Content analysis
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H.S. sophomore Avg
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New words:
abeyance, adherence, adjourned, adjournment, admission, Africa, algorithm, alleviate, allodynic, Alora, alpha, amoubt, amplitude, apptec, Arab, arousal, attrition, Barry, belief, bioanalytic, Biotherapeutic, bradycardia, broader, burst, capsaicin, CDMO, clawback, closure, commercializng, conference, conservation, contemporary, convened, cybersecurity, deep, demographic, density, diligence, disaster, dissolution, divestiture, emulate, escalate, expiry, fashion, FIH, foot, forearm, formal, Frey, frontal, gamma, goodwill, greedy, hair, headcount, hearing, heat, inhibitory, learning, left, leveraged, lockout, MEP, Mexico, middle, morale, neurotransmission, Nowithstanding, PainCart, parietal, path, phishing, PR, prepay, prolongation, prone, propensity, quorum, realignment, recoded, reconvene, regular, remedial, remediate, rescission, resting, RMT, running, Russia, scoring, sensation, sex, skin, sleep, spectral, speculation, tabletop, theta, timepoint, timetable, toxicology, triage, undertaken, underwent, unexposed, unregistered, upper, upward, vendor, video, Von, winding, wuxi
Removed:
abbvie, abdominoplasty, acelrx, Aimovig, Ajovy, Alder, Allergan, Amgen, ANJESO, antibody, APOLLO, arrestin, ASU, ATHENA, attending, avoided, Baudax, biohaven, BMI, Botox, bunionectomy, burden, button, capsule, categorical, CGRP, cohort, colorectal, Colucid, comorbid, conditional, coupling, crystalline, deplete, deploying, derived, desire, disadvantage, discontinued, DOR, durect, economy, educate, efficiency, elderly, electroencephalography, elevated, Eli, emerge, emergence, Emgality, encompassed, erenumab, ergot, ethical, faced, fasted, fed, fluid, focusing, framing, fremanezumab, galcanezumab, gold, gynecologic, half, headache, heightened, hindered, hired, hypoxia, incidence, indefinite, index, inpatient, intensity, interrupt, investigator, knockout, Lasmiditan, leading, lesser, Mallinckrodt, mandated, mice, migraine, minimize, movement, multicenter, multiplicity, NSAID, numerical, NURTEC, obese, offered, OFIRMEV, older, opt, orthopedic, outsource, oxygen, Parallax, peptide, pivotal, potent, preceding, predicted, prematurely, preventative, prioritization, proceed, prophylactic, propranolol, quarantine, rating, regimen, reposition, representative, rescue, responder, REYVOW, Rimegepant, saturation, selective, selectively, SPID, spontaneously, spread, standardized, strain, suffering, suggest, sum, superior, telemedicine, Teva, tolerate, topiramate, triptan, Ubrelvy, ubrogepant, underinsured, uninsured, unique, unnecessarily, validation, vital, volunteer, VyeptiTM, worsening, ZALVISO, zavegepant
Financial report summary
?Competition
Israel • Canada • Heron Therapeutics • Durect • Cumberland Pharmaceuticals • Pacira BioSciences • Talphera • Zevra Therapeutics • Mallinckrodt • Societal CDMORisks
- We have incurred significant losses since our inception. We expect to incur losses over the next several years and may never achieve or maintain profitability.
- Our prospects are highly dependent on the sales of OLINVYK and the successful commercialization of our other product candidates. To the extent we are unable to successfully complete clinical development, obtain regulatory approval for or commercialize one or more of our product candidates, or if delays in doing so, our business, financial condition and results of operations may be materially adversely affected, and the price of our common stock may decline.
- We will need substantial additional funding, which may not be available to us on acceptable terms, or at all. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts and may not be able to continue as a going concern.
- Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
- Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
- The trading price of the shares of our common stock has been and may continue to be volatile, and you may not be able to resell some or all of your shares at a desired price.
- If we are not able to comply with the applicable continued listing requirements or standards of The Nasdaq Stock Market, Nasdaq could delist our common stock.
- If our common stock were delisted and determined to be a “penny stock,” a broker-dealer may find it more difficult to trade our common stock and an investor may find it more difficult to acquire or dispose of our common stock in the secondary market.
- We may be subject to securities class action and stockholder derivative litigation.
- Sales of a substantial number of shares of our common stock could cause the market price of our common stock to drop significantly, even if our business is doing well.
- We are a “smaller reporting company” and, as a result of the reduced disclosure and governance requirements applicable to smaller reporting companies, our common stock may be less attractive to investors.
