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YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or commercialization of product candidates in the most efficient manner or at all; collaborators may not provide us with timely and accurate information regarding development progress and activitie...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. increase our expenses and divert the attention of our management. Further, these transactions and arrangements are contractual in nature and may be terminated or dissolved under the terms of the app...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and, as a result, the EOC License Agreement was terminated effective June 27, 2022. Under the EOC License Agreement, we relied on EOC for a substantial portion of the financial resources and for the...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , we would likely need to seek additional funding and our potential to generate future revenues from FYARRO could be significantly reduced and our business could be materially and adversely harmed. ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. operating r esults. In particular, the loss of one or more of our executive officers or key scientific personnel could be detrimental to us if we cannot recruit suitable replacements in a timely ma...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. to Interim CEO and President, effective March 15, 2023, while our Board conducts an executive search for a successor CEO. These leadership transitions, as well as future other senior management chan...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. appealing to high-quali ty candidates than what we have to offer. If we are unable to continue to attract and retain high-quality personnel, the rate and success at which we can discover, develop a...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. we may lose their services. Furthermore, our advisors may have arrangements with other companies to assist those companies in developing products or technologies that may compete with ours. In parti...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. additional indications that we may seek approval for, or any other product candidate that we may develop in the future, if approved, we must build and maintain marketing, sales, distribution, manage...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. our product candidates that we obtain approval to market will be expensive and time-consuming and will require significant attention of our executive officers to manage. Any failure or delay in the ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , either globally or on a territory-by-territory basis, with third parties that have direct sales forces and established distribution systems, either to augment our own sales force and distribution s...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and attention to sell and market our products effectively. If we are unable to successfully commercialize our approved product candidates, either on our own or through collaborations with one or mor...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , financial and other personnel. Future growth would impose significant added responsibilities on members of management, including: identifying, recruiting, integrating, maintaining and motivating a...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. divert a disproportionate amount of our attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities. We currently rely, and for the...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. obtain regulatory approval of FYARRO for additional indications and any other product candidates that we may develop in the future or otherwise advance our business. We cannot assure you that we wil...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. collaborators, may fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data, or per...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. as security breaches from inadvertent or intentional actions by our employees, contractors, consultants, business partners, and/or other third parties, or from cyber-attacks by malicious third parti...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. applications, or for it to be believed or reported that any of these occurred, we could incur liability and reputational damage and the development and commercialization of our product candidates co...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. be delayed. In addition, the loss of clinical trial data for our product candidates could result in delays in our regulatory approval efforts and significantly increase our costs to recover or repro...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. employees, could harm our reputation directly, compel us to comply with federal and/or state breach notification laws and foreign law equivalents, subject us to mandatory corrective action, and othe...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. For example, the loss of clinical trial data from completed, ongoing or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recov...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the further development and commercialization of our product candidates could be delayed, and we could be subject to significant fines or penalties for any noncompliance with certain state, federal ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. upon whom we depend, may be adversely affected by earthquakes, wildfires and other natural disasters, and our business continuity and disaster recovery plans may not adequately protect us from a ser...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. our product candidate or interruption of our business operations. Earthquakes, wildfires or other natural disasters could further disrupt our operations, including at our California headquarters, an...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which, could have a material adverse effect on our business. As part of our risk ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , results of operations and prospects. Our ability to utilize our net operating loss (“NOL”) carryforwards and certain other tax attributes to offset future taxable income may be limited. Our NOL c...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. limited to 80% of our current year taxable income. It is uncertain if and to what extent various states will conform to the federal legislation. As of December 31, 2022, after consideration of the N...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. 382 and 383 of the Code, if a corporation undergoes an “ownership change” (generally defined as a cumulative change in the corporation’s ownership by “5-percent stockholders” that exceeds 50 percenta...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. deferred tax asset. Our ability to utilize our NOLs and certain other tax attributes could be limited by an “ownership change” as described above and consequently, we may not be able to utilize a m...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. research and experimental expenditures to be capitalized and amortized ratably over a five-year period. Any such expenditures attributable to research conducted outside the United States must be cap...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. in future periods. A variety of risks associated with marketing FYARRO or any product candidates that we may develop in the future, if approved, internationally could materially adversely affect ou...