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])

CytomX Therapeutics Announces Q1 2026 Financial Results and Provides Business Update

On May 7, 2026 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported Q1 2026 financial results and provided a business update.

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"CytomX has continued to gain tremendous momentum in 2026 and we remain highly focused on executing against the multiple layers of potential value creation we see for Varseta-M. Our top priority is to advance this highly differentiated, first in class EpCAM ADC into a registrational study in late-line CRC while also investing to unlock the broader potential of Varseta-M in earlier line CRC and other cancers," said Dr. Sean McCarthy, chairman and CEO of CytomX Therapeutics."

Continued Dr. McCarthy, "Strategically, we view Varseta-M as a company-building asset, uniquely enabled by the CytomX PROBODY therapeutic platform. Varseta-M is the only EpCAM targeted ADC in clinical development and is, we believe, ideally positioned to address the large unmet need in colorectal cancer as well as a broad range of EpCAM-expressing tumors. Based on the highly encouraging clinical results presented to-date and Varseta-M’s pan-tumor potential, we plan to execute with speed and focus to maximize benefit for people with cancer."

Pipeline Program Updates:

Varsetatug masetecan (EpCAM PROBODY Topo-1 ADC, CX-2051)

On March 16th 2026, CytomX announced positive data from the ongoing Phase 1 dose expansion study of Varseta-M in patients with advanced colorectal cancer (CRC).
As of April 2026, enrollment into Varseta-M Dose Optimization cohorts was complete, having reached the goal of 40 total patients across the 8.6 mg/kg Q3W and 10 mg/kg Q3W doses1.
Additional Phase 1 Varseta-M data, including data from ongoing dose optimization, is anticipated to be presented in the second half of 2026. This update is expected to support monotherapy dose selection and a potential registrational trial design in late line CRC.
FDA interactions are planned in 2026 with goal of aligning on the potential first registrational study for Varseta-M monotherapy in advanced CRC starting in 1H 2027.
A Phase 1 Varseta-M combination study with bevacizumab in CRC has commenced with an initial focus on determining combination dose(s) for later phase development, including in earlier lines of therapy. Varseta-M doses to be assessed in combination with bevacizumab will include Q2W and Q4W schedules to align with the approved bevacizumab CRC dose of 5 mg/kg Q2W. Initial clinical data are anticipated by 1H 2027.
Phase 1/2 combination study including Varseta-M administered with bevacizumab, 5-fluorouracil, and leucovorin is planned to start in 2H 2026.
Initiation of initial Phase 1 expansion cohort(s) in non-CRC indications is planned for 2H 2026.
CX-801 (PROBODY Interferon alpha-2b)

The CX-801 Phase 1 study in advanced melanoma is ongoing. The CX-801 monotherapy dose escalation portion of the study has reached the fourth dose level.
CX-801 monotherapy has been generally well tolerated at dose levels exceeding the approved dose of unmasked IFNα2b.2
In May 2025, Phase 1 dose escalation of CX-801 in combination with KEYTRUDA (pembrolizumab) was initiated. Dose escalation of CX-801 in combination with KEYTRUDA is currently enrolling the third dose level.
Biomarker data from the CX‑801 monotherapy study in advanced melanoma were presented at the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, reinforcing CX‑801’s mechanism of action and supporting the ongoing combination trial with KEYTRUDA.
Initial clinical data for CX-801 in combination with KEYTRUDA in advanced melanoma is projected by the end of 2026.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

Corporate and Financial:

Financial:
Completed an equity follow-on offering in March 2026 with gross proceeds of $250 million.
CytomX ended Q1 2026 with $346.7 million of cash, cash equivalents and investments with expected cash runway to at least the second half of 2028.
Research Pipeline and Collaborations:
CytomX has research collaborations with Amgen, Regeneron, and Moderna. Drug discovery programs continue in our research collaborations with a focus on bispecific immunotherapies, including T-cell engagers.
Q1 2026 Financial Results:

Cash, cash equivalents and investments totaled $346.7 million as of March 31, 2026, compared to $137.1 million as of December 31, 2025. Cash as of March 31, 2026 included $234.2 million of net proceeds from the completion of an underwritten public offering in March 2026.

Total revenue was $10.3 million for the quarter ended March 31, 2026, compared to $50.9 million for the first quarter of 2025. The decrease in revenue was driven primarily by the completion of our performance obligations during 2025 in the collaborations with Bristol Myers Squibb and Amgen.

Total operating expense for quarter ended March 31, 2026 was $29.9 million compared to $28.3 million for the first quarter ended March 31, 2025, an increase of $1.6 million.

Research and development expenses increased by $0.4 million during the quarter ended March 31, 2026, to $19.2 million compared to $18.9 million for the quarter ended March 31, 2025. Research and development expenses increased primarily due to increased manufacturing activities for Varseta-M, partially offset by $1.7 million of restructuring expenses incurred in the first quarter of 2025.

General and administrative expenses increased by $1.3 million during the quarter ended March 31, 2026, to $10.7 million, compared to $9.4 million for the quarter ended March 31, 2025. The general and administrative expenses for the first quarter of 2025 included $1.1 million of one-time restructuring expenses.

(Press release, CytomX Therapeutics, MAY 7, 2026, View Source [SID1234665319])