On November 12, 2025 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported to host a virtual R&D Day highlighting the details of its platform innovation and next-generation ADC pipeline. The presentation will include an overview of Sutro’s near- and long-term priorities, beginning with STRO-004, its potential best-in-class Tissue Factor ADC, which has now entered clinical development. The Company will also provide details on its dual-payload ADC programs, uniquely enabled by its proprietary cell-free platform, and reveal STRO-227, its first dual-payload candidate designed to target PTK7.

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"The programs we are advancing showcase our platform’s unique potential to meaningfully expand the therapeutic window and address some of the most persistent challenges with conventional ADCs," said Jane Chung, Sutro’s Chief Executive Officer. "With STRO-004 entering the clinic and our dual-payload programs accelerating, we are positioned to deliver ADCs that combine optimized target engagement, differentiated design, and industry-leading pharmacokinetics to enable deeper and more durable responses to redefine what is possible for cancer care."

Ms. Chung continued: "The selection of PTK7 for our initial dual-payload program underscores our strategy to address difficult-to-treat solid tumors where standard approaches have been insufficient. Additionally, through strategic collaborations including our partnership with Astellas, we continue to broaden the impact of our ADC technology and advance novel payload combinations to deliver therapies with the potential to transform the standard of care to patients."

The event will feature presentations by key members of Sutro’s senior management team and Anthony Tolcher, M.D., FRCPC, FACP, a medical oncologist and founder and head of NEXT Oncology. Sutro management will participate in a Q&A session at the end of the presentation.

Next-Generation ADC Innovation
Sutro’s platform is designed to optimize every component of an ADC—the antibody, linker, and payload—rather than focusing on one or two elements in isolation. This holistic control is enabled by the Company’s cell-free technology, which allows unparalleled flexibility in designing ADCs and the potential to dose higher due to optimized safety and efficacy, even in complex biological settings. In addition, the platform enables sophisticated dual-payload combinations, enabling therapies that could redefine the standard-of-care.

Program Highlights and Near-Term Pipeline Milestones

Single-payload ADC Programs
Single-payload programs will establish Sutro’s foundation by tackling hard-to-reach, complex targets.

STRO-004: A potential best-in-class Tissue Factor (TF) targeting ADC, STRO-004, has entered clinical trials following recent IND clearance from the U.S. Food and Drug Administration (FDA). In preclinical TF-expressing models of head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic cancer, STRO-004 showed promising anti-tumor activity. Combined with a highest non-severely toxic dose of 50 mg/kg in non-human primate studies, STRO-004 is anticipated to meaningfully widen the therapeutic window versus conventional ADCs to address a wide range of tumors of unmet need.

STRO-006: A potential best-in-class, highly selective integrin β6 (ITGB6) targeting ADC, STRO-006, has demonstrated a superior pharmacokinetic profile compared to the current ITGB6-targeting ADC in Phase 3 development. Additionally, STRO-006 demonstrated encouraging anti-tumor activity and duration of response in preclinical models. STRO-006 is expected to enter clinical development in 2026 for the treatment of multiple solid tumors.

Dual-Payload ADC Program
Sutro’s dual-payload ADCs are designed to overcome resistance, delay progression, and potentially set a new standard-of-care by unlocking durable efficacy.

STRO-227: Sutro has selected tyrosine-protein kinase-like 7 (PTK7) as the target for its initial dual-payload candidate. PTK7 is overexpressed in many different cancers, including breast, lung, ovarian and colorectal cancer. The Company is working to accelerate its dual-payload ADC program, with an IND submission now targeted for 2026/2027.

Summary of Pipeline Milestones

STRO-004: Phase 1 study ongoing; initial data expected mid-2026
STRO-006: IND submission targeted for 2026
STRO-227: IND submission targeted for 2026/2027

Next-Generation ADC Collaborations
Research and development programs are progressing under Sutro’s collaboration, with Astellas focused on dual-payload immunostimulatory ADCs (iADCs). The first iADC program is expected to enter the clinic in early 2026.

