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New words:
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Removed:
adequacy, Aid, allocated, amortized, announcement, approximated, assume, Attracting, bear, borrowed, calendar, called, CCA, CIP, clarifying, closing, cluster, complicated, complicating, complied, consummated, contemplate, cooperate, coordinate, crucial, digit, discontinued, double, efficiently, emergence, escalating, evidencing, executed, expanding, focusing, forego, forgiven, framework, franchise, governed, Gregory, incremental, initiated, instance, intra, Kitchener, lender, managerial, medium, move, originally, partnering, Paycheck, permanently, PPP, preempted, prefer, preparing, prepay, present, promissory, prove, pursuit, realizing, recognize, recommenced, refer, regain, relocate, removing, repeal, reportable, reset, responsibility, resumption, safeguarding, SBA, secured, Silicon, Simplifying, software, streamline, submitting, timeline, title, Topic, transferred, transitioning, treasury, underserved, underwriter, underwritten, unsecured, Valley, viability
Financial report summary
?Competition
AMGEN • Teva- Pharmaceutical Industries • Astrazeneca • Inovio Pharmaceuticals • Endo Health Solutions • GSK • Alder Biopharmaceuticals • Radius Health • Impel Pharmaceuticals • AllerganRisks
- RISKS RELATED TO OUR FINANCIAL POSITION AND NEED FOR ADDITIONAL CAPITAL
- We will need to obtain substantial additional funding to fund our operations, and we will not be able to continue as a going concern if we are unable to do so. Without additional capital, our liquidity, financial condition and business prospects will be materially and adversely affected, and we may have to cease operations. Our ability to raise capital is limited by the significant decline in our market capitalization and current market conditions.
- We have a history of operating losses. We expect to continue to incur significant losses in the foreseeable future and are not likely to become profitable.
- We have limited operating history and capabilities.
- Interim, “topline” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
- RISKS RELATED TO THE DEVELOPMENT AND COMMERCIALIZATION OF OUR PRODUCT CANDIDATES
- The development and commercialization of our product candidates are subject to many risks. If we do not successfully develop, receive approval for, and commercialize our product candidates, our business will be adversely affected.
- The Long-term Safety Study (“LTSS”) for M207 was an important step in the development of M207. If we are to resume our M207 program, and the results from the study do not establish the safety of M207 to the FDA's satisfaction, the regulatory approval process could be delayed or failed, and our business could be adversely affected.
- If the FDA does not conclude that our product candidates satisfy the requirements for the 505(b)(2) regulatory approval pathway, or if the requirements for approval of our product candidates under Section 505(b)(2) are not as we expect, the approval pathway for our product candidates will likely take significantly longer, cost significantly more and encounter significantly greater complications and risks than anticipated, and in any case may not be successful.
- Clinical trials are very expensive, time-consuming and difficult to design and implement.
- The COVID-19 pandemic, including any strains or variants of the virus, could adversely impact our business.
- The results of our clinical trials may not support the intended use of M207 or any other product candidates we may develop.
- Clinical failure can occur at any stage of clinical development. Because the results of earlier clinical trials are not necessarily predictive of future results, any product candidate we advance through clinical trials may not have favorable results in later clinical trials or receive regulatory approval.
- We may in the future conduct clinical trials for product candidates in sites around the world, and government regulators, including the FDA in the United States, may choose to not accept data from trials conducted in such locations.
- We will not be able to sell our products if we do not obtain required United States regulatory approvals.
- Even if M207 or any other product candidates we develop in the future receive regulatory approval, our business is subject to extensive regulatory requirements which include ongoing and continued regulatory review, which may result in significant expense and limit our ability to commercialize our products.
- Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
- We or any of our current or future partners may choose not to continue developing a product or product candidate at any time during development, or commercialize it after approval, which would reduce or eliminate our potential return on investment for that product or product candidate.
- Our long-term growth will be limited unless we successfully develop a pipeline of additional product candidates.
- Our product candidates may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved label or market acceptance, or result in significant negative consequences following market approval, if any.
- The manufacture of our product candidates is complex, and we may encounter difficulties in manufacturing sufficient quantities of our product candidates.
- We have only manufactured our proposed product candidates for our clinical trials and we have no experience manufacturing on a commercial scale.
- Even if we receive regulatory approval for any product candidate, we still may not be able to successfully commercialize it and the revenue that we generate from its sales, if any, may be limited.
- We use customized equipment to manufacture, coat and package our transdermal microneedle system; any production or equipment performance failures could negatively impact the clinical trials of our product candidates that we may develop or sales of our product candidate(s), if approved.
- We currently depend on third-party suppliers for the manufacture of certain components of our product candidates. If these manufacturers fail to provide us or our collaborators with adequate supplies of materials for clinical trials or commercial product or fail to comply with the requirements of regulatory authorities, we may be unable to develop or commercialize M207 or any other product candidates we may develop.
- We rely on third parties to conduct our clinical trials and those third parties may not perform satisfactorily, including failing to comply with applicable regulatory requirements or to meet deadlines for the completion of such trials.
- If our current collaborations are not successful or we are not able to establish collaborations, we may have to alter our development plans.
- We may form strategic partnerships and collaborations in the future, and we may not realize the benefits of such alliances.
- We have no experience selling, marketing or distributing approved product candidates and currently have no internal capabilities to do so, and, if we resume our M207 program, we will rely on Eversana or other third parties for the commercialization of M207, and we and they may not be able to effectively market, sell and distribute M207, if approved.
