Roche enters into a definitive merger agreement to acquire PathAI to transform AI-driven diagnostics

On May 7, 2026 Roche (SIX: RO, ROP; OTCQX: RHHBY) reported that it has entered into a definitive merger agreement to acquire PathAI, a US-based company in digital pathology and AI-powered technology for pathology laboratories and the biopharma industry. This acquisition builds on the successful partnership between Roche and PathAI, established in 2021 and scaled up in 2024 to include the development of AI-enabled companion diagnostic algorithms. Subject to the closing of the transaction, which is expected in the second half of the year, the acquired entity will become part of the Diagnostics division.

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This acquisition strengthens Roche’s position in Digital Pathology, which is transforming extensive manual workflows into fully automated, AI-driven processes and insights. Digital pathology enables the creation of high-resolution digital images from physical tissue on slides, allowing pathologists to use AI tools to facilitate diagnostic workflows and provide patients with faster results.

"Digital pathology has the potential to improve precision diagnosis of cancer and enable physicians to offer better tailored treatment regimens," said Matt Sause, CEO of Roche Diagnostics. "Bringing PathAI into Roche Diagnostics will allow us to combine their best-in-class digital pathology tools with our leading oncology diagnosis platforms to deliver better insights for physicians and potentially better outcomes for patients worldwide."

Andy Beck, CEO and Co-Founder of PathAI, adds: "Joining forces with Roche marks a new era for PathAI, enabling us to realise our mission of improving patient outcomes through AI-powered pathology at unprecedented scale and speed. Roche’s global infrastructure and expertise will bring our digital diagnostics technology to patients worldwide."

PathAI’s AISight IMS software interface is efficient and user-friendly, seamlessly integrating advanced analysis and workflow capabilities within the digital pathology laboratory. In the rapidly growing pathology market, Roche intends to scale this solution globally.

In addition, the expanded capabilities strengthen Roche’s competitiveness in precision medicine by enhancing its biopharma services. PathAI’s strength in AI-driven solutions, including clinical trial support and translational research, will complement Roche’s deep expertise in companion diagnostics. Combining these capabilities will foster the discovery of new biomarkers, potential drug targets and novel diagnostic tools, increasing the value Roche can bring to biopharma companies.

Terms of the merger agreement
The closing of the transaction is subject to customary closing conditions, including antitrust and regulatory approvals and is currently expected in the second half of the year.

Under the terms of the agreement, Roche will pay a purchase price of USD 750 million upfront and additional milestone payments of up to USD 300 million.

(Press release, Hoffmann-La Roche, MAY 7, 2026, View Source [SID1234665324])

Exelixis to Webcast Fireside Chats as Part of Upcoming Investor Conferences in May

On May 7, 2026 Exelixis, Inc. (Nasdaq: EXEL) reported that company management will participate in fireside chats at the following investor conferences in May:

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BofA Securities Health Care Conference 2026: Exelixis is scheduled to present at 1:00 p.m. ET / 10:00 a.m. PT on Tuesday, May 12 in Las Vegas.
2026 RBC Capital Markets Global Healthcare Conference: Exelixis is scheduled to present at 9:00 a.m. ET / 6:00 a.m. PT on Tuesday, May 19 in New York City.
2026 Stifel Virtual Targeted Oncology Forum: Exelixis is scheduled to present virtually at 1:30 p.m. ET / 10:30 a.m. PT on Wednesday, May 20.
Bernstein 42nd Annual Strategic Decisions Conference: Exelixis is scheduled to present at 3:30 p.m. ET / 12:30 p.m. PT on Wednesday, May 27 in New York City.

To access the webcast links, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. Replays will also be available at the same location for at least 30 days.

(Press release, Exelixis, MAY 7, 2026, View Source [SID1234665323])

Evaxion announces business update and first quarter 2026 financial results

On May 7, 2026 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology platform, reported business update and announces first quarter 2026 financial results.

