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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 2026.

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 2026, 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.

On June 30, 2024, the database of our CLINGIO trial was locked after reaching 66 PFS events, which triggers the interim analysis Clinical Study Report (CSR) that will end up offering the first unblinded open readout of the trial. To ensure validity, integrity and quality of the results, data will be monitored and analyzed independently, a process that requires between three and five months. Finally, the CSR will be reviewed by the Independent Data Monitoring Committee (IDMC) that will approve the report, which summary we expect to be able to share by the end of this year. If positive, this data will be used for requesting conditional marketing authorization.

And in August 2024, we carried out a new external valuation with an expert analyst who usually analyzes public companies. The result is a total value of the company of 433 million euros, which taking into account the number of shares places the value of each share at €19.0. Less than 1 year ago the result of this valuation with the same analyst was 308 million (€15.5 per share), as you can see with each passing month the value of the company increases.

In addition, you can also watch our last webinar session from June 11, 2024, where you can find out the updated status of the project and the company, and where we answer various queries.

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 65% of said funds (29 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