Legal Proceedings.
−Removed: Two putative class action lawsuits were filed against us and certain of our current and former officers in the United States District Court for the Eastern District of New York, one captioned Richard S.
+Added: Securities Class Action Lawsuits and Derivative Actions
+Added: Two putative class action lawsuits were filed against the Company and certain of its current and former officers in the United States District Court for the Eastern District of New York, one captioned Richard S.
Spero Therapeutics, Inc., Ankit Mahadevia, and Satyavrat Shukla, Case No.
1:22-cv-03125, filed on May 26, 2022, and the other captioned Kashif Memon v.
−Removed: Spero Therapeutics,
−Removed: Inc., Ankit Mahadevia, and Satyavrat Shukla Case No.
+Added: Spero Therapeutics, Inc., Ankit Mahadevia, and Satyavrat Shukla Case No.
1:22-cv-04154, filed on July 15, 2022.
1 unchanged sentence
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 New Drug Application (“NDA”) for tebipenem HBr in an effort to lead investors to believe that the drug would receive approval from the FDA.
+Added: The Amended Complaint generally alleges that the Company and certain of its 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.
Plaintiffs seek unspecified damages, interest, attorneys’ fees, and other costs.
−Removed: We filed a fully-briefed Motion to Dismiss on June 21, 2023.
+Added: The Company filed a fully-briefed Motion to Dismiss on June 21, 2023.
By Order entered on September 30, 2024, the Motion to Dismiss was granted, dismissing the Amended Complaint in its entirety.
The Court ordered the case to be closed by Memorandum and Order entered on October 28, 2024.
−Removed: 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.
+Added: A stockholder derivative action was filed against the Company, as nominal defendant, and certain of the Company's current and former officers in the United States District Court for the District of Delaware, captioned Marti v.
Mahadevia, et al., Case.
2 unchanged sentences
The First Derivative Complaint was transferred to the Eastern District of New York on November 13, 2023.
−Removed: 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.
+Added: A second stockholder derivative action was filed against the Company, as nominal defendant, and certain of its current and former officers in the Supreme Court of the State of New York, Kings County, captioned Heil v.
Mahadevia, et al., Case.
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The Second Derivative Complaint makes primarily the same allegations as the First Derivative Complaint, and the Consolidated Putative Class Action.
−Removed: The plaintiffs in both derivative suits have agreed to a stay pending decision on the class action, subject to court approval.
−Removed: We deny any allegations of wrongdoing and intend to vigorously defend against these lawsuits.
−Removed: However, there is no assurance that we will be successful in our defense or that insurance will be available or adequate to fund any settlement or judgment or the litigation costs of these actions.
−Removed: Moreover, we are unable to predict the outcomes or reasonably estimate a range of possible loss at this time.
+Added: The plaintiffs in both derivative suits agreed to a stay pending decision on the class action, subject to court approval.
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.
−Removed: Additional lawsuits against us and certain of our officers or directors may be filed in the future.
−Removed: If additional similar complaints are filed, absent new or different allegations that are material, we will not necessarily announce such additional filings.
+Added: On March 20, 2025, the Second Derivative Complaint was voluntarily dismissed by the plaintiff.
+Added: On March 31, 2025, the First Derivative Complaint was voluntarily dismissed by the plaintiff.
+Added: Additional lawsuits against the Company and certain of its officers or directors may be filed in the future.
+Added: If additional similar complaints are filed, absent new or different allegations that are material, the Company will not necessarily announce such additional filings.
+Added: SEC Investigation and Wells Notice
+Added: On January 9, 2025, the Company responded to a “Wells Notice” from the Staff of the SEC regarding its preliminary determination to recommend a civil enforcement action or administrative proceeding against the Company, its former Chief Executive Officer and Chairman of the Board of Directors, Ankit Mahadevia, M.D.
+Added: Mahadevia”), and its former Chief Financial Officer and President and Chief Executive Officer, Satyavrat “Sath” Shukla (“Mr.
+Added: Shukla”), relating to certain public disclosures by the Company from March 31, 2022 leading up to the Company’s announcement on May 3, 2022 that it had determined to cease commercialization of tebipenem HBr based on feedback from the U.S.
+Added: Food and Drug Administration, and whether the Company’s disclosures may have violated the federal securities laws (the “Investigation”).
+Added: Specifically, the contemplated civil enforcement action, if approved by the SEC Commissioners, could include allegations that the Company violated Section 17(a) of the Securities Act and Sections 10(b) and 13(a) of the Exchange Act and Rules 10b-5, 12b-20, and 13a-1 thereunder;
+Added: and could allege against Dr.
+Added: Mahadevia and Mr.
+Added: Shukla violations of Section 17(a) of the Securities Act and Section 10(b) of the Exchange Act and Rules 10b-5 and 13a-14 thereunder.
+Added: The Company, Dr.
+Added: Mahadevia and Mr.
+Added: Shukla continue to cooperate with the SEC, they have engaged in further dialogue with the staff and maintain that the Company’s disclosures were appropriate.
+Added: A Wells Notice is neither a formal charge of wrongdoing nor a final determination that the recipient has violated any law, but is a preliminary determination by the Staff to recommend to the SEC Commissioners that a civil enforcement action or administrative proceeding be brought against the recipients.
+Added: It provides the recipients the opportunity to address in a non-public forum the issues raised by the Staff before a recommendation is made to the SEC regarding an enforcement action.
+Added: If the SEC were to authorize an action against the Company and/or any of the identified individuals, it may seek an injunction or cease-and-desist order against future violations of provisions of the federal securities laws, the imposition of civil monetary penalties, disgorgement or other equitable relief.
Ris k Factors.
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Risks Related to Product Development and Commercialization
−Removed: 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.
−Removed: If we fail to execute successfully on this re-prioritized strategic focus, our business and prospects may be adversely affected.
−Removed: 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: Pursuant to our previously announced restructuring, we suspended development of our SPR720 oral program and have shifted our focus and resources to advancing the clinical development of our tebipenem HBr program, as well as other corporate activities.
+Added: We have also discontinued development of SPR206.
+Added: Consequently, our business and prospects are substantially dependent on our tebipenem program and our collaboration with GSK.
+Added: If we fail to execute successfully on this re-prioritized strategic focus, our business and prospects may be materially adversely affected.
+Added: On October 29, 2024, we announced that we suspended development activities for our SPR720 oral program 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.
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.
−Removed: 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: In evaluating the totality of both the efficacy and safety data, we have elected to suspend our current development program for SPR720 and continue to evaluate other potential paths forward as the remaining data are collected and analyzed.
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: Further, in March 2025, we announced that we have discontinued development of SPR206.
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.
However, there is no assurance that we will successfully execute this strategy.
−Removed: As described below, there are risks inherent in the clinical development process, especially for earlier-stage programs, and the regulatory path for
−Removed: SPR720 remains uncertain at this time.
−Removed: If we are unable to execute successfully on this re-prioritized strategic focus, our business and prospects may be adversely affected.
−Removed: Our ability to realize the value of tebipenem HBr depends on us obtaining FDA approval.