Webcast Information:
To access the live audio webcast beginning at 7:00AM PT / 10:00AM ET, please go to View Source An archived replay of the webcast will be available on the Company’s website following the event.

(Press release, Sutro Biopharma, NOV 12, 2025, View Source [SID1234659844])

On November 12, 2025 Novocure (NASDAQ: NVCR) reported that management will participate in the Jefferies Global Healthcare Conference in London on Wednesday, November 19, 2025. Ashley Cordova, Chief Executive Officer, will present on behalf of the company at 2:00 p.m. GMT (9:00 a.m. ET). Ms. Cordova will be joined by Christoph Brackmann, Chief Financial Officer, for one-on-one meetings with investors throughout the event.

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A live audio webcast of this presentation can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the event.

(Press release, NovoCure, NOV 12, 2025, View Source [SID1234659860])

On November 12, 2025 Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, reported its operational and financial results for the third quarter ended September 30, 2025.

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"Through three quarters of launch, we are encouraged by our progress to increase the overall market in r/r B-ALL, reaching patients who previously may not have been considered for CAR T therapy. With mounting experience we see physician enthusiasm for AUCATZYL increasing, validated by real world data from the ROCCA Consortium to be presented at the ASH (Free ASH Whitepaper) Annual Meeting in December," said Dr. Christian Itin, Chief Executive Officer of Autolus. "Despite an expected temporary lag in Q3 sales based on the change in CMS reimbursement policy that occurred in Q2, we executed well on new patient starts and project a strong full year of sales."

Dr. Itin continued, "Building on our strong commercial and manufacturing performance, we enter our next phase of growth for obe-cel focused on three key objectives. First, increasing market share within the indicated adult ALL population; second, based on strong Phase 1 data sets we are conducting potential pivotal studies in pediatric ALL and in severe lupus nephritis to broaden the utility and commercial opportunity of obe-cel; and finally, we continue to innovate on manufacturing technology as a foundation for further expansion of access to CAR T therapies."

Product and Pipeline Updates:

AUCATZYL Launch
Autolus reported net product revenue of $21.1 million for the three months ended September 30, 2025 and deferred revenue of $7.6 million as of September 30, 2025.
The Company has 60 centers fully activated in the U.S. as of November 12, 2025, achieving the target of 60 activated centers prior to year-end.
Patient access to AUCATZYL continues to increase, with coverage secured for greater than 90% of total U.S. medical lives.
Data from the ROCCA (Real-World Outcomes Collaborative for CAR T in Adult ALL) database evaluating patient characteristics, toxicity and response after real-world administration of AUCATZYL (obecabtagene autoleucel) and TECARTUS (brexucabtagene autoleucel) for relapsed acute lymphoblastic leukemia with r/r ALL will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.

Obe-cel data in pediatric r/r B-ALL
Data from the ongoing Phase Ib/II CATULUS study evaluating the safety and efficacy of obe-cel in patients under 18 years with CD19-positive r/r B-ALL or B-cell Non-Hodgkin Lymphoma (NHL) will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Data show the safety profile of obe-cel in pediatric patients is consistent with that previously reported in adults, with low rates of high-grade cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). Overall response rate (ORR) was high at 95% and nearly 90% of responders had ongoing remission at data cut-off. Additional data will be presented in a poster presentation at the ASH (Free ASH Whitepaper) Annual Meeting on December 7, 2025, from 6:00 – 8:00pm ET.
In October 2025, the U.S. Food and Drug Administration (FDA) granted regenerative medicine advanced therapy (RMAT) designation to obe-cel for the treatment of pediatric patients with r/r B-ALL. The RMAT designation is a program created under the 21st Century Cures Act to accelerate development and regulatory review of regenerative medicine therapies, including cell therapies, intended to treat serious or life-threatening diseases.

