On November 12, 2025 BetaGlue Therapeutics ("BetaGlue" or the "Company") a clinical-stage oncology company developing an innovative radiotherapy solution for the targeted treatment of solid tumours, reported that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) has approved the Clinical Trial Application for YntraDose in unresectable Locally Advanced Pancreatic Ductal Adenocarcinoma (LA-PDAC).

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The clinical study is an early feasibility clinical investigation and will assess safety and performance in patients with unresectable locally advanced pancreatic ductal adenocarcinoma. LA-PDAC remains a significant health concern and an unmet medical need. The incidence of LA-PDAC has increased by 1.0% per year since the late 1990s, and it is projected to become the second-leading cause of cancer-related mortality by 2030.

"The approval by the MHRA represents a fundamental milestone in the clinical development of YntraDose and a meaningful step forward in our commitment to innovation in oncology," said Alexis Peyroles, CEO of BetaGlue Therapeutics. "This authorization enables us to initiate our first clinical study in the UK in Q1 2026, marking a critical step toward delivering a novel therapeutic option for patients with unresectable locally advanced pancreatic cancer, one of the most aggressive and deadly malignancies. We are proud of the dedication shown by our team and Clinical Advisory Board and grateful for the collaborative engagement with regulatory authorities".

(Press release, BetaGlue Therapeutics, NOV 12, 2025, View Source [SID1234661240])

On November 12, 2025 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, reported a business and financial update for the third quarter 2025.

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"During the third quarter of 2025 and early in the fourth quarter, the Company made tremendous progress from having successfully implemented a plan of optionality and laying the necessary groundwork for future growth," said Usman Azam, M.D., president and chief executive officer of Cue Biopharma. "I am deeply proud of the Cue team and believe we are strategically positioned to further advance our differentiating Immuno-STAT platform and lead autoimmune asset, CUE-401, toward the clinic to address a major unmet need in autoimmune disease treatment."

Business Highlights

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Announced strategic transition in leadership to further enable next stage of growth with disruptive autoimmune therapeutic candidates most notably, CUE-401, the Company’s lead autoimmune asset
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Usman Azam, M.D., appointed President and Chief Executive Officer, effective as of September 29
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CUE-401 is uniquely engineered and designed as a tolerogenic bifunctional molecule harnessing the power of TGF-beta and IL-2 to re-establish immune tolerance and balance
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Announced strategic collaboration and license agreement with ImmunoScape to develop breakthrough cell therapy approach for solid tumors
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Upfront total payment of $15 million, $10 million in Q4 2025 and $5 million in November of 2026, as well as a 40% equity stake in ImmunoScape
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Exclusive collaboration and license agreement focuses on advancing novel, T cell therapy "Seed-and-Boost" approach exploiting the mechanism of the CUE-100 series of Immuno-STATs

(Press release, Cue Biopharma, NOV 12, 2025, View Source [SID1234659817])

On November 12, 2025 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported financial results for the third quarter ended September 30, 2025, and provided a corporate update.

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"Following a productive meeting with the FDA, we now have a clearly defined pivotal trial design for TSC-101, and we also have an improved commercial-ready manufacturing process in place. We are focused on advancing this promising program for patients with AML and MDS and look forward to sharing updated results from the ALLOHA Phase 1 trial at ASH (Free ASH Whitepaper) next month," said Gavin MacBeath, Ph.D., Chief Executive Officer. "After infusing the first two patients with multiplex TCR-T in our PLEXI-T trial, we have now paused further enrollment to focus on preclinical development of in vivo engineering to treat patients with solid tumors. We believe this approach represents a promising and more cost-efficient way to deliver off-the-shelf, multiplexed TCR-T cells."

Recent Corporate Highlights

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The Company recently announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding its pivotal trial design for TSC-101. The FDA has agreed to a study design that mirrors the current ALLOHA Phase 1 trial (NCT05473910) using a biologically-assigned internal control arm. TScan believes the design of the pivotal trial, which is expected to begin in the second quarter of 2026, will enable efficient enrollment and streamlined assessment of study endpoints.

In addition, the Company announced that it has implemented a commercial-ready manufacturing process that shortens manufacturing time by five days, both lowering the associated cost of goods and reducing the extent of ex vivo T cell expansion. An initial technology transfer of this process to an external contract development and manufacturing organization has been completed. The commercial-ready process will be used in the ongoing Phase 1 as well as future pivotal study.

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In early November, the Company made the strategic decision to prioritize the clinical development of its heme program and pause further enrollment in its solid tumor Phase 1 trial, while focusing its preclinical efforts on in vivo engineering for solid tumors and target discovery in autoimmunity. As a result of these actions, the Company’s existing cash, cash equivalents, and marketable securities are now expected to fund its current operating plan into the second half of 2027.

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In October, the Company presented at the American College of Rheumatology Convergence 2025 where the Company highlighted the potential application of its proprietary TargetScan technology to identify novel targets in T cell-driven autoimmune disorders, including ankylosing spondylitis, scleroderma, and ulcerative colitis. The presentation materials can be found on the Publications tab of the Company’s website at www.tscan.com.

Upcoming Anticipated Milestones

Heme Malignancies Program: TScan’s lead TCR-T therapy candidate, TSC-101, is designed to treat residual disease and prevent relapse in patients with heme malignancies undergoing allogeneic hematopoietic cell transplantation (HCT) (the ALLOHA trial, NCT05473910).

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Plans to present updated clinical data from the ALLOHA Phase 1 heme trial, including two-year relapse data on initial patients treated with TSC-101, at the upcoming 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

Title: TSC-101 eliminates recipient hematopoietic cells and demonstrates potential for improved relapse-free survival in patients with AML, ALL, or MDS undergoing allogeneic HCT: Updated results from the Phase 1 (ALLOHA) trial.
Publication Number: 2391
Presentation Date and Time: December 6, 2025, 5:30-7:30 PM ET

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Plans to submit investigational new drug (IND) applications for two additional TCR-T product candidates to expand HLA coverage of the heme program in the fourth quarter of 2025.
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Plans to launch pivotal trial for TSC-101 for patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in the second quarter of 2026.

Solid Tumor Program: TScan’s strategy is to treat patients with multiple TCR-T therapy candidates to overcome tumor heterogeneity and resistance that may arise from either target or HLA loss (the PLEXI-T trial, NCT05973487).

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PLEXI-T enrollment paused, shifting efforts to preclinical development of an in vivo engineering platform for solid tumors.
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Plans to share safety and efficacy data on patients infused to date in the PLEXI-T solid tumor trial in the first quarter of 2026.

Third Quarter 2025 Financial Results

Revenue: Revenue for the third quarter of 2025 was $2.5 million, compared to $1.0 million for the third quarter of 2024. The increase was primarily due to timing of research activities pursuant to the Company’s collaboration agreement with Amgen.

R&D Expenses: Research and development (R&D) expenses for the third quarter of 2025 were $31.7 million, compared to $26.3 million for the third quarter of 2024. The increase of $5.4 million was primarily driven by increased manufacturing and clinical activities, as well as personnel costs to support these activities. R&D expenses included non-cash stock compensation expense of $1.7 million and $1.2 million for the third quarter of 2025 and 2024, respectively.

G&A Expenses: General and administrative (G&A) expenses for the third quarter of 2025 were $7.9 million, compared to $7.4 million for the third quarter of 2024. The increase of $0.5 million was primarily driven by personnel costs to support business activities. G&A expenses included non-cash stock compensation expense of $1.3 million and $1.3 million for the third quarter of 2025 and 2024, respectively.

Net Loss: Net loss was $35.7 million for the third quarter of 2025, compared to $29.9 million for the third quarter of 2024, and included net interest income of $1.3 million and $2.7 million, respectively.

Cash Position: Cash, cash equivalents, and marketable securities as of September 30, 2025, were $184.5 million, excluding $5.0 million of restricted cash. The Company believes that its existing cash resources will be sufficient to fund its current operating plan into the second half of 2027.

Share Count: As of September 30, 2025, the Company had 56,747,993 shares of common stock outstanding, consisting of 52,471,405 shares of voting common stock and 4,276,588 shares of non-voting common stock. In addition, the Company had 73,087,945 of prefunded warrants outstanding to purchase shares of voting common stock at an exercise price of $0.0001 per share. Pro forma outstanding shares as of September 30, 2025, inclusive of both common stock and prefunded warrants, were 129,835,938.

(Press release, TScan Therapeutics, NOV 12, 2025, View Source [SID1234659832])

On November 12, 2025 LabGenius Therapeutics ("LabGenius"), a drug discovery company combining artificial intelligence (AI) and high-throughput experimentation to advance next-generation multispecific antibodies for solid tumours, reported a scientific poster will be presented at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2025, being held December 10 – 12, 2025, at the Queen Elizabeth II Centre in London, United Kingdom. LabGenius’ presentation will debut the pre-clinical in vivo efficacy (>90% tumour growth inhibition) and tolerability data for their lead asset, a highly tumour selective bispecific T-cell engager (TCE).

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Poster Presentation Details

Title

Novel Selectivity-Enhanced Bispecific T-cell Engager Utilises Avidity to Overcome On-target, Off-tumour Toxicity

Date and time

Wednesday, December 10, 2025, 08:00 (GMT)

Poster number

309P

Location

The Churchill Room, Queen Elizabeth II Centre, London

Bispecific TCE Overview

For the selected target, LabGenius has developed a selectivity-enhanced TCE. The company’s lead optimisation platform, EVA, was used to discover and concomitantly optimise a TCE with improved killing selectivity, potency, efficacy, and manufacturability. The biological mechanism underlying this enhanced selectivity is based on the principle of avidity. By harnessing avidity-driven selectivity, the optimised TCE can distinguish between healthy and diseased cells based on differential tumour-associated antigen expression.

(Press release, LabGenius Therapeutics, NOV 12, 2025, View Source [SID1234659856])

On November 12, 2025 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported financial results and business highlights for the third quarter of 2025 and shared recent operational progress.

