On July 16, 2025 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, reported a clinical update on its most advanced asset, CUE-101, representative of the CUE-100 series (Press release, Cue Biopharma, JUL 16, 2025, View Source [SID1234654411]).

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!

"We are excited to report an additional CR in a patient that had recurrent metastatic HPV+ head and neck squamous cell carcinoma (HNSCC) treated with CUE-101 in combination with pembrolizumab (KEYTRUDA)," said Matteo Levisetti, chief medical officer at Cue Biopharma. "This patient had durable stable disease for close to two years and more recently demonstrated significant tumor reductions and now a complete response. Notably, the patient had multiple sites of disease, including the lungs that cleared prior to the complete response observed in the target lesion. We believe the kinetics of tumor reduction and disease eradication in this patient is due to the repeated stimulation and expansion of tumor-specific T cells given the mechanism of action of CUE-101. It also serves as a clear example of the differences in timing of the clinical activity often observed with immunotherapy compared to traditional cytotoxic therapies and supports the prolonged mOS observed in this trial."

Key data highlights from the expansion portion of the trial evaluating CUE-101 at the recommended Phase 2 dose (RP2D) of 4mg/kg in combination with pembrolizumab in 1L patients (data cutoff of July 14, 2025) include:

ORR of 50% (2 CR and 10 partial responses (PR) in patients with CPS ≥1, compared to an ORR of 19% observed with pembrolizumab alone in the historical third-party KEYNOTE-048 trial).
Survival metrics have continued to mature favorably: 12-month overall survival (OS) of 88% compared to 57% with pembrolizumab alone in the historical KEYNOTE-048 trial, representing a reduction in the risk of death (HR 0.23) compared to historical data.
mOS of 32 months compared to 12.3 months in the historical KEYNOTE-048 trial.
ORR of 50% in patients, including 50% with low PD-L1 expression CPS (1-19).
Dan Passeri, chief executive officer at Cue Biopharma, added, "The culmination of maturing data further support our conviction that CUE-101, representative of our approach with the CUE-100 series, demonstrates a potential breakthrough therapeutic approach for establishing a new standard of care. With this maturing data, we are further emboldened in our conviction that our Immuno-STAT platform represents transformative potential for selectively modulating the patient’s immune system."

About CUE-101 and the Phase 1 Trial
CUE-101 is Cue Biopharma’s most advanced clinical stage drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand HPV16 tumor-specific T cells by presenting two signals or "cues" to T cells. Signal #1 incorporates the HPV E7 protein, harbored by HPV-induced cancer cells, to provide selectivity through interaction with the HPV-specific T cell receptor. Signal #2 consists of an engineered IL-2 variant to stimulate the activity of T cells. CUE-101 is currently being evaluated in a fully enrolled Phase 1 open-label, dose escalation and expansion study, for the treatment of HPV16+ driven recurrent/metastatic head and neck squamous cell carcinoma in second line (2L) and beyond patients as a monotherapy, and as a first line (1L) therapy in combination with pembrolizumab (KEYTRUDA).

On July 16, 2025 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported its biomarker and translational data for pelareorep, the Company’s systemically delivered oncolytic virus (Press release, Oncolytics Biotech, JUL 16, 2025, View Source [SID1234654410]). The data support pelareorep’s mechanism of action and further strengthen the unique biological rationale and therapeutic potential for pelareorep as a platform immunotherapeutic. These include its ability to replicate in cancer cells, activate immune pathways, and drive T cell expansion and tumor infiltration in immunotherapy-resistant cancers.

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!

The translational research included the analysis of blood and tumor samples from patients in the GOBLET (pancreatic ductal adenocarcinoma (PDAC) and other gastrointestinal cancers) and AWARE-1 (breast cancer) studies. Analyses revealed consistent immune activation signatures, including:

•Upregulation of interferons, CXCL9/10/11, and PD-L1
•Conversion of immunologically ‘cold’ tumors into ‘hot’ phenotypes
•Expansion and mobilization of tumor-infiltrating lymphocyte (TIL) clones in the blood, which correlates with a reduction in tumor size
•Modulation of the tumor microenvironment (TME) to enhance responsiveness to immune therapies

"This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep’s immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME – all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep."

"The collection of data here show that pelareorep works how a cancer immunotherapy should work," said Jared Kelly, Chief Executive Officer of Oncolytics. "Pelareorep is a versatile product candidate with strong platform potential to enhance immunological responses in multiple indications, including hard-to-treat cancers. Such compelling findings should be exciting to strategic partners focused on finding a platform immunotherapy in large indications with high unmet medical needs."

