0001410578-22-003306 | 10-Q | XBRL Viewer

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Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2022	Nov. 10, 2022
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2022
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, Address Line One	295 Madison Avenue, Suite 2400
Entity Address, City or Town	NEW YORK
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	10017
City Area Code	833
Local Phone Number	393-6684
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
Trading Symbol	EYEN
Entity Shell Company	false
Title of 12(b) Security	Common Stock, $0.0001 Par Value
Security Exchange Name	NASDAQ
Entity Common Stock, Shares Outstanding		36,112,987
Entity Central Index Key	0001682639
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q3
Amendment Flag	false

Condensed Balance Sheets - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Current Assets:
Cash and cash equivalents	$ 17,398,605	$ 19,461,850
Restricted cash	7,875,000	7,875,000
Deferred clinical supply costs	1,871,096
License fee and expense reimbursements receivable	809,430	1,805,065
Prepaid expenses and other current assets	1,463,020	721,438
Total Current Assets	29,417,151	29,863,353
Property and equipment, net	1,342,657	1,271,225
Security deposits	200,153	132,539
Equipment deposits	445,530	391,941
Total Assets	31,405,491	31,659,058
Current Liabilities:
Accounts payable	1,104,959	1,614,104
Accrued compensation	1,268,009	1,543,618
Accrued expenses and other current liabilities	1,384,803	845,719
Deferred rent - current portion	28,999	18,685
Notes payable	7,229,013	7,150,368
Total Current Liabilities	11,015,783	11,172,494
Deferred rent - non-current portion	60,540	19,949
Total Liabilities	11,076,323	11,192,443
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 September 30, 2022 and December 31, 2021	0	0
Common stock, $0.0001 par value, 90,000,000 shares authorized; 35,525,689 and 28,426,616 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively	3,553	2,844
Additional paid-in capital	132,432,682	110,683,077
Accumulated deficit	(112,107,067)	(90,219,306)
Total Stockholders' Equity	20,329,168	20,466,615
Total Liabilities and Stockholders' Equity	$ 31,405,491	$ 31,659,058

Condensed Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2022	Dec. 31, 2021
Condensed Balance Sheets
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	35,525,689	28,426,616
Common stock, shares outstanding	35,525,689	28,426,616

Condensed Statements of Operations - USD ($)	3 Months Ended		9 Months Ended
Condensed Statements of Operations - USD ($)	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Operating Income
Revenue	$ 0	$ 0	$ 0	$ 4,000,000
Cost of revenue	0	0	0	(1,600,000)
Gross Profit	0	0	0	2,400,000
Operating Expenses:
Research and development	3,876,876	3,552,068	11,176,326	11,559,364
General and administrative	3,353,352	2,372,999	10,362,907	6,914,481
Total Operating Expenses	7,230,228	5,925,067	21,539,233	18,473,845
Loss From Operations	(7,230,228)	(5,925,067)	(21,539,233)	(16,073,845)
Other Income (Expense):
Extinguishment of PPP 7(a) loan		463,353	0	463,353
Other income, net	70,277	11,728	96,580	48,880
Interest expense	(177,138)	(119,212)	(475,811)	(202,407)
Interest income	28,093	600	30,703	2,354
Net Loss	$ (7,308,996)	$ (5,568,598)	$ (21,887,761)	$ (15,761,665)
Net Loss Per Share
Net Loss Per Share - Basic	$ (0.21)	$ (0.21)	$ (0.67)	$ (0.61)
Net Loss Per Share - Diluted	$ (0.21)	$ (0.21)	$ (0.67)	$ (0.61)
Weighted Average Number of Common Shares Outstanding
Weighted Average Number of Common Shares Outstanding - Basic	34,631,774	26,053,532	32,778,551	25,773,098
Weighted Average Number of Common Shares Outstanding - Diluted	34,631,774	26,053,532	32,778,551	25,773,098

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

Common Stock

Additional Paid-In Capital

Accumulated Deficit

Total

Balance at the beginning at Dec. 31, 2020

$ 2,498

$ 92,742,306

$ (77,440,919)

$ 15,303,885

Balance at the beginning (in shares) at Dec. 31, 2020

24,978,585

Exercise of stock warrants

$ 65

1,530,925

1,530,990

Exercise of stock warrants (in shares)

644,992

Stock-based compensation

$ 0

656,913

Net loss

(5,351,667)

Balance at the end at Mar. 31, 2021

$ 2,563

94,930,144

(82,792,586)

12,140,121

Balance at the end (in shares) at Mar. 31, 2021

25,623,577

Balance at the beginning at Dec. 31, 2020

$ 2,498

92,742,306

(77,440,919)

15,303,885

Balance at the beginning (in shares) at Dec. 31, 2020

24,978,585

Net loss

(15,761,665)

Balance at the end at Sep. 30, 2021

$ 2,597

97,446,125

(93,202,584)

4,246,138

Balance at the end (in shares) at Sep. 30, 2021

25,963,185

Balance at the beginning at Mar. 31, 2021

$ 2,563

94,930,144

(82,792,586)

12,140,121

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

25,623,577

Exercise of stock warrants

$ 23

572,978

573,001

Exercise of stock warrants (in shares)

232,022

Exercise of stock options

$ 9

130,081

130,090

Exercise of stock options (in shares)

91,047

Issuance of SVB warrants

^[1]

$ 0

351,390

Stock-based compensation

637,355

Net loss

(4,841,400)

Balance at the end at Jun. 30, 2021

$ 2,595

96,621,948

(87,633,986)

8,990,557

Balance at the end (in shares) at Jun. 30, 2021

25,946,646

Exercise of stock options

$ 2

46,710

46,712

Exercise of stock options (in shares)

16,539

Stock-based compensation

$ 0

777,467

Net loss

(5,568,598)

Balance at the end at Sep. 30, 2021

$ 2,597

97,446,125

(93,202,584)

4,246,138

Balance at the end (in shares) at Sep. 30, 2021

25,963,185

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 and warrants in registered direct offering

^[2]

$ 300

14,897,608

14,897,908

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

^[2]

3,000,000

Issuance of common stock in At the Market offering

^[3]

$ 25

860,340

860,365

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

^[3]

252,449

Stock-based compensation

$ 0

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 loss

$ 0

(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 loss

(21,887,761)

Balance at the end at Sep. 30, 2022

$ 3,553

132,432,682

(112,107,067)

20,329,168

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

35,525,689

Balance at the beginning at Mar. 31, 2022

$ 3,171

127,350,010

(97,558,971)

29,794,210

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

31,698,424

Exercise of stock warrants

$ 187

18,514

18,701

Exercise of stock warrants (in shares)

1,870,130

Stock-based compensation

$ 0

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 loss

$ 0

(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

Issuance of common stock in At the Market offering

^[4]

$ 188

3,098,506

3,098,694

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

^[4]

1,876,314

Stock-based compensation

$ 0

928,733

Issuance of common stock related to vested restricted stock units

$ 2

(2)

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

26,322

Net loss

$ 0

(7,308,996)

Balance at the end at Sep. 30, 2022

$ 3,553

$ 132,432,682

$ (112,107,067)

$ 20,329,168

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

35,525,689

[1]	Allocated fair value of warrants of $354,539, less allocated issuance costs of $3,149.
[2]	Includes gross proceeds of $14,981,299 less total issuance costs of $83,391.
[3]	Includes gross proceeds of $886,974, less total issuance costs of $26,609.
[4]	Includes gross proceeds of $3,194,530, less total issuance costs of $95,836.