Obe-cel in lupus nephritis (LN)
Data from the Phase 1 CARLYSLE clinical trial were presented on October 28, 2025, at the American College of Rheumatology (ACR) Convergence 2025. Data in severe refractory systemic lupus erythematosus (srSLE) suggests obe-cel is well tolerated with no ICANS or high-grade CRS. Preliminary efficacy data demonstrate achievement of definition of remission in SLE (DORIS) in 83% (n=5/6) of patients and complete renal response (CRR) in 50% (n=3/6) of patients. All responses and remissions are ongoing with no evidence of disease activity at a median follow up of 8.9 months (range 6-13.8 months).
Additional findings from the ongoing CARLYSLE study will be presented in an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2025 on December 8, 2025, at 11:30am ET. Data show the B-cell reconstitution profiles suggest that obe-cel may induce a reset of pathologic autoimmunity. Updated Phase 1 data with longer follow-up, and data in patients who received 100×106 CAR T-cells will be presented.
The Company has previously aligned with the FDA on the Phase 2 trial design and potential registrational path to approval. Data to date supported progressing into the Phase 2 LUMINA trial. The first patient is expected to be dosed prior to year-end 2025.

Obe-cel in progressive MS
Autolus is advancing obe-cel into initial clinical development in progressive MS. The first patient in the BOBCAT trial was dosed in October 2025. The Phase 1 trial, expected to include up to 18 adult patients, will determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory progressive forms of multiple sclerosis. The primary endpoint is to assess safety and tolerability of obe-cel. Key secondary endpoints include evaluating the preliminary efficacy of obe-cel using change from baseline in standard efficacy measures.

Early-stage pipeline programs and collaborations
In November 2025, Moderna announced that the first patient has been dosed in a Phase 1/2 study of mRNA-2808, an investigational mRNA-based T-cell engager for participants with relapsed or refractory multiple myeloma. mRNA-2808 utilizes an Autolus proprietary binder that was licensed to Moderna in 2022.
Long term follow up from the AUTO8 MCARTY study in multiple myeloma will be presented in a poster presentation at the ASH (Free ASH Whitepaper) Annual Meeting:

Abstract ID: abs25-14286
Title: CAR-T cells co-targeting BCMA and CD19 in RRMM: Results from the UKMRA Phase 1 MCARTY trial in relapsed refractory multiple myeloma
Date: December 7, 06:00 PM – 08:00 PM EST
Location: OCCC – West Halls B3-B4
Presenting Author: Lydia Lee, MBBS, MRCP, MRCPath (Haem), PhD

The first patient in the AUTO8 ALARIC study in AL Amyloidosis is expected to be dosed prior to year-end 2025.
Autolus’ translational programs with UCL continue to fuel its early-stage pipeline, providing a cost-efficient path to development to support long-term growth.

Operational Updates:

Autolus announced leadership team changes to support the next phase of commercial growth, margin improvement and market expansion.

Cintia Piccina was appointed U.S. Chief Commercial Officer and Country General Manager to lead ongoing momentum in AUCTAZYL U.S. launch and drive future growth. Cintia brings to Autolus extensive cellular therapy experience having led teams that successfully launched and commercialized multiple products in Novartis, Bluebird/2seventy bio, Allovir and Adaptimmune, where she was most recently the Chief Commercial Officer.
Miranda Neville was appointed Chief Technical Officer to drive manufacturing optimization, succeeding David Brochu who will continue as an advisor. Ms. Neville joined Autolus in 2018 from the consulting firm AllianceBIO where she spent four years as a Partner and supported several clinical stage and commercial biopharmaceutical companies. Ms. Neville began her career at Human Genome Sciences (HGS). She spent 10 years at HGS in a variety of roles including Manufacturing, Engineering & Program Management, prior to its acquisition by GlaxoSmithKline.
Patrick McIlvenny was appointed Senior Vice President, Finance and Chief Accounting Officer. Before joining Autolus, Mr. McIlvenny served as Senior Vice President, Chief Accounting Officer for Horizon Therapeutics plc, until the acquisition of Horizon by Amgen, and in various finance roles of increasing responsibilities at Ardagh Group S.A and Elan Corporation plc. Prior to joining Elan, Mr. McIlvenny worked with PricewaterhouseCoopers and Deloitte. Mr. McIlvenny is a Fellow of the Institute of Chartered Accountants in England and Wales.

