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1:22-cv-03125, filed on May 26, 2022, and the other captioned Kashif Memon v.
−Removed: Spero Therapeutics, Inc., Ankit Mahadevia, and Satyavrat Shukla Case No.
+Added: Spero Therapeutics,
+Added: Inc., Ankit Mahadevia, and Satyavrat Shukla Case No.
1:22-cv-04154, filed on July 15, 2022.
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The Amended Complaint generally alleges that we and certain of our current and former officers violated Sections 10(b) and/or 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements concerning the New Drug Application (“NDA”) for tebipenem HBr in an effort to lead investors to believe that the drug would receive approval from the FDA.
−Removed: Plaintiffs seek unspecified damages, interest,
−Removed: attorneys’ fees, and other costs.
+Added: Plaintiffs seek unspecified damages, interest, attorneys’ fees, and other costs.
We filed a fully-briefed Motion to Dismiss on June 21, 2023.
−Removed: The Court has not yet ruled on the Motion.
+Added: By Order entered on September 30, 2024, the Motion to Dismiss was granted, dismissing the Amended Complaint in its entirety.
+Added: The Court ordered the case to be closed by Memorandum and Order entered on October 28, 2024.
A stockholder derivative action was filed against us, as nominal defendant, and certain of our current and former officers in the United States District Court for the District of Delaware, captioned Marti v.
Mahadevia, et al., Case.
−Removed: 1:23-cv-01133-RGA (the “Derivative Complaint”), on October 11, 2023.
+Added: 1:23-cv-01133-RGA (the “First Derivative Complaint”), on October 11, 2023.
The plaintiffs both purport to be current stockholders, and the allegations are primarily the same as those made in the Consolidated Putative Class Action.
−Removed: The Derivative Complaint was transferred to the Eastern District of New York on November 13, 2023.
+Added: The First Derivative Complaint was transferred to the Eastern District of New York on November 13, 2023.
A second stockholder derivative action was filed against us, as nominal defendant, and certain of our current and former officers in the Supreme Court of the State of New York, Kings County, captioned Heil v.
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Moreover, we are unable to predict the outcomes or reasonably estimate a range of possible loss at this time.
+Added: By Order entered on September 30, 2024, the motion to stay the First Derivative Complaint was denied as moot due to the dismissal of the Consolidated Putative Class Action.
Additional lawsuits against us and certain of our officers or directors may be filed in the future.
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Risks Related to Product Development and Commercialization
+Added: Pursuant to our recently announced restructuring, we have suspended our development program with respect to SPR720 and have shifted our focus and resources to advancing the clinical development of our tebipenem HBr program, as well as other corporate activities.
+Added: If we fail to execute successfully on this re-prioritized strategic focus, our business and prospects may be adversely affected.
+Added: On October 29, 2024, we announced that we would suspend development activities for SPR720 based on based on an interim analysis of the Phase 2a proof-of-concept study of SPR720 for the treatment of NTM-PD not meeting its primary endpoint.
+Added: While the data showed antimicrobial activity associated with SPR720, the interim analysis did not show sufficient separation from placebo and highlighted potential dose limiting safety issues in subjects dosed at 1,000 mg orally once daily, including three cases of reversible grade 3 hepatotoxicity.
+Added: In evaluating the totality of both the efficacy and safety data, we have elected to suspend our current development program for SPR720 and will evaluate other potential paths forward as the remaining data are collected and analyzed.
+Added: As a result, we have restructured our operations to focus on supporting the development of tebipenem HBr and other corporate activities while we continue to seek a pathway forward for SPR720.
+Added: We believe this re-prioritized strategic focus is the best way to optimize our financial and other resources to advance our goal of developing and commercializing product candidates to address the unmet need for solutions to antibiotic resistant pathogens.
+Added: However, there is no assurance that we will successfully execute this strategy.
+Added: As described below, there are risks inherent in the clinical development process, especially for earlier-stage programs, and the regulatory path for
+Added: SPR720 remains uncertain at this time.
+Added: If we are unable to execute successfully on this re-prioritized strategic focus, our business and prospects may be adversely affected.
Our ability to realize the value of tebipenem HBr depends on us obtaining FDA approval.