Condensed Statements of Changes in Stockholders' Equity (Parenthetical) - USD ($)	3 Months Ended
	Sep. 30, 2022	Mar. 31, 2022	Jun. 30, 2021
Adjustments to additional paid in capital upon stock issuance costs			$ 3,149
Fair value of warrants			$ 354,539
Common Stock One
Proceeds of stock issued during period gross		$ 14,981,299
Adjustments to additional paid in capital upon stock issuance costs		83,391
Common Stock Two
Proceeds of stock issued during period gross		886,974
Adjustments to additional paid in capital upon stock issuance costs		$ 26,609
Common Stock Three
Proceeds of stock issued during period gross	$ 3,194,530
Adjustments to additional paid in capital upon stock issuance costs	$ 95,836

Condensed Statements of Cash Flows - USD ($)

9 Months Ended

Sep. 30, 2022

Sep. 30, 2021

Cash Flows From Operating Activities

Net loss

$ (21,887,761)

$ (15,761,665)

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

Stock-based compensation

2,874,646

2,071,735

Depreciation of property and equipment

228,898

148,245

Amortization of debt discount

78,645

41,944

Write-off of property and equipment

209,040

Extinguishment of PPP 7(a) Loan

(463,353)

Changes in operating assets and liabilities:

Prepaid expenses and other current assets

(66,250)

35,549

License fee and expense reimbursements receivables

995,635

2,005,859

Deferred clinical supply costs

(1,871,096)

Deferred license costs

1,600,000

Security deposits

(67,614)

Accounts payable

(509,145)

223,068

Accrued compensation

(275,609)

33,564

Accrued expenses and other current liabilities

539,084

(928,356)

Deferred license fee

(4,000,000)

Deferred rent

50,905

(4,397)

Net Cash Used In Operating Activities

(19,700,622)

(14,997,807)

Cash Flows From Investing Activities

Purchases of property and equipment

(509,370)

(1,165,066)

Vendor deposits for property and equipment

(53,589)

Net Cash Used In Investing Activities

(562,959)

(1,165,066)

Cash Flows From Financing Activities

Proceeds from sale of common stock and warrants in registered direct offering

^[1]

14,981,299

Net issuance of common stock in At the Market Offering

^[2]

3,959,059

Proceeds from exercise of stock warrants

18,701

2,103,991

Proceeds from SVB loan

7,500,000

Repayments of notes payable

(675,332)

(547,259)

Payment of offering issuance costs

(83,391)

Payment of loan issuance costs

(66,618)

Proceeds from exercise of stock options

176,802

Net Cash Provided By Financing Activities

18,200,336

9,166,916

Net Decrease in Cash and Cash Equivalents and Restricted Cash

(2,063,245)

(6,995,957)

Cash, cash equivalents and restricted cash - Beginning of Period

27,336,850

28,371,828

Cash, cash equivalents and restricted cash - End of Period

25,273,605

21,375,871

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

Cash and cash equivalents

17,398,605

13,500,871

Restricted cash

7,875,000

Total

25,273,605

21,375,871

Supplemental Disclosure of Cash Flow Information:

Interest

315,550

131,839

Supplemental Disclosure of Non-Cash Investing and Financing Activities

Purchase of insurance premium financed by note payable

675,332

705,360

Issuance of SVB stock warrants

$ 351,390

Issuance of common stock related to vested restricted stock units

$ 9

[1]	Includes gross proceeds of $14,981,299, of which $5,741,299 is pre-funded warrants.
[2]	Includes gross proceeds of $4,081,504, less total issuance costs of $122,445

Condensed Statements of Cash Flows (Parenthetical)	9 Months Ended
Condensed Statements of Cash Flows (Parenthetical)	Sep. 30, 2022 USD ($)
Common Stock One
Proceeds of stock issued during period gross	$ 14,981,299
Common Stock One \| Pre-Funder Warrants
Proceeds of stock issued during period gross	5,741,299
Common Stock Two
Proceeds of stock issued during period gross	4,081,504
Payments of debt issuance costs	$ 122,445

Business Organization, Nature of Operations and Basis of Presentation

9 Months Ended

Sep. 30, 2022

Business Organization, Nature of Operations and Basis of Presentation

Business Organization, Nature of Operations and Basis of Presentation

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

Eyenovia, Inc. (“Eyenovia” or the “Company”) is a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs as well as out-licensing for additional indications. The Company aims to achieve precision in ophthalmic drug delivery of novel and existing ophthalmic pharmaceutical agents. The precise delivery of a low-volume columnar spray by the Optejet® device also minimizes contamination with a non-protruding nozzle and self-closing shutter. The Company believes that this technology could ultimately replace eye droppers by advancing drug delivery beyond the limitations of patient coordination, drug overexposure, gravity, contamination potential, and discomfort towards a more precise, comfortable, and successful drug administration for improved patient care. The ergonomic and functional design of the Optejet® delivers microdroplets horizontally faster than the blink reflex to minimize instillation discomfort and overflow spillage, providing a more comfortable experience. In the clinic, the Optejet® has demonstrated that its targeted delivery achieves a significantly high rate of successful administration of 98% upon first attempt compared to the established rate reported with traditional eye drops of ~ 50%. The diagnostics and therapeutics in the Company’s pipeline have been tested in randomized controlled trials and demonstrated significant results in improving the benefit to risk profile for drug delivery. For example, the Company’s deliberately designed technology provides a 75% reduction in ocular drug and preservative exposure to significantly improve the therapeutic index in drugs used for presbyopia, mydriasis and intraocular pressure (“IOP”) lowering through eight clinical trials. Eyedrops expose the ocular surface to approximately 300% more medication and preservatives that can lead to unintended effects and induce collateral tissue damage. Drug delivery via the Optejet device reduces ocular exposure to preservatives comparable to that of non-preserved formulations demonstrating potentially less surface damage from ocular stress. To address unmet medical needs, the Company is developing the next generation of smart ophthalmic therapeutics to target new indications or new combinations where there are currently no or few drug therapies approved by the U.S. Food and Drug Administration (“FDA”). The Company’s investigational products are classified by the FDA as drug-device combination products with drug primary mode of action, meaning that the Center for Drug Evaluation and Research (“CDER”) is designated as the lead center with primary jurisdictional oversight. Accordingly, the product candidates are submitted to the FDA CDER for premarket review and approval under new drug applications (“NDAs”).

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the condensed financial statements of the Company as of September 30, 2022 and for the three and nine months ended September 30, 2022 and 2021. The results of operations for the nine months ended September 30, 2022 are not necessarily indicative of the operating results for the full year ending December 31, 2022 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, 2021 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 30, 2022.

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2022

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

Note 2 – Summary of Significant Accounting Policies

Since the date of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, there have been no material changes to the Company’s significant accounting policies.

Liquidity and Going Concern

As of September 30, 2022, the Company had unrestricted cash of approximately $17.4 million and an accumulated deficit of approximately $112.1 million. For the nine months ended September 30, 2022 and 2021, the Company incurred net losses of approximately $21.9 million and $15.8 million, respectively, and used cash in operations of approximately $19.7 million and $15.0 million, respectively. Subsequent to September 30, 2022, the Company received approximately $1.3 million in net proceeds from the sale of 587,298 shares of common stock pursuant to the Company’s At-the-Market Offering program with SVB Leerink. Also subsequent to September 30, 2022, the Company used its $7.9 million of restricted cash and $0.1 million of unrestricted cash in order to repay the Loan and Security Agreement, dated May 7, 2021 (the “SVB Loan”) with Silicon Valley Bank (“SVB”), including $7.5 million of principal, a final payment of $0.4 million and a prepayment fee of $0.1 million.

The Company does not have recurring revenue and has not yet achieved profitability. The Company expects to continue to incur cash outflows from operations. The Company expects that its research and development and general and administrative expenses will continue to increase and, as a result, it will eventually need to generate significant product revenues to achieve profitability. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern for at least one year from the date that these financial statements are issued. Implementation of the Company’s plans and its ability to continue as a going concern will depend upon the Company’s ability to commercialize its products and 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 take additional measures to reduce general and administrative and sales and marketing costs in order to conserve its cash.

Cash and Cash Equivalents

The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents in the financial statements.

Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain executed agreements are recorded as Restricted Cash on the balance sheets, such as the collateralized money market account pursuant to the SVB Loan, as amended on September 29, 2021 by the First Amendment to the Loan and Security Agreement (the “First Amendment”). See Note 6 - Notes Payable. In connection with the First Amendment, the Company pledged to establish and maintain a collateralized money market account in the amount of $7,875,000. Subsequent to September 30, 2022, the Company used this entire collateralized money market account plus $0.1 million of unrestricted cash in order to repay the SVB Loan, including $7.5 million of principal, a final payment of $0.4 million and a prepayment fee of $0.1 million.

