Aprea Therapeutics, Inc.
For the period ended Sep 30, 2025. Filed Nov 12, 2025.
View on SEC.govAbout 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, 2025 · Filed Nov 12, 2025
APRE$0.52+4.5%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-12.
0001558370-25-011152
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001104659-25-109867
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe 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 88 previous paragraphs and 88 current paragraphs.
63 unchanged; 22 reworded; 3 added; 2 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 45 previous and 47 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
On October 15, 2025, we determined the recommended Phase 2 dose (RP2D) of 1,100 mg once daily for ATRN-119 in the monotherapy arm of the ongoing ABOYA-119 Phase 1/2a dose-escalation study, in patients with advanced solid tumors. Building on the completion of dose escalation and supported by new preclinical data suggesting potential synergistic anti-tumor effects, we are considering further ATRN-119 development in combination approaches that could expand its therapeutic potential. We believe ATRN-119's mechanism of action, favorable safety profile, and pharmacologic characteristics make it an ideal candidate for combination with other anti-cancer therapies, including radiation therapy, antibody-drug conjugates and immune checkpoint inhibitors. As part of this strategic focus, we voluntarily paused further enrollment in both once daily and twice daily monotherapy dosing arms of ABOYA-119.
Current report
We are currently in discussions with leading academic centers to explore combining ATRN-119 with radiation in patients with HPV+ head and neck cancer, an indication where synergistic anti-tumor effects have been observed in preclinical data. Additional investigator-led studies evaluating ATRN-119 in combination with an I/O agent and antibody-drug conjugates, are also being explored, based on preclinical evidence that ATR inhibition can enhance anti-tumor immune responses.
Current report
Comparison of the nine months ended September 30, 2025 and 2024
Removed paragraphs (2)
Previous report
Comparison of the six months ended June 30, 2025 and 2024
Previous report
The above increase was offset, in part by:
Reworded paragraphs (22)
Previous wording
We are targeting WEE1, a kinase that is a key regulator of multiple phases of the cell cycle. Our lead WEE1 inhibitor product candidate is APR-1051. In March 2024, the FDA cleared our IND application for APR-1051 and in the second quarter of 2024 we enrolled the first patient into ACESOT-1051, our Phase 1 dose escalation study. Given the encouraging tolerability profile to date, we are in a position to accelerate dose escalation and explore higher doses, potentially improving APR-1051 therapeutic impact. We anticipate open-label safety/efficacy data to be available in the second half of 2025 and expect to complete dose-escalation in the first half of 2026.
Current wording
We are targeting WEE1, a kinase that is a key regulator of multiple phases of the cell cycle. Our lead WEE1 inhibitor product candidate is APR-1051. In March 2024, the FDA cleared our IND application for APR-1051 and in the second quarter of 2024 we enrolled the first patient into ACESOT-1051, our Phase 1 dose escalation study. Given the encouraging tolerability profile to date, we are in a position to accelerate dose escalation and explore higher doses, potentially improving APR-1051 therapeutic impact. We anticipate open-label safety/efficacy data to be available in the first quarter of 2026 and expect to complete dose-escalation in the first half of 2026.
Previous wording
Our second clinical-stage synthetic lethality product candidate is ATRN-119, an oral small molecule inhibitor of ataxia telangiectasia and Rad3-related, or ATR. The ATR kinase is master regulator of the DNA damage response, with key roles in cell cycle control and DNA repair following replication stress. We have developed ATRN-119, the first oral macrocyclic ATR inhibitor to enter clinical trials. We are enrolling patients into ABOYA-119, a Phase 1/2a clinical trial to evaluate ATRN-119 under an IND application. Patients are currently being enrolled in once daily or twice daily dosing study arms, with encouraging progress toward characterizing ATRN-119 tolerability and pharmacokinetic profile on a continuous schedule. To further refine and optimize treatment strategies, future cohorts may also assess the potential benefits of intermittent dosing. We anticipate open-label safety/efficacy data to be available in the second half of 2025 and to determine the Recommended Phase 2 Dose (RP2D) in the first half of 2026.
Current wording
Our second clinical-stage synthetic lethality product candidate is ATRN-119, an oral small molecule inhibitor of ataxia telangiectasia and Rad3-related, or ATR. The ATR kinase is master regulator of the DNA damage response, with key roles in cell cycle control and DNA repair following replication stress.
