185,689)	$	10,521,947

[1]	Includes gross proceeds of $3,607,827 less total issuance costs of $108,235.

[2]	Includes gross proceeds of $415,588 less total issuance costs of $12,468.


	For the Three and Six Months Ended June 30, 2022
				Additional				Total
	Common Stock			Paid-In		Accumulated		Stockholders’
	Shares	Amount		Capital		Deficit		Equity
Balance - January 1, 2022	28,426,616	$	2,844	$	110,683,077	$	(90,219,306)	$	20,466,615
Issuance of common stock and warrants in registered direct offering [1]	3,000,000		300		14,897,608		—		14,897,908
Issuance of common stock in At the Market offering [2]	252,449		25		860,340		—		860,365
Stock-based compensation	—		—		908,987		—		908,987
Issuance of common stock related to vested restricted stock units	19,359		2		(2)		—		—
Net loss	—		—		—		(7,339,665)		(7,339,665)
Balance -March 31, 2022	31,698,424	$	3,171	$	127,350,010	$	(97,558,971)	$	29,794,210
Exercise of stock warrants	1,870,130		187		18,514		—		18,701
Stock-based compensation	—		—		1,036,926		—		1,036,926
Issuance of common stock related to vested restricted stock units	54,499		5		(5)		—		—
Net loss	—		—		—		(7,239,100)		(7,239,100)
Balance - June 30, 2022	33,623,053	$	3,363	$	128,405,445	$	(104,798,071)	$	23,610,737

[1]	Includes gross proceeds of $14,981,299 less total issuance costs of $83,391.

[2]	Includes gross proceeds of $886,974, less total issuance costs of $26,609.

The accompanying notes are an integral part of these condensed financial statements.

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EYENOVIA, INC.

Condensed Statements of Cash Flows

(unaudited)


	For the Six Months Ended
	June 30,
	2023		2022
Cash Flows From Operating Activities
Net loss	$	(11,955,226)	$	(14,578,765)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation		1,312,696		1,945,913
Depreciation of property and equipment		187,267		145,901
Amortization of debt discount		313,446		52,431
Non-cash rent expense		280,968		—
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		(1,514)		(461,761)
License fee and expense reimbursements receivables		754,780		1,095,831
Deferred clinical supply costs		(1,293,395)		(1,538,380)
Security and equipment deposits		1,750		(68,868)
Accounts payable		(115,534)		1,072,690
Accrued compensation		(734,073)		(529,534)
Accrued expenses and other current liabilities		(139,645)		(21,417)
Lease liabilities		(284,996)		2,356
Net Cash Used In Operating Activities		(11,673,476)		(12,883,603)

Cash Flows From Investing Activities
Purchases of property and equipment		(2,122,197)		(281,342)
Vendor deposits for property and equipment		—		(118,298)
Net Cash Used In Investing Activities		(2,122,197)		(399,640)

Cash Flows From Financing Activities
Proceeds from sale of common stock and warrants in direct offering [1]		—		14,981,299
Payment of offering issuance costs		—		(83,391)
Proceeds from sale of common stock in At the Market offering		4,023,414		886,974
Payment of issuance costs for At the Market offering		(120,702)		(26,609)
Proceeds from exercise of stock options		27,200		18,701
Proceeds from note payable to Avenue		5,000,000		—
Payment of issuance costs for notes issued to Avenue		(125,982)		—
Repayments of notes payable		(403,689)		(448,999)
Net Cash Provided By Financing Activities		8,400,241		15,327,975
Net (Decrease) Increase in Cash and Cash Equivalents		(5,395,432)		2,044,732
Cash, cash equivalents and restricted cash - Beginning of Period		22,863,520		27,336,850
Cash, cash equivalents and restricted cash - End of Period	$	17,468,088	$	29,381,582


Cash, cash equivalents and restricted cash consisted of the following:
Cash and cash equivalents	$	17,468,088	$	21,506,582
Restricted cash		—		7,875,000
	$	17,468,088	$	29,381,582
Supplemental Disclosure of Cash Flow Information:
Cash paid during the year for:
Interest	$	699,116	$	199,367

Supplemental Disclosure of Non-Cash Investing and Financing Activities
Purchase of insurance policy financed by note payable	$	609,140	$	675,331
Right-of-use assets and lease liabilities recognized upon lease renewal	$	904,437	$	—
Vendor deposits applied to purchases of property and equipment	$	468,376	$	—
Original issue discount on notes payable	$	212,500	$	—
Cashless exercise of stock options	$	2	$	—
Issuance of common stock related to vested restricted stock units	$	4	$	7

[1] Includes gross proceeds of $14,981,299, of which $5,741,299 is pre-funded warrants.

The accompanying notes are an integral part of these condensed financial statements.

