On November 4, 2025 Zetagen Therapeutics, a privately held clinical-stage biopharmaceutical company pioneering first-of-its-kind targeted therapies for both primary and metastatic breast cancer, reported that its abstract titled "Single Intratumoral Drug Injection Yields Complete Response (CR) in Metastatic Breast Cancer (MBC) Bone Lesions", has been accepted and will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) on Wednesday, December 10, 2025.

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The abstract presents preliminary clinical data from a recently completed Phase 2a trial (NCT05280067) performed at the University of British Columbia evaluating ZetaMet (Zeta-BC-003) for safety and efficacy for the treatment of MBC lytic bone lesions in Stage 4 breast cancer patients. Phenotypes treated within the study, TNBC, HR+, HR+/HER2+, and HERS2+/HR-. Each patient underwent a single fluoroscopy-guided injection of ZetaMet while under sedation. All achieved a complete response (CR), ceased tumor activity, with no serious adverse events (SAEs), adverse events (AEs), or skeletal-related events (SREs) and many demonstrated a reconstitution of trabecular bone, which further underscores the potential of ZetaMet to not only halt disease progression but restore skeletal integrity.

The findings build on prior compassionate use cases published in peer-reviewed journals with two-year follow-up, reinforcing ZetaMet’s potential to prevent SREs and improve overall survival. The abstract will be published in SABCS 2025 Proceedings and featured in Clinical Cancer Research.

With the trial now complete and comprehensive analyses underway, this presentation at SABCS will represent the most detailed data release to date. A full report of the findings will also be submitted to Health Canada (HC) and the U.S. Food and Drug Administration (FDA) to inform future planning discussions.

Presentation Details:

Abstract Number: 3549
Presentation Number: PS1-13-18
Presentation Title: Single Intratumoral Drug Injection Yields Complete Response in Metastatic Breast Cancer Bone Lesions: Results from Phase 2a Trial
Poster Presentation: Wednesday, December 10, 2025, 12:30-2:00pm CST
"The promising Phase 2a findings for ZetaMet mirror our earlier peer-reviewed results, reinforcing the strength of our clinically validated strategy in treating metastatic breast cancer." said Joe C. Loy, CEO of Zetagen Therapeutics. "We observed that both treated and adjacent non-treated lesions within the same vertebral body achieved complete response, with no signs of tumor activity and no skeletal-related events—all using the same drug concentration validated in our preclinical studies—strongly affirming the scientific foundation of our approach".

About ZetaMet (Zeta-BC-003)
ZetaMet (Zeta-BC-003) is the first-of-its-kind, synthetic, small-molecule, administered intratumorally to minimize off target toxicity, delivered via a proprietary controlled-release carrier intended to resolve metastatic breast cancer bone lesions, inhibit pain while regenerating bone, with the potential to increase survival rates.

The US Food & Drug Administration (FDA) has recognized Zetagen’s discoveries with multiple Breakthrough Designations including ZetaMet.

Zetagen with FDA and Health Canada (HC) approval via the Expanded Access (Compassionate Use) program has treated eight (8) patients with ZetaMet (Zeta-BC-003) with results published multiple peer-reviewed journals.

Peer-reviewed 2-year follow up clinical data published in 2023 on ZetaMet (Zeta-BC-003) demonstrated resolution of seven (7) lytic lesions (radiated and non-radiated), reduction in pain, significant attrition of opioid pain medication (4-fold), prevention of vertebral fracture, and increased survival rate in a patient living with Stage 4 breast cancer.[i] To view this publication via open access, go to: View Source

(Press release, Zetagen Therapeutics, NOV 4, 2025, View Source [SID1234659381])

On November 4, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported financial results for the quarter ended September 30, 2025.

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Revenue grew 84.7% year-over-year to $334.2 million in the third quarter of 2025
Gross profit reached $209.9 million in the third quarter of 2025, an improvement of 98.4% year-over-year
217,000 clinical tests delivered in the quarter, representing 33% year-over-year volume growth, with Oncology volume growth accelerating to 27% and Hereditary at 37%
Insights bookings of $150 million across multiple new contracts with year-over-year revenue growth of 37.6% in the quarter
Increasing full year 2025 revenue guidance to $1.265 billion, representing approximately 80% growth year-over-year
Ended the quarter with $764.3 million of cash and marketable securities
"Not only are we growing at an incredible rate, reaching positive adjusted EBITDA marks an important milestone and reflects the strength of our underlying business," said Eric Lefkofsky, Founder and CEO of Tempus. "One of the hardest things to do, and a sign of business model endurance, is being able to slow down the rate of reinvesting back into the business and still maintain growth, which is exactly what we achieved this quarter."

