What changed in this filing

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Item 1. Legal Proceedings

2025-11-13 compared with 2025-08-12 · 91 added, 96 removed, 1232 unchanged (13% of the section changed)

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Risks Related to Product Development and Commercialization

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.

We have also discontinued development of SPR206.

As of November 2025, we have ceased 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.

Consequently, our business and prospects are substantially dependent on our tebipenem program and our collaboration with GSK.

If we fail to execute successfully on this re-prioritized strategic focus, our business and prospects may be materially adversely affected.

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.

In evaluating the totality of both the efficacy and safety data, we elected to suspend our development program for SPR720 and continue to determine next steps.

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.

Further, in March 2025, we announced that we 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.

If we fail to execute successfully on this re-prioritized strategic focus, or our collaboration with GSK fails to advance the clinical development of the tebipenem HBr program, our business and prospects may be materially adversely affected.

Additionally, in March 2025, we announced that we ceased 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 identifying and developing novel treatments for rare diseases and diseases caused by MDR bacterial infections with high unmet need.

However, there is no assurance that we will successfully execute this strategy.

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.

As described below, there are risks inherent in the clinical development process, especially for earlier-stage programs.

If we are unable to execute successfully on this re-prioritized strategic focus, our business and prospects may be materially adversely affected.

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If any of these outcomes occur, our business could be materially harmed.

If our clinical trials fail to produce favorable results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of such product candidates.

We may not commercialize, market, promote or sell any product candidate in the United States without obtaining marketing approval from the FDA or in other countries without obtaining approvals from comparable foreign regulatory authorities, such as the European Medicines Agency (“EMA”), and we may never receive such approvals.

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The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion.

We may not be able to initiate, continue or complete clinical trials of our product candidates if we are unable to locate and enroll a sufficient number of eligible patients to participate in clinical trials as required by the FDA or comparable foreign regulatory authorities, such as the EMA.

The initiation, continuation and completion of our clinical trials relies on our ability to locate and enroll a sufficient number of eligible patients to participate in clinical trials as required by the FDA or comparable foreign regulatory authorities, such as the EMA.

Patient enrollment is a significant factor in the timing of clinical trials, and is affected by many factors, including:

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Our inability to enroll a sufficient number of patients for our clinical trials would result in significant delays or might require us to abandon one or more clinical trials altogether.

Enrollment delays in our clinical trials may result in increased development costs for our product candidates, slow down or halt our product candidate development and approval process and jeopardize our ability to seek and obtain the marketing approval required to commence product sales and generate revenue, which would cause the value of our company to decline and limit our ability to obtain additional financing if needed.

Enrollment delays in our clinical trials may result in increased development costs for any of our product candidates, slow down or halt our product candidate development and approval process and jeopardize our ability to seek and obtain the marketing approval required to commence product sales and generate revenue, which would cause the value of our company to decline and limit our ability to obtain additional financing if needed.

Congress also amended the Federal Food, Drug, and Cosmetic Act (“FDCA”) to require sponsors of a Phase 3 clinical trial, or other “pivotal study” of a new drug to support marketing authorization, to design and submit a diversity action plan (“DAP”) for such clinical trial.

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In June 2024, as mandated by the FDCA, the FDA issued draft guidance outlining the general requirements for DAPs.

Unlike most guidance documents issued by the FDA, the DAP guidance when finalized will have the force of law because FDORA specifically dictates that the form and manner for submission of DAPs are specified in FDA guidance.

Unlike most guidance documents issued by the FDA, the DAP guidance when finalized will have the force of law because Food and Drug Omnibus Reform Act of 2022 (“FDORA”) specifically dictates that the form and manner for submission of DAPs are specified in FDA guidance.

On January 27, 2025, in response to an executive order issued by President Trump on January 21, 2025 on Diversity, Equity and Inclusion programs, the FDA removed the draft DAP guidance from its website.

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As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that may prove to have greater commercial potential.

For example, 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.

In evaluating the totality of both the efficacy and safety data, we elected to suspend our development program for SPR720 and continue to determine next steps.

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.

Further, in March 2025, we announced that we have discontinued development of SPR206.

For example, as of November 2025, we have ceased 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.

Additionally, in March 2025, we announced that we have ceased development of SPR206.

Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.

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This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.

In addition, we may not be able to hire a sales force in the United States that is sufficient in size or has adequate expertise in the medical markets that we intend to target.

In addition, we may not be able to hire a sales force in the United States

that is sufficient in size or has adequate expertise in the medical markets that we intend to target.

If we or our collaborators are unable to establish a sales force and marketing and distribution capabilities, our operating results may be adversely affected.

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• unforeseen costs and expenses associated with creating an independent sales and marketing organization.

We intend to use collaborators to assist with the commercialization of any of our product candidates, including the GSK License Agreement for the development and commercialization of tebipenem HBr.

We intend to use collaborators to assist with the commercialization of any of our current and future product candidates, including the GSK License Agreement for the development and commercialization of tebipenem HBr.

As a result of entering into arrangements with third parties to perform sales, marketing and distribution services, our product revenues or the profitability of these product revenues to us would likely be lower than if we were to directly market and sell products in those markets.

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Insurers and other third-party payors may also encourage the use of generic products, for example in the fluoroquinolone class.

However, the susceptibility of urinary tract pathogens to the existing treatment

alternatives is waning.

However, the susceptibility of urinary tract pathogens to the existing treatment alternatives is waning.

If tebipenem HBr is approved, the pricing may be at a significant premium over other competitive products.

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There are several IV-administered products marketed for the treatment of infections resistant to first-line therapy for Gram-negative infections, including Avycaz (ceftazidime-avibactam) from Allergan plc and Pfizer, Zerbaxa (ceftolozane-tazobactam) from Merck & Co., imipenem/cilastatin and Recarbrio (relebactam) from Merck & Co., Zemdri (plazomicin) from Cipla Therapeutics, Inc., Fetroja (cefiderocol) from Shionogi & Co.

Ltd., Xerava (eravacycline) from Innoviva, Inc.

and Vabomere (meropenem-vaborbactam) from Melinta Therapeutics, Inc., and Exblifep (cefepime/enmetazobactam) from Allecra Therapeutics.

Ltd., and Vabomere (meropenem-vaborbactam) from CorMedix Inc., and Exblifep (cefepime/enmetazobactam) from Allecra Therapeutics.

Many of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do.

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If we are not successful in developing and commercializing additional product candidates, our ability to expand our business and achieve our strategic objectives would be impaired.

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 determining next steps for SPR720, a key element of our strategy is to develop and commercialize a portfolio of therapeutics to treat drug resistant bacterial infections.

Although a substantial amount of our efforts are currently focused on our potential approval of our product candidate, tebipenem HBr, a key element of our strategy is to develop and commercialize a portfolio of therapeutics to treat drug resistant bacterial infections.

We are exploring, and intend to explore in the future, strategic partnerships for the development of new product candidates.

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There can be no assurance that we will be successful in preventing cyber-attacks or successfully mitigating their effects.

Despite the implementation of security measures, our internal computer systems and those of our contract research organizations and other contractors and consultants are vulnerable to damage or disruption from hacking, computer viruses, malware, including ransomware, software bugs, unauthorized access, natural disasters, terrorism, war, and telecommunication, equipment and electrical

We have measures in place that are designed to prevent, and if necessary, to detect and respond to such cybersecurity incidents and breaches of privacy and security mandates.

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For example, the European Parliament and the Council of the European Union adopted a comprehensive general data privacy framework called the General Data Protection Regulation (“GDPR”), which took effect in May 2018 and governs the collection and use of personal data in the European Union, including by companies outside of the European Union.

The GDPR, which is wide-ranging in scope, imposes several requirements relating to the consent of the individuals to whom the personal data relates, the information provided to the individuals, the security and confidentiality of the personal data, data breach notification and the use of

third-party processors in connection with the processing of the personal data.

The GDPR also imposes strict rules on the transfer of personal data out of the European Union to the United States, enhances enforcement authority and imposes large penalties for noncompliance, including the potential for fines of up to €20 million or 4% of the annual global revenues of the infringer, whichever is greater.

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Despite our efforts, we may not have fully complied in the past and may not in the future.

That could require us to incur significant expenses, which could significantly affect our business.

