Aprea Therapeutics(US:APRE)2024-11-07 13:35Clinical Programs - Aprea Therapeutics has two clinical programs: ATRN-119, an oral macrocyclic ATR inhibitor, and APR-1051, a next-generation oral WEE1 kinase inhibitor[72][73]. - ATRN-119 is currently in a Phase 1/2a clinical trial, with preliminary data indicating it is safe and well-tolerated, and potential efficacy data expected in the second half of 2025[72]. - APR-1051 has received FDA clearance for its IND application, with the first patient enrolled in the ACESOT-1051 trial, and preliminary results show it is safe with no hematologic toxicity[73]. - Aprea Therapeutics is focusing on synthetic lethality as a treatment strategy for various cancer types, aiming to establish a leadership position in this emerging field[71]. - The company is exploring combination therapy opportunities for its product candidates, supported by a Phase II SBIR grant from the National Cancer Institute[75]. Financial Performance - The company has not generated any revenue from product sales and does not expect to do so in the near future, relying primarily on grant revenue[78][79]. - Grant revenue for the three months ended September 30, 2024, was approximately $354,621, an increase of $35,153 compared to $319,468 for the same period in 2023[105]. - For the nine months ended September 30, 2024, grant revenue was approximately $1.3 million, an increase of $727,608 from $569,156 in the same period in 2023[110]. - Net loss for the three months ended September 30, 2024, was $3,783,769, compared to a net loss of $3,204,515 for the same period in 2023, reflecting an increase of $579,254[105]. - The accumulated deficit as of September 30, 2024, was $318.1 million, with net losses of $10.1 million for the nine months ended September 30, 2024[115]. Expenses - 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[84]. - Research and development expenses for the three months ended September 30, 2024, were approximately $2.8 million, up $723,796 from $2.1 million in the same period in 2023[106]. - Total research and development expenses for the nine months ended September 30, 2024, were approximately $7.0 million, an increase of $1,422,649 from $5.6 million in the same period in 2023[111]. - General and administrative expenses are anticipated to rise due to increased headcount and activities related to potential commercialization of product candidates[89]. - General and administrative expenses for the three months ended September 30, 2024, were approximately $1.6 million, a decrease of $114,477 from $1.7 million in the same period in 2023[108]. - General and administrative expenses for the nine months ended September 30, 2024, were approximately $5.4 million, a decrease of $1,398,465 from $6.8 million in the same period in 2023[112]. Cash Flow and Financing - As of September 30, 2024, the company had cash and cash equivalents of $26.2 million, expected to fund operating expenses for at least the next twelve months[114]. - Net cash used in operating activities was $10.0 million for the nine months ended September 30, 2024, compared to $8.4 million for the same period in 2023, reflecting an increase of $1.6 million primarily due to changes in operating assets and liabilities[116]. - Cash used in investing activities was $15,478 for the nine months ended September 30, 2024, primarily for the purchase of property and equipment, with no cash used in investing activities for the same period in 2023[117]. - Net cash provided by financing activities was $14.7 million for the nine months ended September 30, 2024, from the sale of 1,687,712 shares of common stock and various warrants, after deducting approximately $1.3 million in expenses[118]. - The company raised approximately $4.9 million from the sale of 1,050,000 shares of common stock in February 2023, after deducting underwriting discounts and offering expenses[130]. - The company entered into a securities purchase agreement in March 2024, resulting in gross proceeds of approximately $16.0 million from the issuance of common stock and warrants[134]. Future Outlook - The company expects to continue incurring significant expenses and increasing operating losses for at least the next several years[115]. - The company anticipates increased expenses related to clinical trials, product development, and operating as a public company, necessitating additional financing[120]. - Future capital requirements will depend on various factors, including the scope and progress of clinical trials and potential commercialization activities[122]. - The company has no committed external sources of funds and may face challenges in raising additional capital on favorable terms[126]. Market and Economic Risks - The company does not currently have any significant direct foreign exchange risk and has not used derivative financial instruments to hedge such exposure[139]. - Inflation has not had a material effect on the company's business, financial condition, or results of operations during the nine months ended September 30, 2024[140]. - The primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates[136]. - Historical fluctuations in interest income have not been significant for the company[137]. - The company faces market risk from changes in foreign currency exchange rates affecting its non-U.S. dollar functional currency foreign subsidiaries[138]. - The financial position of subsidiary Aprea AB is measured using the local currency as the functional currency[138]. - Cash accounts holding U.S. dollars at Aprea AB are remeasured based on the exchange rate at the date of remeasurement[138].