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We are a clinical-stage biotechnology company and have not yet generated revenues from product sales.
−Removed: To date, substantially all of our revenues have been derived from grants and contracts with governmental agencies, consisting primarily of our BARDA contract for our anthrax vaccine product candidate.
+Added: To date, substantially all of our revenues have been derived from past grants and contracts with governmental agencies.
We have incurred net losses in most periods since our inception, including a net loss of $88.4 million and $84.7 million for the years ended December 31, 2023 and 2022, respectively.
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Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability.
−Removed: If we are required by the FDA or other regulatory authorities to perform studies in addition to those currently expected, or if there are any delays in completing our clinical trials or the development of any of our product candidates, our expenses could increase.
+Added: If we are required by the FDA or other regulatory authorities to perform studies in addition to those currently expected, if there are any delays in completing our clinical trials or the development of any of our product candidates, or if we choose to perform additional studies for marketing purposes our expenses could increase.
Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
3 unchanged sentences
We also test our indefinite-lived intangible assets for impairment at least annually in the fourth quarter, or when events or changes in the business environment indicate that the carrying value of the reporting unit may exceed its fair value.
−Removed: As of December 31, 2021, we recorded non-cash impairment charges of $11.4 million for construction-in-progress assets that were previously capitalized in connection with the discontinuation of AdCOVID.
−Removed: At December 31, 2022, we continued to carry $12.4 million of indefinite lived intangible assets.
−Removed: Any such significant write-downs of our long-lived assets in the future could adversely affect our balance sheet and results of operations.
+Added: The preliminary data from the HepTcell Phase 2 trial indicates that the results are not sufficient to warrant moving forward with this product candidate.
+Added: As a result, we recorded non-cash impairment charges of $12.4 million for an acquired In-Process Research and Development asset in connection with the discontinuation of our product candidate HepTcell.
+Added: This and other significant write-downs of our long-lived assets in the future could adversely affect our balance sheet and results of operations.
We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed would force us to delay, limit, reduce or terminate our product development or commercialization efforts.
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ability to utilize a Form S-3 registration statement for a primary offering of our securities is limited to one-third of our public float, we may conduct such an offering pursuant to an exemption from registration under the Securities Act or under a Form S-1 registration statement, and we would expect either of those alternatives to increase the cost of raising additional capital relative to utilizing a Form S-3 registration statement.
−Removed: In addition, under current SEC rules and regulations, our common stock must be listed and registered on a national securities exchange in order to utilize a Form S-3 registration statement (i) for a primary offering, if our public float is not at least $75.0 million as of a date within 60 days prior to the date of filing the Form S-3 or a re-evaluation date, whichever is later, and (ii) to register the resale of our securities by persons other than us (i.e., a resale offering).
−Removed: While currently our common stock is listed on the NASDAQ Global Market, there can be no assurance that we will be able to maintain such listing.
Our ability to timely raise sufficient additional capital also may be limited by NASDAQ’s stockholder approval requirements for transactions involving the issuance of our common stock or securities convertible into our common stock.
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Our preclinical and clinical results are not necessarily predictive of the final results of our ongoing or future clinical trials.
−Removed: We have initiated a Phase 2 clinical trial of HepTcell and are currently in Phase 2 and Phase 1 clinical development with pemvidutide for multiple indications.
Success in preclinical studies may not be predictive of similar results in humans during clinical trials, and successful results from early or small clinical trials of a product candidate may not be replicated in later and larger clinical trials.
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For example, we suspended the development of a Densigen platform-based product candidate, Flunisyn, which was being developed as a T-cell vaccine for the treatment of influenza, in favor of NasoVAX.
−Removed: Clinical trials with this product candidate showed that it was generally well-tolerated and able to induce robust T-cell responses against the viral sequences represented, but a comparison of the entire study population in later-stage clinical trials showed no statistical differences between the vaccinated and placebo groups for several measures of protection.
+Added: Clinical trials with this product candidate showed that it was generally well-tolerated and able to induce robust T-cell responses
+Added: against the viral sequences represented, but a comparison of the entire study population in later-stage clinical trials showed no statistical differences between the vaccinated and placebo groups for several measures of protection.
In addition, we can offer no assurances that we have correctly estimated the resources or personnel necessary to seek partners, co-developers or acquirers for our programs.
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Interim 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 additional audit, validation and verification procedures that could result in material changes in the final data.
−Removed: From time to time, we may publish interim data, including interim top-line results or preliminary results from our clinical trials.
+Added: From time to time, we publish interim data, including interim top-line results or preliminary results from our clinical trials.
Any interim data and other results from our clinical trials may materially change as more patient data become available.
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To the extent any adversely affected material is being used in an ongoing clinical trial, the FDA could impose a clinical hold on our trial to investigate and remedy the quality issue.
−Removed: We cannot assure that any manufactured product or
−Removed: product candidate will not suffer a loss in stability or that other issues relating to the manufacture of our product candidates will not occur in the future.
−Removed: Additionally, our CMOs may experience manufacturing difficulties due to resource constraints, material constraints, or as a result of labor disputes or unstable political environments.
+Added: We cannot assure that any manufactured product or product candidate will not suffer a loss in stability or that other issues relating to the manufacture of our product candidates will not occur in the future.
+Added: Additionally, our CMOs may experience manufacturing difficulties due to resource constraints, including manufacturing capacity, material constraints, or as a result of labor disputes or unstable political environments.
If our CMOs were to encounter any of these difficulties, our ability to provide our product candidate to patients in clinical trials, or to provide product for treatment of patients once approved, would be jeopardized.
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● imposition of a clinical hold by regulatory agencies for any reason, including safety concerns raised by other clinical trials of similar product candidates that may reflect an unacceptable risk with the patient population, technology platform, product stability or after an inspection of clinical operations or trial sites;
−Removed: ● failure to perform clinical trials in accordance with the FDA’s GCP or applicable regulatory guidelines in other countries, including the United Kingdom, Canada, Germany, Italy, Spain, Thailand and Australia;
+Added: ● failure to perform clinical trials in accordance with the FDA’s GCP or applicable regulatory guidelines in other relevant countries;
● delays or failure in the testing, validation, manufacturing and delivery of the product candidates to the clinical sites, including as a result of supply chain delays in obtaining materials for the manufacture of our clinical trial materials;
−Removed: ● delays in testing, analysis and other activities by our third-party contractors required in conducting and analyzing our clinical trials as a result of the ongoing COVID-19 pandemic;
−Removed: ● any shelter-in-place orders from local, state or federal governments or clinical trial site policies resulting from the ongoing COVID-19 pandemic that determine essential and non-essential functions and staff, which may impact the ability of site staff to conduct assessments, or result in delays to the conduct of the assessments, as part of our clinical trial protocols, or the ability to enter assessment results into clinical trial databases in a timely manner;
−Removed: ● the number of patients required for our clinical trials may be larger than we anticipate, enrollment in our clinical trials may be slower than we anticipate or participants may, including as a result of the ongoing COVID-19 pandemic, withdraw from our clinical trials, fail to complete dosing or fail to return for post-treatment follow-up at higher rates than we anticipate, any of which could result in significant delay;
+Added: ● the number of patients required for our clinical trials may be larger than we anticipate, enrollment in our clinical trials may be slower than we anticipate or participants may withdraw from our clinical trials, fail to complete dosing or fail to return for post-treatment follow-up at higher rates than we anticipate, any of which could result in significant delay;
● withdrawal of clinical trial sites from our clinical trials, including as a result of changing standards of care or the ineligibility of a site to participate;
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The timing of our clinical trials depends on the speed at which we can recruit subjects to participate in testing our product candidates.
−Removed: If subjects are unwilling to participate in our trials because of the ongoing COVID-19 pandemic and restrictions on travel or healthcare institution policies, negative publicity from adverse events in the biotechnology industries, public perception of vaccine safety issues or for other reasons, including competitive clinical trials for similar patient populations, the timeline for recruiting subjects, conducting studies and obtaining regulatory approval of potential
−Removed: products may be delayed.
+Added: If subjects are unwilling to participate in our trials due to restrictions on travel or healthcare institution policies, negative publicity from adverse events in the biotechnology industries, public perception of vaccine safety issues or for other reasons, including competitive clinical trials for similar patient populations, the timeline for recruiting subjects, conducting studies and obtaining regulatory approval of potential products may be delayed.
These delays could result in increased costs, delays in advancing our product development, delays in testing the effectiveness of our technology or termination of the clinical trials altogether.
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● perceived risks and benefits of the product candidate being tested;
−Removed: ● willingness or availability of subjects to participate in our clinical trials (including due to the COVID-19 pandemic);
+Added: ● willingness or availability of subjects to participate in our clinical trials;
● proximity and availability of clinical trial sites for prospective subjects;
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Even if we enroll a sufficient number of eligible subjects to initiate our clinical trials, we may be unable to maintain participation of these subjects throughout the course of the clinical trial as required by the clinical trial protocol, in which event we may be unable to use the research results from those subjects.
−Removed: For example, we may face difficulties in identifying patient populations with active disease to enroll in our Phase 2 clinical trial of HepTcell in patients with chronic HBV.
+Added: For example, we may face difficulties in identifying patient populations with active disease to enroll in clinical trials of HepTcell in patients with chronic HBV.
Other clinical trials involving patients with active HBV have sometimes faced difficulties in working with these patient populations, which may include significant numbers of individuals with difficulties with treatment compliance, such as active drug users.
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If we have difficulty enrolling and maintaining the enrollment of a sufficient number of subjects to conduct our clinical trials as planned, we may need to delay, limit or terminate ongoing or planned clinical trials, any of which would have an adverse effect on our business.
−Removed: It may be difficult to predict the time and cost of product development.
−Removed: Unforeseen problems may prevent further development or approval of our product candidates.
