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Merus to Present at the Canaccord Genuity 45th Annual Growth Conference

On August 6, 2025 Merus N.V. (Nasdaq: MRUS), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics, Triclonics and ADClonics), reported that Bill Lundberg, M.D., President, Chief Executive Officer of Merus, will participate in a fireside chat at the Canaccord Genuity 45th Annual Growth Conference on Wednesday, August 13, 2025 at 1:30 p.m. ET (Press release, Merus, AUG 6, 2025, View Source [SID1234654884]).

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The webcast of the presentation will be contemporaneously available on the Investors page of the Company’s website. The archived presentation will also be available there for a limited time after the event.

Lantern Pharma’s Subsidiary, Starlight Therapeutics, Announces U.S. Food and Drug Administration Clearance of IND for Phase Ib/2a Glioblastoma Multiforme (GBM) Trial

On August 6, 2025 Starlight Therapeutics, a wholly owned subsidiary of Lantern Pharma Inc. (NASDAQ: LTRN), reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase Ib/2a clinical trial to evaluate STAR-001 (LP-184) in combination with spironolactone for patients with glioblastoma multiforme (GBM) at first progression (Press release, Lantern Pharma, AUG 6, 2025, View Source;Food-and-Drug-Administration-Clearance-of-IND-for-Phase-Ib2a-Glioblastoma-Multiforme-GBM-Trial/default.aspx [SID1234654883]).

The planned Phase Ib/2a clinical trial (IND 178511) is designed to investigate the safety, tolerability, and preliminary efficacy of STAR-001 in combination with spironolactone in patients with recurrent GBM, one of the deadliest and most aggressive forms of brain cancer. GBM represents approximately 15% of all brain tumors and has a median survival of approximately 12 months from initial diagnosis, with fewer than 5% of patients surviving beyond five years.

"This FDA clearance represents a significant milestone for Starlight Therapeutics and our mission to bring innovative treatment options to patients facing the most challenging forms of brain and CNS cancers," said Dr. Marc Chamberlain, Chief Medical Officer of Starlight Therapeutics. "GBM remains one of the most difficult cancers to treat, with virtually no meaningful therapeutic advances in nearly 17 years. We believe our unique combination approach has the potential to offer new hope for patients and their families while advancing a novel mechanism to challenge these recurrent brain cancers."

Targeting GBM Through Innovative Synthetic Lethality

STAR-001 (also referred to as LP-184 when focused on other solid tumor indications) is a synthetically lethal, brain-penetrant, novel DNA-damaging agent that has demonstrated promising preclinical activity against various solid tumors, including pediatric and adult brain cancers. Lantern Pharma has previously been awarded both FDA Orphan Drug Designation and FDA Fast Track Designation for STAR-001 in GBM, underscoring the significant unmet medical need and the drug’s potential to address it. An existing Phase 1a trial to determine safety, dosing, the maximum tolerated dose (MTD) and tolerability across a range of solid tumors, including GBM, is currently underway and expected to complete enrollment in the current quarter. This trial is expected to help establish a baseline dosing level and expectations of drug-concentration in tumor and plasma for future clinical trials, including those being planned by Starlight Therapeutics.

The combination of STAR-001 with spironolactone, an existing FDA approved drug, represents a scientifically rational approach to treating GBM. STAR-001 is a blood-brain barrier permeable small molecule that leverages synthetic lethality to exploit DNA damage repair (DDR) deficiencies, particularly those overexpressing PTGR1. Approximately 60% of GBM cells overexpress PTGR1 levels sufficient to activate STAR-001. Spironolactone significantly enhances this therapeutic effect by inducing degradation of ERCC3, a critical protein involved in nucleotide excision repair (NER). This mechanism leads to NER deficiency (NERD), making GBM cells significantly more sensitive to STAR-001 and less capable of repairing the DNA damage caused by the administration of STAR-001. This synergistic approach is particularly promising in GBM which has often become resistant to therapies in the recurrent setting.

AI-Driven Drug Development Platform

Starlight Therapeutics was formed to pursue the focused clinical development of central nervous system (CNS) oncology indications developed and advanced through Lantern Pharma’s proprietary artificial intelligence drug development platform, RADR. This AI-driven approach enables the identification of optimal drug-cancer combinations and patient populations most likely to benefit from treatment, significantly reducing the time and cost typically associated with traditional drug development.

