What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2026-08-12 compared with 2026-05-13 · 171 added, 91 removed, 213 unchanged (55% of the section changed)

3 unchanged sentences

As a result of many factors, including those factors set forth in the “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q, our actual results could differ materially from the results described in, or implied by, the forward-looking statements contained in the following discussion and analysis.

We are a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need.

Our clinical-stage product candidate, tebipenem HBr, has completed a second Phase 3 trial, and we believe has the potential to be the first oral carbapenem to treat adult patients with complicated urinary tract infections (“cUTIs”), including pyelonephritis, caused by certain microorganisms.

In September 2022, we entered into an exclusive license agreement with GSK for the development, manufacture and commercialization of tebipenem HBr, which includes the transfer of the IND and the New Drug Application (“NDA”) ownership to GSK.

In May 2025, we and GSK announced that the pivotal Phase 3 PIVOT-PO trial evaluating tebipenem HBr met its primary endpoint and was stopped early for efficacy.

GSK has submitted the data from the trial as part of an NDA Class 2 resubmission for tebipenem HBr to the FDA in December 2025, which has been accepted by the FDA.

GSK reported that the Prescription Drug User Fee Act (“PDUFA”) date has been set as June 18, 2026.

Following the termination of our earlier stage programs (SPR206 and SPR720), we remain focused on supporting GSK in the FDA approval process pursuant to our obligations under the GSK License Agreement and advancing other corporate activities, including exploring opportunities to grow our portfolio of clinical-stage product candidates.

We are a clinical-stage biopharmaceutical company advancing next generation medicines for patients with immune-mediated diseases.

Our lead program, SP001, is a third-generation, fully humanized, Fc-silent IgG1 monoclonal antibody targeting CD40L.

On July 8, 2026, we entered into the Innovent Agreement with Innovent, pursuant to which Innovent granted the Company an exclusive (even as to Innovent and its affiliates, subject to Innovent’s right to directly or indirectly conduct certain research, non-clinical development and manufacturing activities), sublicensable right and license under certain Licensed Intellectual Property to research, develop, manufacture, and commercialize SP001, and the Licensed Compounds and Licensed Products worldwide, excluding the Innovent Territory (see Note 12, Subsequent Events ).

SP001 targets CD40L, an immune signal protein that sits upstream of multiple immune pathways and has the potential to be developed across a range of immune-mediated diseases.

We are developingSP001 for the treatment of patients with Immunoglobulin G4 related disease, or IgG4-RD.

IgG4-RD is a rare disease with an estimated 20,000 to 40,000 diagnosed patients in the United States.

Patients with IgG4-RD suffer from serious, chronic fibro-inflammation that can affect multiple organs, including the pancreas, salivary glands, lacrimal glands, kidneys, lungs, lymph nodes, and other tissues.

Left untreated or under-treated IgG4-RD patients may progress to organ failure.

In September 2022, we entered into an exclusive licensing agreement with GSK for Utebzi (tebipenem pivoxil), which included transfer of the IND application and NDA ownership to GSK.

We initially developed Utebzi as tebipenem HBr.

In May 2025, we and GSK announced that the pivotal Phase 3 PIVOT-PO trial evaluating Utebzi met its primary endpoint and was stopped early for efficacy.

GSK submitted the data from the trial as part of an NDA Class 2 resubmission to the FDA in December 2025.

On June 17, 2026, we and GSK announced that the FDA approved Utebzi, an oral antibiotic for the treatment of complicated urinary tract infections (cUTIs) including pyelonephritis, caused by certain susceptible pathogens in adult patients who have limited or no alternative oral treatment options.

We have experienced mostly net losses and significant cash outflows from cash used in operating activities since our inception.

Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and commercialization of tebipenem HBr, or any product candidate we may develop in the future.

As of March 31, 2026, we had an accumulated deficit of $458.3 million, and cash and cash equivalents of $56.1 million.

Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development of SP001 and any other product candidate we may develop in the future, as well as GSK’s commercialization of Utebzi.

As of June 30, 2026, we had an accumulated deficit of $467.8 million, and cash and cash equivalents of $50.8 million.

We expect to continue to incur significant expenses and operating losses for the foreseeable future.

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, offset by the upfront payment the Company is obligated to pay to Innovent in connection with the Innovent Agreement, 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 to support our continuing operations.