Previous wording
In addition to development of these drugs as single agents, we are evaluating potential expansion opportunities for our product candidates through combination with other agents such as poly (ADP-ribose) polymerase inhibitors, or PARPi, where we believe a combination of therapeutic agents may enhance synthetic lethality. We are also evaluating combination opportunities within our pipeline, including research on the combination of ATRN-119 and APR-1051 that is supported by a Phase II SBIR grant from the National Cancer Institute.
Current wording
In addition to development of these drugs as single agents, we are evaluating potential expansion opportunities for our product candidates through combination with other agents such as poly (ADP-ribose) polymerase inhibitors, or PARPi, where we believe a combination of therapeutic agents may enhance synthetic lethality. We are also evaluating combination opportunities within our pipeline, including research on the combination of ATRN-119 and APR-1051 that is supported by a SBIR grant from the National Cancer Institute.
Previous wording
Research and development activities are central to our business model. 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 continue to increase for the foreseeable future as we initiate clinical trials for ATRN-119, APR-1051 and other product candidates and continue to discover and develop additional product candidates.
Current wording
Research and development activities are central to our business model. 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 continue to increase for the foreseeable future as we progress clinical trials for APR-1051 and ATRN-119, for which new patient enrollment is currently paused.
Previous wording
As part of the process of preparing our financial statements, we are required to estimate our accrued research and development expenses at each balance sheet date. This process involves reviewing open contract and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated costs incurred for the services when we have not yet been invoiced or otherwise notified of the actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-
Current wording
As part of the process of preparing our financial statements, we are required to estimate our accrued research and development expenses at each balance sheet date. This process involves reviewing open contract and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated costs incurred for the services when we have not yet been invoiced or otherwise notified of the actual costs. The majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met; however, some require advanced payments. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. Examples of estimated accrued research and development expenses include fees billed by:
Previous wording
Grant revenue primarily from the National Cancer Institute of the National Institutes of Health (“NIH”) for the three months ended June 30, 2025 and 2024 was approximately $0.1 million and $0.6 million, respectively. The decrease in grant revenue of $0.5 million is due to receiving less grant revenue from the NIH.
Current wording
Grant revenue primarily from the National Cancer Institute of the National Institutes of Health (“NIH”) for the three months ended September 30, 2025 and 2024 was $1,848 and $0.4 million, respectively. The decrease in grant revenue of $0.4 million is due to recognizing less grant revenue from the NIH.
Previous wording
Research and development expenses for the three months ended June 30, 2025 were approximately $1.9 million, compared to approximately $2.6 million for the three months ended June 30, 2024. The overall decrease of $0.6 million was primarily due to the following:
Current wording
Research and development expenses for the three months ended September 30, 2025 were approximately $1.6 million, compared to approximately $2.8 million for the three months ended September 30, 2024. The overall decrease of $1.2 million was primarily due to the following:
Previous wording
General and administrative expenses for the three months ended June 30, 2025 were approximately $1.6 million, compared to approximately $1.9 million for the three months ended June 30, 2024. The decrease was primarily due to a decrease of $0.1 million in professional fees primarily related to legal expenses and $0.1 million in personnel costs primarily due to severance expenses recorded in the second quarter of 2024.
Current wording
General and administrative expenses for the three months ended September 30, 2025 were approximately $1.5 million, compared to approximately $1.6 million for the three months ended September 30, 2024. The decrease was primarily due to a decrease of $0.1 million in insurance costs.
Previous wording
Foreign currency loss for the three months ended June 30, 2025 was $29,124 compared to a foreign currency loss of $5,502 for the three months ended June 30, 2024. The change in the foreign currency loss of $23,622 was primarily due to a weakening of the U.S. dollar against the Swedish Krona during the three months ended June 30, 2025 as compared to the three months ended June 30, 2024. Interest income, net for the three months ended June 30, 2025 and 2024 primarily consisted of interest income on our cash and cash equivalents.
Current wording
Foreign currency loss for the three months ended September 30, 2025 was $5,691 compared to a foreign currency loss of $35,494 for the three months ended September 30, 2024. The change in the foreign currency loss of $29,803 was primarily due to a strengthening of the U.S. dollar against the Swedish Krona during the three months ended September 30, 2025 as compared to the three months ended September 30, 2024. Interest income, net for the three months ended September 30, 2025 and 2024 primarily consisted of interest income on our cash and cash equivalents.
Previous wording
Grant revenue primarily from the National Cancer Institute of the National Institutes of Health (“NIH”) for the six months ended June 30, 2025 and 2024 was approximately $0.3 million and $0.9 million, respectively. The decrease in grant revenue of $0.6 million is due to receiving less grant revenue from the NIH.
