Datasets:
ickma
/
sec_AA

Dataset card Data Studio Files
xet
 Community
1
text
stringlengths
198
2.89k
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. investment in research and development in order to advance FYARRO in additional indications through clinical trials. As a result, we expect that our research and development expenses will increase s...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. later-stage clinical trials, our expenses will increase substantially and may become more variable. Cost of Goods Sold Cost of goods sold consist primarily of royalties paid to BMS, costs incurred...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , we recognized no income tax expense on the condensed consolidated statements of operations and comprehensive loss, respectively. Since our formation in 2011, we have not recorded any U.S. federal o...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. 10,956 6,794 Cost of goods sold 529 179 Total operating expenses 22,692 16,121 Loss from operations (16,825) (13,814) Other income (expense), net 1,602 (43) Loss before income tax exp...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. 2023 and 2022 were $5.9 million and $2.3 million, respectively. Operating Expenses Selling, General and Administrative Expenses Selling, general and administrative expenses for the three months en...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. Three Months Ended March 31, 2023 2022 Personnel expenses 6,027 3,552 Consultants 1,399 1,164 External clinical development 2,694 1,749 Clinical drug product manufacturing 753 288 Othe...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. 1 trial, and $0.5 million in clinical drug product manufacturing. Cost of Goods Sold Cost of goods sold was $0.5 million and $0.2 million for the three months ended March 31, 2023, and 2022, resp...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. 2023, compared to the three months ended March 31, 2022 Liquidity and Capital Resources Overview As of March 31, 2023 we had $151.2 million of cash, cash equivalents and short-term investments. ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. principally from costs incurred in connection with research and development activities, selling, general and administrative costs associated with our operations. We expect to continue to incur signi...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. financing and the sale of Series A convertible preferred stock, $9.1 million from the issuance of convertible promissory notes, $145.4 million, net from the 2021 PIPE Financing in connection with th...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. sole discretion, shares of our common stock having aggregate gross proceeds of up to $75.0 million through Cowen as our sales agent. Under the Sales Agreement, we will set the parameters for the sal...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. sold under the Sales Agreement will be issued and sold pursuant to our shelf registration statement on the Form S-3 (File No. 333-255129), which was filed with the SEC on April 8, 2021, and which be...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. registered sales of our securities, subject to market conditions and our future capital needs. The terms of any offering under the shelf registration statement will be established at the time of suc...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. Warrants are exercisable at an exercise price of $0.0001 and will be exercisable until exercised in full. The 2022 PIPE Financing closed on September 26, 2022. Aggregated net proceeds, after deduct...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. equivalents and restricted cash (4,973) (19,140) Operating Activities Our cash used in operating activities primarily results from our net loss adjusted for non-cash expenses, changes in working...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. $7.8 million net decrease in our working capital accounts, primarily driven by an increase in accounts receivable, prepaid expenses, inventory, accounts payable and accrued expenses, and decrease ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. 7.5 million net decrease in our working capital accounts, primarily driven by an increase in accounts receivable, accounts payable and accrued expenses related to the commercial launch of FYARRO in F...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. . Cash provided by financing activities for the three months ended March 31, 2022 related to the exercise of stock options and warrants. Contractual Obligations and Commitments In April 2022, we e...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. clause. Rent expense is being recorded on a straight-line basis. Rent expense related to the Pacific Palisades and Morristown leases was $0.1 million and $0.1 million for the three months ended Ma...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. will purchase FYARRO as a finished drug product from Fresenius Kabi, on a purchase order basis. The Fresenius Agreement contains specific activities such as non-cancellable commitments, minimum purc...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. be modified and the contracts cancelled by us upon written notice. In the event of a cancellation, we would be liable for the cost and expenses incurred to date as well as any close out costs of the...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , judgments or assumptions and actual results, our financial statements will be affected. Historically, revisions to our estimates have not resulted in a material change to our financial statements. ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and are not required to provide information under this Item. Item 4. Controls and Procedures. Management’s Evaluation of our Disclosure Controls and Procedures Under the supervision of and with t...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , processed, summarized and reported, within the time periods specified in the rules and forms promulgated by the SEC. Disclosure controls and procedures include, without limitation, controls and pro...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future event...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the Exchange Act during the quarter ended March 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Limitations on ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. limitations in any control system, misstatements due to error or fraud may occur and not be detected. 34 Table of Contents PART II—OTHER INFORMATION Item 1. Legal Proceedings For discussion of ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. . If any of the following risks actually occur, our business, financial condition, results of operations and future growth prospects could be materially and adversely affected. Risk Factors Summary ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. net losses for the foreseeable future. Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve several objectives relating to the discovery, develo...