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"We are scaling the ZEVASKYN launch to meet patient needs," said Vish Seshadri, Chief Executive Officer of Abeona. "We have strong and growing patient demand. Despite a one-quarter shift in patient starts, we remain steadfast in our 2026 launch goals. Our conviction is built on our expanding treatment site network and powerful momentum from the patient and caregiver community."

Recent Developments

ZEVASKYN (prademagene zamikeracel)

● Product release assay optimized; patient treatment anticipated to start in 4Q’25: During the third quarter, Abeona manufactured a full batch of drug product following patient biopsy collection in August 2025. Although the Company produced bonafide drug product, it could not be released because a rapid sterility assay, mandated by the FDA as a release assay during the final stage of the Biologics License Application (BLA) review, initially yielded a false positive result for sterility. The Company immediately implemented a temporary pause on collecting patient biopsies and worked diligently to optimize the release assay to ensure reliable results and avoid any unnecessary future lot rejections. Upon completion of assay optimization and the necessary regulatory submission for its implementation, Abeona resumed biopsy collection in November 2025. The Company now anticipates commercial product treatment starting in the fourth quarter of 2025.
● Patients at the first two Qualified Treatment Centers (QTCs) are actively advancing through process for ZEVASKYN treatment; Patient demand growing, reflecting unmet need for ZEVASKYN: Of the more than a dozen initial patients identified at the first two QTCs, Abeona has already received ZEVASKYN product order forms (ZPOFs) for 12 patients and they are in the process of scheduling treatments. ZEVASKYN demand has more than doubled at QTCs, with approximately 30 eligible patients now identified.
● Strategic expansion of the QTC network with three activated centers and others progressing through onboarding: With the recent activation of Children’s Hospital Colorado (CHCO), a highly recognized epidermolysis bullosa (EB) center, there are now three activated ZEVASKYN treatment centers along with Lurie Children’s Hospital of Chicago and Lucile Packard Children’s Hospital Stanford. Several additional centers across the US are in various stages of site onboarding.

● Strong early access momentum; focused on driving continued payer engagement and provider readiness: Following ZEVASKYN approval, there has been a steady cadence of coverage decisions from commercial health plans that account for approximately 60 percent of all RDEB patients. Policies covering ZEVASKYN have been published by all major commercial payers including United Healthcare, Cigna, Aetna, Anthem, and most Blue Cross Blue Shield plans, that account for 80 percent of lives covered by commercial insurance, signaling broad and early market acceptance. In addition, the Centers for Medicare and Medicaid Services (CMS) has established a permanent Healthcare Common Procedure Coding System (HCPCS) J-code for ZEVASKYN, J3389 (Topical administration, prademagene zamikeracel, per treatment), effective January 1, 2026.

Other corporate updates

● Pipeline program ABO-503 selected for FDA Rare Disease Endpoint Advancement (RDEA) Pilot Program: ABO-503 gene therapy for X-linked retinoschisis (XLRS) has been selected to participate in the FDA RDEA Pilot Program. As part of the RDEA program, Abeona will have opportunities for enhanced communication and collaboration with the FDA, including frequent advice and regular ad-hoc conversations to accelerate the development and validation of product-specific novel efficacy endpoints for Abeona’s XLRS program.
● Strengthened management team with appointment of Head of Clinical Development & Medical Affairs: Abeona appointed James A. Gow, MD, MBA, MS, MHCM, as the Senior Vice President, Head of Clinical Development & Medical Affairs. Dr. Gow has over 20 years of industry experience in clinical development and medical affairs and is a recognized expert in gene therapy, especially in ophthalmology.

Financial Results

Cash, cash equivalents, restricted cash and short-term investments totaled $207.5 million as of September 30, 2025. The current cash position, without accounting for anticipated revenue from ZEVASKYN, is expected to be sufficient to fund current and planned operations for over two years.

Research and development (R&D) spending for the three months ended September 30, 2025 was $4.2 million, compared to $8.9 million for the same period of 2024. The reduction in R&D expense was primarily due to costs capitalized into inventory and select costs, such as engineering runs and other production costs, reclassified as selling, general, and administrative (SG&A) following FDA approval of ZEVASKYN. SG&A expenses were $19.3 million for the three months ended September 30, 2025, compared to $6.4 million for the same period of 2024. In addition to the reclassification of select R&D expenses to SG&A, the increase in SG&A reflects increased headcount and professional costs associated with the commercial launch of ZEVASKYN.

Net loss was $(5.2) million for the third quarter of 2025, or $(0.10) per basic and diluted common share. Net loss in the third quarter of 2024 was $(30.3) million, or $(0.63) per basic and diluted common share.

Conference Call Details

The Company will host a conference call and webcast on Wednesday, November 12, 2025, at 8:30 a.m. ET, to discuss the financial results and corporate progress. To access the call, dial 877-545-0523 (U.S. toll-free) or 973-528-0016 (international) and Entry Code: 922481 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at View Source The archived webcast replay will be available for 30 days following the call.

(Press release, Abeona Therapeutics, NOV 12, 2025, View Source [SID1234659802])