- The issuance of additional stock in connection with financings, acquisitions, investments, our stock incentive plans or otherwise will dilute all other stockholders.
- Provisions in our corporate charter documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management and hinder efforts to acquire a controlling interest in us, and the market price of our common stock may be lower as a result.
- Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gains and you may never receive a return on your investment.
- OLINVYK or any of our product candidates for which we obtain approval may fail to achieve the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community necessary for commercial success.
- We face substantial competition, which may result in others discovering, developing, or commercializing products before or more successfully than we do.
- OLINVYK or any product candidates for which we are able to obtain regulatory approval in the future may become subject to unfavorable pricing regulations, third-party payor coverage and reimbursement policies, or healthcare reform initiatives.
- Product liability lawsuits against us could cause us to incur substantial liabilities and limit sales of OLINVYK or the development or commercialization of our product candidates.
- Concerns around the abuse of opioids, including law enforcement concerns over diversion of opioids and regulatory efforts to combat abuse, impact our ability to generate significant revenues from OLINVYK or any of our other product candidates and may adversely impact external investor perceptions of our business.
- If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to timely commercialize, or to commercialize at all, our product candidates, and our ability to generate revenue will be materially impaired.
- OLINVYK has been classified as a Schedule II controlled substance under the Controlled Substances Act. The making, use, sale, importation, exportation and distribution of controlled substances are subject to regulation by state, federal and foreign law enforcement and other regulatory agencies. We anticipate that TRV734, if approved, would also be classified as a Schedule II controlled substance under the Federal Controlled Substances Act of 1970.
- Failure to obtain marketing approval in international jurisdictions would prevent OLINVYK or our product candidates from being marketed abroad.
- OLINVYK and any product candidate for which we obtain marketing approval could be subject to post-marketing restrictions 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 our product candidates, when and if any of them are approved.
- We have only one product, OLINVYK, for which we received marketing approval from the FDA. If we are unable to find a commercial partner for OLINVYK, or if we are unable to complete development of our product candidates, or if we experience significant delays in doing so, our business will be materially harmed.
- Nonclinical and clinical drug development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
- We may be unable to obtain regulatory approval for our product candidates under applicable regulatory requirements. The denial or delay of any such approval would delay commercialization of our product candidates and adversely impact our potential to generate revenue, our business and our results of operations.
- If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
- If serious adverse or unacceptable side effects are identified during the development of our product candidates or following their approval by the FDA or foreign regulatory authorities, we may need to abandon or limit our development of some of our product candidates, limit the commercial profile of an approved label, or it may result in significant negative consequences following marketing approval, if any.
- We may not be successful in our efforts to expand our pipeline of product candidates.
- We may expend our limited resources to pursue a particular product candidate or indication and thereby fail to capitalize on other product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- In the future, we may conduct a substantial portion of the clinical trials for our product candidates outside of the United States and, if approved, we may seek to market our product candidates abroad through third-party collaborators. Accordingly, we will be subject to the risks of doing business outside of the United States.
- Our current collaborators are, and any future relationships or collaborations we may enter into may be, important to us. If we are unable to maintain our relationship with any of these collaborations, or if our relationship with these collaborators is not successful, our business could be adversely affected.
- We rely, and expect to continue to rely, on third parties to conduct our nonclinical studies and clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials or complying with applicable regulatory requirements.
- Materials necessary to manufacture our product or product candidates may not be available on commercially reasonable terms, or at all, which may delay the development and commercialization of our product or product candidates.
- We rely on clinical data and results obtained by third parties that could ultimately prove to be inaccurate or unreliable.
- If we are unable to obtain and maintain patent protection for our technology and products or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired.
- We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.
- We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
- 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 material adverse effect on the success of our business.
- If we fail to comply with our obligations in our intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business.
- We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
- Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- Our current and future relationships with customers and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti‑kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.
- Healthcare reform measures may increase the difficulty and cost for us to successfully commercialize our product and product candidates, if approved, and affect the prices we may obtain.
- Governments outside the United States tend to impose strict price controls, which may adversely affect our revenue, if any.
- If we fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business.
- Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
- Raising additional capital may cause dilution to our stockholders, restrict our operations, or require us to relinquish rights to our technologies or product candidates.
- An active trading market for our common stock may not continue to develop or be sustained.
- If equity research analysts do not continue to publish research or reports or publish unfavorable research or reports about us, our business or our industry, our stock price and trading volume could decline.
- 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.
- If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.
- We incur costs and demands upon management as a result of being a public company.
- Our business and operations would suffer in the event of system failures.