Content analysis
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H.S. sophomore Avg
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New words:
abbreviated, accident, accidental, appellate, arguing, arose, asterisk, autoimmune, Bausch, Berkeley, bifurcated, bifurcation, Binder, binomial, blocker, Blvd, Brant, Brickell, Bristol, bulk, Cadent, CAR, Carlo, Celgene, Chamber, Charleston, chemist, Church, Cicala, Clarke, coincide, Colorado, Comera, Commerce, concert, confirmatory, confront, confusion, constrained, constraint, Cornerstone, cybersecurity, database, Deciphera, device, Dickinson, discord, dissuade, diversify, Dorothy, downturn, East, enduring, enterprise, Erasca, eTheRNA, Fairleigh, feature, Feb, FL, flammable, flat, foreclose, Frazier, Freebird, furlough, GE, geopolitical, grace, Hall, Houston, Huff, IAF, Ignyta, inadvertent, incorrect, incorrectly, India, instrument, Intercept, interlocutory, Johnson, judge, learned, liablity, Lomb, Luther, lymphoid, malignancy, Meyer, misuse, Monte, neurotoxicity, NIH, Oak, occupancy, Occupational, oversaw, overturn, passage, passed, pathway, PDAB, Pearl, Peter, Pfizer, Poland, postdoctoral, pressure, Pretzel, procurement, proportionate, provisional, questionnaire, quotient, ratchet, reaming, reappointed, reassessment, recapitalization, recessionary, reevaluate, repayment, repriced, repricing, repurchase, repurchased, risky, Roche, routine, Sanjeev, SC, sentiment, SEPA, Seton, settleable, shutdown, Simplification, simulation, Somvervile, spot, standalone, standby, strained, strictly, stringent, subordinated, Subtenant, SUDO, suspected, suspicion, TIA, tool, treble, tree, TX, Ukraine, unavailable, unconstitutional, underway, uneconomical, unethical, unexercised, unfair, uniformly, unlawfully, unsafe, Unstable, USFRF, vast, veterinary, Wagner, win, workplace
Removed:
aggregated, Aid, allegedly, alter, BIT, collect, collection, community, consummation, content, direction, discounted, eliminate, escrow, evidencing, exemption, expectation, false, federally, Finally, forgiven, functional, inherent, innovative, lender, loading, manage, membership, merged, methodology, partner, Paycheck, penalty, PIP, PPP, preclude, prevention, pro, produce, qualifying, recover, recovered, recruit, regional, reimbursable, relief, reorganization, reserve, retention, small, soliciting, spending, split, Sponsoring, step, subscription, tangible, Treadway, treating, undertaken, unique, utilization, varied, vote
Financial report summary
?Competition
UPSHOWRisks
- We will require substantial additional capital to fund our operations and execute our business strategy, and we may not be able to raise adequate capital on a timely basis, on favorable terms, or at all.
- We have a limited operating history, have incurred significant losses since our inception and expect to continue to incur losses for the foreseeable future, which, together with our limited financial resources and substantial capital requirements, make it difficult to assess our prospects.
- We depend substantially, and expect in the future to continue to depend, on in-licensed intellectual property. Such licenses impose obligations on our business, and if we fail to comply with those obligations, we could lose license rights, which would substantially harm our business.
- Our intellectual property rights may not adequately protect our business.
- We are substantially dependent on intellectual property we have in-licensed from Factor Limited, and if we lose the license to such intellectual property or the A&R Factor License Agreement is terminated for any reason, our ability to enter into strategic partnerships would be harmed, and our business, financial condition and results of operations would be materially and adversely affected.
- We or our licensors may be subject to claims challenging the inventorship or ownership of the patents and other intellectual property that we own or license now or in the future.
- We have identified a material weakness in our internal control over financial reporting. If we are unable to develop and maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results in a timely manner, which may adversely affect investor confidence in us, and materially and adversely affect our business and operating results.
- We may face litigation and other risks as a result of the material weaknesses in our internal control over financial reporting.
- Our business and operations would suffer in the event of system failures, cyber-attacks or a deficiency in our cyber-security.
- If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
- Because gene-editing and cell therapy product candidates that may be developed using our mRNA technology platform are based on novel technologies, we cannot assure that such products will be successful.
