An anonymous director reports

TELESTA THERAPEUTICS CORPORATE UPDATE - TYPE A MEETING WITH THE FDA SCHEDULED

A Type A meeting between Telesta Therapeutics Inc. and the U.S. Food and Drug Administration has been scheduled for Friday, April 15, 2016. This Type A meeting will be focused on the FDA's responses to Telesta's questions concerning the regulatory pathway forward for approval of MCNA (mycobacterium phlei cell wall-nucleic acid complex) in the United States.

As previously announced, it is possible that the answers received to the company's first set of questions on the approval pathway and further clinical development of MCNA will require the preparation for and scheduling of a second meeting with the agency in order to be confident that the regulatory pathway in the U.S. is actionable for the company or for a future partner for MCNA. In addition, the company continues to collaborate with its key development partners to aggressively define and develop the regulatory approval pathway in their respective jurisdictions.

Telesta will provide a corporate update following an analysis of the Type A meeting's outcome and distribute this update via a press release on Monday, April 18, 2016.

About MCNA

MCNA is a biologic therapy developed to provide high-risk, non-muscle invasive bladder cancer patients who are refractory to or relapsing from first-line therapy with bacillus Calmette-Guerin (BCG), 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 BCG therapy, with the advantage that it can be prepared, handled and disposed of easily and safely.

About non-muscle invasive bladder cancer (NMIBC)

Treatment options for high-risk NMIBC patients who fail first-line BCG treatment are extremely limited, and treatment guidelines in most countries around the world call for radical cystectomy, which entails a surgical removal of the bladder and adjacent organs and glands. Bladder removal is a complex surgery associated with at least 28 per cent to 45 per cent surgical complications and up to 8 per cent mortality, in addition to negatively impacting multiple aspects of quality of life. Patients who refuse or are not medically fit to undergo bladder removal face an increased risk of progression to muscle-invasive disease, likely leading to metastases and death.

We seek Safe Harbor.