Release Details
Aprea Therapeutics Reports Third Quarter 2021 Financial Results and Provides Update on Business Operations
Third Quarter Financial Results
- Cash and cash equivalents: As of
September 30, 2021 , the Company had $61.4 million of cash and cash equivalents compared to $89.0 million of cash and cash equivalents as of December 31, 2020. The Company expects cash burn for the full year 2021 to be between$30.0 million and$35.0 million . The Company believes its cash and cash equivalents as of September 30, 2021, will be sufficient to meet its current projected operating requirements into 2023. - Research and Development (R&D) expenses: R&D expenses were $6.0 million for the quarter ended September 30, 2021, compared to $8.8 million for the comparable period in 2020. The decrease in R&D expenses was primarily due to decreases in clinical trial costs for our pivotal Phase 3 clinical trial of eprenetapopt with azacitidine for the frontline treatment of TP53 mutant MDS which completed enrollment in Q2 2020 and our Phase 2 post-transplant MDS/AML clinical trial. These decreases were partially offset by increases in clinical trial costs for our other ongoing clinical trials.
- General and Administrative (G&A) expenses: G&A expenses were $3.4 million for the quarter ended September 30, 2021, compared to $3.5 million for the comparable period in 2020. The decrease in G&A expenses was primarily due to a decrease in pre-commercialization development activities which was partially offset by increased non-cash stock-based compensation.
- Net loss: Net loss was $9.5 million, or
$0.45 per share for the quarter ended September 30, 2021, compared to a net loss of $12.3 million, or$0.58 per share for the quarter ended September 30, 2020. The Company had 21,360,140 shares of common stock outstanding as ofSeptember 30, 2021 .
Business Operations Update:
Myeloid Malignancy Program
On
APR-548 Phase 1 Trial -- The Company’s second product candidate, APR-548, is a next-generation p53 reactivator that is being developed in an oral dosage form. The Company is currently enrolling a Phase 1 dose-escalation clinical trial evaluating the safety, tolerability, and preliminary efficacy of APR-548 with azacitidine in frontline and relapsed/refractory MDS patients. The trial is open and patients are enrolled in the first dosing cohort.
Lymphoid Malignancy Program
On
Solid Tumor Disease Program
Data from the Company’s Phase 1/2 clinical trial in relapsed/refractory gastric, bladder and non-small cell lung cancers assessing eprenetapopt with anti-PD-1 therapy was presented at the
Upcoming Presentations
Investigators will present data from Aprea Therapeutics’ clinical trials evaluating eprenetapopt at the upcoming 63rd
Title: Long-Term Follow-up and Combined Phase 2 Results of Eprenetapopt (APR-246) and Azacitidine (AZA) in Patients with TP53 Mutant Myelodysplastic Syndromes (MDS) and Oligoblastic Acute Myeloid Leukemia (AML)
- Date & Time:
Saturday, December 11, 2021 at3:15 pm ET
- Oral Abstract Session: 637. Myelodysplastic Syndromes—Clinical and Epidemiological: Treatment of High Risk Myelodysplastic Syndrome
Title: Phase II Trial of Eprenetapopt (APR-246) in Combination with Azacitidine (AZA) As Maintenance Therapy for TP53 Mutated AML or MDS Following Allogeneic Stem Cell Transplantation (SCT)
- Date & Time:
Sunday, December 12, 2021 at9:30 am ET
- Oral Abstract Session: 723. Allogeneic Transplantation: Long-term Follow-up and Disease Recurrence
Title: Phase I and Expansion Study of Eprenetapopt (APR-246) in Combination with Venetoclax (VEN) and Azacitidine (AZA) in TP53-Mutant Acute Myeloid Leukemia (AML)
- Date & Time:
Monday, December 13, 2021 , 6:00 –8:00 pm ET
- Poster Abstract Session: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III
About
The Company may use, and intends to use, its investor relations website at https://ir.aprea.com/ as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.
Forward-Looking Statement
Certain information contained in this press release includes “forward-looking statements”, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, related to our study analyses, clinical trials, regulatory submissions, and projected cash position. We may, in some cases use terms such as “future,” “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “targeting,” “confidence,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including risks related to the success and timing of our clinical trials or other studies, risks associated with the coronavirus pandemic and the other risks set forth in our filings with the
Source:
Corporate Contacts:
Sr. Vice President and Chief Financial Officer
617-463-9385
Sr. Vice President and Chief Business Officer
617-463-9385
Condensed Consolidated Balance Sheets
(Unaudited)
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 61,428,404 | $ | 89,017,686 | |||
Prepaid expenses and other current assets | 750,929 | 3,399,019 | |||||
Total current assets | 62,179,333 | 92,416,705 | |||||
Property and equipment, net | 27,318 | 38,515 | |||||
Right of use lease and other noncurrent assets | 278,209 | 349,999 | |||||
Total assets | $ | 62,484,860 | $ | 92,805,219 | |||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 2,548,388 | $ | 4,503,619 | |||
Accrued expenses | 6,267,429 | 10,571,237 | |||||
Lease liability—current | 223,999 | 256,309 | |||||
Total current liabilities | 9,039,816 | 15,331,165 | |||||
Lease liability—noncurrent | 29,773 | 78,847 | |||||
Total liabilities | 9,069,589 | 15,410,012 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Common stock, par value |
21,360 | 21,187 | |||||
Additional paid-in capital | 237,227,804 | 231,418,356 | |||||
Accumulated other comprehensive loss | (10,454,699 | ) | (10,037,261 | ) | |||
Accumulated deficit | (173,379,194 | ) | (144,007,075 | ) | |||
Total stockholders’ equity | 53,415,271 | 77,395,207 | |||||
Total liabilities and stockholders’ equity | $ | 62,484,860 | $ | 92,805,219 |
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
Three Months Ended |
Nine Months Ended |
|||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 6,015,616 | $ | 8,761,095 | $ | 19,433,721 | $ | 28,551,246 | ||||||||
General and administrative | 3,414,795 | 3,473,210 | 10,183,953 | 10,036,564 | ||||||||||||
Total operating expenses | 9,430,411 | 12,234,305 | 29,617,674 | 38,587,810 | ||||||||||||
Other income (expense): | ||||||||||||||||
Interest (expense) income | (33 | ) | (9,212 | ) | (1,678 | ) | 217,908 | |||||||||
Foreign currency (loss) gain | (21,907 | ) | (74,565 | ) | 247,233 | 283,636 | ||||||||||
Total other (expense) income | (21,940 | ) | (83,777 | ) | 245,555 | 501,544 | ||||||||||
Net loss | $ | (9,452,351 | ) | $ | (12,318,082 | ) | $ | (29,372,119 | ) | $ | (38,086,266 | ) | ||||
Other comprehensive income (loss): | ||||||||||||||||
Foreign currency translation | (207,608 | ) | (168,982 | ) | (417,438 | ) | (836,852 | ) | ||||||||
Total comprehensive loss | (9,659,959 | ) | (12,487,064 | ) | (29,789,557 | ) | (38,923,118 | ) | ||||||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.45 | ) | $ | (0.58 | ) | $ | (1.39 | ) | $ | (1.80 | ) | ||||
Weighted-average common shares outstanding, basic and diluted | 21,231,584 | 21,186,827 | 21,201,910 | 21,115,797 |
![](https://ml.globenewswire.com/media/YWJjYzBkNmQtZjc5ZC00ODA4LTk1YWQtYzA2ZDVmZmNmNDliLTExOTI4NDk=/tiny/Aprea-Therapeutics.png)
Source: Aprea Therapeutics