That could require us to incur significant expenses, which could significantly

affect our business.

Failure to comply with data protection laws may expose us to risk of enforcement actions taken by data protection authorities or other regulatory agencies, private rights of action in some jurisdictions, and potential significant penalties if we are found to be non-compliant.

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We have not generated any revenue from the sale of our products and have incurred losses in most years since our inception in 2013.

Our net loss was $1.7 million and $15.6 million during the three and six months ended June 30, 2025, respectively.

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.

Our net loss was $7.4 million and $22.9 million during the three and nine months ended September 30, 2025, respectively.

We have yet to have a product candidate approved for sale and we may never have a product candidate approved for commercialization.

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.

Based on our cash and cash equivalents as of June 30, 2025, together with earned and non-contingent development milestone payments from GSK, including the final payment under the GSK License Agreement of $23.8 million received in the third quarter of 2025, and the decrease in clinical expense as a result of the PIVOT-PO Phase 3 trial for tebipenem HBr stopping early for efficacy following positive interim analysis results, we believe that our cash runway will be sufficient to fund our operating expenses and required capital expenditures into 2028.

Based on our cash and cash equivalents as of September 30, 2025 and the decrease in clinical expense as a result of the completion of the PIVOT-PO Phase 3 trial for tebipenem HBr and the decision to cease development of SPR720, we believe that our cash runway will be sufficient to fund our operating expenses and required capital expenditures into 2028.

During this period, we plan to prioritize finalizing the Phase 3 clinical trial activities for tebipenem HBr under our GSK License Agreement.

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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 in the development of our product candidates, including tebipenem HBr, SPR206, and SPR720.

Although we 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 although we have suspended our development efforts with respect to the SPR720 oral program and are continuing to determine next steps, our business remains heavily dependent on the successful development, regulatory approval, and, if approved, commercialization of tebipenem HBr and other future product candidates.

Although we decided to cease further development of SPR206 and SPR720, our business remains heavily dependent on the successful development, regulatory approval, and, if approved, commercialization of tebipenem HBr and any 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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Our expenses would increase if we are required by the FDA, or any comparable foreign regulatory authority to perform studies in addition to those currently expected, or if there are any delays in completing our clinical trials or the development of any of our product candidates.

We expect that we will need substantial additional funding.

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.

If we are unable to raise capital when needed, or do not receive payments under our government awards or from our commercial partnership agreements, it could limit our ability to support our operations and explore our growth strategy.

Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is a time-consuming, expensive and uncertain process that takes years to complete.

Our expenses are likely to increase as we commence and advance our ongoing and planned clinical trials and other studies for our current and future product candidates, as well as determining next steps for SPR720.

Our expenses are likely to increase if we commence and advance additional studies for any future product candidates.

If we obtain marketing approval for any product candidate, we expect to incur significant expenses related to development, product sales, marketing, distribution and manufacturing.

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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.

Based on our cash and cash equivalents as of June 30, 2025, together with earned and non-contingent development milestone payments from GSK, and the decrease in clinical expense as a result of the PIVOT-PO Phase 3 trial for tebipenem HBr stopping early for efficacy following positive interim analysis results, we believe that our cash runway will be sufficient to fund our operating expenses and capital expenditures into 2028.

Based on our cash and cash equivalents as of September 30, 2025, and the decrease in clinical expense as a result of the completion of the PIVOT-PO Phase 3 trial for tebipenem HBr and the decision to cease development of SPR720, we believe that our cash runway will be sufficient to fund our operating expenses and capital expenditures into 2028.

During this period, we plan to prioritize finalizing the Phase 3 clinical trial activities for tebipenem HBr under our GSK License Agreement.

Beyond this point, or in the event we change our current operating plan, we will

need substantial additional funding to support our continuing operations and pursue our growth strategy.

Beyond this point, or in the event we change our current operating plan, we will need additional funding to support our continuing operations and explore our growth strategy.

Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, government funding arrangements, collaborations, strategic alliances and marketing, distribution or licensing arrangements.

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Our operations to date have been limited to financing and staffing our company, and performing research and development activities to advance our product candidates.

Each of our product candidates is either in clinical or preclinical development.