The Company has cash deposits in a financial institution which, 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 September 30, 2022 and December 31, 2021, the Company had cash balances in excess of FDIC insurance limits of $24,773,605 and $26,836,850, 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 securities are excluded from the calculation of weighted average diluted common shares because their inclusion would have been anti-dilutive:


	September 30,
	2022	2021
Options	5,484,687	3,410,540
Warrants	6,087,845	2,095,993
Restricted stock units	172,800	105,306
Total potentially dilutive shares	11,745,332	5,611,839

Revenue Recognition

The Company’s revenues are generated primarily through research, development and commercialization agreements. The terms of such agreements may contain multiple promised goods and services, which may include (i) licenses to its intellectual property, and (ii) in certain cases, payment in connection with the manufacturing and delivery of clinical supply materials. Payments to us under these arrangements typically include one or more of the following: non-refundable, upfront license fees; milestone payments; payments for clinical product supply, and royalties on future product sales.

The Company analyzes its arrangements to assess whether such arrangements involve joint operating activities. For collaboration arrangements that are deemed to be within the scope of Accounting Standards Codification (“ASC”) Topic 808, “Collaborative Arrangements” (“ASC 808”), the Company allocates the contract consideration between such joint operating activities and elements that are reflective of a vendor-customer relationship and, therefore, within the scope of ASC Topic 606, “Revenue from Contracts with Customers” (“ASC 606”). The Company’s policy is to recognize amounts allocated to joint operating activities as a reduction in research and development expense.

Under ASC 606, we recognize revenue when our customers obtain control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps:

●

Step 1: Identify the contract with the customer;

●

Step 2: Identify the performance obligations in the contract;

●

Step 3: Determine the transaction price;

●

Step 4: Allocate the transaction price to the performance obligations in the contract; and

●

Step 5: Recognize revenue when the company satisfies a performance obligation.

The Company must make significant judgments in its revenue recognition process, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each performance obligation. In addition, arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered discretionary purchase options. The Company assesses whether these options provide a material right to the customer and if so, they are considered performance obligations.

For upfront license fees, the Company must consider how many performance obligations are in the contract and, if more than one, how to allocate the fee to those performance obligations upon satisfaction of the performance obligation(s). Milestone payments represent variable consideration that will be recognized when the performance obligation is achieved. Sales-based royalty payments derived from usage of intellectual property are recognized when those sales occur.

During 2020, the Company entered into a license agreement (the “Arctic Vision License Agreement”) with Arctic Vision (Hong Kong) Limited (“Arctic Vision”) and a license agreement (the “Bausch License Agreement”) with Bausch + Lomb, Inc. (“Bausch + Lomb”). Each license has three revenue components:

an upfront license fee;

milestone payments and

royalty payments.

Deferred License Fee

The Company enters into license agreements which provide for the receipt of non-refundable, upfront licensing payments. These payments are recorded as deferred license fees and will be earned and recognized as revenue upon the satisfaction of performance obligations. See Note 7 – Commitments and Contingencies for additional details.

Clinical Supply Arrangements

Bausch + Lomb and 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. Our 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.

Reclassifications

Certain prior period balances 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.

Recently Adopted Accounting Standards

On May 3, 2021, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) No. 2021-04, “Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options.” This new standard provides clarification and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (such as warrants) that remain equity classified after modification or exchange. This standard is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Issuers should apply the new standard prospectively to modifications or exchanges occurring after the effective date of the new standard. The Company adopted ASU 2021-04 effective January 1, 2022. This standard did not have a material impact on the Company’s financial position, results of operations or cash flow.

Soon To Be Adopted Accounting Standards

In February 2016, the FASB issued ASU 2016-02 “Leases (Topic 842)” (“ASU 2016-02”). ASU 2016-02 requires that a lessee recognize the assets and liabilities that arise from operating leases. A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. ASU 2016-02, as amended, is now effective for emerging growth companies for fiscal years beginning after December 15, 2021, and interim periods within fiscal years beginning after December 15, 2022. The Company plans to adopt ASU 2016-02 on December 31, 2022 and expects that the adoption of this ASU will have a material impact on the Company’s financial statements, primarily as a result of recording right-of-use assets and lease liabilities for its operating leases in the approximate amounts of $1.3 million and $1.4 million, respectively.

Prepaid Expenses and Other Current Assets

9 Months Ended

Sep. 30, 2022

Prepaid Expenses and Other Current Assets

Prepaid Expenses and Other Current Assets

Note 3 – Prepaid Expenses and Other Current Assets

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


	September 30,		December 31,
	2022		2021
Payroll tax receivable		621,063		343,785
Prepaid insurance expenses		455,150		171,370
Prepaid general and administrative expenses		185,845		71,375
Prepaid conference expenses		100,803		12,586
Prepaid patent expenses		49,183		32,797
Other		32,226		4,525
Prepaid security deposits		18,750		18,750
Prepaid board of directors fees		—		66,250
Total prepaid expenses and other current assets	$	1,463,020	$	721,438

Accrued Compensation

9 Months Ended

Sep. 30, 2022

Accrued Compensation

Accrued Compensation

Note 4 – Accrued Compensation

As of September 30, 2022 and December 31, 2021, accrued compensation consisted of the following:


	September 30,		December 31,
	2022		2021
Accrued bonus expenses	$	971,159	$	1,245,795
Accrued payroll expenses		296,850		297,823
Total accrued compensation	$	1,268,009	$	1,543,618

Accrued Expenses and Other Current Liabilities

9 Months Ended

Sep. 30, 2022

Accrued Expenses and Other Current Liabilities

Accrued Expenses and Other Current Liabilities

Note 5 – Accrued Expenses and Other Current Liabilities

As of September 30, 2022 and December 31, 2021, accrued expenses and other current liabilities consisted of the following:


	September 30,		December 31,
	2022		2021
Accrued research and development expenses	$	711,710	$	436,840
Accrued consulting and professional services		386,712		250,000
Accrued interest		152,969		94,792
Credit card payable		58,799		20,000
Accrued franchise tax		39,300		1,680
Other		29,647		42,407
Accrued travel and entertainment expenses		5,666		—
Total accrued expenses and other current liabilities	$	1,384,803	$	845,719

Notes Payable

9 Months Ended

Sep. 30, 2022

Notes Payable

Notes Payable

Note 6 – Notes Payable

As of September 30, 2022 and December 31, 2021, notes payable consisted of the following:


	September 30, 2022						December 31, 2021
	Notes Payable		Debt Discount		Net		Notes Payable		Debt Discount		Net
Silicon Valley Bank loan	$	7,500,000	$	(270,987)	$	7,229,013	$	7,500,000	$	(349,632)	$	7,150,368

On February 24, 2022, the Company issued a note payable for the purchase of directors and officers liability insurance policy (the “D&O Loan”). The D&O Loan had an aggregate principal balance of $675,332 and was payable in six monthly payments consisting of principal and interest amounting to $113,628 per payment. The note accrued interest at a rate of 3.26% per year and matured on August 24, 2022. During the nine months ended September 30, 2022, the Company repaid the full principal balance of $675,332 on the D&O Loan.

During the three months ended September 30, 2022, the Company recorded interest expense of $177,138, of which $176,215 is related to the SVB Loan (including amortization of debt discount of $26,214) and $923 is related to the D&O Loan. During the nine months ended September 30, 2022, the Company recorded interest expense of $475,811, of which $469,376 is related to the SVB Loan (including amortization of debt discount of $78,645) and $6,435 is related to the D&O Loan.

SVB Loan Amendment

On May 6, 2022, the Company and SVB agreed to amend the terms of the SVB Loan dated May 7, 2021. Pursuant to the amendment, the repayment term of the SVB Loan is reduced to 24 consecutive calendar months and the date that the first payment is due by the Company is extended to June 1, 2023. The amendment did not result in a 10% change in the net present value of the SVB Loan cash flows and, accordingly, the amendment was accounted for as a modification (a continuation of the original loan).

The SVB Loan was repaid in full in November 2022. See Note 10 – Subsequent Events.

