As noted throughout this Annual Report, we are subject to a number of risks and uncertainties.
−Removed: You should consider and read carefully all of the risks and uncertainties described below, as well as other information included in this Annual Report, including our financial statements and related notes appearing at the end of this Annual Report and our “Management’s Discussion and Analysis of Financial Conditions and Results of Operations.” The risks described below are not the only ones facing us.
+Added: You should consider and read carefully all the risks and uncertainties described below, as well as other information included in this Annual Report, including our financial statements and related notes appearing at the end of this Annual Report and our “Management’s Discussion and Analysis of Financial Conditions and Results of Operations.” The risks and uncertainties described below are not the only ones facing us.
The occurrence of any of the following risks or additional risks and uncertainties not presently known to us or that we currently believe to be immaterial could materially and adversely affect our business, financial condition or results of operations.
In such case, the trading price of our common stock could decline, and you may lose all or part of your investment.
−Removed: This Annual Report also contains forward-looking statements and estimates that involve risks and uncertainties.
+Added: This Annual Report also contains forward-looking statements and estimates.
Our actual results could differ materially from those anticipated in the forward-looking statements as a result of specific factors, including the risks and uncertainties described below.
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Furthermore, we do not expect to generate any revenue from product sales for the foreseeable future, and we expect to continue to incur significant operating losses for the foreseeable future due to the cost of research and development, preclinical studies and clinical trials and the regulatory approval process for our potential future product candidates.
−Removed: We expect our net losses to increase substantially as we identify product candidates and enter into IND-enabling and other preclinical studies and clinical development related to our IMM-BCP-01 program or our IMM-ONC-01 program.
+Added: We expect our net losses to increase substantially as we continue our operations;
however, the amount of our future losses is uncertain.
−Removed: Our ability to achieve or sustain profitability, if ever, will depend on, among other things, successfully developing product candidates, obtaining regulatory approvals to market and commercialize product candidates, manufacturing any approved products on commercially reasonable terms, entering into potential future strategic partnerships, establishing a sales and marketing organization or suitable third-party
−Removed: alternatives for any approved product and raising sufficient funds to finance business activities.
−Removed: The success of our future product candidates will depend on several factors, including:
−Removed: ● timely and successful completion of preclinical studies, including toxicology studies, biodistribution studies and minimally efficacious dose studies in animals, where applicable, and clinical trials;
−Removed: ● effective investigational new drug applications, or INDs, from the U.S.
−Removed: Food and Drug Administration, or the FDA, or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials for our product candidates;
−Removed: ● sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials;
−Removed: ● successful enrollment and completion of clinical trials, including under the FDA’s current Good Clinical Practices, or GCPs, and current Good Laboratory Practices;
−Removed: ● successful development of, or making arrangements with third-party manufacturers for, our commercial manufacturing processes for any of our product candidates that receive regulatory approval;
−Removed: ● receipt of timely marketing approvals from applicable regulatory authorities;
−Removed: ● launching commercial sales of products, if approved, whether alone or in collaboration with others;
−Removed: ● acceptance of the benefits and use of our products, including method of administration, if approved, by patients, the medical community and third-party payors, for their approved indications;
−Removed: ● the prevalence and severity of adverse events experienced with product candidates arising out of our IMM-ONC-01 and IMM-BCP-01 programs or any other future product candidates;
−Removed: ● the availability, perceived advantages, cost, safety and efficacy of alternative therapies for any product candidate, and any indications for such product candidate, that we develop;
−Removed: ● our ability to produce our future product candidates we develop on a commercial scale;
−Removed: ● obtaining and maintaining patent, trademark and trade secret protection and regulatory exclusivity for our product candidates and otherwise protecting our rights in our intellectual property portfolio;
−Removed: ● maintaining compliance with regulatory requirements, including current Good Manufacturing Practices, or cGMPs, and complying effectively with other procedures;
−Removed: ● obtaining and maintaining third-party coverage and adequate reimbursement and patients’ willingness to pay out-of-pocket in the absence of such coverage and adequate reimbursement;
−Removed: ● maintaining a continued acceptable safety, tolerability and efficacy profile of the products following approval.
+Added: Our ability to achieve or sustain profitability, if ever, will depend on, among other things, successfully identifying and developing product candidates, obtaining regulatory approvals to market and commercialize product candidates, manufacturing any approved products on commercially reasonable terms, performance as anticipated by our vendors, entering into potential future strategic partnerships, establishing a sales and marketing organization or suitable third-party alternatives for any approved product and raising sufficient funds to finance business activities.
If we, or our potential future partners, are unable to commercialize one or more of our product candidates, or if sales revenue from any product candidate that receives approval is insufficient, we will not achieve or sustain profitability, which could have a material and adverse effect on our business, financial condition, results of operations and prospects.
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The development of biopharmaceutical product candidates is capital-intensive.
−Removed: If our potential future product candidates enter and advance through preclinical studies and clinical trials, we will need substantial additional funds to expand our development, regulatory, manufacturing, marketing and sales capabilities.
+Added: If our potential future product candidates continue to advance through preclinical studies and enter into and advance through clinical trials, we will need substantial additional funds to expand our development, regulatory, manufacturing, marketing and sales capabilities.
We have used substantial funds to develop our discovery engine and will require significant funds to continue to develop our discovery platform and conduct further research and development, including preclinical studies and clinical trials of our potential future product candidates, to seek regulatory approvals for our potential future product candidates and to manufacture and market products, if any, that are approved for commercial sale.
1 unchanged sentence
As of December 31, 2021, we had $49.2 million in cash.
−Removed: Based on our current operating plan, we believe that our cash as of December 31, 2020 will be sufficient to fund our operations through the second fiscal quarter of 2022.
+Added: Based on our current operating plan, we believe that our cash as of December 31, 2021 will be sufficient to fund our operations for at least 12 months from the filing date of this Annual Report on Form 10-K.
Our future capital requirements and the period for which we expect our existing resources to support our operations may vary significantly from what we expect.
1 unchanged sentence
Because the length of time and activities associated with successful research and development of product candidates is highly uncertain, we are unable to estimate the actual funds we will require for development and any approved marketing and commercialization activities.
−Removed: The timing and amount of our operating expenditures will depend largely on:
−Removed: ● the timing and progress of preclinical and clinical development activities;
−Removed: ● the timing and progress of our development of our discovery engine;
−Removed: ● the price and pricing structure that we are able to obtain from our third-party contract manufacturers to manufacture our preclinical study and clinical trial materials and supplies;
−Removed: ● the number and scope of preclinical and clinical programs we decide to pursue;
−Removed: ● our ability to maintain our current licenses and research and development programs and to establish new collaborations;
−Removed: ● the progress of the development efforts of parties with whom we may in the future enter into collaboration and research and development agreements;
−Removed: ● the costs involved in obtaining, maintaining, enforcing and defending patents and other intellectual property rights;
−Removed: ● the cost and timing of regulatory approvals;
−Removed: ● our efforts to enhance operational systems, secure sufficient laboratory space and hire additional personnel, including personnel with infectious disease expertise and to support development of our product candidates and satisfy our obligations as a public company.
+Added: The timing and amount of our operating expenditures will depend largely on factors such as the following:
+Added: ● the scope, number, timing and progress of preclinical and clinical development activities;
+Added: ● the price and pricing structure that we are able to obtain from our third-party contract manufacturers to manufacture our preclinical study and clinical trial materials and supplies and other vendors relevant to advancement of our programs;
+Added: ● the costs involved in obtaining, maintaining, enforcing and defending patents and other intellectual property rights and the resources needed to pursue regulatory approvals;
+Added: ● our efforts to enhance operational systems, secure sufficient laboratory space and hire additional personnel, including personnel to support development of our product candidates and satisfy our obligations as a public company.
To date, we have primarily financed our operations through the sale of equity securities and through our other transaction authority contract with the DoD.
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We cannot assure you that we will be successful in acquiring additional funding at levels sufficient to fund our operations or on terms favorable to us or that the DoD will not exercise its termination right under the contract.
−Removed: If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of or suspend one or more of our preclinical studies, clinical trials, research and
−Removed: development programs or commercialization efforts.
−Removed: Because of the numerous risks and uncertainties associated with the development and commercialization of our potential future product candidates and the extent to which we may enter into collaborations with third parties to participate in their development and commercialization, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated preclinical studies and clinical trials.
+Added: If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of or suspend one or more of our preclinical studies, clinical trials, research and development programs or commercialization efforts.
+Added: Because of the numerous risks and uncertainties associated with the development and commercialization of our potential future product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated preclinical studies and clinical trials.
To the extent that we raise additional capital through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our potential future product candidates, future revenue streams or research programs or to grant licenses on terms that may not be favorable to us.
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We do not expect to realize revenue from product sales, milestone payments or royalties from licensed products in the foreseeable future, if at all, and unless and until our potential future product candidates are clinically tested, approved for commercialization and successfully marketed.
−Removed: The potential product candidates related to our IMM-BCP-01 and IMM-ONC-01 programs are in preclinical development and have never been tested in human subjects.
−Removed: We may be unable to advance any potential product candidates through clinical development, obtain regulatory approval and ultimately commercialize any of our product candidates, or experience significant delays in doing so.
−Removed: Our lead programs, IMM-BCP-01 and IMM-ONC-01, are still in the research stage and are moving into development.
−Removed: We have no other identified product candidates at this time, and we may never identify any product candidates or advance to IND-enabling studies or clinical-stage development.
+Added: We may be unable to advance any potential product candidates through clinical development, obtain regulatory approval and ultimately commercialize any of our product candidates, or we may experience significant delays in doing so.
+Added: Other than IMM-BCP-01 and IMM-ONC-01, we have no identified product candidates at this time, and we may never identify any product candidates or advance to IND-enabling studies or clinical-stage development.
We have no products on the market that have gained regulatory approval or that have entered preclinical studies or clinical trials.
None of our potential future product candidates have ever been tested in humans.
−Removed: Our ability to generate revenue and achieve and sustain profitability depends on identifying our product candidates, advancing them into preclinical and clinical development and obtaining regulatory approvals for and successfully commercializing such product candidates, either alone or through a collaboration.
+Added: Our ability to generate revenue and achieve and sustain profitability depends on identifying our product candidates, advancing them into preclinical and
+Added: clinical development and obtaining regulatory approvals for and successfully commercializing such product candidates, either alone or through a collaboration.
Before obtaining regulatory approval for the commercial distribution of any of our current product candidates and future product candidates that we may identify, we, either alone or with or through a collaborator, must conduct extensive preclinical studies, followed by clinical trials to demonstrate the safety and efficacy of our product candidates in humans.
−Removed: We cannot be certain of the timely completion or outcome of our research and development activities or our planned preclinical studies and cannot predict if the FDA or other regulatory authorities will accept our proposed clinical programs or if the outcome of our preclinical studies will ultimately support the further development of our future product candidates.
−Removed: We have not yet met with or discussed our product development plans with FDA or any other regulatory authorities.
−Removed: As a result, we cannot be sure that we will be able to submit INDs or similar applications for our current discovery programs on the timelines we expect, if at all, and we cannot be sure that submission of INDs or similar applications will result in the FDA or other regulatory authorities allowing clinical trials to begin.
−Removed: Our IMM-BCP-01 and IMM-ONC-01 programs are in the research stage, and we are subject to the risks of failure inherent in the identification of potential product candidates and the research and development of those product candidates based on novel approaches, targets and mechanisms of action.
−Removed: We expect to prepare and submit an IND for the product candidate related to our IMM-BCP-01 program prior to initiating a Phase 1 clinical trial in the later part of the second quarter or in the early part of the third quarter of 2021.
−Removed: We expect to prepare and submit to the FDA an IND for the product candidate related to our IMM-ONC-01 program and to initiate a Phase 1 clinical trial for this product candidate in the second half of 2021.
−Removed: However, there can be no guarantee that we will be able to do so or that we will not face regulatory hurdles as a result of that filing, and with respect specifically to IMM-BCP-01, particularly in light of the lack of certainty around the regulatory framework.
−Removed: We may not have the financial resources to continue development of, or to enter into new collaborations for, the product candidates that may result from our IMM-BCP-01 and IMM-ONC-01 programs or any potential future product
+Added: We cannot be certain of the timely completion or outcome of our research and development activities or our planned clinical studies, and we cannot predict the actions of the FDA or other regulatory authorities or if the outcome of our preclinical studies will ultimately support the further development of our future product candidates.
+Added: Our IMM-BCP-01 and IMM-ONC-01 programs are in the early stages, and we are subject to the risks of failure inherent in the identification of potential product candidates and the research and development of those product candidates based on novel approaches, targets and mechanisms of action.
+Added: We submitted an IND for the IMM-BCP-01 program to the FDA in November 2021.
+Added: In March 2022, the FDA communicated that the clinical study can be initiated for our antibody cocktail for the treatment of SARS-CoV-2 following a brief clinical hold.
+Added: We expect to prepare and submit to the FDA an IND for the product candidate related to our IMM-ONC-01 program in the second half of 2022.
+Added: However, there can be no guarantee that we will be able to do so or that we will not face regulatory hurdles, particularly in light of the lack of certainty around the regulatory framework specifically with respect to IMM-BCP-01.
+Added: We may not have the financial resources to continue development of, or to enter into new collaborations for, the product candidates that may result from our IMM-BCP-01 and IMM-ONC-01 programs or any potential future product candidates.
This may be exacerbated if we experience any issues that delay or prevent regulatory approval of, or our ability to commercialize, any product candidate that we identify, such as:
−Removed: ● negative or inconclusive results from our preclinical trials, leading to a decision to conduct additional preclinical studies or abandon a program;
● negative or inconclusive results from our clinical trials or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct additional preclinical studies or clinical trials or abandon a program;
1 unchanged sentence
● delays in submitting IND applications or comparable foreign applications, or delays or failure in obtaining the necessary approvals from regulators to commence a clinical trial, or a suspension or termination of a clinical trial once commenced;
−Removed: ● conditions imposed by the FDA, or other regulatory authorities regarding the scope or design of our clinical trials;
−Removed: ● delays in enrolling research subjects in clinical trials;
−Removed: ● high drop-out rates and high failure rates of research subjects;
● inadequate supply or quality of product candidate components or materials or other supplies necessary for the conduct of our clinical trials;
−Removed: ● greater-than-anticipated clinical trial costs;
● poor effectiveness of our product candidates during clinical trials;
1 unchanged sentence
failure of our third-party contractors or investigators to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner, or at all;
−Removed: ● delays and changes in regulatory requirements, policies and guidelines;
● the FDA or other regulatory agencies interpreting our data differently than we do;
1 unchanged sentence
Further, we and any potential future partners may never receive approval to market and commercialize any product candidate.
−Removed: Even if we or a potential future partner obtains regulatory approval, the approval may be for targets, disease indications or patient populations that are not as broad as we intended or desired or may require labeling that includes significant use or distribution restrictions or safety warnings.
+Added: Even if we or a potential future partner obtains regulatory approval, the approval may be for targets, disease indications or patient populations not as broad as we intended or desired or may require labeling that includes significant use or distribution restrictions or safety warnings.
We or a potential future partner may be subject to post-marketing testing requirements to maintain regulatory approval.
1 unchanged sentence
A key element of our strategy is to use and expand our discovery engine to build a pipeline of product candidates and progress these product candidates through preclinical and clinical development for the treatment of various diseases.
−Removed: Although our research efforts to date suggests that blocking the IL-38 function using an inhibitory antibody restores the
−Removed: immune response to the tumor, this hypothesis may prove incorrect or we may not be able to identify a product candidate that is safe or effective as a cancer treatment.
+Added: Although our research efforts to date suggests that blocking the IL38 function using an inhibitory antibody restores the immune response to the tumor, this hypothesis may prove incorrect, or we may not be able to identify a product candidate that is safe or effective as a cancer treatment.
