Ipsen delivers strong results in the first half of 2025 and upgrades its full-year guidance

On July 31, 2025 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported its financial results for the first half of 2025 (Press release, Ipsen, JUL 31, 2025, View Source [SID1234654820]).

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Revisions to patient enrollment

On July 31, 2025 Pyxis Oncology, Inc.’s (the "Company") reported revisions to patient enrollment participants related to Phase 1 monotherapy clinical trial to evaluate micvotabart pelidotin ("MICVO", formerly PYX-201) were made available on ClinicalTrials.gov (Press release, Pyxis Oncology, JUL 31, 2025, View Source [SID1234654730]). This clinical trial is a first-in-human, open-label, multicenter, Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Micvo in participants with advanced solid tumors and includes a part 1 dose escalation and part 2 dose expansion (NCT05720117).

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Consistent with the industry practices, the revision in patient enrollment participants reflects the maximum number of patients that will be allowed to be enrolled as per protocol. The Company confirms its prior guidance related to estimated number of head and neck squamous cell carcinoma ("HNSCC") patients to be enrolled in the dose expansion phase (Part 2) of the PYX-201-101 monotherapy study as disclosed in its quarterly report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2025.

Genvira and Labskin Receive £1.2 Million ($2.0 Million) UK–Canada Collaboration Award to Advance Immunotherapies for Malignant Melanoma

On July 31, 2025 Genvira Biosciences Inc. ("Genvira"), a Canadian innovator in next-generation viral vectors, Labskin Limited ("Labskin"), a leader in 3D in vitro human skin models, and the National Research Council of Canada (NRC) reported the launch of a collaborative project to develop novel immunotherapies for malignant melanoma (Press release, Genvira Biosciences, JUL 31, 2025, View Source [SID1234654697]). The collaboration is receiving advisory services and up to £1.2 million ($2.0 million) in funding through the Canada–UK Biomanufacturing of Biologics and Advanced Therapies program. UK participants are supported by Innovate UK, part of UK Research and Innovation (UKRI), while in Canada, support for the project is offered through the NRC Industrial Research Assistance Program (NRC IRAP) and the NRC Collaborative Science and Technology Innovation Program (NRC CSTIP).

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Malignant melanoma continues to be a serious global health concern, with an estimated 330,000 new cases and 60,000 deaths each year. This international partnership aims to address the unmet need by developing cutting-edge cancer vaccines and optimizing targeted antigen delivery systems.

As part of the collaboration, Labskin will utilize its expertise in advanced disease modeling to develop a novel 3D human skin model of melanoma, enabling in vitro testing of vaccine candidates. Genvira will contribute its proprietary viral vector and gene delivery platforms, while the NRC will support the integration of mRNA technologies to engineer innovative, targeted immunotherapies tailored to melanoma.

Dr. Nicola Kingswell, Scientific Director at Labskin Limited, stated:

"We’re extremely grateful to Innovate UK for supporting this exciting project. It represents a step-change in the treatment of malignant melanoma, which will benefit many patients worldwide. This partnership will not only produce and validate new immunotherapies, but also establish a framework for developing future cancer therapeutics."

Dr. Jiahu Wang, President of Genvira Biosciences, added:

"We’d like to thank NRC IRAP for their support, and the NRC for their collaborative role. This partnership enables us to rapidly translate our viral vector technologies into clinical applications for melanoma and lays the groundwork for broader advances in cancer immunotherapy."

The project brings together unique and complementary strengths in 3D tissue engineering, gene and viral therapy, mRNA technology, and advanced biomanufacturing. In addition to therapeutic development, the consortium will focus on scalable production processes, quality control assays, and robust technologies to enable rapid response to future healthcare challenges.

This initiative highlights the importance of international collaboration in driving innovation and accelerating the development of advanced biologics and therapies.

Lantern Pharma Completes Targeted Enrollment for Lung Cancer Phase 2 Harmonic™ Clinical Trial in Japan for LP-300

On July 31, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted cancer therapies using its proprietary RADR AI platform, reported the successful completion of targeted enrollment for its Phase 2 HARMONIC clinical trial in Japan (Press release, Lantern Pharma, JUL 31, 2025, View Source [SID1234654696]). The company enrolled 10 patients ahead of schedule across five clinical sites in Japan, including the National Cancer Center Japan.

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The HARMONIC trial is evaluating LP-300 in combination with carboplatin and pemetrexed in never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after receiving treatment with tyrosine kinase inhibitors (TKIs). The successful Japanese enrollment validates Lantern’s strategic decision to expand the trial internationally to regions with significantly higher rates of never-smoker NSCLC patients such as Japan and Taiwan.