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. foreign taxes, including withholding of payroll taxes; foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. our ability to attain or maintain profitable operations. Risks Related to Our Intellectual Property Our success depends on our ability to protect our intellectual property and our proprietary tech...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. relevant issued patents or pending applications from third parties. We also rely on trade secrets to protect aspects of our business that are not amenable to, or that we do not consider appropriate ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. enforceable or may be modified or revoked in proceedings instituted by third parties before various patent offices or in courts. The degree of future protection for us and our licensors’ proprietary ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the United States Patent and Trademark Office (the “USPTO”), courts in the United States or by the patent offices and courts in foreign countries, nor can we be certain that the claims in our issued...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. application, and partial or complete loss of patent rights in the relevant jurisdiction; patent applications may not result in any patents being issued; if clinical trials encounter delays, the pe...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. owned, co-owned, or licensed patents; since patent applications in the United States and most other countries are confidential for a period of time after filing, we cannot be certain that we were t...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and countries other than the Uni...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. to obtain patent protection. If we are unable to obtain or maintain patent protection with respect to any of our proprietary products and technology we develop, our business, financial condition, re...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. after such candidates are commercialized. As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to our...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. in the United States or in many foreign jurisdictions. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our p...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. own or in-licenses currently or in the future issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors or other third parties from comp...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. of operations and prospects. The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents or the patents of our licensors may be challenged ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , allow third parties to commercialize our product or product candidates and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products witho...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the duration of the patent protection of our product or product candidates. Such proceedings also may result in substantial cost and require significant time from our scientists and management, even...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. other remedies awarded if we were to prevail may not be commercially meaningful. Intellectual property rights do not necessarily address all potential threats to our competitive advantage. The deg...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights; it is possible that the pending patent ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. may subsequently file a patent covering such intellectual property. Should any of these events occur, it could significantly harm our business, financial condition, results of operations and prospe...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. could limit our ability to make, use, sell, offer for sale or import our products or products that may be approved in the future, or impair our competitive position. There is a substantial amount of...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the use or manufacture of our product or product candidates. As the biopharmaceutical industry expands and more patents are issued, the risk increases that our product or product candidates may be ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. product or product candidates may infringe or which such third parties claim are infringed by our technologies. In addition, identification of third-party patent rights that may be relevant to our t...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. . If a patent holder believes one or more of our products or product candidates infringes such holder’s patent rights, the patent holder may sue us even if we have received patent protection. Moreove...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. not be possible on a cost-effective basis; subject us to significant liability to third parties; or require us to enter into royalty or licensing agreements, which may not be available on commerci...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. may assert a claim of patent infringement directed at one of our products or product candidates. Any patent-related legal action or any claim relating to intellectual property infringement that is s...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. all. Moreover, even if we or our current or future strategic partners were able to obtain a license, the rights may be nonexclusive, which could result in our competitors gaining access to the same ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the initiation and continuation of any litigation could have material adverse effect on our ability to raise additional funds or otherwise have a material adverse effect on our business, results of ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or product candidates that we may develop in the future. The licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies m...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. intellectual property rights on terms that would be favorable to us or allow us to make an appropriate return on our investment or at all. Even if we are able to obtain a license to intellectual pro...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , time consuming and unsuccessful. Further, our issued patents or our licensors’ patents could be found invalid or unenforceable if challenged in court. Competitors and other third parties may infri...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. products or product candidates, the defendant could counterclaim that our patent or the patent of our licensors is invalid and/or unenforceable in whole or in part. In patent litigation in the Unite...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , even outside the context of litigation. Such mechanisms include re-examination, PGR, IPR, derivation proceedings, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings)....
