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Associated with Our Business
−Removed: COVID-19 coronavirus or other global pandemics could adversely impact our business, including our clinical trials.
−Removed: We cannot predict
−Removed: the ultimate effects of the Covid-19 pandemic on our business.
−Removed: COVID-19 pandemic had and continues to have a major disruptive effect in the US and worldwide, including in countries in which there
−Removed: are planned or active clinical trial sites studying Ampligen.
−Removed: The COVID-19 pandemic or a future major pandemic could severely impact
−Removed: our business and clinical trials, including:
−Removed: or difficulties in enrolling patients in our clinical trials;
−Removed: or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;
−Removed: of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial
−Removed: sites and hospital staff supporting the conduct of our clinical trials;
−Removed: of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by
−Removed: federal or state governments, employers and others;
−Removed: in employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees
−Removed: or their families or the desire of employees to avoid contact with large groups of people;
−Removed: in issuing reports, results and publishing papers;
−Removed: in receiving approval from local regulatory authorities to initiate our planned clinical trials;
−Removed: in clinical sites receiving the supplies and materials needed to conduct our clinical trials;
−Removed: in global shipping that may affect the transport of clinical trial materials, such as investigational drug product used in our clinical
−Removed: in local regulations as part of a response to the COVID-19 coronavirus outbreak which may require us to change the ways in which
−Removed: our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;
−Removed: in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations
−Removed: in employee resources or forced furlough of government employees;
−Removed: of the FDA to accept data from clinical trials in affected geographies outside the United States.
−Removed: noted elsewhere in this Report, progress of our commercial launch in Argentina has been delayed due to pandemic factors.
−Removed: impact of COVID-19 in Argentina is taxing the nation’s health care system and is, understandably, a main priority of its regulators.
−Removed: we are not able to estimate the effects of the COVID-19 outbreak or future pandemics, they may have a material adverse effect on our
−Removed: results of future operations, financial position and liquidity.
may require additional financing which may not be available.
−Removed: development of our products requires the commitment of substantial resources to conduct the time-consuming research, preclinical development,
−Removed: and clinical trials that are necessary to bring pharmaceutical products to market.
−Removed: As of December 31, 2022 we had approximately $34,190,000
−Removed: in cash and cash equivalents.
−Removed: We believe, based on our current financial condition, that we have adequate funds to meet our anticipated
−Removed: operational cash needs and fund current clinical trials over approximately the next sixteen months.
−Removed: At present we do not generate any
−Removed: material revenues from our operations and we do not anticipate doing so in the near future.
−Removed: We may need to obtain additional funding
−Removed: in the future for new studies and/or if current studies do not yield positive results, require unanticipated changes and/or additional
−Removed: In February 2022, the SEC declared our universal shelf registration statement on Form S-3 effective.
−Removed: Pursuant to that registration
−Removed: statement, we can sell up to $100 million of our securities and raise additional capital as needed in the future.
−Removed: No assurance can be
−Removed: given as to the amount of funds that could be raised pursuant to this registration statement or the potential dilution to current stockholders.
+Added: development of our products requires the commitment of substantial resources to conduct the time-consuming research, preclinical
+Added: development, and clinical trials that are necessary to bring pharmaceutical products to market.
+Added: As of December 31, 2023, we had
+Added: approximately $13,070,000 in cash and cash equivalents.
+Added: At present we do not generate any material revenue from our operations, and
+Added: we do not anticipate doing so in the near future.
+Added: We may need to obtain additional funding in the future for new studies and/or if
+Added: current studies do not yield positive results, require unanticipated changes and/or additional studies.
+Added: In February 2022, the SEC
+Added: declared our universal shelf registration statement on Form S-3 effective.
+Added: Pursuant to that registration statement, we can sell up
+Added: to $100 million of our securities and raise additional capital as needed in the future.
+Added: Subsequent to the end of 2023, we raised
+Added: $2,500,000 in net proceeds from the sale of an unsecured Note and we have entered into an equity line agreement (see, Part II;
+Added: Management’s Discussion and Analysis
+Added: of Financial Condition and Results of Operations and Part I;
+Added: Atlas Equity Line of Credit ).
