Alpha Tau Announces Third Quarter 2025 Financial Results and Provides Corporate Update

On November 20, 2025 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported third quarter 2025 financial results and provided a corporate update.

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"The third quarter has seen a fantastic continuation of our accelerating momentum at Alpha Tau, as the pace of patient treatments continues to rise, and we draw increased interest from our peers in the industry" said Alpha Tau Chief Executive Officer Uzi Sofer. "Receiving the radioactive license approval in New Hampshire was a significant milestone in our push for operational commercial readiness, and we are continuing to develop that facility for use in treating patients in the U.S., Canada, and elsewhere, having invested almost $2 million into the facility in Q3. We are very happy with the rate of recruitment in our U.S. multi-center pilot study in pancreatic cancer, and look forward to some potential targeted near-term milestones, including a forthcoming response from the PMDA to our request for marketing authorization in Japan in treating recurrent head & neck cancer, and treating our first patients with glioblastoma multiforme (GBM) shortly. With four IDEs currently active for trials in the U.S., we are continuing to explore with the FDA other potential U.S. trial initiations, potentially in prostate cancer or head & neck cancers."

Recent Corporate Highlights:

● In September, Alpha Tau announced the treatment of the first patient in its U.S. multi-center pancreatic cancer clinical trial. The trial is expected to enroll up to 30 patients with newly diagnosed pancreatic cancer, in two cohorts: 15 patients with locally advanced disease, and 15 patients with metastatic disease. Patients will receive mFOLFIRINOX chemotherapy together with the Alpha DaRT treatment. Up to 87% of newly diagnosed pancreatic cancer patients are considered inoperable at diagnosis and face a dismal prognosis, with limited benefit from existing therapies, and the pilot study is a key part of Alpha Tau’s broader strategy to bring Alpha DaRT to cancer patients with some of the highest unmet needs. For more information, please see here: View Source

● In October, Alpha Tau announced the receipt of a radioactive material license for its New Hampshire manufacturing facility, its first commercial-scale facility. The license paves the way for the introduction of radioactive material and continued positive momentum toward initiating Alpha DaRT treatment manufacturing onsite in 2026. Total expected nameplate capacity from the first phase of construction is approximately 400,000 Alpha DaRT sources for local use, subject to a number of operational and clinical assumptions.

Expected Upcoming Milestone Targets:

● First patient treated in U.S. GBM pilot study in Q4 2025. For more information, please see here: View Source

● Response from Japan’s PMDA around year end 2025 to the application for pre-market approval of Alpha DaRT in patients with recurrent head & neck cancer.

● Completion of patient recruitment in the ReSTART pivotal U.S. multi-center trial in recurrent cutaneous squamous cell carcinoma in Q1 2026. For more information, please see here: View Source

● Completion of patient recruitment in pancreatic cancer pilot study in the U.S. by the end of Q1 2026. For more information, please see here: View Source

Financial Results for Nine Months Ended September 30, 2025

Research and Development expenses for the nine months ended September 30, 2025 were $22.5 million, compared to $19.5 million for the same period in 2024, primarily due to an increase in employee compensation and benefits, costs of raw materials and third-party contractor expenses, reflecting increased clinical activities, as well as decreased government grants, offset by lower share-based compensation expenses and travel expenses.

Marketing expenses for the nine months ended September 30, 2025 were $1.4 million, compared to $1.7 million for the same period in 2024, due to decreased employee compensation and benefits and decreased marketing conference activities and travel expenses.

General and Administrative expenses for the nine months ended September 30, 2025 were $5.8 million, compared to $4.6 million for the same period in 2024, primarily due to increased employee compensation and benefits, including share-based compensation and professional fees (including legal and IR expenses), offset by a decrease in travel expenses and D&O insurance costs.

Financial expense, net, for the nine months ended September 30, 2025 was $0.6 million, compared to financial income, net, of $3.5 million for the same period in 2024, primarily due to an increase in the remeasurement of warrants, a decrease in interest from bank deposits, and changes in foreign exchange rates.