Third Quarter Summary Results

Quarterly revenue increased 84.7% year-over-year to $334.2 million in the third quarter of 2025.
Revenue from Genomics totaled $252.9 million in the third quarter of 2025, growing 117.2% compared to the third quarter of 2024.
Oncology testing (Tempus genomics) contributed $139.5 million, up 31.7% year-over-year in the third quarter of 2025, with approximately 27% volume growth.
Hereditary testing (Ambry genetics) contributed $102.6 million of revenue in the third quarter of 2025, an increase of 32.8% on a pro forma1 basis after giving effect to the Ambry acquisition, with approximately 37% volume growth.
Revenue from Data and services totaled $81.3 million in the third quarter of 2025, delivering 26.1% growth versus the third quarter of 2024, led by Insights (data licensing), which grew 37.6% year-over-year.
Recorded $209.9 million in quarterly gross profit, representing a 98.4% improvement year-over-year.
Reported a net loss of ($80.0 million) in the third quarter of 2025, including $35.0 million in stock compensation expense and related employer payroll taxes, increased amortization expense of intangibles related to the Ambry acquisition, and a one time $12.0 million expense related to the loss on debt extinguishment, compared to a net loss of ($75.8 million) in the third quarter of 2024.
Adjusted EBITDA of $1.5 million in the third quarter of 2025 compared to ($21.8 million) in the third quarter of 2024, an improvement of $23.3 million year-over-year.
1

The pro forma amounts have been calculated after applying the Company’s accounting policies

Third Quarter and Recent Operational Highlights

Acquired Paige, an AI company specializing in digital pathology, to expand our dataset and technical team, and establish a leading footprint in digital pathology.
Selected by Advanced Research Projects Agency for Health (ARPA-H) to provide testing and CRO services in support of the agency’s ADAPT (Advanced Analysis for Precision Cancer Therapy) program.
Obtained 510(k) clearance from the U.S. FDA for xR IVD (RNA NGS in vitro diagnostic device), which will support life sciences’ drug development programs.
Received U.S. FDA 510(k) clearance for updated Tempus Pixel, an AI-powered cardiac imaging platform and for Tempus’ ECG-Low ejection fraction software, which leverages AI to identify patients who may have a low left ventricular ejection fraction.
Expanded collaboration with Northwestern Medicine to integrate David, Tempus’ generative-AI clinical co-pilot within the EHR platform to transform clinical workflows.
Expanded Tempus Next into breast cancer, providing real-time insights to close guideline-based care gaps.
Third Quarter Financial Results

Three Months Ended September 30,

2025

2024

Change

(in thousands, except percentages and per share amounts)

(unaudited)

Revenue

$

334,206

$

180,929

84.7

%

Gross profit

$

209,942

$

105,839

98.4

%

Loss from operations

$

(60,996

)

$

(53,616

)

13.8

%

Net loss

$

(79,982

)

$

(75,840

)

5.5

%

Adjusted EBITDA

$

1,476

$

(21,843

)

106.8

%

Net loss per share attributable to common shareholders, basic and diluted

$

(0.46

)

$

(0.46

)

—

Non-GAAP net loss per share

$

(0.11

)

$

(0.24

)

54.2

%

Financial Outlook and Guidance

Tempus increased full year 2025 revenue guidance to approximately $1.265 billion, which represents ~80% annual growth. Given the acquisition of Paige, which we expect will increase losses by approximately $5 million per quarter, we expect Q4 Adjusted EBITDA to be ~$20 million, resulting in slightly positive Adjusted EBITDA for the full year.

For additional information on the quarter, including a letter from our CEO and CFO, please visit our investor relations site at investors.tempus.com.

Webcast and Conference Call Information

A conference call and webcast will begin today, November 4, 2025 after market close at 4:30 p.m. Eastern Time. Interested parties may access details at:

Conference ID: 5436492
Domestic Dial-in Number: (800) 715-9871
International Dial-in Number: (646) 307-1963
Live webcast: View Source

The webcast may be accessed on the company’s investor relations website at investors.tempus.com. For those unable to listen to the live webcast, a recording will be made available on the company’s website after the event and will be accessible for one year. Visit the investor relations website to find the company’s latest deck, and commentary on the quarter by Eric Lefkofsky, Founder and CEO and Jim Rogers, CFO, which will be discussed on the conference call and webcast.

