11/13/2025 | Press release | Distributed by Public on 11/13/2025 15:11
Management's Discussion and Analysis ofFinancial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with the unaudited financial information and the notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q, and the audited financial information and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2024. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. 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.
Overview
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.
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.
In March 2025, following a reprioritization of our programs, we announced that we were no longer pursuing a Phase 2 clinical trial for SPR206 and we have now ceased further development of the program. Additionally, in November 2025, we announced that we ceased development of SPR720, a product candidate for first-line treatment of NTM-PD. Following the termination of our earlier stage programs, we remain focused on completing our obligations under the GSK License Agreement and other corporate activities.
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.
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.
Because of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
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, 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.
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.
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):
|
Contingent Event |
Milestone Payment |
|||||||
|
Tebipenem NDA Submission by GSK |
$ |
25.0 |
||||||
|
Total potential commercial milestones based on first commercial sales |
$ |
101.0 |
* |
|||||
|
First commercial sale of a product in the United States |
- |
$ |
51.0 |
|||||
|
Second anniversary of first commercial sale of a product in the United States |
- |
$ |
25.0 |
|||||
|
First commercial sale of a product in two European countries |
- |
$ |
25.0 |
|||||
|
Total potential sales milestone payments |
$ |
225.0 |
||||||
|
Net annual sales greater than $200.0 |
- |
$ |
25.0 |
|||||
|
Net annual sales greater than $300.0 |
- |
$ |
25.0 |
|||||
|
Net annual sales greater than $400.0 |
- |
$ |
25.0 |
|||||
|
Net annual sales greater than $500.0 |
- |
$ |
50.0 |
|||||
|
Net annual sales greater than $750.0 |
- |
$ |
50.0 |
|||||
|
Net annual sales greater than $1,000.0 |
- |
$ |
50.0 |
|||||
*Under the terms of the GSK License Agreement, the maximum potential milestone amount was revised from $150.0 million after PIVOT-PO was stopped early for efficacy following completion of a pre-specified interim analysis of data from 1,690 patients enrolled in the trial, thereby reducing the overall cost of the trial to us; the maximum potential milestone payment of $150.0 million was contingent upon the trial continuing to full enrollment, with 2,637 patients enrolled in the trial.
In addition to the milestones described above, GSK is obligated to pay royalties to us on annual net sales of GSK Licensed Products in the GSK Territory. 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.
SPR206
In March 2025, following a reprioritization of our programs, we announced that we were no longer pursuing a Phase 2 clinical trial for SPR206 and had ceased further development of the program. On April 4, 2025, the National Institute of Allergy and Infectious Diseases ("NIAID") informed us that it was canceling the five-year contract, awarded in May 2021, under the Agency's Omnibus Broad Agency Announcement No. HHS-NIH-NIAID-BAA2020-1 award mechanism to support further development of SPR206, effective immediately, for its convenience.
SPR720
In November 2025, we announced that we have ceased development of SPR720.
Components of Our Results of Operations
Sales Revenue
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.
Grant Revenue
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.
Collaboration Revenue
Collaboration revenue relates to our agreements with Pfizer and GSK.
Operating Expenses
Research and Development Expenses
Research and development expenses consist primarily of costs incurred for our research activities, including the development of our product candidates, and are comprised of:
We expense research and development costs as incurred. Nonrefundable advance payments we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.
Our direct research and development expenses are tracked on a program-by-program basis and consist primarily of external costs, such as fees paid to consultants, contractors, CMOs and CROs in connection with our preclinical and clinical development activities. License fees and other costs incurred after a product candidate has been designated and that are directly related to the product candidate are included in direct research and development expenses for that program. License fees and other costs incurred prior to designating a product candidate are included in early-stage research programs. We do not allocate employee costs, costs associated with our preclinical programs or facility expenses, including depreciation or other indirect costs, to specific product development programs because these costs are deployed across multiple product development programs and, as such, are not separately classified.
Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.
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:
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.
General and Administrative Expenses
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.
Impairment Charges
During the third quarter of 2025, we evaluated our real estate lease in light of our new sublease agreements. As a result of the evaluation, we recorded an impairment charge of $0.6 million associated with the right-of-use asset in the third quarter of 2025.
Restructuring
In October 2024, we implemented a strategic restructuring initiative and corresponding reduction in workforce. We restructured our operations to reduce costs and reallocate resources in support of the development of tebipenem HBr and other corporate activities. As of September 30, 2025, we had recognized $1.1 million in expense related to the October 2024 restructuring and do not expect to incur any further charges related to this restructuring.
Other Income (Expense)
Interest Income (Expense)
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.
Other Income (Expense), Net
Other income (expense), net, consists of insignificant amounts of miscellaneous income, as well as realized and unrealized gains and losses from foreign currency-denominated cash balances and vendor payables.
Critical Accounting Policies and Significant Judgments and Estimates
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.
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.
Results of Operations
Comparison of the Three Months Ended September 30, 2025 and 2024
The following tables summarize our results of operations for the three months ended September 30, 2025 and 2024 (in thousands):
|
Three Months Ended September 30, |
||||||||||||
|
2025 |
2024 |
$ Change |
||||||||||
|
Revenues: |
||||||||||||
|
Grant revenue |
$ |
2,394 |
$ |
5,650 |
$ |
(3,256 |
) |
|||||
|
Collaboration revenue - related party |
3,048 |
7,754 |
(4,706 |
) |
||||||||
|
Collaboration revenue |
- |
65 |
(65 |
) |
||||||||
|
Total revenues |
5,442 |
13,469 |
(8,027 |
) |
||||||||
|
Operating expenses: |
||||||||||||
|
Research and development |
8,597 |
26,864 |
(18,267 |
) |
||||||||
|
General and administrative |
4,174 |
5,198 |
(1,024 |
) |
||||||||
|
Impairment charges |
587 |
- |
587 |
|||||||||
|
Total operating expenses |
13,358 |
32,062 |
(18,704 |
) |
||||||||
|
Loss from operations |
(7,916 |
) |
(18,593 |
) |
10,677 |
|||||||
|
Other income (expense): |
||||||||||||
|
Interest income |
532 |
1,182 |
(650 |
) |
||||||||
|
Other income (expense), net |
2 |
(26 |
) |
28 |
||||||||
|
Total other income (expense), net |
534 |
1,156 |
(622 |
) |
||||||||
|
Net loss before income taxes |
(7,382 |
) |
(17,437 |
) |
10,055 |
|||||||
|
Income tax benefit |
- |
290 |
(290 |
) |
||||||||
|
Net loss |
$ |
(7,382 |
) |
$ |
(17,147 |
) |
$ |
9,765 |
||||
Grant Revenue
|
Three Months Ended September 30, |
||||||||||||
|
2025 |
2024 |
$ Change |
||||||||||
|
BARDA Contract (Tebipenem HBr) |
$ |
2,394 |
$ |
5,567 |
$ |
(3,173 |
) |
|||||
|
NIAID Contract (SPR206) |
- |
83 |
(83 |
) |
||||||||
|
Total grant revenue |
$ |
2,394 |
$ |
5,650 |
$ |
(3,256 |
) |
|||||
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.
Collaboration Revenue
|
Three Months Ended September 30, |
||||||||||||
|
2025 |
2024 |
$ Change |
||||||||||
|
GSK (Tebipenem HBr) |
$ |
3,048 |
$ |
7,754 |
$ |
(4,706 |
) |
|||||
|
Pfizer (SPR206) |
- |
65 |
(65 |
) |
||||||||
|
Total collaboration revenue |
$ |
3,048 |
$ |
7,819 |
$ |
(4,771 |
) |
|||||
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.
