What changed in this filing

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Item 1. Legal Proceedings

2026-08-12 compared with 2026-05-13 · 218 added, 215 removed, 1044 unchanged (29% of the section changed)

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SEC Investigation and Wells Notice

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 a former member of its Board of Directors, Ankit Mahadevia, M.D.

On January 9, 2025, the Company responded to a “Wells Notice” from the staff of the SEC (the “Staff”) regarding its preliminary determination to recommend a civil enforcement action or administrative proceeding against the Company, its former Chief Executive Officer and a former member of its Board of Directors, Ankit Mahadevia, M.D.

Mahadevia”), and its former Chief Financial Officer and President and Chief Executive Officer, Satyavrat “Sath” Shukla (“Mr.

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 FDA, and whether the Company’s disclosures may have violated the federal securities laws.

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 pivoxil based on feedback from the FDA, and whether the Company’s disclosures may have violated the federal securities laws.

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.

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On January 30, 2026, Dr.

Mahadevia resigned from the Board of Directors, including from his service on the Development Committee of the Board and from all officer and director positions he then held with any and all subsidiaries of the Company, effective as of January 30, 2026.

Mahadevia resigned from the Board of Directors, including from his service on the Development Committee of the Board of Directors and from all officer and director positions he then held with any and all subsidiaries of the Company, effective as of January 30, 2026.

Ris k Factors.

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Additional risks not presently known to us or other factors not perceived by us to present significant risks to our business at this time also may impair our business operations.

Risks Related to Product Development and Commercialization

As of March 2025, we have ceased development of our SPR206 program, and as of November 2025, we have ceased development of our SPR720 oral program, and have shifted our focus and resources to advancing the development of the 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, or our collaboration with GSK fails to advance the development of the tebipenem HBr program, our business and prospects may be materially adversely affected.

As of March 2025, we have ceased development of SPR206.

Additionally, 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.

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 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.

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

As a result, we are currently substantially dependent on our tebipenem program and our collaboration with GSK.

As described under Note 9 to our condensed consolidated financial statements, 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.

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%.

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.

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.

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.

Our ability to realize the value of tebipenem HBr depends on obtaining FDA approval.

Even if such approval is obtained, the timeline of, and any requirements imposed as part of, such approval may impact the attractiveness of 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.

Our ability to realize the value of tebipenem HBr, currently our only product candidate, depends on the potential FDA approval, and the expected timeline and other requirements that would affect the attractiveness of commercialization of tebipenem HBr through our partnership with GSK.

Further, as part of any approval, the FDA could impose labeling requirements restricting the use of tebipenem HBr, which could reduce its commercial prospects, unless such requirements are subsequently modified to reduce such restrictions.

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

Risks Related to Our Business and Product Candidates

We are substantially dependent on the success of our new product candidate, SP001, and focus on SP001 may not be successful.

On June 17, 2026, we and GSK announced that the FDA approved Utebzi (tebipenem pivoxil).

We are party to an exclusive license agreement with GSK for the development, manufacture and commercialization of Utebzi, which includes the transfer of the

IND and the NDA ownership to GSK, and pursuant to which GSK is obligated to make milestone payments if certain milestones are achieved and to pay royalties based on commercial launch and achievement of pre-specified sales thresholds.

On July 8, 2026, we and our affiliates entered into a non-recourse non-dilutive royalty financing transaction with affiliates of HCRx, pursuant to which HCRx will receive a portion of the future GSK Proceeds.

As such, our receipt of royalty and milestone revenues from GSK is limited to 35% of the GSK Proceeds arising after payment in full of the Notes.

Following the FDA approval of Utebzi, and the termination of our earlier stage programs (SPR206 and SPR720), we remain focused on advancing other corporate activities, including growing our portfolio of clinical-stage product candidates.

On July 8, 2026, we entered into a license agreement with Innovent pursuant to which we received exclusive rights to research, develop, manufacture, and commercialize SP001 worldwide, excluding the Innovent Territory, where Innovent retains rights.

The in-licensing of SP001 represents a strategic pivot by us from the development of tebipenem pivoxil to the development of a new product candidate focused on new indications for which we believe we have relevant but limited prior experience.

Our business and future success depends on our ability to successfully develop, obtain regulatory approval for and successfully commercialize our new lead product candidate, SP001.

SP001 is our only product candidate currently in clinical development, and our business depends on its successful development.

SP001 will require additional clinical and non-clinical development, regulatory review and approval, substantial investment, access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenue from product sales, if ever.

We cannot be certain SP001 will receive regulatory approval or be successfully commercialized even if we receive regulatory approval.

In addition, because SP001 is our only product candidate currently in clinical development, if SP001 encounters safety or efficacy problems, developmental delays or regulatory issues or other problems, our development plans and business would be significantly harmed.

Further, the success of SP001 will depend in part on our ability to integrate this new product candidate into our business and program in an efficient and effective manner.

We may not be able to realize the full potential of business opportunities and growth prospects of SP001 to the extent anticipated or at all.

Challenges associated with the integration of SP001 may include those related to building out our operational and administrative capabilities as well as the hiring of employees to support our strategic pivot.

If we are unable to successfully integrate SP001, or if we experience delays in clinical development, we may incur unanticipated liabilities and be unable to fully realize the potential benefit of future revenue and other anticipated benefits resulting from the in-license of SP001, and our business, results of operations and financial condition could be adversely affected.

There can be no assurance that the FDA will accept data from any trials conducted outside of the United States, including any trials conducted in China.

Subject to FDA clearance of the U.S.

IND, we currently expect to advance SP001 into a Phase 2 trial in IgG4-RD patients in the second quarter of 2027, based in part on data generated by Innovent in its Phase 1b study conducted in China in patients with SjD.

The acceptance of study data from clinical trials conducted outside the United States by the FDA may be subject to certain conditions, or such data may not be accepted at all.

For example, in cases where data from foreign clinical trials are intended to serve as the sole basis for regulatory approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless the data are applicable to the U.S.

population and U.S.

medical practice;

the trials were performed by clinical investigators of recognized competence and pursuant to Good Clinical Practice (“GCP”) regulations;

and the data may be considered valid without the need for an on-site inspection by the FDA, or if the FDA considers such inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means.

Even where the foreign study data are not intended to serve as the sole basis for approval, if the relevant study was not conducted pursuant to an IND, the FDA will generally not accept the data as support for a marketing application unless the study was conducted in accordance with GCP requirements and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary.

There can be no assurance that the FDA will accept data from trials conducted outside of the United States to support our IND application.

For example, the data generated by Innovent in China in its study of patients with SjD may not be acceptable to the FDA or other regulatory authorities.

In May 2026, the United States House Appropriations Committee issued a draft, non-binding report accompanying its proposed Fiscal Year 2027 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act that would bar the FDA from accepting, reviewing, or considering any covered clinical data generated by a clinical investigation site in China, Russia, Iran or North Korea in support of an IND, including any amendment or supplement thereto.

If the FDA or any comparable foreign regulatory authority does not accept such data from our clinical trials of any of our current or future product candidates, we would need to conduct additional trials, which could be costly and time-consuming, and which may not ultimately support approval in the United States.

Our ability to realize the value of tebipenem pivoxil depends on the commercialization of Utebzi (tebipenem pivoxil) through our partnership with GSK.

In June 2026, the FDA approved GSK’s NDA resubmission for Utebzi.

We have invested a significant portion of our efforts and financial resources in the development of tebipenem pivoxil with GSK as a product candidate for the treatment of bacterial infections causing cUTI.

Our ability to realize the value of tebipenem pivoxil depends on the expected timeline and the success of GSK’s commercialization of Utebzi.

Further, on July 8, 2026, we and our affiliates entered into a non-recourse non-dilutive royalty financing transaction with affiliates of HCRx, pursuant to which HCRx will receive a portion of the future GSK Proceeds.

As such, our receipt of royalty and milestone revenues from GSK is limited to 35% of the GSK Proceeds arising after payment in full of the Notes.

If GSK’s commercialization efforts are unsuccessful or significantly delayed, our receipt of royalty and milestone revenues from GSK may not align with our expectations and 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 any existing and future product candidates.

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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.

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.

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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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 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.

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 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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Analyses of preliminary or interim data from our clinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.

We currently have no products approved for sale and we cannot guarantee that we will ever have marketable products.

While we currently have one product approved for sale through our collaboration with GSK, we cannot guarantee that we will ever have additional marketable products.

Clinical failure can occur at any stage of clinical development.

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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.

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.

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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Any of these occurrences may harm our business, financial condition and prospects significantly.

