Category: 3. Business

Although data from the phase 3 SERENA-6 trial (NCT04964934) demonstrated progression-free survival (PFS) and quality-of-life (QOL) benefits with switching from first-line aromatase inhibitor (AI) plus CDK4/6 inhibitor therapy to camizestrant upon the detection of an ESR1 mutation in patients with hormone receptor–positive, HER2-negative advanced breast cancer, additional time to second progression (PFS2) and overall survival (OS) data are needed to support the adoption of molecularly-guided treatment switching in clinical practice, according to Laura Huppert, MD.

Additionally, Huppert noted that dhese data, along with ongoing work with other novel endocrine therapies, could provide expanded and improved options for patients following progression on a CDK4/6 inhibitor–based regimen.

Findings presented during the 2025 ASCO Annual Meeting showed that the median investigator-assessed PFS with camizestrant plus CDK4/6 inhibition (n = 157) was 16.0 months (95% CI, 12.7-18.2) vs 9.2 months (95% CI, 7.2-9.5) with continued AI plus CDK4/6 inhibition (n = 158; HR, 0.44; 95% CI, 0.31-0.60; P < .00001). The 12- and 24-month PFS rates with the camizestrant regimen were 60.7% and 29.7%, respectively. Respective rates with continued AI plus CDK4/6 inhibition were 33.4% and 5.4%.

“If [the camizestrant combination] ends up being an approved regimen, it would definitely be a paradigm shift for how we’re treating breast cancer, because we would need to start monitoring circulating tumor DNA [ctDNA] and switching earlier,” Huppert, an assistant professor of medicine at the University of California, San Francisco School of Medicine, stated in an interview with OncLive®. “The PFS difference is very interesting and compelling; we just need a bit more data to know how we’ll ultimately utilize this in clinical practice.”

In the interview, Huppert discussed the mechanistic differences between oral selective estrogen receptor degraders (SERDs) and proteolysis-targeting chimeras (PROTACs); the current post–CDK4/6 inhibitor treatment landscape in hormone receptor–positive breast cancer; the clinical implications of the SERENA-6 trial for early intervention with camizestrant based on molecular progression; and how novel endocrine therapies could help improved outcomes for patients in later lines of therapy.

OncLive: What is the distinction between oral SERDs and PROTACs in the hormone receptor–positive breast cancer space?

Huppert: Both of these [drug classes represent] different ways to target estrogen receptor [ER] signaling. The idea is that if disrupting that signaling can prevent tumor cell growth. Oral SERDs work by binding to the ER and inducing its degradation, [thereby inhibiting] ER signaling. PROTACs are a novel class of molecules that work by using the cell’s own natural protein degradation system. They bring an enzyme in close proximity to the ER, which labels it for degradation, and then the cell’s own ubiquitination system and proteasome degrade it.

At ASCO 2025, we saw the first [readout of] phase 3 data with a PROTAC [with vepdegestrant in the VERITAC-2 trial (NCT05654623)], which was interesting. It’s a first-in-class molecule and will potentially be a novel form of ER blocking that’s slightly different than oral SERDs and other agents we’ve had before.

What are some of the available treatment options after a patient progresses on a frontline CDK4/6 inhibitor–based regimen?

After progression on first-line AI plus CDK4/6 inhibitor therapy, we typically check next-generation sequencing [NGS] to see what mutations the tumor cells either have or have developed over time that might be targetable. For example, approximately 40% of patients develop an ESR1 mutation [during first-line therapy]. In these patients, we have a currently approved therapy, elacestrant [Orserdu], that can be utilized. If a patient has a PIK3CA, AKT, or PTEN mutation, capivasertib [Truqap] plus fulvestrant [Faslodex] is a currently approved option.

If patients have none of these mutations, we have other options as well. We can use fulvestrant and a switch in CDK4/6 inhibitor, or everolimus [Afinitor] is still an option with fulvestrant or exemestane [Aromasin]. Of course, there are many novel therapies in this arena. Some are likely to be approved, and others are still in development. The second- and third-line endocrine therapy space is a rapidly evolving area at the moment.

With SERENA-6 demonstrating a benefit in switching treatment following the emergence of an ESR1 mutation prior to radiographic progression, what could this mean for future treatment strategies in terms of earlier intervention?

SERENA-6 was a phase 3 trial that evaluated whether it would be beneficial for patients on their first-line AI and CDK4/6 inhibitor [who develop an] ESR1 mutation but don’t have evidence of clinical progression by imaging to switch to [treatment with] an oral SERD, camizestrant, in that setting.

It enrolled patients who were already receiving their AI and CDK4/6 inhibitor, and they were monitored every 3 months with ctDNA testing. Patients who developed an ESR1 mutation [without clinical progression were then] randomly assigned to either stay on their AI and CDK4/6 inhibitor with a placebo, or switch to camizestrant and CDK4/6 inhibitor with a placebo. They followed these patients over time, with the primary end point being PFS.

What they saw was that patients who switched to camizestrant had improved PFS [by a] difference of [6.8] months between the 2 arms, which was definitely very interesting, compelling, and statistically significant data. [The results] also showed that there was improved time to deterioration of global health status and QOL [with this approach], which I thought was interesting as well.

In this trial, PFS2 and OS [were also evaluated]. PFS2 [data] favored the switch to camizestrant, but these were not yet statistically significant. The data are not yet mature. OS data are also not mature.

[SERENA-6] was an interesting and compelling study for multiple reasons. Historically, we wanted to keep patients on each treatment as long as possible until we see evidence of progression by scans or symptoms. However, this was looking at whether we should switch [treatment] at the time of molecular progression, rather than progression on scans.

What still needs to be learned about the benefit of earlier treatment switching based on molecular progression in order to support adopting this approach in clinical practice?

It will be important to look at PFS2 more as those data mature. Does this early switch help people do better on their next line of therapy? Ideally, we’re hoping for OS data to show whether switching early ultimately helps people live longer. We need more of follow-up data to know how to employ this [strategy] in the future.

There are also ongoing trials looking at using oral SERDs from the start [of first-line treatment], rather than switching [from an AI to an] oral SERDs [with subsequent treatment]. We’ll have to see what those trials look like as well. All these moving pieces will help us figure out how to employ these data and what to do with them going forward.

How could a potential approval of the SERENA-6 regimen affect clinical practice in terms of second-line treatment decision-making?

If SERENA-6 is approved and a certain percentage of our patients develop the ESR1 mutation and switch to camizestrant, in the second-line setting, we would still want to check NGS and look for any new mutations that might be present, and then we can choose therapy accordingly.

In patients who were on the SERENA-6 regimen and did switch to an oral SERD, it will be important to potentially think about other endocrine backbones or other combinations beyond just an oral SERD in the subsequent line. This is all the more reason we are excited to have novel endocrine therapy backbones, as well as novel targeted therapy partners, to offer more and more options in the second- and third-line settings.

Despite the incorporation of novel endocrine therapies into the treatment paradigm, what unmet needs still exist for patients with hormone receptor–positive breast cancer after progression on a CDK4/6 inhibitor–based regimen?

In general, patients experience the longest PFS on first-line therapy, which is typically an AI plus a CDK4/6 inhibitor. The duration of response generally shortens in the second- and third-line settings. There is hope that with the introduction of novel agents, it may be possible to achieve longer PFS in these later lines of therapy by utilizing new mechanisms of action with the endocrine therapy backbone, as well as novel targeted therapy combinations. Prolonging PFS in the second- and third-line settings remains an area of unmet need.

