Aprea Therapeutics Inc

Previous wording

Our most advanced synthetic lethality product candidate is ATRN-119, a clinical-stage oral small molecule inhibitor of ataxia telangiectasia and Rad3-related, or ATR. The ataxia telangiectasia and Rad3-related (ATR) kinase is a master regulator of the DNA damage response, with key roles in cell cycle control and DNA repair following replication stress. Aprea Therapeutics has developed ATRN-119, the first oral macrocyclic ATR inhibitor to enter clinical trials. We are enrolling patients into ABOYA-119, a Phase 1/2a clinical trial to evaluate ATRN-119 under an investigational new drug application, or IND. The first five dose cohorts have been completed, and patients with advanced solid tumors having mutations in defined DDR-related genes continue to be enrolled into additional cohorts of the Phase 1 dose escalation part of the trial. The primary endpoint of this Phase 1 part is to evaluate the tolerability and pharmacokinetics of ATRN-119 when administered orally on a continuous, once-daily schedule. We are planning to amend the study protocol to add a group of patients who will receive ATRN-119 twice a day and investigate the effect of food on ATRN-119 absorption and drug exposure in blood. Under the current protocol, we anticipate ABOYA-119 Phase 1 readout to be available in the first half of 2025.

Current wording

Our most advanced synthetic lethality product candidate is ATRN-119, a clinical-stage oral small molecule inhibitor of ataxia telangiectasia and Rad3-related, or ATR. The ATR kinase is a master regulator of the DNA damage response, with key roles in cell cycle control and DNA repair following replication stress. Aprea Therapeutics has developed ATRN-119, the first oral macrocyclic ATR inhibitor to enter clinical trials. We are enrolling patients into ABOYA-119, a Phase 1/2a clinical trial to evaluate ATRN-119 under an investigational new drug (“IND”) application. The first five dose cohorts have been completed, with the sixth cohort currently enrolling. The primary endpoint of this Phase 1 part is to evaluate the tolerability and pharmacokinetics of ATRN-119 when administered orally on a continuous, once-daily schedule. We observed preliminary signs of clinical benefit in the early stages of development, and based on the interim data from our ongoing first-in-human phase study, ATRN-119 has demonstrated the ability to be safe and well tolerated, with no dose-limiting toxicities and no signs of significant hematological toxicity reported. We recently amended the study protocol to 1) add up to four additional groups of patients who will receive ATRN-119 twice a day (BID); 2), add an additional, higher dose level of 1,500mg once a day (QD) and 3) investigate the effect of food on ATRN-119 absorption and drug exposure in blood. Under the current new protocol, we anticipate potential efficacy data readout in second half 2025.

Previous wording

Our second clinical program is a WEE1 inhibitor, APR-1051. WEE1 is a protein kinase that inhibits premature cell cycle progression. Specifically, WEE1 prevents the premature entry of cells into both the DNA synthetic phase of the cell

Current wording

Our second clinical program is a WEE1 inhibitor, APR-1051. WEE1 is a protein kinase that inhibits premature cell cycle progression. Specifically, WEE1 prevents the premature entry of cells into both the DNA synthetic phase of the cell cycle and the phase in which cells divide after the DNA is duplicated. Through these roles, WEE1 prevents loss of genome stability, particularly in CCNE1-overexpressing cancer cells. APR-1051 is an orally bioavailable, highly potent, and selective small molecule inhibitor of WEE1. APR-1051 has demonstrated in vivo anti-proliferative activity in multiple cancer cell lines. Importantly, the pharmacodynamic properties of APR-1051 include lower off-target inhibition of three members of the PLK family of kinases (PLK1, PLK2, and PLK3), which may improve its therapeutic value. In March 2024, the FDA cleared our IND application for APR-1051 and in the second quarter of 2024 we enrolled the first patient into ACESOT-1051. A total of 8 cohorts are planned for ACESOT-1051 that will evaluate doses of 10 mg to 150 mg once daily. As of November 4, 2024, we are enrolling cohort 4 for ACESOT-1051 to evaluate a subtherapeutic dose of 50 mg once daily. Preliminary results indicate APR-1051 is safe and well-tolerated with no hematologic toxicity and one possible treatment-related grade 1 adverse event (abdominal distention) at the dose levels assessed. Active enrollment is ongoing at three sites in the U.S. (NCT06260514) with additional sites planned. We expect open-label safety/efficacy data in the first half of 2025.