Research and Development Expenses
|
Three Months Ended September 30, |
||||||||||||
|
2025 |
2024 |
$ Change |
||||||||||
|
Direct research and development expenses by program: |
||||||||||||
|
Tebipenem HBr |
$ |
4,959 |
$ |
18,020 |
$ |
(13,061 |
) |
|||||
|
SPR720 |
178 |
3,879 |
(3,701 |
) |
||||||||
|
SPR206 |
- |
157 |
(157 |
) |
||||||||
|
Unallocated expenses: |
||||||||||||
|
Personnel related (including stock-based compensation) |
2,244 |
3,836 |
(1,592 |
) |
||||||||
|
Facility related and other |
1,216 |
972 |
244 |
|||||||||
|
Total research and development expenses |
$ |
8,597 |
$ |
26,864 |
$ |
(18,267 |
) |
|||||
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.
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.
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.
The decrease in personnel-related costs of $1.6 million was primarily a result of reduced headcount costs as a result of the restructuring in the fourth quarter of 2024. Personnel-related costs for the three months ended September 30, 2025 and 2024 included stock-based compensation expense of $0.4 million and $0.7 million, respectively.
Facility-related and other costs primarily reflect costs related to supporting our research and development staff.
General and Administrative Expenses
|
Three Months Ended September 30, |
||||||||||||
|
2025 |
2024 |
$ Change |
||||||||||
|
Personnel related (including stock-based compensation) |
$ |
2,352 |
$ |
3,273 |
$ |
(921 |
) |
|||||
|
Professional and consultant fees |
1,185 |
1,374 |
(189 |
) |
||||||||
|
Facility related and other |
637 |
551 |
86 |
|||||||||
|
Total general and administrative expenses |
$ |
4,174 |
$ |
5,198 |
$ |
(1,024 |
) |
|||||
The decrease in personnel-related costs of $0.9 million was primarily a result of reduced headcount costs as a result of the restructuring in the fourth quarter of 2024. Personnel-related costs for the three months ended September 30, 2025 and 2024 included stock-based compensation expense of $0.7 million and $1.5 million, respectively.
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.
Facility-related and other costs primarily reflect costs related to supporting our general and administrative staff.
Impairment Charges
Impairment charges related to our right of use asset were $0.6 million for the three months ended September 30, 2025, compared to no charges for the three months ended September 30, 2024.
Other Income (Expense), Net
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.
Comparison of the Nine Months Ended September 30, 2025 and 2024
The following tables summarize our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands):
|
Nine Months Ended September 30, |
||||||||||||
|
2025 |
2024 |
$ Change |
||||||||||
|
Revenues: |
||||||||||||
|
Grant revenue |
$ |
5,544 |
$ |
14,893 |
$ |
(9,349 |
) |
|||||
|
Collaboration revenue - related party |
19,949 |
17,721 |
2,228 |
|||||||||
|
Collaboration revenue |
12 |
319 |
(307 |
) |
||||||||
|
Total revenues |
25,505 |
32,933 |
(7,428 |
) |
||||||||
|
Operating expenses: |
||||||||||||
|
Research and development |
32,875 |
67,921 |
(35,046 |
) |
||||||||
|
General and administrative |
16,876 |
16,648 |
228 |
|||||||||
|
Impairment charges |
587 |
- |
587 |
|||||||||
|
Restructuring |
258 |
- |
258 |
|||||||||
|
Total operating expenses |
50,596 |
84,569 |
(33,973 |
) |
||||||||
|
Loss from operations |
(25,091 |
) |
(51,636 |
) |
26,545 |
|||||||
|
Other income (expense): |
||||||||||||
|
Interest income |
2,136 |
3,707 |
(1,571 |
) |
||||||||
|
Other income (expense), net |
7 |
(39 |
) |
46 |
||||||||
|
Total other income, net |
2,143 |
3,668 |
(1,525 |
) |
||||||||
|
Net loss before income taxes |
(22,948 |
) |
(47,968 |
) |
25,020 |
|||||||
|
Income tax benefit |
- |
290 |
(290 |
) |
||||||||
|
Net loss |
$ |
(22,948 |
) |
$ |
(47,678 |
) |
$ |
24,730 |
||||
Grant Revenue
|
Nine Months Ended September 30, |
||||||||||||
|
2025 |
2024 |
$ Change |
||||||||||
|
BARDA Contract (Tebipenem HBr) |
$ |
5,515 |
$ |
14,577 |
$ |
(9,062 |
) |
|||||
|
NIAID Contract (SPR206) |
29 |
316 |
(287 |
) |
||||||||
|
Total grant revenue |
$ |
5,544 |
$ |
14,893 |
$ |
(9,349 |
) |
|||||
Grant revenue recognized during the nine 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 nine months ended September 30, 2025 was primarily due to a decrease of $9.1 million under our BARDA contract for tebipenem HBr, and a decrease of $0.3 million under our NIAID agreement relating to SPR206.