"The clearance of this IND demonstrates the power of our efficient, data-driven drug development model in identifying promising therapeutic opportunities in areas of high unmet medical need," said Panna Sharma, President and CEO of Lantern Pharma. "Through Starlight Therapeutics, we are positioned to dedicate focused resources and expertise to advancing treatments for some of the most challenging cancers affecting the brain and central nervous system in both adults and children, while developing meaningful therapies that can reach patients in an accelerated timeline compared to traditional drug development processes."

Market Opportunity and Next Steps

With GBM representing an annual market opportunity of $3 to $5 billion globally and case numbers accelerating worldwide, there is an urgent need for innovative treatment approaches. The current standard of care has remained largely unchanged for over 15 years, highlighting the critical importance of novel therapeutic strategies like the STAR-001 combination.

Starlight is targeting commencement of the Phase Ib/2a trial in late 2025 or early 2026, subject to additional funding, and plans to provide regular updates on trial preparation, patient enrollment progress, and preliminary data as they become available.

About Glioblastoma Multiforme (GBM)

Glioblastoma multiforme is the most common and aggressive form of primary brain tumor in adults, accounting for approximately 15% of all brain tumors. Despite aggressive multimodal treatment including surgery, radiation, and chemotherapy, the prognosis remains extremely poor, with a median survival of only 12 months and a five-year survival rate of less than 5%. The blood-brain barrier presents a significant challenge in treating GBM, as most therapeutic agents cannot effectively penetrate brain tissue.

OmniAb Reports Second Quarter 2025 Financial Results and Business Highlights

On August 6, 2025 OmniAb, Inc. (NASDAQ: OABI) reported financial results for the three and six months ended June 30, 2025, and provided operating and partner program updates (Press release, OmniAb, AUG 6, 2025, View Source [SID1234654882]).

"Our business is performing very well as we continued our momentum in partner additions in the second quarter, reaching 100 active partners. This is a testament to the strength of our innovative technology platform and to our team’s execution, and puts us on pace for one of our strongest years ever in partner adds. Additionally, a recent further streamlining of our operations enhances the scalability and long-term value of our business," said Matt Foehr, Chief Executive Officer of OmniAb. "Our recent launch of the xPloration Partner Access Program demonstrates our commitment to innovation, customer service and value creation. We are excited about this new offering for our partners and for its potential to expand and diversify our revenue streams."

Second Quarter 2025 Financial Results

Revenue for the second quarter of 2025 was $3.9 million, compared with $7.6 million for the same period in 2024. License and milestone revenue decreased primarily due to a $1.8 million decline in milestone revenue. Service revenue declined primarily due to the discontinuation of a small-molecule ion channel program and the related acceleration of non-cash revenue in the prior year period. These decreases were offset by $0.6 million in xPloration revenue as a result of the sale of an instrument and related consumables.

Cost of xPloration revenue was $0.3 million for the second quarter of 2025 and consists of direct costs associated with the sale of the xPloration instrument and associated consumables. Research and development expense was $10.9 million for the second quarter of 2025, compared with $13.9 million for the same period in 2024, with the decrease primarily due to lower share-based compensation expense and reduced headcount, and lower external expenses associated with the small-molecule ion channel programs. General and administrative expense was $7.7 million for the second quarter of 2025, compared with $8.0 million for the same period in 2024, with the decrease primarily due to lower legal fees and share-based compensation expense. Other operating income, net was $1.9 million, which included a gain of $3.0 million from the sale of a small molecule program to Angelini Pharma partially offset by a $1.0 million contingent liability adjustment associated with that program. Other operating income, net for the prior-year period was $2.5 million, which included a $2.6 million reduction in contingent liabilities attributed to changes in partner small molecule ion channel programs.

Net loss for the second quarter of 2025 was $15.9 million, or $0.15 per share, compared with a net loss of $13.6 million, or $0.13 per share, for the same period in 2024.

Cash use in the second quarter of 2025 was $2.0 million.

Year-to-Date Financial Results

Revenue for the first half of 2025 was $8.1 million, compared with $11.4 million for the same period in 2024. License and milestone revenue decreased primarily due to a $0.8 million decline in milestone revenue, partially offset by a $0.2 million increase in license revenue. Service revenue declined primarily due to the discontinuation of a small-molecule ion channel program and the related acceleration of non-cash revenue in the prior year period. These decreases were offset by $0.7 million in xPloration revenue as a result of the sale of an instrument and related consumables.

