On November 6, 2025 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the third quarter ended September 30, 2025.

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Cash and investments in marketable securities on September 30, 2025 were $270.2 million as compared to $269.1 million on December 31, 2024. Nektar’s cash and marketable securities at September 30, 2025 includes $107.2 million of net proceeds from the secondary offering closed on July 2, 2025 and $34.3 million of net proceeds for the issuance of registered stock under the Company’s filed at-the-market, "ATM", offering. Following the end of the third quarter, an additional $38.3 million of net proceeds were also raised from the ATM offering in October 2025. We expect our cash and investments in marketable securities to support our operations into the second quarter of 2027.

"We have made tremendous progress advancing rezpegaldesleukin, and the emerging data from the REZOLVE-AD study continue to demonstrate a highly differentiated profile for this first-in-class, novel regulatory T cell mechanism in moderate-to-severe atopic dermatitis," said Howard W. Robin, President and CEO of Nektar. "We will present important new findings from REZOLVE-AD this weekend at the ACAAI Scientific Meeting highlighting the potential of rezpegaldesleukin to treat atopic dermatitis and co-morbid asthma, which occurs in about 25% of atopic dermatitis patients. These compelling data give rezpegaldesleukin a unique position in the competitive landscape as this efficacy signal has not been observed with other biologic mechanisms recently approved or in advanced development. Notably, this year’s Nobel Prize in Physiology or Medicine, was awarded for discoveries establishing FOXP3-positive Tregs as essential for peripheral immune tolerance, and we were humbled that rezpegaldesleukin data were referenced in the background documents from the Nobel Committee. Finally, we look forward to reporting in December the topline data for rezpegaldesleukin in patients with severe-to-very-severe alopecia areata, a chronic auto-immune condition that greatly impacts quality of life and mental health for these patients."

Summary of Financial Results

Revenue in the third quarter of 2025 was $11.8 million as compared to $24.1 million in the third quarter of 2024. Revenue for the first nine months of 2025 was $33.4 million compared to $69.3 million in the first nine months of 2024. Revenue has decreased year over year because we no longer recognize product sales due to the sale of the Huntsville manufacturing facility in December 2024.

Total operating costs and expenses in the third quarter of 2025 were $43.5 million as compared to $58.5 million in the third quarter of 2024. Total operating costs and expenses in the first nine months of 2025 were $145.9 million compared to $188.8 million in the first nine months of 2024. Operating costs and expenses for the third quarter and first nine months of 2025 decreased due to the elimination of cost of goods sold following the sale of the Huntsville manufacturing facility and deceases in research and development expenses, as well as non-cash impairment charges recorded in the first nine months of 2024.

R&D expense in the third quarter of 2025 was $27.3 million as compared to $35.0 million for the third quarter of 2024. For the first nine months of 2025, R&D expense was $87.6 million compared to $92.2 million in the first nine months of 2024. R&D expense decreased in the first nine months of 2025 primarily due to a decrease in expense for the development of NKTR-255, partially offset by an increase in expenses for the development of rezpegaldesleukin and NKTR-0165.

G&A expense was $16.1 million in the third quarter of 2025 as compared to $19.0 million in the third quarter of 2024. G&A expense was $57.5 million for the first nine months of 2025 compared to $59.6 million in the first nine months of 2024. G&A expense decreased for both the third quarter and the first nine months of 2025 due to decreases in facilities and stock-based compensation expenses offset by an increase in legal expenses.

Non-cash restructuring and impairment charges were not material in the third quarter and the first nine months of 2025. Non-cash restructuring and impairment charges were less than $0.1 million in the third quarter of 2024 and $14.3 million in the first nine months of 2024. These non-cash charges were related to the declining San Francisco commercial real estate market and real estate lease obligations held by Nektar.

In the first quarter of 2025, we began accounting for our investment in the new portfolio company, Gannet BioChem, under the equity method of accounting which calculates our gain or loss based on the change in our share of Gannet BioChem’s equity each quarter. This resulted in non-cash losses from the equity method investment of $0.5 million in the third quarter of 2025 and $7.4 million for the first nine months of 2025.

Net loss for the third quarter of 2025 was $35.5 million or $1.87 basic and diluted loss per share as compared to a net loss of $37.1 million or $2.661 basic and diluted loss per share in the third quarter of 2024. Net loss in the first nine months of 2025 was $128.0 million or $8.14 basic and diluted loss per share compared to a net loss of $126.2 million or $9.271 basic and diluted loss per share in the first nine months of 2024. Excluding the $0.5 million and $7.4 million non-cash loss from our equity method investment in Gannet BioChem, net loss, on a non-GAAP basis, for the third quarter and the first nine months of 2025 were $35.0 million and $120.6 million, respectively, or $1.85 and $7.67 basic and diluted loss per share, respectively.

Recent Business Highlights

· In October of 2025, Nektar’s abstract "Rezpegaldesleukin, Novel Treg-Inducing Therapy, Demonstrates Efficacy in Atopic Dermatitis and Asthma in Phase 2b Trial" was accepted for a late-breaking oral abstract presentation at the American College of Allergy, Asthma and Immunology’s 2025 Annual Scientific Meeting (ACAAI). These data will be presented at ACAAI on Saturday, November 8, 2025 at 5:33pm ET.

1 The per share amounts have been retrospectively adjusted to reflect a one-for-fifteen reverse stock split completed on June 8, 2025.

· In September of 2025, Nektar presented data from the REZOLVE-AD Phase 2b study of rezpegaldesleukin in atopic dermatitis in a late-breaker oral presentation at European Academy of Dermatology and Venereology (EADV) 2025 Congress.

· In July of 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for rezpegaldesleukin for the treatment of severe-to-very-severe alopecia areata (AA) in adults and pediatric patients 12 years of age and older who weigh at least 40 kilograms.

· In July of 2025, Nektar announced the successful closing of a public offering of its common stock including the full exercise of underwriters’ option to purchase additional shares, raising $115 million in gross proceeds.

Conference Call to Discuss Third Quarter 2025 Financial Results

Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time on November 6, 2025.

This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through February 6, 2025.

To access the conference call by phone, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.

(Press release, Nektar Therapeutics, NOV 6, 2025, View Source [SID1234659582])

On November 6, 2025 Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology Company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported financial results for the quarter ended September 30, 2025, and provided a business update.

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Third Quarter Highlights

89% remission* reported among evaluable frontline AML patients across two trials treated with mipletamig in combination therapy, including 100% remission in Cohort 3 in the ongoing RAINIER trial (*Remission = complete remission (CR) and, complete remission with blood markers that have not yet recovered (CRi).

No cytokine release syndrome (CRS) observed among evaluable frontline patients to date – a meaningful distinction in a category where CRS is a common and often dose-limiting toxicity

Introduced the Company’s first trispecific T-cell engagers – APVO451 and APVO452 – expanding the oncology portfolio to five CRIS-7-derived CD3-targeting molecules

These candidates are designed to target tumors that suppress immune activity, a key barrier to durable responses in solid tumors

Both trispecifics leverage Aptevo’s unique use of the CRIS-7-derived CD3 binding domain, a clinically validated T-cell activation approach that has demonstrated favorable safety and tolerability in clinical trials with mipletamig

Continued expansion of the portfolio reflects Aptevo’s intentional platform strategy: purpose-built immune-modulating therapies that aim to be both powerful and clinically manageable for patients

Raised $18.7 million, net in the third quarter and $4.1 million, net since quarter end, extending cash runway well into 4Q26 and enabling the Company to reach important clinical milestones next year

"We continue to make disciplined progress across both our clinical and research programs," said Marvin White, President and Chief Executive Officer of Aptevo. "The Cohort 3 results reinforce mipletamig’s potential to meaningfully improve outcomes for patients with frontline AML – a population that has had very limited treatment options. At the same time, the introduction of trispecific candidates, APVO451 and APVO452, reflects the continued strength of our platform strategy and our commitment to thoughtfully expanding the pipeline where we believe we can have real impact. Our approach remains focused, data-driven, and rooted in the belief that well-designed immunotherapies can be both powerful and tolerable for patients."

"Aptevo raised $22.8 million since the end of the second quarter, extending our runway well into the fourth quarter of 2026 and ensuring we are well-capitalized for the important milestones ahead. We are pleased to have completed this financing in a cost-effective manner and without issuing new warrants, reflecting continued momentum in the business. This additional capital positions us to execute on our clinical and development plans while remaining focused on delivering value for patients and shareholders," said Daphne Taylor, SVP and Chief Financial Officer of Aptevo.

Pipeline Expansion – APVO451 and APVO452 (Trispecific CD3 Portfolio)

During the quarter, Aptevo introduced APVO451 (for multiple solid tumors) and APVO452 (for prostate cancer), two trispecific T-cell engagers designed to more effectively activate the immune system in solid tumors with highly suppressive tumor microenvironments. With these additions, the Company now has five CD3-engaging molecules, all built using Aptevo’s unique application of the CRIS-7-derived CD3 binding domain, specifically engineered to deliver targeted, controlled T-cell activation.

