What Aprea Therapeutics does

Aprea Therapeutics is a clinical-stage biopharmaceutical company developing small-molecule therapeutics that target the DNA Damage Response (DDR) pathway in cancer, with particular emphasis on restoring function of the tumor suppressor p53. Founded in Sweden in 2003, the company is headquartered in Doylestown, Pennsylvania with research and development operations in Stockholm, Sweden, and became a U.S. public company following its incorporation in Delaware in May 2019 and its October 2019 listing on NASDAQ under the ticker APRE, which raised approximately $97.75 million.

The company's pipeline is anchored by eprenetapopt (APR-246), an intravenously administered small molecule that reactivates mutant p53, supplemented by APR-548 (an oral p53 reactivator), APR-1051 (a WEE1 inhibitor), and ATR/ATRi programs acquired through the 2022 acquisition of Atrin Pharmaceuticals. Eprenetapopt has been granted FDA Breakthrough Therapy, Fast Track, and Orphan Drug designations for myelodysplastic syndromes (MDS), where Phase 3 enrollment of 154 patients was completed in June 2020. Reported net losses were $6.2 million in Q3 2019 and $9.4 million in Q1 2020, with cash and equivalents of $122.5 million as of March 31, 2020.

Aprea is pre-revenue and does not currently sell any approved products. Its business model is contingent on successful clinical advancement of its candidates toward regulatory approval, at which point revenue would be generated either through direct commercialization (targeting oncologists, academic cancer centers, and hospital systems treating TP53-mutant MDS, AML, and solid tumor patients) or through partnership, out-licensing, or strategic transactions. As a result, current cash flow is purely a function of capital raised (equity offerings) netted against R&D and G&A burn, with no product-derived revenue line.

Name

Aprea Therapeutics

Legal name

Aprea Therapeutics, Inc.

Website

https://aprea.com

Company type

Public

Founded year

2019

Operating status

Operating

Short description

Aprea Therapeutics is a clinical-stage biopharmaceutical company developing small-molecule DNA Damage Response (DDR) targeted cancer therapeutics, most notably p53 reactivator eprenetapopt for TP53-mutant MDS, with additional WEE1 and ATR inhibitor programs.

Ownership category

akta.pro rank

Product category

Oncology Therapeutics

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Genetic & Genomic Rare Disease Therapeutics (HLAIAIAA)

Keywords

• DDR targeted therapeutics
• P53 reactivator oncology
• Precision medicine cancer
• Small molecule inhibitors
• Biopharmaceutical drug development

Headquarters

HQ city

Doylestown

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Drug Development and Commercialization: Pre-commercial biopharmaceutical company focused on developing novel cancer therapeutics. Revenue will be generated through commercialization of approved drug products, primarily in the oncology/hematology space. Currently in clinical trial stage with no commercialized products generating revenue.
2. Future Product Sales: Revenue anticipated from sales of approved DDR-targeted cancer therapeutics, including APR-246 (eprenetapopt) and other pipeline candidates upon successful clinical development and regulatory approval.
3. Regulatory Exclusivity and IP Licensing: Company holds Breakthrough Therapy, Orphan Drug, and Fast Track designations from FDA providing potential regulatory exclusivity benefits. May pursue licensing agreements for pipeline assets.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Aprea Therapeutics is a clinical-stage biopharmaceutical company developing DNA Damage Response (DDR)-targeted small molecule cancer therapeutics using a precision medicine approach. Its lead product candidate APR-246 (eprenetapopt) is a first-in-class p53 reactivator in Phase 3 development in combination with azacitidine for TP53-mutant myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). The pipeline also includes the next-generation oral p53 reactivator APR-548, the WEE1 inhibitor APR-1051, and an ATR inhibitor program acquired via Atrin Pharmaceuticals in 2022.

Product overview

Aprea Therapeutics is a biopharmaceutical company developing DDR (DNA Damage Response)-targeted small molecule cancer therapeutics using a precision medicine approach. The company's product portfolio centers on p53 tumor suppressor protein reactivation, with lead product candidate APR-246 (eprenetapopt), a small molecule in clinical development for hematologic malignancies including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Additional pipeline candidates include APR-548 (next-generation oral p53 reactivator) and APR-1051 (WEE1 inhibitor). The company develops small molecule inhibitors designed to exploit genetic mutations in cancer to widen the therapeutic window.

Differentiator

Problem solved

Functional benefit

Quantifiable outcome

• Phase 3 MDS trial fully enrolled with 154 patients with primary endpoint of complete remission (CR) rate
• +2 more outcomes

Segments2 records

Ideal customer profiles1 record

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Two partnerships are on record, tiered core.

• Groupe Francophone des Myélodysplasies (GFM)coreStrategic or Co-development PartnerFrench clinical research cooperative group conducting investigator-initiated Phase 2 trial of APR-246 with azacitidine in TP53 mutated MDS and AML patients. This collaboration provides access to French clinical sites and expertise in myelodysplastic syndromes.
• U.S. Clinical Trial SitescoreStrategic or Co-development PartnerMultiple U.S. medical centers and oncology practices participating in Phase 1b/2 investigator-initiated trial of APR-246 with azacitidine for frontline treatment of TP53 mutant MDS and AML patients.

Scale indicators6 records

Recent moves6 records

Expansion highlights4 records

Direct peers

• Zentalis Pharmaceuticals: Clinical-stage oncology biopharma developing azenosertib, a WEE1 inhibitor in co-development with Pfizer, GSK and Zentera. Directly comparable to Aprea's APR-1051 WEE1 program and shares the DDR pathway focus in hematologic malignancies.
• Tango Therapeutics: Clinical-stage oncology company developing synthetic-lethality and DDR-targeted therapies, including PRMT5 and USP1 inhibitors. Comparable as a small-cap, DDR-focused oncology biotech with multiple clinical assets.
• Repare Therapeutics: Clinical-stage precision oncology company developing synthetic-lethality and DDR-targeted therapies including ATR inhibitors and polymerase theta inhibitors. Directly comparable to Aprea on DDR mechanism and small-cap clinical-stage oncology profile.
• Theseus Pharmaceuticals: Clinical-stage biopharma developing DDR kinase inhibitors (including a next-generation KIT inhibitor) for cancer. Comparable as a small-cap clinical-stage oncology company targeting DDR biology.

Emerging players

• Black Diamond Therapeutics: Clinical-stage precision oncology company developing allosteric mutation-targeted therapies across multiple oncogenic drivers. Comparable to Aprea in being a small-cap, mutation-targeted oncology company with a discovery-to-clinical pipeline.
• Schrödinger: Computational drug discovery company with a clinical-stage oncology pipeline developed through its platform. Comparable as a smaller-cap, technology-enabled oncology drug developer, though with a different core approach.

Broad incumbents

• Pfizer: Global pharmaceutical company with an extensive DDR and oncology pipeline, including a co-development deal with Zentalis on the WEE1 inhibitor azenosertib. Comparable as a broad incumbent with overlapping DDR/oncology programs and potential acquirer of Aprea.
• Novartis: Global pharmaceutical company with a large oncology franchise and active DDR/synthetic-lethality programs (e.g., MDM2, CDK4/6). Comparable as a broad incumbent with overlapping oncology DDR strategy and as a potential strategic acquirer of Aprea.
• Merck & Co. Global pharmaceutical company with Keytruda as a backbone for combination oncology strategies (relevant to APR-246 + anti-PD-1 trials). Comparable as a broad incumbent with significant DDR and immuno-oncology combination strategy that intersects with Aprea's pipeline.
• AstraZeneca: Global pharmaceutical company with an active DDR and synthetic-lethality oncology pipeline (e.g., PARP, ATM, WEE1 programs via partnerships). Comparable as a broad incumbent in DDR oncology and a potential strategic acquirer of DDR-focused biotechs like Aprea.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/ApreaTX
• Facebookfacebook.com/apreatherapeutics
• LinkedInlinkedin.com/company/aprea-therapeutics

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Subsidiaries2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Aprea Therapeutics