Cost of xPloration revenue was $0.3 million for the first half of 2025 and consists of direct costs associated with the sale of the xPloration instrument and associated consumables. Research and development expense was $23.5 million for the first half of 2025, compared with $28.5 million for the same period in 2024, primarily due to lower share-based compensation expense and reduced headcount, and lower external expenses associated with the small-molecule ion channel programs and screening technology development. General and administrative expense was $15.6 million for the first half of 2025, compared with $16.3 million for the same period in 2024 with the decrease primarily due to lower legal fees and share-based compensation expense. Other operating income, net for the first half of 2025 reflected a gain of $3.0 million from the sale of a small molecule program to Angelini Pharma, partially offset by a $1.0 million contingent liability adjustment associated with that program, whereas the prior-year period included a $2.6 million reduction in contingent liabilities attributed to changes in partner small molecule ion channel programs.

Net loss for the first half of 2025 was $34.1 million, or $0.32 per share, compared with a net loss of $32.6 million, or $0.32 per share, for the same period in 2024.

As of June 30, 2025, OmniAb had cash, cash equivalents and short-term investments of $41.6 million.

2025 Financial Guidance

OmniAb affirms guidance for 2025 revenue to be in the range of $20 million to $25 million, and for costs and operating expense to be in the range of $85 million to $90 million. In addition, OmniAb continues to expect 2025 cash use to be lower than cash use in 2024. Cash use in 2024 was $38.9 million, excluding the 2024 ATM issuance. The 2025 full year effective tax rate is expected to be approximately 0%.

Second Quarter 2025 and Recent Business Highlights

During the second quarter of 2025, OmniAb entered into six new license agreements, including with Veraxa Biotech, AG, Duke-NUS, University of Strathclyde, University of Maryland, AB-Ray Bio and an undisclosed global clinical research organization, and one asset-based sale. The asset-based sale was with Angelini Pharma for the small molecule Kv7.2 program. OmniAb received an upfront payment of $3 million and is entitled to receive potential milestones of over $170 million and royalties.

As of June 30, 2025, the Company had 100 active partners and 381 active programs, including 32 OmniAb-derived programs in clinical development or being commercialized.

Business and partner highlights from the second quarter of 2025 and recent weeks included the following:

xPloration

In May, OmniAb launched the xPloration Partner Access Program. xPloration is a high-throughput single B-cell screening instrument that leverages machine learning and artificial intelligence to address challenges in primary B-cell screening with traditional methods. xPloration’s competitive edge includes unmatched screening throughput, superior hit recovery, exceptional ease-of-use and reliability.
OmniAb highlighted case studies utilizing xPloration in a presentation titled "xPloration: Simplifying Deep Antibody Mining for Maximum Impact" at the 21 st Annual PEGS Boston Conference and Expo, where xPloration was awarded 2025 Best of Show. The presentation illustrated the platform’s capabilities across various assay formats, including multiplex cell surface binding and cross-blocking assays.
IMVT-1402

In May, Immunovant started recruitment of a randomized, placebo-controlled, double-blind Phase 3 study to assess the efficacy and safety of IMVT-1402 in patients with mild-to-severe generalized myasthenia gravis.
Immunovant is also enrolling patients in potentially registrational trials of IMVT-1402 in chronic inflammatory demyelinating polyneuropathy, Graves’ disease, difficult-to-treat rheumatoid arthritis and Sjogren’s disease. Additionally, a proof-of-concept study has been initiated in a sixth indication, cutaneous lupus erythematosus.
TEV-53408

Teva Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for investigational TEV-53408, an anti-IL15 antibody, for the treatment of people with celiac disease on a gluten-free diet. TEV-53408 is currently being evaluated in Phase 2a and Phase 1 clinical trials to assess the efficacy and safety in adults with celiac disease and vitiligo, respectively.
TEV-56278

Teva Pharmaceutical and Shanghai Fosun Pharmaceutical announced that the companies, through their respective subsidiaries, entered into a strategic partnership for the development of investigational TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy. Teva’s proprietary ATTENUKINE technology provides a new mechanism of action, potentially offering high efficacy and low toxicity in a broad array of oncology indications
JNJ-5322

At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Johnson & Johnson presented initial Phase 1 results of JNJ-5322, a next-generation trispecific T-cell redirecting antibody targeting BCMA x GPRC5D x CD3, in patients with relapsed or refractory multiple myeloma. JNJ-5322 demonstrated a 100% overall response rate (ORR) at the recommended Phase 2 dose of 100 mg in anti-BCMA/-GPRC5D naïve patients, with convenient dosing every four weeks. Initial data with JNJ-5322 suggest a paradigm shift, offering ORRs similar to CAR-Ts but as an off-the-shelf therapy intended for outpatient dosing.
M9140