3 unchanged sentences

The actions necessary to reduce spending under this plan at a level that mitigates the factors described above are not considered probable, as defined in the accounting standards and therefore, the full extent to which management may extend our funds through these actions may not be considered in management’s assessment of our ability to continue as a going concern.

We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for any of our product candidates.

If we obtain regulatory approval for any of our future product candidates and do not enter into a commercialization partnership, we expect to incur significant expenses related to developing our internal commercialization capability to support product sales, marketing and distribution.

We will not generate revenue from product sales on SP001 or any future product candidates unless and until we successfully complete clinical development and obtain regulatory approval for any such product candidate.

If we obtain regulatory approval for any such product candidate and do not enter into a commercialization partnership, we expect to incur significant expenses related to

developing our internal commercialization capability to support product sales, marketing and distribution.

Further, we expect to incur additional costs associated with our continued operation as a public company.

3 unchanged sentences

Recent Developments

Tebipenem HBr

In May 2025, we and GSK announced that the pivotal Phase 3 PIVOT-PO trial evaluating tebipenem HBr, an investigational oral treatment for cUTIs, including pyelonephritis, caused by certain microorganisms, met its primary endpoint and the trial was stopped early for efficacy.

On July 8, 2026, we entered into the Innovent Agreement to in-license SP001, a third-generation, fully humanized, Fc-silent IgG1 monoclonal antibody targeting CD40L, an upstream immune activation signal involved in T-cell, B-cell, antigen-presenting cell, and platelet biology.

SP001 is designed to address platelet activation concerns associated with earlier anti-CD40L antibodies, while preserving key monoclonal antibody properties, including FcRn interaction that supports IgG-like half-life.

We received exclusive rights to research, develop, manufacture, and commercialize SP001 worldwide, excluding the Innovent Territory, where Innovent retains rights.

Innovent has evaluated this antibody in two healthy volunteer Phase 1 trials:

a SAD study and a MAD study.

It has also evaluated SP001 in a Phase 1b MAD study in patients with SjD.

Data from the Phase 1b SjD study were presented in a poster session at the EULAR 2026 Congress.

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.

IgG4-related disease is a serious, rare chronic fibroinflammatory condition that can affect multiple organs, including the pancreas, salivary glands, lacrimal glands, kidneys, lungs, lymph nodes, and other tissues.

The disease can cause immune-mediated inflammation, fibrosis, organ damage, relapse risk, and significant treatment burden.

Tebipenem Pivoxil

On June 17, 2026, the FDA approved Utebzi (tebipenem pivoxil), an oral antibiotic for the treatment of cUTIs including pyelonephritis caused by certain susceptible pathogens in adult patients who have limited or no alternative oral treatment options.

In May 2025, we and GSK announced that the pivotal Phase 3 PIVOT-PO trial evaluating tebipenem pivoxil, an investigational oral treatment for cUTIs, including pyelonephritis, caused by certain microorganisms, met its primary endpoint and the trial was stopped early for efficacy.

The decision followed a recommendation from an Independent Data Monitoring Committee (“IDMC”) that completed a pre-specified interim analysis of data from 1,690 patients enrolled in the trial.

Following the review of the interim analysis data by the IDMC, it was determined that the Phase 3 PIVOT-PO trial met the primary endpoint of non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin in hospitalized adult patients with cUTI, including pyelonephritis, on overall response (composite of clinical cure plus microbiological eradication) at the test-of-cure visit.

The IDMC review did not identify any new safety concerns beyond what has been reported in other studies with tebipenem, with diarrhea and headache as the two most reported adverse events.

In December 2025, GSK resubmitted the NDA for tebipenem HBr to the FDA.

Following the review of the interim analysis data by the IDMC, it was determined that the Phase 3 PIVOT-PO trial met the primary endpoint of non-inferiority of tebipenem pivoxil compared to intravenous imipenem-cilastatin in hospitalized adult patients with cUTI, including pyelonephritis, on overall response (composite of clinical cure plus microbiological eradication) at the test-of-cure visit.

The IDMC review did not identify any new safety concerns beyond what has been reported in other studies with tebipenem pivoxil, with diarrhea and headache as the two most reported adverse events.

In December 2025, GSK resubmitted the NDA for tebipenem pivoxil to the FDA.

In accordance with the terms of the GSK License Agreement, we became entitled to receive a $25.0 million milestone payment upon the filing of the NDA with the FDA, which we received in February 2026.

