▸ Closing down the DPNCheck business may be costly and provide additional regulatory scrutiny.· · · · ● 1 ▸ Litigation may arise in connection with our acquisition of NURO, which could be costly, prevent consummation of the transaction, divert management’s attention, and otherwise harm our business, financial condition, and results of operations.· · · · ● 1 ▸ The closing of our acquisition of NURO is subject to customary closing conditions, and there can be no assurance that NURO will meet the closing conditions, and failure to close the transaction may harm our business and cause our stock price to fall.· · · · ● 1 ▸ Unanticipated costs relating to our acquisition of NURO could have an adverse impact on our business, financial condition, and operating results.· · · · ● 1 ▸ We have limited experience with the supply chain of our human performance product under the brand TAC-STIM and are dependent on third parties for related software development.· · · · ● 1 ▸ We have outsourced certain finance and accounting functions and may outsource other back-office functions, which will make us more dependent upon third parties.· · · · ● 1 ▸ We may not be able to fully realize the benefits from the NURO Transaction.· · · · ● 1 ▸ Any significant interruptions or delays in third-party service and access could result in limited capacity, reduced demand, and loss of customers and adversely affect our business.· · · ● ● 2 ▸ If we are unable to retain or attract the independent contractors in our sales force, our sales efforts may be adversely impacted.· · · ● ● 2 rw ▸ Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations which could subject our business to higher tax liability.· · · ● ● 2 ▸ Our new app-enabled consumer product relies on third-party vendors for application development and management which puts a significant dependency on the third-party vendor.· · · ● ● 2 rw ▸ Our next generation app-enabled consumer wellness product may require modifications and improvements, which may cause added expense and negatively impact our financial results.· · · ● ● 2 ▸ Our products may in the future be subject to notifications, recalls, or voluntary market withdrawals that could harm our reputation, business and financial results.· · · ● ● 2 ▸ group Risks Related to Our Business· · · ● ● 2 ▸ Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and share price.· · · ● ● 2 ▸ We are offering products to government customers through two different contracting vehicles, which may cause confusion for purchasing agents and result in frustration by customers.· · · ● ● 2 ▸ We generate sales of TAC-STIM branded products to active-duty military and accordingly, military budgetary cuts or government strikes could negatively impact our financial results.· · · ● ● 2 ▸ We have limited experience with the supply chain of our next generation app-enabled consumer general wellness product under the brand Truvaga and are dependent on third parties for related software development.· · · ● ● 2 rw ▸ We have signed a distribution agreement with Joerns Healthcare (“Joerns”) to sell certain gammaCore products throughout certain managed healthcare systems through the Joerns contract vehicles which puts a significant dependence on Joerns.· · · ● ● 2 ▸ We have signed a distribution agreement with Lovell to sell certain gammaCore products throughout the government channel through Lovell’s contract vehicles, and we may therefore be dependent on Lovell.· · · ● ● 2 ▸ We may be held responsible for certain taxes or assessments and other obligations relating to the activities of our independent contractors, which could harm our financial condition and operating results.· · · ● ● 2 rw ▸ We recently launched our next generation app-enabled consumer wellness product under the brand Truvaga and there can be no assurance that the new product will continue to be well received or adopted, which may impact our financial results.· · · ● ● 2 rw ▸ We rely on third-party software to develop our products and significant increases in licensing costs or defects in third-party software could harm our business.· · · ● ● 2 ▸ Breakthrough Designation from the FDA may not actually lead to a faster development or regulatory review or approval process and does not assure FDA approval of our devices.· · ● ● ● 3 ▸ Consistent with recent years, we continue not to invest in certain clinical trials in indications that are more exploratory in nature.· · ● ● ● 3 ▸ ESG matters, including those related to climate change and sustainability, may have an adverse effect on our business, financial condition, and operating results and may damage our reputation.· · ● ● ● 3 ▸ In order to commercialize products, we, or our manufacturers, will need to manufacture products in large quantities.· · ● ● ● 3 ▸ In some instances in our advertising and promotion, we may make claims regarding our products relative to competing products, which may subject us to heightened regulatory scrutiny, enforcement risk, and litigation risks.· · ● ● ● 3 ▸ Our consultants and certain of our sales force are classified as independent contractors, and we can face consequences if it is determined that they are misclassified as such.