On October 15, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported that six abstracts have been accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place October 17–21 in Berlin, Germany.

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"We’re sharing research at ESMO (Free ESMO Whitepaper) Congress 2025, including two oral presentations, that highlight the growing role of real-world data and AI in developing more effective, personalized cancer treatments," said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. "These findings not only advance the development of new therapies but also equip clinicians with data-driven insights to guide patient care."

This year, Tempus will highlight its latest scientific and clinical research findings via two oral presentations and four poster presentations.

Oral Presentations:

Efficacy of Cabozantinib and Nivolumab in Cluster 1/2 Metastatic Clear Cell Renal Cell Carcinoma: Results from OPTIC RCC, a phase II trial of a novel RNAseq-based biomarker
Date/Time: October 17, 2025; 4:35 – 4:40pm CEST
Location: Karlsruhe Auditorium – Hall 5.2
Presentation 2591O
Session Name: Mini Oral session 1: GU tumours, renal & urothelial
Summary: The study reports initial results from the OPTIC RCC (NCT 05361720) phase II multicenter trial, a prospective study investigating a biomarker-driven approach to treating metastatic clear cell renal cell carcinoma. Patients are assigned to nivolumab/cabozantinib (IO/TKI) for angiogenic-driven tumors (cluster 1/2) or ipilimumab/nivolumab (IO/IO) for immune-inflamed tumors (cluster 4/5) based on RNAseq-based molecular subtyping. This presentation focuses exclusively on the 26 patients with angiogenic cluster 1/2 tumors who were treated with nivolumab/cabozantinib. Of the 21 patients who received at least one post-baseline scan to date, 100% achieved a reduction in tumor burden, resulting in a RECIST best response of 71% partial response and 29% stable disease, with no progressive disease. These initial findings suggest that using RNAseq data to assign patients with angiogenic tumors to cabozantinib/nivolumab increases the overall response rate compared to unselected historical controls.
Lymphocyte activation gene-3 (LAG3) expression patterns and immunotherapy (IO) response in metastatic renal cell carcinoma (mRCC)
Date/Time: October 17, 2025; 5:10 – 5:15 pm CEST
Location: Karlsruhe Auditorium – Hall 5.2
Presentation Number: 2593MO
Session Name: Mini Oral session 1: GU tumours, renal & urothelial
Summary: This study investigated the relationship between lymphocyte activation gene-3 (LAG3) RNA expression and outcomes in 425 clear cell metastatic renal cell carcinoma (mRCC) patients treated with first-line immunotherapy (IO), using Tempus’ de-identified multimodal data and analytical platform, Lens. The analysis revealed that LAG3 positively correlated with the expression of other immune checkpoint genes and with increased tumor-infiltrating immune cells. Crucially, while real-world overall survival was similar across LAG3 levels, low LAG3 expression was associated with a reduced real-world objective response rate compared to high LAG3. These findings suggest that LAG3 has potential utility as a marker for IO response and supports exploring combination IO strategies in RCC patients.
Poster Presentations:

Impact of tumor suppressor gene (TSG) alteration (alt) burden on outcomes in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC)
Presentation Number: 2452P
Summary: A real-world study of de-identified records from 2,173 patients with metastatic castration-sensitive prostate cancer (mCSPC) sequenced with the Tempus xT DNA assay investigated the impact of tumor suppressor gene (TSG) alterations (alt) on real-world overall survival (rwOS). The analysis was conducted in Tempus Lens Workspaces and compared the characteristics of patients with TSG alt to those with wild type TSG, identifying differences in median prostate-specific antigen (PSA) levels, visceral disease prevalence, and distinct patterns of co-occurring gene alterations. Critically, the analysis of rwOS showed that the presence of TSG alt—particularly an increased TSG alt burden—was associated with inferior survival outcomes following first-line therapy. These findings suggest that patients with mCSPC and high TSG burden constitute a high-risk group that may require biomarker-directed intensive first-line treatment, providing support for the ongoing Alliance phase 3 ASPIRE trial.
Unveiling Integrin Beta-6 (IB6): Real-World Expression from the IB6 Expression and Clinical Outcomes in Non-Small Cell Lung Cancer (BEACON) Study
Presentation Number: 1919P
Summary: Initial findings from the Integrin Beta-6 (IB6) Expression and Clinical Outcomes in Non-Small Cell Lung Cancer (BEACON) study detail a retrospective, real-world observational analysis of IB6 prevalence in patients with metastatic non-small cell lung cancer (mNSCLC). The study leveraged the Tempus de-identified database and analytical platform, Tempus Lens, to examine a preliminary cohort of 200 mNSCLC patient records, utilizing immunohistochemistry to determine IB6 expression levels. The results demonstrate not only that high IB6 expression is common in mNSCLC, but that high expression was particularly frequent in patients with non-squamous histology compared to those with squamous histology. These data underscore the potential of IB6 as a promising novel biomarker and therapeutic target in mNSCLC, supporting the rationale for continued development and investigation of IB6-directed therapies, such as the investigational agent sigvotatug vedotin.
The association between tumor immunogenomic features and first-line (1L) therapeutic outcomes in advanced biliary tract cancer (BTC)
Presentation Number: 94P
Summary: The researchers used Tempus Lens to conduct a real-world analysis of advanced biliary tract cancer (BTC) patients treated with first-line gemcitabine + cisplatin (G+C) with or without immunotherapy (ICI), investigating the association between tumor immunogenomic features and outcomes. The real-world overall survival (rwOS) for the total BTC cohort was similar between the G+C+ICI and G+C groups. The analysis also studied the natural history of patients with BTC and specific genomic alterations and found that FGFR2 fusions and HRR alterations were linked to improved rwOS, while KRAS alterations were associated with worse rwOS, regardless of the treatment regimen. These findings show that 1L regimens for BTC had similar rwOS and that genomic alterations have distinct prognostic impacts. Future analysis in clinical trials may help define new prognostic and predictive biomarkers across both early and late stage BTC.
ImmunoDriver-2: CD8 T cell and PD-L1 levels associate with first-line (1L) overall survival (OS) in immune checkpoint inhibition (ICI)-treated non-small cell lung cancer (NSCLC)
Presentation Number: 1920P
Summary: The research team conducted an analysis of de-identified records from 5,343 NSCLC patients using Tempus Lens to characterize the association of CD8 T cell (CD8T) and PD-L1 proportions with real-world overall survival (rwOS) and driver alterations (dAlts) in early and metastatic NSCLC patients treated with first-line ICI + chemotherapy (CT) or ICI alone. Using a cohort of Tempus’ de-identified data, the study found that in metastatic NSCLC, both PD-L1 and CD8T were associated with improved rwOS after 1L-ICI±CT, with CD8T further stratifying survival within PD-L1 groups. The rwOS was greatest when both CD8T and PD-L1 were high. Immunogenomic profiling showed that CD8T and PD-L1 were highest in tumors with no dAlts and those with KRAS dAlts, but were lowest in tumors with classic/non-classic EGFR dAlts. These findings suggest that the combined analysis of CD8T and PD-L1 may provide a valuable immunophenotype that applies across different disease stages and dAlt statuses to enrich for ICI efficacy.

(Press release, Tempus, OCT 15, 2025, View Source [SID1234656684])

On October 15, 2025 Curium Group reported that together with PeptiDream Inc. and PDRadiopharma Inc., a registrational Phase 2 clinical trial has been initiated in Japan for 64Cu-PSMA-I&T – a PET radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) expressed on prostate cancer cells.

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64Cu-PSMA-I&T is being assessed as a diagnostic PET imaging agent labeled with the radioisotope Copper-64, being developed with its therapeutic pair, 177Lu-PSMA-I&T. The development is conducted under the strategic collaboration between PDRadiopharma, a wholly owned subsidiary of PeptiDream, and Curium aiming at advancing innovative radiopharmaceuticals for prostate cancer in Japan.

The open-label, single-arm Phase 2 study will evaluate the sensitivity, specificity, and safety of 64Cu-PSMA-I&T. The trial will enroll approximately 70 patients who have been newly diagnosed with unfavorable intermediate, high or very high-risk prostate cancer and are scheduled for prostatectomy with pelvic lymph node dissection. This study is being conducted as a registrational trial in Japan and will utilize bridging data from Curium’s ongoing global clinical trials.

