TELESTA THERAPEUTICS INC (Canadian dollars, except where noted)
Montreal, Quebec, November 12, 2015. Telesta Therapeutics Inc. (TSX:TST; PNK:BNHLF) today issued its first quarter consolidated financial statements and associated Management's Discussion and Analysis (MD&A), for the fiscal quarter ended September 30, 2015 which are now published in full on SEDAR (www.sedar.com) and on the Company's website at www.telestatherapeutics.com.
In addition, Telesta provided key corporate updates:
Significantly strengthened balance sheet with the closing of an MCNA1 license agreement for major ex-U.S. regional rights with Ipsen;
Equity coverage of Telesta Therapeutics initiated by Ladenburg Thalmann and Roth Capital;
Publication of a review article on MCNA in the journal Therapeutic Advances in Urology;
The FDA Advisory Committee meeting discussing Telesta's bladder cancer therapeutic, MCNA, will be live webcast by the U.S. Food and Drug Administration on November 18, 2015.
Telesta Therapeutics today announced a loss for Q1/2016 of $3.9 million compared to $2.9 million for the comparable period last year. Of this loss, $3.8 million ($2.5 million in 2015) was from continuing operations while $0.1 million ($.4 million in 2015) was from discontinued operations consisting of the Company's former manufacturing facility in Belleville Ontario. The increase in operating loss compared to the previous period was primarily related to professional and consulting fees associated with the MCNA Biologics License Application (BLA) currently under Priority Review by the U.S. FDA.
The Company's cash and marketable securities position was $40.2 million at September 30, 2015 compared to $4.2 million at June 30, 2015. This increase is a result of the proceeds from the closing of an equity financing of US$28.6 million, as well as warrants exercised that resulted in proceeds of $6.1 million.
On October 28th, 2015, Telesta announced a license and collaboration agreement for MCNA in major ex- US territories with the multinational company, Ipsen, which included the payment of a US$10 million upfront license fee, which was received subsequent to quarter end.
Total debt and repayable government assistance as at September 30th, 2015 was $2.8 million ($2.8 million as at June 30th, 2015) while total debt and repayable government assistance related to discontinued operations was $8.6 million compared to $9.7 million as at June 30th, 2015. Conditionally repayable government assistance (amounts only repayable in the form of a capped royalty to be paid in the event of
the successful commercialisation of MCNA) stood at $9.9 million on September 30th, 2015 compared to comparable figure of $9.7 million as of June 30th, 2015.
Telesta anticipates that its current burn rate will increase, as the Company prepares for the U.S. commercial launch of MCNA in 2016. These increased expenditures will include ongoing and new
1
Mycobacterium phlei cell wall-nucleic acid complex
consulting mandates related to the regulatory advancement of MCNA, increased spending at Telesta's manufacturing site in Montreal Canada, as the facility transitions to commercial production and expenditures related to the establishment of a U.S.-based commercial infrastructure, as the Company prepares for commercial launch in 2016.
Commenting on the quarterly results, Dr. Michael Berendt, Telesta's Chief Executive Officer and Chief Scientist noted: 'I am proud of the effort and dedication of the Telesta team as we have achieved some very significant accomplishments over the last quarter. We have attracted a significant investment from top tier U.S. healthcare investors, the FDA has granted Priority Review to our BLA for MCNA, we have signed an extremely valuable license and collaboration with a great partner, Ipsen, and we have the balance sheet and executive talent, through the engagement of our new Chief Commercial Officer, to launch MCNA in the Unites States. I think it is reasonable to say that we have successfully executed on our strategic transformation of Telesta over the last 24 months and our team and I are very excited by the prospects and challenges in front of us as we look forward to the next 24 months.'
The U.S. FDA's Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee will discuss Telesta Therapeutics BLA for MCNA at a joint meeting that will be held between 8 am and 5 pm EST on Wednesday, November 18th. The FDA undertakes to publish the briefing material for this meeting 48 hours before the meeting and provides access to a live webcast
which can be accessed on the FDA's website at: https://collaboration.fda.gov/ctgtacodac111815/.
Telesta's Annual and Special Shareholders Meeting will be held at 10 am, November 12, 2015 in the Chapleau ABC Room at Norton Rose Fulbright Canada, LLP at 1, Place Ville-Marie, suite 2500, Montreal, Quebec, Canada. In accordance with the Company's practice, next year's meeting will be held in Toronto, Ontario.
Telesta Therapeutics Inc. is a late stage therapeutics company with near term commercial potential. The Company recently submitted a Biologics License Application (BLA) with the FDA for MCNA, its drug for high risk non-muscle invasive bladder cancer, and has been granted Priority Review with a PDUFA date of February 27, 2016. The Company's primary goal is to develop and commercialize products in the United States 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.
For further information:
Donald Olds, Chief Operating Officer Telesta Therapeutics Inc.
Telephone: (514)-394-7921 Donald.Olds@telestatherapeutics.com
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