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts. We are substantially depen...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. -source supplier for the drug product FYARRO, and the loss of such supplier could harm our business. If we cannot replicate the results from our earlier preclinical studies and clinical trials of ou...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. 35 Table of Contents We face significant competition, and if our competitors develop and market technologies or products more rapidly than we do or achieve regulatory approval before we do or that ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. business will be substantially harmed. FYARRO is, and any other product candidate we may develop in the future for which we obtain marketing approval for could be, subject to post-marketing restric...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. plan. If we are unable to establish or appropriately scale up our sales or marketing capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. third parties, some of which are sole source suppliers, increases the risk that we will not have sufficient quality and quantities of FYARRO or such quantities at an acceptable cost, which could del...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. our current business and likelihood of success and viability. We are a commercial-stage biopharmaceutical company with a limited operating history upon which you can evaluate our business and prosp...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. companies in new and rapidly evolving fields, particularly in the biopharmaceutical area. Consequently, any predictions about our future performance may not be as accurate as they would be if we had...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. in May 2021. The U.S. Food and Drug Administration (the “FDA”) accepted our NDA in July 2021 and approved FYARRO for the treatment of advanced malignant PEComa in November 2021. Based on the AMPECT ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. October 2022 we entered into a collaboration and supply agreement with Mirati Therapeutics, Inc. (“Mirati”) to evaluate the combination of Mirati’s adagrasib (KRAZATI™), a KRAS G12C selective inhi...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. necessary for successful product commercialization. As a result, it may be more difficult for you to accurately predict our likelihood of success and viability than it could be if we had a longer op...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. from licenses. Our net losses were $15.2 million and $13.9 million for the three months ended March 31, 2023 and 2022, respectively. We had an accumulated deficit of $218.4 million as of March 31, 2...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. well as research and development expenses related to our ongoing operations. As a result, we expect to continue to incur significant operating expenses for the foreseeable future due to the cost of ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and commercializing FYARRO in additional indications and any future product candidates, we expect to continue to incur significant expenses and increasing operating losses over the next several year...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. to achieve and maintain profitability and the performance of our stock. Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve several objectives ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. FYARRO in foreign jurisdictions or any future product candidates. We do not anticipate generating revenue from product sales significant enough to achieve profitability for the foreseeable future. ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. with one or more collaborators; maintaining commercially viable supply and manufacturing relationships with third parties that can provide adequate, in both amount and quality, products and service...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and maintaining relationships with contract research organizations (“CROs”) and clinical sites for the clinical development of FYARRO in other indications and any other future product candidates tha...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. by third-party payors for product candidates; satisfying any required post-regulatory approval commitments to applicable regulatory authorities; identifying, assessing and developing new product c...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. do, may never generate revenue that is significant or large enough to achieve profitability. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since incept...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. may also arise. In addition, even if we obtain regulatory approval for any of other product candidates, including additional indications for FYARRO , we expect to incur significant commercializati...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , and not for any other indication, or any other product candidate, in the United States. In addition, we will incur additional costs associated with operating as a public company. Accordingly, we ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. exhaust our available capital resources sooner than we currently expect. Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. will require a significant amount of capital. Our existing cash, cash equivalents and short-term investments will not be sufficient to fund all of the activities that are necessary to complete the d...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. financing may not be available to us in sufficient amounts or on acceptable terms, or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. us, which 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 ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or eliminate one or more of our research or development programs, clinical trials or future commercialization efforts Risks Related to the Discovery, Development and Commercialization 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. future success 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...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. whom there were no approved therapies in the United States. FYARRO will require additional clinical development, expansion of manufacturing capabilities, regulatory approval from foreign regulator...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. in a non-clinical 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...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. to use FYARRO 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;...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. truncating TSC1 & TSC2 alterations; maintaining and establishing relationships with CROs and clinical sites for the development of FYARRO both in the United States and internationally; 40 Table...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , we have initiated a registration-directed tumor-agnostic Phase 2 study, PRECISION 1, of FYARRO in patients with malignant solid tumors harboring TSC1 & TSC2 alterations. We completed a Type B m...