electroCore, Inc 10-K for FY2021

electroCore, Inc. (ECOR)

10-K 2022-03-10 For: 2021-12-31

Added on April 11, 2026

About this 10-K

electroCore, Inc filed this 10-K on March 10, 2022, covering the fiscal year ended December 31, 2021 (FY2021).

Headline figures

Fiscal year ended December 31, 2021, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $5.45M; up 55.9% from $3.5M a year earlier
Net loss: $17.22M; compared with a net loss of $23.51M a year earlier

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Delaware		20-3454976
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)
200 Forge Way, Suite 205, Rockaway, NJ		07866
(Address of principal executive offices)		(Zip Code)


Title of each class	Trading symbol(s)	Name of each exchange on which registered
Common Stock, Par Value $0.001 Per Share	ECOR	Nasdaq Global Select Stock Market

Large accelerated filer	☐	Accelerated filer	☐

Non-accelerated filer	☒	Smaller reporting company	☒

Emerging growth company	☒

	Table of Content	Page
PART I
Item 1.	Business	1
Item 1A.	Risk Factors.	20
Item 1B.	Unresolved Staff Comments	79
Item 2.	Properties	79
Item 3.	Legal Proceedings	79
Item 4.	Mine Safety Disclosures	80

PART II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	81
Item 6.	[Reserved]	81
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	82
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	92
Item 8.	Financial Statements and Supplementary Data	92
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	92
Item 9A.	Controls and Procedures	93
Item 9B.	Other Information	93
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections	93

PART III
Item 10.	Directors, Executive Officers and Corporate Governance	94
Item 11.	Executive Compensation	94
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	94
Item 13.	Certain Relationships and Related Transactions, and Director Independence	94
Item 14.	Principal Accountant Fees and Services	94

PART IV
Item 15.	Exhibits and Financial Statement Schedules	95
Item 16.	Form 10-K Summary	95

•	The coronavirus pandemic could have a significant negative impact on our business, revenues, financial condition and results of operations.
•	We have a history of significant losses. If we do not achieve and sustain profitability, our financial condition could suffer. Our failure to become and remain profitable could negatively impact the results of our operations and your investment.
•	We will be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.
•	Commercializing our gammaCore Sapphire CV therapy for the acute treatment of asthma exacerbations in known or suspected COVID-19 patients may require targeted investment in research and development and expansion of our sales and marketing capabilities.
•	We rely upon specialty pharmacies to distribute some of our products in the United States.
•	Regulatory requirements and changes to payers’ prescription benefit plans and medical pathway plans could adversely impact our business and financial results.
•	We must demonstrate to patients, physicians and third-party payers the medical and economic benefits of our gammaCore therapy compared to those of our competitors or other available therapies and such comparisons may not be realizable.
•	Our operating results may vary significantly from quarter to quarter because of seasonality, bulk orders, shipments to distributors or otherwise.
•	Commercialization of our gammaCore Sapphire therapy for additional neurological conditions may require clinical trials that are very expensive, time-consuming, difficult to design and implement and involve uncertain outcomes. Furthermore, results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies, clinical trials or commercial success.
•	If we fail to develop and retain an effective sales and customer service function, our business could suffer.
•	We recently launched new cash pay initiatives, including our gConcierge and gCDirect programs, and patients and providers may be slow to adopt these programs or their pricing which could adversely impact our business and financial results.

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

•	If our competitors are better able to develop and market primary headache treatments that are safer, more effective, less costly, easier to use or otherwise more attractive than our gammaCore therapy, our business and business prospects will be adversely impacted.
•	Many of our competitors are large, well-established companies with substantially greater resources than us and have a long history of competing in the migraine market.
•	Traditional products used to treat cluster headache and migraine have been available for decades, while our gammaCore therapy has only been commercially available in Europe for several years, and for approximately three years in the United States, and, as a result, we have a limited track record compared to our competitors.
•	Our international operations subject us to certain operating and compliance risks, which could adversely impact our results of operations and financial condition.
•	We may not be able to establish or strengthen our brand.
•	We relied upon primary, secondary, and sole source third-party suppliers located in China and elsewhere for components and packaging of our gammaCore products, which suppliers have paused delivery at our request, thereby making us vulnerable to supply shortages, price fluctuations, and an inability to reactivate supply chains, if necessary, all of which could harm our business.
•	Our potential revenue in the United Kingdom is substantially dependent on government funding arrangements and changes in such governmental policy could cause material harm to our business.
•	Our business is subject to extensive governmental regulation that makes it expensive and time consuming for us to bring our gammaCore therapy to market in the United States and other countries and to expand the use of our gammaCore therapy to additional therapeutic indications.
•	Our failure to meet the continued listing requirements of Nasdaq could result in delisting of our common stock, which could negatively impact the market price and liquidity of our common stock and our ability to access the capital markets.
•	We are currently subject to securities class action lawsuits against us, which could result in adverse outcomes.
•	Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
•	We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.
•	Our stock price may be volatile, and you may not be able to resell shares of our common stock at or above the price you paid.