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.

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Risks Related to Our Dependence on Third Parties

We may not achieve the milestones triggering payments to us in our license and collaboration agreements with third parties.

We may not achieve the milestones triggering payments to us in our existing, or any future, license and collaboration agreements with third parties.

We have and may continue to seek third-party collaborators for development and commercialization of certain of our product candidates.

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In addition, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators.

If we are unable to reach agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, we may have to curtail the development of a product candidate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures

and undertake development or commercialization activities at our own expense.

If we elect to fund and undertake development or commercialization activities on our own, we may need to obtain additional expertise and additional capital, which may not be available to us on acceptable terms or at all.

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Although we rely on these third parties to conduct our GLP-compliant nonclinical studies and clinical trials, we remain responsible for ensuring that each of our nonclinical studies and clinical trials are conducted in accordance with applicable laws and regulations, and our reliance on the CROs does not relieve us of our regulatory responsibilities.

The FDA and regulatory authorities in other jurisdictions also require us to comply with standards, commonly referred to as good clinical practices (“GCPs”) for conducting, monitoring, recording and reporting the results of clinical trials to assure that data and reported results are accurate and that the trial subjects are adequately informed of the potential risks of participating in clinical trials.

The FDA and regulatory authorities in other jurisdictions also require us to comply with standards, commonly

referred to as good clinical practices (“GCPs”) for conducting, monitoring, recording and reporting the results of clinical trials to assure that data and reported results are accurate and that the trial subjects are adequately informed of the potential risks of participating in clinical trials.

The FDA enforces these GCPs through periodic inspections of trial sponsors, principal investigators, clinical trial sites and institutional review boards.

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Any performance failure on the part of our distributors could delay clinical development or marketing approval of our product candidates or commercialization of any resulting products, producing additional losses and depriving us of potential product revenue.

We contract with third parties for the manufacture of preclinical and clinical supplies of our product candidates and expect to continue to do so in connection with any future commercialization and for any future clinical trials and commercialization of our other product candidates and potential product candidates.

We contract with third parties for the manufacture of clinical supplies of tebipenem HBr and expect to continue to do so in connection with any future commercialization and for any future clinical trials and commercialization of any potential product candidates.

This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

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In addition, our manufacturers are subject to ongoing periodic unannounced inspections by the FDA and corresponding state and foreign agencies for compliance with cGMPs and similar regulatory requirements.

Failure by any of our manufacturers to comply with applicable cGMPs or other regulatory requirements could result in sanctions being imposed on us,

including fines, injunctions, civil penalties, delays, suspensions or withdrawals of approvals, operating restrictions, interruptions in supply and criminal prosecutions, any of which could significantly and adversely affect supplies of our product candidates and have a material adverse effect on our business, financial condition and results of operations.

Failure by any of our manufacturers to comply with applicable cGMPs or other regulatory requirements could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspensions or withdrawals of approvals, operating restrictions, interruptions in supply and criminal prosecutions, any of which could significantly and adversely affect supplies of our product candidates and have a material adverse effect on our business, financial condition and results of operations.

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.

If we fail to comply with our obligations in the agreements under which we in-license or out-license or acquire development or commercialization rights to products, technology or data from or to third parties, we could lose 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.

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 or to third parties, we could lose rights that are important to our business.

We are a party to agreements with Meiji and GSK for tebipenem HBr, and have legacy agreements with 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.

For example, we have the Meiji License that gives us rights outside of the Meiji Territory to develop, manufacture, and commercialize tebipenem HBr as well as the right to use, cross-reference, file or incorporate by reference any information and relevant Meiji regulatory documentation to support any regulatory filings outside of the Meiji Territory.

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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.

Under the terms of the GSK License Agreement, we received an upfront payment of $66.0 million for GSK to secure rights to tebipenem pivoxil and tebipenem HBr, 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 payment that is payable in four equal semi-annual installments, of which we received $23.8 million in the first quarter of 2024, the third quarter of 2024, the first quarter of 2025 and the third quarter of 2025.

installments, of which we received $23.8 million in the first quarter of 2024, the third quarter of 2024, the first quarter of 2025 and the third quarter of 2025.

Remaining potential payments under the GSK License Agreement are milestone based and are (i) $25.0 million for GSK’s submission of a NDA with the FDA for tebipenem HBr, (ii) up to $101.0 million in commercial milestone payments, and (iii) up to $225.0 million in sales milestone payments.

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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.

As of June 30, 2025, we have two registered U.S.

As of September 30, 2025, we have two registered U.S.

trademarks, 23 registered foreign trademarks, and no pending foreign trademark applications.

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As with the FDA’s other programs for expediting review and approval of new drug products, even if we were to avail ourselves of this new program, there is no guarantee it would result in approval of our marketing applications or that such approval, if granted, would be on an expedited basis.

While we have negotiated a SPA agreement with the FDA relating to our pivotal Phase 3 clinical trial of tebipenem HBr in patients with cUTI, including acute pyelonephritis, this agreement does not guarantee approval of tebipenem HBr or any other particular outcome from regulatory review of the clinical trial or the product candidate.

On July 31, 2023, the Company announced that it received written agreement from the FDA, under a special protocol assessment (“SPA”), on the design and size of PIVOT-PO, a pivotal Phase 3 clinical trial of tebipenem HBr in patients with cUTI, including acute pyelonephritis.

While we have negotiated an SPA agreement with the FDA relating to our pivotal Phase 3 clinical trial of tebipenem HBr in patients with cUTI, including acute pyelonephritis, this agreement does not guarantee approval of tebipenem HBr or any other particular outcome from regulatory review of the clinical trial or the product candidate.

On July 31, 2023, the Company announced that it received written agreement from the FDA, under an SPA, on the design and size of PIVOT-PO, a pivotal Phase 3 clinical trial of tebipenem HBr in patients with cUTI, including acute pyelonephritis.

The FDA’s SPA process is designed to allow the FDA to evaluate the proposed design and size of clinical trials that are intended to form the primary basis for determining a drug product’s efficacy, among other eligible protocols.

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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.

We may seek orphan drug designation for certain of our other product candidates.

We may not be able to obtain or maintain orphan drug designations for any of our other product candidates, and we may be unable to take advantage of the benefits associated with orphan drug designation, including the potential for market exclusivity.

We may seek orphan drug designation for one or more of our product candidates.

We may not be able to obtain or maintain orphan drug designations for any of our product candidates, and we may be unable to take advantage of the benefits associated with orphan drug designation, including the potential for market exclusivity.

Regulatory authorities in some jurisdictions, including the United States, may designate drugs for relatively small patient populations as orphan drugs.

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In addition, if a product candidate that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, it is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications, including an NDA, to market the same drug for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity or where the manufacturer is unable to assure sufficient product quantity.

Even though we have obtained orphan drug designation for SPR720 and may seek orphan drug designation for other product candidates in the future, there is no assurance that we or any third party partner we may have in the future will be the first to obtain marketing approval for NTM infection or for any particular rare indication.

Further, even though we have obtained orphan drug designation for SPR720, or even if we obtain orphan drug designation for other product candidates, such designation may not effectively protect us from competition because different drugs can be approved for the same condition and the same drug can be approved for different conditions and potentially used off-label in the orphan indication.

In March 2020, the FDA granted orphan drug designation for SPR720.

However, in November 2025, we announced that we were ceasing development of SPR720.

Even though we may seek orphan drug designation for other product candidates in the future, there is no assurance that we or any third party partner we may have in the future will obtain orphan drug designation and/or be the first to obtain marketing approval for any particular rare indication.

Further, even if we obtain orphan drug designation for other product candidates, such designation may not effectively protect us from competition because different drugs can be approved for the same condition and the same drug can be approved for different conditions and potentially used off-label in the orphan indication.

Even after an orphan drug is approved, the FDA can subsequently approve a competing drug for the same condition for several reasons, including, if the FDA concludes that the later drug is safer or more effective or makes a major contribution to patient care.

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fully embraced the reasoning of the Catalyst decision in another decision challenging the scope of orphan drug exclusivity.

On April 17, 2025, the FDA appealed this

decision to the U.S.

On April 17, 2025, the FDA appealed this decision to the U.S.

Court of Appeals for the D.C.

