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H.S. senior Avg
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New words:
absent, appraisal, Cameo, Cyclo, deal, depositary, dissent, dissolve, extraordinary, formula, fractional, hearing, Israel, knowable, left, lieu, light, magnitude, mailing, merge, nearest, Nevada, pendency, plaintiff, printing, proxy, reluctant, reorganization, reorganize, restraint, rounded, satisfaction, Shawn, speak, subsidiary, takeover, thereof, timeframe, tranche, wholly
Removed:
consecutive, devoted, fulfill, HITECH, insignificant, regain, unvested
Financial report summary
?Competition
Bristol-Myers Squibb • Pfizer • AMGEN • Gilead Sciences • Arena Pharmaceuticals • Protagonist Therapeutics • Galapagos • Abbvie • Theravance Biopharma • DICE TherapeuticsRisks
- Risk Factors Related to the Merger
- The failure to complete the Merger in a timely manner, or at all, may adversely affect the business and financial results of Cyclo and us and each of our respective stock prices.
- The tax treatment of the Merger is complex.
- The Exchange Ratio will be determined in accordance with a formula and is not yet knowable. The actual Exchange Ratio could be materially different than currently anticipated.
- Uncertainty about the Merger may adversely affect the respective business and stock price of Cyclo and us, whether or not the Merger is completed.
- While the Merger is pending, we and Cyclo are subject to contractual restrictions that could harm each of our respective businesses, operating results and stock price.
- The Merger Agreement limits our ability to pursue alternative transactions which could deter a third party from proposing an alternative transaction.
- The Merger will involve substantial costs.
- The fairness opinion obtained by our board of directors from our financial advisor will not be updated to reflect changes in circumstances between signing the Merger Agreement and the completion of the Merger.
- Certain of our directors and executive officers may have interests in the Merger that are or were different from, or in conflict with or in addition to, those of our stockholders generally.
- Holders of our common stock will not be entitled to appraisal rights in the Merger.
- Cyclo or we may waive one or more of the closing conditions to the Merger without re-soliciting approval from our stockholders.
- After the Merger, our stockholders will have a significantly lower ownership and voting interest in Cyclo than they currently have in us and will exercise less influence over management and policies of the combined company.
- We and Cyclo may be targets of securities class action and derivative lawsuits which could result in substantial costs and may delay or prevent the Merger from being completed.
- The following risk factors do not take the Merger into account and assume that we remain a stand-alone company except as otherwise noted.
- Risks Related to Strategic Process and Potential Strategic Transaction
- We are reviewing strategic alternatives and there can be no assurance that we will be successful in identifying or completing any strategic transactions, that any such strategic transaction will result in additional value for our stockholders or that the process will not have an adverse impact on our business.
- Our decision to discontinue our research and development efforts may not result in the anticipated savings and could disrupt our business.
- Our ability to consummate a strategic transaction of any kind depends on our ability to retain our employees required to explore and consummate a strategic transaction as previously announced.
- Risks Related to Our Business, Financial Condition, and Capital Requirements
- Our preclinical studies and clinical trials have failed to demonstrate evidence of the safety and efficacy of our product candidates, which could prevent, delay, or limit the scope of regulatory approval and commercialization.
- There has been substantial doubt as to our ability to continue as a going concern. If we do not maintain sufficient funding or do not successfully consummate the Merger or any other strategic transaction, we may have to curtail or cease operations.
- We will need to obtain substantial additional capital to finance our operations. A failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce, or terminate our research and drug development programs, future commercialization efforts, product development, or other operations.
- Unless we complete the Merger on or before February 6, 2024, we will be delisted from Nasdaq, which would seriously harm the liquidity of our stock and our ability to raise capital.
- We were early in our development efforts, have a limited operating history and have no products approved for commercial sale, which makes it difficult to evaluate our current business and predict our future success and viability.
- We have incurred significant net losses in each period since inception, and we expect to continue to incur net losses for the foreseeable future.
- Developing biologic therapeutics is a highly uncertain undertaking and involves a substantial degree of risk.
- We may not be successful in our efforts to use and expand our proprietary technology platform to build a pipeline of biologic product candidates.
- We have limited resources. As a result, we may fail to capitalize on other indications or product candidates that may ultimately have proven to be more profitable.
