Plus Therapeutics Highlights ReSPECT-LM Clinical Trial Results at 40th SITC Annual Meeting, Melanoma Research Foundation Brain Metastases Summit 4.0

On November 6, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported its participation at the 40th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, Melanoma Research Foundation (MRF) Brain Metastases Summit 4.0 on November 9, 2025 in Alexandria, VA. Dr. Andrew Brenner, M.D., Ph.D., Professor of Medicine in the Division of Hematology and Oncology at The University of Texas Health Science Center at San Antonio will highlight the Company’s REYOBIQ and ReSPECT-LM clinical trial results in the session on leptomeningeal metastases (LM) disease.

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Recall, at the 2025 SNO/ASCO CNS Metastases conference in August, ReSPECT-LM Phase 1 single dose escalation trial data showed:

REYOBIQ produced a clinical benefit rate of over 75% in 3 clinically relevant outcome measures
RNA sequencing and circulating tumor cell reduction consistent with tumor cell death
No dose limiting toxicities were observed with an overall favorable safety profile up to and including the recommended phase 2 dose of 44.1 mCi
"Given the growing incidence and unmet need, with no approved therapies for LM, we are encouraged by the continued interest in the ReSPECT-LM data, which demonstrated excellent tolerance of REYOBIQ at much higher doses than current standard, which we believe supports its broad therapeutic range," said Dr. Brenner. "REYOBIQ has been granted FDA Fast Track and Orphan Drug Designation, with enrollment in the ReSPECT-LM Dose Optimization Trial ongoing."

About LM
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

(Press release, Plus Therapeutics, NOV 6, 2025, View Source;_hsenc=p2ANqtz-9wK0pEiXdCF6C_QhGr1luNoUuLy0Y0aCzdXjasFH0TXIWLb6Cl_OE8hKG707ChQCieDhElzVLmx2Jvfp8-Ij7lJUmdlw&_hsmi=388703881&utm_content=388703881&utm_source=hs_email [SID1234659609])

Defence Announces Successful Presentation At The World Adc Conference In San Diego And Plans To Expand Evaluation Of Accum In Commercial And Pipeline Adcs

On November 6, 2025 Defence Therapeutics Inc. ("Defence" or the "Company"), a leading biotechnology company pioneering next-generation antibody-drug conjugate ("ADC"), reported the successful presentation of new data on its proprietary Accum platform at the 16th World ADC Conference in San Diego, USA (November 4–5, 2025).

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The presentation generated exceptional interest from both the scientific and industry communities, with attendees continuing discussions around Defence’s poster long after the official session concluded. The results presented by Dr. Maxime Parisotto, Chief Scientific Officer of Defence Therapeutics, demonstrated how Accum enhances intracellular delivery and payload release, thereby amplifying the potency and therapeutic index of ADCs.

"The response to our new data was phenomenal," said Dr. Parisotto. "It’s clear that the Accum platform addresses one of the key challenges in ADC design—efficient endosomal escape and payload delivery. We are now moving forward to test Accum across a broader range of on-market and development-stage ADCs to fully explore its potential to improve efficacy and patient outcomes."

The Company is now expanding its collaborative and internal testing programs to include multiple commercial and clinical-stage ADC constructs, aiming to validate Accum as a plug-and-play enhancer for the next generation of targeted cancer therapies.

"Our goal is to demonstrate that Accum can universally enhance the performance of ADCs, regardless of the payload or antibody used," said Dr. Mark Lambermon, Head of Quality and Operation at Defence Therapeutics who was also in attendance in San Diego. "We are engaging with leading industry partners to accelerate these evaluations and bring this transformative technology closer to patients."

The Defence team extends its gratitude to the organizers of the World ADC Conference and to the many collaborators and industry partners who joined discussions in San Diego.

(Press release, Defence Therapeutics, NOV 6, 2025, View Source;utm_medium=rss&utm_campaign=defence-announces-successful-presentation-at-the-world-adc-conference-in-san-diego-and-plans-to-expand-evaluation-of-accum-in-commercial-and-pipeline-adcs [SID1234659634])

Alkermes to Participate in Two Upcoming Investor Conferences

On November 6, 2025 Alkermes plc (Nasdaq: ALKS) reported that management will participate in two upcoming investor conferences.

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Stifel 2025 Healthcare Conference
Date/Time: Thursday, Nov. 13, 2025 at 2:40 p.m. ET (7:40 p.m. GMT)

Jefferies Global Healthcare Conference in London
Date/Time: Wednesday, Nov. 19, 2025 at 11:30 a.m. ET (4:30 p.m. GMT)

The live webcasts may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

(Press release, Alkermes, NOV 6, 2025, View Source [SID1234659550])

CytomX Therapeutics Announces Third Quarter 2025 Financial Results and Provides Business Update

On November 6, 2025 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported third quarter 2025 financial results and provided a business update.