17 unchanged sentences

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.

Royalty Financing Transaction

On July 8, 2026, we and our affiliates entered into a $105.0 million non-recourse non-dilutive royalty financing transaction with affiliates of HCRx, pursuant to which HCRx will receive a portion of the future GSK Proceeds.

Pursuant to the transaction, the parties entered into, among other documents, the NPA for the Notes, the RPA and the Limited Guaranty.

Under the terms of the NPA, the Notes and other obligations under the NPA are generally payable solely from GSK Proceeds, unless voluntarily prepaid at our option prior to maturity with a premium or subject to certain mandatory prepayment triggers and foreclosure rights.

Under the terms of the RPA, we sold 65% of the GSK Proceeds arising after the payment in full of the Notes while we retain an interest of 35% of the GSK Proceeds arising after payment in full of the Notes.

Pursuant to the Limited Guaranty, we guarantee, subject to certain limitations set forth therein, the obligations of our affiliates under the NPA and RPA.

In connection with the NPA and RPA, we will provide certain servicing, management and administrative functions on behalf of its affiliates (see Note 12, Subsequent Events , in the condensed consolidated financial statements).

Components of Our Results of Operations

1 unchanged sentence

To date, we have not generated any revenue from product sales.

If our development efforts for any of our product candidates are successful and result in regulatory approval, we may generate revenue in the future from product sales.

We cannot predict if, when, or to what extent we will generate revenue from the commercialization and sale of any of our product candidates.

If our development efforts for any of our current or future product candidates are successful and result in regulatory approval, we may generate revenue in the future from product sales.

We cannot predict if, when, or to what extent we will generate revenue from the commercialization and sale of any of our current or future product candidates.

We may never succeed in obtaining regulatory approval for any existing or future product candidates.

5 unchanged sentences

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for our research activities and the development of any of our product candidates, which include:

Research and development expenses consist primarily of costs incurred for our research activities and the development of any of our current or future product candidates, which include:

• employee-related expenses, including salaries, related benefits, travel and share-based compensation expense for employees engaged in research and development functions;

• expenses incurred in connection with the preclinical and clinical development of any of our product candidates, including under agreements with contract research organizations (“CROs”);

• costs incurred in connection with our government awards;

• expenses incurred in connection with the preclinical and clinical development of any of our current and future product candidates, including under agreements with contract research organizations (“CROs”);

• the cost of consultants and contract manufacturing organizations (“CMOs”) that manufacture drug products for use in our preclinical studies and clinical trials;

10 unchanged sentences

At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any existing or future product candidates.

The successful development and commercialization of any of our product candidates is highly uncertain.

The successful development and commercialization of any of our current and future product candidates is highly uncertain.

This is due to the numerous risks and uncertainties, including the following:

2 unchanged sentences

• establishment of arrangements with third-party manufacturers to obtain manufacturing supply;

• obtainment and maintenance of patent, trade secret protection and regulatory exclusivity, both in the United States and internationally, including our ability to maintain our license agreement with Meiji with respect to tebipenem HBr;

• obtainment and maintenance of patent, trade secret protection and regulatory exclusivity, both in the United States and internationally for our current and future product candidates;

• protection of our rights in our intellectual property portfolio;

• launch of commercial sales of any of our product candidates, if approved, whether alone or in collaboration with others;

• acceptance of any of our product candidates, if approved, by patients, the medical community and third-party payors;

• launch of commercial sales of any of our current or future product candidates, if approved, whether alone or in collaboration with others;

• acceptance of any of our current and future product candidates, if approved, by patients, the medical community and third-party payors;

• competition with other therapies;

• a continued acceptable safety profile of any of our product candidates, if approved.

A change in the outcome of any of these variables with respect to the development of any of our product candidates would significantly change the costs and timing associated with the development of that product candidate.

We may never succeed in obtaining regulatory approval for any of our product candidates.

• a continued acceptable safety profile of any of our current our future product candidates, if approved.

A change in the outcome of any of these variables with respect to the development of any of our current or future product candidates would significantly change the costs and timing associated with the development of that product candidate.

We may never succeed in obtaining regulatory approval for any of our current or future product candidates.

General and Administrative Expenses

4 unchanged sentences

Interest Income (Expense)

Interest income (expense) consists of interest income related to the significant financing component related to the GSK License Agreement and interest earned on our cash equivalents, which are primarily invested in money market accounts, as well as interest earned on our investments in marketable securities.

