On May 15, 2025 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reported the Company’s poster presented at the European Society for Medical Oncology’s ("ESMO") Breast Cancer meeting on May 14-17, 2025, in Munich, Germany (Press release, CytoDyn, MAY 15, 2025, View Source [SID1234653150]).

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A copy of the poster is available at the following link: ESMO (Free ESMO Whitepaper) Poster May 2025

More information about the data CytoDyn presented at ESMO (Free ESMO Whitepaper) suggesting the novel mechanism of action of leronlimab for the treatment of solid tumors can be found in the Company’s press release issued on May 13, 2025.

On May 15, 2025 Merck, a leading science and technology company, reported to grow across all three business sectors in the first quarter of 2025 (Press release, Merck KGaA, MAY 15, 2025, View Source [SID1234653090]). In the Life Science sector, Process Solutions reclaimed its position as the main growth driver amid noticeably recovering demand. The Healthcare sector saw strong sales in the Cardiovascular, Metabolism, and Endocrinology franchise. And Electronics continued to benefit from steady and strong demand for semiconductor materials.

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Group net sales rose to € 5.3 billion in the first quarter of 2025, up 2.5% organically compared with the year-earlier quarter. EBITDA pre came in at € 1.5 billion, up 5.8% organically year-on-year. At 29.1%, the EBITDA pre margin expanded by 0.7 percentage points compared with the first quarter of 2024. This was due to temporarily reduced research and development expenses in Healthcare and strict cost discipline across the Group. Earnings per share pre improved from € 2.06 to € 2.12.

"Our solid first-quarter results underscore the resilience of our dynamic, innovation-driven business and our region-for-region approach. I am particularly pleased that Process Solutions has performed strongly, accelerating growth for Life Science. We continue to resolutely execute our strategy, driving efficient and profitable growth. In response to the challenging global backdrop, we’ve slightly adjusted our guidance but continue to remain confident that we are well-positioned to achieve sustainable growth for 2025 and beyond," said Belén Garijo, Chair of the Executive Board and CEO of Merck. "As we navigate the complexities of today’s world, we remain committed to reinforcing our position as a globally diversified pioneer in science and technology. Our recently announced agreement to acquire SpringWorks Therapeutics is a strong proof point to this approach."

On April 28, 2025, Merck announced that it had entered into a definitive agreement to acquire SpringWorks Therapeutics, Inc., a publicly listed Stamford, Connecticut-based commercial-stage biopharmaceutical company focusing on severe rare diseases and cancer. The transaction’s purchase price of US$ 47 per share in cash represents an enterprise value of US$ 3.4 billion (€ 3.0 billion), or an equity value of approximately US$ 3.9 billion. For Merck’s Healthcare sector, it will sharpen the focus on rare tumors, accelerate growth, and strengthen the presence in the U.S., the world’s largest pharma market. The transaction is expected to close in the second half of 2025.

Life Science further accelerates growth

The Life Science business sector of Merck further accelerated its growth in the first quarter of 2025. Net sales increased to € 2.2 billion (organically: +2.5%) and EBITDA pre to € 622 million (organically: +3.1%). This was driven by the very strong recovery in demand in Process Solutions, which markets solutions for the entire pharmaceutical production value chain. Net sales of this business grew organically by 11.4% to € 919 million.

Net sales in Science & Lab Solutions, with its product and service offering for pharmaceutical, biotechnology and academic research, came in at € 1.1 billion. This represented an organic decline of 2.5% year-on-year, on the back of increased uncertainty regarding the funding of scientific research and a still challenging pharmaceutical research spending environment.

Life Science Services recorded net sales of € 151 million (organically: –6.2%). The unit offers customers services as a contract development and manufacturing (CDMO) of medications as well as testing services. While there was some momentum in antibody drug conjugates and small molecules, overall demand remained low. The overall situation for the funding of early-stage biotech projects remained challenging in the first quarter.

Healthcare continues to deliver profitable growth

Healthcare net sales grew organically by 3.4% to € 2.1 billion, while EBITDA pre rose 11.7% to € 796 million. This was primarily driven by temporarily reduced R&D expenditure. The business sector’s Cardiovascular, Metabolism and Endocrinology franchise was the main growth driver with organic growth across all therapeutic areas. Net sales of this franchise climbed organically by 10.6% to € 757 million.

In the Oncology franchise, net sales decreased slightly to € 491 million (organically: –1.9%). Net sales of Erbitux grew organically by 6.2% to € 305 million, benefiting from continued market growth in China. Erbitux is a treatment for metastatic colorectal cancer as well as cancer of the head and neck. Net sales of Bavencio, a drug for treating a type of bladder cancer, declined by 15.4% to € 157 million due to increasing competition.

