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H.S. junior Avg
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New words:
AA, acclimate, accomplishing, adapt, Addendum, adherence, adware, AI, amenable, ANDA, anticancer, arguably, artificial, attendant, authentication, automated, balloon, bona, buy, catheter, CCPA, certainty, chosen, climate, Club, Colorado, comment, complementary, configuration, constituent, content, coordinate, coordinator, credential, cyber, cybersecurity, deceptive, deep, degradation, deploying, destroy, deter, differentiate, diligence, disadvantage, disaggregated, disaster, discover, double, downgraded, East, EEA, email, emerging, encryption, entailed, entailing, enterprise, environmental, Equiniti, expenditure, extrahepatic, factor, fake, feasible, fide, Fitch, foot, forecast, Fundamental, geography, hardware, harvesting, headcount, HEPATO, HEPZATOTM, HHS, HLA, honor, hosted, inaccurate, infer, inhibit, inpatient, inquiring, inquiry, intelligence, Interagency, interruption, introduction, invisible, IPAC, landlord, lymph, malware, mandatorily, manual, Martha, MHMD, Middle, misconduct, misrepresentative, misuse, monotherapy, multi, multicenter, mUM, nationwide, navigate, nearest, network, notification, OfferingSM, opting, organizational, outlining, outsource, overestimate, pathway, permission, phishing, pose, precedent, prematurely, pretreated, pro, profusion, ransomware, rata, rationale, relocate, renew, renewal, reposition, residual, retaliatory, revocation, role, Rook, rounded, sample, scenario, segment, sensitive, sensitivity, server, social, specialist, sterling, stockpiled, stuffing, succeed, sue, SVPF, thirty, traditional, transplant, unclear, undermine, undistributed, unforeseen, unitary, unnecessarily, Unremediated, UPC, upcoming, Utah, vendor, Vice, Virginia, warranty, Washington, whichever, wiretapping
Removed:
abeyance, accommodate, adequacy, Alternatively, analyzed, approach, aspect, attack, BAC, Barbra, biologic, BRAF, cisplatin, Clark, compound, concentrated, conclusive, convened, cumulative, Dabrafenib, dabrafinib, declining, denied, dependence, detecting, dossier, eliminate, enabling, enrolling, evident, exceeded, extremely, feature, fourth, Gastrointest, Gemcitabine, Genentech, GlaxoSmithKline, heart, hypotension, impractical, improvement, inadvisable, inherently, insert, inspected, investigate, investigating, IPO, Italy, ITT, Jennifer, justify, Keck, leased, light, marking, marrow, master, measure, mediation, mediator, medication, MEKINIST, misappropriation, mOM, mutation, neutral, nonqualified, object, Oncologic, OS, outbreak, partially, personally, pertaining, pharmacology, post, postponed, preclude, predefined, predicted, prespecified, promoted, purported, ratio, reaching, refusal, renal, representing, resignation, risky, roth, route, Simpson, SPA, Spring, statistical, statistically, stay, stratified, stroke, subleased, sublessee, summer, suppression, Tafinlar, task, toxic, trametinib, typical, unconditional, underwriter, underwriting, unspecified, validate, validation, voted, withdrawn, Yervoy
Financial report summary
?Competition
Bristol-Myers Squibb • Medtronic • Varian Medical Systems • Merit Medical Systems • Boston Scientific • GSK • Angiodynamic • Medtronic • Immunocore • ICCRisks
- Risks Related to Our Business and Financial Condition
- Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern.
- We will need additional capital to maintain our operations. If we cannot raise additional capital, our potential to generate future revenues will be significantly limited since we will not be able to further commercialize CHEMOSAT and HEPZATO, or conduct future product development, including clinical trials, if any.
- If we are not in compliance with the terms and conditions of our existing debt agreement, our business and financial condition may be adversely affected.
- Raising additional capital, or the exercise or conversion of securities exercisable or convertible into shares of common stock, may cause dilution to our existing stockholders and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights.
- We have incurred significant losses since inception, expect to incur significant and increasing losses for at least this year, and continuing losses may exhaust our capital resources.
- We have in the past, and may in the future, become subject to litigation or claims arising in or outside the ordinary course of business that could negatively affect our business operations and financial condition.
- We may be the subject of product liability claims or product recalls, and we may be unable to maintain insurance adequate to cover potential liabilities.
- Risks Related to Manufacturing, Commercialization and Market Acceptance of CHEMOSAT and HEPZATO
- We have only recently obtained regulatory approval for HEPZATO in the United States and commenced the commercial launch of HEPZATO. We have limited experience as a commercial company and generating revenue from product sales. If the commercial launch of HEPZATO is unsuccessful or any future approved products are unsuccessful, we may never be profitable.
- We must maintain or enter into acceptable arrangements for the supply of melphalan and other critical components of HEPZATO and CHEMOSAT and we may not be able to ensure adequate supply impacting our ability to successfully commercialize HEPZATO in the United States and CHEMOSAT in the EU or complete any future clinical trials.
- If we cannot successfully manufacture CHEMOSAT and HEPZATO, our ability to develop and commercialize the system would be impaired.
- We do not have written contracts with all of our suppliers for the manufacture of components for CHEMOSAT and HEPZATO.
- We may be unsuccessful in commercializing CHEMOSAT and HEPZATO because of inadequate infrastructure or an ineffective commercialization strategy.
- If we are unable to establish, maintain and, if necessary, expand sales and marketing capabilities or enter into agreements with third parties to sell and market HEPZATO in the United States or other product candidates, we may not be successful in commercializing HEPZATO in the United States or any other of our product candidates if they are approved.
- If we fail to overcome the challenges inherent in international operations, our business and results of operations may be materially adversely affected.