Interest income (expense) consists of interest income related to the significant financing component related to the GSK License Agreement, from the first quarter of 2024 through the third quarter of 2025, and interest earned on our cash equivalents, which are primarily invested in money market accounts, as well as interest earned on our investments in marketable securities.

Other Income (Expense), Net

15 unchanged sentences

We believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.

Funding Received from Government Contracts and Collaborations

Since our inception, we were able to obtain partial funding for our research and development activities from government contracts, government tax incentives and collaboration arrangements.

Funding Received from Collaborations

Since our inception, we were able to obtain partial funding for our research and development activities from collaboration arrangements.

The classification within our statement of operations and comprehensive loss of the funding received under these arrangements was subject to management judgment based on the nature of the arrangements we enter into, the source of the funding and whether the funding is considered central to our business operations.

Government Contracts

We had generated revenue from government contracts that reimbursed us for certain allowable costs for funded projects.

For contracts with government agencies, when we had concluded that we were the principal in conducting the research and development expenses and where the funding arrangement is considered central to our ongoing operations, we classify the recognized funding received as revenue.

Revenue from government grants was recognized as the qualifying expenses related to the contracts were incurred, provided that there is reasonable assurance of recoverability.

Revenue recognized upon incurring qualifying expenses in advance of receipt of funding was recorded as unbilled receivables, a component of prepaid expenses and other current assets, in the consolidated balance sheet.

We did not receive any funding under the Biomedical Advanced Research and Development Authority (“BARDA”) contract in the three months ended March 31, 2026 and do not anticipate receiving any additional funding under the BARDA contract as the Company has utilized all fully committed funds under the contract.

Collaboration Agreements

24 unchanged sentences

• vendors in connection with the preclinical development activities;

• CMOs in connection with the production of preclinical and clinical trial materials;

• CROs in connection with preclinical and clinical studies;

• CMOs in connection with the production of preclinical study and clinical trial materials;

• CROs in connection with preclinical studies and clinical trials;

• investigative sites in connection with clinical trials.

15 unchanged sentences

Results of Operations

Comparison of the Three Months Ended March 31, 2026 and 2025

The following table summarizes our results of operations for the three months ended March 31, 2026 and 2025 (in thousands):

Three Months Ended March 31,

Comparison of the Three Months Ended June 30, 2026 and 2025

The following table summarizes our results of operations for the three months ended June 30, 2026 and 2025 (in thousands):

Three Months Ended June 30,

Grant revenue

Collaboration revenue - related party

Total revenues

Operating expenses:

Research and development

General and administrative

Restructuring

Total operating expenses

Loss from operations

Other income (expense):

Interest income

Other income (expense), net

Total other income, net

Grant Revenue (in thousands):

Three Months Ended June 30,

BARDA Contract (tebipenem pivoxil)

Total grant revenue

No grant revenue was recognized during the three months ended June 30, 2026.

Grant revenue recognized during the three months ended March 31, 2025 consisted of the reimbursement of qualifying expenses incurred in connection with our BARDA contract.

The decrease in grant revenue during the three months ended June 30, 2026 was primarily due to a decrease of $2.4 million of committed funds remaining available under our BARDA contract for tebipenem pivoxil.

On July 6, 2026, we and BARDA mutually agreed to terminate the contract between us, and BARDA deobligated all remaining funds under the contract.

We will not receive any additional funding from BARDA under this contract.

Collaboration Revenue (in thousands):

Three Months Ended June 30,

GSK (tebipenem pivoxil)

Total collaboration revenue

No collaboration revenue was recognized during the three months ended June 30, 2026.

During the three months ended June 30, 2025, we recognized $11.8 million in collaboration revenue related to our agreement with GSK.

The decrease in collaboration revenue during the three months ended June 30, 2026 was primarily related to the achievement of remaining development milestone activities under the agreement.

Research and Development Expenses (in thousands):

Three Months Ended June 30,

Direct research and development expenses by program:

Tebipenem pivoxil

Unallocated expenses:

Personnel related (including share-based compensation)

Facility related and other

Total research and development expenses

Direct costs related to our tebipenem pivoxil program decreased by $5.4 million during the three months ended June 30, 2026, compared to the three months ended June 30, 2025, due to decreased clinical activities related to our pivotal Phase 3 clinical trial of tebipenem pivoxil, which was stopped early for efficacy during the first half of 2025 and later approved by the FDA in June 2026.