Commitments and Contingencies

9 Months Ended

Sep. 30, 2022

Commitments and Contingencies

Commitments and Contingencies

Note 7 – Commitments and Contingencies

Employment Agreements

On February 14, 2022, the Compensation Committee of the Board of Directors of the Company (the “Board”) approved amendments to the Employment Agreements with its executive officers (the “Employment Agreement Addendums”). Each of the Employment Agreement Addendums provides that if the executive’s employment is terminated by the Company without “Cause” or the executive suffers an “Involuntary Termination” (each as defined in the employment agreements), provided that the executive has signed a full release of all claims, the executive will be entitled to receive: (i) severance pay equal to twelve months of his or her then-current base salary (estimated at approximately $1,517,000 in the aggregate as of the date of the Employment Agreement Addendums), and (ii) a reimbursement for health insurance benefits under COBRA for the executive and his or her spouse and dependents for a period of twelve months or until the executive becomes eligible for comparable insurance benefits from another employer, whichever is earlier.

Transition of Chief Executive Officer

On July 27, 2022, the Company announced the appointment of Michael Rowe as its new Chief Executive Officer, effective August 1, 2022, with Dr. Tsontcho Ianchulev becoming Executive Chairman of the Board. Mr. Rowe is also serving as a member of the Board.

On July 26, 2022, the Company entered into an Employment Agreement (the “Employment Agreement”) with Mr. Rowe under which he will serve as Chief Executive Officer of the Company. Under the terms of the Employment Agreement, Mr. Rowe will receive an annual salary of $575,000. He is eligible to receive a cash bonus of up to 60% of his base salary. Additionally, Mr. Rowe received an option to purchase 440,000 shares of the Company’s common stock, pursuant to the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan, as amended. Mr. Rowe will also continue to participate in any and all benefit plans, from time to time, in effect for senior management, along with vacation, sick and holiday pay in accordance with the Company’s policies established and in effect from time to time. As a result of the change of salary, the aggregate potential severance pay for the executive officers of the Company is approximately $1,004,000.

The Company also entered into an agreement with Dr. Ianchulev (the “Executive Chairman Agreement”) pursuant to which Dr. Ianchulev will provide medical expertise and consultation related to the Company’s research and development programs, and such other matters as reasonably requested by the Company for an initial period of one year. In consideration for Dr. Ianchulev’s services, the Company has agreed to provide Dr. Ianchulev with a $5,000 monthly retainer throughout the term of the agreement, in addition to the compensation payable to all non-employee members of the Board.

Operating Leases

The Company leased 953 square feet of office space in Reno, Nevada for research and development activities from a company owned by the Company’s former Vice President of Research and Development. The lease, as amended, expired on September 14, 2022 and provided for lease payments of $5,404 per month and a security deposit in the amount of $5,404. The Company has remained in the premises on a month-to-month basis at the same rental rate. Since the inception of the lease, the Company has made $112,600 of leasehold improvements related to this lease which have been fully amortized on the accompanying balance sheets. The Company’s rent expense for this space is recorded in Research and Development on the condensed statement of operations and amounted to $16,212 for the three months ended September 30, 2022 and 2021, and $48,636 for the nine months ended September 30, 2022 and 2021.

On April 8, 2022, the Company agreed to enter into a lease agreement for a new office space of 3,916 square feet commencing on June 1, 2022 in Laguna Hills, CA. The lease expires on July 31, 2027 and provides for lease payments of $9,203 per month payable on the first day of each month commencing September 1, 2022, and a security deposit of $11,400. The Company’s rent expense for this space is recorded in General and Administrative on the condensed statement of operations and amounted to $28,371 during the three months ended September 30, 2022 and $37,828 during the nine months ended September 30, 2022.

On May 19, 2022, the Company agreed to enter into a lease agreement with a non-related party for a new office space located in Reno, Nevada of 10,881 square feet commencing on May 23, 2022. The amended lease expires on September 23, 2027 with an option to extend the lease for an additional period of 60 months, and provides for lease payments ranging from $13,056 per month to $16,663 per month and a security deposit of $53,000. The Company’s rent expense for this space is recorded in Research and Development on the condensed statement of operations and amounted to $41,238 during the three months ended September 30, 2022 and $59,787 during the nine months ended September 30, 2022.

Litigations, Claims and Assessments

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

Stockholders' Equity

9 Months Ended

Sep. 30, 2022

Stockholders' Equity

Stockholders' Equity

Note 8 – Stockholders’ Equity

At-The-Market Offerings

December 2021 Sales Agreement

On December 14, 2021, the Company entered into a Sales Agreement (the “December 2021 Sales Agreement”) with SVB Leerink under which the Company may offer and sell, from time to time at its sole discretion, shares of common stock for gross proceeds of up to $50.0 million through SVB Leerink as its sales agent (the “At-the-Market Offering”). The Company’s prior sales agreement, with SVB Leerink, entered into in May 2021, was terminated upon the effectiveness of the December 2021 Sales Agreement. The issuance and sale of shares, if any, of common stock by the Company under the December 2021 Sales Agreement will be pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-261638) filed with the SEC on December 14, 2021 (the “Registration Statement”), and the prospectus relating to the At-the-Market Offering filed therewith that forms a part of the Registration Statement.

Subject to the terms and conditions of the December 2021 Sales Agreement, SVB Leerink may sell the common stock by any method permitted by law deemed to be an “at –the- market offering” as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended. SVB Leerink will use commercially reasonable efforts to sell the common stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay SVB Leerink a commission equal to three percent (3.0)% of the gross sales proceeds of any common stock sold through SVB Leerink under the December 2021 Sales Agreement, and also has provided SVB Leerink with certain indemnification rights. Through September 30, 2022, the Company received approximately $4.0 million in net proceeds from the sale of 2,128,763 shares of its common stock pursuant to the December 2021 Sales Agreement.

Securities Purchase Agreement

On March 3, 2022, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with an institutional and accredited investor (the “Purchaser”), relating to the issuance and sale of 3,000,000 shares (the “Shares”) of common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase an aggregate of 1,870,130 shares of common stock and warrants to purchase an aggregate of 4,870,130 shares of common stock (the “Investor Warrants”) in a registered direct offering (the “March 2022 Offering”). The Company determined that the warrants qualified for equity classification.

The offering price for the Shares was $3.08 per Share and the offering price for the Pre-Funded Warrants was $3.07 per Pre-Funded Warrant, which represents the per Share public offering price less $0.01 per share exercise price for each Pre-Funded Warrant. The Investor Warrants have an exercise price of $3.54 per share and each Investor Warrant is exercisable for one share of common stock. The Investor Warrants will be exercisable beginning six months from the date of issuance and the Pre-Funded Warrants are exercisable immediately upon issuance. The Pre-Funded Warrants shall terminate when fully exercised and the Investor Warrants will terminate five years from the initial exercisability date. The aggregate gross proceeds to the Company from the March 2022 Offering were approximately $15 million with aggregate issuance costs of approximately $83,000, excluding the proceeds, if any, from the exercise of the Pre-Funded Warrants and the Investor Warrants. No underwriter or placement agent participated in the March 2022 Offering.

The March 2022 Offering was made pursuant to an effective registration statement on Form S-3 (Registration Statement No. 333-261638), as previously filed with and declared effective by the Securities and Exchange Commission and a related prospectus.

Equity Incentive Plan

On June 16, 2022, the stockholders approved an amendment to the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan, reserving an additional 1,500,000 shares of common stock for further issuance under such plan.

Stock-Based Compensation Expense

The Company records stock-based compensation expense related to stock options and restricted stock units (“RSUs”). For the three months ended September 30, 2022 and 2021, the Company recorded expense of $928,733 ($420,619 of which was included within research and development expenses and $508,114 was included within general and administrative expenses on the statements of operations) and $777,467 ($489,121 of which was included within research and development expenses and $288,343 was included within general and administrative expenses on the statements of operations), respectively. For the nine months ended September 30, 2022 and 2021, the Company recorded expense of $2,874,646 ($1,438,469 of which was included within research and development expenses and $1,436,177 was included within general and administrative expenses on the statements of operations) and $2,071,735 ($1,138,331 of which was included within research and development expenses and $933,401 was included within general and administrative expenses on the statements of operations), respectively.