- Rapid technological developments in treatment methods for liver cancer and competition with other forms of liver cancer treatments could affect our ability to achieve meaningful revenues or profit.
- We may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for the commercial success of CHEMOSAT or HEPZATO, in which case we may not generate significant revenue for the foreseeable future.
- The sizes of the market opportunities for our product or product candidates, particularly HEPZATO for the treatment of mUM and CHEMOSAT for the treatment of cancers of the liver, have not been established with precision and may be smaller than we estimate, possibly materially. If our estimates of the sizes overestimate these markets, our sales growth may be adversely affected. We may also not be able to grow the markets for our product candidates as intended or at all.
- Risks Related to FDA and Foreign Regulatory Approvals and Regulatory Matters
- The development and approval process in the United States and abroad could take many years, require substantial resources and may never lead to the approval of our product candidates by the FDA for use in the United States or by foreign regulators in their respective jurisdictions.
- Our ability to market HEPZATO is limited to those uses that are approved.
- If future clinical trials are unsuccessful, significantly delayed or not completed, we may not be able to market HEPZATO for other indications.
- We have obtained the right to affix the CE Mark for the CHEMOSAT Hepatic Delivery System as a medical device for the delivery of melphalan in the EU. Since we may only promote the device within this specific indication, if physicians are unable or unwilling to obtain melphalan separately for use with CHEMOSAT, our ability to commercialize CHEMOSAT in the EU will be significantly limited.
- We are subject to significant ongoing regulatory obligations and oversight in the EU and the United States and will be in any other country where we receive marketing authorization or approval.
- We may not be able to obtain or maintain orphan drug designation or exclusivity for our product candidates.
- We relied and may continue to rely on third parties to conduct certain elements of clinical trials for CHEMOSAT and HEPZATO, should we seek to obtain regulatory approval for use of these products to treat additional indications for which we do not currently have regulatory approval, or for any future product candidates, if any, and if these third parties do not perform their obligations to us, we may not be able to obtain the necessary regulatory approval for our products or product candidates, as applicable.
- Purchasers of CHEMOSAT in Europe may not receive third-party reimbursement or such reimbursement may be inadequate. Without adequate reimbursement, commercialization of CHEMOSAT in Europe may not be successful.
- The success of our products may be harmed if the government, private health insurers or other third-party payors do not provide sufficient coverage or reimbursement.
- CHEMOSAT and HEPZATO may not achieve sufficient acceptance by the medical community to sustain our business.
- We may be subject, directly or indirectly, to federal and state health care fraud and abuse laws, false claims laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
- We are subject to stringent and evolving U.S. and foreign laws, regulations, and rules, contractual obligations, industry standards, policies and other obligations related to information privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation (including class claims) and mass arbitration demands; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse business consequences.
- Changes in health care law and implementing regulations, including government restrictions on pricing and reimbursement, as well as health care policy and other health care payor cost-containment initiatives, may have a material adverse effect on us.
- Consolidation in the healthcare industry could lead to demands for price concessions.
- Risks Related to our Intellectual Property
- Intellectual property rights may not provide adequate protection, which may permit third parties to compete against us more effectively.
- We have not and may not be able to adequately protect our intellectual property rights throughout the world.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- Our success depends in part on our ability to obtain patents, which can be an expensive, time consuming, and uncertain process, and the value of the patents is dependent in part on the breadth of coverage and the relationship between the coverage and the commercial product.
- Our success depends in part on our ability to commercialize CHEMOSAT and HEPZATO prior to the expiration of our patent protection.
- We may in the future become involved in lawsuits to protect or enforce our intellectual property, or to defend our products against assertion of intellectual property rights by a third party, which could be expensive, time consuming and unsuccessful.
- Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product and our technologies.
- Our trademarks may be infringed or successfully challenged, resulting in harm to our business.
- We may rely primarily on trade secret protection for important proprietary technologies.
- We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.
- Risks Related to Our Common Stock
- The market price of our common stock has been, and may continue to be volatile and fluctuate significantly, which could result in substantial losses for investors.
- Because of volatility in our trading price and trading volume, we may incur significant costs from class action securities litigation.
- Sales of a substantial number of shares of our common stock in the public market, or the perception that such sales may occur, could adversely affect the market price of our common stock and could impair our ability to raise additional equity capital.
- We have a history of reverse splits, which have severely impacted our common stock price.
- Anti-takeover provisions in our Amended and Restated Certificate of Incorporation and By-laws may reduce the likelihood of a potential change of control or make it more difficult for our stockholders to replace management.
- We have never declared or paid any dividends to the holders of our common stock and we do not expect to pay cash dividends in the foreseeable future.
- If we engage in acquisitions, reorganizations or business combinations, we will incur a variety of risks that could adversely affect our business operations or our stockholders.
- If securities or industry analysts do not publish or cease publishing research or reports about us, our business, or our market, or if they change their recommendations regarding our securities adversely, the price and trading volume of our securities could decline.
- The loss of key personnel could adversely affect our business.
- We and the third parties that support us rely on the proper function, availability and security of information technology systems to operate our business and a cyber-attack or other breach of these systems could have a material adverse effect on our business, including by not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences.
- We will continue to incur significant costs as a result of operating as a public company, and our management will continue to devote substantial time to compliance initiatives.
- We are a “smaller reporting company” and have elected to comply with reduced public company reporting requirements, which could make our common stock less attractive to investors.
- Our business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises, political crises, global geopolitical conflicts, or other macroeconomic conditions, which have in the past and may in the future negatively impact our business and financial performance.
- Further downgrades of the U.S. credit rating, automatic spending cuts, or a government shutdown could negatively impact our liquidity, financial condition and earnings.
- Environmental, social and governance matters and any related reporting obligations may impact our business.