+Added: It may be difficult to predict the time and cost of product development for our product candidates, and unforeseen problems may prevent further development or approval of our product candidates.
Because our product candidates involve novel therapeutic approaches, it may be difficult to predict the time and cost of product development.
For example, the Densigen platform involves synthetic peptide T-cell vaccines and the EuPort platform involves a novel peptide-based dual GLP-1/glucagon receptor agonist.
−Removed: Unforeseen problems with our
−Removed: approaches to vaccines and therapies may prevent further development or approval of our product candidates.
+Added: Unforeseen problems with our approaches to vaccines and therapies may prevent further development or approval of our product candidates.
Because of the novelty of our approaches, there may be unknown safety risks associated with the vaccines and therapies that we develop or the clinical endpoints that we establish in trials may not be generally accepted by regulatory agencies, which may therefore require us to perform large field studies to demonstrate efficacy.
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Traditionally, regulatory authorities have required extensive study of novel adjuvants because vaccines typically get administered to healthy populations, in particular infants, children and the elderly, rather than in people with disease.
−Removed: As a result, although it is anticipated that HepTcell is intended for the treatment of patients suffering from a disease, regulatory agencies such as the FDA may nevertheless require us to conduct extensive safety testing prior to approval to demonstrate a low risk of rare and severe adverse events caused by our product candidates that include novel vaccine adjuvants.
+Added: As a result, although it is anticipated that HepTcell is intended
+Added: for the treatment of patients suffering from a disease, regulatory agencies such as the FDA may nevertheless require us to conduct extensive safety testing prior to approval to demonstrate a low risk of rare and severe adverse events caused by our product candidates that include novel vaccine adjuvants.
If approved, the novel mechanism of action of the vaccines may adversely affect physician and patient perception and acceptance of our products.
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Furthermore, if these third parties do not successfully carry out their duties under their agreements, if the quality or accuracy of the data they obtain is compromised due to their failure to adhere to clinical trial protocols or to regulatory requirements, or if they otherwise fail to comply with clinical trial protocols or meet expected deadlines, then the clinical trials of our product candidates may not meet regulatory requirements.
−Removed: If clinical trials do not meet regulatory requirements or if these third parties need to be replaced, then preclinical development activities or clinical trials may be extended,
−Removed: delayed, suspended or terminated.
+Added: If clinical trials do not meet regulatory requirements or if these third parties need to be replaced, then preclinical development activities or clinical trials may be extended, delayed, suspended or terminated.
If any of these events occur, we may not be able to obtain regulatory approval of our product candidates on a timely basis or at all.
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These third parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other product development activities, which could affect their performance on our behalf.
−Removed: If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they cannot perform their contractual duties or obligations due to the impacts of the ongoing COVID-19 pandemic on their operations or at the sites they are overseeing, if they need to be replaced or if the quality or accuracy of the preclinical or clinical data they obtain is compromised due to the failure to adhere to our protocols or regulatory requirements or for other reasons, our development timelines, including clinical development timelines, may be extended, delayed or terminated and we may not be able to complete development of, receive regulatory approval of or successfully commercialize our product candidates.
+Added: If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they cannot perform their contractual duties or obligations due to the impacts of public health crises on their operations or at the sites they are overseeing, if they need to be replaced or if the quality or accuracy of the preclinical or clinical data they obtain is compromised due to the failure to adhere to our protocols or regulatory requirements or for other reasons, our development timelines, including clinical development timelines, may be extended, delayed or terminated and we may not be able to complete development of, receive regulatory approval of or successfully commercialize our product candidates.
As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.
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Large pharmaceutical companies, in particular, have extensive experience in clinical testing, obtaining regulatory approvals, recruiting patients and manufacturing pharmaceutical products.
−Removed: Large and established companies such as Eli Lilly, Roche, Novo Nordisk and Pfizer, among others, compete in the same market as our product candidates.
+Added: Large and established companies such as Eli Lilly, Roche, Novo Nordisk, Pfizer, AstraZeneca, Amgen, Boehringer Ingelheim and Merck, among others, compete in the same market as our product candidates.
These companies compete with us with their greater experience and resources to support their research and development efforts, conduct testing and clinical trials, obtain regulatory approvals to market products, manufacture such products on a broad scale and market approved products.
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We also face competition from smaller companies who, like us, rely on investors to fund research and development and compete for co-development and licensing opportunities from large and established pharmaceutical companies.
−Removed: We face competition for pemvidutide, our dual GLP 1/glucagon dual agonist for the treatment of obesity and NASH.
−Removed: For obesity, we face competition from companies such as Novo Nordisk, whose GLP-1 agonist, brand named Wegovy, or compound name semaglutide, was approved in June 2021.
−Removed: Other companies with potentially competitive candidates in development, include Eli Lilly with GLP-1/glucose-dependent insulinotropic polypeptide receptor (“GIP”) dual agonists, including Mounjaro, or compound name tirzepatide, currently approved for type 2 diabetes;
−Removed: Boehringer Ingelheim, Merck/Hanmi Pharmaceutical, AstraZeneca, Innovent Biologics/Eli Lilly, Carmot and D&D Pharma, with
−Removed: GLP-1/glucagon receptor dual agonists;
+Added: We face competition for pemvidutide, our dual GLP-1/glucagon dual agonist for the treatment of obesity and MASH.
+Added: For obesity, we face competition from companies such as Novo Nordisk, whose GLP-1 agonist, brand named Wegovy, or compound name semaglutide, was approved for weight loss in June 2021.
+Added: Other companies with potentially competitive products or product candidates, include Eli Lilly with GLP-1/glucose-dependent insulinotropic polypeptide receptor (“GIP”) dual agonists, including Zepbound, or compound name tirzepatide, approved for obesity in November 2023;
+Added: Boehringer Ingelheim, AstraZeneca, Innovent Biologics/Eli Lilly, and Roche through its acquisition of Carmot and D&D Pharma, with GLP-1/glucagon receptor dual agonists;
Hanmi Pharmaceutical and Eli Lilly with GLP-1/glucagon/GIP triple agonists;
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and Novo Nordisk with Amylin and Amylin-GLP-1 combination candidates.
−Removed: We face competition in NASH from companies such as Intercept Pharmaceuticals, which is developing a farnesoid X receptor (“FXR”) agonist;
−Removed: Madrigal Pharmaceuticals, Terns, Aligos and Viking Therapeutics, which are developing orally administered, thyroid hormone receptor (“THR”) β-selective agonist;
−Removed: Akero Therapeutics, 89Bio, Novo Nordisk, Boston Pharmaceuticals and Roche, which are developing fibroblast growth factor 21 analogs;
+Added: Other companies have been developing oral candidates for the treatment of obesity with GLP-1 monoagonist or GLP-1/GIP dual receptor agonists including Pfizer, Lilly, Structure Therapeutics, AstraZeneca through its acquisition of Eccogene and Roche through its acquisition of Carmot.
+Added: In addition, Novo Nordisk has an FDA-approved oral GLP-1 therapy, Rybelsus or compound name semaglutide.
+Added: We face competition in MASH from companies such as Madrigal Pharmaceuticals, Terns, Aligos and Viking Therapeutics, which are developing orally administered, thyroid hormone receptor (“THR”) β-selective agonist;
+Added: Akero Therapeutics, 89Bio, Novo Nordisk and Boston Pharmaceuticals, which are developing fibroblast growth factor 21 (“FGF-21”) analogs;
Novo Nordisk, which is developing a GLP-1 agonist;
−Removed: and, Inventiva, which is developing a pan-peroxisome proliferator-activated receptor (“PPAR”) agonist and orally based GLP-1 agents that either deliver GLP-1 monoagonist activity either as a peptide (Novo Nordisk) or small molecule (Pfizer, Eli Lilly).
−Removed: In addition, many other small companies are developing other new technologies directed towards obesity or NASH.
−Removed: Finally, we face competition for HepTcell, our immunotherapeutic HBV product candidate, from companies such as GSK, Janssen, Vaccitech VBI Vaccines, all of which are developing a therapeutic vaccine against chronic HBV infection.
−Removed: In addition, many other companies are developing direct acting antivirals against HBV.
+Added: Merck/Hanmi Pharmaceutical, which is developing a GLP-1/glucagon dual agonist, Eli Lilly, which is developing a GLP-1/GIP dual agonist, Inventiva, which is developing a pan-peroxisome proliferator-activated receptor (“PPAR”) agonist;
+Added: Sagimet which is developing a fatty acid synthetase inhibitor, HEC Pharma which is developing a GLP-1/FGF-21dual agonist;
+Added: and Pfizer and Eli Lilly, which are developing small molecule GLP-1 agonists.
+Added: In addition, many other small companies are developing other new technologies directed towards obesity or MASH.
As a result of all of these factors, our competitors may succeed in obtaining patent protection and/or FDA approval or discovering, developing and commercializing products before we do.
−Removed: In addition, any new product that we develop that competes with an approved product must demonstrate compelling advantages in efficacy, convenience, tolerability and safety in order to overcome price competition and to be commercially successful.
+Added: In addition, any new product that we develop that
+Added: competes with an approved product must demonstrate compelling advantages in efficacy, convenience, tolerability and safety in order to overcome price competition and to be commercially successful.
If we are not able to compete effectively against potential competitors, our business will not grow, and our financial condition and operations will suffer.
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Furthermore, until such time as we are able to build a broader product candidate pipeline, if ever, any adverse developments with respect to our leading product candidate, pemvidutide, would have a more significant adverse effect on our overall business than if we maintained a broader portfolio of product candidates.
+Added: If we fail to establish and maintain strategic partnerships related to pemvidutide, we will bear all of the risk and costs related to its development which could negatively affect the development of pemvidutide and materially affect our business and financial condition.
Even if a current or future product candidate receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payers and others in the medical community necessary for commercial success.
