Aprea Therapeutics Reports Second Quarter 2025 Financial Results and Provides a Clinical Update
Aprea Therapeutics (Nasdaq: APRE) has reported Q2 2025 financial results and provided updates on its clinical programs. The company's WEE1 inhibitor APR-1051 showed early disease control in three patients during the Phase 1 ACESOT-1051 trial, while their ATR inhibitor ATRN-119 demonstrated activity with seven patients achieving stable disease, including three with tumor shrinkage at 550mg twice daily.
Financially, Aprea reported $16.5 million in cash as of June 30, 2025, expected to fund operations into Q2 2026. The company posted a reduced net loss of $3.2 million ($0.53 per share) compared to $3.5 million in Q2 2024, with decreased R&D expenses of $1.9 million and G&A expenses of $1.6 million.
Aprea Therapeutics (Nasdaq: APRE) ha reso noti i risultati finanziari del secondo trimestre 2025 e ha fornito aggiornamenti sui suoi programmi clinici. Il inibitore WEE1 APR-1051 ha mostrato un controllo precoce della malattia in tre pazienti nel trial di Fase 1 ACESOT-1051, mentre l'inibitore di ATR ATRN-119 ha evidenziato attività con sette pazienti che hanno raggiunto una malattia stabile, inclusi tre con riduzione tumorale alla dose di 550 mg due volte al giorno.
Dal punto di vista finanziario, Aprea riportava $16,5 milioni in cassa al 30 giugno 2025, somma che dovrebbe finanziare le operazioni fino al secondo trimestre 2026. La società ha registrato una perdita netta ridotta di $3,2 milioni ($0,53 per azione) rispetto ai $3,5 milioni del Q2 2024, con una diminuzione delle spese di ricerca e sviluppo di $1,9 milioni e delle spese generali e amministrative di $1,6 milioni.
Aprea Therapeutics (Nasdaq: APRE) informó los resultados financieros del segundo trimestre de 2025 y proporcionó actualizaciones sobre sus programas clínicos. El inhibidor de WEE1 APR-1051 mostró control temprano de la enfermedad en tres pacientes durante el ensayo de fase 1 ACESOT-1051, mientras que el inhibidor de ATR ATRN-119 mostró actividad: siete pacientes alcanzaron enfermedad estable, incluidos tres con reducción tumoral a 550 mg dos veces al día.
En términos financieros, Aprea reportó $16,5 millones en efectivo al 30 de junio de 2025, cantidad que, según la compañía, financiaría las operaciones hasta el segundo trimestre de 2026. La compañía registró una pérdida neta reducida de $3,2 millones ($0,53 por acción) frente a $3,5 millones en el Q2 de 2024, con menores gastos de I+D por $1,9 millones y una reducción de $1,6 millones en gastos generales y administrativos.
Aprea Therapeutics (Nasdaq: APRE)는 2025년 2분기 재무실적을 발표하고 임상 프로그램에 대한 현황을 업데이트했습니다. WEE1 억제제 APR-1051은 1상 ACESOT-1051 시험에서 3명의 환자에게서 초기 질병 조절을 보였고, ATR 억제제 ATRN-119는 7명이 질병 안정(stable disease)을 달성했으며 그중 3명은 1일 2회 550mg 투여로 종양 축소를 확인했습니다.
재무적으로 Aprea는 2025년 6월 30일 기준 $16.5 million의 현금을 보유하고 있어 2026년 2분기까지 운영자금을 확보할 것으로 예상됩니다. 회사는 순손실이 $3.2 million으로 축소(주당 $0.53)되었다고 발표했으며, 이는 2024년 2분기의 $3.5 million보다 개선된 수치입니다. 연구개발비(R&D)가 $1.9 million, 일반관리비(G&A)가 $1.6 million 감소했습니다.
