Prometic Life Sciences (TSX:PLI, OTCQX:PFSCF) released their financial result for 2016 and its fourth quarter.
“Positive efficacy data demonstrated for both PBI-4050 and plasminogen in their respective clinical trials, brings our partnering discussions to the next level and facilitates monetization of our therapeutic assets”, stated Mr. Pierre Laurin, President and Chief Executive Officer of Prometic. “We are committed to entering into optimal partnership agreements that de-risk execution, increase commercial reach and maximize value for our shareholders”.
Greg Weaver, Chief Financial Officer of Prometic said: “In a matter of the past several weeks the Company has successfully entered into three significant transactions totaling $69 million in 2017 cash inflows, namely: $23 million from the ChinaCo JV, $25 million from the loan with Structured Alpha, and $21 million from an investor warrant exercise, and when added to our 2017 beginning cash balance creating a pro-forma cash runway of $108 million as we enter 2017 and the upcoming commercial launch of Plasminogen”.
2016 Therapeutic Highlights
- The Corporation’s pivotal phase 2/3 clinical trial required for the accelerated regulatory approval pathway with the FDA met its primary and secondary endpoints with the intravenous plasminogen treatment. In addition to being safe, well tolerated and without any drug related serious adverse events, Prometic’s plasminogen treatment achieved a 100% success rate of its primary end point, a targeted increase in the blood plasma concentration level of plasminogen as a surrogate target for sustainable human protein therapeutic blood levels. Moreover, all patients who had active visible lesions when enrolled in the trial had complete healing of their lesions within weeks of treatment, a 100% response rate for this secondary end point. Moreover, it was agreed with the FDA that Prometic would not have to conduct additional clinical studies to demonstrate the clinical efficacy of its plasminogen, and that it would continue to monitor the patients currently enrolled in the study for an additional 36 weeks.
- The Corporation initiated the rolling submission of its Biologics License Application (“BLA”) for plasminogen with the FDA for treatment of patients with plasminogen congenital deficiency. As a result of having received a Fast Track designation, Prometic is allowed to file on a rolling basis, portions of the regulatory application to be submitted and reviewed by the FDA on an ongoing basis.
- The Corporation started a pivotal phase 3 open label, single arm, two-cohort multicenter clinical trial investigating the safety, tolerability, efficacy and pharmacokinetics of Prometic’s plasma purified IVIG in a total of 75 patients suffering from primary immunodeficiency diseases (“PIDD”), including 50 adults (cohort 1) and 25 children (cohort 2). The enrolment of the adult patient population has been completed and the enrolment of children is progressing as planned.
- Thescale up of the manufacturing process for additional plasma derived therapeutics is also on-going to enable the commencement of their respective clinical programs leading to an expected series of sequential product launches following plasminogen and IVIG.