−Removed: Even if such approval is obtained, the timeline of, and any requirements imposed as of part of, such approval may impact the attractiveness of eventual commercialization of tebipenem HBr through our partnership with GSK.
+Added: As described below, there are risks inherent in the clinical development process, especially for earlier-stage programs, and the regulatory path for 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 materially adversely affected.
+Added: As a result, we are currently substantially dependent on our tebipenem program and our collaboration with GSK.
+Added: As described under Note 10 - License, Collaboration and Service Agreements—Tebipenem HBr Agreements, GSK has the right to terminate the GSK License Agreement (1) at any time upon a specified number of days’ notice, (2) upon a material breach by us or (3) upon a bankruptcy of Spero.
+Added: Alternatively, in the case of a material breach by Spero, GSK may, in lieu of terminating the GSK License Agreement, elect to reduce any commercial milestone payments to Spero by 50%.
+Added: In addition, in such circumstance, GSK may assume the responsibility and expense of development of tebipenem HBr in the United States, in which case no development milestone payments would be payable to Spero (including unpaid installments of any earned milestone payments).
+Added: In the case of a Change of Control (as defined in the GSK License Agreement) of Spero, GSK similarly may, in lieu of terminating the GSK License Agreement, assume responsibility and expense of development of tebipenem HBr in the United States and no development milestones would be payable to Spero, as described above.
+Added: Any termination of the GSK License Agreement or any failure to earn, or reduction in, milestone payments may materially adversely affect our business and prospects.
+Added: Our ability to realize the value of tebipenem HBr depends on obtaining FDA approval.
+Added: Even if such approval is obtained, the timeline of, and any requirements imposed as part of, such approval may impact the attractiveness of eventual commercialization of tebipenem HBr through our partnership with GSK.
We currently have no products approved for sale and have invested a significant portion of our efforts and financial resources in the development of tebipenem HBr as a product candidate for the treatment of bacterial infections causing cUTI.
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• the design of the clinical trial;
+Added: • the availability of clinically evaluable patients;
• our ability to recruit clinical trial investigators with appropriate competencies and experience;
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In the future, we will be required to submit a diversity action plan to the FDA by the time we submit a Phase 3 clinical trial, or pivotal study, protocol to the agency for review, unless we are able to obtain a waiver for some or all of the requirements for a diversity action plan.
−Removed: It is unknown at this time how the diversity action plan may affect the planning and timing of any future Phase 3 clinical trial for our product candidates or what specific information FDA will expect in such plans.
+Added: It is unknown at this time how the diversity action plan may affect the planning and timing of any future Phase 3 clinical trial for our product candidates.
However, initiation of such trials may be delayed if the FDA objects to our proposed diversity action plans for any future Phase 3 clinical trial for our product candidates, and we may experience difficulties recruiting a diverse population of patients in attempting to fulfill the requirements of any approved diversity action plan.
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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
−Removed: 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 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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Serious adverse events or undesirable side effects or other unexpected properties of any of our product candidates may be identified during development or after approval that could delay, prevent or cause the withdrawal of regulatory approval, limit the commercial potential, or result in significant negative consequences following marketing approval.
−Removed: Serious adverse events or undesirable side effects caused by, or other unexpected properties of, our product candidates could cause us, an IRB, or regulatory authorities to interrupt, delay or halt our clinical trials and could result in a more restrictive label, the imposition of distribution or use restrictions or the delay or denial of regulatory approval by the FDA or comparable foreign regulatory authorities.
+Added: Serious adverse events or undesirable side effects caused by, or other unexpected properties of, our product candidates could cause us, an IRB, or regulatory authorities to interrupt, delay or halt our clinical trials and could result in a more restrictive label, the
+Added: imposition of distribution or use restrictions or the delay or denial of regulatory approval by the FDA or comparable foreign regulatory authorities.
If any of our other product candidates are associated with serious or unexpected adverse events or undesirable side effects, the FDA, the IRBs responsible for overseeing our studies, or a DSMB, could suspend or terminate our clinical trials or the FDA or comparable foreign regulatory authorities could order us to cease clinical trials or deny approval of our product candidates for any or all targeted indications.
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• regulatory authorities may require one or more post-market studies to monitor the safety and efficacy of the product;
−Removed: • we may be required to implement a risk evaluation and mitigation strategy (“REMS”), which may include the creation of a medication guide outlining the risks of such side effects for distribution to patients or restrictions on distribution;
+Added: • we may be required to implement a risk evaluation and mitigation strategy (“REMS”), which may include the creation of a medication guide outlining the risks of such side effects for distribution to patients or restrictions on distribution or other elements;
• we could be sued and held liable for harm caused to patients exposed to or taking our product candidates;
99 unchanged sentences
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, 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.
−Removed: 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.
−Removed: Research programs to identify product candidates require substantial technical, financial and human resources, whether or not any product candidates are ultimately identified.
+Added: Although a substantial amount of our efforts will focus on our ongoing and planned clinical trials and potential approval of our product candidate, tebipenem HBr, 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.
+Added: We are exploring, and intend to explore in the future, strategic partnerships for the development of new product candidates.
+Added: Research programs to identify product candidates, whether pursued internally or through strategic partnerships, require substantial technical, financial and human resources, whether or not any product candidates are ultimately identified.
Our research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates for clinical development for many reasons, including the following:
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As the use of digital technologies has increased, cyber incidents, including deliberate attacks and attempts to gain unauthorized access to computer systems and networks, have increased in frequency and sophistication.
+Added: In particular, ransomware attacks, including those from organized criminal threat actors, nation-states and nation-state supported actors, are becoming increasingly prevalent and severe and can lead to significant interruptions, delays, or outages in our operations, loss of data, including sensitive customer information, loss of income, significant extra expenses to restore data or systems, reputational loss and the diversion of funds.
+Added: To alleviate the negative impact of a ransomware attack, it may be preferable to make payments to the threat actor(s), but we may be unwilling or unable to do so, including, for example, if applicable laws or regulations prohibit such payments.
+Added: Finally, developments in artificial intelligence and machine learning provide threat actors with the capability to use more sophisticated means to attack our systems and may exacerbate cybersecurity risk.
These threats pose a risk to the security of our systems and networks and the confidentiality, availability and integrity of our data.
3 unchanged sentences
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
−Removed: 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 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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To the extent that any disruption or cybersecurity incident results in a loss of or damage to our data or applications, or inappropriate disclosure or theft of confidential or proprietary information, in addition to incurring liability, the further development of our product candidates could be delayed or our competitive position could be compromised.
−Removed: Additionally, such disruptions or cybersecurity incidents could result in enforcement actions by United States or foreign regulatory authorities, regulatory penalties, and other legal liabilities such as but not limited to private litigation, the incurrence of significant remediation costs, disruptions to our development programs, business operations and collaborations, diversion of management efforts and damage to our reputation, all of which could harm our business and operations.
+Added: Additionally, such disruptions or cybersecurity incidents could result in enforcement actions by U.S.
+Added: or foreign regulatory authorities, regulatory penalties, and other legal liabilities such as but not limited to private litigation, the incurrence of significant remediation costs, disruptions to our development programs, business operations and collaborations, diversion of management efforts and damage to our reputation, all of which could harm our business and operations.
Our actual or perceived failure to comply with data protection laws and regulations could lead to government enforcement actions, private litigation and/or adverse publicity and could negatively affect our business.
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The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches that may increase data breach litigation.
−Removed: Although the CCPA includes exemptions for certain clinical trials data, and the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) protected health information, the law may increase our compliance costs and potential liability with respect to other personal information we collect about California residents.
+Added: Although the CCPA includes exemptions for certain clinical
+Added: trials data, and the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) protected health information, the law may increase our compliance costs and potential liability with respect to other personal information we collect about California residents.
Additionally in 2020, California voters passed the California Privacy Rights Act (“CPRA”), which went into full effect on January 1, 2023.
3 unchanged sentences
states are enacting similar legislation, increasing compliance complexity and increasing risks of failures to comply.
−Removed: In 2023, comprehensive privacy laws in Virginia, Colorado, Connecticut, and Utah all took effect, and laws in Montana, Oregon, and Texas will take effect in 2024.
−Removed: In addition, laws in other U.S.
−Removed: states are set to take effect beyond 2024, and additional U.S.
+Added: In 2023, comprehensive privacy laws in Virginia, Colorado, Connecticut, and Utah all took effect, and laws in Montana, Oregon, and Texas took effect in 2024.
+Added: Laws in a number of other U.S.
+Added: states took effect, or are set to take effect, in 2025, in 2026, and beyond, and additional U.S.
states have proposals under consideration, all of which are likely to increase our regulatory compliance costs and risks, exposure to regulatory enforcement action and other liabilities.
+Added: In addition, other federal and state laws establish additional requirements for protecting the privacy and security of health information that is not protected by HIPAA.
+Added: For instance, Washington state recently passed the “My Health My Data” Act, which came into force in 2024 and regulates “consumer health data,” which is defined as “personal information that is linked or reasonably linkable to a consumer and that identifies a consumer’s past, present, or future physical or mental health.” The “My Health My Data” Act provides exemptions for personal data used or shared in connection with certain research activities, including data subject to 45 C.F.R.
+Added: Parts 46, 50 and 56.
+Added: Notably, the “My Health My Data” Act contains a private right of action.
+Added: In addition, Nevada recently enacted a consumer health data privacy bill, SB 370, which also took effect in 2024, and regulates “consumer health data.” SB 370 shares many similarities with Washington’s “My Health My Data” Act, and Connecticut recently amended its comprehensive privacy law to include heighted regulation of “consumer health data.” Additional states may adopt health-specific privacy laws that could impact our business activities and our collection and handling of health-related data.
Numerous other countries have, or are developing, laws governing the collection, use and transmission of personal information as well.
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if we are unable to obtain additional capital, we may not be able to continue our operations on the scope or scale as currently conducted, and that could have a material adverse effect on our business, results of operations and financial condition.
−Removed: 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 $17.1 million and $47.7 million during the three and nine months ended September 30, 2024.
+Added: We have not generated any revenue from the sale of our products and have incurred losses in most years since our inception in 2013.
+Added: Our net loss was $13.9 million during the three months ended March 31, 2025.
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.
−Removed: In accordance with ASU 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), we are required to evaluate whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern from the issuance date of our financial statements.
−Removed: 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 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.
−Removed: 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.
−Removed: If we are not able to secure adequate additional funding, we plan to make reductions in spending.
−Removed: In that event, we may have to delay, scale back, or eliminate some or all of our planned clinical trials, research stage programs and commercial activities.
−Removed: We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future;
+Added: In accordance with ASU 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205- 40), we have evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that these consolidated financial statements are issued.
+Added: Based on our cash and cash equivalents as of March 31, 2025, together with earned and non-contingent development milestone payments from GSK, we believe that our cash runway will be sufficient to fund our operating expenses and required capital expenditures into the second quarter of 2026.
+Added: During this period, we plan to prioritize advancing the Phase 3 clinical trial activities for tebipenem HBr under our GSK License Agreement and completing our analysis of the full dataset from the 25 treated patients in the Phase 2a proof-of-concept trial of SPR720.
+Added: Beyond this point we will need additional funding, which we expect will primarily consist of raising additional capital through some combination of equity or debt financings, potential new collaborations or additional grant funding.
+Added: If we are not able to secure adequate additional funding, we plan to make further reductions in spending.
+Added: In that event, we may have to delay, scale back, or eliminate some or all of our planned development activities.
+Added: The actions necessary to reduce spending under this plan at a level that mitigates the factors described above is not considered probable, as defined in the accounting standards and therefore, the full extent to which management may extend our funds through these actions may not be considered in management’s assessment of our ability to continue as a going concern.
+Added: As a result, management has concluded that substantial doubt exists about our ability to continue as a going concern.
+Added: We expect to continue to incur significant expenses and operating losses for the foreseeable future;
if we are unable to achieve commercialization, revenue from product sales, and, ultimately, profitability, the market value of our common stock will likely decline.
−Removed: We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future as we continue to advance our product candidates through preclinical and clinical development and marketing approval for such candidates whose clinical trials are successful.
+Added: We expect to continue to incur significant expenses and operating losses for the foreseeable future as we continue to advance our product candidates through preclinical and clinical development and marketing approval for such candidates whose clinical trials are successful.
Our expenses will also increase substantially if and as we:
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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.
−Removed: 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: Although we have decided to discontinue further development of SPR206 and are exploring strategic options, including potential out-licensing, to maximize the value for the program and allow us to leverage the expertise of strategic partners and have suspended our current development efforts with respect to the SPR720 oral program, although we continue to 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 tebipenem HBr and other future product candidates.
We cannot be certain that any product candidate will receive regulatory approval or will be successfully commercialized even if it receives regulatory approval.
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Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods.
−Removed: Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ equity and working capital.
+Added: Our prior losses, combined with
+Added: expected future losses, have had and will continue to have an adverse effect on our stockholders’ equity and working capital.
If we are unable to achieve and sustain profitability, the market value of our common stock will likely decline.
2 unchanged sentences
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 or from our commercial partnership agreements, 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 payments 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.
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Our failure to raise capital as and when needed would have a negative effect on our financial condition and our ability to pursue our business strategy.
−Removed: 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 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.
−Removed: 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.
−Removed: Changing circumstances could cause us to consume capital significantly faster than we currently anticipate, and we may need to spend more than currently expected because of circumstances beyond our control.
−Removed: Our future funding requirements, both short-term and long-term, will depend on many factors, including:
+Added: Based on our cash and cash equivalents as of March 31, 2025, together with earned and non-contingent development milestone payments from GSK, we believe that our cash runway will be sufficient to fund our operating expenses and capital expenditures into the second quarter of 2026.
+Added: During this period, we plan to prioritize advancing the Phase 3 clinical trial activities for tebipenem HBr under our GSK License Agreement and completing our analysis of the full dataset from the 25 treated patients in the Phase 2a proof-of-concept trial of SPR720.
