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Boston Scientific announces results for second quarter 2025

On July 23, 2025 Boston Scientific Corporation reported the company generated net sales of $5.061 billion during the second quarter of 2025, growing 22.8 percent on a reported basis, 21.6 percent on an operational1 basis and 17.4 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, JUL 23, 2025, View Source [SID1234656859]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $797 million or $0.53 per share (EPS), compared to $324 million or $0.22 per share a year ago, and achieved adjusted3 EPS of $0.75 for the period, compared to $0.62 a year ago.

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"This was another excellent quarter — marked by exceptional top-line performance — that delivered margin expansion and prioritized investment for future growth," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "I am incredibly grateful to our dedicated global team for demonstrating clinical and commercial excellence across the company and positioning us for differentiated long-term performance."

Second quarter financial results and recent developments:

Reported net sales of $5.061 billion, representing an increase of 22.8 percent on a reported basis, compared to the company’s guidance range of 17.5 to 19.5 percent; 21.6 percent on an operational basis; and 17.4 percent on an organic basis, compared to the company’s guidance range of 13 to 15 percent, all compared to the prior year period.

Reported GAAP net income attributable to Boston Scientific common stockholders of $0.53 per share, compared to the company’s guidance range of $0.45 to $0.47 per share, and achieved adjusted EPS of $0.75 per share, compared to the guidance range of $0.71 to $0.73 per share.

Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 15.7 percent reported, 14.7 percent operational and 7.0 percent organic
Cardiovascular: 26.8 percent reported, 25.5 percent operational and 23.2 percent organic

Achieved the following net sales growth in each region, compared to the prior year period:
United States (U.S.): 30.7 percent reported and operational
Europe, Middle East and Africa (EMEA): 6.8 percent reported and 1.8 percent operational
Asia-Pacific (APAC): 18.0 percent reported and 15.4 percent operational
Latin America and Canada (LACA): 4.0 percent reported and 8.9 percent operational
Emerging Markets4: 11.6 percent reported and 12.1 percent operational

Received U.S. Food and Drug Administration approval to expand instructions for use labeling to include the treatment of drug refractory, symptomatic persistent atrial fibrillation (AF) with the FARAPULSE Pulsed Field Ablation (PFA) System.

Commenced enrollment in the ReMATCH IDE clinical trial to evaluate the safety and effectiveness of the FARAWAVE and FARAPOINT PFA Catheters in patients with persistent AF who previously received a cardiac ablation and experienced a recurrence of the condition.5

Received CE mark for the WATCHMAN FLX Pro Left Atrial Appendage Closure Device, which is optimized for healing and designed to improve visualization during device placement and treat a broader range of patient anatomies.

Completed the acquisition of Intera Oncology Inc., a medical device company that provides the Intera 3000 Hepatic Artery Infusion Pump and floxuridine, a chemotherapy drug.

Completed the acquisition of SoniVie Ltd., the developer of the TIVUS Intravascular Ultrasound System, an investigational renal nerve denervation technology designed to treat hypertension.5
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.

5. The FARAPOINT PFA Catheter and the TIVUS Intravascular Ultrasound System are investigational devices. Restricted by Federal law to investigational use only. Not available for sale in the U.S.

Q2 2025 Highlights

On July 23, 2025 Boston Scientific reported second quarter 2025 financial results (Presentation, Boston Scientific, JUL 23, 2025, View Source [SID1234656858]).

Lithea Receives U.S. FDA Orphan Drug Designation for Lead Osteosarcoma Therapy, LIT1001

On July 23, 2025 Lithea Pharma reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its lead investigational therapy, LIT1001, intended for the treatment of osteosarcoma (Press release, Lithea Pharma, JUL 23, 2025, View Source [SID1234656338]).

This designation marks a key regulatory milestone and reinforces the potential of LIT1001 to address a critical unmet medical need in oncology. The ODD status provides significant development incentives, including seven years of market exclusivity upon approval, tax credits for clinical trial costs, waived FDA fees, and protocol assistance from the FDA.

"We are proud that the FDA acknowledges the potential of LIT1001 to outperform current standard-of-care treatments," said Ludvig Sjöberg, CEO of Lithea. "Our preclinical data demonstrate that LIT1001’s targeted delivery of doxorubicin significantly improves tumor control while reducing systemic toxicity – a promising advancement for young patients with osteosarcoma."