Dr. Itin commented, "Our new team members bring a breadth of leadership experience and will focus on market growth, strategic planning and operational excellence driving growth and efficiency of the ALL business. We are grateful to our prior team members who were instrumental in setting our organization on the right course for a successful launch."

Summary of Anticipated News Flow:

ALL: Initial clinical data from CATULUS trial in pediatric ALL December 7, 2025

SLE: Longer-term follow up data from CARLYSLE trial
December 8, 2025

LN: Expect to dose first patient in Phase 2 LUMINA trial By year-end 2025

ALA: Expect to dose first patient in Phase 1 ALARIC trial in AL amyloidosis By year-end 2025

ALL: acute lymphoblastic leukemia
SLE: systemic lupus erythematosus
LN: lupus nephritis
ALA: light-chain amyloidosis

Financial Results for the Quarter Ended September 30, 2025

Product revenue, net for the three months ended September 30, 2025, was $21.1 million. Deferred revenue balance at September 30, 2025, was $7.6 million, representing product that was shipped and received by centers but not yet dosed.

Cost of sales for the three months ended September 30, 2025, totaled $28.6 million. This amount includes the cost of all commercial product delivered to the authorized treatment centers, including product delivered but not yet recorded as product revenue which is captured as deferred revenue. Additionally, cost of sales includes any cancelled orders in the period, patient access program product, inventory reserves and write-offs and 3rd party royalties for certain technology licenses.

Research and development expenses decreased from $40.3 million to $27.9 million for the three months ended September 30, 2025, compared to the same period in 2024. This change was primarily due to commercial manufacturing-related employee and infrastructure costs shifting to cost of sales and inventory.

Selling, general and administrative expenses increased from $27.3 million to $36.3 million for the three months ended September 30, 2025, compared to the same period in 2024. This increase was primarily due to salaries and other employment-related costs, driven by increased headcount supporting commercialization activities.

Loss from operations for the three months ended September 30, 2025, was $71.6 million, as compared to $67.9 million for the same period in 2024.

Net loss was $79.1 million for the three months ended September 30, 2025, compared to $82.1 million for the same period in 2024. Basic and diluted net loss per ordinary share for the three months ended September 30, 2025, totaled $(0.30), compared to basic and diluted net loss per ordinary share of $(0.31) for the same period in 2024.

Cash, cash equivalents and marketable securities at September 30, 2025, totaled $367.4 million, as compared to $588.0 million at December 31, 2024. The decrease was primarily driven by net cash used in operating activities and impacted by a delayed cash receipt of approximately $20.1 million in the Company’s 2023 R&D tax credit expected from the UK HMRC.

Autolus estimates that, with its current cash and cash equivalents and marketable securities, the Company is well capitalized to to drive the launch and commercialization of obe-cel in r/r B-ALL and to generate data in the LN and pALL potential pivotal trials and MS Phase 1 trial

Financial Results for the Period Ended September 30, 2025
Selected Consolidated Balance Sheet Data
(In thousands)

September 30
December 31
2025
2024
Assets
Cash and cash equivalents $ 86,124 $ 227,380
Marketable securities – Available-for-sale debt securities $ 281,289 $ 360,643
Total current assets $ 514,577 $ 660,929
Total assets $ 661,947 $ 782,725
Liabilities and shareholders’ equity
Total current liabilities $ 83,071 $ 60,743
Total liabilities $ 396,495 $ 355,400
Total shareholders’ equity $ 265,452 $ 427,325

Selected Consolidated Statements of Operations and Comprehensive Loss Data
(In thousands, except share and per share amounts)

