Oncolytics Biotech® to Engage FDA for Potential Registration-Enabled Study in First-Line Pancreatic Cancer with Goal to Launch Trial Activities by Year-End

On July 29, 2025 Oncolytics Biotech Inc. (Nasdaq: ONCY) (TSX: ONC) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported it has initiated regulatory discussions with the U.S. Food and Drug Administration (FDA) for a potential registration-enabled pivotal study in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) (Press release, Oncolytics Biotech, JUL 29, 2025, View Source [SID1234654603]). Assuming discussions with the FDA go as expected, the Company expects to commence study start-up activities before the end of 2025.

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This milestone reflects Oncolytics’ conviction in pelareorep’s differentiated mechanism of action and its encouraging survival signal in one of the most lethal and underserved solid tumors. The FDA interaction will focus on finalizing a clinical trial design that leverages pelareorep’s demonstrated synergy with chemotherapy with or without checkpoint inhibition, and overall survival as the primary endpoint. Among the potential options, Oncolytics will consider proposing an adaptive study in collaboration with a third party.

"We expect to move quickly and decisively down a clear regulatory path," said Jared Kelly, Chief Executive Officer of Oncolytics. "This is about execution and focus. Our goal is to win on survival—and this pivotal study is how we do it. We believe this program not only creates significant value for shareholders but also positions Oncolytics as a highly attractive partner for pharma companies seeking to break open the immunotherapy landscape in mPDAC and other GI tumors."

Oncolytics’ recent Key Opinion Leader event reinforced the clinical promise of pelareorep in mPDAC and other gastrointestinal (GI) cancers, including KRAS-mutated colorectal cancer, and validated its ability to transform "cold" tumors into immunologically active ones. Experts emphasized the scarcity of innovation in pancreatic cancer and the urgent demand for new immunotherapies that can deliver a survival benefit in this setting.

With Fast Track and Orphan Drug designations in mPDAC and translational data supporting pelareorep’s immunologic activity, the Company believes it is well-positioned to engage potential partners seeking to bolster their GI oncology pipelines. The upcoming regulatory discussions and planned trial initiation represent major catalysts for strategic collaboration and long-term value creation.

Additional information on the study design, timelines, and next steps will be provided following regulatory feedback.

NanoCell Announces Publication of Research Data in Journal for ImmunoTherapy of Cancer Demonstrating First-in-Class Non-Viral DNA-Based In Vivo CAR-T Generation

On July 29, 2025 NanoCell Therapeutics, Inc. ("NanoCell"), a biotechnology company developing a non-viral, DNA-based in vivo gene therapy platform, reported the publication of research data in the Journal for ImmunoTherapy of Cancer demonstrating its novel targeted lipid nanoparticle delivery system, termed NCtx (Press release, NanoCell Therapeutics, JUL 29, 2025, View Source [SID1234654602]). This technology enables the direct in vivo generation of chimeric antigen receptor T-cells (CAR-T), potentially transforming the accessibility and scalability of CAR-T therapies for cancer patients worldwide.

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The study, titled "T cell-specific non-viral DNA delivery and in vivo CAR-T generation using targeted lipid nanoparticles," represents the first successful demonstration of efficient non-viral DNA delivery to T cells in vivo, positioning NCtx as a promising advancement in the field of in vivo CAR-T therapy.

While CAR-T therapy has shown remarkable success in treating hematologic malignancies, current approaches face significant barriers including high manufacturing costs (approximately $300,000 per patient), complex logistics, lengthy manufacturing times, and limited patient access due to specialized facility requirements. The NCtx platform co-delivers minicircle DNA encoding a CAR construct and transposase mRNA in a single targeted nanoparticle, enabling stable genomic integration and durable CAR expression. The system utilizes dual CD7/CD3 targeting to achieve T cell specificity while activating cells for enhanced DNA uptake.

Researchers demonstrated that a single intravenous dose of NCtx led to robust CAR-T cell generation in multiple humanized mouse models, effective tumor control and significantly extended survival, durable CAR expression and functional anti-tumor activity at doses as low as 4 µg/kg.

"This research demonstrates a new path forward for CAR-T therapy," said Dr. Jacek Lubelski, senior author and CTO at NanoCell Therapeutics. "By enabling in vivo CAR-T generation through a single, targeted nanoparticle injection, we can potentially dramatically simplify treatment protocols while expanding access in the future to patients worldwide who currently cannot benefit from conventional CAR-T therapies."

Results were generated using a dual-CAR construct targeting CD19 and CD22, developed by Shanghai Cell Therapy Group (SHCell) View Source

"Our collaboration with SHCell underscores the power of combining innovative delivery platforms with cutting-edge CAR designs," said Dr. Maurits Geerlings, CEO and President of NanoCell Therapeutics. "We are excited about the potential of this partnership to accelerate the development of transformative therapies for patients with B cell cancers and beyond."

The platform’s modular design enables rapid adaptation for multiple therapeutic targets across oncology and autoimmune diseases. The study was conducted by research teams at NanoCell Therapeutics and the University Medical Centre Utrecht, with support from the European Union’s Horizon Europe and Horizon 2020 research programs.

As NanoCell continues to advance its NCtx platform, the company is expected to pursue an IMPD application pending financing, marking a critical step toward clinical development.

Merck & Co., Inc., Rahway, N.J., USA Announces Second-Quarter 2025 Financial Results

On July 29, 2025 Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), known as MSD outside the United States and Canada, reported financial results for the second quarter of 2025 (Press release, Merck & Co, JUL 29, 2025, View Source [SID1234654601]).

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"Earlier this month, we were pleased to announce our pending acquisition of Verona Pharma, which augments our portfolio and pipeline and is another example of acting decisively when science and value align," said Robert M. Davis, chairman and chief executive officer. "Today, we announced a multiyear optimization initiative that will redirect investment and resources from more mature areas of our business to our burgeoning array of new growth drivers, further enable the transformation of our portfolio, and drive our next chapter of productive, innovation-driven growth. With these actions, I am confident that we are well positioned to generate near- and long-term value for our shareholders and, most importantly, deliver for our patients."

Financial Summary

$ in millions, except EPS amounts

Second Quarter

2025

2024

Change

Change Ex-
Exchange

Sales

$15,806

$16,112

-2%

-2%

GAAP net income2

4,427

5,455

-19%

-17%

Non-GAAP net income that excludes certain items2,3*

5,366

5,809

-8%

-6%

GAAP EPS

1.76

2.14

-18%

-16%

Non-GAAP EPS that excludes certain items3*

2.13

2.28

-7%

-5%

*Refer to table on page 7.

For the second quarter of 2025, Generally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $1.76 and non-GAAP EPS was $2.13. GAAP and non-GAAP EPS in the second quarter of 2025 include a charge of $0.07 per share for an upfront payment to Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) upon closing of a license agreement. Non-GAAP EPS excludes acquisition- and divestiture-related costs, costs related to restructuring programs, and income and losses from investments in equity securities. Non-GAAP EPS in the second quarter of 2025 also excludes tax benefits primarily resulting from favorable audit adjustments. Non-GAAP EPS in the second quarter of 2024 also excludes a tax benefit due to a reduction in reserves for unrecognized income tax benefits, resulting from the expiration of the statute of limitations for assessments related to the 2019 federal tax return year.

Year-to-date results can be found in the attached tables.

Second-Quarter Sales Performance
The following table reflects sales of the Company’s top products and significant performance drivers.

Second Quarter

$ in millions

2025

2024

Change

Change Ex-
Exchange

Commentary

Total Sales

$15,806

$16,112

-2%

-2%

Pharmaceutical

14,050

14,408

-2%

-3%

Decline primarily due to vaccines and immunology, partially offset by growth in oncology and cardiology.

KEYTRUDA

7,956

7,270

9%

9%

Growth driven by continued strong global demand from metastatic indications, including bladder, endometrial and gastric cancers, and increased global uptake in earlier-stage indications, including triple-negative breast cancer, renal cell carcinoma (RCC) and cervical cancer, as well as non-small cell lung cancer in the U.S.

GARDASIL/GARDASIL 9

1,126

2,478

-55%

-55%

Decline primarily due to lower demand in China. Excluding China, sales declined 3%, or 4% excluding impact of foreign exchange, reflecting lower demand in Japan following a national catch-up immunization program, as well as timing of public-sector purchases in certain international markets. U.S. sales increased 2% in the quarter.

JANUVIA/JANUMET

623

629

-1%

Decrease primarily attributable to lower demand in China, impacts of generic competition in most international markets, and lower demand in the U.S. due to competitive pressure, which were largely offset by higher net pricing in the U.S.

PROQUAD, M-M-R II and VARIVAX

609

617

-1%

-2%

Decrease primarily reflects lower U.S. sales due to unfavorable VARIVAX public-sector activity and M-M-R II private-sector buy-out, partially offset by partial replenishment of PROQUAD doses borrowed from the U.S. Centers for Disease Control and Prevention (CDC) Pediatric Vaccine Stockpile, and higher pricing.

BRIDION

461

455

1%

1%

Increase primarily due to higher demand in the U.S., partially offset by lower demand in most international markets due to ongoing generic competition.

Lynparza*

370

317

17%

15%

Growth primarily due to higher demand in the U.S. and certain international markets.

WINREVAIR

336

70

N/M

N/M

Growth reflects continued uptake since second-quarter 2024 launch in the U.S.

Lenvima*

265

249

6%

5%

Increase primarily due to higher sales in the U.S. reflecting higher demand, partially offset by lower pricing.

VAXNEUVANCE

229

189

21%

20%

Growth primarily due to favorable public-sector activity in the U.S. and increased demand in certain international markets, partially offset by lower demand in the U.S. and Japan due to competitive pressure.

PREVYMIS

228

188

21%

20%

Growth primarily due to higher demand in the U.S. and Europe, partially offset by lower demand in China due to generic competition.

WELIREG

162

126

29%

29%

Growth primarily driven by higher demand in the U.S. and early launch uptake in certain EU markets, partially offset by lower pricing in the U.S.

CAPVAXIVE

129

Represents continued uptake since third-quarter 2024 launch in the U.S.

SIMPONI

172

-100%

-100%

Marketing rights in former territories of the Company reverted to Johnson & Johnson on Oct. 1, 2024.

Animal Health

1,646

1,482

11%

11%

Growth primarily due to higher demand for Livestock products, as well as inclusion of sales from Elanco aqua business acquired in July 2024, higher pricing and improved supply.

Livestock

961

837

15%

16%

Growth primarily driven by higher demand across all species, as well as inclusion of sales from Elanco aqua business acquired in July 2024.

Companion Animal

685

645

6%

6%

Increase primarily driven by higher pricing. Sales of BRAVECTO were $335 million and $331 million in current and prior year quarters, respectively, which represents an increase of 1%, both nominally and excluding impact of foreign exchange.

Other Revenues**

110

222

-50%

-3%

Primarily due to unfavorable impact of revenue-hedging activities.

*Alliance revenue for this product represents the Company’s share of profits, which are product sales net of cost of sales and commercialization costs.

**Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities.

N/M- Not meaningful.

Second-Quarter Expense, EPS and Related Information
The table below presents selected expense information.

$ in millions

GAAP

Acquisition-
and
Divestiture-
Related Costs4

Restructuring
Costs

(Income)
Loss From
Investments
in Equity
Securities

Non-
GAAP3

Second Quarter 2025

Cost of sales

$3,557

$576

$165

$-

$2,816

Selling, general and administrative

2,649

15

1

2,633

Research and development

4,048

3

53

3,992

Restructuring costs

560

560

Other (income) expense, net

(7)

(61)

54

Second Quarter 2024

Cost of sales

$3,745

$606

$66

$-

$3,073

Selling, general and administrative

2,739

24

31

2,684

Research and development

3,500

20

3,480

Restructuring costs

80

80

Other (income) expense, net

42

(17)

(49)

108

GAAP Expense, EPS and Related Information
Gross margin was 77.5% for the second quarter of 2025 compared with 76.8% for the second quarter of 2024. The increase was primarily due to the favorable impact of product mix, partially offset by higher restructuring costs and inventory write-offs.

Selling, general and administrative (SG&A) expenses were $2.6 billion in the second quarter of 2025, a decrease of 3% compared with the second quarter of 2024. The decrease was primarily due to lower administrative, restructuring and promotional costs.

Research and development (R&D) expenses were $4.0 billion in the second quarter of 2025, an increase of 16% compared with the second quarter of 2024. The increase was primarily due to a $200 million charge for an upfront payment made in the second quarter of 2025 for a license agreement with Hengrui Pharma, increased clinical development spending, higher compensation and benefit costs, and higher restructuring costs.

Other (income) expense, net, was $7 million of income in the second quarter of 2025 compared with $42 million of expense in the second quarter of 2024.

The effective tax rate of 11.4% for the second quarter of 2025 includes a 2.9 percentage point favorable impact due to tax benefits primarily resulting from favorable audit adjustments.

GAAP EPS was $1.76 for the second quarter of 2025 compared with $2.14 for the second quarter of 2024. The decrease reflects increased operating expenses driven by higher restructuring costs and research and development spending, a charge related to the closing of a license agreement with Hengrui Pharma, unfavorable tax impacts, and the unfavorable impact of foreign exchange.

Non-GAAP Expense, EPS and Related Information
Non-GAAP gross margin was 82.2% for the second quarter of 2025 compared with 80.9% for the second quarter of 2024. The increase was primarily due to the favorable impact of product mix, partially offset by higher inventory write-offs.

Non-GAAP SG&A expenses were $2.6 billion in the second quarter of 2025, a decrease of 2% compared with the second quarter of 2024. The decrease was primarily due to lower administrative and promotional costs.

Non-GAAP R&D expenses were $4.0 billion in the second quarter of 2025, an increase of 15% compared with the second quarter of 2024. The increase was primarily due to a $200 million charge for an upfront payment made in the second quarter of 2025 for a license agreement with Hengrui Pharma, increased clinical development spending, and higher compensation and benefit costs.

Non-GAAP other (income) expense, net, was $54 million of expense in the second quarter of 2025 compared with $108 million of expense in the second quarter of 2024.

The non-GAAP effective tax rate was 15.0% for the second quarter of 2025.

Non-GAAP EPS was $2.13 for the second quarter of 2025 compared with $2.28 for the second quarter of 2024. The decrease reflects increased operating expenses driven by higher research and development spending, a charge related to the closing of a license agreement with Hengrui Pharma, and the unfavorable impact of foreign exchange.

A reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows.

Second Quarter

$ in millions, except EPS amounts

2025

2024

EPS

GAAP EPS

$1.76

$2.14

Difference

0.37

0.14

Non-GAAP EPS that excludes items listed below3

$2.13

$2.28

Net Income

GAAP net income2

$4,427

$5,455

Difference

939

354

Non-GAAP net income that excludes items listed below2,3

$5,366

$5,809

Excluded Items:

Acquisition- and divestiture-related costs4

$594

$633

Restructuring costs

779

177

Income from investments in equity securities

(61)

(49)

Decrease to net income before taxes

1,312

761

Estimated income tax (benefit) expense5

(373)

(407)

Decrease to net income

$939

$354

Planned Acquisition of Verona Pharma
On July 9, 2025, the Company furthered its science-led business development strategy by announcing an agreement under which the Company, through a subsidiary, will acquire Verona Pharma plc (Verona Pharma) for $107 per American Depository Share, each of which represents eight Verona Pharma ordinary shares, for a total transaction value of approximately $10 billion. Through the acquisition, the Company will add Ohtuvayre, a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4), to its growing cardio-pulmonary pipeline and portfolio.

The U.S. Food and Drug Administration (FDA) approved Ohtuvayre in June 2024 for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. It is the first novel inhaled mechanism for the treatment of COPD in more than 20 years. The transaction is anticipated to close in the fourth quarter of 2025.

Pipeline and Portfolio Highlights
In the second quarter, the Company continued to advance its broad and diverse pipeline with multiple regulatory and clinical milestones.

In oncology, the FDA approved KEYTRUDA as part of a therapy regimen for the treatment of certain adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC), based on results from the Phase 3 KEYNOTE-689 trial. This approval is the first perioperative anti-PD-1 treatment regimen for adults with resectable locally advanced HNSCC whose tumors express PD-L1 (CPS ≥1). In addition, the Ministry of Health, Labor and Welfare (MHLW) in Japan approved WELIREG as monotherapy for the treatment of adults with von Hippel-Lindau (VHL) disease-associated tumors, and for adults with unresectable or metastatic RCC that has progressed after chemotherapy.

At the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the Company announced new research across more than 25 types of cancer in multiple treatment settings. Data were presented for several candidates, including MK-1084, an investigational oral selective KRAS G12C inhibitor, and from the Company’s pipeline of antibody-drug conjugates (ADCs). The Company also presented data from Phase 3 trials evaluating new combination regimens with KEYTRUDA, and longer-term data for studies of KEYTRUDA and WELIREG, with the KEYTRUDA studies including people with earlier stages of cancer.

The Company announced results from the Phase 3 KEYNOTE-B96 trial (also known as ENGOT-ov65) evaluating KEYTRUDA plus chemotherapy, which met its primary endpoint of progression-free survival (PFS) for the treatment of patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 and in all comers, as well as a secondary endpoint of overall survival (OS) in patients whose tumors express PD-L1. In addition, a pre-specified interim analysis of the Phase 3 KEYNOTE-937 study found that compared to placebo, KEYTRUDA did not show a statistically significant improvement in the primary endpoint of recurrence-free survival for certain patients with hepatocellular carcinoma. Also, a pre-specified interim analysis of the Phase 3 LEAP-014 trial found that KEYTRUDA plus Lenvima, in combination with platinum-based chemotherapy, did not show a statistically significant improvement in its primary endpoint of OS compared to KEYTRUDA plus chemotherapy for the first-line treatment of patients with metastatic esophageal squamous cell carcinoma (ESCC).

In vaccines and infectious diseases, the Company received FDA approval of ENFLONSIA for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants who are born during or entering their first RSV season. ENFLONSIA is the first and only RSV preventive option administered to infants using the same dose regardless of weight. The CDC’s Advisory Committee on Immunization Practices (ACIP) also recommended ENFLONSIA for the prevention of RSV in infants younger than 8 months of age born during or entering their first RSV season. In addition, the Company announced initiation of the MOBILIZE-1 Phase 3 trial evaluating V181, an investigational single-dose quadrivalent vaccine for the prevention of dengue disease.

In addition, the FDA accepted a New Drug Application (NDA) for doravirine/islatravir, an investigational, once-daily, oral, two-drug regimen for the treatment of adults with virologically suppressed HIV-1 based on the Phase 3 MK-8591A-051 and MK-8591A-052 trials. The FDA set a Prescription Drug User Fee Act (PDUFA) date of April 28, 2026. The Company also announced the initiation of the EXPrESSIVE Phase 3 trials for MK-8527, its investigational once-monthly oral candidate for HIV pre-exposure prophylaxis (PrEP).

In cardiovascular disease, the Company announced positive topline results from Phase 3 CORALreef HeFH and CORALreef AddOn, the first two of three Phase 3 clinical trials evaluating the safety and efficacy of enlicitide decanoate, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for the treatment of adults with hyperlipidemia already on lipid-lowering therapies, including at least a statin. In both trials, enlicitide demonstrated statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol. If approved, it would be the first marketed oral PCSK9 inhibitor.

In addition, the FDA granted priority review for a new supplemental Biologics License Application for WINREVAIR seeking approval to update the U.S. product label based on compelling results from the Phase 3 ZENITH trial. The FDA has set a PDUFA date of Oct. 25, 2025. The Company also provided an update on the Phase 3 HYPERION study evaluating WINREVAIR in recently diagnosed adults with pulmonary arterial hypertension (PAH). In the study, WINREVAIR added on top of background therapy within 12 months after initial diagnosis of PAH demonstrated a statistically significant and clinically meaningful reduction in the risk of clinical worsening events when compared to placebo. Further, the MHLW in Japan approved sotatercept for the treatment of adults with PAH under the trademark AIRWIN. It is the first activin signaling inhibitor therapy for PAH approved in Japan.

In the Animal Health business, the FDA approved BRAVECTO QUANTUM, an injectable formulation of BRAVECTO for dogs for the treatment and persistent killing of fleas and ticks. In addition, the European Commission (EC) approved NUMELVI tablets for dogs, a once-daily, second-generation Janus kinase (JAK) inhibitor, indicated for the treatment of pruritus associated with allergic dermatitis including atopic dermatitis and treatment of clinical manifestations of atopic dermatitis.

Notable recent news releases on the Company’s pipeline and portfolio are provided in the table that follows. Visit the News Releases section of the Company’s website to read the releases*.

Oncology

FDA Approved KEYTRUDA for PD-L1+ Resectable Locally Advanced HNSCC as Neoadjuvant Treatment, Continued as Adjuvant Treatment Combined With Radiotherapy With or Without Cisplatin Then as a Single Agent; Based on Results From Phase 3 KEYNOTE-689 Trial

FDA Approved WELIREG for Treatment of Adults and Pediatric Patients 12 Years and Older With Locally Advanced, Unresectable, or Metastatic Pheochromocytoma or Paraganglioma; Based on Results From Phase 2 LITESPARK-015 Clinical Trial

Phase 3 KEYNOTE-B96 Trial Met Primary Endpoint of PFS in Patients With Platinum-Resistant Recurrent Ovarian Cancer Whose Tumors Expressed PD-L1 and in All Comers

KEYTRUDA Plus Trodelvy Reduced Risk of Disease Progression or Death by 35% Versus KEYTRUDA Plus Chemotherapy in First-Line PD-L1+ Metastatic Triple-Negative Breast Cancer; Based on Results From Phase 3 ASCENT-04/KEYNOTE-D19 Trial

MK-1084, an Investigational KRAS G12C Inhibitor, Showed Antitumor Activity in Phase 1 Trial of Patients With Advanced Colorectal Cancer and Non-Small Cell Lung Cancer Whose Tumors Harbor KRAS G12C Mutations

Investigational Zilovertamab Vedotin at 1.75 mg/kg Dose Plus Standard of Care Showed Promising Antitumor Activity, Including Complete Response Rate, in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma; Based on Results From Phase 2 WaveLINE-003 Trial

IDeate-Prostate01 Phase 3 Trial of Ifinatamab Deruxtecan Initiated in Patients With Pretreated Metastatic Castration-Resistant Prostate Cancer

IDeate-Esophageal01 Phase 3 Trial of Ifinatamab Deruxtecan Initiated in Certain Patients With Pretreated Advanced or Metastatic ESCC

Vaccines and
Infectious Diseases

FDA Approved ENFLONSIA for Prevention of RSV Lower Respiratory Tract Disease in Infants Born During or Entering Their First RSV Season; Based on Results From Phase 2b/3 CLEVER Trial

ACIP Recommended Use of ENFLONSIA for Prevention of RSV Lower Respiratory Tract Disease in Infants Younger Than 8 Months of Age Born During or Entering Their First RSV Season

FDA Accepted NDA for Doravirine/Islatravir, an Investigational, Once-Daily, Oral, Two-Drug Regimen for Treatment of Adults With Virologically Suppressed HIV-1; Based on Results From Phase 3 MK-8591A-051 and MK-8591A-052 Trials; FDA Set PDUFA Date of April 28, 2026

EXPrESSIVE Phase 3 Trials Initiated for Investigational Once-Monthly HIV Prevention Pill, MK-8527

The Company Initiated MOBILIZE-1 Phase 3 Study Evaluating Dengue Vaccine Candidate

Cardiovascular

FDA Granted Priority Review for WINREVAIR to Update Label Based on Results From ZENITH Trial; FDA Set PDUFA Date of Oct. 25, 2025

The Company Announced Positive Topline Results From First Two Phase 3 CORALreef Trials Evaluating Enlicitide Decanoate for the Treatment of Adults With Hyperlipidemia

Phase 3 HYPERION Study of WINREVAIR Met Primary Endpoint in Recently Diagnosed Adults With PAH

Animal Health

FDA Approved BRAVECTO QUANTUM

EC Approved NUMELVI Tablets for Dogs

*References to the Company’s name in the above news release titles have been modified for the purpose of this announcement.

New Multiyear Optimization Initiative, Which Includes a Restructuring Program
The Company launched a new multiyear optimization initiative to enable the transformation of its portfolio by generating an expected $3.0 billion in annual cost savings from productivity actions, which will be fully reinvested to support new product launches and its pipeline across multiple therapeutic areas.

In July 2025, as part of this initiative, the Company approved a new restructuring program, in which it expects to eliminate certain administrative, sales and R&D positions. The Company will, however, continue to hire employees into new roles across strategic growth areas of the business. In addition, the Company will reduce its global real estate footprint and continue to optimize its manufacturing network, aligning the geography of its global manufacturing to its customers and reflecting changes in the Company’s business.

The Company anticipates cumulative pretax costs related to the program to be approximately $3.0 billion. For the second quarter of 2025, the Company recorded charges in its GAAP results of $649 million related to this restructuring program.

The Company expects the actions under the restructuring program to result in annual cost savings of approximately $1.7 billion, which will be substantially realized by the end of 2027. This restructuring program is part of the multiyear optimization initiative expected to achieve $3.0 billion in annual cost savings by the end of 2027.

Manufacturing and R&D Investment
The Company continued to make long-term investments in its U.S. manufacturing and R&D capabilities. This includes the start of construction for a $1.0 billion, 470,000-square-foot state-of-the-art biologics center of excellence in Wilmington, Delaware, which will serve as a launch and commercial production facility and the primary U.S. manufacturing site for KEYTRUDA. In addition, the Company announced an $895 million expansion of its Animal Health manufacturing facility in De Soto, Kansas; the 200,000-square-foot facility will increase capacity for Animal Health vaccines and biologic products.

Full-Year 2025 Financial Outlook
The following table summarizes the Company’s full-year financial outlook.

Full Year 2025

Updated

Prior

Sales*

$64.3 billion to $65.3 billion

$64.1 billion to $65.6 billion

Non-GAAP Gross margin3

Approximately 82%

Approximately 82%

Non-GAAP Operating expenses3**

$25.6 billion to $26.4 billion

$25.6 billion to $26.6 billion

Non-GAAP Other (income) expense, net3

$300 million to $400 million expense

$300 million to $400 million expense

Non-GAAP Effective tax rate3

15.0% to 16.0%

15.5% to 16.5%

Non-GAAP EPS3***

$8.87 to $8.97

$8.82 to $8.97

Share count (assuming dilution)

Approximately 2.51 billion

Approximately 2.51 billion

*The Company does not have any non-GAAP adjustments to sales.

**Includes one-time R&D charges of $300 million for a milestone payment to LaNova Medicines Ltd. (LaNova) associated with the technology transfer for MK-2010 expected to be recorded in the third quarter of 2025 and $200 million for the upfront payment for the license agreement completed with Hengrui Pharma in the second quarter of 2025.

Outlook does not assume any additional significant potential business development transactions.

***Includes one-time charges totaling $0.16 per share associated with the payment for the LaNova technology transfer for MK-2010 and upfront payment to Hengrui Pharma.

The Company has not provided a reconciliation of forward-looking non-GAAP gross margin, non-GAAP operating expenses, non-GAAP other (income) expense, net, non-GAAP effective tax rate and non-GAAP EPS to the most directly comparable GAAP measures, given it cannot predict with reasonable certainty the amounts necessary for such a reconciliation, including intangible asset impairment charges, legal settlements, and income and losses from investments in equity securities either owned directly or through ownership interests in investment funds, without unreasonable effort. These items are inherently difficult to forecast and could have a significant impact on the Company’s future GAAP results.

The Company now expects full-year 2025 sales to be between $64.3 billion and $65.3 billion, including a revised negative impact of foreign exchange of approximately 0.5% at mid-July 2025 exchange rates.

The Company now expects its full-year non-GAAP effective income tax rate to be between 15.0% and 16.0%.

The Company now expects its full-year non-GAAP EPS to be between $8.87 and $8.97, including a revised negative impact of foreign exchange of approximately $0.15 per share. This revised non-GAAP EPS range continues to reflect the impacts of a one-time charge of $200 million (recorded in the second quarter of 2025) for an upfront payment made in connection with the closing of a license agreement with Hengrui Pharma and the one-time charge of $300 million (to be recorded in the third quarter of 2025) related to a payment to LaNova for the completion of the technology transfer for MK-2010, which will impact EPS by approximately $0.16 in the aggregate. In 2024, non-GAAP EPS of $7.65 was negatively impacted by a net charge of $1.28 per share related to certain asset acquisitions, licensing agreements and collaborations.

The financial outlook does not include the anticipated impact of the announced acquisition of Verona Pharma.

Consistent with past practice, the financial outlook does not assume additional significant potential business development transactions.

The $200 million of costs previously included in the Company’s financial outlook related to the impact of tariffs is unchanged pending the outcome of additional potential government actions.

Earnings Conference Call
Investors, journalists and the general public may access a live audio webcast of the call on Tuesday, July 29, at 9 a.m. ET via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures and slides highlighting the results, will be available on the Company’s website.

All participants may join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 9818590.

INNATE PHARMA ANNOUNCES ITS PARTICIPATION IN BTIG VIRTUAL BIOTECHNOLOGY CONFERENCE

On July 29, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that the company’s CEO Jonathan Dickinson and COO Yannis Morel will participate in the BTIG Virtual Biotechnology Conference being held on July 29-30, 2025 (Press release, Innate Pharma, JUL 29, 2025, View Source [SID1234654600]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BTIG, a global financial services firm specializing in investment banking, institutional trading, research and related brokerage services, recently initiated analyst coverage of Innate Pharma.

The Fireside chat will be held on Wednesday July 30 at 2pm EST, with 1×1 meetings hosted the same day.

About BTIG

BTIG is a global financial services firm specializing in institutional trading, investment banking, research and related brokerage services. With an extensive global footprint and more than 700 employees, BTIG, LLC and its affiliates operate out of 20 cities throughout the U.S., and in Europe, Asia and Australia. BTIG offers execution, expertise and insights for equities, equity derivatives, ETFs and fixed income, currency and commodities.

Incyte Reports 2025 Second Quarter Financial Results and Provides Updates
on Key Clinical Programs

On July 29, 2025 Incyte (Nasdaq:INCY) reported 2025 second quarter financial results, and provides a status update on the Company’s clinical development portfolio (Press release, Incyte, JUL 29, 2025, View Source [SID1234654599]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"As I begin my tenure as CEO, I look forward to leading Incyte through its next phase of growth and value creation for patients, partners and shareholders. Our second quarter results reflect strong growth for Jakafi (ruxolitinib), Opzelura (ruxolitinib) cream and Niktimvo (axatilimab), positioning us well to deliver on our 2025 objectives," said Bill Meury, Chief Executive Officer, Incyte. "During the quarter, we achieved two regulatory milestones with the approvals of Zynyz (retifanlimab-dlwr) for squamous cell anal carcinoma and Monjuvi (tafasitamab-cxix) for follicular lymphoma, further expanding our ability to address patients’ needs. Continued progress and diversification of our portfolio, including advancements with povorcitinib and mutCALR, are strengthening the foundation for sustainable, long-term growth."

Key Commercial Highlights
Jakafi:
Net product revenues for the second quarter 2025 of $764 million (+8% Y/Y):
▪Net product revenue growth in the second quarter of 2025 versus the same quarter in the prior year, was driven by an increase in paid demand of 8% reflecting continued demand growth in all indications. Jakafi inventory levels were within normal range at the end of the second quarter of 2025.

Opzelura:
Net product revenues for the second quarter 2025 of $164 million (+35% Y/Y):
▪U.S. net product revenue of $132 million in the second quarter of 2025 increased 19% compared to the second quarter of 2024 driven by increased patient demand and refills in both atopic dermatitis (AD) and vitiligo. Opzelura inventory levels were within normal range at the end of the second quarter of 2025.
▪Ex-U.S. net product revenues of $32 million in the second quarter of 2025 were primarily driven by continued growth in sales in France, and the recent launches in Italy and Spain.
Pipeline Updates
Myeloproliferative Neoplasms (MPNs) and Graft-Versus-Host Disease (GVHD) – key highlights
▪In June 2025, data from the Phase 1 study evaluating INCA033989 in mutCALR positive patients with essential thrombocythemia (ET) were presented during a late-breaking session at the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Milan, Italy. The data showed rapid and durable normalization of platelet counts across all dose levels and importantly, a reduction in peripheral blood mutCALR variant allele frequency (VAF) correlating with hematologic response. INCA033989 was well tolerated with a favorable safety profile with no dose limiting toxicities reported. Together, the data demonstrates the potential of INCA033989 for disease modification by directly inhibiting and eliminating oncogenic mutCALR cells, while sparing healthy cells and restoring normal blood cell production. The Phase 1 data in patients with myelofibrosis (MF) as monotherapy and in combination with ruxolitinib are anticipated in the second half of 2025.
▪A Phase 1 study evaluating JAK2V617Fi in MPNs is ongoing. Initial proof of concept data are anticipated in the first half of 2026.
▪A Phase 2 trial evaluating axatilimab (Niktimvo) in combination with ruxolitinib (Jakafi) in patients with newly diagnosed chronic GVHD is ongoing.
▪A Phase 3 trial evaluating axatilimab in combination with corticosteroids in patients with newly diagnosed chronic GVHD is ongoing.
MPN and GVHD Programs Indication and status
Ruxolitinib XR (QD)
(JAK1/JAK2) Myelofibrosis, polycythemia vera and GVHD
Ruxolitinib + INCB57643
(JAK1/JAK2 + BETi) Myelofibrosis: Phase 2
Ruxolitinib + axatilimab1
(JAK1/JAK2 + anti-CSF-1R)
Chronic GVHD: Phase 2
Steroids + axatilimab1
(Steroids + anti-CSF-1R)
Chronic GVHD: Phase 3
INCA033989
(mutCALR) Myelofibrosis, essential thrombocythemia: Phase 1
INCB160058
(JAK2V617Fi) Myeloproliferative Neoplasms (MPNs): Phase 1

Other Hematology/Oncology – key highlights
▪In May 2025, Zynyz was approved by the U.S. Food and Drug Administration (FDA) in combination with chemotherapy and as a single agent for the treatment of adult patients with advanced squamous cell carcinoma of the anal canal (SCAC). The Priority Review and FDA approval were based on data from two trials: the Phase 3 POD1UM-303/InterAACT2 and the Phase 2 POD1UM-202 trial. Incyte has also submitted a Type II variation Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and a Japanese New Drug Application (J-NDA) for retifanlimab in advanced SCAC.
▪In June 2025, Monjuvi was approved by the FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) in combination with rituximab and lenalidomide. The Priority Review and FDA approval were based on data from the pivotal Phase 3 inMIND trial.
▪Incyte plans to initiate Phase 3 studies for its potentially first-in-class CDK2 inhibitor (INCB123667), in ovarian cancer in 2025 and is also evaluating INCB123667 in combination with other treatments.
▪The Phase 3 study evaluating tafasitamab as first-line treatment for diffuse large B-cell lymphoma (DLBCL) is ongoing. The Phase 3 data are anticipated in the second half of 2025.
▪The Phase 1 studies evaluating KRASG12D and TGFßR2×PD-1 in solid tumors are ongoing. Initial proof of concept data for both studies are anticipated in the second half of 2025.
Heme/Oncology Programs Indication and status
Tafasitamab (Monjuvi/Minjuvi)
(CD19)
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL): Phase 3 (B-MIND)
First-line DLBCL: Phase 3 (frontMIND)
Retifanlimab (Zynyz)1
(PD-1)
Non-small cell lung cancer (NSCLC): Phase 3 (POD1UM-304)
MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204)
INCB123667
(CDK2i) Solid tumors with CCNE1 amplification/Cyclin E overexpression: Phase 1
INCB161734
(KRASG12D) Advanced metastatic solid tumors with a KRASG12D mutation: Phase 1
INCA33890
(TGFßR2×PD-1)2
Advanced or metastatic solid tumors: Phase 1

1 Retifanlimab licensed from MacroGenics.
2 Development in collaboration with Merus.
Inflammation and Autoimmunity (IAI) – key highlights
Ruxolitinib Cream
▪In April 2025, Incyte announced positive topline results from the Phase 3 (TRuE-AD4) study evaluating ruxolitinib cream in adult patients with moderate atopic dermatitis. The study met the co-primary endpoints at Week 8, with a statistically significant proportion of patients achieving both Investigator’s Global Assessment Treatment Success (IGA-TS) and EASI75, which is defined as a 75% or greater improvement in the Eczema Area Severity Index score from baseline. In addition, the study met all key secondary endpoints. Ruxolitinib cream was well tolerated with no new safety signals. The full dataset will be presented at an upcoming medical conference.
▪In June 2025, two Phase 3 studies (TRuE-HS2 and TRuE-HS2) evaluating ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS) were initiated and are ongoing.
▪In June 2025, the FDA extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura) for the treatment of children 2-11 years old with mild to moderate atopic dermatitis (AD). The Prescription Drug User Fee Act (PDUFA) action date was extended by three months to September 19, 2025.