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Clinical testing is expensive, difficult to design and implement, can take many years to complete and is inherently uncertain as to outcome.
−Removed: The clinical development of any of our product candidates is susceptible to the risk of failure inherent at any stage of drug development, including failure to demonstrate efficacy in a trial or across a broad population of patients, the occurrence of severe adverse events, failure to comply with protocols or applicable regulatory requirements, and determination by the FDA or any
−Removed: comparable foreign regulatory authority that a drug product is not approvable.
+Added: The clinical development of any of our product candidates is susceptible to the risk of failure inherent at any stage of drug development, including failure to demonstrate efficacy in a trial or across a broad population of patients, the occurrence of severe adverse events, failure to comply with protocols or applicable regulatory requirements, and determination by the FDA or any comparable foreign regulatory authority that a drug product is not approvable.
A number of companies in the pharmaceutical industry, including biotechnology companies, have suffered significant setbacks in clinical trials, even after promising results in earlier nonclinical studies or clinical trials.
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We could also encounter delays if a clinical trial is suspended or terminated by us, by the institutional review boards (“IRBs”) responsible for overseeing such trials, by the Data Safety Monitoring Board (“DSMB”) if any, for such trial or by the FDA or other regulatory authorities.
−Removed: Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure to
−Removed: 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 changes in governmental regulations or administrative actions.
+Added: Such authorities may suspend or terminate a clinical trial 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 changes in governmental regulations or administrative actions.
If we are required to conduct additional clinical trials or other testing of any of our product candidates beyond the trials and testing that we contemplate, if we are unable to successfully complete clinical trials or other testing of our product candidates, if the results of these trials or tests are unfavorable or are only modestly favorable or if there are safety concerns associated with any of our product candidates, we may:
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Success in preclinical studies and early-stage clinical trials does not mean that future larger registration clinical trials will be successful.
−Removed: This is because product candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA and comparable foreign regulatory authorities despite having progressed through preclinical studies and early-stage clinical trials.
+Added: This is because product candidates in later-stage
+Added: clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA and comparable foreign regulatory authorities despite having progressed through preclinical studies and early-stage clinical trials.
Analyses of preliminary or interim data from our clinical studies are not necessarily predictive of analyses of final data.
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The healthcare industry is focused on cost containment, both in the United States and elsewhere.
−Removed: Government authorities and third-party payors have attempted to control
−Removed: costs by limiting coverage and the amount of reimbursement for particular medications, which could affect our ability to sell our product candidates profitably.
+Added: Government authorities and third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications, which could affect our ability to sell our product candidates profitably.
Increasingly, third-party payors are requiring higher levels of evidence of the benefits and clinical outcomes of new technologies and are challenging the prices charged.
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For example, as a carbapenem, tebipenem HBr is not active against organisms expressing a resistance mechanism mediated by enzymes known as carbapenemases.
−Removed: Although occurrence of this resistance mechanism is currently rare, we cannot predict whether carbapenemase-mediated resistance will become widespread in regions where we tebipenem HBr may be marketed if it is approved.
+Added: Although occurrence of this resistance mechanism is currently rare, we cannot predict whether carbapenemase-mediated resistance will become widespread in regions where tebipenem HBr may be marketed if it is approved.
The growth of drug resistant infections in community settings or in countries with poor public health infrastructures, or the potential use of any of our product candidates outside of controlled hospital settings, could contribute to the rise of resistance.
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If we are not successful in discovering, developing and commercializing additional product candidates, our ability to expand our business and achieve our strategic objectives would be impaired.
−Removed: Although a substantial amount of our efforts will focus on our ongoing and planned clinical trials and potential approval of our product candidates, SPR720, tebipenem HBr and SPR206, a key element of our strategy is to discover, develop and commercialize a portfolio of therapeutics to treat drug resistant bacterial infections.
+Added: Although a substantial amount of our efforts will focus on our ongoing and planned clinical trials and potential approval of our product candidates, tebipenem HBr and SPR206, as well as exploring clinical and development pathways forward for SPR720, a key element of our strategy is to discover, develop and commercialize a portfolio of therapeutics to treat drug resistant bacterial infections.
We are seeking to do so through our internal research programs and are exploring, and intend to explore in the future, strategic partnerships for the development of new product candidates.