Aprea Therapeutics (Nasdaq: APRE) a publié ses résultats financiers du 2e trimestre 2025 et a fait le point sur ses programmes cliniques. L'inhibiteur de WEE1 APR-1051 a montré un contrôle précoce de la maladie chez trois patients lors de l'essai de phase 1 ACESOT-1051, tandis que l'inhibiteur d'ATR ATRN-119 a présenté une activité avec sept patients en maladie stable, dont trois ayant montré une réduction tumorale à 550 mg deux fois par jour.
Sur le plan financier, Aprea disposait de $16,5 millions en trésorerie au 30 juin 2025, montant qui devrait financer les opérations jusqu'au 2e trimestre 2026. La société a affiché une perte nette réduite de $3,2 millions (0,53 $ par action) contre $3,5 millions au T2 2024, avec des dépenses de R&D en baisse de $1,9 million et une réduction de $1,6 million des frais généraux et administratifs.
Aprea Therapeutics (Nasdaq: APRE) hat die Finanzergebnisse für das 2. Quartal 2025 veröffentlicht und Updates zu seinen klinischen Programmen gegeben. Der WEE1-Inhibitor APR-1051 zeigte in der Phase-1-Studie ACESOT-1051 bei drei Patienten eine frühe Krankheitskontrolle, während der ATR-Inhibitor ATRN-119 Aktivität zeigte: Sieben Patienten erreichten eine stabile Erkrankung, darunter drei mit Tumorverkleinerungen bei 550 mg zweimal täglich.
Finanziell meldete Aprea $16,5 Millionen in bar zum 30. Juni 2025, was die operative Tätigkeit voraussichtlich bis ins 2. Quartal 2026 finanzieren wird. Das Unternehmen verzeichnete einen reduzierten Nettoverlust von $3,2 Millionen (0,53 $ je Aktie) gegenüber $3,5 Millionen im Q2 2024, bei um $1,9 Millionen niedrigeren Forschungs- und Entwicklungskosten und um $1,6 Millionen reduzierten allgemeinen und administrativen Kosten.
- None.
- Cash position decreased to $16.5M from $22.8M in December 2024
- Dose limiting toxicity observed in two patients at 550mg twice daily for ATRN-119
- Phase 1 trials still in early stages with limited efficacy data
Insights
Aprea shows early but promising signals with cancer drugs APR-1051 and ATRN-119, though still in early development with modest efficacy.
Aprea's Q2 update reveals preliminary evidence of clinical activity for both lead programs, though investors should understand these are still early signals. For the WEE1 inhibitor APR-1051, three patients achieving stable disease represents an encouraging start, but far from definitive efficacy. The tumor reduction of 5% in HPV+ head and neck cancer at just 70mg (considered subtherapeutic) is particularly intriguing since HPV+ cancers often have compromised DNA damage response pathways that WEE1 inhibitors can potentially exploit.
For ATRN-119, the ATR inhibitor, seven patients with stable disease including three showing tumor shrinkage (7%, 14%, and 21%) provides slightly stronger preliminary evidence of activity. However, the dose-limiting toxicities at 550mg requiring a step back to 400mg twice daily indicates the narrow therapeutic window typical of DNA damage response inhibitors.
Both programs target well-defined molecular vulnerabilities – WEE1 inhibition for Cyclin E overexpressing tumors and ATR inhibition for DDR-mutated cancers. The biomarker-guided approach is scientifically sound, but the clinical validation remains preliminary. The dose escalation phases continuing into 2026 means definitive efficacy data remains distant. The collaboration with MD Anderson showing preclinical synergy with immunotherapy for APR-1051 offers a potential expansion pathway, but requires substantial additional clinical validation.
With
Aprea's Q2 update shows an operating loss of
The R&D spending decrease to
From a financial perspective, Aprea is executing a disciplined capital allocation strategy, maintaining sufficient resources to reach critical data readouts for both lead programs. The company's focus on biomarker-selected patient populations represents a capital-efficient development approach, potentially allowing them to demonstrate clinical proof-of-concept with relatively small trials.
The early signals of clinical activity, while preliminary, are important for a company at this stage. However, the runway through Q2 2026 means Aprea will almost certainly need additional financing before either program reaches pivotal trials. Successful interim data in late 2025 or early 2026 would be critical to secure favorable financing terms. The modest cash position and early clinical stage represent typical biotech development risk, with clinical validation still pending for both lead assets.
Early evidence of disease control was observed in the ongoing Phase 1 ACESOT-1051 trial, with three patients achieving stable disease in the 70 mg and 100 mg cohorts treated with the WEE1 inhibitor, APR-1051
DOYLESTOWN, Pa., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, today reported financial results for the second quarter ended June 30, 2025, and provided a business update.
"We are pleased with our progress in 2025, as emerging data from both of our lead programs demonstrate evidence of clinical activity,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. “In the ACESOT-1051 trial of our oral WEE1 inhibitor APR-1051, we have observed three patients with stable disease to date, one in the 70mg cohort and two in the 100mg cohort, including an early clinical signal in an HPV-positive head and neck squamous cell carcinoma, and in rectal and uterine cancer patients. For our macrocyclic ATR inhibitor, ATRN-119, the ongoing dose escalation study has shown early activity, with seven patients achieving stable disease to date, including three with meaningful tumor shrinkage at the 550 mg twice daily dose. Overall, these early signs of clinical validation continue to strengthen our confidence in the potential of our DDR assets and to deliver meaningful therapeutic advances for patients with cancer.”
Key Business Updates and Potential Upcoming Key Milestones
ACESOT-1051: A Biomarker Focused, Phase 1 Trial of Oral WEE1 inhibitor, APR-1051
- APR-1051 is a potent and selective small molecule WEE1 inhibitor designed to potentially solve tolerability challenges of the WEE1 class and may achieve greater clinical activity than other programs currently in development. Aprea is advancing APR-1051 as monotherapy in cancers with well-defined biomarkers that may predict sensitivity to WEE1 inhibition. Among these, cancers over-expressing Cyclin E represent a high unmet medical need. Patients with Cyclin E over-expression have poor prognosis and, currently, lack effective therapies options.
- Patients are currently being enrolled at the 100 mg once-daily dose level in the ongoing Phase 1 ACESOT-1051 (A Multi-Center Evaluation of WEE1 Inhibitor in Patients with Advanced Solid Tumors, APR-1051). Based on data to date, APR-1051 has demonstrated an encouraging tolerability profile. Following successful clearance of the 100 mg cohort, dose escalation is expected to continue with enrollment at 150 mg level. Earlier in 2025, the dosing schedule was revised based on pharmacokinetic data to potentially further support a higher therapeutic window.
- Enrollment criteria in the ACESOT-1051 trial have been expanded to include patients with HPV+ tumors. Evidence of early disease control has been observed in a patient diagnosed with HPV+ head and neck squamous cell carcinoma (HNSCC) treated with a subtherapeutic 70 mg once daily oral dose of APR-1051. At the first radiographic assessment, this patient was noted to have stable disease with a
5% tumor reduction. - Additional safety and efficacy data from the ACESOT-1051 study are anticipated in the second half of 2025, with completion of the dose-escalation phase expected in the first half of 2026. Aprea intends to submit an abstract to a major oncology conference.
- Pending additional data, future arms of ACESOT-1051 may evaluate APR-1051 in combination with checkpoint inhibitors to address unmet medical needs across distinct patient populations.
- For more information, refer to ClinicalTrials.gov NCT06260514.
Collaboration with MD Anderson Cancer Center
- Aprea entered into a translational research collaboration with MD Anderson Cancer Center earlier in 2025. New preclinical results on APR-1051 showed: 1) potent single-agent activity for APR-1051 across a broad panel of human and murine head and neck cancer cell lines, including HPV+ subtypes, and 2) significant anti-tumor synergy with APR-1051 plus anti–PD-1 therapies in HPV+ HNSCC models, positioning APR-1051 as a candidate for combination-based clinical trials.
