MONTREAL, Feb. 13, 2015 /CNW/ - Telesta Therapeutics Inc. (TSX:TST; PNK:BNHLF) today issued its financial statements and associated Management's Discussion and Analysis (MD&A), for the 6 month period ended December 31, 2014. In addition Telesta provided key corporate updates covering:
- An update on the timetable for the submission of a Biologics Licensing Application (BLA) with the United States Food and Drug Administration (FDA) for marketing approval of MCNA1
- An update on MCNA partnering interest;
- The reporting of summary results from the 3rd party assessment of the US commercial opportunity for MCNA;
- The engagement of Bristol Capital to lead the Company's outreach to the North American and European institutional investment community
- The launch of its new corporate website at www.telestatherapeutics.com;
Telesta Therapeutics today released its financial results for the 6 month period ended December 31, 2014. These financial statements and associated Management's Discussion and Analysis (MD&A) have been posted on www.sedar.com and on the company's website. The Company's cash and receivables position from continuing operations totalled $12.0 million as at December 31, 2014, compared to the position on June 30th, of $15.8 million. The Company estimates that it has adequate liquidity to fund its operations and financial obligations into calendar Q4, 2015, but will need to bring in additional funding, through partnerships, equity and/or debt financing to continue its operations beyond that point.
Yesterday, February 12th, Telesta participated in a Type C facility meeting with the US FDA. A Type C facility meeting is held in order to seek FDA feedback on questions that the applicant may have related to its manufacturing facility and its preparedness for a FDA pre-license inspection. As a result of this meeting, Telesta has decided to amend its internal objective of filing the MCNA BLA by up to 3 months, from March 31st to June 30th. This decision was taken to accommodate specific recommendations provided by the FDA concerning the Company's manufacturing facility.
Commenting on this decision, Dr. Michael Berendt, Telesta's CEO and Chief Scientist, took the opportunity to thank his CMC, clinical and regulatory staff and consultants. He stated: "While I am known to set aggressive timetables for myself and my staff, I have always emphasized that our primary objective is to file the BLA for MCNA that is best positioned for approval by the FDA, rather than simply meeting an internal deadline. We were provided with recommendations by the FDA in our Type C meeting yesterday and we will be acting on these recommendations so as to best position our manufacturing facility for ultimate FDA approval."
The Company also reported that there is significant 3rd party interest in the MCNA program and that it is in receipt of multiple non-binding expressions of interest from a variety of public and private pharmaceutical and biotechnology companies. Due to the confidential nature of the ongoing discussions, Telesta will only provide further updates to shareholders upon signature of a binding agreement.
Dr. Michael Berendt, CEO & Chief Scientist of Telesta cautioned that: "We will fully evaluate and negotiate the current offers to ensure that if we take the decision to partner MCNA or sell the company at this juncture, that such a decision will capture significant value for our investors."
Telesta today also confirmed the completion in December, of a third party assessment of the commercial opportunity for MCNA, in the United States. This commercial assessment, conducted by Medical Marketing Economics ("MME"), a global leader in the development of value-based strategies and market research, employed rigorous qualitative and quantitative primary market research with payers (managed care organizations/decision makers both from the private and public sector) and urologists (community urologists and key opinion leaders), to define market size, pricing strategy and market access context as well as reimbursement potential for MCNA.
The Company's analysis of the full MME data set, including data related to market size (epidemiology), anticipated market access and pricing, has led to the announcement today that the previously reported internal peak market estimates for the U.S. of up to $200 million per year were conservative and have been updated to reflect peak market estimates for the U.S. of more than $400 million. The full results of this comprehensive analysis are being made available, under confidentiality agreements, to potential partners and investors.
Telesta also announced today they have engaged Bristol Capital, an internationally focused Investor Relations firm, to lead the company's efforts to communicate the company's potential to a broader audience of potential investors, with a strong focus on U.S., European and Canadian institutional funds and brokers with an interest and focus on small cap Canadian growth stories. Telesta's new corporate website which can be viewed at www.telestatherapeutics.com.
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. 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.
1 Mycobacterium phlei cell wall – nucleic acid complex
SOURCE Telesta Therapeutics Inc.
For further information: Donald Olds, Chief Operating Officer, Telesta Therapeutics Inc., Telephone: (514) 394-7921, [email protected]