Mr. White commented, "Bispecifics already deliver selective T-cell activation and are clinically validated and commercially viable today. Trispecifics, APVO451 and APVO452, build on that foundation to more flexibly fight tumors that have evolved to create a suppressive tumor microenvironment. In these cases, trispecifics add a third coordinated signal to help overcome that suppression. We are excited about adding to the pipeline and expanding our potential to impact a broader range of tumor types."

The design is intended to advance potent anti-tumor activity while reducing the risk of systemic cytokine release, a known challenge for traditional CD3-based therapies; these candidates extend Aptevo’s platform to a broader range of tumor biology, while preserving the Company’s core safety-first approach to immune activation via the CRIS-7-derived CD3 pathway.

Mipletamig (CD123 x CD3) in Frontline AML

Across two trials evaluating mipletamig in combination with venetoclax + azacitidine, 89% of newly diagnosed, evaluable AML patients unfit for intensive chemotherapy achieved remission. No cytokine release syndrome has been observed among frontline patients to date, supporting mipletamig’s emerging profile of favorable safety and tolerability, combined with high response rates among evaluable patients.

Q3 2025 Summary Financial Results

Cash Position: Aptevo had cash and cash equivalents as of September 30, 2025, totaling $21.1 million. During the third quarter of 2025, the Company raised $18.7 million, net under the Company’s Standy Equity Purchase Agreement (SEPA) with Yorkville and the Company’s ATM agreement with Roth. An additional $4.1 million, net was raised under the ATM agreement in October, bringing the proforma cash and cash equivalents at September 30, 2025, to $25.2 million. The SEPA and ATM programs carry lower fees than traditional equity raises, are done at market prices and do not include warrants that could result in additional shareholder dilutions. As such, they enable the Company to raise capital on as-needed basis, providing liquidity to support our ongoing operations. The Company now has sufficient cash resources to meet our projected operating requirements for at least twelve months from the date of issuance of the financial statements.

Research and Development Expenses: Research and development expenses increased by $0.9 million, from $3.1 million for the three months ended September 30, 2024, to $4.0 million for the three months ended September 30, 2025. The increase was primarily due to increased mipletamig and employee costs and was offset by lower costs on ALG.APV-527.

General and Administrative Expenses: General and administrative expenses increased by $1.5 million, from $2.1 million for the three months ended September 30, 2024, to $3.6 million for the three months ended September 30, 2025. The increase is primarily due to higher employee costs.

Net Income (Loss): Aptevo had a net loss of $7.5 million or $2.23 per share for the three months ended September 30, 2025, compared to a net loss of $5.1 million or $357.86 per share for the corresponding period in 2024.

Dividend Attributable to Down Round Feature of Warrants: This non-cash amount reflects the impact of reducing the exercise price of the Company’s June 2025 warrants from the original $3.25 per share to $1.39 per share, the lowest price at which we sold common shares after issuance of such common warrants due to contractual requirements of the warrants. The $1.5 million recorded in three months ended September 30, 2025, reflects dividend deemed to common shareholders and it increases net loss attributable to common shareholders to $9.0 million for EPS purposes.

(Press release, Aptevo Therapeutics, NOV 6, 2025, View Source [SID1234659610])

On November 6, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer reported it will present a poster on its proprietary VacDesignR computational tool at the upcoming ESMO (Free ESMO Whitepaper) AI & Digital Oncology 2025 conference, held in Berlin, Germany, from 12-14 November 2025.

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The presentation will highlight how VacDesignR streamlines the design and production of recombinant Modified Vaccinia Ankara (MVA)-based vectors, enabling faster and more reliable manufacturing of individualized neoantigen therapeutic vaccines (INTV).
The individualized immunotherapies developed through the myvac platform, currently being evaluated in a Phase I/II clinical trial (NCT04183166), are based on an MVA viral vector and their design already leverages the VacDesignR tool.

Developed in-house, VacDesignR is a computational design engine that optimizes recombinant plasmid architecture for MVA vectors, a core component of Transgene’s myvac platform. By minimizing unwanted homologous recombination and intelligently selecting peptide sequences for cassette assembly, VacDesignR significantly improves production reliability and vector quality.

Future iterations of VacDesignR will incorporate AI-based components to further improve performance and scalability, supporting Transgene’s strategy to accelerate production timelines for individualized therapeutic vaccines, including its lead candidate TG4050 designed to treat HPV-negative head and neck cancers following surgery and adjuvant therapy.