(Press release, Tempus, NOV 4, 2025, View Source [SID1234659399])

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.

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"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])

On November 4, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the third quarter ended September 30, 2025. The quarter was distinguished by significant operational momentum in its "Win-in-MRD" strategy, headlined by increasing clinical tests delivered and robust clinical evidence generation.

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Third Quarter 2025 and Recent Business Highlights

●
Accelerated Clinical Adoption: Delivered 4,388 clinical tests, demonstrating robust 26% sequential increase over Q2 2025 and a 364% year-over-year growth fueled by increasing physician adoption of the NeXT Personal platform for cancer monitoring.
●
Submitted for Medicare Lung Cancer Coverage: Submitted a third dossier for Medicare coverage. The Company has three pending indications and remains confident its evidence will meet the standard for coverage.
●
Presented New Lung Cancer Data: Presented positive new data from AstraZeneca’s Phase 3 NeoADAURA trial in lung cancer. The findings show NeXT Personal is a strong predictor of patient outcomes and a more sensitive and accurate measure of MRD in the neoadjuvant setting. Data from the LAURA trial was also presented at ESMO (Free ESMO Whitepaper) that showed NeXT Personal could detect recurrence 5 months ahead of blinded expert review and NeXT Personal could be utilized for treatment response monitoring in adjuvant lung cancer.
●
Launched Prospective Breast Cancer Utility Study: Launched the CATE clinical trial in collaboration with Yale Cancer Center. The study aims to demonstrate the utility of NeXT Personal in guiding treatment decisions for patients with HR+/HER2- breast cancer to prevent metastatic relapse.
"Our third-quarter results demonstrate clear progress in our strategy to Win-in-MRD," said Chris Hall, Chief Executive Officer and President of Personalis. "The 364% year-over-year growth in our clinical test volume is a powerful indicator of physician enthusiasm for NeXT Personal. We believe the compelling data from the AstraZeneca NeoADAURA and LAURA studies and the launch of our CATE trial with Yale are helping to build an unimpeachable evidence base for our technology. With our third indication submitted for Medicare coverage, we are well positioned for success in this large market."

Third Quarter 2025 Financial Results Compared with 2024

Revenue of $14.5 million for the third quarter of 2025 compared with $25.7 million. The decrease of 44% was primarily due to the expected decline of $4.6 million in revenue from Natera, a decrease in population sequencing revenue of $4.2 million, and a decrease in revenue from pharma tests and services, and other customers of $2.5 million.

○
Pharma tests and services, and other customers of $13.2 million for the third quarter of 2025 compared with $15.7 million, a decrease of 16%.

○
Population sequencing of $0.2 million for the third quarter of 2025 compared with $4.4 million, a decrease of 95%.

●
Gross margin of 13.2% for the third quarter of 2025 compared with 34.0%. The decrease was primarily due to a reduction in fixed cost absorption from the lower revenue volume and increased unreimbursed clinical test costs demonstrating the interest in our tests as we await reimbursement.

●
Net loss of $21.7 million, and net loss per share of $0.24 based on a weighted-average basic and diluted share count of 88.7 million in the third quarter 2025, compared with a net loss of $39.1 million, and net loss per share of $0.64 based on a weighted-average basic and diluted share count of 61.1 million; the prior year net loss included a $26.0 million non-cash expense from warrants which were exercised in the third quarter of the prior year.

●
Cash, cash equivalents, and short-term investments of $150.5 million as of September 30, 2025; cash usage of $23.4 million from operations and capital equipment additions in the third quarter of 2025.