Restricted Stock Units

A summary of the restricted stock units activity during the nine months ended September 30, 2022 is presented below:


		Weighted
		Average
	Number of	Grant Date Value
	RSUs	Per Share
RSUs non-vested January 1, 2022	41,778	$	3.59
Granted	193,304		1.93
Vested	(55,319)		3.37
Forfeited	(6,963)		3.59
RSUs non-vested September 30, 2022	172,800	$	1.80

Vested RSUs undelivered September 30, 2022	41,086	$	3.64

To date, the RSUs have only been granted to directors in accordance with the Company’s Amended and Restated 2018 Omnibus Stock Incentive Plan. The Company’s policy is not to deliver shares underlying the RSUs until the termination of service.

As of September 30, 2022, there was $254,152 of unrecognized stock-based compensation expense related to RSUs which will be recognized over a weighted average period of 0.8 years.

Stock Options

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


	For the Three Months Ended		For the Nine Months Ended
	September 30,		September 30,
	2022	2021	2022	2021
Expected term (years)	5.41 - 5.85	5.85	0.58 - 10.00	5.85 - 10.00
Risk free interest rate	2.66% - 3.02%	0.81%	0.76% - 3.35%	0.45% - 1.58%
Expected volatility	85% - 87%	92%	82% - 90%	92% - 94%
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 weighted average estimated grant date fair value of the stock options granted for the three months ended September 30, 2022 and 2021 was approximately $1.22 and $3.56 per share, respectively. The weighted average estimated grant date fair value of the stock options granted for the nine months ended September 30, 2022 and 2021 was approximately $1.61 and $4.16 per share, respectively.

A summary of the option activity during the nine months ended September 30, 2022 is presented below:


				Weighted
		Weighted		Average
		Average		Remaining	Aggregate
	Number of	Exercise		Life	Intrinsic
	Options	Price		In Years	Value
Outstanding, January 1, 2022	4,377,398		3.89
Granted	1,167,310		2.23
Forfeited	(60,021)		4.21
Outstanding, September 30, 2022	5,484,687	$	3.53	7.4	$	375,417

Exercisable, September 30, 2022	3,518,147	$	3.72	6.5	$	188,738

The following table presents information related to stock options as of September 30, 2022:


Options Outstanding			Options Exercisable
			Weighted
		Outstanding	Average	Exercisable
Exercise		Number of	Remaining Life	Number of
Price		Options	In Years	Options
	$1.00 - $1.99	1,577,286	4.1	827,636
	$2.00 - $2.99	1,010,018	7.7	762,034
	$3.00 - $3.99	1,241,069	7.0	820,883
	$4.00 - $4.99	385,305	8.8	147,760
	$5.00 - $5.99	100,805	6.2	79,805
	$6.00 - $6.99	1,005,286	7.1	715,111
	$7.00+	164,918	5.5	164,918
		5,484,687	6.5	3,518,147

As of September 30, 2022, there was $4,058,569 of unrecognized stock-based compensation expense related to stock options which will be recognized over a weighted average period of 1.6 years.

Warrants

A summary of the warrant activity for the nine months ended September 30, 2022 is presented below:


				Weighted
		Weighted		Average
		Average		Remaining	Aggregate
	Number of	Exercise		Life	Intrinsic
	Warrants	Price		In Years	Value
Outstanding January 1, 2022	1,217,715	$	2.69
Granted	6,740,260		2.56
Exercised	(1,870,130)		0.01
Outstanding September 30, 2022	6,087,845	$	3.37	4.5	$	—

Exercisable September 30, 2022	6,087,845	$	3.37	4.5	$	—

The following table presents information related to warrants as of September 30, 2022:


Warrants Outstanding		Warants Exercisable
		Weighted
	Outstanding	Average	Exercisable
Exercise	Number of	Remaining Life	Number of
Price	Warrants	In Years	Warrants
$2.4696	909,451	2.5	909,451
$2.7240	216,380	2.5	216,380
$4.7600	91,884	8.6	91,884
$3.5400	4,870,130	4.9	4,870,130
	6,087,845	4.5	6,087,845

Stock Warrant Exercises

During the nine months ended September 30, 2022, the Company issued an aggregate of 1,870,130 shares of common stock pursuant to the exercise of pre-funded warrants for aggregate proceeds of $18,701 at an exercise price of $0.01 per share.

- Definition

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

+ References

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

+ Details

Employee Benefit Plans

9 Months Ended

Sep. 30, 2022

Employee Benefit Plans

Employee Benefit Plans

Note 9 – Employee Benefit Plans

401(k) Plan

In April 2019, the Company adopted the Eyenovia 401(k) Plan (the “Plan”), which went into effect in May 2019. All Company employees are able to participate in the Plan, subject to eligibility requirements as outlined in the Plan documents. Under the terms of the Plan, eligible employees are able to defer a percentage of their pay every pay period up to annual limitations set by Congress and the Internal Revenue Service under Section 401(k) of the Internal Revenue Code. For 2022 and 2021, the Board has approved a matching contribution equal to 100% of elective deferrals up to 4% of eligible earnings with the matching contribution subject to certain vesting requirements as outlined in the Plan documents. During the three months ended September 30, 2022 and 2021, the Company recorded expense of $39,914 and $34,076 associated with its matching contributions, respectively. During the nine months ended September 30, 2022 and 2021, the Company recorded expense of $173,896 and $144,917 associated with its matching contributions, respectively.

Subsequent Events

9 Months Ended

Sep. 30, 2022

Subsequent Events

Subsequent Events

Note 10 – Subsequent Events

At-the-Market Offering Program

Subsequent to September 30, 2022, the Company received approximately $1.4 million in gross proceeds ($1.3 million in net proceeds) from the sale of 587,298 shares of our common stock pursuant to our At-the-Market Offering program with SVB Leerink.

SVB Loan Repayment

On November 4, 2022, the Company repaid the SVB Loan in full. The full amount of the payment was $8.0 million, and included the principal amount of the loan ($7,500,000), the final payment ($375,000) and a 2% prepayment fee ($150,000). The entire restricted cash account in the amount of $7,875,000 was used to make the substantial amount of the payment.

Summary of Significant Accounting Policies (Policies)

9 Months Ended

Sep. 30, 2022

Summary of Significant Accounting Policies

Liquidity and Going Concern

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.

Net Loss Per Common Share

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


	September 30,
	2022	2021
Options	5,484,687	3,410,540
Warrants	6,087,845	2,095,993
Restricted stock units	172,800	105,306
Total potentially dilutive shares	11,745,332	5,611,839

Revenue Recognition

●

Step 1: Identify the contract with the customer;

●

Step 2: Identify the performance obligations in the contract;

●

Step 3: Determine the transaction price;

●

Step 4: Allocate the transaction price to the performance obligations in the contract; and

●

Step 5: Recognize revenue when the company satisfies a performance obligation.

an upfront license fee;

milestone payments and

royalty payments.