The GOBLET study continues to enroll PDAC and anal carcinoma patients, and additional translational data readouts are expected next year. The Company expects these and its other clinical data to support its focused and aggressive regulatory path and serve as the biological foundation for registration-enabled studies in immunotherapy-resistant solid tumors. As regulatory conversations progress throughout the summer, the Company expects to provide an updated clinical timeline before the end of the third quarter.

On July 16, 2025 NKGen Biotech, Inc. (OTC: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer ("NK") cell therapeutics, reported that it has raised $2 million in new capital from a Japanese strategic investor, who will help NKGen bring its novel NK cell therapy, troculeucel, autologous expanded NK cell therapy, to the Japanese market (Press release, NKGEN Biotech, JUL 16, 2025, View Source [SID1234654409]).

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!

The new investment was made in the form of shares of the Company’s common stock priced at $0.25 per share and warrants, as described in the Company’s Form 8-K filed with the Securities and Exchange Commission on July 16, 2025. This new injection of capital, the Company’s ramping up of its Phase 2 clinical trial, the expected near-term satisfaction of public company reporting requirements and satisfaction of the previously disclosed payment obligation on the Company’s senior secured debt are all critical to position the Company for long-term success.

"This past year presented significant external challenges, particularly stemming from the unexpected bankruptcy of our former parent company, NKMax Co., Ltd. in June 2024," said Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen. "This event initially disrupted our ability to raise capital in the U.S. despite the encouraging progress we continued to make in our clinical trials and compassionate use cases. However, our team remained focused and committed to our mission. Through disciplined execution of our science and clinical programs, we not only sustained our momentum but also succeeded in securing the capital necessary to acquire a majority stake in NKMax out of bankruptcy, as previously disclosed. This transaction, expected to officially close in the coming month, removes a major overhang and allows us to consolidate key intellectual property rights across Asia. This strategic acquisition has already sparked renewed interest from both U.S. and international investors. We look forward to sharing further details in the near future about NKMax and strategic relationships and plans in Asia."

"This marks our first strategic investor in an important market for our therapy for Alzheimer’s and other neurodegenerative diseases," said James Graf, NKGen’s Interim Chief Financial Officer. As in our other recently announcing funding, this new funding comes at a pivotal time for the Company, which has faced operational challenges due to limited financial resources and the need to make hard decisions on our use of cash, including the unfortunate but unavoidable delay in our financial filings. With all the necessary service providers fully engaged on the effort now, we’re on track to regain compliance in the near term."

Mr. Graf continued, "The Company has been informed by the OTC Markets Group that its trading will move from OTC Pink to the Expert Market until it regains compliance in its financial filings. The Expert Market allows for limited trading but does not allow public access to bid and ask prices or other information, including trading volume. Instead, pricing information will only be accessible to brokers and market makers. The move will make it more difficult for investors to freely trade the shares of NKGen during this short period until we regain filing compliance. We take our filing obligations seriously and greatly regret the short-term impact resulting from our prior limited access to capital. We ask our investors for patience during this time, after which we expect to emerge on OTCQB and later back on Nasdaq well-positioned for the future."

The Company also announced that it is committed to uplisting back to Nasdaq or to NYSE American as soon as it meets the requirements for newly listed companies, including among other things SEC filing compliance, minimum market capitalization and public float and minimum share price. On February 25, 2025, the Company’s shareholders approved a reverse split that is intended to aid in compliance with the share price requirement before uplisting, if so exercised.

About Troculeucel

Troculeucel is a novel cell-based, patient specific, ex vivo expanded autologous NK cell immunotherapeutic drug candidate. NKGen is developing troculeucel for the treatment of neurodegenerative disorders and a broad range of cancers. Troculeucel is the International Nonproprietary Name ("INN") for SNK01 assigned by the World Health Organization ("WHO"). The WHO INN approval of troculeucel establishes a universally recognized nonproprietary drug name for SNK01 and marks a significant step on NKGen’s journey toward bringing this therapy to market.

On July 16, 2025 Johnson & Johnson (NYSE: JNJ) reported results for second-quarter 2025 (Press release, Johnson & Johnson, JUL 16, 2025, View Source [SID1234654408]). "Today’s strong results reflect the depth and strength of Johnson & Johnson’s uniquely diversified business operating across both MedTech and Innovative Medicine," said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. "Our portfolio and pipeline position us for elevated growth in the second half of the year, with game-changing approvals and submissions anticipated in areas like lung and bladder cancer, major depressive disorder, psoriasis, surgery and cardiovascular, which will extend and improve lives in transformative ways."
Overall financial results
Q2
($ in Millions, except EPS)
2025
2024
% Change
Reported Sales

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!

$23,743
$22,447
5.8%
Net Earnings
$5,537
$4,686
18.2%
EPS (diluted)
$2.29
$1.93
18.7%

Q2
Non-GAAP* ($ in Millions, except EPS)
2025
2024
% Change
Operational Sales1,2

4.6%
Adjusted Operational Sales1,3

3.0%
Adjusted Net Earnings1,4
$6,699
$6,840
-2.1%
Adjusted EPS (diluted)1,4
$2.77
$2.82
-1.8%
Free Cash Flow6,7
~$6,200
$7,507

Regional sales results
Q2

% Change

($ in Millions)
2025
2024
Reported
Operational1,2
Currency
Adjusted
Operational1,3
U.S.
$13,544
$12,569
7.8%
7.8
–
5.0
International
10,199
9,878
3.2
0.6
2.6
0.4
Worldwide
$23,743
$22,447
5.8%
4.6
1.2
3.0

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

Segment sales results
Q2

% Change

($ in Millions)
2025
2024
Reported
Operational1,2
Currency
Adjusted
Operational1,3
Innovative Medicine
$15,202
$14,490
4.9%
3.8
1.1
2.4
MedTech
8,541
7,957
7.3
6.1
1.2
4.1
Worldwide
$23,743
$22,447
5.8%
4.6
1.2
3.0

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

Second-Quarter 2025 segment commentary:

Operational sales* reflected below excludes the impact of translational currency.

Innovative Medicine

Innovative Medicine worldwide operational sales grew 3.8%*, with net acquisitions and divestitures positively impacting growth by 1.4%. Growth was primarily driven by DARZALEX, CARVYKTI, ERLEADA and RYBREVANT/LAZCLUZE in Oncology, TREMFYA and SIMPONI/SIMPONI ARIA in Immunology, and SPRAVATO in Neuroscience. Growth was partially offset by an approximate (1,170) basis points impact from STELARA in Immunology, and an approximate (130) basis points impact from COVID-19 in Infectious Diseases.

MedTech

MedTech worldwide operational sales grew 6.1%*, with net acquisitions and divestitures positively impacting growth by 2.0%. Growth was primarily driven by electrophysiology products and Abiomed in Cardiovascular, as well as wound closure products in General Surgery.

Full-year 2025 guidance:
Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.
($ in Billions, except EPS)
July 2025
April 2025
Adjusted Operational Sales1,2,5
Change vs. Prior Year / Mid-point
3.2% – 3.7% / 3.5%
2.0% – 3.0% / 2.5%
Operational Sales2,5 / Mid-point
Change vs. Prior Year / Mid-point
$92.7B – $93.1B / $92.9B
4.5% – 5.0% / 4.8%
$91.6B – $92.4B / $92.0B
3.3% – 4.3% / 3.8%
Estimated Reported Sales3,5/ Mid-point
Change vs. Prior Year / Mid-point
$93.2B – $93.6B / $93.4B
5.1% – 5.6% / 5.4%
$91.0B – $91.8B / $91.4B
2.6% – 3.6% / 3.1%
Adjusted Operational EPS (Diluted)2,4 / Mid-point
Change vs. Prior Year / Mid-point
$10.63 – $10.73 / $10.68
6.5% – 7.5% / 7.0%
$10.50 – $10.70 / $10.60
5.2% – 7.2% / 6.2%
Adjusted EPS (Diluted)3,4 / Mid-point
Change vs. Prior Year / Mid-point
$10.80 – $10.90 / $10.85
8.2% – 9.2% / 8.7%
$10.50 – $10.70 / $10.60
5.2% – 7.2% / 6.2%

1Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2Non-GAAP financial measure; excludes the impact of translational currency
3Calculated using Euro Average Rate: July 2025 = $1.13 and April 2025 = $1.10 (Illustrative purposes only)
4Non-GAAP financial measure; excludes intangible amortization expense and special items
5Excludes COVID-19 Vaccine
Note: percentages may have been rounded
Other modeling considerations will be provided on the webcast
Notable announcements in the quarter:
The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at News Releases, as well as Innovative Medicine News Center, MedTech News & Events, and www.factsabouttalc.com.
Regulatory
Supplemental new drug application submitted to U.S.
FDA for CAPLYTA (lumateperone) with data
demonstrating significant schizophrenia relapse prevention compared to placebo1
Press Release
DARZALEX (daratumumab) receives the first positive CHMP opinion for patients with high-risk smouldering multiple myeloma
Press Release
IMBRUVICA (ibrutinib) receives positive CHMP opinion for the treatment of patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplant
Press Release
U.S. FDA Oncologic Drugs Advisory Committee votes in favor of the benefit-risk profile of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma
Press Release
Johnson & Johnson receives FDA approval for IMAAVY (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG)
Press Release