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and may harm our business, results of operations and prospects. Events that may result in a delay or unsuccessful completion of additional clinical development of FYARRO include, among other things: ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or failure to conduct the trial in accordance with regulatory requirements; failure of third parties, such as CROs, to satisfy their contractual duties or meet expected deadlines; delays in the te...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. , such as the COVID-19 pandemic. 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 deve...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. FYARRO in additional indications or for 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...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. IND-enabling studies. Moreover, 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 i...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. preclinical and clinical development. The historical failure rate for product candidates is high due to risks relating to safety, efficacy, clinical execution, changing standards of medical care and...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. product candidate for use in clinical trials; and generating sufficient safety and efficacy data to warrant continued development and which are satisfactory to the FDA or any other regulatory autho...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. success, which would limit the 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 deve...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. as boxed warnings or contraindications in labeling, or a risk evaluation and mitigation strategy, if any, which may not be required of alternative treatments and competitor products; the potential ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. to try new therapies and undergo required diagnostic screening to determine treatment eligibility and of physicians to prescribe these therapies and diagnostic tests; the effectiveness of sales and...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the benefits of our product candidates may require significant resources and may never be successful. The market opportunities for FYARRO and any other product candidates we may develop in the futu...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. radiation, antibody drugs, tumor-targeted small molecules, or a combination of these. Third line therapies can include chemotherapy, antibody drugs and small molecule tumor- targeted therapies, more...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. future product candidates are based on our estimates, which may prove to be incorrect. Additionally, the potentially addressable patient population for FYARRO and any future product candidates may b...
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 unfavorable third-party coverage and reimbursement practices, as well as pricing regulations. The availability and extent of coverage and adequate reimbursement by third-party pay...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. the future. Even if coverage 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 invest...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. regulatory approval. Market acceptance and 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 ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. reimbursed under Medicare, and private third-party payors often follow CMS’s decisions regarding coverage and reimbursement to a substantial degree. However, one third-party payor’s determination to...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Increasingly, third-party payors are requiring that drug com...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. (an “ASP”) and best 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 rebat...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to prescription drug pricing, review t...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. ,” with multiple provisions aimed at increasing competition for prescription drugs. In August 2022, Congress passed the Inflation Reduction Act of 2022, which includes prescription drug provisions th...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. compliance burdens and expose us to greater liability under such laws once we begin commercialization for FYARRO or, after obtaining regulatory approval, any of our other product candidates that we ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. continue to put pressure on the pricing 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 co...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. allow companies to fix their own prices for products but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that ...
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 candidates that we 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...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. or more product candidates that 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 ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. of an NDA is 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 proc...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. early clinical setting, among 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 associ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. required to obtain approval in 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...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. and any other jurisdictions, we must obtain separate marketing approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve a...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. United States does not ensure approval 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 ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. what happens when a local seller, 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 ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. Act (“FCPA”) or comparable foreign regulations; challenges enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellec...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. as potential responses to them by Russia, is currently unknown and they could adversely affect our business, supply chain, business partners or customers. These and other risks associated with our ...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. when approved, we, among other requirements, must complete preclinical development and extensive clinical trials to demonstrate with substantial evidence the safety and efficacy of such product or o...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. . In addition, initial 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 in...
YOU are a financial analyst. You are reading a report of a company. The report is about the company's financial status. develop in the future, 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 ...