Q1 2025 Highlights

On April 23, 2023 Boston Scientific reported first quarter for 2025 highlights (Presentation, Boston Scientific, APR 23, 2025, View Source [SID1234654129]).

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Verastem Oncology Announces U.S. IND Clearance of VS-7375, Oral KRAS G12D (ON/OFF) Inhibitor, Enabling Phase 1/2a Trial in Advanced Solid Tumors

On April 23, 2025 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, reported the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of VS-7375, an oral KRAS G12D (ON/OFF) inhibitor for clinical evaluation (Press release, Verastem, APR 23, 2025, View Source [SID1234652065]). The Company expects to initiate a Phase 1/2a study in mid-2025 with plans for multiple expansion cohorts, including combinations, in advanced solid tumors, such as pancreatic cancer, colorectal cancer, and non-small cell lung cancer.

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The Company also announced the acceptance of an abstract, by our partner GenFleet Therapeutics, for rapid oral presentation of the preliminary dose escalation phase of the Phase 1/2 study of VS-7375 (also known as GFH375) conducted by GenFleet at the upcoming 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held on May 30-June 3, 2025, in Chicago, IL. The abstract is under embargo until May 22, 2025, at 5:00 pm EDT, when additional data will be released.

"We’re excited to advance the clinical program for VS-7375 in the U.S. and build on the initial dose escalation work conducted by GenFleet in China that demonstrated oral bioavailability and no dose-limiting toxicities across six dose levels, with partial responses achieved among multiple patients with both pancreatic and advanced lung cancers," said Dan Paterson, president and chief executive officer of Verastem Oncology. "We believe there remains a significant opportunity to improve on the efficacy seen to date with other KRAS G12D-selective agents. VS-7375’s dual inhibition of both the ON/OFF states has the potential to drive deep and durable cancer responses and allow for better combinability with other agents. We look forward to our partner GenFleet’s oral presentation that will include updated safety and efficacy data from the Phase 1 study at the ASCO (Free ASCO Whitepaper) annual meeting."

The Phase 1/2a study will be conducted in the U.S., with the potential to expand globally, and will evaluate the safety and efficacy of VS-7375 in patients with advanced KRAS G12D mutant solid tumors. The starting dose for the Phase 1 study is based on an efficacious dose identified in the initial data from the GenFleet study to accelerate the trial’s progress. Verastem plans to dose escalate across levels where cancer responses were observed in GenFleet’s study and will assess in the Phase 2a portion the efficacy and safety of VS-7375, both as monotherapy and in combination, in patients with advanced solid tumors, such as pancreatic, colorectal, and non-small cell lung cancers.

ASCO 2025 Presentation Details:

The abstract is under embargo until May 22, 2025, at 5:00 pm EDT.

Title: A First-in-Human Phase I/II Study of GFH375, a Highly Selective and Potent Oral KRAS G12D Inhibitor in Patients with KRAS G12D Mutant Advanced Solid Tumors
Abstract Number: 3013
Session: Rapid Oral Abstract Sessions: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date/Time: Monday, June 2, 2025, from 8:00 am to 9:30 am CDT
About KRAS G12D

KRAS G12D represents 26% of all KRAS mutations, making it the most prevalent KRAS mutation in human cancers. The KRAS G12D mutation occurs most commonly in pancreatic (37%), colorectal (12.5%), endometrial (8%), and non-small cell lung (5%) cancers. Currently, no therapies are approved by the U.S. Food and Drug Administration specifically targeting KRAS G12D mutations in cancer.

About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor

VS-7375 is a potential best-in-class, potent, and selective oral KRAS G12D dual ON/OFF inhibitor. VS-7375 is the lead program from the Verastem Oncology discovery and development collaboration with GenFleet Therapeutics. Verastem announced in April 2025 that the U.S. Investigational New Drug (IND) application for VS-7375 was cleared and plans to initiate a Phase 1/2a clinical trial in mid-2025. GenFleet’s IND for VS-7375 (known as GFH375 in China) was approved in China in June 2024, and the first patient was dosed in a Phase 1/2 study in July 2024.

Tempus Signs Expanded Strategic Agreements with AstraZeneca and Pathos to Develop the Largest Multimodal Foundation Model in Oncology

On April 23, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported multi-year, strategic collaborations with AstraZeneca (LSE/STO/Nasdaq: AZN) and Pathos AI, Inc., in which the companies will work together to build a multimodal foundation model in oncology which can be used to gather biological and clinical insights, discover novel drug targets, and develop therapeutics for the broader oncology community (Press release, Tempus, APR 23, 2025, View Source [SID1234652081]).