Deferred License Fee

Clinical Supply Arrangements

Reclassifications

Recently Adopted Accounting Standards

Soon To Be Adopted Accounting Standards

Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2022

Summary of Significant Accounting Policies

Schedule of anti-dilutive weighted average diluted common shares


	September 30,
	2022	2021
Options	5,484,687	3,410,540
Warrants	6,087,845	2,095,993
Restricted stock units	172,800	105,306
Total potentially dilutive shares	11,745,332	5,611,839

Prepaid Expenses and Other Current Assets (Tables)

9 Months Ended

Sep. 30, 2022

Prepaid Expenses and Other Current Assets

Schedule of prepaid expenses and other current assets


	September 30,		December 31,
	2022		2021
Payroll tax receivable		621,063		343,785
Prepaid insurance expenses		455,150		171,370
Prepaid general and administrative expenses		185,845		71,375
Prepaid conference expenses		100,803		12,586
Prepaid patent expenses		49,183		32,797
Other		32,226		4,525
Prepaid security deposits		18,750		18,750
Prepaid board of directors fees		—		66,250
Total prepaid expenses and other current assets	$	1,463,020	$	721,438

Accrued Compensation (Tables)

9 Months Ended

Sep. 30, 2022

Accrued Compensation

Schedule of accrued compensation


	September 30,		December 31,
	2022		2021
Accrued bonus expenses	$	971,159	$	1,245,795
Accrued payroll expenses		296,850		297,823
Total accrued compensation	$	1,268,009	$	1,543,618

Accrued Expenses and Other Current Liabilities (Tables)

9 Months Ended

Sep. 30, 2022

Accrued Expenses and Other Current Liabilities

Schedule of accrued expenses and other current liabilities


	September 30,		December 31,
	2022		2021
Accrued research and development expenses	$	711,710	$	436,840
Accrued consulting and professional services		386,712		250,000
Accrued interest		152,969		94,792
Credit card payable		58,799		20,000
Accrued franchise tax		39,300		1,680
Other		29,647		42,407
Accrued travel and entertainment expenses		5,666		—
Total accrued expenses and other current liabilities	$	1,384,803	$	845,719

Notes Payable (Tables)

9 Months Ended

Sep. 30, 2022

Notes Payable

Schedule of notes payable


	September 30, 2022						December 31, 2021
	Notes Payable		Debt Discount		Net		Notes Payable		Debt Discount		Net
Silicon Valley Bank loan	$	7,500,000	$	(270,987)	$	7,229,013	$	7,500,000	$	(349,632)	$	7,150,368

Stockholders' Equity (Tables)

9 Months Ended

Sep. 30, 2022

Stockholders' Equity

Summary Of Restricted Stock Units Activity


		Weighted
		Average
	Number of	Grant Date Value
	RSUs	Per Share
RSUs non-vested January 1, 2022	41,778	$	3.59
Granted	193,304		1.93
Vested	(55,319)		3.37
Forfeited	(6,963)		3.59
RSUs non-vested September 30, 2022	172,800	$	1.80

Vested RSUs undelivered September 30, 2022	41,086	$	3.64

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


	For the Three Months Ended		For the Nine Months Ended
	September 30,		September 30,
	2022	2021	2022	2021
Expected term (years)	5.41 - 5.85	5.85	0.58 - 10.00	5.85 - 10.00
Risk free interest rate	2.66% - 3.02%	0.81%	0.76% - 3.35%	0.45% - 1.58%
Expected volatility	85% - 87%	92%	82% - 90%	92% - 94%
Expected dividends	0.00%	0.00%	0.00%	0.00%

Schedule of the stock option activity


				Weighted
		Weighted		Average
		Average		Remaining	Aggregate
	Number of	Exercise		Life	Intrinsic
	Options	Price		In Years	Value
Outstanding, January 1, 2022	4,377,398		3.89
Granted	1,167,310		2.23
Forfeited	(60,021)		4.21
Outstanding, September 30, 2022	5,484,687	$	3.53	7.4	$	375,417

Exercisable, September 30, 2022	3,518,147	$	3.72	6.5	$	188,738

Schedule of information related to stock options

The following table presents information related to stock options as of September 30, 2022:


Options Outstanding			Options Exercisable
			Weighted
		Outstanding	Average	Exercisable
Exercise		Number of	Remaining Life	Number of
Price		Options	In Years	Options
	$1.00 - $1.99	1,577,286	4.1	827,636
	$2.00 - $2.99	1,010,018	7.7	762,034
	$3.00 - $3.99	1,241,069	7.0	820,883
	$4.00 - $4.99	385,305	8.8	147,760
	$5.00 - $5.99	100,805	6.2	79,805
	$6.00 - $6.99	1,005,286	7.1	715,111
	$7.00+	164,918	5.5	164,918
		5,484,687	6.5	3,518,147

Summary of the warrant activity and related information


				Weighted
		Weighted		Average
		Average		Remaining	Aggregate
	Number of	Exercise		Life	Intrinsic
	Warrants	Price		In Years	Value
Outstanding January 1, 2022	1,217,715	$	2.69
Granted	6,740,260		2.56
Exercised	(1,870,130)		0.01
Outstanding September 30, 2022	6,087,845	$	3.37	4.5	$	—

Exercisable September 30, 2022	6,087,845	$	3.37	4.5	$	—

Schedule of warrants outstanding

The following table presents information related to warrants as of September 30, 2022:


Warrants Outstanding		Warants Exercisable
		Weighted
	Outstanding	Average	Exercisable
Exercise	Number of	Remaining Life	Number of
Price	Warrants	In Years	Warrants
$2.4696	909,451	2.5	909,451
$2.7240	216,380	2.5	216,380
$4.7600	91,884	8.6	91,884
$3.5400	4,870,130	4.9	4,870,130
	6,087,845	4.5	6,087,845

Business Organization, Nature of Operations and Basis of Presentation (Details)	9 Months Ended
	Sep. 30, 2022
Business Organization, Nature of Operations and Basis of Presentation
High rate of Optejet	98.00%
Rate of traditional eye drops	50.00%
Technology Provides Reduction In Ocular Drug And Preservative Exposure, Percent	75.00%
Percentage eyedrops expose the ocular surface	300.00%

Summary of Significant Accounting Policies - Anti-dilutive weighted average diluted common shares (Details) - shares	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
Anti-dilutive securities
Total potentially dilutive shares	11,745,332	5,611,839
Option
Anti-dilutive securities
Total potentially dilutive shares	5,484,687	3,410,540
Warrants
Anti-dilutive securities
Total potentially dilutive shares	6,087,845	2,095,993
Restricted stock units
Anti-dilutive securities
Total potentially dilutive shares	172,800	105,306

Summary of Significant Accounting Policies - Additional Information (Details) - USD ($)					3 Months Ended						9 Months Ended
	Nov. 04, 2022	Oct. 01, 2022	Mar. 03, 2022	Dec. 14, 2021	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2021	Jun. 30, 2021	Mar. 31, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Summary of Significant Accounting Policies
Cash and cash equivalents					$ 17,398,605			$ 13,500,871			$ 17,398,605	$ 13,500,871	$ 19,461,850
Accumulated deficit					(112,107,067)						(112,107,067)		(90,219,306)
Net loss					(7,308,996)	$ (7,239,100)	$ (7,339,665)	$ (5,568,598)	$ (4,841,400)	$ (5,351,667)	(21,887,761)	(15,761,665)
Cash used in operations											(19,700,622)	$ (14,997,807)
Amount pledged to establish and maintain a collateralized money market account					7,875,000						7,875,000
Cash, Uninsured Amount					24,773,605						24,773,605		$ 26,836,850
Accounting Standards Update 2016-02 \| Cumulative Effect, Period of Adoption, Adjustment
Summary of Significant Accounting Policies
Operating lease, Right of use assets					1,300,000						1,300,000
Operating lease, liabilities					$ 1,400,000						$ 1,400,000
Securities purchase agreement
Summary of Significant Accounting Policies
Net proceeds			3,000,000
Securities purchase agreement \| March 2022 offering
Summary of Significant Accounting Policies
Proceeds from issuance of common stock			$ 15,000,000
Clinical Supply Arrangements
Summary of Significant Accounting Policies
Clinical trials, percentage of additional mark-up on cost											10.00%
December 2021 Sales Agreement
Summary of Significant Accounting Policies
Proceeds from issuance of common stock				$ 50,000,000.0							$ 4,000,000.0
Net proceeds											2,128,763
Subsequent Event
Summary of Significant Accounting Policies
Proceeds from issuance of common stock		$ 1,300,000
Net proceeds		587,298
Subsequent Event \| Silicon Valley Bank loan
Summary of Significant Accounting Policies
Cash and cash equivalents	$ 100,000
Restricted cash used for substantial repayment	7,875,000
Aggregate principal payments	7,500,000
Final payment	400,000
Prepayment fee	$ 100,000

Prepaid Expenses and Other Current Assets (Details) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Prepaid Expenses and Other Current Assets
Payroll tax receivable	$ 621,063	$ 343,785
Prepaid insurance expenses	455,150	171,370
Prepaid general and administrative expenses	185,845	71,375
Prepaid conference expenses	100,803	12,586
Prepaid patent expenses	49,183	32,797
Other	32,226	4,525
Prepaid security deposits	18,750	18,750
Prepaid board of directors fees	0	66,250
Total prepaid expenses and other current assets	$ 1,463,020	$ 721,438

