On November 14, 2019 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, reported financial results for the three and nine months ended September 30, 2019 and provided a corporate update (Press release, Aprea, NOV 14, 2019, View Source [SID1234551292]).
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Third quarter 2019 Corporate Update:
APR-246 Update
Earlier this month, the Company announced that it will present updated data from two Phase 1b/2 clinical studies at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper) on December 9, 2019. Data from the U.S. Phase 1b/2 trial and interim results from the French Phase 1b/2 trial of the Company’s lead product candidate APR-246 in combination with Azacitidine (AZA) in patients with TP53 mutant Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) were both chosen for oral presentations at ASH (Free ASH Whitepaper). The titles of the oral presentations are:
· "Phase 2 Results of APR-246 and Azacitidine (AZA) in Patients with TP53 mutant Myelodysplastic Syndromes (MDS) and Oligoblastic Acute Myeloid Leukemia (AML)"; and
· "APR-246 combined with Azacitidine (AZA) in TP53 mutated myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). A phase 2 study by Groupe Francophone des Myélodysplasies (GFM)"
The Company will host a Clinical Update Meeting and Webcast on December 9, 2019 at 12:00 PM ET. This Clinical Update meeting will be webcast live and can be accessed from "Events Calendar" in the News and Events section of the Company’s website at View Source
Initial Public Offering
On October 7, 2019, Aprea completed its initial public offering (IPO) of 6,516,667 shares of its common stock at a price to the public of $15.00 per share, which included the exercise in full by the underwriters of their option to purchase an additional 850,000 shares of common stock. The Company received gross proceeds, before deducting underwriting discounts and commissions and other offering expenses, of approximately $97.75 million.
Third Quarter Financial Results
·Cash and cash equivalents: As of September 30, 2019, prior to completing its IPO on October 7, 2019, Aprea had $52.3 million of cash and cash equivalents compared to $65.7 million of cash and cash equivalents as of December 31, 2018. In October 2019, the Company completed the sale of 6,516,667 shares of common stock in an initial public offering resulting in gross proceeds of approximately $97.75 million. The Company believes its cash and cash equivalents as of September 30, 2019 along with the proceeds received from its initial public offering will be sufficient to meet its current projected operating requirements into 2023.
·Research and Development (R&D) expenses: R&D expenses were $4.9 million for the quarter ended September 30, 2019, compared to $2.3 million for the comparable period in 2018. The increase in R&D expenses was primarily related to the advancement of the Company’s lead product candidate, APR-246. In Q1 2019 the Company commenced a pivotal Phase 3 clinical trial of APR-246 with azacitidine for frontline treatment of TP53 mutant MDS which is supported by two ongoing Phase 1b/2 investigator initiated trials, one in the U.S. and one in France, testing APR-246 with azacitidine as frontline treatment in TP53 mutant MDS and AML patients.
·General and Administrative (G&A) expenses: G&A expenses were $2.3 million for the quarter ended September 30, 2019, compared to $0.6 million for the comparable period in 2018. The increase in G&A expenses was primarily due to increased professional fees of approximately $1.3 million associated with preparation for the Company’s IPO, which was completed in October 2019, as well as increased personnel costs of $0.3 million.
·Net loss: Net loss was $6.2 million for the quarter ended September 30, 2019, compared to a net loss of $3.1 million for the quarter ended September 30, 2018.