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Tempus’ de-identified oncology data will be used to build the foundation model. Upon completion, the model will be shared among all three parties to advance their individual efforts to improve patient care. The agreements include $200 million in data licensing and model development fees to Tempus.

The agreement with AstraZeneca expands on the strategic partnership between the two companies announced in 2021 and aims to leverage Tempus’ AI-enabled platform and vast repository of multimodal data to advance novel therapeutic programs in oncology on a global scale.

"Generative AI and the emergence of large multimodal models is the final catalyst needed to usher in precision medicine in oncology at scale," said Eric Lefkofsky, Founder and CEO of Tempus. "Tempus has spent the last decade investing billions of dollars into collecting the necessary data needed for a foundation model of this kind to take shape. We look forward to working with AstraZeneca and Pathos to apply AI-enabled solutions to advance therapies in an effort to help patients live longer and healthier lives."

"Cancer drug discovery and clinical development are being transformed by the ability to analyze vast amounts of rich data using artificial intelligence," said Jorge Reis-Filho, Chief AI and Data Scientist, Oncology R&D, AstraZeneca. "We are excited to collaborate with Tempus and Pathos to advance our data and AI-driven R&D strategy through the development of a multimodal oncology foundation model that we believe will accelerate and increase the probability of clinical success across our diverse pipeline."

"As artificial intelligence becomes more prominent in drug discovery and development, the opportunity for companies like Pathos to build foundation models that seemed almost unimaginable a few years ago is now taking shape," said Mohamad Makhzoumi, Co-CEO of NEA and Pathos Board Member. "We couldn’t be more excited to collaborate with Tempus and AstraZeneca given the potential of these models to improve patient outcomes."

Interim Report 1-3/2025

On April 23, 2025 Orion reported interim financial report (Presentation, Orion, APR 23, 2025, View Source [SID1234654297]).

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Boston Scientific announces results for first quarter 2025

On April 23, 2025 Boston Scientific Corporation (NYSE: BSX) reported net sales of $4.663 billion during the first quarter of 2025, growing 20.9 percent on a reported basis, 22.2 percent on an operational1 basis and 18.2 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, APR 23, 2025, View Source [SID1234652050]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $674 million or $0.45 per share (EPS), compared to $495 million or $0.33 per share a year ago, and achieved adjusted3 EPS of $0.75 for the period, compared to $0.56 a year ago.

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"We delivered an exceptional quarter to start the year, reflecting the effectiveness of our highly engaged global team and the strength of our product portfolio," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "We remain well-positioned for the future as we continue to focus on meaningful innovation, clinical science and the execution of our category leadership strategy to drive differentiated growth and performance for the long-term."

First quarter financial results and recent developments:

Reported net sales of $4.663 billion, representing an increase of 20.9 percent on a reported basis, compared to the company’s guidance range of 17 to 19 percent; 22.2 percent on an operational basis; and 18.2 percent on an organic basis, compared to the company’s guidance range of 14 to 16 percent, all compared to the prior year period.

Reported GAAP net income attributable to Boston Scientific common stockholders of $0.45 per share, compared to the company’s guidance range of $0.43 to $0.45 per share, and achieved adjusted EPS of $0.75 per share, compared to the guidance range of $0.66 to $0.68 per share.

Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 11.7 percent reported, 12.8 percent operational and 5.3 percent organic
Cardiovascular: 26.2 percent reported, 27.6 percent operational and 25.6 percent organic

Achieved the following net sales growth in each region, compared to the prior year period:
United States (U.S.): 31.1 percent reported and operational
Europe, Middle East and Africa (EMEA): 5.5 percent reported and 7.9 percent operational
Asia-Pacific (APAC): 8.2 percent reported and 10.6 percent operational
Latin America and Canada (LACA): 4.4 percent reported and 14.1 percent operational
Emerging Markets4: 6.5 percent reported and 9.8 percent operational

Commenced enrollment in the ELEVATE-PF clinical trial to evaluate the safety and effectiveness of the FARAFLEX Mapping and Pulsed Field Ablation (PFA) Catheter for treatment of persistent atrial fibrillation (AF).

Began the OPTION-A clinical trial in the Asia-Pacific region to evaluate the safety and effectiveness of catheter ablation with the FARAPULSE PFA System and subsequent implant of the WATCHMAN Left Atrial Appendage Closure Device in a concomitant procedure.

Published in The New England Journal of Medicine and presented as late-breaking science at the 2025 European Heart Rhythm Association annual meeting were results from the investigator-sponsored SINGLE SHOT CHAMPION clinical trial which demonstrated the FARAPULSE PFA System achieved superior effectiveness for the treatment of symptomatic paroxysmal AF versus the Arctic Front Advance cardiac cryoablation catheter (Medtronic).