Accrued Compensation (Details) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Accrued Compensation
Accrued bonus expenses	$ 971,159	$ 1,245,795
Accrued payroll expenses	296,850	297,823
Total accrued compensation	$ 1,268,009	$ 1,543,618

Accrued Expenses and Other Current Liabilities (Details) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Accrued Expenses and Other Current Liabilities
Accrued research and development expenses	$ 711,710	$ 436,840
Accrued consulting and professional services	386,712	250,000
Accrued interest	152,969	94,792
Credit card payable	58,799	20,000
Accrued franchise tax	39,300	1,680
Other	29,647	42,407
Accrued travel and entertainment expenses	5,666	0
Total accrued expenses and other current liabilities	$ 1,384,803	$ 845,719

Notes Payable - Schedule of notes payable (Details) - Silicon Valley Bank loan - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Notes payable
Notes Payable, Total	$ 7,500,000	$ 7,500,000
Debt Discount, Total	(270,987)	(349,632)
Notes payable, Net of Debt Discount, Total	$ 7,229,013	$ 7,150,368

Notes Payable - Additional Information (Details) - USD ($)			3 Months Ended	9 Months Ended
	Feb. 24, 2022	May 07, 2021	Sep. 30, 2022	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Notes Payable
Notes payable			$ 7,229,013	$ 7,229,013		$ 7,150,368
Repayments of loan				675,332	$ 547,259
Debt issuance costs				0	$ 66,618
D&O insurance policy loan
Notes Payable
Number of monthly payments	6 months
Notes payable	$ 675,332
Number of monthly payments	$ 113,628
Interest rate (as a percent)	3.26%
Maturity date	Aug. 24, 2022
Repayments of loan				675,332
Amortization of debt discount			26,214	78,645
Debt issuance costs			923	6,435
Silicon Valley Bank loan
Notes Payable
Interest expense			177,138	475,811
Loan issuance costs			$ 176,215	$ 469,376
Net present value (as a percent)		0.10%

Commitments and Contingencies - Additional Information (Details)				3 Months Ended		9 Months Ended
	Jul. 26, 2022 USD ($) shares	May 19, 2022 USD ($) ft²	Apr. 08, 2022 USD ($) ft²	Sep. 30, 2022 USD ($) ft²	Sep. 30, 2021 USD ($)	Sep. 30, 2022 USD ($) ft²	Sep. 30, 2021 USD ($)	Feb. 14, 2022 USD ($)
Commitments and Contingencies
Aggregate current base salary								$ 1,517,000
Mr. Rowe
Commitments and Contingencies
Annual salary	$ 575,000
Aggregate potential severance pay for executive officers	$ 1,004,000
Maximum cash bonus percentage	60.00%
Number of options to purchase common stock, shares issued \| shares	440,000
Dr. Ianchulev, Executive Chairman
Commitments and Contingencies
Initial period of service	1 year
Monthly retainer	$ 5,000
Lease agreement for new office located in Laguna Hills, CA
Commitments and Contingencies
Area of land \| ft²			3,916
Lease expiration date			Jul. 31, 2027
Lease payments per month			$ 9,203
Security deposit			$ 11,400
Lease agreement for new office located in Reno, Nevada
Commitments and Contingencies
Area of land \| ft²		10,881
Lease expiration date		Sep. 23, 2027
Security deposit		$ 53,000
Additional number of months in which option to extend the lease		60 months
Lease agreement for new office located in Reno, Nevada \| Minimum
Commitments and Contingencies
Lease payments per month		$ 13,056
Lease agreement for new office located in Reno, Nevada \| Maximum
Commitments and Contingencies
Lease payments per month		$ 16,663
Research and Development
Commitments and Contingencies
Rent expense						$ 48,636	$ 48,636
Research and Development \| Lease agreement for new office located in Reno, Nevada
Commitments and Contingencies
Rent expense				$ 41,238		59,787
General and Administrative \| Lease agreement for new office located in Laguna Hills, CA
Commitments and Contingencies
Rent expense				$ 28,371		$ 37,828
Vice President of Research And Development
Commitments and Contingencies
Net rentable area \| ft²				953		953
Lease payments						$ 5,404
Security and equipment deposits				$ 5,404		5,404
Leasehold improvements				112,600		$ 112,600
Lease expiration date						Sep. 14, 2022
Vice President of Research And Development \| Research and Development
Commitments and Contingencies
Rent expense				$ 16,212	$ 16,212

Stockholders' Equity - Restricted stock units activity (Details)	9 Months Ended
	Sep. 30, 2022 $ / shares shares
Number of RSUs
RSUs non-vested at beginning of period \| shares	41,778
Granted \| shares	193,304
Vested \| shares	(55,319)
Forfeited \| shares	(6,963)
RSUs non-vested at end of the period \| shares	172,800
Vested RSUs undelivered \| shares	41,086
Weighted Average Grant Date Value Per Share
RSUs non-vested January 1, 2021 \| $ / shares	$ 3.59
Granted \| $ / shares	1.93
Vested \| $ / shares	3.37
Forfeited \| $ / shares	3.59
RSUs non-vested September 30, 2022 \| $ / shares	1.80
Vested RSUs undelivered September 30, 2022 \| $ / shares	$ 3.64

Stockholders' Equity - Black Scholes option (Details)	3 Months Ended		9 Months Ended
Stockholders' Equity - Black Scholes option (Details)	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Expected term (years)		5 years 10 months 6 days
Risk free interest rate		0.81%
Expected volatility		92.00%
Expected dividends	0.00%	0.00%	0.00%	0.00%
Minimum
Expected term (years)	5 years 4 months 28 days	5 years 10 months 6 days	6 months 29 days	5 years 10 months 6 days
Risk free interest rate	2.66%	0.81%	0.76%	0.45%
Expected volatility	85.00%		82.00%	92.00%
Maximum
Expected term (years)	5 years 10 months 6 days		10 years	10 years
Risk free interest rate	3.02%		3.35%	1.58%
Expected volatility	87.00%		90.00%	94.00%

Stockholders' Equity - Summary of option activity (Details) - Stock Options - USD ($)	9 Months Ended
	Sep. 30, 2022
Number of Options, Outstanding \| Shares	4,377,398
Number of Options, Granted \| Shares	1,167,310
Number of Options, Forfeited \| Shares	(60,021)
Number of Options, Outstanding \| Shares	5,484,687
Number of Options, Exercisable \| Shares	3,518,147
Weighted Average Exercise Price, Outstanding \| $ / Shares	$ 3.89
Weighted Average Exercise Price, Granted \| $ / Shares	2.23
Weighted Average Exercise Price, Forfeited \| $ / Shares	4.21
Weighted Average Exercise Price, Outstanding \| $ / Shares	3.53
Weighted Average Exercise Price, Exercisable \| $ / Shares	$ 3.72
Weighted Average Remaining Life In Years, Outstanding	7 years 4 months 24 days
Weighted Average Remaining Life In Years, Exercisable	6 years 6 months
Aggregate Intrinsic Value, Outstanding \| $	$ 375,417
Aggregate Intrinsic Value, Exercisable	$ 188,738