Typically, patients receive 2 to 3 lines of endocrine therapy before becoming resistant and needing to transition to chemotherapy or antibody-drug conjugates. However, with emerging agents, it may be possible to extend the number of endocrine therapy lines. The goal is to prolong the endocrine-sensitive phase of disease by leveraging these novel agents, which are often oral and better tolerated than chemotherapy. Delaying the need for cytotoxic therapies may enhance both QOL and OS. Therefore, there is significant interest in optimizing treatment options in the second- and third-line settings.

Reference

Turner N, Mayer E, Park YH, et al. Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent ESR1 mutations during first-line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): Phase 3, double-blind ctDNA-guided SERENA-6 trial. J Clin Oncol. 2025;43(suppl 17):LBA4. doi:10.1200/JCO.2025.43.17_suppl.LBA4

News Summary

• Second-quarter revenue was $12.9 billion, flat year-over-year (YoY).

• Second-quarter earnings (loss) per share (EPS) attributable to Intel was $(0.67); non-GAAP EPS attributable to Intel was $(0.10).

• $(0.45) impact to GAAP EPS attributable to Intel from $1.9 billion of restructuring charges; $(0.23) and $(0.20) impact to GAAP and non-GAAP EPS attributable to Intel, respectively, from $800 million of impairment charges and $200 million in one-time period costs.

• Forecasting third-quarter 2025 revenue of $12.6 billion to $13.6 billion; expecting third-quarter EPS attributable to Intel of $(0.24) and non-GAAP EPS attributable to Intel of $0.00.

• Taking actions to drive improved execution and efficiency; continue to target $17 billion of non-GAAP¹ operating expenses in 2025 and $16 billion in 2026; $18 billion in gross capital expenditures for 2025.

SANTA CLARA, Calif.–(BUSINESS WIRE)–
Intel Corporation today reported second-quarter 2025 financial results.

“Our operating performance demonstrates the initial progress we are making to improve our execution and drive greater efficiency,” said Lip-Bu Tan, Intel CEO. “We are laser-focused on strengthening our core product portfolio and our AI roadmap to better serve customers. We are also taking the actions needed to build a more financially disciplined foundry. It’s going to take time, but we see clear opportunities to enhance our competitive position, improve our profitability and create long-term shareholder value.”

“Our results reflect solid demand across our business and good execution on our priorities,” said David Zinsner, Intel CFO. “The changes we are making to reduce our operating costs, improve our capital efficiency and monetize non-core assets are having a positive impact as we work to strengthen our balance sheet and position the business for the future.”

Progress on Driving Greater Efficiency and Execution

Intel continues to make progress to simplify its business, improve efficiency and enhance execution. These efforts are focused on reducing expenses, strengthening the balance sheet, optimizing the global footprint and concentrating resources on the most critical growth areas.

• On track to achieve $17 billion non-GAAP operating expense¹ target for 2025: Intel has completed the majority of the planned headcount actions it announced last quarter to reduce its core workforce by approximately 15%. These changes are designed to create a faster-moving, flatter and more agile organization. As a result of these actions, the company recognized $1.9 billion in restructuring charges in the second quarter of 2025, which were excluded from its non-GAAP results. These charges impacted GAAP EPS by $(0.45) per share. Intel plans to end the year with a core workforce of about 75,000 employees as a result of workforce reductions and attrition.

• Improving capital efficiency; driving to gross capital expenditures² of $18 billion for 2025: Intel is taking action to optimize its manufacturing footprint and drive greater returns on invested capital. As part of this effort, Intel will no longer move forward with planned projects in Germany and Poland. The company also intends to consolidate its assembly and test operations in Costa Rica into its larger sites in Vietnam and Malaysia. In addition, Intel will further slow the pace of construction in Ohio to ensure spending is aligned with market demand.

Intel also recognized approximately $800 million of non-cash impairment and accelerated depreciation charges related to excess tools with no identified re-use and approximately $200 million of one-time period costs in the second quarter of 2025. These charges reduced both GAAP and non-GAAP gross margin by approximately 800 basis points and GAAP and non-GAAP EPS by approximately $(0.23) and $(0.20) cents per share, respectively.

These restructuring charges and impairments were not incorporated into the guidance Intel provided for the second quarter of 2025.

1		Non-GAAP operating expense refers to non-GAAP R&D and marketing, general and administrative (MG&A). See below for more information on and reconciliations of Intel’s non-GAAP financial measures.
2		Gross capital expenditures refers to GAAP additions to property, plant and equipment.

Q2 2025 Financial Results

	GAAP				Non-GAAP
	Q2 2025	Q2 2024	vs. Q2 2024		Q2 2025	Q2 2024	vs. Q2 2024
Revenue ($B)	$12.9	$12.8	flat
Gross margin	27.5%	35.4%	down 7.9 ppts		29.7%	38.7%	down 9 ppts
R&D and MG&A ($B)	$4.8	$5.6	down 13%		$4.3	$4.9	down 13%
Operating margin (loss)	(24.7)%	(15.3)%	down 9.4 ppts		(3.9)%	0.2%	down 4.1 ppts
Tax rate	(9.2)%	17.5%	down 26.7 ppts		12.0%	13.0%	down 1 ppt
Net income (loss) attributable to Intel ($B)	$(2.9)	$(1.6)	down 81%		$(0.4)	$0.1	*n/m
Earnings (loss) per share attributable to Intel—diluted	$(0.67)	$(0.38)	down 76%		$(0.10)	$0.02	*n/m

In the second quarter, the company generated $2.1 billion in cash from operations.

Full reconciliations between GAAP and non-GAAP measures are provided below.

*Not meaningful

Business Unit Summary

In the first quarter of 2025, the company made an organizational change to integrate the Network and Edge Group (NEX) into CCG and DCAI and modified Intel’s segment reporting to align to this and certain other business reorganizations. All prior-period segment data has been retrospectively adjusted to reflect the way Intel’s chief operating decision maker internally receives information and manages and monitors the company’s operating segment performance. There are no changes to Intel’s consolidated financial statements for any prior periods.

Business Unit Revenue and Trends		Q2 20253		vs. Q2 2024
Intel Products:
Client Computing Group (CCG)		$7.9 billion		down	3%
Data Center and AI (DCAI)		$3.9 billion		up	4%
Total Intel Products revenue		$11.8 billion		down	1%
Intel Foundry		$4.4 billion		up	3%
All Other		$1.1 billion		up	20%
Intersegment Eliminations		$(4.4) billion
Total net revenue		$12.9 billion		flat

3

Numbers are presented as actual and rounded; as a result, totals may not sum.

Business Highlights

• Intel launched three new additions to its Intel® Xeon® 6 series of central processing units (CPUs), delivering customizable CPU core frequencies to boost graphics processing unit (GPU) performance across demanding AI workloads. One of these, the Intel® Xeon® 6776P processor, currently serves as the host CPU for NVIDIA DGX B300, the company’s latest generation of AI-accelerated systems.

• The first Panther Lake processor SKU remains on track to begin shipping later this year, with additional SKUs coming in the first half of 2026.

• Intel 18A reached a key milestone with the start of production wafers in Arizona.

• Intel made key leadership appointments, including Greg Ernst as chief revenue officer and Srinivasan Iyengar, Jean-Didier Allegrucci and Shailendra Desai in key engineering leadership roles.

