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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
October 9, 2024
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.) |
|
|
|
3805 Old Easton Road
Doylestown,
PA
(Address of principal executive offices) |
18902
(Zip Code) |
|
|
|
|
Registrant's
telephone number, including area code: (617)
463-9385
(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 |
|
Trading
Symbol(s) |
|
Name
of each exchange on
which registered |
Common
stock, par value $0.001 per share |
|
APRE |
|
The Nasdaq Stock Market LLC |
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.
Item 2.02 |
Results of Operations and
Financial Condition. |
Aprea Therapeutics, Inc. (the “Company”)
is currently finalizing its financial quarterly closing process for the three months ended September 30, 2024. While complete financial
information and operating data are not yet available, the Company expects cash and cash equivalents to be approximately $26.2 million
as of September 30, 2024, down sequentially as compared to approximately $28.7 million as of June 30, 2024.
This estimate of cash and cash equivalents is
preliminary and subject to completion. As a result, this unaudited preliminary financial information reflects the Company's preliminary
estimate with respect to such information, based on information currently available to management, and may vary from the Company’s
actual financial position as of September 30, 2024. The unaudited preliminary cash and cash equivalents figure included in this
Current Report on Form 8-K has been prepared by, and is the responsibility of, the Company’s management. The Company's independent
registered public accounting firm, EisnerAmper LLP, has not audited, reviewed, compiled or completed its procedures with respect to such
unaudited financial information and, accordingly, EisnerAmper LLP does not express an opinion or any other form of assurance with respect
thereto. It is possible that the Company or its independent registered public accounting firm may identify items that require the Company
to make adjustments to the financial information set forth above.
On October 9, 2024,
the Company issued a press release announcing that the Company engaged Phillipe Pultar, MD to serve as its Senior Medical Advisor
and that Dr. Nadeem Mirza will be stepping down as Chief Medical Officer effective as of October 9, 2024, to pursue other
professional endeavors but will remain with the Company through a date not later than December 13, 2024, to ensure a smooth
leadership transition. The full text of the press release is filed herewith as Exhibit 99.1 and incorporated herein by
reference.
Item 9.01 - |
Financial
Statements and Exhibits. |
(d) Exhibits
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.
Date: October 9, 2024 |
APREA THERAPEUTICS, INC. |
|
|
|
By: |
/s/ Oren Gilad |
|
|
Oren Gilad, Ph.D., Chief Executive Officer |
Exhibit 99.1
Aprea
Therapeutics Engages Philippe Pultar, MD to Serve as Senior Medical Advisor and Lead WEE1
Clinical Development
DOYLESTOWN, PA, October 09, 2024 (GLOBE
NEWSWIRE) – Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage
biopharmaceutical company focused on precision oncology through synthetic lethality, today announced that it has engaged Philippe Pultar,
MD as its senior medical advisor to support Aprea with developing and advancing APR-1051, Aprea’s potential best in class WEE1
inhibitor.
Dr. Pultar is a seasoned pharmaceutical
executive with extensive experience in oncology, including the development of a WEE1 inhibitor (azenosertib) from early to late-stage
clinical development. Dr. Pultar has vast experience in clinical development within both large and early-stage pharmaceutical companies.
Engaging Dr. Pultar aligns with Aprea’s commitment to provide its WEE1 inhibitor program with all the necessary resources, including
the best available professional talent and expertise, to succeed. Dr. Pultar was most recently employed at Zentalis Pharmaceuticals where
he played a key role in the strategy and execution of the global clinical development of azenosertib, a WEE1 inhibitor.
Patient enrollment is currently ongoing
in the Phase 1 ACESOT-1051 study, designed to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of
single-agent APR-1051 in advanced solid tumors harboring certain cancer-associated gene alterations. Aprea intends to provide an
update on the progress of this clinical study by year end 2024. The WEE1 program is part of Aprea’s portfolio of DDR-targeted therapeutics
aimed to deliver precision medicine solutions that ensure the right patients receive the most effective Aprea treatment, with the goals
of improving outcomes and reducing treatment resistance.
