(Canadian dollars, except where noted)
MONTREAL, May 10, 2016 /CNW Telbec/ - Telesta Therapeutics Inc. (TSX: TST) (PNK: BNHLF) today issued its third quarter consolidated financial statements and associated Management's Discussion and Analysis (MD&A) for the fiscal quarter ended March 31, 2016, which are now published in full on SEDAR (www.sedar.com) and on the Company's website at www.telestatherapeutics.com.
Telesta Therapeutics announced a net loss for the three-month period ending March 31, 2016 of $1.6 million, compared to a net loss for the comparable period ending March 31, 2015 of $3.3 million. For the nine-month period ending March 31, 2016, Telesta's net income was $6.5 million, compared to a loss of $11.5 million for the comparable period last year. The quarterly loss is attributed to operating expenditures related to research and development and general and administrative expenses, along with a foreign exchange loss of $1.6 million, and an additional impairment of $2.3 million of an asset held for sale, off-set by a $6.5 million gain related to a reduction in the Company's estimate of the amount owed for conditionally repayable government assistance, all as more extensively detailed in the company's third quarter financial statements.
Total R&D expenditures for the 9-month period were $8.5 million, compared to $5.0 million for the comparable period last year. This increase is primarily due to non-recurring consulting fees related to the BLA ($1.9 million for the 9 months ending March 31, 2016 compared to $0.6 million for the same period the previous year), increased expenses related to production and quality control staff, decreased financial expenses and increased external service contract expenses. General and administrative expenses for the 9-month period ending March 31, 2016 was $5.5 million compared to $3.6 million for the same period last year. This increase is primarily related to higher legal fees related to the October licensing transaction with Ipsen, an increase in expenses related to the establishment of a U.S. commercial operation and non-cash stock-based compensation.
Total debt and repayable government assistance as at March 31, 2016 was $3.2 million ($4.3 million as at June 30, 2015) while total debt and repayable government assistance related to discontinued operations was $8.1 million, compared to $9.7 million as at June 30, 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 nil on March 31, 2016, compared to $9.7 million as of June 30, 2015. This reduction is related to a change in management's estimates of the forecasted timing of future sales of MCNA.
The Company's cash and marketable securities position was $44.2 million at March 31, 2016, compared to $4.2 million at June 30, 2015.
Telesta's management team and Board of Directors are actively evaluating opportunities to create shareholder value, both through the monetization of Telesta's key assets, including its MCNA franchise, and through the execution of one or more strategic options including, but not limited to, the sale of the Company, the acquisition of development-stage or commercial assets, or the merger of the Company with another public or private biotechnology company. As previously reported, the Company is considering the engagement of an investment bank if the Board of Directors determines that such an engagement would accelerate the successful conclusion of this strategic review process.
Since Telesta has determined that it will seek a partner to develop MCNA for the U.S. market, following the recent decision by the U.S. Food and Drug Administration (FDA) to require an additional Phase 3 study prior to considering commercial approval of MCNA, Telesta is in discussions with its existing development partners and is actively approaching other potential partners. As these discussions are held under confidentiality agreements, Telesta will only be announcing developments on these fronts when they are finalized.
The Company continues to identify and implement opportunities to reduce ongoing operating expenditures and estimates that average cash expenditures for the last quarter of the fiscal year will be less than $0.8 million per month. Almost half of these ongoing expenditures are related to the Company's Montreal MCNA manufacturing facility, and the Company expects that responsibility for these costs will be taken up by its MCNA development partners.
Dr. Michael Berendt, Telesta's Chief Executive Officer and Chief Scientist noted: "This is a difficult time for our shareholders as we work on multiple operational and strategic fronts simultaneously, while our ability to communicate our progress on these fronts is constrained by our confidentiality obligations and the need to negotiate in parallel with multiple parties. I would like to assure our shareholders that our Board of Directors and management team are extremely aware of the need to move quickly, and that all of us are working diligently to successfully deliver on our mission to preserve and create value for all of our stakeholders."
About Telesta Therapeutics Inc.
Telesta Therapeutics Inc. is a public biotechnology company focused on developing and commercializing human therapeutics for the U.S. market 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.
SOURCE Telesta Therapeutics Inc.
For further information: Donald Olds, Chief Operating Officer, Telesta Therapeutics Inc., Telephone: (514) 787-3456, [email protected]