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H.S. junior Avg
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New words:
ADC, aerial, Albert, Alexion, Androgen, angiogenic, architecture, AstraZeneca, Avastin, bachelor, Baxter, Bioscience, bladder, Boehringer, Boesgaard, bombardment, border, brain, built, cabinet, Cardinal, Carey, castration, CFO, chemoradiation, Chicago, CI, Cincinnati, civilian, classification, Cleveland, Clonality, Columbia, Copenhagen, Core, Cornell, Counsel, Covance, CPS, cut, cytokine, DC, Deacetylase, deal, deep, disaggregated, docetaxel, doctorate, Dohme, driven, Eisai, Erroneously, escalation, ESWI, explained, FDORA, featured, Flom, Gaza, GE, graduate, HDAC, hematologist, hematology, Hezbollah, Histone, Houthi, IC, identification, immunocytokine, indeterminate, INF, infectimune®, Ingelheim, Insulet, internship, Israel, Israeli, Ivey, Johnson, Kaposi, Kirk, lab, Lebanon, main, Meagher, Middle, naive, neutropenia, Nordisk, Novo, oncologist, Ontario, oversaw, Palestinian, panel, passage, pegged, Pennsylvania, pose, proportion, quantity, reconciling, reg, Regeneron, residency, residing, rocket, Roka, roundtable, salvage, Sarcoma, scientist, score, segment, session, Sharpe, Shepard, Shephard, Skadden, Slate, SOC, southern, spanning, spent, standing, Stereotactic, store, Strip, subset, succeeding, symptom, Takeda, tech, tenure, terrorist, thirteen, TRAE, unconfirmed, VEGF, veteran, Vice, weaker, West, Western, widening, Wilmington, Yemen
Removed:
Alter, Aspire, calculation, cDNA, CEO, Chapel, Cie, crystal, Eshelman, excellent, fellow, founder, functional, highlighted, Hill, Huang, impacting, injectable, Jumpstart, launching, Lauren, Leaf, lieu, Linkbase, meaningfully, mRNA, noncreditable, oncosec, opened, outbreak, pioneered, postdoctoral, quarantine, run, siRNA, spike, step, tablet, TB, vector, vested, withdrawing
Financial report summary
?Competition
Vaxart • Cel-Sci • Alaunos Therapeutics • ONCOSEC MEDICAL • Flugen • Genocea Biosciences • Scorpius • F-star Therapeutics • Merus • Gritstone BioRisks
- We have a limited operating history and have never generated any product revenue.
- We have incurred significant losses since our inception and expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability.
- We are dependent on the success of our Versamune®, PDS01ADC and Infectimune® products, which are still in clinical development, and if our Versamune®, PDS01ADC and Infectimune® products do not receive regulatory approval or are not successfully commercialized, our business may be harmed.
- We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of our Versamune®, PDSO1ADC and Infectimune® based products.
- Raising additional funds by issuing securities may cause dilution to existing stockholders and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights.
- Our operating activities may be restricted as a result of covenants related to the outstanding indebtedness under our venture loan and security agreement with Horizon and we may be required to repay the outstanding indebtedness in an event of default, which could have a materially adverse effect on our business.
- Our future success depends on our ability to retain executive officers and attract, retain and motivate qualified personnel.
- If we fail to obtain or maintain adequate coverage and reimbursement for PDS0101 or PDS01ADC, our ability to generate revenue could be limited.
- Even if any of our product candidates receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
- We will need to expand our organization, and may experience difficulties in managing this growth, which could disrupt operations.
- Our employees, independent contractors, principal investigators, consultants, commercial collaborators, service providers and other vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
- Our failure to comply with international data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.
- Our failure to comply with state and/or national data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.
- 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. Further, we continue to incur significant increased costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives.
- Periodic reporting requirements under the Exchange Act and compliance with the Sarbanes-Oxley Act of 2002, including establishing and maintaining acceptable internal control over financial reporting, are costly and may increase substantially and, as a smaller reporting company, we may take advantage of reduced reporting requirements which may make our common stock less attractive to investors.
- We have identified conditions and events that raise substantial doubt regarding our ability to continue as a going concern.
- Clinical drug development is a lengthy and expensive process, with an uncertain outcome. If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs, experience delays in completing, or ultimately be unable to complete, the development of our product candidates or be unable to obtain marketing approval.
- The successful development of immunotherapies is highly uncertain.
- We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
- PDS0101 and PDS01ADC may cause adverse effects or have other properties that could delay or prevent its regulatory approval or limit the scope of any approved label or market acceptance.
- If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize, or will be delayed in commercializing, PDS0101 and PDS01ADC, and our ability to generate revenue will be impaired.
- If any of our product candidates receives marketing approval and we, or others, later discover that the drug is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability, or that of any future collaborators, to market the drug could be compromised.
- We rely, and intend to continue to rely, on third parties to conduct our clinical trials and perform some of our research and preclinical studies. If these third parties do not satisfactorily carry out their contractual duties, fail to comply with applicable regulatory requirements or do not meet expected deadlines, our development programs may be delayed or subject to increased costs or we may be unable to obtain regulatory approval, each of which may have an adverse effect on our business, financial condition, results of operations and prospects.
