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New words:
abundantly, adware, aforementioned, akin, Alfred, ameliorate, amyotrophic, anatomical, anti, anticonvulsant, Antipsychotic, artificial, ASM, atypical, automated, Benzodiazepine, Bioscience, CCM, cerebral, clearance, cohort, Colorado, comment, cord, core, corollary, creative, credential, curate, cybersecurity, cytoskeletal, debilitating, deceptive, degenerative, deploying, destroy, dispose, domain, Draft, easily, electrophysiological, encryption, endeavor, enduring, environmental, enzymatic, era, essence, Extortion, extrinsic, eye, FACP, factor, fake, fear, filtering, Fitzgerald, footprint, graft, Graviton, hardware, harvesting, headcount, hemorrhage, HIPPA, hope, hyperactivated, hyperexcitability, immaterial, Importantly, injection, instrument, intelligence, Interagency, intervention, intracellular, intracranial, intravenously, intrinsic, Kevin, kinase, lab, leaky, Ligand, Macau, malformation, Michael, milieu, misrepresentative, monetization, myelination, nerve, neural, neuro, Neuropharmacology, neuropsychiatric, neurovascular, offline, online, outflow, pause, phasic, phishing, pioneered, POC, Poole, possession, posture, radiographic, readied, reorganization, requalify, Rezurock, rho, Robert, ROCK, RSE, scanning, segregation, server, skeletal, spinal, Stephen, stimulation, streamlined, stuffing, surface, surrogate, symptomatology, synapse, synaptic, synthetic, Taiwan, thin, threat, tissue, transcranial, trauma, tube, unfair, unlocked, unsold, unwanted, unwilling, vascular, vendor, versatility, Virginia, whichever
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AG, agonist, aminotransferase, Angelini, assessing, attacked, aware, baseline, circumvent, compel, Concurrently, constrained, convert, corrective, Cowen, database, defect, distracting, DNA, earned, EGC, extraction, finalizing, functional, GABAA, golden, impactful, jointly, Jumpstart, mandated, maternal, NEPTUNE, neurodevelopmental, pandemic, parachute, paternal, pathology, peer, personally, Pharma, removing, repealing, School, sequester, settlement, shared, Trump, Turkey, ultimate, unfavorable, verify
Financial report summary
?Competition
Ionis Pharmaceuticals • Roche • PTC Therapeutics • Jazz Pharmaceuticals • Marinus Pharmaceuticals • Ucb • GW Pharmaceuticals • Zogenix • Neurelis • Ultragenyx PharmaceuticalRisks
- Summary of Selected Risks Associated with Our Business
- Risks Related to Our Financial Position and Need for Additional Capital
- We expect to continue to incur substantial operating losses for the foreseeable future and may never achieve or maintain profitability.
- Our operating history may make it difficult to evaluate the success of our business to date and to assess our future viability.
- We will require additional capital to finance our operations, which may not be available on acceptable terms, if at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate certain of our drug development efforts or other operations.
- Our ability to use our net operating loss (“NOL”) carryforwards and certain other tax attributes to offset future taxable income may be subject to limitation.
- Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition, or results of operations.
- Risks Related to the Development and Commercialization of Our Drug Candidates
- Our future success is dependent on the successful clinical development, regulatory approval and commercialization of our current and future drug candidates. If we, or our licensees, are not able to obtain the required regulatory approvals, we, or our licensees, will not be able to commercialize our drug candidates, and our ability to generate revenue will be adversely affected.
- Because the results of preclinical studies or earlier clinical trials are not necessarily predictive of future results, our drug candidates may not have favorable results in planned or future preclinical studies or clinical trials, or may not receive regulatory approval.
- Interim topline and preliminary results 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, which could result in material changes in the final data.
- Preclinical studies and clinical trials are very expensive, time-consuming and difficult to design and implement and involve uncertain outcomes. Further, we may encounter substantial delays in our clinical trials or we may fail to demonstrate safety and efficacy in our preclinical studies and clinical trials to the satisfaction of applicable regulatory authorities.
- If we are not successful in discovering, developing and commercializing additional drug candidates, our ability to expand our business and achieve our strategic objectives would be impaired.
- Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside our control.
- Our drug candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial potential or result in significant negative consequences following any potential marketing approval.
- If the market opportunities for our drug candidates are smaller than we believe they are, even assuming approval of a drug candidate, our business may suffer. Because the patient populations in the market for our drug candidates may be small and difficult to assess, we must be able to successfully identify patients and acquire a significant market share to achieve profitability and growth.