We also may not be able to identify an antibody cocktail product candidate containing a mixture of antibodies that we can demonstrate to be safe or effective, and we may not be able to develop any other product candidates.
−Removed: Our discovery engine is evolving and may not reach a state at which building a pipeline of product candidates is possible.
+Added: Our scientific research that forms the basis of our efforts to discover product candidates based on our discovery engine is ongoing.
+Added: Further, the scientific evidence to support the feasibility of developing therapeutic antibodies based on our platform has not been established.
+Added: Our discovery engine may not be proven to be superior to competing technologies.
Even if we are successful in building our pipeline of product candidates, the potential product candidates that we identify may not be suitable for clinical development or generate acceptable clinical data, including as a result of being shown to have unacceptable toxicity or other characteristics that indicate that they are unlikely to be products that will receive marketing approval from the FDA or other regulatory authorities or achieve market acceptance.
If we do not successfully develop and commercialize product candidates, we will not be able to generate product revenue in the future.
−Removed: Our approach to developing and identifying our therapeutic product candidates using our discovery engine is novel and unproven and may not result in marketable products.
−Removed: We plan to develop a pipeline of product candidates using our discovery engine.
−Removed: We believe that we may be able to overcome certain key limitations of the current oncology drug discovery paradigm by focusing on our ability to interrogate hybridoma libraries generated from memory B cells to identify antibodies with high affinity for particular antigen targets.
−Removed: However, our scientific research that forms the basis of our efforts to discover product candidates based on our discovery engine is ongoing.
−Removed: Further, the scientific evidence to support the feasibility of developing therapeutic antibodies based on our platform has not been established.
−Removed: We may not be correct in our beliefs about the differentiated nature of our discovery engine to competing technologies, and our platform may not prove to be superior.
−Removed: If our discovery engine is not able to develop approved antibody constructs that are effective at the necessary speed or scale, it could have a material and adverse effect on our business, financial condition, results of operations and prospects.
We may expend our limited resources and access to capital to pursue a particular product candidate;
these decisions may prove to be wrong and may adversely impact our business.
−Removed: Because we have limited financial and managerial resources, we intend to focus our efforts on specific research and development programs, including clinical development of product candidates related to our COVID antibody cocktail program, or IMM-BCP-01, and our IL-38 targeting antibody program, or IMM-ONC-01.
+Added: Because we have limited financial and other resources, we intend to focus our efforts on specific research and development programs, including IMM-BCP-01 and IMM-ONC-01.
As a result, we may forgo or delay pursuit of other opportunities, including with potential future product candidates that later prove to have greater commercial potential.
2 unchanged sentences
If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through partnership, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate.
−Removed: The effects of health epidemics, including the ongoing COVID-19 pandemic, in regions where we, or the third parties on which we rely, have business operations could adversely impact our business, including our preclinical studies and anticipated clinical trials.
−Removed: The COVID-19 pandemic could materially affect our operations, including at our offices in Philadelphia Metro Area, which are currently subject to executive orders, and at our future clinical trial sites, as well as the business or operations of our CROs or other third parties with whom we conduct business.
−Removed: Our business could be adversely affected by health epidemics in regions where we have concentrations business operations or where we may in the future have clinical trial sites and could cause significant disruption in the operations of third party-manufacturers and CROs upon whom we rely.
−Removed: In December 2019, a novel strain of coronavirus, COVID-19, was reported to have surfaced in Wuhan, China.
−Removed: Since then, COVID-19 has spread globally.
−Removed: Our company headquarters is located in the Philadelphia Metro Area, and we anticipate that our CROs and CMOs will be located in the United States.
−Removed: In March 2020, the World Health Organization declared the COVID-19 outbreak a pandemic, and the U.S.
−Removed: government imposed travel restrictions on travel between the United States, Europe and certain other countries.
−Removed: Further, the President of the United States declared the COVID-19 pandemic a national emergency, invoking powers under the Stafford Act, the legislation that directs federal emergency disaster response.
−Removed: In addition, states including Pennsylvania have ordered residents to stay at their place of residence for periods of time (subject to certain exceptions
−Removed: to facilitate authorized necessary activities) to mitigate the impact of the COVID-19 pandemic.
−Removed: Such orders may be implemented or changed at any time.
−Removed: In response to these public health directives and orders, we implemented work-from-home policies to support the community efforts to reduce the transmission of COVID-19 and protect employees, complying with guidance from federal, state/provincial or municipal government and health authorities.
+Added: Health epidemics, including the ongoing COVID-19 pandemic- and may - adversely impact our business.
+Added: Our business could be adversely affected by health epidemics in regions where we operate or where we may in the future have clinical trial sites and could cause significant disruption in the operations of third party-manufacturers, CROs and other vendors upon whom we rely.
+Added: The COVID-19 pandemic has affected business operations in the United States and globally.
+Added: Our company headquarters is located in the greater Philadelphia area, and we anticipate that our CROs and CMOs will be located in and outside of the United States.
+Added: Therefore, our business and other third parties on which we rely are subject to U.S.
+Added: federal and state regulations and their foreign equivalents adopted in response to the COVID-19 pandemic, including travel restrictions, stay-at-home orders, vaccine mandates, and related regulatory guidance.
+Added: In 2021, we continued to implement work-from-home policies to support the community efforts to reduce the transmission of COVID-19 and protect employees, and these work-from-home policies continue in effect.
We implemented a number of measures to ensure employee safety and business continuity.
−Removed: Employees who can work from home have been doing so, while those needing to work in laboratory facilities are divided into shifts to reduce the number of people gathered together at one time.
+Added: Employees who can work from home have been doing so, while those needing to work in our facilities are divided into shifts to reduce the number of people gathered together at one time.
+Added: We have implemented a back-to-office policy which is tailored to the role of each team member and evolves as the specific conditions associated with the COVID-19 pandemic continue to evolve.
We have also taken measures to secure our research activities while work in laboratories has been organized to reduce risk of COVID-19 transmission.
−Removed: These measures have resulted in decreased productivity of our laboratory-based workforce and may continue to do so for as long as such measures remain in place.
−Removed: Additionally, business travel has been suspended, and online and teleconference technology is used to meet virtually rather than in person.
+Added: Business travel has been suspended, and online and teleconference technology is used to meet virtually as often as possible rather than in person.
While certain of the restrictions in Pennsylvania and other locations in which we have employees or independent contractors have recently been relaxed or lifted, these restrictions may be re-implemented, or new restrictions imposed if rates or incidence of infection increase.
−Removed: The effects of the executive orders and our work-from-home policies may negatively impact productivity, disrupt our business and delay our programs and timelines (for example, our timeline for anticipated IND filings related to our IMM-BCP-01 and IMM-ONC-01 programs), 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: Quarantines, shelter-in-place and similar government orders, or the perception that such orders, shutdowns or other restrictions on the conduct of business operations could be imposed or re-instituted, related to COVID-19 or other infectious diseases could impact personnel at third-party facilities, including those from which we currently obtain tissue and blood samples or on which we may in the future rely for manufacturing, in the United States and other countries, or the availability or cost of materials, which would disrupt our supply chain.
−Removed: In addition, our ongoing and planned preclinical research and clinical trials may continue to be affected by the ongoing COVID- 19 pandemic.
−Removed: Ways in which the pandemic has affected our business or may in the future impact our business include the following:
+Added: The COVID-19 pandemic may impact our business, including our ongoing and planned preclinical research and clinical trials, in the following ways:
+Added: ● reduction in productivity, and potential delays our programs and timelines, as a result of our work-from-home policies;
+Added: ● disruption in operations of third-party facilities, including those from which we currently obtain tissue and blood samples or on which we may in the future rely for manufacturing, in the United States and other countries, or the availability or cost of materials, which would disrupt our supply chain;
● delays or difficulties in enrolling and retaining patients in our clinical trials, including patients that may not be able or willing to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services;
−Removed: ● delays or difficulties or increases in costs associated with clinical site initiation, including difficulties in recruiting and retaining clinical site investigators and clinical site staff;
−Removed: ● delays in receiving the supplies, materials and services needed to conduct preclinical research and clinical trials;
+Added: ● delays or difficulties or increases in costs associated with clinical site initiation, including difficulties in recruiting and retaining clinical site investigators and clinical site staff, and receiving the supplies, materials and services needed to conduct preclinical research and clinical trials;
● increased rates of patients withdrawing from our clinical trials following enrollment as a result of contracting COVID-19, being forced to quarantine or being unable to visit clinical trial locations or otherwise comply with clinical trial protocols;
−Removed: ● diversion or prioritization of healthcare resources away from the conduct of clinical trials and towards the ongoing COVID-19 pandemic, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials, and because, who, as healthcare providers, may have heightened exposure to COVID-19 and adversely impact our clinical trial operations;
−Removed: ● interruption of our clinical supply chain or key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal, state/provincial or municipal governments, employers and others;
+Added: ● diversion or prioritization of healthcare resources away from the conduct of clinical trials and towards the ongoing COVID-19 pandemic, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials, who, as healthcare providers, may have heightened exposure to COVID-19;
+Added: ● interruption of our clinical supply chain or key clinical trial activities, such as clinical trial site monitoring, due to travel restrictions imposed or recommended by governments, employers and others;
● limitations in employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people.
The ongoing COVID-19 pandemic continues to evolve.
−Removed: The extent to which the COVID-19 pandemic may impact our business and contemplated clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the pandemic, travel restrictions and social distancing in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.
−Removed: If any of our future product candidates, including those that may result from our IMM-BCP-01 and IMM-ONC-01 programs, are ever tested in human subjects, they may not demonstrate the combination of safety and efficacy necessary to become approvable or commercially viable.
+Added: The extent to which the COVID-19 pandemic may impact our business continues to be highly uncertain and cannot be predicted with confidence.
+Added: If any of our future product candidates are ever tested in human subjects, they may not demonstrate the combination of safety and efficacy necessary to become approvable or commercially viable.
We have not conducted testing in human subjects of any product candidate resulting from our IMM-BCP-01 and IMM-ONC-01 programs or any other product candidate.
We may ultimately discover that any product candidates we develop do not possess certain properties that we believe will be helpful for therapeutic effectiveness and safety.
−Removed: For example, although our IL-38 targeting program has exhibited encouraging results in preclinical research, it may not demonstrate similar results in further research or exhibit the same properties in humans and may interact with human biological systems in unforeseen, ineffective or harmful ways.
−Removed: As a result, we may never succeed in developing a marketable product based on our IMM-ONC-01 and IMM-BCP-01 programs or based on our discovery engine.
−Removed: If the product candidates resulting from our IMM-BCP-01 and IMM-ONC-01 programs or any of our potential future product candidates prove to be ineffective, unsafe or commercially unviable, our entire pipeline could have little, if any, value, which could require us to change our focus and approach to discovery and development, which would have a material and adverse effect on our business, financial condition, results of operations and prospects.
−Removed: Our pursuit of an antibody cocktail product candidate is at a very early stage.
−Removed: We may be unable to identify or produce a product that successfully treats COVID-19 or prevents infection from the SARS-CoV-2 virus in a timely manner, if at all, and preliminary data may not be indicative of future success.
+Added: Similarly, although both IMM-BCP-01 and IMM-ONC-01 have exhibited encouraging results in preclinical research, it is possible that neither would demonstrate similar results in further research or exhibit the same properties in humans and may interact with human biological systems in unforeseen, ineffective or harmful ways.
+Added: As a result, we may never succeed in developing a marketable product.
+Added: If the product candidates resulting from any of our future product candidates prove to be ineffective, unsafe or commercially unviable, our entire pipeline could have little, if any, value, which could require us to change our focus and approach to discovery and development, which would have a material and adverse effect on our business, financial condition, results of operations and prospects.
+Added: Our pursuit of IMM-BCP-01 presents specific risks not present for programs targeting other conditions.
Our work in our IMM-BCP-01 program is in early stages, and we may be unable to produce an antibody cocktail product candidate that successfully treats COVID19 or prevents infection from the SARS-CoV2 virus in a timely manner, if at all.
4 unchanged sentences
We will not be able to commercialize or market any antibody cocktail product candidate unless and until we are able to demonstrate that our antibody cocktail candidate is safe and effective in humans.
−Removed: In July 2020, we were awarded up to $13.3 million in funding from the U.S.
−Removed: Department of Defense, or DoD, to develop an antibody cocktail as a potential approach to combat the ongoing COVID- 19 pandemic.
+Added: We are dependent upon the award from the DoD related to our IMM-BCP-01 Program.
+Added: If the DoD were to eliminate, reduce or delay the funding for this award or disallow reimbursement of some of our incurred costs, we would have to fund these costs through other resources.
+Added: In contracting with DoD, we are subject to various U.S.
+Added: government contract requirements, which may limit reimbursement or may lead to termination of the contract if we are found to be in violation of such requirements.
+Added: Additionally, the DoD may terminate our agreement for convenience upon 30 days’ notice to us.
+Added: government terminates our award for its convenience, or if we default by failing to perform in accordance with the award schedule and terms, this could have a negative impact on our program.
+Added: Finally, clinical trials are expensive to run.
+Added: In any event, we are required to self-fund any program overages.
+Added: We also do not know how changes in the U.S.
+Added: government or their views on antibody therapeutics could impact the likelihood that our contract with DoD would be terminated before completion or our ability to apply for and receive additional funding from the U.S.
+Added: We are aware of a substantial number of companies, individuals and institutions that have developed a vaccine against SARS-CoV2 and treatments for COVID19, many of which have substantially greater financial, scientific and other resources than us, and another party may be successful in producing a vaccine against SARS-CoV2 or a more efficacious treatment for COVID19.
Various government entities, including the U.S.
government, are offering incentives, grants and contracts to encourage additional investment by commercial organizations into preventative and therapeutic agents against coronavirus, and this may have the effect of increasing the number of competitors and/or providing advantages to known competitors.
−Removed: As well, our COVID-19 program is being funded by DoD, and they can terminate our contract with them at-will.
−Removed: We do not know how recent changes in the U.S.
−Removed: government may impact the likelihood that our contract with DoD would be terminated before
−Removed: In addition, even if the DoD does not terminate their contract with us, the DoD funds will not be sufficient to fund full development efforts through commercialization, and we will need to find alternate sources of capital for this purpose.
−Removed: We are aware of a substantial number of companies, individuals and institutions that have developed a vaccine against SARS-CoV-2 and treatments for COVID-19, many of which have substantially greater financial, scientific and other resources than us, and another party may be successful in producing a vaccine against SARS-CoV-2 or a more efficacious treatment for COVID-19, which may also lead to the diversion of governmental and quasi-governmental funding away from us and toward other companies, and lead to demand being driven away from our product, even if developed.
The rapid expansion of development and production programs directed at COVID19 has also generated, and may continue to generate, a scarcity of manufacturing capacity among contract research organizations that provide cGMP materials for development and commercialization of biopharmaceutical products.
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If the delays or costs associated with manufacturing of any antibody cocktail product candidate result in budget overages, we may need to self-fund the program.
−Removed: Additionally, the current and any future vaccine against SARS-CoV-2 and treatments for COVID-19 could negatively affect patient recruitment for our future clinical trials of our antibody cocktail product candidate in SARS-CoV-2 and the clinical utility and success of our antibody cocktail product candidate may be compromised.
−Removed: Any of these entities may develop further COVID-19 vaccines or an alternative treatment that is more effective than any antibody cocktail product candidate that we may develop, develop a product that becomes the standard of care, develop alternative treatments at a lower cost or earlier than we are able to develop any antibody cocktail product candidate, or be more successful at commercializing a vaccine or alternative treatment than we are at commercializing any potential antibody cocktail product candidate.
+Added: In November 2021, we submitted an IND application for the IMM-BCP-01 program with the FDA.
+Added: In March 2022, the FDA communicated that the clinical study can be initiated for our antibody cocktail for the treatment of SARS-CoV-2 following a brief clinical hold.
