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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. by the United States or other countries could materially adversely affect our results of operations and financial condition. Risks Related to Our Reliance on Third Parties We contract with qualifi...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and expect to continue to rely, on third-party manufacturers for the production of FYARRO and product candidates for preclinical studies and clinical trials under the guidance of members of our orga...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. us, and we will purchase FYARRO as a finished drug product from Fresenius Kabi, on a purchase-order basis. The Fresenius Agreement, as amended in January 2023, will be effective through March 31, 20...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. supply agreements in place for key raw materials used in the manufacture of FYARRO such as for the drug substance sirolimus and for human albumin, which are key ingredients in the drug product. If w...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. future for any reason, whether as a result of manufacturing, supply or storage issues or otherwise, we could experience delays, disruptions, suspensions or terminations in commercializing FYARRO for...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. impact the commercialization of FYARRO, and, in the event that we do not have sufficient product to complete our planned clinical trials, it could delay such trials. Even if we are able to establish...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. inconvenient for us; the breach by the third-party contractors of our agreements with them; the failure of third-party contractors to comply with applicable regulatory requirements, including manu...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. . We do not have complete control over all aspects of the manufacturing process of our contract manufacturing partners and are dependent on these contract manufacturing partners for compliance with ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. protect against any potential supply disruptions. However, we may be unsuccessful in putting in place such framework agreements or protecting against potential supply disruptions. Third-party manuf...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. materials or products for such companies, which exposes our manufacturers to regulatory risks for the production of such materials and products. As a result, failure to satisfy the regulatory requir...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and develop, obtain regulatory approval for or market FYARRO for other indications or any of our other product candidates that we may develop in the future, if approved. Our reliance on CMOs also ex...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. drugs that we may develop in the future and harm our business and results of operations. In addition, the manufacture of pharmaceutical products is complex and requires significant expertise and ca...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. Any stability or other issues relating to the manufacture of our product candidates may occur in the future. Further, as product candidates are developed through preclinical studies to late-stage cl...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. on the conduct of business operations could occur, related to COVID-19 or other infectious diseases could impact personnel at our third-party manufacturing facilities upon which we rely, or the avai...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. depending upon the period of delay, require us to commence new clinical trials at additional expense or terminate clinical trials completely. Any of these challenges could delay completion of clini...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and competitive basis. We are dependent on a single-source supplier for the drug product FYARRO, and the loss of such supplier could harm our business. We rely on a single-source supplier, Freseni...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. of FYARRO such as for the drug 73 Table of Contents substance sirolimus and for human albumin, which are key ingredients in the drug product. Our suppliers could discontinue the manufacturing or ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. time and effort to locate and qualify an alternative source of supply. We currently rely on a single company for such manufacturing for FYARRO. Any contractual disputes between us and such manufactu...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or be required to seek additional regulatory clearances or approvals if we experience any delay or deficiency in the quality of products obtained from suppliers or if we have to replace our supplier...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. for the key raw materials used in the manufacture of FYARRO also could adversely affect clinical development of FYARRO in other indications. If we are not able to identify alternate sources of suppl...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. -party manufacturers encounter such difficulties, our ability to provide adequate supply of FYARRO for patients or for clinical trials or any other product candidate that we may develop in the future...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. Slight deviations anywhere in the manufacturing process, including filling, labeling, packaging, storage and shipping and quality control and testing, may result in lot failures, product recalls or ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. of these challenges, or otherwise, our development and commercialization efforts would be impaired, which would have an adverse effect on our business, financial condition, results of operations and...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. ”). We are required to use commercially reasonable efforts or diligent efforts to commercialize products based on the licensed rights and to pay certain royalties based off our net sales, certain sub...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. ize products could suffer. We rely, and expect to continue to rely, on third parties to conduct our preclinical studies and clinical trials and those third parties may not perform satisfactorily, in...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. future. We enter into agreements with third parties that have a significant role in the conduct of our preclinical studies and clinical trials and the subsequent collection and analysis of data. The...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. iii) experience regulatory compliance issues, (iv) undergo changes in priorities or become financially distressed, or (v) have relationships with other entities, some of which may be our competitors,...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. will remain responsible for ensuring that each of our preclinical studies and clinical trials is conducted in accordance with the general investigational plan and protocols for the trial and legal, ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. If we or any of our CROs fail to comply with applicable GCP requirements, the clinical data generated in our preclinical studies and clinical trials may be deemed unreliable and the FDA, EMA or comp...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. process and could also subject us to enforcement action up to and including civil and criminal penalties. We are also required to register certain ongoing clinical trials and post the results of cer...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. candidates that we may develop in the future and will not be able to, or may be delayed in our efforts to, successfully commercialize such product candidates, if approved. 75 Table of Contents We...