+Added: No assurance can be given as to the amount of funds that could be
+Added: raised pursuant to this registration statement or the potential dilution to current stockholders.
will need to allocate capital to eventually commercialize and sell Ampligen and/or recommence sales of Alferon N Injection.
believe, based on our current financial condition, that we have adequate funds to meet our anticipated operational cash needs and fund
−Removed: current clinical trials over approximately the next sixteen months.
−Removed: If our funds are not adequate, and we are subsequently unable to
−Removed: obtain additional funding, through joint venturing, sales of securities and/or otherwise, our ability to develop our products, commercially
+Added: current clinical trials over approximately the next twenty-four months.
+Added: If our funds are not adequate, and we are subsequently unable
+Added: to obtain additional funding, through joint venturing, sales of securities and/or otherwise, our ability to develop our products, commercially
produce inventory or continue our operations may be materially adversely affected.
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clinical trials and other studies, a product candidate could fail to receive regulatory approval for many reasons, including the following:
−Removed: be able to demonstrate to the satisfaction of the FDA that our product candidate is safe
−Removed: and effective for any indication;
+Added: be able to demonstrate to the satisfaction of the FDA that our product candidate is safe and effective for any indication;
FDA may disagree with the design or implementation of our clinical trials or other studies;
−Removed: results of the clinical trials or other studies may not demonstrate that a product candidate’s
−Removed: clinical and other benefits outweigh its safety risks;
+Added: results of the clinical trials or other studies may not demonstrate that a product candidate’s clinical and other benefits
+Added: outweigh its safety risks;
FDA may disagree with our interpretation of data from clinical trials or other studies;
−Removed: data collected from clinical trials and other studies of a product candidate may not be sufficient
−Removed: to support the submission of an NDA;
−Removed: approval policies or regulations of the FDA may significantly change in a manner rendering
−Removed: our clinical and other study data insufficient for approval;
+Added: data collected from clinical trials and other studies of a product candidate may not be sufficient to support the submission of an
+Added: approval policies or regulations of the FDA may significantly change in a manner rendering our clinical and other study data insufficient
+Added: for approval;
FDA may not approve the proposed manufacturing processes and facilities for a product candidate.
+Added: COVID-19 coronavirus or other global pandemics could adversely impact our business, including our clinical trials.
+Added: We cannot predict
+Added: the ultimate effects of the COVID-19 virus on our business.
+Added: COVID-19 pandemic had and to a certain extent continues to have a major disruptive effect in the US and worldwide, including in countries
+Added: in which there are planned or active clinical trial sites studying Ampligen.
+Added: The COVID-19 pandemic or a future major pandemic could severely
+Added: impact our business and clinical trials, including:
+Added: or difficulties in enrolling patients in our clinical trials;
+Added: or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;
+Added: of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial
+Added: sites and hospital staff supporting the conduct of our clinical trials;
+Added: of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by
+Added: federal or state governments, employers and others;
+Added: in employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees
+Added: or their families or the desire of employees to avoid contact with large groups of people;
+Added: in issuing reports, results and publishing papers;
+Added: in receiving approval from local regulatory authorities to initiate our planned clinical trials;
+Added: in clinical sites receiving the supplies and materials needed to conduct our clinical trials;
+Added: in global shipping that may affect the transport of clinical trial materials, such as investigational drug product used in our clinical
+Added: in local regulations as part of a response to the COVID-19 coronavirus outbreak which may require us to change the ways in which
+Added: our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;
+Added: in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations
+Added: in employee resources or forced furlough of government employees;
+Added: of the FDA to accept data from clinical trials in affected geographies outside the United States.
+Added: noted elsewhere in this Report, progress of our commercial launch in Argentina has been delayed due to pandemic factors.
+Added: impact of COVID-19 in Argentina is taxing the nation’s health care system and is, understandably, a main priority of its regulators.
+Added: we are not able to estimate the effects of the COVID-19 outbreak or future pandemics, they may have a material adverse effect on our
+Added: results of future operations, financial position, and liquidity.
may be subject to product liability claims from the use of Ampligen, Alferon N Injection, or other of our products which could negatively
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obtained insurance coverage to mitigate any potential significant loss in this area.
