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.

On May 15, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company leveraging its proprietary RADR artificial intelligence (AI) and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported operational highlights and financial results for the first quarter 2025 ended March 31, 2025, and provided an update on its portfolio of AI-driven drug candidates, the RADR platform for precision oncology drug development enhancements, and other operational progress (Press release, Lantern Pharma, MAY 15, 2025, View Source [SID1234653173]).

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AI-Powered Drug Development Pipeline Highlights:

LP-300

Lantern’s Phase 2 HARMONIC trial for LP-300 continued to advance during Q1 2025 with patients enrolled in Japan and Taiwan and ongoing enrollment in the US. Never-smokers with NSCLC in East Asia represent approximately 33% to 40% of new NSCLC cases as compared to the U.S., where never smokers account for approximately 15% of new NSCLC cases. LP-300 is being evaluated in combination with standard-of-care chemotherapy (carboplatin + pemetrexed) in never-smokers with NSCLC adenocarcinoma who have progressed after TKI therapy. The trial is designed to enroll approximately 90 patients across the U.S. and East Asia.

Phase 2 Clinical Results: Preliminary data from the Phase 2 U.S. safety, lead-in cohort showed an 86% clinical benefit rate and a 43% objective response rate. Additional patient data from the expansion cohort continues to support, at the current time, a similar patient response and clinical benefit rate trend. Lantern plans on sharing additional results, which will include updated data from patients enrolled in the lead-in cohort and new data from patients in the Asian expansion cohort, during Q3 of 2025.

LP-184

LP-184 continued advancements through a Phase 1a trial in multiple solid tumors, which is targeted to finish enrollment during June of 2025. LP-184 has received Fast Track Designations from the FDA for GBM (Glioblastoma Multiforme) and TNBC (Triple Negative Breast Cancer). Additionally, LP-184 has four Rare Pediatric Disease Designations for hepatoblastoma, rhabdomyosarcoma, and malignant rhabdoid tumors, and ATRT (atypical teratoid, rhabdoid tumors).

Phase 1a Results: Safety, Tolerability, Pharmacokinetics including MTD Determination – The trial has now enrolled through cohort 12, and early indications of clinical activity have been observed at higher dose levels, consistent with preliminary PK data. During Q1 2025, the Safety Review Committee (SRC) along with the Company, made the decision to backfill dose levels 10 and 11 to ensure clarity on the maximum tolerated dose (MTD) while ensuring the safety of study participants, and assessing the clinical activity of the dose to guide future LP-184 clinical trials. Enrollment at dose level 9 and higher has been focused on inclusion of advanced solid tumor patients that have identified DNA damage repair mutations. A broader clinical data update is slated for Q3 of 2025, when complete safety, pharmacokinetic and dose response data along with biomarker correlations is expected to be available.

Future Planned Phase 1b/2 Trials: Lantern has recently cleared two clinical trial protocols with the FDA that can provide a path towards a regulatory approval.

The first, announced on May 5th, is for a Phase 1b/2 study in TNBC evaluating LP-184 in both a combination regimen with the PARP inhibitor, Olaparib and as monotherapy in the same indication. The FDA has raised no objections to the protocol, and Lantern plans to initiate this trial in both the US and at leading academic cancer centers in Nigeria and India, subject to clinical priorities and funding. The average survival for newly diagnosed, metastatic TNBC is estimated at 8 to 13 months and presents an annual market opportunity in excess of $4 billion USD.

The second, announced on May 12th, is for a Phase1b/2 study in a biomarker defined subset of drug-resistant non-small cell lung cancer that has mutations in the STK11 and/or KEAP1 genes. This unique trial is aimed at addressing a critical unmet clinical need in lung cancer care: the median overall survival in newly diagnosed, advanced NSCLC patients with KEAP1 and/or STK11 mutations treated with chemo-immunotherapy averages 15 months, substantially lower than outcomes in mutation negative populations. For patients that fail earlier lines of therapies the overall survival tends to skew even lower at approximately 6.3 months. This represents a market opportunity exceeding $2 billion annually, given the prevalence and poor prognosis for patients with these mutations.

Additionally, an investigator-led, exploratory clinical trial of LP-184 for recurrent bladder cancer is planned to begin in Denmark during Q3 of 2025. This clinical trial is designed to test LP-184 as a monotherapy specifically in advanced, recurrent bladder cancer patients with DNA damage repair mutations with the potential to create a path towards data to support usage in the 3rd line setting.

RADR A.I. Platform:

Lantern’s proprietary RADR platform has grown during Q1 2025 to approximately 200 billion oncology-focused data points across multiple sources (proprietary, collaborative and public) of oncology, molecular, clinical, biochemical, and preclinical datasets.

RADR continues to play an important role in advancing:

● drug candidate optimization,
● development and validation of clinically relevant drug-candidate combinations,
● identification of mechanism(s) of action,
● identification of optimal indications for drug-candidate advancement,
● creation of biomarker signatures to support patient selection,
● optimization and characterization of molecular features, and
● prediction of the blood brain barrier (BBB) potential of a molecule.

AI and platform-driven insights contributed to LP-184’s clinical biomarker strategy, including a qPCR assay for PTGR1 to guide patient stratification, and aided in the identification of multiple indications leading to orphan and rare pediatric disease designations. Additionally, RADR also underpinned combination strategies, such as LP-184 with PARP inhibitors and LP-284 with rituximab. Future plans and proposed developments include additional collaborations with leading oncology development groups and biopharma companies in both adult and pediatric cancers. Lantern expects to publicly release multiple modules (validated A.I. frameworks) that can be accessed by Lantern collaborators and the research community for specific needs in oncology drug development—such as prediction of certain molecular features including the BBB penetrability of a molecule, identification of potential cancer indications that are more likely to show a higher sensitivity to a molecule or drug-candidate, and aiding the development of optimized paths to demonstrate potential therapeutic utility of a molecule in a rare cancer.

Starlight Therapeutics:

Lantern’s wholly owned subsidiary focused on CNS and brain cancers, Starlight Therapeutics, made key advances towards the design, development and approval of adult and pediatric trials, including potential investigator-initiated clinical trials for STAR-001. LP-184, referred to as STAR-001 for CNS indications, was highlighted at the Society for Neuro-Oncology (SNO) 2024 conference, with a Phase 1b/2 trial in recurrent GBM anticipated to begin in late 2025 subject to successful additional funding and clearance of the protocol. Additionally, further preclinical studies led by Lantern’s collaborators at Johns Hopkins provided independent confirmation of LP-184 hypersensitivity in rare pediatric brain tumors, in support of a clinical trial being planned with a pediatric consortium in CNS tumors.

Additional Operational Highlights:

Lantern also advanced a proprietary BBB permeability prediction algorithm with a favorable PCT patent application report, advancing our AI leadership with Lantern’s algorithms now holding five of the top ten positions on Therapeutic Data Commons (TDC) Leaderboard. The company is developing a publicly available tool to predict the BBB permeability of any molecule that can be readily accessed by the research and drug development community, which is planned for initial launch during the second half of 2025.

First Quarter 2025 Financial Highlights:

➢ Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $19.7 million as of March 31, 2025, compared to approximately $24.0 million as of December 31, 2024.

➢ R&D Expenses: Research and development expenses were approximately $3.3 million for the quarter ended March 31, 2025, compared to approximately $4.3 million for the quarter ended March 31, 2024.

➢ G&A Expenses: General and administrative expenses were approximately $1.5 million for the quarter ended March 31, 2025, essentially unchanged from approximately $1.5 million for the quarter ended March 31, 2024.

➢ Net Loss: Net loss was approximately $4.5 million (or $0.42 per share) for the quarter ended March 31, 2025, compared to a net loss of approximately $5.4 million (or $0.51 per share) for the quarter ended March 31, 2024.

➢ Warrant Exercises: There were no warrants exercised during the three months ended March 31, 2025. The company has warrants to purchase 70,000 shares of common stock outstanding and exercisable as of March 31, 2025 at a weighted-average exercise price of $18.75 per share. These warrants will expire on June 10, 2025.

On May 15, 2025 RyboDyn, Inc., a biotechnology company pioneering first-in-class immunotherapies targeting the dark proteome, reported the expansion of its strategic collaboration with Moffitt Cancer Center, a global leader in cancer care and research (Press release, RyboDyn, MAY 15, 2025, View Source [SID1234653191]). The partnership aims to accelerate the development of immunotherapies targeting novel, cancer-specific proteins identified through RyboDyn’s proprietary sequencing and AI-driven target discovery platform, RyboCypher.

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Earlier this year, RyboDyn reported the identification of a cryptic class of proteins derived from overlooked RNA species—called Dark Targets. These novel antigens, invisible to standard detection methods, represent a new and largely untapped frontier for oncology drug development. Through its expanded collaboration with Moffitt, RyboDyn will validate the presence and therapeutic potential of these Dark Targets across a wide array of tumor types, leveraging Moffitt’s uniquely annotated tumor repository—one of the largest and most comprehensive in the world. "Moffitt’s tumor bank is a critical resource in validating novel targets across a diverse set of cancer patients," said Dr. Alex Jaeger, PhD, assistant member of the Molecular Oncology Department at Moffitt Cancer Center. "The ability to correlate molecular signals with deep clinical metadata significantly accelerates both discovery and translational development."

Initial studies from the collaboration have confirmed that select Dark Targets are consistently presented on tumors—but not in healthy tissues—de-risking this novel class of antigens and providing a path toward scalable, tumor-specific therapies. "The fact that our lead targets are consistently presented across patient samples—yet absent in healthy tissues, gives us high confidence in their relevance," said Corey Dambacher, PhD, President, CTO, and Co-founder of RyboDyn.

These data support RyboDyn’s core hypothesis: while not all Dark Targets are cancer-specific, a distinct subset is uniquely and consistently presented on tumor cells—making them highly compelling candidates for therapeutic development. "We’re not building a personalized medicine platform—we’re designing therapies that combine precision with broad reach," said Imad Ajjawi, PhD, MBA, CEO and Co-founder of RyboDyn. "By focusing on conserved targets with tumor-specific presentation, we’re unlocking new opportunities for scalable, off-the-shelf therapies in oncology."

"This collaboration reflects our shared commitment to advancing the next generation of cancer immunotherapies," said Dr. Jaeger. "By combining Moffitt’s clinical and translational expertise with RyboDyn’s novel discovery platform, we’re accelerating progress toward more precise and effective treatments."

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.