+Added: Beyond this point we will need additional funding, which we expect will primarily consist of raising additional capital through some combination of equity or debt financings, potential new collaborations or additional grant funding.
+Added: If we are not able to secure adequate additional funding, we plan to make further reductions in spending.
+Added: In that event, we may have to delay, scale back, or eliminate some or all of our planned development activities, including:
• the timing and terms of the potential FDA approval of tebipenem HBr;
13 unchanged sentences
We filed a universal shelf registration statement on Form S-3 (Registration No.
−Removed: 333-254170) with the SEC on March 11, 2021, which was declared effective on March 29, 2021 (the “2021 Form S-3”), and pursuant to which we registered for sale up to $300.0 million of any combination of our common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that we may determine, including up to $75.0 million of our common stock available for issuance pursuant to the Sales Agreement that we entered into with Cantor.
+Added: 333-254170) with the SEC on March 11, 2021, which was declared effective on March 29, 2021 (the “2021 Form S-3”), and pursuant to which we registered for sale up to $300.0 million of any combination of our common stock,
+Added: preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that we could determine, including up to $75.0 million of our common stock available for issuance pursuant to the Sales Agreement that we entered into with Cantor.
The 2021 Form S-3 expired on March 29, 2024.
−Removed: We filed the 2024 Form S-3 with the SEC on March 15, 2024, which became effective on March 22, 2024 and pursuant to which we registered for sale up to $300.0 million of any combination of our common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that we may determine, including up to $75.0 million of its common stock available for issuance pursuant to the Sales Agreement with Cantor.
+Added: We filed the 2024 Form S-3 on March 15, 2024, which became effective on March 22, 2024 and pursuant to which we registered for sale up to $300.0 million of any combination of our common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that we may determine, including up to $75.0 million of our common stock available for issuance pursuant to the Sales Agreement with Cantor.
Under the Sales Agreement, Cantor may sell shares of our common stock by any method permitted by law deemed to be an “at-the-market” offering as defined in Rule 415 of the Securities Act, subject to the terms of the Sales Agreement.
+Added: While we currently have an effective shelf registration statement, as of the filing of our Annual Report on Form 10-K for the year ended December 31, 2024, our public float was less than $75 million, and under SEC regulations for so long as our public float remains less than $75 million, the amount we can raise through primary public offerings of securities in any twelve-month period using shelf registration statements is limited to an aggregate of one-third of our public float, which is referred to as the baby shelf rules.
+Added: As of March 21, 2025, our public float was approximately $45.1 million, based on 54,969,832 shares of outstanding common stock held by non-affiliates and at a price of $0.82 per share, which was the closing price of our common stock on the Nasdaq GS on March 21, 2025.
+Added: As a result of our public float being below $75 million, we are limited by the baby shelf rules until such time our public float exceeds $75 million, which means we only have the capacity to sell shares up to one-third of our public float in primary offerings under our shelf registration statement on Form S-3 in any twelve-month period.
+Added: Although alternative public and private transaction structures may be available, these may require additional time and cost, may impose operational restrictions on us, and may not be available on attractive terms.
We may seek to raise additional capital at any time.
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Our ability to use our net operating loss carryforwards may be limited.
−Removed: As of December 31, 2023, we had United States federal, state and foreign net operating loss carryforwards ("NOLs") of $94.7 million, $90.9 million and $4.6 million, respectively.
−Removed: All Federal NOLs can be carried forward indefinitely.
+Added: As of December 31, 2024, we had U.S.
+Added: federal, state and foreign net operating loss carryforwards (“NOLs”) of $165.2 million, $120.6 million and $4.6 million, respectively.
+Added: $152.0 million of the federal NOLs can be carried forward indefinitely and $13.2 million of the federal NOLs begin to expire in 2034.
The state NOLs begin to expire in 2034 and will expire at various dates through 2044.
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Utilization of these NOLs depends on many factors, including our future income, which cannot be assured.
−Removed: These state NOLs could expire unused and be unavailable to offset our future income tax liabilities.
+Added: Aside from the NOLs that can be carried forward indefinitely, the remaining NOLs could expire unused and be unavailable to offset our future income tax liabilities.
In addition, under Section 382 of the Internal Revenue Code of 1986, as amended (the "Code") and corresponding provisions of state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change, by value, in its equity ownership by 5% stockholders over a three-year period, the corporation’s ability to use its pre-change NOLs and other pre-change tax attributes to offset its post-change income may be limited.
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Future ownership changes may limit our ability to utilize remaining tax attributes.
−Removed: Under current United States federal tax legislation, although the treatment of NOLs arising in tax years beginning on or before December 31, 2017 has generally not changed, NOLs arising in tax years beginning after December 31, 2017 may be used to offset only 80% of taxable income.
+Added: Under current U.S.
+Added: federal tax legislation, although the treatment of NOLs arising in tax years beginning on or before December 31, 2017 has generally not changed, NOLs arising in tax years beginning after December 31, 2017 may be used to offset only 80% of taxable income.
In addition, net operating losses arising in tax years beginning after December 31, 2017 may be carried forward indefinitely, as opposed to the 20-year carryforward under prior law.
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Each of our product candidates is either in clinical or preclinical development.
−Removed: We have not yet demonstrated an ability to successfully obtain marketing approval, manufacture a commercial scale product, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization.
+Added: We have not yet demonstrated an ability to successfully obtain marketing approval, manufacture a commercial scale product, or arrange for a
+Added: third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization.
Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing pharmaceutical products.
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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
−Removed: 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 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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Our current and anticipated future dependence upon others for the manufacture of our product candidates and potential product candidates may adversely affect our future profit margins and our ability to commercialize any products for which we receive marketing approval on a timely and competitive basis.
−Removed: If we fail to comply with our obligations in the agreements under which we in-license or acquire development or commercialization rights to products, technology or data from third parties, we could lose such rights that are important to our business.
+Added: If we fail to comply with our obligations in the agreements under which we in-license or out-license acquire development or commercialization rights to products, technology or data from or to third parties, we could lose such rights that are important to our business.
We are a party to agreements with Meiji and GSK for tebipenem HBr, Vertex Pharmaceuticals for SPR720 and Pfizer, Everest and PBB Distributions Limited for SPR206, and we may enter into additional agreements, including license agreements, with other parties in the future that impose diligence, development and commercialization timelines, milestone payments, royalties, insurance and other obligations on us.
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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 and 23.8 million in August 2024.
−Removed: 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.
+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, $23.8 million in August 2024 and $23.8 million in February 2025.
+Added: Remaining potential payments under the GSK License Agreement are milestone based and are (i) approximately $25.0 million in payments for GSK's submission of a NDA with the FDA for tebipenem HBr, (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.
We are responsible for the execution and costs of the follow-up Phase 3 clinical trial of tebipenem HBr.
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Termination of these agreements or reduction or elimination of our rights under these agreements may result in our having to negotiate new or reinstated agreements with less favorable terms or cause us to lose our rights under these agreements, including our rights to important intellectual property or technology.
−Removed: Risks Related to Our United States Government Contracts and to Certain Grant Agreements
+Added: Risks Related to Our U.S.
