On July 30, 2025 GSK reported continued strong performance for quarter ending June 30, 2025 (Press release, GlaxoSmithKline, JUL 30, 2025, View Source [SID1234654636]).

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Strong Specialty Medicines performance drives sales and core operating profit growth

Total Q2 2025 sales £8.0 billion +1% AER; +6% CER

Specialty Medicines sales £3.3 billion (+15%); Respiratory, Immunology & Inflammation £1.0 billion (+10%); Oncology £0.5 billion (+42%); HIV sales £1.9 billion (+12%)
Vaccines sales £2.1 billion (+9%); Shingrix £0.9 billion (+6%); Meningitis vaccines £0.4 billion (+22%); and Arexvy £0.1 billion (+13%)
General Medicines sales £2.6 billion (-6%); Trelegy £0.8 billion (+4%)
Total operating profit +33% and Total EPS +35% driven by lower CCL charges partly offset by intangible asset impairments
Core operating profit +12% and Core EPS +15% reflecting Specialty Medicines and Vaccines growth, higher royalty income and disciplined increased investment in R&D portfolio progression in Oncology and Vaccines
Cash generated from operations of £2.4 billion with free cash flow of £1.1 billion
Q2 2025 Year to date
£m % AER % CER £m % AER % CER
Turnover 7,986 1 6 15,502 2 5
Total operating profit 2,023 23 33 4,239 35 41
Total operating margin % 25.3% 4.5ppts 5.4ppts 27.3% 6.8ppts 7.2ppts
Total EPS 35.5p 23 35 75.3p 38 45
Core operating profit 2,631 5 12 5,164 4 8
Core operating margin % 32.9% 1.1ppts 1.8ppts 33.3% 0.8ppts 1.1ppts
Core EPS 46.5p 7 15 91.4p 6 10
Cash generated from operations 2,433 47 3,734 35

Pipeline progress and investment delivering future growth opportunities:
5 major new product approvals expected in 2025:

3 US Approvals now received for Penmenvy meningitis vaccine, Blujepa first-in-class antibiotic treatment for uUTIs and Nucala, anti-IL5 biologic for COPD

Blenrep (for multiple myeloma) approved in EU, Japan, UK, Canada and Switzerland. Constructive discussion ongoing with FDA with new PDUFA date set for 23 October 2025
US regulatory decision on depemokimab (for asthma with type 2 inflammation, nasal polyps) expected in December 2025
Progress on 14 key opportunities expected to launch 2025-2031 each with PYS potential above £2 billion:
Phase III PIVOT-PO study for tebipenem, a potential new antibiotic for cUTIs, stopped early for efficacy, with filing now planned by year end

Phase III development programme for depemokimab COPD started with launch of ENDURA studies
Pivotal/Phase III trial starts planned in H2 25 for: potential cancer treatments GSK’227 B7H3 ADC for ES-SCLC and GSK’981 IDRx-42 for 2L GIST; efimosfermin for treatment of MASH; and cabotegravir ultra long acting + rilpivirine (Q4M) for HIV treatment

Targeted business development continues strengthening RI&I and Oncology pipeline
Acquisition of efimosfermin a potential best in class specialty medicine for steatotic liver disease from Boston Pharmaceuticals completed

Agreements announced with Hengrui Pharma to develop up to 12 medicines in RI&I and Oncology, including licence for
potential best-in-class PDE3/4 inhibitor in clinical development for treatment of COPD
Continued commitment to shareholder returns
Dividend declared of 16p for Q2 2025; 64p expected for full year 2025
£822 million spent in H1 2025 as part of the £2 billion share buyback programme announced at FY 2024
Confident for delivery of 2025 guidance – towards top of range
Increase towards the top end of range for turnover growth of 3% to 5%; Core operating profit growth of 6% to 8%; and
Core EPS growth of 6% to 8%

mma Walmsley, Chief Executive Officer, GSK:
"GSK’s strong momentum in 2025 continues with another quarter of excellent performance driven mainly by Specialty Medicines, our largest business, with double-digit sales growth in Respiratory, Immunology & Inflammation, Oncology and HIV. We also continue to make very good progress in R&D, with 3 major FDA approvals achieved so far this year, 16 assets now in late-stage development, and 4 more promising medicines to treat cancer, liver disease and HIV expected to enter Phase III and pivotal development by the end of the year. With all this, we now expect to be towards the top end of our financial guidance for 2025 and remain confident in our long-term outlooks."