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● the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
−Removed: ● the strength of marketing and distribution support;
● the ability to obtain sufficient third-party coverage and adequate reimbursement, including with respect to the use of the approved product as a combination therapy;
2 unchanged sentences
● the extent and strength of marketing and distribution support;
−Removed: ● the limitations or warnings contained in a product’s approved labeling;
−Removed: ● distribution and use restrictions imposed by the FDA or other regulatory authorities outside the United States or that are part of a REMS or voluntary risk management plan;
+Added: ● any limitations or warnings contained in a product’s approved labeling;
+Added: ● any distribution and use restrictions imposed by the FDA or other regulatory authorities outside the United States or that are part of a REMS or voluntary risk management plan;
● the prevalence and severity of any side effects, including the tolerability and effect on comorbidities relative to alternative treatments.
1 unchanged sentence
If our products do not achieve an adequate level of acceptance among physicians, patients and third-party payers, we may not generate meaningful revenues and we may not become profitable.
−Removed: We may not be able to comply with the requirements of foreign jurisdictions in conducting trials within the United Kingdom, European Union or any other foreign country.
−Removed: We are conducting our Phase 2 clinical trial of HepTcell in the U.S., United Kingdom, Canada, Germany Italy, Spain and Thailand;
+Added: We may not be able to comply with the requirements of foreign jurisdictions in conducting trials within the United Kingdom, European Union (“EU”) or any other foreign country.
+Added: We have in the past conducted clinical trials in the U.S.
+Added: and other countries;
and future clinical trials may be conducted in other foreign jurisdictions.
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● the potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation of the conduct of clinical trials, pharmaceutical and biotechnology products and treatment.
−Removed: ● the acceptability of data obtained from studies conducted outside the United States to the FDA in support of U.S.
−Removed: marketing authorizations, such as an NDA or BLA.
If we fail to successfully meet requirements for the conduct of clinical trials outside of the United States, we may be delayed in obtaining, or be unable to obtain, regulatory approval for our product candidates in the United States or in countries outside of the United States.
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Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel.
−Removed: We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions.
+Added: We also experience competition for the hiring of scientific and clinical personnel from universities
+Added: and research institutions.
In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy.
3 unchanged sentences
Our global operations expose us to risks associated with public health crises and epidemics/pandemics, such as COVID-19.
−Removed: The global spread of COVID-19 has created significant volatility, uncertainty and worldwide economic disruption, resulting in an economic slowdown of potentially extended duration and may impact our operations, including the potential interruption of our clinical trial activities, regulatory reviews and our supply chain.
−Removed: For example, the ongoing COVID-19 pandemic (including the Delta and Omicron variants and any future variants that may emerge) may delay preclinical testing and enrollment in our clinical trials due to prioritization of laboratory and hospital resources toward the outbreak or other factors, and some patients may be unwilling to enroll in our trials or be unable to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services, which would delay our ability to conduct clinical trials or release clinical trial results and could delay our ability to obtain regulatory approval and commercialize our product candidates.
−Removed: In addition, since the beginning of the COVID-19 pandemic, several vaccines for COVID-19 have received Emergency Use Authorization by the FDA and a number of those later received marketing approval.
−Removed: Additional vaccines may be authorized or approved in the future.
−Removed: The resultant demand for vaccines and potential for manufacturing facilities and materials to be commandeered under the Defense Production Act of 1950, or equivalent foreign legislation, may make it more difficult to obtain materials or manufacturing slots for the products needed for our clinical trials, which could lead to delays in these trials.
−Removed: Furthermore, the spread of the virus may affect the operations of key governmental agencies, such as the FDA, which may delay the development of our product candidates.
−Removed: The spread of an infectious disease, including COVID-19, its subvariants and other SARS-CoV-2 viruses, may also result in the inability of our suppliers to deliver components or raw materials on a timely basis or at all.
+Added: Such risks include significant volatility, uncertainty and worldwide economic disruption which resulted in an economic slowdown of potentially extended duration.
+Added: Similar events in the future could impact our operations, including the potential interruption of our clinical trial activities, regulatory reviews and our supply chain.
+Added: For example, future outbreaks of infectious disease, such as COVID 19, and any future variants or subvariants that may emerge, may delay preclinical testing and enrollment in our clinical trials due to prioritization of laboratory and hospital resources toward the outbreak or other factors, and some patients may be unwilling to enroll in our trials or be unable to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services, which would delay our ability to conduct clinical trials or release clinical trial results and could delay our ability to obtain regulatory approval and commercialize our product candidates.
+Added: The spread of an infectious disease, including COVID 19, its subvariants and other SARS-CoV-2 viruses, may affect the operations of key governmental agencies, such as the FDA, which may delay the development of our product candidates or also result in the inability of our suppliers to deliver components or raw materials on a timely basis or at all.
In addition, hospitals may reduce staffing and reduce or postpone certain treatments in response to the spread of an infectious disease.
1 unchanged sentence
Such events may result in a period of business disruption, and in reduced operations, or doctors and medical providers may be unwilling to participate in our clinical trials, any of which could materially affect our business, financial condition and results of operations.
−Removed: In response to COVID-19-related government and public health directives and orders, we have implemented work-from-home and hybrid policies for certain employees.
−Removed: The effects of these orders and our work-from-home and hybrid policies may negatively impact productivity, disrupt our business and delay our clinical programs and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course.
−Removed: These and similar, and perhaps more severe, disruptions in our operations could negatively impact our business, operating results and financial condition.
−Removed: In addition, the trading prices for our common stock and other biopharmaceutical companies have been highly volatile as a result of the COVID-19 pandemic.
+Added: In response to COVID 19 related government and public health directives and orders, we implemented and continue to maintain work-from-home and hybrid policies for certain employees.
+Added: The effects of these policies may negatively impact productivity, disrupt our business and delay our clinical programs and timelines and could negatively impact our business, operating results and financial condition.
+Added: In addition, the trading prices for our common stock and other biopharmaceutical companies may be highly volatile as a result of a pandemic, epidemic or the spread of infectious disease.
As a result, we may face difficulties raising capital through sales of our common stock or such sales may be on unfavorable terms.
−Removed: The extent to which the COVID-19 pandemic may impact our business will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of the coronavirus, the geographic spread of the disease, the duration of the outbreak, new strains of the virus, and any future variants that may emerge, and the actions to contain the coronavirus or treat its impact, including vaccination campaigns, travel restrictions and other social distancing restrictions in the United States and other countries, among others.
−Removed: A significant outbreak of coronavirus and other infectious diseases could result in a widespread health crisis that could adversely affect the economies and financial markets worldwide, resulting in an economic downturn that could impact our business, financial condition and results of operations.
+Added: A significant outbreak of infectious disease could result in a widespread health crisis that could adversely affect the economies and financial markets worldwide, resulting in an economic downturn that could impact our business, financial condition and results of operations.
Labor shortages and constraints in the supply chain could adversely affect our results of operations.
−Removed: In 2022, many companies experienced labor shortages and other labor-related issues, which were pronounced as a result of the ongoing COVID-19 pandemic.
A number of factors may adversely affect the labor force available to us or increase labor costs, including high employment levels, federal unemployment subsidies, increased wages offered by other employers, vaccine mandates and other government regulations and our responses thereto.
As more employers offer remote work, we may have more difficulty recruiting for jobs that require on-site attendance.
−Removed: We have recently observed an overall tightening and increasingly competitive labor market.
If we are unable to hire and retain employees capable of performing at a high-level, our business could be adversely affected.
−Removed: A sustained labor shortage, lack of skilled labor, or increased turnover within our employee base, caused by COVID-19 or as a result of general macroeconomic factors, could have a material adverse impact on our business and operating results.
−Removed: In addition, recent developments in the national and worldwide supply chain slowdown, including as a result of the conflict in Ukraine, have resulted in increased cost and reduced supply for supplies and materials.
+Added: A sustained labor shortage, lack of skilled labor, or increased turnover within our employee base, caused by a pandemic, epidemic or the spread of infectious disease or as a result of general macroeconomic factors, could have a material adverse impact on our business and operating results.
+Added: In addition, recent developments in the national and worldwide supply chain slowdown, including as a result of the conflict in Israel and the Gaza Strip, and the conflict in Ukraine, have resulted in increased cost and reduced supply for supplies and materials.
It is impossible to predict how long this supply chain slowdown will last or how much it will impact our business operations, but it is likely that our costs will increase for supplies.
−Removed: Legal, political and economic uncertainty surrounding the exit of the United Kingdom (“U.K.”), from the European Union (“EU”) may be a source of instability in international markets, create significant currency fluctuations, adversely affect our operations in the U.K.
−Removed: and pose additional risks to our business, revenue, financial condition and results of operations.
−Removed: On June 23, 2016, the U.K.
−Removed: held a referendum in which a majority of the eligible members of the electorate voted to leave the EU.
−Removed: The U.K.’s withdrawal from the EU is commonly referred to as Brexit.
−Removed: Pursuant to Article 50 of the Treaty on European Union, the U.K.
−Removed: ceased being a Member State of the EU on January 31, 2020.
−Removed: The U.K.’s withdrawal from the EU has created significant uncertainty concerning the future relationship between the U.K.
−Removed: On December 24, 2020, the EU and U.K.
−Removed: reached an agreement in principle on the framework for their future relationship, the EU-UK Trade and Cooperation Agreement.
−Removed: The Agreement primarily focuses on ensuring free trade between the EU and the U.K.
−Removed: in relation to goods, including medicinal products.
−Removed: Among the changes that will now occur are that Great Britain (England, Scotland and Wales) will be treated as a third country.
−Removed: Northern Ireland will, with regard to EU regulations, continue to follow the EU regulatory rules.
−Removed: As part of the Agreement, the EU and the U.K.
−Removed: will recognize GMP inspections carried out by the other Party and the acceptance of official GMP documents issued by the other Party.