Current wording
Grant revenue primarily from the National Cancer Institute of the National Institutes of Health (“NIH”) for the nine months ended September 30, 2025 and 2024 was approximately $0.3 million and $1.3 million, respectively. The decrease in grant revenue of $1.0 million is due to recognizing less grant revenue from the NIH.
Previous wording
Research and development expenses for the six months ended June 30, 2025 were approximately $4.4 million, compared to approximately $4.2 million for the six months ended June 30, 2024. The overall increase of $0.2 million was primarily due to the following:
Current wording
Research and development expenses for the nine months ended September 30, 2025 were approximately $6.0 million, compared to approximately $7.0 million for the nine months ended September 30, 2024. The overall decrease of $1.0 million was primarily due to the following:
Previous wording
General and administrative expenses for the six months ended June 30, 2025 were approximately $3.4 million, compared to approximately $3.8 million for the six months ended June 30, 2024. The decrease was primarily due to decreases of $0.3 million in professional fees primarily related to legal expenses and $0.1 million in insurance premiums.
Current wording
General and administrative expenses for the nine months ended September 30, 2025 were approximately $4.8 million, compared to approximately $5.4 million for the nine months ended September 30, 2024. The decrease was primarily due to decreases of $0.3 million in professional fees primarily related to legal expenses and $0.2 million in insurance premiums.
Previous wording
Foreign currency loss for the six months ended June 30, 2025 was $80,927 compared to a foreign currency gain of $50,674 for the six months ended June 30, 2024. The change in the foreign currency (loss) gain of $131,601 was primarily due to a weakening of the U.S. dollar against the Swedish Krona during the six months ended June 30, 2025 as compared to the six months ended June 30, 2024. Interest income, net for the six months ended June 30, 2025 and 2024 primarily consisted of interest income on our cash and cash equivalents.
Current wording
Foreign currency loss for the nine months ended September 30, 2025 was $86,618 compared to a foreign currency gain of $15,180 for the nine months ended September 30, 2024. The change in the foreign currency (loss) gain of $101,798 was primarily due to a weakening of the U.S. dollar against the Swedish Krona during the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024. Interest income, net for the nine months ended September 30, 2025 and 2024 primarily consisted of interest income on our cash and cash equivalents.
Previous wording
Since our inception, we have incurred significant losses on an aggregate basis. We have not yet commercialized any of our product candidates, which are in various phases of preclinical and clinical development, and we do not expect to generate revenue from sales of any products for several years, if at all. Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more of our product candidates. Since 2019, our primary source of funds has been from the public sales of our common stock. As of June 30, 2025, we had cash and cash equivalents of $16.5 million. We believe that our existing cash and cash equivalents will not enable us to fund our operating expenses and capital expenditure requirements through at least twelve months from the date of issuance of these condensed consolidated financial statements.
Current wording
Since our inception, we have incurred significant losses on an aggregate basis. We have not yet commercialized any of our product candidates, which are in various phases of preclinical and clinical development, and we do not expect to generate revenue from sales of any products for several years, if at all. Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more of our product candidates. Since 2019, our primary source of funds has been from the public sales of our common stock. As of September 30, 2025, we had cash and cash equivalents of $13.7 million. We believe that our existing cash and cash equivalents will not enable us to fund our operating expenses and capital expenditure requirements through at least twelve months from the date of issuance of these condensed consolidated financial statements.
Previous wording
Our net losses were $7.2 million and $6.3 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $328.2 million. These losses have resulted primarily from costs incurred in connection with research and development activities, patent investment, and general and administrative costs associated with our operations. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years.
Current wording
Our net losses were $10.1 million and $10.1 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $331.2 million. These losses have resulted primarily from costs incurred in connection with research and development activities, patent investment, and general and administrative costs associated with our operations. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years.
Previous wording
On November 8, 2024, we entered into an At the Market Offering Agreement, or the 2024 ATM Agreement, with H.C. Wainright & Co., LLC, or HCW. Pursuant to the 2024 ATM Agreement and the prospectus supplement filed in connection therewith, we may, from time to time, in our sole discretion, issue and sell through HCW, acting as sales agent and/or principal, up to $3.0 million of shares of our common stock. During the three months ended June 30, 2025,
Current wording
On November 8, 2024, we entered into an At the Market Offering Agreement, or the 2024 ATM Agreement, with H.C. Wainright & Co., LLC, or HCW. Pursuant to the 2024 ATM Agreement and the prospectus supplement filed in connection therewith, we may, from time to time, in our sole discretion, issue and sell through HCW, acting as sales
Previous wording
we issued and sold 220,733 shares of common stock under the 2024 ATM Agreement resulting in net proceeds of approximately $0.4 million after deducting approximately $15,000 in issuance costs. During the six months ended June 30, 2025 we issued and sold 243,139 shares of common stock under the Sales Agreement resulting in net proceeds of approximately $0.4 million. During the year ended December 31, 2024, we issued and sold 41,152 shares of common stock under the Sales Agreement resulting in net proceeds of approximately $0.1 million.