Direct costs related to our SPR720 program decreased by $0.3 million during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025, due to the cessation of development and subsequent termination of the SPR720 program, which was announced in November 2025.

The decrease in personnel-related costs of $1.3 million was primarily a result of decreased headcount costs in our research and development functions between the periods.

Personnel-related costs for the three months ended June 30, 2026 and 2025 included share-based compensation expense of $0.3 million and $0.4 million, respectively.

Facility-related and other costs primarily reflect costs related to supporting our research and development staff.

General and Administrative Expenses (in thousands):

Three Months Ended June 30,

Personnel related (including share-based compensation)

Professional and consultant fees

Facility related and other

Total general and administrative expenses

The decrease in personnel-related costs of $1.6 million was primarily a result of decreased headcount costs in our general and administrative functions between periods.

Personnel-related costs for the three months ended June 30, 2026 and 2025 included stock-based compensation expense of $0.5 million and $0.3 million, respectively.

The increase in professional and consultant fees of $2.2 million was primarily due to an increase in business development, legal and consulting expenses incurred in the three months ended June 30, 2026.

Facility-related and other costs primarily reflect costs related to supporting our general and administrative staff.

Other Income (Expense), Net

Other income (expense), net was $0.4 million for the three months ended June 30, 2026, compared to $0.7 million for the three months ended June 30, 2025.

Total other income for the three months ended June 30, 2026, included $0.4 million of interest income, offset by immaterial fluctuations in unrealized foreign currency.

Total other income for the three months ended June 30, 2025, included $0.7 million of interest income, of which $0.4 million related to the significant financing component recognized under the GSK License Agreement, offset by immaterial fluctuations in unrealized foreign currency.

Comparison of the Six Months Ended June 30, 2026 and 2025

The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025 (in thousands):

Six Months Ended June 30,

Grant revenue

Collaboration revenue - related party

Collaboration revenue

9 unchanged sentences

Other income (expense), net

Total other income (expense), net

Total other income, net

Grant Revenue (in thousands):

Three Months Ended March 31,

BARDA Contract (Tebipenem HBr)

Six Months Ended June 30,

BARDA Contract (tebipenem pivoxil)

NIAID Contract (SPR206)

Total grant revenue

No grant revenue was recognized during the three months ended March 31, 2026.

Grant revenue recognized during the three months ended March 31, 2025 consisted of the reimbursement of qualifying expenses incurred in connection with our various government awards.

The decrease in grant revenue during the three months ended March 31, 2026 was primarily due to a decrease of $0.7 million of committed funds remaining available under our BARDA contract for tebipenem HBr, and a decrease of $0.1 million in qualifying expenses incurred under our U.S.

National Institute of Allergy and Infectious Diseases (“NIAID”) award relating to SPR206.

We ceased development of SPR206 and the NIAID award was terminated in April 2025 and the committed funds under the BARDA contract have been fully utilized by the Company.

No grant revenue was recognized during the six months ended June 30, 2026.

Grant revenue recognized during the six months ended June 30, 2025 consisted of the reimbursement of qualifying expenses incurred in connection with our various government awards.

The decrease in grant revenue during the six months ended June 30, 2026 was primarily due to a decrease of $3.1 million under our BARDA contract for tebipenem pivoxil, and a decrease of less than $0.1 million under our agreement with U.S.

National Institute of Allergy and Infectious Diseases (“NIAID”) relating to SPR206.

On July 6, 2026, we and BARDA mutually agreed to terminate the contract between us, and BARDA deobligated all remaining funds under the contract.

We will not receive any additional funding from BARDA under this contract.

Collaboration Revenue (in thousands):

Three Months Ended March 31,

GSK (Tebipenem HBr)

Six Months Ended June 30,

GSK (tebipenem pivoxil)

Pfizer (SPR206)

Total collaboration revenue

During the three months ended March 31, 2026, we recognized $0.3 million in collaboration revenue related to our agreement with GSK and no collaboration revenue related to our agreement with Pfizer as we terminated the Pfizer agreement in December 2025.

During the three months ended March 31, 2025, we recognized $5.1 million in collaboration revenue related to our agreement with GSK and less than $0.1 million in collaboration revenue related to our agreement with Pfizer.