−Removed: The Agreement also encourages, although it does not oblige, the parties to consult one another on proposals to introduce significant changes to technical regulations or inspection procedures.
−Removed: Among the areas of absence of mutual recognition are batch testing and batch release.
−Removed: has unilaterally agreed to accept EU batch testing and batch release for a period of at least two years until January 1, 2023.
−Removed: However, the EU continues to apply EU laws that require batch testing and batch release to take place in the EU territory.
−Removed: This means that medicinal products that are tested and released in the U.K.
−Removed: must be retested and re-released when entering the EU market for commercial use.
−Removed: As regards marketing authorizations, Great Britain will have a separate regulatory submission process, approval process and a separate national marketing authorization.
−Removed: Northern Ireland will, however, continue to be covered by the marketing authorizations granted by the European Commission.
−Removed: This lack of clarity on future U.K.
−Removed: laws and regulations and their interaction with EU laws and regulations may negatively impact foreign direct investment in the U.K., increase costs, depress economic activity, and restrict access to capital.
−Removed: The uncertainty concerning the U.K.’s legal, political and economic relationship with the EU after Brexit may be a source of instability in the international markets, create significant currency fluctuations, and/or otherwise adversely affect trading agreements or similar cross-border co-operation arrangements (whether economic, tax, fiscal, legal, regulatory or otherwise) beyond the date of Brexit.
−Removed: These developments, or the perception that any of them could occur, may have a significant adverse effect on global economic conditions and the stability of global financial markets, and could significantly reduce global market liquidity and limit the ability of key market participants to operate in certain financial markets.
−Removed: In particular, it could also lead to a period of considerable uncertainty in relation to the U.K.
−Removed: financial and banking markets, as well as on the regulatory process in Europe.
−Removed: Asset valuations, currency exchange rates and credit ratings may also be subject to increased market volatility.
−Removed: We may also face new regulatory costs and challenges that could have an adverse effect on our operations.
+Added: Our overall performance depends in part on worldwide economic conditions and uncertainties.
+Added: Global inflation rates have increased to levels not seen in several decades, which may result in increases in our operating costs, including our labor costs, constrained credit and liquidity, reduced government spending and volatility in financial markets which may adversely affect the Company’s business and financial condition.
+Added: Additionally, the upcoming 2024 U.S.
+Added: Presidential election could cause additional legal, political and economic uncertainty.
+Added: The Federal Reserve and other international government agencies have raised, and may again raise, interest rates in response to concerns over inflation risk.
+Added: Increases in interest rates on credit and debt that would increase the cost of any borrowing that we may make from time to time and could impact our ability to access the capital markets.
Our acquisitions may expose us to unknown liabilities.
−Removed: Because we have acquired all the outstanding shares of most of our acquired companies, our investment in those companies are or will be subject to all of their liabilities other than their respective debts which we paid or will pay at the time of the acquisitions.
+Added: Because we have historically acquired all the outstanding shares of most of our acquired companies, our investment in those companies are or will be subject to all of their liabilities other than their respective debts which we paid or will pay at the time of the acquisitions.
If there are unknown liabilities or other obligations, our business could be materially affected.
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federal and state taxable income.
−Removed: For these purposes, an ownership change generally occurs in the event of a
−Removed: cumulative change in ownership of the Company of more than 50% within any three-year period.
−Removed: We have not determined if we have experienced Section 382 ownership changes in the past and if a portion of our NOL and tax credit carryforwards are subject to an annual limitation under Section 382.
−Removed: Our existing NOLs are subject to limitations arising from previous ownership changes that impact the timing and amount.
+Added: For these purposes, an ownership change generally occurs in the event of a cumulative change in ownership of the Company of more than 50% within any three-year period.
+Added: We have reviewed our stock ownership for any ownership changes as defined under IRC Section 382 from January 1, 2021 through November 3, 2023 and determined that the ownership change was less than 50% during that period.
+Added: Our existing NOLs are subject to limitations arising from previous ownership changes impacting the timing and amount, and the impact of such changes is reflected in the NOL amounts disclosed above.
In addition, future changes in our stock ownership, many of which are outside of our control, could result in an ownership change.
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The FDA and corresponding regulatory authorities in other jurisdictions have a significant amount of discretion in deciding whether or not to approve a marketing application.
−Removed: Our product candidates could fail to
−Removed: receive regulatory approval from the FDA or comparable regulatory authorities outside the United States for several reasons, including:
+Added: Our product candidates could fail to receive regulatory approval from the FDA or comparable regulatory authorities outside the United States for several reasons, including:
● disagreement with the design or implementation of our clinical trials ;
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Any of these events could prevent us from achieving or maintaining marketing approvals for and market acceptance of our product candidates and could have a material adverse effect on our business and financial results.
+Added: Fast track designation by the FDA may not lead to a faster development or regulatory review or approval process, and does not assure FDA approval of any product candidates that we may develop.
+Added: FDA’s fast track program is intended to expedite the development of certain qualifying products intended for the treatment of serious diseases and conditions.
+Added: If a product candidate is intended for the treatment of a serious or life threatening condition and preclinical or clinical data demonstrate the product’s potential to address an unmet medical need for this condition, the sponsor may apply for FDA fast track designation.
+Added: In October 2023, we announced that the FDA granted fast track designation to our clinical program investigating pemvidutide for the treatment of MASH.
+Added: Even with fast track designation, we may not experience a faster development process, review or approval for pemvidutide compared to conventional FDA procedures, and fast track designation does not ensure that a product candidate will receive marketing approval at all.
+Added: In addition, the FDA may withdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development program.
If we fail to obtain regulatory approval in non-U.S.
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Manufacturers and manufacturers’ facilities are also required to comply with extensive FDA and comparable foreign regulatory authority requirements, including ensuring that quality control and manufacturing procedures conform to cGMP regulations and applicable product tracking and tracing requirements.
−Removed: Additionally, under the Food and Drug Omnibus Reform Act of 2022 (“FDORA”), sponsors of approved drugs and biologics must provide six months’ notice to the FDA of any changes in marketing status, such as the withdrawal of a drug, and failure to do so could result in the FDA placing the product on a list of discontinued products, which would revoke the product’s ability to be marketed.
Any such restrictions may result in significant additional expense or could limit sales of the approved product.
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Certain ANDAs, and certain biosimilar products that are deemed under applicable laws to be “interchangeable with” our biological product, once approved, may be substituted for our product candidates, subject to applicable state laws.
−Removed: We may also be subject to competition from biosimilar products in Europe.
+Added: We may also be subject to competition from biosimilar products in the EU.
To date, many biosimilar products have been authorized by the European Commission, after application at EMA for a centralized marketing authorization.
−Removed: As in the United States the regulatory approval pathway for biosimilar products in Europe is abbreviated.
+Added: As in the United States the regulatory approval pathway for biosimilar products in the EU is abbreviated.
A biosimilar sponsor must however still provide all of the preclinical and clinical data required to demonstrate the similarity of their product with the reference product.
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If granted, pediatric exclusivity may add six months to certain patents or regulatory exclusivity periods for an approved drug, and to regulatory exclusivity periods for an approved biological product.
−Removed: In the EU, as well, pediatric studies are incentivized by the reward of additional exclusivity.
−Removed: Pediatric Investigation Plans (“PIPs”), are determined by the Pediatric Committee of the EMA.
−Removed: Where an application for a marketing authorization is submitted in respect of a medicinal product designated as an orphan medicinal product and that application contains the results of the PIP studies, market exclusivity for that orphan medicinal product is extended by two years.
−Removed: Where an application for a marketing authorization is submitted in respect of a medicinal product that is not designated as an orphan medicinal product and that application contains the results of the PIP studies, it may be possible to obtain a 6-month extension of a supplementary protection certificate extending patent protection for a medicinal product.
+Added: In the EU, pediatric studies are also incentivized by the reward of additional exclusivity.
+Added: Pediatric Investigation Plans (“PIPs”) must be agreed with the Pediatric Committee of the EMA, unless a waiver or deferral applies with respect to the product.
+Added: Where an application for a marketing authorization is submitted in respect of a medicinal product designated as an orphan medicinal product and that application contains the results of studies conducted in compliance with an approved PIP, market exclusivity for that orphan medicinal product may be extended by two years.
+Added: Where an application for a marketing authorization is submitted in respect of a medicinal product that is not designated as an orphan medicinal product and that application contains the results of studies conducted in compliance with an approved PIP, it may be possible to obtain a six month extension of a supplementary protection certificate extending patent protection for a medicinal product.
Orphan drug designation presents yet another regulatory incentive that may be available to us and our competitors.
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Orphan drug designation can provide opportunities for grant funding towards clinical trial costs, tax advantages and FDA user fee exemptions.
−Removed: In addition, if a product that has an orphan drug designation subsequently receives FDA approval for the indication for which it has such designation, the product may be entitled to orphan drug exclusivity, which means the FDA would not approve any other application to
−Removed: market the same drug for a period of seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity.
+Added: In addition, if a product that has an orphan drug designation subsequently receives FDA approval for the indication for which it has such designation, the
+Added: product may be entitled to orphan drug exclusivity, which means the FDA would not approve any other application to market the same drug for a period of seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity.
In the European Union, orphan drug status offers similar but not identical benefits as those in the United States.
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Even if patents do successfully issue and even if such patents cover our product candidates, third parties may challenge their validity, enforceability or scope, which may result in such patents being narrowed or invalidated.
−Removed: Any successful challenge to our patents or patent applications, or to any other patents or patent applications owned by or licensed to us, could deprive us of the rights necessary to prevent competition from third parties, which may impair the
−Removed: commercial success of any product candidate that we may develop.
+Added: Any successful challenge to our patents or patent applications, or to any other patents or patent applications owned by or
+Added: licensed to us, could deprive us of the rights necessary to prevent competition from third parties, which may impair the commercial success of any product candidate that we may develop.