• In line with Intel’s commitment to strengthen its balance sheet and monetize non-core assets, the company sold, via a secondary offering, 57.5 million of net Class A shares of Mobileye in July 2025, adding approximately $922 million to the balance sheet. Intel remains the majority shareholder in Mobileye and continues to have strong conviction in its long-term growth opportunity.

Business Outlook

Intel’s guidance for the third quarter of 2025 includes both GAAP and non-GAAP estimates as follows:

Q3 2025		GAAP		Non-GAAP
Revenue		$12.6-13.6 billion
Gross margin		34.1%		36.0%
Tax Rate		(23)%		12%
Earnings (Loss) Per Share Attributable to Intel—Diluted		$(0.24)		$0.00

Reconciliations between GAAP and non-GAAP financial measures are included below. Actual results may differ materially from Intel’s business outlook as a result of, among other things, the factors described under “Forward-Looking Statements” below. The gross margin and EPS outlooks are based on the midpoint of the revenue range.

Earnings Webcast

Intel will hold a public webcast at 2 p.m. PDT today to discuss the results for its second quarter of 2025. The live public webcast can be accessed on Intel’s Investor Relations website at www.intc.com. The corresponding earnings presentation and webcast replay will also be available on the site.

Forward-Looking Statements

This release contains forward-looking statements that involve a number of risks and uncertainties. Words such as “accelerate”, “achieve”, “aim”, “ambitions”, “anticipate”, “believe”, “committed”, “continue”, “could”, “designed”, “estimate”, “expect”, “forecast”, “future”, “goals”, “grow”, “guidance”, “intend”, “likely”, “may”, “might”, “milestones”, “next generation”, “objective”, “on track”, “opportunity”, “outlook”, “pending”, “plan”, “position”, “possible”, “potential”, “predict”, “progress”, “ramp”, “roadmap”, “seek”, “should”, “strive”, “targets”, “to be”, “upcoming”, “will”, “would”, and variations of such words and similar expressions are intended to identify such forward-looking statements, which may include statements regarding:

• our business plans and strategy and anticipated benefits therefrom, including with respect to our IDM strategy, Smart Capital strategy, partnerships with Apollo and Brookfield, internal foundry model, updated reporting structure, and AI strategy;

• projections of our future financial performance, including future revenue, gross profits, capital expenditures, and cash flows;

• projected costs and yield trends;

• future cash requirements, the availability, uses, sufficiency, and cost of capital resources, and sources of funding, including for future capital and R&D investments and for returns to stockholders, such as stock repurchases and dividends, and credit ratings expectations;

• future products, services, and technologies, and the expected goals, timeline, ramps, progress, availability, production, regulation, and benefits of such products, services, and technologies, including future process nodes and packaging technology, product roadmaps, schedules, future product architectures, expectations regarding process performance, per-watt parity, and metrics, and expectations regarding product and process leadership;

• investment plans and impacts of investment plans, including in the US and abroad;

• internal and external manufacturing plans, including future internal manufacturing volumes, manufacturing expansion plans and the financing therefor, and external foundry usage;

• future production capacity and product supply;

• supply expectations, including regarding constraints, limitations, pricing, and industry shortages;

• plans and goals related to Intel’s foundry business, including with respect to anticipated customers, future manufacturing capacity and service, technology, and IP offerings;

• expected timing and impact of acquisitions, divestitures, and other significant transactions, including the agreed-upon sale of a controlling interest of Altera;

• expected completion and impacts of restructuring activities and cost-saving or efficiency initiatives;

• future social and environmental performance goals, measures, strategies, and results;

• our anticipated growth, future market share, customer demand, and trends in our businesses and operations;

• projected growth and trends in markets relevant to our businesses;

• anticipated trends and impacts related to industry component, substrate, and foundry capacity utilization, shortages, and constraints;

• expectations regarding government incentives, policies, and priorities;

• future technology trends and developments, such as AI;

• future macro environmental and economic conditions;

• geopolitical tensions and conflicts, including with respect to international trade policies in areas such as tariffs and export controls, and their potential impact on our business;

• tax- and accounting-related expectations;

• expectations regarding our relationships with certain sanctioned parties; and

• other characterizations of future events or circumstances.

Such statements involve many risks and uncertainties that could cause our actual results to differ materially from those expressed or implied, including those associated with:

• the high level of competition and rapid technological change in our industry;

• the significant long-term and inherently risky investments we are making in R&D and manufacturing facilities that may not realize a favorable return;

• the complexities and uncertainties in developing and implementing new semiconductor products and manufacturing process technologies;

• our ability to time and scale our capital investments appropriately and successfully secure favorable alternative financing arrangements and government grants;

• implementing new business strategies and investing in new businesses and technologies;

• changes in demand for our products;

• macroeconomic conditions and geopolitical tensions and conflicts, including geopolitical and trade tensions between the US and China, the impacts of Russia’s war on Ukraine, tensions and conflict affecting Israel and the Middle East, and rising tensions between mainland China and Taiwan;

• the evolving market for products with AI capabilities;

• our complex global supply chain supporting our manufacturing facilities and incorporating external foundries, including from disruptions, delays, trade tensions and conflicts, or shortages;

• recently elevated geopolitical tensions, volatility and uncertainty with respect to international trade policies, including tariffs and export controls, impacting our business, the markets in which we compete and the world economy;

• product defects, errata and other product issues, particularly as we develop next-generation products and implement next-generation manufacturing process technologies;

• potential security vulnerabilities in our products;

• increasing and evolving cybersecurity threats and privacy risks;

• IP risks including related litigation and regulatory proceedings;

• the need to attract, retain, and motivate key talent;

• strategic transactions and investments;

• sales-related risks, including customer concentration and the use of distributors and other third parties;

• our significantly reduced return of capital in recent years;

• our debt obligations and our ability to access sources of capital;

• complex and evolving laws and regulations across many jurisdictions;

• fluctuations in currency exchange rates;

• changes in our effective tax rate;

• catastrophic events;

• environmental, health, safety, and product regulations;

• our initiatives and new legal requirements with respect to corporate responsibility matters; and

• other risks and uncertainties described in this release, our 2024 Form 10-K, our Q1 2025 Form 10-Q, our Q2 2025 Form 10-Q, and our other filings with the SEC.

Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Readers are urged to carefully review and consider the various disclosures made in this release and in other documents we file from time to time with the SEC that disclose risks and uncertainties that may affect our business.

Unless specifically indicated otherwise, the forward-looking statements in this release do not reflect the potential impact of any divestitures, mergers, acquisitions, or other business combinations that have not been completed as of the date of this filing. In addition, the forward-looking statements in this release are based on management’s expectations as of the date of this release, unless an earlier date is specified, including expectations based on third-party information and projections that management believes to be reputable. We do not undertake, and expressly disclaim any duty, to update such statements, whether as a result of new information, new developments, or otherwise, except to the extent that disclosure may be required by law.

About Intel

Intel (Nasdaq: INTC) is an industry leader, creating world-changing technology that enables global progress and enriches lives. Inspired by Moore’s Law, we continuously work to advance the design and manufacturing of semiconductors to help address our customers’ greatest challenges. By embedding intelligence in the cloud, network, edge and every kind of computing device, we unleash the potential of data to transform business and society for the better. To learn more about Intel’s innovations, go to newsroom.intel.com and intel.com.

© Intel Corporation. Intel, the Intel logo, and other Intel marks are trademarks of Intel Corporation or its subsidiaries. Other names and brands may be claimed as the property of others.