In the Neurology & Immunology franchise, net sales came in at € 407 million (organically: –3.7%). Net sales of the multiple sclerosis drug Mavenclad rose organically by 9.2% to € 287 million, driven by increased demand in North America and Europe in particular. Net sales of Rebif, the other multiple sclerosis treatment offered by Merck, decreased organically by 25.1% to € 120 million in line with the interferon market.

The Fertility franchise achieved around stable net sales of € 382 million (organically: –0.4%) despite still elevated year-earlier figures, which were influenced by supply shortages at competitors.

Semiconductor materials demand drove growth in Electronics

Electronics generated first-quarter net sales of € 948 million, with organic growth of 0.6%. EBITDA pre rose 2.0% to € 244 million. Continued demand for semiconductor materials used in Artificial Intelligence technologies drove the strong and steady growth of the business. As a result, net sales of Semiconductor Solutions, which develops products and services for the semiconductor industry, grew by 2.0% organically to € 649 million. Demand for high-value materials used in advanced nodes – manufacturing technologies with the smallest feature sizes enabling AI – continued to drive a strong volume growth.

Optronics increased sales to € 198 million. The business unit is a supplier of cutting-edge optical technologies for the electronics industry. The organic development was around stable, while Unity-SC contributed nicely with a 4.3% portfolio effect. Merck fully acquired the specialist for high-precision metrology instruments in October 2024.

Surface Solutions sales amounted to € 101 million (organically: –6.9%) with weaker cosmetics demand. In 2024, Merck announced it had agreed to divest this business unit. The transaction is expected to close in the second half of 2025.

Merck confident it will deliver sustainable growth in 2025

Merck has slightly adapted its full-year guidance for the Group for 2025 to reflect the impact of the current macro-economic and geopolitical environment. In particular, foreign-exchange effects may become more of a headwind in all three business sectors. The slight adjustment to the guidance in Life Science, Merck’s biggest business sector, is also related to the current uncertainties around tariffs. Merck remains confident it will deliver sustainable growth in 2025. The company now expects Group full-year net sales of between € 20.9 billion and € 22.4 billion and EBITDA pre of between € 5.8 billion and € 6.4 billion. This corresponds to organic sales growth of 2% to 6% and an organic EBITDA pre growth of 2% to 7%.

Overview of the key figures

Merck Group

Key figures

€ million

Q1 2025

Q1 2024

Change

Net sales

5,280

5,120

3.1%

Operating result (EBIT)1

1,006

931

8.0%

Margin (% of net sales)1

19.0%

18.2%

EBITDA2

1,479

1,385

6.8%

Margin (% of net sales)1

28.0%

27.0%

EBITDA pre1

1,535

1,454

5.6%

Margin (% of net sales)1

29.1%

28.4%

Profit after income tax

738

699

5.5%

Earnings per share (€)

1.69

1.60

5.6%

Earnings per share pre (€)1

2.12

2.06

2.9%

Operating cash flow

556

1,035

-46.3%

Net financial debt1, 3

7,121

7,155

-0.5%

Number of employees4

62,604

62,345

0.4%

1 Not defined by International Financial Reporting Standards (IFRS).

2 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses.

3 Figures for the reporting period ending on March 31, 2025, prior-year figures as of December 31, 2024.

4 Figures for the reporting period ending on March 31, 2025, prior-year figures as of March 31, 2024. This figure refers to all employees at sites of fully consolidated entities.