Previous wording

Our management’s discussion and analysis of financial condition and results of operations is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of our financial statements and related disclosures requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, costs and expenses in our financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

Current wording

The preparation of our financial statements and related disclosures requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, costs and expenses in our financial statements. We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.

Previous wording

We also award restricted stock units (“RSUs”) to employees and directors. RSUs are generally subject to forfeiture if employment terminates prior to completion of the vesting restrictions. We expense the cost of the RSUs, which is

Current wording

We also award restricted stock units (“RSUs”) to employees and directors. RSUs are generally subject to forfeiture if employment terminates prior to completion of the vesting restrictions. We expense the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse.

Previous wording

Grant revenue primarily from the National Cancer Institute of the National Institutes of Health (“NIH”) for the three months ended June 30, 2024 and 2023 was approximately $0.6 million and $0.2 million, respectively.

Current wording

Grant revenue primarily from the National Cancer Institute of the National Institutes of Health (“NIH”) for the three months ended September 30, 2024 and 2023 was approximately $0.4 million and $0.3 million, respectively.

Previous wording

Research and development expenses for the three months ended June 30, 2024 were approximately $2.6 million, compared to approximately $2.2 million for the three months ended June 30, 2023. The overall increase of $0.4 million was primarily due to the following:

Current wording

Research and development expenses for the three months ended September 30, 2024 were approximately $2.8 million, compared to approximately $2.1 million for the three months ended September 30, 2023. The overall increase of $0.7 million was primarily due to the following:

Previous wording

General and administrative expenses for the three months ended June 30, 2024 were approximately $1.9 million, compared to approximately $1.7 million for the three months ended June 30, 2023. The increase of $0.2 million was primarily due to an increase of $0.2 million in personnel costs primarily related to severance expense.

Current wording

General and administrative expenses for the three months ended September 30, 2024 were approximately $1.6 million, compared to approximately $1.7 million for the three months ended September 30, 2023. The decrease of $0.1 million was primarily due to a decrease of $0.1 million in insurance costs.

Previous wording

Foreign currency loss for the three months ended June 30, 2024 was $5,502 compared to a foreign currency gain of $56,363 for the three months ended June 30, 2023. The change in the foreign currency of $61,865 was primarily due to a weakening of the U.S. dollar against the Swedish Krona during the three months ended June 30, 2024 as compared to the three months ended June 30, 2023. Interest income, net for the three months ended June 30, 2024 and 2023 primarily consisted of interest income on our cash and cash equivalents.

Current wording

Foreign currency loss for the three months ended September 30, 2024 was $35,494 compared to a foreign currency loss of $2,880 for the three months ended September 30, 2023. The change in the foreign currency of $32,614 was primarily due to a weakening of the U.S. dollar against the Swedish Krona during the three months ended September 30, 2024 as compared to the three months ended September 30, 2023. Interest income, net for the three months ended September 30, 2024 and 2023 primarily consisted of interest income on our cash and cash equivalents.

Previous wording

Grant revenue primarily from the National Cancer Institute of the National Institutes of Health (“NIH”) for the six months ended June 30, 2024 and 2023 was approximately $0.9 million and $0.2 million, respectively.

Current wording

Grant revenue primarily from the National Cancer Institute of the National Institutes of Health (“NIH”) for the nine months ended September 30, 2024 and 2023 was approximately $1.3 million and $0.6 million, respectively.

Previous wording

Research and development expenses for the six months ended June 30, 2024 were approximately $4.2 million, compared to approximately $3.5 million for the six months ended June 30, 2023. The overall increase of $0.7 million was primarily due to the following:

Current wording

Research and development expenses for the nine months ended September 30, 2024 were approximately $7.0 million, compared to approximately $5.6 million for the nine months ended September 30, 2023. The overall increase of $1.4 million was primarily due to the following:

Previous wording

General and administrative expenses for the six months ended June 30, 2024 were approximately $3.8 million, compared to approximately $5.1 million for the six months ended June 30, 2023. The decrease of $1.3 million was primarily due to a decrease of $1.3 million in personnel costs primarily related to severance expense for former executives.