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"CytomX continued to execute against its pipeline priorities this quarter, highlighted by robust Phase 1 expansion enrollment for CX-2051. We remain on track for a CX-2051 Phase 1 data update in Q1 2026. Looking ahead to 2026, CX-2051 is well positioned as a first-in-class EpCAM-directed, topoisomerase-1 ADC designed to address the high unmet need in CRC and a wide range of other EpCAM-expressing indications. CytomX’s top priority is to advance CX-2051 towards a potential registrational study in advanced, late-line CRC. Additionally, we continue to plan for focused investments to further unlock the potential of CX-2051, including moving into earlier lines of CRC therapy and additional EpCAM positive cancers," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX.

Dr. McCarthy continued "We are also pleased with the dose escalation progress for our PROBODY interferon alpha-2b, CX-801, and look forward to presenting encouraging initial biomarker data at SITC (Free SITC Whitepaper) which underscore this potent masked cytokine’s therapeutic potential in combination with checkpoint inhibitors in advanced melanoma."

Q3 2025 Pipeline Program Updates:

CX-2051 (EpCAM PROBODY Topo-1 ADC)

CX-2051 Phase 1 dose expansions across the 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses, administered every three weeks (Q3W) are ongoing.
In Q3 2025, dose expansion enrollment continued with the goal of supporting a potential registrational study of CX-2051 monotherapy in advanced CRC.
Phase 1 study enrollment is projected to reach approximately 100 patients by the planned CX-2051 Phase 1 update in Q1 2026.
A Phase 1b CX-2051 combination study with bevacizumab in CRC is expected to start in Q1 2026, data from which is intended to inform potential late-phase development in earlier lines of CRC therapy.
Evaluation ongoing of multiple non-CRC, EpCAM-expressing tumor indications for potential future CX-2051 development.
CX-801 (PROBODY Interferon alpha-2b)

Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting
CX-801 monotherapy biomarker data in advanced melanoma patients to be presented that support CX-801’s mechanism of action and the ongoing combination study with KEYTRUDA (pembrolizumab).
CX-801 monotherapy has been well tolerated at doses exceeding the approved dose of unmasked IFNα2b.1
Gene expression analysis of pre- and post-treatment patient tumor biopsies demonstrated consistently increased expression of interferon-stimulated genes.
Patients demonstrated evidence of T-cell and NK cell activation and upregulation of immune checkpoint genes, including PD-1 and PD-L1.
Evidence of sustained elevation of CXCL10 in the tumor but not the blood was observed, suggesting preferential CX-801 activity in the tumor versus the periphery.
PK analysis also demonstrated dose-proportional exposure of CX-801, which remained predominantly in its intact (masked) form in circulation.
The CX-801 Phase 1 study is ongoing with a focus in advanced melanoma. CX-801 monotherapy dose escalation has reached the fourth dose level.
In May 2025, Phase 1 dose escalation of CX-801 in combination with KEYTRUDA was initiated. Dose escalation of CX-801 in combination with KEYTRUDA is currently enrolling the 2nd dose level.
Initial clinical data for CX-801 in the combination with KEYTRUDA in advanced melanoma is anticipated in 2026.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

Corporate and Financial:

Corporate:
In October 2025, announced the appointment of Rachael Lester, MBA as Senior Vice President, Chief Business Officer.
Financial:
CytomX ended the third quarter of 2025 with $143.6 million of cash, cash equivalents and investments with expected cash runway to the second quarter of 2027.
Research Pipeline and Collaborations:
CytomX has research collaborations with Bristol Myers Squibb, Amgen, Astellas, Regeneron, and Moderna. Multiple drug discovery programs continue across our research collaborations with a focus on bispecific immunotherapies, including T-cell engagers.
At SITC (Free SITC Whitepaper) 2025, preclinical data will be presented for CX-908, a dually masked PROBODY T-cell Engager targeting CDH3 and CD3. CX-908 potently induced tumor regressions in established breast and lung cancer xenograft tumor models and demonstrated a 100-fold improvement in tolerability, including significantly reduced cytokine release vs. an unmasked CDH3xCD3 molecule.

Third Quarter 2025 Financial Results:

Cash, cash equivalents and investments totaled $143.6 million as of September 30, 2025, compared to $158.1 million as of June 30, 2025.

Total revenue was $6.0 million for the quarter ended September 30, 2025, compared to $33.4 million for the quarter ended September 30, 2024. The decrease in revenue was driven primarily by the completion of our performance obligations in the Bristol Myers Squibb collaboration and a decrease in Moderna activities due to Moderna budget considerations.

Total operating expense in the third quarter of 2025 was $21.7 million compared to $29.3 million in the third quarter of 2024, a decrease of $7.6 million.

Research and development expenses were $15.3 million for the three months ended September 30, 2025, a decrease of $6.1 million compared to the corresponding period of 2024. Reduced research and development expenses were primarily due to a reduction in CX-904 spend due to program de-prioritization in Q1 2025, reduced research expenses following the Q1 2025 restructuring, and lower CX-2051 manufacturing expenses which was partially offset by the increase in CX-2051 clinical spend.

General and administrative expenses were $6.4 million for the three months ended September 30, 2025, a decrease of $1.5 million compared to the corresponding period of 2024. The decrease in general and administrative expenses was primarily driven by personnel costs as well as patent and legal expenses.

(Press release, CytomX Therapeutics, NOV 6, 2025, View Source [SID1234659566])

Nektar Therapeutics Reports Third Quarter 2025 Financial Results

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])