At the ASCO (Free ASCO Whitepaper) Annual Meeting, Merck KGaA presented data on M9140, a novel antibody-drug conjugate with topoisomerase 1 inhibitor payload targeting tumors that express carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5). In the Phase 1 PROCEADE-CRC-01 study, M9140 showed a predictable, manageable safety profile and promising early clinical activity in heavily pretreated metastatic colorectal cancer (mCRC) patients. The ORR of 31% (17.2% confirmed) and median progression free survival (mPFS) of 6.9 months at 2.8 mg/kg every three weeks compares favorably with current monotherapy standard of care (ORRs 1-2%, mPFS 1.9-3.7 months) and recent Phase 3 data with trifluridine–tipiracil + bevacizumab (ORR 6.1%, mPFS 5.6 months) in 3L+ mCRC. These results suggest 2.8 mg/kg as the recommended Phase 2 dose for further development in colorectal cancer, and other solid tumors.
Merck KGaA also presented the PROCEADE PanTumor Phase 1b/2 clinical trial study design at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper). This study will assess the antitumor activity, tolerability, safety and pharmacokinetics of M9140 either as monotherapy or in combination with other anticancer agents in patients with advanced/metastatic gastric cancer, non-small cell lung cancer (NSCLC) and pancreatic adenocarcinoma.
Sugemalimab

CStone Pharmaceuticals announced the publication of long-term survival data from its Phase 3 GEMSTONE-302 trial in The Lancet Oncology. This study evaluates sugemalimab combined with platinum-based chemotherapy as a first-line treatment for both squamous and non-squamous, non-oncogene-addicted metastatic NSCLC. This marks the trial’s third publication in a top-tier journal, following earlier publications of final progression-free survival results in The Lancet Oncology(2022) and interim overall survival results in Nature Cancer(2023).
CStone Pharmaceuticals also announced an exclusive partnership with Istituto Gentili, a European biopharmaceutical company with a century-long heritage in oncology, to commercialize sugemalimab across Western Europe and the UK. Under the agreement, Gentili received exclusive commercialization rights for sugemalimab in 23 European countries, as well as the UK and other geographies.
BC3195

At the ASCO (Free ASCO Whitepaper) Annual Meeting, BioCity presented data on BC3195, a first-in-human antibody-drug conjugate targeting CDH3. BC3195 demonstrated a manageable safety profile and favorable pharmacokinetics, with impressive preliminary antitumor activity in heavily pretreated NSCLC patients – most of whom had EGFR mutations – achieving an ORR of 50%. Dose optimization and expansion are ongoing.
Conference Call and Webcast

OmniAb management will host a conference call with accompanying slides today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (800) 549 8228 using the conference ID 93102. Slides, as well as the live and replay webcast, are available at View Source

Sandoz delivers strong H1 2025 results, with accelerated sales growth in the second quarter

On August 6, 2025 Sandoz (SIX: SDZ; OTCQX: SDZNY), the global leader in generic and biosimilar medicines, reported its financial results for the first half of 2025 (Press release, Sandoz, AUG 6, 2025, View Source [SID1234654880]). Growth in this document is shown at constant currencies (CC)[1] unless stated otherwise.

FINANCIAL RESULTS

H1 2025 H1 2024 change
USD m
USD m
USD %
CC %
CGR %[2]

Net sales 5,232 5,047 4% 4% 6%
Generics 3,736 3,704 1% 1% 2%
Biosimilars 1,496 1,343 11% 12% 17%

Core EBITDA 1,046 885 18% 20%
Core EBITDA margin (%) 20.0% 17.5%
Core diluted earnings per share (USD) 1.46 1.12 30% 33%
Management free cash flow 503 237 nm[3]

Richard Saynor, Chief Executive Officer of Sandoz, said: "The first half of the year marked another phase of good progress for Sandoz. Strong underlying sales growth was underpinned by the double-digit performance from our biosimilars which, in the second quarter, represented 30% of net sales for the first time, marking a true milestone for the company. Europe and International also performed particularly well, while we launched more important medicines for patients in North America.

"Reflecting this year’s launch program, weighted to the second half, we anticipate an even stronger sales performance in the second half, particularly in North America. Further investments in our biosimilars future, in Slovenia and via the proposed acquisition of Just-Evotec Biologics EU SAS, reflect the latest step in our strategic plan to capitalize on the unprecedented patent-expiries’ opportunity over the next ten years. This will only be enhanced by the effects of regulatory streamlining. It is the combination of the growing platform of opportunities, consistently strong financial results and our unrelenting focus on patients that offers such attractive long-term value for our stakeholders."