"Completing our targeted enrollment in Japan ahead of schedule demonstrates excellent execution of our international expansion strategy and validates our decision to focus on regions where never-smoker NSCLC has the highest prevalence," said Panna Sharma, President and CEO of Lantern Pharma. "This achievement builds momentum as we continue enrollment in Taiwan and the United States, bringing us closer to generating the clinical data that could establish LP-300 as a treatment option for this underserved patient population with significant unmet medical need."

The completion of Japanese enrollment represents an important milestone in the global HARMONIC trial, which is designed to enroll approximately 90 patients across multiple regions. Japan’s notably higher rate of never-smoker NSCLC patients (33-40% of new cases) compared to Western populations (typically 15%) makes it a strategically important region for the trial. Similarly, Taiwan, where more than 50% of lung cancer cases occur in never-smokers, represents another key enrollment region.

The HARMONIC trial previously demonstrated encouraging results in its initial safety lead-in cohort, showing an 86% clinical benefit rate and 43% objective response rate among the first seven patients enrolled in the United States. Notably, recent data revealed that one patient has achieved a durable complete response in target cancer lesions with survival continuing for nearly two years, demonstrating the potential for LP-300 to deliver meaningful long-term outcomes for never-smoker NSCLC patients.

Never-smoker NSCLC is increasingly recognized as a distinct disease entity with unique clinical and genomic characteristics1, representing a global market opportunity estimated at over $4 billion annually. Currently, there are no therapies specifically approved for never-smoker NSCLC patients, highlighting the significant unmet medical need this population faces.

Lantern is actively exploring collaboration and partnering opportunities to maximize LP-300’s commercial potential in multiple geographies. Lantern is scheduled to provide further clinical and outcome data from the HARMONIC trial later this quarter, with updates covering both Asian and U.S. patient cohorts.

About LP-300 LP-300 is a disulfide small molecule and investigational drug candidate with a multimodal mechanism of action directed toward tyrosine kinase receptors and cell redox enzymes. It modulates cellular redox in key signaling pathways in NSCLC and directly engages with TKI receptors via cysteine modification. LP-300 has been evaluated in multiple Phase 1, 2, and 3 clinical trials in over 1,000 subjects, with retrospective analysis showing significant survival benefit in never-smoker lung adenocarcinoma patients.

About the HARMONIC Trial The HARMONIC trial is a multicenter, open-label, randomized Phase 2 trial designed to evaluate the efficacy and safety of LP-300 in combination with standard-of-care chemotherapy (pemetrexed/carboplatin) versus chemotherapy alone in never-smoker NSCLC patients who have relapsed following TKI treatment. The trial is expected to enroll approximately 90 patients across sites in the United States, Japan, and Taiwan. The primary endpoints are progression-free survival (PFS) and overall survival (OS). For more information about the trial, visit www.harmonictrial.com or clinicaltrials.gov (NCT05456256).

OPM Announces Its 2025 Half-Year Financial Results and Provides an Update on Its Clinical Developments and Financial Position

On July 31 2025 Oncodesign Precision Medicine (OPM) (ISIN: FR001400CM63; Mnemonic: ALOPM), a biopharmaceutical company specializing in precision medicine for the treatment of resistant and metastatic cancers, reported its financial results for the first half of 2025, as approved by the Board of Directors on July 31, 2025 (Press release, Oncodesign Precision Medicine, JUL 31, 2025, View Source [SID1234654695]).

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Philippe GENNE, Chairman and CEO of Oncodesign Precision Medicine, comments: "To date, it remains impossible to raise funds on Euronext for a biotechnology company that needs to conduct clinical proof-of-concept trials. As a result, our hopes for revenue and therefore cash availability rest primarily on discussions with potential buyers of our assets. The various cost-cutting measures we have taken since the beginning of this year are enabling us to continue these discussions over time, and the last quarter will be crucial in this regard."

Karine LIGNEL, Managing Director and COO of Oncodesign Precision Medicine adds: "In a very difficult financial environment, we have taken management decisions that have enabled us to significantly reduce our expenses and thus extend our cash flow horizon as much as possible. We have also set up an equity financing line to deal with market uncertainties. Nevertheless, the situation remains complicated, and we are making every effort to secure a partnership for one of our assets."

