Both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) approved InnoMedica’s application and granted „Orphan Drug Status” (EMA: „Orphan Medicinal Product Designation” / FDA: „Orphan Drug Designation”) to Talineuren for the treatment of Amyotrophic Lateral Sclerosis (ALS). This confirms the potential of InnoMedica’s neurology product for the treatment of ALS, as evaluated in preclinical studies by both regulatory authorities.
ALS is a rare, to date incurable and not adequately treatable neurodegenerative disease of the motor nervous system. It leads to increasing muscle atrophy in affected patients and to a reduction in life expectancy to an average of three to five years after diagnosis. InnoMedica has developed Talineuren, which embeds the regenerative active ingredient GM1 in liposomes, thereby creating optimized conditions for the therapeutic effect to unfold. Preclinical studies on ALS have shown that treatment with Talineuren can halt motoneuron degeneration and lead to significant improvements in motor performance.
By granting „Orphan Drug Status“, the EU and the USA offer support in the development of drugs for the treatment of rare diseases. The „Orphan Drug Status” supports the development of Talineuren for the indication ALS in multiple ways. InnoMedica receives direct and free support from the regulators EMA and FDA in the form of scientific advice. In addition, fees for other regulatory activities such as the submission of clinical trial applications or marketing approvals will be substantially reduced or waived entirely. „Orphan drug status” at the time of approval will guarantee Talineuren multi-year market exclusivity in the respective geographic area for the treatment of ALS. Receiving „Orphan Drug Status” from EMA and FDA is an important step for InnoMedica towards bringing Talineuren to patients and ultimately into the market.
Capital increase 2021
Important milestones have been reached with the imminent submission of the market authorization application for Talidox, with the upcoming start of the first clinical trial for Talineuren, and with the „Orphan Drug Designation” for Talineuren. The positive ruling from EMA and FDA accelerates the internationalization of InnoMedica and provides a good basis for first studies in the USA and Europe.
InnoMedica will conduct a capital increase in spring 2021 in order to finance the next two years. The preliminary round designed for larger investments will run until March 31, 2021. It offers interested investors the opportunity for a comprehensive review of the investment in direct contact with Dr. Jonas Zeller, Chief Financial Officer (firstname.lastname@example.org).
The preliminary round will be followed by a public offering in the middle of April, during which both the existing shareholder base and new investors will be approached. The capital increase provides for an offer of a maximum of 1,338,230 registered shares at a share price of CHF 33.90 with a nominal value of CHF 0.10, resulting in a maximum capital raising of CHF 45.3 million.
In addition, InnoMedica was able to negotiate an agreement with an existing shareholder group that has been invested in InnoMedica for more than 20 years, to contribute 2 million of its shares at a preferential price of CHF 8.48 to the capital increase 2021. For each subscription of a new share at a price of CHF 33.90, the investor will receive a free option to purchase 1.5 additional shares from the existing shareholders at a price of CHF 8.48. By following the price proposal of the Board of Directors of InnoMedica Holding AG and thus foregoing a significant part of the potential return, the existing shareholders make a significant contribution to the attractiveness of the subscription of new shares.
The Board of Directors supports an active restructuring of the shareholder base that is adapted to the risk profile of the company and provides a balanced benefit for all parties involved. The existing shareholders have supported InnoMedica’s high-risk phase as pioneers with their original investments. As the company moves closer to market entry, the risk profile decreases while the capital requirements increase. This constellation addresses a different segment of investors, which InnoMedica today can address confidently in light of its track record and high professional standards.
The prospectus of the public offering is currently being reviewed by SIX Exchange Regulation AG in accordance with the new Financial Services Act of 1.1.2021 and the complete investor documentation is being prepared. All documents will be sent to the shareholders as well as to interested investors at the beginning of the capital increase.