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EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

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

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

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

Note 2 – Going Concern and Summary of Significant Accounting Policies

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

Going Concern

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

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

Reclassifications

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

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EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

Cash and Cash Equivalents

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

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

Net Loss Per Common Share

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

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


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

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

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

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


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

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EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

Clinical Supply Arrangements

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

Recently Adopted Accounting Standards

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

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

Note 3 – Prepaid Expenses and Other Current Assets

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


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

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EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

Note 4 – Accrued Compensation

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


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

Note 5 – Accrued Expenses and Other Current Liabilities

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


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

Note 6 – Notes Payable

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


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

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

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

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EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

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

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

Note 7 – Commitments and Contingencies

Operating Leases

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

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

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


	For the Six Months Ended
	June 30, 2023

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

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


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

Weighted Average Discount Rate
Operating leases		10.0	%

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EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

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


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

Litigations, Claims and Assessments

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

Note 8 – Stockholders’ Equity

Equity Incentive Plan

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

At-The-Market Offering

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

Stock-Based Compensation Expense

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

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EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

Restricted Stock Units

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


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

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

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

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

Stock Options

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


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

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

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

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EYENOVIA, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(UNAUDITED)

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




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

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

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


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

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

Note 9 – Employee Benefit Plans

401(k) Plan

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

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of the results of operations and financial condition of Eyenovia, Inc. (“Eyenovia,” the “Company,” “we,” “us” and “our”) as of June 30, 2023 and for the three and six months ended June 30, 2023 and 2022 should be read in conjunction with our unaudited condensed financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q and with our audited financial statements and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2022 as filed with the Securities and Exchange Commission (“SEC”) on March 31, 2023, as amended by Amendment No. 1, as filed with the SEC on May 1, 2023.

Forward Looking Statements

This Quarterly Report on Form 10-Q contains “forward-looking statements” that involve risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. The statements contained in this Quarterly Report on Form 10-Q that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such forward-looking statements include our estimates regarding expenses, future revenue, capital requirements and our need for additional financing and other financial items; any statements of the plans, strategies and objectives of management for future operations; any statements about the advantages of our product candidates and platform technology; estimates regarding the potential market opportunity for our product candidates and platform technology; statements regarding our clinical trials; factors that may affect our operating results; statements about our ability to establish and maintain intellectual property rights; statements about our ability to retain key personnel and hire necessary employees and appropriately staff our operations; statements related to future capital expenditures; statements related to future economic conditions or performance; and other matters that do not relate strictly to historical facts or statements of assumptions underlying any of the foregoing. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “will,” “plan,” “project,” “seek,” “should,” “target,” “would,” and similar expressions or variations intended to identify forward-looking statements. These statements are based on the beliefs and assumptions of our management based on information currently available to management. Such forward-looking statements are subject to risks, uncertainties and other important factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the sections titled “Summary Risk Factors” and “Risk Factors” included in Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2023, and as amended by Amendment No. 1, as filed with the SEC on May 1, 2023, and the risks discussed in our other SEC filings. Furthermore, such forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.

FDA Approval of Mydcombi™

We received notification from the FDA on May 5, 2023 that our NDA for the Mydcombi™ product was approved. It is the only FDA-approved fixed combination of the two leading mydriatic agents in the United States. As an ophthalmic spray, Mydcombi may present a number of benefits for the optometric and ophthalmic offices as well as patients. Those benefits may include better tolerability, more efficient use of office time and resources, and an overall improved doctor-patient experience. We have begun the commercialization of Mydcombi, with the first commercial sale of the product on August 3, 2023 as part of a targeted launch, and are continuing to expand the manufacturing process in preparation for a broader launch in 2024, when internal manufacturing capabilities are expected to come on-line.

Overview

We are an ophthalmic technology company developing the Optejet® delivery system for use both in combination with our own drug-device therapeutic programs as well as out-licensing for additional indications. Our aim is to improve the delivery of topical ophthalmic medication through ergonomic design that facilitates ease-of-use, delivery of more physiologically appropriate medication volume, with the goal to reduce side effects and improve tolerability, and introduce digital health technology to improve therapy compliance and ultimately medical outcomes.

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The ergonomic and functional design of the Optejet® allows for horizontal drug delivery and eliminates the need to tilt the head back or the manual dexterity to squeeze a bottle, to administer medications. Drug is delivered in a microscopic array of droplets faster than the blink reflex to help ensure instillation success. The precise delivery of a low-volume columnar spray by the Optejet® device minimizes contamination with a non-protruding nozzle and self-closing shutter. In clinical trials, the Optejet® has demonstrated that its targeted delivery achieves a high rate of successful administration, with 98% of sprays being accurately delivered upon first attempt compared to the established rate reported with traditional eye drops of ~ 50%.