Intel Corporation Consolidated Condensed Statements of Operations and Other Information
		Three Months Ended
(In Millions, Except Per Share Amounts; Unaudited)		Jun 28, 2025				Jun 29, 2024
Net revenue		$	12,859			$	12,833
Cost of sales			9,317				8,286
Gross profit			3,542				4,547
Research and development			3,684				4,239
Marketing, general, and administrative			1,144				1,329
Restructuring and other charges			1,890				943
Operating expenses			6,718				6,511
Operating income (loss)			(3,176	)			(1,964	)
Gains (losses) on equity investments, net			502				(120	)
Interest and other, net			(95	)			80
Income (loss) before taxes			(2,769	)			(2,004	)
Provision for (benefit from) taxes			255				(350	)
Net income (loss)			(3,024	)			(1,654	)
Less: net income (loss) attributable to non-controlling interests			(106	)			(44	)
Net income (loss) attributable to Intel		$	(2,918	)		$	(1,610	)
Earnings (loss) per share attributable to Intel—basic		$	(0.67	)		$	(0.38	)
Earnings (loss) per share attributable to Intel—diluted		$	(0.67	)		$	(0.38	)
Weighted average shares of common stock outstanding:
Basic			4,369				4,267
Diluted			4,369				4,267

Other information:
(In Thousands; Unaudited)		Jun 28, 2025		Mar 29, 2025		Jun 29, 2024
Employees
Intel		96.4		97.6		116.5
Mobileye and other subsidiaries		5.0		5.0		5.3
NAND1		—		—		3.5
Total Intel		101.4		102.6		125.3

1

Employees of the NAND memory business, which we divested to SK hynix upon the first closing on Dec. 29, 2021, and fully deconsolidated in Q1 2022. Employees are excluded from Intel’s total employee count following the completion of the second closing of the divestiture on March 27, 2025.

Intel Corporation Consolidated Condensed Balance Sheets
(In Millions, Except Par Value; Unaudited)		Jun 28, 2025			Dec 28, 2024
Assets
Current assets:
Cash and cash equivalents		$	9,643		$	8,249
Short-term investments			11,563			13,813
Accounts receivable, net			2,360			3,478
Inventories
Raw materials			1,194			1,344
Work in process			6,484			7,432
Finished goods			3,699			3,422
			11,377			12,198
Other current assets			8,432			9,586
Total current assets			43,375			47,324
Property, plant, and equipment, net			109,510			107,919
Equity investments			5,383			5,383
Goodwill			23,912			24,693
Identified intangible assets, net			3,057			3,691
Other long-term assets			7,283			7,475
Total assets		$	192,520		$	196,485
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable			10,666			12,556
Accrued compensation and benefits			4,249			3,343
Short-term debt			6,731			3,729
Income taxes payable			887			1,756
Other accrued liabilities			12,433			14,282
Total current liabilities			34,966			35,666
Debt			44,026			46,282
Other long-term liabilities			7,777			9,505
Stockholders’ equity:
Common stock and capital in excess of par value, 4,377 issued and outstanding (4,330 issued and outstanding as of December 28, 2024)			52,334			50,949
Accumulated other comprehensive income (loss)			65			(711	)
Retained earnings			45,484			49,032
Total Intel stockholders’ equity			97,883			99,270
Non-controlling interests			7,868			5,762
Total stockholders’ equity			105,751			105,032
Total liabilities and stockholders’ equity		$	192,520		$	196,485

Intel Corporation Consolidated Condensed Statements of Cash Flows
		Six Months Ended
(In Millions; Unaudited)		Jun 28, 2025				Jun 29, 2024
Cash and cash equivalents, beginning of period		$	8,249			$	7,079
Cash flows provided by (used for) operating activities:
Net income (loss)			(3,911	)			(2,091	)
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
Depreciation			5,213				4,403
Share-based compensation			1,348				1,959
Restructuring and other charges			382				219
Amortization of intangibles			474				717
(Gains) losses on equity investments, net			(390	)			(84	)
Deferred taxes			106				(1,339	)
Impairments and net (gain) loss on retirement of property, plant, and equipment			482				126
Changes in assets and liabilities:
Accounts receivable			1,004				272
Inventories			99				(116	)
Accounts payable			114				181
Accrued compensation and benefits			1,022				(1,015	)
Income taxes			(1,338	)			(835	)
Other assets and liabilities			(1,742	)			(1,328	)
Total adjustments			6,774				3,160
Net cash provided by (used for) operating activities			2,863				1,069
Cash flows provided by (used for) investing activities:
Additions to property, plant, and equipment			(8,733	)			(11,652	)
Proceeds from capital-related government incentives			964				699
Purchases of short-term investments			(5,730	)			(17,634	)
Maturities and sales of short-term investments			8,575				17,214
Proceeds from divestitures			1,935				—
Other investing			984				(355	)
Net cash provided by (used for) investing activities			(2,005	)			(11,728	)
Cash flows provided by (used for) financing activities:
Issuance of commercial paper, net of issuance costs			3,493				5,804
Repayment of commercial paper			(1,496	)			(2,609	)
Partner contributions			2,238				11,861
Additions to property, plant, and equipment			(1,962	)			—
Issuance of long-term debt, net of issuance costs			—				2,975
Repayment of debt			(1,500	)			(2,288	)
Proceeds from sales of common stock through employee equity incentive plans			491				631
Payment of dividends to stockholders			—				(1,063	)
Other financing			(678	)			(444	)
Net cash provided by (used for) financing activities			586				14,867
Net increase (decrease) in cash and cash equivalents			1,444				4,208
Cash and cash equivalents, end of period1		$	9,693			$	11,287

1

Includes $50 million of cash recorded within other current assets on the Consolidated Condensed Balance Sheets relating to Altera cash held for sale.

Intel Corporation Supplemental Operating Segment Results
		Three Months Ended
(In Millions; Unaudited)		Jun 28, 2025
		Intel Products
		CCG			DCAI			Total Intel Products			Intel Foundry				All Other1			Corporate Unallocated				Intersegment Eliminations				Total Consolidated
Revenue		$	7,871		$	3,939		$	11,810		$	4,417			$	1,053		$	—			$	(4,421	)		$	12,859
Cost of sales and operating expenses			5,818			3,306			9,124			7,585				984			2,755				(4,413	)			16,035
Operating income (loss)		$	2,053		$	633		$	2,686		$	(3,168	)		$	69		$	(2,755	)		$	(8	)		$	(3,176	)

		Three Months Ended
(In Millions; Unaudited)		Jun 29, 2024
		Intel Products
		CCG		DCAI		Total Intel Products		Intel Foundry		All Other1		Corporate Unallocated		Intersegment Eliminations		Total Consolidated
Revenue		$ 8,143		$ 3,805		$ 11,948		$ 4,282		$ 881		$ —		$ (4,278)		$ 12,833
Cost of sales and operating expenses		5,502		3,563		9,065		7,084		927		1,708		(3,987)		14,797
Operating income (loss)		$ 2,641		$ 242		$ 2,883		$ (2,802)		$ (46)		$ (1,708)		$ (291)		$ (1,964)

1

The “All Other” category includes the results of operations from other non-reportable segments, including our Altera and Mobileye businesses, our IMS business, startup businesses that support our initiatives, and historical results of operations from divested businesses.

