On November 12, 2025 Prelude Therapeutics Incorporated (Nasdaq: PRLD), a precision oncology company, reported its financial results for third quarter ended September 30, 2025, and provided an update on its pipeline and other corporate developments.

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"Last week, we announced a number of strategic updates that significantly strengthen and shape our path forward heading into 2026," stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude. "We have two promising programs advancing rapidly towards clinical development – our mutant selective JAK2V617F inhibitor program and our highly selective KAT6A degrader program. Both programs target clinically validated mechanisms in disease areas of significant unmet need for patients with clear paths to differentiation in early clinical development."

Key Pipeline Programs
Mutant selective JAK2V617F JH2 inhibitor program

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 thrombocythemia (ET) and 55% of patients with myelofibrosis (MF). Identifying JAK2 JH2 inhibitors that selectively target V617F+ cells has long been a shared goal and challenge for industry. Prelude has discovered novel allosteric inhibitors that bind into the JAK2 JH2 "deep pocket" where the V617F mutation resides. These candidates demonstrate mutant specific inhibition in multiple preclinical models of MPNs. Prelude believes this approach may have the potential to reduce mutant allele burden, slow or even reverse disease progression, and transform treatment outcomes for MPN patients.

The Company has advanced the lead candidate from this program into IND-enabling studies and expects to file an IND and advance into clinical trials in the first half of 2026. The first disclosure of preclinical data from this program has been accepted for oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 67th Annual Meeting taking place in Orlando, FL December 6-9, 2025. The abstract can be found on the ASH (Free ASH Whitepaper) 2025 website ASH (Free ASH Whitepaper) Annual Meeting & Exposition – Hematology.org.

The JAK2V617F inhibitor program is subject to an exclusive option agreement with Incyte announced in November 2025.

Highly selective KAT6A oral degrader program

KAT6 is an emerging, clinically-validated target in the treatment of ER+ breast cancer. Prelude discovered and is developing first-in-class, highly potent, highly selective and orally bioavailable KAT6A selective degraders. Prelude believes that selectively degrading KAT6A has the potential for improved efficacy, tolerability and combinability with other agents relative to non-selective inhibitors of KAT6A/B. The Company recently presented preclinical data supporting this hypothesis at the AACR (Free AACR Whitepaper) Annual Meeting 2025. The presentation can be found at Publications – Prelude Therapeutics.

The Company has selected a development candidate and is on track to file an IND in mid-2026 and initiate a phase 1 dose escalation study in the second half of 2026.

Degrader payloads for next generation DACs

Prelude is leveraging our expertise in targeted protein degradation to discover and develop novel degrader payloads for use with next generation DACs. We have developed highly potent SMARCA2/4 and CDK9 degrader payloads optimized for efficacy, tolerability and developability when coupled to a wide range of different antibodies.

The Company has amended and expanded the scope of our existing DAC collaboration with AbCellera Biologics. This enables AbCellera to use our degrader payloads on additional undisclosed antibody targets of interest and also enables Prelude to utilize our degrader payloads in licensing arrangements with other potential partners. The Company’s payloads and corresponding payload-linkers are available for licensing to partners to expand the reach of this new technology.

We have recently published preclinical data demonstrating that next generation DACs using Prelude degrader payloads have potential for significantly better in vivo efficacy and tolerability compared to traditional cytotoxic ADCs when tested head-to-head in xenograft models. These data can be found at: Publications – Prelude Therapeutics

Mutated calreticulin (mCALR) DAC discovery program

Mutant CALR is a neoantigen presented on the cell surface of malignant myeloid cells but not normal cells and is found in approximately 25-35% of patients with myelofibrosis (MF) and essential thrombocythemia (ET). Recently, a mCALR-targeted monoclonal antibody demonstrated robust clinical activity in high-risk ET patients. Prelude is exploring mCALR-targeted DACs using the Company’s proprietary degrader payloads as a differentiated approach for patients with CALR mutations. This early discovery program is wholly owned and controlled by Prelude.

The Company presented the first preclinical data from the program at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress in June. The presentation can be found at Publications – Prelude Therapeutics. Updated preclinical data from this program has been accepted for oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 67th Annual Meeting taking place in Orlando, FL December 6-9, 2025. The abstract can be found on the ASH (Free ASH Whitepaper) 2025 website ASH (Free ASH Whitepaper) Annual Meeting & Exposition – Hematology.org.

Third Quarter 2025 Financial Results 

Cash, Cash Equivalents, Restricted Cash and Marketable Securities:

At September 30, 2025, the Company had cash, cash equivalents, restricted cash and marketable securities totaling $58.2 million. Subsequent to September 30, 2025, the Company received an additional license payment from its expanded collaborative agreement with AbCellera in October 2025 and $60 million from Incyte in November 2025. Based on preliminary estimates, the Company anticipates that its existing cash, cash equivalents, restricted cash and marketable securities will fund Prelude’s operations into 2027.

Research and Development (R&D) Expenses:

For the third quarter of 2025, R&D expense decreased to $21.7 million from $29.5 million for the prior year period. Included in the R&D expense for the three months ended September 30, 2025 was $1.4 million of non-cash expense related to stock-based compensation, including employee stock options, compared to $3.4 million for the three months ended September 30, 2024. Along with the decrease in stock-based compensation expense, research and development expenses decreased due to a decrease in expense related to our SMARCA2 clinical trials. Research and development expenses may fluctuate from period to period depending upon the stage of certain projects and the level of preclinical and clinical trial-related activities.

General and Administrative (G&A) Expenses:

For the third quarter of 2025, G&A expenses decreased to $5.2 million from $7.7 million for the prior year period. Included in general and administrative expenses for the three months ended September 30, 2025, was $1.0 million of non-cash expense related to stock-based compensation, including employee stock options, compared to $2.5 million for the three months ended September 30, 2024. The decrease in general and administrative expenses was primarily due to a decrease in stock-based compensation due to lower valuation on more recent grants due to the decrease in our stock price.

Net Loss:

For the three months ended September 30, 2025, net loss was $19.7 million, or $0.26 per share compared to $32.3 million, or $0.43 per share, for the prior year period. Included in the net loss for the three months ended September 30, 2025, was $2.4 million of non-cash expenses related to the impact of expensing share-based payments, including employee stock options, as compared to $5.9 million for the same period in 2024.

Conference Call and Webcast Information

Prelude Therapeutics management team will host a conference call, live webcast with slides and a Q&A on Wednesday, November 12, 2025 at 8:00 AM ET. A live webcast of the presentation will be available at Events & Presentations – Prelude Therapeutics (preludetx.com) A replay of the webcast will be available shortly after the conclusion of the call at Events & Presentations – Prelude Therapeutics (preludetx.com) and archived on the Company’s website for 60 days following the call.

(Press release, Prelude Therapeutics, NOV 12, 2025, View Source [SID1234659827])

On November 12, 2025 Pillar Biosciences, Inc., the leader in Decision Medicine, reported the launch of oncoReveal Lymphoid, a research-use-only (RUO) next-generation sequencing (NGS) kit designed to enable laboratories to perform rapid tumor profiling of lymphoid malignancies.

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The oncoReveal Lymphoid panel interrogates 84 genes of interest, including full coding DNA sequence (CDS) of 29 genes with a single-tube, fully automatable NGS workflow that can be performed by any NGS-equipped molecular laboratory.

"We are excited to launch oncoReveal Lymphoid, specifically designed to meet the needs of local laboratories looking for rapid and efficient NGS-based testing solutions to help interrogate lymphomas," said ShiPing Zou, Sr. Director of Product Management at Pillar Biosciences. "oncoReveal Lymphoid is compatible with our current heme-oncology offerings including oncoReveal Myeloid and oncoReveal Heme Fusion. "Together, this suite of products provides full coverage of heme oncology tumor profiling needs for molecular pathology labs."