+Added: Government Contracts and to Certain Grant Agreements
Our use of government funding for certain of our programs adds complexity to our research and commercialization efforts with respect to those programs and may impose requirements that increase the costs of commercialization and production of product candidates developed under those government-funded programs.
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• suspend the contractor from receiving new contracts pending resolution of alleged violations of procurement laws or regulations;
−Removed: • impose United States manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements;
+Added: • impose U.S.
+Added: manufacturing requirements for products that embody inventions conceived or first reduced to practice under such agreements;
• suspend or debar the contractor or grantee from doing future business with the government;
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• pursue criminal or civil remedies under the False Claims Act (the “FCA”), the False Statements Act and similar remedy provisions specific to government agreements.
−Removed: We may not have the right to prohibit the United States government from using certain technologies developed by us, and we may not be able to prohibit third-party companies, including our competitors, from using those technologies in providing products and services to the United States government.
−Removed: The United States government generally takes the position that it has the right to royalty-free use of technologies that are developed under United States government contracts.
+Added: We may not have the right to prohibit the U.S.
+Added: government from using certain technologies developed by us, and we may not be able to prohibit third-party companies, including our competitors, from using those technologies in providing products and services to the U.S.
+Added: government generally takes the position that it has the right to royalty-free use of technologies that are developed under U.S.
+Added: government contracts.
In addition, government contracts and grants, and subcontracts and subawards awarded in the performance of those contracts and grants, normally contain additional requirements that may increase our costs of doing business, reduce our profits, and expose us to liability for failure to comply with these terms and conditions.
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If we fail to maintain compliance with these requirements, we may be subject to potential contract or FCA liability and to termination of our contracts.
−Removed: United States government agencies have special contracting requirements that give them the ability to unilaterally control our contracts.
−Removed: United States government contracts typically contain unfavorable termination provisions and are subject to audit and modification by the government at its sole discretion, which will subject us to additional risks.
−Removed: These risks include the ability of the United States government to unilaterally:
+Added: government agencies have special contracting requirements that give them the ability to unilaterally control our contracts.
+Added: government contracts typically contain unfavorable termination provisions and are subject to audit and modification by the government at its sole discretion, which will subject us to additional risks.
+Added: These risks include the ability of the U.S.
+Added: government to unilaterally:
• audit and object to our government contract-related costs and fees, and require us to reimburse all such costs and fees;
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• change certain terms and conditions in our contract.
−Removed: The United States government will be able to terminate any of its contracts with us, either for convenience or if we default by failing to perform in accordance with or to achieve the milestones set forth in the contract schedules and terms.
+Added: government will be able to terminate any of its contracts with us, either for convenience or if we default by failing to perform in accordance with or to achieve the milestones set forth in the contract schedules and terms.
Termination-for-convenience provisions generally enable us to recover only our costs incurred or committed and settlement expenses on the work completed prior to termination.
Except for the amount of services received by the government, termination-for-default provisions do not permit these recoveries and would make us liable for excess costs incurred by the United States government in procuring undelivered items from another source.
−Removed: Our business is subject to audit by the United States government and other potential sources for grant funding, including under our contracts with BARDA, NIAID and DoD, and a negative outcome in an audit could adversely affect our business.
+Added: Our business is subject to audit by the U.S.
+Added: government and other potential sources for grant funding, including under our contracts with BARDA and NIAID and a negative outcome in an audit could adversely affect our business.
United States government agencies such as the Department of Health and Human Services (“DHHS”) and the Defense Contract Audit Agency (the “DCAA”) routinely audit and investigate government contractors.
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Any changes in applicable laws and regulations could restrict our ability to maintain our existing BARDA and other government contracts and obtain new contracts, which could limit our ability to conduct our business and materially adversely affect our results of operations.
−Removed: Provisions in our United States government contracts, including our contracts with BARDA, may affect our intellectual property rights.
−Removed: Certain of our activities have been funded, and may in the future be funded, by the United States government, including through our contracts with BARDA.
−Removed: When new technologies are developed with United States government funding, the government obtains certain rights in any resulting patents, including the right to a nonexclusive license authorizing the government to use the invention and rights that may permit the government to disclose our confidential information to third parties and to exercise “march-in” rights.
−Removed: The government can exercise its march-in rights if it determines that action is necessary because we fail to achieve practical application of the United States government-funded technology, because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations or to give preference to United States industry.
−Removed: In addition, United States government-funded inventions must be reported to the government, United States government funding must be disclosed in any resulting patent applications, and our rights in such inventions may be subject to certain requirements to manufacture products in the United States.
+Added: Provisions in our U.S.
+Added: government contracts, including our contracts with BARDA, may affect our intellectual property rights.
+Added: Certain of our activities have been funded, and may in the future be funded, by the U.S.
+Added: government, including through our contracts with BARDA.
+Added: When new technologies are developed with U.S.
+Added: government funding, the government obtains certain rights in any resulting patents, including the right to a nonexclusive license authorizing the government to use the invention and rights that may permit the government to disclose our confidential information to third parties and to exercise “march-in” rights.
+Added: The government can exercise its march-in rights if it determines that action is necessary because we fail to achieve practical application of the U.S.
+Added: government-funded technology, because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations or to give preference to U.S.
+Added: In addition, U.S.
+Added: government-funded inventions must be reported to the government, U.S.
+Added: government funding must be disclosed in any resulting patent applications, and our rights in such inventions may be subject to certain requirements to manufacture products in the United States.
Risks Related to Our Intellectual Property
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Our success depends in large part on our ability to obtain and maintain patent protection in the United States and other countries with respect to our proprietary chemistry technology and product candidates.
−Removed: If we do not adequately protect our intellectual property, competitors may be able to use our technologies and erode or negate any competitive advantage that we may have, which could harm our business and ability to achieve profitability.
+Added: If we do not adequately protect our intellectual property, competitors may be able to use our technologies and erode or negate any competitive advantage that we may have, which could harm
+Added: our business and ability to achieve profitability.
To protect our proprietary position, we file patent applications in the United States and abroad related to our novel technologies and product candidates that are important to our business.
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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
−Removed: 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 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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Our commercial success depends, in part, on our ability to develop, manufacture, market and sell our product candidates and use our proprietary chemistry technology without infringing the intellectual property and other proprietary rights of third parties.
−Removed: Numerous third-party United States and non-United States issued patents and pending applications exist in the area of antibacterial treatment, including compounds, formulations, treatment methods and synthetic processes that may be applied towards the synthesis of antibiotics.
+Added: Numerous third-party U.S.
+Added: issued patents and pending applications exist in the area of antibacterial treatment, including compounds, formulations, treatment methods and synthetic processes that may be applied towards the synthesis of antibiotics.
If any of their patents or patent applications cover our product candidates or technologies, we may not be free to manufacture or market our product candidates as planned.
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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
−Removed: 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 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 September 30, 2024, we have two registered United States trademarks, 23 registered foreign trademarks, and no pending foreign trademark applications.
+Added: As of March 31, 2025, we have two registered U.S.
+Added: 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 are given an opportunity to respond to those rejections, but we may not be able to overcome such rejections.