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. financial and cash flow difficulties that force them to limit or reduce their efforts under their collaboration agreement with us; our collaboration partners may be pursuing alternative technologie...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. even if we believe that the development of product candidates is worth pursuing, our partners may choose not to continue with such development. If any of our collaborations are terminated, we may no...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. -based milestone payments upon the occurrence of certain milestone events totaling $257 million, as well as tiered royalties based on annual net sales of FYARRO. In addition, EOC was responsible for ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. EOC's termination of the EOC License Agreement prior to completing development or commercialization of the FYARRO under the collaboration adversely impacts the potential approval and our revenue fro...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. for additional alliances or collaborations may also require us to incur non-recurring and other charges, increase our near- and long-term expenditures, issue securities that dilute our existing stoc...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities, and subject us to other risks. ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. key personnel and uncertainties in our ability to maintain key business relationships; risks and uncertainties associated with the other party to such a transaction, including the prospects of that...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. drug development programs and the potential commercialization of our product candidates will require substantial additional cash to fund expenses. We may seek to selectively form collaborations to e...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. of factors. Those factors may include the design or results of clinical trials, the likelihood of approval by the FDA, EMA or comparable foreign regulatory authorities, the potential market for the ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. collaborative effort and third parties may not view them as having the requisite potential to demonstrate safety and efficacy. In addition, there have been a significant number of recent business c...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to increase our expendit...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. will likely have limited control over the amount and timing of resources that our collaborators dedicate to the development or commercialization of our product candidates. Our ability to generate re...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. sale or disposition of a business unit or development function, or available funding or external factors such as an acquisition that diverts resources or creates competing priorities; collaborators...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. product candidate that we may develop in the future, if approved, relative to other products; we may grant exclusive rights to our collaborators that would prevent us from collaborating with others...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; collaboration agreements may not lead to development or commerci...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. be in compliance with applicable laws, resulting in civil or criminal proceedings. Disputes between us and our collaborators may result in litigation or arbitration which would increase our expense...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. a termination for convenience. EOC had the right to terminate the agreement for convenience upon 120 days advance written notice. We waived such notice period in connection with EOC's termination no...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. It may be necessary for us to assume the responsibility at our own expense for the development of FYARRO in the EOC Territory or find another partner for the territory. In that event, we would likel...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. scientific and medical staff. If we do not succeed in attracting and retaining qualified personnel, particularly at the management level, it could adversely affect our ability to execute our busines...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. President and CEO, effective March 14, 2023, and the appointment of Scott Giacobello, our Chief Financial Officer to Interim CEO and President, effective March 15, 2023, while our Board conducts an ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. us. They also may provide higher compensation, more diverse opportunities and better prospects for career advancement. Some of these characteristics may be more appealing to high-quality candidates ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. agreements with us. If a conflict of interest arises between their work for us and their work for another entity, we may lose their services. Furthermore, our advisors may have arrangements with oth...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. candidates that obtain regulatory approval. In order to commercialize FYARRO for advanced malignant PEComa or any additional indications that we may seek approval for, or any other product candidat...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. advanced malignant PEComa, for example. Establishing and maintaining an internal sales or marketing team with technical expertise and supporting distribution capabilities to commercialize our produ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. may be costly, and our investment would be lost if we cannot retain or reposition our commercialization personnel. Alternatively, if we choose to collaborate, either globally or on a territory-by-te...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. commercialization may experience delays or limitations. We may have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and marke...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. we transition into operating as a public company, we expect to need additional managerial, operational, development, sales, marketing, financial and other personnel. Future growth would impose signi...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert a disproportionate amount of our attention away from day-to-day activities in...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. compromised for any reason, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval of FYARRO for additional indications and any other produc...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. development and commercialization goals. Our internal computer systems, or those of any of our CROs, manufacturers, other contractors or consultants or potential future collaborators, may fail or s...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. vulnerable to breakdown or other damage or interruption from service interruptions, system malfunction, natural disasters, terrorism, war and telecommunication and electrical failures, as well as se...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. that any disruption or security breach were to result in a loss, destruction, unavailability, alteration or dissemination of, or damage to, our data or applications, or for it to be believed or repo...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. an event were to occur and cause interruptions in our operations, it could result in a material disruption of our programs and the development of our product candidates could be delayed. In addition...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. event that leads to unauthorized access, use, or disclosure of personal information, including personal information regarding our clinical trial subjects or employees, could harm our reputation dire...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. to a security incident could impact our reputation and cause us to incur significant costs, including legal expenses and remediation costs. For example, the loss of clinical trial data from complete...