Fourth Quarter and Full Year 2025 Outlook

Personalis expects the following for the fourth quarter of 2025:

●
Total company revenue to be in the range of $15.7 to $20.7 million
●
Revenue from pharma tests and services, and all other customers to be in the range of $12.0 to $17.0 million
●
Revenue from population sequencing and enterprise sales of approximately $3.7 million

Personalis now expects the following for the full year of 2025 (updated guidance):

●
Total company revenue in the range of $68.0 to $73.0 million (reduced range from prior guidance of $70.0 to $80.0 million)
●
Revenue from pharma tests and services, and all other customers in the range of $50.0 to $54.0 million (reduced range from prior guidance of $52.0 to $58.0 million)
●
Revenue from population sequencing and enterprise sales in the range of $16.5 to $17.0 million (increased range from prior guidance of $15.0 to $16.0 million)
●
Revenue from clinical tests reimbursed in the range of $1.5 to $2.0 million (reduced range from prior guidance of $3.0 to $6.0 million to account for reimbursement milestone later in 2025)
●
Gross margin in the range of 22% to 24% (no change from prior guidance), which is lower than the 32% gross margin for the full year of 2024 as we invest to drive clinical use of NeXT Personal ahead of reimbursement
●
Net loss of approximately $85 million (no change from prior guidance)
●
Cash usage of approximately $75 million (no change from prior guidance)

Webcast and Conference Call Information

Personalis will host a conference call to discuss the third quarter financial results, as well as plans for the remainder of 2025, after market close on Tuesday, November 4, 2025, at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live by dialing 877-451-6152 for domestic callers or 201-389-0879 for international callers. The live webinar can be accessed at View Source A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

(Press release, Personalis, NOV 4, 2025, View Source [SID1234659366])

On November 4, 2025 Catalent, Inc., a leading global contract development and manufacturing organization, reported new innovations from its SMARTag antibody-drug conjugate (ADC) technology platform. The company announced preclinical efficacy and tolerability data demonstrating the potential of CAT-09-833, a SMARTag ADC targeting MUC1, for the treatment of platinum-resistant ovarian cancer. The company also introduced SMARTag Enhanced Conjugates, a new class of ADCs that combines different payload types to benefit more patients by amplifying efficacy without compromising safety.

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The updates were presented at the 16th World ADC San Diego conference in a session in the Translational Medicine track entitled "SMARTag Enhanced Conjugates: Novel Payload Combinations to Enhance ADC Efficacy & Payload Delivery." The presentation was made by Ayodele Ogunkoya, Ph.D., Bioconjugation Group Leader, Catalent. World ADC provides a leading opportunity for Catalent to spotlight its ADC technologies and services to more than 1,400 ADC biopharma attendees actively seeking new partnerships and solutions.

"There is a growing appreciation for the role that ADCs may play in ovarian cancer treatment. The MUC1 tumor-associated antigen, which is highly expressed in ovarian tumors, demonstrates expression complementary to that of other ovarian ADC targets, such as folate receptor alpha," said Penelope Drake, Ph.D., Head of R&D Bioconjugates, Catalent. "Our novel antibody offers a unique way to access this target with an ADC, and the data thus far suggest that CAT-09-833 has a promising preclinical profile. We look forward to seeing the molecule advance and learning more about its potential to help cancer patients."

Catalent’s new SMARTag Enhanced Conjugates incorporate both cytotoxic and non-cytotoxic payloads to create unique dual- and triple-payload ADCs that can be optimized to the specific biology of the target tumor to amplify the effect of the cytotoxic payload without compromising safety. They are enabled by the SMARTag platform, which allows for a tunable drug-to-antibody ratio (DAR). Catalent presented data from a xenograft model demonstrating that the use of certepetide as a non-cytotoxic payload can yield improved ADC efficacy and broaden the distribution of the ADC cytotoxic payload and antibody in the tumor microenvironment. Certepetide is an internalizing RGD (iRGD) cyclic peptide that Catalent licensed (along with its analogs) from Lisata Therapeutics, Inc. for use with its SMARTag technology platform, with a goal of selectively targeting and penetrating solid tumors with ADCs more effectively.

Mike Blank, General Manager, Catalent, said, "We have a history of innovation dating back to 2008 when we spun the SMARTag technology out of the Bertozzi lab at UC Berkeley. Since then, we have made continuous progress on expanding the capabilities of the platform and understanding the design elements that underpin a successful ADC. We believe the new SMARTag Enhanced Conjugates represent the latest innovation in ADCs, allowing for the creation of an entirely new class of molecules that we hope will expand the scope of treatable cancer indications, reaching—and ultimately helping—more patients in need."

(Press release, Catalent, NOV 4, 2025, https://www.catalent.com/catalent-news/catalents-smartagadc-pipeline-and-new-enhanced-conjugates-offering-featured-at-16th-world-adc-san-diego/ [SID1234659383])