Assumptions and cautionary statement regarding forward-looking statements
The Group’s management believes that the assumptions outlined above are reasonable, and that the guidance, outlooks, and expectations described in this report are achievable based on those assumptions. However, given the forward-looking nature of these guidance, outlooks, and expectations, they are subject to greater uncertainty, including potential material impacts if the above assumptions are not realised, and other material impacts related to foreign exchange fluctuations, macro-economic activity, the impact of outbreaks, epidemics or pandemics, changes in legislation, regulation, government actions, including the impact of any potential tariffs or other restrictive trade policies on the Group’s products, or intellectual property protection, product development and approvals, actions by our competitors, and other risks inherent to the industries in which we operate.

This document contains statements that are, or may be deemed to be, "forward-looking statements". Forward-looking statements give the Group’s current expectations or forecasts of future events. An investor can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as ‘anticipate’, ‘estimate’, ‘expect’, ‘intend’, ‘will’, ‘project’, ‘plan’, ‘believe’, ‘target’ and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, dividend payments and financial results. Other than in accordance with its legal or regulatory obligations (including under the Market Abuse Regulation, the UK Listing Rules and the Disclosure Guidance and Transparency Rules of the Financial Conduct Authority), the Group undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The reader should, however, consult any additional disclosures that the Group may make in any documents which it publishes and/or files with the SEC. All readers, wherever located, should take note of these disclosures. Accordingly, no assurance can be given that any particular expectation will be met and investors are cautioned not to place undue reliance on the forward-looking statements.

On July 30, 2025 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "the Company") reported the financial results for the first three months (April 1, 2025 – June 30, 2025) of the fiscal year 2025 ending March 31, 2026 (FY2025) (Press release, Astellas, JUL 30, 2025, View Source [SID1234654635]).

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On July 30, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the Canadian Intellectual Property Office (CIPO) has issued a Notice of Allowance for a new patent related to its breast cancer vaccine technology (Press release, Anixa Biosciences, JUL 30, 2025, https://ir.anixa.com/news/detail/1089/anixa-biosciences-receives-notice-of-allowance-from-canadian-intellectual-property-office-for-patent-covering-breast-cancer-vaccine-technology [SID1234654634]). This patent, exclusively licensed from Cleveland Clinic, will provide composition-of-matter protection for the Company’s novel immunogenic approach to breast cancer prevention and treatment in Canada.

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With this allowance, Anixa continues to expand the international scope of its intellectual property portfolio, reinforcing its leadership in the field of cancer immunoprevention. The Canadian patent complements issued and pending patents in the United States and other key global jurisdictions, and represents an important step toward future regulatory and commercial efforts outside the U.S.

"This newly allowed patent further illustrates the international recognition of the novelty and potential of our breast cancer vaccine," stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "As we continue advancing clinical development in the U.S., this allowance further strengthens our ability to pursue strategic global opportunities in regions with a high burden of breast cancer."

Breast cancer remains the most commonly diagnosed cancer in women globally and a leading cause of cancer-related death. In Canada, breast cancer accounts for approximately 25% of all new cancer cases in women and 13% of female cancer deaths annually. Despite widespread awareness and screening efforts, there is currently no approved vaccine for the prevention of breast cancer—highlighting a significant and unaddressed need in public health.

Anixa’s vaccine is based on immunizing against human α-lactalbumin, a protein associated with lactation that is aberrantly expressed in certain types of breast cancer. This "retired" protein strategy, developed at Cleveland Clinic and licensed exclusively to Anixa, aims to selectively prime the immune system to prevent tumor formation while avoiding harm to normal tissue.