Collaboration Revenue
|
Nine Months Ended September 30, |
||||||||||||
|
2025 |
2024 |
$ Change |
||||||||||
|
GSK (Tebipenem HBr) |
$ |
19,949 |
$ |
17,721 |
$ |
2,228 |
||||||
|
Pfizer (SPR206) |
12 |
319 |
(307 |
) |
||||||||
|
Total collaboration revenue |
$ |
19,961 |
$ |
18,040 |
$ |
1,921 |
||||||
During the nine months ended September 30, 2025, we recognized $19.9 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. During the nine months ended September 30, 2024, we recognized $17.7 million in collaboration revenue related to our agreement with GSK and $0.3 million in collaboration revenue related to our agreement with Pfizer. The increase 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.
Research and Development Expenses
|
Nine Months Ended September 30, |
||||||||||||
|
2025 |
2024 |
$ Change |
||||||||||
|
Direct research and development expenses by program: |
||||||||||||
|
Tebipenem HBr |
$ |
20,321 |
$ |
39,937 |
$ |
(19,616 |
) |
|||||
|
SPR720 |
975 |
13,087 |
(12,112 |
) |
||||||||
|
SPR206 |
49 |
503 |
(454 |
) |
||||||||
|
Unallocated expenses: |
||||||||||||
|
Personnel related (including stock-based compensation) |
8,192 |
10,768 |
(2,576 |
) |
||||||||
|
Facility related and other |
3,338 |
3,626 |
(288 |
) |
||||||||
|
Total research and development expenses |
$ |
32,875 |
$ |
67,921 |
$ |
(35,046 |
) |
|||||
Direct costs related to our tebipenem HBr program decreased by $19.6 million during the nine months ended September 30, 2025, compared to the nine 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.
Direct costs related to our SPR720 program decreased by $12.1 million during the nine months ended September 30, 2025, as compared to the nine 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.
Direct costs related to our SPR206 program decreased by $0.5 million during the nine 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.
The decrease in personnel-related costs of $2.6 million was primarily a result of reduced headcount costs as a result of the restructuring in the fourth quarter of 2024. Personnel-related costs for the nine months ended September 30, 2025 and 2024 included stock-based compensation expense of $1.3 million and $2.1 million, respectively.
Facility-related and other costs primarily reflect costs related to supporting our research and development staff.
General and Administrative Expenses
|
Nine Months Ended September 30, |
||||||||||||
|
2025 |
2024 |
$ Change |
||||||||||
|
Personnel related (including stock-based compensation) |
$ |
9,838 |
$ |
9,781 |
$ |
57 |
||||||
|
Professional and consultant fees |
5,433 |
5,183 |
250 |
|||||||||
|
Facility related and other |
1,605 |
1,684 |
(79 |
) |
||||||||
|
Total general and administrative expenses |
$ |
16,876 |
$ |
16,648 |
$ |
228 |
||||||
The increase in personnel-related costs of $0.1 million was primarily a result of retention bonus and executive severance expense in our general and administrative functions during the period offsetting reduced headcount costs as a result of the restructuring in the fourth quarter of 2024. Personnel-related costs for the nine months ended September 30, 2025 and 2024 included stock-based compensation expense of $2.0 million and $4.2 million, respectively.