There is no assurance that all potentially relevant prior art relating to our patents and patent applications or those of our licensors has been found, and prior art that we have not identified could be used by a third party to invalidate a patent or prevent a patent from issuing from a pending patent application.
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The actual length of the extension will depend on the amount of patent term lost while the product was in clinical trials.
−Removed: If any of our biologic products qualify as being a “first licensure” under the Biologics Price Competition and Innovation Act (“BPCIA”) provisions of the Affordable Care Act (“ACA”), we also expect to seek regulatory exclusivity for those products from the FDA, which can grant twelve (12) years of exclusivity under the BPCIA provisions of the ACA.
−Removed: However, the applicable authorities, including the USPTO and FDA in the United States, and any equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions are available or whether any of our products qualify as a first licensure, and may refuse to grant extensions to our patents, or may grant more limited extensions than we request, or may not grant regulatory exclusivity.
+Added: However, the applicable authorities, including the USPTO and FDA in the United States, and any equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions are available and may refuse to grant extensions to our patents, or may grant more limited extensions than we request, or may not grant regulatory exclusivity.
If this occurs, our competitors may be able to take advantage of our investment in development and clinical trials by referencing our clinical and preclinical data, and then may be able to launch their product earlier than might otherwise be the case.
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There may be third-party patents or patent applications with claims, for example, to materials, formulations, methods of manufacture, methods of analysis and/or methods for treatment related to the use or manufacture of our product candidates.
−Removed: For instance, we and certain of our executive officers have been named in a lawsuit brought by a former employee, De-Chu Christopher Tang.
−Removed: The lawsuit asserts a number of claims, including claims that Dr.
−Removed: Tang owns certain portions of our intellectual property and that we wrongfully retained Dr.
−Removed: Tang’s lab notebooks after the conclusion of his employment in 2012.
−Removed: We believe the claims are without merit.
In some cases, we may have failed to identify such relevant third-party patents or patent applications.
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An award of monetary damages may be substantial and may include treble damages and attorneys’ fees for willful infringement.
−Removed: An award of injunctive relief could block our ability to develop and commercialize the applicable product candidate until such patent expired or
−Removed: unless we obtain a license.
+Added: An award of injunctive relief could block our ability to develop and commercialize the applicable product candidate until such patent expired or unless we obtain a license.
Such licenses may not be available on acceptable terms, if at all.
Even if we were able to obtain a license, the rights may be non-exclusive, which could result in our competitors gaining access to the same intellectual property.
−Removed: Ultimately, we could be forced to redesign an infringing product, prevented from commercializing a product, or forced to cease some aspect of our business operations, if, as a result of actual or threatened patent infringement claims, we are unable to enter into licenses on acceptable terms.
+Added: Ultimately, we could be forced to redesign an infringing product, prevented from commercializing a product, or
+Added: forced to cease some aspect of our business operations, if, as a result of actual or threatened patent infringement claims, we are unable to enter into licenses on acceptable terms.
Defending against claims of patent infringement or misappropriation of trade secrets could be costly and time consuming, regardless of the outcome.
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We are a party to a number of license agreements that are important to our business, and we may enter into additional license agreements in the future.
−Removed: Certain of our in-licensed intellectual property covers, or may cover, RespirVec technology, EuPort technology, and certain of our product candidates including pemvidutide.
+Added: Certain of our in-licensed intellectual property covers, or may cover, EuPort technology, and certain of our product candidates including pemvidutide.
Our existing license agreements impose, and we expect that future license agreements will impose, various diligence, milestone payment, royalty and other of our obligations.
−Removed: If there is any conflict, dispute, disagreement or issue of non-performance between
−Removed: the Company and our licensing partners regarding our rights or obligations under the license agreements, including any such conflict, dispute or disagreement arising from our failure to satisfy payment obligations under any such agreement, we may owe damages, our licensor may have a right to terminate the affected license, and our ability to utilize the affected intellectual property in our product discovery and development efforts and our ability to enter into collaboration or marketing agreements for an affected product candidate may be adversely affected.
+Added: If there is any conflict, dispute, disagreement or issue of non-performance between the Company and our licensing partners regarding our rights or obligations under the license agreements, including any such conflict, dispute or disagreement arising from our failure to satisfy payment obligations under any such agreement, we may owe damages, our licensor may have a right to terminate the affected license, and our ability to utilize the affected intellectual property in
+Added: our product discovery and development efforts and our ability to enter into collaboration or marketing agreements for an affected product candidate may be adversely affected.
We may need to license certain intellectual property from third parties, and such licenses may not be available on commercially reasonable terms or at all.
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If any approved products are not accepted by the market to the extent that we expect, we may not be able to generate significant revenue and our business would suffer.
−Removed: We rely on, and expect to continue to rely on, third parties to manufacture our product candidates and related materials for our clinical trials and preclinical studies, and these third parties may not perform satisfactorily.
+Added: We rely on, and expect to continue to rely on, third parties to manufacture our product candidates and related materials for our products, if approved, as well as for our clinical trials and preclinical studies, and these third parties may not perform satisfactorily.
We do not have any manufacturing facilities or personnel, and we rely on, and expect to continue to rely on, third-party manufacturers and suppliers to manufacture and supply vaccines, drug substance and drug product for our preclinical studies and clinical trials, and on related materials, such as HBV products and pemvidutide.
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In addition, our reliance on these third parties for manufacturing activities will reduce our control over these activities but will not relieve us of our responsibility to ensure compliance with all required regulations regarding manufacturing.
−Removed: Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured the product candidates itself, including:
+Added: Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured the product candidates ourself, including:
● the inability to negotiate manufacturing agreements with third parties under commercially reasonable terms;
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● the possible misappropriation of our proprietary information, including our trade secrets and know-how or infringement of third-party intellectual property rights by our contract manufacturers;
−Removed: ● disruptions to the operations of our third-party manufacturers or suppliers caused by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier.
+Added: ● disruptions to the operations of our third-party manufacturers or suppliers caused by conditions unrelated to our business or operations, including the bankruptcy or change in ownership of the manufacturer or supplier.
Any of these events could lead to preclinical study and clinical trial delays or failure to obtain regulatory approval or affect our ability to successfully commercialize future products.
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Our third-party manufacturers may be subject to damage or interruption from, among other things, fire, natural or man-made disaster, power loss, telecommunications failure, unauthorized entry, computer viruses, denial-of-service attacks, acts of terrorism, human error, vandalism or sabotage, financial insolvency, bankruptcy and similar events.
−Removed: Since March 2020, when foreign and domestic inspections of facilities were largely placed on hold due to the ongoing COVID-19 pandemic, the FDA has been working to resume pre-pandemic levels of inspection activities, including routine surveillance, bioresearch monitoring and pre-approval inspections.
−Removed: \ Should FDA determine that an inspection is necessary for approval of a marketing application and an inspection cannot be completed during the review cycle due to restrictions on travel, FDA has stated that it generally intends to issue a complete response letter.
−Removed: Further, if there is inadequate information to make a determination on the acceptability of a facility, FDA may defer action on the application until an inspection can be completed.
−Removed: Throughout the duration of the public health emergency, several companies announced receipt of complete response letters due to the FDA’s inability to complete required inspections for their applications.
−Removed: Regulatory authorities outside the U.S.
−Removed: may adopt similar restrictions or other policy measures in response to the COVID 19 pandemic and may experience delays in their regulatory activities.
−Removed: The extent to which the ongoing COVID-19 pandemic may impact our results will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of COVID-19, the emergence of new variants, and the actions to contain COVID-19 or treat its impact, among others.
Our product candidates and any products that we may develop may compete with other product candidates and products for access to manufacturing facilities.
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We likely will have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively.
−Removed: If we do not establish sales, marketing
−Removed: and distribution capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates.
+Added: If we do not establish sales, marketing and distribution capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates.
We may encounter difficulties in managing our growth and expanding our operations successfully.
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Our future financial performance and our ability to commercialize our product candidates and to compete effectively will depend, in part, on our ability to manage any future growth effectively.
−Removed: To that end, we must be able to manage our development efforts and clinical trials effectively and hire, train and integrate additional management, administrative and, if necessary, sales and marketing personnel.
+Added: To that end, we must be able to manage our development efforts and clinical trials effectively and hire, train and integrate
+Added: additional management, administrative and, if necessary, sales and marketing personnel.
We may not be able to accomplish these tasks, and our failure to accomplish any of them could prevent us from successfully growing our business.
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Furthermore, prospective partners will likely negotiate for certain rights to control decisions regarding the development and commercialization of our product candidates, if approved, and may not conduct those activities in the same manner as we would.
−Removed: If we fail to establish and maintain strategic partnerships related to our product candidates, we will bear all of the risk and costs related to the development of any such product candidate, and we may need to seek additional financing, hire additional employees and otherwise develop expertise which we do not have and for which we have not budgeted.
−Removed: This could negatively affect the development of any unpartnered product candidate.
+Added: If we fail to establish and maintain strategic partnerships related to our product candidates, including pemvidutide, we will bear all of the risk and costs related to the development of any such product candidate, and we may need to seek additional financing, hire additional employees and otherwise develop expertise which we do not have and for which we have not budgeted.
+Added: This could negatively affect the development of any unpartnered product candidate and materially affect our business and financial condition.
We may acquire other businesses, form joint ventures or make investments in other companies or technologies that could negatively affect our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.
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Any future acquisitions also could result in the incurrence of debt, contingent liabilities or future write-offs of intangible assets or goodwill, any of which could have a negative impact on our cash flows, financial condition and results of operations.
−Removed: Integration of an acquired company also may disrupt ongoing operations and require management resources that we would
−Removed: otherwise focus on developing our existing business.
+Added: Integration of an acquired company also may disrupt ongoing operations and require management resources that we would otherwise focus on developing our existing business.