A more physiologically appropriate volume of medication in the range of seven to nine microliters is delivered by the Optejet, which is approximately one fifth of the 35 to 50 microliter dose typically delivered in a single eye drop. Lower volume of medication exposes the ocular surface to less active ingredient and preservatives, potentially reducing ocular stress and surface damage and improving tolerability. The lower volume also minimizes the potential for drug to enter systemic circulation, with the goal of avoiding some common side effects that are related to overdosing of the eye.

We are developing versions of the Optejet with on-board digital technology to provide reminders via Bluetooth to smart devices and date and time stamp device use. This information can then be used by practitioners and health care systems to measure treatment compliance and improve medical decision making. In this way, the Optejet could serve as an extension of the physician’s office by providing information that is not currently possible to collect except through the use of diaries.

Our drug-device product line includes Mydcombi™ (tropicamide and phenylephrine HCL ophthalmic spray) and therapeutic programs MicroPine (atropine ophthalmic spray) and MicroLine (pilocarpine ophthalmic spray). MicroPine is our first-in-class topical therapy for the treatment of progressive myopia, a back-of-the-eye ocular disease associated with pathologic axial elongation and sclero-retinal stretching. In the United States, myopia is estimated to affect approximately 25 million children, with up to five million considered to be at high risk for progressive myopia. In February 2019, the FDA accepted our IND to initiate the CHAPERONE study to reduce the progression of myopia in children. The first patient was enrolled in the CHAPERONE study in June 2019.

On October 9, 2020, we entered into the Bausch License Agreement with B+L, pursuant to which B+L may develop and commercialize MicroPine in the United States and Canada. Under the terms of the Bausch License Agreement, we received an upfront payment of $10.0 million and we may receive up to a total of $35.0 million in additional payments, based on the achievement of certain regulatory and launch-based milestones. B+L also will pay royalties to Eyenovia on a tiered basis (ranging from mid-single digit to mid-teen percentages) on gross profits from sales of MicroPine in the United States and Canada, subject to certain adjustments. Under the terms of the Bausch License Agreement, B+L assumed sponsorship of the IND as well as ownership and the costs related to the ongoing CHAPERONE study.

We have also successfully expanded our manufacturing capabilities through a partnership with Coastline International, Inc. located in Tijuana, Mexico, and the construction of our own fill and finish facility in Redwood City, California. As of the date of filing, we are up-to-date supplying clinical product for the CHAPERONE and VISION Studies.

MicroLine is our investigational pharmacologic treatment for presbyopia. Presbyopia is a non-preventable, age-related hardening of the lens, which causes the gradual loss of the eye’s ability to focus on near objects and impairs near visual acuity. Allergan recently launched Vuity™, a pilocarpine drug product for the treatment of presbyopia. Our second Phase III study, VISION-2, used the same drug, delivered with the advantages of our Optejet® device. We released positive top-line results from VISION-2 in the fourth quarter of 2022.

Mydcombi™ is our fixed combination formulation of tropicamide-phenylephrine for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. Mydcombi is a novel approach for the over 106 million office-based comprehensive and diabetic eye exams performed every year in the United States. As the only FDA-approved fixed combination of the two leading mydriatic agents in the United States and as an ophthalmic spray, Mydcombi may present a number of benefits for the optometric and ophthalmic offices as well as patients. Those benefits may include better tolerability, more efficient use of office time and resources, and an overall improved doctor-patient experience. As noted above in “FDA Approval of Mydcombi”, we received FDA approval on May 5, 2023, and are preparing to commercialize the product starting with a targeted launch and expanding in 2024 when we expect our internal manufacturing capabilities to come on-line.

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On August 10, 2020, we entered into the Arctic Vision License Agreement with Arctic Vision, which was amended on September 14, 2021, pursuant to which Arctic Vision may develop and commercialize MicroPine, MicroLine and Mydcombi in Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea. Under the terms of the Arctic Vision License Agreement, as amended, we received an upfront payment of $4.25 million before any payments to Senju Pharmaceutical Co., Ltd. (“Senju”). In addition, we may receive up to a total of $39.7 million in additional payments, based on various development and regulatory milestones, including the initiation of clinical research and approvals in Greater China and South Korea, and development costs. Arctic Vision also will purchase its supply of MicroPine, MicroLine and Mydcombi from Eyenovia or, for such products not supplied by Eyenovia, pay a mid-single digit percentage royalty on net sales of such products, subject to certain adjustments. We will pay between 30 and 40 percent of such payments, royalties, or net proceeds of such supply to Senju pursuant to an exclusive license agreement with Senju dated March 8, 2015, as amended (the “Senju License Agreement”).

We are in active discussions with manufacturers of existing and late-stage ophthalmic medications to explore whether development with the Optejet technology can solve unmet medical and business needs. Some of those business needs could include extension of exclusivity under the Optejet patents, improvement in a drug’s tolerability profile, or potential improvement in treatment compliance.