The increase in professional and consultant fees of $0.3 million was primarily due to an increase in legal and consulting expenses incurred in the nine months ended September 30, 2025.
Facility-related and other costs primarily reflect costs related to supporting our general and administrative staff.
Impairment Charges
Impairment charges related to our right of use asset were $0.6 million for the nine months ended September 30, 2025, compared to no charges for the nine months ended September 30, 2024.
Other Income (Expense), Net
Total other income (expense), net was $2.1 million for the nine months ended September 30, 2025, compared to $3.7 million for the nine months ended September 30, 2024. Total other income for the nine months ended September 30, 2025, included $2.1 million of interest income, of which $0.9 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 nine months ended September 30, 2024, included $3.7 million of interest income, of which $1.2 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
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.
We filed the 2024 Form S-3 on March 15, 2024, which became effective on March 22, 2024, and pursuant to which we registered for sale up to $300.0 million of any combination of our common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that we may determine, including up to $75.0 million of our common stock available for issuance pursuant to the Sales Agreement with Cantor. Under the Sales Agreement, Cantor may sell shares of our common stock by any method permitted by law deemed to be an "at-the-market" offering as defined in Rule 415 of the Securities Act, subject to the terms of the Sales Agreement.
During the three and nine months ended September 30, 2025, we did not sell any shares of our common stock under the Sales Agreement.
Cash Flows
The following table summarizes our sources and uses of cash for the nine months ended September 30, 2025 and 2024 (in thousands):
|
Nine Months Ended September 30, |
||||||||
|
2025 |
2024 |
|||||||
|
Cash used in operating activities |
$ |
(4,273 |
) |
$ |
(43 |
) |
||
|
Net decrease in cash and cash equivalents |
$ |
(4,273 |
) |
$ |
(43 |
) |
||
Operating Activities
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.
Net cash used in operating activities for the nine months ended September 30, 2024, was less than $0.1 million, primarily resulting from our net loss of $47.7 million, adjusted for an increase to non-cash items of $7.1 million (primarily stock-based compensation). Net cash provided by changes in our operating assets and liabilities was $40.6 million and consisted primarily of a
$45.2 million decrease in our related party collaboration receivable, due to the receipt of the first and second installment payments from GSK (see Note 11), a $18.0 million decrease in deferred revenue, a $1.2 million net increase in receivables, a $4.7 million increase in accounts payable, a $2.4 million increase in prepaid expenses and other assets, an increase of $8.8 million in accrued expenses, and a $1.3 million decrease in operating lease liability and other liabilities.
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.
Investing Activities
We did not undertake any investing activities during the nine months ended September 30, 2025 or 2024.
Financing Activities
We did not undertake any financing activities during the nine months ended September 30, 2025 or 2024.
Funding Requirements
Our future use of operating cash and capital requirements, and the timing and amount thereof, will depend largely on:
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.
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.
We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical product candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increase significantly as a result of many factors, including those listed above.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through a combination of equity offerings, debt financings, government funding, collaborations, strategic alliances and marketing, distribution or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, our stockholders' ownership interests will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. 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, research programs or product candidates or grant licenses on terms that may not be favorable to us. If our access to capital is restricted or associated borrowing costs increase as a result of developments in financial markets, our operations and financial condition could be adversely impacted. If we are unable to raise additional funds through equity or debt financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Contractual Obligations and Commitments
During the three and nine months ended September 30, 2025, there have been no material changes to our contractual obligations and commitments 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, 2024.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
Recently Issued and Adopted Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.