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Exact Sciences to Participate in November Investor Conference

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])

Delcath Systems Reports Third Quarter 2025 Results and Business Highlights

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.

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])

Day One Reports Third Quarter 2025 Financial Results and Corporate Progress

On November 4, 2025 Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported its third quarter 2025 financial results and highlighted recent corporate achievements.

"Our third quarter results reflect acceleration across every key dimension of OJEMDA’s performance and growing confidence among prescribers as we continue to build the case for second-line standard-of-care through execution and additional data readouts," said Jeremy Bender, Ph.D., chief executive officer of Day One. "Combined with steady pipeline progress, we are well positioned to deliver sustainable growth for shareholders while we continue our mission to bring meaningful therapies to patients."

OJEMDA Commercial Performance

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OJEMDA net product revenue was $38.5 million in the third quarter of 2025, an increase of 15% from the second quarter of 2025.

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Achieved $102.6 million in U.S. OJEMDA net product revenue for 2025 year-to-date through the third quarter of 2025, representing an 89% increase over fiscal year 2024.

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Quarterly prescriptions (TRx) grew to 1,256 in the third quarter of 2025, representing an 18% increase compared to the second quarter of 2025.

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Third quarter new patient starts grew 19% compared to the second quarter of 2025, driven by the FIREFLY-1 clinical trial 2-year follow-up data.

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The Company is raising the OJEMDA full-year 2025 net product revenue guidance to $145 to $150 million, reflecting continued strength in underlying demand.

Program Highlights

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Progressing enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial in first-line pediatric low-grade glioma (pLGG), with enrollment completion anticipated in the first half of 2026.

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Advancing dose escalation in the Phase 1a clinical trial of DAY301, a PTK7-targeted antibody drug conjugate (ADC).

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Tovorafenib added as a category 2a recommended therapy in the National Comprehensive Cancer Network (NCCN) treatment guidelines for adult patients with recurrent or progressive BRAF-altered glioma.

Corporate Highlights

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Seasoned biopharmaceutical executive Heather Adkins Huet, PhD, joined Day One in September 2025 as Chief Scientific Officer. Dr. Huet brings over two decades of experience leading and managing the full life cycle of oncology therapeutics, from discovery through life-cycle management of approved products, in biotech startup, mid-cap and large-cap companies including ImmunoGen, Takeda Pharmaceuticals, and Unum Therapeutics.

Third Quarter 2025 Financial Highlights

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Product Revenue, Net: OJEMDA net product revenue was $38.5 million for the third quarter of 2025 compared to $20.1 million for the third quarter of 2024 driven by higher patient demand.

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License Revenue: License revenue from the sale of ex-U.S. commercial rights for tovorafenib was $1.3 million for the third quarter of 2025 compared to $73.7 million for the third quarter of 2024 during which period the upfront consideration received from Ipsen for the pLGG license rights of $73.5 million was recognized.

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R&D Expenses: Research and development expenses were $31.4 million for the third quarter of 2025 compared to $33.6 million for the third quarter of 2024.

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SG&A Expenses: Selling, general and administrative expenses were $28.1 million for the third quarter of 2025 compared to $29.0 million for the third quarter of 2024.

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Net Loss: Net loss totaled $19.7 million for the third quarter of 2025 with non-cash stock-based compensation expense of $9.6 million, compared to a net income of $37.0 million for the third quarter of 2024, with non-cash stock-based compensation expense of $11.6 million.

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Cash Position: The Company’s cash, cash equivalents and short-term investments totaled $451.6 million as of September 30, 2025.

Upcoming Events

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Three-year data from the pivotal FIREFLY-1 trial will be presented in an oral presentation titled ‘Clinical stability following tovorafenib treatment in relapsed/refractory pediatric low-grade glioma:

updated results from the phase 2 FIREFLY-1 trial’ on Sunday, Nov. 23 at 11:49 a.m. HST during the 2025 Society for Neuro Oncology Annual Meeting.

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Piper Sandler 37th Annual Healthcare Conference, December 2-4, 2025.