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Business highlights (since last quarterly update)
Evaxion has had a good start to the year executing on our plans and achieving our first milestone for 2026 as expected. Highlights include:

New data demonstrating an 86% vaccine target recognition by AI-Immunology in personalized cancer vaccine EVX-01 is a further scientific validation of the platform’s precision in driving immune response. This marked our first milestone for the year
Another new set of data confirming the platform’s unique scalability in glioblastoma
Successful completion of the one-year extension of our phase 2 trial with EVX-01 paving the way for presentation of three-year clinical data in the second half of 2026
Presentation of potentially superior design concepts for new polio vaccines stemming from our collaboration with The Gates Foundation
Organizational optimization for strategy execution with the promotion of Birgitte Rønø to the dual role of Chief Scientific and Chief Operating Officer and the election of Jens Bitsch-Nørhave to the Board of Directors
Cash runway unchanged with cash at hand to fund operations into the second half of 2027
"We maintain strong operational momentum as we continue our work to consolidate our position as a leader in AI-based target discovery, drug design and development. The validation of AI-Immunology continues to be reinforced with a host of new promising data presented, which forms a solid foundation for our ongoing business development efforts. We are pleased to have further strengthened our organization to focus on these with the promotion of Birgitte Rønø and inclusion of Jens Bitsch-Nørhave as a formal member of our Board of Directors," says Helen Tayton-Martin, CEO of Evaxion.

Conference call and webcast
Evaxion’s Executive Management will host a conference call and webcast at 8.30 ET/14.30 CET today, presenting the business update and financial results as well as taking questions.

To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event.

To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event.

Research & Development (R&D) update
Evaxion has a R&D pipeline of innovative vaccine candidates for both cancer and infectious diseases.

EVX-01 is our most advanced asset. Developed with AI-Immunology, it is a personalized cancer vaccine designed to target multiple neoantigens; cancer unique proteins arising from mutations. We completed the initially planned two-years of treatment in the phase 2 trial with EVX-01 in patients with advanced melanoma (skin cancer) last year with unprecedented results and presented new immunogenicity data from the trial at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting last month.

The data demonstrates that AI-Immunology identifies and selects the most therapeutically relevant vaccine targets as 86% of the targets included in EVX-01 trigger a tumor-specific immune response. This is a success rate much higher than what has been reported for other methods.

The record-high vaccine target precision underscores the therapeutic potential of EVX-01 and is also a further validation of AI-Immunology as an effective tool for developing potentially transformational treatments in melanoma as well as potentially other cancer indications with high mutational burden. This is of course important for the technology itself, but also very supportive of our ongoing work to enter additional strategic partnerships and business development deals.

At AACR (Free AACR Whitepaper), we also presented new data confirming the scalability of AI-Immunology allowing for its application in several diseases. This includes the deadly brain cancer glioblastoma, for which the platform uniquely can identify a novel source of targets to include in therapeutic vaccines, potentially enhancing their efficacy.

The data was generated in collaboration with Duke University School of Medicine and has created significant interest in the field of glioblastoma, an area of high unmet medical need.

We have completed the one-year extension of the phase 2 trial with EVX-01 with the last patient having last physician visit in April. In the third year, patients received EVX-01 as monotherapy, allowing an evaluation of the vaccine’s effect also as stand-alone treatment. Further, the three-year data may provide additional insights into potential enhanced treatment effects and durability of the induced immune response. We expect to present this data in the second half of 2026.

We also maintain a high activity level within our infectious disease programs as showcased by our presentation of new polio vaccine design concepts stemming from our collaboration with The Gates Foundation. These could potentially be superior to currently used vaccines and provide a basis for designing a specific new polio vaccine.

Current polio vaccines are based on inactivated or attenuated versions of the virus. Whilst these vaccines are effective, they each have shortcomings in certain settings. Thus, it has been a long-standing – but so far unreachable – goal to create a novel polio vaccine that combines the strongest aspects of the existing vaccines.

To achieve this, we have deployed AI-Immunology to develop novel vaccine design concepts for a next-generation polio vaccine, which may enhance the chances of completing and sustaining polio eradication once and for all.

Business development update
We remain active in several parallel partnership discussions based on external interest in both our platform and pipeline as we continue to pursue our strategy of strengthening our platform and building value through multiple partnerships.

To this end, we were pleased to promote Birgitte Rønø to joint role of Chief Scientific and Chief Operating Officer reflecting optimal internal organization to support partnering activities and internal strategy execution.

Further, we are excited to have welcomed Jens Bitsch-Nørhave to our Board of Directors. With more than 25 years of leadership experience in the biotech and pharmaceutical industry, specializing in corporate strategy, global expansion, and dealmaking, Jens will be a strong contributor to our business development activities.

First quarter 2026 financial results
The financial results for the first quarter 2026 showed a net loss of $3.6 million, compared to $1.6 million first quarter 2025. This is explained by financial income from remeasurement of derivative liability in the first quarter last year, whereas the operating expenses and results were slightly reduced in first quarter 2026.

Research and development (R&D) expenses were $2.3 million for the first quarter 2026, which is a slight increase compared to same period last year, as we progress our pipeline according to plan.

