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 [SID1234653157]).

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"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 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported financial results and business highlights for the first quarter of 2025 and shared recent operational progress (Press release, Abeona Therapeutics, MAY 15, 2025, View Source [SID1234653156]).

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"ZEVASKYN’s approval just a few weeks ago is a landmark achievement for recessive dystrophic epidermolysis bullosa patients and signifies Abeona’s transition to a commercial-stage cell and gene therapy company," said Vish Seshadri, Chief Executive Officer of Abeona. "We are rapidly advancing the launch of ZEVASKYN and building positive momentum. Patients can now start their treatment journey with Lurie Children’s activated as our initial treatment center ready to identify patients and our scheduling system is operational. In addition, we are collecting patient registrations through our patient support program, Abeona Assist, and have entered into agreements with commercial payer groups ensuring broad access to ZEVASKYN."

Recent Developments

ZEVASKYN FDA approval, commercial launch progress and new data

● FDA approval of first-in-class RDEB therapy: On April 28, 2025, the U.S. FDA approved ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-cel, as the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with RDEB. There is no cure for RDEB and ZEVASKYN is the only FDA-approved product to treat RDEB wounds with a single application.
● Activation of first ZEVASKYN Qualified Treatment Center (QTC): Following approval, ZEVASKYN is now commercially available in the U.S. after the activation of Ann & Robert H. Lurie Children’s Hospital of Chicago, a top-ranked hospital, as the first of five QTCs for ZEVASKYN. The first patient is expected to be treated in the third quarter of 2025. Abeona expects to activate all five QTCs by the end of 2025.
● High interest from patients and caregivers: Since approval, approximately 30 patients and caregivers have started registering in the Abeona Assist patient services program.
● Increasing enthusiasm from healthcare professionals: New data from two posters were presented at the 2025 Society for Investigative Dermatology (SID) Annual Meeting. One poster presentation details the potential progenitor cell populations within ZEVASKYN that may contribute to long-term wound closure and persistent COL7A1 expression observed after a single treatment. A second poster presentation details the absence of insertional oncogenesis and replication competent retrovirus in clinical and pre-clinical experience with ZEVASKYN.

● Securing broad patient access: Abeona has executed value-based agreements with several commercial payer groups representing dozens of downstream plans and approximately 100 million commercially-insured lives. In addition, Abeona is in active discussions with multiple commercial and government payers to further expand ZEVASKYN access to eligible patients in the U.S.

Key corporate updates

● Secured non-dilutive capital: Abeona entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease PRV for gross proceeds of $155 million upon the closing of the transaction. Abeona was awarded the PRV following the FDA approval of ZEVASKYN.

"The proceeds from our PRV sale fully fund our operations for over two years, extending our runway through our projected ZEVASKYN-driven profitability in early 2026," said Joe Vazzano, Chief Financial Officer of Abeona. "This robust financial footing, achieved even before ZEVASKYN revenues, eliminates the need for additional capital to reach this crucial commercial milestone."

Financial Results

Cash, cash equivalents, restricted cash and short-term investments totaled $84.5 million as of March 31, 2025, before accounting for the proceeds pending the close of the PRV sale. As of December 31, 2024, cash, cash equivalents, restricted cash and short-term investments totaled $98.1 million.

Research and development spending for the three months ended March 31, 2025 was $9.9 million, compared to $7.2 million for the same period of 2024. The increase was primarily due to increased headcount related to scale-up of manufacturing capacity in preparation for the planned ZEVASKYN commercial launch and pre-clinical development work. General and administrative expenses were $9.8 million for the three months ended March 31, 2025, compared to $7.1 million for the same period of 2024. The increase was primarily due to increased headcount associated with the planned launch of ZEVASKYN.

Net loss was $12.0 million for the first quarter of 2025, or $0.24 loss per common share. Net loss in the first quarter of 2024 was $31.6 million, or $1.16 loss per common share.

Conference Call Details

The Company will host a conference call and webcast on Thursday, May 15, 2025, at 8:30 a.m. ET, to discuss the financial results and corporate progress. To access the call, dial 877-545-0523 (U.S. toll-free) or 973-528-0016 (international) and Entry Code: 292299 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at View Source The archived webcast replay will be available for 30 days following the call.

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.

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%