Life Science

Net sales by business unit

€ million

Q1 2025

Share

Organic growth1

Exchange rate effects1

Acquisitions/ divestments1

Total change

Q1 20242

Share

Science & Lab Solutions

1,149

52%

-2.5%

0.5%

0.2%

-1.8%

1,170

55%

Process Solutions

919

41%

11.4%

0.5%

0.5%

12.4%

817

38%

Life Science Services

151

7%

-6.2%

2.2%

–

-4.0%

157

7%

Life Science

2,218

100%

2.5%

0.6%

0.3%

3.5%

2,144

100%

1 Not defined by International Financial Reporting Standards (IFRS).

2 Prior-year figures have been adjusted owing to an internal realignment.

Healthcare

Net sales by major product lines/products

€ million

Q1 2025

Share

Organic
growth1

Exchange rate effects1

Total change

Q1 2024

Share

Oncology

491

23%

-1.9%

0.1%

-1.8%

500

24%

thereof: Erbitux

305

14%

6.2%

–

6.2%

287

14%

thereof: Bavencio

157

7%

-15.4%

-0.1%

-15.6%

186

9%

Neurology & Immunology

407

19%

-3.7%

0.9%

-2.8%

419

20%

thereof: Mavenclad

287

14%

9.2%

0.8%

10.1%

261

13%

thereof: Rebif

120

6%

-25.1%

1.1%

-24.0%

158

8%

Fertility

382

18%

-0.4%

0.2%

-0.2%

383

19%

thereof: Gonal-f

206

10%

0.3%

0.7%

1.0%

204

10%

thereof: Pergoveris

78

4%

13.6%

-1.3%

12.2%

70

3%

Cardiovascular, Metabolism and Endocrinology

757

36%

10.6%

-0.7%

9.9%

689

34%

thereof: Glucophage

242

11%

10.4%

-0.9%

9.5%

221

11%

thereof: Concor

157

7%

12.2%

0.3%

12.5%

140

7%

thereof: Euthyrox

155

7%

12.7%

-0.9%

11.9%

139

7%

thereof: Saizen

103

5%

18.6%

-2.4%

16.1%

89

4%

Other

77

4%

57

3%

Healthcare

2,114

100%

3.4%

-0.2%

3.2%

2,048

100%

1 Not defined by International Financial Reporting Standards (IFRS).

Electronics

Net sales by business unit

€ million

Q1 2025

Share

Organic growth1

Exchange rate effects1

Acquisitions/ divestments1

Total change

Q1 2024

Share

Semiconductor Solutions

649

68%

2.0%

0.9%

-0.3%

2.6%

633

68%

Optronics

198

21%

-0.1%

1.6%

4.3%

5.8%

187

20%

Surface Solutions

101

11%

-6.9%

-0.1%

–

-7.0%

109

12%

Electronics

948

100%

0.6%

0.9%

0.6%

2.1%

On May 15, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported that a 60.8% response rate and 90.2% disease control rate, according to RECIST1.1, has been achieved in the investigator-initiated INSIGHT-003 trial as of the data-cut off date of 06 May 2025 (Press release, Immutep, MAY 15, 2025, View Source [SID1234653089]). INSIGHT-003 is evaluating eftilagimod alpha (efti) in combination with the anti-PD-1 therapy, KEYTRUDA (pembrolizumab) and doublet chemotherapy as first-line treatment for patients with advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC).

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Marc Voigt, CEO of Immutep, stated, "Our level of confidence in efti driving a new standard of care for patients with non-small cell lung cancer via our pivotal TACTI-004 trial continues to rise with the strength of the data from INSIGHT-003 and TACTI-002. Across two trials we have now efficacy data from 165 patients with 1L NSCLC who have been treated with efti and KEYTRUDA, either with or without chemotherapy. In multi-national settings, efti has generated consistent and remarkable improvements in response rates. In particular, the interim ORR data in patients with PD-L1 expression below 50% in the ongoing INSIGHT-003 trial, who represent over two-thirds of the 1L NSCLC patient population, is very encouraging."

Majority of Patients have PD-L1 TPS <50%
Notably, ~92% of all evaluable patients (N=51) in the INSIGHT-003 study have PD-L1 TPS <50%. This includes 49% of patients with PD-L1 Tumour Proportion Score (TPS) of 1-49% and 43% of patients with PD-L1 TPS <1%, as shown in the table below.

Strong Response Rates Across All PD-L1 Expression Levels
Data from all evaluable patients demonstrates significant improvement of Overall Response Rate (ORR) according to RECIST 1.1 across all levels of PD-L1 expression compared to historical control from a registrational trial of anti-PD-1 and doublet chemotherapy in non-squamous 1L NSCLC1:

75.0% ORR versus 62.1% ORR in patients with high PD-L1 expression (TPS >50%)
64.0% ORR versus 49.2% ORR in patients with low PD-L1 expression (TPS 1-49%)
54.5% ORR versus 32.3% ORR in patients with negative PD-L1 expression (TPS <1%)

The 60.8% response rate regardless of PD-L1 expression (TPS 0-100%) represents a substantial improvement compared to historical control of 48.0%.1 The relative outperformance is particularly strong given the registrational trial has four times as many patients with high PD-L1 expression (~32% of patients versus ~8% in INSIGHT-003), who have the highest response rates.

