Telesta Therapeutics Reports Q2, 2016 Financial Statements and Provides Corporate Updates

Telesta Therapeutics Inc. (TSX:TST, OTCPINK:BNHLF) issued its second quarter consolidated financial statements and associated Management’s Discussion and Analysis (MD&A) for the fiscal quarter ended December 31, 2015.
According to the press release:

Telesta Therapeutics announced net income for the 6-month period ending December 31, 2015 of $8.2 million compared to a loss of$8.2 million for the comparable period last year. This profit was primarily due to the recognition of $13.1 ($US10 million) of licensing revenue in this quarter and a non-cash gain of $3.6 million resulting from a reduction of management’s estimate of the value of conditionally repayable government assistance. Following the receipt of a Complete Response Letter from the U.S. FDA to Telesta’s Biologics License Application (BLA) for MCNA, management has revised its assumptions for the calculation of this potential future liability. As Telesta continues to work to clarify the future regulatory pathway for MCNA, these assumptions will be further reviewed.

Dr. Michael Berendt, Telesta’s Chief Executive Officer and Chief Scientist noted:

Under other circumstances, I would be very pleased to release our second quarter financial statements demonstrating both a profitable quarter and a very healthy balance sheet. However this quarter’s results are completely over-shadowed by the receipt of a Complete Response Letter from the FDA that we reported last week.
While I understand the frustration of our shareholders who want to know exactly what our path forward is for MCNA, I must ask them to be patient as we methodically review the situation. We have begun meeting with our advisors, consultants and partners and are preparing a written submission requesting a Type A meeting with the FDA, where we will be able to ask specific questions concerning the future regulatory pathway for MCNA. It is critical that we clearly understand what will now be required by the FDA to consider approval for MCNA in the United States. In parallel, we are working with our development partners to seek regulatory clarity in key jurisdictions outside the U.S. particularly as it relates to the path to approval in Europe. At the end of this exercise, which I caution will take several months, we will be in a position to evaluate with our board the different strategic options available to us which will ensure that we can deliver on our primary mission of creating value for our shareholders. As communicated last week, we will organize a shareholders update teleconference as soon as we have substantial news to report.

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