During the six months ended June 30, 2026, we recognized $0.3 million in collaboration revenue related to our agreement with GSK.

During the six months ended June 30, 2025, we recognized $16.9 million in collaboration revenue related to our agreement with GSK and less than $0.1 million in collaboration revenue related to our agreement with Pfizer.

The decrease in revenue under the GSK License Agreement was primarily related to the Phase 3 PIVOT-PO trial for tebipenem pivoxil stopping early for efficacy in the first half of 2025 following the pre-specified interim analysis.

Research and Development Expenses (in thousands):

Three Months Ended March 31,

Six Months Ended June 30,

Direct research and development expenses by program:

Tebipenem HBr

Unallocated expenses:

Tebipenem pivoxil

Personnel related (including share-based compensation)

1 unchanged sentence

Total research and development expenses

Direct costs related to our tebipenem HBr program decreased by $8.3 million during the three months ended March 31, 2026, compared to the three months ended March 31, 2025, due to decreased clinical activities related to our pivotal Phase 3 clinical trial of tebipenem HBr, which was stopped early for efficacy during the first half of 2025.

Direct costs related to our SPR720 program decreased by $0.4 million during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025, due to the cessation of development of the SPR720 program, which was announced in November 2025.

Direct costs related to our SPR206 program decreased by less than $0.1 million during the three months ended March 31, 2026, primarily due to the cessation of development of the SPR206 program, which was announced in March 2025.

The decrease in personnel-related costs of $1.7 million was primarily a result of decreased headcount costs in our research and development functions between the periods.

Personnel-related costs for the three months ended March 31, 2026 and 2025 included share-based compensation expense of $0.3 million and $0.5 million, respectively.

Direct costs related to our tebipenem pivoxil program decreased by $13.7 million during the six months ended June 30, 2026, compared to the six months ended June 30, 2025, due to a decrease in clinical activities related to our pivotal Phase 3 PIVOT-PO trial for tebipenem pivoxil, which met its primary endpoint and was stopped early for efficacy during the first half of 2025 and later approved by the FDA in June 2026.

Direct costs related to our SPR720 program decreased by $0.8 million during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, due to the cessation of development and subsequent termination of the SPR720 program, which was announced in November 2025.

Direct costs related to our SPR206 program decreased by less than $0.1 million during the six months ended June 30, 2026, primarily due to the cessation and subsequent termination of the SPR206 program, which was announced in March 2025.

The decrease in personnel-related costs of $2.9 million was primarily a result of decreased headcount costs in our research and development functions between periods.

Personnel-related costs for the six months ended June 30, 2026 and 2025 included stock-based compensation expense of $0.6 million and $0.9 million, respectively.

Facility-related and other costs primarily reflect costs related to supporting our research and development staff.

General and Administrative Expenses (in thousands):

Three Months Ended March 31,

Six Months Ended June 30,

Personnel related (including share-based compensation)

3 unchanged sentences

The decrease in personnel-related costs of $3.4 million was primarily a result of decreased headcount costs in our general and administrative functions between the periods.

Personnel-related costs for the three months ended March 31, 2026 and 2025 included share-based compensation expense of $0.8 million and $1.0 million, respectively.

The decrease in professional and consultant fees of $0.6 million was primarily due to a decrease in legal and consulting expenses incurred in the three months ended March 31, 2026.

Personnel-related costs for both the six months ended June 30, 2026 and 2025 included share-based compensation expense of $1.3 million.

The increase in professional and consultant fees of $1.6 million was primarily due to an increase in business development, legal and consulting expenses incurred in the six months ended June 30, 2026.

Facility-related and other costs primarily reflect costs related to supporting our general and administrative staff.

Other Income (Expense), Net

Other income (expense), net was $0.3 million for the three months ended March 31, 2026, compared to $0.9 million for the three months ended March 31, 2025.

Total other income for the three months ended March 31, 2025, included $0.9 million of interest income, of which $0.4 million related to the significant financing component recognized under the GSK License Agreement, offset by immaterial fluctuations in unrealized foreign currency.

Total other income (expense), net was $0.7 million for the six months ended June 30, 2026, compared to $1.6 million for the six months ended June 30, 2025.

Total other income for the six months ended June 30, 2026, included $0.7 million of interest income, offset by immaterial fluctuations in unrealized foreign currency.