Presented late-breaking findings from the VITALYST Early Feasibility Study at the Technology and Heart Failure Therapeutics conference which demonstrated successful early experience with the investigational VITALYST Temporary Percutaneous Transvalvular Circulatory Support System in patients undergoing elective high-risk percutaneous coronary intervention.

Published in JAMA Network Open real-world data demonstrating that patients with prostate cancer treated with SpaceOAR Hydrogel showed a 25% reduction in bowel disorder risk and a 46% decrease in procedures like colonoscopies four years post-radiation therapy.

Completed the acquisition of Bolt Medical, Inc., the developer of an intravascular lithotripsy advanced laser-based platform for the treatment of coronary and peripheral artery disease.

Announced agreement to acquire SoniVie Ltd., the developer of the TIVUS Intravascular Ultrasound System, an investigational nerve denervation technology designed to treat hypertension — such as renal artery denervation in the kidneys — subject to customary closing conditions.
1. Operational net sales growth excludes the impact of foreign currency fluctuations.

2. Organic net sales growth excludes the impact of foreign currency fluctuations and net sales attributable to certain acquisitions and divestitures for which there are less than a full period of comparable net sales.

3. Adjusted EPS excludes the impacts of certain charges (credits) which may include amortization expense, goodwill and other intangible asset impairment charges, acquisition/divestiture-related net charges (credits), investment portfolio net losses (gains) and impairments, restructuring and restructuring-related net charges (credits), certain litigation-related net charges (credits), European Union (EU) Medical Device Regulation (MDR) implementation costs, debt extinguishment net charges, deferred tax expenses (benefits) and certain discrete tax items.

4.Our Emerging Markets countries include all countries except the United States, Western and Central Europe, Japan, Australia, New Zealand and Canada.

Net sales for the first quarter by business and region:

View News Release Full Screen

Increase/(Decrease)


Three Months Ended

March 31,


Reported
Basis


Impact of
Foreign
Currency
Fluctuations


Operational

Basis


Impact of
Certain
Acquisitions/Divestitures


Organic
Basis

(in millions)

2025

2024



Endoscopy

$ 673

$ 642


4.7 %


1.2 %


5.9 %


(0.4) %


5.5 %


Urology

633

513


23.5 %


1.0 %


24.5 %


(20.1) %


4.4 %


Neuromodulation

271

256


5.8 %


0.9 %


6.8 %


— %


6.8 %


MedSurg

1,577

1,412


11.7 %


1.1 %


12.8 %


(7.5) %


5.3 %


Cardiology

2,429

1,872


29.8 %


1.4 %


31.2 %


— %


31.2 %


Peripheral Interventions

656

573


14.4 %


1.4 %


15.8 %


(8.4) %


7.4 %


Cardiovascular

3,085

2,445


26.2 %


1.4 %


27.6 %


(2.0) %


25.6 %

Net Sales

$ 4,663

$ 3,856


20.9 %


1.3 %


22.2 %


(4.0) %


18.2 %

View News Release Full Screen

Increase/(Decrease)


Three Months Ended
March 31,


Reported
Basis


Impact of
Foreign
Currency
Fluctuations


Operational

Basis

(in millions)

2025

2024



U.S.

$ 2,960

$ 2,258


31.1 %


— %


31.1 %


EMEA

846

803


5.5 %


2.4 %


7.9 %


APAC

701

647


8.2 %


2.4 %


10.6 %


LACA

155

149


4.4 %


9.6 %


14.1 %


Net Sales

$ 4,663

$ 3,856


20.9 %


1.3 %


22.2 %



Emerging Markets4

$ 690

$ 648


6.5 %


3.3 %


9.8 %



Amounts may not add due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.



Net sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of certain acquisitions/divestitures are not prepared in accordance with U.S. GAAP.

Guidance for Full Year and Second Quarter 2025

The company estimates net sales growth for the full year 2025, versus the prior year period, to be approximately 15 to 17 percent on a reported basis and 12 to 14 percent on an organic basis. Full year organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to certain acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates EPS on a GAAP basis in a range of $1.86 to $1.93 and estimates adjusted EPS, excluding certain charges (credits), of $2.87 to $2.94.

The company estimates net sales growth for the second quarter of 2025, versus the prior year period, to be in a range of approximately 17.5 to 19.5 percent on a reported basis, and 13 to 15 percent on an organic basis. Second quarter organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to certain acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates EPS on a GAAP basis in a range of $0.45 to $0.47 and estimates adjusted EPS, excluding certain charges (credits), of $0.71 to $0.73.

Conference Call Information
Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. ET. The company will webcast the call to interested parties through its website: investors.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.