In parallel, a clinical trial for 177Lu-PSMA-I&T as a therapeutic agent is being planned to evaluate its efficacy and safety in patients with metastatic castration-resistant prostate cancer (mCRPC).

Renaud Dehareng, CEO of Curium Group commented: "Conducting these registrational trials, in partnership with PeptiDream and PDRadiopharma, marks a significant milestone in our mission to expand access to cutting-edge radiopharmaceuticals to patients with prostate cancer across Asia. By combining Curium’s global development expertise with PDRadiopharma’s deep local knowledge and infrastructure, we are well-positioned to deliver transformative solutions to prostate cancer patients in Japan."

Patrick C. Reid, President & CEO of PeptiDream commented: "Targeted radiopharmaceuticals are rapidly revolutionizing how we both diagnose and treat cancer. At PeptiDream and PDRadiopharma we are focused on expanding our pipeline of these targeted therapies, and we are thrilled to be able to accelerate those efforts by partnering with Curium to bring their prostate cancer targeting radiopharmaceuticals to patients in Japan."

About Prostate Cancer

Prostate cancer continues to be widely prevalent in Japan. Annually, there are approximately 90,000 – 100,000 new cases (*1), with patients with metastatic castration-resistant prostate cancer having an overall survival rate of approximately three years in clinical trial settings, and even shorter in the real-world, and there remains a significant unmet medical need for therapies.

*1: National Cancer Center Japan

Clinical trial progress

Phase 3 ECLIPSE trial – 177Lu-PSMA-I&T, a PSMA-targeting ligand conjugated with the radioisotope Lutetium-177, has been tested by Curium in a global pivotal Phase 3 ECLIPSE trial (ClinicalTrials.gov identifier; NCT05204927). It reported that the primary endpoint was met, demonstrating a statistically significant and clinically meaningful benefit for patients with mCRPC.

Phase 3 trial SOLAR RECUR and SOLAR STAGE – 64Cu-PSMA-I&T trials are being conducted to diagnose biochemical recurrence of prostate cancer (SOLAR RECUR trial, ClinicalTrials.gov identifier NCT06235099) and for men newly diagnosed with unfavorable intermediate to very high-risk prostate cancer, electing to undergo surgery (SOLAR STAGE trial, ClinicalTrials.gov identifier NCT06235151). The first in human Phase 1/2 SOLAR trial met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate in patients with histologically-proven metastatic prostate cancer.

Partnership Details

Under the terms of the partnership, Curium and PDRadiopharma will jointly collaborate on clinical development activities of 64Cu-PSMA-I&T and177Lu-PSMA-I&T and in Japan, with PDRadiopharma leading regulatory filing, manufacturing, commercialization, and distribution activities in Japan. Curium will continue to lead global development of the two agents and support PDRadiopharma through technology transfer to support the set-up of manufacturing lines in Japan – including a high throughput Copper 64 manufacturing line based on Curium’s proprietary technology.

(Press release, Curium Pharma, OCT 15, 2025, View Source [SID1234656636])

On October 15, 2025 Abbott (NYSE: ABT) reported financial results for the third quarter ended Sept. 30, 2025.

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Third-quarter sales increased 6.9 percent on a reported basis, 5.5 percent on an organic basis, or 7.5 percent when excluding COVID-19 testing-related sales1.
Third-quarter GAAP diluted EPS of $0.94 and adjusted diluted EPS of $1.30, which excludes specified items.
Year-to-date sales increased 6.1 percent on a reported basis, 6.4 percent on an organic basis, or 7.7 percent when excluding COVID-19 testing-related sales2.
Abbott reaffirms previously provided full-year 2025 organic sales growth guidance.
Abbott reaffirms the midpoint of previously provided full-year 2025 adjusted diluted EPS guidance range and narrows the range to $5.12 to $5.18, reflecting double-digit growth at the midpoint.
In July, Abbott announced it received regulatory approval in Japan for TriClip, a first of-its-kind, minimally invasive treatment option for patients with tricuspid regurgitation, or a leaky tricuspid heart valve.
In August, Abbott announced it received CE Mark for an expanded indication for the company’s Navitor transcatheter aortic valve implantation (TAVI) system to treat people with symptomatic, severe aortic stenosis who are at low or intermediate risk for open-heart surgery.
In August, at the European Society of Cardiology (ESC) Congress, new treatment guidelines were issued that provide additional support for the use of MitraClip and TriClip in treating valvular heart disease. These new guidelines were backed by evidence from multiple clinical studies.
"Our third-quarter results demonstrate our ability to deliver consistent, high-quality performance," said Robert B. Ford, chairman and chief executive officer, Abbott. "Our differentiated product pipeline continues to power our performance and positions Abbott to deliver durable long-term value to our shareholders."