Povorcitinib (INCB54707)
▪Two Phase 3 studies (STOP-V1 and STOP-V2) evaluating povorcitinib versus placebo in patients with vitiligo are ongoing. The Phase 3 data are anticipated in 2026.
▪Two Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib versus placebo in patients with PN are ongoing. The Phase 3 data are anticipated in 2026.
▪A Phase 2 trial evaluating povorcitinib in asthma is ongoing. Data are anticipated in the second half of 2025.
IAI and Dermatology Programs Indication and status
Ruxolitinib cream (Opzelura)1
(JAK1/JAK2)
Atopic dermatitis: Phase 3 pediatric study (TRuE-AD3); sNDA under review in the U.S.
Hidradenitis suppurativa: Phase 3 (TRuE-HS1, TRuE-HS2)
Prurigo nodularis: Phase 3 (TRuE-PN1, TRuE-PN2)
Povorcitinib
(JAK1) Hidradenitis suppurativa: Phase 3 (STOP-HS1, STOP-HS2)
Vitiligo: Phase 3 (STOP-V1, STOP-V2)
Prurigo nodularis: Phase 3 (STOP-PN1, STOP-PN2)
Chronic spontaneous urticaria: Phase 2
Asthma: Phase 2
INCA034460
(anti-CD122) Vitiligo: Phase 1

1 Novartis’ rights to ruxolitinib outside of the United States under our Collaboration and License Agreement with Novartis do not include topical administration.
Other
Other Program Indication and Phase
Zilurgisertib
(ALK2) Fibrodysplasia ossificans progressiva: Pivotal Phase 2

2025 Second Quarter Financial Results
The financial measures presented in this press release for the three and six months ended June 30, 2025 and 2024 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte’s GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company’s business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company’s core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company’s core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers.
Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.

Revenue Details
Revenue Details
(unaudited, in thousands)
Three Months Ended
June 30, %
Change
(as reported)
%
Change
(constant currency)1
Six Months Ended
June 30, %
Change
(as reported)
%
Change
(constant currency)1
2025 2024 2025 2024
Net product revenues:
Jakafi $ 763,788 $ 705,973 8 % NA $ 1,473,200 $ 1,277,812 15 % NA
Opzelura 164,499 121,695 35 % 34 % 283,204 207,419 37 % 36 %
Iclusig 32,729 26,862 22 % 16 % 62,273 57,205 9 % 8 %
Pemazyre 22,192 20,269 9 % 8 % 40,632 37,945 7 % 7 %
Minjuvi/ Monjuvi 31,131 31,116 0 % (1 %) 60,682 54,990 10 % 10 %
Niktimvo 36,154 — NM NA 49,767 — NM NA
Zynyz 8,921 651 1,270 % NA 11,930 1,118 967 % NA
Total net product revenues 1,059,414 906,566 17 % 16 % 1,981,688 1,636,489 21 % 21 %
Royalty revenues:
Jakavi 109,714 99,317 10 % 7 % 201,859 188,912 7 % 8 %
Olumiant 33,482 31,702 6 % 4 % 64,282 62,291 3 % 5 %
Tabrecta 6,632 5,298 25 % NA 13,045 10,532 24 % NA
Other 1,287 876 47 % NM 2,553 1,424 79 % NM
Total royalty revenues 151,115 137,193 10 % 281,739 263,159 7 %
Total net product and royalty revenues 1,210,529 1,043,759 16 % 2,263,427 1,899,648 19 %
Milestone and contract revenues 5,000 — NM NM 5,000 25,000 (80 %) (80 %)
Total GAAP revenues $ 1,215,529 $ 1,043,759 16 % $ 2,268,427 $ 1,924,648 18 %

NM = not meaningful
NA = not applicable
1 Percentage change in constant currency is calculated using 2024 foreign exchange rates to recalculate 2025 results.
Product and Royalty Revenues Total net product revenues for the quarter ended June 30, 2025 increased 17% over the prior year comparative period. Total net product and royalty revenues for the quarter ended June 30, 2025 increased 16% over the prior year comparative period, primarily driven by the following:
•Jakafi net product revenue increased 8% versus the prior year comparable period, driven by an increase in paid demand of 8% reflecting continued demand growth in all indications. Jakafi inventory levels were within normal range at the end of the second quarter of 2025.
•Opzelura net product revenue increased 35% due to increased patient demand and refills in the U.S. in both AD and vitiligo, and increased contribution from ex-U.S. driven by continued uptake in France, and growth from the recent launches in Italy and Spain. Opzelura inventory levels were within normal range at the end of the second quarter of 2025.
•Niktimvo net product revenue reflects continued strong uptake of the product following its commercial launch during the first quarter of 2025.
•Zynyz net product revenue increase driven by the approval of the product in squamous cell anal carcinoma in the second quarter of 2025.

•Total royalty revenues for the quarter increased 10% versus the prior year comparable period, primarily driven by growth in Jakavi royalty revenue.
Operating Expenses
Operating Expense Summary
(unaudited, in thousands)
Three Months Ended
June 30, %
Change Six Months Ended
June 30, %
Change
2025 2024 2025 2024
GAAP cost of product revenues $ 78,766 $ 76,634 3 % $ 151,954 $ 137,590 10 %
Non-GAAP cost of product revenues1
72,544 70,899 2 % 139,489 125,858 11 %
Contract dispute settlement (242,251) — NM (242,251) — NM
Non-GAAP contract dispute settlement2
— — NM — — NM
GAAP research and development 494,917 1,138,380 (57 %) 932,196 1,567,640 (41 %)
Non-GAAP research and development3
455,635 1,089,089 (58 %) 855,655 1,477,526 (42 %)
GAAP selling, general and administrative 331,022 305,982 8 % 656,713 606,238 8 %
Non-GAAP selling, general and administrative4
304,771 262,572 16 % 607,063 539,907 12 %
GAAP loss (gain) on change in fair value of acquisition-related contingent consideration 22,761 893 NM 34,333 437 NM
Non-GAAP loss (gain) on change in fair value of acquisition-related contingent consideration — — NM — — NM
GAAP (profit) and loss sharing under collaboration agreements — — NM — (1,025) NM