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Compass Therapeutics, Inc.

For the period ended Sep 30, 2026. Filed Nov 9, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2026 · Filed Nov 9, 2026

CMPX$0.84+10.3%Stored close · as of Nov 9, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-06-30; filed 2026-08-06.

0001171843-26-005295

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-09.

0001171843-26-007258

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 74 previous paragraphs and 70 current paragraphs.

45 unchanged; 22 reworded; 3 added; 6 removed; 1 previous and 0 current paragraphs rearranged.

Tables are not compared: 39 previous and 35 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (3)

Current report

In September 2026, we announced receipt of written communication from the FDA in which they recommended that we conduct a trial to demonstrate a survival benefit prior to submitting a BLA for tovecimig. We do not believe a new trial is warranted prior to submitting a BLA based on the data from the Phase 2/3 COMPANION-002 study and the urgent unmet medical need for patients with BTC. As a result, we intend to further engage with the FDA, as we continue to prepare a BLA submission for tovecimig.

Current report

Data demonstrating a novel mechanism of action for CTX-10726 was presented at the SITC 2026 Annual Meeting, highlighting its differentiated profile in the field. In preclinical studies, CTX-10726 was shown to cleave PD-1 receptors from t-cells in tumors expressing high levels of VEGF-A, linking tumor angiogenic signaling directly to checkpoint control. This VEGF-A-mediated effect was seen in vitro and in vivo with CTX-10726, and not seen with pembrolizumab or bevacizumab.

Current report

Comparison of the Nine Months Ended September 30, 2026 and 2025
Removed paragraphs (6)

Previous report

In April 2026, we announced survival and safety data from our Phase 2/3 randomized trial of tovecimig in combination with paclitaxel in patients with biliary tract cancer (“BTC”) treated in the second-line setting. We expect feedback from the FDA in the third quarter regarding the COMPANION-002 Phase 2/3 data, prior to a potential BLA filing later this year.

Previous report

CTX-8371 (PD-1 x PD-L1 bispecific) Phase 1 Expansion Cohorts Enrolling

Previous report

Phase 1 cohort expansions are actively enrolling patients with triple-negative breast cancer (“TNBC”), Hodgkin lymphoma (“HL”) and non-small cell lung cancer (“NSCLC”) at two dose levels: 3.0 mg/kg and 10.0 mg/kg. The evaluation of an RP2D for further development. Additional data from the cohort expansions are expected in the fourth quarter of 2026.

Previous report

At the ASCO Annual Meeting in May 2026, we presented data from the dose-escalation portion of this Phase 1, open-label, first-in-human study evaluating CTX-8371 in patients with metastatic or locally advanced malignancies.

Previous report

The first patients have been dosed in the Phase 1 dose-escalation study of CTX-10726 with locally advanced, unresectable or metastatic renal cell carcinoma, gastroesophageal cancer, hepatocellular carcinoma, or endometrial cancer, in whom standard of care therapies have failed. Clinical data from the dose-escalation cohort is expected in the fourth quarter of 2026.
Reworded paragraphs (22)

Previous wording

The following discussion of the financial condition and results of operations of Compass Therapeutics, Inc. should be read in conjunction with the financial statements and the notes to those statements included in this Quarterly Report on Form 10-Q for the three and six months ended June 30, 2026. Some of the information contained in this discussion and analysis, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risk, uncertainties and assumptions. You should read the“Risk Factors”* section of this Quarterly Report on Form 10-Q and the*“Risk Factors”* section included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025**, for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.*

Current wording

The following discussion of the financial condition and results of operations of Compass Therapeutics, Inc. should be read in conjunction with the financial statements and the notes to those statements included in this Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2026. Some of the information contained in this discussion and analysis, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risk, uncertainties and assumptions. You should read the“Risk Factors”* section of this Quarterly Report on Form 10-Q and the*“Risk Factors”* section included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.*

Previous wording

Tovecimig Results in COMPANION-002 Phase 2/3 Study in the Second Line Setting for Patients with BTC

Current wording

Updates on Tovecimig in the Second Line Setting for Patients with BTC

Previous wording

The study met the primary endpoint of overall response rate (“ORR”) with 18.0% in the tovecimig combination arm compared to 5.3% in the paclitaxel control arm, including one complete response in the tovecimig arm. In the final data analysis, the ORR improved to 18.0% (20/111 patients) in the tovecimig combination arm from a previously reported 17.1%. One patient initially characterized as “Non-CR / Non-PD” due to target lesion characteristics was ultimately adjudicated by blinded independent central review to be a partial response. With this change, the p-value also improved to 0.0228 compared to paclitaxel alone (vs previously reported p=0.031). The tovecimig combination arm also demonstrated a highly statistically significant improvement versus paclitaxel alone in the secondary endpoint of median progression-free survival (PFS) of 4.7 months versus 2.6 months, providing a 56% reduction in the risk of progression (hazard ratio=0.44, p<0.0001). Secondary endpoint analyses of overall survival (OS) were confounded by both high crossover (54%) and notably prolonged survival in crossover patients randomized to the control arm then treated with tovecimig and, therefore, did not meet statistical significance.

Current wording

The study met the primary endpoint of overall response rate (“ORR”) with 18.0% in the tovecimig combination arm compared to 5.3% in the paclitaxel control arm (p=0.0228), including one complete response in the tovecimig arm. The tovecimig combination arm also demonstrated a statistically significant improvement versus paclitaxel alone in the secondary endpoint of median progression-free survival of 4.7 months versus 2.6 months, providing a 56% reduction in the risk of progression (hazard ratio=0.44, p<0.0001). Secondary endpoint analyses of overall survival (OS) were confounded by both high crossover (54%) and notably prolonged survival in crossover patients randomized to the control arm then treated with tovecimig and, therefore, did not meet statistical significance.

Previous wording

In July 2026, we announced data from this study has been selected for a proffered paper oral presentation at the 2026 ESMO Congress.

Current wording

Data from the COMPANION-002 study was the subject of a proffered paper oral presentation at the 2026 ESMO Congress in October 2026 and were also published in the Journal of Clinical Oncology, following independent peer review.

Previous wording

Two additional ISTs have been initiated, including a study of tovecimig plus FOLFIRI in patients with colorectal cancer in the second line setting (NCT07662031) and a study of tovecimig plus CTX-471 in patients with glioblastoma in the second line setting (NCT07392957). We are evaluating additional studies for tovecimig in other indications, including both ISTs and Company-sponsored studies.

Current wording

There are currently three ongoing investigator sponsored trials (“ISTs”) of tovecimig: a study of tovecimig in combination with the current first-line, standard-of-care regimen of gemcitabine, cisplatin, and durvalumab in patients with BTC (NCT06548412);a study of tovecimig plus CTX-471 in patients with glioblastoma in the second line setting (NCT07392957); and a study of tovecimig plus FOLFIRI in patients with colorectal cancer in the second line setting (NCT07662031).

Previous wording

CTX-10726 (PD-1 x VEGF-A bispecific) Phase 1 Dose-Escalation Study Enrolling

Previous wording

We have incurred significant operating losses since inception and have not generated any revenue from the sale of products and we do not expect to generate any revenue from the sale of products in the near future, if at all. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of our therapies and any future product candidates. Our net losses were $25.2 million and $19.9 million for the three months ended June 30, 2026 and 2025, respectively. Our net losses were $43.5 million and $36.5 million for the six months ended June 30, 2026 and 2025, respectively. We had an accumulated deficit of $475 million on June 30, 2026. We expect to continue to incur significant expenses for at least the next several years as we advance through clinical development, develop additional product candidates and seek regulatory approval of any product candidates that complete clinical development. In addition, if we obtain marketing approval for any product candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. We may also incur expenses in connection with the in-licensing or acquisition of additional product candidates.

Current wording

We have incurred significant operating losses since inception and have not generated any revenue from the sale of products and we do not expect to generate any revenue from the sale of products in the near future, if at all. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of our therapies and any future product candidates. Our net losses were $27.2 million and $14.3 million for the three months ended September 30, 2026 and 2025, respectively. Our net losses were $70.6 million and $50.8 million for the nine months ended September 30, 2026 and 2025, respectively. We had an accumulated deficit of $502 million on September 30, 2026. We expect to continue to incur significant expenses for at least the next several years as we advance through clinical development, develop additional product candidates and seek regulatory approval of any product candidates that complete clinical development. In addition, if we obtain marketing approval for any product candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution. We may also incur expenses in connection with the in-licensing or acquisition of additional product candidates.

Previous wording

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through equity and debt financings, or other capital sources, which may include collaborations with other companies or other strategic transactions. As of June 30, 2026, we had $180 million in cash, cash equivalents and marketable securities. We expect that such cash resources will enable us to fund our operating expenses and capital expenditure requirements into 2028. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, reduce or eliminate the development and commercialization of one or more of our product candidates or delay our pursuit of potential in-licenses or acquisitions.

Current wording

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through equity and debt financings, or other capital sources, which may include collaborations with other companies or other strategic transactions. As of September 30, 2026, we had $163 million in cash, cash equivalents and marketable securities. We expect that such cash resources will enable us to fund our operating expenses and capital expenditure requirements into 2028. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as and when needed, we may have to significantly delay, reduce or eliminate the development and commercialization of one or more of our product candidates or delay our pursuit of potential in-licenses or acquisitions.

Previous wording

In the first six months of 2026, there were no issuances of common stock through our Open Market Sale Agreement SM with Jefferies LLC (“Jefferies ATM Agreement”). In December 2025, we entered into a Sales Agreement for our ATM offering with Leerink Partners LLC and Cantor Fitzgerald & Co. (the “2026 ATM Agreement”), and the prior Jefferies ATM Agreement was terminated. In the first six months of 2026, we did not sell any shares of common stock under the 2026 ATM Agreement.

Current wording

In December 2025, we entered into a Sales Agreement for our ATM offering with Leerink Partners LLC and Cantor Fitzgerald & Co. In the first nine months of 2026, we did not sell any shares of common stock under this agreement.

Previous wording

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. We expect that our research and development expenses will increase substantially in connection with our planned clinical development activities in the future. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the clinical development of any future product candidates.

Current wording

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. We expect that our research and development expenses may increase substantially in connection with our planned clinical development activities in the future. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the clinical development of any future product candidates.

Previous wording

We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our business operations.

Current wording

We anticipate that our general and administrative expenses may increase in the future to support our business operations.

Previous wording

Research and development expenses increased by $3.2 million, or 19%, for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. The increase was primarily driven by $2.6 million related to non-personnel project expenses for tovecimig.

Current wording

Research and development expenses increased by $9.2 million, or 72%, for the three months ended September 30, 2026, as compared to the three months ended September 30, 2025. The increase was primarily driven by $8.6 million of manufacturing costs related to tovecimig.

Previous wording

General and administrative expenses increased by $2.8 million, or 59%, for the three months ended June 30, 2026 as compared to the same period in 2025. The increase was primarily due to an increase of $1.4 million of pre-commercialization expenses and an increase of $0.8 million of stock-based compensation expense.

Current wording

General and administrative expenses increased by $3.8 million, or 126%, for the three months ended September 30, 2026, as compared to the same period in 2025. The increase was primarily due to an increase of $1.8 million in stock-based compensation expense and $1.5 million of pre-commercialization expenses.

Previous wording

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

Current wording

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

Previous wording

Research and development expenses increased by $3.5 million, or 12%, for the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. This was primarily driven by an increase of $2.5 million of stock-based compensation expense and $1.3 million of manufacturing expense.

Current wording

Research and development expenses increased by $12.7 million, or 30%, for the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025. This was primarily driven by an increase of $11.1 million of manufacturing expense related to tovecimig.

Previous wording

General and administrative expenses increased by $4.8 million, or 50%, for the six months ended June 30, 2026 as compared to the same period in 2025. This was primarily driven by an increase of $1.8 million of pre-commercialization expenses, an increase of $1.3 million of personnel expenses related to commercialization and an increase of $2.1 million of stock-based compensation expense.

Current wording

General and administrative expenses increased by $8.5 million, or 68%, for the nine months ended September 30, 2026, as compared to the same period in 2025. This was primarily driven by an increase of $3.8 million of stock-based compensation expense and $4.6 million of pre-commercialization expenses.

Previous wording

Since our inception, we have devoted substantially all of our efforts to organizing and staffing our Company, business planning, raising capital, research and development activities, building our intellectual property portfolio and providing general and administrative support for these operations. We have funded our operations primarily with proceeds from the sale of our equity securities. Through June 30, 2026, we have received $568 million in gross proceeds from the sale of equity securities. As of June 30, 2026, we had cash, cash equivalents and marketable securities of $180 million.

Current wording

Since our inception, we have devoted substantially all of our efforts to organizing and staffing our Company, business planning, raising capital, research and development activities, building our intellectual property portfolio and providing general and administrative support for these operations. We have funded our operations primarily with proceeds from the sale of our equity securities. Through September 30, 2026, we have received $568 million in gross proceeds from the sale of equity securities. As of September 30, 2026, we had cash, cash equivalents and marketable securities of $163 million.

Previous wording

During the six months ended June 30, 2026, we used $32.0 million of cash in operating activities, resulting from our net loss of $43.5 million, partially offset by the change in operating assets and liabilities of $1.2 million and non-cash charges of $10.2 million (primarily from share-based compensation expense of $9.9 million).

Current wording

During the nine months ended September 30, 2026, we used $48.3 million of cash in operating activities, resulting from our net loss of $70.6 million, partially offset by the change in operating assets and liabilities of $7.6 million and non-cash charges of $14.7 million (primarily from share-based compensation expense of $13.9 million).

Previous wording

During the six months ended June 30, 2025, we used $25.0 million of cash in operating activities, resulting from our net loss of $36.5, million partially offset by the change in operating assets and liabilities of $5.5 million and non-cash charges of $5.9 million (primarily from share-based compensation expense of $5.3 million).

Current wording

During the nine months ended September 30, 2025, we used $35.9 million of cash in operating activities, resulting from our net loss of $50.8 million partially offset by the change in operating assets and liabilities of $7.7 million and non-cash charges of $7.2 million (primarily from share-based compensation expense of $6.5 million).

Previous wording

During the six months ended June 30, 2026, $33.5 million of cash was provided by investing activities related to the net sales of marketable securities. During the six months ended June 30, 2025, $5.2 million of cash was provided by investing activities related to the net sale of marketable securities.

Current wording

During the nine months ended September 30, 2026, $55.8 million of cash was provided by investing activities related to the net sales of marketable securities. During the nine months ended September 30, 2025, $90.0 million of cash was used in investing activities related to the net purchases of marketable securities.

Previous wording

During the six months ended June 30, 2026, $3.9 million of cash was provided by financing activities due to the exercise of stock options, partially offset by $0.5 million of taxes paid by us for settlement of RSU shares. During the six months ended June 30, 2025, $0.8 million of cash was used in financing activities due to taxes paid by us for settlement of RSU shares.

Current wording

During the nine months ended September 30, 2026, $3.9 million of cash was provided by financing activities due to the exercise of stock options, partially offset by $0.5 million of taxes paid by us for settlement of RSU shares. During the nine months ended September 30, 2025, $128.5 million of cash was provided by financing activities due to the issuance of common shares.

Previous wording

During the six months ended June 30, 2026, there were no material changes to our critical accounting estimates described under "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in the Annual Report.

Current wording

During the nine months ended September 30, 2026, there were no material changes to our critical accounting estimates described under "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in the Annual Report.
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

The previously disclosed investigator sponsored trial (“IST”) of tovecimig in combination with the current first-line, standard-of-care regimen of gemcitabine, cisplatin, and durvalumab in patients with BTC (NCT06548412) is ongoing with expansion to additional sites expected.