For information about our operating segments, including the nature of segment revenues and expenses, and a reconciliation of our operating segment revenue and operating income (loss) to our consolidated results, refer to our Q2 2025 Form 10-Q.

Intel Corporation

Explanation of Non-GAAP Measures

In addition to disclosing financial results in accordance with US GAAP, this document references non-GAAP financial measures below. We believe these non-GAAP financial measures provide investors with useful supplemental information about our operating performance, enable comparison of financial trends and results between periods where certain items may vary independent of business performance, and allow for greater transparency with respect to key metrics used by management in operating our business and measuring our performance. These non-GAAP financial measures are used in our performance-based RSUs and our cash bonus plans.

Our non-GAAP financial measures reflect adjustments based on one or more of the following items, as well as the related effects to income taxes and net income (loss) attributable to non-controlling interests effects. Income tax effects are calculated using a fixed long-term projected tax rate. For 2025 and 2024, we determined the projected non-GAAP tax rate to be 12% and 13%, respectively. We project this long-term non-GAAP tax rate on at least an annual basis using a five-year non-GAAP financial projection that excludes the income tax effects of each adjustment. The projected non-GAAP tax rate also considers factors such as our tax structure, our tax positions in various jurisdictions, and key legislation in significant jurisdictions where we operate. This long-term non-GAAP tax rate may be subject to change for a variety of reasons, including the rapidly evolving global tax environment, significant changes in our geographic earnings mix, or changes to our strategy or business operations. Management uses this non-GAAP tax rate in managing internal short- and long-term operating plans and in evaluating our performance; we believe this approach facilitates comparison of our operating results and provides useful evaluation of our current operating performance. Non-GAAP adjustments attributable to non-controlling interests are calculated by adjusting for the minority stockholder portion of non-GAAP adjustments we make for relevant acquisition-related costs, share-based compensation, restructuring and other charges, and income tax effects, as applicable to each majority-owned subsidiary.

Our non-GAAP financial measures should not be considered a substitute for, or superior to, financial measures calculated in accordance with US GAAP, and the financial results calculated in accordance with US GAAP and reconciliations from these results should be carefully evaluated.

Non-GAAP adjustment or measure	Definition	Usefulness to management and investors
Acquisition-related adjustments	Amortization of acquisition-related intangible assets consists of amortization of intangible assets such as developed technology, brands, and customer relationships acquired in connection with business combinations. Charges related to the amortization of these intangibles are recorded within both cost of sales and MG&A in our US GAAP financial statements. Amortization charges are recorded over the estimated useful life of the related acquired intangible asset, and thus are generally recorded over multiple years.	We exclude amortization charges for our acquisition-related intangible assets for purposes of calculating certain non-GAAP measures because these charges are inconsistent in size and are significantly impacted by the timing and valuation of our acquisitions. These adjustments facilitate a useful evaluation of our current operating performance and comparison to our past operating performance and provide investors with additional means to evaluate cost and expense trends.
Share-based compensation	Share-based compensation consists of charges related to our employee equity incentive plans.	We exclude charges related to share-based compensation for purposes of calculating certain non-GAAP measures because we believe these adjustments provide comparability to peer company results and because these charges are not viewed by management as part of our core operating performance. We believe these adjustments provide investors with a useful view, through the eyes of management, of our core business model, how management currently evaluates core operational performance, and additional means to evaluate expense trends, including in comparison to other peer companies.
Restructuring and other charges	Restructuring charges are costs associated with restructuring plans and are primarily related to employee severance and benefit arrangements. Q2 2025 primarily includes charges associated with the 2025 Restructuring Plan. Other charges include periodic goodwill and asset impairments, and other costs associated with certain non-core activities. Q2 2024 includes a charge arising out of the R2 litigation.	We exclude restructuring and other charges, including any adjustments to charges recorded in prior periods, for purposes of calculating certain non-GAAP measures because these costs do not reflect our core operating performance. These adjustments facilitate a useful evaluation of our core operating performance and comparisons to past operating results and provide investors with additional means to evaluate expense trends.
(Gains) losses on equity investments, net	(Gains) losses on equity investments, net consists of ongoing mark-to-market adjustments on marketable equity securities, observable price adjustments on non-marketable equity securities, related impairment charges, and the gains (losses) from the sale of equity investments and other.	We exclude these non-operating gains and losses for purposes of calculating certain non-GAAP measures to provide comparability between periods. The exclusion reflects how management evaluates the core operations of the business.
(Gains) losses from divestiture	(Gains) losses are recognized at the close of a divestiture, or over a specified deferral period when deferred consideration is received at the time of closing.	We exclude gains or losses resulting from divestitures for purposes of calculating certain non-GAAP measures because they do not reflect our current operating performance. These adjustments facilitate a useful evaluation of our current operating performance and comparisons to past operating results.
Adjusted free cash flow	We reference a non-GAAP financial measure of adjusted free cash flow, which is used by management when assessing our sources of liquidity, capital resources, and quality of earnings. Adjusted free cash flow is operating cash flow adjusted for (1) additions to property, plant, and equipment, net of proceeds from capital-related government incentives and net partner contributions, and (2) payments on finance leases.	This non-GAAP financial measure is helpful in understanding our capital requirements and sources of liquidity by providing an additional means to evaluate the cash flow trends of our business.
Net capital spending	We reference a non-GAAP financial measure of net capital spending, which is additions to property, plant, and equipment, net of proceeds from capital-related government incentives and net partner contributions.	We believe this measure provides investors with useful supplemental information about our capital investment activities and capital offsets, and allows for greater transparency with respect to a key metric used by management in operating our business and measuring our performance.

Intel Corporation

Supplemental Reconciliations of GAAP Actuals to Non-GAAP Actuals

Set forth below are reconciliations of the non-GAAP financial measure to the most directly comparable US GAAP financial measure. These non-GAAP financial measures should not be considered a substitute for, or superior to, financial measures calculated in accordance with US GAAP, and the reconciliations from US GAAP to Non-GAAP actuals should be carefully evaluated. Please refer to “Explanation of Non-GAAP Measures” in this document for a detailed explanation of the adjustments made to the comparable US GAAP measures, the ways management uses the non-GAAP measures, and the reasons why management believes the non-GAAP measures provide useful information for investors.