Total other income for the six months ended June 30, 2025, included $1.6 million of interest income, of which $0.7 million related to the significant financing component recognized under the GSK License Agreement, offset by immaterial fluctuations in unrealized foreign currency.

Liquidity and Capital Resources

2 unchanged sentences

Department of Defense, NIAID, Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator and BARDA, the GSK License Agreement and our license agreements with Everest and Pfizer.

We have not yet commercialized any of our product candidates and we may not generate revenue from sales of any product candidates.

To date, we have funded our operations with payments received under license and collaboration agreements and funding from government contracts, and from the proceeds of multiple common stock offerings.

As of March 31, 2026, we had cash and cash equivalents of $56.1 million.

In February 2026, we received a $25.0 million milestone payment under the GSK agreement, which we were entitled to receive upon GSK’s filing of an NDA for tebipenem HBr with the FDA in December 2025.

The following table summarizes our sources and uses of cash for the three months ended March 31, 2026 and 2025 (in thousands):

Three Months Ended March 31,

We have not yet commercialized any product candidates and we may not generate revenue from sales of any current or future product candidates.

To date, we have funded our operations with payments received under license and collaboration agreements and funding from government contracts, from the proceeds of multiple common stock offerings, and proceeds received from royalty financing transaction that closed in July 2026.

As of June 30, 2026, we had cash and cash equivalents of $50.8 million.

The following table summarizes our sources and uses of cash for the six months ended June 30, 2026 and 2025 (in thousands):

Six Months Ended June 30,

Cash provided by (used in) operating activities

1 unchanged sentence

Operating Activities

Net cash provided by operating activities for the three months ended March 31, 2026, was $15.9 million, primarily resulting from our net loss of $7.2 million, adjusted for non-cash items of $1.3 million (primarily share-based compensation).

Net cash provided by changes in our operating assets and liabilities was $21.7 million and consisted primarily of a $25.4 million decrease in our related party collaboration receivable, primarily due to the receipt of the milestone payment upon the filing of the NDA from GSK (see Note 9 - License, Collaboration and Service Agreements), offset by a $2.4 million decrease in accrued expenses, a $0.6 million decrease in other liabilities, a $0.5 million decrease in accounts payable, a $0.3 million decrease in deferred revenue, and a $0.2 million decrease in prepaid expenses.

Net cash used in operating activities for the three months ended March 31, 2025, was $4.0 million, primarily resulting from our net loss of $13.9 million, adjusted for non-cash items of $1.8 million (primarily share-based compensation).

Net cash provided by changes in our operating assets and liabilities was $8.0 million and consisted primarily of a $25.8 million decrease in our related party collaboration receivable, primarily due to the receipt of the third installment payment from GSK (see Note 9 - License, Collaboration and Service Agreements), a $9.5 million decrease in accrued expenses, a $5.5 million decrease in accounts payable, a $5.1 million decrease in deferred revenue, a $2.4 million net decrease in other receivables, and a $0.4 million decrease in prepaid expenses.

Net cash provided by operating activities for the six months ended June 30, 2026, was $10.5 million, primarily resulting from our net loss of $16.8 million, adjusted for an increase to non-cash items of $2.4 million (primarily stock-based compensation).

Net cash provided by changes in our operating assets and liabilities was $24.9 million and consisted primarily of a $25.4 million decrease in the collaboration receivable-related party, due to the receipt of the NDA resubmission milestone payment from GSK (see Note 9, License, Collaboration and Service Agreements , in the condensed consolidated financial statements), a $0.3 million decrease in deferred revenue a $0.5 million increase in accrued expenses, a $0.5 million decrease in accounts payable, a $0.9 million increase in prepaid expenses and other receivables and a $0.9 million decrease in operating lease liability.

Net cash used in operating activities for the six months ended June 30, 2025, was $21.7 million, primarily resulting from our net loss of $15.6 million, adjusted for an increase to non-cash items of $2.8 million (primarily stock-based compensation).

Net cash used by changes in our operating assets and liabilities was $9.0 million and consisted primarily of a $24.9 million decrease in the collaboration receivable-related party, due to the receipt of the third installment payment from GSK (see Note 9, License, Collaboration and Service Agreements , in the condensed consolidated financial statements), a $16.9 million decrease in deferred revenue, a $11.0 million decrease in accrued expenses, a $6.5 million decrease in accounts payable, a $0.6 million increase in prepaid expenses, a $0.6 million net increase in other receivables, and a $0.7 million decrease in operating lease liability.