We may experience losses related to investments in other companies, which could harm our financial condition and results of operations.
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A breakdown in our information technology systems could result in a significant disruption to our business.
−Removed: Our operations and those of our business partners, such as CROs and others that manage sensitive data, are highly dependent on information technology systems, including Internet-based systems, which may be vulnerable to breakdown, wrongful intrusions, data breaches and malicious attack.
+Added: Our operations and those of our business partners, such as CROs, vendors and others that manage sensitive data, are highly dependent on information technology systems, including Internet-based systems, which may be vulnerable to damage or interruption from, among other things, computer viruses, computer hackers, phishing attacks, ransomware, malware, social engineering, malicious code, employee theft, fraud, misconduct or misuse, denial-of-service attacks, sophisticated nation-state and nation-state-supported actors, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures, breakdown, wrongful intrusions, data breaches and malicious attack.
Information security risks have generally increased in recent years.
Our systems, and those of our third-party providers, are potentially vulnerable to data security breaches or cyberattack, whether by employees or others, which may expose sensitive data to unauthorized persons.
−Removed: A data security breach could lead to the loss of trade secrets or other intellectual property, the value of which may be contingent upon maintaining our confidentiality, or could lead to the public exposure of personal information (including sensitive personal medical information) of clinical trial participants, our employees and others, or adversely impact the conduct of scientific research and clinical trials, including the submission of research results to support marketing authorizations.
+Added: A data security breach or compromise could lead to the loss of trade secrets or other intellectual property, the value of which may be contingent upon maintaining our confidentiality, or could lead to
+Added: the public exposure of personal information (including sensitive personal medical information) of clinical trial participants, our employees and others, or adversely impact the conduct of scientific research and clinical trials, including the submission of research results to support marketing authorizations.
This could require us to expend significant efforts and resources or incur significant expense to eliminate these problems and address related security concerns.
In addition, procedures and safeguards must continually evolve to meet new data security challenges, and enhancing protections, and conducting investigations and remediation, may impose additional costs on the Company.
−Removed: If we were to suffer a breakdown in our systems, storage, distribution or tracing, we could experience significant disruptions affecting our business, reputational harm or claims against us by private parties and/or governmental agencies.
−Removed: In addition, the European Parliament and the Council of the European Union have adopted a new pan-European General Data Protection Regulation (“GDPR”), effective May 25, 2018, which increases privacy rights for individuals in Europe, extends the scope of responsibilities for data controllers and data processors and imposes increased requirements and potential penalties on companies, offering goods or services to individuals who are located in Europe or monitoring the behavior of such individuals (including by companies based outside of Europe).
−Removed: Noncompliance can result in penalties of up to the greater of EUR 20 million, or 4% of global company revenues.
−Removed: While we expect to have substantially compliant programs and controls in place to comply with the GDPR requirements, our compliance with the new regulation is likely to impose additional costs on us and we cannot predict whether the interpretations of the requirements, or changes in our practices in response to new requirements or interpretations of the requirements could have a material adverse effect on our business.
+Added: If we or our third-party providers were to experience a cybersecurity compromise or breach or other security incident, suffer a breakdown in our systems, storage, distribution or tracing, we could experience significant disruptions affecting our business, supply chain interruptions, processing inefficiencies, data loss or the loss of or damage to intellectual property or other proprietary, personal or confidential information, and reputational harm which could negatively impact our relationship with our customers, partners, vendors and other third parties, and fines and penalties resulting from claims against us by private parties and/or governmental agencies.
Risks Related to Reimbursement and Government Regulation
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Coverage and reimbursement can vary significantly from payer to payer.
−Removed: As a result, obtaining coverage and reimbursement approval for any approved product from each government and other third-party payer may require us to provide supporting scientific, clinical and cost-effectiveness data for the use of such products to each payer separately, with no assurance that we will be able to provide data sufficient to gain acceptance
−Removed: with respect to coverage and reimbursement.
+Added: As a result, obtaining coverage and reimbursement approval for any approved product from each government and other third-party payer may require us to provide supporting scientific, clinical and cost-effectiveness data for the use of such products to each payer separately, with no assurance that we will be able to provide data sufficient to gain acceptance with respect to coverage and reimbursement.
We cannot be sure that coverage or adequate reimbursement will be available for any of our product candidates, and we cannot be sure that coverage determinations or reimbursement amounts will not reduce the demand for, or the price of, our products.
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In some countries, particularly member states of the European Union, the pricing of prescription pharmaceuticals is subject to governmental control.
−Removed: In these countries, pricing negotiations with governmental authorities can take considerable time after receipt of marketing approval for a product.
+Added: In these countries, pricing negotiations with governmental authorities can take considerable time after receipt of marketing approval for a
In addition, there can be considerable pressure by governments and other stakeholders on coverage, prices and reimbursement levels, including as part of cost containment measures.
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We are subject to multiple and substantial federal and state health care and other laws, and the complexity of our regulatory compliance obligations is likely to increase in the event our product candidates are commercialized.
−Removed: Our business operations and activities may be directly or indirectly subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute and the federal FCA, and their implementing regulations, such as recent rules finalized by OIG which added safe harbor protections under the Anti-Kickback Statute for certain coordinated care and value-based arrangements among clinicians, providers, and others and that (with exceptions) became effective January 19, 2021.
+Added: Our business operations and activities may be directly or indirectly subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute and the federal FCA, and their implementing regulations.
If we obtain FDA approval for any of our product candidates and begin commercializing those products in the United States, our potential exposure under such laws will increase significantly, and our costs associated with compliance with such laws are also likely to increase.
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● the FCPA, which regulates certain financial relationships with foreign government officials (which could include, for example, certain medical professionals), and anti-bribery laws and related laws, and laws pertaining to the accuracy of our internal books and records, which have been the focus of increasing enforcement activity in recent years;
−Removed: ● state law equivalents of each of the above federal laws, such as anti-kickback, false claims, consumer protection and unfair competition laws, which may apply to our business practices, including but not limited to, research, distribution, sales-and-marketing arrangements as well as submitting claims involving health care items or services reimbursed by any third-party payer, including commercial insurers;
+Added: ● state law equivalents of each of the above federal laws, such as anti-kickback, false claims, consumer protection and unfair competition laws, which may apply to our business practices, including but not limited
+Added: to, research, distribution, sales-and-marketing arrangements as well as submitting claims involving health care items or services reimbursed by any third-party payer, including commercial insurers;
state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government that otherwise restricts payments that may be made to health care providers;
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We operate in a highly regulated industry and new laws, regulations, or judicial decisions, or new interpretations of existing laws, regulations, or decisions, related to, among other things, health care availability, or the method of delivery of or payment for health care products and services could negatively impact our business, operations and financial condition.
−Removed: For example, in the United States there is significant interest in promoting health care reform, as evidenced by the enactment in the United States of the Health Care Reform Law.
+Added: For example, in the United States there is significant interest in promoting health care reform, as evidenced by the enactment in the United States of the Affordable Care Act of 2010 (the “Health Care Reform Law”).
The Health Care Reform Law substantially changed the way health care is financed by both governmental and commercial payers and significantly impacts the pharmaceutical industry.
1 unchanged sentence
The Health Care Reform Law established and provided significant funding for a new Patient-Centered Outcomes Research Institute to coordinate and fund comparative effectiveness research.
−Removed: While the stated intent of comparative effectiveness research is to develop information to guide providers to the most efficacious therapies, outcomes of comparative effectiveness research could influence the reimbursement or coverage for therapies that are determined to be less cost effective than others.
+Added: While the stated intent of comparative
+Added: effectiveness research is to develop information to guide providers to the most efficacious therapies, outcomes of comparative effectiveness research could influence the reimbursement or coverage for therapies that are determined to be less cost effective than others.
Should any of our products be approved for sale, but then determined to be less cost effective than alternative therapies, the levels of reimbursement for these products, or the willingness to reimburse at all, could be impacted, which could materially impact our financial results.
Certain provisions of the Health Care Reform Law have been subject to judicial challenges, as well as efforts to repeal, replace or otherwise modify them or to alter their interpretation or implementation.
−Removed: For example, the Tax Cuts and Jobs Act enacted on December 22, 2017, eliminated the tax-based payment for individuals who fail to maintain minimum essential coverage under section 5000A of the Internal Revenue Code of 1986, as amended, commonly referred to as the “individual mandate,” effective January 1, 2019.
−Removed: Further, the Bipartisan Budget Act of 2018 among other things, amended the Medicare statute, effective January 1, 2019, to reduce the coverage gap in most Medicare prescription drug plans, commonly known as the “donut hole,” by raising the manufacturer discount under the Medicare Part D coverage gap discount program to 70%.
+Added: For example, the Tax Cuts and Jobs Act of 2017, eliminated the tax-based payment for individuals who fail to maintain minimum essential coverage under section 5000A of the Internal Revenue Code of 1986, as amended, commonly referred to as the “individual mandate,” effective January 1, 2019.
+Added: Further, the Bipartisan Budget Act of 2018 among other things, amended the Medicare statute, effective January 1, 2019, to reduce the coverage gap in most Medicare prescription drug plans, commonly known as the “donut hole,” by raising the manufacturer discount under the Medicare Part D coverage gap discount program from 50% to 70%.
Additional legislative changes, regulatory changes and judicial challenges related to the Health Care Reform Law remain possible.
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We cannot predict what affect further changes to the Health Care Reform Law would have on our business, especially including under the Biden administration.
−Removed: Another provision of the Health Care Reform Law, generally referred to as the Physician Payment Sunshine Act or Open Payments Program, requires manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information related to direct or indirect payments and other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors) and teaching hospitals, as well as ownership and investment interests held in the company by physicians and their immediate family members.