LIT1001: An innovative localized chemotherapy approach
LIT1001 is a next-generation chemotherapeutic formulation designed to deliver doxorubicin directly into the tumor environment, bypassing systemic exposure and enhancing local efficacy. Built on Lithea’s proprietary bone mineral platform – a biocompatible matrix of hydroxyapatite and calcium sulfate – LIT1001 enables sustained, controlled release of doxorubicin at the tumor site, with the goal of minimizing toxic side effects while maximizing therapeutic impact.

"Osteosarcoma is highly aggressive and unforgiving. In preclinical studies, LIT1001 has shown the ability to suppress local tumor growth while preserving healthy tissue," said Dr. Mathias Lidgren, Chief Medical Officer at Lithea. "By delivering chemotherapy directly to the tumor, we are pioneering a new paradigm for localized cancer treatment."

Osteosarcoma – a life-threatening diagnosis with no new treatments in over 40 years
Osteosarcoma is the most common primary bone cancer in children and young adults. Despite aggressive multimodal treatment, including surgery and systemic chemotherapy, survival rates have remained stagnant for decades. While localized disease has a 5-year survival rate of around 60–70%, metastatic or recurrent osteosarcoma has a 5-year survival rate below 30%. Critically, no new drugs have been approved for this indication in over 40 years.

A platform for future oncology therapies
Lithea’s proprietary platform is based on over 40 years of academic research, initially developed at Lund University and now validated across multiple preclinical oncology models. The underlying bone mineral matrix can be loaded with various anticancer agents and is designed to address a broad range of solid tumor indications. In addition, its unique ability to be "recharged" by systemically administered drugs offers further treatment flexibility and opens the door to combination therapies.

Multiple pipeline programs based on this platform are in development, targeting other hard-to-treat solid tumors with tailored, localized drug delivery.

https://akaritx.com/2025/07/23/akari-therapeutics-continues-key-research-on-its-novel-antibody-drug-conjugate-payload-ph1-to-further-demonstrate-its-unique-ability-to-target-cancers-2/

On July 23, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel immuno-oncology payload antibody drug conjugates (ADCs) for the treatment of cancer, reported its commitment to ongoing research to better understand the multiple effects of its novel spliceosome modulator, PH1, having demonstrated it may also act to inhibit key drivers in cancer tumors (Press release, Akari Therapeutics, JUL 23, 2025, View Source [SID1234654668]).

"We are excited to build on the scientific data already established for our novel PH1 spliceosome modulator payload with continued, ongoing research," commented Abizer Gaslightwala, President and CEO of Akari Therapeutics. "In addition to the cytotoxic and immuno-oncology modes of action for this payload, we have also demonstrated its ability to induce cytotoxicity in cancer cells under the influence of key oncogenic drivers such as KRAS, BRAF, and FGFR3 (Patent WO2024220546A2). As such, we are continuing to further investigate how this novel payload may impact other key drivers relevant to cancer tumors, and we look forward to releasing this key data in the near future."

Akari’s ADCs utilize its novel spliceosome modulator payload, PH1, and have the potential to significantly improve future oncology therapies based on current preclinical data demonstrating the following:

• Killing cancer cells while activating the immune system: In addition to killing cancer cells, spliceosome modulation by the PH1 payload causes the accumulation of mis-spliced proteins, generating neoantigens that activate the immune system to further attack the cancer tumor.

• Reducing off-target toxicity: Linker is engineered to only release PH1 payload intracellularly within targeted cancer cells to mitigate off-target toxicity.

• Circumventing traditional cancer resistance mechanisms: PH1 is resistant to standard efflux transporters that can cause cancer cells to become resistant to current payloads used on ADCs.

Akari continues to build on this key data for its spliceosome modulator payload with further research ongoing on how the payload can also disrupt key drivers responsible for cancer cell growth. Preliminary data from additional preclinical research experiments testing activity of PH1 against an established oncogenic driver unique to a major tumor are expected before year-end.

Dispatch Bio Launches to Deliver Universal Treatment Across Solid Tumors with Novel Immunotherapy Approach

On July 23, 2025 Dispatch Bio reported its official launch, with a mission to engineer a universal treatment across solid tumors, which represent approximately 90% of cancers worldwide (Press release, Dispatch Bio, JUL 23, 2025, View Source [SID1234654496]).

Immunotherapies have struggled to effectively treat solid tumors due to two main challenges: the lack of a tumor-specific target and the presence of an immune-suppressive tumor microenvironment. Dispatch’s first-in-class Flare platform was specifically engineered to overcome both. It works by delivering a viral vector carrying a novel, universal antigen – called Flare – that precisely tags solid tumor cells while simultaneously breaking down the tumor’s inhibitory environment. Once in place, the Flare antigen acts as a beacon, directing the immune system to find and clear the cancer cells — without harming healthy tissue.

"At Dispatch, we are leveraging the ideal tumor target – one that is only expressed by the tumor cells in a patient – and advances in cell therapy engineering and immune system activation at the right place, at the right time, to get to deep and durable responses in cancer," said Sabah Oney, Ph.D., Chief Executive Officer of Dispatch. "This work matters deeply to me, as it does to so many whose lives have been touched by cancer. We’ve built a strong scientific foundation, assembled an exceptional team and developed innovative technology that give us a real shot at making a difference. We are fully committed to doing everything we can for patients who urgently need new options."

Dispatch was established through a pivotal collaboration with the Parker Institute for Cancer Immunotherapy (PICI) and convergence of groundbreaking technologies from the laboratories of Andy Minn, M.D., Ph.D.; Carl June, M.D.; Chris Garcia, Ph.D.; and Kole Roybal, Ph.D.

"With this confluence of innovative technologies from the labs across PICI, we are poised to shift how cancer therapies are conceived," said Sean Parker, founder and chairman of PICI, as well as a member of Dispatch’s board of directors. "We can now pursue the ultimate goal – a universal cure for most solid tumor cancers – using cutting-edge modalities."

Renowned Leadership and Pioneering Scientists

Since its founding in 2022, Dispatch has focused on building a world-class leadership team and executing its broad pipeline of programs. The founding team at Dispatch includes:

Scientific Co-Founders

Andy Minn, M.D., Ph.D., Chair of Immuno-Oncology at Memorial Sloan Kettering Cancer Center
Carl June, M.D., PICI Center Director and the Richard W. Vague Professor in Immunotherapy in the Perelman School of Medicine at the University of Pennsylvania
Chris Garcia, Ph.D., Professor of Structural Biology and Molecular and Cellular Physiology at Stanford School of Medicine, Stanford University
Kole Roybal, Ph.D., PICI Center Director and Professor of Microbiology and Immunology at University of California, San Francisco
Board of Directors

Jeff Marrazzo, Chairman; Co-founder and Former CEO, Spark Therapeutics
Jake Bauer, Venture Partner, ARCH Venture Partners
John Connolly, Ph.D., Chief Scientific Officer, PICI
Robert Nelsen, Co-founder and Managing Director, ARCH Venture Partners
Sabah Oney, Ph.D., Chief Executive Officer, Dispatch
Sean Parker, Founder and Chairman, PICI
Steve Gillis, Ph.D., Managing Director, ARCH Venture Partners
Leadership Team

Sabah Oney, Ph.D., Chief Executive Officer
Barbra Sasu, Ph.D., Chief Scientific Officer
Chris Wiwi, Ph.D., Senior Vice President, Technical Operations
Jennifer Flaisher, Chief People and Culture Officer
Lex Johnson, Ph.D., Co-Founder and Chief Platform Officer
Naveen Bazaj, Senior Vice President, Corporate Development
Scientific Advisory Board

Kole Roybal, Ph.D., University of California, San Francisco; SAB Chairman
Andy Minn, M.D., Ph.D., Memorial Sloan Kettering Cancer Center
Antoni Ribas, M.D., Ph.D., University of California, Los Angeles
Anusha Kalbasi, M.D., Stanford University
Brad Rosenberg, M.D., Ph.D., Icahn School of Medicine at Mount Sinai
Carl June, M.D., University of Pennsylvania
Chris Garcia, Ph.D., Stanford University
Christine Brown, Ph.D., City of Hope
David Kirn, M.D., 4D Molecular Therapeutics; University of California, Berkeley
John Connolly, Ph.D., PICI
Kristen Hege, M.D., University of California, San Francisco
Lisa Coussens, M.D., Ph.D., FAACR, Oregon Health & Science University
Matt Porteus, M.D., Ph.D., Stanford University
Series A Funding to Support First-in-Human Studies

The Series A syndicate includes founding investors ARCH Venture Partners and PICI, along with Bristol Myers Squibb, the University of Pennsylvania, Stanford University, and Alexandria Venture Investments. With this recently closed funding round, Dispatch has raised a total of $216 million to date.

Proceeds from the financing will be used to advance the company’s therapeutic candidates into first-in-human clinical studies and beyond, with the first program expected to enter the clinic in 2026.

"We are on the wave of a revolution in cancer therapy, where innovations like Dispatch’s tumor-agnostic approach to immunotherapy have the potential to treat a majority of solid tumors," said Steve Gillis, Ph.D., board member of Dispatch and managing director at ARCH Venture Partners. "We are excited to support the Dispatch team as they continue to advance their programs."