Changes in accounts payable, accrued expenses and other current liabilities and prepaid expenses and other current assets in all periods were generally due to the advancement of our program and the timing of vendor invoicing and payments.

2 unchanged sentences

Investing Activities

We did not undertake any investing activities during either of the three months ended March 31, 2026 or 2025.

We did not undertake any investing activities during either of the six months ended June 30, 2026 or 2025.

Financing Activities

We did not undertake any financing activities during either of the three months ended March 31, 2026 or 2025.

We did not undertake any financing activities during either of the six months ended June 30, 2026 or 2025.

Funding Requirements

Our future use of operating cash and capital requirements, and the timing and amount thereof, will depend largely on:

• the initiation, progress, timing, costs and results of any preclinical studies and clinical trials of any of our product candidates and potential new product candidates;

• the amount of funding that we receive under government contracts that we may apply for in the future;

• the initiation, progress, timing, costs and results of any preclinical studies and clinical trials of any of our current or future product candidates;

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

3 unchanged sentences

• the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights, including milestone and royalty payments and patent prosecution fees that we are obligated to pay pursuant to our license agreements;

• the amount of funding that we receive under government contracts that we may apply for in the future;

• the costs of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against any intellectual property related claims;

1 unchanged sentence

• the extent to which we in-license or acquire other products and technologies;

• costs associated with litigation and any government investigation.

As of March 31, 2026, we had cash and cash equivalents of $56.1 million.

• costs associated with litigation and any government investigation, and maintaining compliance with government regulations.

As of June 30, 2026, we had cash and cash equivalents of $50.8 million.

In accordance with ASU 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), we are required to evaluate whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern from the issuance date of our financial statements.

Based on our current operating plan, we believe that our cash and cash equivalents as of March 31, 2026 will enable us to fund our operating expenses and required capital expenditure requirements for at least 12 months from the issuance of the financial statements included in this report and into 2028.

This timeline is uncertain and subject to change as we explore opportunities to grow our pipeline.

Based on our current operating plan, we believe that our cash and cash equivalents as of June 30, 2026, together with proceeds from the royalty financing transaction that closed in July 2026, will enable us to fund our operating expenses and required capital expenditure requirements for at least 12 months from the issuance of the financial statements included in this report and into the second half of 2029.

This timeline is uncertain and subject to change as we explore opportunities to grow our program.

We have developed plans to mitigate this risk, which primarily consist of raising additional capital through some combination of equity or debt financings, potential new collaborations and/or reducing cash expenditures.

If we are not able to secure adequate additional funding, we plan to make reductions in spending.

In that event, we may have to delay, scale back, or eliminate some or all of our planned clinical trials, and research stage programs.

In that event, we may have to delay, scale back, or eliminate some or all of our planned clinical trials, and any research stage programs.

9 unchanged sentences

Contractual Obligations and Commitments

During the three months ended March 31, 2026, there have been no material changes to our contractual obligations and commitments outside the ordinary course of business from those described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Contractual Obligations and Commitments” in our Annual Report on Form 10-K for the year ended December 31, 2025.

During the three and six months ended June 30, 2026, there have been no material changes to our contractual obligations and commitments outside the ordinary course of business from those described under the heading “Management’s Discussion and

Analysis of Financial Condition and Results of Operations—Contractual Obligations and Commitments” in our Annual Report on Form 10-K for the year ended December 31, 2025.

Off-Balance Sheet Arrangements

3 unchanged sentences

Quantitative and Qualitati ve Disclosures About Market Risk.

As of March 31, 2026, we had cash and cash equivalents of $56.1 million, consisting of cash and money market accounts.

As of June 30, 2026, we had cash and cash equivalents of $50.8 million, consisting of cash and money market accounts.

The primary objectives of our investment activities are to preserve principal, provide liquidity and maximize income without significantly increasing risk.

1 unchanged sentence

Treasury interest rates.

We did not have any assets classified as marketable securities as of March 31, 2026.

We did not have any assets classified as marketable securities as of June 30, 2026.

As we incur research expenses in foreign countries, we face exposure to movements in foreign currency exchange rates, primarily the Euro, British Pound and Australian dollar against the U.S.

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 2. Management’s Discussion and Analysis