−Removed: Effective January 1, 2022, these reporting obligations have been extended to include transfers of value made (starting in 2021) to certain non-physician providers such as physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives.
−Removed: CMS publishes information from these reports on a publicly available website.
−Removed: Our compliance with these rules may also impose additional costs and may impact our relationships with physicians, teaching hospitals, and other non-physician health care providers.
In addition, other legislative changes have been proposed and adopted since the Health Care Reform Law was enacted.
−Removed: For example, the Budget Control Act of 2011, as amended by the American Taxpayer Relief Act of 2012, among
−Removed: other things led to aggregate reductions in Medicare payments for all items and services, including prescription drugs and biologics, to service providers of, on average, 2% per fiscal year beginning April 1, 2013, and, due to subsequent legislation, will continue until 2030 (with the exception of a temporary suspension from May 1, 2020, through March 31, 2021) unless Congress takes additional action.
+Added: For example, the Budget Control Act of 2011, as amended by the American Taxpayer Relief Act of 2012, among other things, created measures for spending reductions by Congress that include aggregate reductions of Medicare payments to providers of on average 2% per fiscal year, which remain in effect through 2032.
+Added: Due to the Statutory Pay-As-You-Go Act of 2010, estimated budget deficit increases resulting from the American Rescue Plan Act of 2021, and subsequent legislation, Medicare payments to providers will be further reduced starting in 2025 absent further legislation.
+Added: American Taxpayer Relief Act of 2012 further reduced Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.
+Added: These laws and regulations may result in additional reductions in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our drug candidates for which we may obtain regulatory approval or the frequency with which any such drug candidate is prescribed or used.
Additional legislative changes, regulatory changes or guidance could be adopted, which may impact the marketing approvals and reimbursement for our product candidates.
For example, on July 9, 2021, President Biden issued an executive order directing the FDA to, among other things, continue to clarify and improve the approval framework for biosimilars, including the standards for interchangeability of biological products, facilitate the development and approval of biosimilar and interchangeable products, clarify existing requirements and procedures related to the review and submission of BLAs, and identify and address any efforts to impede biosimilar competition.
+Added: Additionally, there has been increasing legislative and enforcement interest in the United States with respect to drug pricing practices.
+Added: Specifically, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several U.S.
+Added: Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, and review the relationship between pricing and manufacturer patient programs.
+Added: The Inflation Reduction Act of 2022 (IRA), for example, includes several provisions that may impact our business to varying degrees, including provisions that reduce the out-of-pocket spending cap for Medicare Part D beneficiaries from $7,050 to $2,000 starting in 2025, thereby eliminating the so-called coverage gap;
+Added: impose new manufacturer financial liability on certain drugs under Medicare Part D;
+Added: allow the U.S.
+Added: government to negotiate Medicare Part B and Part D price caps for certain high-cost drugs and biologics without generic or biosimilar competition;
+Added: require companies to pay rebates to Medicare for certain drug prices that increase faster than inflation;
+Added: and delay until January 2032 the implementation of the HHS rebate rule that would have limited the fees that pharmacy benefit managers can charge.
+Added: Further, under the IRA, orphan drugs are exempted from the Medicare drug price negotiation program, but only if they have one orphan designation and for which the only approved indication is for that disease or condition.
+Added: If a product receives multiple orphan designations or has multiple approved indications, it may not qualify for the orphan drug exemption.
+Added: The implementation of the IRA is currently subject to ongoing litigation challenging the constitutionality of
+Added: the IRA’s Medicare drug price negotiation program.
+Added: The effects of the IRA on our business and the healthcare industry in general is not yet known.
Further, there has been increasing legislative, regulatory and enforcement interest in the United States with respect to drug pricing practices.
There have been several Congressional inquiries and proposed and enacted federal and state legislation and regulatory initiatives designed to, among other things, bring more transparency to product pricing, evaluate the relationship between pricing and manufacturer patient programs, and reform government healthcare program reimbursement methodologies for drug products.
−Removed: For example, on November 20, 2020, CMS issued an interim final rule to implement a “Most Favored Nation” demonstration project to test Medicare Part B reimbursement of certain separately payable drugs and biologicals based on international reference prices.
−Removed: The rule has become subject to judicial challenges, and federal courts have enjoined the rule at this time.
−Removed: If the rule survives judicial scrutiny, the Most Favored Nation model will subject certain drugs or biologicals identified by CMS as having the highest annual Medicare Part B spending to an alternative payment methodology based on international reference prices, with the list of products to be updated annually to add more products and products not to be removed absent limited circumstances.
−Removed: There has also been legislation that would establish an international reference price-based Medicare Part B drug and biological payment methodology.
It is possible that the Health Care Reform Law, as currently enacted or may be amended or otherwise modified in the future, as well as other health care reform measures that may be adopted in the future, may result in additional reductions in Medicare payment and other health care financing, more rigorous coverage criteria, and new payment methodologies and in additional downward pressure on coverage and payment and the price that we receive for any approved product.
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Violations of laws such as the Anti-Kickback Statute and FCA, the FD&C Act, or any regulations promulgated under their authority, may result in jail sentences, fines or exclusion from federal and state programs, as may be determined by Medicare, Medicaid, the Department of Defense, other regulatory authorities and the courts.
−Removed: There can be no assurance that our activities will not come under the scrutiny of regulators and other government authorities or that our practices will not be found to violate applicable laws, rules and
−Removed: regulations or prompt lawsuits by private citizen “relators” under federal or state false claims laws.
+Added: There can be no assurance that our activities will not come under the scrutiny of regulators and other government authorities or that our practices will not be found to violate applicable laws, rules and regulations or prompt lawsuits by private citizen “relators” under federal or state false claims laws.
In the United States, among the laws that may affect our ability to operate and market our products include, but are not limited to:
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Practices that involve remuneration to those who prescribe, purchase, or recommend pharmaceutical products, including certain discounts, or engaging such individuals as consultants, advisors and speakers, may be subject to scrutiny if they do not fit squarely within an exception or safe harbor.
−Removed: Moreover, there are no safe harbors for many common practices, such as educational and research grants, charitable donations, product support and patient assistance programs.
+Added: Moreover, there are
+Added: no safe harbors for many common practices, such as educational and research grants, charitable donations, product support and patient assistance programs.
Violations of the Anti-Kickback Statute may be punished by civil and criminal penalties, damages, fines, or exclusion from participation in federal health care programs like Medicare and Medicaid.
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● The FD&C Act and comparable foreign laws, in addition to prohibiting the promotion of the safety or effectiveness of product candidates not yet approved for commercialization, an act known as pre-approval promotion, also generally restrict companies from promoting approved products for indications other than those indications for which a product is approved, which is also referred to as off-label use.
−Removed: This means, for example, that we may not make claims about the use of our products, should they be approved for sale, outside of their approved indications, and we may not proactively discuss or provide information regarding any of their off-label uses subject to very specific and limited exceptions.
+Added: This means, for example, that we may not make claims about the use of our products, should they be approved for sale,
+Added: outside of their approved indications, and we may not proactively discuss or provide information regarding any of their off-label uses subject to very specific and limited exceptions.
If we or our business partners fail to comply with applicable laws and regulations governing off-label uses of our product candidates, if approved, then we could be subject to administrative or judicially imposed sanctions, including, but not limited to:
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We must comply with data privacy and security laws and regulations, and failure to comply with these laws and regulations could expose us to significant liabilities.
−Removed: We must operate in compliance with various data privacy and security regulations in the United States by both the federal government and the states in which we conduct our business, as well as in other jurisdictions outside of the United States, such as the United Kingdom, the EU and Asia, where we conduct clinical trials.
−Removed: In the U.S., we may be subject to data privacy and security laws and regulations by both the federal government and the states in which we conduct our business, including, for example, state data breach notification laws, state health information and/or genetic privacy laws and federal and state consumer protection laws (e.g., Section 5 of the FTC Act and the CCPA), govern the collection, use, disclosure, and protection of health-related and other personal information.
−Removed: Many of these laws differ from each other in significant ways and may not have the same effect, thus complicating
−Removed: compliance efforts.
−Removed: Compliance with these laws is difficult, constantly evolving, and time consuming.
+Added: We must operate in compliance with various data privacy and security regulations in the United States by both the federal government and the states in which we conduct our business, as well as in other jurisdictions outside of the United States, such as the U.K., the European Economic Area (“EEA”) and Asia, where we conduct clinical trials.
+Added: Our operations entail the collection, use, disclosure, transfer, and processing of sensitive and personal information.
+Added: Further, our operations extend to commercial partnerships and third-party processors, each of which may be governed by their distinct privacy regulations and cybersecurity laws.
+Added: These laws are continually evolving and subject to varying interpretations, which requires us to periodically update policies and procedures to maintain compliance.
+Added: In the U.S., we may be subject to data privacy and security laws and regulations by both the federal government and the states in which we conduct our business, including, for example, state data breach notification laws, state health information and/or genetic privacy laws and federal and state consumer protection laws (e.g., Section 5 of the FTC Act and the California Consumer Privacy Act (“CCPA”)), which, govern the collection, use, disclosure, and protection of health-related and other personal information.
+Added: Many of these laws and regulations differ from each other in significant ways and the impact of such laws may vary, thus potentially complicating compliance efforts.
+Added: Compliance with these laws is difficult, constantly evolving, and time consuming, thus we may be required to incur substantial costs and expenses in order to comply with them.
Federal regulators, state attorneys general, and plaintiffs’ attorneys, including class action attorneys, have been and will likely continue to be active in this space.
3 unchanged sentences
Although we are not directly subject to HIPAA other than with respect to providing certain employee benefits, we could potentially be subject to criminal penalties if we, our affiliates, or our agents knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA.
−Removed: The CCPA became effective on January 1, 2020 and establishes certain requirements for data use and sharing transparency, and provides California residents certain rights concerning the use, disclosure, and retention of their personal data.
