Aprea Therapeutics(US:APRE)2024-08-12 12:35Clinical Programs - Aprea Therapeutics has two clinical programs: ATRN-119, an oral macrocyclic ATR inhibitor, and APR-1051, a next-generation oral WEE1 inhibitor, both targeting synthetic lethality in cancer treatment[70][73] - The Phase 1/2a clinical trial for ATRN-119 (ABOYA-119) has completed the first five dose cohorts, with readout expected in the first half of 2025[70] - The FDA cleared the IND application for APR-1051 in March 2024, with the first patient enrolled in the ACESOT-1051 study in Q2 2024, and updates anticipated by year-end 2024[73] - The initiation of the second clinical trial study for APR-1051 contributed to an increase of $0.5 million in research and development expenses[101] - The company is exploring combination therapy opportunities for its product candidates, including a preclinical research program on the combination of ATRN-119 and APR-1051[74] Financial Performance - Aprea Therapeutics has not generated any revenue from product sales and relies primarily on grant revenue, which is recognized as research and development services are performed[76][77] - Grant revenue for Q2 2024 was approximately $0.6 million, up from $0.2 million in Q2 2023, representing a 180% increase[98] - Total operating expenses for Q2 2024 were approximately $4.4 million, compared to $3.9 million in Q2 2023, reflecting a 13% increase[99] - Research and development expenses for Q2 2024 were approximately $2.6 million, an increase of $0.4 million or 18% compared to $2.2 million in Q2 2023[101] - General and administrative expenses for Q2 2024 were approximately $1.9 million, up from $1.7 million in Q2 2023, indicating a 12% increase[102] - Net loss for Q2 2024 was approximately $3.5 million, compared to a net loss of $3.3 million in Q2 2023, representing a 6% increase in loss[99] - Grant revenue for the six months ended June 30, 2024, was approximately $0.9 million, up from $0.2 million in the same period of 2023, representing a 350% increase[105] - Total operating expenses decreased to $7.9 million for the six months ended June 30, 2024, from $8.5 million in 2023, a reduction of $0.6 million or 6.9%[104] - Research and development expenses increased to approximately $4.2 million for the six months ended June 30, 2024, compared to $3.5 million in 2023, an increase of $0.7 million or 20.2%[107] - General and administrative expenses decreased to approximately $3.8 million for the six months ended June 30, 2024, down from $5.1 million in 2023, a decrease of $1.3 million or 25.5%[108] - Net loss for the six months ended June 30, 2024, was $6.3 million, compared to a net loss of $7.6 million in 2023, reflecting an improvement of $1.4 million or 18.4%[111] Cash and Financing - Cash and cash equivalents as of June 30, 2024, were $28.7 million, expected to fund operations into the fourth quarter of 2025[110] - Net cash used in operating activities was $7.6 million for the six months ended June 30, 2024, compared to $6.2 million in 2023, an increase of $1.4 million or 22.6%[113] - Net cash provided by financing activities was $14.7 million for the six months ended June 30, 2024, compared to $5.1 million in 2023, an increase of $9.6 million or 188.2%[114] - The company filed a universal shelf registration statement for the issuance of securities up to an aggregate of $350 million, which expired on November 30, 2023[127] - In February 2023, the company issued 1,050,000 shares at a public offering price of $5.25 per share, resulting in net proceeds of approximately $4.9 million after expenses[128] - A new shelf registration statement was filed on January 26, 2024, for the issuance of securities up to $150 million, including a prospectus for the sale of $1 million of common stock[128] - The company entered into an ATM Agreement allowing the issuance of up to $2 million of common stock, but no sales were made under this agreement before its termination in March 2024[129] - On March 11, 2024, the company agreed to issue 1,687,712 shares at a purchase price of $7.29 per share, with gross proceeds expected to total approximately $16 million before fees[130] - The potential future warrant cash exercises from the recent securities purchase agreement are expected to yield up to approximately $18 million[130] Expenses and Liabilities - Research and development expenses are expected to increase as clinical trials for ATRN-119 and APR-1051 are initiated, reflecting the higher costs associated with later-stage clinical development[81] - General and administrative expenses are projected to rise due to increased headcount and activities related to potential commercialization of product candidates[86] - The company has provided a valuation allowance for deferred tax assets, indicating uncertainty in realizing tax benefits from net losses incurred[88] - The accumulated deficit as of June 30, 2024, was $314.4 million, indicating the ongoing financial challenges faced by the company[111] - The company does not currently have any off-balance sheet arrangements[132] Company Classification - The company remains classified as an emerging growth company until December 31, 2024, unless certain financial thresholds are met[95] - The company is also classified as a smaller reporting company, with market value held by non-affiliates below $700 million and annual revenue below $100 million[96] Market and Economic Conditions - The company does not believe that inflation has materially affected its business during the six months ended June 30, 2024[135] - The company has not used any derivative financial instruments to hedge foreign exchange risk, as it does not currently have significant direct foreign exchange exposure[134] - As of June 30, 2024, the company’s cash equivalents consisted of bank deposits and money market accounts, with no significant historical fluctuations in interest income[133]