+Added: Additionally, the current and any future vaccine against SARS-CoV2 and treatments for COVID-19, and the status of infection rates, could negatively affect patient recruitment for our future clinical trials of our antibody cocktail product candidate in SARS-CoV2 and the clinical utility and success of our antibody cocktail product candidate may be compromised.
+Added: Any of these entities may develop further COVID-19 vaccines or an alternative treatment that is more effective than any antibody cocktail product candidate that we may develop, develop a product that becomes the standard of care, develop alternative treatments at a lower cost or earlier than we are able to develop any antibody cocktail product candidate, or be more successful at commercializing a vaccine or alternative treatment than we are at
+Added: commercializing any potential antibody cocktail product candidate.
Accordingly, there can be no assurance that we will be able to successfully establish a competitive market share for our antibody cocktail product candidate, if any.
−Removed: We have never generated revenue from product sales and may never be profitable.
−Removed: Our ability to become and remain profitable depends on our ability to generate revenue.
−Removed: We do not expect to generate significant revenue, if any, unless and until we, either alone or with a collaborator, are able to obtain regulatory approval for, and successfully commercialize, product candidates we may develop.
−Removed: Successful commercialization will require achievement of many key milestones, including demonstrating safety and efficacy in clinical trials, obtaining regulatory, including marketing, approval for these product candidates, manufacturing, marketing and selling those products for which we, or any of our future collaborators, may obtain regulatory approval, satisfying any post-marketing requirements and obtaining reimbursement for our products from private insurance or government payors.
−Removed: Because of the uncertainties and risks associated with these activities, we are unable to accurately and precisely predict the timing and amount of revenues, the extent of any further losses or if or when we might achieve profitability.
−Removed: We and any future collaborators may never succeed in these activities and, even if we do, or any future collaborators do, we may never generate revenues that are large enough for us to achieve profitability.
−Removed: Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
−Removed: Additionally, our expenses could increase if we are required by the FDA or any comparable foreign regulatory authority to perform clinical trials 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.
−Removed: Our failure to become and remain profitable may depress the market price of our common stock and could impair our ability to raise capital, expand our business, diversify our product offerings or continue our operations.
−Removed: If we continue to suffer losses as we have in the past, investors may not receive any return on their investment and may lose their entire investment.
−Removed: The amount of our future losses is uncertain and our quarterly and annual operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.
−Removed: Our quarterly and annual operating results may fluctuate significantly in the future due to a variety of factors, many of which are outside of our control and may be difficult to predict, including the following:
−Removed: ● the timing and success or failure of preclinical studies and clinical trials for our product candidates or competing product candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or partners;
−Removed: ● our ability to successfully recruit and retain subjects for clinical trials, once initiated, and any delays caused by difficulties in such efforts;
−Removed: ● our ability to obtain marketing approval for our future product candidates, and the timing and scope of any such approvals we may receive;
−Removed: ● the timing and cost of, and level of investment in, research and development activities relating to our product candidates, which may change from time to time;
−Removed: ● the cost of manufacturing our product candidates, which may vary depending on the quantity of production and the terms of our agreements with manufacturers;
−Removed: ● our ability to attract, hire and retain qualified personnel;
−Removed: ● expenditures that we will or may incur to develop additional product candidates;
−Removed: ● the level of demand for our product candidates should they receive approval, which may vary significantly;
−Removed: ● the risk/benefit profile, cost and reimbursement policies with respect to our product candidates, if approved, and existing and potential future therapeutics that compete with our product candidates;
−Removed: ● general market conditions or extraordinary external events, such as recessions or the COVID-19 pandemic;
−Removed: ● the changing and volatile U.S.
−Removed: and global economic environments;
−Removed: ● future accounting pronouncements or changes in our accounting policies.
−Removed: The cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results.
−Removed: As a result, comparing our operating results on a period-to-period basis may not be meaningful.
−Removed: This variability and unpredictability could also result in our failing to meet the expectations of industry or financial analysts or investors for any period.
−Removed: If our revenue or operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if the forecasts we provide to the market are below the expectations of analysts or investors, the price of our common stock could decline substantially.
−Removed: Such a stock price decline could occur even when we have met any previously publicly stated guidance we may provide.
−Removed: Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish proprietary rights.
−Removed: Until we can generate sufficient product and/or royalty revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements and grant funding.
−Removed: If we raise additional capital through public or private equity offerings, the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights.
−Removed: Further, to the extent that we raise additional capital through the sale of common stock or securities convertible or exchangeable into common stock, your ownership interest will be diluted.
−Removed: If we raise additional capital through debt financing, we would be subject to fixed payment obligations and may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
−Removed: If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us.
−Removed: If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, reduce or terminate our product development or future commercialization efforts or grant rights to third parties to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
−Removed: We face risks related to government funded awards.
−Removed: Department of Defense were to eliminate, reduce or delay funding from these awards, this would have a significant negative impact on our IMM-BCP-01 program.
−Removed: We are dependent upon an award from the U.S.
−Removed: Department of Defense, or DoD, related to our IMM-BCP-01 Program.
−Removed: If DoD were to eliminate, reduce or delay the funding for this award or disallow reimbursement of some of our incurred costs, we would have to obtain additional funding for continued development or regulatory approval for our IMM-BCP-01 program or delay, reduce or stop the development effort.
−Removed: In contracting with DoD, we are subject to various U.S.
−Removed: government contract requirements, which may limit reimbursement or may lead to termination of the contract if we are found to be in violation of such requirements.
−Removed: Additionally, the DoD may terminate our agreement for convenience upon 30 days’ notice to us.
−Removed: government terminates our award for its convenience, or if we default by failing to perform in accordance with the award schedule and terms, significant negative impact on our cash flows and operations could result.
−Removed: Finally, clinical trials are expensive to run.
−Removed: Based upon future guidance from the FDA we may be allowed to perform initial clinical testing in patients, rather than healthy volunteers.
−Removed: However, and regardless of this guidance, clinical testing will require funds not in the original DoD budget.
−Removed: If the DoD does not increase our budget, we will need to self-fund any program overages.
We have obtained rights to use human samples in furtherance of our research and development of our potential future product candidates.
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Because our potential future product candidates are based on new technologies and discovery approaches, we expect that they will require extensive research and development and have substantial manufacturing and processing costs.
−Removed: For example, we anticipate that our future antibody cocktail product candidate will
−Removed: include a combination of antibodies to prevent or treat the SARS-CoV-2 virus, which may complicate the clinical development program, for example by requiring factorial study design to determine the relative contribution of each antibody to the therapeutic activity of the product candidate, and require us or our CROs to conduct additional or more complex clinical trials.
+Added: For example, we anticipate that our future antibody cocktail product candidate will include a combination of antibodies to prevent or treat the SARS-CoV-2 virus, which may complicate the clinical development program, for example by requiring factorial study design to determine the relative contribution of each antibody to the therapeutic activity of the product candidate, and require us or our CROs to conduct additional or more complex clinical trials.
In addition, costs to treat patients and to treat potential side effects that may result from our product candidates may be significant.
Accordingly, our clinical trial costs are likely to be high and could have a material and adverse effect on our business, financial condition, results of operations and prospects.
−Removed: Clinical development includes a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
+Added: Clinical development has an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
Our potential future product candidates related to our IMM-BCP-01 and IMM-ONC-01 programs are in preclinical development, and the risk of failure related to these potential product candidates is high.
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Particularly with respect to our IMM-BCP-01 program, we may be unable to complete clinical development and testing while COVID-19 remains a global health threat.
−Removed: Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain.
−Removed: Failure can occur at any time during the development process.
+Added: Clinical testing can take many years to complete, and its outcome is inherently uncertain.
The results of preclinical studies and early clinical trials of any of our potential future product candidates may not be predictive of the results of later-stage clinical trials.
Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials.
−Removed: A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or safety profiles, notwithstanding promising results in earlier trials.
−Removed: We expect to prepare and submit an IND for the product candidate related to our IMM-BCP-01 program prior to initiating a Phase 1 clinical trial in the later part of the second quarter or in the early part of the third quarter of 2021.
−Removed: We expect to prepare and submit to the FDA an IND for the product candidate related to our IMM-ONC-01 program and to initiate a Phase 1 clinical trial for this product candidate in the second half of 2021.
−Removed: Commencing any clinical trial is subject to finalizing the trial design and filing an IND with the FDA.
−Removed: Even after we file an IND related to either of these programs, the FDA could disagree that we have satisfied their requirements to commence our clinical trials or disagree with our study design, which may require us to complete additional preclinical studies or amend our protocols or impose stricter conditions on the commencement of clinical trials.
+Added: A number of pharmaceutical companies have suffered significant setbacks in advanced clinical trials due to lack of efficacy or safety profiles, notwithstanding promising results in earlier trials.
+Added: In November 2021, we submitted an IND application for the IMM-BCP-01 program with the FDA.
+Added: In March 2022, the FDA communicated that the clinical study can be initiated for our antibody cocktail for the treatment of SARS-CoV-2 following a brief clinical hold.
+Added: We expect to prepare and submit to the FDA an IND for the product candidate related to our IMM-ONC-01 program in the second half of 2022.
+Added: Commencing any clinical trial is subject to finalizing the trial
+Added: design and filing an IND with the FDA.
+Added: Even after an IND is filed, the FDA could disagree that we have satisfied their requirements to commence our clinical trials or disagree with our study design, which may require us to complete additional preclinical studies or amend our protocols or impose stricter conditions on the commencement of clinical trials.
We may experience delays in completing our preclinical studies and initiating or completing clinical trials of our potential future product candidates.
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● delays in developing suitable assays for screening patients for eligibility for trials with respect to certain product candidates;
−Removed: ● the FDA or other regulatory authorities requiring us to submit additional data or imposing other requirements before permitting us to initiate a clinical trial;
● delays in reaching agreement with the FDA, EMA or other regulatory authorities as to the design or implementation of our clinical trials;
−Removed: ● obtaining regulatory approval to commence a clinical trial;
● reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;
● obtaining institutional review board, or IRB, approval at each clinical trial site;
−Removed: ● recruiting suitable patients to participate in a clinical trial;
−Removed: ● having patients complete a clinical trial or return for post-treatment follow-up;
+Added: ● recruiting suitable patients to participate in a clinical trial and having patients complete a clinical trial or return for post-treatment follow-up;
● clinical trial sites, CROs or other third parties deviating from trial protocol or dropping out of a trial;
● failure to perform in accordance with the FDA’s GCP requirements, or applicable regulatory guidelines in other countries;
+Added: ● any unresolved ethical issues associated with enrolling patients in clinical trials of our potential future product candidates in lieu of prescribing existing treatments that have established safety and efficacy profiles.
● addressing patient safety concerns that arise during the course of a trial, including occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits;
−Removed: ● adding new clinical trial sites;
● having inadequate supply or quality of product candidate components or materials or other supplies necessary for the conduct of our preclinical studies or clinical trials.
−Removed: ● manufacturing sufficient quantities of our product candidates for use in clinical trials.
Furthermore, we expect to rely on CROs and clinical trial sites to ensure the proper and timely conduct of our clinical trials and, while we expect to enter into agreements governing their committed activities, we have limited influence over their actual performance.
−Removed: We could encounter delays if prescribing physicians encounter unresolved ethical issues associated with enrolling patients in clinical trials of our potential future product candidates in lieu of prescribing existing treatments that have established safety and efficacy profiles.
−Removed: Further, a clinical trial may be suspended or terminated by us, our partners, the IRBs of the institutions in which such trials are being conducted, the Data Safety Monitoring Board for such trial or by the FDA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug or therapeutic biologic, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.
+Added: A clinical trial may be suspended or terminated by us, our partners, the IRBs of the institutions in which such trials are being conducted, the Data Safety Monitoring Board for such trial or by the FDA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities
+Added: resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug or therapeutic biologic, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.
If we experience delays in the completion of, or termination of, any clinical trial of any of our potential future product candidates, the commercial prospects of such product candidate will be harmed, and our ability to generate product revenue from such product candidates will be delayed.
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We may not be able to initiate or continue clinical trials for our potential future product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or other regulatory authorities.
−Removed: In particular, we are preparing to advance a product candidate related to our IMM-BCP-01
−Removed: program into a Phase 1 clinical trial in humans in 2021 with large scale vaccinations being undertaken across the country, potentially limiting the number of patients willing, or eligible, to enter clinical trials.
−Removed: We cannot predict how difficult it will be to enroll subjects for trials.
−Removed: We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons.
The enrollment of patients depends on many factors, including:
● the severity of the disease under investigation;
−Removed: ● the patient eligibility criteria defined in the clinical trial protocol;
−Removed: ● the size of the patient population required for analysis of the trial’s primary endpoints;
+Added: ● the patient eligibility criteria defined in the clinical trial protocol and the size of the patient population required for analysis of the trial’s primary endpoints;
● the existence of approved vaccines, or ones available under Emergency Use Authorizations, may limit the overall number of COVID-19 positive patients;
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Since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials at such clinical trial sites.
−Removed: Additionally, because we anticipate that some of our clinical trials will be in patients with advanced solid tumors, the patients are typically in the late stages of the disease and may experience disease progression or adverse events independent from our product candidates, making them unevaluable for purposes of the trial and requiring additional enrollment.
+Added: Additionally, because we anticipate
+Added: that some of our clinical trials will be in patients with advanced solid tumors, the patients are typically in the late stages of the disease and may experience disease progression or adverse events independent from our product candidates, making them unevaluable for purposes of the trial and requiring additional enrollment.
Delays in patient enrollment may result in increased costs or may affect the timing or outcome of the planned clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of our product candidates.
−Removed: We have not yet tested any product candidates in clinical trials.
−Removed: Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials.
−Removed: Success in preclinical testing and early clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate.
−Removed: Preclinical tests and Phase 1 and Phase 2 clinical trials are primarily designed to test safety, to study pharmacokinetics and
−Removed: pharmacodynamics and to understand the side effects of product candidates at various doses and schedules.
−Removed: Success in preclinical or animal studies and early clinical trials does not ensure that later large-scale efficacy trials will be successful nor does it predict final results.
−Removed: Our product candidates may fail to show the desired safety and efficacy in clinical development despite positive results in preclinical studies or having successfully advanced through initial clinical trials.
−Removed: Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials even after achieving promising results in preclinical testing and earlier-stage clinical trials.
−Removed: Data obtained from preclinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent regulatory approval.
−Removed: In addition, we may experience regulatory delays or rejections as a result of many factors, including changes in regulatory policy during the period of our product candidate development.
−Removed: Any such delays could negatively impact our business, financial condition, results of operations and prospects.
−Removed: Preliminary results from our preclinical studies and clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
+Added: Preliminary results from our preclinical studies and clinical trials that we announce or publish from time to time may change as more patient data becomes available and as the data undergoes audit and verification procedures.
From time to time, we may publish preliminary results from our preclinical studies and clinical trials.
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As a result, interim and preliminary data should be viewed with caution until the final data are available.
−Removed: Differences between preliminary or interim data and final data could significantly harm our business prospects and may cause the trading price of our common stock to fluctuate significantly.
−Removed: We may attempt to secure approval from the FDA through the use of accelerated approval pathways.
−Removed: If unable to obtain approval via the accelerated approval pathway, we may be required to conduct additional preclinical studies or clinical trials which could increase the expense of obtaining, reduce the likelihood of obtaining or delay the timing of obtaining, necessary marketing approvals.
−Removed: Even if we receive accelerated approval from the FDA, if our confirmatory trials do not verify clinical benefit, or if we do not comply with rigorous post-marketing requirements, the FDA may seek to withdraw accelerated approval.
−Removed: We may seek an accelerated approval development pathway for our product candidates.
−Removed: Under the accelerated approval provisions of the Federal Food, Drug, and Cosmetic Act, or the FDCA, and the FDA’s implementing regulations, the FDA may grant accelerated approval to a product designed to treat a serious or life-threatening condition that provides meaningful therapeutic advantage over available therapies and demonstrates an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit.