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Our measures to prevent, respond to, and minimize such risks may be unsuccessful.
−Removed: While we have not, to our knowledge, experienced any significant system failure, accident or material cybersecurity incident to date, if such an event were to occur and cause interruptions in our operations or the operations of those third parties with which we contract, it could result in a material disruption of our programs and our business operations, as well as our financial condition.
+Added: While we have not, to our knowledge, experienced any significant system failure, accident or material cybersecurity incident to date, if such an event were to occur and cause interruptions in our operations or the operations of those third parties with
+Added: which we contract, it could result in a material disruption of our programs and our business operations, as well as our financial condition.
For example, the loss of clinical trial data from completed or ongoing clinical trials for any of our product candidates could result in delays in our development and regulatory approval efforts and significantly increase our costs to recover or reproduce the data.
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Numerous other countries have, or are developing, laws governing the collection, use and transmission of personal information as well.
−Removed: For example, the European Parliament and the Council of the European Union adopted a comprehensive general
−Removed: data privacy framework called the General Data Protection Regulation ("GDPR"), which took effect in May 2018 and governs the collection and use of personal data in the European Union, including by companies outside of the European Union.
+Added: For example, the European Parliament and the Council of the European Union adopted a comprehensive general data privacy framework called the General Data Protection Regulation ("GDPR"), which took effect in May 2018 and governs the collection and use of personal data in the European Union, including by companies outside of the European Union.
The GDPR, which is wide-ranging in scope, imposes several requirements relating to the consent of the individuals to whom the personal data relates, the information provided to the individuals, the security and confidentiality of the personal data, data breach notification and the use of third-party processors in connection with the processing of the personal data.
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We have not generated any revenue from the sale of our products and have incurred losses in each year since our inception in 2013 through 2023.
−Removed: Our net loss was $17.9 million and $30.5 million during the three and six months ended June 30, 2024.
+Added: Our net loss was $17.1 million and $47.7 million during the three and nine months ended September 30, 2024.
All of our product candidates are in development, none have been approved for sale and we may never have a product candidate approved for commercialization.
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We believe that our existing cash and cash equivalents, together with expected collections from our collaboration receivables – related party, will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the issuance of the financial statements included in this report.
−Removed: Based on our cash and cash equivalents as of June 30, 2024, we believe that our cash runway will be sufficient to fund us into late 2025.
+Added: Based on our cash and cash equivalents as of September 30, 2024, our announced strategic restructuring described above, and the suspension of development activities for SPR720, together with earned and non-contingent development milestone payments from GSK, as well as other non-dilutive funding commitments, we believe that our cash runway will be sufficient to fund our operating expenses and capital expenditure requirements into mid-2026.
Beyond this point we will need additional funding, which primarily consist of raising additional capital through some combination of equity or debt financings, potential new collaborations or partnerships, additional grant funding and/or reducing cash expenditures.
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• acquire or in-license other product candidates and technologies.
+Added: We currently have no products approved for sale and have historically invested a significant portion of our efforts and financial resources on the development of our product candidates, including tebipenem HBr, SPR206, and SPR720.
+Added: Although we have now suspended our current development efforts with respect to SPR720, while we evaluate other potential paths forward as the remaining data are collected and analyzed, our business remains heavily dependent on the successful development, regulatory approval, and, if approved, commercialization of our other product candidates.
+Added: We cannot be certain that any product candidate will receive regulatory approval or will be successfully commercialized even if it receives regulatory approval.
If our product candidates fail to demonstrate safety and efficacy in clinical trials, do not gain regulatory approval, or do not achieve market acceptance following regulatory approval and commercialization, we may never become profitable.
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We expect that we will need substantial additional funding.
−Removed: If we are unable to raise capital when needed, or do not receive payment under our government awards, we could be forced to delay, reduce or eliminate our product development programs.
+Added: If we are unable to raise capital when needed, or do not receive payment under our government awards or from our commercial partnership agreements, we could be forced to delay, reduce or eliminate our product development programs.
Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is a time-consuming, expensive and uncertain process that takes years to complete.
−Removed: We expect that our expenses will continue to increase as we commence and advance our ongoing and planned clinical trials and other studies of SPR720, tebipenem HBr and SPR206.