If unexpected adverse events occur in any of our ongoing or planned clinical trials, we may need to abandon development of any product candidates, or limit development to lower doses or to certain uses or subpopulations in which the undesirable side effects or other unfavorable characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.

If unexpected adverse events occur in any of our ongoing or planned clinical trials, we may need to abandon development of product candidates, or limit development to lower doses or to certain uses or subpopulations in which the undesirable side effects or other unfavorable characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.

Many compounds that initially showed promise in clinical or earlier stage testing are later found to cause undesirable or unexpected side effects that prevented further development of the compound.

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Even if a product candidate does obtain regulatory approval, it may never achieve the market acceptance by physicians, patients, hospitals, third-party payors and others in the medical community that is necessary for commercial success and the market opportunity may be smaller than we estimate.

Even if we obtain FDA or other regulatory approvals and are able to launch any product candidates commercially, the approved product candidate may nonetheless fail to gain sufficient market acceptance among physicians, patients, hospitals (including pharmacy directors) and third-party payors and, ultimately, may not be commercially successful.

For example, physicians are often reluctant to switch their patients from existing therapies even when new and potentially more effective or convenient treatments enter the market.

Even if we obtain FDA or other regulatory approvals and are able to launch any of our current or future product candidates commercially, the approved product candidate may nonetheless fail to gain sufficient market acceptance among physicians, patients, hospitals (including pharmacy directors) and third-party payors and, ultimately, may not be commercially successful.

For example, Utebzi, which was approved in June 2026, may fail to gain sufficient market acceptance despite commercialization efforts by GSK.

Physicians are often reluctant to switch their patients from existing therapies even when new and potentially more effective or convenient treatments enter the market.

Further, patients often acclimate to the therapy that they are currently taking and do not want to switch unless their physicians recommend switching products or they are required to switch therapies due to lack of coverage and reimbursement for existing therapies.

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• adverse publicity about the product or favorable publicity about competitive products;

• the emergence of bacterial resistance to the product;

• the rate at which resistance to other drugs in the target infections grows.

• the emergence of bacterial resistance to the product, in the case of Utebzi;

• the rate at which resistance to other drugs in the target infections grows, in the case of Utebzi.

Any failure of any product candidates that obtains regulatory approval to achieve market acceptance or commercial success would adversely affect our business prospects.

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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, 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.

For example,we have terminated our SPR206 program and our SPR720 oral program and have shifted our focus and resources to advancing the clinical development of SP001, as well as other corporate activities.

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

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If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to the product candidate.

If we or our collaborators are unable to establish sales, marketing and distribution capabilities or enter into sales, marketing and distribution agreements with third parties, we may not be successful in commercializing any product candidates if such product candidates are approved.

If we or our collaborators are unable to establish sales, marketing and distribution capabilities or enter into sales, marketing and distribution agreements with third parties, we or our collaborators may not be successful in commercializing Utebzi or any of our future product candidates, if such product candidates are approved.

To achieve commercial success for any approved product, we must either develop a sales and marketing organization or outsource those functions to third parties.

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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 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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We face competition from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide with respect to any product candidates that we may seek to develop and commercialize in the future.

There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of product candidates for the treatment of resistant infections.

There are a number of large pharmaceutical and biotechnology companies that currently market and sell products or are pursuing the development of product candidates in immunology and inflammation for patients with serious diseases, and product candidates for the treatment of resistant infections.

Potential competitors also include academic institutions, government agencies and other public and private research organizations.

Our competitors may succeed in developing, acquiring or licensing technologies and drug products that are more effective or less costly than the product candidates that we are currently developing or that we may develop, which could render our existing or future product candidates obsolete and noncompetitive.

There are a variety of available oral therapies marketed for the treatment of cUTIs that we would expect would compete with tebipenem HBr, if approved, such as Levaquin, Cipro and Bactrim.

There are a number of approved products and product candidates in development that may compete with our product candidates in IgG4-related disease, SjD, and other autoimmune and inflammatory disorders.

For example, UPLIZNA® (inebilizumab), a CD19-directed B-cell depleting antibody marketed by Amgen Inc., is approved for the treatment of IgG4-related disease.

Additional product candidates are in clinical development for IgG4-related disease, including obexelimab (Zenas BioPharma, Inc./Bristol Myers Squibb Company), a bifunctional CD19/FcγRIIB-targeting antibody;

rilzabrutinib (Sanofi S.A.), a BTK inhibitor, and efgartigimod (argenx SE), an FcRn inhibitor.

In SjD and related autoimmune indications, numerous companies are developing therapies directed against pathways including CD40/CD40L, BAFF, APRIL, BAFF-R, FcRn, BTK, TYK2 and other immune targets.

These companies include large pharmaceutical and biotechnology companies such as Amgen, Novartis AG, argenx, Johnson & Johnson, Sanofi, Bristol Myers Squibb, UCB SA, and others, as well as emerging biotechnology companies developing novel therapies.

Product candidates currently in development include dazodalibep, ianalumab, efgartigimod, nipocalimab, telitacicept and several additional investigational agents.

We may also face competition from companies developing therapies that target the same biological pathway as SP001, including other CD40 or CD40L-directed therapies.

In addition, future advances in immunology, autoimmune disease and inflammatory disease treatment may result in the development of products that are safer, more effective, more convenient to administer, less expensive or more rapidly adopted by physicians, patients and payors than our product candidates.

If our competitors successfully develop or commercialize such products before us, our commercial opportunity could be materially reduced.

There are a variety of available oral therapies marketed for the treatment of cUTIs that we expect to compete with Utebzi, such as Levaquin, Cipro and Bactrim.

Many of the available therapies are well established and widely accepted by physicians, patients and third-party payors.

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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.

This may make it difficult for tebipenem HBr to compete with these products.

There are several IV-administered products marketed for the treatment of infections resistant to first-line therapy for Gram-negative infections, including Emblaveo (Aztreonam-avibactam) from Allergan, Avycaz (ceftazidime-avibactam) from Allergan 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., Vabomere (meropenem-vaborbactam) from CorMedix Inc., Exblifep (cefepime/enmetazobactam) from Allecra Therapeutics, and Contepo (fosfomycin) from Meitheal Pharmaceuticals.

In addition, GSK’s pricing of Utebzi may be at a significant premium over other competitive products, which may make it difficult for Utebzi to compete with these other products.

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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These third parties compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.

Even if we or our partners are able to commercialize our existing or future product candidates, the product may become subject to unfavorable pricing regulations, or third-party payor coverage and reimbursement policies that could harm our business.

Utebzi, or any existing or future product candidates that we may commercialize, may become subject to unfavorable pricing regulations, or third-party payor coverage and reimbursement policies that could harm our business

Marketing approvals, pricing, coverage and reimbursement for new drug products vary widely from country to country.

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Adverse pricing limitations may hinder our ability to recoup our investment in one or more product candidates, even if our existing or future product candidates obtain marketing approval.

We currently expect that our product candidate, if approved, will be administered in a hospital inpatient setting.

We currently expect that Utebzi will be administered in a hospital inpatient setting.

In the United States, governmental and other third-party payors generally reimburse hospitals a single bundled payment established on a prospective basis intended to cover all items and services provided to the patient during a single hospitalization.

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An inability to promptly obtain coverage and adequate payment rates from both government-funded and private payors for any approved products used on an outpatient basis that we develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.

We cannot predict whether bacteria may develop resistance to our product candidate, if approved, which could affect its revenue potential.

Tebipenem HBr is designed to treat bacterial infections, including drug-resistant infections.

We cannot predict whether bacteria may develop resistance to tebipenem pivoxil, which could affect its revenue potential.

Tebipenem pivoxil is designed to treat bacterial infections, including drug-resistant infections.

The bacteria responsible for these infections evolve quickly and readily transfer their resistance mechanisms within and between species.

We cannot predict whether or when bacterial resistance to tebipenem HBr may develop.

For example, as a carbapenem, tebipenem HBr is not active against organisms expressing a resistance mechanism mediated by enzymes known as carbapenemases.

Although occurrence of this resistance mechanism is currently rare, we cannot predict whether carbapenemase-mediated resistance will become widespread in regions where tebipenem HBr may be marketed if it is approved.

We cannot predict whether or when bacterial resistance to tebipenem pivoxil may develop.

For example, as a carbapenem, tebipenem pivoxil is not active against organisms expressing a resistance mechanism mediated by enzymes known as carbapenemases.

The growth of drug resistant infections in community settings or in countries with poor public health infrastructures, or the potential use of our product candidate outside of controlled hospital settings, could contribute to the rise of resistance.

If resistance to our product candidate becomes prevalent, our ability to generate revenue could suffer.

If resistance to tebipenem pivoxil becomes prevalent, our ability to generate revenue could suffer.

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 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.

A key element of our strategy is to develop and commercialize a portfolio of therapeutics to treat immunology and inflammation patients.

We recently entered into the Innovent Agreement for the in-license of SP001, and may explore in the future, strategic partnerships for the development of new product candidates.

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.

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• the research methodology used may not be successful in identifying potential product candidates;

• we may be unable to successfully modify candidate compounds to be active in Gram-negative bacteria or defeat bacterial resistance mechanisms or identify viable product candidates in our screening campaigns;

• competitors may develop alternatives that render our existing or future product candidates obsolete;

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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.

For example, the loss of clinical trial data from completed or ongoing clinical trials for any of our current or future product candidates could result in delays in our development and regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

Such a loss could also expose us to regulatory enforcement, civil liability and reputational damage.

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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.

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.

Furthermore, the number of government investigations related to data security incidents and privacy violations continue to increase and government investigations typically require significant resources and generate negative publicity, which could harm our business and reputation.

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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 $7.2 million and $13.9 million for the three months ended March 31, 2026 and 2025, respectively.

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

Our net loss was $9.6 million and $16.8 million for the three and six months ended June 30, 2026, respectively.

While the FDA approved GSK’s NDA resubmission for Utebzi, we do not have any other product candidates approved for sale and we may never have another product candidate approved for commercialization.

The success of Utebzi depends on GSK’s ability to commercialize the product.

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 current operating plan, we believe that our cash and cash equivalents as of March 31, 2026 will be sufficient to fund our operating expenses and capital expenditure requirements at least into 2028.

During this period, we remain focused on supporting GSK in the FDA approval process pursuant to our obligations under our GSK License Agreement and advancing other corporate activities, including exploring opportunities to grow our portfolio of clinical-stage product candidates.

Based on our current operating plan, we believe that our cash and cash equivalents as of June 30, 2026, together with and including the net proceeds from the royalty financing transaction that closed in July 2026, will be sufficient to fund our operating expenses and capital expenditure requirements into the second half of 2029.

During this period, we are focused on advancing next-generation medicines in immunology and inflammation for patients with serious diseases and major treatment gaps.

Beyond this point, or in the event we change our current operating plan, 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 grant funding.

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Our expenses will also increase substantially if and as we:

• conduct additional clinical trials and studies of our existing or future product candidates;

• conduct clinical trials and studies of our existing or future product candidates;

• continue to discover and develop additional product candidates;

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• acquire or in-license other product candidates and technologies.

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 any of our product candidates, including tebipenem HBr, SPR206, and SPR720.

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 currently have one product 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 pivoxil, SPR206, and SPR720.

Although we decided to cease further development of SPR206 and SPR720, our business remains heavily dependent on the successful commercialization of tebipenem pivoxil, the success of which depends on GSK’s ability to commercialize Utebzi, and the successful development, regulatory approval, and, if approved, commercialization of SP001 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.

If any of our product candidates fail to demonstrate safety and efficacy in clinical trials, do not gain regulatory approval, or do not achieve market acceptance following regulatory approval and commercialization, we may never become profitable.

If any of our current or future product candidates fail to demonstrate safety and efficacy in clinical trials, do not gain regulatory approval, or do not achieve market acceptance following regulatory approval and commercialization, we may never become profitable.

Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods.

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Because of the numerous risks and uncertainties associated with developing biopharmaceutical products, we are unable to predict the extent of any future losses or when, if ever, we will become profitable.

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.

If we are unable to raise capital when needed, or do not receive payments from our collaboration partnership agreements, it could limit our ability to support our operations.

Our expenses would increase significantly 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 current and future product candidates.

If we are unable to raise capital when needed, or do not receive payments from our collaboration partnership agreements or royalty financing agreements, it could limit our ability to support our operations.

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 if we commence and advance additional studies for any future product candidates.

We expect that our expenses will increase if and as we commence and advance additional preclinical studies and clinical trials 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.

Some of these expenses may be incurred in advance of marketing approval and could be substantial.

Accordingly, we will be required to obtain further funding through public or private equity offerings, debt financings, collaborations, licensing arrangements, government funding or other sources.

Accordingly, we will be required to obtain further funding through public or private equity offerings, debt financings, royalty financing transactions, collaborations, licensing arrangements, government funding or other sources.

Adequate additional financing may not be available to us on acceptable terms, or at all.

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.

During this period, we are focused on advancing next-generation medicines in immunology and inflammation for patients with serious diseases and major treatment gaps.

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

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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;

• the timing, costs and results potential clinical trials for any of our existing and future product candidates;

• the amount of funding that we receive under our government awards;

• the number and characteristics of product candidates that we pursue;

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Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to any of our technologies or product candidates.

Unless and until we can generate a substantial amount of revenue from our existing and future product candidates, we expect to finance our future cash needs through public or private equity offerings, debt financings, collaborations, licensing arrangements and government funding arrangements.

Unless and until we can generate a substantial amount of revenue from our existing and future product candidates, we expect to finance our future cash needs through public or private equity offerings, debt financings, royalty financing transactions, collaborations, licensing arrangements and government funding arrangements.

In addition, we may seek additional capital due to favorable market conditions or strategic considerations, even if we believe that we have sufficient funds for our current or future operating plans.

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In addition, securing additional financing would require a substantial amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our management’s ability to oversee the development of our existing or future product candidates.

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us.

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, or royalty financing transactions, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that may not be favorable to us.

We have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future viability.

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

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.

We have only recently demonstrated an ability to successfully obtain marketing approval, through the FDA approval of Utebzi in June 2026, and have not yet demonstrated an ability to successfully 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.

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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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 to offset its post-change income may be limited.

We recently completed a Section 382 study and concluded that we underwent several ownership changes as defined by the Code, the last of which occurred during the year ended December 31, 2018.

We recently completed a Section 382 study and concluded that we underwent several ownership changes as defined by the Code, the last of which occurred during the

year ended December 31, 2018.

Any NOL carryforwards that will expire prior to utilization have been removed from deferred tax assets, with a corresponding reduction of the valuation allowance.

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Risks Related to Our Dependence on 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 may not achieve the milestones triggering payments to us, or may not receive royalty payments pursuant to, our existing or any future license and collaboration or royalty financing agreements with third parties.

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

Currently we are party to license and collaboration agreements with third parties as described in Note 9 to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.

Currently we are party to license and collaboration agreements with third parties as described in Note 9, License, Collaboration and Service Agreements, and Note 12, Subsequent Events , to our condensed consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.

Our likely collaborators for any other marketing, distribution, development, licensing or broader collaboration arrangements we may pursue include large and mid-size pharmaceutical companies, regional and national pharmaceutical companies and biotechnology companies.

We may derive revenue from research and development fees, license fees, milestone payments and royalties under any collaborative arrangement into which we enter.

Our ability to generate revenue from these arrangements will depend on our collaborators’ abilities to successfully perform the functions assigned to them in these arrangements.

Our ability to generate revenue from these arrangements will depend on our collaborators’ abilities to successfully perform the functions assigned to them in these arrangements and also the limitations of any royalty financing transaction we may have entered into.

In addition, our collaborators may have the right to abandon research or development projects and terminate applicable agreements, including funding obligations, prior to or upon the expiration of the agreed upon terms.

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• collaborators may not perform their obligations as expected;

• collaborators may not pursue development and commercialization of any of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus or available funding or external factors, such as an acquisition, that divert resources or create competing priorities;

• collaborators may not be able to develop, manufacture, market and sell any of our product candidates and use our intellectual property without infringing or misappropriating the intellectual property and other proprietary rights of third parties;

• collaborators may not pursue development and commercialization of any of our current or future product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus or available funding or external factors, such as an acquisition, that divert resources or create competing priorities;

• collaborators may not be able to develop, manufacture, market and sell any of our current or future product candidates and use our intellectual property without infringing or misappropriating the intellectual property and other proprietary rights of third parties;

• collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;

• product candidates discovered in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or products, which may cause collaborators to cease to devote resources to the commercialization of any of our product candidates;

• a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to the marketing and distribution of such product or products;

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We will require additional funds to complete the development and potential commercialization of our existing and future product candidates.

For any of our product candidates, we may decide to collaborate with pharmaceutical and biotechnology companies for the development and potential commercialization of those product candidates.

For any of our current or future product candidates, we may decide to collaborate with pharmaceutical and biotechnology companies for the development and potential commercialization of those product candidates.

