Aprea Therapeutics(APRE)

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Aprea Therapeutics Engages Philippe Pultar, MD to Serve as Senior Medical Advisor and Lead WEE1 Clinical Development
GlobeNewswire News Room· 2024-10-09 12:30
Company Update - Aprea Therapeutics has engaged Dr Philippe Pultar as its senior medical advisor to support the development and advancement of APR-1051, a potential best-in-class WEE1 inhibitor [1] - Dr Pultar brings extensive experience in oncology, including the development of a WEE1 inhibitor (azenosertib) from early to late-stage clinical development [2] - Dr Pultar's prior role at Zentalis Pharmaceuticals involved strategy and execution of the global clinical development of azenosertib, a WEE1 inhibitor [2] Clinical Development - Patient enrollment is ongoing in the Phase 1 ACESOT-1051 study, which assesses the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of APR-1051 in advanced solid tumors with certain cancer-associated gene alterations [3] - Aprea plans to provide an update on the progress of the ACESOT-1051 clinical study by the end of 2024 [3] - The WEE1 program is part of Aprea's portfolio of DDR-targeted therapeutics aimed at delivering precision medicine solutions [3] Leadership and Expertise - Dr Pultar has over 17 years of experience in early and late-stage clinical development, including roles at Zentalis Pharmaceuticals, Novartis Oncology, Agennix AG, and ImClone Systems [5] - Dr Pultar initiated seven Phase 1 and Phase 2 trials with azenosertib as a single agent and in combination with chemotherapy and targeted agents across multiple indications [5] - Dr Pultar's foundational education includes Medical Studies and Residency at Université de Médecine de Poitiers, France [6] Strategic Vision - Dr Pultar believes WEE1 inhibition is a promising therapeutic approach in oncology and is impressed by the progress of APR-1051, which has a differentiated profile and compelling pre-clinical data [4] - Aprea's President and CEO, Dr Oren Gilad, highlights Dr Pultar's track record of successfully leading programs through late-stage development and regulatory approval [4] - Dr Pultar's addition aligns with Aprea's strategy to bring in exceptional talent to advance its programs and maximize the therapeutic potential of APR-1051 [4] Leadership Transition - Dr Nadeem Mirza will step down as Chief Medical Officer effective October 9, 2024, but will remain with the company until no later than December 13, 2024, to ensure a smooth transition [4]
Aprea Therapeutics, Inc. (APRE) Reports Q2 Loss, Tops Revenue Estimates
ZACKS· 2024-08-12 14:45
Company Performance - Aprea Therapeutics reported a quarterly loss of $0.58 per share, better than the Zacks Consensus Estimate of a loss of $0.64, and an improvement from a loss of $0.87 per share a year ago, indicating a 33.33% year-over-year improvement [1] - The company achieved a revenue of $0.56 million for the quarter, surpassing the Zacks Consensus Estimate by 462%, compared to $0.25 million in the same quarter last year [1] - Over the last four quarters, Aprea Therapeutics has exceeded consensus EPS estimates three times and topped consensus revenue estimates two times [1] Market Outlook - Aprea Therapeutics shares have declined approximately 28.5% since the beginning of the year, contrasting with the S&P 500's gain of 12% [2] - The current consensus EPS estimate for the upcoming quarter is -$0.65 on revenues of $0.15 million, and for the current fiscal year, it is -$2.57 on revenues of $0.8 million [4] Industry Context - The Medical - Biomedical and Genetics industry, to which Aprea Therapeutics belongs, is currently ranked in the top 30% of over 250 Zacks industries, suggesting a favorable industry outlook [5] - Precigen, Inc., another company in the same industry, is expected to report a quarterly loss of $0.09 per share, reflecting a year-over-year change of -12.5%, with revenues anticipated to be $1.28 million, down 27.7% from the previous year [5][6]
Aprea Therapeutics(APRE) - 2024 Q2 - Quarterly Results
2024-08-12 12:40