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. would lose at least part, and perhaps all, of the patent protection on our technology or platform, product or any product candidates that we may develop. Such a loss of patent protection would have ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the patents and patent applications of our licensors, which may, nonetheless, ultimately be found to affect the validity or enforceability of a claim. If a defendant were to prevail on a legal asse...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. legal proceedings relating to our intellectual property rights may cause us to incur significant expenses and could distract our technical and management personnel from their normal responsibilities...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. initiation and continuation of patent litigation or other proceedings could compromise our ability to compete in the marketplace. Furthermore, because of the substantial amount of discovery require...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the litigation as well as results of hearings, rulings on motions, and other interim proceedings or developments in the litigation. If securities analysts or investors regard these announcements as ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. respect to our patents or patent applications or those of our licensors. An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to us from the ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. prosecution of our patent applications or those of our licensors and the enforcement or defense of our issued patents or those of our licensors. On September 16, 2011, the Leahy-Smith America Inven...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. to invent the claimed invention. A third party that files a patent application in the USPTO after March 2013 but before us could therefore be awarded a patent covering an invention of ours even if w...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. file any patent application related to our product or product candidates or (2) invent any of the inventions claimed in the patents or patent applications. The Leahy-Smith Act also includes a numbe...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. PTO proceedings compared to the evidentiary standard in United States federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding suf...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. a material adverse effect on our business, financial condition, results of operations and prospects. Changes in United States patent law, or laws in other countries, could diminish the value of pat...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. patents. We cannot predict the breadth of claims that may be allowed or enforced in our patents or in third-party patents. In addition, Congress or other foreign legislative bodies may pass patent r...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. ways that would weaken our ability to obtain new patents or to enforce our existing patents and the patents we might obtain or license in the future. We may be subject to claims challenging the inv...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. we regard as our intellectual property. Litigation may be necessary to defend against these and other claims challenging inventorship or ownership. If we fail in defending any such claims, in additi...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. visional effective filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our product or product candidates th...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. In January 2022, we filed an application for patent term extension based on the approval of FYARRO. Depending upon the timing, duration and specifics of FDA regulatory approval of our product candida...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. total of 14 years from the date of product approval and only those claims covering such approved drug product, a method for using it or a method for manufacturing it may be extended. Patent term ext...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. our revenue could be reduced, possibly materially. Further, if this occurs, our competitors may take advantage of our investment in development and trials by referencing our clinical and preclinical...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. . In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to pr...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. those granted before the introduction of such a system. Under the unitary patent system, European applications will soon have the option, upon grant of a patent, of becoming a Unitary Patent which w...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. certainty the long-term effects of any potential changes. Competitors may use our technologies in jurisdictions where we do not pursue or have not obtained patent protection to develop their own pr...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. legal systems of many foreign countries do not favor the enforcement of patents and other intellectual property protection, which could make it difficult for us to stop the infringement of our paten...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license. Many countries have compu...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. procedural, documentary, fee payment and other requirements imposed by regulations and governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. of procedural, documentary, fee payment and other similar provisions during the patent application process and over the lifetime of our owned patents and applications. We employ reputable law firms ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. prospects. 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. ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Over the...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , or that we do not consider appropriate for, patent protection. In addition, we rely on the protection of our trade secrets, including unpatented know-how, technology and other proprietary informati...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. in all circumstances, and it is possible that any of these parties may breach the agreements and may unintentionally or willfully disclose our proprietary information, including our trade secrets, a...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect tr...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. reduced, and our competitive position in the marketplace, business, financial condition, results of operations and prospects may be materially adversely affected. If we do not apply for patent prote...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. become subject to litigation where a third party asserts that we or our employees, consultants or advisors inadvertently or otherwise breached the agreements and used or disclosed trade secrets or o...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers. As is common in the ph...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel, which could adversely affect our business. Even if we are successful in defending...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. technology in all relevant fields of use and in all territories in which we may wish to develop or commercialize our technology and products in the future. In addition, subject to the terms of any ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and our rights to develop and commercialize any of our products that are subject of such licensed rights could be adversely affected. Our licensors may have relied on third-party consultants or col...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. may be non-exclusive, thereby giving our competitors access to the same technologies 91 Table of Contents licensed to us. In that event, we may be required to expend significant time and resource...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. manufacture, sales or future sales, or, with respect to our future sales, an obligation on our part to pay royalties and/or other forms of compensation to third parties, which could be significant. ...