		Three Months Ended
(In Millions, Except Per Share Amounts; Unaudited)		Jun 28, 2025				Jun 29, 2024
GAAP gross profit		$	3,542			$	4,547
Acquisition-related adjustments			101				224
Share-based compensation			170				195
Non-GAAP gross profit		$	3,813			$	4,966
GAAP gross margin percentage			27.5	%			35.4	%
Acquisition-related adjustments			0.8	%			1.7	%
Share-based compensation			1.3	%			1.5	%
Non-GAAP gross margin percentage			29.7	%			38.7	%
GAAP R&D and MG&A		$	4,828			$	5,568
Acquisition-related adjustments			(18	)			(41	)
Share-based compensation			(494	)			(585	)
Non-GAAP R&D and MG&A		$	4,316			$	4,942
GAAP operating income (loss)		$	(3,176	)		$	(1,964	)
Acquisition-related adjustments			119				265
Share-based compensation			664				780
Restructuring and other charges			1,890				943
Non-GAAP operating income (loss)		$	(503	)		$	24
GAAP operating margin (loss)			(24.7	)%			(15.3	)%
Acquisition-related adjustments			0.9	%			2.1	%
Share-based compensation			5.2	%			6.1	%
Restructuring and other charges			14.7	%			7.3	%
Non-GAAP operating margin (loss)			(3.9	)%			0.2	%
GAAP tax rate			(9.2	)%			17.5	%
Income tax effects			21.2	%			(4.5	)%
Non-GAAP tax rate			12.0	%			13.0	%
GAAP net income (loss) attributable to Intel		$	(2,918	)		$	(1,610	)
Acquisition-related adjustments			119				265
Share-based compensation			664				780
Restructuring and other charges			1,890				943
(Gains) losses on equity investments, net			(502	)			120
(Gains) losses from divestiture			—				(39	)
Adjustments attributable to non-controlling interest			(21	)			(18	)
Income tax effects			327				(358	)
Non-GAAP net income (loss) attributable to Intel		$	(441	)		$	83
(In Millions, Except Per Share Amounts; Unaudited)		Jun 28, 2025				Jun 29, 2024
GAAP earnings (loss) per share attributable to Intel—diluted		$	(0.67	)		$	(0.38	)
Acquisition-related adjustments			0.03				0.06
Share-based compensation			0.15				0.18
Restructuring and other charges			0.43				0.22
(Gains) losses on equity investments, net			(0.11	)			0.03
(Gains) losses from divestiture			—				(0.01	)
Adjustments attributable to non-controlling interest			—				—
Income tax effects			0.07				(0.08	)
Non-GAAP earnings (loss) per share attributable to Intel—diluted		$	(0.10	)		$	0.02
GAAP net cash provided by (used for) operating activities		$	2,050			$	2,292
Additions to property, plant, and equipment (gross capital expenditures)			(4,492	)			(5,682	)
Proceeds from capital-related government incentives			145				107
Partner contributions, net			1,250				11,438
Net purchase of property, plant, and equipment (net capital expenditures)			(3,097	)			5,863
Payments on finance leases			(3	)			—
Adjusted free cash flow		$	(1,050	)		$	8,155
GAAP net cash provided by (used for) investing activities		$	(2,086	)		$	(9,165	)
GAAP net cash provided by (used for) financing activities		$	782			$	11,237

Intel Corporation

Supplemental Reconciliations of GAAP Outlook to Non-GAAP Outlook

Set forth below are reconciliations of the non-GAAP financial measure to the most directly comparable US GAAP financial measure. These non-GAAP financial measures should not be considered a substitute for, or superior to, financial measures calculated in accordance with US GAAP, and the financial outlook prepared in accordance with US GAAP and the reconciliations from this Business Outlook should be carefully evaluated. Please refer to “Explanation of Non-GAAP Measures” in this document for a detailed explanation of the adjustments made to the comparable US GAAP measures, the ways management uses the non-GAAP measures, and the reasons why management believes the non-GAAP measures provide useful information for investors.

(Unaudited)		Q3 2025 Outlook1
		Approximately
GAAP gross margin percentage			34.1	%
Acquisition-related adjustments			0.8	%
Share-based compensation			1.1	%
Non-GAAP gross margin percentage			36.0	%
GAAP tax rate			(23	)%
Income tax effects			35	%
Non-GAAP tax rate			12	%
GAAP earnings (loss) per share attributable to Intel—diluted		$	(0.24	)
Acquisition-related adjustments			0.02
Share-based compensation			0.14
Restructuring and other charges			0.07
Adjustments attributable to non-controlling interest			(0.01	)
Income tax effects			0.02
Non-GAAP earnings (loss) per share attributable to Intel—diluted		$	0.00

1

Non-GAAP gross margin percentage and non-GAAP earnings (loss) per share attributable to Intel outlook based on the mid-point of the revenue range.

Intel Corporation

Supplemental Reconciliations of Other GAAP to Non-GAAP Forward-Looking Estimates

Set forth below are reconciliations of the non-GAAP financial measure to the most directly comparable US GAAP financial measure. These non-GAAP financial measures should not be considered a substitute for, or superior to, financial measures calculated in accordance with US GAAP, and the reconciliations should be carefully evaluated. Please refer to “Explanation of Non-GAAP Measures” in this document for a detailed explanation of the adjustments made to the comparable US GAAP measures, the ways management uses the non-GAAP measures, and the reasons why management believes the non-GAAP measures provide useful information for investors.

(In Billions; Unaudited)			Full-Year 2025				Full-Year 2026
			Approximately				Approximately
GAAP additions to property, plant and equipment (gross capital expenditures)			$	18.0
Proceeds from capital-related government incentives			(3.0 – 5.0)
Partner contributions, net			(4.0 – 5.0)
Non-GAAP net capital expenditures			$8.0 – $11.0
GAAP operating expenses			$	22.1			$	19.0
Acquisition-related adjustments				(0.1	)			(0.1	)
Share-based compensation				(2.5	)			(2.9	)
Restructuring and other charges				(2.5	)			—
Non-GAAP operating expenses			$	17.0			$	16.0

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20250724988641/en/

Investor Relations

investor.relations@intel.com

Sophie Metzger

Media Relations

sophie.metzger@intel.com

Source: Intel Corporation

Released Jul 24, 2025 • 4:01 PM EDT

At the Society for Pediatric Dermatology Annual Meeting, 2 poster presentations from the TRuE-AD3 (NCT04921969) study demonstrated that children aged 2 to 11 years with mild to moderate atopic dermatitis (AD) achieved long-term disease control and meaningful time off treatment using as-needed ruxolitinib cream. Both strengths of the topical Janus kinase inhibitor were well tolerated over 52 weeks, even among those with more extensive disease at baseline.

The first poster from the TRuE-AD3 study focused on evaluating long-term disease control and safety of ruxolitinib cream in children aged 2 to 11 with moderate and/or more extensive AD, defined as an Investigator’s Global Assessment (IGA) score of 3 and/or 10% or greater affected body surface area (BSA) at baseline.¹ In this randomized, double-blind trial, children received twice-daily ruxolitinib cream (0.75% or 1.5%) or vehicle for 8 weeks, followed by 44 weeks of as-needed treatment with either ruxolitinib cream strength.

Among 180 children initially randomized to ruxolitinib with an IGA score of 3, 71.4% to 74.6% achieved clear or almost clear skin (IGA 0/1) at week 52, and mean affected BSA decreased to 2.0% to 2.3%. Similar improvements were observed in the subset with 10% or greater BSA at baseline. Both concentrations of ruxolitinib cream were well tolerated, with no serious treatment-related adverse events reported, supporting its sustained efficacy and safety in managing moderate pediatric AD.

The second poster evaluated long-term disease control and time off treatment among children aged 2 to 11 with mild to moderate AD who received ruxolitinib cream in the TRuE-AD3 study.² After an initial 8-week randomized treatment period, patients who had received ruxolitinib cream (0.75% or 1.5%) continued into a 44-week long-term safety (LTS) period with as-needed application. Among those who applied at least 1 dose during the LTS period (n = 119 for 0.75%; n = 114 for 1.5%), affected BSA decreased from 9.9% to 11.1% at baseline to 1.9% to 2.0% at week 52.

Clear or almost clear skin (IGA 0/1) was achieved at least once during the LTS period by 80.7% (ruxolitinib, 0.75%) and 91.2% (ruxolitinib, 1.5%) of patients, and these scores were maintained for 60.0% and 69.0% of visits, respectively. Additionally, median days off treatment due to lesion clearance totaled 136.0 and 151.0 for the 0.75% and 1.5% groups, respectively, accounting for approximately half the LTS period. Both regimens were well tolerated with no serious treatment-related adverse events, underscoring the effectiveness of as-needed ruxolitinib cream in maintaining disease control and reducing treatment burden in pediatric AD.

