On May 15, 2025 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported the pricing of an offering of 834,237 shares of its common stock at an offering price of $6.61 per share and pre-funded warrants to purchase 1,587,108 shares of its common stock at an offering price of $6.6099 per pre-funded warrant share in an underwritten registered direct offering to a limited number of existing institutional investors, including entities affiliated with Adiumentum Capital Management, EcoR1 Capital, Panacea Venture and Redmile Group (Press release, Atara Biotherapeutics, MAY 15, 2025, View Source [SID1234653158]). The pre-funded warrants will have an exercise price of $0.0001 per share and will be immediately exercisable upon issuance. The offering is expected to close on or about May 16, 2025, subject to the satisfaction of customary closing conditions.

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The gross proceeds from the offering are expected to be $16 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Atara. Atara currently intends to use the net proceeds from the offering to fund its ongoing activities required to achieve biologics license application (BLA) approval for tab-cel, and for working capital and general corporate purposes.

TD Cowen is acting as the sole bookrunner for the offering.

The securities described above are being offered by Atara pursuant to a shelf registration statement on Form S-3 (No. 333-275256), including a base prospectus, that was previously filed by Atara with the U.S. Securities and Exchange Commission (the "SEC") on November 1, 2023 and was declared effective on November 13, 2023. A prospectus supplement containing additional information relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may also be obtained by contacting TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at [email protected]

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

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 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 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that the first pediatric AML patient has been dosed in the ongoing Phase 2 trial of SLS009 (tambiciclib), a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML) (Press release, Sellas Life Sciences, MAY 15, 2025, View Source [SID1234653151]).

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"Building upon our promising Cohort 3 data, we are pleased to dose our first pediatric AML patient as part of the ongoing Phase 2 trial," said Dragan Cicic, MD, Chief Development Officer of SELLAS. "This milestone reflects our commitment to addressing critical unmet needs in hematologic disorders as we develop treatments for the most difficult to treat patients, particularly pediatric patients, with very few available options, including multi-hit TP53 mutation, failure of azacitidine and venetoclax, failure of transplant, and almost all available high-intensity chemotherapies. With the Rare Pediatric Disease Designation already in place, we are hopeful that our work will bring meaningful progress and potential regulatory advantages as we continue to advance this important program."

SELLAS was granted the FDA RPDD for the treatment of pediatric AML in July 2024. If, in the future, a New Drug Application (NDA) for SLS009 for the treatment of pediatric AML is approved by the FDA, SELLAS will be eligible to receive a Priority Review Voucher (PRV) that could be redeemed to receive a priority review for any subsequent marketing application. PRVs may be used by the sponsor or sold to another sponsor for their use and have recently sold for approximately $100 million.

The Phase 2 clinical trial of SLS009 is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine at two dose levels, 45 and 60 mg. In the 60 mg dose cohort, patients were treated at either a 60 mg dose once per week or a 30 mg dose two times per week. The trial was expanded to include two additional cohorts, one with ASXL1-mutated AML patients and one with patients with myelodysplasia-related molecular abnormalities other than ASXL1. The target response rate at the optimal dose level is 20% with a target median survival of at least 3 months. In addition, the study aims to identify biomarkers for the target patient population and enrichment for further trials. For more information on the study, visit clinicaltrials.gov identifier NCT04588922.