FINANCIAL HIGHLIGHTS

H1 2025 net sales of USD 5,232 million:
Up by 4% at CC and USD, with volume growth of 7%; on a CGR basis, H1 net sales grew by 6%
In the second quarter, accelerated growth of 5% at CC and 8% in USD; growth of 7% at CGR
Biosimilars H1 sales up by 12% at CC and 17% at CGR
H1 generics growth of 1% at CC and 2% at CGR
The 10 largest-selling medicines grew by a combined 10% at CC and represented 33% of net sales
A core EBITDA margin in H1 of 20.0%, representing a 2.5 percentage-point year-on-year improvement, primarily driven by operating leverage and the mix of sales
Management free cash flow in H1 of USD 503 million (H1 2024: USD 237 million). Free cash flow of USD 207 million (H1 2024: USD 21 million)
Core diluted earnings per share of USD 1.46 in H1 represented growth of 33% at CC and 30% in USD
Full-year 2025 guidance confirmed: mid-single-digit net-sales growth at CC and a core EBITDA margin of around 21%
BUSINESS HIGHLIGHTS

There were a number of business highlights since the publication of the Q1 2025 sales update.

Biosimilars

The company recently signed a non-binding term sheet with Evotec SE to acquire its Just-Evotec Biologics’ in-house development and manufacturing capabilities in Toulouse, France. The proposed transaction would seamlessly align with the strategic objective of capitalizing on the projected USD 300 billion biosimilar-market opportunity over the next 10 years[4]
Sandoz recently announced the start of construction for a new, state-of-the-art biosimilars production center for sterile product manufacturing in Brnik, Slovenia. This complements ongoing investments in Slovenia, namely a new biosimilar drug-substance production center in Lendava and a biosimilar development center in Ljubljana
Following feedback from major regulatory authorities, Sandoz has decided to streamline the clinical-development programs for its proposed nivolumab and ocrelizumab biosimilars, respectively. The company is winding down the Phase III NivoReach trial for its proposed biosimilar nivolumab. Sandoz is also modifying its Strive-MS integrated Phase I/III trial to become a comparative pharmacokinetic trial for its proposed ocrelizumab biosimilar. The development programs, including comprehensive analytical and clinical pharmacokinetic data, have been designed to align with updated regulatory guidance and confirm biosimilarity to their respective reference medicines, while maintaining the highest scientific and regulatory standards
The aforementioned streamlining reflects ongoing encouraging and favorable regulatory developments for biosimilars and follows Sandoz’s decision earlier in the year to minimize its Phase III trial for its proposed pembrolizumab biosimilar
Launches

Sandoz recently launched Wyost and Jubbonti in the US, the first and only interchangeable denosumab biosimilars. Pyzchiva (ustekinumab) was also launched in the US, including in private label. Finally, a Pyzchiva autoinjector was also rolled out to become the first commercially available ustekinumab biosimilar in a pre-filled pen in Europe
Anticipated biosimilar launches in the second half of the year include Wyost & Jubbonti and Afqlir (aflibercept) in Europe, while the company retains its ambition to launch Tyruko (natalizumab) in the US before the end of the year[5]
FULL-YEAR 2025 GUIDANCE

The company expects further major biosimilar launches this year, while price erosion is expected to return to normalized levels of a low to mid-single-digit percentage. Sandoz continues to anticipate core EBITDA-margin expansion this year to reflect the mix of sales, simplification of the external network and the ongoing transformation program. As a result, the company confirms its expectations for 2025:

Net sales to grow at CC by a mid-single-digit percentage
A core EBITDA margin in FY 2025 of around 21%
This guidance excludes any impacts of unforeseen events or unconfirmed developments, such as significant further potential trade tariffs emanating from the US government.

H1 AND Q2 2025 NET SALES

Net sales by business

H1 2025 % of net sales H1 2024 change
USD m USD m USD % CC % CGR %

Generics 3,736 71 3,704 1% 1% 2%
Biosimilars 1,496 29 1,343 11% 12% 17%
Net sales 5,232 100 5,047 4% 4% 6%

Net sales for the first half of 2025 were USD 5,232 million, up by 4% at CC and by 6% at CGR. Volumes grew by 7%, partly offset by price erosion of 3%; the erosion was in line with a full-year assumption of a low to mid-single-digit decline. Net-sales growth was primarily driven by the performance of biosimilars, which continues to benefit from an extensive pipeline and launch program.

Generics overview
Net sales of generics in H1 were USD 3,736 million, reflecting growth of 1% at CC and 2% at CGR. Generics represented 71% of net sales (H1 2024: 73%, Q2 2025: 70%).

