▸ Additional time may be required to obtain regulatory approval for our product candidates because they are combination products.· · ● 1 ▸ An NDA submitted under Section 505(b)(2) subjects us to the risk that we may be subject to a patent infringement lawsuit that would delay or prevent the review or approval of our product candidates.· · ● 1 ▸ Because we became a reporting company under the Exchange Act by means other than a traditional underwritten initial public offering, we may not be able to attract the attention of research analysts at major brokerage firms.· · ● 1 ▸ Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.· · ● 1 ▸ Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.· · ● 1 ▸ Changes in tax law may adversely affect our business and financial condition· · ● 1 ▸ Current and future legislation may increase the difficulty and cost of commercializing our product candidates and may affect the prices that we may obtain if our product candidates are approved for commercialization.· · ● 1 ▸ Even if one or more of our product candidates receive regulatory approval in the U.S., we may never receive comparable approvals outside of the U.S.· · ● 1 ▸ FINRA sales practice requirements may limit a stockholder’s ability to buy and sell our common stock.· · ● 1 ▸ Final marketing approval of NPM-139 or any of our other product candidates by the FDA or other regulatory authorities may be delayed, limited, or denied, any of which would adversely affect our ability to generate operating revenues.· · ● 1 ▸ If the FDA or other applicable regulatory authorities approve generic products that compete with any of our product candidates, the sales of our product candidates, if approved, could be adversely affected.· · ● 1 ▸ If we are unable to develop our own commercial organization or enter into agreements with third parties to sell and market our product candidates, if approved, we may be unable to generate significant revenues.· · ● 1 ▸ If we fail to obtain and sustain an adequate level of reimbursement by third-party payors for our product candidates, if approved, potential future sales would be materially adversely affected.· · ● 1 ▸ If we fail to retain current members of our senior management and scientific personnel, or to attract and keep additional key personnel, our ability to conduct our business will be impaired.· · ● 1 ▸ Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.· · ● 1 ▸ Our efforts to identify and develop product candidates beyond those in our current pipeline may not succeed, and any product candidates that we select for clinical development may not actually begin clinical trials.· · ● 1 ▸ Our efforts to seek, secure and maintain partnerships, collaborations or other strategic initiatives with respect to one or more of our programs may not be successful.· · ● 1 ▸ Our employees, independent contractors, vendors, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.· · ● 1 ▸ Our principal stockholders and management own a significant percentage of our stock and will be able to exercise significant influence over matters subject to stockholder approval.· · ● 1 ▸ Our research and development activities involve the use of hazardous materials, which are subject to regulation, related costs and delays and potential liabilities.· · ● 1 ▸ group Reserve for uncertain income tax positions Nil· · ● 1 ▸ Results of clinical trials or preclinical studies may not be predictive of the results of later-stage clinical trials, and many product candidates fail to achieve regulatory approval despite showing initial promise in early-stage testing.· · ● 1 ▸ Rising inflation rates could negatively impact our expenses.· · ● 1 ▸ Risks Related to Our Financial Position and Need for Additional Capital· · ● 1 ▸ group Risks Related to Our Reliance on Third Parties· · ● 1 ▸ Risks Related to Product Development, Clinical Testing and Commercialization· · ● 1 ▸ Risks Related to Regulatory Approval and Other Legal and Compliance Matters· · ● 1 ▸ group State R&D carry-forward, no expiration date $ 9,048· · ● 1 ▸ The FDA, the EMA and comparable foreign regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses.· · ● 1 ▸ The commercial success of our product candidates, if approved, depends upon their market acceptance among physicians, patients, healthcare payors, and the medical community.· · ● 1 ▸ The designation of our common stock as “penny stock” would limit the liquidity of our common stock.· · ● 1 ▸ The impact of recent healthcare reform legislation and other changes in the healthcare industry and in healthcare spending on us is currently unknown, and may adversely affect our business model.· · ● 1 ▸ The market price of our common stock may be highly volatile, and may be influenced by numerous factors, some of which are beyond our control.· · ● 1 ▸ The spin-off may not have the benefits we anticipate.· · ● 1 ▸ There could be significant income tax liability if the spin-off or certain related transactions are determined to be taxable for U.S. federal income tax purposes.· · ● 1 ▸ Use of third parties to manufacture our product candidates may increase the risk that we will not have sufficient quantities of our product candidates, products, or necessary quantities at an acceptable cost.· · ● 1 ▸ We are a clinical-stage company with a limited operating history, and have no products approved for commercial sale.· · ● 1 ▸ We are dependent on the successful design, development, regulatory approval and commercialization of one or more of our product candidates, there can be no assurance that we may achieve any of these objectives.· · ● 1 ▸ We are subject to a multitude of complex manufacturing challenges and risks, including reliance on third parties, any of which could substantially increase our costs and limit supply of our product candidates.· · ● 1 ▸ We could experience delays in the commencement or completion of clinical trials, which could result in increased costs or otherwise impair our research and development efforts.· · ● 1 ▸ We do not anticipate generating revenue from product sales for the foreseeable future and may never be profitable.