−Removed: rely upon information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cyber
−Removed: security incidents, could harm our ability to operate our business effectively.
+Added: rely upon information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity
+Added: incidents, could harm our ability to operate our business effectively.
operations could be disrupted if our information systems fail, if we are unsuccessful in implementing necessary upgrades or if we are
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a material adverse effect on our business, results of operations, financial condition, and cash flows.
−Removed: Company and its vendors’ sophisticated information technology operations are spread across multiple, sometimes inconsistent, platforms,
+Added: and our vendors’ sophisticated information technology operations are spread across multiple, sometimes inconsistent, platforms,
which pose difficulties in maintaining data integrity across systems.
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cloud-based computing, creates opportunities for the unintentional or improper dissemination or destruction of confidential information
−Removed: stored in the Company’s systems.
+Added: stored in our systems.
breach of our security measures or the accidental loss, inadvertent disclosure, unapproved dissemination, misappropriation or misuse
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on our business, financial condition, results of operations, cash flows and stock price.
+Added: Please see Part I;
+Added: Item 1C “Cybersecurity”
loss of services of key personnel could hurt our chances for success.
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Associated with Our Products
−Removed: addition to the risks disclosed above, the development of Ampligen is subject to a number of significant risks.
+Added: The development of
+Added: Ampligen is subject to significant risks.
Ampligen may be found
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the extent that we are required by the FDA, pursuant to the Ampligen NDA, to conduct additional studies and take additional actions,
−Removed: approval of any applications that we submit may be delayed by several years, or may require us to expend more resources than we have
−Removed: It is also possible that additional studies, if performed and completed, may not be successful or considered sufficient by
−Removed: the FDA for approval or even to make our applications approvable.
−Removed: If any of these outcomes occur, we may be forced to abandon one or
−Removed: more of our future applications for approval, which might significantly harm our business and prospects.
−Removed: As a result, we cannot predict
−Removed: when or whether regulatory approval will be obtained for any product candidate we develop.
+Added: approval of any applications that we submit may be delayed by several years or may require us to expend more resources than we have available.
+Added: It is also possible that additional studies, if performed and completed, may not be successful or considered sufficient by the FDA for
+Added: approval or even to make our applications approvable.
+Added: If any of these outcomes occur, we may be forced to abandon one or more of our
+Added: future applications for approval, which might significantly harm our business and prospects.
+Added: As a result, we cannot predict when or whether
+Added: regulatory approval will be obtained for any product candidate we develop.
approved, one or more of the potential side effects of the drug might deter usage of Ampligen in certain clinical situations and, therefore,
could adversely affect potential revenues and physician/patient acceptability of our product.
+Added: The development of Alferon N Injection
+Added: is subject to significant risks.
Alferon N Injection is approved for marketing in the United States for intralesional treatment of refractory or recurring external genital
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of our product.
−Removed: We believe that Ampligen has been generally well tolerated with a low incidence of clinical toxicity, particularly given the severely
−Removed: debilitating or life-threatening diseases that have been treated.
−Removed: A mild flushing reaction has been observed in approximately 15-20%
−Removed: of patients treated in our various studies.
−Removed: This reaction is occasionally accompanied by a rapid heartbeat, a tightness of the chest,
−Removed: urticaria (swelling of the skin), anxiety, shortness of breath, subjective reports of “feeling hot”, sweating and nausea.
−Removed: The reaction is usually infusion-rate related and can generally be controlled by reducing the rate of infusion.
−Removed: Other adverse side effects
−Removed: include liver enzyme level elevations, diarrhea, itching, asthma, low blood pressure, photophobia, rash, visual disturbances, slow or
−Removed: irregular heart rate, decreases in platelets and white blood cell counts, anemia, dizziness, confusion, elevation of kidney function
−Removed: tests, occasional temporary hair loss and various flu-like symptoms, including fever, chills, fatigue, muscular aches, joint pains, headaches,
−Removed: nausea and vomiting.
+Added: believe that Ampligen has been generally well tolerated with a low incidence of clinical toxicity, particularly given the severely debilitating
+Added: or life-threatening diseases that have been treated.
+Added: A mild flushing reaction has been observed in approximately 15-20% of patients treated
+Added: in our various studies.
+Added: This reaction is occasionally accompanied by a rapid heartbeat, a tightness of the chest, urticaria (swelling
+Added: of the skin), anxiety, shortness of breath, subjective reports of “feeling hot”, sweating and nausea.
+Added: The reaction is usually
+Added: infusion-rate related and can generally be controlled by reducing the rate of infusion.
+Added: Other adverse side effects include liver enzyme
+Added: level elevations, diarrhea, itching, asthma, low blood pressure, photophobia, rash, visual disturbances, slow or irregular heart rate,
+Added: decreases in platelets and white blood cell counts, anemia, dizziness, confusion, elevation of kidney function tests, occasional temporary
+Added: hair loss and various flu-like symptoms, including fever, chills, fatigue, muscular aches, joint pains, headaches, nausea and vomiting.
These flu-like side effects typically subside within several months.
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could adversely affect potential revenues and physician/patient acceptability of our product.
−Removed: At present, Alferon N Injection is approved for the intralesional (within the lesion) treatment of refractory or recurring
−Removed: external genital warts in adults.
−Removed: In clinical trials conducted for the treatment of genital warts with Alferon N Injection, patients
−Removed: did not experience serious side effects;
−Removed: however, there can be no assurance that unexpected or unacceptable side effects will not be
−Removed: found in the future for this use or other potential uses of Alferon N Injection which could threaten or limit such product’s usefulness.
−Removed: Related to our activities associated with Ampligen’s potential effectiveness as a treatment for COVID-19
−Removed: is not possible to predict the future of the ongoing SARS-CoV-2 global pandemic or the development of potential treatments.
−Removed: can be given that Ampligen will aid in or be applied to the treatment of this virus.
−Removed: additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 and no assurance
−Removed: can be given that it will be the case.
−Removed: We base our belief that Ampligen may be effective in the treatment of COVID-19 on the result of
−Removed: studies that we reviewed and referenced.
−Removed: No assurance can be given that future studies will not result in findings that are different
−Removed: from those in the studies that we have relied upon.
−Removed: We are one of many companies working to develop a treatment for this virus, most
−Removed: of whom have far greater resources than us.
−Removed: This includes research into a range of COVID-19-related circumstances, from prophylactic
−Removed: and early-onset treatments to therapies for Post-COVID conditions.
−Removed: If one of these companies develops an effective treatment along the
−Removed: same lines as a therapy being developed by AIM, the development of Ampligen for this virus most likely will be adversely affected.
−Removed: there already are available treatments.
+Added: present, Alferon N Injection is approved for the intralesional (within the lesion) treatment of refractory or recurring external genital
+Added: warts in adults.
+Added: In clinical trials conducted for the treatment of genital warts with Alferon N Injection, patients did not experience
+Added: serious side effects;
+Added: however, there can be no assurance that unexpected or unacceptable side effects will not be found in the future
+Added: for this use or other potential uses of Alferon N Injection which could threaten or limit such product’s usefulness.
+Added: Related to our activities associated with Ampligen’s potential effectiveness as a treatment for COVID-19 of Post-COVID Conditions
+Added: It is not possible to predict the future of COVID-19, and related Post-COVID
+Added: Conditions, as a global public health threat or the development of related therapies.
+Added: No assurance can be given that Ampligen will aid
+Added: in or be applied to the treatment of this virus.
+Added: additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 or Post-COVID
+Added: conditions, and no assurance can be given that it will be the case.
+Added: We base our belief that Ampligen may be effective in the treatment
+Added: of COVID-19 or Post-COVID conditions on the result of studies that we reviewed and referenced.
+Added: No assurance can be given that future
+Added: studies will not result in findings that are different from those in the studies that we have relied upon.
+Added: We are one of many companies
+Added: working to develop a treatment for this virus, most of whom have far greater resources than us.
+Added: This includes research into a range of
+Added: COVID-19-related circumstances, from prophylactic and early-onset treatments to therapies for Post-COVID conditions.
+Added: If one of these
+Added: companies develops an effective treatment along the same lines as a therapy being developed by AIM, the development of Ampligen for this
+Added: virus most likely will be adversely affected.
+Added: Moreover, there already are available treatments.
in foreign countries carries with it many risks.
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Associated with Our R&D
+Added: cannot predict what additional studies and/or additional testing or information may be required by the FDA.
+Added: Accordingly, we are unable
+Added: to estimate the nature, timing, costs and necessary efforts to complete these projects nor the anticipated completion dates.
+Added: we have no basis for estimating when material net cash inflows may commence.
+Added: We have yet to generate significant revenues from the sale
+Added: of these developmental products.
to the inherent uncertainty involved in the design and conduct of clinical trials and the applicable regulatory requirements, including
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Associated with Our Manufacturing
−Removed: Injection commercial sales were halted due to lack of finished goods inventory.
+Added: Alferon N Injection Commercial Sales were halted due to lack of finished goods inventory.
If we are unable to gain the necessary FDA
−Removed: approvals related to Alferon N Injection, our operations most likely will be materially and/or adversely affected.
+Added: approvals related to Alferon N Injection, or if we are unable to identify a CMO or CMOs that meet our requirements, then our operations
+Added: would most likely be materially and/or adversely affected.
are exploring engaging a Contract Manufacturing Organization (“CMO”) to produce Alferon API.
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Additionally, although our old New Brunswick facility was FDA approval under the
−Removed: BLA for Alferon N Injection and we intend to maintain a certain amount of space at that facility, this status will need to be reapproved
−Removed: when a CMO or a new facility is identified for the production of the drug.
−Removed: We cannot provide any guarantee that a CMO or other future
−Removed: facility will pass an FDA pre-approval inspection for Ampligen or Alferon N Injection manufacture.
+Added: BLA for Alferon N Injection, this status will need to be reapproved when a CMO or a new facility is identified for the production of
+Added: We cannot provide any guarantee that a CMO or other future facility will pass an FDA pre-approval inspection for Ampligen or
+Added: Alferon N Injection manufacture.
we are unable to gain the necessary FDA approvals related to the manufacturing process and/or final product of new Alferon N Injection
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no assurance that we will be able to obtain such products and materials on terms acceptable to us or at all.
−Removed: we have produced limited quantities of active pharmaceutical ingredients (“API”) for our products in our old New Brunswick,
−Removed: NJ facility, the sale of this facility necessitates our exploring the engagement of a CMO to produce API for both Ampligen and Alferon.
+Added: we produced limited quantities of active pharmaceutical ingredients (“API”) for our products in our old New Brunswick, NJ
+Added: facility, the sale of this facility necessitated our exploring the engagement of a CMO to produce API for both Ampligen and Alferon.
While we believe we have sufficient API to meet our current Ampligen needs, we are also continually exploring new efficiencies so as
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Manufacturing” above.
−Removed: are a limited number of organizations in the United States available to provide the final manufacturing steps of formulation, fill, finish
+Added: are limited number of organizations in the United States available to provide the final manufacturing steps of formulation, fill, finish
and packing sets for Alferon N Injection and Ampligen.
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Manufacturing” above.
−Removed: is no assurance that, upon successful, manufacture of a drug on a limited-scale basis for investigational use will lead to a successful
+Added: is no assurance that, upon success, manufacture of a drug on a limited-scale basis for investigational use would lead to a successful
transition to commercial, large-scale production.
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final approval to begin commercial sales.
−Removed: This testing and approval process is currently delayed due to the COVID-19 pandemic and ANMAT’s
−Removed: internal processes.
+Added: This testing and approval process is currently delayed due ANMAT’s internal processes.
Once final approval by ANMAT is obtained, GP Pharm will begin distributing Ampligen in Argentina.
−Removed: We continue to
−Removed: pursue our Ampligen NDA, for the treatment of CFS with the FDA.
+Added: We continue to pursue our Ampligen
+Added: NDA, for the treatment of CFS with the FDA.
Associated with Our Marketing and Distribution
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other regulatory product approvals more rapidly than us.
−Removed: There are no drugs approved for commercial sale with respect to treating CFS
−Removed: in the United States, and standard of care is to focus on symptom relief, such as addressing pain specifically or depression specifically
−Removed: The dominant competitors with drugs to treat disease indications which we plan to address include Pfizer, GlaxoSmithKline, Merck &
−Removed: Co., Novartis and AstraZeneca.
−Removed: Biotech competitors include Baxter International, Fletcher/CSI, AVANT Immunotherapeutics, AVI BioPharma
−Removed: These potential competitors are among the largest pharmaceutical companies in the world, are well known to the public and
−Removed: the medical community, and have substantially greater financial resources, product development, and manufacturing and marketing capabilities
−Removed: than we have.
−Removed: Although we believe our principal advantage is the unique mechanism of action of Ampligen on the immune system, we cannot
−Removed: assure that we will be able to compete.
+Added: There are no drugs approved for U.S.
+Added: commercial sale for the treatment of CFS;
+Added: standard of care is to focus on symptom relief, such as addressing pain or depression.
+Added: The dominant competitors with drugs to treat disease
+Added: indications which we plan to address include Pfizer, GlaxoSmithKline, Merck & Co., Novartis and AstraZeneca.
+Added: Biotech competitors
+Added: include Baxter International, Fletcher/CSI, AVANT Immunotherapeutics, AVI BioPharma and Genta.
+Added: These potential competitors are among
+Added: the largest pharmaceutical companies in the world, are well known to the public and the medical community, and have substantially greater
+Added: financial resources, product development, and manufacturing and marketing capabilities than we have.
+Added: Although we believe our principal
+Added: advantage is the unique mechanism of action of Ampligen on the immune system, we cannot assure that we will be able to compete.
Our competitors are among the largest pharmaceutical companies in the world, are well known to the public and the medical
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This is especially true given the current significant instability
−Removed: in the financial markets, in part caused by the COVID-19 coronavirus and the major adverse effects it has had and will continue to have
−Removed: and worldwide economies and markets as well as the adverse effects and disruptions caused by the war in the Ukraine.
−Removed: progress slow or results of testing or activities by others negatively impact our efforts, it is just as likely that our stock price
−Removed: will be significantly adversely affected, and in such case, investors could sustain substantial losses.
−Removed: In addition to the foregoing
−Removed: and, general economic, political and market conditions, the price and trading volume of our stock could fluctuate widely in response
−Removed: to many factors, including:
+Added: in the financial markets, and the adverse effects and disruptions caused by the war in the Ukraine, Israel and Gaza.
+Added: Should our progress
+Added: slow or results of testing or activities by others negatively impact our efforts, it is just as likely that our stock price will be significantly
+Added: adversely affected, and in such case, investors could sustain substantial losses.
+Added: In addition to the foregoing and, general economic,
+Added: political and market conditions, the price and trading volume of our stock could fluctuate widely in response to many factors, including:
announcements
62 unchanged sentences
Series A Junior Participating Preferred Stock, par value $0.01 per share at a Purchase Price of $21.00 per Unit, subject to adjustment.
−Removed: While our Rights Agreement was scheduled to expire in late 2022, we have extended it for a short period of time and expect to again extend
−Removed: it for a longer period of time.
−Removed: associated with Stockholder activism.
+Added: While our Rights Agreement was scheduled to expire in late 2022, we extended it on May 14, 2023 and will now expire on May 14, 2028.
business, financial condition and operating results could be negatively affected as a result of actions by activist investors.
−Removed: activist stockholder (the “Activist”) submitted a notice to our Board, purporting to nominate two nominees to our three-member
−Removed: Board at the 2022 Annual Meeting of Stockholders.
−Removed: We informed the Activist that our Board determined its purported notice of nomination
−Removed: was invalid, as it did not comply with our Amended and Restated Bylaws.
−Removed: We initiated a lawsuit against the Activist, the Activist’s
−Removed: two nominees, and four additional individuals–all of whom we believe to be acting as a group, orchestrated and funded by two convicted
−Removed: securities law felons, to attempt to effectuate a takeover of our Board without registering as a group pursuant to U.S.
−Removed: securities laws
−Removed: and some of whom we believe have committed other unlawful actions.