- We face substantial competition, which may result in others developing or commercializing drugs before or more successfully than us.
- Even if our current or future drug candidates receive marketing approval, they may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.
- Even if we obtain and maintain approval for our current or future drug candidates from the FDA, we may never obtain approval for our current or future drug candidates outside of the United States, which would limit our market opportunities and could harm our business.
- If we seek approval to commercialize our current or future drug candidates outside of the United States, a variety of risks associated with international operations could harm our business.
- Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any drug candidate that we may develop.
- Risks Related to Licensing and Collaboration Arrangements
- Under the RLT Agreement, we are entitled to receive royalty and milestone payments in connection with the development and commercialization of soticlestat. If Takeda fails to progress or discontinues the development of soticlestat, we may not receive some or all of such payments, which would materially harm our business.
- Risks associated with the in-licensing or acquisition of drug candidates could cause substantial delays in the preclinical and clinical development of our drug candidates.
- We may be required to relinquish important rights to and control over the development and commercialization of our drug candidates to any future collaborators.
- If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities and subject us to other risks.
- We may explore additional strategic collaborations that may never materialize or may fail.
- Risks Related to Regulatory Compliance
- Our relationships with customers, physicians, and third-party payors may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
- Coverage and adequate reimbursement may not be available for our current or any future drug candidates, which could make it difficult for us to sell profitably, if approved.
- Healthcare legislative reform measures may have a negative impact on our business and results of operations.
- We may not be able to obtain or maintain orphan drug designations or exclusivity for our drug candidates, which could limit the potential profitability of our drug candidates.
- Even if we obtain regulatory approval for our current or future drug candidates, they will remain subject to ongoing regulatory oversight.
- Risks Related to Our Intellectual Property
- If we are unable to obtain and maintain patent protection for our current or any future drug candidates, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- Patent terms may be inadequate to protect our competitive position on our drug candidates for an adequate amount of time.
- Intellectual property rights do not necessarily address all potential threats to our business.
- Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a negative impact on the success of our business.
- We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
- We may be involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time consuming and unsuccessful.
- Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our current and any future drug candidates.
- We may not be able to protect our intellectual property rights throughout the world, which could negatively impact our business.
- 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.
- Risks Related to Our Dependence on Third Parties
- We do not have our own manufacturing capabilities and will rely on third parties to produce clinical and commercial supplies of our current and any future drug candidates.
- We intend to rely on third parties to conduct, supervise and monitor our preclinical studies and clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business.
- Risks Related to Our Business Operations, Employee Matters and Managing Growth
- We are highly dependent on the services of our senior management team, including our Chairman and Chief Executive Officer, Dr. Jeremy Levin, and if we are not able to retain these members of our management team or recruit and retain additional management, clinical and scientific personnel, our business will be harmed.
- We may need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.
- Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
- Significant disruptions of our information technology systems or data security incidents could result in significant financial, legal, regulatory, business and reputational harm to us.
- We are subject to stringent and evolving privacy and security laws, regulations, contractual obligations, industry standards, policies, and other obligations, and our failure or perceived failure to comply with such obligations could result in regulatory investigations or actions, litigation (including class actions), fines and penalties, disruptions of our business operations, loss of revenue or profits, reputational damage and other adverse business consequences.
- Risks Related to Being a Public Company
- We are a “smaller reporting company” and the reduced disclosure requirements applicable to such companies may make our common stock less attractive to investors.
- If we fail to maintain an effective system of internal control over financial reporting in the future, we may not be able to accurately report our financial condition, results of operations or cash flows, which may adversely affect investor confidence in us and, as a result, the value of our common stock.
- Risks Related to the Ownership of Our Common Stock and Other General Matters
- Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and share price.
- We may sell additional equity or debt securities or enter into other arrangements to fund our operations, which may result in dilution to our stockholders and impose restrictions or limitations on our business.
- You will be diluted by any conversions of outstanding Series A convertible preferred stock and exercises of outstanding options.
- Concentration of ownership of our common stock among our executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions.
- If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline.
- Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
- Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
- We may be subject to securities litigation, which is expensive and could divert management attention.
- Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would benefit our stockholders and may prevent attempts by our stockholders to replace or remove our current management.
- Sales of a substantial number of shares of our common stock in the public market could cause the market price of our common stock to drop significantly.