Three Months Ended
September 30, Nine Months Ended
September 30,
2025
2024
2025
2024
Product revenue, net $ 21,144 $ — $ 51,049 $ —
License revenue 50 — 50 10,091
Cost and operating expenses:
Cost of sales (28,643) — (71,039) —
Research and development expenses, net (27,892) (40,323) (82,056) (107,606)
Selling, general and administrative expenses (36,280) (27,330) (96,079) (67,410)
Loss on disposal of property and equipment — (223) (3) (223)
Impairment of operating lease right-of-use assets and related property and equipment — — — (414)
Loss from operations (71,621) (67,876) (198,078) (165,562)
Total other (expenses) income, net (6,965) (14,196) 4,037 (27,428)
Net loss before income tax (78,586) (82,072) (194,041) (192,990)
Income tax expenses (532) (22) (3,155) (66)
Net loss attributable to ordinary shareholders (79,118) (82,094) (197,196) (193,056)
Other comprehensive (loss) income, net of tax (5,782) 27,010 24,254 28,094
Total comprehensive loss $ (84,900) $ (55,084) $ (172,942) $ (164,962)

Basic and diluted net loss per ordinary share $ (0.30) $ (0.31) $ (0.74) $ (0.77)
Weighted-average basic and diluted ordinary
shares 266,141,431 266,084,589 266,136,518 255,480,521

Conference Call
Management will host a conference call and webcast today at 8:30am EST/1:30pm GMT to discuss the company’s financial results. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call. A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website at View Source

(Press release, Autolus, NOV 12, 2025, View Source [SID1234659806])

On November 12, 2025 Leap Therapeutics, Inc. (Nasdaq: LPTX) reported it will change its name to Cypherpunk Technologies Inc., and unveiled a digital asset treasury strategy to accumulate Zcash’s native coin, ZEC. Cypherpunk has to date used $50 million of proceeds from the previously announced private placement to purchase 203,775.27 ZEC at an average purchase price of $245.37 per ZEC.

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In addition, the company also plans to change its ticker symbol to (Nasdaq: CYPH) as part of the rebranding under the Cypherpunk name. The company will begin trading under its new name and ticker symbol CYPH on Thursday, November 13. Until then, investors can continue to buy and sell the company’s stock under the current ticker symbol LPTX without interruption.

Cypherpunk also announced the appointment of Khing Oei and Will McEvoy to its Board of Directors, effective November 11, 2025. This strategic move comes as part of the Company’s recently completed $58.88 million private placement led by Winklevoss Capital to initiate a digital asset treasury strategy. Notably, Winklevoss Capital was the only institutional investor in the private placement, contributing a majority of the total raised.

"The recent weak performance of digital asset treasury companies stems from PIPEs dominated by short-term, mercenary capital. We’ve taken a different path by building a syndicate of value-aligned investors who believe in the long-term importance of Zcash and privacy for the United States and the world." – Will McEvoy, Chief Investment Officer of Cypherpunk

Khing Oei has been appointed Chairman of the Board, while Will McEvoy will also serve as the company’s first-ever Chief Investment Officer, effective in each case as of November 11, 2025. Concurrently with Mr. Oei’s appointment, Christopher Mirabelli, PhD, will step down from his role as Chairman, while remaining a member of the Board.

"We are pleased to welcome Khing and Will to the Board of Directors, and to have Will serve as Chief Investment Officer as we advance our strategy to create long-term shareholder value through active participation in Zcash. Participant control and privacy, enabled by Zcash, are critical as financial transactions move increasingly to blockchain and tokenization. The rebranding and new leadership appointments mark a transformational step in expanding our mission as we enter a new phase of growth." – Douglas E. Onsi, President and Chief Executive Officer of Cypherpunk

Why This Matters

Cypherpunk is a company dedicated to self-sovereignty. As the world becomes increasingly digitized, privacy has become a rare and vanishing resource. And despite their critical importance, privacy enhancing technologies remain under-adopted. Backing privacy today is both a generational mission and a massive opportunity. Privacy is the foundation that allows freedom of speech, thought, and association to thrive. Without it, these societal tentpoles may exist on paper but can’t be exercised meaningfully in practice. In other words, privacy is the silent precondition of freedom. Additionally, in a world where privacy is scarce, it becomes the most valuable commodity.

Why Zcash?