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. to, our data, or inappropriate disclosure of confidential or proprietary information, we could be exposed to litigation and governmental investigations, the further development and commercialization...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. high deductibles in any event, and defending a suit, regardless of its merit, could be costly and divert management attention. We, or the third parties upon whom we depend, may be adversely affecte...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. basis, and have significant negative consequences on our financial and operating conditions. Loss of access to these facilities may result in increased costs, delays in the development of our produc...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. period of time. The disaster recovery and business continuity plans we have in place may prove inadequate in the event of a serious disaster or similar event. We may incur substantial expenses as a ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. time, any or all of our research and development programs may be harmed. Any business interruption may have a material and adverse effect on our business, financial condition, results of operations ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , but the deductibility of federal NOLs in tax years beginning after December 31, 2020 is limited to 80% of our current year taxable income. It is uncertain if and to what extent various states will...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. 0 million available as of December 31, 2022, which begin to expire in 2037. Under Sections 382 and 383 of the Code, if a corporation undergoes an “ownership change” (generally defined as a cumulativ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. limitations will cause NOL and research and development credit carryforwards to expire unused, these tax attributes have been removed from our deferred tax asset. Our ability to utilize our NOLs an...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. Inflation Reduction Act, which implemented a number of changes, including a 1% excise tax on stock buybacks and an alternative minimum tax on adjusted financial statement income. Such enacted and ot...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. risks related to operating in foreign countries if we obtain the necessary approvals, including: differing regulatory requirements and reimbursement regimes in foreign countries; unexpected change...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the United States; production ...
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 operate without infringing upon the valid and enforceable patents and proprietary rights of others. We generally seek to protect our proprietary position by filing patent applications...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. be no assurance that our patent applications or the patent applications of our licensors will result in additional patents being issued in any particular jurisdiction or that issued patents will aff...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. product candidates could have a material adverse effect on our financial condition and results of operations. Although we own or license twelve (12) issued patents in the United States, we cannot b...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. any of our current or potential future collaborators will be successful in protecting our product or product candidates by obtaining and defending patents. These risks and uncertainties include the ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. forceable, found to be not infringed or otherwise may not provide any competitive advantage; our competitors, many of whom have substantially greater resources than we do and many of whom have made ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and the outcome of such litigation would be uncertain. Moreover, any actions we may bri...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and we and our licensors may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner or in all jurisdictions where protection may ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. CROs, third-party manufacturers, consultants, advisors and other third parties, any of these parties may breach such agreements and disclose such output before a patent application is filed, thereby...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. of biopharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has been the subject of much litigation in recent years. As a result, the issuance, sc...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. protecting our proprietary rights in these countries. Our pending and future patent applications and those of our licensors may not result in patents being issued that protect our product or product...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. result of challenges by third parties. Consequently, we do not know whether our product or product candidates will be protectable or remain protected by valid and enforceable patents. Our competito...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. involved in opposition, derivation, revocation, reexamination, post-grant review (“PGR”) and inter partes review (“IPR”), or other similar proceedings challenging our owned patent rights. An adver...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. of invention or other features of patentability with respect to our patents and patent applications and those of our licensors. Such challenges may result in loss of patent rights, loss of exclusivi...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. with us to license, develop or commercialize current or future products or product candidates. If any of our patents, if and when issued, covering our product candidates are invalidated or found une...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. any future product candidates but that are not covered by the claims of the patents that we own or license; we or our licensors or collaborators might not have been the first to make the inventions...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets; we may not develop a...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. our developmental and commercialization efforts. Our commercial success depends in part on avoiding infringement or misappropriation of the patents, intellectual property and proprietary rights of ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , IPR proceedings and PGR proceedings before the USPTO and/or corresponding foreign patent offices. Numerous third-party United States and foreign issued patents and pending patent applications exist...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. commercialization of our product or any of our product candidates, and we cannot be certain that we were the first to file a patent application related to a product or technology. Moreover, because ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. do not believe is relevant to our business, which may, nonetheless, ultimately be found to limit our ability to make, use, sell, offer for sale or import our products that may be approved in the fut...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and could: result in costly litigation that may cause negative publicity; divert the time and attention of our technical personnel and management; cause development delays; prevent us from comme...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. of the date of this Annual Report, others may hold proprietary rights that could prevent FYARRO or our product candidates from being marketed. For example, various patent offices periodically grant ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , and require us to obtain a license to manufacture or market our product or product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and w...