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Company and project information

Firstly, we include a video explaining our most relevant pharmaceutical product (LAM561), which is in phase III of the clinical study and is expected to hit the market in 2027.

On the other hand, in September 2022 we received the recognition of Fast Track in the United States from the American Medicines Agency (FDA – Food and Drug Administration), which is a new advance in the process of getting the medicine to patients in 2027, as a continuation of the orphan drug designation in the United States last October 2021. And just a few months ago in September 2023 we received the “Rare pediatric disease” designation from the FDA for LAM561 for the treatment of patients with glioma high-grade diffuse pediatric type. We also want to share with you that the data from the phase 1/2a clinical study have already been made public through an article published in the British Journal of Cancer, from the Nature group, which shows encouraging antitumor activity and a good safety profile of the compound LAM561. against brain tumors (gliomas and glioblastomas, the most aggressive and common brain tumors) and other types of cancer.

Also, on September 29, 2023, a meeting was held where an independent expert committee, known as IDMC (Independent Data Monitoring Committee), evaluated the clinical study data at the level of SAFETY and FUTILITY. This means first of all, at a safety level, verifying that LAM561 is not negatively affecting the patients who take it, and thus making its administration unethical. At the same time, futility is evaluated, so that if LAM561 was not having any effect on the population that takes it, or if it was negative, it would indicate that the study should undergo modifications. We share that the result of this analysis was positive, which brings us closer to the goal of approval of the Medicine.

In December 2023, the company incorporated to the pipeline a treatment for the neuropathic pain and spinal cord injury, that is in phase 2a.

On February 23, 2024, the independent expert committee (IDMC) met again to evaluate the trial data. On this occasion, the EFFICACY was evaluated in comparison with the placebo, blindly again for Laminar, but not for the committee, and the result has been… Continue without modifications! The best possible scenario that we could expect, and which indicates that, for the moment, there is sufficient statistical confidence in the efficacy of LAM561+SoC compared to placebo+SoC for us to be recommended to request conditional authorization with 66 progression events (already reached, see below). This is the biggest turning point that our compound has had since the lack of efficacy is the first reason for failure in phase 3 clinical studies, and this is a giant step for LAM561 to be able to jump that gap and demonstrate its effectiveness. We also want to mention that on June 10th the 140 necessary patients were recruited, so that recruitment is completed now. To consider, it was on January 2023 when we shared that we had reached the 45 patients recruited in the phase 3 trial for glioblastoma.

And on June 30, 2024, our CLINGIO trial database was locked after reaching 66 PFS events, triggering the interim analysis of the Clinical Study Report (CSR) that provided the first open-label, unblinded readout of the trial and took place on November 22, 2024. In this analysis, the Independent Data Monitoring Committee (IDMC) had access to the data as of June 30, 2024 and only compared the total LAM561+SoC population versus placebo+SoC (standard of care), without taking into account the different strata that affect the diagnosis and progression of the disease, such as the methylation status of the MGMT gene promoter and the RTOG score. Following this, the iDMC shared its recommendation stating:

• That the study should continue without modifications, until reaching 90 overall survival (OS) events, at which time the final analysis will be performed, estimated for Q4 2026.
• The study should not be stopped for reasons of safety or futility.
• Open the study, that is, remove the blind. From that moment on, patients, doctors and Laminar know if any patient in question is taking or took placebo or LAM561, which has allowed us to follow the data in real time.
• Statistical significance was not reached in the comparison of progression-free survival (PFS) when comparing all patients in the placebo+SoC arm with the LAM561+SoC group.

After the meeting, all the results that the iDMC used were shared with us. The interesting thing is the fact that because the study is no longer blinded, we can evaluate the data as of today, without doing statistical analysis, but taking into account the different subgroups, which is essential in a condition like glioblastoma. So far, we have observed a clear positive trend that we must continue to explore in patients with methylated MGMT gene promoters. These results have been published in this press release and show an improvement in progression-free survival of more than 30 weeks, with a Hazard-ratio as of February 18, 2025 of 0.55, indicating a 45% reduction in the probability of suffering progression in those patients taking LAM561+SoC compared to placebo+SoC. Methylated MGMT patients represent a very important group in the glioblastoma population and have an unmet therapeutic need.

In addition, the corporate website includes a lot of information about the projects we have and we share it with you below: https://laminarpharma.com. You can also find updated information on our linkedIn page.

Awards received since 2022:

• “R&D award in biotechnology, for developing therapies for diseases with high unmet clinical needs”, (December 20, 2023).
• “CEPYME Award at the National Level in Technological Innovation”, (March 28, 2023).
• “Onda Cero Award in Mallorca in the Science and Research modality”, (February 14, 2022).

Financial information and investment:

As important data, we tell you that the company has raised more than 43 million euros in capital in the 18 years of the company’s life, of which more than 70% of said funds (30 million euros) have been raised since 2021 . In 2022 we exceeded the figure of 6 million euros raised, in 2023 the company finally raised 12 million euros and finally in 2024 the Company has raised 9 million euros.

Thank you very much for your interest! And remember that if you have any questions you can contact us at inversores@laminarpharma.com

Financial information

In order to advance our innovative R&D pipeline we are continuously seeking new collaborations. We welcome licensing, partnering and alliances with leading players in the industry who can effectively contribute to bring novel melitherapy-based products to the market and make them available to patients globally.

Get involved!

Would you like to become a shareholder in our company so we can establish melitherapy as a reference treatment globally? We are looking forward to working with private investors and institutions by joining the stock market.

We are also looking for partnering opportunities for our lead R&D program with LAM561A1 in oncology, which has completed two clinical studies (a phase 1/2a and a phase 1b trials) with excellent results and has initiated a pivotal phase 2b/3 clinical study. We are open to discussing global partnering opportunities as well as potential collaborations with strong and motivated local development and commercial partners in specific markets like Japan, China, South Korea, Russia, Europe, Mexico or North America, were we hold strong IP rights for this product.  We are also considering partnering and investing opportunities for other melitherapy-based products in our pipeline, and particularly for our promising LAM226A1 program in Alzheimer’s disease.

If you are interested in investing or partnering opportunities, please contact us at bd@laminarpharma.com