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
September 28, 2020
Date of Report (Date of earliest event reported)
Aprea Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39069 | 84-2246769 | |
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
|
535 Boylston Street Boston, Massachusetts 02116 (Address of principal executive offices) |
|||
|
Registrant's telephone number, including area code: (617) 463-9385
(Former name or former address, if changed since last report): Not applicable
| |||
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:
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) |
Name of each exchange on which registered | ||
| Common stock, par value $0.001 per share | APRE | NASDAQ Global Select Market |
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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On September 28, 2020, the Board of Directors (the “Board”) of Aprea Therapeutics, Inc. (the “Company”) appointed Michael A. Kelly as a Class III member of the Board. Mr. Kelly has been appointed to the Audit Committee and the Nominating and Corporate Governance Committee of the Board.
Mr. Kelly will receive the standard cash compensation amounts payable to non-employee directors of the Company, as well as the equity compensation (including the initial equity grant) described in the Company’s definitive proxy statement on Schedule 14A filed with the United States Securities and Exchange Commission on April 29, 2020.
Item 7.01 Regulation FD Disclosure.
The Company issued a press release discussing the appointment of Mr. Kelly, which is being furnished and is attached hereto as Exhibit 99.1.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
|
Exhibit |
Description |
| 99.1 | Press release issued by Aprea Therapeutics, Inc. dated September 29, 2020. |
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.
| Aprea Therapeutics, Inc. | ||
| Dated: September 29, 2020 | By: | /s/ Christian S. Schade |
| Name: | Christian S. Schade | |
| Title: | Chairman and Chief Executive Officer | |
Exhibit 99.1
Aprea Therapeutics Appoints Michael A. Kelly to Board of Directors
BOSTON, MA., September 29, 2020 (GLOBE NEWSWIRE) – Aprea Therapeutics Inc., (NASDAQ: APRE), a clinical-stage biotechnology company focused on developing and commercializing novel cancer therapeutics that reactivate mutant p53 tumor suppressor protein, today announced the appointment of Michael A. Kelly to its Board of Directors. Mr. Kelly will serve as a member of the audit committee and nominating and corporate governance committee.
Mr. Kelly brings more than 20 years of executive leadership in the life sciences industry, including 14 years in senior leadership roles with Amgen Inc., and is the Founder and President of Sentry Hill Partners, LLC, a global life sciences management consulting business. Prior to founding Sentry Hill Partners, Mr. Kelly held multiple finance and operations positions at Amgen, most recently serving as Senior Vice President of Global Business Services and, in 2010 and 2014, was acting CFO. Prior to Amgen, he held senior and executive leadership positions at Tanox, Inc. Biogen, Inc., and Monsanto Life Sciences. Mr. Kelly holds a Bachelor of Science degree in business administration from Florida A&M University.
“Michael Kelly is a distinguished industry executive with considerable experience in the management and growth of innovative life sciences companies,” said Christian S. Schade, Chairman and Chief Executive Officer of Aprea Therapeutics. “His deep operational and financial expertise will be invaluable as Aprea continues with its progress to advance our mutant p53 reactivator oncology programs toward commercialization. It is a great pleasure to welcome Michael to the Aprea team and our Board of Directors.”
About Aprea Therapeutics
Aprea Therapeutics, Inc., (NASDAQ: APRE) is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein p53. The Company’s lead product candidate is APR-246 (eprenetapopt), a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). APR-246 has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the European Commission for MDS, AML and ovarian cancer. For more information, please visit the company website at www.aprea.com.
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.
About p53 and APR-246
The p53 tumor suppressor gene is the most frequently mutated gene in human cancer, occurring in approximately 50% of all human tumors. These mutations are often associated with resistance to anti-cancer drugs and poor overall survival, representing a major unmet medical need in the treatment of cancer.
APR-246 is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein – by restoring wild-type p53 conformation and function – and thereby induce programmed cell death in human cancer cells. Pre-clinical anti-tumor activity has been observed with APR-246 in a wide variety of solid and hematological cancers, including MDS, AML, and ovarian cancer, among others. Additionally, strong synergy has been seen with both traditional anti-cancer agents, such as chemotherapy, as well as newer mechanism-based anti-cancer drugs and immuno-oncology checkpoint inhibitors. In addition to pre-clinical testing, a Phase 1/2 clinical program with APR-246 has been completed, demonstrating a favorable safety profile and both biological and confirmed clinical responses in hematological malignancies and solid tumors with mutations in the TP53 gene.
A pivotal Phase 3 clinical trial of APR-246 and azacitidine for frontline treatment of TP53 mutant MDS is ongoing. APR-246 has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration for MDS, and Orphan Drug designation from the European Medicines Agency for MDS, AML and ovarian cancer.
Forward-Looking Statements
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 clinical trials and regulatory submissions. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “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 and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
Corporate Contacts:
Scott M. Coiante
Sr. Vice President and Chief Financial Officer
617-463-9385
Gregory A. Korbel
Vice President of Business Development
617-463-9385
Source: Aprea Therapeutics, Inc.