Together, these findings from the TRuE-AD3 study reinforce the long-term efficacy, safety, and practical benefits of ruxolitinib cream as an as-needed monotherapy for children with mild to moderate AD. Whether managing more extensive disease or maintaining remission over time, ruxolitinib cream enabled substantial lesion clearance, prolonged periods off treatment, and a favorable safety profile over 52 weeks. These results offer promising evidence to support its use as a long-term treatment option tailored to the needs of pediatric patients and their caregivers.

References

1. Eichenfield LF, Simpson EL, Armstrong AW, et al. 52-week ruxolitinib cream disease control and safety in children with moderate/more extensive atopic dermatitis. Poster presented at: Society for Pediatric Dermatology Annual Meeting 2025; July 23-26, 2025; Seattle, WA. Abstract POS-05.

2. Eichenfield LF, Joyce JC, Lee LW, et al. Ruxolitinib cream demonstrated long-term disease control with time off treatment in children with atopic dermatitis. Poster presented at: Society for Pediatric Dermatology Annual Meeting 2025; July 23-26, 2025; Seattle, WA. POS-18.

Collaboration Key to Advancing High-Confidence Design Analysis Tools for Safe, Efficient Aircraft of the Future  

LAS VEGAS — Rich Wahls, Sustainable Flight National Partnership Mission Integration Manager with NASA’s Aeronautics Research Mission Directorate (ARMD) and AIAA Fellow, delivered the Applied Aerodynamics Award Lecture this week at the 2025 AIAA AVIATION Forum, offering a rare behind-the-scenes look at the evolution of aerodynamic testing and the future of flight. 

In a wide-ranging conversation, Wahls shared insights from his decades-long career, highlighting the enduring importance of wind tunnels, the rise of computational tools, and the importance of national and international collaboration to enhance the state of the art in aerospace engineering.

A Career at the Cutting Edge of Aerodynamics

Wahls’ journey in aerodynamics began in the early 1980s, when he first visited NASA Langley Research Center as an undergraduate. 

“I happened to come into this tunnel in 1983, the year they first turned on the fan,” he recalled, referencing the National Transonic Facility (NTF), a unique cryogenic wind tunnel that would become central to his career. By 1989, Wahls was hired as the “applied aerodynamics guy,” tasked with helping users across the country get the most out of this one-of-a-kind facility.

Why Wind Tunnels Still Matter

Despite the rapid advance of computational fluid dynamics (CFD) and digital modeling, Wahls is adamant that wind tunnels remain indispensable. “They always have been, and they will for a long, long time,” he said.

The NTF, for example, allows researchers to test small-scale models of aircraft under conditions that closely mimic real flight, thanks to its ability to pressurize and cool nitrogen gas. Pressurizing and cooling effectively scales the air flow to the model scale for more accurate simulation of the real flow physics in full-scale flight.

Wahls explained that while computational tools have improved dramatically, they are not yet a complete substitute for physical testing. 

“There’s always a push, because wind tunnels are big infrastructure, to close them down,” he noted. “But computations are not mature enough to eliminate the need for wind tunnels.” 

Early to Current Collaboration

He recounted the early 2000s working with others to organize the first AIAA drag prediction workshops, where experts from around the world were invited to model a standard airliner geometry. The results, he said, “were all over the map,” underscoring the limitations of even the best CFD tools. This drag prediction series continues today and has been further enhanced by use of a NASA common research model airline that provides “a modern / relevant, open / public configuration as a test subject for international collaboration,” noted Wahls.

In recent years, the concept of the “digital twin”—a computational model that mirrors a physical system—has gained traction in aerospace. Digital twins are now used alongside physical models to validate results and improve design confidence. Modelers can connect the digital and the physical model at the scale they’re testing, and ultimately for the full-scale airplane.

Wahls emphasized the need for experienced engineers to interpret results and avoid the “black-box syndrome,” where users trust computer outputs without understanding the underlying assumptions.

NASA’s wind tunnels continue to be used with both commercial and military partners, often through arrangements that balance proprietary data with the need for open research. Wahls noted that bringing together experts from around the world “raises the water level for everybody.” 

He also described how advances in computational tools have made the design process more efficient, reducing the number of physical models needed for testing and allowing engineers to approach the wind tunnel phase with greater confidence.

Looking to the Future

Wahls is optimistic about the future of aerodynamics, pointing to recent breakthroughs in high-fidelity physics modeling and the increasing power of computers. “In the last five or six years, there’s been a pretty big step change in the confidence and how we do that,” he said. 

The ultimate goal, he explained, is to reduce risk and ensure that new aircraft perform as expected when they finally take to the skies.

As the aviation industry faces new challenges—from sustainability to the integration of advanced materials and propulsion systems—Wahls believes the combination of physical testing, computational modeling, and human expertise will remain essential. 

“The need for the wind tunnel is not going away, even with the advancement in the computational side,” he concluded. “Ultimately, what you really care about is the airplane at the end, the real airplane.”

With his deep experience, Wahls offered AIAA attendees a compelling vision of how tradition and innovation will continue to shape the future of flight.

During the forum, Wahls received the 2025 AIAA Applied Aerodynamics Award for outstanding leadership and technical contributions advancing high-confidence computational and experimental aerodynamic tools for prediction and analysis of airplane configurations and technologies.

A small, non-randomized pilot clinical trial found that fecal microbiota transplantation (FMT) was well-tolerated in long-term acute care hospital (LTACH) patients colonized with multidrug-resistant organism (MDROs), researchers reported today in JAMA Network Open.

For the trial, which was conducted from April to December 2023 at an LTACH in the southeastern United States, a team led by researchers from Emory University enrolled 42 patients with MDRO colonization, with 10 selected to receive FMT via gastrostomy or enema and 32 in the control group. LTACH populations have a high prevalence of MDRO colonization, which can put them at increased risk of MDRO infection, and investigators wanted to see if FMT might be a safe way to help reduce intestinal MDRO colonization. 

The primary outcome was the frequency and severity of adverse events. The secondary outcome was the proportion of participants with positive perirectal or stool culture results at week 2 and 4 after FMT.

No serious adverse events attributed to FMT

No serious adverse events were attributed to FMT, and post-FMT solicited adverse were mild. All perirectal cultures from FMT recipients grew at least one MDRO at days 14 and 28. Although post hoc analyses found that fewer FMT recipients had positive blood culture results and pathogen intestinal dominance compared with controls in the 6 months after prevalence survey, and that FMT recipients had numerically fewer days of antibiotic therapy per 1000 patient-days than controls, these differences were not statistically significant.  

The study authors say that while the effect on MDRO decolonization observed in the trial was smaller than found in previous studies, the findings suggest FMT warrants further investigation for infection prevention.

“Although a small cohort was studied, these findings suggest that microbiota therapies, particularly with improved formulations that are easier to administer and acceptable to patients, could have potential for preventive treatment for patients at high risk of infection or transmission,” they wrote. “This approach could be especially important for LTACHs and other health care facilities that care for patients with a high prevalence of intestinal MDRO colonization for which there are no currently available FDA-approved therapies.”