−Removed: In addition, in the United States Patent and Trademark Office and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks.
+Added: In addition, in the USPTO and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks.
Opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive such proceedings.
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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
−Removed: 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 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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However, an SPA agreement does not guarantee approval of a product candidate, and even if the FDA agrees to the design, execution and analysis proposed in protocols reviewed under the SPA process, the FDA may revoke or alter its agreement in certain circumstances.
−Removed: In particular, an SPA agreement is not binding on the FDA if public health concerns emerge that were unrecognized at the time of the SPA agreement, if other new scientific concerns regarding product safety or efficacy arise, if the sponsor fails to comply with the agreed upon trial protocols or modifies such protocols without prior FDA agreement, or if the relevant data, assumptions or information provided by the sponsor change or are found to be false or omit relevant facts.
+Added: In particular, an SPA agreement is not binding on the FDA if public health concerns emerge that were unrecognized at
+Added: the time of the SPA agreement, if other new scientific concerns regarding product safety or efficacy arise, if the sponsor fails to comply with the agreed upon trial protocols or modifies such protocols without prior FDA agreement, or if the relevant data, assumptions or information provided by the sponsor change or are found to be false or omit relevant facts.
In addition, even after an SPA agreement is finalized, the SPA agreement may be modified, and such modification will be deemed binding on the FDA review division, except under the circumstances described above, so long as the FDA and the sponsor agree in writing to modify the protocol and such modification is intended to improve the study.
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We cannot assure you that the FDA will deem each of the clinical trial sites to have complied with applicable laws and regulations, and negative inspection results could significantly delay or prevent any potential approval for tebipenem HBr.
−Removed: If the FDA revokes or alters its agreement under
−Removed: the SPA, or interprets the data collected from the clinical trial differently than we do, the FDA may not deem the data sufficient to support an application for regulatory approval, which could materially adversely affect our business, financial condition and results of operations.
+Added: If the FDA revokes or alters its agreement under the SPA, or interprets the data collected from the clinical trial differently than we do, the FDA may not deem the data sufficient to support an application for regulatory approval, which could materially adversely affect our business, financial condition and results of operations.
In March 2020, the FDA granted orphan drug designation for SPR720.
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Resulting legislative, administrative, or policy changes from payors may reduce payments for any products for which we obtain marketing approval and could affect future revenues.
−Removed: The Affordable Care Act (“ACA”) became law in the United States in March 2010 with the goals of broadening access to health insurance, reducing or constraining the growth of healthcare spending, enhancing remedies against fraud and abuse, adding new transparency requirements for the health care and health insurance industries and imposing additional health policy reforms.
+Added: The ACA became law in the United States in March 2010 with the goals of broadening access to health insurance, reducing or constraining the growth of healthcare spending, enhancing remedies against fraud and abuse, adding new transparency requirements for the health care and health insurance industries and imposing additional health policy reforms.
Provisions of ACA may negatively affect our future revenues.
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Moreover, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products.
−Removed: There have been several United States Congressional inquiries and proposed bills designed to, among other things, bring
−Removed: more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.
+Added: There have been several United States Congressional inquiries and proposed bills designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.
Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical 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.
1 unchanged sentence
Supreme Court held unanimously that federal law does not preempt the states’ ability to regulate pharmaceutical benefit managers (“PBMs”) and other members of the health care and pharmaceutical supply chain, an important decision that may lead to further and more aggressive efforts by states in this area.
−Removed: The Federal Trade Commission in mid-2022 also launched sweeping investigations into the practices of the PBM industry that could lead to additional federal and state legislative or regulatory proposals targeting such entities’ operations, pharmacy networks, or financial arrangements.
−Removed: During the current congressional session, numerous PBM reforms are being considered in both the Senate and the House of Representatives;
+Added: The Federal Trade Commission in mid-2022 also launched sweeping investigations into the practices of the PBM industry, and published interim reports with its finding in mid-2024 and January 2025, that could lead to additional federal and state legislative or regulatory proposals targeting such entities’ operations, pharmacy networks, or financial arrangements, including in the current 2025-2026 congressional session.
+Added: During the previous congressional session, numerous bipartisan PBM reforms were considered in both the Senate and the House of Representatives;
they include diverse legislative proposals such as eliminating rebates;
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Significant efforts to change the PBM industry as it currently exists in the United States may affect the entire pharmaceutical supply chain and the business of other stakeholders, including biopharmaceutical developers like us.
+Added: In September 2023, the Federal Trade Commission (“FTC”) issued a policy statement articulating its view that certain “improper” patent listings by drug developers in FDA’s Orange Book represent an unfair trade practice and indicated that industry should be prepared for potential enforcement actions based on its analysis.
+Added: The FTC followed that action in November 2023 by publicly calling out over 100 “improper” patent listings made by ten large pharmaceutical companies and initiating an FDA administrative process with respect to those patents.
+Added: The controversy regarding the appropriateness of listing such patents has led to numerous lawsuits alleging anticompetitive conduct by biopharmaceutical companies.
+Added: It remains to be seen whether the FTC under the Trump Administration will continue to prioritize the policy issue of “improper” patent listings or whether Congress may take any legislative actions related to this issue.
+Added: Accordingly, regulatory and government interest in biopharmaceutical industry business practices continues to expand and pose a risk of uncertainty.
Further, in August 2022, President Biden signed into the law the Inflation Reduction Act (“IRA”).
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Additionally, starting for payment year 2026, Centers for Medicare & Medicaid Services (“CMS”) will negotiate drug prices annually for a select number of single source Part D drugs without generic or biosimilar competition.
−Removed: CMS will also negotiate drug prices for a select number of Part B drugs starting for payment year 2028.
+Added: CMS is negotiating drug prices for a select number of Part B drugs starting for payment year 2028.
If a drug product is selected by CMS for negotiation, it is expected that the revenue generated from such drug will decrease.
−Removed: CMS has begun to implement these new authorities, including with its publication of the first list of 10 Medicare Part D drugs for negotiation in September 2023 and entering into agreements to conduct negotiations with the relevant manufacturers of those selected drugs in October 2023.
+Added: CMS has begun to implement these new authorities, entering into agreements to conduct negotiations with the relevant manufacturers of those selected drugs in October 2023 and ultimately announcing the first round of negotiated prices for the first 10 drugs in August 2024;
+Added: those negotiated “maximum fair prices” will be effective as of January 1, 2026 (payment year 2026).
+Added: CMS is currently engaged in its second round of negotiations and published the next 15 drugs selected for negotiation in January 2025.
However, the impact of this program on the biopharmaceutical industry in the United States remains uncertain, in part because multiple large pharmaceutical companies and other stakeholders (e.g., the U.S.
Chamber of Commerce) have initiated federal lawsuits against CMS arguing the program is unconstitutional for a variety of reasons, among other complaints.
−Removed: Those lawsuits are currently ongoing.
+Added: The outcome of such ongoing lawsuits, as well as potential legislative changes enacted by Congress or programmatic changes implemented at CMS by the Trump Administration, may impact the IRA drug price negotiation program in the future.