	•	Exploiting our qualifying contract on the FSS, which we secured in December 2018, and open market sales to individual VA facilities. Veteran's Administration Headache Center of Excellence Annual Report, approximately 410,000 patients saw a VA healthcare provider for headache in 2020 and VA's National Director of the Headache Center of Excellence program has stated that the VA has approximately 29,000 cluster headache sufferers. The VA and DoD have become our primary source of U.S. revenue and, accordingly, we have redeployed most of our sales function to generating sales from this channel.

	•	Expanding our direct-to-consumer promotion, including the opening of telemedicine portal and online stores in the United States and United Kingdom to reach patients and their health care advisors for the prevention and treatment of primary headache disorders.

	•	Expanding call points from the traditional neurology headache specialists to include the wide range of medical providers who manage patients' headache conditions. Those specialties include prescribers in primary care, women's health, pain management, functional and integrative medicine, as well as chiropractors, and PharmDs (Doctors of Pharmacy).

	•	In the United Kingdom, continued expansion under the MTFM program for cluster headache and cash pay product offerings via the online store.

	•	Working towards leveraging the unique HCPCS code K1020 "non-invasive vagus nerve stimulator" that was established as part of CMS' second biannual 2020 Coding Cycle for non-drug and non-biological items and services, and which we believe could streamline reimbursement for both government and commercial payers.


	•	Utilizing selected distribution partners to commercialize our gammaCore therapy in territories outside of the United States and United Kingdom.

	•	Developing future iterations of our therapy delivery platform, including the use of our intellectual property around the delivery of smartphone-integrated and smartphone-connected non-invasive therapies.

	•	notices of corrections or removals; and

	•	HIPAA compliance around patient information.


	•	established competitors with strong relationships with customers, including ecommerce and telehealth platforms, systems, marketing agencies and a critical mass of existing patients;

	•	limitations in our ability to demonstrate differentiation and advantages of our product compared to competing products and the relative safety, efficacy and ease of use of our product;

	•	the limited size of our marketing team and the learning curve required to gain experience selling our product direct-to-consumer;

	•	insufficient financial or other resources to support our commercialization efforts necessary to reach profitability; and

	•	the introduction and market acceptance of new, more effective or less expensive competing products and technologies.


	•	regulatory hurdles;

	•	anticipated benefits may not materialize;

	•	cultural challenges associated with integrating employees from the acquired company into our organization;

	•	integration of the acquired company's products and technology;

	•	integration of the acquired company's accounting, management information, human resources and other administrative systems;

	•	the need to implement or improve controls, procedures and policies at a business that prior to the acquisition may have lacked effective controls, procedures and policies;


	•	coordination of product development and sales and marketing functions;

	•	liability for activities of the acquired company before the acquisition, including relating to privacy and data security, patent and trademark infringement claims, violations of laws, commercial disputes, tax liabilities and other known and unknown liabilities; and

	•	litigation or other claims in connection with the acquired company, including claims from terminated employees, users, former stockholders or third parties.

