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 PMV Pharmaceuticals, Inc. ("PMV Pharma" or the "Company"; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, reported financial results for the third quarter ended September 30, 2025, and provided a corporate update.

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"I am incredibly proud of our team and their commitment to rapidly and efficiently advancing the PYNNACLE study," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "We are excited by the data emerging from this study and look forward to submitting an NDA in the first quarter of 2027 for platinum-resistant/refractory ovarian cancer."

Corporate Highlights

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Updated clinical results from the Phase 2 pivotal portion of the PYNNACLE study evaluating rezatapopt were featured in late-breaking oral and poster presentations at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) on October 24, 2025.
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Confirmed responses were observed in patients whose tumors were TP53 Y220C mutated and KRAS wild-type in eight tumor types including ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder cancers, and ampullary carcinoma.
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Overall response rate (ORR) of 34% (35/103 patients) per investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, including confirmed and unconfirmed responses. The cohort-specific ORRs were as follows:
§ Ovarian cancer: 46% ORR (22/48 patients, including one confirmed complete response, 18 confirmed partial responses, and three unconfirmed partial responses [uPR])

§ Breast cancer: 17% ORR (2/12 patients)

§ Endometrial cancer: 60% ORR (3/5 patients, including one uPR)

§ Lung cancer: 21% ORR (4/19 patients, including one uPR)

§ Other solid tumors: 21% ORR (4/19 patients)

o Across all cohorts, the median time to response was 1.3 months and the median duration of response was 7.6 months. In the ovarian cancer cohort, the median time to response was 1.3 months and median duration of response was 8.0 months.

o Post the September 4, 2025 data cutoff date, four uPRs were confirmed and one uPR (ovarian cancer) remains on treatment.

o A poster entitled "Natural history and prognostic value of TP53 Y220C mutation in advanced solid tumors: A real-world study," was also presented at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) which concluded that patients with TP53 Y220C-mutated solid tumors had poor prognoses and reduced overall survival compared to patients without a TP53 Y220C mutation.

Third Quarter 2025 Financial Results

PMV Pharma ended the third quarter with $129.3 million in cash, cash equivalents, and marketable securities, compared to $148.3 million as of June 30, 2025. Net cash used in operations was $56.4 million for the nine months ended September 30, 2025, compared to $34.6 million for the nine months ended September 30, 2024.

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Net loss for the quarter ended September 30, 2025, was $21.1 million compared to $19.2 million for the quarter ended September 30, 2024. The net loss increase was primarily due to increased research and development (R&D) costs.
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R&D expenses were $18.2 million for the quarter ended September 30, 2025, compared to $16.9 million for the quarter ended September 30, 2024. The increase in R&D expenses was primarily due to increased contractual research organization costs for the advancement of the rezatapopt program.
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General and administrative (G&A) expenses were $4.3 million for the quarter ended September 30, 2025, compared to $4.9 million for the quarter ended September 30, 2024. The decrease in G&A expenses was primarily due to reduced spend for stock-based compensation and facility and operational expenses.

About Rezatapopt

Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation.

About the PYNNACLE Clinical Trial

The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the clinical trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers were also assessed. The Phase 2 portion is a registrational, single arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, and endometrial cancers, and other solid tumors) with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C and KRAS wild-type advanced solid tumors. For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).

(Press release, PMV Pharma, NOV 12, 2025, View Source [SID1234659826])

On November 12, 2025 NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the "Company"), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, reported that Company management will participate in a fireside chat at the following conference:

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Jefferies London Healthcare Conference
Date: Monday, November 17, 2025
Time: 3pm GMT / 10am ET / 4pm CET
Location: London, UK
Presenters: Laurent Levy, Chief Executive Officer of Nanobiotix and Bart van Rhijn, Chief Financial & Business Officer of Nanobiotix
Webcast link: Click here

The fireside chat will be webcast live from the events page of the Investors section of the Company’s website. Replay of the webcast will be available following the event.

(Press release, Nanobiotix, NOV 12, 2025, View Source [SID1234659825])

On November 12, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viral infections, reported it has entered into research and material transfer agreement with the University of North Carolina at Chapel Hill (UNC) for investigator-initiated preclinical research evaluating Annamycin for the treatment of pancreatic cancer.

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Under the terms of the agreement Moleculin will supply Annamycin and William C. Zamboni, PharmD, PhD, professor at the UNC Eshelman School of Pharmacy, UNC Lineberger Comprehensive Cancer Center, and Carolina Institute of Nanomedicine will conduct the planned preclinical research as part of a series of funded grants. The studies covered under this agreement will evaluate the ability of novel treatment agents and modalities to enhance the tumor delivery of liposomal Annamycin (L-Annamycin) and Free-Annamycin as compared to Doxil and Free-doxorubicin in the PDAC GEMM models.

Walter Klemp, Chairman and CEO of Moleculin, commented, "We are pleased to establish this agreement with the team at UNC-Chapel Hill, a leading institution in oncology innovation and translational research, and take another important step in our strategy to advance and develop Annamycin through multiple investigator-initiated studies to realize its full potential. Pancreatic cancer remains one of the most lethal and underserved cancers, with limited effective treatment options and a clear need for new therapeutic approaches. Evaluating Annamycin in collaboration with UNC’s world-class translational scientists dovetails well with our recently announced investigator-funded clinical trial in pancreatic cancer patients."

"Annamycin has a demonstrated high affinity for and ability to concentrate in the pancreas, and recently published data reveals that the upregulation of topoisomerase II, the primary target of Annamycin, is highly correlated with poor survival in pancreatic cancer patients," continued Mr. Klemp. "This is why we believe targeting pancreatic cancer in addition to acute myeloid leukemia and soft tissue sarcoma provides a critical strategic opportunity to expand the potential clinical applications of our technology into an indication with significant unmet need and market potential. We look forward to generating data that will help define Annamycin’s role in pancreatic cancer and further strengthen our oncology development pipeline as we work to deliver meaningful value for patients and shareholders."

Annamycin, also known by its non-proprietary name of naxtarubicin, currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, in addition to Orphan Drug Designation for the treatment of STS lung mets. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory AML from the EMA.

Moleculin is currently conducting pivotal Phase 2B/3, multi-center, randomized, double-blind, placebo-controlled, adaptive design study of Annamycin in combination with cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") for the treatment of adult patients with acute myeloid leukemia (AML) who are refractory to or relapsed (R/R) after induction therapy (R/R AML). This Phase 3 "MIRACLE" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) is a global approval trial, including sites in the US, Europe and the Middle East.

For more information about the MIRACLE trial, visit clinicaltrials.gov and reference identifier NCT06788756. Additionally, the clinical trial in the EU is on euclinicaltrials.eu and the reference identifier there is 2024-518359-47-00.

(Press release, Moleculin, NOV 12, 2025, View Source [SID1234659824])

On November 12, 2025 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, reported financial results for the third quarter ended September 30, 2025, and provided an update on its recent corporate progress.

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"During the third quarter, our team aggressively advanced each of our previously outlined strategic priorities, which we believe will position MacroGenics for long-term success. Importantly, we secured $75 million in additional non-dilutive partnership payments, which we expect to receive during the fourth quarter. As part of these recent partnering activities, we extended our relationship with Gilead to include a preclinical program based on our novel T-cell engager platform," said Eric Risser, President and CEO of MacroGenics. "On the clinical front, following a portfolio review and evaluation of interim data from the LORIKEET study, we have decided not to pursue further development of lorigerlimab in prostate cancer. Despite this decision, we remain committed to exploring lorigerlimab’s potential in ovarian and other gynecologic cancers and continue to enroll patients in the Phase 2 LINNET study. We also continue to advance our three other ADC programs and recently initiated two Phase 1 expansion cohorts for the MGC026 program."

"Our team continues to be laser-focused on building shareholder value by advancing treatment options that have transformative potential for patients. We look forward to continuing to deliver on our strategic priorities to position the company for success in 2026 and beyond," Mr. Risser concluded.

Key Strategic Priorities for 2025 and 2026

Determine development path for lorigerlimab.
Advance portfolio of antibody-drug conjugates (ADCs), including MGC026, MGC028, and MGC030.
Initiate Investigational New Drug (IND)-enabling studies for two new product candidates.
Forge partnerships and collaborations to accelerate development of MacroGenics’ proprietary product candidates and platforms.
Strengthen MacroGenics’ financial position through a combination of enhanced operational efficiency, collaboration revenue, and monetization of assets.
Recent Highlights in Advancing MacroGenics’ Strategic Priorities

Determine Development Path for Lorigerlimab
As MacroGenics assesses how best to invest its resources across its product portfolio, the Company has decided to not pursue further development of lorigerlimab (a bispecific, tetravalent PD-1 × CTLA-4 DART molecule) in combination with docetaxel and prednisone for the treatment of second-line metastatic castration-resistant prostate cancer (mCRPC). MacroGenics will continue the ongoing LINNET Phase 2 monotherapy study of lorigerlimab in patients with either platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC).

LORIKEET Study. The Company determined not to pursue further development of lorigerlimab in second-line mCRPC based on interim data from the Phase 2 LORIKEET trial, a 150-patient randomized study evaluating lorigerlimab in combination with docetaxel and prednisone vs. docetaxel and prednisone in second-line, chemotherapy-naïve patients with mCRPC. Based on review of study data with an October 17, 2025 data cut-off, the Company determined that the experimental treatment arm will not reach the study’s primary goal of showing an improvement in rPFS vs. that of the control arm for the targeted patient population. The Company intends to present or publish the final LORIKEET data at a future date.

LINNET Study. MacroGenics continues the ongoing LINNET study, a Phase 2 monotherapy trial evaluating lorigerlimab in patients with either PROC or CCGC. The Company believes lorigerlimab can be a differentiated treatment option for patients with gynecologic cancers and could be complementary with some of the emerging therapies being developed for this patient population. The Company continues to enroll patients in the LINNET study and currently expects to provide a clinical update on the first part of the two-stage trial by mid-2026.
Advance Innovative ADC Pipeline
MacroGenics is developing three ADCs that each incorporate a novel, glycan-linked topoisomerase 1 inhibitor (TOP1i)-based payload developed by the Company’s collaboration partner, Synaffix (a Lonza company).

MGC026 targets B7-H3, an antigen with broad expression across multiple solid tumors and a member of the B7 family of molecules involved in immune regulation. The Company recently completed Phase 1 dose escalation and initiated dose expansion in two solid tumor indications.

MGC028 targets ADAM9, a member of the ADAM family of multifunctional type 1 transmembrane proteins that play a role in tumorigenesis and cancer progression and is overexpressed in multiple cancers. MGC028 is currently being evaluated in a Phase 1 dose escalation study in patients with advanced solid tumors.

MGC030 is a preclinical ADC that targets an undisclosed antigen expressed across several solid tumors. An IND application to the U.S. Food and Drug Administration (FDA) for MGC030 is planned for 2026.
Forge Partnerships & Strengthen MacroGenics’ Financial Position

Gilead. In November 2025, Gilead licensed an additional MacroGenics preclinical program under a 2022 collaboration agreement, triggering a $25 million payment to MacroGenics. The licensed program leverages the Company’s novel, proprietary platform with the goal of improving upon the safety and efficacy of traditional T-cell engagers. Under this collaboration, MacroGenics and Gilead are now advancing three programs, including MGD024, a clinical-stage CD123 × CD3 bispecific DART molecule, a preclinical TRIDENT program and this latest preclinical DART program. The Company remains eligible to receive up to $1.6 billion in future milestones as well as royalties related to these three product candidates.

Sanofi. Sanofi continues to advance TZIELD (teplizumab-mzwv), an antibody targeting CD3 that the Company sold in 2018 to a partner that was subsequently acquired by Sanofi S.A. (Sanofi). In August and September 2025, TZIELD was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom and by the National Medical Products Administration (NMPA) in China, respectively, triggering total milestone payments of $50 million, which are expected to be received during the fourth quarter. In October 2025, Sanofi announced that TZIELD had been accepted for expedited review in the U.S. for stage 3 type 1 diabetes through the FDA Commissioner’s National Priority Voucher pilot program. MacroGenics remains eligible to receive up to $330 million in additional milestones related to TZIELD.
Third Quarter 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities balance as of September 30, 2025, was $146.4 million, compared to $201.7 million as of December 31, 2024. The cash balance as of September 30, 2025, does not include the $50.0 million from Sanofi or the $25.0 million from Gilead, which are expected to be received by year-end 2025.
Revenue: Total revenue was $72.8 million for the quarter ended September 30, 2025, compared to $110.7 million for the quarter ended September 30, 2024. Total revenue included contract manufacturing revenue of $19.8 million for the quarter ended September 30, 2025, compared to $4.6 million for the quarter ended September 30, 2024, reflecting increased third-party production in 2025. Collaboration revenue was $53.0 million for the quarter ended September 30, 2025, compared to $101.4 million for the quarter ended September 30, 2024. The difference was due to $100.0 million recognized from milestones under the Incyte License Agreement in 2024 compared to $50.0 million recognized from milestones under the Provention (Sanofi) Asset Purchase Agreement in 2025.
R&D Expenses: Research and development expenses were $32.7 million for the quarter ended September 30, 2025, compared to $40.5 million for the quarter ended September 30, 2024. The decrease was primarily due to discontinued internal development of the vobra duo program, decreased IND-enabling costs for MGC028 and decreased costs related to margetuximab.
Cost of Manufacturing Services: Cost of manufacturing services was $11.6 million for the quarter ended September 30, 2025, compared to $1.7 million for the quarter ended September 30, 2024.
SG&A Expenses: Selling, general and administrative expenses were $9.9 million for the quarter ended September 30, 2025, compared to $14.1 million for the quarter ended September 30, 2024. The decrease was primarily due to lower stock-based compensation expense and cessation of MARGENZA (margetuximab-cmkb) commercialization activities.
Net Income: Net Income was $16.8 million for the quarter ended September 30, 2025, compared to net income of $56.3 million for the quarter ended September 30, 2024.
Shares Outstanding: Shares of common stock outstanding as of September 30, 2025, were 63,258,532.
Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $146.4 million as of September 30, 2025, in addition to subsequent receipt of $75.0 million in partnering payments from Sanofi and Gilead, plus projected and anticipated future payments from partners and anticipated savings from the Company’s ongoing cost-reduction initiatives, is expected to support its cash runway into late 2027.

(Press release, MacroGenics, NOV 12, 2025, View Source [SID1234659823])