MONTREAL, April 27, 2015 /PRNewswire/ - Telesta Therapeutics Inc. (TSX:TST; PNK:BNHLF) provided the following key corporate updates:
- Submission of Biologics Licensing Application (BLA) to the United States Food and Drug Administration (FDA) for marketing approval of MCNA1 remains targeted for June 30, 2015;
- Negotiations for the partnering of MCNA are ongoing;
- Presentations scheduled at two upcoming investor forums;
- Equity coverage initiated by two investment banks;
Telesta Therapeutics announced today that it is continuing to target the submission of a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for the marketing approval of MCNA by June 30th. Commenting on this update, Dr. Michael Berendt, CEO and Chief Scientist noted: "My clinical, regulatory, quality and manufacturing teams are working hard and we remain committed to submitting our BLA before the end of the second calendar quarter. As we approach this key value inflection point, it is critical that we do everything we can to file the highest quality BLA possible to ensure that we are able to deliver a new and much needed therapeutic option for bladder cancer patients that have not seen a new drug approved since 1998!"
The Company also reported that there continues to be significant 3rd party interest in the MCNA program and that it is seriously evaluating partnering opportunities and actively negotiating multiple non-binding expressions of interest from a number of public and private pharmaceutical and biotechnology companies who are attracted to MCNA's late stage specialty product profile, therapeutic area and market potential. Due to the confidential nature of the ongoing discussions, Telesta will only provide further updates to shareholders on execution of a binding agreement.
Telesta also announced today that they are continuing to work with Bristol Capital, an internationally focused Investor Relations firm, to organize an ongoing program of investor meetings in key North American financial centers. Telesta will be presenting at two upcoming institutional investors forums: the 2015 Bloom Burton Healthcare Investor Conference in Toronto, Ontario as well as the LD Micro-Invitational Investor Conference in Los Angeles, California; details of both conferences can be found on Telesta's website at www.telestatherapeutics.com.
In addition, initial equity coverage of Telesta Therapeutics has recently been initiated by Euro Pacific Canada (March 4, 2015) and M Partners (April 22, 2015) and the company remains in discussions with other North American financial institutions concerning the possibility of adding to this coverage in the months to come.
1 Mycobacterium phlei cell wall – nucleic acid complex
About Telesta Therapeutics Inc.
Telesta Therapeutics Inc. is a late stage therapeutics company with near term commercial potential focused on the manufacturing, marketing and licensing/acquisition of proprietary and innovative therapies for the global health market. The Company's primary goal is to develop and commercialize products that advance human health and increase shareholder value with a focus on its near-commercial specialty therapeutic, MCNA. For more information, please visit www.telestatherapeutics.com
Except for historical information, this news release may contain "forward-looking statements" and "forward-looking information" within the meaning of applicable securities laws that reflect the Company's current expectation regarding future events. Forward-looking statements and information are necessarily based upon a number of estimates and assumptions that, while, considered reasonable by management, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Readers are cautioned that any such forward-looking statements and information are not guarantees and there can be no assurance that such statements and information will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements and information. These forward-looking statements and information involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. The Company expressly disclaims any intention or obligation to update or revise any forward-looking statements and information whether as a result of new information, future events or otherwise. All written and oral forward-looking statements and information attributable to us or persons acting on our behalf are expressly qualified in their entirety by the foregoing cautionary statements.
SOURCE Telesta Therapeutics Inc.