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New words:
ABEA, accused, actor, Addendum, AIVITA, alleviate, arbitration, await, BL, blockade, born, Boston, CCPA, cessation, COBRA, CODM, Colorado, column, conflict, Connecticut, conveying, COSM, counsel, counted, covenant, CR, credential, CRs, Cytovation, de, deceptive, deep, deficient, degradation, delete, designee, Disability, disadvantage, disaggregated, dLNP, download, Draft, dysphonia, EEA, email, encryption, EP, Ernst, exploited, Extortion, factor, fractional, Frantz, fulfill, gap, GDPR, Geral, Gritstone, handheld, harvesting, highest, honor, image, Immunocore, immunodeficiency, ImVax, inquiry, Interagency, interval, irreversible, Israel, jay, justify, Laryngoscope, Lei, LGPD, LLP, locaregionally, locoregionally, LOQTORZI, LOQTORZITM, maker, malfeasance, manual, Michael, Mimivax, misrepresentative, monumental, mutation, nonrecurring, North, Northwest, notification, offline, ORR, Otolaryngology, outpatient, outset, PapiVax, payroll, Pharma, phishing, PIPL, posed, PR, preliminarily, pressure, provisional, radiographic, Recoupment, recoverable, relocate, reluctance, remediate, Remote, repayment, reprioritization, reprioritized, resent, routinely, salary, sector, server, shepard, specialist, split, Spring, sterling, stuffing, sum, Sumner, supersede, synthesized, text, thawing, TIGIT, trimer, ultracold, Union, Vaccitech, verify, Virginia, voluntary, vulnerability, vulnerable, Western, window, wiretapping
Removed:
ablating, abnormal, accrue, acute, adding, adjust, AEs, Africa, agent, AMP, Andrew, androgen, antidilutive, antitumor, appealing, appointed, apportioned, Arabia, back, bankruptcy, Beheshti, biosimilar, birth, bleeding, Brandywine, calendar, capped, captioned, cascade, CIN, cleared, close, companion, complement, concurrently, consecutive, constrained, constraint, correlated, correlation, CRI, cutting, deducting, defendant, dendritic, denying, derive, detectable, Devarakonda, developmental, diagnostic, dictate, disfigurement, disrupt, dissemination, East, economically, endemic, eventually, excise, exist, explained, Fettig, forecasted, forthcoming, genital, healed, hemorrhagic, histopathological, iii, Illumina, indexed, induced, infertility, inhibition, insolvency, intention, Isman, ITT, iv, kill, killing, KRW, landlord, leakage, leaving, licensee, ligand, liquidation, LP, LSIL, mandatory, Manuel, master, mature, mCRPC, metastatic, mg, middle, mirroring, miscarriage, mITT, mobilizer, modulator, momentum, monitored, movement, nanoparticle, NextSeq, noncontrolling, nondeductible, occupied, occurring, offered, oncogenic, paper, papilloma, Parker, penile, PhD, PICI, plc, poverty, preceding, predominant, preference, prejudice, premised, procure, productivity, promised, promissory, proportionately, proven, PSA, psychological, QIAGEN, ranging, reached, ready, realization, recognizing, redeem, redeemed, redemption, refund, region, regressed, reproductive, repurchased, reserve, reservoir, retained, REVEAL, reversal, room, round, Saudi, scheduled, sequencing, settled, smart, sooner, stayed, stimulate, stressful, syndrome, temperature, thereof, thereunder, thermal, timeline, transformed, transforming, Translate, transmitted, uncollectible, unconstrained, undiscounted, unintentional, unpaid, USD, vaginal, variant, viability, West, white, Zenoff, Zika
Financial report summary
?Competition
Bristol-Myers Squibb • Pfizer • Imunon • Gilead Sciences • Astrazeneca • Leep • Novavax • Agenus • Ayala Pharmaceuticals • Sonnet BioTherapeuticsRisks
- A small number of licensing partners and government contracts have accounted for a substantial portion of our revenue.
- We will need substantial additional capital to develop our DNA medicines and proprietary device technology, which may prove difficult or costly to obtain.
- If we are unable to obtain FDA approval of our product candidates, we will not be able to commercialize them in the United States.
- If we pursue accelerated approval for INO-3107 or any of our other product candidates, it may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.
- Even if our products receive regulatory approval in the United States, we may never receive approval or commercialize our products outside of the United States, and the same risk applies for products approved outside the United States, with respect to regulatory approval in the United States.
- Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
- Delays in the commencement, conduct or completion of clinical testing could result in increased costs to us and delay or limit our ability to generate revenues.
- None of our DNA medicine candidates have been approved for sale, and we may never develop commercially successful DNA medicine products.
- We previously expended significant resources on the development of a COVID-19 vaccine candidate. We are now only pursuing development in collaboration with third parties, as both a primary and heterologous booster vaccine, but there can be no assurance that our candidate will ever receive regulatory approval as a primary vaccine or a booster in any country, whether by Emergency Use Authorization or otherwise.
- If we and the contract manufacturers upon whom we rely fail to produce our proprietary devices and DNA medicine candidates in the volumes that we require on a timely basis, or at all, or if these contractors fail to comply with their obligations to us or with stringent regulations, we may face delays in the development and commercialization of our proprietary device and DNA medicine candidates.