· · ● 1 ▸ We face risks associated with tariffs and other trade restrictions, which may have a material adverse impact on our results of operations and financial condition.· · ● 1 ▸ We may be exposed to product liability risks which could place a substantial financial burden on our business.· · ● 1 ▸ We may be subject to a range of privacy and data protection laws across jurisdictions, which could present compliance challenges and regulatory risk.· · ● 1 ▸ We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties.· · ● 1 ▸ We may be unable to adequately prevent disclosure of trade secrets and other proprietary information.· · ● 1 ▸ We may experience delays in the enrollment of patients in our clinical trials, which would adversely affect our ability to initiate, conduct and complete such trials on our anticipated timelines.· · ● 1 ▸ We may not be able to complete the spin-off of Cortigent on the terms anticipated or at all.· · ● 1 ▸ We may not be able to protect our intellectual property rights throughout the world.· · ● 1 ▸ We may not be successful in obtaining or maintaining necessary rights to develop and commercialize our product candidates.· · ● 1 ▸ We will continue to incur increased costs as a result of being a public company and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.· · ● 1 ▸ We will need to increase the size of our organization and may not successfully manage our growth.· · ● 1 ▸ group Risks Relating to Our Intellectual Property· ● ● 2 ▸ We may infringe the intellectual property rights of others, which may prevent or delay our development efforts and prevent us from commercializing or increase the costs of commercializing our product candidates, if approved.· ● ● 2 ▸ We may not be able to adequately protect our proprietary or licensed technology.· ● ● 2 ▸ Act of 2012 further reduced Medicare payments to several providers, including hospitals and cancer treatment centers, and increased· ● · 1 ▸ group Changes in U.S. patent law could diminish the value· ● · 1 ▸ group Current and future legislation may increase the difficulty· ● · 1 ▸ group Even if one or more of our product candidates receive· ● · 1 ▸ group If we are unable to develop our own commercial organization· ● · 1 ▸ Medicare payments will vary from 1% in 2022 to up to 3% in the final fiscal year of this sequester. The American Taxpayer Relief· ● · 1 ▸ NPM-139 and NPM-159 are limited to feasibility testing, but if we advance these programs for further development, we will need· ● · 1 ▸ group Our efforts to seek, secure and maintain partnerships,· ● · 1 ▸ group We may be subject to claims that our employees, consultants,· ● · 1 ▸ group We may not be able to protect its intellectual property· ● · 1 ▸ group We will need to increase the size of our organization· ● · 1 ▸ A pandemic, epidemic or outbreak of an infectious disease, such as COVID-19, a novel strain of coronavirus, may materially and adversely affect our business and our financial results.● · · 1 ▸ Any failure or delay in completing clinical trials or studies for new product candidates or next generation of our products and the expense of those trials could adversely affect our business.● · · 1 ▸ Any of these occurrences that we might experience will cause our operations to suffer, harm our competitive standing and result in further losses that adversely affect our financial condition.● · · 1 ▸ Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and initial trials may not be predictive of future trial results.● · · 1 ▸ Delisting of our common stock from national exchange can cause material dilution of our stock in future financings which can erode shareholder value.● · · 1 ▸ Despite early positive results in our limited initial trials at UCLA and Baylor School of Medicine our ongoing development efforts may never demonstrate the feasibility of our Orion technology.● · · 1 ▸ Despite promising results from the Early Feasibility Study for Orion being conducted at UCLA and Baylor we currently have no commercial products or product revenue and may never become profitable.● · · 1 ▸ Even if issued, patents may be challenged, invalidated, or circumvented, which could limit our ability to stop competitors from marketing similar products or limit the length of term of patent protection that we may have for our products.● · · 1 ▸ Even if we obtain clearance or approval to sell our products, we are subject to ongoing requirements and inspections that could lead to the restriction, suspension or revocation of our clearance.● · · 1 ▸ If shares of our common stock cease to be listed on a national exchange our securities will not be eligible for federal preemption rights and be subject to state “blue sky” laws which may affect our capabilities of raising capital.● · · 1 ▸ If we are unable to protect the intellectual property used in our products, others may be able to copy our innovations which may impair our ability to compete effectively in our markets.● · · 1 ▸ If we fail to comply with our obligations in the agreements under which we license development or commercialization rights to products or technology from third parties, we could lose license rights that are important to our business.● · · 1 ▸ If we fail to develop new products or enhance existing products, our leadership in the markets we serve could erode, and our business, financial condition and results of operations may be adversely affected.● · · 1 ▸ If we or our licensors are unable to protect our/their intellectual property, then our financial condition, results of operations and the value of our technology and products could be adversely affected.● · · 1 ▸ In May 2020 we entered an underwriting agreement with ThinkEquity, a division of Fordham Financial Management, Inc., pursuant to which we sold 7,500,000 shares of common stock in an underwritten public offering● · · 1 ▸ Lawsuits may be filed against Second Sight challenging the Business Combination and an adverse ruling in any such lawsuit may prevent the Business Combination from being completed or from being completed within the expected time frame.● · · 1 ▸ Legislative or regulatory reform of the health care system in the U.S. and foreign jurisdictions may adversely impact our business, operations or financial results.