Zcash is one of the oldest and most respected privacy-preserving blockchains, launched in 2016 as a fork of Bitcoin with advanced cryptography that enables selective transparency. Built on the same sound monetary principles as Bitcoin, with a fixed 21 million coin supply, Zcash introduced a breakthrough in privacy technology through the use of zero-knowledge proofs (zk-SNARKs), allowing transactions to be verified without revealing sender, receiver, or amount. This innovation has since influenced the entire cryptographic landscape, inspiring privacy advancements across other blockchains like Ethereum and Solana.

Since its inception, Zcash has processed tens of millions of transactions and consistently ranked among the top privacy coins by market capitalization. Its underlying protocol continues to evolve with major upgrades — including Halo 2, a trustless recursive proof system that eliminates the need for trusted setup ceremonies and enhances scalability. Nearly a decade after launch, Zcash remains one of the few digital assets with the potential for both Bitcoin-level decentralization and cutting-edge privacy, offering real utility with private yet auditable digital transactions.

Cypherpunk Technologies Inc. sees Zcash as digital privacy in asset form, the same way Bitcoin has proven to be digital gold. Zcash also represents an important hedge against the transparency of Bitcoin and the existing financial infrastructure in an AI-abundant future.

New Board Members

· Khing Oei is a seasoned investor with a strong track record of investing in public, private and digital markets. Oei is the Founder and CEO of Treasury, an emerging euro-denominated Bitcoin treasury firm. Before Treasury, Oei was the Founder and CEO of Captur (formerly AlphaSwap), a decentralized asset management platform. He was previously the Founder and Chief Investment Officer of Eyck Capital, a London-based event-driven hedge fund focused on distressed and special situations across credit and equities, managing over $200 million in assets. Prior to that role, Oei was a Managing Principal and Portfolio Manager at Bardin Hill (formerly Halcyon), a $10 billion multi-strategy hedge fund where, as CEO of its European operations, he led European distressed investments and managed the firm’s $2.5 billion CLO platform. Oei began his career at Goldman Sachs in the Special Situations Group and later worked at Fortress Investment Group’s Drawbridge Special Opportunities Fund. He holds a MSc in Econometrics from The Vrije Universiteit Amsterdam.

· Will McEvoy is a Principal at Winklevoss Capital, where he invests and identifies opportunities on the frontier, from crypto and space to energy, bio, and defense. He focuses on companies and technologies that slow entropy and create order in critical civilizational domains. Before joining Winklevoss Capital, Will authored Bitcoin and crypto research at Fundstrat and helped build one of Dynasty Financial Partners’ highest-performing client platforms. He also serves on the board of Real Bedford FC and holds a degree from The George Washington University.

(Press release, Leap Therapeutics, NOV 12, 2025, View Source [SID1234659822])

On November 12, 2025 Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported financial results for the third quarter ended September 30, 2025, and provided a corporate update.

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"Recent presentations of clinical data for VCN-01 and preclinical data for VCN-12 at medical congresses have highlighted the progress made across our oncology pipeline," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "Having successully completed the VIRAGE Phase 2b clinical trial, we are now pursuing interactions with the European Medicines Agency and the US FDA to seek alignment on a protocol for a proposed Phase 3 study of VCN-01 plus gemcitabine/nab-paclitaxel standard-of-care chemotherapy as first-line treatment for metastatic PDAC. In addition, we have made significant progress on the design of a potential Phase 2/3 clinical trial in the rare pediatric disease retinoblastoma for potential discussion with regulators in the first half of 2026. With capital raised from our recent warrant inducement and sales made pursuant to our at-the-market (ATM) facility, we are well positioned to advance our regulatory and clinical strategies and explore potential partnerships for the innovative assets in our pipeline."

