On May 6, 2025 Agendia, Inc., reported that new data from its ongoing FLEX Study will be presented at the upcoming ESMO (Free ESMO Whitepaper) Breast Cancer 2025 congress taking place May 14-17 in both Munich, Germany and virtually (Press release, Agendia, MAY 6, 2025, View Source [SID1234652614]).

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The FLEX Study (NCT03053193) is a prospective real-world evidence, observational breast cancer study designed to correlate whole transcriptome gene expression in early-stage breast cancer with clinical outcomes, and to evaluate how genomic insights can inform treatment decisions in early-stage breast cancer. In this analysis, researchers examined the impact of BluePrint, Agendia’s 80-gene molecular subtyping assay, on pathological complete response (pCR) rates and chemotherapy (CT) decision-making in patients with hormone receptor-positive (HR+), HER2-negative tumors classified as High Risk by MammaPrint. BluePrint further stratified these tumors into Basal or Luminal B subtypes, offering a more nuanced view of tumor biology and potential treatment response.

The poster presentation, titled "The Impact of the 80-gene signature on pCR and chemotherapy treatment decisions in Early-Stage Breast Cancer: A FLEX Analysis [70P]," (A.M. Brufsky, et al.), highlights findings from the analysis of two cohorts from the FLEX Study: one consisting of patients who underwent genomic analysis on pre-operative core needle biopsy, and received neoadjuvant chemotherapy with available pCR data and another cohort with documented physician chemotherapy recommendations. The analysis found that patients with MammaPrint High Risk, HR+ HER2- Basal-type tumors were more likely to achieve a pCR following neoadjuvant chemotherapy compared to those with Luminal B tumors. The analysis also showed that these Basal-type tumors were more frequently recommended for chemotherapy overall, more often treated with neoadjuvant chemotherapy specifically, and received more intensive regimens compared to Luminal B tumors. These results suggest that BluePrint provides actionable molecular insights that physicians are using to inform real-world treatment decisions, even among patients already eligible for chemotherapy based on MammaPrint High Risk status.

"These results reinforce the value of BluePrint in helping physicians personalize treatment plans for early-stage breast cancer," said Adam Brufsky, MD, PhD, Professor and Associate Chief of Hematology and Oncology at UPMC Hillman Cancer Center. "By identifying Basal-type tumors that are more likely to respond to chemotherapy, BluePrint can guide decisions about treatment intensity and timing that align with each patient’s individual tumor biology."

Poster Presentation Details:

Title: The Impact of the 80-gene signature on pCR and chemotherapy treatment decisions in Early-Stage Breast Cancer: A FLEX Analysis [70P]
Date and Time: Thursday, May 15, 12:00 PM CEST
Location: ICM – International Congress Center of the Munich Messe, Hall B0

On May 6, 2025 Sonoma Biotherapeutics, Inc., a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases, reported that it will be sharing oral and poster presentations at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 28th Annual Meeting, taking place in New Orleans May 13-17, 2025 (Press release, Sonoma Biotherapeutics, MAY 6, 2025, View Source [SID1234652613]).

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"We are excited to share data demonstrating the promise of Treg-based cell therapies at this year’s ASGCT (Free ASGCT Whitepaper) Annual Meeting," said Jeff Bluestone, Ph.D., Chief Executive Officer and President of Sonoma Biotherapeutics. "Sharing the latest insights on the potential impact this research can have in autoimmune diseases is a privilege for all of us at Sonoma Biotherapeutics."

Details of the presentations are as follows:

Scientific Symposium Oral Presentation Details:

Title: "Engineered Treg therapies to treat Autoimmune Diseases"
Presenting Author: Jeff Bluestone, PhD, Sonoma Biotherapeutics
Session: Expanding Modalities Beyond Their Initial Use: Discussions on Translating Immune Cell Therapies into Non-Oncology Indications
Date/Time: Saturday May 17, 8:00 – 9:45 a.m. PDT
Location: Room 293-296
Oral Presentation Details:

Title: "Transcriptomic and Epigenomic Analysis of CAR Treg Stability"
Presenting Author: Zhang "Frank" Cheng, PhD, Sonoma Biotherapeutics
Session: Cell Therapy Product Engineering I
Date/Time: Wednesday May 14, 8:30 – 9:45 a.m. PDT
Location: Room 293-296
Poster Presentation Details:

Title: "Treg Specific Synthetic Promoters (TRSP) for Antigen Specific Treg Therapy"
Presenting Author: Jia Wei, PhD, Sonoma Biotherapeutics
Poster number: 1764
Session: Poster Reception
Date/ Time: Thursday, May 15, 5:30 – 7:00 p.m. PDT
Location: Poster Hall 2

On May 6, 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 March 31, 2025 (Press release, Tempus, MAY 6, 2025, View Source [SID1234652612]).