· · ● ● ● 3 ▸ The regulatory environment governing information, cybersecurity, and privacy is increasingly demanding and continues to evolve.· · ● ● ● 3 ▸ We have a limited history commercializing our general wellness and human performanceproducts in the United States for which market acceptance and commercial success are uncertain.· · ● ● ● 3 rw ▸ We must demonstrate to customers the benefits of nVNS platform technology for general wellness and human performance compared to those of our competitors and such comparisons may not be realizable.· · ● ● ● 3 rw ▸ Any significant disruption to our ecommerce business could result in lost sales.· ● ● ● ● 4 rw ▸ Future acquisitions, including the recently announced acquisition of NURO, strategic investments, or alliances could disrupt our business and harm our business, financial condition, and operating results.· ● ● ● ● 4 rw ▸ 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 or general wellness markets.· ● ● ● ● 4 rw ▸ Our product development initiatives may be delayed or fail to succeed and could also lead to challenging intellectual property rights issues.· ● ● ● ● 4 rw ▸ The requirements of being a publicly traded company may strain our resources and divert management’s attention.· ● ● ● ● 4 rw ▸ We are subject to increasing operating costs and inflation risks, which may adversely affect our performance.· ● ● ● ● 4 rw ▸ We have a limited history commercializing our nVNS platform technology, including through direct-to-consumer channels, and commercial success is uncertain.· ● ● ● ● 4 rw ▸ We must successfully attract, hire, train, and retain qualified professionals to service our direct-to-consumer sales channels, and we must productively deploy our professionals to become profitable.· ● ● ● ● 4 rw ▸ The ongoing coronavirus pandemic could have a significant negative impact on our business, revenues, financial condition, results of operations, and cash flow, and other epidemics or outbreaks of infectious diseases may have a similar impact.· · ● · · 1 ▸ Changes in certain areas of our business have resulted in the adoption of new accounting principles.· ● · · · 1 ▸ In the United States we are dependent on a third-party platform to provide patients with an end-to-end experience that would result in a prescription and purchase of gammaCore therapy.· ● · · · 1 ▸ 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.· ● · · · 1 ▸ A share price of less than $1.00 may impact our Nasdaq listing.● · · · · 1 ▸ Because of these and other factors, it is likely that, in some future period, our operating results will not meet investor expectations or those of public market analysts.● ● ● · · 3 rw ▸ Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.● ● · · · 2 ▸ More generally, in the future, our business, financial results, and financial condition may be negatively impacted by the effects of other disease outbreaks, epidemics, pandemics, or similar widespread public health concerns.● ● ● · · 3 ▸ On July 10, 2020, we were granted an EUA from the FDA for use of our gammaCore Sapphire CV for the acute treatment of asthma exacerbations in known or suspected COVID-19 patients.● · · · · 1 ▸ Our plans to expand our direct-to-consumer cash-pay business channel may not be able to generate significant revenues.● ● ● · · 3 rw ▸ Our reported financial results may be adversely affected by new accounting pronouncements or changes in existing accounting standards and practices.● ● · · · 2 ▸ group Risks Related to COVID-19● ● ● · · 3 ▸ Risks Related to Our Business and the Development of Our gammaCore Therapy● ● ● · · 3 ▸ The coronavirus pandemic could have a significant negative impact on our business, revenues, financial condition and results of operations.● ● · · · 2 ▸ There is no guarantee that the FDA will grant 510(k) clearance or PMA approval of our future products and failure to obtain necessary clearances or approvals for our future products would adversely affect our ability to grow our business.● ● · · · 2 ▸ We are an “emerging growth company,”and as a result of the reduced disclosure and governance requirements applicable to emerging growth companies, our common stock may be less attractive to investors.● ● ● · · 3 rw ▸ We have incurred, currently incur and will incur significantly increased costs and devote substantial management time as a result of operating as a public company.● · · · · 1 ▸ We rely upon specialty pharmacies to distribute some of our products in the United States.● ● · · · 2 ▸ Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant influence control over matters subject to stockholder approval.● · · ● ● 3 rw ▸ An active, liquid and orderly market for our common stock may not continue to be sustained, and our stockholders may not be able to resell their shares at a desired market price and could lose all or part of their investment.● ● ● ● ● 5 ▸ Any clinical trial we conduct in the United States may subject us to additional costs and detriments compared to a foreign clinical trial, which may negatively impact our financial condition and our business.