General and administrative (G&A) expenses were $1.5 million for the quarter, compared to $1.7 million in first quarter 2025. The decrease is primarily driven by lower capital market costs.

Financial income of $0.3 million first three months of 2026 compared to $2.4 million same period last year, is due to financial income recorded in 2025 from remeasurement of derivative liability from the January 2025 public offering.

Cash and cash equivalents as of March 31, 2026, were $18.4 million, compared to $23.2 million as of December 31, 2025, and confirms our current cash runway until second half of 2027.

Total equity amounts to $13.2 million as of March 31, 2026, reflecting the net result of the first quarter 2026 when compared to $17.0 million as of December 31, 2025.

Evaxion A/S
Consolidated statement of financial position data
(USD in thousands)

Mar 31,
2026 Dec 31,
2025
Cash and cash equivalents 18,440 23,234
Total assets 23,642 28,408
Total liabilities 10,435 11,369
Share capital 16,040 15,791
Other reserves 130,891 127,492
Accumulated deficit (133,724) (126,244)
Total equity 13,207 17,039
Total liabilities and equity 23,642 28,408

Evaxion A/S
Consolidated statement of comprehensive loss data
(USD in thousands, except per share data)

Three Months Ended
Mar 31,
2026 2025
Revenue 0 0
Research and development (2,298) (2,156)
General and administrative (1,521) (1,712)
Operating gain / loss (3,819) (3,868)
Finance income 305 2,493
Finance expenses (332) (397)
Net gain/ loss before tax (3,845) (1,772)
Income tax benefit 216 192
Net gain / loss for the period (3,629) (1,580)
Net loss attributable to shareholders of Evaxion A/S (3,629) (1,580)
Loss per share – basic and diluted (0.01) (0.01)
Number of shares used for calculation (basic and diluted) 417,010,756 276,311,927

(Press release, Evaxion, MAY 7, 2026, View Source [SID1234665322])

Delcath Systems Reports First Quarter 2026 Results and Business Highlights

On May 7, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported financial results and business highlights for the first quarter ended March 31, 2026.

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First Quarter 2026 Financial Results

Total revenue of $25.0 million, compared with $19.8 million in the first quarter of 2025
HEPZATO KIT revenue of $23.3 million, compared to $18.0 million in the first quarter of 2025
CHEMOSAT revenue of $1.7 million, compared to $1.8 million in the first quarter of 2025
Gross margins of 85%, compared to 86% in the first quarter of 2025
Net loss of $1.1 million, compared to a net income of $1.1 million in the first quarter of 2025
Non-GAAP adjusted EBITDA of $3.4 million, compared to $7.6 million in the first quarter of 2025
Cash provided by operations of $0.9 million in the quarter; compared to $2.2 million provided by operations in the first quarter of 2025
Repurchased 316,023 common shares for proceeds of approximately $3.0 million in the first quarter of 2026 under the approved $25 million Share Buyback Program
Cash and investments of $89.3 million as of March 31, 2026
Business Highlights

Currently 29 active centers
Approximately 36% growth in HEPZATO volume in the first quarter 2026 compared to the first quarter 2025
Announced the publication of full results from the investigator-initiated CHOPIN randomized Phase 2 trial in The Lancet Oncology, demonstrating that adding ipilimumab and nivolumab to percutaneous hepatic perfusion significantly improved progression-free survival in metastatic uveal melanoma.
Announced that CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (M-PHP) has been included as a recommended liver-directed regional therapy option in the newly published Uveal Melanoma: ESMO (Free ESMO Whitepaper)–EURACAN Clinical Practice Guideline for diagnosis, treatment and follow-up (April 2026)
"We delivered a strong first quarter, marked by 20% volume growth over the prior quarter and a strong increase in new patient starts," said Gerard Michel, Chief Executive Officer. "The recent publication of the full CHOPIN results in The Lancet Oncology is already having a meaningful impact on prescribing patterns, further validating HEPZATO KIT and positioning us for continued momentum and long-term value for patients and shareholders alike."

2026 Full Year Financial Guidance
The Company’s financial outlook for fiscal year 2026:

Total CHEMOSAT and HEPZATO KIT revenue to be at least $100 million, reflecting an increase in HEPZATO KIT volume of at least 20% over 2025
Gross margins in the range of 84% to 87%
Positive adjusted EBITDA
First Quarter 2026 Results
Total revenue for the quarter ending March 31, 2026, was $25.0 million compared to $19.8 million for the same period in the prior year. Revenue in the quarter includes sales of $23.3 million of HEPZATO in the U.S. and $1.7 million of CHEMOSAT in Europe.