Conference Call

Day One will host a conference call and webcast today, Nov. 4 at 4:30 p.m. Eastern Time. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13745150. Live audio webcast will be accessible from the Events page. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events section of the Day One Media & Investors page for 30 days following the event.

About OJEMDA

OJEMDA (tovorafenib) is a Type II RAF kinase inhibitor of mutant BRAF V600, wild-type BRAF, and wild-type CRAF kinases.

OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Tovorafenib was granted Breakthrough Therapy and Rare Pediatric Disease designations by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration, and it was evaluated by the FDA under priority review. Tovorafenib has also received Orphan Drug designation from the FDA for the treatment of malignant glioma and from the European Commission for the treatment of glioma.

For more information, please visit www.ojemda.com.

(Press release, Day One, NOV 4, 2025, View Source [SID1234659351])

CytomX Therapeutics to Present CX-801 Phase 1 Monotherapy Biomarker Data at the Society for Immunotherapy of Cancer (SITC) Annual Meeting

On November 4, 2025 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported that initial translational data from the ongoing Phase 1 study of CX-801 in patients with advanced melanoma will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Anniversary Annual Meeting, being held in National Harbor, MD on November 7-9, 2025.

"CX-801 was intentionally designed to unlock the powerful immune-modulating effects of interferon alpha-2b by leveraging our PROBODY therapeutic platform. We are excited to share initial Phase 1 biomarker data for CX-801 which suggest the molecule is working as designed by inducing tumor-localized activation of immune cell populations and interferon-stimulated genes in paired tumor biopsies, including PD-1 and PD-L1," said Marcia Belvin, Ph.D. SVP, chief scientific officer of CytomX Therapeutics.

"We are pleased with the Phase 1 progress for CX-801 to-date, including initial evidence that CX-801 is generally well tolerated and can modulate the immune tumor microenvironment in patients with metastatic melanoma refractory to prior immune checkpoint inhibitor therapy. These initial data support the rationale for the ongoing Phase 1 combination study of CX-801 combined with KEYTRUDA in melanoma, an area of significant unmet need. We look forward to providing Phase 1 clinical data of CX-801 combined with KEYTRUDA in 2026," said Dr. Wayne Chu, M.D., chief medical officer of CytomX Therapeutics.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

Details for CytomX Therapeutics Presentations at SITC (Free SITC Whitepaper) 2025

CX-801 poster presentation:
Presentation Title: Pharmacodynamic Activity of CX-801, a Masked IFNα2b PROBODY Cytokine, in Patients with Advanced Melanoma
Abstract Number: 606
Session Date and Time: Saturday, November 8, 2025, 5:10 pm – 6:35 pm ET

Preclinical Masked T-cell Engager Targeting CDH3:
Presentation Title: CX-908, a PROBODY T Cell Engager Targeting CDH3 and CD3, Induces Tumor Regressions and Improves the Therapeutic Window in Preclinical Studies
Abstract Number: 961
Session Date and Time: Friday, November 7, 2025, 5:35 pm – 7:00 pm ET

(Press release, CytomX Therapeutics, NOV 4, 2025, View Source [SID1234659350])

Corvus Pharmaceuticals Provides Business Update and Reports Third Quarter 2025 Financial Results

On November 4, 2025 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and announced financial results for the third quarter ended September 30, 2025.

"We are advancing the development of our ITK inhibitor, soquelitinib, in both atopic dermatitis and T cell lymphomas. We believe soquelitinib has the potential to be ideally positioned as a well-tolerated treatment for a range of immune diseases and cancers that works through a novel mechanism of action," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We look forward to reporting results from extension cohort 4 of the soquelitinib Phase 1 trial in atopic dermatitis in the coming months, which will provide additional information on the 200 mg twice daily dose and a longer 8-week treatment period. In addition, we remain on track to initiate an atopic dermatitis Phase 2 trial with soquelitinib in early Q1 2026. In oncology, our Phase 3 registration clinical trial in PTCL continues to enroll and we are pleased that the final results from the related Phase 1/1b trial will be presented in an oral session at ASH (Free ASH Whitepaper). These data add to the growing clinical evidence supporting soquelitinib as a safe and active agent with potential in a range of diseases."