● ● ● ● ● 5 ▸ Any termination or disruption of any future collaboration could result in delayed development of product candidates, increased cost to develop product candidates, or termination of development of a product candidate.● ● ● ● ● 5 rw ▸ Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our existing and future products and processes.● ● ● ● ● 5 ▸ Clinical trials may be delayed, suspended, or terminated for many reasons, which will increase our expenses and delay the time it takes to develop and expand our prescription gammaCoretherapy in additional treatment indications.● ● ● ● ● 5 rw ▸ Comprehensive U.S. federal income tax reform could adversely affect us.● ● ● ● ● 5 ▸ Cybersecurity incidents, including data security breaches or computer viruses, could harm our business by disrupting our delivery of services, damaging our reputation, or exposing us to liability.● ● ● ● ● 5 rw ▸ Healthcare legislative reform measures may have a material adverse effect on us.● ● ● ● ● 5 ▸ If our trademarks and trade names are not adequately protected, then, we may not be able to build name recognition in our markets of interest and our business may be adversely affected.● ● ● ● ● 5 rw ▸ If securities or industry analysts cease publishing regular research or reports about our business or issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.● ● ● ● ● 5 ▸ If the financial condition of our customers were to deteriorate, resulting in an impairment of their ability to make payments, or if third-party payors were to deny claims, additional provisions for doubtful accounts may be required.● ● ● ● ● 5 rw ▸ If third-party payors do not provide adequate coverage and reimbursement for the use of gammaCore, it may affect our ability to generate significant revenues.● ● ● ● ● 5 rw ▸ If we are not able to establish or maintain collaborations, we may have to alter some of our future development, regulatory clearance, and commercialization plans.● ● ● ● ● 5 rw ▸ If we are unable to enroll patients in future clinical trials, our research and development efforts could be adversely affected.● ● ● ● ● 5 ▸ If we are unable to protect the confidentiality of our trade secrets, our business and competitive position may be harmed.● ● ● ● ● 5 ▸ If we cannot show access and copying, then, our copyrights may not provide protection for our software and our business may be adversely affected.● ● ● ● ● 5 rw ▸ If we do not successfully enter into future collaborations for the development, regulatory clearance, and commercialization of our prescription gammaCore therapy in international markets, our business may be harmed.● ● ● ● ● 5 rw ▸ If we experience any of these risks, our sales in non-U.S. jurisdictions may be harmed, and our results of operations would suffer.● ● ● ● ● 5 rw ▸ If we fail to continue to develop and retain an effective sales force, our business could suffer.● ● ● ● ● 5 rw ▸ If we fail to properly manage our anticipated growth, our business could suffer.● ● ● ● ● 5 ▸ If we fail to retain our key executives or recruit and hire new employees, our operations and financial results may be adversely affected while we attract other highly qualified personnel.● ● ● ● ● 5 ▸ Intellectual property rights do not necessarily address all potential threats to our business.● ● ● ● ● 5 ▸ Legislative or regulatory reforms may make it more difficult and costly for us to obtain regulatory clearance of our product candidates and to manufacture, market, and distribute our products after clearance is obtained.● ● ● ● ● 5 rw ▸ Modifications to our products may require new regulatory clearances or approvals or may require us to recall or cease marketing our products until clearances or approvals are obtained.● ● ● ● ● 5 ▸ Once applicable, the MDR may impose increased compliance obligations for us to access the EU market.● ● ● ● ● 5 ▸ Our business and stock price could be negatively affected as a result of actions of activist stockholders, and such activism could impact the trading value of our securities.● ● ● ● ● 5 ▸ Our certificate of incorporation and bylaws provide that we will indemnify our directors and officers to the fullest extent permitted by Delaware law.● ● ● ● ● 5 ▸ Our commercial success depends significantly on our ability to operate without infringing upon the intellectual property rights of third parties.● ● ● ● ● 5 ▸ Our commercialization strategy of gammaCore may expose us to increased billing, cash application, and credit risks.● ● ● ● ● 5 rw ▸ Our cost-control efforts might not assure profitability and may affect morale and make it difficult to retain employees, independent contractors, or attract new ones.● ● ● ● ● 5 rw ▸ Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.● ● ● ● ● 5 rw ▸ Our failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock, which could negativelyimpact the market price and liquidity of our common stock and our ability to access the capital markets.● ● ● ● ● 5 rw ▸ Our future success depends on our leadership development and succession planning.● ● ● ● ● 5 ▸ Our future success in part depends on our ability to develop, receive regulatory clearance or approval for, and introduce new products or product enhancements that will be accepted by the market in a timely manner.