Current wording
agent and/or principal, up to $3.0 million of shares of our common stock. During the three months ended September 30,2025, we issued and sold 225,428 shares of common stock under the 2024 ATM Agreement resulting in net proceeds of approximately $0.4 million after deducting approximately $17,000 in issuance costs. During the nine months ended September 30, 2025 we issued and sold 468,567 shares of common stock under the Sales Agreement resulting in net proceeds of approximately $0.8 million. During the year ended December 31, 2024, we issued and sold 41,152 shares of common stock under the Sales Agreement resulting in net proceeds of approximately $0.1 million.
Previous wording
Cash used in operating activities resulted primarily from our net losses adjusted for non-cash charges and changes in components of working capital. Net cash used in operating activities was $6.8 million for the six months ended June 30, 2025 compared to $7.6 million for the six months ended June 30, 2024. The decrease in cash used in operating activities of $0.8 million was primarily attributable to a change in operating assets and liabilities of $1.5 million, partially offset by an increase in our net loss of $0.9 million.
Current wording
Cash used in operating activities resulted primarily from our net losses adjusted for non-cash charges and changes in components of working capital. Net cash used in operating activities was $9.9 million for the nine months ended September 30, 2025 compared to $10.0 million for the nine months ended September 30, 2024. The decrease in cash used in operating activities of $0.1 million was primarily attributable to a change in operating assets and liabilities of $0.1 million, partially offset by an increase in our net loss of $0.1 million.
Previous wording
No cash was used in or provided by investing activities the six months ended June 30, 2025. Cash used in investing activities of $15,478 for the six months ended June 30, 2024 was for the purchase of property and equipment.
Current wording
No cash was used in or provided by investing activities the nine months ended September 30, 2025. Cash used in investing activities of $15,478 for the nine months ended September 30, 2024 was for the purchase of property and equipment.
Previous wording
Net cash provided by financing activities was $0.4 million for the six months ended June 30, 2025. Cash provided by financing activities for the six months ended June 30, 2025 was attributable to the net proceeds of approximately $0.4 million, after deducting approximately $18,000 in issuance costs, received from sales of common stock under our ATM program.
Current wording
Net cash provided by financing activities was $0.8 million for the nine months ended September 30, 2025. Cash provided by financing activities for the nine months ended September 30, 2025 was attributable to the net proceeds of approximately $0.8 million, after deducting approximately $36,000 in issuance costs, received from sales of common stock under our ATM program.
Previous wording
Net cash provided by financing activities of $14.7 million for the six months ended June 30, 2024 was attributable tothe net proceeds of $14.7 million, after deducting underwriting discounts and offering expenses of approximately $1.3 million, received from the sale of 1,687,712 shares of common stock, 507,076 pre-funded common stock purchase warrants, 1,097,394 tranche A common stock purchase warrants and 1,097,394 tranche B common stock purchase warrants in March 2024.
Current wording
Net cash provided by financing activities of $14.7 million for the nine months ended September 30, 2024 was attributable tothe net proceeds of $14.7 million, after deducting underwriting discounts and offering expenses of approximately $1.3 million, received from the sale of 1,687,712 shares of common stock, 507,076 pre-funded common stock purchase warrants, 1,097,394 tranche A common stock purchase warrants and 1,097,394 tranche B common stock purchase warrants in March 2024.
Previous wording
As of June 30, 2025, we had cash and cash equivalents of $16.5 million. We believe that our existing cash and cash equivalents will not enable us to fund our operating expenses and capital expenditure requirements through at least twelve months from the date of issuance of these condensed consolidated financial statements. Therefore, we have concluded that substantial doubt exists about our ability to continue as a going concern.
Current wording
As of September 30, 2025, we had cash and cash equivalents of $13.7 million. We believe that our existing cash and cash equivalents will not enable us to fund our operating expenses and capital expenditure requirements through at least twelve months from the date of issuance of these condensed consolidated financial statements. Therefore, we have concluded that substantial doubt exists about our ability to continue as a going concern.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
determined schedule or when contractual milestones are met; however, some require advanced payments. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. Examples of estimated accrued research and development expenses include fees billed by: