On July 22, 2025 Quest Diagnostics Incorporated (NYSE: DGX), a leading provider of diagnostic information services, reported financial results for the second quarter ended June 30, 2025 (Press release, Quest Diagnostics, JUL 22, 2025, View Source [SID1234654469]).

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"Through continued execution of our strategy, we delivered a strong second quarter, with revenues growing 15.2% which includes 5.2% from organic revenues, as well as adjusted EPS growth of 11.5%," said Jim Davis, Chairman, CEO and President. "Demand for our innovative clinical solutions and expanded business from enterprise accounts complemented growth from acquisitions. We also realized productivity gains as we continued to deploy automation and digital technologies across our operations. Given our performance in the quarter and continued utilization trends, we are raising our full year 2025 guidance."

Three Months Ended June 30,

Six Months Ended June 30,

2025

2024

Change

2025

2024

Change

(dollars in millions, except per share data)

Reported:

Net revenues

$ 2,761

$ 2,397

15.2 %

$ 5,413

$ 4,763

13.7 %

Diagnostic Information Services revenues

$ 2,699

$ 2,333

15.7 %

$ 5,288

$ 4,631

14.2 %

Revenue per requisition

(0.4) %

— %

Requisition volume

16.3 %

14.3 %

Organic requisition volume

2.1 %

0.6 %

Operating income (a)

$ 438

$ 355

23.3 %

$ 784

$ 655

19.7 %

Operating income as a percentage of net revenues (a)

15.9 %

14.8 %

1.1 %

14.5 %

13.7 %

0.8 %

Net income attributable to Quest Diagnostics (a)

$ 282

$ 229

23.1 %

$ 502

$ 423

18.6 %

Diluted EPS (a)

$ 2.47

$ 2.03

21.7 %

$ 4.41

$ 3.75

17.6 %

Cash provided by operations

$ 544

$ 360

51.5 %

$ 858

$ 514

67.1 %

Capital expenditures

$ 108

$ 92

17.3 %

$ 225

$ 196

14.4 %

Adjusted (a):

Operating income

$ 466

$ 398

17.3 %

$ 872

$ 747

16.8 %

Operating income as a percentage of net revenues

16.9 %

16.6 %

0.3 %

16.1 %

15.7 %

0.4 %

Net income attributable to Quest Diagnostics

$ 298

$ 266

12.3 %

$ 549

$ 496

10.7 %

Diluted EPS

$ 2.62

$ 2.35

11.5 %

$ 4.83

$ 4.39

10.0 %

(a)

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

Updated Guidance for Full Year 2025

The company updates its full year 2025 guidance as follows:

Updated Guidance

Prior Guidance

Low

High

Low

High

Net revenues

$10.80 billion

$10.92 billion

$10.70 billion

$10.85 billion

Net revenues increase

9.4 %

10.6 %

8.4 %

9.9 %

Reported diluted EPS

$8.60

$8.80

$8.62

$8.87

Adjusted diluted EPS

$9.63

$9.83

$9.55

$9.80

Cash provided by operations

Approximately $1.55 billion

Approximately $1.5 billion

Capital expenditures

Approximately $500 million

Approximately $500 million

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, gains and losses associated with changes in the carrying value of our strategic investments, impairment charges and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables below include reconciliations of non-GAAP adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, passcode: 7895081; or via live webcast on our website at www.QuestDiagnostics.com/investor. We suggest participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or, from approximately 10:30 a.m. Eastern Time on July 22, 2025 until midnight Eastern Time on August 5, 2025, by phone at 866-388-5361 for domestic callers or 203-369-0416 for international callers. Anyone listening to the call is encouraged to read our periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On July 22, 2025 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage cancer diagnostics including CyPath Lung, the Company’s commercially available test for early-stage lung cancer, reported its patent related to a method to detect lung disease through flow cytometry analysis of sputum has been allowed by the Canadian Patent Office (Press release, BioAffinity Technologies, JUL 22, 2025, View Source [SID1234654467]). This patent strengthens the international protection of the Company’s diagnostic platform that powers its flagship test, CyPath Lung.

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"As with the recent announcement of the award of our patent in China, this Canadian patent reflects our continued execution toward building long-term shareholder value through innovation, protection of our unique assets, and a clear focus on early cancer detection that can save lives," said Maria Zannes, President and CEO of bioAffinity Technologies.

Lung cancer is the leading cause of cancer death in Canada, according to the Canadian Cancer Society. In 2024, approximately 31,000 Canadians were diagnosed with lung cancer, and approximately 20,700 people died of the disease. More than 70% of the lung cancer deaths were linked to smoking.

"We believe that the award of this patent by the Canadian Patent Office further validates the diagnostic platform behind CyPath Lung, expands the global footprint of our intellectual property portfolio and highlights the strength of our science," Ms. Zannes said. "Recent case studies highlight CyPath Lung’s ability to detect lung cancer at its earliest stages, making our test all the more valuable in Canada where 50% of all lung cancer cases are diagnosed late at Stage IV with the five-year survival rate overall of about 19% in Canada, according to government statistics."

The Canadian patent (Patent No. 3,136,245) – titled "System and Method for Determining Lung Health" – protects the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in the sputum.

CyPath Lung is the Company’s first commercial product, with clinical study results demonstrating 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters.

About CyPath Lung

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.

On July 22, 2025 Alloy Therapeutics Co. Ltd. ("Alloy Japan") reported the signing of a Memorandum of Understanding (MOU) with the Kansai Startup Academia Coalition ("KSAC"), represented by Kyoto University, to foster the global expansion of university-affiliated life science startups across Japan (Press release, Alloy Therapeutics, JUL 22, 2025, View Source [SID1234654446]). This strategic collaboration is designed to accelerate research and development (R&D) activities by providing critical support and connecting academic innovations with the global biopharmaceutical industry.

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KSAC is a coalition of more than 90 academic institutions located in western Japan, formed under the leadership of Kyoto University and with support from Japan’s Ministry of Education, Culture, Sports, Science and Technology (MEXT). KSAC’s mission is to bridge academia and industry by managing GAP funds for research, delivering entrepreneurship education, supporting digital workshop networks, and showcasing early-stage technologies through events and exhibitions both domestically and internationally.

Alloy Therapeutics Inc. ("Alloy") is a Boston-based biotechnology ecosystem company that democratizes access to foundational biologics discovery technologies. Through its suite of platform technologies and discovery services as well as its venture studio, 82VS, Alloy enables scientists and entrepreneurs around the world to accelerate the discovery of medicines. Alloy recently launched its Japan subsidiary, Alloy Japan, which is focused on iPS cell therapy development and is continuing to broaden its offerings by supporting ecosystem growth throughout Japan and greater Asia.

Through this MOU, Alloy Japan and KSAC will collaborate to connect promising academic seeds from Japan to global Biopharma markets, while also bringing valuable insights from the global community back to strengthen Japan’s startup ecosystem. Together, they aim to enrich critical capabilities across Japan’s academic and entrepreneurial communities to foster the development of globally competitive life science startups.

"Alloy’s capabilities and global network bring a highly complementary strength to our mission of empowering academic startups to compete internationally. Alloy Japan offers a highly distinct and complementary contribution to our activities with Global Incubators and Venture Capital firms," said Koji Murota, Director-General of the Office of Institutional Advancement and Communications at Kyoto University, representing KSAC. "By collaborating with ecosystem builders like Alloy Japan, we can provide our researchers and entrepreneurs with access to additional scientific resources, global Biopharma insights, and opportunities to scale their innovations beyond Japan."

As a first step, Alloy Japan will support KSAC’s GAP Fund program, which provides funding to selected academic projects within the KSAC network. Over the three-year term of the MOU, the collaboration is expected to expand to additional KSAC initiatives aimed at building a globally integrated and innovation-driven biotech community.

"Our collaboration with KSAC builds on Alloy Japan’s commitment to deep, sovereign partnerships that nurture innovation at the academic and early translational stages," said Victor Stone (Yoshihide Ishii), CEO of Alloy Japan. "By working alongside KSAC and its network of universities, we aim to strengthen the bridge between Japanese academic excellence and the Biopharma ecosystem, accelerating the global growth of life science startups."

On July 21, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions for urothelial and specialty cancers, reported the publication of results of a five-year long-term extension study of the Phase 2b OPTIMA II trial evaluating ZUSDURI (mitomycin) for intravesical solution in patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) demonstrating durable, long-term complete responses (CRs) in patients who initially achieved a CR following treatment with ZUSDURI (Press release, UroGen Pharma, JUL 21, 2025, View Source [SID1234654465]). The publication, titled "Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer With UGN-102: Outcomes From the 5-year Long-Term Extension Study of the Single-Arm, Phase 2b OPTIMA II Study", is now available online at View Source

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"Low-grade intermediate-risk bladder cancer is a chronic, recurring disease that often requires repeated surgical intervention," said Neal D. Shore, MD, FACS Medical Director for the START Carolinas/Carolina Urologic Research Center and lead author of the study. "The long-term data from the extension study of OPTIMA II highlight ZUSDURI’s ability to deliver sustained responses in an outpatient setting, which may be especially valuable for recurrent patients and thus for physicians who prefer a different, non-surgical treatment option."

Among the 41 patients who achieved CR at three months post-treatment with ZUSDURI in the OPTIMA II trial, 25 remained in CR at 12 months and 17 entered the long-term follow-up study. For the 41 patients achieving CR at three months, the median Kaplan-Meier estimate of duration of response (DOR) was 24.2 months (95% CI 9.7, 42.1) with a median follow-up of 35.8 months. For the 17 patients in the long-term follow-up study, the median DOR was 42.1 months by Kaplan-Meier estimate (95% CI: 24.2, NE), with a median follow-up of 50.4 months. These results build upon previously published 12-month DOR data, showing ZUSDURI’s potential to deliver meaningful, lasting event-free periods.

"These results reflect our continued commitment to bringing forward innovative treatments that give patients and physicians more options," said Mark Schoenberg, MD, Chief Medical Officer, UroGen. "For recurrent patients facing repeated surgeries, it offers a non-surgical approach that can empower patients and providers to choose a path that best fits individual needs and preferences."

Safety data were not collected during the long-term follow-up trial. The most commonly reported treatment emergent adverse events (>10% of patients) from the parent OPTIMA II study were dysuria in 26 (41% of patients); pollakiuria in 13 (21%); hematuria in 10 (16%); urgency to urinate or urinary tract infection, both occurring in 9 (14%); and fatigue in 7 (11%).

The OPTIMA II trial included both newly diagnosed and recurrent adult patients with LG-IR-NMIBC. Of the 17 patients that entered long-term follow up, 16 (94%) were recurrent and 1 (6%) was newly diagnosed. This cohort of patients had a median DOR of 3.5 years by Kaplan-Meier estimate. ZUSDURI is indicated only for the treatment of adults with recurrent LG-IR-NMIBC.

About ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, ZUSDURI is delivered directly into the bladder in an out-patient procedure by a trained healthcare professional using a urinary catheter to enable the treatment of tumors by non-surgical means. Visit ZUSDURI.com for more information.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

LG-IR-NMIBC affects around 82,000 people in the U.S. every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include trans-urethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.

About OPTIMA II

OPTIMA II (OPTimized Instillation of Mitomycin for Bladder Cancer Treatment) was an open-label, single-arm, multi-center Phase 2b clinical trial of ZUSDURI to evaluate its safety and efficacy in patients with LG-IR-NMIBC.

Learn more about the Phase 2b OPTIMA II trial at www.clintrials.gov (NCT03558503).

On July 21, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage oncology company leveraging its proprietary RADR artificial intelligence (AI) platform to accelerate drug discovery, reported that the European Patent Office (EPO) has issued a notice of allowance for a composition of matter patent covering its drug candidate LP-284 (Press release, Lantern Pharma, JUL 21, 2025, View Source [SID1234654464]). This patent, expected to be granted in the coming months with exclusivity through early 2039, strengthens Lantern’s global intellectual property (IP) portfolio and supports the development and commercialization path for LP-284, a novel therapy in development for relapsed or refractory non-Hodgkin’s lymphoma (NHL), including mantle cell lymphoma (MCL) and high-grade B-cell lymphomas (HGBL).

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LP-284, a next-generation acylfulvene, was optimized using Lantern’s RADR platform, which identified its synthetically lethal mechanism targeting cancer cells with DNA damage repair deficiencies. Currently in a Phase 1 clinical trial (NCT06132503), LP-284 has demonstrated preclinical potential in addressing aggressive NHL subtypes, including MCL and double-hit lymphoma (DHL). The drug candidate has earned Orphan Drug Designations from the U.S. FDA for both MCL and HGBL, highlighting its role in tackling rare cancers with significant unmet needs.

Expanding Global Patent Protection

The EU patent complements a composition of matter patent granted in Japan (June 2024) and the U.S. (April 2023), with additional patent allowances grants in India and Mexico, and applications pending in China, Australia, Canada, and Korea. This expanding international IP portfolio positions LP-284 for global commercialization and strategic partnerships.

"The EU patent allowance for LP-284 is a critical milestone that enhances our ability to deliver this AI-advanced therapy to patients globally," said Panna Sharma, President and CEO of Lantern Pharma. "Our RADR platform enabled us to rapidly advance LP-284’s unique mechanism, achieving clinical trial readiness in under three years at a cost of approximately $1.5 to $2.0 million. This patent reinforces our commitment to precision oncology and creates opportunities for strategic collaborations with biotech partners."

Addressing Significant Market Need

LP-284 targets a global market estimated at $4 billion annually for blood cancers, driven by the rising incidence of NHL globally. Nearly all patients diagnosed with aggressive NHL subtypes like MCL will relapse after treatment, creating an urgent need for novel therapeutic approaches.

Lantern’s RADR platform, powered by over 200 billion oncology-focused data points and 200+ machine learning algorithms, has streamlined LP-284’s development, reducing timelines and costs compared to traditional drug discovery. This efficiency and capability positions Lantern to attract investment and partnerships with biotech and pharma companies seeking innovative oncology solutions.

About LP-284

LP-284 is an investigational next-generation acylfulvene designed to exploit synthetic lethal interactions in cancer cells with DNA damage repair deficiencies. Developed with guidance from Lantern’s AI platform RADR, LP-284 represents a novel therapeutic approach for treating relapsed or refractory non-Hodgkin’s lymphoma and other hematologic malignancies. The compound is currently being evaluated in a Phase 1 clinical trial (NCT06132503) to determine its safety profile, optimal dosing, and preliminary efficacy in patients with aggressive NHL subtypes who have failed standard therapies.

LP-284 has received multiple Orphan Drug Designations from the U.S. FDA, including designations for mantle cell lymphoma and high-grade B-cell lymphomas, recognizing its potential to address significant unmet medical needs in rare cancer populations.