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Revenue increased 75.4% year-over-year to $255.7 million in the first quarter of 2025
Quarterly gross profit increased 99.8% year-over-year, reaching $155.2 million with continued gross margin improvement in both Genomics and Data and services
Announced multi-year, strategic collaborations with AstraZeneca and Pathos to work together to build the largest multimodal foundation model in oncology, resulting in additional $200.0 million in data licensing and model development fees over the next 3 years
Increasing full year 2025 revenue guidance to $1.25 billion, representing approximately 80% growth year-over-year. Expect positive Adjusted EBITDA of $5 million for full year 2025, increasing approximately $110 million over 2024
"The business is performing well with revenues growing, margins improving, and our costs remaining in check, allowing us to demonstrate significant year-over-year operating leverage," said Eric Lefkofsky, Founder and CEO of Tempus. "Our strategic investments in AI have us uniquely positioned to advance what is possible in diagnostics and drug development, as evidenced by our announcement to build the largest foundation model in oncology with AstraZeneca and Pathos. We believe this is just the beginning as more and more healthcare providers and life science companies embrace AI."

First Quarter Summary Results

Quarterly revenue increased 75.4% year-over-year to $255.7 million in the first quarter of 2025.
Genomics contributed $193.8 million in revenue in the first quarter of 2025, growing 88.9% compared to the first quarter of 2024.
Oncology testing (legacy Tempus clinical) revenue delivered $119.0 million, up 31.0% year-over-year in the first quarter of 2025, with approximately 20% volume growth.
Hereditary testing (legacy Ambry Genetics) contributed $63.5 million in revenue in the first quarter, with approximately 23% unit growth.
Revenue from Data and services totaled $61.9 million in the first quarter of 2025, delivering 43.2% growth versus the first quarter of 2024, led by Insights (data licensing), which grew 58.0% year-over-year.
Generated $155.2 million in quarterly gross profit, reflecting a 99.8% improvement year-over-year.
Reported a net loss of ($68.0 million) in the first quarter of 2025, including $28.2 million in stock compensation expense and related employer payroll taxes and fair value losses of $31.8 million related to our marketable equity securities, compared to a net loss of ($64.7 million) in the first quarter of 2024.
Adjusted EBITDA of ($16.2 million) in the first quarter of 2025 compared to ($43.9 million) in the first quarter of 2024, an improvement of $27.8 million year-over-year.
First Quarter and Recent Operational Highlights

Announced multi-year, strategic collaborations with AstraZeneca and Pathos to work together to build a multimodal foundation model in oncology, which include $200.0 million in additional data licensing and model development fees to Tempus over the next 3 years.
Completed the acquisition of Ambry Genetics on February 3, 2025.
Disclosed a collaboration with Illumina combining its AI technologies with Tempus’ comprehensive multimodal data platform to train genomic algorithms and accelerate clinical adoption of molecular testing.
Reported the acquisition of Deep 6 AI, broadening Tempus’s reach and enhancing applications like Next and TIME.
Launched olivia, an AI-enabled personal health concierge app for patients nationally.
Nationally launched xT CDx with ADLT pricing established at $4,500 per test.
First Quarter Financial Results

Three Months Ended March 31,

2025

2024

Change

(in thousands, except percentages and per share amounts)

(unaudited)

Revenue

$

255,737

$

145,820

75.4

%

Gross profit

$

155,203

$

77,697

99.8

%

Loss from operations

$

(68,689

)

$

(53,274

)

NM(1)

Non-GAAP loss from operations

$

(25,777

)

$

(53,274

)

51.6

%

Net loss

$

(68,037

)

$

(64,743

)

NM(1)

Adjusted EBITDA

$

(16,174

)

$

(43,926

)

63.2

%

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

$

(0.40

)

$

(1.47

)

72.8

%

Non-GAAP net loss per share

$

(0.24

)

$

(1.03

)

76.3

%

____________
(1)

Not meaningful due to the impact of including stock compensation expense and related employer payroll taxes

Financial Outlook and Guidance

Tempus now expects full year 2025 revenue of approximately $1.25 billion for the consolidated Tempus and Ambry Genetics business, which represents approximately 80% annual growth, and Adjusted EBITDA of $5 million for full year 2025, an improvement of approximately $110 million over 2024.