Research and development expenses for the quarter ending March 31, 2026, were $9.8 million compared to $5.0 million for the same period in the prior year. The increase is primarily due to the continued costs associated with expanding the clinical team, including the share-based compensation expense related to an increase in headcount, and continuation of the Phase 2 clinical trials evaluating HEPZATO.

Selling, general and administrative expenses for the quarter ended March 31, 2026, were $13.1 million compared to $11.3 million for the same period in the prior year. The increase is primarily due to continued commercial expansion activities including marketing-related expenses, additional personnel in the commercial team and share-based compensation expenses.

Net loss for the quarter ended March 31, 2026, was $1.1 million compared to net income of $1.1 million for the same period in the prior year.

Non-GAAP adjusted EBITDA for the quarter ended March 31, 2026 was $3.4 million compared to adjusted EBITDA of $7.6 million for the same period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.

As of March 31, 2026, the Company had $89.3 million in cash and investments, and no debt.

Conference Call Information
To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date: Thursday, May 7, 2026
Time: 8:30 AM Eastern Time

Participant Numbers:
Toll Free: 1-800-717-1738
International: 1-646-307-1865
Webcast: View Source;tp_key=463dd4d428

A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website View Source

(Press release, Delcath Systems, MAY 7, 2026, View Source [SID1234665321])

Delcath Systems Announces Presentation of New Data on Percutaneous Hepatic Perfusion with Melphalan in Liver-Dominant Metastatic Breast Cancer at ESMO Breast Cancer 2026

On May 7, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that new data from a retrospective analysis by independent investigators on percutaneous hepatic perfusion with melphalan (M-PHP) using the CHEMOSAT Hepatic Delivery System was presented today at the ESMO (Free ESMO Whitepaper) Breast Cancer Congress 2026.

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Presentation details

Congress: ESMO (Free ESMO Whitepaper) Breast Cancer Congress 2026
Date: May 7, 2026
Session: 13:15 (local congress time)
Format: E-poster
Title: Safety and Feasibility of Percutaneous Hepatic Perfusion with Melphalan in Patients with Liver-Dominant Metastatic Breast Cancer
Presenter: Cornelia Lieselotte Angelika Dewald, MD (Hannover Medical School)
Abstract number: 574eP
Background

Liver-dominant metastatic breast cancer remains a significant clinical challenge, as progression in the liver can be a major driver of morbidity and may limit the effectiveness of systemic therapies. M-PHP is a liver-directed procedure designed to deliver high-dose melphalan to the liver while reducing systemic exposure through extracorporeal hemofiltration.

About the analysis

Independent investigators at three European centers retrospectively identified 15 patients with liver-dominant metastatic breast cancer treated with M-PHP (CHEMOSAT) at three European centers. The analysis evaluated feasibility, safety, and tumor response per RECIST v1.1.

Key findings (retrospective cohort; N=15)

Patient population: Fifteen patients were treated between September 2015 and May 2024 after a median of 4 prior systemic therapy lines (range 1–6).
Treatment delivery: Patients received a median of 1 M-PHP cycle (range 1–7), typically followed by ICU admission of 1–2 days.
Safety: 67% of patients required blood transfusions (primarily packed red blood cells). Intra-/peri-procedural adverse events occurred in 60% of patients (primarily hematologic or hemodynamic). Grade 3–4 post-procedure adverse events occurred in 80% of patients, predominantly bone marrow suppression with neutropenic-related infections; events typically onset early (median 1 day) and resolved in a median of 7 days.
Liver response: Hepatic partial response was observed in 9 of 15 treated patients (60%); 3 patients were not evaluable for response.
Overall survival: Median overall survival from first M-PHP was 6.0 months (95% CI, 2.9–NR; range 0.1–76.5); 33% (5/15) of patients were alive at last follow-up. Median follow-up was 55.6 months (95% CI, 53.7–NR).
"These data from independent European investigators represent real-world evidence supporting the use of HEPZATO KIT and CHEMOSAT in liver-dominant metastatic breast cancer and underscore the need for further evaluation in this heavily pretreated population," said Gerard Michel, Chief Executive Officer of Delcath Systems.

HEPZATO KIT is currently being evaluated in a randomized Phase 2 trial in metastatic breast cancer patients with liver dominant disease (PHP-MBC-202; ClinicalTrials.gov identifier NCT06875128).

(Press release, Delcath Systems, MAY 7, 2026, View Source [SID1234665320])