- Even if we obtain FDA approval in the United States, we may never obtain approval for or commercialize PDS0101 or PDS01ADC in any other jurisdiction, which would limit our ability to realize each product’s full market potential.
- Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more subject data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.
- The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, interim results of a clinical trial do not necessarily predict final results, and the results of our clinical trials may not satisfy the requirements of the FDA or comparable foreign regulatory authorities.
- Even if we obtain regulatory approval, we will still face extensive ongoing regulatory requirements, and PDS0101, PDS01ADC and other candidates may face future development and regulatory difficulties.
- Even if PDS0101 or PDS01ADC receives licensure, it may fail to achieve market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success.
- We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- If we fail to comply with federal and state healthcare regulatory laws, including in our relationships with healthcare providers and customers and third-party payors, we could face criminal prosecution and sanctions, substantial civil penalties, damages, fines, disgorgement, exclusion from participation in governmental healthcare programs, contractual damages, reputational harm, and the curtailment of our operations, any of which could harm our business.
- Even if we are able to commercialize any product candidate, such product candidate may become subject to unfavorable pricing regulations, third-party coverage and reimbursement policies or healthcare reform initiatives, which could harm our business.
- Product liability lawsuits against us could cause us to incur substantial liabilities and could limit the commercialization of PDS0101 and PDS01ADC.
- If we are unable to establish sales, marketing and distribution capabilities either on our own or in collaboration with third parties, we may not be successful in commercializing PDS0101, PDS01ADC and other product candidates, if approved.
- If we obtain approval to commercialize PDS0101, PDS01ADC or other product candidates outside of the United States, a variety of risks associated with international operations could harm our business.
- Recently enacted and future healthcare legislation, regulations, and policy initiatives may increase the difficulty and cost for us to obtain marketing approval of and commercialize PDS0101, PDS01ADC or other product candidates and affect the prices we may obtain and our profitability.
- We have no manufacturing, sales, marketing or distribution capability and we must rely upon third parties for such.
- We intend to rely on third parties to conduct, supervise and monitor our clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business.
- If we are unable to establish or manage strategic collaborations in the future, our revenue and drug development may be limited.
- The failure of third parties to meet their contractual, regulatory, and other obligations could adversely affect our business.
- Our business could be adversely affected by the effects of health epidemics, pandemics, or outbreaks of infectious diseases in regions where we or third parties on which we rely have significant manufacturing facilities, concentrations of clinical trial sites or other business operations.
- If we are unable to obtain and/or maintain patent protection for our Versamune®, Versamune® in combination with PDS01ADC platforms, PDS0101, other Versamune® based Products or Infectimune®, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.
- We may have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
- We may be involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, or defend our products and methods against the property rights of others, which could be expensive, time consuming and unsuccessful.
- 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 our products.
- We may not be able to protect our intellectual property rights throughout the world, which could impair our business.
- 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 be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
- Our stock price is expected to be volatile, and the market price of our common stock may drop in the future.
- We are required to meet the Nasdaq Capital Market’s continued listing requirements and other Nasdaq rules, and if we fail to meet such rules and requirements, we may be subject to delisting. Delisting could negatively affect the price of our common stock, which could make it more difficult for us to sell securities in a future financing or for you to sell our common stock.
- We do not anticipate that we will pay any cash dividends in the foreseeable future.
- Future sales of shares by existing stockholders could cause our stock price to decline.
- Because the Merger resulted in an ownership change under Section 382 of the Code for Edge, pre-merger U.S. net operating loss carryforwards and certain other tax attributes will be subject to limitations.
- Our effective tax rate may increase in the future, including as a result of tax legislation changes, which may have a material adverse effect on our business, financial condition and results of operations.
- Anti-takeover provisions under Delaware law could make an acquisition more difficult and may prevent attempts by our stockholders to replace or remove our current or future management.
- Provisions in our amended and restated bylaws could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
- We are currently operating in a period of economic uncertainty and capital markets disruption, which has been significantly impacted by geopolitical instability, an ongoing military conflict between Russia and Ukraine, Israel and Hamas and record inflation. Our business, financial condition and results of operations could be materially adversely affected by any negative impact on the global economy and capital markets resulting from the conflict in Ukraine, the Middle East, geopolitical tensions or record inflation.
- 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, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and our financial condition and results of operations.
Management Discussion
- For the year ended December 31, 2023, research and development expenses decreased to approximately $27.8 million compared to approximately $29.4 million for the year ended December 31, 2022. The decrease of $1.7 million was primarily attributable to a decrease in quality and manufacturing costs of $10.2 million, mainly driven by the $10.0 million purchase in 2022 of the rights to PDS01ADC from Merck KGaA, Darmstadt Germany, offset by an increase in personnel costs of $2.1 million, clinical costs of $6.1 million, facilities costs of $0.2 million, and professional fees of $0.1 million.