	•	the outcome, timing of, and costs involved with negotiating, obtaining, maintaining and enhancing payer coverage;

	•	the outcome, timing of, and costs involved with our plan to potentially expand our direct-to-consumer cash-pay business channel;

	•	patients' acceptance of gammaCore therapy;

	•	payor adoption;

	•	estimated useful life of products

	•	the timing of when individual payer coverage becomes available;

	•	patient and physician product returns;

	•	the timing, expense and results of research and development activities, future clinical trials and regulatory clearance or approvals;

	•	fluctuations in our expenses associated with expanding our commercial operations and operating as a public company;

	•	fluctuations in our marketing spend to drive patient purchases;

	•	the introduction of new products, therapies and technologies by competitors;

	•	the imposition of new trade restrictions.; and

	•	disruptions caused by Brexit

	•	Even if our patents are determined by the U.S. Patent and Trademark Office, or USPTO, foreign patent office, or a court to be valid and enforceable, they may not be drafted or interpreted sufficiently broadly to prevent others from marketing products and services similar to ours or designing around our patents. For example, third parties may be able to develop therapies, or make systems or devices, that are similar to ours but that are not covered by the claims of our patents. Third parties may assert that we or our licensors were not the first to make the inventions covered by our issued patents or pending patent applications. The claims of our issued patents or patent applications when issued may not cover our commercial technology or the future products and services that we develop. We may not have freedom to operate unimpeded by the patent rights of others. Third parties may have dominating, blocking or other patents relevant to our technology of which we are not aware. In addition, because patent applications in the United States and many foreign jurisdictions are typically not published until 18 months after the filing of certain priority documents (or, in some cases, are not published until they issue as patents) and because publications in the scientific literature often lag behind actual discoveries, we cannot be certain that others have not filed patent applications for our technology or our contemplated technology. Any such patent applications may have priority over our patent applications or issued patents, which could further require us to obtain rights from third parties to issued patents or pending patent applications covering such technologies to allow us to commercialize our technology. There may be prior public disclosures of which we are not aware that could invalidate our patents or a portion of the claims of our patents. Further, we may not develop additional proprietary technologies and, even if we do, they may not be patentable.

	•	Patent law can be highly uncertain and involve complex legal and factual questions for which important principles remain unresolved. In the United States and in many foreign jurisdictions, policies regarding the breadth of claims allowed in patents can be inconsistent. The U.S. Supreme Court and the U.S. Court of Appeals for the Federal Circuit have made, and will likely continue to make, changes in how the patent laws of the United States are interpreted. Similarly, foreign courts have made, and will likely continue to make, changes in how the patent laws in their respective jurisdictions are interpreted. We cannot predict future changes in the interpretation of patent laws or changes to patent laws that might be enacted into law by U.S. and foreign legislative bodies. Those changes may materially affect our patents or patent applications, our ability to obtain patents, or the patents and patent applications of our licensors. Future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage, which could adversely affect our financial condition and results of operations.


	•	We may not be able to accurately estimate or control our future operating expenses in relation to obtaining, enforcing and/or defending intellectual property, which could lead to cash shortfalls. Our operating expenses may fluctuate significantly in the future as a result of the costs of preparing, filing, prosecuting, defending and enforcing patent claims and other patent related costs, including litigation costs and the results of such litigation.

	•	Occupational Safety and Health Administration requirements;

	•	Federal Trade Commission;

	•	health information privacy and security, including the Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and comparable state laws; and

	•	any action asserting a claim against us arising under the Delaware General Corporation Law, our certificate of incorporation, or our bylaws; and

	•	any action asserting a claim against us that is governed by the internal-affairs doctrine, in each case provided that the Chancery Court has subject matter jurisdiction. If the Chancery Court does not have subject matter jurisdiction, then such actions may be brought in any state court located in the state of Delaware, or State Courts, or, if and only if the State Courts lack subject matter jurisdiction, in the federal district court for the District of Delaware.

	•	our operating results and financial position;
	•	announcements related to regulatory clearance to market gammaCore for the treatment of various conditions in the United States;
	•	results from, or any delays in, clinical trial programs relating to our product candidates;
	•	announcements of new products by us or our competitors;
	•	adverse actions taken by regulatory agencies with respect to our clinical trials, manufacturing supply chain or sales and marketing activities;
	•	changes or developments in laws or regulations applicable to our products;
	•	any adverse changes in our relationship with any manufacturers or suppliers;
	•	the success of our efforts to acquire or develop additional products;
	•	any intellectual property infringement actions in which we may become involved;
	•	announcements concerning our competitors or the medical device industry in general;
	•	achievement of expected product sales and profitability;
	•	changes or developments in our commercial strategy and tactics;
	•	manufacture, supply or distribution shortages;
	•	actual or anticipated fluctuations in our operating results;
	•	FDA or other U.S. or foreign regulatory actions affecting us or our industry or other healthcare reform measures in the United States;
	•	changes in financial estimates or recommendations by securities analysts
	•	trading volume of our common stock;
	•	sales of our common stock by us, our executive officers, directors or stockholders;
	•	general economic and market conditions and overall fluctuations in the U.S. equity markets; and
	•	the loss of any of our key scientific or management personnel.