Pillar’s oncoReveal Lymphoid panel uses their proprietary Stem-Loop Inhibition-Mediated amplification (SLIMamp) technology, a tiled amplicon-based library prep chemistry designed to provide highly accurate genetic profiles down to 2% variant allele frequency (VAF). oncoReveal Lymphoid is powered by PiVAT, an automated secondary bioinformatics software that supports the identification of somatic mutations from DNA with high sensitivity and specificity. Pillar Biosciences’ proprietary PiVAT technology is fully compatible with third-party clinical reporting solutions.

(Press release, Pillar Biosciences, NOV 12, 2025, View Source [SID1234659850])

On November 12, 2025 Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, and Bristol Myers Squibb (NYSE: BMY), a leading biopharmaceutical company, reported an expanded strategic collaboration aimed at accelerating the development of innovative cancer therapies and increasing access to clinical trials for patients across the U.S.

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Central to the collaboration is SCRI’s Accelero, a next-generation clinical trial delivery model that streamlines operations and accelerates trial execution across SCRI’s expansive network of more than 200 locations. By aligning Bristol Myers Squibb’s pioneering oncology pipeline with SCRI’s research infrastructure and expertise, the collaboration is designed to bring cutting-edge research directly to patients—where they live and receive care.

"At Bristol Myers Squibb, we recognize that accelerating clinical trial enrollment requires not only scientific innovation but also operational innovation. This includes a deep commitment to equity and inclusion, while we look to accelerate overall patient enrollment," said Mokash Sharma, Senior Vice President, Global Development Operations, Bristol Myers Squibb. "Improving access to clinical research isn’t just about science—it’s about trust, and meeting people where they are. By leveraging data-driven strategies through our collaboration with Sarah Cannon Research Institute, we’re working to ensure that more patients—especially those from medically underserved populations—have access to vital cancer research advances in their communities. This partnership reflects our shared vision to transform clinical trial delivery and advance health equity across the oncology landscape."

Through this collaboration, SCRI and Bristol Myers Squibb are expanding access to Bristol Myers Squibb’s innovative therapies by embedding clinical trials in community settings. With more than 1,300 physicians engaged in research across over 20 states, SCRI’s network enables broader participation in clinical trials.

"Together, SCRI and Bristol Myers Squibb are translating innovative science into clinical trials and accelerating patient enrollment through SCRI’s Accelero model that prioritizes speed, quality, and access, and ultimately brings promising therapies to patients faster and closer to home," said Dee Anna Smith, Chief Executive Officer, SCRI. "We look forward to the impact we will have together as we reach more patients and continue to redefine how clinical trials are delivered across the country."

In the early phase of the collaboration, SCRI achieved a 45% reduction in study startup timelines across eight Bristol Myers Squibb clinical trials—significantly outperforming timelines observed at non-SCRI sites. By scaling these capabilities across SCRI’s research network, the collaboration reinforces a shared commitment to transforming clinical trial delivery and ensuring that more people can access the latest cancer treatments and innovations.

(Press release, Bristol-Myers Squibb, NOV 12, 2025, View Source [SID1234659812])

On November 12, 2025 Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, reported an update on the company’s development pipeline and reported financial results for the third quarter ended September 30, 2025.

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Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, said, "Quince remains on track to report topline results for our pivotal Phase 3 NEAT clinical trial evaluating our lead asset eDSP (encapsulated dexamethasone sodium phosphate) for the treatment of Ataxia-Telangiectasia (A-T) in the first quarter of 2026. The NEAT study is powered at approximately 90% to test for a statistically significant difference between eDSP and placebo, and data management metrics suggest low rates of missing data and study discontinuations. Additionally, all patients completing the NEAT study have elected to participate in the open label extension (OLE) study. We also recently received a positive outcome of a NEAT safety analysis conducted by an independent data and safety monitoring board (iDSMB), which recommended that the study continue without any modifications. All of these factors support our ongoing confidence in a successful outcome for our pivotal Phase 3 NEAT clinical trial."