For the nine months ended September 30, 2025, the Company had a net loss of $30.5 million, or $0.39 per share, compared to a net loss of $22.3 million, or $0.32 per share, in the nine months ended September 30, 2024.

Balance Sheet Highlights

As of September 30, 2025, the Company had cash and cash equivalents, short-term deposits and restricted deposits of $75.9 million, compared to $62.9 million at December 31, 2024.

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

(Press release, Alpha Tau Medical, NOV 20, 2025, View Source [SID1234660838])

Abbott to acquire Exact Sciences, a leader in large and fast-growing cancer screening and precision oncology diagnostics segments

On November 20, 2025 Abbott (NYSE: ABT) and Exact Sciences (NASDAQ: EXAS) reported a definitive agreement for Abbott to acquire Exact Sciences, which will enable it to enter and lead in fast-growing cancer diagnostics segments, serving millions more people. Under the terms of the agreement, Exact Sciences shareholders will receive $105 per common share, representing a total equity value of approximately $21 billion.

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Together, the companies will accelerate innovation, expand access to life-changing diagnostics, and help more people detect and manage cancer at its earliest, most treatable stages.

Exact Sciences focuses on the early detection of cancer and supporting personalized treatments. Exact Sciences’ comprehensive product offerings support patients and their healthcare providers before, during and after a cancer diagnosis. The company is a leader in cancer screening, precision oncology and genetic testing, helping to detect cancer earlier, guide treatment decisions and monitor for recurrence.

Its product offerings include the Cologuard test, a market-leading noninvasive colorectal cancer screening option; Oncotype DX, which informs personalized treatment decisions for patients with breast cancer; Oncodetect, which identifies molecular residual disease (MRD) to help assess the risk of recurrence and guide follow-up care; and Cancerguard, a multi-cancer early detection blood test.

Approximately 20 million people globally, including 2 million Americans, are diagnosed with cancer every year. These numbers are only expected to rise in the coming years due to population growth, aging and other contributing factors.*

"Exact Sciences’ innovation, its strong brand and customer-focused execution are unrivaled in the cancer diagnostics space, and its presence and strengths are complementary to our own," said Robert B. Ford, chairman and chief executive officer, Abbott. "Abbott has repeatedly taken on the world’s most challenging health issues and made a meaningful impact on the lives of people in areas such as diabetes, cardiovascular disease and infectious diseases. We’re excited to bring Exact Sciences’ people and know-how into Abbott so that together, we can take on the global challenge of cancer."

"Together with Abbott, we can reach more patients, advance earlier detection, and deliver answers that change lives," said Kevin Conroy, chairman and chief executive officer, Exact Sciences. "Abbott’s culture of innovation and global commercial reach will help accelerate our mission of eradicating cancer and expanding access to our tests worldwide, while delivering immediate and substantial value to our shareholders. I want to thank the 7,000 Exact Sciences’ team members for their extraordinary work and dedication — our journey has just begun."

Financial & Operational
Under the terms of the agreement, Abbott will acquire all outstanding shares of Exact Sciences for $105 per common share in cash, at a total equity value of approximately $21 billion and an estimated enterprise value of $23 billion. Abbott’s financing contemplates absorption of Exact Sciences’ estimated $1.8 billion of net debt.

The closing is expected in the second quarter of 2026 and is subject to Exact Sciences’ shareholder approval, as well as receipt of applicable regulatory approvals and other customary closing conditions. The transaction was unanimously approved by both companies’ boards of directors.

Exact Sciences is projected to generate more than $3 billion in revenue this year, with a high teens organic sales growth rate. Once the transaction is completed, Exact Sciences will become a subsidiary of Abbott, and Abbott’s total diagnostics sales will exceed $12 billion annually.

Following the closing, Exact Sciences will maintain its presence in Madison, Wis. Kevin Conroy will remain with the company in an advisory role to support the transition into Abbott and accelerate its global impact in helping to eradicate cancer worldwide.

