Spero Therapeutics, Inc.

Previous wording

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

Current wording

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

Previous wording

Our clinical-stage product candidate, tebipenem HBr, has completed a Phase 3 trial with the potential to be the first broad-spectrum oral carbapenem to treat adult patients with cUTIs, including pyelonephritis, caused by certain microorganisms. 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. Results from the Phase 3 PIVOT-PO trial were featured in a late breaking oral presentation on October 20, 2025, at IDWeek in Atlanta, GA. GSK plans to submit the data from the trial as part of an FDA filing during the fourth quarter of 2025.

Current wording

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.

Previous wording

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 eventual commercialization of tebipenem HBr, or any product candidate we may develop in the future. As of September 30, 2025, we had an accumulated deficit of $482.6 million, and cash and cash equivalents of $48.6 million. We expect to continue to incur significant expenses and operating losses for at least the next year. Based on our cash and cash equivalents as of September 30, 2025 and the decrease in clinical expense as a result of the completion of the PIVOT-PO Phase 3 trial for tebipenem HBr and the decision to cease development of SPR720, we believe that our cash runway will be sufficient to fund our operating expenses and required capital expenditures into 2028. During this period, we plan to prioritize finalizing the Phase 3 clinical trial activities for tebipenem HBr under our GSK License Agreement. Beyond this point, or in the event we change our current operating plan, we will need additional funding to support our continuing operations and explore our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, government funding arrangements, collaborations, strategic alliances and marketing, distribution or licensing arrangements. If we are not able to secure adequate additional funding, we will have to make further reductions in spending. In that event, we may have to delay, scale back, or eliminate some or all of our planned development activities. 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.

Current wording

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. 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. Beyond this point, or in the event we change our current operating plan, we will need additional funding to support our continuing operations. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, government funding arrangements, collaborations, strategic alliances and marketing, distribution or licensing arrangements. If we are not able to secure adequate additional funding, we will have to make further reductions in spending. In that event, we may have to delay, scale back, or eliminate some or all of our planned development activities. 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.

Previous wording

We will not generate revenue from product sales unless and until we successfully complete clinical development and obtain regulatory approval for 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. Further, we expect to incur additional costs associated with our continued operation as a public company.

Current wording

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

Previous wording

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, met its primary endpoint and has 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.

Current wording

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. 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.

Previous wording

The 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. Results from the Phase 3 PIVOT-PO trial were featured in a late breaking oral presentation on October 20, 2025, at IDWeek in Atlanta, GA. GSK plans to submit the data from the trial as part of an FDA filing during the fourth quarter of 2025.

Current wording

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. 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.

Previous wording

Remaining potential payments under the GSK License Agreement, which include milestones and royalties based on future regulatory events, commercial launch, and achievement of pre-specified sales thresholds, are as follows (in millions):

Current wording

Remaining potential payments under the GSK License Agreement, which include milestones and royalties based on commercial launch and achievement of pre-specified sales thresholds, are as follows (in millions):

Previous wording

To date, we have not generated any revenue from product sales. If our development efforts for our current and 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 our product candidates. We may never succeed in obtaining regulatory approval for any of our product candidates.

Current wording

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

Previous wording

We expect a portion of our revenue for the next few years will continue to be derived from payments under our active government awards and any awards that we may receive in the future.

Current wording

A portion of our revenue may be derived from payments under any government awards that we may receive in the future.

Previous wording

Research and development expenses consist primarily of costs incurred for our research activities, including the development of our product candidates, and are comprised of:

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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 of our product candidates. The successful development and commercialization of our product candidates is highly uncertain. This is due to the numerous risks and uncertainties, including the following:

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

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

Current wording

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

Previous wording

General and administrative expenses consist primarily of salaries and related costs, including stock-based compensation, for personnel in executive, finance and administrative functions. General and administrative expenses also include direct and allocated facility-related costs as well as professional fees for legal, patent, consulting, investor and public relations, accounting and audit services. We also anticipate that we will continue to incur accounting, audit, legal, regulatory, compliance, infrastructure and director and officer insurance costs, as well as investor and public relations expenses associated with our continued operation as a public company.

Current wording

General and administrative expenses consist primarily of salaries and related costs, including share-based compensation, for personnel in executive, finance and administrative functions. General and administrative expenses also include direct and allocated facility-related costs as well as professional fees for legal, patent, consulting, investor and public relations, accounting and audit services. We anticipate that we will continue to incur accounting, audit, legal, regulatory, compliance, infrastructure and director and officer insurance costs, as well as investor and public relations expenses associated with our continued operation as a public company.

Previous wording

Interest income (expense) during the three and nine months ended September 30, 2025 and 2024 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.

Current wording

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.

Previous wording

Our consolidated financial statements are prepared in accordance with GAAP. The preparation of our consolidated financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities, revenue, costs and expenses, and related disclosures. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

Current wording

Our consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). The preparation of our consolidated financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities, revenue, costs and expenses, and related disclosures. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

Previous wording

Our critical accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements. We have made no changes to our existing critical accounting policies described in our Annual Report on Form 10-K for the year ended December 31, 2024.