By reinforcing its global patent estate, Anixa is laying the groundwork for future international development and commercialization strategies. The Company’s broader vaccine platform also targets other high-incidence cancers and is designed to transform how the medical community approaches cancer prevention.

On July 30, 2025 AB Science SA (Euronext – FR0010557264 – AB) reported the approval of the third of four stages of the Phase I/II study (AB18001) with the compound AB8939 in adult patients with relapsed/refractory acute myeloid leukemia (AML) (Press release, AB Science, JUL 30, 2025, View Source [SID1234654633]).

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The third stage has been approved in France, Germany, Spain and Greece. The objective of the Phase 1 study is to determine the maximum tolerated dose (MTD) for different treatment stages of AB8939.

-Stage 1: Determination of the MTD after 3 consecutive days of treatment with AB8939 alone.
-Stage 2: Determination of the MTD after 14 consecutive days of treatment with AB8939 alone.
-Step 3: Determination of the MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax.
-Stage 4: Determination of MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax and azacitidine.

The first two stages of Phase 1 were completed with 28 and 13 patients enrolled, respectively, and determined the MTD of AB8939 after 3 consecutive days of treatment (21.3 mg/m2 ) and after 14 consecutive days of treatment (21.3 mg/m2 ).

The third stage now consists of evaluating the MTD after 14 consecutive days of treatment with AB8939 in combination with venetoclax, a standard treatment for AML.

Professor Olivier Hermine, MD, President of the Scientific Committee of AB Science and member of the Académie des Sciences in France said, "The approval of this third stage is a key milestone for the Phase I/II study with AB8939 in AML. The combination of AB8939 and venetoclax has the potential to change the standard of care in the treatment of relapsed/refractory AML".

▪Rationale for the AB8939 + venetoclax combination

The combination of AB8939 + venetoclax has several potential benefits:

1 – Both molecules have low hematologic toxicity. This combination could therefore be less toxic than azacitidine + venetoclax as first-line treatment for AML.

2 – These two molecules act on different and complementary targets in cancer cells, which could have an additive or even synergistic effect in terms of efficacy.

-AB8939 has two modes of action:

oMicrotubule destabilization: Microtubules are cellular structures essential for cell division (mitosis). By destabilizing them, AB8939 prevents cancer cells from dividing properly, leading to their death. The advantage is that this type of chemotherapy is independent of the TP53 mutation that creates the most resistance to standard chemotherapies.

oInhibition of ALDH (aldehyde dehydrogenase): ALDH is an enzyme found in cancer stem cells, a subtype of cells in AML that are particularly resistant to treatment and responsible for relapses, as they can survive conventional chemotherapy. By inhibiting ALDH, AB8939 specifically targets these stem cells, reducing resistance to treatment and limiting the risk ofrelapse.

-Mechanism of action of venetoclax: Inhibition of BCL2

oBCL2 is a protein that prevents apoptosis (programmed cell death) in cancer cells.

oBCL2 is another factor in AML resistance, as it allows cancer cells to survive despite treatment.

oBy blocking BCL2, venetoclax promotes apoptosis, making cancer cells more vulnerable.

-There is an additive, even synergistic, potential for the combination By simultaneously targeting these mechanisms, the combination could reduce the chances of cancer cells escaping treatment (resistance). This potential synergistic effect arises from the fact that inhibiting ALDH and BCL2 could weaken the resistance mechanisms of cancer stem cells, while destabilizing microtubules prevents cell proliferation. Together, these actions are more powerful than if each molecule were used alone.

3 – Finally, AML is difficult to treat due to its heterogeneity and resistance mechanisms. AB8939 is effective in vitro and in vivo in animals and generates responses in human patients with the poorest prognostic factors when treated with standard of care chemotherapies, namely TP53 mutation, MECOM and complex karyotype.