- If we resume our M207 program, and M207, if approved, does not obtain sufficient market share against competitive products, we may not achieve substantial product revenues and our business will suffer.
- Products developed or under development by competitors may render our product candidates or technologies obsolete or non-competitive.
- We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability and may have to limit development of a product candidate or commercialization of an approved product.
- We may be exposed to liability claims associated with the use of hazardous materials and chemicals.
- Business disruptions could seriously harm our future revenues, results of operations and financial condition and increase our costs and expenses.
- If we fail to comply with our obligations to our licensor in our intellectual property license, we could lose license rights that are important to our business.
- Our failure to obtain and maintain patent protection for our technology and our product candidates could permit our competitors to develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and product candidates may be adversely affected.
- Bearing the costs and other requirements associated with prosecution of pending patent applications and maintenance of issued patents are essential to procurement and maintenance of patents integral to our product candidates, and our patent protection could be reduced or eliminated for non-compliance for these requirements.
- Our business will be harmed if we do not successfully protect the confidentiality of our trade secrets.
- We could be prevented from selling our product candidates, if approved, and could be forced to pay damages and defend against litigation, if we infringe the rights of third-parties.
- If we resume our product development activities, we intend to pursue FDA approval for M207 and potential future product candidates under Section 505(b)(2) of the FDCA. Such submissions involve significant costs, and we may also encounter difficulties or delays in obtaining regulatory approval for M207 or any other product candidates under Section 505(b)(2).
- We may become involved in costly and time-consuming lawsuits with uncertain outcomes to protect or enforce our patents.
- We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
- Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
- Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
- We may not be successful in obtaining necessary rights to future product candidates through acquisitions and in-licenses.
- We may not be able to protect our intellectual property rights throughout the world.
- If we do not obtain patent term extensions and data exclusivity for our product candidates, our business may be materially harmed.
- 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.
- Intellectual property rights do not necessarily address all potential threats to any competitive advantage we may have.
- Our relationships with customers and third-party payers will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
- Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations, and financial condition.
- Our ability to generate revenue from the sale of our product candidates will be diminished if we are unable to obtain third-party coverage and adequate levels of reimbursement for any approved product candidate.
- Healthcare reform may have a material adverse effect on our industry and our results of operations.
- Governments outside the United States may impose strict price controls, which may adversely affect our revenue, if any.
- Changes in U.S. tax law could adversely affect our business and financial condition.
- Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
- We rely on key executive officers and qualified personnel and their knowledge of our business and technical expertise would be difficult to replace.
- If we are unable to hire additional qualified personnel, our business may be harmed.
- Our operations and employees face risks related to health epidemics that could adversely affect our financial condition and operating results.
- Our employees may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
- We may enter into or seek to enter into business partnerships, combinations and/or acquisitions which may be difficult to integrate, disrupt our business, divert management attention or dilute stockholder value.
- Risks associated with use of our company-wide enterprise resource planning (“ERP”) system may adversely affect our business and results of operations or the effectiveness of internal control over financial reporting.
- The trading price of our common stock has been volatile with substantial price fluctuations on heavy volume, which could result in substantial losses for purchasers of our common stock and existing stockholders.
- We and certain of our current and former executive officers were named as defendants in a securities class action lawsuit, and a related shareholder derivative lawsuit was filed. Although both of these lawsuits have ended, defending against any future lawsuits could cause us to incur substantial costs and divert management's attention, financial resources and other company assets.
- If we are unable to maintain listing of our securities on the Nasdaq Capital Market or another reputable stock exchange, it may be more difficult for our stockholders to sell their securities.
- Substantial future sales of shares by existing stockholders, or the perception that such sales may occur, could cause our stock price to decline.
- We have a significant number of warrants outstanding, and while these warrants are outstanding, it may be more difficult to raise additional capital, and the outstanding warrants may adversely affect our stock price and cause dilution to existing stockholders.
- We do not currently intend to pay cash 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.
- Anti-takeover provisions in our amended and restated certificate of incorporation and amended and restated bylaws, as well as provisions in Delaware law, might discourage, delay or prevent a change of control of our company or changes in our management and, therefore, depress the trading price of our common stock.
- We are no longer an “emerging growth company” and may no longer take advantage of certain exemptions from various reporting requirements that are applicable to other public companies.
- Our business and operations may suffer in the event of information technology system failures, cyberattacks or deficiencies in our cybersecurity.
- If equity research analysts do not publish research or reports, or publish unfavorable research or reports about us, our business or our market, our stock price and trading volume could decline.
- Requirements associated with being a public reporting company will continue to increase our costs significantly, as well as divert significant company resources and management attention.
- If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.
- Our disclosure controls and procedures may not be effective to ensure that we make all required disclosures.
Management Discussion
- * Not meaningful.
- For the three months ended March 31, 2022, service revenue decreased approximately $0.1 million, or 49% as compared to the same period in 2021. The decrease is a result of only one remaining active feasibility study related to an agreement with a pharmaceutical company as compared to three such active studies in the three months ended March 31, 2021. We expect this study to be complete in the second quarter of 2022. We do not anticipate having additional service revenue unless and until we enter into new agreements.
- For the three months ended March 31, 2022, cost of service revenue decreased approximately $0.1 million, or 47% as compared to the same period in 2021. The decrease is a result of only one remaining active feasibility study related to an agreement with a pharmaceutical company as compared to three such active studies in the three months ended March 31, 2021. We expect this study to be completed in the second quarter of 2022. We do not anticipate having additional cost of service revenue unless and until we enter into new agreements.