Aprea Therapeutics(US:APRE)2024-05-14 12:35Oncology Focus - Aprea Therapeutics is focused on precision oncology through synthetic lethality, with a pipeline enriched by novel targets in cancer treatment[65] - The company is exploring combination therapies with other agents, such as PARP inhibitors, to enhance synthetic lethality[71] - Aprea Therapeutics has no ongoing preclinical studies or clinical trials involving reactivators of mutant p53, focusing instead on DDR pathways[66] Clinical Trials - The lead product candidate, ATRN-119, is currently in a Phase 1/2a clinical trial, with readout expected in Q1 2025[68] - The first four dose cohorts of the ATRN-119 trial have been completed, with ongoing enrollment for additional cohorts[68] - The FDA cleared the IND application for APR-1051, with patient enrollment anticipated in Q2 2024 and safety/efficacy data expected in Q2 2025[69] Financial Performance - Grant revenue for Q1 2024 was approximately $0.4 million, a significant increase of $380,569 compared to no grant revenue in Q1 2023[95] - Total operating expenses decreased to $3.5 million in Q1 2024 from $4.6 million in Q1 2023, a reduction of $1.1 million[96] - Research and development expenses increased to approximately $1.6 million in Q1 2024 from $1.3 million in Q1 2023, an increase of $0.3 million[97] - General and administrative expenses decreased to approximately $1.9 million in Q1 2024 from $3.4 million in Q1 2023, a decrease of $1.4 million[98] - Net loss for Q1 2024 was $2.8 million, compared to a net loss of $4.4 million in Q1 2023, reflecting an improvement of $1.6 million[101] - Cash and cash equivalents as of March 31, 2024, were $32.4 million, expected to fund operations into Q3 2025[100] Funding and Capital - Net cash provided by financing activities was $14.7 million in Q1 2024, significantly higher than $5.1 million in Q1 2023[105][106] - A total of $350 million was registered for issuance under the 2020 Shelf Registration Statement, which expired on November 30, 2023[117] - In February 2023, the company raised approximately $4.9 million by issuing 1,050,000 shares at a public offering price of $5.25 per share[118] - A new shelf registration statement for $150 million was filed on January 26, 2024, including a prospectus for the sale of $1 million of common stock[119] - The company entered into an At the Market Offering Agreement allowing for the sale of up to $2 million of common stock, but no sales have been made under this agreement to date[120] - A private placement offering on March 11, 2024, resulted in gross proceeds of approximately $16 million from the sale of 1,687,712 shares at $7.29 per share[121] - The company has no committed external source of funds and may face dilution of ownership interests if additional capital is raised through equity or convertible debt securities[114] Expenses and Deficits - Research and development expenses are expected to increase as clinical trials for ATRN-119 and APR-1051 are initiated[77] - General and administrative expenses are projected to rise due to increased headcount and activities related to potential commercialization[81] - The company anticipates increased expenses related to ongoing and planned development activities, including clinical trials and product commercialization[107][109] - The accumulated deficit as of March 31, 2024, was $310.9 million, primarily due to research and development costs and general administrative expenses[101] Market Risks - Interest income sensitivity is the primary exposure to market risk, with no significant historical fluctuations noted[124] - Inflation has not materially affected the company's business or financial condition during the three months ended March 31, 2024[126] - Developing drug products is a lengthy and costly process, with no guarantee of obtaining marketing approval or generating revenue[113] Team and Expertise - Aprea Therapeutics has assembled a team with extensive experience in oncology drug development to support its mission[71]