(Press release, Abbott, NOV 20, 2025, View Source,-a-leader-in-large-and-fast-growing-cancer-screening-and-precision-oncology-diagnostics-segments [SID1234660837])

POSITIVE RESPONSE FROM US FDA TO AMPLIA THERAPEUTICS’ TYPE D MEETING

On November 20, 2025 Amplia Therapeutics Limited (ASX: ATX; OTCQB: INNMF), referred to as "Amplia" or "the Company," reported it has received positive feedback from the US Food and Drug Administration (FDA) in response to questions posed by the Company as part of a recent Type D meeting.

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The Company received a positive response to the Type D questions around the dose optimisation strategy for narmafotinib in the proposed registration-enabling Phase 2b/3 trial which will investigate the combination of the Company’s lead compound, narmafotinib, in combination with gemcitabine and Abraxane in pancreatic cancer. The FDA’s response gives confidence in meeting current projected timelines for the Phase 2b/3 study planned to commence in late 2026. The full protocol will now be prepared for submission for FDA comment in H1 2026.

Dr Chris Burns, CEO and Managing Director of Amplia, commented, "FDA’s response supports the dose comparison design of the Phase 2b portion of this trial prior to the pivotal Phase 3 stage. We see this as a positive outcome as the changes proposed will have minimal impact to the trial timeline. This feedback also allows us to better plan the trial, and a full protocol will now be drafted for FDA comment in H1 2026."

A Type D meeting is a formal interaction with the FDA that allows companies to obtain focused feedback on specific regulatory questions outside of a standard review cycle.

(Press release, Amplia Therapeutics, NOV 20, 2025, View Source [SID1234660097])

Defence Therapeutics To Build Adc Drug Delivery Powerhouse Using Its Proprietary Accum Technology

On November 19, 2025 Defence Therapeutics Inc. ("Defence" or the "Company"), a leading biotechnology company pioneering next-generation antibody-drug conjugate ("ADC"), reported a major step forward in the fight against cancer that goes beyond the ADCs current limitations.

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Following successful presentations and meetings at the World ADC Conference in San Diego with ADC companies as well as with industry leaders and pioneers at CPHI in Frankfurt, Defence is moving forward with the strategy to become a supplier of its Accum platform technology to ADC companies struggling with dosing and toxicity as well as to improve the drug delivery precision to cancer cells more effectively for the benefit of cancer patients.

"Many pharmaceuticals and biotech companies have ADCs on the market or in development. A lot of these companies are facing the same challenge, their ADC being toxic for the patients at therapeutic dose. Defence’s Accum technology can universally enhance the potency of any ADCs, reducing their toxicity, while retaining their epitope selectivity and tumor targeting" said Dr. Maxime Parisotto, Chief Scientific Officer at Defence Therapeutics.

Defence has completed studies confirming its ability to enhance ADCs potency. The most recent comparative study, in mouse xenograft models of HER2-positive breast cancer (JIMT-1 cells), demonstrated a ~20-fold higher anti-tumor efficacy with Accum-Kadcyla than Kadcyla alone when administered at the same dose (0.5 mg/kg). The tumor growth significantly halted in the Accum-Kadcyla-treated group, resulting in a consistent and near-complete response in 90% of the mice while Kadcyla alone at the same dose (0.5 mg/kg) had no effective results on inhibiting tumor growth (see November 4, 2025 press release).

Defence is engaging with ADC companies to transform the ADC cancer therapies with its unique proprietary Accum technology platform to be used with any antibodies and on any indications. Defence’s technology and team are in place to deliver the strategy and build an ADC drug delivery powerhouse.

(Press release, Defence Therapeutics, NOV 19, 2025, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-to-build-adc-drug-delivery-powerhouse-using-its-proprietary-accum-technology [SID1234660863])

Vir Biotechnology to Participate in the 8th Annual Evercore Healthcare Conference

On November 19, 2025 Vir Biotechnology, Inc. (Nasdaq: VIR), reported that Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer, will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference on Wednesday, December 3 at 10:50 a.m. ET / 7:50 a.m. PT in Miami, Florida.

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A live webcast of the presentation will be made available under Events & Presentations in the Investors section of the Vir Biotechnology website and will be archived for 30 days.

(Press release, Vir Biotechnology, NOV 19, 2025, View Source [SID1234660106])