LOS ANGELES, Nov. 19, 2025 (GLOBE NEWSWIRE) -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Prelude Therapeutics Incorporated (“Prelude” or “the Company”) (NASDAQ: PRLD) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Prelude announced it would pause clinical development of it ...

Prelude Therapeutics (NasdaqGS:PRLD) Q3 2025 Earnings Call November 12, 2025 08:00 AM ET Speaker3Morning, everyone, and welcome everyone to the Prelude Therapeutics Investor Conference Call. Today's call is being recorded and is expected to last up to 45 minutes. At this time, I will now turn the call over to Prelude's Chief Financial Officer and Chief Legal Officer, Bryant Lim. Please go ahead.Speaker0Thank you, Operator. During today's call, we will make forward-looking statements based on current expecta ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 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: 001-39527 PRELUDE THERAPEUTICS INCORPORATED (Exact Name of Registrant as Specified in its Charter) Delaware 81-1384762 (State or ...

Exhibit 99.1 Prelude Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update Lead candidate from mutant selective JAK2V617F JH2 inhibitor program advancing with IND filing expected in the first quarter of 2026 JAK2V617F is the primary driver mutation responsible for disease progression in the majority of patients living with myeloproliferative neoplasms (MPNs). The mutation impacts approximately 95% of patients with polycythemia vera (PV), 60% of patients with essential throm ...

Core Insights - Prelude Therapeutics is advancing two promising drug programs targeting significant unmet needs in oncology, specifically the JAK2V617F inhibitor and KAT6A degrader programs [3][4][19] - The company expects to file Investigational New Drug (IND) applications for both programs in 2026, with the JAK2V617F program anticipated in the first quarter and the KAT6A program in mid-2026 [5][8] Pipeline Programs - **JAK2V617F Inhibitor Program**: This program targets the JAK2V617F mutation, which is prevalent in myeloproliferative neoplasms (MPNs), affecting approximately 95% of polycythemia vera patients, 60% of essential thrombocythemia patients, and 55% of myelofibrosis patients. Prelude has developed novel allosteric inhibitors that selectively target V617F+ cells, showing potential to reduce mutant allele burden and improve treatment outcomes [4][6] - **KAT6A Degrader Program**: This program focuses on KAT6A, a target in ER+ breast cancer. Prelude is developing first-in-class, highly selective oral KAT6A degraders, which may offer improved efficacy and tolerability compared to non-selective inhibitors. Preclinical data supporting this approach has been presented at relevant conferences [7][8] Financial Overview - As of September 30, 2025, Prelude had cash, cash equivalents, restricted cash, and marketable securities totaling $58.2 million. The company anticipates that this funding will support operations into 2027 [14] - Research and Development (R&D) expenses for Q3 2025 decreased to $21.7 million from $29.5 million in the prior year, while General and Administrative (G&A) expenses also saw a decline to $5.2 million from $7.7 million [15][16] - The net loss for Q3 2025 was reported at $19.7 million, or $0.26 per share, compared to a net loss of $32.3 million, or $0.43 per share, for the same period in 2024 [17][21]

Core Viewpoint - Prelude Therapeutics Incorporated is under investigation by the Schall Law Firm for potential violations of securities laws, particularly regarding misleading statements and failure to disclose critical information to investors [1][2]. Company Summary - The investigation centers on Prelude's announcement to pause the clinical development of its SMARCA2 degrader program, which was made on November 4, 2025. This decision was based on a thorough review of clinical data and an assessment of resource allocation compared to other programs [2]. - Following the announcement, Prelude's shares experienced a significant decline, falling by approximately 55.8% on the same day [2]. Legal Context - The Schall Law Firm is encouraging shareholders who have suffered losses to participate in the investigation and is offering free consultations regarding their rights [3].