ABOYA-119: Ongoing Clinical Trial Evaluating ATR inhibitor, ATRN-119
- ATRN-119 is a potent and highly selective first-in-class macrocyclic ATR inhibitor, designed and developed to be used in patients with mutations in DDR-related genes. Cancers with mutations in DDR-related genes represent a high unmet medical need. These patients often have a poor prognosis and currently lack effective therapeutics options.
- ATRN-119 is being evaluated in the open-label Phase 1/2a clinical trial (ABOYA-119) as monotherapy in patients with advanced solid tumors having at least one mutation in a defined panel of DDR-related genes. Seven patients have demonstrated stable disease to date, with three patients in the 550 mg twice daily cohort showing tumor shrinkage of
7% ,14% and21% . Dose limiting toxicity was observed in two patients at 550 mg twice daily. Patients are now being dosed at a 400 mg twice daily schedule to further refine and optimize therapeutic efficacy and tolerability. - Additional safety and efficacy data from ABOYA-119 are expected in the second half of 2025 and the recommended Phase 2 dose is expected to be identified in the first half of 2026.
- Pending additional data, future arms of ABOYA-119 may evaluate ATRN-119 in combination with other therapies to address unmet medical needs for a distinct patient population.
- For more information on ABOYA-119, please refer to clinicaltrials.gov NCT04905914.
Select Financial Results for the Second quarter Ended June 30, 2025
- As of June 30, 2025, the Company reported cash and cash equivalents of
$16.5 million compared to$22.8 million as of December 31, 2024. The Company believes its cash and cash equivalents as of June 30, 2025, will be sufficient to meet its currently projected operating expenses and capital expenditure requirements into Q2 2026. - For the second quarter ended June 30, 2025, the Company reported an operating loss of
$3.4 million , compared to an operating loss of$3.8 million in the second quarter of 2024. - Research and Development (R&D) expenses were
$1.9 million for the quarter ended June 30, 2025, compared to$2.6 million for the second quarter of 2024. The decrease in R&D expense was primarily related to higher expenses in 2024 related to study start up activities in preparation for enrollment of the first patient into ACESOT-105, our Phase 1 dose-escalation study of APR-1051, and a decrease in personnel costs. - General and Administrative (G&A) expenses were
$1.6 million for the quarter ended June 30, 2025, compared to$1.9 million for the second quarter of 2024. The decrease in G&A expense was primarily related to a decrease in professional fees primarily related to legal expenses and a decrease in personnel costs. - The Company reported a net loss of
$3.2 million ($0.53 per basic share) on approximately 6.1 million weighted average common shares outstanding for the quarter ended June 30, 2025, compared to a net loss of$3.5 million ($0.58 per basic share) on approximately 5.9 million weighted average common shares outstanding for the comparable period in 2024.
About Aprea
Aprea is pioneering a new approach to treat cancer by exploiting vulnerabilities associated with cancer cell mutations. This approach was developed to kill tumors but to minimize the effect on normal, healthy cells, decreasing the risk of toxicity that is frequently associated with chemotherapy and other treatments. Aprea’s technology has potential applications across multiple cancer types, enabling it to target a range of tumors, including ovarian, endometrial, colorectal, prostate, and breast cancers. The company’s lead programs are APR-1051, an oral, small-molecule inhibitor of WEE1 kinase, and ATRN-119, a small molecule ATR inhibitor, both in clinical development for solid tumor indications. For more information, please visit the company website at www.aprea.com.
The Company may use, and intends to use, its investor relations website at https://ir.aprea.com/ as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.
Forward-Looking Statement
Certain information contained in this press release includes “forward-looking statements”, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended related to our study analyses, clinical trials, regulatory submissions, and projected cash position. We may, in some cases use terms such as “future,” “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “targeting,” “confidence,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team and on information currently available to management that involve risks, potential changes in circumstances, assumptions, and uncertainties. All statements contained in this press release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize, and achieve market acceptance of our current and planned products and services, our research and development efforts, including timing considerations and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including, without limitation, risks related to the success, timing, and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of our ongoing clinical trials, our understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs, our ability to continue as a going concern, and the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to update such forward-looking statements for any reason, except as required by law.
Investor Contact:
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
| Aprea Therapeutics, Inc. | ||||||||
| Consolidated Balance Sheets | ||||||||
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | (unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 16,532,199 | $ | 22,849,885 | ||||
| Prepaid expenses and other current assets | 395,011 | 726,254 | ||||||
| Total current assets | 16,927,210 | 23,576,139 | ||||||
| Property and equipment, net | 70,665 | 81,522 | ||||||
| Restricted cash | 40,673 | 40,170 | ||||||
| Other noncurrent assets | 271,162 | 281,662 | ||||||
| Total assets | $ | 17,309,710 | $ | 23,979,493 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,195,838 | $ | 1,352,240 | ||||
| Accrued expenses | 1,971,830 | 2,008,735 | ||||||
| Total current liabilities | 3,167,668 | 3,360,975 | ||||||
| Commitments and contingencies | ||||||||
| Series A convertible preferred stock, | 727,361 | 1,311,063 | ||||||
| Stockholders’ equity: | ||||||||
| Common stock, | 5,752 | 5,481 | ||||||
| Additional paid-in capital | 352,250,747 | 350,971,225 | ||||||
| Accumulated other comprehensive loss | (10,628,417 | ) | (10,627,379 | ) | ||||
| Accumulated deficit | (328,213,401 | ) | (321,041,872 | ) | ||||
| Total stockholders’ equity | 13,414,681 | 19,307,455 | ||||||
| Total liabilities and stockholders' equity | $ | 17,309,710 | $ | 23,979,493 | ||||
| Aprea Therapeutics, Inc. | ||||||||||||||||
| Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Grant revenue | $ | 118,111 | $ | 561,574 | 280,574 | $ | 942,143 | |||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,912,213 | 2,557,679 | $ | 4,395,279 | $ | 4,158,052 | ||||||||||
| General and administrative | 1,593,671 | 1,850,819 | 3,358,650 | $ | 3,780,685 | |||||||||||
| Total operating expenses | 3,505,884 | 4,408,498 | 7,753,929 | 7,938,737 | ||||||||||||
| Loss from operations | (3,387,773 | ) | (3,846,924 | ) | (7,473,355 | ) | (6,996,594 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income, net | 178,027 | 382,374 | 382,753 | $ | 665,777 | |||||||||||
| Foreign currency (loss) gain | (29,124 | ) | (5,502 | ) | (80,927 | ) | $ | 50,674 | ||||||||
| Total other income | 148,903 | 376,872 | 301,826 | 716,451 | ||||||||||||
| Net loss | $ | (3,238,870 | ) | $ | (3,470,052 | ) | $ | (7,171,529 | ) | $ | (6,280,143 | ) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Foreign currency translation | (1,681 | ) | (1,948 | ) | (1,038 | ) | $ | (17,031 | ) | |||||||
| Total comprehensive loss | $ | (3,240,551 | ) | $ | (3,472,000 | ) | $ | (7,172,567 | ) | $ | (6,297,174 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.53 | ) | $ | (0.58 | ) | $ | (1.19 | ) | $ | (1.24 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 6,083,329 | 5,937,291 | 6,038,845 | $ | 5,067,809 | |||||||||||
FAQ
What clinical results did Aprea Therapeutics (APRE) report for APR-1051 in Q2 2025?
What are the latest financial results for Aprea Therapeutics (APRE) in Q2 2025?
What are the key milestones expected for Aprea's ATRN-119 clinical trial?
How long will Aprea's current cash position last?
What were the clinical results for ATRN-119 in Aprea's latest update?