Moreover, we intend to utilize a variety of types of collaboration arrangements for the potential commercialization of our existing or future product candidates outside the United States.

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If we fail to enter into collaborations and do not have sufficient funds or expertise to undertake the necessary development and commercialization activities, we may not be able to further develop our existing and future product candidates or bring them to market and our business may be materially and adversely affected.

As part of our royalty financing transaction with HCRx, we transferred the GSK License Agreement and our rights thereunder, along with related intellectual property, to one of two newly formed special purpose subsidiaries of ours, and provided HCRx with a right of first recourse to such assets to satisfy our obligations to HCRx.

As a result, if we are unable to satisfy our obligations under the royalty financing transaction, we could lose all retained rights to future royalty payments from HCRx and related assets, which could have a material adverse effect on our business, financial condition and stock price.

We and our affiliates have entered into a $105.0 million non-recourse non-dilutive royalty financing transaction with HCRx, pursuant to which HCRx will receive a portion of the future milestone and royalty payments due to us from GSK arising under the GSK License Agreement.

As part of the royalty financing transaction, the parties entered into, among other agreements, the NPA for senior secured notes in an aggregate principal amount of $105.0 million, referred to herein as the Notes, the RPA and the Limited Guaranty.

The royalty financing transaction creates obligations of the Company and our special purpose subsidiaries to make payments to HCRx from proceeds of the GSK License Agreement, which agreement provides GSK certain rights to develop and commercialize Utebzi.

To the extent that the commercialization of Utebzi does not generate sufficient proceeds to satisfy the obligations to HCRx when due in accordance with the terms of the royalty financing transaction, HCRx will generally not have recourse to our assets unrelated to the Utebzi program.

However, to the extent we are unable to pay the Notes and other obligations under the NPA in full when due, HCRx will have the right, as a secured creditor with a security interest in the assets related to the Utebzi program, to foreclose on and otherwise take control of the assets related to the Utebzi program, including our equity in the special purpose subsidiaries created to hold the assets related to the Utebzi program.

Additionally, in the case of certain defined breaches and defaults under the royalty financing transaction, HCRx may have recourse beyond the assets related to the Utebzi program, although in most instances our obligations in respect of such breaches and defaults are limited to actual damages, and such obligations are generally subject to a fixed cap.

In the event that HCRx has recourse to our assets beyond those related to the Utebzi program, we may not have sufficient funds to satisfy our obligations to HCRx as and when those obligations become due and payable, which could have a material adverse effect on our business, financial condition and stock price.

We rely on third parties to conduct all of our nonclinical studies and all of our clinical trials.

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We also do not have the ability to independently conduct clinical trials of any product candidates.

We rely on third parties, such as contract research organizations, clinical data management organizations, medical institutions and clinical investigators, to conduct clinical trials of our existing and future product candidates and potential product candidates.

Any of these third parties may terminate their engagements with us at any time.

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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 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.

If we or our third-party contractors fail to comply with applicable GCP standards, the clinical data generated in our clinical trials may be deemed unreliable and the FDA may require us to perform additional clinical trials before approving any of our product candidates, which would delay the regulatory approval process.

If we or our third-party contractors fail to comply with applicable GCP standards, the clinical data generated in our clinical trials may be deemed unreliable and the FDA may require us to perform additional clinical trials before approving any of our current and future product candidates, which would delay the regulatory approval process.

We cannot make assurances that, upon inspection, the FDA will determine that any of our clinical trials comply with GCP.

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These contractors may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other drug development activities, which could impede their ability to devote appropriate time to our clinical programs.

If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we may not be able to obtain, or may be delayed in obtaining, marketing approvals for any of our product candidates.

If that occurs, we may not be able to, or may be delayed in our efforts to, successfully commercialize any of our product candidates.

In such an event, our financial results and the commercial prospects for any of our product candidates could be harmed, our costs could increase and our ability to generate revenue could be delayed, impaired or foreclosed.

If that occurs, we may not be able to, or may be delayed in our efforts to, successfully commercialize any of our current or future product candidates.

In such an event, our financial results and the commercial prospects for any of our current or future product candidates could be harmed, our costs could increase and our ability to generate revenue could be delayed, impaired or foreclosed.

We also rely on other third parties to store and distribute drug supplies for our clinical trials.

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

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

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

We have historically contracted with third parties for the manufacture of clinical supplies of our current or future product candidates and expect to continue to do so in connection with 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 existing and future product candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

We do not currently have nor do we plan to build the internal infrastructure or capability to manufacture our existing or future product candidates for use in the conduct of our preclinical research, our clinical trials or for commercial supply.

We currently rely on and expect to continue to rely on third-party contract manufacturers to manufacture supplies of our existing or future product candidates, and we expect to rely on third-party contract manufacturers to manufacture commercial quantities of any product candidate that we commercialize following approval for marketing by applicable regulatory authorities, if any.

We have historically relied on and expect to continue to rely on third-party contract manufacturers to manufacture supplies of our existing or future product candidates, and we expect to rely on third-party contract manufacturers to manufacture commercial quantities of any product candidate that we commercialize following approval for marketing by applicable regulatory authorities, if any.

Reliance on third-party manufacturers entails risks, including:

• manufacturing delays if our third-party manufacturers give greater priority to the supply of other products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreement between us;

• manufacturing delays if our third-party manufacturers give greater priority to the supply of other products over our current or future product candidates or otherwise do not satisfactorily perform according to the terms of the agreement between us;

• the possible termination or nonrenewal of the agreement by the third-party at a time that is costly or inconvenient for us;

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• the possible misappropriation of our proprietary information, including our trade secrets and know-how.

We currently rely on a small number of third-party contract manufacturers and one supplier for all of our required raw materials, drug substance and finished product for our preclinical research and clinical trials.

We have historically relied on a small number of third-party contract manufacturers and suppliers for all of our required raw materials, drug substance and finished product for our preclinical research and clinical trials.

We do not have long-term agreements with any of these third parties.

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If any of our existing manufacturers should become unavailable to us for any reason, we may incur delays in identifying or qualifying replacements.

In addition, because some of our manufacturers have manufacturing facilities in Taiwan, their ability to provide us with adequate supplies of high-quality products on a timely and cost-efficient basis is subject to a number of additional risks and uncertainties, including political, social and economic instability and factors that could impact the shipment of supplies.

In addition, because some of our manufacturers may have manufacturing facilities outside of the United States, their ability to provide us with adequate supplies of high-quality products on a timely and cost-efficient basis is subject to a number of additional risks and uncertainties, including political, social and economic instability and factors that could impact the shipment of supplies.

If our manufacturers are unable to provide us with adequate supplies of high-quality products on a timely and cost-efficient basis, our operations would be disrupted and our net revenue and profitability would suffer.

Our third-party contract manufacturers are based in Asia.

In the past, our third-party contract manufacturers have been subject to various supply chain disruptions.

Further, if our third-party contract manufacturers are based in Asia we may be subject to various supply chain disruptions.

These supply chain disruptions have increased the price of certain materials due to the significant increase in costs of raw materials and shipping costs.

Our ability to produce and timely deliver our products may be materially impacted in the future if these supply chain disruptions continue or worsen.

Further, a major catastrophe, such as an earthquake or other natural disaster, labor strike, or work stoppage at any of our manufacturing facilities, or a manufacturing facility of our suppliers or customers, could result in a prolonged interruption of our business.

Moreover, a major catastrophe, such as an earthquake or other natural disaster, labor strike, or work stoppage at any of our manufacturing facilities, or a manufacturing facility of our suppliers or customers, could result in a prolonged interruption of our business.

A disruption resulting from any one of these events could cause significant delays in shipments of our products and the loss of revenue and customers, which could have a material adverse effect on our financial position, results of operations, and cash flows.

Our manufacturer's facilities in Japan are located in seismically-active areas.

If any existing or future product candidates are approved by any regulatory agency, we intend to enter into agreements with third-party contract manufacturers for the commercial production of those products.

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The inability or failure of our manufacturers to successfully manufacture material that conforms to the strict regulatory requirements of the FDA and any applicable foreign regulatory authority, may require us to find alternative manufacturing facilities, which could result in delays in obtaining approval for the applicable product candidate.

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.

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 existing or future product candidates and have a material adverse effect on our business, financial condition and results of operations.

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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 such rights that are important to our business.

We are a party to agreements with Meiji and GSK for tebipenem HBr 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, the Meiji License 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.

In addition, we have the right to develop, manufacture and have manufactured tebipenem HBr in the Meiji Territory solely for the purpose of furthering development, manufacturing and commercialization of tebipenem HBr outside of the Meiji Territory.

In exchange for those rights, we are obligated to satisfy diligence requirements, including using commercially reasonable efforts to develop and commercialize tebipenem HBr and to implement a specified development plan, meeting specified development milestones and providing an update on progress on an annual basis.

We are a party to agreements with Meiji and GSK for tebipenem pivoxil and Innovent for SP001, 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, the Meiji License gives us rights outside of the Meiji Territory to develop, manufacture, and commercialize tebipenem pivoxil 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.

In addition, we have the right to develop, manufacture and have manufactured tebipenem pivoxil in the Meiji Territory solely for the purpose of furthering development, manufacturing and commercialization of tebipenem pivoxil outside of the Meiji Territory.

In exchange for those rights, we are obligated to satisfy diligence requirements, including using commercially reasonable efforts to develop and commercialize tebipenem pivoxil and to implement a specified development plan, meeting specified development milestones and providing an update on progress on an annual basis.

The Meiji License requires us to pay future milestone payments of up to $1.0 million upon the achievement of specified regulatory milestones and royalties of 1% of net sales on a product-by-product and country-by-country basis.

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 were entitled to receive a $95.0 million development milestone payment payable in four equal semi-annual installments, of which we received $23.8 million in each of the first quarter of 2024, the third quarter of 2024, the first quarter of 2025 and the third quarter of 2025 and a $25.0 million milestone for GSK’s submission of an NDA with the FDA for tebipenem HBr, which was received in February 2026.

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 pivoxil, a $30.0 million milestone payment upon achievement of a development milestone in the third quarter of 2023, and were entitled to receive a $95.0 million development milestone payment payable in four equal semi-annual installments, of which we received $23.8 million in each of the first quarter of 2024, the third quarter of 2024, the first quarter of 2025 and the third quarter of 2025 and a $25.0 million milestone for GSK’s submission of an NDA with the FDA for tebipenem pivoxil, which was received in February 2026.

Remaining potential payments under the GSK License Agreement are milestone based and are (i) up to $101.0 million in commercial milestone payments, and (ii) up to $225.0 million in sales milestone payments.

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Such royalties are 1% for annual sales up to $750.0 million each year and range from high single-digit percentages on annual net sales above $750.0 million each year to low double-digit percentages on annual net sales above $1,000.0 million each year.

We were responsible for the execution and costs of the follow-up Phase 3 clinical trial of tebipenem HBr.

GSK is responsible for the execution and costs of additional further development, including commercialization activities for tebipenem HBr in the balance of the GSK Territory outside of the United States.

Additionally, we were responsible for providing and paying for the clinical supply of tebipenem HBr while GSK will be responsible for the costs of the commercial supply of tebipenem HBr.

If we fail to comply with our obligations to Meiji, GSK, or any of our other partners, our counterparties may have the right to terminate these agreements, in which event we might not be able to develop, manufacture or market any product candidate that is covered by these agreements, which could materially adversely affect the value of the product candidate being developed under any such agreement.

We were responsible for the execution and costs of the follow-up Phase 3 clinical trial of tebipenem pivoxil.

GSK is responsible for the execution and costs of additional further development, including commercialization activities for tebipenem pivoxil in the balance of the GSK Territory outside of the United States.

Additionally, we were responsible for providing and paying for the clinical supply of tebipenem pivoxil while GSK will be responsible for the costs of the commercial supply of tebipenem pivoxil.

Further, the Innovent Agreement gives us exclusive rights, even as to Innovent, to research, develop, manufacture, and commercialize SP001 and certain backup and derivative monoclonal antibodies targeting CD40L worldwide, excluding the Innovent Territory, subject to Innovent's right to conduct certain research, non-clinical development and manufacturing activities in the Innovent Territory.

In addition, we have a non-exclusive right to research, non-clinically develop and manufacture SP001 in the Innovent Territory in connection with our exploitation of those compounds and products in the Licensed Territory.

In exchange for those rights, we are obligated to use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize SP001 in at least one indication in the United States and any one of France, Germany, Italy, Spain, the United Kingdom or Japan, and to file an IND for SP001 in the United States within 12 months of the effective date, subject to specified extensions.

The Innovent Agreement required us to pay Innovent a $35.0 million upfront payment, future milestone payments of up to approximately $1.05 billion upon the achievement of certain development, regulatory and commercial milestones, and tiered royalties ranging from a high single-digit to a mid-teen-digit percentage of annual net sales on a product-by-product and country-by-country basis.

If we fail to comply with our obligations to Meiji, GSK, Innovent, or any of our other partners, our counterparties may have the right to terminate these agreements, in which event we might not be able to develop, manufacture or market any product candidate that is covered by these agreements, which could materially adversely affect the value of the product candidate being developed under any such agreement.

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.

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Even if our patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage.

Our competitors may be able to circumvent our owned or licensed patents by developing similar or alternative technologies or products in a non-infringing manner.

Our competitors

may be able to circumvent our owned or licensed patents by developing similar or alternative technologies or products in a non-infringing manner.

Our competitors may seek to market generic versions of any approved products by submitting Abbreviated New Drug Applications (“ANDAs”) to the FDA in which they claim that patents owned or licensed by us are invalid, unenforceable and/or not infringed.

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The outcome of intellectual property litigation is subject to uncertainties that cannot be adequately quantified in advance.

With respect to our Meiji License of certain know-how and regulatory documents concerning tebipenem pivoxil, we are neither a party to, nor an express third-party beneficiary of, the letter agreements, which were signed in January 2017 and in February 2022, between Meiji and Global Pharma consenting to Meiji’s arrangements with us.

With respect to our Meiji License of certain know-how and regulatory documents concerning tebipenem pivoxil, we are neither a party to, nor an express third-party beneficiary

of, the letter agreements, which were signed in January 2017 and in February 2022, between Meiji and Global Pharma consenting to Meiji’s arrangements with us.

As such, if any dispute among the parties were to occur, our direct enforcement rights with respect to the letter agreements may be limited or uncertain.

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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 March 31, 2026, we have two registered U.S.

As of June 30, 2026, we have two registered U.S.

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

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Results from nonclinical studies and clinical trials can be interpreted in different ways.

Even if we believe that the nonclinical or clinical data for any of our product candidates are promising, such data may not be sufficient to support approval by the FDA and other regulatory authorities.

The FDA may also require us to conduct additional nonclinical studies or clinical trials for any of our product candidates either prior to or post-approval, and it may otherwise object to elements of our clinical development program.

Even if we believe that the nonclinical or clinical data for any of our current or future product candidates are promising, such data may not be sufficient to support approval by the FDA and other regulatory authorities.

The FDA may also require us to conduct additional nonclinical studies or clinical trials for any of our curren or future product candidates either prior to or post-approval, and it may otherwise object to elements of our clinical development program.

An NDA must include extensive preclinical and clinical data and supporting information to establish the product candidate’s safety and efficacy for each desired indication.

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Obtaining marketing approval for marketing of a product candidate in one country does not ensure that we will be able to obtain marketing approval in other countries, but the failure to obtain marketing approval in one jurisdiction could negatively affect our ability to obtain marketing approval in other jurisdictions.

The FDA or any foreign regulatory bodies can delay, limit or deny approval of any of our product candidates or require us to conduct additional nonclinical or clinical testing or abandon a program for many reasons, including:

The FDA or any foreign regulatory bodies can delay, limit or deny approval of any of our current or future product candidates or require us to conduct additional nonclinical or clinical testing or abandon a program for many reasons, including:

• the FDA or the applicable foreign regulatory agency’s disagreement with the design or implementation of our clinical trials;

• negative or ambiguous results from our clinical trials or results that may not meet the level of statistical significance required by the FDA or comparable foreign regulatory agencies for approval;

• serious and unexpected drug-related side effects experienced by participants in our clinical trials or by individuals using drugs similar to any of our product candidates;

• our inability to demonstrate to the satisfaction of the FDA or the applicable foreign regulatory body that any of our product candidates are safe and effective for the proposed indication;

• serious and unexpected drug-related side effects experienced by participants in our clinical trials or by individuals using drugs similar to any of our current or future product candidates;

• our inability to demonstrate to the satisfaction of the FDA or the applicable foreign regulatory body that any of our current or future product candidates are safe and effective for the proposed indication;

• the FDA’s or the applicable foreign regulatory agency’s disagreement with the interpretation of data from nonclinical studies or clinical trials;

• our inability to demonstrate the clinical and other benefits of any of our product candidates outweigh any safety or other perceived risks;

• our inability to demonstrate the clinical and other benefits of any of our current or future product candidates outweigh any safety or other perceived risks;

• the FDA’s or the applicable foreign regulatory agency’s requirement for additional nonclinical studies or clinical trials;

• the FDA’s or the applicable foreign regulatory agency’s disagreement regarding the formulation, labeling and/or the specifications for any of our product candidates;

• the FDA’s or the applicable foreign regulatory agency’s disagreement regarding the formulation, labeling and/or the specifications for any of our current or future product candidates;

• the potential for approval policies or regulations of the FDA or the applicable foreign regulatory agencies to significantly change in a manner rendering our clinical data insufficient for approval.

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The lengthy review process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval, which would significantly harm our business, financial condition, results of operations and prospects.

Even if we eventually receive approval of an NDA or foreign marketing application for any of our product candidates, the FDA or the applicable foreign regulatory agency may grant approval contingent on the performance of costly additional clinical trials, often referred to as Phase 4 clinical trials, and the FDA may require the implementation of a REMS which may be required to ensure safe use of the drug after approval.

Even if we eventually receive approval of an NDA or foreign marketing application for any of our current or future product candidates, the FDA or the applicable foreign regulatory agency may grant approval contingent on the performance of costly additional clinical trials, often referred to as Phase 4 clinical trials, and the FDA may require the implementation of a REMS which may be required to ensure safe use of the drug after approval.

The FDA or the applicable foreign regulatory agency also may approve a product candidate for a more limited indication or patient population than we originally requested, and the FDA or applicable foreign regulatory agency may not approve the labeling that we believe is necessary or desirable for the successful commercialization of a product candidate.

Any delay in obtaining, or inability to obtain, applicable regulatory approval would delay or prevent commercialization of that product candidate and would materially adversely impact our business and prospects.

A fast track designation may not actually lead to a faster development or regulatory review or approval process.

We received fast track designation for tebipenem HBr for the treatment of cUTI, including pyelonephritis, and we may seek fast track designation for one or more of our future product candidates.

If a drug is intended for the treatment of a serious condition and nonclinical or clinical data demonstrate the potential to address unmet medical need for this condition, a drug sponsor may apply for fast track designation by the FDA for the particular indication under study.

If fast track designation is obtained, the FDA may initiate review of sections of an NDA before the application is complete.

This “rolling review” is available if the applicant provides and the FDA approves a schedule for the remaining information.

If we seek fast track designation for a product candidate, we may not receive it from the FDA.

However, even if we receive fast track designation, fast track designation does not ensure that we will receive marketing approval or that approval will be granted within any particular timeframe.

We may not experience a faster development or regulatory review or approval process with fast track designation compared to conventional FDA procedures.

In addition, the FDA may withdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development program.

Fast track designation alone does not guarantee qualification for the FDA’s priority review procedures.

Additionally, the FDA has designated tebipenem HBr as a Qualified Infectious Disease Product (“QIDP”) for the treatment of cUTI,

community-acquired pneumonia (“CABP”) and diabetic foot infections (“DFI”) under the Generating Antibiotic Incentives Now (“GAIN”) Act.

Among other benefits of a QIDP designation, the first marketing application for the QIDP-designated indication qualifies for priority review by the FDA.

Further, if tebipenem HBr is approved for the treatment of cUTI, the FDA’s QIDP designation previously granted to tebipenem HBr for this indication will entitle the drug product to receive a one-time five-year extension to any non-patent exclusivity period awarded to tebipenem HBr in the United States, such as a five-year New Chemical Entity exclusivity granted under the Hatch-Waxman Act, among other possible periods of regulatory exclusivity that would qualify for a GAIN exclusivity extension.

The QIDP designation for tebipenem HBr, however, does not guarantee a faster development process or ensure FDA approval.

Priority review designation by the FDA may not lead to a faster regulatory review or approval process and, in any event, does not assure FDA approval.

If the FDA determines that a product candidate intended to treat a serious disease, if approved, would provide a significant improvement in safety or effectiveness of the treatment of the disease, the FDA may designate the drug application for that product candidate for priority review.

A priority review designation means that the goal for the FDA to review the marketing application is six months from the date of NDA acceptance for filing, rather than the standard review period of ten months from the date of NDA acceptance for filing.

A priority review designation does not necessarily mean a faster regulatory review process or necessarily confer any advantage with respect to approval compared to conventional FDA procedures.

Receiving a priority review designation from the FDA does not guarantee approval of the drug application within the six-month review cycle or any time thereafter.

On June 17, 2025, the FDA announced the creation of a new voucher program to expedite the development and approval of new drug products.

Vouchers issued under the new program, which is known as the Commissioner’s National Priority Voucher (“CNPV”) Program, may reportedly be redeemed by sponsors to shorten the review time of an NDA from approximately 10 to 12 months to one to two months.

The FDA has indicated that the new CNPV process will convene experts from the FDA’s offices for a team-based review rather than using the standard review system of a drug application being sent to numerous FDA offices.

Clinical information will be reviewed by a multidisciplinary team of physicians and scientists who will pre-review the submitted information and convene for a one-day meeting.

Vouchers under this program will reportedly be given to companies aligned with U.S.

national priorities.

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 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 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.

Upon specific written request by a clinical trial sponsor, the FDA will evaluate the planned protocol and respond to a sponsor’s questions regarding, among other things, primary efficacy endpoints, trial conduct and data analysis.

The FDA ultimately assesses whether the protocol design and planned analysis of the trial adequately address scientific and regulatory requirements for the particular purposes identified by the sponsor, which in this case was that the PIVOT-PO protocol can be considered an adequate and well-controlled study in support of our future resubmission of the tebipenem HBr marketing application.

All agreements between the FDA and the sponsor regarding an SPA must be clearly documented in writing, either in the form of an SPA letter or minutes of a meeting between the sponsor and the FDA at which the SPA agreement was reached.

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.

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.

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.

The FDA retains significant latitude and discretion in interpreting the terms of an SPA agreement, as well as the data and results obtained from any study that is the subject of the SPA agreement.

We cannot assure you that our pivotal Phase 3 clinical trial will succeed, or that the SPA agreement will ultimately be binding on the FDA or will result in any FDA approval of tebipenem HBr.

We expect that the FDA will review our compliance with the protocol that is subject to the SPA agreement, and, as with all NDA reviews, evaluate the results of the trial and conduct inspections of some of the sites where the trial will be conducted.

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.

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.

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

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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.

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.

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Congress may further reevaluate and revise the Orphan Drug Act and its regulations and policies.

For example, in September 2021, the Court of Appeals for the Eleventh Circuit held that, for the purpose of determining the scope of orphan drug exclusivity, the term “same disease or condition” means the designated “rare disease or condition” and not the “indication or use” for which the product is approved.

For example, in September 2021, the Court of Appeals for the Eleventh Circuit held that, for the purpose of determining the scope of

orphan drug exclusivity, the term “same disease or condition” means the designated “rare disease or condition” and not the “indication or use” for which the product is approved.

Subsequently, in another case, a federal district court in Washington, D.C.

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It overruled these court decisions and codified the FDA’s longstanding interpretation of the scope of orphan drug exclusivity to apply to “the same drug for the same approved use or indication within such [designated] rare disease or condition.” This change, which applies retroactively, expressly authorizes the FDA to approve multiple versions of the same orphan drug for different sub-indications and subpopulations, such as adult and pediatric patients or multiple variations of the same disease that are caused by different genetic variants.

If approved for commercial marketing in the United States, our existing or future product candidates may face generic competition sooner than anticipated.

Even if we are successful in achieving regulatory approval to commercialize a product candidate, it may face competition from generic products earlier or more aggressively than anticipated, depending upon how well our future products perform in the U.S.

If approved for commercial marketing in the United States, Utebzi our existing or future product candidates may face generic competition sooner than anticipated.

Utebzi, and any current or future product candidate for which we achieve regulatory approval, may face competition from generic products earlier or more aggressively than anticipated, depending upon how well our future products perform in the U.S.

prescription drug market.

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The FDA is prohibited by statute from approving an ANDA when certain marketing or data exclusivity protections apply to the RLD.

If the FDA ultimately approves tebipenem HBr for the treatment of cUTI, including pyelonephritis, caused by certain microorganisms in adult patients who have limited oral treatment options, we expect that it will be designated by the agency as an RLD and that it will be eligible for five-year new chemical entity exclusivity under the Hatch-Waxman provisions of the FDCA.

In June 2026, the FDA approved GSK’s NDA resubmission for Utebzi.

This exclusivity period would block FDA from approving either a subsequent ANDA or 505(b)(2) NDA that references our future NDA, if approved.