−Removed: The FDA considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease.
−Removed: For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit.
−Removed: An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.
−Removed: The accelerated approval development pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage, but is a clinically important improvement from a patient and public health perspective.
−Removed: If granted, accelerated approval is contingent on the sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the drug’s clinical profile or risks and benefits for accelerated approval.
−Removed: The FDA may require that any such confirmatory study be initiated or substantially underway prior to the submission of an application for accelerated approval.
−Removed: If such post-approval studies fail to confirm the drug’s clinical profile or risks and benefits, the FDA may withdraw its approval of the drug.
+Added: Differences between preliminary or interim data and final data could significantly affect our business prospects.
+Added: If we are unable to obtain approval via the accelerated approval pathway, we may be required to conduct additional preclinical studies or clinical trials.
+Added: Even if we receive accelerated approval from the FDA, the FDA may seek to withdraw accelerated approval.
+Added: We may seek an accelerated approval development pathway for our product candidates (see “Expedited Development and Review Programs” section for discussion about the accelerated approval pathway.
If we choose to pursue accelerated approval, we intend to seek feedback from the FDA or will otherwise evaluate our ability to seek and receive such accelerated approval.
−Removed: There can be no assurance that, after our evaluation of the feedback from the FDA or other factors, we will decide to pursue or submit a BLA for accelerated approval or any other form of expedited development, review or approval.
−Removed: Furthermore, if we submit an application for accelerated approval,
−Removed: there can be no assurance that such application will be accepted or that approval will be granted on a timely basis, or at all.
+Added: After our evaluation of the feedback from the FDA or other factors, we may decide not to pursue or submit a BLA for accelerated approval or any other form of expedited development, review or approval.
+Added: Furthermore, if we submit an application for accelerated approval, there can be no assurance that such application will be accepted or that approval will be granted on a timely basis, or at all.
Particularly as it relates to our IMM-BCP-01 program, the existence of approved vaccines, or ones available under Emergency Use Authorizations, may cause the FDA to limit the number of additional accelerated approvals granted.
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or we disseminate promotional materials that are found by the FDA to be false and misleading.
−Removed: A failure to obtain accelerated approval or any other form of expedited development, review or approval for a product candidate that we may choose to develop would result in a longer time period prior to commercializing such product candidate, could increase the cost of development of such product candidate and could harm our competitive position in the marketplace.
+Added: A failure to obtain accelerated approval or any other form of expedited development, review or approval for a product candidate that we may choose to develop would delay our commercialization of such product candidate, could increase the cost of development of such product candidate and could harm our competitive position in the marketplace.
We may not elect or be able to take advantage of any expedited development or regulatory review and approval processes available to product candidates granted breakthrough therapy or fast track designation by the FDA.
−Removed: We intend to evaluate and engage in discussions with the FDA on regulatory strategies that could enable us to take advantage of expedited development pathways for certain of our future product candidates, although we cannot be certain that our future product candidates will qualify for any expedited development pathways or that regulatory authorities will grant, or allow us to maintain, the relevant qualifying designations.
−Removed: Potential expedited development pathways that we could pursue include breakthrough therapy and fast track designation.
−Removed: Breakthrough therapy designation is intended to expedite the development and review of product candidates that are designed to treat serious or life-threatening diseases when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
−Removed: The designation of a product candidate as a breakthrough therapy provides potential benefits that include more frequent meetings with FDA to discuss the development plan for the product candidate and ensure collection of appropriate data needed to support approval;
−Removed: more frequent written correspondence from FDA about such things as the design of the proposed clinical trials and use of biomarkers;
−Removed: intensive guidance on an efficient drug development program, beginning as early as Phase 1;
−Removed: organizational commitment involving senior managers;
−Removed: and eligibility for rolling review and priority review.
−Removed: Fast track designation is designed for product candidates intended for the treatment of a serious or life-threatening disease or condition, where nonclinical or clinical data demonstrate the potential to address an unmet medical need for this disease or condition.
−Removed: Accordingly, even if we believe a particular future product candidate is eligible for breakthrough therapy or fast track designation, we cannot assure you that the FDA would decide to grant it.
+Added: We intend to evaluate and discuss with the FDA on regulatory strategies that could enable us to take advantage of expedited development pathways for certain of our future product candidates.
+Added: Potential expedited development pathways that we could pursue include breakthrough therapy and fast track designation (see discussion about those pathways in our “Expedited Development and Review Programs” section).
+Added: We cannot assure you that any of our particular future product candidates would be eligible for, or be granted, breakthrough therapy or fast track designation.
Breakthrough therapy designation and fast track designation do not change the standards for product approval, and there is no assurance that such designation or eligibility will result in expedited review or approval or that the approved indication will not be narrower than the indication covered by the breakthrough therapy designation or fast track designation.
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The FDA may withdraw breakthrough therapy or fast track designation if it believes that the product no longer meets the qualifying criteria.
−Removed: Our business may be harmed if we are unable to avail ourselves of these or any other expedited development and regulatory pathways.
+Added: Our business may be harmed if we are unable to avail ourselves of, or to maintain, these or any other expedited development and regulatory pathways.
The market may not be receptive to our potential future product candidates, and we may not generate any revenue from the sale, partnering or licensing of our product candidates.
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Market acceptance of our potential future product candidates will depend on, among other factors:
−Removed: ● the timing of our receipt of any marketing and commercialization approvals;
−Removed: ● the terms of any approvals and the countries in which approvals are obtained;
+Added: ● the timing of our receipt of any marketing and commercialization approvals and the terms of such approvals;
● the safety and efficacy of our product candidates;
−Removed: ● the prevalence and severity of any adverse side effects associated with our product candidates;
● limitations or warnings contained in any labeling approved by the FDA or other regulatory authority;
● relative convenience and ease of administration of our product candidates;
−Removed: ● the success of our physician education programs;
−Removed: ● the availability of coverage and adequate government and third-party payor reimbursement;
−Removed: ● the pricing of our products, particularly as compared to alternative treatments;
+Added: ● the availability of coverage and adequate government and third-party payor reimbursement and the pricing of our products, particularly as compared to alternative treatments;
● availability of alternative effective treatments for the disease indications our product candidates are intended to treat and the relative risks, benefits and costs of those treatments.
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In the event that any of our potential future product candidates receive regulatory approval and we or others identify undesirable side effects caused by one of these products, any of the following adverse events could occur, which could result in the loss of significant revenue to us and materially and adversely affect our results of operations and business:
−Removed: ● regulatory authorities may withdraw their approval of the product or seize the product;
+Added: ● regulatory authorities may withdraw their approval of the product, seize the product or additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof;
● we may be required to recall the product, change the way the product is administered to patients, conduct additional preclinical studies or clinical trials or change the labeling of the product;
−Removed: ● additional restrictions may be imposed on the marketing of the particular product or the manufacturing processes for the product or any component thereof;
−Removed: ● we may be subject to fines, injunctions or the imposition of civil or criminal penalties;
+Added: ● we may be sued, subject to fines, injunctions or the imposition of civil or criminal penalties;
● regulatory authorities may require the addition of labeling statements, such as a “black box” warning or a contraindication or a limitation on the indications for use or impose restrictions on the distribution in the form of a Risk Evaluation and Mitigation Strategy, or REMS, in connection with approval.
−Removed: ● we could be sued and held liable for harm caused to patients;
−Removed: ● the product may become less competitive;
−Removed: ● our reputation may suffer.
If any of our product candidates is approved for marketing and commercialization in the future and we are unable to develop sales, marketing and distribution capabilities on our own or enter into agreements with third parties to perform these functions on acceptable terms, we will be unable to successfully commercialize any such future products.
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We will need to develop internal sales, marketing and distribution capabilities to commercialize each potential future product candidate that gains FDA approval, which would be expensive and time-consuming, or enter into strategic partnerships with third parties to perform these services.
−Removed: If we decide to market any approved products directly, we will need to commit significant
−Removed: financial and managerial resources to develop a marketing and sales force with technical expertise and supporting distribution, administration and compliance capabilities.
+Added: If we decide to market any approved products directly, we will need to commit significant financial and managerial resources to develop a marketing and sales force with technical expertise and supporting distribution, administration and compliance capabilities.
If we rely on third parties with such capabilities to market any approved products or decide to co-promote products with partners, we will need to establish and maintain marketing and distribution arrangements with third parties, and there can be no assurance that we will be able to enter into such arrangements on acceptable terms or at all.
−Removed: In entering into third-party marketing or distribution arrangements, any revenue we receive will depend upon the efforts of the third parties and we cannot assure you that such third parties will establish adequate sales and distribution capabilities or be successful in gaining market acceptance for any approved product.
+Added: In entering into third-party marketing or distribution arrangements, any revenue we receive will depend upon the efforts of the third parties and we cannot assure you that such third parties will establish adequate sales and distribution capabilities or be successful in gaining market acceptance for any approved
If we are not successful in commercializing any product approved in the future, either on our own or through third parties, our business and results of operations could be materially and adversely affected.
−Removed: Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
+Added: Additional regulatory burdens and other risks and uncertainties in foreign markets may limit our growth.
Our future growth may depend, in part, on our ability to develop and commercialize product candidates in foreign markets for which we may rely on strategic partnership with third parties.
−Removed: We will not be permitted to market or promote any product candidate before we receive regulatory approval from the applicable regulatory authority in a foreign market, and we may never receive such regulatory approval for any product candidate.
+Added: We will not be permitted to market or promote any product candidate before we receive regulatory approval from the applicable regulatory authority in a foreign market, and we may never receive such regulatory approval.
To obtain separate regulatory approval in foreign countries, we generally must comply with numerous and varying regulatory requirements of such countries regarding safety and efficacy and governing, among other things, clinical trials and commercial sales, pricing and distribution of a product candidate, and we cannot predict success in these jurisdictions.
If we obtain approval of any of our potential future product candidates and ultimately commercialize any such product candidate in foreign markets, we would be subject to risks and uncertainties, including the burden of complying with complex and changing foreign regulatory, tax, accounting and legal requirements and the reduced protection of intellectual property rights in some foreign countries.
−Removed: Our business entails a significant risk of product liability, and our inability to obtain sufficient insurance coverage could have a material and adverse effect on our business, financial condition, results of operations and prospects.
+Added: Our business entails a significant risk of product liability, which may not be sufficiently covered by our insurance.
As we move into conducting preclinical studies and clinical trials of our potential future product candidates, we will be exposed to significant product liability risks inherent in the development, testing, manufacturing and marketing of antibody treatments.
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If we desire to enter into strategic transactions but are not able to do so, we may not have access to required liquidity or expertise to further develop our potential future product candidates or our discovery engine.
−Removed: Any such collaboration, or other strategic transaction, may require us to incur non-recurring or other charges, increase our near- and long-term expenditures and pose significant integration or implementation challenges or disrupt our management or
+Added: Any such collaboration, or other strategic transaction, may require us to incur non-recurring or other charges, increase our near- and long-term expenditures and pose significant integration or implementation challenges or disrupt our management or business.
We may acquire additional technologies and assets, form strategic alliances or create joint ventures with third parties that we believe will complement or augment our existing business, but we may not be able to realize the benefit of acquiring such assets.
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These transactions would entail numerous operational and financial risks, including:
−Removed: ● exposure to unknown liabilities;
−Removed: ● disruption of our business and diversion of our management’s time and attention in order to manage a collaboration or develop acquired products, product candidates or technologies;
−Removed: ● incurrence of substantial debt or dilutive issuances of equity securities to pay transaction consideration or costs;
−Removed: ● higher-than-expected collaboration, acquisition or integration costs, write-downs of assets or goodwill or impairment charges, increased amortization expenses;
−Removed: ● difficulty and cost in facilitating the collaboration or combining the operations and personnel of any acquired business;
−Removed: ● impairment of relationships with key suppliers, manufacturers or customers of any acquired business due to changes in management and ownership;
−Removed: ● the inability to retain key employees of any acquired business.
+Added: ● exposure to unknown liabilities and higher-than-expected collaboration, acquisition or integration costs, write-downs of assets or goodwill or impairment charges, increased amortization expenses;
+Added: ● disruption of our business and diversion of our management’s time and attention in order to manage a collaboration or develop acquired products, product candidates or technologies, including impairment of
+Added: relationships with key suppliers, manufacturers or customers of any acquired business due to changes in management and ownership.
Accordingly, although there can be no assurance that we will undertake or successfully complete any transactions of the nature described above, any transactions that we do complete may be subject to the foregoing or other risks and our business could be materially harmed by such transactions.
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The third parties with which we may contract might not be diligent, careful or timely in conducting our preclinical studies or clinical trials, resulting in the preclinical studies or clinical trials being delayed or unsuccessful.
−Removed: If we cannot contract with acceptable third parties on commercially reasonable terms, or at all, or if these third parties do not carry out their contractual duties, satisfy legal and regulatory requirements for the conduct of preclinical studies or clinical trials or meet expected deadlines, our clinical development programs could be delayed and otherwise
−Removed: adversely affected.
−Removed: In all events, we will be responsible for ensuring that each of our preclinical studies and clinical trials are conducted in accordance with the general investigational plan and protocols for the trial.
The FDA requires certain preclinical studies to be conducted in accordance with good laboratory practices and clinical trials must be conducted in accordance with good clinical practices, including for designing, conducting, recording and reporting the results of preclinical studies and clinical trials to ensure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of clinical trial participants are protected.
3 unchanged sentences
We rely on third-party contract manufacturers for our preclinical and future clinical trial product materials and commercial supplies.
−Removed: As part of this, we have engaged Abzena as our contract manufacturing and development organization for our IMM-BCP-01 and IMM-ONC- 01 programs.
We do not intend to produce any meaningful quantity of our future product candidates for preclinical and clinical development through our internal resources, and we do not currently own manufacturing facilities for producing such supplies.
−Removed: While we intend to avoid sole-source arrangements with any of our manufacturing, supply and testing vendors, it may not always be possible to do so.
+Added: While we intend to try to avoid sole-source arrangements with any of our manufacturing, supply and testing vendors, it may not always be possible to do so.
We cannot assure you that our preclinical or future clinical development product supplies and commercial supplies will not be limited or interrupted, especially with respect to any sole source third-party manufacturing and supply partners or will be of satisfactory quality or continue to be available at acceptable prices.
In particular, any replacement of our manufacturers could require significant effort and expertise because there may be a limited number of qualified replacements.
−Removed: For any future sole source third-party manufacturing and supply partners, we may be unable to negotiate binding agreements with them or find replacement manufacturers to support our preclinical and future clinical activities at commercially reasonable terms in the event that their services to us becomes interrupted for any reason.
−Removed: Establishing additional or replacement sole source vendors, if required, may not be accomplished quickly.
−Removed: Any delays resulting from manufacturing or supply interruptions associated with our reliance on third-party manufacturing and supply partners, including those that may be sole source, could impede, delay, limit or prevent our drug development efforts, which could harm our business, result of operations, financial condition and prospects.
The manufacturing process for a product candidate is subject to FDA and other regulatory authority review.
−Removed: Suppliers and manufacturers must meet applicable manufacturing requirements and undergo rigorous facility and process validation tests required by regulatory authorities in order to comply with regulatory standards, such as cGMP.
+Added: Suppliers and manufacturers must meet applicable manufacturing requirements and undergo rigorous facility and
+Added: process validation tests required by regulatory authorities in order to comply with regulatory standards, such as cGMP.
In the event that any of our future manufacturers fails to comply with such requirements or to perform its obligations to us in relation to quality, timing or otherwise, or if our supply of components or other materials becomes limited or interrupted for other reasons, we may be forced to manufacture the materials ourselves, for which we currently do not have the capabilities or resources, or enter into an agreement with another third party, which we may not be able to do on reasonable terms, or at all.