Historically, we have financed our operations principally through equity offerings. We have also generated cash through licensing arrangements and our credit facilities with SVB and Avenue. However, based upon our current operating plan, there is substantial doubt about our ability to continue as a going concern for at least one year from the date that our financial statements are issued. Our ability to continue as a going concern depends on our ability to complete additional licensing or business development transactions or raise additional capital through the sale of equity or debt securities to support our future operations. If we are unable to secure additional capital, we may be required to curtail our research and development initiatives and/or take additional measures to reduce costs.

Our net losses were $6.2 million and $12.0 million for the three and six months ended June 30, 2023. As of June 30, 2023, we had working capital and an accumulated deficit of $19.2 million and $130.2 million, respectively.

Financial Overview

Research and Development Expenses

Research and development expenses are incurred in connection with the research and development of our microdose-therapeutics and consist primarily of personnel-related expenses. Given where we are in our life cycle, we do not separately track research and development expenses by project. Our research and development expenses consist of:

●

direct clinical and non-clinical expenses, which include expenses incurred under agreements with contract research organizations, contract manufacturing organizations, and costs associated with preclinical activities, development activities and regulatory activities;

●

personnel-related expenses, which include expenses related to consulting agreements with individuals that have since entered into employment agreements with us as well as salaries and other compensation of employees that is attributable to research and development activities; and

●

facilities and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, marketing, insurance and other supplies used in research and development activities.

We expense research and development costs as incurred. We record costs for some development activities, such as clinical trials, based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, clinical site activations or other information our vendors provide to us.

We expect that our research and development expenses will increase with the continuation of the aforementioned initiatives.

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General and Administrative Expenses

General and administrative expenses consist primarily of payroll and related expenses, legal and other professional services, as well as non-cash stock-based compensation expense. We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research and development and the potential commercialization of our product candidates.

Results of Operations

Three Months Ended June 30, 2023 Compared with Three Months Ended June 30, 2022

Research and Development Expenses


	For the Three Months Ended June 30,
	2023		2022
Personnel-related expenses	$	1,747,020	$	1,524,119
Direct clinical and non-clinical expenses		452,026		994,426
Non-cash stock-based compensation expenses		36,197		516,669
Facilities expenses		267,952		294,726
Supplies and materials		153,063		115,380
Other expenses		154,802		141,546
Total research and development expenses	$	2,811,060	$	3,586,866

Research and development expenses for the three months ended June 30, 2023 totaled $2.8 million, a decrease of $0.8 million, or 22%, as compared to $3.6 million recorded for the three months ended June 30, 2022. The increase in personnel-related expenses was primarily due to salary increases and new staff additions made throughout 2022, primarily related to the anticipated Mydcombi launch. The decrease in direct clinical and non-clinical expenses was primarily due to the VISION-2 Study being concluded in 2022. The decrease in non-cash stock-based compensation expenses was primarily due to the change in the allocation percentages of a grant from research and development expenses to general and administrative expenses and adjustments for forfeitures and expirations resulting from the review of outstanding options.

General and Administrative Expenses


	For the Three Months Ended June 30,
	2023		2022
Salaries and benefits	$	975,393	$	905,017
Professional fees		779,788		1,061,299
Stock-based compensation		457,435		520,257
Insurance expense		227,257		268,571
Sales and marketing		201,516		318,198
Facilities expense		126,251		115,923
Director fees and expense		106,250		95,000
Other		275,920		250,325
	$	3,149,810	$	3,534,590

General and administrative expenses for the three months ended June 30, 2023 totaled $3.1 million, a decrease of $0.4 million, or 11%, as compared to $3.5 million recorded for the three months ended June 30, 2022. The decrease was primarily attributable to a sharp decrease in professional fees which resulted from legal and recruiting expenses associated with the addition of new directors in 2022 that were not incurred in the first half of 2023. The decrease in sales and marketing expenses primarily resulted from the decrease in promotional expenses.

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Six Months Ended June 30, 2023 Compared with Six Months Ended June 30, 2022

Research and Development Expenses


	For the Six Months Ended June 30,
	2023		2022
Personnel-related expenses	$	3,361,872	$	2,972,710
Direct clinical and non-clinical expenses		278,225		1,706,952
Non-cash stock-based compensation expenses		411,327		1,017,850
Facilities expenses		494,999		508,333
Supplies and materials		511,994		859,635
Other expenses		274,594		233,970
Total research and development expenses	$	5,333,011	$	7,299,450

Research and development expenses for the six months ended June 30, 2023 totaled $5.3 million, a decrease of $2.0 million, or 27%, as compared to $7.3 million recorded for the six months ended June 30, 2022. The increase in personnel-related expenses was primarily due to salary increases and costs related to staff additions made throughout 2022 mainly related to the ramp up for the Mydcombi launch. The decrease in direct clinical and non-clinical expenses was primarily due to the VISION-2 Study being concluded in 2022. The decrease in non-cash stock-based compensation expenses was primarily due to the change in the allocation percentages of a grant from research and development expenses to general and administrative expenses and adjustments for forfeitures and expirations resulting from the review of outstanding options. The decrease in supplies and materials expenses resulted from the increase in the cost reimbursements for the clinical supplies that were supplied to our clinical partners (Arctic Vision and B+L).

General and Administrative Expenses


	For the Six Months Ended June 30,
	2023		2022
Salaries and benefits	$	1,997,344	$	1,933,800
Professional fees		1,392,823		2,268,148
Stock-based compensation		901,369		928,063
Insurance expense		483,993		519,789
Sales and marketing		397,136		497,506
Facilities expense		247,669		221,954
Director fees and expense		203,750		180,833
Other		462,611		459,462
	$	6,086,695	$	7,009,555

General and administrative expenses for the six months ended June 30, 2023 totaled $6.1 million, a decrease of $0.9 million, or 13%, as compared to $7.0 million recorded for the six months ended June 30, 2022. The decrease was primarily attributable to a sharp decrease in professional fees which resulted from legal and recruiting expenses associated with the addition of new directors in 2022 that were not incurred in the first half of 2023. The decrease in sales and marketing expense primarily resulted from the decrease in promotional expenses.

Liquidity and Capital Resources and Going Concern

We measure our liquidity in a number of ways, including the following:


	June 30,		December 31,
	2023		2022
Cash and cash equivalents	$	17,468,088	$	22,863,520

Working capital	$	19,212,583	$	23,130,178

Notes payable (gross)	$	15,842,950	$	10,425,000

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Since inception, we have experienced negative cash flows from operations. As of June 30, 2023, our accumulated deficit since inception was $130.2 million.

As of June 30, 2023, we had a cash and cash equivalents balance of $17.5 million, working capital of $19.2 million and stockholders’ equity of $10.5 million. As of June 30, 2023 and December 31, 2022, we had $15.8 million and $10.4 million, respectively, of debt outstanding.

These conditions raise substantial doubt about our ability to continue as a going concern for at least one year from the date that the financial statements included elsewhere in this Quarterly Report on Form 10-Q are issued. Our financial statements do not include adjustments to the amounts and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern. Our ability to continue as a going concern depends on our ability to raise additional capital through the sale of equity or debt securities to support our future operations. Our operating needs include the planned costs to operate our business, including amounts required to fund research and development activities including clinical studies, working capital and capital expenditures. Our future capital requirements and the adequacy of our available funds will depend on many factors, including our ability to successfully commercialize our 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 our product and service offerings. If we are unable to secure additional capital, we may be required to curtail our research and development initiatives and take additional measures to reduce general and administrative and sales and marketing costs in order to conserve our cash.

During the six months ended June 30, 2023 and 2022, our sources and uses of cash were as follows:

Net cash used in operating activities for the six months ended June 30, 2023 was $11.7 million, which includes cash used to fund a net loss of $12.0 million, reduced by $2.1 million of non-cash expenses, plus $1.8 million of cash used to fund changes in operating assets and liabilities. Net cash used in operating activities for the six months ended June 30, 2022 was $12.9 million, which includes cash used to fund a net loss of $14.6 million, reduced by $2.1 million of non-cash expenses, plus $0.4 million of cash used to fund changes in operating assets and liabilities.

Cash used in investing activities for the six months ended June 30, 2023 was $2.1 million, which was related to purchases of property and equipment. Cash used in investing activities for the six months ended June 30, 2022 was $0.4 million, which was related to purchases of and vendor deposits for property and equipment.

Net cash provided by financing activities for the six months ended June 30, 2023 totaled $8.4 million, which was attributable to $4.0 million of gross proceeds received from sales under our At-the-Market Offering Program and $5.0 million of gross proceeds from the additional tranche under the Loan and Security Agreement. This was slightly offset by the repayment of $0.4 million of notes payable in connection with the D&O Loan, $0.1 million of the At-the-Market offering issuance costs relating to our At-the-Market Offering Program and $0.1 million of issuance costs related to the additional tranche under the Loan and Security Agreement. Net cash provided by financing activities for the six months ended June 30, 2022 totaled $15.3 million, which was attributable to $15.9 million of gross proceeds received from the March 2022 Offering (as defined in our Annual Report on Form 10-K, as filed with the SEC on March 31, 2023, as amended by Amendment No. 1, as filed with the SEC on May 1, 2023) and the At-the-Market Offering Program. This was slightly offset by the repayment of $0.4 million of notes payable in connection with the D&O Loan and the $0.1 million payment of issuance costs related to the March 2022 Offering.

Contractual Obligations and Commitments

During the next twelve months we have commitments to pay: (a) $2.7 million to settle our June 30, 2023 accounts payable, accrued compensation, and accrued expenses and other current liabilities; (b) $0.4 million relating to our non-cancelable operating lease commitments; and (c) $1.0 million of potential payments due under our notes payable. In addition, we would be required to pay an aggregate of $1.5 million of executive severance pay under the provisions of the Executive Employment Agreements with three executive officers, in the event that their respective employment with us were to be terminated without cause or if there is an involuntary termination (as defined in the agreement).

After twelve months we have commitments to pay an additional $1.6 million relating to our non-cancelable operating lease commitments and notes payable in the amount of $14.8 million.

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Off-Balance Sheet Arrangements

There are no off-balance sheet arrangements between us and any other entity that have, or are reasonably likely to have, a current or future effect on financial conditions, changes in financial conditions, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to stockholders.

Critical Accounting Policies and Estimates

For a description of our critical accounting policies, including critical accounting estimates, see Item 7 – Critical Accounting Policies in our Annual Report on Form 10-K, as filed with the SEC on March 31, 2023, as amended by Amendment No. 1, as filed with the SEC on May 1, 2023.

Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of financial statements requires us to make estimates and judgements that affect the reported amounts of assets, liabilities, revenues, costs and expenses and related disclosures. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Changes in estimates are reflected in reported results for the period in which they become known. Actual results could differ significantly from the estimates made by our management.

There have been no material changes to our critical accounting policies and estimates from those disclosed in our financial statements and the related notes and other financial information included in our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 31, 2023, as amended by Amendment No. 1, as filed with the SEC on May 1, 2023.

Recently Adopted Accounting Standards

For a description of recently adopted accounting standards, including adoption dates and estimated effects, if any, on our condensed financial statements, see Note 2 – Summary of Significant Accounting Policies in Part 1, Item 1 of this Quarterly Report on Form 10-Q.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

Smaller reporting companies such as Eyenovia are not required to provide the information required by this Item.

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Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

As of the end of the period covered by this Quarterly Report on Form 10-Q, we carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

In designing and evaluating our disclosure controls and procedures, management recognizes that any disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs.

Based on their evaluation, our principal executive officer and principal financial officer concluded that, as of June 30, 2023, our disclosure controls and procedures were designed to, and were effective to, provide assurance at a reasonable level that the information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosures as of June 30, 2023.

Changes in Internal Control over Financial Reporting

There has been no change in our internal control over financial reporting that occurred during the quarter ended June 30, 2023, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II - OTHER INFORMATION

Item 1. Legal Proceedings.

We are not currently a party to any material legal proceedings. From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity, reputational harm and other factors.

Item 1A. Risk Factors.

There have been no material changes to the risk factors set forth in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 31, 2023, as amended by Amendment No. 1, as filed with the SEC on May 1, 2023.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

Recent Sales of Unregistered Securities

None.

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

None.

Item 3. Defaults Upon Senior Securities.

Not applicable.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

Securities Trading Plans of Directors and Executive Officers

During the three months ended June 30, 2023, none of our directors or officers adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement.”

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Item 6. Exhibits. (TO BE UPDATED – WILL CHECK WITH COVINGTON)


Exhibit		Incorporated by Reference from Filings as Noted Below (Unless Otherwise Indicated)
Number	Exhibit Description	Form	File No.	Exhibit	Filing Date
3.1	Third Amended and Restated Certificate of Incorporation	8-K	001-38365	3.1	January 29, 2018
3.1.1	Certificate of Amendment to the Third Amended and Restated Certificate of Incorporation	8-K	001-38365	3.1.1	June 14, 2018
3.2	Second Amended and Restated Bylaws	8-K	001-38365	3.1	February 7, 2022
10.1	Eyenovia Inc. Amended and Restated 2018 Omnibus Stock Incentive Plan, as Amended	8-K	001-38365	10.1	June 27, 2023

31.1	Certification of the Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002	—	—	—	Filed herewith
31.2	Certification of the Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002	—	—	—	Filed herewith
32.1*	Certification of the Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002	—	—	—	Filed herewith
32.2*	Certification of the Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002	—	—	—	Filed herewith
101.INS	Inline XBRL Instance Document - the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document	—	—	—	Filed herewith
101.SCH	Inline XBRL Taxonomy Extension Schema Document	—	—	—	Filed herewith
101.CAL	Inline XBRL Taxonomy Extension Calculation Linkbase Document	—	—	—	Filed herewith
101.DEF	Inline XBRL Taxonomy Extension Definition Linkbase Document	—	—	—	Filed herewith
101.LAB	Inline XBRL Taxonomy Extension Label Linkbase Document	—	—	—	Filed herewith
101.PRE	Inline XBRL Taxonomy Extension Presentation Linkbase Document	—	—	—	Filed herewith
104	Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document contained in Exhibit 101	—	—	—	Filed herewith

*This certification is deemed not filed for purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

+ Management contract or other compensatory plan.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


	EYENOVIA, INC.