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Our product candidates, if approved, could be subject to restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product candidates, when and if approved.

Any product candidate for which we obtain marketing approval will also be subject to ongoing regulatory requirements for labeling, packaging, storage, distribution, advertising, promotion, record keeping and submission of safety and other post-market information.

For example, approved products, manufacturers and manufacturers’ facilities are required to comply with extensive FDA requirements, including ensuring that quality control and manufacturing procedures conform to cGMPs.

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These laws and regulations include, for example, the false claims and anti-kickback statutes and regulations.

At such time as we market, sell and distribute any products for which we obtain marketing approval and reimbursement, it is possible that our business activities could be subject to challenge under one or more of these laws and regulations.

time as we market, sell and distribute any products for which we obtain marketing approval and reimbursement, it is possible that our business activities could be subject to challenge under one or more of these laws and regulations.

Restrictions under applicable federal and state healthcare laws and regulations include the following:

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they include diverse legislative proposals such as eliminating rebates;

divorcing service fees from the price of a drug,

discount, or rebate;

divorcing service fees from the price of a drug, discount, or rebate;

prohibiting spread pricing;

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These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.

Activities subject to these laws also involve the improper use or misrepresentation of information obtained in the course of clinical trials or creating fraudulent data in our preclinical studies or clinical trials, which could result in regulatory sanctions and serious harm to our reputation.

serious harm to our reputation.

It is not always possible to identify and deter misconduct by our employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.

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For example, while the FDA RIF did not reportedly specifically target FDA reviewers, many operations, administrative and policy staff that help support such reviews were affected and those losses could lead to delays in PDUFA reviews and related activities.

As of July 15, 2025, there has been at least one report in which the FDA failed to meet a PDUFA goal date for approval of an NDA due to heavy workload and limited resources.

There has been at least one report in which the FDA failed to meet a PDUFA goal date for approval of an NDA due to heavy workload and limited resources.

In addition, while currently unclear, there is a risk that the RIF and budget cutbacks could threaten the integrity of the PDUFA program itself.

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These include Executive Order 14192, “Unleashing Prosperity Through Deregulation,” January 31, 2025;

Executive Order 14212, “Establishing the President’s Make America Healthy

Again Commission,” February 13, 2025;

Executive Order 14212, “Establishing the President’s Make America Healthy Again Commission,” February 13, 2025;

and Executive Order 14219, “Ensuring Lawful Governance and Implementing the President’s ‘Department of Government Efficiency’ Deregulatory Initiative,” February 21, 2025.

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eliminating agency information and resources for facilitating research activity;

delaying or terminating federal agency procedures for authorizing international transactions;

terminating federal agency procedures for authorizing international transactions;

initiating aggressive enforcement actions that may disrupt the operations of major research universities that are significant contributors to life sciences research in the U.S., and threatening access to federal agency contracts and other funding awards based on companies’ otherwise lawful corporate policies and choice of counsel.

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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.

We may be materially adversely affected by the imposition of duties and tariffs and other trade barriers and retaliatory countermeasures implemented by the U.S.

and other governments.

Changes in and uncertainty surrounding U.S.

and international trade policies, particularly with respect to China, may adversely impact our business and operating results.

This past spring, the U.S.

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In response, several countries threatened retaliatory measures, including Canada and China, which then imposed retaliatory tariffs.

to when the country-specific reciprocal tariffs were scheduled to take effect, the Trump administration delayed the effective date of such tariffs for all countries except China to August 1, 2025.

Later, the United States and China reached a framework agreement that resulted in the suspension of the higher reciprocal tariffs on China until August 12, 2025.

Several countries including, among others, the European Union, Japan, and the United Kingdom, have reached deals with the U.S.

Prior to when the country-specific reciprocal tariffs were scheduled to take effect, the Trump administration delayed the effective date of such tariffs for all countries except China to August 1, 2025.

Later, the United States and China reached a framework agreement that ultimately resulted in the suspension of the higher reciprocal tariffs on China until November 11, 2025.

Since the April announcement, several countries including the European Union, Japan, South Korea and the United Kingdom, among others, have reached deals with the U.S.

that include reduced tariff rates to varying levels and other measures.

The Trump administration has not definitively indicated the effective date for these deals.

As of July 31, 2025, the 10% baseline reciprocal tariff announced in April on all countries remains in effect, in addition to the other tariffs on China (which were a minimum of an additional 20% as of July 15, 2025) and on Canada and Mexico (which were 25% as of July 15, 2025 for goods that are not covered by the USMCA).

On July 31, 2025, President Trump issued an Executive Order detailing new reciprocal tariff rates for individual countries that took effect on August 7, 2025.

The new reciprocal rates, which are consistent with the rates reflected in the trade deals already announced, range from 10% to 41%.

The new rates do not apply to Canada, China, Mexico and a few other countries.

For China, the 10% baseline reciprocal tariff announced in April remains in effect, in addition to a minimum of an additional 20%.

Regarding Canada and Mexico, the rate remains 25% for goods that are not covered by the USMCA for Mexico and, effective August 1, 2025, was increased to 35% on imports from Canada that are not covered by the USMCA.

Sustained uncertainty about, or the further escalation of, trade and political tensions between the United States and China could result in a disadvantageous research and manufacturing environment in China, particularly for U.S.

based companies, including retaliatory restrictions that hinder or potentially inhibit our ability to rely on CMOs and other service providers that operate in China.

Separately, on April 16, 2025, the U.S.

Department of Commerce announced an investigation under Section 232 of the Trade Expansion Act of 1962 into imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, and key starting materials, and derivative products of those items.

The investigation will examine the impact of these imports on U.S.

national security culminating in a decision by the President whether to take action to remedy any identified threats, including by imposing additional tariffs.

The statute provides that the Commerce Department report must be completed within 270 days of initiation of the investigation and that the President must decide whether to act within 90 days of receiving the report.

Certain countries have reached agreements with the U.S.

that cap pharmaceutical tariffs at 15%.

These include the European Union, Japan, South Korea and the United Kingdom.

Separately, in April 2025, the U.S.

Department of Commerce initiated an investigation under Section 232 of the Trade Expansion Act of 1962 into the impact on U.S.

national security of the imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, and key starting materials, and derivative products of those items.

On September 25, 2025, via a post on Truth Social, President Trump announced that, beginning October 1, 2025, all branded or patented drugs imported in the U.S.

would face a 100% tariff.

At the same time, Trump indicated that these tariffs could be avoided by building pharmaceutical manufacturing facilities in the U.S.

Thereafter, Trump delayed the October 1st effective date of the tariffs on branded or patented pharmaceutical products announcing that the Administration had now “begun preparing” tariffs on manufacturers that don’t build in the U.S.

or enter into an MFN drug pricing agreement with the Trump administration.

As a result of changes in tariffs that have been announced and/or implemented, and the underlying uncertainty currently surrounding international trade, we could experience a negative impact to our costs of materials and production processes, and supply chain disruptions and delays as a result of any new tariff policies or trade restrictions.

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Although we have formal employment agreements with our executive officers, these agreements do not prevent them from terminating their employment with us at any time.

On October 29, 2024, we implemented a restructuring plan that reduced our workforce by approximately 39%.

In October 2024, we implemented a restructuring plan that reduced our workforce by approximately 39%.

While we have confidence in our remaining employees, and our leadership team, including our current President, Chief Executive Officer and Chief Financial Officer, Ms.

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We undertook internal restructuring activities that could result in disruptions to our business or otherwise materially harm our results of operations or financial condition.

On October 29, 2024, we announced a restructuring plan and implemented a workforce reduction.

In October 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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The volatility of pharmaceutical, biotechnology and other life sciences company stocks often does not relate to the operating performance of the companies represented by the stock.

In the past, securities class action litigation has often been initiated against companies following periods of volatility in their stock price, such as the two putative class action lawsuits filed against us and certain of our current and former officers in 2022 and the stockholder derivative action filed against us and certain of our current and former officers in 2023 and 2024.

In the past, securities class action litigation has often been initiated against companies following periods of volatility in their stock price, such as the two putative class action lawsuits filed in 2022 against us and certain of our former officers and the stockholder derivative actions filed in 2023 and 2024 against us and certain of our former officers.