Legislative and regulatory proposals also have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.
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We expect that additional state and federal health care reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for health care products and services.
−Removed: If we successfully commercialize one of our product candidates, failure to comply with our reporting and payment obligations under United States governmental pricing programs could have a material adverse effect on our business, financial condition and results of operations.
+Added: If we successfully commercialize one of our product candidates, failure to comply with our reporting and payment obligations under U.S.
+Added: governmental pricing programs could have a material adverse effect on our business, financial condition and results of operations.
If we participate in the Medicaid Drug Rebate Program if and when we successfully commercialize a product candidate, we will be required to report certain pricing information for our product to the Centers for Medicare & Medicaid Services, the federal agency that administers the Medicaid and Medicare programs.
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Additionally, the 2021 Consolidated Appropriations Act signed into law on December 27, 2020 incorporated extensive healthcare provisions and amendments to existing laws, which includes a requirement that all manufacturers of drug products covered under Medicare Part B report the product’s average sales price to DHHS beginning on January 1, 2022, subject to enforcement via civil money penalties.
+Added: Increasingly there are state laws and regulations that require prescription drug price reporting or impose other restrictions designed to control pharmaceutical product pricing, such as price or patient reimbursement constraints and discounts.
Our employees, independent contractors, principal investigators, contract research organizations, consultants or vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
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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 significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished potential profits and future earnings, and curtailment of our operations, any of which could adversely affect our business, financial condition, results of operations or prospects.
−Removed: Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent our product candidates from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business relies, which could negatively impact our business.
+Added: Disruptions of funding for the FDA, the SEC and other government agencies caused by funding shortages, mass layoffs, or global health concerns could hinder their ability to hire and retain key leadership and other personnel, prevent our product candidates from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business relies, which could negatively impact our business.
The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes.
2 unchanged sentences
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, over the last several years, the United States government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities.
−Removed: If a prolonged government shutdown occurs, it could significantly affect the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
+Added: For example, over the last several years, the United States government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities during that period.
+Added: In early 2025, following the inauguration of President Trump, the Trump Administration began terminating federal government employees, including at the FDA.
+Added: The impact of mass layoffs at the agency and other governmental offices with which we interact is unclear at this time.
+Added: However, it is expected that
+Added: with a proposed reduction in staff of up to 50%, the FDA in the future may be unlikely to meet its application review goals or to continue to be available for timely interactions with medical product developers.
+Added: It is currently unclear how the U.S.
+Added: biopharmaceutical industry will be affected by the Trump Administration’s major changes to the FDA and the federal government as a whole.
+Added: Separately, during the COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points.
+Added: Even though the FDA has since resumed standard inspection operations of domestic facilities where feasible, the agency has continued to monitor and implement changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates, and any resurgence of the virus or emergence of new infectious disease outbreaks may lead to future inspectional delays.
+Added: Regulatory authorities outside the United States may adopt similar policy measures in response to emerging infectious disease outbreaks, epidemics, or pandemics.
+Added: If a prolonged government shutdown or slowdown occurs, or if global health concerns similar to COVID-19 prevent the FDA or other regulatory agencies from conducting their regular inspections, review, or other regulatory activities, it could significantly affect the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.
Further, in our operations as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
+Added: Further, three decisions from the U.S.
+Added: Supreme Court issued in July 2024 may lead to an increase in litigation against regulatory agencies that could create uncertainty and thus negatively impact our business.
+Added: The first decision overturned established precedent that required courts to defer to regulatory agencies’ interpretations of ambiguous statutory language.
+Added: The second decision overturned regulatory agencies’ ability to impose civil penalties in administrative proceedings.
+Added: The third decision extended the statute of limitations within which entities may challenge agency actions.
+Added: These cases may result in increased litigation by industry against regulatory agencies, including but not limited to the FDA and SEC, and may impact how such agencies choose to pursue enforcement and compliance actions.
+Added: However, the specific, lasting effects of these decisions, which may vary within different judicial districts and circuits, is unknown.
+Added: We also cannot predict the extent to which FDA and SEC regulations, policies, and decisions may become subject to increasing legal challenges, delays, and changes.
Risks Related to Employee Matters and Managing Growth
−Removed: Our future success depends on our ability to retain our chief executive officer and other key executives and to attract, retain and motivate qualified personnel.
+Added: Our future success depends on our ability to retain our key executives and to attract, retain and motivate qualified personnel.
Our industry has experienced a high rate of turnover of management personnel in recent years.
−Removed: We are highly dependent on the development, regulatory, commercialization and business development expertise of Satyavrat Shukla, our President and Chief Executive Officer, as well as the other principal members of our management, scientific and clinical team.
+Added: We are highly dependent on the development, regulatory, commercialization and business development expertise of principal members of our management, scientific and clinical team.
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.
−Removed: On October 29, 2024, we implemented a restructuring that reduced our workforce by approximately 39%.
−Removed: 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: On October 29, 2024, we implemented a restructuring plan that reduced our workforce by approximately 39%.
+Added: While we have confidence in our remaining employees, and our leadership team, including our current President, Chief Executive Officer and Chief Financial Officer, Ms.
+Added: Rajavelu, who was appointed President and Chief Executive Officer effective as of May 2, 2025 following our separation with Mr.
+Added: Shukla, the inherent uncertainty following this restructuring may cause concerns from third parties with whom we do business, and may increase the likelihood of turnover of other key officers and employees.
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.
−Removed: 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.
+Added: If we lose one or more of our named executive officers or key employees, our ability to implement our business strategy successfully could be seriously harmed.
Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to develop, gain regulatory approval of and commercialize product candidates successfully.
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If we are unable to continue to attract and retain high quality personnel, our ability to develop and commercialize product candidates will be limited.
−Removed: 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.
−Removed: As described above, on October 29, 2024, we announced a restructuring plan and implemented a workforce reduction.
+Added: We undertook 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: On October 29, 2024, we announced a restructuring plan and implemented a workforce reduction.
There can be no assurance that our restructuring will achieve the cost savings, operating efficiencies or other benefits that we may initially expect.
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Risks Related to Our Common Stock
−Removed: The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for our stockholders.
+Added: The price of our common stock has been and, in the future, may continue to be volatile whether related or unrelated to our operations, which could result in a decline in value for our stockholders.
Our stock price may be volatile.
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An active trading market for our common stock may never develop or be sustained.
−Removed: Although our common stock is listed on the Nasdaq Global Select Market (“Nasdaq GS”), an active trading market for our shares may never develop or be sustained.
+Added: Although our common stock is listed on the Nasdaq GS, an active trading market for our shares may never develop or be sustained.
As a result, it may be difficult for our stockholders to sell their shares without depressing the market price for the shares, or at all.
−Removed: If in the future we fail to satisfy the requirements of the Nasdaq GS it could result in a delisting of our common stock and could negatively affect the market price of our common stock, our liquidity and our ability to raise capital.
+Added: Our shares of common stock could be delisted from the Nasdaq GS, which could result in, among other things, a decline in the price of our common stock and less liquidity for our stockholders.