−Removed: The Activist subsequently sued AIM and each of our board members in
−Removed: the Court of Chancery of the State of Delaware, seeking a declaratory judgment that the purported notice of nominations was valid and
−Removed: certain injunctive relief.
−Removed: The Delaware Chancery Court denied the Activist’s motion on October 28, 2022, and the Activist announced
−Removed: on November 2, 2022, that it did not intend to appeal the decision.
−Removed: Had the Activist prevailed in its lawsuit, we most likely would have
−Removed: been involved in a proxy contest for control of our Board, despite the deficiencies in the Activist’s purported notice of nominations.
−Removed: Certain members of this group also persistently disparaged the stock using alias names on message boards.
−Removed: Even though we prevailed in
−Removed: the Delaware litigation, the litigation and the campaign by the Activist and those with whom the Activist is acting in concert against
−Removed: us (which includes two convicted securities law felons) has, and will have, likely diverted the time and energies of management and required
−Removed: us to incur substantial expense, possibly causing a decrease in stockholder value.
+Added: activist group (the “Activist Group”) submitted a notice (the “Notice”) to our Board, seeking to put forth three
+Added: individuals for election as directors to our four-person Board at our 2023 Annual Meeting.
+Added: The Activist Group includes many of the persons
+Added: who made a similar but failed attempt at our 2022 Annual Meeting.
+Added: The Board once again found that the Activist Group’s Notice was
+Added: invalid and rejected it.
+Added: After a full trial, the Delaware Chancery Court upheld our rejection.
proxy contest and related litigation, along the lines discussed above, could have a material adverse effect on us for the following reasons:
−Removed: investors may attempt to effect changes in our governance and strategic direction or to acquire
−Removed: control over the Board or AIM.
−Removed: In particular, if the Activist is successful in its litigation
−Removed: and subsequent proxy contest, it may gain control of the Board.
−Removed: we welcome the opinions of all stockholders, responding to proxy contests and related litigation
−Removed: by activist investors is likely to be costly and time-consuming, disrupt our operations,
−Removed: and potentially divert the attention of our Board, management team and other employees away
−Removed: from their regular duties and the pursuit of business opportunities to enhance stockholder
−Removed: uncertainties as to our future direction as a result of potential changes to the composition
−Removed: of the Board may lead to the perception of a change in the strategic direction of the business,
−Removed: instability or lack of continuity, which may cause concern to our existing or potential strategic
−Removed: partners, customers, employees and stockholders;
+Added: investors may attempt to effect changes in our governance and strategic direction or to acquire control over the Board or AIM.
+Added: particular, if the Activist is successful in its litigation and subsequent proxy contest, it may gain control of the Board.
+Added: we welcome the opinions of all stockholders, responding to proxy contests and related litigation by activist investors is likely
+Added: to be costly and time-consuming, disrupt our operations, and potentially divert the attention of our Board, management team and other
+Added: employees away from their regular duties and the pursuit of business opportunities to enhance stockholder value.
+Added: uncertainties as to our future direction as a result of potential changes to the composition of the Board may lead to the perception
+Added: of a change in the strategic direction of the business, instability or lack of continuity, which may cause concern to our existing
+Added: or potential strategic partners, customers, employees and stockholders;
may be exploited by our competitors;
−Removed: result in the loss of potential business opportunities or limit our ability to timely initiate
−Removed: or advance clinical trials;
−Removed: and may make it more difficult to attract and retain qualified
−Removed: personnel and business partners.
−Removed: contests and related litigation by activist investors could cause significant fluctuations
−Removed: in our stock price based on temporary or speculative market perceptions or other factors
−Removed: that do not necessarily reflect the underlying fundamentals and prospects of our business.
−Removed: Staff Comments.
+Added: may result in the loss
+Added: of potential business opportunities or limit our ability to timely initiate or advance clinical trials;
+Added: and may make it more difficult
+Added: to attract and retain qualified personnel and business partners.
+Added: contests and related litigation by activist investors could cause significant fluctuations in our stock price based on temporary
+Added: or speculative market perceptions or other factors that do not necessarily reflect the underlying fundamentals and prospects of our
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.