Current wording

General and administrative expenses for the nine months ended September 30, 2024 were approximately $5.4 million, compared to approximately $6.8 million for the nine months ended September 30, 2023. The decrease of $1.4 million was primarily due to a decrease of $1.3 million in personnel costs primarily related to severance expense for former executives.

Previous wording

Foreign currency gain for the six months ended June 30, 2024 was $50,674 compared to a foreign currency gain of $42,566 for the six months ended June 30, 2023. The change in the foreign currency of $8,108 was primarily due to a strengthening of the U.S. dollar against the Swedish Krona during the six months ended June 30, 2024 as compared to the six months ended June 30, 2023. Interest income, net for the six months ended June 30, 2024 and 2023 primarily consisted of interest income on our cash and cash equivalents.

Current wording

Foreign currency gain for the nine months ended September 30, 2024 was $15,180 compared to a foreign currency gain of $39,686 for the nine months ended September 30, 2023. The change in the foreign currency of $24,506 was primarily due to a weakening of the U.S. dollar against the Swedish Krona during the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023. Interest income, net for the nine months ended September 30, 2024 and 2023 primarily consisted of interest income on our cash and cash equivalents.

Previous wording

Since our inception, we have incurred significant losses on an aggregate basis. We have not yet commercialized any of our product candidates, which are in various phases of preclinical and clinical development, and we do not expect to generate revenue from sales of any products for several years, if at all. Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more of our product candidates. Since 2019, our primary source of funds has been from the public sales of our common stock. As of June 30, 2024, we had cash and cash equivalents of $28.7 million. We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025.

Current wording

Since our inception, we have incurred significant losses on an aggregate basis. We have not yet commercialized any of our product candidates, which are in various phases of preclinical and clinical development, and we do not expect to generate revenue from sales of any products for several years, if at all. Our ability to generate product revenue sufficient to achieve profitability will depend on the successful development and eventual commercialization of one or more of our product candidates. Since 2019, our primary source of funds has been from the public sales of our common stock. As of September 30, 2024, we had cash and cash equivalents of $26.2 million. We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements through at least twelve months from the date of issuance of these condensed consolidated financial statements.

Previous wording

Our net losses were $6.3 million and $7.6 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $314.4 million. These losses have resulted primarily from costs incurred in connection with research and development activities, patent investment, and general and administrative costs associated with our operations. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years.

Current wording

Our net losses were $10.1 million and $10.8 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $318.1 million. These losses have resulted primarily from costs incurred in connection with research and development activities, patent investment, and general and administrative costs associated with our operations. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years.

Previous wording

Cash used in operating activities resulted primarily from our net losses adjusted for non-cash charges and changes in components of working capital. Net cash used in operating activities was $7.6 million for the six months ended June 30, 2024 compared to $6.2 million for the six months ended June 30, 2023. The increase in cash used in operating activities of $1.4 million was primarily attributable to a change in operating assets and liabilities of $2.7 million and a decrease in non-cash stock-based compensation of $0.1 million, partially offset by a decrease in our net loss of $1.4 million.

Current wording

Cash used in operating activities resulted primarily from our net losses adjusted for non-cash charges and changes in components of working capital. 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 nine months ended September 30, 2023. The increase in cash used

Previous wording

Cash used in investing activities of $15,478 for the six months ended June 30, 2024 was for the purchase of property and equipment. No cash was used in or provided by investing activities for the six months ended June 30, 2023.

Current wording

Cash used in investing activities of $15,478 for the nine months ended September 30, 2024 was for the purchase of property and equipment. No cash was used in or provided by investing activities for the nine months ended September 30, 2023.

Previous wording

Net cash provided by financing activities was $14.7 million for the six months ended June 30, 2024. Cash provided by financing activities for the six months ended June 30, 2024 was attributable to the net proceeds of $14.7 million, after deducting underwriting discounts and offering expenses of approximately $1.3 million, received from the sale of 1,687,712 shares of common stock, 507,076 pre-funded common stock purchase warrants, 1,097,394 tranche A common stock purchase warrants and 1,097,394 tranche B common stock purchase warrants in March 2024.