Business Update and Strategy

Soquelitinib (Corvus’ selective ITK inhibitor) for Immune Diseases

Completed enrollment in extension cohort 4 of the soquelitinib atopic dermatitis Phase 1 clinical trial, which includes 24 patients randomized 1:1 between active (soquelitinib 200 mg twice per day) and placebo. The treatment period for this group is 8 weeks with a 30-day follow-up period with no treatment. The extension cohort 4 is studying the same dose as cohort 3 of the Phase 1 trial, but for a longer treatment period (cohort 3 was 4 weeks). Cohort 3 patients experienced earlier responses and deeper separation from placebo compared to cohorts 1 and 2, which studied a lower dose of 100 mg twice per day or 200 mg once per day. Cohort 3 patients also had a clinically meaningful reduction in itch as early as day 8. Announcement of data from extension cohort 4 is anticipated in January 2026.
On track to initiate atopic dermatitis Phase 2 clinical trial in early Q1 2026. The trial is anticipated to enroll approximately 200 patients with moderate-to-severe atopic dermatitis that have failed at least one prior topical or systemic therapy. The trial is anticipated to enroll four cohorts of 50 patients each, with soquelitinib doses of: 200 mg once per day; 200 mg twice per day; and 400 mg once per day; along with a placebo group. The treatment period is anticipated to be 12 weeks with a 30-day follow-up period with no treatment.
Corvus also continues to advance its next-generation ITK inhibitor preclinical product candidates, which are designed to deliver precise T-cell modulation that is optimized for specific immunology and oncology indications.
Collaboration with National Institute of Allergy and Infectious Diseases (NIAID)

Patient enrollment continues in the Autoimmune Lymphoproliferative Syndrome (ALPS) Phase 2 clinical trial, which is being conducted under a clinical research and development agreement with NIAID. The Phase 2 clinical trial (NCT06730126) is anticipated to enroll up to 30 patients aged 16 or older with confirmed ALPS based on genetic testing.
Soquelitinib for T Cell Lymphoma

Corvus continues to enroll patients in a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL at multiple clinical sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed/refractory PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate. The primary endpoint of the trial is progression free survival. There are no FDA fully approved agents for the treatment of relapsed/refractory PTCL, and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least 2 lines of systemic therapy.
The final data from the Company’s Phase 1/1b clinical trial evaluating soquelitinib in patients with T cell lymphoma will be reported in an oral presentation at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2025. Previously reported interim data from this trial supported the initiation of the ongoing registrational Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL.
Financial Results
As of September 30, 2025, Corvus had cash, cash equivalents and marketable securities of $65.7 million as compared to $52.0 million as of December 31, 2024. Consistent with last quarter, Corvus expects its cash to fund operations into the fourth quarter of 2026.

Research and development expenses for the three months ended September 30, 2025 totaled $8.5 million compared to $5.2 million for the same period in 2024. The increase of approximately $3.3 million was primarily due to higher clinical trial and manufacturing costs associated with the development of soquelitinib as well as an increase in personnel related costs.

Net loss for the three months ended September 30, 2025 was $10.2 million compared to a net loss of $40.2 million for the same period in 2024. Included in net loss for the three months ended September 30, 2024 was a non-cash loss of $32.8 million associated with a change in fair value of the Company’s warrant liability. Total stock compensation expense for the three months ended September 30, 2025 was $1.2 million compared to $0.7 million for the same period in 2024, and the non-cash loss from Corvus’ equity method investment in Angel Pharmaceuticals was $0.3 million for the three months ended September 30, 2025 compared to a non-cash loss of $0.7 million for the same period in 2024.

Conference Call Details
Corvus will host a conference call and webcast today, Tuesday, November 4, 2025, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the third quarter 2025 financial results. The conference call can be accessed by dialing 1-800-717-1738 (toll-free domestic) or 1-646-307-1865 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.

(Press release, Corvus Pharmaceuticals, NOV 4, 2025, View Source [SID1234659349])