When Christina Marie Chapman first stumbled blindly into a web of international intrigue, in 2020, she’d been trying to turn her life around. She was living in the tiny town of Brook Park, Minnesota, occupying a run-down travel trailer on a rural property her mother owned. Over Chapman’s adult life she’d lived in Texas, England and Colorado—drifting between jobs at big-box stores, fast-food chains, casinos, mortgage brokers—“not anything that I ever dreamed of doing as a child,” she recalls.

The daughter of an ex-Marine father and an accountant mother, she’d been born in South Korea, where her father was stationed, and bounced around before spending her formative years in Pine City, a dozen miles from Brook Park. Now, at 44, she’d retreated home to start over. She took out loans to attend a coding boot camp, hoping to pull herself out of the mire of dead-end jobs. Finally done with the coursework after five months and thousands of dollars, she created a LinkedIn profile to advertise her new skills. Occupation: software engineer.

Global law firm K&L Gates LLP advised Carousel Capital, a North Carolina-based private equity firm, and its portfolio company Landscape Workshop, a leading provider of route-based commercial landscaping services, on the sale of a majority interest in Landscape Workshop to Ares Management Corporation (NYSE: ARES).

Since Carousel Capital’s initial investment in 2020, Landscape Workshop has achieved substantial growth and now operates across 38 locations throughout the Southeastern United States. The company provides a full suite of commercial landscaping services, including maintenance, enhancements, irrigation systems, seasonal color programs, and landscape installation. With nearly four decades of operational history, Landscape Workshop is one of the largest and most established players in the US landscaping market.

The corporate deal team was led by Charlotte partners Kevin Stichter and Barry Price, with assistance from associates Kristin Taylor, Ryan Beachum, Morgan Kleinhandler, and Andreas Myers. The multi-office team also included Charlotte partner Jared Mobley and associate France Beard Johnson for tax matters; Raleigh partner David Lindsay and associate Claire Healy for labor matters; San Francisco partner Rikki Sapolich-Krol and Pittsburgh associate Samantha Beatty for employee benefits matters; Boston partner James Fajkowski for intellectual property matters; Seattle partner Jake Bernstein and associate Jane Petoskey for data privacy matters; Nashville of counsel Christian Schütz and associate Sean Wood for real estate matters; Raleigh partner Stanford Baird for environmental matters; Washington, DC partner Vishal Mehta, Chicago counsel John Susoreny, and Seattle associate Henry Brockway for antitrust matters; and Wilmington partner Kelly Terribile for Delaware law matters.

Stichter commented: “This transaction underscores the breadth and depth of K&L Gates’ capabilities across the private equity lifecycle. From complex structuring and diligence to regulatory and industry-specific guidance, our integrated platform allowed us to deliver seamless, business-focused counsel that helped drive a successful outcome for our client.”

K&L Gates’ Corporate practice is one of the most substantial in the legal industry, with hundreds of lawyers in offices on five continents providing clients with practical legal solutions in the structuring, financing, and completion of domestic, international, and cross-border transactions.

The European Commission and Health Canada have approved belantamab mafodotin (Blenrep) in combination with bortezomib (Velcade) and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior therapy; and in combination with pomalidomide (Pomalyst) and dexamethasone (BPd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior therapy, including lenalidomide (Revlimid).^1,2

These regulatory decisions were supported by data from the phase 3 DREAMM-7 trial (NCT04246047), which evaluated BVd, and the phase 3 DREAMM-8 trial (NCT04484623), which examined BPd. In both studies, the belantamab mafodotin–based combinations demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) vs standard-of-care triplet regimens.

“With the approval of [belantamab mafodotin] combinations in the European Union, we now have additional tools in our efforts to keep patients in remission longer, maintain quality of life and extend survival,” María-Victoria Mateos, MD, PhD, head of Myeloma and Clinical Trials Unit in the Haematology Department and professor of medicine at the University of Salamanca in Spain, as well as the DREAMM-7 principal investigator, stated in a news release.¹

Notably, both of these regulatory approvals followed a July 17, 2025, vote by the FDA’s Oncologic Drugs Advisory Committee (ODAC), which did not endorse the risk:benefit profiles of the proposed dosages of belantamab mafodotin in these combinations.³ Specifically, the ODAC voted 5 to 3 against the risk:benefit profile of the BVd combination and 7 to 1 against the BPd combination. On July 23, GSK announced that the FDA extended the review period for the biologics license application seeking the approval of these combinations; the new Prescription Drug User Fee Act action date is October 23, 2025.⁴

DREAMM-7 Data

In DREAMM-7, BVd produced a median PFS of 36.6 months compared with 13.4 months for daratumumab (Darzalex) plus bortezomib and dexamethasone (DVd; HR, 0.41; 95% CI, 0.31-0.53; P < .00001).¹ The trial also met its key secondary end point, demonstrating a 42% reduction in the risk of death (HR, 0.58; 95% CI, 0.43-0.79; P = .00023) at a median follow-up of 39.4 months. The median overall survival (OS) was not reached (NR) in either arm, although the 3-year OS rate favored the belantamab mafodotin arm (74% vs 60%).

DREAMM-8 Findings

In DREAMM-8, BPd produced a median PFS that was NR (95% CI, 20.6-NR) vs 12.7 months (95% CI, 9.1-18.5) for bortezomib plus pomalidomide and dexamethasone (PVd) at a median follow-up of 21.8 months.

Safety Data

Safety findings from both trials demonstrated that the ocular adverse effects (AEs) commonly associated with belantamab mafodotin were generally manageable and reversible with appropriate dose modifications and routine ophthalmologic monitoring. These measures enabled patients to continue treatment and maintain clinical benefit, with eye-related toxicities leading to treatment discontinuation in less than 9% of patients in both studies.

Non-ocular AEs occurring in more than 30% of patients in the belantamab mafodotin combination arms included thrombocytopenia (87%) and diarrhea (32%) in DREAMM-7, and neutropenia (63%), thrombocytopenia (55%), and COVID-19 (37%) in DREAMM-8. These safety profiles were consistent with the known effects of the individual agents used in combination.

“The robust efficacy supported by the DREAMM-7 and DREAMM-8 trials, together with manageable outpatient administration in academic and community settings, positions [belantamab mafodotin] combinations as a fundamentally differentiated treatment approach for [patients with] multiple myeloma starting from first relapse,” Mateos concluded.

References

1. Blenrep (belantamab mafodotin) combinations approved in EU for treatment of relapsed/refractory multiple myeloma. News Release. GSK. July 24, 2025. Accessed July 24, 2025. https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-eu-for-treatment-of-relapsedrefractory-multiple-myeloma/
2. Blenrep (belantamab mafodotin) combinations approved in Canada for the treatment of relapsed/refractory multiple myeloma. News Release. GSK. July 23, 2025. Accessed July 24, 2025.https://ca.gsk.com/en-ca/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-canada-for-the-treatment-of-relapsedrefractory-multiple-myeloma/
3. July 17, 2025, Meeting of the Oncologic Drugs Advisory Committee (ODAC). FDA. Accessed July 24, 2025. https://www.youtube.com/live/CLhBI3UXWyg
4. GSK announces extension of US Food and Drug Administration review period for Blenrep (belantamab mafodotin-blmf) in relapsed/refractory multiple myeloma. News release. GSK. July 23, 2025. Accessed July 24, 2025. https://www.gsk.com/en-gb/media/press-releases/gsk-announces-extension-of-us-food-and-drug-administration-review-period-for-blenrep-belantamab-mafodotin-blmf-in-relapsedrefractory-multiple-myeloma/