Europe net sales of generics grew by 2% at CC in the first half, reflecting the impact of launches in 2024. International net sales of generics declined by 1% at CC; after adjusting for the 2024 divestment of the Sandoz business in China, International net sales of generics grew by 3% at CGR. In North America, generics net-sales growth of 2% at CC benefited from the successful launch of paclitaxel in 2024.

Biosimilars overview
Net sales of biosimilars in H1 of USD 1,496 million reflected growth of 12% at CC and 17% at CGR. Biosimilars represented 29% of total net sales (H1 2024: 27%, Q2 2025: 30%).

Strong Europe biosimilars net-sales growth of 17% at CC benefited from a number of good performances, including recently launched Pyzchiva and Tyruko, while strong International biosimilar net-sales growth of 30% at CC partly reflected the strong contribution from Omnitrope (somatropin). Major biosimilar launches in International in 2025 will all occur in the second half of the year.

North America biosimilar net sales declined by 9% at CC in the half, reflecting the withdrawal of Cimerli in Q1 2025 and the effect of private-label adalimumab pricing; excluding the impact of the 2024 acquisition of Cimerli, North America biosimilar net sales grew by 9%.

Q2 2025 % of net sales Q2 2024 change
USD m USD m USD % CC % CGR %

Generics 1,927 70 1,835 5% 2% 3%
Biosimilars 825 30 720 15% 12% 20%
Net sales 2,752 100 2,555 8% 5% 7%

Net sales for the second quarter were USD 2,752 million, up by 5% at CC and by 7% at CGR. Volumes grew by 8%, partly offset by price erosion of 3%.

Net sales by region

H1 2025 % of net sales H1 2024 change
USD m USD m USD % CC % CGR %

Europe 2,832 54 2,634 8% 6% 6%
International 1,284 25 1,269 1% 5% 8%
North America 1,116 21 1,144 -2% -1% 4%
Net sales 5,232 100 5,047 4% 4% 6%

Europe overview
Net sales in Europe in H1 were USD 2,832 million, reflecting growth of 6% at CC and CGR. Europe net sales of generics grew by 2% at CC in the first half, with growth in biosimilars of 17% at CC primarily a result of commercial execution and recent launches, including Pyzchiva and Tyruko.

International overview
Net sales in International in H1 were USD 1,284 million, with growth of 5% at CC and 8% at CGR. In the second quarter, International net sales grew by 11% at CC and by 13% at CGR, despite major biosimilar launches this year all coming in H2. Pricing increased in generics during the first half of 2025, with strong International biosimilar net-sales growth of 30% at CC partly a result of the continued good performance from Omnitrope.

North America overview
Net sales in North America in H1 were USD 1,116 million, reflecting a decline of 1% at CC. Growth at CGR however, namely excluding the impact of the acquisition of Cimerli, amounted to 4%. A good performance from generics was driven by the successful recent launch of paclitaxel, as well as continued strong growth in Canada. Biosimilar net-sales growth would have been positive when excluding the aforementioned impact of the Cimerli acquisition. Price erosion was driven by reduced Cimerli sales, private-label adalimumab pricing and Omnitrope.

Q2 2025 % of net sales Q2 2024 change
USD m USD m USD % CC % CGR %

Europe 1,460 53 1,308 12% 6% 6%
International 694 25 627 11% 11% 13%
North America 598 22 620 -4% -3% 5%
Net sales 2,752 100 2,555 8% 5% 7%

H1 2025 KEY OPERATING AND NON-OPERATING RESULTS

H1 2025 H1 2024 change
USD m USD m USD % CC %

Net sales 5,232 5,047 4% 4%
Gross profit 2,411 2,380 1% 2%
Operating income 602 332 81% 90%
EBITDA 870 576 51% 55%
Net income 377 151 nm nm

Core results

Core gross profit 2,575 2,544 1% 2%
Core gross profit margin (%) 49.2% 50.4%

Core operating income 901 763 18% 20%
Core operating income margin (%) 17.2% 15.1%

Core EBITDA 1,046 885 18% 20%
Core EBITDA margin (%) 20.0% 17.5%

Core net income 635 484 31% 34%
Core diluted earnings per share (USD) 1.46 1.12 30% 33%

Core gross profit amounted to USD 2,575 million (H1 2024: USD 2,544 million), resulting in a core gross profit margin of 49.2% (H1 2024: 50.4%). The favorable product mix from double-digit biosimilars growth, as well as operational improvements, was more than offset by price erosion and inflation on cost of goods sold.