Our common stock is listed on the Nasdaq GS, which imposes, among other requirements, a minimum $1.00 per share bid price requirement for continued inclusion on the Nasdaq GS pursuant to Nasdaq Listing Rule 5450(a)(1) (the “Bid Price Requirement”).
The closing bid price for our common stock must remain at or above $1.00 per share to comply with the Bid Price Requirement for continued listing.
−Removed: In August 2022, we received a deficiency letter from the Listing Qualifications Department, or the Nasdaq Staff, informing us that we were not in compliance with the continued listing requirements of the Nasdaq Global Select Market because the bid price for our common stock had closed below $1.00 per share for 30 consecutive business days.
−Removed: In October 2022, we received written notification from the Nasdaq Staff informing us that we had regained compliance with the minimum bid price requirement as a result of our common stock maintaining a closing bid price of $1.00 per share or greater for at least 10 consecutive business days.
−Removed: However, there can be no assurance that we will be able to keep the closing bid price above $1.00 per share.
+Added: On February 25, 2025, we received a deficiency letter (the “Notice”) from the Listing Qualifications Department of Nasdaq, or the Nasdaq Staff, informing us that we were not in compliance with the continued listing requirements of the Nasdaq GS because the bid price for our common stock had closed below $1.00 per share for 30 consecutive trading days.
+Added: In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have until August 25, 2025 (the “Compliance Date”), to regain compliance with the Bid Price Requirement.
+Added: According to the Notice, if at any time before August 25, 2025, the closing bid price of our common stock is at least $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written notification that we have achieved compliance with the Bid Price Requirement and our common stock will continue to be eligible for listing on the Nasdaq GS.
+Added: If we do not regain compliance with the Bid Price Requirement by the Compliance Date, we may be eligible for an additional 180 day compliance period under the following circumstances.
+Added: To qualify, we would need to transfer the listing of the common stock to the Nasdaq Capital Market, provided that we meet the continued listing requirement for the market value of publicly held shares and all other initial listing standards, with the exception of the Bid Price Requirement.
+Added: To effect such a transfer, we would also need to pay an application fee to Nasdaq and will need to provide written notice to Nasdaq of our intention to cure the deficiency during the additional compliance period by effecting a reverse stock split, if necessary.
+Added: As part of its review process, Nasdaq would make a determination of whether it believes we will be able to cure this deficiency.
+Added: If Nasdaq concludes that we will not be able to cure the deficiency, or if we do not cure the deficiency within such additional 180 day compliance period, Nasdaq will provide written notification to us that our common stock will be subject to delisting.
+Added: At that time, we may appeal Nasdaq’s delisting determination to a Nasdaq Listing Qualifications Panel (the “Panel”).
+Added: However, there can be no assurance that, if we receive a delisting notice and appeal the delisting determination by Nasdaq to the Panel, such appeal would be successful.
+Added: There can be no assurance that we will be able to keep the closing bid price above $1.00 per share for the required 10 consecutive trading days by August 25, 2025.
+Added: Further, if we are unable to maintain the closing bid price at $1.00 for the required period, there is no guarantee that we will regain compliance with the Bid Price Requirement.
+Added: There is no guarantee that a reverse stock split would be approved by the stockholders or that a reverse stock split would allow us to regain compliance with the Bid Price Requirement.
Any potential delisting of our common stock could have a material adverse effect on the market for, and liquidity and price of, our common stock and would adversely affect our ability to raise capital on terms acceptable to us, or at all.
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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
−Removed: 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 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 common stock and may, if appropriate, consider implementing available options to regain 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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In addition, if one or more of these analysts cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which could cause our share price or trading volume to decline.
−Removed: 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: 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 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.
−Removed: 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.
+Added: Unstable global economic and political conditions, including economic uncertainty tied to volatility in interest rates and 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.
+Added: Unstable global economic and political conditions, including economic uncertainty tied to volatility in interest rates and 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.
+Added: The global economy, in particular the financial markets, have recently experienced significant disruption and volatility, including without limitation, as a result of volatility in interest rates and inflation, capital markets volatility, 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: In addition, market, interest rate, and inflation volatility may increase our cost of financing or restrict our access to potential sources of future capital.
Furthermore, our stock price may further decline due in part to the volatility of the stock market and any general economic downturn.
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Alternatively, if a court were to find the choice of forum provisions contained in our Amended and Restated Certificate of Incorporation, as amended, to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, results of operations and financial condition.
−Removed: Provisions in our charter and other provisions of Delaware law could limit the price that investors are willing to pay in the future for shares of our common stock.
+Added: Provisions in our Amended and Restated Certificate of Incorporation, as amended, and other provisions of Delaware law could limit the price that investors are willing to pay in the future for shares of our common stock.
+Added: We have received a “Wells Notice” from the SEC contemplating a civil enforcement action, which could have a material adverse effect on our business, financial condition and results of operations, prospects, and/or our stock price.
+Added: On January 9, 2025, we responded to the “Wells Notice” from the Staff of the SEC, as further described in Part II, Item 1 “Legal Proceedings” of this Quarterly Report on Form 10-Q.
+Added: A Wells Notice is neither a formal charge of wrongdoing nor a final determination that the recipient has violated any law, but is a preliminary determination by the Staff to recommend to the SEC Commissioners that a civil enforcement action or administrative proceeding be brought against the recipients.
+Added: If the SEC were to authorize an action against us and/or any of the identified individuals, it may seek an injunction or cease-and-desist order against future violations of provisions of the federal securities laws, the imposition of civil monetary penalties, disgorgement or other equitable relief within the SEC’s authority, or any combination of the foregoing.
+Added: The SEC could also seek an order barring each identified individual from serving as an officer or director of a public company for a specified period of time.
+Added: Mahadevia and Mr.
+Added: Shukla are cooperating with the SEC and have made a submission in response to the Wells Notice explaining why an enforcement action would not be appropriate.
+Added: We cannot predict the results of the Investigation and the Wells Notice process and any corresponding enforcement action against us and/or any of the identified individuals, and the costs, timing and other potential consequences of responding and complying therewith with any certainty.
+Added: The Investigation, and the Wells Notice process continues to be expensive and disruptive, and we are subject to indemnifying each of the individuals for their costs associated with the Wells Notices.
+Added: Our insurance, to the extent maintained, may not cover all claims that may be asserted against us or the specified individuals, and we are unable to predict how long the Investigation will continue.
+Added: An unfavorable outcome may have an adverse impact on our business, financial condition and results of operations, prospects, or our stock price.
+Added: Any proceeding could also negatively impact our reputation among our stakeholders.
We may become involved in securities litigation that could divert management’s attention and harm the company’s business, and insurance coverage may not be sufficient to cover all costs and damages.
−Removed: In the past, securities litigation has often followed certain significant business transactions, such as the announcement of a strategic restructuring, or the announcement of negative events, such as negative results from clinical trials.
+Added: In the past, securities litigation has often followed certain significant business activities, such as the announcement of a strategic restructuring, or the announcement of negative events, such as negative results from clinical trials.
We may be exposed to such litigation even if no wrongdoing occurred.
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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.