- We are dependent on single-source suppliers for some of the components and materials used in, and the processes required to develop, our product candidates and investigational medicines.
- Even if our products receive regulatory approval, they may still face future development and regulatory difficulties.
- We are developing some of our investigational DNA medicines using new endpoints or methodologies for the treatment of diseases in which there is little clinical experience. As a result, the FDA or other regulatory authorities may not consider the endpoints of our clinical trials to provide clinically meaningful results.
- We have obtained Orphan Drug Designation for one of our DNA medicine candidates. As part of our business strategy, we may continue to seek Orphan Drug Designation for additional DNA medicine candidates, and we may be unsuccessful in obtaining new designations or may be unable to obtain or maintain the benefits associated with Orphan Drug Designation, including the potential for orphan drug exclusivity.
- A breakthrough therapy designation or fast track designation by the FDA for a drug may not lead to a faster development or regulatory review or approval process, and it would not increase the likelihood that the drug will receive marketing approval.
- If we lose or are unable to secure collaborators or partners, or if our collaborators or partners do not apply adequate resources to their relationships with us, our product development and potential for profitability will suffer.
- We have agreements with government agencies that are subject to termination and uncertain future funding. Termination or cessation of funding would have a negative impact on our ability to develop certain of our pipeline candidates and/or require us to seek alternative funding sources to advance product candidates.
- We and our collaborators rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we and our collaborators may not be able to obtain regulatory approval for or commercialize our DNA medicine candidates.
- We currently have only a small marketing organization and no sales organization. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, if approved, we may not be able to generate product revenues.
- If products for which we receive regulatory approval do not achieve broad market acceptance, the revenues that we generate from their sales will be limited.
- We are subject to uncertainty relating to coverage and reimbursement policies which, if not favorable to our DNA medicine candidates, could hinder or prevent our products' commercial success.
- Our operating results may be harmed if our corporate restructuring plans and cost reduction efforts do not achieve the anticipated results or cause undesirable consequences.
- We are currently subject to litigation and may become subject to additional litigation, which could harm our business, financial condition and reputation.
- We depend upon key personnel who may terminate their employment with us at any time and we may need to hire additional qualified personnel in order to obtain financing, pursue collaborations or develop or market our DNA medicine candidates.
- Our business could be adversely affected by the effects of health epidemics.
- We face intense and increasing competition and steps taken by our competitors such as the introduction of a new, disruptive technology may impede our ability to develop and commercialize our DNA medicines.
- Our failure to successfully acquire, develop and market additional product candidates or approved products would impair our ability to grow.
- Changes in funding for the FDA and other government agencies could prevent new products from being developed or commercialized in a timely manner, which could negatively impact our business.
- If our information technology systems or those of third parties upon which we rely or our data, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to, regulatory
- investigations and actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue and profits; and other adverse consequences.
- We face potential product liability exposure and, if successful claims are brought against us, we may incur substantial liability.
- Healthcare reform measures could hinder or prevent our products' commercial success.
- If we fail to comply with applicable healthcare regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected.
- Our business involves the use of hazardous materials and we and our third-party manufacturers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
- We have entered into collaborations with Chinese companies and rely on clinical materials manufactured in China for our development efforts. Uncertainties regarding the interpretation and enforcement of Chinese laws, rules and regulations, a trade war, political unrest or unstable economic conditions in China could materially adversely affect our business, financial condition and results of operations.
- Our employees, principal investigators, and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
- Employee litigation and unfavorable publicity could negatively affect our future business.
- It is difficult and costly to generate and protect our intellectual property and our proprietary technologies, and we may not be able to ensure their protection.
- If we are sued for infringing intellectual property rights of third parties, it will be costly and time-consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.
- We have not yet registered our trademarks in all of our potential markets, and failure to secure those registrations could adversely affect our business.
- An active trading market for our common stock may not be sustained.
- The price of our common stock has been and may continue to be volatile, and an investment in our common stock could decline substantially in value.
- We have broad discretion in the use of our cash, cash equivalents, and investments, and may not use them effectively.
- Anti-takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock.
- We have never paid cash dividends on our common stock and we do not anticipate paying dividends in the foreseeable future.
- Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.
- Our quarterly operating results may fluctuate significantly.
- Our results of operations and liquidity needs could be materially affected by market fluctuations and general economic conditions.
- Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, could adversely impact our business, financial condition and results of operations.
- If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.
- The issuance of additional stock in connection with financings, acquisitions, investments, our stock incentive plans or otherwise will dilute all other stockholders.
- We incur significant costs and demands upon management as a result of being a public company.
- Changes in tax laws could adversely affect our business and financial condition.
- The increasing use of social media platforms presents new risks and challenges.
- 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 data 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; and other adverse business consequences.
Management Discussion
- ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
- This report contains forward-looking statements, as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements relate to future events or our future financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential” or “continue,” the negative of such terms or other comparable terminology. These statements are only predictions. Actual events or results may differ materially.
- Although we believe that the expectations reflected in the forward-looking statements are reasonable based on our current expectations and projections, we cannot guarantee future results, levels of activity, performance or achievements. Moreover, neither we, nor any other person, assume responsibility for the accuracy and completeness of the forward-looking statements. We are under no obligation to update any of the forward-looking statements after the filing of this Annual Report to conform such statements to actual results or to changes in our expectations.