Recent Highlights and Anticipated Milestones

VCN-01

Metastatic Pancreatic Ductal Adenocarcinoma (PDAC):

Expanded data from the VIRAGE randomized, controlled clinical trial investigating up to two doses of VCN-01 (zabilugene almadenorepvec) in combination with gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy in 112 metastatic PDAC patients were presented at ESMO (Free ESMO Whitepaper) 2025:
The ESMO (Free ESMO Whitepaper) presentation included data for patients randomized into the modified intent to treat (mITT) population, who received at least 1 dose of SoC chemotherapy (Arm I) or at least 1 dose of VCN-01 (Arm II) regardless of whether they received SoC chemotherapy. These were compared to data for the full analysis set (FAS), where patients received at least 1 dose of gemcitabine/nab-paclitaxel SoC chemotherapy (Arm I) or VCN-01 followed by at least 1 dose of SoC chemotherapy (Arm II).
As previously reported, the two doses of VCN-01 were well tolerated and the study met its primary endpoints, such that metastatic PDAC patients receiving VCN-01 with SoC chemotherapy had improved overall survival (OS), progression free survival (PFS) and Duration of Response (DoR) compared to SoC chemotherapy alone. Improvements in these parameters were observed in both the mITT and FAS populations.
Patients who received 2 doses of VCN-01 and started cycle 4 of SoC chemotherapy (Arm II) showed greater improvement in OS and PFS compared to patients who started cycle 4 of SoC chemotherapy alone (Arm I), indicating a potential benefit of additional VCN-01 doses.
Expanded data presented at ESMO (Free ESMO Whitepaper) 2025 showed that peaks of VCN-01 viral genomes (vg) in blood were similar after both VCN-01 doses and circulating vgs were measurable for at least 3 months after each dose despite the presence of neutralizing antibodies. These data highlight the persistent bioactivity of intravenously administered VCN-01 upon repeated dosing.
Following the successful VIRAGE Phase 2b trial, a study protocol for a potential Phase 3 clinical trial investigating VCN-01 plus gemcitabine/nab-paclitaxel SoC chemotherapy as first-line treatment for metastatic PDAC is planned to be discussed with regulators in Europe and the United States.
VCN-12

VCN-12 is a next generation oncolytic adenovirus developed as part of Theriva’s VCN-X discovery program
VCN-12 uses the same virus capsid as the Company’s lead clinical candidate VCN-01 (zabilugene almadenorepvec), but includes modifications intended to (i) increase stroma degradation by replacing human hyaluronidase PH20 with the more active bee hyaluronidase; and (ii) increase tumor cell lysis by expressing the pore forming protein parasporin-2 to enable both cytotoxic and immunogenic cell death.
Preclinical data for VCN-12 was presented at the ESGCT 32nd Annual Congress:
Data presented at ESGCT showed that VCN-12 provided increased cell killing compared to VCN-01 in a variety of cancer cell models in vitro and displayed higher levels of hyaluronidase activity. In animal studies, intravenous VCN-12 had a similar toxicity profile to VCN-01 in immunodeficient mice bearing human tumor xenografts. Intratumoral VCN-12 significantly reduced tumor growth compared to VCN-01 in immunocompetent hamsters bearing HP-1 pancreatic tumors and appeared to stimulate a persistent anti-tumor immune response that prevented tumor establishment in some VCN-12 treated animals. Additional preclinical studies to confirm these findings are ongoing.
Third Quarter Ended September 30, 2025 Financial Results

General and administrative expenses decreased to $1.9 million for the three months ended September 30, 2025, from $2.3 million for the three months ended September 30, 2024. This decrease of 18% is primarily comprised of the decrease in compensation costs offset by the increase in the fair value of the contingent consideration and increased investor relations expense. The charge related to stock-based compensation expense was the same for the three months ended September 30, 2025 and September 30, 2024. The Company expects general and administrative expenses to decrease due to the workforce reduction implemented on September 30, 2025.

Research and development expenses decreased to $2.6 million for the three months ended September 30, 2025, from approximately $2.7 million for the three months ended September 30, 2024. This decrease of 7% is primarily the result of lower clinical trial expenses related to the completion of the Company’s VIRAGE Phase 2b clinical trial of VCN-01 in PDAC, lower indirect cost related to decreased compensation and lower clinical trial expenses related to its Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients, offset by higher patent expenses related to SYN-020. The Company anticipates research and development expenses to decrease due to the completion of its VIRAGE Phase 2b clinical trial of VCN-01 as it focuses on regulatory interactions around potential pivotal clinical trials of VCN-01 in PDAC and retinoblastoma, continues exploratory VCN-01 manufacturing scale-up activities, and continues supporting the Company’s other preclinical and discovery initiatives. The charge related to stock-based compensation expense was $110,000 for the three months ended September 30, 2025, compared to $59,000 related to stock-based compensation expense for the three months ended September 30, 2024.

Other income was $79,000 for the three months ended September 30, 2025 compared to other income of $161,000 for the three months ended September 30, 2024. Other income for the three months ended September 30, 2025 is primarily comprised of interest income of $65,000 and an exchange gain of $14,000. Other income for the three months ended September 30, 2024 is primarily comprised of interest income of $158,000 and exchange gain of $3,000.

Cash and cash equivalents totaled $7.5 million as of September 30, 2025, compared to $11.6 million as of December 31, 2024. Following a capital raise subsequent to September 30, 2025, the Company’s cash and cash equivalents totaled $15.5 millon. The Company’s current cash of approximately $15.5 million at early November 2025 will allow it to fund operations into the first quarter of 2027, including overhead costs, close out of the VIRAGE Phase 2b clinical trial, exploratory VCN-01 manufacturing scale-up activities, regulatory interactions regarding proposed VCN-01 clinical trials in PDAC and retinoblastoma, and preclinical studies supporting VCN-01 and VCN-12, the first candidate from the Company’s VCN-X discovery program. Additional funding will be required to initiate new VCN-01 clinical trials.

About VCN-01

VCN-01 (zabilugene almadenorepvec) is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to 142 patients to date in clinical trials of different cancers, including pancreatic ductal adenocarcinoma (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at Clinicaltrials.gov.

About Pancreatic Ductal Adenocarcinoma

Cancer of the pancreas consists of two main histological types: cancer that arises from the ductal (exocrine) cells of the pancreas or, much less often, cancers may arise from the endocrine compartment of the pancreas. Pancreatic ductal adenocarcinoma ("PDAC") accounts for more than 90% of all pancreatic tumors. It can be located either in the head of the pancreas or in the body/tail. Pancreatic cancer usually metastasizes to the liver and peritoneum. Other less common metastatic sites are the lungs, brain, kidney and bone. In its early stages, pancreatic cancer does not typically result in any characteristic symptoms, so in most cases it is diagnosed in its late stages (locally advanced non-metastatic or metastatic disease) when surgical resection and possibly curative treatment is not possible. It is generally assumed that only 10% of cases are resectable at presentation, whereas 30-40% of patients are diagnosed at local advanced/unresectable stage and 50-60% present with distant metastases.

About VIRAGE

VIRAGE was a two-arm, Phase 2b open-label, randomized, controlled, multicenter clinical trial in patients with histologically confirmed, newly-diagnosed metastatic PDAC. Patients were enrolled at 5 sites in the U.S. and 9 sites in Spain. In both the control and VCN-01 (zabilugene almadenorepvec) treatment arms, patients received gemcitabine/nab-paclitaxel standard-of-care chemotherapy in repeated 28-day cycles until disease progression. In the VCN-01 treatment arm only, patients were also administered intravenous VCN-01 seven-days prior to starting the first and fourth cycles of gemcitabine/nab-paclitaxel treatment (study days 1 and ~92, respectively). Primary endpoints for the trial include overall survival and VCN-01 safety/tolerability. Additional endpoints include progression free survival, duration of response, and measures of VCN-01 biodistribution, replication, and immune response. More information about the trial is available on Clinicaltrials.gov (NCT05673811), through the Spanish Clinical Trials Registry and European Union Drug Regulating Authorities Clinical Trials Database (EudraCT Number: 2022-000897-24).

(Press release, Theriva Biologics, NOV 12, 2025, View Source [SID1234659845])