Date: August 11, 2023	By:	/s/ John Gandolfo
		John Gandolfo
		Chief Financial Officer (Principal Financial Officer)

Exhibit 31.1

CERTIFICATION OF THE PRINCIPAL EXECUTIVE OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Michael Rowe, certify that:

I have reviewed this Quarterly Report on Form 10-Q of Eyenovia, Inc. for the quarterly period ended June 30, 2023;

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting( as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.


Date: August 11, 2023	/s/ Michael Rowe
	Name:	Michael Rowe
	Title:	Chief Executive Officer
		(Principal Executive Officer)

Exhibit 31.2

CERTIFICATION OF THE PRINCIPAL FINANCIAL OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, John Gandolfo, certify that:

I have reviewed this Quarterly Report on Form 10-Q of Eyenovia, Inc. for the quarterly period ended June 30, 2023;

The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)

(b)

(c)

(d)

(a)

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.


Date: August 11, 2023	/s/ John Gandolfo
	Name:	John Gandolfo
	Title:	Chief Financial Officer
		(Principal Financial Officer)

Exhibit 32.1

CERTIFICATION OF THE PRINCIPAL EXECUTIVE OFFICER

PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with this Quarterly Report of Eyenovia, Inc. (the “Company”) on Form 10-Q for the quarterly period ended June 30, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Michael Rowe, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:

(1)

The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.


Date: August 11, 2023	/s/ Michael Rowe
	Name:	Michael Rowe
	Title:	Chief Executive Officer
		(Principal Executive Officer)

Exhibit 32.2

CERTIFICATION OF THE PRINCIPAL FINANCIAL OFFICER

PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with this Quarterly Report of Eyenovia, Inc. (the “Company”) on Form 10-Q for the quarterly period ended June 30, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, John Gandolfo, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:

(1)

The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.


Date: August 11, 2023	/s/ John Gandolfo
	Name:	John Gandolfo
	Title:	Chief Financial Officer
		(Principal Financial Officer)

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

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

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

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

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

Common Stock

Additional Paid-In Capital

Accumulated Deficit

Total

Balance at the beginning at Dec. 31, 2021

$ 2,844

$ 110,683,077

$ (90,219,306)

$ 20,466,615

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

28,426,616

Issuance of common stock in At the Market offering

^[1]

$ 25

860,340

860,365

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

^[1]

252,449

Issuance of common stock and warrants in registered direct offering

^[2]

$ 300

14,897,608

14,897,908

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

^[2]

3,000,000

Stock-based compensation

908,987

Issuance of common stock related to vested restricted stock units

$ 2

(2)

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

19,359

Net Income (Loss)

(7,339,665)

Balance at the end at Mar. 31, 2022

$ 3,171

127,350,010

(97,558,971)

29,794,210

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

31,698,424

Balance at the beginning at Dec. 31, 2021

$ 2,844

110,683,077

(90,219,306)

20,466,615

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

28,426,616

Net Income (Loss)

(14,578,765)

Balance at the end at Jun. 30, 2022

$ 3,363

128,405,445

(104,798,071)

23,610,737

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

33,623,053

Balance at the beginning at Mar. 31, 2022

$ 3,171

127,350,010

(97,558,971)

29,794,210

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

31,698,424

Exercise of stock warrants

$ 187

18,514

18,701

Exercise of stock warrants (in shares)

1,870,130

Stock-based compensation

1,036,926

Issuance of common stock related to vested restricted stock units

$ 5

(5)

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

54,499

Net Income (Loss)

(7,239,100)

Balance at the end at Jun. 30, 2022

$ 3,363

128,405,445

(104,798,071)

23,610,737

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

33,623,053

Balance at the beginning at Dec. 31, 2022

$ 3,667

135,461,361

(118,230,463)

17,234,565

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

36,668,980

Issuance of common stock in At the Market offering

^[3]

$ 130

3,499,462

3,499,592

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

^[3]

1,299,947

Cashless exercise of stock options

$ 2

(2)

Cashless exercise of stock options (in shares)

19,530

Stock-based compensation

819,064

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

3,289

Net Income (Loss)

(5,739,366)

Balance at the end at Mar. 31, 2023

$ 3,799

139,779,885

(123,969,829)

15,813,855

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

37,991,746

Balance at the beginning at Dec. 31, 2022

$ 3,667

135,461,361

(118,230,463)

17,234,565

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

36,668,980

Net Income (Loss)

(11,955,226)

Balance at the end at Jun. 30, 2023

$ 3,817

140,703,819

(130,185,689)

10,521,947

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

38,169,398

Balance at the beginning at Mar. 31, 2023

$ 3,799

139,779,885

(123,969,829)

15,813,855

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

37,991,746

Issuance of common stock in At the Market offering

^[4]