+Added: Our expenses are likely to increase as we commence and advance our ongoing and planned clinical trials and other studies for our current and future product candidates, as well as explore clinical and development pathways forward for SPR720.
If we obtain marketing approval for any product candidate, we expect to incur significant expenses related to development, product sales, marketing, distribution and manufacturing.
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We believe that our existing cash and cash equivalents, together with expected collections from our collaboration receivables – related party, will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the issuance of the financial statements included in this report.
−Removed: Based on our cash and cash equivalents as of June 30, 2024, we believe that our cash runway will be sufficient to fund us into late 2025.
+Added: Based on our cash and cash equivalents as of September 30, 2024, our announced strategic restructuring described above, and the suspension of development activities for SPR720, together with earned and non-contingent development milestone payments from GSK, as well as other non-dilutive funding commitments, we believe that our cash runway will be sufficient to fund our operating expenses and capital expenditure requirements into mid-2026.
Our cash forecasts are based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.
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Accordingly, stockholders should not rely upon the results of any quarterly or annual periods as indications of future operating performance.
−Removed: We and certain of our current and former officers have been named as defendants in two initiated putative class action lawsuits, which were ordered consolidated, and two derivative lawsuits, that could result in substantial costs and divert management’s attention.
−Removed: We, and certain of our current and former executive officers, were named as defendants in two purported class action lawsuits that generally allege that we and certain of our current and former officers violated Sections 10(b) and/or 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements concerning the NDA for tebipenem HBr in an effort to lead investors to believe that the drug would receive approval from the FDA.
−Removed: The parties moved to consolidate the two complaints on July 22, 2022, which were ordered consolidated on August 5, 2022.
−Removed: The parties filed an Amended Complaint on December 5, 2022, purported to be brought on behalf of stockholders who purchased our common stock from September 8, 2020 through May 2, 2022.
−Removed: The Amended Complaint generally alleges that we and certain of our current and former officers violated Sections 10(b) and/or 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder by making allegedly false and/or misleading statements concerning the NDA for tebipenem HBr in an effort to lead investors to believe that the drug would receive approval from the FDA.
−Removed: Plaintiffs seek unspecified damages, interest, attorneys’ fees, and other costs.
−Removed: We filed a fully-briefed Motion to Dismiss on June 21, 2023.
−Removed: The Court has not yet ruled on the Motion.
−Removed: Additionally, we, as nominal defendant, and certain of our current and former executive officers and directors, were named as defendants in two derivative actions, containing allegations that are primarily the same as those made in the consolidated class action described above.
−Removed: The first derivative complaint was filed on October 11, 2023.
−Removed: The parties filed a stipulation to stay the case pending outcome of the Motion to Dismiss the class action on November 20, 2023.
−Removed: The stipulation is subject to Court approval.
−Removed: The second derivative complaint was filed on February 21, 2024.
−Removed: We intend to engage in a vigorous defense of the lawsuit.
−Removed: However, we are unable to predict the outcome of this matter at this time.
−Removed: Moreover, any conclusion of this matter in a manner adverse to us would have a material adverse effect on our financial condition and business.
−Removed: We could incur substantial costs not covered by our directors’ and officers’ liability insurance, suffer a significant adverse impact on our reputation and divert management’s attention and resources from other priorities, including the execution of business plans and strategies that are important to our ability to grow our business, any of which could have a material adverse effect on our business.
−Removed: In addition, this matter could require payments that are not covered by, or exceed the limits of, our available directors’ and officers’ liability insurance, which could have a material adverse effect on our operating results or financial condition.
Risks Related to Our Dependence on Third Parties
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For example, notwithstanding the obligations of a contract research organization for a trial of one of our product candidates, we remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial and applicable regulatory requirements.
−Removed: While we will have agreements governing their activities, we control only certain aspects of their activities and have limited influence over their actual performance.
+Added: While we will have agreements governing their
+Added: activities, we control only certain aspects of their activities and have limited influence over their actual performance.
The third parties with whom we contract for execution of our GLP studies and our clinical trials play a significant role in the conduct of these studies and trials and the subsequent collection and analysis of data.
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If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we may not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates.
−Removed: If that occurs, we may not be able
−Removed: to, or may be delayed in our efforts to, successfully commercialize our product candidates.