Territory	Distributor	Country
North America	RSK Medical	Canada
Eastern Europe	Pro Medical Baltic	Lithuania, Latvia, Belarus, Kazakhstan, and Ukraine
Western Europe	Silvert Medical Nv-Sa.	Belgium, Luxembourg, the Netherlands, and France
Australia	Medistar2 PTY Ltd	Australia
Asia	Kromax International Corp. Kromax South Asia Pte Ltd.	Taiwan and China Malaysia, Singapore, and Indonesia
Middle East	East Agency Melidonia Cyrus Medexsol	Qatar Cypress United Arab Emirates and Oman Saudi Arabia and Bahrain

	Years ended December 31,
	2021			2020			Change
	(in thousands)
Net sales	$	5,451.2		$	3,495.8		$	1,955.4
Cost of goods sold		1,385.0			1,737.5			(352.5	)
Gross profit		4,066.2			1,758.3			2,307.9
Operating expenses:
Research and development		2,535.9			4,201.3			(1,665.4	)
Selling, general and administrative		21,573.4			21,840.9			(267.5	)
Restructuring and other severance related charges		—			464.6			(464.6	)
Total operating expenses		24,109.3			26,506.8			(2,397.5	)
Loss from operations		(20,043.1	)		(24,748.5	)		4,705.4
Other (income) expense:
Gain on extinguishment of debt		(1,422.2	)		—			(1,422.2	)
Gain on termination of joint venture		(549.3	)		—			(549.3	)
Interest and other income		(10.7	)		(84.3	)		73.6
Other expense		8.3			17.8			(9.5	)
Total other (income) expense		(1,973.9	)		(66.5	)		(1,907.4	)
Loss before income taxes		(18,069.2	)		(24,682.0	)		6,612.8
Benefit from income taxes		851.2			1,170.9			(319.7	)
Net loss		(17,218.0	)		(23,511.1	)		6,293.1

electroCore, Inc 10-K for FY2021

About this 10-K

Headline figures

Table of Content

Page

	December 31,
	2021			2020
	(in millions)
Net cash (used in) provided by
Operating activities	$	(13.6	)	$	(20.1	)
Investing activities	$	18.2		$	(8.0	)
Financing activities	$	25.7		$	18.9

Report of Independent Registered Public Accounting Firm PCAOB ID # 688	F-2
Consolidated Balance Sheets	F-4
Consolidated Statements of Operations	F-5
Consolidated Statements of Comprehensive Loss	F-6
Consolidated Statements of Equity	F-7
Consolidated Statements of Cash Flows	F-8
Notes to Consolidated Financial Statements	F-9

Exhibit Number	Description
3.1***		Certificate of Incorporation of electroCore, Inc.

3.2*****		Amended and Restated Bylaws of electroCore, Inc.

4.1*****		Registration Rights Agreement, dated March 27, 2020, between electroCore, Inc. and Lincoln Park Capital Fund, LLC

4.2*		Description of Capital Stock

10.2†**		electroCore, Inc. 2018 Omnibus Equity Incentive Plan

10.3†*		Form of Employee Restricted Stock Unit Agreement for electroCore, Inc. 2018 Omnibus Equity Incentive Plan

10.4†*		Form of Non-qualified Stock Option Agreement for electroCore, Inc. 2018 Omnibus Equity Incentive Plan

10.5†**		Form of Employee Restricted Stock Award Agreement for electroCore, Inc. 2018 Omnibus Equity Incentive Plan

10.6†**		Form of Non-Employee Director Inaugural Deferred Stock Unit Award Agreement for electroCore, Inc. 2018 Omnibus Equity Incentive Plan

10.7†**		Form of Non-Employee Director Inaugural Non-qualified Stock Option Agreement for electroCore, Inc. 2018 Omnibus Equity Incentive Plan