[Executive Summary](index=1&type=section&id=Executive%20Summary) Aprea Therapeutics presents its Q2 2024 performance, emphasizing clinical trial advancements and a strong cash position [Second Quarter 2024 Highlights](index=1&type=section&id=Second%20Quarter%202024%20Highlights) Aprea Therapeutics reported Q2 2024 results, initiating ACESOT-1051 Phase 1 trial with no myelosuppression and extending cash runway into Q4 2025 - Enrollment commenced in the ACESOT-1051 Phase 1 trial evaluating APR-1051, with **no myelosuppression observed** in the first of eight planned cohorts at a sub-therapeutic dose[1](index=1&type=chunk) - The Company reported **$28.7 million in cash and cash equivalents** as of June 30, 2024[1](index=1&type=chunk) - Cash runway is extended into **Q4 2025**[1](index=1&type=chunk) [Business Update](index=1&type=section&id=Business%20Update) Aprea provides updates on its clinical pipeline progress and key corporate developments, including leadership changes [Clinical Pipeline Progress](index=1&type=section&id=Clinical%20Pipeline%20Progress) Aprea advances its clinical pipeline with APR-1051 and ATRN-119, targeting oncology with promising early clinical development [ACESOT-1051 (APR-1051, WEE1 Inhibitor)](index=1&type=section&id=ACESOT-1051%20(APR-1051,%20WEE1%20Inhibitor)) Details on the ACESOT-1051 Phase 1 trial for APR-1051, a WEE1 inhibitor, covering enrollment and anticipated readouts - APR-1051 is a potent and selective small molecule WEE1 inhibitor designed for greater clinical activity, especially in cancers with Cyclin E overexpression[2](index=2&type=chunk) - Enrollment commenced in June 2024 for the ACESOT-1051 Phase 1 clinical trial, with the first patient dosed without **dose-limiting toxicities or myelosuppression**[2](index=2&type=chunk) - Primary objectives of the Phase 1 study include measuring safety, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD/MAD), and recommended Phase 2 dose (RP2D)[2](index=2&type=chunk) - An update on clinical study progress is expected by **year-end 2024**, with open-label safety/efficacy data anticipated in **H1 2025**[3](index=3&type=chunk) - APR-1051 was featured in a virtual KOL event in **June 2024** and two posters at the **AACR annual meeting in April 2024**[3](index=3&type=chunk) [ABOYA-119 (ATRN-119, ATR Inhibitor)](index=2&type=section&id=ABOYA-119%20(ATRN-119,%20ATR%20Inhibitor)) Outlines the ABOYA-119 Phase 1/2a clinical trial for ATRN-119, an ATR inhibitor, detailing dose cohorts and protocol amendments - ATRN-119 is a potent and highly selective first-in-class macrocyclic ATR inhibitor, designed for patients with **DDR-related gene mutations**[4](index=4&type=chunk) - The ABOYA-119 Phase 1/2a clinical trial is ongoing as monotherapy in advanced solid tumors with DDR-related gene mutations, with **five dose cohorts completed**[4](index=4&type=chunk) - Aprea plans to amend the study protocol to add a group for **twice-daily ATRN-119 administration** and investigate food effect on drug absorption[4](index=4&type=chunk) - The ABOYA-119 Phase 1 readout is anticipated in **H1 2025**[4](index=4&type=chunk) - An update on the ongoing trial was featured in a poster at the **AACR Annual Meeting in April**[4](index=4&type=chunk) [Corporate Developments](index=2&type=section&id=Corporate%20Developments) Aprea strengthened its leadership with the appointment of Nadeem Q. Mirza as Chief Medical Officer, effective May 1, 2024 - **Nadeem Q. Mirza, M.D., M.P.H.** was appointed as Chief Medical Officer (CMO), effective **May 1, 2024**, to lead the Company's clinical pipeline development[5](index=5&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) Aprea presents its financial performance, including balance sheet and statements of operations, detailing key changes [Balance Sheet Overview](index=2&type=section&id=Balance%20Sheet%20Overview) Aprea's cash and cash equivalents increased to $28.7 million by June 30, 2024, extending cash runway into Q4 2025, with decreased liabilities Consolidated Balance Sheet Highlights | Metric | June 30, 2024 ($) | December 31, 2023 ($) | Change ($) | Change (%) | | :-------------------------- | :------------ | :---------------- | :--------- | :--------- | | Cash and cash equivalents | $28,694,694 | $21,606,820 | $7,087,874 | 32.8% | | Total current assets | $29,559,786 | $22,521,095 | $7,038,691 | 31.3% | | Total assets | $29,964,587 | $22,650,174 | $7,314,413 | 32.3% | | Total current liabilities | $3,094,229 | $4,385,605 | $(1,291,376) | -29.4% | | Total liabilities | $3,094,229 | $4,385,605 | $(1,291,376) | -29.4% | | Total stockholders' equity | $25,559,295 | $16,953,506 | $8,605,789 | 50.7% | - The Company believes its cash and cash equivalents as of **June 30, 2024**, will be sufficient to meet operating expenses and capital expenditure requirements into **Q4 2025**[5](index=5&type=chunk) [Statements of Operations Overview](index=3&type=section&id=Statements%20of%20Operations%20Overview) Aprea reported a Q2 2024 operating loss of $3.8 million, driven by increased R&D and G&A expenses, with decreased net loss per share Consolidated Statements of Operations Highlights (Three Months Ended June 30) | Metric | Q2 2024 ($) | Q2 2023 ($) | Change ($) | Change (%) | | :-------------------------- | :------------ | :------------ | :--------- | :--------- | | Grant revenue | $561,574 | $249,688 | $311,886 | 124.9% | | Research and development | $2,557,679 | $2,202,657 | $355,022 | 16.1% | | General and administrative | $1,850,819 | $1,698,712 | $152,107 | 9.0% | | Total operating expenses | $4,408,498 | $3,901,369 | $507,129 | 13.0% | | Loss from operations | $(3,846,924) | $(3,651,681) | $(195,243) | 5.3% | | Net loss | $(3,470,052) | $(3,259,097) | $(210,955) | 6.5% | | Net loss per share (basic) | $(0.58) | $(0.87) | $0.29 | -33.3% | | Weighted-average common shares outstanding | 5,937,291 | 3,731,571 | 2,205,720 | 59.1% | - Research and development expenses increased by approximately **$0.35 million**, primarily due to the initiation of the ACESOT-1051 Phase 1 dose-escalation study in **Q2 2024**[6](index=6&type=chunk) - General and administrative expenses increased by approximately **$0.15 million**, primarily due to increased personnel costs, including severance expense[7](index=7&type=chunk) [Company Information](index=3&type=section&id=Company%20Information) Overview of Aprea Therapeutics, its forward-looking statements, and contact information for investors and media [About Aprea Therapeutics](index=3&type=section&id=About%20Aprea%20Therapeutics) Aprea Therapeutics is a clinical-stage biopharmaceutical company focused on precision oncology, with lead programs ATRN-119 and APR-1051 - Aprea Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on **precision oncology through synthetic lethality**[8](index=8&type=chunk) - The Company's lead programs are **ATRN-119**, a clinical-stage small molecule ATR inhibitor, and **APR-1051**, an oral, small-molecule WEE1 inhibitor that recently entered the clinic[8](index=8&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) Standard disclaimer on forward-looking statements, cautioning about inherent risks and uncertainties, with no obligation to update unless legally required - The press release contains "forward-looking statements" regarding study analyses, clinical trials, regulatory submissions, and projected cash position, based on current beliefs and expectations but involving risks and uncertainties[9](index=9&type=chunk) - These statements are subject to risks including the success, timing, and cost of ongoing and anticipated clinical trials, and readers are cautioned not to place undue reliance on them[10](index=10&type=chunk) - The Company undertakes no obligation to update such forward-looking statements for any reason, except as required by law[10](index=10&type=chunk) [Investor and Media Contacts](index=4&type=section&id=Investor%20and%20Media%20Contacts) Contact information for investor relations and media inquiries is provided for external communication - Investor contact: **Mike Moyer at LifeSci Advisors** (mmoyer@lifesciadvisors.com)[11](index=11&type=chunk) - Media contact: **Ignacio Guerrero-Ros, Ph.D., or David Schull at Russo Partners, LLC** (Ignacio.guerrero-ros@russopartnersllc.com, David.schull@russopartnersllc.com)[11](index=11&type=chunk)
Aprea Therapeutics(APRE) - 2024 Q2 - Quarterly Report
2024-08-12 12:35
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39069 Aprea Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 84-2246769 (State or other ...
Aprea Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update
GlobeNewswire News Room· 2024-08-12 12:30
Enrollment commenced in the ACESOT-1051 Phase 1 trial evaluating APR-1051 – no myelosuppression observed in the first of eight planned cohorts at sub-therapeutic dose $28.7 million in cash and cash equivalents as of June 30, 2024 with cash runway extended into Q4 2025 DOYLESTOWN, Pa., Aug. 12, 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 reported financ ...
Aprea Therapeutics to Host Virtual KOL Event on APR-1051, a Highly Selective and Potentially Best-in-Class Oral WEE1 Inhibitor, on Monday, June 24, 2024
Newsfilter· 2024-06-21 12:00
DOYLESTOWN, Pa., June 21, 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 will host a virtual KOL event to discuss APR-1051, a highly selective and potentially best-in-class oral WEE1 inhibitor, on Monday, June 24, 2024 at 9:00 AM ET. To register, click here. The webinar will feature Joseph Vacca, PhD, Medicinal Chemistry Expert and Consul ...
Aprea Therapeutics Announces First Patient Dosed in ACESOT-1051 Phase 1 Trial Evaluating Oral WEE1 Inhibitor APR-1051
Newsfilter· 2024-06-17 12:30
APR-1051 is a highly selective and potentially best-in-class oral WEE1 inhibitor Phase 1 ACESOT-1051 clinical trial is evaluating APR-1051 as monotherapy treatment in patients with significant unmet medical need Dosing of the first patient in the ACESOT-1051 study represents a key advancement in Aprea's clinical pipeline DOYLESTOWN, Pa., June 17, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company focused on precision oncolo ...
Aprea Therapeutics Announces that Safety Review Committee (SRC) Endorses Dosing of Patients with ATRN-119 at 800 mg Once Daily in Ongoing ABOYA-119 Clinical Trial
Newsfilter· 2024-05-28 12:45
Core Insights - ATRN-119 is the first and only macrocyclic ATR inhibitor in clinical trials, showing best-in-class potential [1] - The ongoing ABOYA-119 clinical trial is on track to complete dose escalation and potentially generate initial human efficacy data in the second half of 2024 [1][4] - Safety Review Committee has approved the commencement of dosing at 800 mg once daily for Cohort 6, following positive safety and pharmacokinetic data from Cohort 5 [2][3] Clinical Trial Progress - A total of 17 patients have been enrolled across the first five cohorts with doses ranging from 50 mg to 550 mg once daily [3] - Preliminary signs of clinical benefit have been observed, with two patients achieving stable disease at different dose levels [3] - The Phase 1 dose escalation is expected to be completed by the fourth quarter of 2024, with the recommended Phase 2 dose anticipated in the first quarter of 2025 [4] Drug Characteristics - ATRN-119 is designed for patients with mutations in DNA damage response (DDR) pathways, addressing a high unmet medical need in oncology [4] - The drug has demonstrated a differentiated selectivity and toxicity profile compared to other ATR inhibitors [2][4] - Pharmacokinetic data indicate that systemic exposure increases with each dose level, with therapeutic plasma concentrations observed at doses of 550 mg and above [2][5]
Aprea Therapeutics(APRE) - 2024 Q1 - Quarterly Results
2024-05-14 12:40
Exhibit 99.1 Aprea Therapeutics Reports First quarter 2024 Financial Results and Provides a Business Update U.S. FDA cleared IND for APR-1051, a highly selective and potentially best-in-class oral WEE1 inhibitor; Company plans to initiate Phase 1 ACESOT-1051 clinical trial in June 2024 First-in-class macrocyclic ATR inhibitor, ATRN-119, on track to complete dose escalation in ABOYA-119 clinical trial and potentially generate initial human ef icacy data in 2H 2024 Company had four poster presentations at the ...
Aprea Therapeutics(APRE) - 2024 Q1 - Quarterly Report
2024-05-14 12:35
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39069 Aprea Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 84-2246769 (State or other ...