Core EBITDA was USD 1,046 million (H1 2024: USD 885 million), resulting in a core EBITDA margin of 20.0% (H1 2024: 17.5%). The strong increase was primarily driven by leveraging expenses from a growing top line and savings from the transformation program. EBITDA was USD 870 million (H1 2024: USD 576 million). Core adjustments for EBITDA in the first half of 2025 were USD 176 million (H1 2024: USD 309 million). These were mainly driven by separation costs of USD 156 million, costs of rationalization of internal manufacturing sites of USD 54 million and favorable impacts from adjustments for legal costs of USD 28 million.

Core net income was USD 635 million (H1 2024: USD 484 million), mainly driven by higher core operating income and a lower core net financial result, partly offset by higher core income taxes, while the effective tax rate remained broadly unchanged. Core diluted earnings per share were USD 1.46 (H1 2024: USD 1.12). The weighted average number of shares diluted was 435.8 million as of June 30, 2025, versus 432.2 million in the prior-year period.

NET CASH FLOW, NET WORKING CAPITAL AND NET DEBT

H1 2025 H1 2024 change
USD m USD m USD m

Net cash flows from operating activities 523 229 294
Cash flows used for net capex (310) (205) (105)
Free cash flow 207 21 186
Management free cash flow 503 237 266

Sandoz generated net cash flows from operating activities of USD 523 million in the first half of the year (H1 2024: USD 229 million). This was mainly driven by working-capital enhancements through improvements in receivables; inventory levels were stable versus December 2024.

Cash flows used for capital expenditures were USD 310 million (H1 2024: USD 205 million). This included the company’s ongoing investment in Slovenia, namely a new biosimilar drug substance production center in Lendava, a biosimilar development center in Ljubljana and a new production plant in Brnik. It also included separation-related investments in facilities and technology.

Management free cash flow, defined as free cash flow adjusted for one-off items, was USD 503 million (H1 2024: USD 237 million). The increase was mainly driven by a higher core EBITDA. Free cash flow amounted to USD 207 million (H1 2024: USD 21 million). The improvement was mainly due to increased net cash flows from operating activities, partly offset by higher cash flows used for capital expenditures.

Jun 30, 2025 Dec 31, 2024 change
USD m USD m USD m

Net working capital 3,638 3,486 152
Net debt 3,909 3,329 580

Net working capital increased by USD 152 million, largely due to currency-translation effects of USD 305 million, offset by improvements in underlying net working capital.

Non-current financial debt increased by USD 811 million, reflecting the issuance of three bonds in the first half of 2025 of EUR 500 million and CHF 400 million, respectively and currency-translation effects. This was partly offset by the repayment of USD 750 million equivalent in USD and EUR term loans.

Cash and cash equivalents increased by USD 198 million as cash generated from operating activities and proceeds from the issuance of non-current financial debt were partly offset by the repayment of term loans, the annual dividend payment and purchases of property, plant and equipment.

As a result of the above, net debt increased to USD 3.9 billion compared to USD 3.3 billion on December 31, 2024, mainly related to currency-translation effects of USD 422 million.

CONFERENCE CALL

A conference call and webcast for investors and analysts will begin today at 9am CET. Details can be found here, with the accompanying presentation here.

NOTES

The performance shown in this announcement covers the six-month period to June 30, 2025 (H1 2025) and the three-month period to June 30, 2025 (Q2 2025), compared to the six-month period to June 30, 2024 (H1 2024) and the three-month period to June 30, 2024 (Q2 2024), respectively. Commentary is based on the performance in H1 2025, unless stated otherwise.

CALENDAR

The company intends to publish its nine-months’ and third-quarter sales update on October 30, 2025.

HALF-YEAR REPORT

Sandoz published its Half-Year Report 2025 today, which can be found here.

[1] Non-IFRS measures are defined in the Supplementary financial information section of the Half-Year Report 2025.
[2] Sandoz defines the comparable growth rate (CGR) as the growth rate of net sales at CC excluding the effects of material acquisitions and divestments. In the case of divestments, net sales are excluded for the corresponding period. Similarly, for acquisitions, the relevant net sales are excluded for the corresponding period. Material acquisitions and divestments are transactions in scope of significant transactions in the company’s Consolidated financial statements. Sandoz believes the presentation of CGR is meaningful for management and investors to evaluate the performance of the business over time. In this announcement, adjustments relate to the impact of the 2024 acquisition of US biosimilar Cimerli (ranibizumab) and the 2024 divestment of the Sandoz business in China.
[3] Not meaningful.
[4] Based on March 2025 data from IPD Analytics Evaluate Pharma, covering the period 2026–2035.
[5] Subject to regulatory approval of John Cunningham virus assay and pending litigation.