Johnson & Johnson MedTech Announces Completion of First Cases with OTTAVA Robotic Surgical System
Press Release
Data Releases IMAAVY (nipocalimab-aahu) showed greater sustained disease control versus approved FcRn blockers for generalized myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly published indirect treatment comparison (ITC)
Press Release
Investigational combination of first-in-class bispecifics TALVEY and TECVAYLI shows deep and durable responses in heavily pretreated multiple myeloma patients with extramedullary disease
Press Release
Johnson & Johnson’s dual-targeting CAR T-cell therapy shows encouraging first results in large B-cell lymphoma
Press Release
New results for Johnson & Johnson’s bleximenib demonstrate promising antileukemic activity in combination with venetoclax and azacitidine for acute myeloid leukemia
Press Release
Significant efficacy benefit of IMBRUVICA (ibrutinib) plus venetoclax versus acalabrutinib plus venetoclax in frontline treatment of patients with chronic lymphocytic leukaemia suggested by indirect treatment comparison
Press Release
New data show TREMFYA (guselkumab) is the only IL-23 inhibitor proven to significantly inhibit progression of joint structural damage in active psoriatic arthritis
Press Release
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)-based regimen shows 95 percent progression-free survival at four years in transplant-eligible, newly diagnosed patients with multiple myeloma who achieved sustained MRD negativity
Press Release
Early results from Johnson & Johnson’s trispecific antibody show promising response in heavily pretreated multiple myeloma patients
Press Release
Single infusion of CARVYKTI (ciltacabtagene autoleucel) delivered lasting treatment-free remissions for at least five years in patients with relapsed or refractory multiple myeloma
Press Release
Johnson & Johnson leads with first PARP inhibitor combo to improve efficacy in patients with HRR-altered mCSPC
Press Release
Johnson & Johnson unveils first-in-human results for pasritamig, showing early anti-tumor activity in prostate cancer
Press Release
Shockwave Medical Study Confirms Benefit of IVL-First Strategy in Real-World Female Patients with Complex Calcified Lesions in Late-Breaking Data Presentation at EuroPCR 2025
Press Release
Icotrokinra results show significant skin clearance in patients with difficult-to-treat scalp and genital psoriasis
Press Release
TREMFYA (guselkumab) delivers sustained clinical and endoscopic remission in ulcerative colitis through two years
Press Release
TREMFYA (guselkumab) positioned to become the first and only IL-23 inhibitor to offer subcutaneous induction in ulcerative colitis as demonstrated in new data through 24 weeks
Press Release
Johnson & Johnson’s TAR-200 monotherapy achieves high disease-free survival of more than 80 percent in BCG-unresponsive, high-risk papillary NMIBC
Press Release
Johnson & Johnson’s TAR-200 monotherapy demonstrates highest complete response rate with sustained clinical benefits in patients with certain types of bladder cancer
Press Release

Johnson & Johnson MedTech Presents 3-Month Data from Omny-IRE Clinical Trial at 2025 Heart Rhythm Society Annual Meeting
Press Release

Product Launch
Johnson & Johnson Launches First and Only Daily Disposable Multifocal Toric Contact Lens – ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM
Press Release
Johnson & Johnson Launches VOLT Wrist and Proximal Humerus Plating Systems in the U.S.
Press Release
Johnson & Johnson Launches New TECNIS Odyssey Next-Generation Intraocular Lens in Europe, the Middle East, and Canada Offering Cataract Patients Precise Vision at Every Distance in Any Lighting
Press Release
Johnson & Johnson Launches KINCISE 2 System, the Only Automated Surgical Impactor Approved for Knee and Hip Revision Procedures
Press Release
Johnson & Johnson MedTech Launches SOUNDSTAR CRYSTAL in the US, Redefining Image Clarity in 2D Intracardiac Imaging
Press Release

Other
Johnson & Johnson Elects Daniel Pinto, President, JPMorganChase to its Board of Directors
Press Release

Webcast information:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company’s website at events-and-presentations.

On July 16, 2025 Genmab A/S (Nasdaq: GMAB) reported worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by J&J were USD 3,539 million in the second quarter of 2025 (Press release, Genmab, JUL 16, 2025, View Source [SID1234654407]). Net trade sales were USD 2,017 million in the U.S. and USD 1,521 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to J&J to develop, manufacture and commercialize daratumumab.

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!