Importantly, in patients with TPS <50% (N=47), who have a high unmet need and represent over two-thirds of the 1L NSCLC patient populaton, the triple combination with efti achieved a 59.6% response rate as compared to historical control of 40.8%.1

INSIGHT-003 Overall Response Rate & Disease Control Rate, according to RECIST1.1
PD-L1 Expression Levels TPS 0-100%
(N=51) TPS <1%
(N=22) TPS 1-49%
(N=25) TPS <50%
(N=47) TPS ≥50%
(N=4)
ORR % 60.8 54.5 64.0 59.6 75.0
DCR % 90.2 86.4 92.0 89.4 100

Safety
Safety continues to be favourable for the triple combination in 1L NSCLC with no new safety signals.

Next Steps
Additional data updates from this trial are expected to be presented at a medical conference in 2025 and beyond.

About INSIGHT-003
INSIGHT-003 is an investigator-initiated study conducted by the Frankfurt Institute of Clinical Cancer Research IKF and several other German centres. It is being run as the third arm (Stratum C) of the ongoing Phase I INSIGHT trial with Prof. Dr. Salah-Eddin Al-Batran as lead investigator. The study is evaluating a triple combination therapy in front-line non-small cell lung cancer patients consisting of efti administered subcutaneously in conjunction with an existing approved standard-of-care combination of anti-PD-1 therapy (pembrolizumab) and chemotherapy (carboplatin and pemetrexed) delivered intravenously. The trial will assess the safety, tolerability, and initial efficacy of the combination.

About Eftilagimod Alfa (efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

On May 14, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath©, a novel, FDA-cleared drug-delivery device, reported that Chief Executive Officer, Shaun Bagai, will participate in a fireside chat at the Alliance Global Partners (A.G.P.) Virtual Healthcare Company Showcase hosted by Scott Henry, Managing Director and Healthcare Analyst at A.G.P., on May 21, 2025 (Press release, Renovorx, MAY 14, 2025, View Source [SID1234653103]).

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Mr. Bagai will share recent business developments, highlighting continuing momentum with the Company’s RenovoCath commercialization, as well as progress in the ongoing Phase III TIGeR-PaC clinical trial. TIGeR-PaC is evaluating RenovoRx’s novel drug-device combination oncology product candidate (intra-arterial gemcitabine, known as IAG) for treatment in locally advanced pancreatic cancer (LAPC), which is currently under investigation, and has not yet been approved for commercial sale.

Fireside Chat Details:
Date: Wednesday, May 21, 2025
Time: 12:40 p.m. ET
Speaker: Shaun Bagai, CEO
Moderator: Scott Henry, AGP Managing Director and Healthcare Analyst
Webcast: View Source

To schedule a one-on-one investor meeting with Mr. Bagai, please contact your A.G.P. representative or KCSA Strategic Communications at [email protected].

About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-G-Universal-IFU.pdf.

About the TIGeR-PaC Clinical Trial

TIGeR-PaC is an ongoing Phase III randomized multi-center trial evaluating the proprietary TAMP (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of LAPC. RenovoRx’s first investigational drug-device combination product candidate using the TAMP therapy platform is enabled with the Company’s FDA-cleared RenovoCath device for the intra-arterial administration of chemotherapy (intra-arterial gemcitabine, known as IAG).

On May 14, 2025 Hangzhou Qihan Biotech Co., Ltd. ("Qihan" or "Qihan Biotech" or "the Company"), an industry leader in applying multiplexable genome editing technology to cell therapies and organ transplantation, reported new advancements in its universal CAR-T cell therapy research, to be presented at the 28th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) (Press release, Qihan Biotech, MAY 14, 2025, View Source [SID1234653102]).

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Through systematic exploration of T cell cytokine pathways, Qihan Biotech identified two novel cytokines that significantly enhance CAR-T cell activity. By engineering the corresponding receptor pathways, the company achieved robust CAR-T expansion in non-human primate models without lymphodepletion preconditioning and observable toxicity. This breakthrough offers a promising strategy to optimize CAR-T therapies and enables safer application in autoimmune diseases, paving the way for broader clinical use of CAR-T therapies.

Dr. Luhan Yang, Founder and CEO of Qihan Biotech, stated: "This research marks a significant step forward in CAR-T therapies. Enhancing CAR-T efficacy without lymphodepletion and toxicity could unlock its full potential in treating autoimmune diseases. We plan to begin clinical studies in 2025."

Poster Presentation Details:

Poster #1761: Enhanced CAR-T cell functions without lymphodepletion via engineering cytokine pathways

Session: Poster Abstract Session

Session Dates: May 13–15, 2025