+Added: If that occurs, we may not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates.
In such an event, our financial results and the commercial prospects for our product candidates could be harmed, our costs could increase and our ability to generate revenue could be delayed, impaired or foreclosed.
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In addition, pursuant to our GSK License Agreement, we granted GSK an exclusive royalty-bearing license, with the right to grant sublicenses, under our intellectual property and regulatory documents and a sublicense under certain intellectual property of Meiji and Meiji’s regulatory documents to develop, manufacture and commercialize the GSK Licensed Products in the GSK Territory.
−Removed: Under the terms of the GSK License Agreement, we received an upfront payment of $66.0 million for GSK to secure rights to the medicine, a $30.0 million milestone payment upon achievement of a development milestone in the third quarter of 2023, and are entitled to receive a $95.0 million development milestone that is payable in four equal semi-annual installments, of which we received $23.8 million in February 2024.
+Added: Under the terms of the GSK License Agreement, we received an upfront payment of $66.0 million for GSK to secure rights to the medicine, a $30.0 million milestone payment upon achievement of a development milestone in the third quarter of 2023, and are entitled to receive a $95.0 million development milestone that is payable in four equal semi-annual installments, of which we received $23.8 million in February 2024 and 23.8 million in August 2024.
Remaining potential payments are milestone based and are (i) approximately $25.0 million in payments for the achievement of development milestones, (ii) up to $150.0 million in commercial milestone payments, (iii) up to $225.0 million in sales milestone payments, and (iv) tiered low single-digit to low double-digit royalties (if sales exceed $1.0 billion) tiered on net sales of GSK Licensed Products in the GSK Territory.
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However, as a result of the lag in the publication of patent applications following filing in the United States, we are still not be able to be certain upon filing that we are the first to file for patent protection for any invention.
−Removed: Moreover, we may be subject to a third-party preissuance submission of prior art to the United States Patent and Trademark Office (“USPTO”) or become involved in opposition, derivation, reexamination, inter partes review or interference proceedings, in the United States or elsewhere, challenging our patent rights or the patent rights of others.
+Added: Moreover, we may be subject to a third-party pre-issuance submission of prior art to the United States Patent and Trademark Office (“USPTO”) or become involved in opposition, derivation, reexamination, inter partes review or interference proceedings, in the United States or elsewhere, challenging our patent rights or the patent rights of others.
An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or product candidates and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights.
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Any of these occurrences could adversely affect our competitive business position, business prospects and financial condition.
−Removed: Similarly, if we assert trademark infringement claims, a court may determine that the marks we have asserted are invalid or unenforceable, or that the party against whom we have asserted trademark infringement has superior rights to the marks in question.
+Added: Similarly, if we assert trademark infringement
+Added: claims, a court may determine that the marks we have asserted are invalid or unenforceable, or that the party against whom we have asserted trademark infringement has superior rights to the marks in question.
In this case, we could ultimately be forced to cease use of such trademarks.
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If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel.
−Removed: Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and be a distraction to our management and scientific personnel.
+Added: Even if we are
+Added: successful in prosecuting or defending against such claims, litigation could result in substantial costs and be a distraction to our management and scientific personnel.
If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business would be harmed.
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We have registered our trademarks for our name and logo in the United States and other countries and have a number of pending trademark applications in the United States and other countries.
−Removed: As of June 30, 2024, we have two registered United States trademarks, 23 registered foreign trademarks, and no pending foreign trademark applications.
+Added: As of September 30, 2024, we have two registered United States trademarks, 23 registered foreign trademarks, and no pending foreign trademark applications.
If our registered trademarks are invalidated, we may be unable to exclusively use our name or logo in certain jurisdictions or may need to change our name or logo in certain jurisdictions, which could affect our business.
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We have only limited experience in filing and supporting the applications necessary to gain marketing approvals and have relied on third-party contract research organizations to assist us in this process.
−Removed: The time required to obtain approval, if any, by the FDA and comparable foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities.
+Added: The time required to obtain approval, if any, by the FDA and comparable foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of
+Added: the regulatory authorities.
In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions.
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Although we have formal employment agreements with our executive officers, these agreements do not prevent them from terminating their employment with us at any time.
