MONTREAL, Aug. 19, 2015 /CNW Telbec/ - Telesta Therapeutics Inc. (TSX: TST) (PNK: BNHLF) announced today that it has closed a private placement financing of US$28.6 million. This transaction was led by several prominent U.S. healthcare investors, including Consonance Capital Investors, Boxer Capital of Tavistock Life Sciences and Omega Funds. In addition, certain members of the senior management team and board of directors of Telesta participated in the transaction.
Commenting on this strategic financing, Dr. Michael Berendt, Chief Executive Officer and Chief Scientist noted: "Attracting strong U.S. institutional investors has been a key corporate objective for us since we began our work to focus Telesta Therapeutics on human health and the U.S. market opportunity for MCNA. This financing will allow us to continue our dialogue with the U.S. Food and Drug Administration (FDA) as they evaluate our Biologics License Application (BLA) while accelerating our work to prepare for the commercial launch of MCNA in anticipation of US regulatory approval which could come as early as Q1/2016. These efforts include preparation for a potential advisory committee, the manufacture of MCNA commercial product and the development of the commercial infrastructure to launch MCNA in the United States."
Details of the Offering
Under terms of this financing, Telesta has issued 108,966,814 common shares at a subscription price per share of C$0.3405/US$0.2623 being the 5-day volume weighted average price of Telesta's common shares at the close of markets on Wednesday, August 12th. The issuance of these shares brings the total number of issued common shares in Telesta to 280,798,258.
Funds affiliated with Consonance Capital Investors have purchased 56,037,004 common shares in this financing representing 19.96% of the outstanding shares of Telesta post financing. The private placement was completed primarily with accredited investors outside of Canada.
Ladenburg Thalmann acted as sole lead placement agent for this financing while Roth Capital Partners and Euro Pacific Canada Inc. acted as co-placement agents.
MCNA – Regulatory and Commercial Update
Telesta submitted its BLA to the U.S. FDA for MCNA on June 29, 2015 and expects to receive communication letters from the Agency in the next 30 days on i) the priority review determination (the Agency will grant either regular (10 month) or priority (6 month) review); ii) any filing issues identified; and iii) whether the Agency will establish an advisory committee as part of their review process. While all of these items remain review issues, Telesta is planning its internal regulatory, production and commercial activities in anticipation of priority review.
Partnering interest in MCNA remains robust both because of the late stage nature of the asset and the significant unmet medical need. Each of these partnership opportunities will be evaluated carefully in terms of the strength of the potential partner and the value brought to Telesta's shareholders.
MCNA is a biologic therapy developed to provide high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from front line therapy with a therapeutic alternative to surgery. MCNA is derived from the cell wall fractionation of a non-pathogenic bacteria. Its activity is believed to be through a dual mechanism of immune stimulation and direct anti-cancer effects. MCNA was developed to be delivered as a sterile suspension for intravesical administration by urologists and urology nurses, following the same dosing paradigm as first-line bacillus Calmette-Guérin (BCG) therapy, with the advantage that it can be prepared, handled and disposed of easily and safely. The efficacy, duration of responses and safety data from MCNA's pivotal Phase 3 trial was recently published in The Journal of Urology. Telesta continues to prosecute novel composition of matter, methods of use and manufacturing patents in most regions of the world and recently announced the granting of the key composition of matter patent in the United States providing intellectual property coverage of MCNA to 2031.
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.
SOURCE Telesta Therapeutics Inc.
For further information: Donald Olds, Chief Operating Officer, Telesta Therapeutics Inc., Telephone: (514) 394-7921, [email protected]