On May 15, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), a biotechnology company developing novel Antibody Drug Conjugates (ADCs) with immuno-oncology payloads for the treatment of cancer, reported its financial results for the first quarter ended March 31, 2025 and provided a corporate update (Press release, Akari Therapeutics, MAY 15, 2025, View Source [SID1234653207]).

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 remain laser focused on becoming a key player in the ADC space and advancing our novel ADC platform built around immuno-oncology payloads and our lead asset AKTX-101, an ADC targeting Trop2 with our immuno-oncology payload, PH1. We continue to develop and execute a clear path forward for our ADC pipeline and support these efforts with ongoing activities and building the team that we believe positions us for success in the near and long term," commented Abizer Gaslightwala, President and Chief Executive Officer of Akari. "In particular, we were pleased to recently welcome Mark Kubik, a seasoned leader in the Antibody Drug Conjugate space, as Head of Business Development, Oncology and believe his expertise will be invaluable as we continue to advance our novel ADC platform technology."

Leveraging its innovative payload platform, the Company is advancing a pipeline of potentially first-in-class, best-in-class ADC candidates across a wide range of cancer tumor targets. These initial candidates have shown significant tumor-killing activity in preclinical models with the ability to robustly activate the immune system to drive durable, and sustained outcomes.

Upcoming Expected Value-Driving Milestones

Novel ADC’s With Immuno-Oncology Payloads

Anticipate presenting preclinical data showing that a proof-of-concept ADC with PH1 payload exhibits robust immuno-oncology activity, at a scientific conference in second half of 2025.
Complete additional preclinical studies for novel PH1 payload exploring activity in prostate cancer cell lines.
Explore preclinical activity for AKTX-101 in different solid tumor indications including lung, as single agent and in combination with other approved agents.
Continue to focus on operational excellence and efficient capital allocation to advance novel payload ADC platform.
Ongoing efforts to seek strategic partners for research collaborations on PH1 immuno-oncology payload across customized tumor targets. Continued discussions with partners on advancing AKTX-101 ADC (Trop2/PH1 payload) through additional IND-enabling activities.
Non-Core Asset Out Licensing

Continue efforts to out-license non-core assets across inflammation, ophthalmology, and rare diseases as a source of non-dilutive capital to invest into ADC platform.
Summary of Financial Results for First Quarter 2025

The net loss from operations for the three months ended March 31, 2025 was approximately $3.7 million compared to $5.6 million for the same period in 2024.

The Company reported research and development expenses of $0.8 million for the three months ended March 31, 2025 compared to approximately $2.3 million for the same period in 2024. The decrease was primarily due to our decision to suspend our HSCT-TMA clinical stage program with nomacopan in May 2024.

General and administrative expenses were approximately $2.7 million for the three months ended March 31, 2025 compared to approximately $3.7 million for the same period in 2024. The decrease was primarily due to (i) decreases in legal and professional fees (primarily related to the Merger) and (ii) a decrease in directors’ and officers’ insurance.

As of March 31, 2025, the Company had cash of approximately $2.6 million. The net proceeds from the Company’s March 2025 offering, after deducting placement agent fees and other offering expenses, were approximately $6.0 million, of which $4.0 million was received in April 2025.

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).

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!

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 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]).

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!

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 Alpheus Medical, Inc., a private, clinical-stage oncology company pioneering sonodynamic therapy (SDT) for the treatment of solid body cancers, reported the closing of an oversubscribed $52 million Series B financing round (Press release, Alpheus Medical, MAY 15, 2025, View Source [SID1234653190]). The funds will support a Phase 2B randomized controlled trial (RCT) evaluating the efficacy of SDT in patients with newly diagnosed glioblastoma (GBM) – one of the most aggressive and deadly forms of brain cancer.

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!

Backed by leading healthcare investors, the round was co-led by HealthQuest Capital and Samsara BioCapital with participation from existing investors OrbiMed and Action Potential Venture Capital. In addition, venture investors committed to transforming cancer care participated, including BrightEdge, the impact investment and innovation arm of the American Cancer Society, the Brain Tumor Investment Fund, a subsidiary of the National Brain Tumor Society, and Sontag Innovation Fund, a subsidiary of The Sontag Foundation.

"The complex and diffuse nature of glioblastomas has long hindered therapeutic innovation," said Conrad Wang M.D., Partner at HealthQuest Capital. "Alpheus’ sonodynamic therapy represents a novel, non-invasive whole brain approach with compelling early data. This investment reflects our commitment to advancing transformative technologies that seek to fill critical gaps in patient unmet needs."

Alpheus’ platform delivers non-thermal, tumor-selective therapy activated by low-intensity diffuse ultrasound (LIDU) with oral 5-aminolevulinic acid (5-ALA). Without the need for imaging or sedation, this combination selectively targets and destroys cancer cells across the entire brain hemisphere. This novel treatment option is performed in an outpatient setting. Promising early results from two studies highlight the potential of SDT therapy in both newly diagnosed and recurrent glioblastoma patients.

"This investment is a key inflection point for Alpheus and the glioblastoma community – advancing sonodynamic therapy from promise to clinical validation," commented Vijay Agarwal, MD, FAANS, FCNS, President and CEO of Alpheus Medical. "With this support, we are poised to generate pivotal evidence that could help establish a new standard of care for newly diagnosed brain tumors."

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.

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!

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%