“WEE1 inhibition is a promising
therapeutic approach in oncology and my prior experience has given me a thorough understanding of biomarker driven clinical studies,
the development and regulatory landscape as well as the likely attributes for a successful therapeutic,” said Dr. Pultar. “Aprea
has a great opportunity to be a leader in this space. I am quite impressed by the progress the team has made advancing APR-1051, which
has a differentiated profile, and is supported by compelling pre-clinical data. I am very excited to be associated with this program
and I believe APR-1051 has the potential to be best in class. I look forward to working with the talented scientists at Aprea with the
goals of advancing its WEE1 program and bringing new treatments to patients battling difficult-to-treat cancers.”
“Dr. Pultar is a highly capable
scientific leader with a track record of successfully leading programs through late-stage development and regulatory approval,”
said Oren Gilad, Ph.D., President and CEO of Aprea. “Given the recent initiation of our Phase 1 ACESOT-1051 clinical trial
evaluating our promising WEE1 inhibitor, APR-1051, we are excited to bring on a high caliber advisor such as Dr. Pultar. Dr. Pultar’s
prior experience in managing multiple clinical trials for a WEE1 inhibitor is particularly relevant and we hope to leverage his expertise
as we advance our own program and maximize the therapeutic potential of APR-1051. His addition to the team is part of our broader strategy
to bring in exceptional talent with the experience and skills to successfully advance our programs.”
Dr. Nadeem Mirza will be stepping down
as Chief Medical Officer effective as of October 9, 2024, to pursue other professional endeavors but will remain with the Company through
a date not later than December 13, 2024, to ensure a smooth leadership transition.
About Philippe Pultar, MD
Dr. Pultar brings over 17 years of extensive
experience in early and late-stage clinical development. From 2020 to 2023 he was Vice President, Clinical Development at Zentalis Pharmaceuticals
where he was responsible for the strategy and execution of the global clinical development of azenosertib, working closely with co-development
partners GSK, Pfizer, and Zentera for China. He initiated seven Phase 1 and Phase 2 trials with azenosertib as single agent and in combination
with chemotherapy and targeted agents across multiple indications. Prior to Zentalis, he spent seven years at Novartis Oncology (2013
to 2020), including as Senior Clinical Development Medical Director. He was appointed Medical Lead in rare diseases and was assigned
to New Drug Application (NDA) activities for Isturisa® (osilodrostat). He led the writing and review of key EU and US NDA documents
for Isturisa®, resulting in its approval with broad indication in Cushing’s syndrome with limited post-approval commitments.
He was also Medical Lead for Phase 2, 3 and 4 trials on Isturisa®, Signifor® (pasireotide) and Odomzo® (sonidegib). Prior
to Novartis he was employed in senior clinical development roles at Agennix AG (2011 to 2013) and ImClone Systems (2007 to 2011). Earlier
in his career, he held positions at GPC Biotech, ALTANA Pharma, REDEON and MEDICERCLE.
Dr. Pultar earned his medical thesis
from Université de Médecine de Poitiers, France and practiced as a physician for several years. His foundational education
includes Medical Studies and Residency at Université de Médecine de Poitiers, providing him with a solid academic background
to complement his extensive practical experience in clinical development.
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, including timing
considerations 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, without limitation, risks related to the success, timing, and cost of our ongoing clinical trials and anticipated clinical
trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion
of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently
projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary
results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of
our ongoing clinical trials, our understanding of product candidates mechanisms of action and interpretation of preclinical and early
clinical results from its clinical development programs, and the other risks, uncertainties, and other factors described under “Risk
Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere
in the documents we file 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.
About Aprea
Aprea Therapeutics, Inc.
is a clinical-stage biopharmaceutical company headquartered in Doylestown, Pennsylvania, focused on precision oncology through synthetic
lethality. The Company’s lead program is ATRN-119, a clinical-stage small molecule ATR inhibitor in development for solid tumor
indications. APR-1051, an oral, small-molecule WEE1 inhibitor, recently entered the clinic. For more information, please visit the company
website at www.aprea.comhttps://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.
Investor Contact:
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
Media Contacts:
Ignacio Guerrero-Ros, Ph.D., or David Schull
Russo Partners, LLC
Ignacio.guerrero-ros@russopartnersllc.com
David.schull@russopartnersllc.com
(858) 717-2310
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