Current wording

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

Previous wording

The following tables summarize our results of operations for the three months ended September 30, 2025 and 2024 (in thousands):

Current wording

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

Previous wording

Grant revenue recognized during the three months ended September 30, 2025 and 2024 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 September 30, 2025 was primarily due to a decrease of $3.2 million under our BARDA contract for tebipenem HBr, and a decrease of $0.1 million under our NIAID agreement relating to SPR206.

Current wording

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.

Previous wording

During the three months ended September 30, 2025, we recognized $3.0 million in collaboration revenue related to our agreement with GSK and no revenue related to our agreement with Pfizer. During the three months ended September 30, 2024, we recognized $7.8 million in collaboration revenue related to our agreement with GSK and $0.1 million in collaboration revenue related to our agreement with Pfizer. The decrease in revenue under the GSK License Agreement was directly related to the adjusted service period due to the pivotal Phase 3 PIVOT-PO trial stopping early for efficacy in the first half of 2025 following the pre-specified interim analysis.

Current wording

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.

Previous wording

Direct costs related to our tebipenem HBr program decreased by $13.1 million during the three months ended September 30, 2025, compared to the three months ended September 30, 2024, due to a decrease in clinical activities related to our pivotal Phase 3 PIVOT-PO trial, which met its primary endpoint and was stopped early for efficacy during the first half of 2025.

Current wording

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.

Previous wording

Direct costs related to our SPR720 program decreased by $3.7 million during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024, due to decreased clinical activity during the period related to our Phase 2a clinical trial of SPR720. Subsequently, in November 2025, we announced that we ceased development of SPR720.

Current wording

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.

Previous wording

Direct costs related to our SPR206 program decreased by $0.2 million during the three months ended September 30, 2025, primarily due to decreased preclinical activity. In March 2025, following a reprioritization of our programs, we announced that we ceased development of SPR206.

Current wording

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.

Previous wording

The decrease in professional and consultant fees of $0.2 million was primarily due to a decrease in legal and consulting expenses incurred in the three months ended September 30, 2025.

Current wording

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.

Previous wording

Other income (expense), net was $0.5 million for the three months ended September 30, 2025, compared to $1.2 million for the three months ended September 30, 2024. Total other income for the three months ended September 30, 2025, included $0.5 million of interest income, of which $0.2 million related to the significant financing component recognized under the GSK License Agreement, offset by immaterial fluctuations in unrealized foreign currency. Total other income for the three months ended September 30, 2024, included $1.2 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.

Current wording

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.

Previous wording

Since our inception, we have incurred significant operating losses. We have recognized revenue to date from funding arrangements with the U.S. Department of Defense, NIAID, CARB-X and BARDA, the GSK License Agreement and our license agreements with Everest and Pfizer. We have not yet commercialized any product candidates and we may not generate revenue from sales of any product candidate. 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 September 30, 2025, we had cash and cash equivalents of $48.6 million.

Current wording

Since our inception, we have incurred significant operating losses. We have recognized revenue to date from funding arrangements with the U.S. 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.

Previous wording

The following table summarizes our sources and uses of cash for the nine months ended September 30, 2025 and 2024 (in thousands):

Current wording

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

Previous wording

Net cash used in operating activities for the nine months ended September 30, 2025, was $4.3 million, primarily resulting from our net loss of $22.9 million, adjusted for an increase to non-cash items of $4.7 million (primarily stock-based compensation). Net cash provided by changes in our operating assets and liabilities was $13.9 million and consisted primarily of a $48.5 million decrease in the collaboration receivable-related party, due to the receipt of the third and fourth installment payments from GSK (see Note 11), a $20.0 million decrease in deferred revenue, a $9.9 million decrease in accrued expenses, a $5.9 million decrease in accounts payable, a $0.7 million increase in prepaid expenses and other assets, a $1.5 million net increase in other receivables, and a $0.9 million decrease in operating lease liability and other liabilities.

Current wording

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.

Previous wording

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 programs and the timing of vendor invoicing and payments. Changes in deferred revenue are primarily related to the GSK License Agreement and our license agreement with Pfizer. Changes in collaboration receivable related to the GSK License Agreement.

Current wording

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. Changes in deferred revenue are related to the GSK License Agreement. Changes in collaboration receivable - related party are related to the GSK License Agreement.

Previous wording

We did not undertake any investing activities during the nine months ended September 30, 2025 or 2024.

Current wording

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

Previous wording

We did not undertake any financing activities during the nine months ended September 30, 2025 or 2024.

Current wording

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

Previous wording

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

Current wording

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;

Previous wording

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

Current wording

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

Previous wording

the number and characteristics of product candidates that we pursue;

Current wording

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

Previous wording

the costs of commercialization activities for our product candidates if we receive marketing approval, including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities;

Current wording

the costs of commercialization activities for our future product candidates if we receive marketing approval, including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities;

Previous wording

As of September 30, 2025, we had cash and cash equivalents of $48.6 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 such cash and cash equivalents as of September 30, 2025 and the decrease in clinical expense as a result of the completion of the PIVOT-PO Phase 3 trial for tebipenem HBr and the decision to cease development of SPR720, we believe that our cash runway will 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.

Current wording

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

Previous wording

This timeline is subject to uncertainty as to the timing of future expenditures. 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. 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.

Current wording

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