Pivotal Phase 3 NEAT Clinical Trial

Quince completed enrollment in its pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A-T; NCT06193200/IEDAT-04-2022) clinical trial in July 2025 with a total of 105 participants, including 83 participants in the six to nine year-old primary analysis population and 22 participants aged 10 years and older.
Quince expects to report topline results from its Phase 3 NEAT clinical trial in the first quarter of 2026.
Concluding the NEAT study with 83 enrolled participants in the six to nine year-old primary analysis population reflects powering of approximately 90% to determine statistical significance on the primary endpoint.
100% of NEAT participants to date have elected to transition to the OLE study (NCT06664853/IEDAT-04-2022). Participants who complete the full treatment period, complete study assessments, and provide informed consent are eligible to transition to the OLE study.
The Phase 3 NEAT clinical trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).
Assuming positive study results, the company plans to submit a New Drug Application (NDA) to the FDA in the second half of 2026.
Quince was granted FDA Fast Track designation for the company’s eDSP System for the treatment of patients with A-T based on the potential to address a high unmet medical need.
NEAT is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the neurological effects of Quince’s lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells; previously referred to as EryDex), in patients with A-T.
Participants are randomized (1:1) between eDSP or placebo and treatment consists of six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last efficacy visit using the Rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo.
Pipeline and Corporate Updates

Hosted a virtual 2025 Investor Day on October 2, 2025 showcasing Quince’s latest clinical development and corporate updates, the replay of which can be accessed here. Notable featured topics included a presentation of multiple synergistic mechanisms of action that support eDSP’s potential efficacy and disease modifying activity while mitigating corticosteroid toxicity, and how transcriptomic profiling reveals novel insights and potential biomarkers in A-T; insights into the company’s attractive commercial opportunity and launch preparedness planning for eDSP, including details of its recently announced strategic relationship with Option Care Health; a look at Quince’s strong competitive positioning and significant opportunity to quickly expand its development pipeline into additional high-value, rare disease indications; as well as a demonstration of the company’s proprietary drug/device combination eDSP System, among other key topics and highlights.
Announced the outcome of the company’s pre-planned safety analysis conducted by an independent data and safety monitoring board (iDSMB) for its Phase 3 NEAT clinical trial with the iDSMB recommending that the study continue without any modifications.
Pursuing ongoing study initiation activities to support Quince’s European Union pediatric investigational plan (PIP) – named the Pediatric Encapsulated Dexamethasone Sodium Phosphate (PeD) study – to evaluate the safety and pharmacokinetics of eDSP in smaller patients with A-T who weigh between nine and 15 kilograms.
Advanced commercial readiness activities, including completion of qualitative payer research covering more than 200 million U.S. lives. Findings were highly encouraging with payers recognizing the significant unmet need in A-T and expressing broad support for eDSP as a potential first-to-market treatment.
Participated at the 54th Child Neurology Society (CNS) Annual Meeting with a poster presentation of patient-reported walking capacity in children with A-T, which describes the pattern of age-related walking capacity loss in patients with A-T and compares the subjective walking scale to the two measures – International Cooperative Ataxia Rating Scale (ICARS) and Rescored modified ICARS (RmICARS) – used in Quince’s Phase 3 NEAT clinical trial. Results showed that all three scales tracked age-related loss of ambulation in a similar way, suggesting suitability of RmICARS walking capacity components in assessing A-T disease progression.
Continuing advancement of the evaluation of Duchenne muscular dystrophy (DMD) as Quince’s second targeted eDSP indication, including preparing for protocol finalization, contract research organization (CRO) evaluation and selection, and site feasibility in preparation for dosing the first patient in a DMD Phase 2 clinical study in 2026.
Published an advanced population pharmacokinetic (PK) modeling study in the scientific journal CPT: Pharmacometrics & Systems Pharmacology (PSP) that addresses the development of a pediatric PK model based on data from the study of healthy adults and pediatric patients with A-T administered monthly with eDSP and predicts the exposure data in the A-T patient population over a six-month period, which is accessible here.
Entered into a second amendment of Quince’s European Investment Bank (EIB) debt agreement in September 2025 that reduces the company’s required minimum cash balance for the period from January 1, 2026 to March 31, 2026 to €5.0 million.
Received an update on the company’s previously sold legacy small molecule protease inhibitor portfolio acquired by Lighthouse Pharmaceuticals in January 2023. Lighthouse Pharma was awarded $49.2 million grant from the National Institute on Aging to support its Phase 2 clinical trial in patients with Alzheimer’s disease. Quince retains a 7.5% ownership position in Lighthouse Pharma and is positioned to benefit from milestone and royalty commitments related to Lighthouse’s ability to successfully advance the development of its compounds through regulatory approval and subsequent commercialization.
Third Quarter 2025 Financial Results

Reported cash, cash equivalents, and short-term investments of $26.3 million for the third quarter ended September 30, 2025. Quince expects its existing cash runway to be sufficient to fund the company’s capital efficient development plan through Phase 3 NEAT topline results into the second quarter of 2026. If warrants related to the company’s recent financing are exercised in full for cash, Quince’s cash runway would extend into the second half of 2026.
Reported research and development (R&D) expenses of $8.1 million for the third quarter ended September 30, 2025. R&D expenses primarily included costs related to ongoing Phase 3 NEAT clinical trial activities and related manufacturing costs.
Reported general and administrative (G&A) expenses of $3.3 million for the third quarter ended September 30, 2025. G&A expenses primarily included personnel-related and stock-based compensation expenses, commercial planning and new product planning expenses, and other professional administrative costs.
Reported a net loss of $13.3 million, or a net loss of $0.25 per basic and diluted share, for the third quarter ended September 30, 2025. Weighted average shares outstanding – basic and diluted – for the quarter were 54.0 million.
Reported net cash used in operating activities of $30.9 million for the nine months ended September 30, 2025. Cash used in operating activities was primarily due to net loss of $44.5 million for the period, adjusted for $13.2 million of non-cash items, including $4.5 million change in the fair value of contingent consideration liabilities, $4.2 million change in the fair value of warrants, $3.9 million in stock-based compensation, $1.3 million change in the fair value of the EIB loan, and a net decrease in operating assets of $0.3 million, offset by a net increase in accounts payable, accrued expenses, and other current liabilities of $0.7 million.

(Press release, Quince Therapeutics, NOV 12, 2025, View Source [SID1234659828])

On November 12, 2025 AtomVie Global Radiopharma (AtomVie), a leading radiopharmaceutical CDMO, reported that it has successfully supplied the first dose of Ariceum Therapeutics’ (Ariceum) 225Ac-SSO110, a potentially first- and best-in-class Actinium-225-labelled antagonist of the somatostatin type 2 receptor (SSTR2), being evaluated in Ariceum’s Phase 1/2 clinical trial (SANTANA-225) for the treatment of extensive-stage small cell lung cancer (SCLC) and Merkel Cell Carcinoma (MCC).

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With this partnership, AtomVie is leveraging its state-of-the-art cGMP facilities and deep technical expertise to enable the robust and reliable manufacturing of 225Ac-SSO110. This collaboration secures a consistent supply and uncompromising quality of 225Ac-SSO110 to support the SANTANA-225 study.

"We are honored to partner with Ariceum to deliver the critical supply of 225Ac-SSO110 for the SANTANA-225 clinical trial. Our mission of transforming patients’ lives with high quality radiopharmaceuticals drives every step of our work, and we are proud to contribute to bringing promising therapies in oncology closer to patients." said Bruno Paquin, CEO of AtomVie.

"Dosing the first patient in our SANTANA-225 clinical trial marks a significant milestone for Ariceum," said Manuel Sturzbecher-Höhne, Chief Technology Officer of Ariceum Therapeutics. "We are proud to partner with AtomVie on the manufacturing of 225Ac-SSO110. Their proven GMP expertise and unwavering commitment to quality give us confidence as we advance 225Ac-SSO110 through clinical development, and deliver on our mission to bring transformative therapies to patients facing these aggressive and underserved cancers."

(Press release, Ariceum Therapeutics, NOV 12, 2025, View Source [SID1234659851])