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Denny's Corporation (DENN) is up 49% at $6.16 [3] - Cambium Networks Corporation (CMBM) is up 25% at $2.55 [3] - Tactile Systems Technology, Inc. (TCMD) is up 22% at $19.35 [3] - Upwork Inc. (UPWK) is up 19% at $18.60 [3] - Kforce Inc. (KFRC) is up 12% at $27.50 [3] - Super Group (SGHC) Limited (SGHC) is up 12% at $11.91 [3] - Innovex International, Inc. (INVX) is up 10% at $22.62 [3] - Sanmina Corporation (SANM) is up 9% at $154.03 [3] - Exact Sciences Corporation (EXAS) is up 8% at $72.69 [3] - OTG Acquisition Corp. I Class A Ordinary Share (OTGA) is up 7% at $10.77 [3] Premarket Losers - Sarepta Therapeutics, Inc. (SRPT) is down 40% at $14.44 [4] - JELD-WEN Holding, Inc. (JELD) is down 32% at $2.81 [4] - Ichor Holdings, Ltd. (ICHR) is down 29% at $16.05 [4] - Insperity, Inc. (NSP) is down 27% at $32.50 [4] - Prelude Therapeutics Incorporated (PRLD) is down 22% at $3.08 [4] - Forward Industries, Inc. (FORD) is down 20% at $11.11 [4] - Navitas Semiconductor Corporation (NVTS) is down 18% at $10.03 [4] - Diginex Limited (DGNX) is down 17% at $19.51 [4] - Atlas Energy Solutions Inc. (AESI) is down 16% at $10.58 [4] - Chijet Motor Company, Inc. (CJET) is down 15% at $3.24 [4]

Core Insights - Prelude Therapeutics has entered into an exclusive option agreement with Incyte Corporation to advance its JAK2V617F mutant selective inhibitor program, which includes an upfront payment of $35 million and a $25 million equity investment, with potential additional payments of $100 million if the option is exercised [1][2] - The company is prioritizing the development of its KAT6A selective degrader program for ER+ breast cancer, aiming to enter clinical development in 2026 [3][6] - Prelude has decided to pause the clinical development of its SMARCA2 degrader program due to resource allocation considerations [4][6] Financial Overview - Prelude expects its cash runway to extend into 2027 based on preliminary estimates, potentially extending into the third quarter of 2028 if Incyte exercises its option on the JAK2 program [5] - As of October 31, 2025, the company had approximately $52 million in cash, cash equivalents, and marketable securities, with an additional $60 million expected from the Incyte agreement [5] Strategic Developments - The company is focusing on the JAK2V617F and KAT6A programs, believing they present significant opportunities for addressing unmet patient needs and creating value for investors [6] - Prelude's KAT6A program is positioned to potentially offer improved efficacy and safety compared to existing non-selective KAT6A/B inhibitors [8] - The JAK2V617F program targets a mutation present in approximately 95% of patients with polycythemia vera, 60% of patients with essential thrombocythemia, and 55% of patients with myelofibrosis, aiming to transform treatment outcomes for these patients [9] Leadership Changes - The company announced the departure of President and Chief Medical Officer Jane Huang, with Victor Sandor stepping in to provide strategic oversight for clinical development [7][8]

Core Insights - Prelude Therapeutics has entered into an exclusive option agreement with Incyte for the acquisition of its mutant selective JAK2V617F JH2 inhibitor program, which has potential in treating myeloproliferative neoplasms (MPNs) [1][2][3] - The agreement includes a $35 million upfront payment, a $25 million strategic equity investment, and potential future payments totaling up to $910 million, including milestones and royalties [1][4] Agreement Details - Incyte will secure an exclusive option to acquire Prelude's JAK2V617F program for $100 million during the option period [3][4] - Prelude will receive a total of $60 million in capital, which includes the upfront payment and equity investment, to advance its JAK2V617F program and other pipeline assets [3][4] - If Incyte does not exercise its option, Prelude retains full ownership of the JAK2V617F program [5] Program Significance - The JAK2V617F mutation is a key driver in the progression of MPNs, affecting approximately 95% of patients with polycythemia vera, 60% with essential thrombocythemia, and 55% with myelofibrosis [6][7] - Prelude has developed novel allosteric inhibitors that specifically target the JAK2 JH2 'deep pocket' where the V617F mutation resides, showing promise in preclinical models [7] Future Developments - Prelude aims to advance the JAK2V617F program to predefined milestones, with the first program data set to be presented at the American Society of Hematology (ASH) Annual Meeting in December 2025 [7]

Core Insights - Prelude Therapeutics Incorporated (PRLD) has been evaluated with concerns regarding the lack of robust clinical trial data and an extended timeline for development [1] Company Analysis - The company is currently facing scrutiny due to insufficient clinical trial results, which may impact investor confidence and future funding opportunities [1] - The timeline for clinical development appears to be lengthy, which could delay potential market entry and revenue generation [1] Industry Context - The biotech industry often requires rigorous clinical trial data to attract investment, and companies lacking this may struggle to secure necessary capital [1] - The importance of educating investors on the scientific aspects of biotech investments is emphasized, highlighting the need for due diligence in this sector [1]