Pharmamel is a spin-off from the University of Granada and holds the technology license from the Andalusian Health Service and the University of Granada for an injectable intravenous melatonin treatment for sepsis (the leading cause of death in ICUs).
The company is at a pivotal moment in its growth and development, both in the corporate and scientific arenas, as it has initiated the process to list on the BME Scale, signing a strategic agreement with the registered advisor Armanext and entering the pre-market environment of Bolsa y Mercados Españoles (BME). Pharmamel is expected to be publicly listed in the fourth quarter of 2024. In the scientific field, the company faces the important challenge of completing a Phase IIB/III clinical trial.
This trial represents a significant value inflection point for Pharmamel, as positive results would add to the excellent outcomes already achieved in previous Phase II studies, potentially increasing the company’s valuation and allowing for early monetization following the “Fast-track” submission to both EMA and FDA and the pre-licensing of the new intravenous melatonin injectable.
To fully fund the Phase IIB/III clinical trial in Europe and the U.S. in line with EMA and FDA standards, and to bring the drug to market, Pharmamel is opening a new Pre-IPO capital increase round on Capital Cell, a platform regulated by CNMV, at a pre-money valuation of €37 million, with a projected listing valuation of €45 million on BME Scale.
This round is expected to be complemented by funding from CDTI, NextGenerationEU, ENISA, and other grants the company has already applied for, as well as contributions from private and specialized investors and public-private investment funds with whom Pharmamel has pre-signed investment agreements/LOIs, aiming for a completion timeline of 6 to 12 months.
After conducting two successful Phase II clinical trials, demonstrating the drug’s safety and efficacy, Pharmamel now has the ideal candidate drug. However, to proceed, Pharmamel must complete the Phase IIB/III trial and obtain early market authorization (Fast-Track) from EMA and FDA, leading to subsequent licensing to the pharmaceutical industry.
Having demonstrated the effectiveness, efficacy, and safety of the new drug in sepsis and COVID-19 clinical trials (both bacterial and viral sepsis), the international regulatory affairs consultant and CRO Veristat has developed the regulatory strategy and roadmap for Pharmamel to achieve drug registration with EMA and FDA.
Based on promising Phase II results, industrial protection, and technological advancement, an independent valuation of Pharmamel was conducted by Axispharma, a specialist in biotech companies, estimating Pharmamel’s value at €130 million.
Following a thorough analysis of the situation and financial alternatives, Pharmamel has initiated the process to list on BME Scale, establishing a strategic alliance with registered advisor Armanext and entering the BME pre-market environment. The IPO will strongly reinforce the company by:
- Enhancing visibility and strategic international positioning for future licensing operations.
- Securing necessary short-term resources.
- Creating an exit opportunity for both new and existing shareholders.
- Increasing company and stock value by achieving significant milestones.
Following the successful capital increase round on Capital Cell in 2023, Pharmamel currently has sufficient resources to begin the IPO process and to initiate the initial stages of the Phase IIB/III clinical trial.