THIRD-QUARTER BUSINESS OVERVIEW
Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange and the impact of discontinuing the ZonePerfect product line in the Nutrition business, is an appropriate way for investors to best understand the core underlying performance of the business. Management further believes that measuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to best understand the underlying performance of the company as the demand for COVID-19 tests has significantly declined following the transition from a pandemic to endemic phase.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Third Quarter 2025 Results (3Q25)

Sales 3Q25 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical
Devices

U.S.

4,299

888

886

—

2,521

International

7,070

1,265

1,367

1,511

2,927

Total reported

11,369

2,153

2,253

1,511

5,448

% Change vs. 3Q24

U.S.

2.3

(6.5)

(14.1)

n/a

13.8

International

9.9

13.3

(1.0)

7.5

15.6

Total reported

6.9

4.2

(6.6)

7.5

14.8

Impact of foreign exchange

1.4

0.2

1.2

0.4

2.3

Organic

5.5

4.0

(7.8)

7.1

12.5

Impact of COVID-19 testing sales 1

(2.0)

—

(8.2)

—

—

Organic (excluding COVID-19 tests)

7.5

4.0

0.4

7.1

12.5

Organic

U.S.

2.3

(6.5)

(14.1)

n/a

13.8

International

7.6

13.0

(3.1)

7.1

11.3

First Nine Months 2025 Results (9M25)

Sales 9M25 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical
Devices

U.S.

12,743

2,800

2,568

—

7,363

International

20,126

3,711

3,912

4,154

8,349

Total reported

32,869

6,511

6,480

4,154

15,712

% Change vs. 9M24

U.S.

6.4

1.4

(7.4)

n/a

14.4

International

6.0

5.3

(3.3)

5.8

11.3

Total reported

6.1

3.6

(5.0)

5.8

12.8

Impact of foreign exchange

(0.3)

(0.9)

(0.2)

(1.7)

0.4

Impact of business exit*

—

(0.2)

—

—

—

Organic

6.4

4.7

(4.8)

7.5

12.4

Impact of COVID-19 testing sales 2

(1.3)

—

(5.4)

—

—

Organic (excluding COVID-19 tests)

7.7

4.7

0.6

7.5

12.4

Organic

U.S.

6.5

1.9

(7.4)

n/a

14.4

International

6.4

6.9

(3.0)

7.5

10.7

Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue.

*Reflects the impact of discontinuing the ZonePerfect product line in the Nutrition business in March 2024.

Nutrition

Third Quarter 2025 Results (3Q25)

Sales 3Q25 ($ in millions)

Total

Pediatric

Adult

U.S.

888

520

368

International

1,265

457

808

Total reported

2,153

977

1,176

% Change vs. 3Q24

U.S.

(6.5)

(8.4)

(3.8)

International

13.3

17.9

10.9

Total reported

4.2

2.3

5.8

Impact of foreign exchange

0.2

(0.1)

0.4

Organic

4.0

2.4

5.4

U.S.

(6.5)

(8.4)

(3.8)

International

13.0

18.2

10.2

Worldwide Nutrition sales increased 4.2 percent on a reported basis and 4.0 percent on an organic basis in the third quarter.

Growth in the quarter was led by Adult Nutrition, where sales increased 5.8 percent on a reported basis and 5.4 percent on an organic basis, led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading brand of products designed to meet the nutritional requirements for people with diabetes.

First Nine Months 2025 Results (9M25)

Sales 9M25 ($ in millions)

Total

Pediatric

Adult

U.S.

2,800

1,695

1,105

International

3,711

1,377

2,334

Total reported

6,511

3,072

3,439

% Change vs. 9M24

U.S.

1.4

3.0

(0.9)

International

5.3

—

8.8

Total reported

3.6

1.6

5.5

Impact of foreign exchange

(0.9)

(0.9)

(0.9)

Impact of business exit*

(0.2)

—

(0.4)

Organic

4.7

2.5

6.8

U.S.

1.9

3.0

0.3

International

6.9

1.8

10.2

*Reflects the impact of discontinuing the ZonePerfect product line in the Nutrition business in March 2024.

Diagnostics

Third Quarter 2025 Results (3Q25)

Sales 3Q25 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics

U.S.

886

366

36

111

373

International

1,367

998

95

47

227

Total reported

2,253

1,364

131

158

600

% Change vs. 3Q24

U.S.

(14.1)

10.4

(1.5)

7.9

(33.5)

International

(1.0)

1.6

4.3

8.9

(14.2)

Total reported

(6.6)

3.8

2.6

8.2

(27.3)

Impact of foreign exchange

1.2

1.6

1.8

0.4

0.4

Organic

(7.8)

2.2

0.8

7.8

(27.7)

U.S.

(14.1)

10.4

(1.5)

7.9

(33.5)

International

(3.1)

(0.6)

1.7

7.7

(15.6)

Global Diagnostics sales decreased 6.6 percent on a reported basis, decreased 7.8 percent on an organic basis, and increased 0.4 percent when excluding COVID-19 testing-related sales1.

COVID-19 testing-related sales were $69 million in the quarter, compared to $265 million in the third quarter of the prior year.

Global Core Laboratory Diagnostics sales increased 3.8 percent on a reported basis and increased 2.2 percent on an organic basis. Growth in the quarter was impacted by challenging market conditions in China, including the impact of volume-based procurement programs.

First Nine Months 2025 Results (9M25)

Sales 9M25 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics

U.S.

2,568

1,049

111

315

1,093

International

3,912

2,850

265

133

664

Total reported

6,480

3,899

376

448

1,757

% Change vs. 9M24

U.S.

(7.4)

8.3

(0.5)

2.4

(21.2)

International

(3.3)

(1.0)

(2.7)

(0.1)

(12.9)

Total reported

(5.0)

1.3

(2.0)

1.7

(18.2)

Impact of foreign exchange

(0.2)

(0.3)

—

(0.1)

(0.2)

Organic

(4.8)

1.6

(2.0)

1.8

(18.0)

U.S.

(7.4)

8.3

(0.5)

2.4

(21.2)

International

(3.0)

(0.7)

(2.7)

0.3

(12.4)

Established Pharmaceuticals

Third Quarter 2025 Results (3Q25)

Sales 3Q25 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

—

—

—

International

1,511

1,097

414

Total reported

1,511

1,097

414

% Change vs. 3Q24

U.S.

n/a

n/a

n/a

International

7.5

10.3

0.6

Total reported

7.5

10.3

0.6

Impact of foreign exchange

0.4

(0.8)

3.1

Organic

7.1

11.1

(2.5)

U.S.

n/a

n/a

n/a

International

7.1

11.1

(2.5)

Established Pharmaceuticals sales increased 7.5 percent on a reported basis and 7.1 percent on an organic basis in the third quarter.

Key Emerging Markets include several emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 10.3 percent on a reported basis and 11.1 percent on an organic basis, led by double-digit growth in several countries across Asia, Latin America and the Middle East.

First Nine Months 2025 Results (9M25)

Sales 9M25 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

—

—

—

International

4,154

3,121

1,033

Total reported

4,154

3,121

1,033

% Change vs. 9M24

U.S.

n/a

n/a

n/a

International

5.8

7.3

1.7

Total reported

5.8

7.3

1.7

Impact of foreign exchange

(1.7)

(2.4)

0.5

Organic

7.5

9.7

1.2

U.S.

n/a

n/a

n/a

International

7.5

9.7

1.2

Medical Devices

Third Quarter 2025 Results (3Q25)

Sales 3Q25 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

2,521

350

322

280

280

297

196

796

International

2,927

336

383

86

465

338

58

1,261

Total reported

5,448

686

705

366

745

635

254

2,057

% Change vs. 3Q24

U.S.

13.8

21.1

13.2

10.7

8.5

10.1

3.3

18.4

International

15.6

9.3

17.6

22.6

5.5

16.9

24.9

19.9

Total reported

14.8

15.0

15.6

13.3

6.6

13.6

7.6

19.3

Impact of foreign exchange

2.3

2.0

1.9

1.2

1.9

2.3

0.8

3.1

Organic

12.5

13.0

13.7

12.1

4.7

11.3

6.8

16.2

U.S.

13.8

21.1

13.2

10.7

8.5

10.1

3.3

18.4

International

11.3

5.5

14.1

17.2

2.5

12.4

21.2

14.7

Worldwide Medical Devices sales increased 14.8 percent on a reported basis and 12.5 percent on an organic basis in the third quarter.

Sales growth in the quarter was led by double-digit growth in Diabetes Care, Electrophysiology, Rhythm Management, Heart Failure and Structural Heart.

In Diabetes Care, sales of continuous glucose monitors were $2.0 billion and grew 20.5 percent on a reported basis and 17.2 percent on an organic basis.

First Nine Months 2025 Results (9M25)

Sales 9M25 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

7,363

994

943

824

831

868

565

2,338

International

8,349

950

1,091

249

1,381

980

171

3,527

Total reported

15,712

1,944

2,034

1,073

2,212

1,848

736

5,865

% Change vs. 9M24

U.S.

14.4

16.7

12.2

12.4

5.6

14.1

0.3

23.2

International

11.3

3.9

10.9

15.9

4.2

11.8

20.6

15.9

Total reported

12.8

10.1

11.5

13.2

4.7

12.9

4.4

18.7

Impact of foreign exchange

0.4

0.4

0.2

0.3

0.1

0.4

(0.1)

0.6

Organic

12.4

9.7

11.3

12.9

4.6

12.5

4.5

18.1

U.S.

14.4

16.7

12.2

12.4

5.6

14.1

0.3

23.2

International

10.7

3.2

10.5

14.6

4.0

11.2

20.8

14.9

(Press release, Abbott, OCT 15, 2025, View Source [SID1234656667])

On October 15, 2025 Eikon Therapeutics, Inc., a late-stage clinical biopharmaceutical company dedicated to integrating advanced engineering with cutting-edge laboratory and in silico research to accelerate drug discovery, reported that new data from an ongoing Phase 2 study of EIK1001 (TeLuRide-005) will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place in Berlin, Germany from October 17-21, 2025.

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The presentation, titled "TeLuRide-005: Phase II study of EIK1001, a toll-like receptor 7/8 (TLR7/8) co-agonist with pembrolizumab (pembro)+chemotherapy (chemo) as first-line (1L) therapy in stage 4 non-small cell lung cancer (NSCLC)", will be delivered by Richard J. Gralla, M.D., Albert Einstein College of Medicine, during the Mini Oral Session 2 (1850MO – NSCLC metastatic) on Monday, October 20 at 10:55AM CEST.

"EIK1001 represents a unique approach to stimulating the immune system, and we are encouraged by its potential to improve outcomes for patients with advanced non-small cell lung cancer," said Roy Baynes, M.D., Ph.D., Chief Medical Officer of Eikon Therapeutics. "By combining a systemically administered TLR7/8 co-agonist with standard-of-care pembrolizumab and chemotherapy, our goal is to broaden immune activation and enhance anti-tumor responses in this hard-to-treat population. These results, reviewed in a successful end-of-Phase-2 meeting with the FDA earlier this year, support the continued advancement of this program into a registration-enabling Phase 2/3 trial. We look forward to sharing these data at ESMO (Free ESMO Whitepaper)."

TeLuRide-005 (NCT06246110) is a Phase 2 study evaluating EIK1001 in combination with pembrolizumab (KEYTRUDA) and histology-appropriate chemotherapy (carboplatin plus either pemetrexed or paclitaxel) in patients with Stage 4 NSCLC. By stimulating a broad immune response through TLR7/8 co-activation, EIK1001 is designed to enhance T-cell recognition and tumor killing, potentially overcoming immune resistance often observed in advanced NSCLC. The molecule is designed to activate innate and adaptive immunity, providing both direct anti-tumor activity and complementary effects when used in combination with checkpoint inhibitors. The trial’s primary objective is to evaluate the safety and tolerability of EIK1001 in the triplet combination. In addition, Eikon hopes to explore whether the immunomodulatory mechanism of EIK1001 might improve lung cancer treatment regimens. EIK1001 is also being studied in a seamless Phase 2/3 trial (TeLuRide-006; NCT06697301) evaluating its addition to standard-of-care pembrolizumab for the treatment of patients with advanced melanoma.

"The data being presented at ESMO (Free ESMO Whitepaper) mark another step forward for EIK1001 and underscore the increasing momentum across our oncology portfolio," said Roger M. Perlmutter, M.D., Ph.D., Chief Executive Officer of Eikon Therapeutics. "This progress reflects the deep expertise of our team in advancing groundbreaking cancer therapies through clinical development, and we are eager to build on this foundation as we work to deliver important new medicines that address grievous illnesses."

Eikon is also advancing a portfolio of differentiated oncology programs, including both mid-stage clinical assets and internally derived candidates informed by the company’s proprietary single-molecule tracking (SMT) platform. They include:

EIK1003-001 (NCT06253130): A highly selective non-CNS-penetrant PARP1 inhibitor, currently being evaluated in a Phase 1/2 study of adults with advanced solid tumors. Initial pharmacokinetic, safety, tolerability, and early efficacy findings from the monotherapy dose-escalation cohort were reported at ASCO (Free ASCO Whitepaper) 2025.
EIK1004-001 (NCT06907043): A CNS-penetrant PARP1 inhibitor currently in a Phase 1/2 study assessing safety, pharmacokinetics/pharmacodynamics, and preliminary antitumor activity in patients with advanced solid tumors, including those with brain metastases.
EIK1005: A novel, internally derived program targeting Werner (WRN) helicase for microsatellite unstable cancers and sensitive cancers that have other defects in DNA repair. EIK1005 is expected to begin Phase 1 clinical testing in Q4, 2025.

(Press release, Eikon Therapeutics, OCT 15, 2025, View Source [SID1234656685])

On October 15, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX) (the "Company"), an oncology biotechnology company developing novel payload antibody drug conjugates (ADCs), reported that it has entered into a definitive agreement for the issuance and sale of an aggregate of 3,125,000 of the Company’s American Depositary Shares ("ADSs"), each representing 2,000 ordinary shares at a purchase price of $0.80 per ADS in a registered direct offering.

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Ladenburg Thalmann & Co. Inc. is acting as the exclusive placement agent for the offering.

In addition, in a concurrent private placement, the Company will issue unregistered Series E Warrants to purchase up to 3,125,000 of the Company’s ADSs and unregistered Series F Warrants to purchase up to 3,125,000 of the Company’s ADSs, each at an exercise price of $0.98 per share. The Series E Warrants will be exercisable on the date of shareholder approval (the "Shareholder Approval Date") for the exercisability of the warrants and have a term of five years from the initial exercise date. The Series F Warrants will be exercisable on the Shareholder Approval Date and have a term of thirty months from the initial exercise date. The offering is expected to close on or about October 16, 2025, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be approximately $2.5 million. The Company intends to use the net proceeds for working capital, general corporate purposes, and continued research and development ("R&D"). Specifically with regard to its focused R&D work, the Company intends to use these funds to generate differentiated data on the novel ADC payload that highlights its unique action against cancer and builds on new data being presented at the upcoming Society for Immunotherapy Cancer Society Annual Meeting in early November.

The ADSs (but not the warrants issued in the private placement or the ADSs underlying such warrants) are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-289056) originally filed with the U.S. Securities and Exchange Commission (the "SEC") on July 29, 2025 and declared effective by the SEC on July 31, 2025. The ADSs to be issued in the registered direct offering are being offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to, and describing the terms of, the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the final prospectus supplement and the accompanying base prospectus relating to the registered direct offering, when available, may also be obtained by contacting Ladenburg Thalmann & Co. Inc., 640 Fifth Avenue, 4th Floor, New York, NY 10019, by phone at (212) 409-2000, or by email at [email protected].

The warrants described above are being issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder and, along with the ADSs underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying ADSs may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

(Press release, Akari Therapeutics, OCT 15, 2025, View Source [SID1234656670])