Zentalis Pharmaceuticals Reports Second Quarter 2025 Financial Results and Operational Progress

On August 6, 2025 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company developing a potentially first-in-class and best-in-class WEE1 inhibitor for patients with ovarian cancer and other tumor types, reported financial results for the second quarter 2025 and highlighted recent operational progress (Press release, Zentalis Pharmaceuticals, AUG 6, 2025, View Source [SID1234654876]).

"This quarter, we continued to execute on our focused strategy to advance the late-stage clinical development of azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is no approved treatment option specifically for this biomarker selected population, which comprises approximately 50% of PROC patients," said Julie Eastland, Chief Executive Officer of Zentalis. "We are maintaining momentum with the DENALI Phase 2 clinical trial and remain on track to disclose topline data from DENALI Part 2 by year end 2026."

Business Updates

•Phase 2 DENALI clinical trial remains on track.
◦Enrollment is ongoing in DENALI Part 2a of the Phase 2 DENALI clinical trial (NCT05128825) of azenosertib in patients with Cyclin E1-positive PROC. DENALI Part 2a is designed to confirm the primary dose-of-interest with a target enrollment of up to approximately 30 patients at each of two dose levels: 400mg QD 5:2 (intermittent daily dosing with a five days on, two days off dosing schedule) and 300mg QD 5:2. DENALI Part 2b is designed to enroll approximately 70 patients at a single dose, the selection of which will be informed by the Part 2a results, subject to FDA feedback.
◦The Company expects to disclose topline data from DENALI Part 2 (Part 2a and Part 2b) by year end 2026. DENALI Part 2, if successful, has the potential to support an accelerated approval, subject to FDA review.

•Completed strategic restructuring announced in January 2025, supporting late-stage clinical development of azenosertib.
◦The Company has operationally completed the restructuring and does not expect to incur further associated related non-recurring expenses.
◦This restructuring prioritizes the late-stage development of azenosertib and extends the Company’s cash runway into late 2027, beyond the Company’s anticipated DENALI Part 2 topline data.

Second Quarter 2025 Financial Results

•Cash, Cash Equivalents and Marketable Securities Position: As of June 30, 2025, the Company had cash, cash equivalents and marketable securities of $303.4 million, which includes $16.8 million representing the June 30, 2025 fair value of Immunome common stock received by the Company from the sale of its ROR1 antibody-drug conjugate (ADC) product candidate and ADC platform to Immunome in October 2024. The Company believes that its existing cash, cash equivalents and marketable securities as of June 30, 2025 will be sufficient to fund its operating expenses requirements into late 2027.

•Research and Development Expenses: Research and development (R&D) expenses for the three months ended June 30, 2025 were $27.6 million, compared to $48.4 million for the three months ended June 30, 2024. The decrease of $20.8 million was primarily due to decreases of $15.9 million for clinical expenses, $3.6 million for lab services, $3.4 million for drug manufacturing, $0.6 million related to personnel expenses and $0.4 million of miscellaneous expenses. These decreases were partially offset by an increase in companion diagnostic expense of $3.1 million.

•General and Administrative Expenses: General and administrative expenses for the three months ended June 30, 2025 were $8.4 million, compared to $16.7 million during the three months ended June 30, 2024. This decrease of $8.3 million was attributable to a decrease of $6.8 million in personnel expense, $1.1 million related to consulting and $0.4 million miscellaneous expenses.
•Operating Expenses: Total operating expenses were $36.1 million for the three months ended June 30, 2025, compared to $65.1 million for the three months ended June 30, 2024.

About Azenosertib
Azenosertib is a novel, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated as a monotherapy and combination clinical studies in ovarian cancer and additional tumor types. WEE1 acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.

About DENALI Clinical Trial
DENALI is a multi-part Phase 2 clinical trial studying azenosertib in platinum-resistant ovarian cancer (PROC) patients. Part 1b enrolled patients with PROC regardless of Cyclin E1 protein expression, all treated at 400mg 5:2 (intermittent daily dosing with a five days on, two days off dosing schedule). Interim results from Part 1b were presented at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting. Part 2 is ongoing and is enrolling PROC patients with Cyclin E1 protein overexpression based on Zentalis’ proprietary immunohistochemistry cutoff. Part 2 includes Part 2a, a dose confirmation portion evaluating two doses, 300mg 5:2 and 400mg 5:2, and Part 2b, a portion designed to complete enrollment at the selected dose. Part 2, in total, is designed for accelerated approval, pending study outcome and discussions with the U.S. Food and Drug Administration.