Current Report Filing (8-k)
13 August 2021 - 6:26AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
August 12, 2021 (August 11, 2021)
Date of Report (Date of earliest event reported)
Aprea Therapeutics, Inc.
(Exact name of registrant as specified in
its charter)
Delaware
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001-39069
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84-2246769
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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535 Boylston Street
Boston, Massachusetts
(Address of principal executive offices)
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02116
(Zip Code)
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Registrant's telephone number, including area code:
(617) 463-9385
(Former name or former address, if changed since
last report): Not applicable
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Check the appropriate box below if the Form 8-K filing
is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨
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Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
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¨
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Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12)
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¨
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Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b))
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¨
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Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on
which registered
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Common stock, par value $0.001 per share
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APRE
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NASDAQ Global Select Market
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Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. x
Item 2.02 Results of Operations and Financial Condition
On August 12, 2021, the Company issued a press
release announcing its financial results for the second quarter ended June 30, 2021 and an update on the Company’s operations for
the same period. The Company is furnishing a copy of the press release, which is attached hereto as Exhibit 99.1.
In accordance with General Instruction B.2 of Form
8-K, the information included in this Item 2.02, including Exhibit 99.1 hereto, shall not be deemed "filed" for the purposes
of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities
of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or Securities
Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
Item 8.01 Other Events
On August 11, 2021, Aprea
Therapeutics, Inc. (“Aprea”) was notified by the U.S. Food and Drug Administration (FDA) that it placed a clinical on its
clinical trial evaluating eprenetapopt with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies. There is one CLL
patient currently on study treatment receiving eprenetapopt in combination with venetoclax and rituximab. This patient may continue to
receive study treatment as long as the patient is deriving clinical benefit. No additional patients can be enrolled until the clinical
hold is resolved. Aprea intends to work closely with the FDA to address the specific questions raised and seek to resolve the clinical
hold as soon as possible.
On August 12, 2021, the Company
issued a press release announcing the clinical hold. A copy of this press release is filed herewith as Exhibit 99.2 to this Current Report.
Item 9.01.
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Financial Statements and Exhibits.
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SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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Aprea Therapeutics, Inc.
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Dated: August 12, 2021
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By:
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/s/ Christian
S. Schade
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Name:
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Christian S. Schade
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Title:
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Chairman and Chief Executive Officer
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