▪Non-clinical pharmacology data Animal studies have demonstrated the following properties of AB8939 that are relevant for the treatment of AML: -AB8939 is active ex vivo against AML cancer cells from chemotherapy-naive or chemotherapy-refractory/relapsed patients, particularly those with TP53 mutations or complex karyotypes.

-AB8939 eradicates blasts in the blood and bone marrow in PDX models resistant to 5-AraC (cytarabine), particularly those with MECOM rearrangements. -AB8939 increases survival and has an additive effect in combination with the standard treatments azacitidine and venetoclax. -ALDH expression is a characteristic of cancer stem cells (CSCs), and AB8939 is an ALDH1/2 inhibitor. Therefore, AB8939 is a targeted therapy for leukemic cancer stem cells.

-AB8939 eradicates leukemia cancer stem cells in a human PDX model of AML.

▪Potential market for AB8939 in AML

Treatments for AML represent an estimated market potential of more than €2 billion per year.

AB8939 was entirely discovered by AB Science, which retains full ownership of the intellectual property rights, reflecting AB Science’s priority to develop innovative drugs aimed at improving patients’ lives.

The composition of AB8939, including its use in the treatment of AML, is covered until 2026 by a patent granted in all geographical areas where AB8939 could be marketed, including Europe (patent EP 3253749), the United States (US 10,570,122), Canada (CA 2975644), China (CN 107531685), South Korea (KR 10-2544132), Japan (JP 6713000), Hong Kong (HK 1243700), Israel (IL 253779), Australia (AU 2016214283), Russia (RU 2758259), Brazil (BR 112017016883-9), Mexico (MX 377742), India (IN 480996) and South Africa (ZA 2017/05537). An extension of this protection for 5 years is possible in certain countries.

A second patent application for medical use has been filed to protect the use of AB8939 in the treatment of AML with certain chromosomal abnormalities. If this application is accepted, protection for AB8939 will be extended until 2044 for these subpopulations of AML patients. In addition to patent protection, AB8939 is also eligible for regulatory data protection in numerous countries, preventing generic competition for a period of up to 8 years from product registration.

AB8939 has also received orphan drug designation for AML from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). This orphan drug designation confers 10 and 7 years of marketing exclusivity in Europe and the US, respectively, from the date of product registration.

On July 30, 2025 Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, reported that it has signed a non-binding term sheet with Evotec SE (Press release, Sandoz, JUL 30, 2025, View Source [SID1234654611]). This paves the way for Sandoz to potentially acquire 100% of the issued and outstanding equity interests of Just–Evotec Biologics EU SAS for an amount of around USD 300 million, which owns the J.POD biologics development and manufacturing facility in Toulouse, France.

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Richard Saynor, CEO of Sandoz, said: "We aim to capitalize on the projected USD 300 billion biosimilar market opportunity over the next decade. The intended acquisition is fully in line with our strategy to reinforce in-house biosimilar capabilities, while creating additional strategic flexibility. Following successful completion, the Toulouse site would be used to develop and manufacture Sandoz biosimilars. JEB´s fully automated and high throughput technology platform will help us move faster, scale smarter, and maintain high quality while keeping costs under control."

Sandoz and Evotec SE will now work to negotiate details of the contracts and carry out the relevant works-council consultation processes, as well as the mandatory employee bid process in France. Closing the proposed transaction will be subject to finalizing the contracts and obtaining all necessary approvals. Further details of the terms cannot be shared at this stage and will only be disclosed after successful signing of the contracts.

Just-Evotec Biologics has been a key strategic partner for Sandoz since 2023. The proposed acquisition would complement previously announced investments in Sandoz biosimilar manufacturing and development sites. The planned investment would be in line with existing Sandoz capital-expenditure commitments related to Sandoz operations in Europe.

Upon completion of the proposed transaction, JEB employees would transfer with the acquired entity and would become part of the Sandoz Group. JEB brings an advanced and integrated continuous manufacturing platform with automation that enables manufacturing to run continuously end-to-end.