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New words:
Actelion, Aid, Bob, bona, Brownian, built, Carlo, Cereno, Cox, CSF, digital, disability, DPF, elevated, fide, footprint, Gal, Geometric, input, Insmed, John, Johnson, macitentan, magnitude, median, Mochida, NIST, OrphAI, pace, palmitil, parent, ph, Pharmosa, premium, PROSERA, Quisel, ratification, repriced, repricing, rollover, Russell, selexipag, spearheaded, threat, transmit, treprostinil, unified, Unitary, UPC, version
Removed:
AbbVie, accelerate, activate, adaptive, affinity, assumption, AstraZeneca, barrier, begun, Bilenker, biopharma, capitalize, commerce, contracted, deep, departure, deprioritized, discovering, distancing, earned, endothelin, forgo, foundation, freely, globe, Gujrathi, half, heath, Hedging, hospital, immune, immunological, incorporating, infection, inhibition, Joshua, licensee, mediator, minimizing, movement, myeloid, outbreak, partner, PD, penetration, phosphodiesterase, pipeline, prioritization, pursuit, rationale, recommended, remeasured, remission, replacing, restriction, screen, selecting, selective, separated, serving, Sheila, Shield, spend, stay, stimulation, studying, Subtopic, surge, Taiwan, tradable, transport, treating, undertaken, unregistered, Vectura, viable, volunteer, warranted
Financial report summary
?Competition
Bristol-Myers Squibb • Tenax Therapeutics • Pfizer • AMGEN • Teva- Pharmaceutical Industries • Regeneron Pharmaceuticals • Gilead Sciences • Arena Pharmaceuticals • United Therapeutics • InsmedRisks
- Any difficulties or delays in the commencement or completion, or termination or suspension, of our current or planned clinical trials could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects.
- We may find it difficult to enroll patients in our clinical trials. If we encounter difficulties enrolling subjects in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
- Use of seralutinib could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude approval, cause us to suspend or discontinue clinical trials, abandon seralutinib, limit the commercial profile of an approved label or result in other significant negative consequences that could severely harm our business, prospects, results of operations and financial condition.
- Although we have completed Phase 2 clinical trials for multiple product candidates including seralutinib, we have not as an organization completed later-stage clinical trials or submitted an NDA, and we may be unable to do so for seralutinib.
- Seralutinib is subject to extensive regulation and compliance, which is costly and time consuming, and such regulation may cause unanticipated delays or prevent the receipt of the required approvals to commercialize seralutinib.
- We may not be able to obtain or maintain orphan drug designations for seralutinib, and we may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.
- We are currently conducting, and may in the future conduct, certain of our clinical trials for seralutinib outside of the United States. However, the FDA and other foreign equivalents may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business.
- Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data or cause us not to proceed into further clinical development.
- Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, cleared or approved or commercialized in a timely manner or at all, which could negatively impact our business.
- Our business is subject to risks arising from pandemic and epidemic diseases.
- We rely on third parties to conduct many of our preclinical studies and clinical trials. Any failure by a third party to conduct the clinical trials according to GCPs and other requirements and in a timely manner may delay or prevent our ability to seek or obtain regulatory approval for or commercialize seralutinib.
- We rely on third parties for the manufacture of seralutinib for clinical development and expect to continue to do so for the foreseeable future. This reliance on third parties increases the risk that we will not have sufficient quantities of seralutinib or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
- Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
- We may seek to enter into collaborations, licenses and other similar arrangements and may not be successful in doing so, and even if we are, we may not realize the benefits of such relationships.
- Even if we receive regulatory approval for seralutinib, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, seralutinib, if approved, could be subject to labeling and other restrictions on marketing or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with seralutinib, when and if it is approved.
- The commercial success of seralutinib will depend upon the degree of its market acceptance by physicians, patients, healthcare payors and others in the medical community.
- The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are found or alleged to have improperly promoted off-label uses, we may become subject to significant liability.
- We face significant competition, and if our competitors develop technologies or product candidates more rapidly than we do or their technologies are more effective, our ability to develop and successfully commercialize seralutinib may be adversely affected.
- If the market opportunities for seralutinib are smaller than we believe they are, our revenue may be adversely affected, and our business may suffer.