- We expect to rely on third parties to conduct our clinical trials and some aspects of our research and preclinical studies, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such clinical trials, research, or testing.
- The manufacturing of our product candidates is complex. We and our third-party manufacturers may encounter difficulties in production. If we encounter any such difficulties, our ability to supply our product candidates for clinical trials or, if approved, for commercial sale, could be delayed or halted entirely.
- We have relied on third-party manufacturers to produce our product candidates. Any failure by a third-party manufacturer to produce acceptable product candidates for us pursuant to our specifications and regulatory standards may delay or impair our ability to initiate or complete our clinical trials, obtain and maintain regulatory approvals or commercialize approved products.
- We depend on third-party suppliers for key raw materials used in our manufacturing processes, and the loss of these third-party suppliers or their inability to supply us with adequate raw materials could harm our business.
- The COVID-19 pandemic, and actions taken to mitigate the spread of the virus, has impacted and could continue to adversely impact our business.
- Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
- Changes in our effective tax rate or tax liability may have an adverse effect on our operating results.
- We are a fully-remote company, meaning that our team members work remotely which poses a number of risks and challenges that can affect our business, operating results, and financial condition. We are increasingly dependent on technology in our operations and if our technology fails, our business could be adversely affected.
- Risks Related to the Discovery, Development, and Commercialization of Our Product Candidates
- Research and development related to novel biologic therapeutics is inherently risky. Our business is heavily dependent on the successful development of our product candidates, which is currently discontinued. We cannot give any assurance that any of our product candidates will receive regulatory or marketing approval, which is necessary before they can be commercialized.
- We may encounter delays in our preclinical studies or clinical trials, or may not be able to conduct or complete our preclinical studies or clinical trials on the timelines we expect, if at all.
- If we do not achieve our projected development goals in the timeframes we announce and expect, our stock price may decline.
- We may encounter difficulties enrolling patients or healthy volunteers in our clinical trials, and our clinical development activities could thereby be delayed or otherwise adversely affected.
- We face significant competition and if our competitors develop and market technologies or products that are more effective, safer or less expensive than our product candidates, our commercial opportunities will be negatively impacted.
- Our product candidates may face competition sooner than anticipated.
- Even if any product candidates we develop receive marketing approval, our product candidates may not achieve adequate market acceptance by physicians, patients, healthcare payors, and others in the medical community necessary for commercial success.
- If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any product candidates we may develop, we may not be successful in commercializing those product candidates if and when they are approved.
- If the market opportunities for any product that we develop are smaller than we believe they are, our revenue may be adversely affected and our business may suffer.
- Risks Related to Regulatory Approval and Other Legal Compliance Matters
- We may be unable to obtain U.S. or foreign regulatory approval for our product candidates and, as a result, may be unable to commercialize our product candidates.
- Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences.
- If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products.
- Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
- Coverage and reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance. If reimbursement is not available or is not sufficient for our products, it is less likely that our products will be widely used.
- We have conducted clinical trials for AMT-101 and AMT-126 outside of the United States, and we may do so for our other product candidates, which exposes us to additional risks. For example, the FDA, EMA, and applicable foreign regulatory authorities may not accept data from such clinical trials, in which case our development plans will be delayed, which could materially harm our business.
- Preliminary data from our clinical trials that we announce or publish from time to time may change as additional patient data become available and are subject to verification procedures that could result in material changes in the final data or clinical conclusions.
- Even if we obtain regulatory approval for a product candidate, our products will remain subject to extensive regulatory scrutiny.
- We have sought and may again seek orphan drug designation for one or more of our product candidates, but we may be unable to obtain such designations or to maintain the benefits associated with orphan drug status, including market exclusivity, which may cause our revenue, if any, to be reduced.
- A breakthrough therapy designation or Fast Track designation by the FDA for a drug may not lead to a faster development or regulatory review or approval process, and it would not increase the likelihood that the drug will receive marketing approval.
- Current and future legislation may increase the difficulty and cost for us to commercialize our product candidates, if approved, and affect the prices we may obtain.
- Our employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- If we fail to comply with healthcare laws, we could face substantial penalties and our business, operations, and financial conditions could be adversely affected.
- If we or any contract manufacturers and suppliers we engage fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on our business.