● · · 1 ▸ Materials necessary to manufacture Orion may not be available on commercially reasonable terms, or at all, which may delay development, manufacturing and commercialization of our products.● · · 1 ▸ Our business is subject to international economic, political and other risks that could negatively affect our results of operations or financial position.● · · 1 ▸ Our commercial and financial success depends on our products being accepted in the market, and if not achieved will result in our not being able to generate revenues to support our operations.● · · 1 ▸ Our financial statements have been prepared assuming we are a going concern.● · · 1 ▸ Our financial success is dependent on our ability to price our products in a manner acceptable to government and private payors while still maintaining our profit margins. Numerous factors that may be beyond our control may● · · 1 ▸ Our revenue from sales of Orion will be dependent upon the pricing and reimbursement guidelines adopted in each country and if pricing and reimbursement levels are inadequate to achieve profitability our operations will suffer.● · · 1 ▸ Product liability lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our products.● · · 1 ▸ group Risks Related to Dependence on Our Commercial Products● · · 1 ▸ group Risks Related to Intellectual Property and Other Legal Matters● · · 1 ▸ group Risks Related to Our Business and Industry● · · 1 ▸ Risks Related to the Securities Market, and Ownership of Our Common Stock● · · 1 ▸ group Risks Relating to Our Operations● · · 1 ▸ group Risks Relating to the Business Combination● · · 1 ▸ Sales of substantial amounts of our common stock in the public or private markets could reduce the price of our common stock and may dilute your voting power and ownership interest in us.● · · 1 ▸ Sales, or the availability for sale, of substantial amounts of our common stock could adversely affect the value of our common stock.● · · 1 ▸ Share Consideration at the closing may have a greater or lesser value than at the time that the Memorandum of Understanding was signed.● · · 1 ▸ Since we have had an operating history of losses and have no current revenue producing operations, the future of our business is difficult to evaluate.● · · 1 ▸ Substantial future sales of shares of our common stock in the public market could cause our stock price to fall.● · · 1 ▸ The Share Consideration is not adjustable based on the market price of the common stock of either Second Sight or Pixium but is intended to result in Pixium owning approximately 60% of the resulting combined entity, so the● · · 1 ▸ The activities of competitive medical device companies, or others, may limit our revenue from the sale of the Orion system.● · · 1 ▸ The combined company may be unable to successfully integrate the business of Pixium and Second Sight or realize the anticipated benefits of the Business Combination.● · · 1 ▸ The realization of any of these or other risks associated with operating in Europe or other non-U.S. countries could have a material adverse effect on our business, results of operations or financial condition.● · · 1 ▸ There may be future sales or other dilution of our equity, which may adversely affect the market price of our common stock.● · · 1 ▸ Third-party claims of intellectual property infringement may prevent or delay our development and commercialization activities for Orion.● · · 1 ▸ To establish our sales and marketing infrastructure, we will need to grow the size of our organization, and we may experience delays or other difficulties in managing this growth.● · · 1 ▸ We are also subject to stringent government regulation in European and other foreign countries, which could delay or prevent our ability to sell our products in those jurisdictions.● · · 1 ▸ We are subject to business uncertainties and contractual restrictions while the Business Combination is pending, which could adversely affect our business and operations.● · · 1 ▸ We are subject to stringent domestic and foreign medical device regulation and any unfavorable regulatory action may materially and adversely affect our financial condition and business operations.● · · 1 ▸ We could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws.● · · 1 ▸ We do not intend to pay dividends for the foreseeable future and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.● · · 1 ▸ We expect to incur substantial expenses related to the completion of the Business Combination and the integration of Pixium’s and our businesses.● · · 1 ▸ We have experienced operating losses, and we may continue to incur operating losses for the next several years as we implement our business plan. Currently, we have no revenue and do not have arrangements in place for all the● · · 1 ▸ We have incurred operating losses since inception and may continue to incur losses for the foreseeable future.● · · 1 ▸ We have no large-scale manufacturing experience, which could limit our growth.● · · 1 ▸ We have not been profitable to date and expect our operating losses to continue for the foreseeable future; we may never be profitable.● · · 1 ▸ We may acquire additional businesses or form strategic alliances in the future, and we may not realize the benefits of such acquisitions or alliances.● · · 1 ▸ We may be assessed penalties and fines under California’s board gender diversity statute which required publicly held companies to have a minimum of one female on boards of directors as of the end of 2019.● · · 1 ▸ We may become involved in future lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful.● · · 1 ▸ We may face substantial competition in the future and may not be able to keep pace with the rapid technological changes which may result from others discovering, developing or commercializing products before or more successfully than we do.● · · 1 ▸ Our ability to utilize its net operating loss (“NOL”) carry-forwards and certain other tax attributes may be limited.● · ● 2 rw ▸ group Risks Related to Ownership of Our Common Stock● · ● 2 rw ▸ We are a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to smaller reporting companies will make our common stock less attractive to investors.● · ● 2 rw