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

Webcast and Conference Call Information

A conference call and webcast will begin today, May 6, 2025 after market close at 4:30 p.m. Eastern Time. Interested parties may access details at:

Conference ID: 4680302
Domestic Dial-in Number: (888) 672-2415
International Dial-in Number: (646) 307-1952
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.

On May 6, 2025 TFS HealthScience (TFS), a leading global Contract Research Organization (CRO), reported that it is deepening its collaboration with Oncomatryx, a biopharmaceutical company developing novel antibody-drug conjugates (ADCs) targeting the tumor microenvironment (Press release, Oncomatryx, MAY 6, 2025, View Source [SID1234652611]). TFS will support a newly initiated Phase Ib clinical trial evaluating OMTX705—an anti-fibroblast activation protein antibody-drug conjugate (FAP-ADC)— in patients with advanced or metastatic pancreatic adenocarcinoma. The trial will be conducted across sites in Spain and the United States.

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According to the World Cancer Research Foundation, pancreatic cancer remains one of the deadliest malignancies globally, accounting for more than 510,000 new cases and over 466,000 deaths annually. Despite advances in oncology, treatment options for patients with advanced or metastatic disease remain limited. The five-year survival rate for pancreatic cancer continues to hover below 10%, underscoring the urgent need for new and more effective treatment options.

This Phase Ib study builds on an earlier collaboration between TFS and Oncomatryx during a Phase I trial evaluating OMTX705 as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. The promising results from that study laid the foundation for this next phase of development and exemplified the consistent performance, deep therapeutic expertise, and oncology specialization that Oncomatryx values in its continued partnership with TFS.

"Our continued collaboration with Oncomatryx reflects a shared commitment to accelerating the development of innovative therapies for challenging cancers like pancreatic adenocarcinoma," said Kris O’Brien, Vice President and Head of Oncology & Rare Diseases at TFS. "TFS brings deep therapeutic insight and operational agility to every program we support—helping to move promising science forward where it’s needed most."

"We’re entering an exciting new phase in the clinical development of OMTX705," said Laureano Simón, CEO of Oncomatryx. TFS has proven to be a trusted, expert partner—key to advancing our science toward patients who urgently need new options."

TFS brings over two decades of experience in oncology research, supporting clinical trials across solid tumors, hematological malignancies, and rare cancers. With a focus on agility, scientific rigor, and global reach, TFS has successfully guided numerous early-phase and late-phase oncology programs from concept to clinic. Through its long-standing partnerships, including this renewed collaboration with Oncomatryx, TFS continues to empower its partners with tailored clinical solutions—advancing science with the ultimate goal of enriching the lives of patients worldwide.

Backed by strong financial support following a €25 million fundraising round completed at the end of 2024, and with Phase I clinical data expected at major oncology conferences throughout 2025, the OMTX705 program is gaining momentum and drawing increased attention as a promising new approach for hard-to-treat tumors like pancreatic adenocarcinoma.

On May 6, 2025 Andelyn Biosciences, Inc., a leading and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (CDMO), reported it has manufactured viral vector with its AAV Curator Platform for Nationwide Children’s Hospital’s Cellular Therapy and Cancer Immunology Program (Press release, Nationwide Children’s Hospital, MAY 6, 2025, View Source [SID1234652610]). The Adeno-Associated Virus (AAV) will be utilized in a novel cell therapy for Universal-Donor CD38KO CD33CAR-NK cells, to be studied in a forthcoming clinical trial. The Phase 1 trial will study the safety of the novel therapy in patients with advanced, high-risk acute myeloid leukemia (AML).

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Within the field of cell therapy, there is a consistent need from researchers to manufacture cGMP virus to support the advancements of these critical therapies. While many AAV manufacturing platforms are specifically designed to be scaled to support large scale indications, Andelyn’s AAV Curator Platform utilizes Optimization-by-Design to be correctly sized for scale and speed to the clinic. The well-established platform allows for the ability to support the exacting viral vector manufacturing needs of the NCH NK cells created on the hospital’s patented universal-donor NK cell platform.

Matt Niloff, Chief Commercial Officer at Andelyn said, "We are excited to be playing a key role in this very promising Universal Donor CD38KO CD33CAR-NK cell therapy technology by NCH. We look forward to the clinical trial and ushering in a new era for patients with AML and other blood cancers."

Andelyn is enabling the progression of life-altering cell and gene therapies for both rare and prevalent diseases with the highest quality standards and scalable end-to-end development and manufacturing capabilities at its Columbus, Ohio facilities.