This type of litigation could result, and has in the past resulted, in substantial costs and divert our management’s attention and resources, and could also require us to make substantial payments to satisfy judgments or to settle litigation.

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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.

An unfavorable outcome may have an adverse impact on our

business, financial condition and results of operations, prospects, or our stock price.

An unfavorable outcome may have an adverse impact on our business, financial condition and results of operations, prospects, or our stock price.

Any proceeding could also negatively impact our reputation among our stakeholders.

3 unchanged sentences

In the past, we have failed to maintain certain continued listing requirements of the Nasdaq GS and could fail to maintain those requirements again in the future, which could negatively affect the market price of our common stock, our liquidity and our ability to raise capital.

Our potential failure to meet the continued listing requirements of Nasdaq GS in the future could result in a delisting of our common stock.

Our potential failure to meet the continued listing requirements of Nasdaq GS in the future could result in the delisting of our common stock.

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”).

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If the disruption and volatility persist or heighten, it may impact our ability to raise sufficient additional capital on agreeable terms, if at all.

reducing or altogether terminating both internal and external costs related to our operations and research and development programs.

If we are unable to raise sufficient additional capital, our business, financial condition, stock price and results of operations could be adversely affected, and we will need to implement cost reduction strategies, which could include delaying, reducing or altogether terminating both internal and external costs related to our operations and research and development programs.

In addition, political developments impacting government spending and international trade, including changes in trade agreements, trade disputes, tariffs and investment restrictions, such as the ongoing trade dispute between the United States and China, may negatively impact markets and cause weaker macroeconomic conditions.

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We are subject to Section 404 of The Sarbanes-Oxley Act of 2002 (“Section 404”) and the related rules of the SEC, which generally require our management and independent registered public accounting firm to report on the effectiveness of our internal control over financial reporting.

However, for so long as we remain a “smaller reporting company” (“SRC”) and non-accelerated filer, we intend to take advantage of certain exemptions from various reporting requirements, including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404.

required to comply with the auditor attestation requirements of Section 404.

Once we do not meet the definition of a SRC and non-accelerated filer or, if prior to such date, we opt to no longer take advantage of the applicable exemption, we will be required to include an attestation report from our independent registered public accounting firm on the effectiveness of our internal controls over financial reporting.

15 unchanged sentences

Sales of a substantial number of shares of our common stock in the public market could occur at any time.

These sales, or the perception in the market that the holders of a large number of shares of common stock intend to sell shares, could reduce the market

price of our common stock.

These sales, or the perception in the market that the holders of a large number of shares of common stock intend to sell shares, could reduce the market price of our common stock.

Our outstanding shares of common stock may be freely sold in the public market at any time to the extent permitted by Rules 144 and 701 under the Securities Act, or to the extent that such shares have already been registered under the Securities Act and are held by non-affiliates of ours.

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Provisions in our Amended and Restated Certificate of Incorporation, as amended, and Amended and Restated Bylaws may discourage, delay or prevent a merger, acquisition or other change in control of us that our stockholders may consider favorable, including transactions in which our stockholders might otherwise receive a premium for their shares.

These provisions could also limit the price that investors might be willing to pay in the future for shares of our common stock, thereby depressing the market price of our common stock.

These provisions could also limit the price that investors might be willing to pay in the future for shares of our common stock, thereby depressing the market price of

our common stock.

In addition, because our Board of Directors is responsible for appointing the members of our management team, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our Board of Directors.

25 unchanged sentences

We have in the past, and may in the future, become subject to securities litigation.

For example, two putative class action lawsuits were filed against us and certain of our current and former officers in 2022 and a stockholder derivative action was filed against us and certain of our current and former officers in 2023 and 2024.

For example, two putative class action lawsuits were filed in 2022 against us and certain of our former officers and stockholder derivative actions were filed in 2023 and 2024 against us and certain of our former officers.

Litigation is usually expensive and diverts management’s attention and resources, which could adversely affect our business and cash resources and our ability to execute on our partnership with GSK to eventually commercialize tebipenem HBr, or the ultimate value our stockholders receive in such partnership or other opportunity.

4 unchanged sentences

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.

What changed 10-Q

Item 1. Legal Proceedings