Current wording

Net cash provided by financing activities was $14.7 million for the nine months ended September 30, 2024. Cash provided by financing activities for the nine months ended September 30, 2024 was attributable to the net proceeds of $14.7 million, after deducting underwriting discounts and offering expenses of approximately $1.3 million, received from the sale of 1,687,712 shares of common stock, 507,076 pre-funded common stock purchase warrants, 1,097,394 tranche A common stock purchase warrants and 1,097,394 tranche B common stock purchase warrants in March 2024.

Previous wording

Net cash provided by financing activities of $5.1 million for the six months ended June 30, 2023 was attributable to the net proceedsof $4.9 million, after deducting underwriting discounts and offering expenses of approximately $0.6 million, received from the sale of 1,050,000 shares of common stock in February 2023 and the net proceeds of approximately $0.3 million, after deducting approximately $8,000 in issuance costs, received from sales of common stock under our ATM program.

Current wording

Net cash provided by financing activities of $5.1 million for the nine months ended September 30, 2023 was attributable to the net proceedsof $4.9 million, after deducting underwriting discounts and offering expenses of approximately $0.6 million, received from the sale of 1,050,000 shares of common stock in February 2023 and the net proceeds of approximately $0.3 million, after deducting approximately $8,000 in issuance costs, received from sales of common stock under our ATM program.

Previous wording

As of June 30, 2024, we had cash and cash equivalents of $28.7 million. We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2025. We have based this estimate on assumptions that may prove to be inaccurate, and we could exhaust our available capital resources sooner than we expect.

Current wording

As of September 30, 2024, we had cash and cash equivalents of $26.2 million. We believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements through at least twelve months from the date of issuance of these condensed consolidated financial statements. We have based this estimate on assumptions that may prove to be inaccurate, and we could exhaust our available capital resources sooner than we expect.

Previous wording

On November 12, 2020, we filed a universal shelf registration statement with the SEC for the issuance of common stock, preferred stock, warrants, rights and debt securities and units up to an aggregate of $350.0 million, or the 2020 Shelf Registration Statement. On November 30, 2020, the Shelf Registration Statement was declared effective by the SEC and expired on November 30, 2023. The universal shelf registration statement included an at-the-market offering program and we filed a Prospectus Supplement dated September 2, 2022 for the sale of up to $14,744,728 of shares of our common stock pursuant to our ATM offering program. During the six months ended June 30, 2023, we issued and sold 26,302 shares of common stock under the ATM offering program resulting in net proceeds of approximately $0.3 million after deducting approximately $8,000 in issuance costs. The ATM offering program has terminated and is no longer effective.

Current wording

On November 12, 2020, we filed a universal shelf registration statement with the SEC for the issuance of common stock, preferred stock, warrants, rights and debt securities and units up to an aggregate of $350.0 million, or the 2020 Shelf Registration Statement. On November 30, 2020, the Shelf Registration Statement was declared effective by the SEC and expired on November 30, 2023. The universal shelf registration statement included an at-the-market offering program and we filed a Prospectus Supplement dated September 2, 2022 for the sale of up to $14,744,728 of shares of our common stock pursuant to our ATM offering program. During the nine months ended September 30, 2023, we issued and sold 26,302 shares of common stock under the ATM offering program resulting in net proceeds of approximately $0.3 million after deducting approximately $8,000 in issuance costs. The ATM offering program has terminated and is no longer effective.

Previous wording

On January 26, 2024, we filed a shelf registration statement, or the 2024 Shelf Registration Statement, with the SEC for the issuance of common stock, preferred stock, warrants, rights and debt securities and units up to an aggregate of $150 million, including a prospectus for the sale of $1 million of shares of our common stock under the ATM Agreement, as discussed below, which was declared effective on February 2, 2024. We subsequently filed a prospectus supplement to the 2024 Shelf Registration Statement for the sale of up to $2 million of shares of our common stock pursuant to the ATM Agreement.

Current wording

million, including a prospectus for the sale of $1 million of shares of our common stock under the ATM Agreement, as discussed below, which was declared effective on February 2, 2024. We subsequently filed a prospectus supplement to the 2024 Shelf Registration Statement for the sale of up to $2 million of shares of our common stock pursuant to the ATM Agreement.