● ● ● ● ● 5 rw ▸ Our intellectual property agreements with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of our rights to the relevant intellectual property or technology.● ● ● ● ● 5 ▸ Our international operations subject us to certain operating and compliance risks, which could adversely impact our results of operations and financial condition.● ● ● ● ● 5 ▸ Our operating results and profitability may be adversely affected by increases in reserves for product returns, doubtful accounts receivable, and inventory.● ● ● ● ● 5 rw ▸ Our platform utilizes open-source software, and any failure to comply with the terms of one or more of these open source licenses could negatively affect our business.● ● ● ● ● 5 rw ▸ Our potential revenue in the United Kingdom is substantially dependent on government funding arrangements, and changes in governmental policy for such arrangements could cause material harm to our business.● ● ● ● ● 5 rw ▸ Our results may be impacted by changes in foreign currency exchange rates.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 ▸ Outside the United States, we rely on a single third-party distributor to effectively distribute the majority of our products.● ● ● ● ● 5 rw ▸ Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time.● ● ● ● ● 5 ▸ Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.● ● ● ● ● 5 ▸ Regulatory requirements and changes to payors’ prescription benefit plans and medical pathway plans could adversely impact our business and financial results.● ● ● ● ● 5 rw ▸ Risk Related to our Financial Position, Operating Results and Need for Additional Capital● ● ● ● ● 5 ▸ group Risks Related to Intellectual Property● ● ● ● ● 5 ▸ group Risks Related to Our Common Stock● ● ● ● ● 5 ▸ group Risks Related to Regulation of our Industry● ● ● ● ● 5 ▸ group Risks Related to our Dependence on Third Parties● ● ● ● ● 5 rw ▸ Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.● ● ● ● ● 5 ▸ Should any of these events occur, they could significantly harm our business and results of operations.● ● ● ● ● 5 ▸ The increasing use of social media could give rise to liability.● ● ● ● ● 5 ▸ We are currently subject to securities class action lawsuits against us, which could result in adverse outcomes.● ● ● ● ● 5 ▸ We are required to report certain malfunctions, deaths, and serious injuries associated with our products, which can result in voluntary corrective actions or agency enforcement actions.● ● ● ● ● 5 ▸ We are subject to federal, state, and foreign healthcare laws and regulations, and a finding of failure to comply with such laws and regulations could have a material adverse effect on our business.● ● ● ● ● 5 rw ▸ We derive a material portion of our revenue from a limited number of customers, and the loss of one or more of these customers could adversely impact our business, results of operations, and financial condition.● ● ● ● ● 5 ▸ 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.● ● ● ● ● 5 ▸ We have broad discretion to determine how to use most of our financial resources and may use them in ways that may not enhance our operating results or the price of our common stock.● ● ● ● ● 5 ▸ We may be required to obtain additional funds in the future, and these funds may not be available on acceptable terms or at all.● ● ● ● ● 5 rw ▸ We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties.● ● ● ● ● 5 rw ▸ We may become involved in lawsuits to protect or enforce our patents, which could be expensive, time-consuming, and unsuccessful.● ● ● ● ● 5 rw ▸ We may engage in future acquisitions that increase our capital requirements, dilute our stockholders, cause us to incur debt, or assume contingent liabilities that subject us to other risks.● ● ● ● ● 5 rw ▸ We may expend our limited resources to pursue a particular product candidate or disease and fail to capitalize on product candidates or diseases that may be more profitable or for which there is a greater likelihood of success.● ● ● ● ● 5 ▸ We may face product liability claims that could result in costly litigation and significant liabilities.● ● ● ● ● 5 ▸ We may not be able to adequately protect our intellectual property rights throughout the world.● ● ● ● ● 5 ▸ We may not be able to establish or strengthen our brands.● ● ● ● ● 5 rw ▸ We may not be successful in obtaining necessary intellectual property rights to future products through acquisitions and in-licenses.● ● ● ● ● 5 ▸ We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products.● ● ● ● ● 5 rw ▸ We must demonstrate to patients, physicians, and third-party payors the medical and economic benefits of our prescription gammaCore therapy compared to those of our competitors or other available therapies, and such comparisons may not be realizable.● ● ● ● ● 5 rw ▸ We rely on a variety of intellectual property rights, and if we are unable to maintain or protect our intellectual property, our business and results of operations will be harmed.● ● ● ● ● 5 ▸ We rely on third parties to conduct and support clinical trials and investigator - initiated trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.● ● ● ● ● 5 
