Form 8-K
8-K — Aprea Therapeutics, Inc.
Accession: 0001104659-26-094542
Filed: 2026-08-12
Period: 2026-08-12
CIK: 0001781983
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Results of Operations and Financial Condition
Item: Other Events
Item: Financial Statements and Exhibits
Documents
8-K — apre-20260812x8k.htm (Primary)
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EX-99.2 (apre-20260812xex99d2.htm)
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8-K
8-K (Primary)
Filename: apre-20260812x8k.htm · Sequence: 1
Aprea Therapeutics, Inc._August 12, 2026
0001781983false00017819832026-08-122026-08-12
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, 2026
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: (215) 948-4119
(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
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 ☐
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 2.02Results of Operations and Financial Condition.
On August 12, 2026, Aprea Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the three and six months ended June 30, 2026, and provided 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 8.01Other Events.
On August 12, 2026, the Company updated its corporate presentation slide deck. A copy of the corporate presentation slide deck is filed as Exhibit 99.2 hereto and incorporated herein by reference.
Item 9.01Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
Number
Description
99.1
Press release issued by Aprea Therapeutics, Inc. dated August 12, 2026.
99.2
Corporate Presentation (August 2026).
104
Cover Page Interactive Data File (embedded within the inline XBRL document).
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: August 12, 2026
By:
/s/ Oren Gilad
Name:
Oren Gilad, Ph.D.
Title:
President and Chief Executive Officer
EX-99.1
EX-99.1
Filename: apre-20260812xex99d1.htm · Sequence: 2
Exhibit 99.1
Aprea Therapeutics Announces Second Quarter 2026 Financial Results
Enrollment in the ongoing Phase 1 dose escalation ACESOT-1051 trial of oral WEE1 inhibitor APR-1051 is accelerating as dose escalation advances
Aprea plans to advance APR-1051 in uterine serous carcinoma (USC), and Cyclin E–overexpressing platinum-resistant ovarian cancer (PROC) while also evaluating combination regimens with standard of care in HPV-positive head and neck cancer and colorectal cancer
Updated Phase 1 data presented at ASCO 2026 showed early single-agent activity for APR-1051, including partial responses and disease stabilization, with a manageable tolerability profile
$41.2 million in cash and cash equivalents as of June 30, 2026
DOYLESTOWN, PA, August 12, 2026 (GLOBE NEWSWIRE) — Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers,
today reported financial results for the second quarter ended June 30, 2026, and provided a business update.
"Having observed early signs of clinical activity for APR-1051, we are now expanding the ongoing ACESOT-1051 trial,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. “We are accelerating enrollment, advancing dose escalation to inform dose selection, and preparing to evaluate APR-1051 both as a single agent in uterine serous carcinoma (USC) and Cyclin E-overexpressing platinum-resistant ovarian cancer (PROC) and also in combination with standard of care in HPV-positive head and neck cancer and colorectal cancer. We look forward to sharing our next clinical data update at a medical meeting in the fourth quarter of 2026. This ongoing progress reflects our commitment to developing targeted cancer therapies that have the potential to improve outcomes and quality of life for patients, while also creating value for our shareholders."
Key Business Updates and Upcoming Key Milestones
ACESOT-1051: A Biomarker-Focused, Phase 1 Trial of Oral WEE1 Inhibitor, APR-1051
• APR-1051 is a potent and selective, oral small molecule WEE1 inhibitor designed to potentially address therapeutic window limitations observed with earlier WEE1 programs. It is currently being evaluated in ACESOT-1051, a multi-center, open-label Phase 1 study. The primary objectives of this study are safety, dose-limiting toxicity, maximum tolerated or maximum administered dose, and
RP2D. Secondary objectives include pharmacokinetics and antitumor activity assessed by RECIST/PCWG3.
• Aprea expects to report the next clinical data update from ACESOT-1051 at a medical meeting in the fourth quarter of 2026. Enrollment is accelerating ahead of this anticipated clinical catalyst, with the number of active clinical sites expanding from three to ten. The Company expects enrollment to reach 6 to 10 patients per month by Q4 of 2026, potentially increasing the pace of clinical data generation.
• Supported by the $30 million private placement that closed in the first quarter of 2026, the Company is expanding enrollment in ACESOT to include at least 50 patients with uterine serous carcinoma or cyclin E-overexpressing, platinum-resistant ovarian cancer. Completion of dose escalation and backfill expansion is anticipated in the second quarter of 2027. This expansion is intended to further characterize the clinical activity of APR-1051 in biomarker-defined tumor populations with a mechanistic rationale for WEE1 inhibition.
• Aprea also plans to evaluate APR-1051 in combination settings, supported by preclinical synergy observed in relevant disease models. In HPV-positive head and neck squamous cell carcinoma, APR-1051 will be combined with immune checkpoint therapy. In colorectal cancer, APR-1051 will be combined with a standard-of-care chemotherapy. Advancing clinically evaluated, active doses are intended to support the tolerability and dosing of APR-1051 when added to standard-of-care treatment.
• For more information on ACESOT-1051, refer to ClinicalTrials.gov NCT06260514.
APR-1051 Presentation at ASCO 2026
• On May 30, 2026, Aprea presented updated data from ACESOT-1051 in a poster titled “Early results from the first-in-human phase 1 study of WEE1 inhibitor APR-1051 in patients with advanced solid tumors (ACESOT-1051)” (Abstract #3107) at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting in Chicago, Illinois. The presentation summarized data as of a May 6, 2026 cutoff. A copy of the poster can be found on the Aprea corporate website here.
ATR inhibitor, ATRN-119
• ATRN-119 is a potent and highly selective potentially first-in-class macrocyclic ATR inhibitor designed for patients with tumors harboring mutations in DDR-related genes. Cancers with mutations in DDR-related genes represent a high unmet medical need, and these patients often have a poor prognosis and currently lack effective therapeutic options.
• During 2025, Aprea determined the recommended Phase 2 monotherapy dose (RP2D) of 1,100 mg once daily for ATRN-119 in the ABOYA-119 Phase 1/2a dose-escalation study and subsequently closed this study to focus resources on the clinical development of APR-1051. Building on the completion of dose escalation, the Company is considering further ATRN-119 development in combination approaches that could expand its therapeutic potential. Aprea believes ATRN-119's mechanism of action, potentially favorable safety profile, and pharmacologic characteristics could make it an ideal candidate for combination with other anti-cancer therapies, including radiation therapy, chemotherapy, antibody-drug conjugates (ADCs) and immune checkpoint inhibitors.
• Aprea is currently in discussions with leading academic centers to explore various combinations for ATRN-119. These include investigator-initiated studies evaluating ATRN-119 in combination with I/O
agents, chemotherapy, ADCs and/or radiation. Potential indications for these combinations include advanced solid tumors (e.g. HPV+ head and neck cancers, sarcomas, ovarian, colorectal, lung) and hematologic malignancies (e.g. Acute Myeloid Leukemia, Myelodysplastic syndromes).
Pipeline
• Aprea also has an early-stage program, a macrocyclic DYRK1A/B inhibitor, that potentially could enter IND enabling studies in the fourth quarter of 2026, subject to available resources.
Financial Results for the Second Quarter Ended June 30, 2026
• As of June 30, 2026, the Company reported cash and cash equivalents of $41.2 million, compared to $14.6 million as of December 31, 2025. The Company believes that its cash and cash equivalents as of June 30, 2026 will be sufficient to meet its currently projected operating expenses and capital expenditure requirements into the first quarter of 2028.
• For the second quarter ended June 30, 2026, the Company reported an operating loss of $4.0 million, compared to an operating loss of $3.4 million in the second quarter of 2025.
• Research and Development (R&D) expenses were $2.5 million for the quarter ended June 30, 2026, compared to $1.9 million for the second quarter of 2025. The increase in R&D expense was primarily related to higher expenses in ACESOT-1051, our Phase 1 dose-escalation study for APR-1051, partially offset by lower expense in the ABOYA-119 clinical trial to evaluate ATRN-119, which has been closed.
• General and Administrative (G&A) expenses were $1.6 million for each of the quarters ended June 30, 2026 and 2025.
• The Company reported a net loss of $3.6 million, or $(0.07) per basic share, on approximately 53.5 million weighted-average common shares outstanding for the quarter ended June 30, 2026, compared to a net loss of $3.2 million, or $(0.53) per basic share, on approximately 6.1 million weighted-average common shares outstanding for the comparable period in 2025.
About Aprea
Aprea is a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers. The Company is pioneering a new approach to treat cancer by exploiting vulnerabilities associated with cancer cell mutations. This approach was developed to kill tumors while minimizing the effect on normal, healthy cells. Aprea’s technology has potential applications across multiple cancer types, enabling it to target a range of tumors, including ovarian, endometrial, colorectal and head and neck squamous cell carcinoma. The company’s lead programs are APR-1051, an oral, small-molecule inhibitor of WEE1 kinase, and ATRN-119, a small molecule ATR inhibitor, both in clinical development for solid tumor indications. 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, development plans 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 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, and 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 product candidates, our research and development efforts, including timing considerations and other matters regarding our business strategies, use of capital, results of operations and financial position, projected cash runway, plans and objectives for future operations, the timing, progress, enrollment and completion of our ongoing and planned clinical trials, the timing of expected clinical data updates and medical meeting presentations, the potential expansion of ACESOT-1051, the potential development of APR-1051 in single-agent and combination settings, the potential further development of ATRN-119, and the potential advancement of our early-stage programs. 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 and anticipated clinical trials for our current product candidates, including the timing of initiation, pace of enrollment and completion of trials, our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses, the receipt and timing of interim or preliminary results, which are not necessarily indicative of final results, our understanding of product candidate mechanisms of action and interpretation of preclinical and early clinical results from our clinical development programs, our ability to predict clinical outcomes based on such preclinical and early clinical results, the timing and outcome of regulatory interactions, and the other risks, uncertainties and 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.
Investor Contact:
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
Aprea Therapeutics, Inc.
Consolidated Balance Sheets
June 30, 2026
December 31, 2025
Assets
(unaudited)
Current assets:
Cash and cash equivalents
$
41,233,428
$
14,599,347
Prepaid expenses and other current assets
679,686
961,899
Total current assets
41,913,114
15,561,246
Property and equipment, net
64,033
59,807
Restricted cash
41,615
41,186
Other noncurrent assets
271,162
271,162
Total assets
$
42,289,924
$
15,933,401
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
935,139
$
713,668
Accrued expenses
2,157,163
2,050,690
Total current liabilities
3,092,302
2,764,358
Commitments and contingencies
Series A convertible preferred stock, $0.001 par value, 40,000,000 shares authorized; 31,194 shares issued and outstanding at June 30, 2026 and December 31, 2025
727,361
727,361
Stockholders’ equity:
Common stock, $0.001 par value, 400,000,000 shares authorized, 12,391,136 and 8,192,538 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively
12,391
8,192
Additional paid-in capital
389,596,149
356,709,645
Accumulated other comprehensive loss
(10,617,617)
(10,634,714)
Accumulated deficit
(340,520,662)
(333,641,441)
Total stockholders’ equity
38,470,261
12,441,682
Total liabilities and stockholders' equity
$
42,289,924
$
15,933,401
Aprea Therapeutics, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
Three Months Ended June 30,
Six Months Ended June 30,
2026
2025
2026
2025
Grant revenue
$
—
$
118,111
$
—
$
280,574
Operating expenses:
Research and development
2,462,042
1,912,213
4,073,209
4,395,279
General and administrative
1,570,138
1,593,671
3,389,383
3,358,650
Total operating expenses
4,032,180
3,505,884
7,462,592
7,753,929
Loss from operations
(4,032,180)
(3,387,773)
(7,462,592)
(7,473,355)
Other income (expense):
Interest income, net
358,923
178,027
493,707
382,753
Other income
79,000
—
79,000
—
Foreign currency gain (loss)
2,953
(29,124)
10,664
(80,927)
Total other income
440,876
148,903
583,371
301,826
Net loss
$
(3,591,304)
$
(3,238,870)
$
(6,879,221)
$
(7,171,529)
Other comprehensive loss:
Foreign currency translation
8,083
(1,681)
17,097
(1,038)
Total comprehensive loss
$
(3,583,221)
$
(3,240,551)
$
(6,862,124)
$
(7,172,567)
Net loss per share attributable to common stockholders, basic and diluted
$
(0.07)
$
(0.53)
$
(0.20)
$
(1.19)
Weighted-average common shares outstanding, basic and diluted
53,483,504
6,083,329
34,191,653
6,038,845
EX-99.2
EX-99.2
Filename: apre-20260812xex99d2.htm · Sequence: 3
Exhibit 99.2
1
| © 2026 Aprea Therapeutics, Inc. All Rights Reserved
A clinical-stage precision
medicine oncology company
focused on the discovery and
development of targeted
therapies for patients with
biomarker-defined cancers
August 2026
2
| © 2026 Aprea Therapeutics, Inc. All Rights Reserved
Forward-Looking Statements
Certain information contained in this presentation 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
presentation 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 product candidates, our research and development efforts, including timing considerations and other
matters regarding our business strategies, use of capital, results of operations and financial position, project cash runway, plans and objectives for future
operations, the timing, progress, enrollment and completion of our ongoing and planned clinical trials, the timing of expected clinical data updates and medical
meeting presentations, the potential expansion of ACESOT-1051, the potential development of APR-1051 in single-agent and combination settings, the potential
further development of ATRN-119, and the potential advancement of our early-stage programs. 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 and anticipated clinical trials for our current product
candidates, including the timing of initiation, pace of enrollment and completion of trials, our ability to fully fund our disclosed clinical trials, which assumes no
material changes to our currently projected expenses, the receipt and timing of interim or preliminary results, which are not necessarily indicative of final results,
our understanding of product candidate mechanisms of action and interpretation of preclinical and early clinical results from our clinical development programs, our
ability to predict clinical outcomes based on such preclinical and early clinical results, the timing and outcome of regulatory interactions, and the other risks,
uncertainties, and 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 presentation. We undertake no obligation to update such forward-looking statements for any reason, except
as required by law. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of any
securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any
such state or jurisdiction. This presentation may not be reproduced, forwarded to any person or published, in whole or in part.
APR-1051 and ATRN-119 are investigational drugs and have not yet been approved by the U.S. Food and Drug Administration or any other regulatory authority.
3
| © 2026 Aprea Therapeutics, Inc. All Rights Reserved
Aprea Therapeutics (NASDAQ: APRE)
One Critical Pathway - Multiple Targets
1. Ngoi N, et al. Targeting the replication stress response through synthetic lethal strategies in cancer medicine.
Trends in Cancer. (2021); 7(10):930-957
Precision
Medicine
Synthetic
Lethality Aprea
DYRK1
Target
Trends in Cancer 1
Positioned at the forefront of synthetic lethality and precision medicine
Transition from broad, toxic chemotherapy
to potentially safer, precision-guided
targeted therapies
Targeted Oncology
Develop highly selective cancer therapies
that exploit tumor-specific mutations to
maximize cancer cell killing while sparing
healthy tissue
Precision-Driven
Development
All programs are designed to address
significant unmet medical needs across
genetically defined cancer populations
Pipeline with
Clinical Momentum
Preliminary signals of monotherapy activity
observed in ongoing Phase 1 trial
Early Clinical
Proof-of-Concept
4
| © 2026 Aprea Therapeutics, Inc. All Rights Reserved
2025 2026 2027 2028
H2 H1 H2 H1 H2 H1 H2
Financing
WEE1
APR-1051
ATR
ATRN-119
(mosipasertib)
DYRK1
APR-1602
Robust DDR Development Pipeline and Corporate Milestones
2025-2028 Accomplished and anticipated milestones
DNA Damage Response (DDR)
*Planned major medical conference presentation
**FPI contingent upon execution of a research collaboration or partnering agreement; study initiation is expected to
be externally supported without use of current company resources.
RP2D for
QD dosing
ACESOT-1051: Phase 1 – Monotherapy Dose Escalation
Complete Dose
Escalation and Backfill
ACESOT-1051: Monotherapy Dose Selection Optimization
Safety &
Efficacy Data
Safety &
Efficacy Data
Phase 1/2a : Combinations to Expand Therapeutic Potential
Open Backfill
Cohorts
Lead Identification and Optimization
ABOYA-119: Phase 1/2a
Dose Escalation: QD/BID
Interim Safety &
Efficacy Presentation*
FPI**
IND Ready
$30 Million Raise
Enriched for USC and Cyclin E PROC
Combinations in HPV+ Head and Neck Cancer and Colorectal Cancer
5
| © 2026 Aprea Therapeutics, Inc. All Rights Reserved
Strong Drug Development and Commercial Expertise
Experienced team in synthetic lethality and targeted therapy
Management
Board of Directors
Richard Peters, MD, PhD
Chairman of the Board
Oren Gilad, PhD
President and CEO
Jean-Pierre Bizzari, MD
Director
Marc Duey
Director
Michael Grissinger
Director
Gabriela Gruia, MD
Director
John Henneman
Director
Rifat Pamukcu, MD
Director
Bernd R. Seizinger, MD, PhD
Director
Oren Gilad, PhD
President and CEO
John P. Hamill
SVP and CFO
Eugene Kennedy, MD
Chief Medical Advisor
Ze’ev Weiss, CPA,
BSc
Chief Business Advisor
Mike Carleton, PhD
Translational Medicine
Advisor
Brian Wiley
SVP, Corporate
Strategy
6
| © 2026 Aprea Therapeutics, Inc. All Rights Reserved 6
WEE1 Inhibitor: APR-1051
ACESOT-1051:
Clinical Proof-Of-Concept
7
| © 2026 Aprea Therapeutics, Inc. All Rights Reserved
WEE1 Has Emerged as a Therapeutic Target of Significant Industry Interest
1. Zentalis Corporate Presentation, April 2026
2. Debio 0123-101, A Phase 1 Trial of Debio 0123 In Combination With Carboplatin In Advanced Solid Tumors:
Safety, Pharmacokinetic, And Preliminary Antitumor Activity Data, Poster ASCO 2023
3. Abstract 3120, ASCO 2024
4. Poster CT022, AACR 2026
Clinically validated, prior WEE1 inhibitors have been challenged by narrow therapeutic windows
Aprea is applying key insights to advance APR-1051 as a potentially best-in-class WEE1 inhibitor
Program Clinical Limitations Strategic Outcome What It Signals
Adavosertib
(AstraZeneca)
Hematologic & GI toxicity limited
dose intensity
Terminated further clinical development
Returned by AstraZeneca to
Merck & Co.
Biology works, narrow
therapeutic window
Azenosertib
(Zentalis) Continuous dosing not tolerated1 TRAEs leading to dose reductions,
interruptions and discontinuation
Biology works, therapeutic
window still being defined
Debio 0123
(Debiopharm)
QT prolongation liability at high
doses2
Limited single-agent activity – no
responses up to MTD3; activity seen in
combination with PKMYT1 inhibitor4
Potential future as
combination agent
No head-to-head studies have been conducted. Trial information is based on publicly available data and should be interpreted cautiously
Program Engineered Profile Strategic Outcome What It Signals
APR-1051
(Aprea Therapeutics)
Structurally differentiated, highly
potent, limited off-target
inhibition
Preliminary signals of monotherapy
activity without class-limiting tox to date
Potential to expand
therapeutic window
TRAEs – Treatment related adverse events
8
| © 2026 Aprea Therapeutics, Inc. All Rights Reserved
ACESOT-1051: Phase 1 Study Design
Multi-center, open-label Phase 1 single-agent dose escalation and dose selection optimization
Part 1 Dose escalation
up to 100 patients
RP2D
Oral single-agent APR-1051 will be administered once-daily for 28-day cycles
Objectives
Primary: Safety, DLT, MTD/MAD, RP2D
Secondary: Pharmacokinetics, Antitumor activity (RECIST/PCWG3)
Exploratory: Pharmacodynamics
= cleared
Accelerated titration; 1-6 patients per dose level
BOIN design; 3-12 patients per dose level
Part 2 Dose selection optimization
Up to 80 patients
Selected
dose 2
Selected
dose 1
1:1
randomization
R
Dose level 1-3
10 – 30 mg
Dose level 4
50 mg
Dose level 5
70 mg
Dose level 6
100 mg
Dose level 7
150 mg
Dose level 8
220 mg
Dose level 9
300mg
Confirmed
PR Observed
First uPR
Observed
Select 2
dose levels
Eligible patients
≥ 18 yo with advanced solid
tumor harboring cancer-associated gene alterations
o USC regardless
biomarker status
o Cyclin E-overexpressing
platinum-resistant
ovarian cancer (PROC)
o CCNE1, CCNE2, FBXW7
or PPP2R1A
o HPV+ oropharyngeal
squamous cell carcinoma,
cervical, vaginal, or vulvar
carcinoma
o KRAS-GLY12/GLY13 &
TP53 colorectal cancer
= currently enrolling
Backfill
Backfill
Backfill
Dose level 10
400mg
Dose level 11
500mg
Backfill
9
© 2026 Aprea Therapeutics, Inc. All Rights Reserved
223
49
43
178
56
36
112
85
181
28
38
21
12
140
58
84
44
13
9
0 50 100 150 200 250
01-005
03-005
02-003
03-006
01-006
03-007
03-008
01-008
01-010
03-010
03-013
01-014
03-011
01-011
03-012
01-012
01-013
01-015
02-004
300 mg
220 mg
150 mg
100 mg
70 mg
Days on treatment
Study patient
✼
APR-1051 once-daily dose
Not all data source verified
Data Cutoff: May 6, 2026
APR-1051 Summary of Duration of Treatment (n=28 for all dose levels)
✼ Progressive disease (PD)
Stable disease (SD)
Consent withdrawn
Treatment continues
Unrelated death
Partial response (PR)
Enrollment status
✼
✼
✼
✼
✼
✼
✼
✼
✼
Not shown:
50 mg (n=6)
30 mg (n=1)
20 mg (n=1)
10 mg (n=1)
10 © 2026 Aprea Therapeutics, Inc. All Rights Reserved
MedDRA Preferred Term APR-1051 All dose levels (N=28)
Treatment-related AEs, n (%)a All Grades Grade ≥ 3b
Nausea 10 (35.7) 0 (0)
Fatigue 4 (14.3) 0 (0)
Vomiting 3 (10.7) 0 (0)
Alanine aminotransferase increased 1 (3.6) 1 (3.6)c
Anemia 1 (3.6) 0 (0)
Aspartate aminotransferase increase 1 (3.6) 1 (3.6)c
Blood bilirubin increased 1 (3.6) 0 (0)
Constipation 1 (3.6) 0 (0)
Dehydration 1 (3.6) 0 (0)
Dysgeusia 1 (3.6) 0 (0)
Dyspepsia 1 (3.6) 0 (0)
Eczema 1 (3.6) 0 (0)
Gastroesophageal reflux disease 1 (3.6) 0 (0)
Hypokalemia 1 (3.6) 0 (0)
Lymphocyte count decreased 1 (3.6) 1 (3.6)
Platelet count decreased 1 (3.6) 0 (0)
Treatment-related AEs in Patients Treated with APR-1051 (N=28)
a A patient may have more than one AE and/or have the same AE more than once
b Grade 3 unless otherwise indicated
c Increased alanine aminotransferase and aspartate aminotransferase occurred in the same patient, was determined to be serious, and considered one DLT event
Not all data source verified
Data Cutoff: May 6, 2026
11 © 2026 Aprea Therapeutics, Inc. All Rights Reserved
Confirmed Partial Response in Patient 01-011
220mg QD – Currently on treatment
Demographics: 63-year-old Black Female
Site: MD Anderson Cancer Center
Diagnosis: Uterine carcinosarcoma
Key Mutations: PPP2R1A
Treatment History (4 prior lines)
• Line 1: Carboplatin + Paclitaxel → 126 days, PD
• Line 2: Doxorubicin → 56 days, PD
• Line 3: Topotecan → 70 days, PD
• Line 4: Pembrolizumab + Lenvatinib → 5months, PD
APR-1051 – Treatment Outcome
• C1D1: Dec 18, 2025
• Current Status: On treatment 140 days (C6D1) – May 6, 2026
• Best Response: Confirmed Partial Response (PR)
• PR (-50%) at first assessment Feb 10, 2026
• Confirmed PR with additional -9.5% reduction from C3D1 Mar 10, 2026; scan April 8, 2026 showed 0% change
• Tumor marker: CA-125 reduction from BL 362.4 U/mL to C3D1 46.8 U/mL (87% decrease); 40.2 U/mL Mar 11, 2026; 53 U/ml April 08, 2026
• Adverse Events: C1D22 Gr 1 rash. C1D15 Gr1 thrombocytopenia , possibly related to IP; intermittent nausea Gr1 probably related; amylase
increase Gr1 unlikely related. No DLT
12 | © 2026 Aprea Therapeutics, Inc. All Rights Reserved
Disease Control Observed in Early Patient Outcomes
APR-1051 shows preliminary evidence of disease control in rectal cancer with mutated FBXW7
100 mg Cohort Case Report
Patient: 86-year-old Asian Female
Diagnosis: Rectal Cancer
Key Mutations: FBXW7 (Drives Cyclin E accumulation and overexpression)
Treatment History: 5 prior lines - heavily pretreated
• Line 1: Capecitabine/oxaliplatin → 191 days, PD
• Line 2: Capecitabine/oxaliplatin/bevacizumab → 45 days, PD
• Line 3: FOLFIRI + bevacizumab → 43 days, PD
• Line 4: Local XRT (lung mets) → 12 days, not evaluable
• Line 5: Tretinoin/bevacizumab/Tecentriq (ATRT trial) → 50 days, PD
APR-1051 Activity:
• Current Status: Consent withdrawn after 178 days
• Best Response: SD at third scan (-15% tumor response)
Notes: Durable SD maintained 181 days in a heavily pretreated 86-year-old patient; well tolerated with minimal toxicity.
FBXW7 mutation may be relevant to response
Stable disease maintained for 178 days in patient with FBXW7 mutation (100 mg QD) (elected to stop study participation)
13 | © 2026 Aprea Therapeutics, Inc. All Rights Reserved
70 mg Cohort Case Report
Disease Control Observed in Early Patient Outcomes
Patient: 62-year-old White Male
Diagnosis: HPV+ Oropharyngeal Squamous Cell Carcinoma (base of tongue)
Key Mutations: P16+
Treatment History: 3 prior lines
• Line 1: Concomitant cisplatin/XRT → 49 days, PD
• Line 2: Pembrolizumab→ 84 days, PD
• Line 3: Paclitaxel/carboplatin → 184 days, PD
APR-1051 Activity
• Current Status: PD after 223 days of SD treatment
• Best Response: SD at first scan (-5% tumor response)
Notes: Stable disease maintained for 223 days.
APR-1051 shows preliminary evidence of disease control in HPV+ head and neck cancer
Stable disease maintained for 223 days in patient 01-005 HPV+ head and neck cancer (70 mg QD) (PD)
14 | © 2026 Aprea Therapeutics, Inc. All Rights Reserved
Biomarker Defined Registration Path
*Data as of May 6, 2026 and are preliminary from an ongoing dose-escalation study. Responses and stable disease
require confirmation in additional patients and may change as follow-up matures. Safety and efficacy outcomes may
vary by dose, schedule, and patient characteristics.
Preliminary signals of monotherapy activity across cohorts in genomically defined tumors including
uterine cancer, endometrial cancer, CRC and HNSCC
• Responses across dose levels support a biomarker enriched expansion path
• Activity beyond endometrial cancer supports additional biomarker-defined cohorts
Clinical Activity by Indication and Biomarker Path to Registrational Cohort
1 Expand USC and CycE-PROC
Add additional cohorts
• CRC FBXW7-mutated
• HPV+ cancers
• PPP2R1A mutated
2
Confirm durability, consistency of
response and safety 3
Indication Biomarker / Altered
Genes
Clinical Activity in
ACESOT-1051*
Uterine/
Endometrial
Cancer
PPP2R1A
2 PR
CCNE1 overexpressed 2 SD
TP53
CRC
KRAS & TP53
3 SD
FBXW7
HNSCC HPV+ 1 SD
15 | © 2026 Aprea Therapeutics, Inc. All Rights Reserved 15
APR-1051:
Potentially Differentiated WEE1 Inhibitor
Pre-Clinical
16 | © 2026 Aprea Therapeutics, Inc. All Rights Reserved
APR-1051: Potentially Best-in-Class WEE1 Inhibitor
Structurally differentiated: high potency, limited off-target inhibition design compared to other molecules
AstraZeneca
Adavosertib (AZD-1775)
Zentalis
Azenosertib (ZN-c3)
Aprea
APR-1051
Undisclosed
APR-1051 is based on a different molecular structure than AZD-1775 and ZN-c3 (not an analogue)
No head-to-head clinical studies have been conducted.
17 | © 2026 Aprea Therapeutics, Inc. All Rights Reserved
APR-1051: Potentially Best-in-Class WEE1 Inhibitor
Potent inhibitor of WEE1
Does not substantially inhibit structurally and functionally related PLK1, PLK2 or PLK3
-10 -9 -8 -7 -6 -5 -4
0
25
50
75
100
125
PLK1 IC50 Determination
Log10 [conc] (M)
% Activity
ZN-c3
APR-1051
-10 -9 -8 -7 -6 -5 -4
0
25
50
75
100
125
PLK2 IC50 Determination
Log10 [conc] (M)
% Activity
ZN-c3
APR-1051
-10 -9 -8 -7 -6 -5 -4
0
25
50
75
100
125
PLK3 IC50 Determination
Log10 [conc] (M)
% Activity
ZN-c3
APR-1051
ZN-c3 = 92.1 nM
APR-1051 = 15,900 nM
PLK1 Inhibition
IC50 >150-fold difference
ZN-c3 = 32.0 nM
APR-1051 = 1,800 nM
PLK2 Inhibition
IC50 >50-fold difference
ZN-c3 = 52.2 nM
APR-1051 = 31,600 nM
PLK3 Inhibition
IC50 >600-fold difference
Important difference in off-target inhibition between APR-1051 and ZN-c3 On 1
-target WEE1 potency1
ZN-c3 = 2.9 nM
APR-1051 = 1.6 nM
WEE1 Inhibition
IC50 similar to ZN-c3
125
100
75
50
25
0
10 9 8 7 6 5
APR 1051
c3
WEE1 IC50 Determination
% Activity
Log10 [conc] (M)
AACR-NCI-EORTC Meeting, Poster B323, 2024
1Data from exploratory in-vitro studies. No head-to-head clinical studies have been conducted.
APR-1051 specificity for WEE1 opens potential for greater therapeutic window
18 | © 2026 Aprea Therapeutics, Inc. All Rights Reserved
PLK1 Inhibition Counteracts Effect of WEE1 Inhibitors1
Minimal PLK1 co-inhibition enhances therapeutic window for APR-1051 37 nM 111 nM 333 nM 1 µM 37 nM 111 nM 333 nM 1 µM
Phos-H2AX
Control
(MCM3)
NT
Phos-CDK1
APR-1051
75 nM
GSK-PLKi
Control
(MCM3)
37 nM
111 nM
333 nM
1 µM
37 nM
111 nM
333 nM
NT
1 µM
Phos-H2AX
400 nM
BI-PLKi
APR-1051
Phos-CDK1
PLK inhibitor, BI-2536, interferes with the
effects of APR-1051 in OVCAR-3 cells
1 AACR-NCI-EORTC Meeting, Poster B323, 2024 Data from exploratory in-vitro studies
Evidence of DNA damage
allowed by WEE1 inhibition.
PLK1 reduces functional
potency of WEE1 inhibition
PLK inhibitor, GSK-461364, interferes with
the effects of APR-1051 in OVCAR-3 cells
Inhibition of PLK1 reduces efficacy of WEE1 inhibition. Results in requiring higher
doses of WEE1 inhibitors and introduces PLK1 related toxicity
19 | © 2026 Aprea Therapeutics, Inc. All Rights Reserved
Studies Show PLK1 Suppression is Associated with Sepsis-Induced
Loss of Intestinal Barrier Function
1 PLK1 protects against sepsis-induced intestinal barrier dysfunction, Cao et al, Scientific Reports (2018).
2 PLK1 protects intestinal barrier function in sepsis: A translational research, Cao et al, Cytokine (2023).
3 PLK1 protects intestinal barrier function in sepsis: A translational research, Cao et al, Molecular Medicine (2022).
4 LncRNA DANCR improves the dysfunction of the intestinal barrier and alleviates epithelial injury by targeting the
miR‐1306‐5p/PLK1 axis in sepsis, Wang et al., Cell Biology International (2021).
20 | © 2026 Aprea Therapeutics, Inc. All Rights Reserved
HPV+ Cancer – Collaboration with MD Anderson Ovarian Cancer*
UMSCC47 tumor cells OVCAR3 tumor xenograft
Tumor Volume (mm3
)
Vehicle
Aprea ATRi 30 mg/kg QD
Aprea WEE1i 30 mg/kg QD
Combination – half dose,
15mg/kg each
Days Post Treatment
Tumor Volume (mm3
)
Days since start of xenograft
mEER tumor cells
Tumor Volume (mm3
)
Days since start of xenograft
APR-1051 Showed Preclinical Activity in Combination with Chemo, IO
and ATRi Across Multiple Cancer Models
* Data on file.
Start of
treatment
3
rea ed
AP
Cis a i
C
Start of
treatment
** P<0.0001
* P=0.0067
**
** *
Chemotherapy Immuno-oncology DDR combination
APR-1051 suggests synergistic potential preclinically with standard oncology agents
21 | © 2026 Aprea Therapeutics, Inc. All Rights Reserved
APR-1051 WEE1 Summary
A next-generation WEE1i with the potential to deliver meaningful clinical benefit and durable value
1
Clinically validated target
• WEE1 inhibitors have shown promising activity in genomically defined tumors
• Competitor programs constrained by low therapeutic window
APR-1051 clinical highlights
• Preliminary clinical proof-of-concept at 150 mg and 220 mg dose levels with two partial
responses and six patients with stable disease presented at ASCO 2026
• Potentially favorable safety profile at active dose levels
• Enrollment accelerating with expansion from three to ten active clinical sites
• Interim clinical data to be presented Q4 2026
APR-1051 preclinical differentiation and potentially best-in-class opportunity
• Novel structure with high potency, limited off-target inhibition design
• Minimal PLK1 inhibition enhances therapeutic window
• Potential for synergy demonstrated in combination with standard oncology agents
2
3
22 | © 2026 Aprea Therapeutics, Inc. All Rights Reserved 22
Intellectual Property Portfolio
Financial Summary & Capitalization
Investment Highlights
23 | © 2026 Aprea Therapeutics, Inc. All Rights Reserved
Robust Global Intellectual Property Protection
Family 1 Ataxia Telangiectasia and
Rad3-Related (ATR) Protein
Kinase Inhibitors
• Macrocyclic inhibitors of ATR & methods of using them to treat various cancers, filed on Oct. 13th, 2015
• Patents granted in AU, BR, CA, CN, EP, IL, IN, JP, KR, MX, HK.
• 1.1: Issued on May 30, 2017 as U.S. Patent 9,663,535; 1.2: Issued on May 29, 2018 as U.S. Patent 9,981,989; 1.3: Issued
on Feb. 5, 2019 as U.S. Patent 10,196,405
Family 2 ATR Inhibitors and Methods
of Use
• Carboxylic acid-containing macrocyclic ATR inhibitors, and prodrugs; methods of using these inhibitors to treat various
cancers; filed on Apr. 12, 2017
• Issued on May 28th, 2019 as U.S. Patent 10,301,324
Family 3 ATR Inhibitor Pharmaceutical
Composition and Methods
• International application filed on Apr. 14, 2023
• Pharmaceutical formulation and composition of our lead ATR inhibitor in the clinic
• Patent granted in JP and EA; Applications pending US, AU, BR, CA, CN, EP, HK, IL, IN, KR, MX, NZ, PH, SG, ZA
Family 4 WEE1 Inhibitor
Pharmaceutical
Compositions and Methods
• International Application filed on Jun. 3, 2022
• Composition of our lead WEE1 inhibitor compounds
• Patent granted in AU; Applications pending in US, AU, BR, CA, CN, EP, HK, IL, IN, JP, KR, MX, ZA
Family 5 Methods of Treating Cancer • Clinical methods of treating advanced solid cancer tumors using lead ATR inhibitor
• International application filed on Sept. 19, 2025
Family 6 Macrocyclic DYRK1A-B
Inhibitors and Methods of
their Preparation and Use
• International application filed on Jan. 22, 2026
• Macrocyclic inhibitors of DYRK1A-B and methods of using them to treat disease
Family 7 Macrocyclic DDR Target
Inhibitors and Methods of
their Preparation and Use
• International application filed on Jan. 25, 2026
Family 8 Methods of Treating Cancer • Provisional application filed on Jan. 9, 2026
• Clinical methods of treating cancer using lead Wee1 inhibitor
24 | © 2026 Aprea Therapeutics, Inc. All Rights Reserved
Securities Common Equivalents
as of August 12, 2026
Preferred Stock (as converted) 15,596
Common Stock (1) 12,591,136
Warrants (2) 89,438,517
Options 1,137,333
Restricted Stock Units 65,438
Fully Diluted Equivalents 103,248,020
Aprea Therapeutics (NASDAQ: APRE)
1. 400,000,000 common shares authorized
2. Total warrants include pre-funded, Tranche A, Tranche B and Purchase
Cash and Equivalents of ~$41.2M as of June 30, 2026
$30.0M in gross proceeds raised in private placement that closed on March 31, 2026
Financial Summary and Capitalization
25 | © 2026 Aprea Therapeutics, Inc. All Rights Reserved
Expected cash runway into Q1 2028
• Achieve near term inflection points and catalysts
• Evaluate optimal strategic partnerships
Near term catalysts
• APR-1051: Q4 2026 Interim clinical data; Q2 2027 Complete dose escalation
• ATRN-119: October 2025 RP2D ✓ H2 2026 Potential collaborations on combinations
Highly potent and selective design, potential best in class inhibitors
• Diversified portfolio including WEE1 (APR-1051) and ATR (ATRN-119) inhibitors
• Preliminary evidence of clinical activity including PRs with APR-1051
• Single agent and combination potential therapies
Technology developed by pioneers in synthetic lethality
• Management with strong drug development and commercial expertise
• Focused on addressing unmet needs for patients with biomarker defined cancers
Investment Highlights
26 | © 2026 Aprea Therapeutics, Inc. All Rights Reserved
Aprea Therapeutics
(NASDAQ: APRE)
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- Definition
Name of the state or province.
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No definition available.
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dei_EntityAddressStateOrProvince
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dei:stateOrProvinceItemType
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- Definition
A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
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- Definition
Indicate if registrant meets the emerging growth company criteria.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
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- Definition
Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
No definition available.
+ Details
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dei_EntityFileNumber
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Data Type:
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Balance Type:
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- Definition
Two-character EDGAR code representing the state or country of incorporation.
+ References
No definition available.
+ Details
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dei_EntityIncorporationStateCountryCode
Namespace Prefix:
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Data Type:
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- Definition
The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
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- Definition
The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
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Balance Type:
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Period Type:
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- Definition
Local phone number for entity.
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No definition available.
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Namespace Prefix:
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Balance Type:
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- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 13e
-Subsection 4c
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Namespace Prefix:
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- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14d
-Subsection 2b
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- Definition
Title of a 12(b) registered security.
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Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b
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- Definition
Name of the Exchange on which a security is registered.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
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- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
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- Definition
Trading symbol of an instrument as listed on an exchange.
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No definition available.
+ Details
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Namespace Prefix:
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Data Type:
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Balance Type:
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Period Type:
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- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
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Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
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