3 unchanged sentences
The delays associated with the verification of a new manufacturer could negatively affect our ability to develop product candidates in a timely manner or within budget.
−Removed: We also expect to continue to rely on third-party manufacturers, including if we receive regulatory approval for any of our product candidates and we may enter into additional manufacturing arrangements with third parties in the future.
−Removed: We depend on these third parties, and likely will continue to depend on them, to perform their obligations in a timely manner consistent with contractual and regulatory requirements, including those related to quality control and assurance.
If we are unable to maintain or obtain third-party manufacturing for any product candidate, or to do so on commercially reasonable terms, we may not be able to develop and commercialize our product candidates successfully.
−Removed: Our or a third
−Removed: party’s failure to execute on our manufacturing requirements and comply with cGMP could adversely affect our business in a number of ways, including:
+Added: Our or a third party’s failure to execute on our manufacturing requirements and comply with cGMP could adversely affect our business in a number of ways, including:
● an inability to initiate or continue clinical trials of any product candidates then under development;
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in the event of approval to market and commercialize a product candidate, an inability to meet commercial demands for our products.
−Removed: Our third-party manufacturers may be unable to successfully scale manufacturing of our potential future product candidates in sufficient quality and quantity, which would delay or prevent us from developing product candidates and commercializing approved products, if any.
+Added: We may be unable to successfully scale manufacturing of our potential future product candidates in sufficient quality and quantity, which would delay or prevent us from developing product candidates and commercializing approved products, if any.
In order to conduct our research and development efforts, including clinical trials, for our potential future product candidates, we will need to manufacture large quantities of these product candidates.
If the product candidates are commercialized, we will need to scale up our manufacturing efforts even further.
−Removed: We have engaged Abzena as our contract development and manufacture organization for both of our current programs, and currently expect to continue to use Abzena and other third parties for our manufacturing needs.
+Added: We currently expect to continue to use third parties for our manufacturing needs, as we do not currently have, nor do we currently intend to establish, our own manufacturing capacity.
Our manufacturing partners may be unable to successfully increase the manufacturing capacity for any potential future product candidate in a timely or cost-effective manner, or at all.
In addition, quality issues may arise during scale-up activities and our manufacturers may fail to perform under their contracts with us, which could result in an unexpected need to change manufacturers.
−Removed: If our manufacturing partners are unable to successfully scale the manufacture of any of our product candidates or, if successful, products, in sufficient quality and quantity, the development, testing and clinical trials of that product candidate or product may be delayed or infeasible, and regulatory approval or commercial launch of any potential resulting product may be delayed or not obtained, which could significantly harm our business.
−Removed: We have received funding under the Coronavirus Aid, Relief and Economic Security (CARES) Act.
−Removed: On April 30, 2020, we executed a promissory note in favor of Silicon Valley Bank evidencing an unsecured loan, or the PPP loan, in the aggregate principal amount of approximately $0.5 million, which was made pursuant to the Paycheck Protection Program, or the PPP, established under the CARES Act, administered by the U.S.
−Removed: Small Business Administration, or the SBA.
−Removed: The promissory note provides for a fixed interest rate of one percent per year with a maturity date of April 30, 2022.
−Removed: The loan may be prepaid by the Company at any time prior to April 30, 2022 with no prepayment penalties or premiums.
−Removed: The Company has used all proceeds from the loan to retain employees, maintain payroll and make lease and utility payments.
−Removed: Under the terms of the CARES Act, loan recipients can apply for and be granted forgiveness for all or a portion of the loans granted under the PPP.
−Removed: Such forgiveness will be subject to approval by the SBA and the lender and determined, subject to limitations, based on factors set forth in the CARES Act, including verification of the use of loan proceeds for payment of payroll costs and payments of mortgage interest, rent and utilities.
−Removed: In the event the loan, or any portion thereof, is forgiven, the amount forgiven is applied to outstanding principal.
−Removed: If the loan is not forgiven, we will be required to repay the outstanding principal, along with accrued interest.
−Removed: In January 2021, the Company applied for loan forgiveness;
−Removed: however, no assurance can be given that the Company will ultimately obtain forgiveness of the PPP loan in whole or in part.
+Added: If we or our manufacturing partners are unable to successfully scale the manufacture of any of our product candidates or, if successful, products, in sufficient quality and quantity, the development, testing and clinical trials of that product candidate or product may be delayed or infeasible, and regulatory approval or commercial launch of any potential resulting product may be delayed or not obtained, which could significantly harm our business.
+Added: Our significant reliance on third-party vendors could impair our ability to implement our business plan.
+Added: We rely on, and expect to continue to rely on, third-party vendors for many aspects of our business.
+Added: We depend on these third parties, and likely will continue to depend on them, to perform their obligations in a timely manner consistent with contractual and regulatory requirements.
+Added: We may also need to rely on certain vendors as our sole source for manufacturing or other services, establishing additional or replacement sole source vendors, if required, may not be accomplished quickly.
+Added: If we are unable to make arrangements with a vendor for a particular need, or maintain our relationship with that vendor, on commercially reasonable terms, we may not be able to develop and commercialize our
+Added: product candidates successfully or operate our business as we intend, which could harm our business, result of operations, financial condition and prospects.
Any inability to attract and retain qualified key management, technical personnel and employees would impair our ability to implement our business plan.
Our success largely depends on the continued service of key management, advisors and other specialized personnel.
−Removed: While we have a written employment agreement with each of our key employees, those employment arrangements are at-will and could be terminated at any time.
−Removed: The loss of one or more members of our executive team, management team or other key employees or advisors could delay our research and development programs and have a material and adverse
−Removed: effect on our business, financial condition, results of operations and prospects.
+Added: While we have a written employment agreement with our management team and each of our key employees, those employment arrangements are at-will and could be terminated at any time.
+Added: The loss of one or more members of our executive team, management team or other key employees or advisors could delay our research and development programs and have a material and adverse effect on our business, financial condition, results of operations and prospects.
We do not currently maintain “key man” insurance on any of our executive officers.
−Removed: In November 2020, our board of directors appointed Diane Marcou as our Interim Chief Financial Officer until a permanent successor can be named.
−Removed: We have an ongoing search in process to select the Company's next Chief Financial Officer.
−Removed: Leadership transitions can be inherently difficult to manage, and an inadequate transition to a permanent Chief Financial Officer may cause disruption within the Company.
−Removed: In addition, if we are unable to attract and retain a qualified candidate to become the permanent Chief Financial Officer in a timely manner, our financial performance and ability to meet operational goals and strategic plans could be adversely impacted.
The relationships that our key management team members have cultivated within our industry make us particularly dependent upon their continued employment with us.
We are dependent on the continued service of our technical personnel because of the highly technical nature of our product candidates and technologies and the specialized nature of the regulatory approval process.
−Removed: Because our management team and key employees are not obligated to provide us with continued service, they could terminate their employment with us at any time without penalty.
Our future success will depend in large part on our continued ability to attract and retain other highly qualified scientific, technical and management personnel, as well as personnel with expertise in clinical testing, manufacturing, governmental regulation and commercialization.
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We may need to hire and retain new employees to execute our future clinical development and manufacturing plans.
−Removed: We cannot provide assurance that we will be able to hire or retain adequate staffing levels to advance our platform, develop our potential future product candidates or run our operations or to accomplish all of our objectives.
+Added: We cannot provide assurance that we will be able to hire or retain adequate staffing levels to advance our platform, develop our potential future product candidates or run our operations or to accomplish our objectives.
We may experience difficulties in managing our growth and expanding our operations.
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Such misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation.
−Removed: For example, individuals conducting the non-interventional clinical studies that we sponsor through which we obtain antibodies for development into potential antibody-based therapeutics may violate applicable laws and regulations regarding patients’ personal data.
−Removed: It is not always possible to identify and deter
−Removed: misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.
+Added: For example, individuals conducting the non-interventional clinical studies that we sponsor through which we obtain antibodies for development into potential antibody-based therapeutics may violate
+Added: applicable laws and regulations regarding patients’ personal data.
+Added: It is not always possible to identify and deter misconduct, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.
If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a material and adverse effect on our business and financial condition, including the imposition of significant criminal, civil, and administrative fines or other sanctions, such as monetary penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government-funded healthcare programs, such as Medicare and Medicaid, integrity obligations, reputational harm and the curtailment or restructuring of our operations.
−Removed: Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation or adverse publicity and could negatively affect our operating results and business.
−Removed: We and our current and potential collaborators may be subject to federal, state and foreign data protection laws and regulations ( i.e.
−Removed: , laws and regulations that address privacy and data security).
−Removed: In the United States, numerous federal and state laws and regulations, including federal health information privacy laws ( e.g.
−Removed: , the Health Insurance Portability and Accountability Act, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH), state data breach notification laws, state health information privacy laws and federal and state consumer protection laws ( e.g.
−Removed: , Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our collaborators.
−Removed: In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under the HIPAA, as amended by HITECH, or other privacy and data security laws.
−Removed: Depending on the facts and circumstances, we could be subject to criminal penalties if we 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: International data protection laws, including Regulation 2016/679, known as the General Data Protection Regulation, or GDPR, may also apply to health-related and other personal information obtained outside of the United States.
−Removed: The GDPR went into effect on May 25, 2018.
−Removed: The GDPR introduced new data protection requirements in the European Union, as well as potential fines for noncompliant companies of up to the greater of €20 million or 4% of annual global revenue.
−Removed: The regulation imposes numerous new requirements for the collection, use and disclosure of personal information, including more stringent requirements relating to consent and the information that must be shared with data subjects about how their personal information is used, the obligation to notify regulators and affected individuals of personal data breaches, extensive new internal privacy governance obligations and obligations to honor expanded rights of individuals in relation to their personal information ( e.g.
−Removed: , the right to access, correct and delete their data).
−Removed: In addition, the GDPR includes restrictions on cross-border data transfers.
−Removed: The GDPR will increase our responsibility and liability in relation to personal data that we process where such processing is subject to the GDPR, and we may be required to put in place additional mechanisms to ensure compliance with the GDPR, including as implemented by individual countries.
−Removed: Further, national laws of member states of the EU are in the process of being adapted to the requirements under the GDPR, thereby implementing national laws which may partially deviate from the GDPR and impose different obligations from country to country, so that we do not expect to operate in a uniform legal landscape in the EEA.
−Removed: Also, as it relates to processing and transfer of genetic data, the GDPR specifically allows national laws to impose additional and more specific requirements or restrictions, and European laws have historically differed quite substantially in this field, leading to additional uncertainty.
−Removed: Finally, the United Kingdom’s vote in favor of exiting the EU, often referred to as Brexit, has created uncertainty with regard to data protection regulation in the United Kingdom.
−Removed: In particular, it is unclear how data transfers to and from the United Kingdom will be regulated.
−Removed: In addition, many state laws govern the privacy and security of health information in specified circumstances, many of which differ from each other in significant ways, are often not pre-empted by HIPAA, and may have a more prohibitive effect than HIPAA, thus complicating compliance efforts.
−Removed: California recently enacted the California Consumer Privacy Act, or CCPA, which creates new individual privacy rights for California consumers (as defined in the law) and places increased privacy and security obligations on entities handling personal data of consumers or households.
−Removed: The CCPA will require covered companies to provide new disclosure to consumers about such companies’ data collection, use and sharing practices, provide such consumers new ways to opt-out of certain sales or transfers of
−Removed: personal information, and provide consumers with additional causes of action.
−Removed: The CCPA went into effect on January 1, 2020, and the California Attorney General commenced bringing enforcement actions for violations starting on July 1, 2020.
−Removed: The CCPA was amended on September 23, 2018, and it remains unclear what, if any, further modifications will be made to this legislation or how it will be interpreted.
−Removed: While there is currently an exception for protected health information that is subject to HIPAA and clinical trial regulations, as currently written, the CCPA may impact our business activities.
−Removed: As currently written, the CCPA may impact our business activities and exemplifies the vulnerability of our business to the evolving regulatory environment related to personal data and protected health information.
−Removed: Compliance with U.S.
−Removed: and international data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions.
−Removed: Failure to comply with U.S.
−Removed: and international data protection laws and regulations could result in government enforcement actions (which could include civil or criminal penalties), private litigation or adverse publicity and could negatively affect our operating results and business.
−Removed: Moreover, clinical trial subjects about whom we or our potential collaborators obtain information, as well as the providers who share this information with us, may contractually limit our ability to use and disclose the information.
−Removed: Claims that we have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time consuming to defend and could result in adverse publicity that could harm our business.
−Removed: If we experience security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data or personal data, we may face costs, significant liabilities, harm to our brand and business disruption.
+Added: A cyber-attack or breach of our information technology systems could cause substantial costs, significant liabilities, harm to our brand and business disruption a material adverse effect on our business.
In connection with the Immunome discovery engine and efforts, we may collect and use a variety of personal data, such as name, mailing address, email addresses, phone number and clinical trial information.
−Removed: Although we have extensive measures in place to prevent the sharing and loss of patient data in our sample collection process associated with our discovery platform, any failure to prevent or mitigate security breaches or improper access to, use of, or disclosure of our clinical data or patients’ personal data could result in significant liability under state ( e.g.
−Removed: , state breach notification laws), federal ( e.g.
−Removed: , HIPAA, as amended by HITECH), and international law ( e.g.
−Removed: Additionally, we are aware that hackers have recently been targeting healthcare organizations and businesses working to develop treatments for COVID-19 and vaccines against the SARS-CoV-2 virus.
−Removed: Our work to develop a potential antibody cocktail product candidate may make us a more attractive target for a cyber-attack.
−Removed: Any failure to prevent or mitigate security breaches or improper access to, use of, or disclosure of our clinical data or patients’ personal data may cause a material adverse impact to our reputation, affect our ability to conduct new studies and potentially disrupt our business.
−Removed: We may also rely on third-party service providers to host or otherwise process some of our data and that of users, and any failure by such third party to prevent or mitigate security breaches or improper access to or disclosure of such information could have similarly adverse consequences for us.
−Removed: If we are unable to prevent or mitigate the impact of such security or data privacy breaches, we could be exposed to litigation and governmental investigations, which could lead to a potential disruption to our business.
−Removed: We depend on sophisticated information technology systems to operate our business and a cyber-attack or other breach of these systems could have a material adverse effect on our business.
−Removed: We rely on information technology systems that we or our third-party vendors operate to process, transmit and store electronic information in our day-to-day operations.
−Removed: The size and complexity of our information technology systems makes them vulnerable to a cyber-attack, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption.
+Added: Although we have extensive measures in place to prevent the sharing and loss of patient data in our sample collection process associated with our discovery platform, any failure to prevent or mitigate security breaches or improper access to, use of, or disclosure of our clinical data or patients’ personal data could result in significant liability under state (e.g., state breach notification laws), federal (e.g., HIPAA, as amended by HITECH), and international law (e.g., the GDPR).
+Added: We rely on information technology and other internal infrastructure systems that we or our third-party vendors operate to process, transmit and store electronic information in our day-to-day operations.
+Added: The size and complexity of our information technology systems makes them vulnerable to a cyber-attack, malicious intrusion, breakdown, destruction, loss of data privacy, systems failure or other significant disruption.
Additionally, we are aware that hackers have recently been targeting healthcare organizations and businesses working to develop treatments for COVID-19 and vaccines against the SARS-CoV2 virus.
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A successful attack could result in the theft or destruction of intellectual property, data, or other misappropriation of assets, or otherwise compromise our confidential or proprietary information and disrupt our operations.
−Removed: Cyber-attacks are becoming more sophisticated and frequent.
We have invested in our systems and the protection and recoverability of our data to reduce the risk of an intrusion or interruption, and we monitor and test our systems on an ongoing basis for any current or potential threats.
−Removed: There can be no assurance that these measures and efforts will prevent future interruptions or
+Added: There can be no assurance that these measures and efforts will prevent future interruptions or breakdowns.
If we or our third-party vendors fail to maintain or protect our information technology systems and data integrity effectively or fail to anticipate, plan for or manage significant disruptions to these systems, we or our third-party vendors could have difficulty preventing, detecting and controlling such cyber-attacks and any such attacks could result in losses described above as well as disputes with physicians, patients and our partners, regulatory sanctions or penalties, increases in operating expenses, expenses or lost revenues or other adverse consequences, any of which could have a material adverse effect on our business, results of operations, financial condition, prospects and cash flows.
−Removed: Our information technology systems could face serious disruptions that could adversely affect our business.
−Removed: Our information technology and other internal infrastructure systems, including corporate firewalls, servers, leased lines and connection to the internet, face the risk of systemic failure that could disrupt our operations.
−Removed: A significant disruption in the availability of our information technology and other internal infrastructure systems could cause interruptions and delays in our research and development work.
−Removed: Additionally, some of the information technology on which our discovery engine is based is provided by a single, third-party supplier.
−Removed: Any disruption in this third party’s technology or infrastructure could materially impact our ability utilize the Immunome discovery engine and could delay our research and development efforts.
If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.
−Removed: Our research, development and manufacturing involves the use of hazardous materials and various chemicals.
−Removed: We maintain quantities of various flammable and toxic chemicals in our facilities that are required for our research, development and manufacturing activities.
+Added: Our research, development and manufacturing involve the use of hazardous materials and various flammable and toxic chemicals.
We are subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials.
−Removed: We believe our procedures for storing, handling and disposing of these materials in our facilities comply with the relevant guidelines of the Commonwealth of Pennsylvania and the Occupational Safety and Health Administration of the U.S.
−Removed: Department of Labor.
−Removed: Although we believe that our safety procedures for handling and disposing of these materials comply with the standards mandated by applicable regulations, the risk of accidental contamination or injury from these materials cannot be eliminated.
−Removed: If an accident occurs, we could be held liable for resulting damages, which could be substantial.
+Added: Although we believe our procedures for storing, handling and disposing of these materials in our facilities comply with the relevant guidelines of the Commonwealth of Pennsylvania and the Occupational Safety and Health Administration of the U.S.
+Added: Department of Labor, the risk of accidental contamination or injury from these materials cannot be eliminated.
+Added: If an accident occurs, we could be held liable for substantial resulting damages.
We are also subject to numerous environmental, health and workplace safety laws and regulations, including those governing laboratory procedures, exposure to blood-borne pathogens and the handling of animals and biohazardous materials.
−Removed: Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of these materials, this insurance may not provide adequate coverage against potential liabilities.
−Removed: Although we have some environmental liability insurance covering certain of our facilities, we may not maintain adequate insurance for all environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological or hazardous materials.
+Added: Our workers’ compensation insurance may not provide adequate coverage against costs and expenses we may incur due to injuries to our employees resulting from the use of these materials.
+Added: Our current environmental liability insurance covering certain of our facilities could be inadequate for all environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological or hazardous materials.
Additional federal, state and local laws and regulations affecting our operations may be adopted in the future.
We may incur substantial costs to comply with, and substantial fines or penalties if we violate, any of these laws or regulations.
−Removed: Our current laboratory operations are concentrated in one location, and we or the third parties upon whom we depend may be adversely affected by natural or other disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
+Added: Our current laboratory operations are concentrated in one location, and we or the third parties upon whom we depend on may be adversely affected by natural or other disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
Our current business operations are concentrated in the greater Philadelphia area.
2 unchanged sentences
Natural disasters such as tornadoes, hurricanes, earthquakes, wildfires, floods or tsunamis or pandemics, such as the ongoing COVID-19 pandemic, could further disrupt our operations, and have a material negative impact on our business, financial condition, results of operations and prospects.
−Removed: For example, we have instituted a temporary work from home policy for our non-
−Removed: laboratory personnel and it is possible that this could have a negative impact on the execution of our business plans and operations.
If a natural disaster, power outage or other event occurred that prevented us from using all or a significant portion of our headquarters, that damaged critical infrastructure, such as our research facilities or the manufacturing facilities of our third-party contract manufacturers, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible, for us to continue our business for a substantial period of time.
−Removed: The disaster recovery and business continuity plans we have in place may prove inadequate in the event of a serious disaster or similar event.
+Added: The disaster recovery and business continuity plan we have in place may prove inadequate in the event of a serious disaster or similar event.
We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which could have a material adverse effect on our business.
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There is no guarantee that any patent covering this technology will issue from the patent application we own, or, if it does, that the issued claims will provide adequate protection for the Immunome discovery engine or any meaningful competitive advantage.
−Removed: In addition, under the DoD Agreement, we have a duty to disclose each invention that we conceive or reduce to practice in performing the agreement.
+Added: In addition, under the OTA Agreement, we have a duty to disclose each invention that we conceive or reduce to practice in performing the agreement.
If we fail to strictly follow these disclosure requirements, the U.S.
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A PCT patent application is an international patent application and a type of non-provisional patent application but one that does not directly mature into a granted patent.
−Removed: A PCT patent application must enter the national phase, be filed in the patent office
−Removed: of a PCT member country or region where it is examined and from which a country patent may or may not be granted.
+Added: A PCT patent application must enter the national phase, be filed in the patent office of a PCT member country or region where it is examined and from which a country patent may or may not be granted.
If a PCT national phase application is not filed in a PCT member country or region, no patent will result in that country or region from that particular PCT patent application.
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For example, there is no uniform worldwide policy regarding patentable subject matter or the scope of claims allowable in patents.
−Removed: Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our owned or in-licensed patents or narrow the scope of our patent protection.
+Added: either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our owned or in-licensed patents or narrow the scope of our patent protection.
Even if patents do successfully issue and even if such patents cover our current or any future technologies or product candidates, third parties may challenge their validity, enforceability or scope, which may result in such patents being narrowed, invalidated, or held unenforceable.
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License termination could result in a material adverse effect on our inability to develop, manufacture and sell products that are covered by the licensed technology or could enable a competitor to gain access to the licensed technology.
−Removed: In certain circumstances, our licensed patent rights are subject to our reimbursing our licensors
−Removed: for their patent prosecution and maintenance costs.
+Added: In certain circumstances, our licensed patent rights are subject to our reimbursing our licensors for their patent prosecution and maintenance costs.
For example, our license agreements with Whitehead and TJU each require us to bear the costs of filing and maintaining patent applications, and our agreement with Arrayjet requires us to reimburse Arrayjet for applicable patent costs.
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and extension is available for only those claims covering the approved drug, a method for using it, or a method for manufacturing it.
−Removed: The applicable authorities, including the FDA and the USPTO 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
−Removed: more limited extensions than we request.
+Added: The applicable authorities, including the FDA and the USPTO 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.
An extension may not be granted or may be limited where there is, for example, a failure to exercise due diligence during the testing phase or regulatory review process, failure to apply within applicable deadlines, failure to apply before expiration of relevant patents, or some other failure to satisfy applicable requirements.
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As the field of antibody-based therapeutics continues to mature, patent applications are being processed by national patent offices around the world.
−Removed: There is uncertainty about which patents will issue, and, if they do, there is uncertainty as to when, to whom, and with what claims.
+Added: There is uncertainty about which patents will issue, and, if they do, when, to whom, and with what claims.
In addition, third parties may attempt to invalidate our or our licensors’ intellectual property rights.
Even if such rights are not directly challenged, disputes could lead to the weakening of our or our licensors’ intellectual property rights.
−Removed: Our defense against any attempt by third parties to circumvent or invalidate our intellectual property rights could be costly to us, could require significant time and attention of our management, and
−Removed: could have a material and adverse impact on our profitability, financial condition and prospects or ability to successfully compete.
+Added: Our defense against any attempt by third parties to circumvent or invalidate our intellectual property rights could be costly to us, could require significant time and attention of our management, and could have a material and adverse impact on our profitability, financial condition and prospects or ability to successfully compete.
Further, we cannot guarantee that we are aware of all of patents and patent applications potentially relevant to our technology or products.
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Many companies have encountered significant difficulties in protecting and defending such rights in such jurisdictions.
−Removed: The legal systems of certain countries, including certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biotechnology, which could make it difficult for us to stop the infringement of our owned and in-licensed patents or the marketing of competing products in violation of our intellectual property and proprietary rights generally.
+Added: The legal systems of certain countries, including certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biotechnology, which
+Added: could make it difficult for us to stop the infringement of our owned and in-licensed patents or the marketing of competing products in violation of our intellectual property and proprietary rights generally.
Proceedings to enforce our owned or in-licensed intellectual property and proprietary rights in foreign jurisdictions could result in substantial costs and could divert our efforts and attention from other aspects of our business.
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The biotechnology and pharmaceutical industries are characterized by extensive and complex litigation regarding patents and other intellectual property rights.
−Removed: We or our licensors, or any future strategic partners, may be party to, or be threatened with, adversarial proceedings or litigation regarding intellectual property rights with respect to any potential future product candidates and technologies, including derivation, reexamination, inter parte s review, post-grant review or interference proceedings before the USPTO and similar proceedings in jurisdictions outside of the United States such as opposition proceedings.
+Added: We or our licensors, or any future strategic partners, may be party to, or be threatened with, adversarial proceedings or litigation regarding intellectual property rights with respect to any potential future product candidates and technologies.
In some instances, we may be required to indemnify our licensors for the costs associated with any such adversarial proceedings or litigation.
−Removed: For example, we are obligated under our license agreements with Whitehead to indemnify, hold harmless and defend Whitehead for damages from any claim of any kind arising out of or related to the license agreement with Whitehead.
−Removed: Third parties may assert infringement claims against us, our licensors or our strategic partners based on existing patents or patents that may be granted in the future, regardless of their merit.
−Removed: There is a risk that third parties may choose to engage in litigation or other adversarial proceedings with us, our licensors or our strategic partners to enforce or otherwise assert their patent rights.
−Removed: Even if we believe such claims are without merit, a court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could have a material adverse impact on our ability to utilize the Immunome discovery engine or to commercialize any future product candidates.
−Removed: In order to successfully challenge the validity of any such U.S.
−Removed: patent in federal court, we would need to overcome a presumption of validity by presenting clear and convincing evidence of invalidity.
−Removed: There is no assurance that a court of competent jurisdiction, even if presented with evidence we believe to be clear and convincing, would invalidate the claims of any such U.S.
+Added: Third parties may assert infringement claims in litigation or other adversarial proceedings against us, our licensors or our strategic partners based on existing patents or patents that may be granted in the future, regardless of their merit.
+Added: A court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could have a material adverse impact on our ability to utilize the Immunome discovery engine or to commercialize any future product candidates.
Further, we cannot guarantee that we will be able to successfully settle or otherwise resolve such adversarial proceedings or litigation.
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In addition, we or our licensors may find it necessary to pursue claims or to initiate lawsuits to protect or enforce our owned or in-licensed patent or other intellectual property rights.
−Removed: The cost to us in defending or initiating any litigation or other proceeding relating to our owned or in-licensed patent or other intellectual property rights, even if resolved in our favor, could be substantial, and any litigation or other proceeding could divert our management’s attention.
+Added: The cost to us in defending or initiating any litigation or other proceeding relating to our owned or in-licensed patent or other intellectual property rights, even if resolved in our
+Added: favor, could be substantial, and any litigation or other proceeding could divert our management’s attention.
Such litigation or proceedings could materially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities.
1 unchanged sentence
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could delay our research and development efforts and materially limit our ability to continue our operations.
−Removed: Furthermore, because of the substantial amount of discovery required in connection with certain such proceedings, there is a risk that some of our
−Removed: confidential information could be compromised by disclosure.
+Added: Furthermore, because of the substantial amount of discovery required in connection with certain such proceedings, there is a risk that some of our confidential information could be compromised by disclosure.
In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, such announcements could have a material adverse effect on the price of our common stock.
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Third party intellectual property right holders may also actively bring infringement, misappropriation or violation or other claims alleging violations of intellectual property rights against us.
−Removed: We cannot guarantee that we will be able to successfully settle or otherwise resolve such claims.
+Added: We cannot guarantee that we will be able to
+Added: successfully settle or otherwise resolve such claims.
If we are unable to successfully settle future claims on terms acceptable to us, we may be required to engage in or to continue costly, unpredictable and time-consuming litigation and may be prevented from or experience substantial delays in marketing our product candidates.
If we fail in any such dispute, in addition to being forced to pay damages, we may be temporarily or permanently prohibited from commercializing any of our current or future technologies or product candidates that are held to be infringing, misappropriating or otherwise violating third-party intellectual property rights.
−Removed: We might, if possible, also be forced to redesign current or future technologies or product candidates so that we no longer infringe, misappropriate or violate the
−Removed: third-party intellectual property rights.
+Added: We might, if possible, also be forced to redesign current or future technologies or product candidates so that we no longer infringe, misappropriate or violate the third-party intellectual property rights.
Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business, which could have a material adverse effect on our financial condition and results of operations.
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
−Removed: As referenced above, in addition to seeking patent protection for certain aspects of our current or future technologies and product candidates, we also consider trade secrets, including confidential and unpatented know-how, important to the maintenance of our competitive position.
+Added: We consider trade secrets, including confidential and unpatented know-how, important to the maintenance of our competitive position.
However, trade secrets and know-how can be difficult to protect.
2 unchanged sentences
Despite these efforts, we may not obtain these agreements in all circumstances.
−Removed: Moreover, individuals with whom we have such agreements may not comply with their terms.
−Removed: Any of these parties may breach such agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for any such breaches.
+Added: Moreover, individuals with whom we have such agreements may breach such agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for any such breaches.
We may also become involved in inventorship disputes relating to inventions and patents developed by our employees or consultants under such agreements.
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We employ reputable law firms and other professionals to help us comply with these requirements, and we are also dependent on our licensors to take the necessary action to comply with these requirements with respect to our in-licensed intellectual property.
−Removed: many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules.
+Added: In many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules.
There are situations, however, in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
4 unchanged sentences
If we are unable to establish name recognition based on our trademarks and trade names, we may not be able to compete effectively, and our business may be materially adversely affected.
−Removed: Additionally, while we own trademark registrations for the IMMUNOME mark, if such mark was challenged and found to be generic or merely descriptive, we could lose the ability to enforce our name against other parties, including competitors.
+Added: Additionally, while we own trademark registrations for the IMMUNOME mark, if such mark were challenged and found to be generic or merely descriptive, we could lose the ability to enforce our name against other parties, including competitors.
Furthermore, if a party challenges our trademark rights in the IMMUNOME mark, we would need to expend resources defending our rights.
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● issued patents that we own, in-license, or control may not provide us with any competitive advantages, or may be narrowed or held invalid or unenforceable, including as a result of legal challenges;
−Removed: ● our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights, and may then use the information learned from such activities to develop competitive products for sale in our major commercial markets;
+Added: ● our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well
+Added: as in countries where we do not have patent rights, and may then use the information learned from such activities to develop competitive products for sale in our major commercial markets;
● we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such trade secrets or know-how;
2 unchanged sentences
Risks Related to Government Regulation
+Added: Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation or adverse publicity and could negatively affect our operating results and business.
+Added: We and our current and potential collaborators may be subject to federal, state and foreign data protection laws and regulations ( i.e.
+Added: , laws and regulations that address privacy and data security).
+Added: In the United States, numerous federal and state laws and regulations, including federal health information privacy laws ( e.g.
+Added: , the Health Insurance Portability and Accountability Act, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH), state data breach notification laws, state health information privacy laws and federal and state consumer protection laws ( e.g.
+Added: , Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our collaborators.
+Added: In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under the HIPAA, as amended by HITECH, or other privacy and data security laws.
+Added: Depending on the facts and circumstances, we could be subject to criminal penalties if we 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.
+Added: International data protection laws, including Regulation 2016/679, known as the General Data Protection Regulation, or GDPR, may also apply to health-related and other personal information obtained outside of the United States.
+Added: The GDPR introduced new data protection requirements in the European Union, as well as potential fines for noncompliant companies of up to the greater of €20 million or 4% of annual global revenue.
+Added: The regulation imposes numerous new requirements for the collection, use and disclosure of personal information and includes restrictions on cross-border data transfers.
+Added: The GDPR will increase our responsibility and liability in relation to personal data that we process where such processing is subject to the GDPR, and we may be required to put in place additional mechanisms to ensure compliance with the GDPR, including as implemented by individual countries.
+Added: Further, national laws of member states of the EU are in the process of being adapted to the requirements under the GDPR, thereby implementing national laws which may partially deviate from the GDPR and impose different obligations from country to country, so that we do not expect to operate in a uniform legal landscape in the EEA.
+Added: Also, as it relates to processing and transfer of genetic data, the GDPR specifically allows national laws to impose additional and more specific requirements or restrictions, and European laws have historically differed quite substantially in this field, leading to additional uncertainty.
+Added: Finally, the United Kingdom’s vote in favor of exiting the EU, often referred to as Brexit, has created uncertainty with regard to data protection regulation in the United Kingdom.
+Added: In addition, many state laws govern the privacy and security of health information in specified circumstances, many of which differ from each other in significant ways, are often not pre-empted by HIPAA, and may have a more prohibitive effect than HIPAA, thus complicating compliance efforts.
+Added: California recently enacted the California Consumer Privacy Act, or CCPA, which creates new individual privacy rights for California consumers (as defined in the law) and places increased privacy and security obligations on entities handling personal data of consumers or households.
+Added: The CCPA requires covered companies to provide new disclosure to consumers about such companies’ data collection, use and sharing practices, provide such consumers new ways to opt-out of certain sales or transfers of personal information, and provide consumers with additional causes of action.
+Added: It remains unclear what, if any, further modifications will be made to this legislation or how it will be interpreted.
+Added: While there is currently an exception for protected health information that is subject to HIPAA and clinical trial regulations, as currently written, the CCPA may impact our business activities.
+Added: As currently written, the CCPA may impact our
+Added: business activities and exemplifies the vulnerability of our business to the evolving regulatory environment related to personal data and protected health information.
+Added: Compliance with U.S.
+Added: and international data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions.
+Added: Failure to comply with U.S.
+Added: and international data protection laws and regulations could result in government enforcement actions (which could include civil or criminal penalties), private litigation or adverse publicity and could negatively affect our operating results and business.
+Added: Moreover, clinical trial subjects about whom we or our potential collaborators obtain information, as well as the providers who share this information with us, may contractually limit our ability to use and disclose the information.
+Added: Claims that we have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time consuming to defend and could result in adverse publicity that could harm our business.
Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.
In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs.
−Removed: For example, in March 2010, the Patient Protection and Affordable Care Act, or the ACA, was enacted, which substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacted the U.S.
−Removed: pharmaceutical industry.
−Removed: Among the provisions of the ACA, of greatest importance to the pharmaceutical and biotechnology industry are the following:
−Removed: ● an annual, nondeductible fee on any entity that manufactures or imports certain specified branded prescription drugs and biologic agents apportioned among these entities according to their market share in some government healthcare programs;
−Removed: ● an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13% of the average manufacturer price for most branded and generic drugs, respectively, and capped the total rebate amount for innovator drugs at 100% of the Average Manufacturer Price, or AMP;
−Removed: ● a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for certain drugs and biologics that are inhaled, infused, instilled, implanted or injected;
−Removed: ● extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;
−Removed: ● expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for individuals with income at or below 133% of the federal poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability;
−Removed: ● a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (and increased to 70% pursuant to the Bipartisan Budget Act of 2018, or BBA, starting January 1, 2019) point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;
−Removed: ● expansion of the entities eligible for discounts under the Public Health program;
−Removed: ● a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;
−Removed: ● establishment of a Center for Medicare Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending;
−Removed: ● implementation of the federal physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine Act.”
−Removed: Some of the provisions of the ACA have yet to be fully implemented, and there have been legal and political challenges to certain aspects of the ACA.
−Removed: Since January 2017, President Trump has signed two executive orders and other directives designed to delay, circumvent, or loosen certain requirements mandated by the ACA.
−Removed: Concurrently, Congress has considered legislation that would repeal or repeal and replace all or part of the ACA.
−Removed: While Congress has not passed comprehensive repeal legislation, two bills affecting the implementation of certain taxes under the ACA have been signed into law.
−Removed: The Tax Cuts and Jobs Act of 2017, or the Tax Act, includes a provision that repealed, effective January 1, 2019, the tax-based shared responsibility payment imposed by the ACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year, that is commonly referred to as the “individual mandate.”
−Removed: Additionally, on January 22, 2018, President Trump signed a continuing resolution on appropriations for fiscal year 2018 that delayed the implementation of certain ACA-mandated fees, including the so-called “Cadillac” tax on certain high cost employer-sponsored insurance plans, the annual fee imposed on certain health insurance providers based on market share, and the medical device excise tax on non-exempt medical devices.
−Removed: On December 20, 2019, President Trump signed into law the Further Consolidated Appropriations Act (H.R.
−Removed: 1865), which repeals the Cadillac tax, the health insurance provider tax, and the medical device excise tax.
−Removed: Further, the BBA, among other things, amended the ACA, effective January 1, 2019, to close the coverage gap in most Medicare drug plans, commonly referred to as the “donut hole.” In July 2018, CMS published a final rule permitting further collections and payments to and from certain ACA qualified health plans and health insurance issuers under the ACA risk adjustment program in response to the outcome of federal district court litigation regarding the method CMS uses to determine this risk adjustment.
−Removed: Since then, the ACA risk adjustment program payment parameters have been updated annually.
−Removed: It is unclear whether the ACA will be overturned, repealed, replaced, or further amended.
−Removed: On December 14, 2018, a U.S.
−Removed: District Court Judge in the Northern District of Texas ruled that the individual mandate is an inseverable feature of the ACA, and therefore, because it was repealed as part of the Tax Act, the remaining provisions of the ACA are invalid as well.
−Removed: On December 18, 2019, the Fifth Circuit U.S.
−Removed: Court of Appeals held that the individual mandate is unconstitutional, and remanded the case to the lower court to reconsider its earlier invalidation of the full ACA.
−Removed: On March 2, 2020, the U.S.
−Removed: Supreme Court granted the petitions for writs of certiorari to review the case, although it is unclear when a decision will be made or how the Supreme Court will rule.
−Removed: In addition, there may be other efforts to challenge, repeal or replace the ACA.
−Removed: In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted.
−Removed: On August 2, 2011, the Budget Control Act of 2011 among other things, created measures for spending reductions by Congress.
−Removed: A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs.
−Removed: This includes aggregate reductions of Medicare payments to providers of 2% per fiscal year.
−Removed: These reductions went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2030 unless additional Congressional action is taken.
−Removed: These Medicare sequester reductions have been suspended from May 1, 2020 through December 31, 2020 due to the COVID-19 pandemic.
−Removed: On January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers.
−Removed: Additionally, there has been heightened governmental scrutiny recently over the manner in which manufacturers set prices for their marketed products.
−Removed: For example, there have been several recent Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.
−Removed: On March 10, 2020, the Trump administration sent “principles” for drug pricing to Congress, calling for legislation that would, among other things, cap Medicare Part D beneficiary out-of-pocket pharmacy expenses, provide an option to cap Medicare Part D beneficiary monthly out-of-pocket expenses, and place limits on pharmaceutical price increases.
−Removed: Further, the Trump administration released a “Blueprint” to lower drug prices and reduce out of pocket costs of drugs that contains additional proposals to increase manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products and reduce the out of pocket costs of drug products paid by consumers.
−Removed: HHS has solicited feedback on some of these measures and has implemented others under its existing authority.
−Removed: For example, in May 2019, CMS issued a final rule to allow Medicare Advantage Plans the option of using step therapy for Part B drugs beginning January 1, 2020.
−Removed: This final rule codified CMS’s policy change that was effective January 1, 2019.
−Removed: On July 24, 2020, President Trump signed four Executive Orders aimed at lowering drug prices.
−Removed: The Executive Orders direct the Secretary of HHS to:
−Removed: (1) eliminate protection under an Anti-Kickback Statute safe harbor for certain retrospective price reductions provided by drug manufacturers to sponsors of Medicare Part D plans or pharmacy benefit managers that are not applied at the point-of-sale;
−Removed: (2) allow the importation of certain drugs from other countries through individual waivers, permit the re-importation of insulin products, and prioritize finalization of the proposed rule to permit the importation of drugs from Canada;
−Removed: (3) ensure that payment by the Medicare program for certain Medicare Part B drugs is not higher than the payment by other comparable countries (depending on whether pharmaceutical manufacturers agree to other measures);
−Removed: and (4) allow certain low-income individuals receiving insulin and epinephrine purchased by a Federally Qualified Health Center, or FQHC, as part of the 340B drug program to purchase those drugs at the discounted price paid by the FQHC.
−Removed: In addition, in September 2020, the Executive Order of the President entitled "Lowering Drug Prices by Putting America First"
−Removed: (the "MFN Executive Order") was issued.
−Removed: The MFN Executive Order provides that it is "the policy of the United States that the Medicare program should not pay more for costly Part B or Part D prescription drugs or biological products than the most-favored-nation price"
−Removed: within the member countries of the Organization for Economic Co-operation and Development (the "MFN Price");
−Removed: and directs the Secretary of the HHS to implement rulemaking to test a payment model (the "MFN Model") pursuant to which Medicare would pay no more than the MFN Price for certain drugs covered by Medicare Parts B and D.
−Removed: On November 20, 2020, HHS, acting through CMS, issued an interim final rule with comment period to implement the MFN Model (the "MFN Interim Final Rule"), which was intended to commence on January 1, 2021.
−Removed: The MFN Interim Final Rule has been challenged in court by various groups and individual companies.
−Removed: Preliminary injunctive relief preventing the MFN Interim Final Rule from becoming effective on January 1, 2021 has been granted and such relief has not been appealed.
−Removed: Similarly, President Biden and various members of the current U.S.
−Removed: Congress have indicated that lowering drug prices continues to be a legislative and political priority, and some have introduced proposals aimed at drug pricing.
−Removed: Although a number of these, and other potential, proposals will require additional authorization to become effective, Congress and the executive branch have each indicated that it will continue to seek new legislative or administrative measures to control drug costs.
−Removed: At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures and, in some cases, designed to encourage importation from other countries and bulk purchasing.
−Removed: These new laws and initiatives may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on our future customers and accordingly, our financial operations.
+Added: See our discussion of those initiatives in the “Healthcare Reform” section.
+Added: Those new laws and initiatives may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on our future customers and accordingly, our financial operations.
We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional pricing pressures.
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Our current and future arrangements with third-party payors, providers and customers, among others, may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute our product candidates for which we obtain marketing approval.
−Removed: Restrictions under applicable federal and state healthcare laws and regulations, include the following:
−Removed: ● the federal Anti-Kickback Statute, which prohibits, among other things, a person or entity from knowingly and willfully soliciting, offering, paying, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease order, arranging for or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, by a federal healthcare program, such as Medicare or Medicaid.
−Removed: The term remuneration has been interpreted broadly to include anything of value.
−Removed: Further, courts have found that if “one purpose” of remuneration is to induce referrals, the federal Anti-Kickback statute is violated.
−Removed: Violations are subject to significant civil and criminal fines and penalties for each violation, plus up to three times the remuneration involved, imprisonment, and exclusion from government healthcare programs.
−Removed: A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.
−Removed: The Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers, and formulary managers, among others, on the other.
−Removed: There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution.
−Removed: In addition, a violation of the Anti-Kickback Statute can form the basis for a violation of the federal False Claims Act (discussed below);
−Removed: ● federal civil and criminal false claims laws and civil monetary penalties laws, including the federal False Claims Act, which provides for civil whistleblower or qui tam actions, that impose penalties against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government.
−Removed: In addition, the government may assert that a claim including items and services resulting from a referral made in violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act.
−Removed: Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims.
−Removed: The FCA also permits a private individual acting as a “whistleblower” to bring qui tam actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery or settlement.
−Removed: When an entity is determined to have violated the FCA, the government may impose civil fines and penalties for each false claim, plus treble damages, and exclude the entity from participation in Medicare, Medicaid and other federal healthcare programs;
−Removed: ● HIPAA, which imposes criminal and civil liability for executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payors, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation in connection with the delivery of or payment for healthcare benefits, items or services.
−Removed: Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
−Removed: ● HIPAA, as amended by HITECH, and their respective implementing regulations, including the Final Omnibus Rule published in January 2013, which impose obligations on certain covered entity healthcare providers, health plans, and healthcare clearinghouses as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information, and require notification to affected individuals and regulatory authorities of certain breaches of security of individually identifiable health information.
−Removed: HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions;
−Removed: ● the federal false statements statute, which prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services;
−Removed: ● the federal transparency requirements known as the federal Physician Payments Sunshine Act, created as part of ACA, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to CMS information related to payments and other transfers of value made by that entity to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
−Removed: Effective January 1, 2022, these reporting obligations will extend to include transfers of value made in the previous year to certain non-physician providers such as physician assistants and nurse practitioners;
−Removed: ● analogous local, state and foreign laws and regulations, such as state anti-kickback and false claims laws that may apply to healthcare items or services reimbursed by third party payors, including private insurers;
−Removed: local, state and foreign transparency laws that require manufacturers to report information related to payments and transfers of value to other healthcare providers and healthcare entities, marketing expenditures, or drug pricing;
−Removed: state laws that require pharmaceutical companies to register certain employees engaged in marketing activities in the location and comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government;
−Removed: and state and foreign laws governing the privacy
−Removed: and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
+Added: Restrictions under applicable federal and state healthcare laws and regulations, include:
+Added: ● the federal Anti-Kickback Statute;
+Added: ● federal civil and criminal false claims laws and civil monetary penalties laws, including the federal False Claims Act;
+Added: ● HIPAA, as amended by HITECH, and their respective implementing regulations, including the Final Omnibus Rule;
+Added: ● the federal false statements statute;
+Added: ● the federal transparency requirements known as the federal Physician Payments Sunshine Act, created as part of ACA;
+Added: ● analogous local, state and foreign laws and regulations.
Ensuring that our future business arrangements with third parties comply with applicable healthcare laws and regulations could involve substantial costs.
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Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.
−Removed: For example, in recent years, including in 2018, 2019 and 2020, the U.S.
+Added: For example, in recent years, including in 2021, the U.S.
government shut down several times and certain regulatory agencies, such as the FDA and the SEC, had to furlough critical employees and stop critical activities.
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Patients are unlikely to use our future products, if any, unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost.
−Removed: In the United States, no uniform policy for coverage and reimbursement for products exists among third-party payors.
−Removed: Therefore, coverage and reimbursement for our products can differ significantly from payor to payor.
−Removed: The process for determining whether a payor will provide coverage for a product may be separate from the process for setting the reimbursement rate that the payor will pay for the product.
−Removed: One payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage and reimbursement for the product.
−Removed: Third-party payors may also limit coverage to specific products on an approved list, or formulary, which might not include all of the FDA-approved products for a particular indication.
−Removed: We cannot be sure that coverage and reimbursement will be available for, or accurately estimate the potential revenue from, our product candidates or assure that coverage and reimbursement will be available for any product that we may develop.
−Removed: A decision by a third-party payor not to cover or not to separately reimburse for products could reduce physician utilization of our products once approved.
−Removed: Assuming there is coverage for our product candidates by a third-party payor, the resulting reimbursement payment rates may not be adequate or may require co-payments that patients find unacceptably high.
