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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. may have a material adverse effect on our business, operating results and prospects. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. development programs, clinical trials or future commercialization efforts. Risks Related to the Discovery, Development and Commercialization of Our Product Candidates We have only one product, FYA...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. is dependent on our ability to successfully commercialize FYARRO, and to timely and successfully obtain regulatory approval for additional indications for FYARRO. We are investing the majority of ou...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. approved therapies in the United States. FYARRO will require additional clinical development, expansion of manufacturing capabilities, regulatory approval from foreign regulatory authorities in ju...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. inical trial setting that those demonstrated in our clinical trials; the effectiveness of our sales, marketing and distribution efforts; the maintenance of existing or the establishment of new supp...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. RO and continue to use FYARRO; the availability of coverage and adequate reimbursement and pricing by private and government payors; the prevalence and severity of adverse side effects; the conven...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. SC1 & TSC2 alterations; maintaining and establishing relationships with CROs and clinical sites for the development of FYARRO both in the United States and internationally; the type, frequency and...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. -agnostic Phase 2 study, PRECISION 1, of FYARRO in patients with malignant solid tumors harboring TSC1 & TSC2 alterations. We completed a Type B meeting with the FDA in which we discussed the tri...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. operations and prospects. Events that may result in a delay or unsuccessful completion of additional clinical development of FYARRO include, among other things: unexpectedly high rate of patients w...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. with regulatory requirements; failure of third parties, such as CROs, to satisfy their contractual duties or meet expected deadlines; delays in the testing, validation, manufacturing and delivery ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. . An inability by us to timely complete clinical development could result in additional costs to us or impair our ability to generate substantial product sales or development, regulatory, commercial...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. other product candidates, we may not be able to continue our operations. In addition to FYARRO, our prospects depend in part upon discovering, developing and commercializing additional product cand...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , we cannot be sure that submission of an IND will result in the FDA allowing further clinical trials to begin, or that, once begun, issues will not arise that result in the suspension or termination...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. The historical failure rate for product candidates is high due to risks relating to safety, efficacy, clinical execution, changing standards of medical care and other unpredictable variables. The re...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. trials; and generating sufficient safety and efficacy data to warrant continued development and which are satisfactory to the FDA or any other regulatory authority for marketing approval. Even if ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. revenue that we generate from our sales. Even though FYARRO has been approved for advanced malignant PEComa, and even if any other product candidates that we may develop in the future receive regul...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. dications in labeling, or a risk evaluation and mitigation strategy, if any, which may not be required of alternative treatments and competitor products; the potential and perceived advantages of ou...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. eligibility and of physicians to prescribe these therapies and diagnostic tests; the effectiveness of sales and marketing efforts; 43 Table of Contents unfavorable publicity relating to our prod...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. may require significant resources and may never be successful. The market opportunities for FYARRO and any other product candidates we may develop in the future, if approved, may be limited to cert...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. -targeted small molecules, or a combination of these. Third line therapies can include chemotherapy, antibody drugs and small molecule tumor- targeted therapies, more invasive forms of surgery and ne...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. our estimates, which may prove to be incorrect. Additionally, the potentially addressable patient population for FYARRO and any future product candidates may be limited or may not be amenable to tre...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. coverage and reimbursement practices, as well as pricing regulations. The availability and extent of coverage and adequate reimbursement by third-party payors, including government health administr...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize an adequate return on our investment. Coverage and reimbursem...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. sales of FYARRO or any other product candidates we may develop in the future for which we obtain regulatory approval will depend on reimbursement policies and may be affected by healthcare reform me...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. third-party payors often follow CMS’s decisions regarding coverage and reimbursement to a substantial degree. However, one third-party payor’s determination to provide coverage for a product candida...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Increasingly, third-party payors are requiring that drug companies provide them with predetermine...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. price. Penalties may apply in some cases when such metrics are not submitted accurately and timely. Further, these prices for drugs may be reduced by mandatory discounts or rebates required by gover...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. proposed and enacted federal and state legislation designed to, among other things, bring more transparency to prescription drug pricing, review the relationship between pricing and manufacturer pat...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. competition for prescription drugs. In August 2022, Congress passed the Inflation Reduction Act of 2022, which includes prescription drug provisions that have significant implications for the pharma...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. liability under such laws once we begin commercialization for FYARRO or, after obtaining regulatory approval, any of our other product candidates that we may develop in the future. The implementatio...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and usage of therapeutics such as FYARRO or any other product candidates that we may develop in the future if approved. In many countries, particularly the countries of the European Union, medical p...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. profits. Additional foreign price controls or other changes in pricing regulation could restrict 45 Table of Contents the amount that we are able to charge for FYARRO or any other product candida...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. may develop in the future if approved from third-party payors, the adoption of FYARRO or those other products if approved, the prices of FYARRO or those other products if approved and sales revenue ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. we may develop in the future for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future. We may not be able to obtain FDA ap...