+Added: On October 29, 2024, we implemented a restructuring that reduced our workforce by approximately 39%.
+Added: While we have confidence in our remaining employees, including our leadership team, and the board of directors, the uncertainty inherent in this ongoing restructuring may be difficult to manage, may cause concerns from third parties with whom we do business, and may increase the likelihood of turnover of other key officers and employees.
+Added: Continued disruption caused by the transition or by the loss of ongoing services of any qualified scientific and management personnel could delay or prevent the successful development of our product candidates.
If we lose one or more of our other executive officers or key employees, our ability to implement our business strategy successfully could be seriously harmed.
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We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions.
−Removed: In addition, we rely on
−Removed: consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy.
+Added: In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy.
Our consultants and advisors may be engaged by entities other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us.
If we are unable to continue to attract and retain high quality personnel, our ability to develop and commercialize product candidates will be limited.
+Added: We are undertaking internal restructuring activities that could result in disruptions to our business or otherwise materially harm our results of operations or financial condition, and we may not realize the expected benefits from our restructuring and we may incur additional costs implementing it or other difficulties.
+Added: As described above, on October 29, 2024, we announced a restructuring plan and implemented a workforce reduction.
+Added: There can be no assurance that our restructuring will achieve the cost savings, operating efficiencies or other benefits that we may initially expect.
+Added: Restructuring activities may also result in a loss of continuity, accumulated knowledge and inefficiency during transitional periods and thereafter.
+Added: Further, internal restructurings can require a significant amount of time and focus from management and other employees, which may divert attention from operations.
+Added: Additionally, our restructuring may result in unexpected expenses or liabilities and/or write-offs.
+Added: If our restructuring fails to achieve some or all of the expected benefits therefrom, our cash resources may not last as long as estimated and our business, results of operations and financial condition could be materially and adversely affected.
If foreign approvals are obtained, we will be subject to additional risks in conducting business in international markets.
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Such a delisting from the Nasdaq GS would also make trading our common stock more difficult for stockholders to sell their shares in the public market.
−Removed: We intend to actively monitor the closing bid price of our common stock and may, if appropriate, consider implementing available options to maintain compliance with the minimum bid price requirement under the Nasdaq Listing Rules.
+Added: We intend to actively monitor the closing bid price of our
+Added: common stock and may, if appropriate, consider implementing available options to maintain compliance with the minimum bid price requirement under the Nasdaq Listing Rules.
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our share price and trading volume could decline.
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Unstable global economic and political conditions, including economic uncertainty tied to interest rates and heightened inflation, credit and financial market instability, and uncertainty related to ongoing geopolitical conflicts, could adversely affect our business, financial condition, stock price and ability to raise capital.
−Removed: The global economy, in particular the financial markets, have
−Removed: recently experienced significant disruption and volatility, including without limitation, as a result of heightened inflation, capital market volatility, interest rate and currency rate fluctuations, volatility in commodity prices, decline in consumer confidence and economic growth, supply chain disruptions, banking disruptions, and uncertainty resulting from geopolitical events, including trade wars, civil and political unrest, wars and other armed conflicts.
+Added: The global economy, in particular the financial markets, have recently experienced significant disruption and volatility, including without limitation, as a result of heightened inflation, capital market volatility, interest rate and currency rate fluctuations, volatility in commodity prices, decline in consumer confidence and economic growth, supply chain disruptions, banking disruptions, and uncertainty resulting from geopolitical events, including trade wars, civil and political unrest, wars and other armed conflicts.
In addition, market volatility, high levels of inflation and high interest rates may increase our cost of financing or restrict our access to potential sources of future capital.
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To maintain compliance with Section 404, we are required to document and evaluate our internal control over financial reporting, which is both costly and challenging.
−Removed: We will need to continue to dedicate internal resources, continue to engage outside consultants and follow a detailed work plan to continue to assess and document the adequacy of internal control over financial reporting, continue to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous
−Removed: reporting and improvement process for internal control over financial reporting.
+Added: We will need to continue to dedicate internal resources, continue to engage outside consultants and follow a detailed work plan to continue to assess and document the adequacy of internal control over financial reporting, continue to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting.
If we identify one or more material weaknesses, it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.
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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.