−Removed: We cannot be sure that coverage and reimbursement in the United States will be available for our current or future product candidates, or for any procedures using such product candidates, and any reimbursement that may become available may not be adequate or may be decreased or eliminated in the future.
−Removed: Cost-containment is a priority in the U.S.
−Removed: healthcare industry and elsewhere.
−Removed: As a result, government authorities and other third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications.
−Removed: Increasingly, third party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products.
−Removed: Third-party payors also may request additional clinical evidence beyond the data required to obtain marketing approval, requiring a company to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of its product.
−Removed: Commercial third-party payors often rely upon Medicare coverage policy and payment limitations in setting their reimbursement rates, but also have their own methods and approval process apart from Medicare determinations.
−Removed: Therefore, coverage and reimbursement for pharmaceutical products in the United States can
−Removed: differ significantly from payor to payor.
−Removed: Factors payors consider in determining reimbursement are based on whether the product is:
−Removed: ● a covered benefit under its health plan;
−Removed: ● safe, effective and medically necessary;
−Removed: ● appropriate for the specific patient;
−Removed: ● cost-effective;
−Removed: ● neither experimental nor investigational.
−Removed: Additionally, the regulations that govern regulatory approvals, pricing and reimbursement for new drugs and therapeutic biologics vary widely from country to country.
−Removed: Some countries require approval of the sale price of a drug or therapeutic biologic before it can be marketed.
−Removed: In many countries, the pricing review period begins after marketing approval is granted.
−Removed: In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted.
−Removed: As a result, we might obtain regulatory approval for a product in a particular country, but then be subject to price regulations that delay our commercial launch of the product, possibly for lengthy time periods, and negatively impact the revenues we are able to generate from the sale of the product in that country.
−Removed: Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates, even if our product candidates obtain regulatory approval.
−Removed: There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our product candidates.
−Removed: Historically, products launched in the European Union do not follow price structures of the United States and generally prices tend to be significantly lower.
We are subject to U.S.
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The trading price of our common stock following our IPO has been volatile, and it may continue to be volatile, with the trading price seeing significant increases and decreases from time to time.
−Removed: The market price for our common stock may be influenced by many factors, including the other risks described in this section, titled “Risk Factors” and the following:
−Removed: ● our ability to advance potential future product candidates into the clinic;
−Removed: ● results of preclinical studies and clinical trials of our potential future product candidates, or those of our competitors or potential future partners;
−Removed: ● regulatory or legal developments in the United States and other countries, especially changes in laws or regulations applicable to our products;
−Removed: ● the success of competitive products or technologies;
−Removed: ● introductions and announcements of new products by us, our future commercialization partners, or our competitors, and the timing of these introductions or announcements;
−Removed: ● actions taken by regulatory agencies with respect to our products, clinical trials, manufacturing process or sales and marketing terms;
−Removed: ● actual or anticipated variations in our financial results or those of companies that are perceived to be similar to us;
−Removed: ● the success of our efforts to acquire or in-license additional technologies, products or product candidates;
−Removed: ● developments concerning any future collaborations, including, but not limited to, those with our sources of manufacturing supply and our commercialization partners;
−Removed: ● market conditions in the pharmaceutical and biotechnology sectors;
−Removed: ● announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;
−Removed: ● developments or disputes concerning patents or other proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our products;
−Removed: ● our ability or inability to raise additional capital and the terms on which we raise it;
−Removed: ● the recruitment or departure of key personnel;
−Removed: ● changes in the structure of healthcare payment systems;
−Removed: ● actual or anticipated changes in earnings estimates or changes in stock market analyst recommendations regarding our common stock, other comparable companies or our industry generally;
−Removed: ● our failure or the failure of our competitors to meet analysts’ projections or guidance that we or our competitors may give to the market;
−Removed: ● fluctuations in the valuation of companies perceived by investors to be comparable to us;
−Removed: ● announcement and expectation of additional financing efforts;
−Removed: ● speculation in the press or investment community;
−Removed: ● trading volume of our common stock;
−Removed: ● sales of our common stock by us or our stockholders;
−Removed: ● the concentrated ownership of our common stock;
−Removed: ● changes in accounting principles;
−Removed: ● terrorist acts, acts of war or periods of widespread civil unrest;
−Removed: ● natural disasters and other calamities;
−Removed: ● general economic, industry and market conditions.
+Added: The market price for our common stock may be influenced by many factors, including the other risks described in this section, titled “Risk Factors.
“In addition, the stock markets in general, and the markets for pharmaceutical, biopharmaceutical and biotechnology stocks in particular, have experienced extreme volatility that has been often unrelated to the operating performance of the issuer, including very recently in connection with the ongoing COVID-19 pandemic, which has resulted in decreased or increased stock prices for many companies notwithstanding the lack of a fundamental change in their underlying business models or prospects.
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This type of litigation, if instituted, could result in substantial costs and a diversion of management’s attention and resources, which would harm our business, operating results, or financial condition.
−Removed: If securities or industry analysts issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.
−Removed: The trading market for our common stock is influenced by the research and reports that industry or securities analysts publish about us or our business.
−Removed: If few securities or industry analysts commence coverage of our company, the trading price for our common stock would be negatively impacted.
−Removed: If any of the analysts who cover us issue an adverse or misleading opinion regarding us, our business model, our intellectual property rights or our common stock performance, or if our target studies and operating results fail to meet the expectations of the analysts, our stock price would likely decline.
−Removed: If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, we could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.
Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
Based on the beneficial ownership of our capital stock as of December 31, 2021, our executive officers and directors, together with holders of 5% or more of our capital stock and their respective affiliates, beneficially owned approximately 35.7% of our common stock on an as-converted basis.
−Removed: As a result, these stockholders, if acting together, have significant influence over the outcome of corporate actions requiring stockholder approval, including the election
−Removed: of directors, any merger, consolidation or sale of all or substantially all of our assets and any other significant corporate transaction.
+Added: As a result, these stockholders, if acting together, have significant influence over the outcome of corporate actions requiring stockholder approval, including the election of directors, any merger, consolidation or sale of all or substantially all of our assets and any other significant corporate transaction.
The interests of these stockholders may not be the same as, and may even conflict with, your interests.
6 unchanged sentences
Of these shares, only the shares of common stock sold in the IPO have been freely tradable without restriction in the public market.
−Removed: The lock-up agreements pertaining to the IPO will expire after 180 days from the date of the final prospectus, or March 30, 2021.
In addition, shares of common stock that are either subject to outstanding options or reserved for future issuance under our 2008 Plan, 2018 Plan and 2020 Plan will become eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules, the lock-up agreements and Rule 144 and Rule 701 under the Securities Act of 1933, as amended, or the Securities Act.
3 unchanged sentences
To raise capital, we may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time.
+Added: In this regard, we filed a shelf registration statement on Form S-3, which was declared effective by the SEC on October 14, 2021, pursuant to which we may issue from time to time securities with an aggregate value of up to $200.0 million in one or more offerings at prices and terms to be determined at the time of sale, including one or more “at the market” offerings pursuant to the ATM Agreement (as defined below) with Jefferies Group LLC (which provides that, upon the terms and subject to certain conditions and limitations therein, we may elect, from time to time, to offer and sell common shares under the registration statement having an aggregate offering price of up to $75.0 million through Jefferies Group LLC).
If we sell common stock, convertible securities or other equity securities, investors may be materially diluted by subsequent sales.
6 unchanged sentences
We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act, or JOBS Act.
−Removed: For as long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting
−Removed: requirements that are applicable to other public companies that are not emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, or Section 404, reduced disclosure obligations regarding executive compensation in this Annual Report and our periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.
+Added: For as long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, or Section 404, reduced disclosure obligations regarding executive compensation in this Annual Report and our periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.
In addition, as an emerging growth company, we are only required to provide two years of audited financial statements and two years of selected financial data in this Annual Report.
33 unchanged sentences
Any such limitation may significantly reduce our ability to utilize our net operating loss carryforwards and tax credit carryforwards before they expire.
−Removed: Private placements, the IPO and other transactions that have occurred since our inception may trigger such an ownership change pursuant to Sections 382 and 383.
+Added: Private placements, the IPO and other transactions that
+Added: have occurred since our inception may trigger such an ownership change pursuant to Sections 382 and 383.
Any such limitation, whether as the result of prior issuances of securities by us, sales of our common stock by our existing stockholders or additional sales of our common stock by us, could have a material adverse effect on our results of operations in future years.
The reduction of the corporate tax rate under the Tax Cuts and Jobs Act of 2017 may cause a reduction in the economic benefit of our net operating loss carryforwards and other deferred tax assets available to us.
−Removed: Our lack of internal controls over financial reporting may affect the market for and price of our common stock.
−Removed: Our internal controls over financial reporting are not effective.
−Removed: We do not have the financial resources or personnel to develop or implement systems that would provide us with the necessary information on a timely basis so as to be able to implement financial controls.
−Removed: Our financial condition makes it difficult for us to implement a system of internal control over financial reporting, and we cannot assure you that we will be able to develop and implement the necessary controls.
−Removed: The absence of internal control over financial reporting may inhibit investors from purchasing our stock and may make it more difficult for us to raise capital or borrow money and subject us to sanctions or investigations by The Nasdaq Stock Market LLC, the SEC or other regulatory authorities.
−Removed: In addition, our common stock may not be able to remain listed on The Nasdaq Capital Market or any other securities exchange.
−Removed: Implementing any appropriate changes to our internal controls may require specific compliance training of our directors and employees, entail substantial costs in order to modify our existing accounting systems, take a significant period of time to complete and divert management’s attention from other business concerns.
−Removed: These changes may not, however, be effective in developing or maintaining internal control.
Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
2 unchanged sentences
We believe that any disclosure controls and procedures or internal controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.
−Removed: These inherent limitations include the realities that judgments
−Removed: in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake.
+Added: These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake.
Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls.
Accordingly, because of the inherent limitations in our control system, misstatements or insufficient disclosures due to error or fraud may occur and not be detected.
−Removed: We have identified material weaknesses in our internal control over financial reporting.
−Removed: If our remediation of the material weaknesses is not effective, or if we experience additional material weaknesses in the future or otherwise fail to maintain an effective system of internal controls in the future, we may not be able to accurately report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our common stock.
−Removed: In connection with our preparation and the audits of our financial statements as of and for the years ended December 31, 2020 and 2019, we and our auditor identified material weaknesses as defined under the Exchange Act and by the Public Company Accounting Oversight Board (United States) in our internal control over financial reporting.
−Removed: The material weaknesses relate to the design of our internal control over financial reporting.
+Added: We have previously identified material weaknesses in our internal control over financial reporting, which have since been remediated.
+Added: If we experience future material weaknesses or otherwise fail to maintain an effective system of internal controls in the future, we may not be able to accurately report our financial condition or results of operations.
+Added: In connection with our preparation and the audits of our financial statements as of and for the year ended December 31, 2020, we and our auditor identified material weaknesses as defined under the Exchange Act and by the Public Company Accounting Oversight Board in our internal control over financial reporting.
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our financial statements will not be prevented or detected on a timely basis.
The material weaknesses that we identified related to the lack of review of journal entries, lack of timely and effective review of financial statement account balances and our lack of maintaining a sufficient complement of personnel commensurate with our accounting and reporting requirements.
−Removed: To address these material weaknesses, we have implemented a monthly financial statement close process that includes formal review of financial statement account balances and journal entries.
−Removed: We have also created a disclosure committee consisting of key executives and accounting personnel who review the Company’s financial statements and related disclosures to oversee accounting and reporting requirements.
−Removed: We are also actively recruiting for open positions and anticipate hiring additional qualified accounting and financial reporting personnel in 2021.
−Removed: While significant progress has been made to enhance our internal control over financial reporting, we are still in the process of implementing, documenting and testing these processes, procedures and controls.
−Removed: We will continue to devote significant time and attention to these remediation efforts.
−Removed: However, the material weaknesses cannot be considered remediated until the applicable remedial controls operate for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively.
−Removed: We and our auditor were not required to perform an evaluation of our internal control over financial reporting as of December 31, 2020 and 2019 in accordance with the provisions of the Sarbanes-Oxley Act.
−Removed: Accordingly, we cannot provide assurance that we have identified all, or that we will not in the future have additional, material weaknesses.
−Removed: Material weaknesses may still exist when we report on the effectiveness of our internal control over financial reporting as required by reporting requirements under Section 404.
−Removed: If we fail to remediate the material weaknesses identified above, our management may conclude that our internal control over financial reporting is not effective.
−Removed: This conclusion could adversely impact the market price of our shares due to a loss of investor confidence in the reliability of our reporting processes.
−Removed: Furthermore, if we fail to establish and maintain effective internal control over financial reporting in the future, our operating results and our ability to operate our business could be harmed.
−Removed: Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be a stockholder’s sole source of gain.
+Added: We initiated several steps to evaluate and implement measures designed to improve our internal control over financial reporting in order to remediate the control deficiencies noted above.
+Added: These steps include hiring a Chief Financial Officer, a Corporate Controller, and a Finance Manager who are responsible for the preparation and review of the Company’s financial statements and related disclosures.
+Added: In addition, we enhanced our reporting process, thereby reducing the risk of undetected errors, by (i) implementing a monthly financial statement close process that includes formal review of financial statement account balances and journal entries, and (ii) creating a disclosure committee consisting of key executives and accounting personnel who review the Company’s financial statements and related disclosures on a quarterly basis.
+Added: As a result of these efforts, the Company determined that the material weaknesses were remediated and our internal control over financial reporting was effective as of December 31, 2021.
+Added: If, in the future, we identify further material weaknesses in our internal controls over financial reporting, we may not detect errors on a timely basis, and our financial statements may be materially misstated.
+Added: We or our independent registered public accounting firm may not be able to conclude on an ongoing basis that we have effective internal control over financial reporting, which could harm our operating results, cause investors to lose confidence in our reported financial information and cause the trading price of our stock to fall.
+Added: In addition, as a public company, we will be required to file accurate and timely quarterly and annual reports with the SEC under the Exchange Act.
+Added: Any failure to report our financial results on an accurate and timely basis could result in sanctions, lawsuits, delisting of our shares from The Nasdaq Global Select Market or other adverse consequences that would materially harm our business.
+Added: In addition, we could become subject to investigations by Nasdaq, the SEC, and other regulatory authorities, and become subject to litigation from investors and stockholders, which could harm our reputation and our financial condition, or divert financial and management resources from our core business.
+Added: An independent registered public accounting firm has not performed an evaluation of our internal control over financial reporting in accordance with the provision of the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act, because no such evaluation has been required.
+Added: Had an independent registered public accounting firm performed an evaluation of our internal control over financial reporting in accordance with the provisions of the Sarbanes-Oxley Act, material weaknesses may have been identified.
+Added: Capital appreciation, if any, will be a stockholder’s sole source of gain.
We have never declared or paid cash dividends on our capital stock.
13 unchanged sentences
These provisions would apply even if the proposed merger or acquisition could be considered beneficial by some stockholders.
−Removed: Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and, to the extent enforceable, the federal district courts of the United States of America will be the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
+Added: The choice of forum provision in our certificate of incorporation limits our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law:
3 unchanged sentences
or any action asserting a claim against us that is governed by the internal affairs doctrine.
−Removed: This provision would not apply to suits brought to enforce a duty or liability created by the Exchange Act.
+Added: This provision would not apply to suits brought to enforce a duty or
+Added: liability created by the Exchange Act.
Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions.
4 unchanged sentences
Unresolved Staff Comments
−Removed: We currently lease 11,000 square feet of office and laboratory space in Exton, Pennsylvania under a lease that expires on August 31, 2022.
+Added: We currently lease 11,000 square feet of office and laboratory space in Exton, Pennsylvania under a lease that expires on March 31, 2024.
We believe the leased space is sufficient to meet our immediate facility needs, and that any additional space we may require will be available on commercially reasonable terms.
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.