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. not guaranteed. The approval process is expensive and uncertain and may take several years. The FDA and foreign regulatory entities also have substantial discretion in the approval process. The numb...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. other goals. How the FDA plans to implement those goals and their impact on specific clinical programs and the industry are unclear. Despite the time and expense associated with preclinical studies ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. other countries might differ from that required to obtain FDA approval. The regulatory approval process in other countries may include all of the risks associated with FDA approval as well as additi...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. we must obtain separate marketing approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing. The time r...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. by regulatory authorities in other countries or jurisdictions or by the FDA. However, failure to obtain approval in one jurisdiction may impact our ability to obtain approval elsewhere. We may not b...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , faced with high or higher local prices, opts to import goods from a foreign market with low or lower prices rather than buying them locally; unexpected changes in tariffs, trade barriers, price an...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. comparable foreign regulations; challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property ri...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. Russia, is currently unknown and they could adversely affect our business, supply chain, business partners or customers. These and other risks associated with our international operations may compr...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. other requirements, must complete preclinical development and extensive clinical trials to demonstrate with substantial evidence the safety and efficacy of such product or other product candidates. ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. success in clinical trials may not be indicative of results obtained when such trials are completed. Moreover, preclinical and clinical data are often susceptible to varying interpretations and anal...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. including: receipt of feedback from regulatory authorities that require us to modify the design of our clinical trials; negative or inconclusive clinical trial results that may require us to condu...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. anticipated; the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates being insufficient or inadequate; and delays due to h...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. companies, to our knowledge, there are no mTOR inhibitors approved specifically for the treatment of advanced malignant PEComa other than FYARRO. As such, the development of FYARRO and our stock pri...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. in size and type of the patient populations, differences in and adherence to the dose and dosing regimen and other trial protocols and the rate of dropout among clinical trial participants. Patients...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. additional indications or for any other product candidates we may develop in the future. If we are required to conduct additional clinical trials or other testing of our product beyond those that we...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. Contents after obtaining regulatory approval. Even if regulatory approval is secured for any of our product candidates, the terms of such approval may limit the scope and use 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. approved products or investigational new drugs, we may need to conduct additional studies to further evaluate the product candidates’ safety, interrupt, delay or abandon their development or halt cl...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. generate revenues, and may harm our business, financial condition and prospects significantly. For example, in our AMPECT trial of FYARRO, most treatment-related adverse events were mild or moderate...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. planned clinical trials may in the future suffer other significant adverse events or other side effects not observed or anticipated based on our preclinical studies or previous clinical trials. FYAR...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. events due to other therapies or medications that such patients may be using or due to the gravity of such patients’ illnesses. For example, it is expected that some of the patients enrolled in our ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks or adverse side effects. Some potential th...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. candidates obtains regulatory approval, toxicities associated with such product candidates and not seen during clinical testing may also develop after such approval and lead to a requirement to (i) ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. -stage clinical trials. Results from early preclinical studies and clinical trials of FYARRO or other product candidates that we may develop in the future are not necessarily predictive of the resul...
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 are able to complete our planned preclinical studies and clinical trials according to our current development timeline, the results from such preclinical studies and clinical trials may n...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain FDA or EMA approval. We are subject to risks relating to open-label clinical trials. Som...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. receiving treatment. Open-label clinical trials may be subject to biases, including a “patient bias” where patients perceive their symptoms to have improved merely due to their awareness of receivin...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or as additional analyses are conducted and are subject to audit and verification procedures that could result in material changes in the final data. From time to time, we may publicly disclose pre...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. all data. As a result, the topline results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional dat...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. significantly harm our business and prospects. Further, additional disclosure of interim data by us or by our competitors in the future could result in volatility in the price of our common stock. ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. obtain approval for, and commercialize, FYARRO in other indications or any other product candidates that we may develop in the future may be harmed, which could harm our business, financial conditio...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. collaborations, we may grant such collaboration partners with the right to develop and commercialize the same compounds licensed to us, including FYARRO, in such foreign jurisdictions. As a result, ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. in clinical trials, our regulatory submissions or receipt of necessary regulatory approvals could be delayed or prevented. We may not be able to initiate or continue clinical trials for FYARRO or a...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. TSC1 & TSC2 study are screened using genomic information to identify alterations in the TSC1 & TSC2 genes and utilizing such criteria and/or certain highly specific criteria related to the cance...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. approved label. We may also engage third parties to develop companion diagnostics for use in our clinical trials, but such third parties may not be successful in developing such companion diagnostic...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. completing recruitment for one or more of our trials. Patient enrollment and retention for our current or any future clinical trials may be affected by other factors, including: size and nature of ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. ; clinicians’ willingness to screen their patients for biomarkers to indicate which patients may be eligible for enrollment in our clinical trials; patient referral practices of physicians; 51 Ta...
