Aprea Therapeutics(US:APRE)2023-11-08 16:00Company Overview - Aprea Therapeutics is focused on precision oncology through synthetic lethality, with a pipeline enriched by integrated discovery technologies[73]. - The acquisition of Atrin Pharmaceuticals was completed on May 16, 2022, and is now fully integrated into Aprea's operations[74]. - Aprea has shifted focus from reactivating mutant p53 tumor suppressor proteins to developing molecules targeting DDR pathways through synthetic lethality[79]. Product Development - The company’s lead product candidate, ATRN-119, is currently in a Phase 1/2a clinical trial, with tolerability and pharmacokinetic data expected in Q1 2024[76]. - Aprea anticipates filing an IND for its WEE1 inhibitor, ATRN-1051, by the end of 2023[77]. - The company has no ongoing preclinical studies or clinical trials involving reactivators of mutant p53, focusing instead on synthetic lethality[79]. Financial Performance - The company has not generated any revenue from product sales and relies primarily on grant revenue from government organizations[86][87]. - Grant revenue for the three months ended September 30, 2023 was approximately $0.3 million, compared to $0 for the same period in 2022, representing a change of $319,468[113]. - Grant revenue for the nine months ended September 30, 2023 was approximately $0.6 million, compared to no grant revenue for the same period in 2022[122]. - Total operating expenses for the three months ended September 30, 2023 were approximately $3.8 million, compared to $4.2 million for the same period in 2022, a decrease of $357,876[113]. - Total operating expenses decreased to $12.4 million for the nine months ended September 30, 2023, down from $110.7 million in 2022, a reduction of $98.4 million[121]. - The net loss for the three months ended September 30, 2023 was $3.2 million, compared to a net loss of $4.0 million for the same period in 2022, an improvement of $820,203[113]. - Net loss for the nine months ended September 30, 2023 was $10.8 million, significantly improved from a net loss of $110.2 million in 2022, an improvement of $99.4 million[129]. Expenses - Research and development expenses are expected to increase as clinical trials for ATRN-119 and other candidates are initiated[91]. - Research and development expenses increased to approximately $2.1 million for the three months ended September 30, 2023, up from approximately $1.1 million in the same period of 2022, an increase of $1.0 million[115]. - The increase in research and development expenses was primarily due to a $1.2 million increase related to IND enabling studies for ATRN-1051, a small molecule WEE1 inhibitor[117]. - General and administrative expenses decreased to approximately $1.7 million for the three months ended September 30, 2023, down from approximately $3.1 million in the same period of 2022, a decrease of $1.4 million[116]. - General and administrative expenses decreased to approximately $6.8 million for the nine months ended September 30, 2023, down from $18.8 million in 2022, a reduction of $12.1 million[126]. - The company expects general and administrative expenses to increase in the future due to headcount growth and commercialization activities[95]. Cash Flow and Financing - Cash and cash equivalents as of September 30, 2023 were $25.4 million, expected to fund operations through the end of Q4 2024[135]. - Net cash used in operating activities was $8.4 million for the nine months ended September 30, 2023, compared to $21.0 million in 2022, a decrease of $12.6 million[130]. - Net cash provided by financing activities was $5.1 million for the nine months ended September 30, 2023, attributed to the sale of common stock[131]. - The company raised approximately $4.9 million from the sale of 1,050,000 shares of common stock at a public offering price of $5.25 per share in February 2023[146]. - During the nine months ended September 30, 2023, the company issued 26,302 shares under the ATM offering program, resulting in net proceeds of approximately $0.3 million[145]. - The company is subject to a limitation on raising funds through primary public offerings, restricted to one-third of the aggregate market value of common equity held by non-affiliates until the public float exceeds $75 million[145]. - The company expects to incur significant expenses related to ongoing development activities and may require additional financing to support operations[138]. Other Financial Information - The company has provided a valuation allowance for the full amount of net deferred tax assets, indicating uncertainty in realizing benefits from these items[99]. - The company does not currently have any off-balance sheet arrangements[148]. - The company does not believe that inflation has had a material effect on its business during the three months ended September 30, 2023[151]. - The company has not used derivative financial instruments to hedge foreign exchange risk, as it does not currently have significant direct foreign exchange exposure[150]. - The company does not believe that any recently issued accounting pronouncements will have a material impact on its financial statements[147]. - A reverse stock split at a ratio of one-for-20 was approved and became effective on February 10, 2023[85]. - As of September 30, 2023, the company’s cash equivalents consisted of bank deposits and money market accounts, with no significant historical fluctuations in interest income[149]. - Foreign currency loss for the three months ended September 30, 2023 was $2,880, compared to a foreign currency gain of $24,353 for the same period in 2022, a change of $27,233[120].