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The new Pharma Package would, among other things, set a baseline period of eight years of data exclusivity and one year of market exclusivity with possible extensions for new indications up to a maximum of 11 years total.

The new framework is expected to be adopted by mid-2026 and there will likely be a transition period of 24 months, with the changes taking effect in mid-2028.

The new framework is expected to be adopted by late-2026 and there will likely be a transition period of 24 months, with the changes taking effect in mid-2028.

Additionally, we could face heightened risks with respect to obtaining marketing authorization in the United Kingdom as a result of the withdrawal of the United Kingdom from the EU, commonly referred to as Brexit.

The United Kingdom is no longer part of the European Single Market and EU Customs Union.

The United Kingdom is no longer part

of the European Single Market and EU Customs Union.

As of January 1, 2025, the Medicines and Healthcare Products Regulatory Agency (“MHRA”) is responsible for approving all medicinal products destined for the U.K.

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The IRP is open to applicants that have already received an authorization for the same product from one of the MHRA’s specified Reference Regulators (“RRs”).

The RRs notably include the EMA and regulators in the EU/European Economic Area (“EEA”) member states for approvals in the EU centralized procedure and mutual recognition procedure as well as the FDA (for product approvals granted in the United States).

The RRs notably include the EMA and regulators in the EU/European Economic Area member states for approvals in the EU centralized procedure and mutual recognition procedure as well as the FDA (for product approvals granted in the United States).

However, the concrete functioning of the IRP is currently unclear.

Any delay in obtaining, or an inability to obtain, any marketing approvals may force us or any of our future collaborators to restrict or delay efforts to seek regulatory approval in the United Kingdom for any product candidates, which could significantly and materially harm our business.

If we receive regulatory approval for any product candidates, we will be subject to ongoing obligations and continuing regulatory review, which may result in significant additional expense.

Our existing or future 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 existing or future product candidates, when and if approved.

We will be subject to ongoing obligations and continuing regulatory review for Utebzi and any existing or future product candidates that receive regulatory approval in the future, which may result in significant additional expense.

Utebzi and our existing or future 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 Utebzi or our existing or future 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.

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In addition, even if marketing approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed, may be subject to significant conditions of approval or may impose requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product.

The FDA may also require a REMS as a condition of approval of any of our product candidates, which could include requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.

The FDA may also require a REMS as a condition of approval of any of our current or future product candidates, which could include requirements for a medication guide, physician communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.

The FDA closely regulates the post-approval marketing and promotion of drugs to ensure that drugs are marketed only for the approved indications and in accordance with the provisions of the approved labeling and regulatory requirements.

The FDA also imposes stringent restrictions on manufacturers’ communications regarding off-label use and if we do not restrict the marketing of our products only to their approved indications, we may be subject to enforcement action for off-label marketing.

For example, on September 9, 2025, the President issued a Memorandum directing HHS to “ensure transparency and accuracy in direct-to-consumer (“DTC”) prescription drug advertising, including by increasing the amount of information regarding any risks associated with the use of any such prescription drug required to be provided in prescription drug advertisements.” To that end, the FDA announced that it is initiating a rulemaking process “to eliminate the ‘adequate provision’ loophole that allows pharmaceutical advertisements to hide safety information by placing it in another format or location.” In this context, the FDA declared that it will no longer tolerate what it characterized as “deceptive practices” in prescription drug advertising and that the agency would “aggressively deploy” its available enforcement tools, with “heightened scrutiny” of fair balance and disclosures in social media promotions.

For example, on September 9, 2025, the President issued a Memorandum directing HHS to “ensure transparency and accuracy in direct-to-consumer prescription drug advertising, including by increasing the amount of information regarding any risks associated with the use of any such prescription drug required to be provided in prescription drug advertisements.” To that end, the FDA announced that it is initiating a rulemaking process “to eliminate the ‘adequate provision’ loophole that allows pharmaceutical advertisements to hide safety information by placing it in another format or location.” In this context, the FDA declared that it will no longer tolerate what it characterized as “deceptive practices” in prescription drug advertising and that the agency would “aggressively deploy” its available enforcement tools, with “heightened scrutiny” of fair balance and disclosures in social media promotions.

The FDA also issued a generic “notice letter” directing companies to “remove any noncompliant advertising and bring all promotional communications into compliance.”

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• issue injunctions or impose civil or criminal penalties.

The FDA’s policies may change and additional government regulations may be enacted that could prevent, limit or delay marketing approval of any of our product candidates.

The FDA’s policies may change and additional government regulations may be enacted that could prevent, limit or delay marketing approval of any of our current or future product candidates.

If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, which would adversely affect our business, prospects and ability to achieve or sustain profitability.

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as in the case of the federal healthcare Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate the statute in order to have committed a violation;

• HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, also imposes obligations on certain covered entities as well as their business associates that perform services involving the use or disclosure of protected health information, including mandatory contractual terms, with respect to safeguarding the privacy and security of protected health information, and requires notification to affected individuals and regulatory authorities of certain breaches of security of protected health information;

privacy and security of protected health information, and requires notification to affected individuals and regulatory authorities of certain breaches of security of protected health information;

• the federal False Statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services;

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The extent to which future legislation or regulations, if any, relating to healthcare fraud and abuse laws or enforcement, may be enacted or what effect such legislation or regulation would have on our business remains uncertain.

Recently enacted and future policies and legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize any of our product candidates and may affect the reimbursement made for any product candidate for which we receive marketing approval.

Recently enacted and future policies and legislation may increase the difficulty and cost for us to obtain marketing approval of any of our current or future product candidates, and commercialize Utebzi or any of our current or future product candidates, and may affect the reimbursement made for Utebzi or any product candidate for which we receive marketing approval.

The pricing and reimbursement environment may become more challenging due to, among other reasons, policies advanced by the presidential administration, federal agencies, new healthcare legislation passed by the U.S.

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The BCA caps the cuts to Medicare payments for items and services and payments to Part D plans at 2%.

As long as these cuts remain in effect, they could adversely affect payment for any of our product candidates, if approved for commercial marketing.

We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for any of our product candidates or additional pricing pressures.

As long as these cuts remain in effect, they could adversely affect payment for any of our current or future product candidates, if approved for commercial marketing.

We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in reduced demand for any of our current or future product candidates or additional pricing pressures.

Moreover, there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products.

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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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For example, on May 8, 2025, the U.S.

Court of Appeals for the Third Circuit rejected AstraZeneca L.P.’s challenge to the Medicare price negotiation program, finding that the program did not violate the company’s due process rights under the Constitution.

Court of Appeals for the Third Circuit rejected AstraZeneca L.P.’s challenge to the Medicare price negotiation

program, finding that the program did not violate the company’s due process rights under the Constitution.

Litigation involving these and other provisions of the IRA will continue with unpredictable and uncertain results.

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We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad.

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.

Changes in tax laws or in their implementation or interpretation could adversely affect our business and financial condition.

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In addition, it is uncertain if and to what extent various states will conform to changes in federal tax legislation.

If we successfully commercialize one of our product candidates, failure to comply with our reporting and payment obligations under U.S.

governmental pricing programs could have a material adverse effect on our business, financial condition and results of operations.

Failure to comply with our reporting and payment obligations under U.S.

governmental pricing programs for any of our current or future product candidates that we may commercialize, 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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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.

Disruptions at the FDA and other government agencies from funding cuts, personnel losses, regulatory reform, government shutdowns and other developments could hinder our ability to obtain guidance from the FDA regarding our clinical development program and develop and secure approval of any of our product candidates in a timely manner, which would negatively impact our business.

The FDA and comparable regulatory agencies in foreign jurisdictions, such as the EMA and Committee for Medicinal Products for Human Use, play an important role in the development of any of our product candidates by providing guidance on our clinical development programs and reviewing our regulatory submissions, including INDs, requests for special designations and marketing applications.

If these oversight and review activities are disrupted, then correspondingly our ability to develop and secure timely approval of any of our product candidates could be impacted in a negative manner.

For example, the loss of FDA leadership and personnel could lead to disruptions and delays in FDA guidance, review and approval of any of our product candidates.

Disruptions at the FDA and other government agencies from funding cuts, personnel losses, regulatory reform, government shutdowns and other developments could hinder our ability to obtain guidance from the FDA regarding our clinical development program and develop and secure approval of any of our current or future product candidates in a timely manner, which would negatively impact our business.

The FDA and comparable regulatory agencies in foreign jurisdictions, such as the EMA and Committee for Medicinal Products for Human Use, play an important role in the development of any of our current or future product candidates by providing guidance on our clinical development programs and reviewing our regulatory submissions, including INDs, requests for special designations and marketing applications.

If these oversight and review activities are disrupted, then correspondingly our ability to develop and secure timely approval of any of our current or future product candidates could be impacted in a negative manner.

For example, the loss of FDA leadership and personnel could lead to disruptions and delays in FDA guidance, review and approval of any of our current or future product candidates.

Pursuant to President Trump’s Executive Order 14210, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative,” the Secretary of HHS announced on March 27, 2025, a reorganization and Reduction in Force (“RIF”) across the Department of approximately 20,000 employees (82,000 to 62,000), with FDA’s workforce of approximately 20,000 to decrease by 3,500 full-time employees.

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In November 2025, a Congressional Continuing Resolution ended the government shutdown, providing full-year funding for the FDA for Fiscal Year 2026 through September 30, 2026 at approximately $7 billion with a slight increase in user fees for drug and device companies.

While the FDA’s review of marketing applications and other activities for new drugs and biologics is largely funded through the user fee program established under the Prescription Drug User Fee Act (“PDUFA”), it remains unclear how the administration’s RIF and budget cuts will impact this program and the ability of the FDA to provide guidance and review any of our product candidates in a timely manner.

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.

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delaying or 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.

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

government actions could, directly or indirectly, significantly disrupt, delay, prevent, or increase the costs of our research and product commercialization programs, including our ability to develop new product candidates, conduct clinical trials, implement research collaborations with other companies or institutions, and obtain approvals to market and sell new products.

In addition, government funding of the government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

For example, the federal government shut down on October 1, 2025, and did not reopen for 43 days.

For example, the

federal government shut down on October 1, 2025, and did not reopen for 43 days.

With the shutdown, the FDA issued a public notice stating that agency operations would continue to the extent permitted by law, such as activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fee funds.

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Previously, the U.S.

government had imposed a 25% tariff on Canada and Mexico for goods not covered by the United States-Mexico-Canada Agreement (“USMCA”) and tariffs due to drug trafficking equaling 20% on imports from China.

government had imposed a 25% tariff on Canada and Mexico for goods not covered by the United States-Mexico-Canada Agreement and tariffs due to drug trafficking equaling 20% on imports from China.

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

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The deals with the European Union, Japan, South Korea, Switzerland (and Liechtenstein), the United Kingdom and others cap pharmaceutical tariffs at 15%.

In addition, an agreement with Malaysia provides a zero percent tariff exemption for pharmaceutical products that are not patented in the U.S.

and are used in pharmaceutical applications and an agreement with Switzerland and Lichenstein caps tariffs on pharmaceuticals imported from those two countries at 15%.

In addition, an agreement with Malaysia provides a zero percent tariff exemption for pharmaceutical products that are not patented in the United States and are used in pharmaceutical applications and an agreement with Switzerland and Lichenstein caps tariffs on pharmaceuticals imported from those two countries at 15%.

Finally, an agreement with Taiwan concluded on January 15, 2026 eliminates tariffs on generic pharmaceuticals and their active ingredients imported from Taiwan.

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Shortly thereafter, the President issued a new Executive Order revoking the IEEPA tariffs and Customs and Border Protection ceased collecting the tariffs as of 12:01 am on February 24, 2026.

At the same time, however, the Trump Administration imposed a new 10% global tariff under Section 122 of the Trade Act of 1974, effective February 24, 2026.

Pursuant to the statute, absent an extension by Congress, these tariffs will expire in 150 days on July 24, 2026.

For those countries that have concluded trade deals with the United States, the tariff rates agreed to – including with regard to pharmaceuticals and pharmaceutical ingredients – have now reverted to 10% until July 24, 2026.

Like the IEEPA tariffs, pharmaceuticals and pharmaceutical ingredients are exempt from the Section 122 tariffs along with a list of other products.

The Administration has announced that it also plans to initiate new investigations on “most major trading partners” under Section 301 of the same act, which will likely lead to additional tariffs.

At the same time, however, the Trump

Administration imposed a new 10% global tariff under Section 122 of the Trade Act of 1974, effective February 24, 2026.

Pursuant to the statute, these tariffs expired on July 24, 2026.

However, on July 23, 2026, the Office of the U.S.

Trade Representative announced final action under Section 301 of the Trade Act of 1974 imposing new tariffs on imports from 60 trading partners based on findings that those countries had failed to adopt and effectively enforce prohibitions on imports of goods produced with forced labor.

The new tariffs, set at either 10% or 12.5% depending on the country’s level of commitment to forced-labor import restrictions, took effect on July 24, 2026, and replaced the tariffs that had been imposed under Section 122.

The Administration has announced that it also plans to initiate new investigations related to excess capacity on “most major trading partners” under Section 301 of the same act, which will likely lead to additional tariffs.

Neither the Supreme Court’s decision nor the Executive Order revoking the IEEPA tariffs addressed refunds, leaving the issue to renewed proceedings before the U.S.

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On September 25, 2025, the U.S.

administration 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, the administration indicated that these tariffs could be avoided by building pharmaceutical manufacturing facilities in the U.S.

Thereafter, the administration delayed the October 1, 2025 effective date of the tariffs on branded or patented pharmaceutical products announcing that the administration had now “begun preparing” tariffs on manufacturers that do not build in the U.S.

or enter into a most-favored-nation drug pricing agreement with the administration.

administration announced that, beginning October 1, 2025, all branded or patented drugs imported in the United States would face a 100% tariff.

At the same time, the administration indicated that these tariffs could be avoided by building pharmaceutical manufacturing facilities in the United States Thereafter, the administration delayed the October 1, 2025 effective date of the tariffs on branded or patented pharmaceutical products announcing that the administration had now “begun preparing” tariffs on manufacturers that do not build in the United States or enter into a most-favored-nation drug pricing agreement with the administration.

On April 2, 2026, President Trump issued a Proclamation invoking Section 232 of the Trade Expansion Act of 1962 to impose tariffs on imports of patented pharmaceuticals, biologics, and associated ingredients into the United States.

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• the success of existing or new competitive products or technologies;

• the timing of clinical trials of any of our product candidates;

• the timing of clinical trials of any of our current or future product candidates;

• results of clinical trials of any existing or future product candidates;

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An active trading market for our common stock may not be sustained.

Although our common stock is listed on the Nasdaq GS, there is a risk that an active trading market for our shares may not continue to develop or be sustained.

Although our common stock is listed on the Nasdaq Global Select Market, there is a risk that an active trading market for our shares may not continue to 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.

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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.

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.

economic growth, supply chain disruptions, banking disruptions, and uncertainty resulting from geopolitical events, including trade wars, civil and political unrest, wars and other armed conflicts.

In addition, market, interest rate, and inflation volatility may increase our cost of financing or restrict our access to potential sources of future capital.

3 unchanged sentences

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.

These global economic and political factors could also strain certain of our suppliers and manufacturers, possibly resulting in supply disruptions or increased raw material or manufacturing costs, or adversely impacting their ability to manufacture clinical trial materials for any of our product candidates.

Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic and geopolitical climate and financial market conditions could adversely impact our business.

1 unchanged sentence

Our management has broad discretion in the application of our cash reserves and could spend these funds in ways that do not improve our results of operations or enhance the value of our common stock.

The failure by our management to apply these funds effectively could result in financial losses that could have a material adverse effect on our business, cause the price of our common stock to decline and delay the development of any of our product candidates.

Pending their use, we may invest our cash reserves in a manner that does not produce income or that loses value.

6 unchanged sentences

As a public company, we incur significant legal, accounting and other expenses that we did not incur as a private company.

Sarbanes-Oxley, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of the Nasdaq GS and other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices.

Sarbanes-Oxley, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of the Nasdaq Global Select Market and other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices.

Our management and other personnel devote a substantial amount of time to these compliance initiatives.

6 unchanged sentences

To maintain compliance with Section 404, we are required to document and evaluate our internal control over financial reporting, which is both costly and challenging.

We will need to continue to dedicate internal resources, continue to engage outside consultants and follow a detailed work plan to continue to assess and document the adequacy of internal control over financial reporting, continue to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting.

control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting.

If we identify one or more material weaknesses, it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

18 unchanged sentences

Among other things, these provisions:

• establish a classified Board of Directors such that all members of the board are not elected at one time;

• establish a classified Board of Directors such that all members of the Board of Directors are not elected at one time;

• allow the authorized number of our directors to be changed only by resolution of our Board of Directors;

23 unchanged sentences

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.

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 planned development of SP001, or the ultimate value our stockholders receive in such partnership or other opportunity.

Unregistered Sales of Equity Securities and Use of Proceeds.

3 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