+Added: The CCPA, for example, establishes data privacy rights for individuals located in California and imposes certain requirements for how businesses can collect and use personal data about them.
+Added: The California Privacy Rights Act, or CPRA, significantly modified the CCPA and imposes additional obligations on covered businesses, including by expanding consumers’ rights with respect to their personal data and establishes a state agency vested with the authority to enforce the CCPA.
The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation.
−Removed: The CCPA and its implementing regulations have already been amended multiple times since their enactment.
−Removed: The CCPA could mark the beginning of a trend toward more stringent state privacy legislation in the U.S., which could increase our potential liability and adversely affect our business.
+Added: Other states, such as Virginia, Colorado, Utah Connecticut, Texas, Oregon, Tennessee, Delaware and Iowa have recently passed or enacted similar, comprehensive privacy and data protection legislation.
+Added: Many state privacy and data protection laws differ from each other in significant ways, and it is not yet fully clear how such laws will be enforced and interpreted.
The obligations to comply with the CCPA and other evolving legislation may require us, among other things, to update our notices and develop new processes internally and with our partners.
−Removed: In addition, the European Parliament and the Council of the European Union have adopted a new pan-European General Data Protection Regulation (“GDPR”), effective May 25, 2018, which increases privacy rights for individuals in Europe, extends the scope of responsibilities for data controllers and data processors and imposes increased requirements and potential penalties on companies, offering goods or services to individuals who are located in the EU or monitoring the behavior of such individuals (including by companies based outside of the EU).
−Removed: The GDPR governs the collection, use, storage, disclosure, transfer, or other processing of personal data regarding individuals in the EU, including personal health data.
−Removed: It is wide-ranging in scope and imposes numerous requirements on companies that process personal data, including requirements relating to processing health and other sensitive data, providing information to individuals regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, providing notification of data breaches, and taking certain measures when engaging third-party processors.
+Added: In Europe, the collection and use of personal information, including health data, is governed by the EU’s General Data Protection Regulation and the United Kingdom’s implementation of the same (collectively, the “GDPR”).
+Added: The GDPR is wide-ranging in scope and imposes numerous requirements on covered companies, including requirements related to individual notice regarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, providing notification of data breaches, and taking certain measures when engaging third-party processors.
The GDPR also imposes strict rules on the transfer of personal data to countries outside the EU, including the United States, and permits data protection authorities to impose large penalties for violations of the GDPR.
1 unchanged sentence
The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR.
−Removed: In addition, the GDPR includes restrictions on cross-border data transfers.
−Removed: While we expect to have substantially compliant programs and controls in place to comply with the GDPR requirements, our compliance with the new regulation is likely to impose additional costs on us and we cannot predict whether the interpretations of the requirements, or changes in our practices in response to new requirements or interpretations of the requirements could have a material adverse effect on our business.
+Added: While we expect to have substantially compliant programs and controls in place to comply with the GDPR requirements , our compliance with the regulation is likely to impose additional costs on us and we cannot predict whether the interpretations of the requirements, or changes in our practices in response to new requirements or interpretations of the requirements could have a material adverse effect on our business.
There is a risk that we may be subject to fines and penalties, litigation, and reputational harm in connection with our European activities.
−Removed: Further, the United Kingdom’s decision to leave the EU, often referred to as Brexit, has created uncertainty with regard to data protection regulation in the United Kingdom.
−Removed: On June 28, 2021, the EU Commission adopted decisions on the U.K.’s adequacy under the EU’s GDPR.
−Removed: This means that most personal data can continue to flow from the EU and the EEA to the U.K.
−Removed: without the need for additional safeguards.
−Removed: However, restricted transfers from the U.K.
−Removed: to other countries, including to the EEA, are subject to transfer rules under the U.K.
−Removed: On February 2, 2022, the U.K.
−Removed: announced the implementation of a new series of U.K.
−Removed: Standard Contractual Clauses, which must be adopted by U.K.
−Removed: companies no later than March 21, 2024.
−Removed: transfer rules broadly mirror the EU GDPR rules, but the U.K.
−Removed: has the independence to keep the framework under review, lending uncertainty to future data transfers in to and out of the U.K.
−Removed: We must also ensure that we maintain adequate safeguards to enable the transfer of personal data outside of the EEA, in particular to the United States in compliance with European data protection laws.
−Removed: We expect that we will continue to face uncertainty as to whether our efforts to comply with our obligations under European privacy laws will be sufficient.
−Removed: If we are investigated by a European data protection authority, we may face fines and other penalties.
−Removed: Any such investigation or charges by European data protection authorities could have a negative effect on our existing business and
−Removed: on our ability to attract and retain new clients or pharmaceutical collaboration partners.
−Removed: We may also experience hesitancy, reluctance, or refusal by European or multi-national clients or pharmaceutical partners to continue to use our products due to the potential risk exposure as a result of the current (and, in particular, future) data protection obligations imposed on them by certain data protection authorities in interpretation of current law, including the GDPR.
−Removed: Such clients or pharmaceutical collaboration partners may also view any alternative approaches to compliance as being too costly, too burdensome, too legally uncertain, or otherwise objectionable and therefore decide not to do business with us.
−Removed: Any of the foregoing could materially harm our business, prospects, financial condition and results of operations.
+Added: Any investigation or charges by European data protection authorities could have a negative effect on our existing business and on our ability to attract and retain new clients or pharmaceutical collaboration partners.
+Added: We may also experience hesitancy, reluctance, or refusal by European or multi-national clients or pharmaceutical partners to do business with us due to the potential risk of exposure as a result of the current and future data protection obligations imposed on them by certain data protection authorities in interpretation of European privacy and data protection laws, including the GDPR.
+Added: Such clients or partners may view any alternative approaches to compliance as being too costly, too burdensome, too legally uncertain, or otherwise objectionable and therefore decide not to continue their relationship with us.
+Added: Any of the foregoing could materially harm our business, prospects, financial condition and results of operations and prospects, and we may be required to incur substantial costs and expenses in an effort to comply with our legal and regulatory obligations.
+Added: While data generally flows freely between the U.K.
+Added: and the EEA and vice versa as a result of adequacy decisions and regulations, to enable the transfer of personal data outside of the EEA or the UK, adequate safeguards must be implemented in compliance with the GDPR.
+Added: On June 4, 2021, the European Commission issued new forms of standard contractual clauses (“SCCs”) for data transfers from controllers or processors in the EEA (or otherwise subject to the GDPR) to controllers or processors established outside the EEA (and not subject to the GDPR).
+Added: As of December 27, 2022 the new SCCs replace the SCCs that were adopted previously under the EU Data Protection Directive.
+Added: The UK is not subject to the European Commission’s new SCCs, and instead it has published the UK International Data Transfer Agreement (“IDTA”) and the International Data Transfer Addendum to the new SCCs (“Addendum”), which enable transfers from the UK.
+Added: For new transfers, the IDTA (or SCCs and Addendum) must be in place, and such measures must be in place for all existing transfers from the UK from March 21, 2024.
+Added: Companies relying on SCCs or the IDTA to govern transfers of personal data to third countries will also need to assess whether the data importer can ensure sufficient guarantees for safeguarding the personal data under GDPR, including an analysis of the laws in the recipient’s country.
+Added: When conducting restricted data transfers, including to the U.S., under the EU GDPR and UK GDPR (i.e., the UK’s post-Brexit transposition of the GDPR), we must ensure these safeguards are in place.
We are subject to extensive government regulatory compliance and ethics oversight, and we will need to develop more extensive compliance and ethics policies in the future.
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We cannot eliminate the risk of accidental injury or contamination from the use, manufacture, distribution, storage, handling, treatment or disposal of hazardous materials.
−Removed: In the event of contamination or injury, or failure to comply with environmental, occupational health and safety and export control laws and regulations, we could be held liable for any resulting damages and any such liability could exceed our assets and resources.
+Added: In the event of contamination
+Added: or injury, or failure to comply with environmental, occupational health and safety and export control laws and regulations, we could be held liable for any resulting damages and any such liability could exceed our assets and resources.
In addition, we may be required to pay damages or civil judgments related to third-party claims, for which we are uninsured, including those relating to personal injury (including exposure to hazardous chemicals and biological materials), product quality issues, property damage or contribution to remedial obligations.
33 unchanged sentences
In addition, in the event of stock dividends, stock splits, reorganizations or similar events affecting our common stock, we may be required to proportionally adjust the conversion price, exercise price or number of shares issuable upon exercise of our outstanding warrants.
−Removed: If we do not meet the continued listing standards of The NASDAQ Global Market our common stock could be delisted from trading, which could limit investors’ ability to make transactions in our common stock and subject us to additional trading restrictions.
−Removed: Our common stock is listed on Nasdaq Global Market, a national securities exchange, which imposes continued listing requirements with respect to listed shares.
+Added: If we do not meet the continued listing standards of NASDAQ our common stock could be delisted from trading, which could limit investors’ ability to make transactions in our common stock and subject us to additional trading restrictions.
+Added: Our common stock is listed on NASDAQ, a national securities exchange, which imposes continued listing requirements with respect to listed shares.
If we fail to satisfy the continued listing standards, including with respect to the maintenance of a minimum share price, or if NASDAQ in its discretion, determines that a condition exists that makes further dealings of our Company on the exchange unwarranted, NASDAQ may issue a non-compliance letter or initiate delisting proceedings.
13 unchanged sentences
Whether we pay any dividends in the future will depend on our financial condition, results of operations, and other factors that we will consider.
−Removed: Unresolved Staff Comments
−Removed: Our principal executive offices are located in Gaithersburg, Maryland, where we occupy approximately 19,699 square feet of laboratory and office space.
−Removed: For additional information, see Note 6 to our consolidated financial statements.
−Removed: Management believes that these facilities are suitable and adequate to meet our anticipated needs.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.