"Participating at the first edition of the ESMO (Free ESMO Whitepaper) AI & Digital Oncology meeting highlights Transgene’s pioneering role in combining viral vector-based individualized cancer vaccines with its vaccine design tool to optimize product performance and redefine the future of oncology treatment", commented Maurizio Ceppi, Chief Scientific Officer of Transgene.

Title of the abstract: "VacDesignR: a computational tool to optimize viral-based individualized neoantigen therapeutic vaccine production"

Title of the poster: "VacDesignR: a tool for optimizing recombinant poxvirus vaccine production"

Poster and Abstract number: 385P
Session: Drug development
Date: November 12, 2025
Author: B. Grellier
The poster presentation will take place on November 12 at ESMO (Free ESMO Whitepaper)-AI conference and will be available that day on Transgene’s website.

VacDesignR is a computer-assisted method protected through patent and patent applications derived from WO2021/130210.

(Press release, Transgene, NOV 6, 2025, View Source [SID1234659484])

On November 6, 2025 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported corporate updates and announced financial results for the quarter ended September 30, 2025. The Company continues to advance a portfolio that seeks to redefine access to cell therapy, bringing the power of CAR T earlier in disease, more reliably, and across a broader range of treatment settings.

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"With our unique allogeneic approach to CAR T, the field has the ability to shift from highly personalized, patient-specific therapies to a new era of readily available, off-the-shelf treatments that can reach more patients earlier in their disease and wherever they receive care," said David Chang, M.D., Ph.D., President, Chief Executive Officer and Co-Founder of Allogene. "Having treated hundreds of patients, we’ve gained valuable insight into how ex vivo manufacturing enables more precise definition and control of our cell products before they reach patients, enhancing consistency, safety, and quality. This transformation is evident and goes far beyond incremental progress, it begins to establish a scalable allogeneic CAR T paradigm built to reach more patients, expand into broader care settings, and unlock the full potential of cell therapy."

Cema-Cel: Pivotal Phase 2 ALPHA3 1L Consolidation Trial in LBCL
The pivotal Phase 2 ALPHA3 trial with cema-cel is pioneering the use of allogeneic CAR T therapy in earlier-line treatment of LBCL, an approach that could expand access for patients before disease progression and simplify delivery across community and academic centers. By leveraging minimal residual disease (MRD) as a guide for treatment intervention, a rapidly emerging focus across oncology, the ALPHA3 trial aims to position Allogene at the forefront of a transformative shift toward earlier, more precise, treatment. More than 50 clinical sites are active across the United States and Canada, spanning both community cancer centers and leading academic institutions. Additional sites in Australia and South Korea are progressing toward activation and are expected to open in early 2026.

The next milestone will be the futility analysis comparing MRD conversion between the two arms comparing cema-cel after standard fludarabine and cyclophosphamide (FC) lymphodepletion versus observation, expected in the first half of 2026. At that time, the Company plans to share MRD conversion rates from the randomized portion of the study.

ALLO-329: CD19/CD70 Dual CAR with Dagger Technology in AID
The Phase 1 RESOLUTION trial with ALLO-329, a dual CD19/CD70 CAR incorporating Dagger technology, is enrolling in a basket trial across multiple autoimmune conditions, including systemic lupus erythematosus (with or without lupus nephritis), idiopathic inflammatory myopathies, and systemic sclerosis. In this dose-escalation study, two treatment regimens are being explored: one with reduced intensity cyclophosphamide-only lymphodepletion, and the other with no lymphodepletion at all, a potential breakthrough for improving tolerability and enabling treatment in a broader patient population.

With its built-in lymphodepletion coming from the Dagger technology as well as its ability to target both B cells and activated T cells, key drivers of autoimmune pathology, ALLO-329 represents one of the first to investigate how allogeneic CAR T could be uniquely suited to treat autoimmune disease at scale, with reduced or without lymphodepletion to facilitate a broader CAR T adoption in autoimmune indications. The first clinical update, expected in 1H 2026, will include biomarker data and clinical proof-of-concept data.

ALLO-316: TRAVERSE Trial in RCC
ALLO-316 remains the only allogeneic CAR T therapy to show clinically significant response rates and meaningful durability of response in a metastatic solid tumor. The TRAVERSE trial in renal cell carcinoma has completed enrollment in its Phase 1b cohort, evaluating ALLO-316 in heavily pretreated patients. Updated data presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting demonstrated early signs of efficacy and tolerability.

2025 Third Quarter Financial Results

Research and development expenses were $31.2 million for the third quarter of 2025, which includes $2.8 million of non-cash stock-based compensation expense.
General and administrative expenses were $13.7 million for the third quarter of 2025, which includes $5.9 million of non-cash stock-based compensation expense.
Net loss for the third quarter of 2025 was $41.4 million, or $0.19 per share, including non-cash stock-based compensation expense of $8.7 million.
The Company had $277.1 million in cash, cash equivalents, and investments as of September 30, 2025.
The Company continues to expect its cash runway to extend into the second half of 2027. Guidance for 2025 is an expected decrease in cash, cash equivalents, and investments of approximately $150 million. GAAP Operating Expenses are expected to be approximately $230 million, including estimated non-cash stock-based compensation expense of approximately $45 million. These estimates exclude any impact from potential business development activities.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 2:00 p.m. PT / 5:00 p.m. ET to discuss financial results and provide a business update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

(Press release, Allogene, NOV 6, 2025, View Source [SID1234659551])

On November 6, 2025 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported financial results for the third quarter ended September 30, 2025, and provided a review of recent program and corporate developments.

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"We are incredibly proud of the progress across our entire pipeline this quarter, most notably around our NDA submission for bitopertin in EPP at the end of September and subsequent receipt of the CNPV," said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. "Achieving this milestone is a strong testament to our team’s commitment to execution and dedication to bringing a potential new treatment option to the EPP patient community. We continue to work with the Agency on their review of our application, and we are furthering our commercial infrastructure in preparation for a potential launch."

"Beyond bitopertin, our broader pipeline is progressing well, as we expect new data from the Phase 2 trial of DISC-0974 in MF anemia by the end of the year and data from studies of DISC-3405 in PV and SCD next year. With a strong balance sheet providing cash runway into 2029, we are well-positioned to prepare for the anticipated launch of bitopertin and ultimately advancing towards our goal of delivering new treatment options to patients suffering from hematological diseases."

Recent Highlights and Anticipated Milestones:

Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator)

Submitted NDA for bitopertin in EPP seeking priority review and accelerated approval with reduction in protoporphyrin IX (PPIX) as the surrogate endpoint for approval supported by clinical results from BEACON and AURORA Phase 2 trials
Received the CNPV, which is designed to shorten the NDA review process to 1-2 months from NDA acceptance
Accelerating activities to support a potential US approval and launch in late 2025 or early 2026
Progressing confirmatory Phase 3 APOLLO clinical trial of bitopertin in adults and adolescents with EPP
DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression)

Initial data from Phase 2 RALLY-MF trial of DISC-0974 in patients with anemia of myelofibrosis (MF) to be presented at ASH (Free ASH Whitepaper) Annual Meeting in December, with topline data expected in 2026
Data from recently completed multiple-dose cohorts of Phase 1b study of DISC-0974 in patients with anemia of NDD-CKD to be presented at ASN Kidney Week
DISC-0974 was generally well-tolerated with substantial decreases in hepcidin, increases in iron, and improvements in markers of erythropoiesis
Meaningful hemoglobin increases observed in only a subset of patients were in part driven by those with higher baseline erythropoietin (EPO) levels
Disc is assessing options for the program based on full analysis of the data
Phase 2 study in patients with inflammatory bowel disease (IBD) and anemia anticipated to begin in Q1 2026
DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)

Progressing ongoing Phase 2 study of DISC-3405 in patients with PV with initial data expected in 2026
Initiated Phase 1b study of DISC-3405 in patients with SCD in October 2025 with initial data expected in 2026
Third Quarter 2025 Financial Results:

Cash Position: Cash, cash equivalents, and marketable securities were $615.9 million as of September 30, 2025. In October 2025, Disc completed a public offering with net proceeds of approximately $211 million, extending cash runway into 2029.
Research and Development Expenses: R&D expenses were $50.3 million for the three months ended September 30, 2025, as compared to $24.7 million for the three months ended September 30, 2024. The increase in R&D expenses was primarily driven by the progression of Disc’s portfolio, including bitopertin’s clinical studies and drug manufacturing, the advancement of the DISC-0974 program, and increased headcount, as well as a payment of a $10.0 million milestone upon first administration to a patient in the Phase 2 trial of DISC-3405.
Selling, General and Administrative Expenses: SG&A expenses were $17.4 million for the three months ended September 30, 2025, as compared to $8.2 million for the three months ended September 30, 2024. The increase in SG&A expenses was primarily due to increased headcount including establishing infrastructure to support potential commercialization.
Net Loss: Net loss was $62.3 million for the three months ended September 30, 2025, as compared to $26.6 million for the three months ended September 30, 2024. The increase was primarily due to higher operating costs in the current period to support the continued advancement of our pipeline.

(Press release, Disc Medicine, NOV 6, 2025, View Source [SID1234659567])