Date: 2013-10-30
Type of information: Credit line
Company: Santhera Pharmaceuticals (Switzerland)
Investors:
Amount: CHF 10 Million (€ 8 million)
Funding type:
Planned used: The funds will be used to secure a bridge financing that will allow Santhera to progress towards important clinical and regulatory milestones over the next months. The company intends to submit a new marketing authorization application (MAA) for Raxone® (idebenone) in Leber\'s Hereditary Optic Neuropathy (LHON) in the first quarter of 2014 in Europe. Last January, the European Medicines Agency\'s Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on Santhera\'s MAA for Raxone® for LHON. In March 2013, Santhera Pharmaceuticals has withdrawn its MAA for Raxone®. The company has also announced that it plans to file a new application based on emerging clinical evidence supporting the efficacy of Raxone® in the treatment of LHON. New data i the DELOS Phase III study with Catena® in steroid non-using Duchenne Muscular Dystrophy patients will become available in Q2 2014. A Phase II study with Catena® in primary progressive multiple sclerosis, in which Santhera collaborates with the National Institutes of Health, is also ongoing.
Others: * On October 30, 2013, Santhera Pharmaceuticals has announced that it has entered into a Standby Equity Distribution Agreement (SEDA) with YA Global Master SPV Ltd. (YA Global). Under the terms of the agreement, YA Global has committed to provide up to CHF 10 million in equity financing. In exchange for the funds to be provided, YA Global will receive Santhera shares. It remains at the sole discretion of Santhera to determine the timing of the funding.
The SEDA has been established to provide funding in support of Santhera\'s operations. Santhera will pay an upfront fee of 3% of YA Global\'s commitment to be paid in newly issued Santhera shares from existing conditional capital (approx. 85,000 shares). Upon signing of the agreement, Santhera will be able to initially use 600,000 shares to be created from its conditional capital for the SEDA. In order to allow further equity funding over a period of up to 36 months, Santhera will have to create additional conditional capital at a Shareholders\' meeting.
At any time during the 36 month commitment period, Santhera may request YA Global to purchase newly created Santhera shares. The price to be paid equals 95% of the lowest daily volume-weighted average share price of the five trading days following the date on which Santhera requests an equity funding. Further, should the market price on certain of the five trading days following the date of the funding request fall below a minimum price specified by Santhera, the pro rata subscription for such days will not be executed.
YA Global will never hold more than 9.9% of the outstanding Santhera shares. YA Global will not short sell or enter into any hedging transactions related to Santhera stock. YA Global is not restricted in its right to sell Santhera shares without any limit of time, including during the pricing period, in compliance with applicable laws, rules and regulations.
Therapeutic area: Rare diseases - Neurodegenerative diseases - Neuromuscular diseases - Ophtalmological diseases