- We face intense competition and rapid technological change and the possibility that our competitors may develop therapies that are more advanced, safer, or more effective than any therapy we develop in the future, which may adversely affect our financial condition.
- Negative public opinion and increased regulatory scrutiny of gene therapy and genetic research may damage public perception of our future product candidates or adversely affect our ability to conduct our business or obtain and maintain marketing approvals for our future product candidates.
- The manufacture of biotechnology products is complex, and manufacturers often encounter difficulties in production.
- Six stockholders collectively own a significant percentage of our outstanding common stock, and as a result of such ownership, such stockholders may influence the election of directors and other matters submitted to stockholders.
- There may be future sales or other dilution of our equity, which may adversely affect the market price of our common stock.
- In addition to the shares that may be sold to Lincoln Park under the SEPA, a large number of shares may be issued and subsequently sold upon the exercise of outstanding options and warrants and upon the conversion of our outstanding convertible notes.
- The terms of our convertible notes could limit our growth and our ability to finance our operations, fund our capital needs, respond to changing conditions and engage in other business activities that may be in our best interests.
- The requirement that we redeem our convertible notes in cash could adversely affect our business plan, liquidity, financial condition, and results of operations.
- Our failure to meet the continued listing requirements of Nasdaq could result in a delisting of our common stock.
- Anti-takeover provisions of Delaware law and provisions in our charter and bylaws could make a third-party acquisition of us difficult.
- We may acquire businesses, assets or products, or form strategic alliances, in the future, and we may not realize the benefits of such acquisitions.
- Our ability to utilize our net operating loss carryforwards and tax credit carryforwards may be subject to limitations.
- We are subject to extensive and costly government regulation.
- The regulatory approval processes of the FDA and comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable. If our potential strategic partners are ultimately unable to obtain regulatory approval for their product candidates, we may be unable to product revenue and our business will be substantially harmed.
- Changes in regulatory requirements, agency guidance or unanticipated events during our non-clinical studies and future clinical studies of our future product candidates may occur, which may result in changes to non-clinical or clinical study protocols or additional non-clinical or clinical study requirements, which could result in increased costs to us and could delay our projected development timeline.
- The results of non-clinical studies and early-stage clinical trials of our future therapeutic candidates may not be predictive of the results of later stage clinical trials.
- Disruptions at the FDA and other government agencies caused by funding shortages or other events or conditions outside of their control could negatively impact our business.
- If we are unable to obtain and maintain patent and other intellectual property protection, or if the scope of the patent and other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products similar or identical to those derived from our intellectual property, and our ability to achieve profitability may be adversely affected.
- We cannot ensure that patent rights relating to inventions described and claimed in our pending patent applications will issue, or that our issued patents or patents that issue in the future will not be challenged and rendered invalid and/or unenforceable.
- Obtaining and maintaining 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.
- If we do not obtain patent term extension for future products that we or our strategic partners or collaborators may successfully develop, our business may be materially harmed.
- Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect future products and product candidates that we or our strategic partners or collaborators may develop.
- We may not be able to protect our intellectual property rights throughout the world.
- We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products.
- 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.
- We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
- We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
- If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our marks of interest and our business may be adversely affected.
Management Discussion
- During the year ended December 31, 2023, we recognized revenue related to the cell line customization activities we performed for a third party. We did not perform any such activities, or otherwise recognize any revenue, during the year ended December 31, 2022.
- During the year ended December 31, 2023, our cost of revenues includes direct labor and materials to perform the customization cell line activities for a third party, as well as royalty expense owed to Factor Limited in accordance with our exclusive license agreement with Factor Limited. There were no comparable expenses for the year ended December 31, 2022.
- Total research and development expenses decreased by approximately $4.5 million for the year ended December 31, 2023 compared to the year ended December 31, 2022 primarily due to (a) decreased expenses under our master services agreement (“MSA”) with Factor Bioscience during 2023 and (b) decreased payroll expense and stock-based compensation expense due to employee terminations and a reduction in clinical trial expense as a result of our clinical trial ending in 2022, partially offset by (i) a full year of fees paid to Factor Bioscience under the MSA during 2023 and (ii) an increase in professional fees in 2023 related to consulting activities.