Oncodesign Precision Medicine – Income Statement

in M€
Audited data

H1 2025

H1 2024

Evolution

In %

in value

Revenues

0.14

0.14

0%

+0.00

Other revenues and operating income

0.60

0.50

21%

+0.10

Total revenues and operating income

0.74

0.64

16%

+0.10

Stock variation

13.00

NS

+13.00

Purchases consumed

(2.24)

(3.33)

-33%

+1.09

Personnel costs

(1.51)

(1.35)

12%

-0.16

Other operating expenses

(0.02)

(0.03)

-19%

+0.01

Taxes and duties

(0.03)

(0.03)

19%

-0.01

Net change in depreciation and amortization

(0.15)

(0.13)

16%

-0.02

Total operating expenses

9.05

(4.86)

NS

+13.91

Operating result

9.79

(4.22)

-332%

+14.01

Financial income and expenses

(0.26)

(0.06)

342%

-0.20

Income from ordinary activities of consolidated companies

9.53

(4.28)

-323%

+13.81

Extraordinary income and expenses

0

(0.01)

NS

+0.01

Income tax

0.31

0.65

-52%

-0.34

Net result

9.85

(3.64)

NS

+13.48

Key financial data

A cost reduction program was implemented in the first half of 2025:

Negotiations were held with the banks and BPI that granted the loan, resulting in a six-month deferral of principal repayments starting in April 2025
Expenses were reduced through
The layoff of five employees in early 2025
A 50% reduction in the compensation of non-salaried corporate officers
A freeze on salaries and bonus payments for the 2024 fiscal year
A reduction in spending on non-priority programs.
In terms of cash flow, rather than from an accounting perspective, this results in a reduction in payroll costs of €242k in the first half of 2025 and a projected reduction of €440k in the second half of this year. The reduction in expenditure is particularly significant for the item "subcontracting and fees," which will fall from €2,900k in the first half of 2024 to €1,773k in the first half of 2025.

R&D expenses amounted to €1.74 million in the first half of 2025, compared with €3.61 million in the same period last year, as the company focused its efforts on the clinical development of OPM-101.

Oncodesign Precision Medicine – R&D expenditure

in M€
Analytical data

H1 2025

H1 2024

Evolution

In %

in value

Partnerships

0.46

0.68

-32%

-0.2

Licensing

1.28

2.93

-56%

-1.7

Total R&D expenses

1.74

3.61

-52%

-1.9

Reintegration, in close collaboration with Servier, of all OPM-201 data and product stocks

The most significant financial item in the first half of 2025 is the reintegration, as provided for in the partnership agreement, of the stock of OPM-201 GMP material produced by Servier. As this reintegration is being carried out without financial competing, OPM has called upon an external expert to determine fair value for these stocks. This expert carried out three different valuations to arrive at this fair value.

A summary of these valuations is shown in the table below:

in M€

Min.

Centrale

Max.

Valuation of inventories based on cost price

7.2

7.2

7.2

Valuation of inventories using the "milestone economy" method

13.0

13.0

13.0

Valuation of inventories using rNPV discounting

15.3

15.7

16.2

The expert concluded that the fair value of these inventories falls within a range of €13 million to €16.2 million. OPM used the lower end of this range.

OPM’s revenue for the first half of 2025 was €0.1 million, the same as in the first half of 2024.

Other income mainly consists of subsidies amounting to €0.3 million and €0.3 million in provision reversals.

OPM’s financial result was (€0.26) million, compared with (€0.1) million in the same period last year, mainly due to interest on outstanding loans and financial income from cash investments.

OPM recorded €0.4 million in R&D tax credits in the first half of 2025, down 52% compared to last year. The amount of R&D tax credits was reduced by the amount of public aid, the R&D expenditure base decreased, and the rules for collecting R&D tax credits changed (exclusion of technology watch patents, etc.).

OPM’s half-year net income thus stands at €9,846k, due to the integration of OPM-201 inventories at an estimated value of €13m.

Cash position of €2.5m at June 30, 2025

As of June 30, 2025, OPM had cash reserves of €2.5 million, before receiving the Research Tax Credit, compared to €9.6 million (including the Research Tax Credit) as of June 30, 2024.

The Research Tax Credit, amounting to €1.1 million, was received in July 2025.

OPM has access to a maximum €5 million equity financing facility, which it has not yet used. The Company is in discussions with financial and pharmaceutical partners with the goal of signing a partnership agreement or raising funds.

2025 perspectives

OPM has submitted its Phase 1b/2a protocol for the REVERT study evaluating OPM-101 in patients with advanced melanoma resistant to anti-PD1 and is awaiting a response from Swiss ethics institutions. The first patient is expected to be enrolled by the end of 2025.

Work on radioligands is continuing as part of the COMETE project.

Partnership prospects or transfer mainly focus on the two most advanced molecules to date (OPM-101 and OPM-201).

OPM’s goal is to license or transfer OPM-101 at the end of Phase 2a to a pharmaceutical partner who will complete its development and commercialization. While we do not anticipate licensing or sales before the end of this phase in 2027, we are considering the possibility of a pharmaceutical partner taking a licensing option with the payment of an exclusivity fee, giving them first refusal on the results.

For OPM-201, the objective is to find a partnership similar to the one we found with Servier in 2019 or a buyer.

Availability of the 2025 half-year financial report

The 2025 half-year financial report will be available on the company’s website, within the legal deadline, before October 31, 2025.