Avanza MolMed +5,75% in Piazza Affari. On the eve of the launch of the capital increase, the biotech company, the only one listed with Italian capital, announced that it had filed an application for early placing on the market through the Conditional procedure with EMA, the European Medicines Agency Marketing Authorization for TK, its own experimental gene-cell therapy.
TK is a treatment associated with hematopoietic stem cell transplantation in patients with high-risk leukemia. The Conditional Marketing Authorization represents a particular marketing authorization procedure that can be granted even in the absence of the final data of Phase III pivotal studies. This early authorization is essentially based on safety and efficacy data obtained in previous clinical studies. In 2013, only 8 requests were made at European level. The application was submitted following treatment of more than 120 patients treated worldwide and an ongoing Phase 3 study.
Claudio Bordignon, President and CEO of MolMed, comments: “We are convinced that, by providing rapid immune reconstitution and eliminating the need for post-transplant immunosuppression, TK can represent a new and powerful tool capable of providing an effective therapeutic option for high-risk leukemia patients who do not have a fully matched donor.” The announcement comes on the eve of the launch, Monday 10 March, of the capital increase for 5 million.
The shareholders Fininvest, Airain, H-Equity and H-Invest have expressed their willingness to subscribe in full to the quota reserved under option – equal to 24,903%, 6,645%, 4,062% and 3,616% respectively – of the increase. Furthermore, Fininvest has declared its willingness to subscribe any unopted shares as long as they do not exceed the threshold of 30% of the capital. Airain and H-Equity have declared their willingness to subscribe to the unopted shares for a maximum value of 437.514 and 267.550 euros, respectively.
The group closed 2013 with operating revenues of 6,7 million euros, up 32,7% on the previous year. MolMed expects that the net financial requirement up to 31 January 2015 will be equal to 15,1 million euros, which will be covered by the increase up to 5 million, by the commitments of Fininvest, Airain and H-Equity to guarantee financial support for up to 12,7 .XNUMX million.