10.8†**		Form of Non-Employee Director Inaugural Restricted Stock Unit Agreement for electroCore, Inc. 2018 Omnibus Equity Incentive Plan

10.9†**		Form of Non-Employee Director Annual Deferred Stock Unit Award Agreement for electroCore, Inc. 2018 Omnibus Equity Incentive Plan

10.10†**		Form of Non-Employee Director Annual Non-qualified Stock Option Agreement for electroCore, Inc. 2018 Omnibus Equity Incentive Plan

10.11†**		Form of Non-Employee Director Annual Restricted Stock Unit Agreement for electroCore, Inc. 2018 Omnibus Equity Incentive Plan

10.12†**		Form of Indemnification Agreement between the Registrant and each of its executive officers and directors

10.13†**		Form of electroCore, Inc. Management Severance Plan

10.14†*		electroCore, Inc. Non-Employee Director Compensation Policy

10.15****		Rockaway, NJ Office Lease between Anson Logistics Assets LLC and electroCore, Inc.

10.17**		Form of Common Unit Warrant

10.18**		Form of Series A Warrant

10.19**		Form of Bridge Warrant


10.20†		Employment Offer Letter, dated as of September 26, 2019, between electroCore, Inc. and Daniel Goldberger, incorporated by reference to the Company's Current Report on Form 8-K, as filed with the Commission on October 2, 2019.

10.21†		Brian Posner Employment Agreement, dated as of January 30, 2019, incorporated by reference to the Company's Current Report on Form 8-K, as filed with the Commission on March 12, 2019.

10.22†		Amendment to Brian Posner Employment Agreement, dated as of August 8, 2019, incorporated by reference to the Company's Quarterly Report on Form 10-Q, as filed with the Commission on August 14, 2019.

21.1*		List of subsidiaries of electroCore, Inc.

23.1*		Consent of Marcum LLP

31.1*		Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2*		Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1*		Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2*		Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS		Inline XBRL Instance Document

101.SCH		Inline XBRL Taxonomy Extension Schema Document

101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB		Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document

******	Incorporated by reference to the Company's Current Report on Form 8-K as filed with Commission on December 23, 2021
†	Indicates management agreement

	electroCore, Inc.

Date: March 10, 2022	By:	/s/ DANIEL S. GOLDBERGER
		Daniel S. Goldberger
		Chief Executive Officer and Director (Principal Executive Officer)
Date: March 10, 2022	By:	/s/ BRIAN M. POSNER
		Brian M. Posner
		Chief Financial Officer (Principal Financial and Accounting Officer)

Name	Title	Date

/s/ Peter Cuneo	Chairman of the Board	March 10, 2022
Peter Cuneo

/s/ Michael G. Atieh	Director	March 10, 2022
Michael G. Atieh

/s/ Daniel S. Goldberger	Director	March 10, 2022
Daniel S. Goldberger
/s/ John Gandolfo	Director	March 10, 2022
John Gandolfo

/s/ Joseph P. Errico	Director	March 10, 2022
Joseph P. Errico

/s/ Thomas Patton	Director	March 10, 2022
Thomas Patton

/s/ Thomas J. Errico, M.D.	Director	March 10, 2022
Thomas J. Errico, M.D.

/s/ Trevor J. Moody	Director	March 10, 2022
Trevor J. Moody

Report of Independent Registered Public Accounting Firm PCAOB ID # 688	F-2

Consolidated Balance Sheets as of December 31, 2021 and 2020	F-3

Consolidated Statements of Operations for the Years ended December 31, 2021 and 2020	F-4

Consolidated Statements of Comprehensive Loss for the Years ended December 31, 2021 and 2020	F-5

Consolidated Statements of Equity for the Years ended December 31, 2021 and 2020	F-6

Consolidated Statements of Cash Flows for the Years ended December 31, 2021 and 2020	F-7