$ 13

403,107

403,120

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

^[4]

121,989

Cashless exercise of stock options (in shares)

1,219

Exercise of stock options (in shares)

10,000

Exercise of stock options

$ 1

27,199

27,200

Stock-based compensation

493,632

Issuance of common stock related to vested restricted stock units

$ 4

(4)

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

44,444

Net Income (Loss)

(6,215,860)

Balance at the end at Jun. 30, 2023

$ 3,817

$ 140,703,819

$ (130,185,689)

$ 10,521,947

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

38,169,398

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

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

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

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

Business Organization, Nature of Operations and Basis of Presentation

6 Months Ended

Jun. 30, 2023

Business Organization, Nature of Operations and Basis of Presentation

Business Organization, Nature of Operations and Basis of Presentation

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

Going Concern and Summary of Significant Accounting Policies

6 Months Ended

Jun. 30, 2023

Going Concern and Summary of Significant Accounting Policies

Going Concern and Summary of Significant Accounting Policies

Note 2 – Going Concern and Summary of Significant Accounting Policies

Going Concern

Reclassifications

Cash and Cash Equivalents

Net Loss Per Common Share

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


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

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

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

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


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

Clinical Supply Arrangements

Recently Adopted Accounting Standards

Prepaid Expenses and Other Current Assets

6 Months Ended

Jun. 30, 2023

Prepaid Expenses and Other Current Assets

Prepaid Expenses and Other Current Assets

Note 3 – Prepaid Expenses and Other Current Assets

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


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

Accrued Compensation

6 Months Ended

Jun. 30, 2023

Accrued Compensation

Accrued Compensation

Note 4 – Accrued Compensation

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


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

Accrued Expenses and Other Current Liabilities

6 Months Ended

Jun. 30, 2023

Accrued Expenses and Other Current Liabilities

Accrued Expenses and Other Current Liabilities

Note 5 – Accrued Expenses and Other Current Liabilities

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


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

Notes Payable

6 Months Ended

Jun. 30, 2023

Notes Payable

Notes Payable

Note 6 – Notes Payable

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


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

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

Commitments and Contingencies

6 Months Ended

Jun. 30, 2023

Commitments and Contingencies

Commitments and Contingencies

Note 7 – Commitments and Contingencies

Operating Leases

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


	For the Six Months Ended
	June 30, 2023

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

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


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

Weighted Average Discount Rate
Operating leases		10.0	%

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


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

Litigations, Claims and Assessments

Stockholders' Equity

6 Months Ended

Jun. 30, 2023

Stockholders' Equity

Stockholders' Equity

Note 8 – Stockholders’ Equity

Equity Incentive Plan

At-The-Market Offering

Stock-Based Compensation Expense

Restricted Stock Units

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


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

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

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

Stock Options

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


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

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




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

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

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


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

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

Employee Benefit Plans

6 Months Ended

Jun. 30, 2023

Employee Benefit Plans

Employee Benefit Plans

Note 9 – Employee Benefit Plans

401(k) Plan

Going Concern and Summary of Significant Accounting Policies (Policies)

6 Months Ended

Jun. 30, 2023

Going Concern and Summary of Significant Accounting Policies

Going Concern

Reclassifications

Cash and Cash Equivalents

Net Loss Per Common Share

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


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

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

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

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


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

Clinical Supply Arrangements

Recently Adopted Accounting Standards

Going Concern and Summary of Significant Accounting Policies (Tables)

6 Months Ended

Jun. 30, 2023

Going Concern and Summary of Significant Accounting Policies

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


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

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

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

Schedule of weighted average diluted common shares


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

Prepaid Expenses and Other Current Assets (Tables)

6 Months Ended

Jun. 30, 2023

Prepaid Expenses and Other Current Assets

Schedule of prepaid expenses and other current assets


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

Accrued Compensation (Tables)

6 Months Ended

Jun. 30, 2023

Accrued Compensation

Schedule of accrued compensation


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

Accrued Expenses and Other Current Liabilities (Tables)

6 Months Ended

Jun. 30, 2023

Accrued Expenses and Other Current Liabilities

Schedule of accrued expenses and other current liabilities


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

Notes Payable (Tables)

6 Months Ended

Jun. 30, 2023

Notes Payable

Schedule of notes payable


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

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

Commitments and Contingencies (Tables)

6 Months Ended

Jun. 30, 2023

Commitments and Contingencies

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


	For the Six Months Ended
	June 30, 2023

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

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


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

Weighted Average Discount Rate
Operating leases		10.0	%

Schedule of future minimum operating lease payments


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

Stockholders' Equity (Tables)

6 Months Ended

Jun. 30, 2023

Stockholders' Equity

Schedule of Restricted Stock Units activity


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

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

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


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

Summary of the option activity




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

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

Schedule of information related to stock options

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


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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