SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
Registrant’s telephone number, including area code: (
(Former name or former address, if changed since last report):
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
Name of each exchange on
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
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.
Item 5.02Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On May 5, 2023, the Board of Directors (the “Board”) of Aprea Therapeutics, Inc. (the “Company”) increased the size of the Board from eight to nine directors and appointed Gabriela Gruia, M.D., as a Class II director and new member of the Board to fill the vacancy on the Board, effective immediately, to serve until the Company’s 2024 annual meeting of stockholders or until her earlier resignation or removal. Dr. Gruia will not serve on any of the Board’s committees.
Dr. Gruia, age 66, is an oncologist with over 25 years of experience in oncology drug development, spanning cell and gene therapy, bi-specifics, biologics, immunotherapy, and small molecules and currently serves as the Founder and Principal of Gabriela Gruia Consulting, LLC. From February 2020 to January 2021, Dr. Gruia served as Chief Development Officer at Ichnos Sciences, where she oversaw development activities for several key functions, including Clinical Development and Clinical Operations, Regulatory Sciences, Clinical Pharmacology, Toxicology, and Biostatistics. From August 2004 to February 2020, Dr. Gruia was Senior Vice President and Global Head of Regulatory Affairs for Novartis Oncology, where she led the world class oncology regulatory affairs organization and oversaw all regulatory activities in close partnership with research collaborators, preclinical development, development organization and senior management. While at Novartis, Dr. Gruia spearheaded the worldwide submission and approval of multiple new molecular entities, including Tasigna®, Jakavi®, Afinitor®, Signifor®, Zykadia®, Farydak®, Rydapt®, Odomzo®, Kisqali®, Kymriah®, Adakveo®, and Piqray®. Dr. Gruia serves as a member of the board of directors of TSCAN Therapeutics, Tessa Therapeutics Ltd., and Molecular Templates, Inc. Dr. Gruia earned a doctorate in medicine from Bucharest Medical School in Romania and a Masters in Breast Pathology and Mammography from the Rene Huguenin/Curie Institute Cancer Center in Paris, France. She completed training in oncology and hematology at Rene Descartes University in Paris, France.
There are no arrangements or understandings between Dr. Gruia and any other persons pursuant to which she was chosen as a director of the Company. There are no family relationships between Dr. Gruia and any of the Company’s directors, executive officers, or persons nominated or chosen by the Company to become a director or executive officer. Dr. Gruia is not a party to any current or proposed transaction with the Company for which disclosure is required under Item 404(a) of Regulation S-K.
On May 5, 2023, Dr. Gruia was granted an option to purchase 12,500 shares of the Company’s common stock at an exercise price of $3.88 per share, which was the closing price of the Company’s common stock on Nasdaq on the date of grant. The option will vest in full on the one year anniversary of the date of grant, subject to Dr. Gruia’s continuous service.
Item 8.01Other Events.
On May 8, 2023, the Company issued a press release announcing the appointment of Dr. Gruia as a director. The full text of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Item 9.01Financial Statements and Exhibits.
Cover Page Interactive Data File (embedded within the Inline XBRL Document).
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.
Date: May 8, 2023
APREA THERAPEUTICS, INC.
/s/ Oren Gilad
Oren Gilad, Ph.D.,
President and Chief Executive Officer
Aprea Therapeutics Appoints Gabriela Gruia, M.D. to Board of Directors
DOYLESTOWN, PA, May 8 2023 (GLOBE NEWSWIRE) – Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical stage biopharmaceutical company focused on developing novel synthetic lethality-based cancer therapeutics targeting DNA damage response (DDR) pathways, today announced the appointment of Gabriela Gruia, M.D. to its Board of Directors, effective as of May 5, 2023. Dr. Gruia joins Aprea with over 25 years of clinical, regulatory and life science leadership experience.
“We are honored to welcome Dr. Gruia to the Aprea Board of Directors, where her deep experience and accomplishments in drug development and regulatory affairs will be of immense importance in advancing and expanding our pipeline of synthetic lethality inhibitors,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. “Dr. Gruia’s proven skills in executing successful drug development strategies will provide valuable support to our growing pipeline, as we look ahead to upcoming milestones, including continued advancement of our lead candidate, ATRN-119, currently in a Phase 1/2a monotherapy trial for the treatment of cancers with DDR mutations.”
Dr. Gruia currently serves as Principal at Gabriela Gruia Consulting, LLC, which she founded in January 2021. She also serves as an Independent Board Director at Tessa Therapeutics, TScan Therapeutics, and Molecular Templates. Prior to her time as a consultant, Dr. Gruia served as the Chief Development Officer at Ichnos Sciences Inc. where she led clinical development activities. Prior to that, she was Senior Vice President and Head of Drug Regulatory Affairs for Novartis Oncology, where she led an oncology regulatory affairs organization which oversaw worldwide regulatory submissions and approvals of twelve molecular oncological entities, and over 100 sNDAs and MAAs. Previously, Dr. Gruia held leadership roles in research and development at Novartis, Pfizer, Pharmacia, Aventis and Rhone Poulenc. Dr. Gruia received her M.D. from Bucharest Medical School in Romania and a Masters in Breast Pathology and Mammography from Rene Huguenin/Curie Institute Cancer Center in Paris, France. She received her training in oncology and hematology from Rene Descartes University in Paris, France.
“I am thrilled to join Aprea at this pivotal moment in the company’s growth. I was impressed by Aprea’s approach to cancer therapy using synthetic lethality, and I look forward to applying my expertise in R&D and regulatory affairs to help grow this promising pipeline of synthetic lethality inhibitors, and poise the company for success with regulatory agencies,” said Dr. Gruia. “I share Aprea’s mission and commitment to addressing unmet medical needs for patients suffering from cancers.”
About Aprea Therapeutics, Inc.
Aprea Therapeutics, Inc. is a clinical stage biopharmaceutical company headquartered in Doylestown, Pennsylvania, focused on developing and commercializing novel synthetic lethality-based cancer therapeutics targeting a critical pathway and some of the most central targets in DDR and cancer progression. The Company’s lead program is ATRN-119, a clinical-stage small molecule ATR inhibitor being developed for solid tumor indications. Our WEE1 inhibitor is being advanced to IND submission. 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.
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 and on information currently available to management that involve risks, potential changes in circumstances, assumptions, and uncertainties. All statements contained in this press release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. 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 U.S. Securities and Exchange Commission. 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 update such forward-looking statements for any reason, except as required by law.
Source: Aprea Therapeutics, Inc.
Investors and Media: