On November 4, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the European Patent Office (EPO) has communicated its intent to grant Genprex a patent for the use of Reqorsa Gene Therapy (quaratusugene ozeplasmid) in combination with PD-1 antibodies for the treatment of cancer.

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"We are pleased to continue bolstering our patent estate, which includes multiple patents for the use of REQORSA in combination with both PD-1 and PD-L1 antibodies across many markets," said Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing at Genprex. "This European patent will further strengthen our intellectual property portfolio and the patent protection around REQORSA in order to safeguard our gene therapy with target-specific combination therapy."

This patent will expand on the previously granted patents for REQORSA in combination with PD-1 antibodies, which have been granted in the U.S., Japan, Mexico, Russia, Australia, Chile, China, and Singapore.

REQORSA is initially being developed in combination with prominent, approved cancer drugs to treat lung cancer. In preclinical studies, REQORSA has been shown to be complementary with targeted drugs and immunotherapies. The Company believes REQORSA’s unique attributes position it to provide potential treatments that improve on these current therapies for patients with lung cancer and possibly other cancers.

According to Eurostat, in 2021, nearly a quarter of a million people died from lung cancer in the EU, accounting for almost a fifth of all cancer deaths and accounting for 4.3% of the total number of deaths. According to the European Commission, it is estimated that in the EU-27 countries in 2020, lung cancer accounted for 11.9% of all new cancer diagnoses (excluding non-melanoma skin cancers) and 20.4% of all deaths due to cancer. In addition, lung cancer was the fourth most frequently occurring cancer (after prostate, breast, and colorectal cancers) and the leading cause of cancer death.

According to data from GLOBOCAN 2022, lung cancer stood as the most frequently diagnosed cancer and the primary cause of cancer-related deaths on a global scale with approximately 2.48 million new cases and 1.8 million deaths, respectively. If the incidence and mortality rates remain stable as in 2022, the burden of lung cancer is projected to increase to 4.62 million new cases and 3.55 million deaths by 2050.

(Press release, Genprex, NOV 4, 2025, View Source [SID1234659356])

On November 4, 2025 FORE Biotherapeutics reported that the Company will participate at the following investor conferences:

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Stifel 2025 Healthcare Conference. The Company will attend on Tuesday, November 11, and will provide a corporate presentation at 10:40 a.m. – 11:10 a.m. ET.
Jefferies London Global Healthcare Conference. The Company will attend and participate in one-on-one meetings on Monday, November 17 – Wednesday, November 19.
Management will host and participate in one-on-one meetings. Please contact Argot Partners to schedule one-on-one meetings with the management team.

(Press release, Fore Biotherapeutics, NOV 4, 2025, View Source [SID1234659355])

On November 4, 2025 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the third quarter of 2025, provided an update on progress toward achieving key corporate objectives, and outlined its commercial, clinical and pipeline development milestones.

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"In the third quarter of 2025, Exelixis gained momentum in the cabozantinib franchise and delivered on critical strategic priorities across the research & development portfolio," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "The cabozantinib franchise continued to outperform with sustained growth in renal cell carcinoma and neuroendocrine tumors, where CABOMETYX built on its position as the leading oral therapy for new patient market share in second-line and later settings. In October, we presented the detailed positive results from the STELLAR-303 pivotal trial evaluating zanzalintinib in combination with atezolizumab in advanced colorectal cancer at the 2025 European Society for Medical Oncology Congress, along with a simultaneous publication in The Lancet. Based on these results, we intend to complete the submission of our first new drug application for zanzalintinib in the U.S. before year-end. We also made strong progress across the range of ongoing and planned zanzalintinib pivotal trials, as well as the four ongoing phase 1 clinical studies from our early-stage pipeline where we’re looking to profile and move the most promising candidates into full development. I want to thank the entire Exelixis team for their collective efforts and unwavering commitment as we work toward our goals of improving standards of care and helping more patients with cancer."

Third Quarter 2025 Financial Results
Total revenues for the quarter ended September 30, 2025 were $597.8 million, as compared to $539.5 million for the comparable period in 2024.
Total revenues for the quarter ended September 30, 2025 included net product revenues of $542.9 million, as compared to $478.1 million for the comparable period in 2024. The increase in net product revenues was primarily due to an increase in sales volume.
Collaboration revenues, composed of license revenues and collaboration services revenues, were $54.8 million for the quarter ended September 30, 2025, as compared to $61.5 million for the comparable period in 2024. The decrease in collaboration revenues was primarily related to lower milestone-related revenues recognized in the quarter and lower development cost reimbursements earned, partially offset by higher royalty revenues for the sales of cabozantinib outside the U.S. generated by Exelixis’ collaboration partner Ipsen Pharma SAS (Ipsen).
Research and development expenses for the quarter ended September 30, 2025 were $199.2 million, as compared to $222.6 million for the comparable period in 2024. The decrease in research and development expenses was primarily related to decreases in clinical trial costs and license and other collaboration costs.
Selling, general and administrative expenses for the quarter ended September 30, 2025 were $123.7 million, as compared to $111.8 million for the comparable period in 2024. The increase in selling, general and administrative expenses was primarily related to increases in stock-based compensation and consulting and outside services.
Provision for income taxes for the quarter ended September 30, 2025 was $58.8 million, as compared to $36.8 million for the comparable period in 2024.
Restructuring expenses for the quarter ended September 30, 2025 were $19.8 million. The restructuring expenses primarily consist of severance and employee-related costs. In August 2025, Exelixis’ Board of Directors authorized a corporate reorganization plan (the Plan) to reorganize the Company’s workforce and close the office located in King of Prussia, Pennsylvania. In connection with the Plan, the Company estimates that it will incur aggregate charges of approximately $20.5 million. The majority of these costs were incurred in the third quarter of 2025. The Plan was implemented in the third quarter of fiscal year 2025 and is expected to be substantially completed by the end of fiscal year 2025.
Impairment of long-lived assets for the quarter ended September 30, 2024 of $51.7 million was related to the non-cash asset impairment charge to certain of Exelixis’ leased facilities.
GAAP net income for the quarter ended September 30, 2025 was $193.6 million, or $0.72 per share, basic and $0.69 per share, diluted, as compared to GAAP net income of $118.0 million, or $0.41 per share, basic and $0.40 per share, diluted, for the comparable period in 2024. GAAP net income per share for the quarter ended September 30, 2025 was favorably impacted by lower weighted-average common shares outstanding for the quarter ended September 30, 2025, as compared to the comparable period in 2024, as a result of the stock repurchase programs.

(Press release, Exelixis, NOV 4, 2025, View Source [SID1234659354])

On November 4, 2025 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that company management will participate in the following conference and invited investors to participate by webcast.

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Jefferies London Healthcare Conference, London
Fireside chat on Tuesday, November 18, 2025 at 7:30 a.m. ET (12:30 p.m. GMT)
The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

(Press release, Exact Sciences, NOV 4, 2025, View Source [SID1234659353])

On November 4, 2025 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported financial results and business highlights for the third quarter ended September 30, 2025.

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Third Quarter 2025 Financial Results

Total revenue of $20.6 million, compared with $11.2 million in the third quarter of 2024
HEPZATO KIT revenue of $19.3 million, compared to $10.0 million in the third quarter of 2024
CHEMOSAT revenue of $1.3 million, compared to $1.2 million in the third quarter of 2024
Gross margins of 87%, compared to 85% in the third quarter of 2024
Net income of $0.8 million, compared to a net income of $1.9 million in the third quarter of 2024
Non-GAAP positive adjusted EBITDA in the third quarter of $5.3 million, compared to a positive adjusted EBITDA of $1.0 million in the third quarter of 2024
Cash provided by operations of $4.8 million in the quarter; compared to $3.6 million used by operations in the third quarter of 2024
Cash and investments of $88.9 million as of September 30, 2025
Business Highlights

There are currently 25 active centers across the U.S.
In August, the first patient was dosed at City of Hope National Medical Center in the global Phase 2 trial of HEPZATO in combination with trifluridine-tipiracil and bevacizumab for liver-dominant metastatic colorectal cancer. The study will enroll approximately 90 patients across 20+ sites in the U.S. and Europe, with topline data expected in 2028
Announced that results from the investigator-initiated Phase 2 CHOPIN trial at Leiden University Medical Center evaluating CHEMOSAT with ipilimumab and nivolumab in metastatic uveal melanoma were presented at the October 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress by Principal Investigator Ellen Kapiteijn, MD, showing a significant improvement in one-year progression-free survival versus CHEMOSAT alone
"In the third quarter, we made strong progress with our clinical programs, reporting compelling positive CHOPIN results and first-patient dosing in our global Phase 2 trial in liver-dominant metastatic colorectal cancer," said Gerard Michel, Chief Executive Officer of Delcath Systems. "While revenue results in the quarter reflected the impact of NDRA discounts and seasonal factors, our fundamentals remain strong. We are confident that the growing clinical validation of HEPZATO positions us well to drive continued progress and long-term value for patients and shareholders."

2025 Full Year Financial Guidance

The Company’s financial outlook for fiscal year 2025:

Total CHEMOSAT and HEPZATO KIT revenue to be in the range of $83 to $85 million, an increase in volume of approximately 150% over 2024
Gross margins in the range of 85% to 87%
Positive adjusted EBITDA and cashflow in each quarter of 2025
Third Quarter 2025 Results

Total revenue for the quarter ending September 30, 2025 was $20.6 million compared to $11.2 million for the same period in the prior year. Revenue in the quarter includes sales of $19.3 million of HEPZATO in the U.S. and $1.3 million of CHEMOSAT in Europe.

Research and development expenses for the quarter ending September 30, 2025, were $8.0 million compared to $3.9 million for the same period in the prior year. The increase is primarily due to costs associated with expanding the clinical team including the share-based compensation expense related to an increase in headcount and initiation of the Phase 2 clinical trial evaluating HEPZATO in combination with standard of care for metastatic colorectal cancer and Phase 2 clinical trial in metastatic breast cancer. In 2024, these costs primarily related to medical affairs and regulatory costs associated with the approved products.

Selling, general and administrative expenses for the quarter ended September 30, 2025, were $10.3 million compared to $7.0 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 income for the quarter ended September 30, 2025 was $0.8 million compared to net income of $1.9 million for the same period in the prior year.

Non-GAAP adjusted EBITDA for the quarter ended September 30, 2025 was $5.3 million compared to adjusted EBITDA of $1.0 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 September 30, 2025, the Company had $88.9 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, November 6, 2025
Time: 8:30 AM Eastern Time

Participant Numbers:
Toll Free: 1-877-407-3982
International: 1-201-493-6780
Webcast: View Source;tp_key=a3bb91787b

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, NOV 4, 2025, View Source [SID1234659352])