- We currently have no marketing and sales organization and have no experience as a company in commercializing products, and we may have to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell seralutinib, we may not be able to generate product revenue.
- Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
- Our results of operations may fluctuate significantly, which makes our future results of operations difficult to predict and could cause our results of operations to fall below expectations or any guidance we may provide.
- We are dependent on the services of our management and other clinical and scientific personnel, and if we are not able to retain these individuals or recruit additional management or clinical and scientific personnel, our business will suffer.
- We may encounter difficulties in managing our growth and expanding our operations successfully.
- We are subject to various federal, state and foreign healthcare laws and regulations, and our failure to comply with these laws and regulations could harm our results of operations and financial condition.
- Recently enacted legislation, future legislation and healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize seralutinib and may affect the prices we may set.
- If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of seralutinib.
- We and any of our potential future collaborators will be required to report to regulatory authorities if any of our approved products cause or contribute to adverse medical events, and any failure to do so would result in sanctions that would materially harm our business.
- Our employees and independent contractors, including principal investigators, CROs, consultants and vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
- Our success depends on our ability to protect our intellectual property and our proprietary technologies.
- If we fail to comply with our obligations in the agreements under which we license intellectual property rights for seralutinib from third parties, or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights for seralutinib. Additionally, our license agreement for seralutinib includes sublicenses from a third party, and we must rely on Pulmokine's compliance with its obligations under its original license agreement.
- If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected.
- The patent protection and patent prosecution for seralutinib may be dependent on third parties.
- Some of our intellectual property has been discovered through government-funded programs and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies. Compliance with such regulations may limit our exclusive rights and limit our ability to contract with non-U.S. manufacturers.
- Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
- Our commercial success depends significantly on our ability to operate without infringing the patents and other proprietary rights of third parties. Claims by third parties that we infringe their proprietary rights may result in liability for damages or prevent or delay our developmental and commercialization efforts.
- We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful. Further, our issued patents could be found invalid or unenforceable if challenged in court.
- Intellectual property litigation may lead to unfavorable publicity that harms our reputation and causes the market price of our common shares to decline.
- Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
- Changes in U.S. patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing our ability to protect seralutinib.
- We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
- Patent terms may be inadequate to protect our competitive position on seralutinib for an adequate amount of time.
- If we do not obtain patent term extension for seralutinib, our business may be materially harmed.
- We may not be able to protect our intellectual property rights throughout the world.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by regulations and governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers.
- An active, liquid and orderly market for our common stock may not be maintained.
- The trading price of the shares of our common stock could be highly volatile, and purchasers of our common stock could incur substantial losses.
- Our failure to meet the continued listing requirements of the Nasdaq could result in a delisting of our common stock.
- Our executive officers, directors and principal stockholders, if they choose to act together, have the ability to control or significantly influence all matters submitted to stockholders for approval. Furthermore, many of our current directors were appointed by our principal stockholders.
- We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation, if any, in the price of our common stock.
- Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall.
- Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
- Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, and our amended and restated bylaws provide that the federal district courts shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
- Our ability to use net operating loss carryforwards and other tax attributes may be limited.
- We have been involved in securities class action litigation and could be subject in the future to securities class action litigation.
- We are a smaller reporting company within the meaning of the Securities Act, and if we decide to take advantage of certain exemptions from various reporting requirements applicable to smaller reporting companies, our common stock could be less attractive to investors.
- We and any of our third-party manufacturers or suppliers may use potent chemical agents and hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time consuming or costly.
- Our information technology systems, or those of any of our CROs, manufacturers, other contractors or consultants or potential future collaborators, may fail or suffer security breaches, which could result in a material disruption of our seralutinib development program, which could materially affect our results.
- Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
- Unfavorable global economic conditions and adverse developments with respect to financial institutions and associated liquidity risk could adversely affect our business, financial condition and stock price.
- We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We could face criminal liability and other serious consequences for violations, which could harm our business.
- We incur significant costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives.
- If securities or industry analysts do not publish research or reports or publish unfavorable research or reports about our business, our stock price and trading volume could decline.
- Changes in tax laws may materially adversely affect our financial condition, results of operations and cash flows.