Notes to Consolidated Financial Statements	F-8

					Additional						Accumulated other			Total electroCore, Inc.,
	Common Stock				paid-in			Accumulated			comprehensive			stockholders'			Noncontrolling			Total
	Shares		Amount		capital			deficit			income (loss)			equity			interest			equity
Balances as of December 31, 2019		29,835,183		29,835		107,752,066			(83,479,098	)		(41,295	)		24,261,508			635,610			24,897,118
Net loss		—		—		—			(23,511,050	)		—			(23,511,050	)		—			(23,511,050	)
Other comprehensive income		—		—		—			—			(210,172	)		(210,172	)		—			(210,172	)
Issuance of stock (see Note 12)		14,308,048		14,308		19,370,888			—			—			19,385,196			—			19,385,196
Equity financing commitment fee*		692,514		693		(693	)		—			—			—			—			—
Financing fees		—		—		(182,821	)		—			—			(182,821	)		—			(182,821	)
Issuance of common stock in connection with employee stock plans, net of forfeitures		724,020		724		(724	)		—			—			—			—			—
Share based compensation		—		—		3,266,311			—			—			3,266,311			—			3,266,311
Balances as of December 31, 2020		45,559,765		45,560		130,205,027			(106,990,148	)		(251,467	)		23,008,972			635,610			23,644,582
Net loss		—		—		—			(17,218,070	)		—			(17,218,070	)		—			(17,218,070	)
Other comprehensive income		—		—		—			—			264,215			264,215			—			264,215
Issuance of stock (see Note 12)		23,450,000		23,450		25,658,712			—			—			25,682,162			—			25,682,162
Issuance of stock to satisfy certain obligations (see Note 12)		1,152,380		1,152		1,207,323			—			—			1,208,475			—			1,208,475
Issuance of common stock in connection with employee stock plans, net of forfeitures		376,565		377		(377	)		—			—			—			—			—
Settlement of accrued bonus		165,413		165		399,832			—			—			399,997			—			399,997
Share based compensation		—		—		3,302,083			—			—			3,302,083			—			3,302,083
Termination of joint venture		—		—		—			—			—			—			(635,610	)		(635,610	)
Balances as of December 31, 2021		70,704,123	$	70,704	$	160,772,600		$	(124,208,218	)	$	12,748		$	36,647,834		$	—		$	36,647,834

	Year ended December 31,
	2021			2020
Cash flows from operating activities:
Net loss	$	(17,218,070	)	$	(23,511,050	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock based compensation		3,302,083			3,266,311
Depreciation and amortization		381,509			399,242
Amortization of marketable securities premium		142,244			31,096
Gain on extinguishment of debt		(1,422,214	)		—
Gain on termination of joint venture		(549,254	)		—
Gain on lease settlement		(57,371	)		—
Increase in allowance for doubtful accounts		49,489			—
(Gain) loss on legal fee obligation settled with stock		(9,525	)		156,434
Noncash lease expense		55,114			372,304
Inventory reserve charge		69,972			433,918
Write-off of right of use operating lease asset		—			557,543
Other		—			676
Changes in operating assets and liabilities:
Accounts receivable		(217,186	)		225,594
Inventories		370,996			735,637
Prepaid expenses and other assets		716,044			982,129
Accounts payable		464,333			(1,581,579	)
Accrued expense and other current liabilities		425,219			(1,632,617	)
Right of use operating lease assets		(151,137	)		—
Operating lease liabilities		20,131			(486,445	)
Net cash used in operating activities		(13,627,623	)		(20,050,807	)
Cash flows from investing activities:
Purchase of marketable securities		(5,082,730	)		(24,463,158	)
Proceeds from maturities of marketable securities		23,300,000			16,500,000
Net cash provided by (used in) investing activities		18,217,270			(7,963,158	)
Cash flows from financing activities:
Proceeds from shares issued, net of related expenses		25,682,162			17,489,563
Proceeds from note issued		—			1,410,524
Net cash provided by financing activities		25,682,162			18,900,087
Effect of changes in exchange rates on cash and cash equivalents		175,134			(207,976	)
Net increase (decrease) in cash and cash equivalents		30,446,943			(9,321,854	)
Cash and cash equivalents – beginning of year		4,241,937			13,563,791
Cash and cash equivalents – end of year	$	34,688,880		$	4,241,937

Supplemental cash flows disclosures:
Proceeds from sale of state net operating losses	$	876,690		$	1,170,890
Income taxes paid	$	38,622		$	3,769
Interest paid	$	9,941		$	12,895
Supplemental schedule of noncash activity:
Settlement of certain obligations through issuance of common stock	$	1,275,370		$	1,548,702
2020 bonus paid in stock	$	399,997		$	—