- Our business activities may be subject to the Foreign Corrupt Practices Act (FCPA) and similar anti-bribery and anti-corruption laws, as well as U.S. and certain foreign export controls, trade sanctions, and import laws and regulations. We can face criminal liability and other serious consequences for violations, which can harm our business.
- Data collection under European and U.S. laws is governed by restrictive regulations addressing the collection, use, processing and, in the case of Europe, cross-border transfer, of personal information.
- Risks Related to Our Intellectual Property
- If we are unable to obtain and maintain patent protection for any product candidates we develop, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize any product candidates we may develop may be adversely affected.
- If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical technology and product candidates would be adversely affected.
- If we are unable to obtain licenses from third parties on commercially reasonable terms or fail to comply with our obligations under such agreements, our business could be harmed.
- Our rights to develop and commercialize our product candidates may be subject, in part, to the terms and conditions of agreements with others.
- If we fail to comply with our obligations in agreements under which we option or license intellectual property rights from future collaborators or licensors or otherwise experience disruptions to our business relationships with future collaborators or licensors, we could lose intellectual property rights that are important to our business.
- We may not be able to protect our intellectual property and proprietary rights throughout the world.
- Issued patents covering our product candidates and other technologies could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
- Third-party claims of intellectual property infringement, misappropriation, or other violation against us may prevent or delay the development and commercialization of our product candidates and other technologies.
- We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time consuming, and unsuccessful.
- Patent terms may be inadequate to protect our competitive position on our products and services for an adequate amount of time.
- We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
- If we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially harmed.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- If any of our patent applications do not issue as patents in any jurisdiction, we may not be able to compete effectively.
- Intellectual property rights do not necessarily address all potential threats.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
- U.S. government sanctions on Russia and Russian government decrees in response thereto, may prevent us from obtaining, maintaining and/or enforcing our intellectual property rights in Russia.
- We may be subject to claims that our employees, consultants, or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
- 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.
- Risks Related to Our Operations
- We are highly dependent on our key personnel, and if we are not successful in attracting, motivating, and retaining highly qualified personnel, we may not be able to successfully implement our business strategy or execute a strategic transaction.
- We may in the future engage in strategic transactions, acquisitions, collaborations, or partnerships, which may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, require us to relinquish
- rights to certain of our technologies or product candidates that we would otherwise seek to develop or commercialize ourselves, and subject us to other risks.
- Future strategic transactions, partnerships and collaborations may be important to us. We will face significant competition in seeking new strategic partners.
- Any legal proceedings or claims against us could be costly and time-consuming to defend and could harm our reputation regardless of the outcome.
- Our business is subject to economic, political, regulatory, and other risks associated with international operations.
- Inflation in the global economy could negatively impact our business and results of operations.
- Our internal computer systems, or those used by our CROs or other contractors or consultants, may fail or suffer other breakdowns, cyberattacks, or information security breaches or incidents that could compromise the confidentiality, integrity, and availability of such systems and data, and affect our reputation.
- Risks Related to Ownership of Our Common Stock
- The market price of our common stock has been volatile, which could result in substantial losses for investors.
- An active trading market of our common stock may not be sustained.
- If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline.
- Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
- Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
- Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
- We have incurred and will continue to incur increased costs and management resources as a result of operating as a public company.
- If we are unable to maintain effective internal controls, our business, financial position, and results of operations could be adversely affected.
- Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
- Delaware law and provisions in our amended and restated certificate of incorporation and bylaws might discourage, delay, or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our common stock.
- Our amended and restated bylaws provide that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
- Changes in interpretation or application of generally accepted accounting principles may adversely affect our operating results.
- Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
- We do not expect to pay any dividends for the foreseeable future. Investors may never obtain a return on their investment.
Management Discussion
- Research and development expenses decreased by approximately $18.0 million from $18.2 million for the three months ended September 30, 2022 to approximately $0.3 million for the three months ended September 30, 2023. The decrease in research and development expenses was attributable to our restructuring of operations and related reductions in workforce implemented in March 2023, which impacted 56 research and development employees as we discontinued research activities following an assessment of our clinical programs and the current business environment while focusing our operations on completing and closing out clinical trials, exploring strategic alternatives, maintaining and prosecuting our extensive intellectual property portfolio, and continuing business development activities.