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 may make it difficult or impossible to recruit and retain patients in other clinical trials we are conducting. Similarly, negative results reported by our competitors about th...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. -up periods. In addition, we rely on clinical trial sites to ensure timely conduct of our clinical trials and, while we have entered into agreements governing their services, we are limited in our ab...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. G12C mutant non-small cell lung cancer (NSCLC) and other solid tumors. Patients may not be able to tolerate FYARRO or any of our future product candidates in combination with other therapies or dosi...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , manufacturing or supply issues could arise with these existing therapies. In addition, it is possible that existing therapies with which our product candidates are approved for use could themselves...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. regulatory approval. If the FDA, EMA or other comparable foreign regulatory authorities do not approve or revoke their approval of these other therapies, or if safety, efficacy, commercial adoption...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. of serious adverse effects, may delay or prevent the development and approval of our product candidates. Additionally, if the third-party providers of therapies or therapies in development used in ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. . We are currently focusing our resources and efforts on developing and commercializing FYARRO for particular indications. As a result, because we have limited financial and managerial resources, we...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. clinical trial success, commercial potential or target markets for FYARRO or any of our other product candidates that we may develop in the future, we may relinquish valuable rights to that product ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. Our competitors have developed, are developing or may develop products, product candidates and processes competitive with FYARRO for advanced malignant PEComa or for any additional indications we ma...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. products. In particular, there is intense competition in the field of oncology. We have competitors both in the United States and internationally, including major multinational pharmaceutical compa...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. a commonly receive chemotherapy regimens and currently mTOR inhibitors including sirolimus, everolimus, and temsirolimus are recommended in the National Comprehensive Cancer Network (the “NCCN”) guid...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. include dual mTORC1/2 inhibitors in clinical trials or next generation mTOR inhibitors in development. Any potential competitors may have significantly greater financial, manufacturing, marketing, d...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage com...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. label, are marketed more effectively, are more widely reimbursed or are less expensive than any products that we may develop and commercialize. Our competitors also may obtain regulatory approval fr...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. generate revenue from the sale of FYARRO or any product candidates we may develop in the future, if approved, could be adversely affected. Changes in methods of product candidate manufacturing or f...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. cause FYARRO and any other product candidate that we may develop in the future to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. in-licensing and acquisition opportunities to further expand our portfolio, we may not be able to identify suitable licensing or acquisition opportunities, and even if we do, we may not be able to su...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. appropriate return on our investment, or at all. If we are unable to successfully license or acquire additional product candidates to expand our portfolio, our pipeline, competitive position, busine...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or any other product we develop allegedly causes injury or is found to be otherwise unsuitable during product testing, manufacturing, marketing or sale. Any such product liability claims may include...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. . FDA, EMA or other regulatory authority investigations could potentially lead to a recall of our products or more serious enforcement action, limitations on the approved indications for which they m...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. against losses caused by product liability claims that could have an adverse effect on our business and financial condition. Large judgments have been awarded in class action lawsuits based on drugs...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and deaths related to COVID-19 are disrupting certain healthcare and healthcare regulatory systems globally. Such disruptions could divert healthcare resources away from, or materially delay review ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. offices, or country borders. Constraints surrounding hospital resources, infrastructure, staff and other resources, can also make it more difficult to enroll new patients in ongoing or planned clini...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the conduct of our clinical trials; interruption of key clinical trial activities, such as clinical trial site data monitoring, due to limitations on travel imposed or recommended by federal or sta...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems, including as a result of the COVID-19 pandemic; interruptions in preclinical studies due to restric...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. from clinical trials in affected geographies outside the United States. The extent of the impact of the COVID-19 pandemic on our future liquidity and operational performance will depend on certain ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. cost more or entail greater complications and risks than anticipated, which may delay or prevent the approval of a product candidate and/or new indications for commercial use. We submitted a Sectio...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. axman Amendments”) and permits the submission of an NDA where at least some of the information required for approval comes from preclinical studies or clinical trials not conducted by or for the appl...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. if any new indication or product candidate is approved under the Section 505(b)(2) regulatory pathway, the approval may be subject to limitations on the indicated uses for which we may be marketed o...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and will continue to be subject to extensive governmental regulations relating to, among other things, research, testing, development, manufacturing, safety, efficacy, approval, recordkeeping, repor...