Stockholders' Equity - Summary of information related to stock options (Details)	9 Months Ended
	Sep. 30, 2022 $ / shares shares
Options Outstanding, Outstanding Number of Options	5,484,687
Options Exercisable, Weighted Average Remaining Life In Years	6 years 6 months
Options Exercisable, Exercisable Number of Options	3,518,147
Exercise Price, $1.00 - $1.99
Options Outstanding, Outstanding Number of Options	1,577,286
Options Exercisable, Weighted Average Remaining Life In Years	4 years 1 month 6 days
Options Exercisable, Exercisable Number of Options	827,636
Exercise Price, $1.00 - $1.99 \| Minimum
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 1.00
Exercise Price, $1.00 - $1.99 \| Maximum
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 1.99
Exercise Price, $2.00 - $2.99
Options Outstanding, Outstanding Number of Options	1,010,018
Options Exercisable, Weighted Average Remaining Life In Years	7 years 8 months 12 days
Options Exercisable, Exercisable Number of Options	762,034
Exercise Price, $2.00 - $2.99 \| Minimum
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 2.00
Exercise Price, $2.00 - $2.99 \| Maximum
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 2.99
Exercise Price, $3.00 - $3.99
Options Outstanding, Outstanding Number of Options	1,241,069
Options Exercisable, Weighted Average Remaining Life In Years	7 years
Options Exercisable, Exercisable Number of Options	820,883
Exercise Price, $3.00 - $3.99 \| Minimum
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 3.00
Exercise Price, $3.00 - $3.99 \| Maximum
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 3.99
Exercise Price, $4.00 - $4.99
Options Outstanding, Outstanding Number of Options	385,305
Options Exercisable, Weighted Average Remaining Life In Years	8 years 9 months 18 days
Options Exercisable, Exercisable Number of Options	147,760
Exercise Price, $4.00 - $4.99 \| Minimum
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 4.00
Exercise Price, $4.00 - $4.99 \| Maximum
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 4.99
Exercise Price, $5.00 - $5.99
Options Outstanding, Outstanding Number of Options	100,805
Options Exercisable, Weighted Average Remaining Life In Years	6 years 2 months 12 days
Options Exercisable, Exercisable Number of Options	79,805
Exercise Price, $5.00 - $5.99 \| Minimum
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 5.00
Exercise Price, $5.00 - $5.99 \| Maximum
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 5.99
Exercise Price, $6.00 - $6.99
Options Outstanding, Outstanding Number of Options	1,005,286
Options Exercisable, Weighted Average Remaining Life In Years	7 years 1 month 6 days
Options Exercisable, Exercisable Number of Options	715,111
Exercise Price, $6.00 - $6.99 \| Minimum
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 6.00
Exercise Price, $6.00 - $6.99 \| Maximum
Options Outstanding, Outstanding Exercise Price \| $ / shares	6.99
Exercise Price, $7.00+
Options Outstanding, Outstanding Exercise Price \| $ / shares	$ 7.00
Options Outstanding, Outstanding Number of Options	164,918
Options Exercisable, Weighted Average Remaining Life In Years	5 years 6 months
Options Exercisable, Exercisable Number of Options	164,918

Stockholders' Equity - Warrants Activity (Details)	9 Months Ended
Stockholders' Equity - Warrants Activity (Details)	Sep. 30, 2022 $ / shares shares
Number of Warrants
Outstanding at beginning balance \| shares	1,217,715
Granted \| shares	6,740,260
Exercised \| shares	(1,870,130)
Outstanding at ending balance \| shares	6,087,845
Exercisable Number of warrants \| shares	6,087,845
Weighted Average Exercise Price
Outstanding at beginning balance \| $ / shares	$ 2.69
Granted \| $ / shares	2.56
Exercised \| $ / shares	0.01
Outstanding at ending balance \| $ / shares	3.37
Exercisable \| $ / shares	$ 3.37
Weighted Average Remaining Life, Outstanding	4 years 6 months
Weighted Average Remaining Life, Exercisable	4 years 6 months

Stockholders' Equity - Related to warrants (Details) - USD ($)	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021
Related to warrants
Exercise price	$ 0.01
Outstanding Number of Warrants	6,087,845		1,217,715
Weighted Average Remaining Life, Exercisable	4 years 6 months
Exercisable Number of Warrants	6,087,845
Number of warrants exercised	1,870,130
Proceeds from exercise of warrants	$ 18,701	$ 2,103,991
Warrants at exercise price of $2.4696
Related to warrants
Exercise price	$ 2.4696
Outstanding Number of Warrants	909,451
Weighted Average Remaining Life, Exercisable	2 years 8 months 12 days
Exercisable Number of Warrants	909,451
Warrants at exercise price of $2.7240
Related to warrants
Exercise price	$ 2.7240
Outstanding Number of Warrants	216,380
Weighted Average Remaining Life, Exercisable	2 years 6 months
Exercisable Number of Warrants	216,380
Warrants at exercise price of $4.7600
Related to warrants
Exercise price	$ 4.7600
Outstanding Number of Warrants	91,884
Weighted Average Remaining Life, Exercisable	8 years 7 months 6 days
Exercisable Number of Warrants	91,884
Warrants at exercise price of $3.5400
Related to warrants
Exercise price	$ 3.5400
Outstanding Number of Warrants	4,870,130
Weighted Average Remaining Life, Exercisable	4 years 10 months 24 days
Exercisable Number of Warrants	4,870,130

Stockholders' Equity - Additional Information (Details) - USD ($)			3 Months Ended			9 Months Ended
	Mar. 03, 2022	Dec. 14, 2021	Sep. 30, 2022	Sep. 30, 2021	Jun. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Jun. 16, 2022
Number of warrants issued			1,870,130			1,870,130
Share-based compensation			$ 928,733	$ 777,467		$ 2,874,646	$ 2,071,735
Unrecognized stock - based compensation expense			$ 4,058,569			$ 4,058,569
Weighted average period of recognition						1 year 7 months 6 days
Proceeds from Issuance of Warrants						$ 18,701
Proceeds from Stock Options Exercised						$ 0	176,802
Exercise price of warrants			$ 0.01			$ 0.01
Securities purchase agreement
Net proceeds	3,000,000
Share price	$ 3.08
Research and Development
Share-based compensation			$ 420,619	489,121		$ 1,438,469	1,138,331
General and Administrative
Share-based compensation			508,114	$ 288,343		1,436,177	$ 933,401
Restricted stock units
Unrecognized stock - based compensation expense			$ 254,152			$ 254,152
Weighted average period of recognition						9 months 18 days
Options
Weighted average estimated grant date fair value			$ 1.22	$ 3.56		$ 1.61	$ 4.16
Common Stock
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period				16,539	91,047
December 2021 Sales Agreement
Proceeds from issuance of common stock		$ 50,000,000.0				$ 4,000,000.0
Net proceeds						2,128,763
December 2021 Sales Agreement \| Common Stock
Percentage on gross sale		3.00%
Amended and Restated 2018 Omnibus Stock Incentive Plan
Number of shares of common stock reserved for further issuance								1,500,000
Pre-Funded Warrants \| Securities purchase agreement
Number of warrants issued	1,870,130
Share price	$ 3.07
Decrease in exercise price	$ 0.01
Investor Warrants \| Securities purchase agreement
Number of warrants issued	4,870,130
Share price	$ 3.54
March 2022 offering \| Securities purchase agreement
Proceeds from issuance of common stock	$ 15,000,000
Aggregate issuance costs of pre-funded warrants and investor warrants	$ 83,000

Employee Benefit Plans (Details) - USD ($)	1 Months Ended	3 Months Ended		9 Months Ended
Employee Benefit Plans (Details) - USD ($)	Apr. 30, 2019	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
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		$ 39,914	$ 34,076	$ 173,896	$ 144,917

Subsequent Events (Details) - USD ($)			9 Months Ended
Subsequent Events (Details) - USD ($)	Nov. 04, 2022	Oct. 01, 2022	Sep. 30, 2022	Sep. 30, 2021
Subsequent Events
Repayments of long-term debt, total			$ 0	$ 66,618
Subsequent Events
Subsequent Events
Gross proceeds		$ 1,300,000
Subsequent Events \| Silicon Valley Bank loan
Subsequent Events
Repayments of long-term debt, total	$ 8,000,000.0
Aggregate principal payments	7,500,000
Final payment of loan	$ 375,000
Percentage of prepayment fees	2.00%
Prepayment fees	$ 150,000
Restricted cash used for substantial repayment	$ 7,875,000
Subsequent Events \| At Market Offering Program
Subsequent Events
Gross proceeds		1,400,000
Net proceeds from At-the-Market Offering Program		$ 1,300,000
Subsequent Events \| At Market Offering Program \| Silicon Valley Bank loan
Subsequent Events
Number of shares sold in At-the-Market Offering Program		587,298