- Acquisition of Telesta Therapeutics adds $37.4 million in cash and short-term investments to $39.0 million balance reported at end of Q3
- Investment in commercial & manufacturing infrastructure ahead of plasminogen commercial launch included in R&D expense
- Plasminogen pivotal clinical trial results performed at 100% response rate meeting primary and secondary end points in plasminogen deficient patients
- Primary and secondary endpoints met in clinical trials in metabolic syndrome patients
- 2016 YTD revenues of $12.3 million vs. $10.5 million for same 2015 period
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"We are entering a very exciting phase of our corporate development as we prepare for the commercial launch of plasminogen, our first of several plasma-derived therapeutics to be produced with our proprietary manufacturing platform" said Mr. Pierre Laurin, President and CEO of ProMetic Life Sciences Inc. "You can't do better than 100% success rate in a clinical trial" added Mr. Laurin referring to plasminogen meeting its primary and secondary end points with a 100% healing rate in patients with lesions. "PBI-4050 also delivered a similar performance to date with an excellent safety and tolerability profile and clear demonstration of efficacy in patients" concluded Mr Laurin.
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"The $58.5 million in cash and short-term investments contributed from the Telesta acquisition and the expected exercise of warrants in the next few months provide the Corporation with a comfortable runway to execute on several strategic initiatives" stated Mr. Greg Weaver, Chief Financial Officer of ProMetic. "Our investments in plasma processing manufacturing activities and pre-commercial inventory build reflect our focus on executing on our plans for the commercial launch of plasminogen in 2017" added Mr. Weaver.
Third Quarter 2016 Highlights
Corporate:
- The Corporation entered into a binding agreement for the acquisition of Telesta by way of a plan of arrangement under the Canada Business Corporations Act (the "Acquisition");
- The Corporation completed the enrolment of the adult patient population (50 adult patients) in its pivotal IVIG phase 3 clinical trial for the treatment of primary immunodeficiency diseases;
- The Corporation completed the enrolment of the congenital plasminogen deficient patients in its pivotal phase 2/3 clinical trial required for the accelerated regulatory approval pathway with the Food and Drug Administration ("FDA");
- The Corporation announced the pursuit of tympanic membrane perforations, as one of its new plasma-derived plasminogen targeted clinical indications.
- The Corporation announced the closing of the Telesta acquisition by way of a plan of arrangement under the Canada Business Corporations Act for a consideration of $0.14 per Telesta common share payable in ProMetic common shares. Concurrently with the Acquisition, the Corporation also closed a private placement entered into with Structured Alpha LP ("SALP"), an investment vehicle of Peter J. Thomson. This concurrent private placement was completed in connection with the exercise by SALP of its pre-emptive right. The private placement is for the subscription of 1,401,632 common shares of the Corporation at a price of $2.98 per common share. The proceeds from this private placement have been used to offset and reduce the total amount owed by ProMetic to SALP under its second amended and restated loan agreement by $4.2 million.
- The Corporation announced that the Drug Safety Monitoring Board ("DSMB") recommended that patient enrolment should continue in the Corporation's ongoing Alström syndrome phase 2 clinical trial. The early efficacy results in the phase 2, open-label study demonstrated that the first five patients (100%) who completed 12 weeks of treatment with PBI-4050 had a significant reduction of liver fibrosis, as measured by transient elastography (FibroScan®)
- The Corporation announced the completion of its phase 2 clinical trial in patients with metabolic syndrome and type 2 diabetes and achievement of its primary and secondary endpoints.
- The Corporation announced that its pivotal phase 2/3 clinical trial in patients with plasminogen deficiency had a 100% success rate of its primary end points, namely, a targeted increase in the blood plasma concentration level of plasminogen as a surrogate target and secondary endpoints with the intravenous plasminogen treatment. The phase 2/3 clinical trial also had a 100% response of its secondary end points, namely the complete healing of active visible lesions within weeks of treatment.
- The Corporation held a successful pre-BLA meeting with the FDA, where it was agreed that ProMetic would continue along the Accelerated Approval Regulatory Pathway and file the pharmacokinetic safety data on 10 plasminogen deficient patients along with efficacy data available for each of these patients that have completed 12 weeks of treatment.
The financial information for the third quarter ended September 30, 2016 should be read in conjunction with the Corporation's condensed interim consolidated financial statements as well as the Management's Discussion and Analysis for the quarter ended September 30, 2016.
Total revenues for the quarter ended September 30, 2016 were $3.7 million compared to $5.7 million for the quarter ended September 30, 2015, and $12.3 million for the first nine months of 2016 compared to $10.5 million for the first nine months of 2015. Revenues from the sale of goods amounted to $2.4 million for the third quarter of 2016 compared to $5.1 million for the third quarter of 2015 and $9.6 million for the first nine 9 months of 2016 compared to $9.2 million for the first nine months of 2015. Services revenues for the quarter ended September 30, 2016 were $1.4 million compared to $0.6 million for the quarter ended September 30, 2015, and $2.7 million for the first nine 9 months of 2016 compared to $1.3 million for the first nine months of 2015.
Research and development expenses were $23.6 million for the quarter ended September 30, 2016 compared to $11.9 million for the quarter ended September 30, 2015 and $59.4 million for the first nine months of 2016 compared to $32.3 million for the first nine months of 2015. The increase is mainly due to the setting up of the manufacturing and commercial infrastructure related to four plasma-derived therapeutics in development and the preparation of Plasminogen in anticipation of its commercial launch in 2017 followed by the filing of the IVIG BLA in late 2017. It also reflects the growth in the number of clinical trials in progress, the continuing pre-clinical development of additional therapeutics and the continued efforts toward the filing of future IND's. The third quarter 2016 R&D expenses included investment of $9.2 million in our two plasma manufacturing sites in Laval and Winnipeg to support our growing plasma protein manufacturing operations, specifically in both people and resources including the cost of plasma, resins, filters used as well as the related overhead costs as we produce the quantities of plasminogen product for clinical needs. These costs are expensed to R&D in the current period.
Administration, selling and marketing expenses totaled $6.5 million for the quarter ended September 30, 2016 compared to $4.1 million for the quarter ended September 30, 2015 and $16.5 million for the first nine month of 2016 compared to $11.2 million for the first nine months of 2015. The increase in administrative costs is indicative of a higher head count and preparatory work for the forthcoming launch of Plasminogen.
The Corporation incurred a net loss of $28.0 million during the quarter ended September 30, 2016 compared to a net loss of $10.6 million for the corresponding period of 2015 and $70.6 million for the first nine months of 2016 compared to $44.5 million for the first nine months of 2015. The net loss for the third quarter and first nine months of 2016 are higher primarily due to the increase in research and development activities in the protein technologies segment, and to a lesser extent in the small molecules therapeutics segment, associated with the numerous ongoing clinical trials, and the continuing development of additional therapeutic candidates.
Finally, ProMetic closed the quarter ended September 30, 2016 with a cash position of $39.0 million. This excludes the $37.4 million in cash and short term investments added as of the closing of the Telesta acquisition on October 31, 2016.
Conference Call Information
ProMetic will host a conference call at 8:30am (EST) on Tuesday November 15, 2016. The telephone numbers to access the conference call are (647) 427-7450 and 1-888-231-8191 (Toll-free). A replay of the call will be available from November 15, 2016 at 11.30 am. until November 22, 2016. The numbers to access the replay are 1-416-849-0833 (passcode: 16582906) and 1-855-859-2056 (passcode: 16582906). A live audio webcast of the conference call will be available through the following: http://event.on24.com/r.htm?e=1308498&s=1&k=773962E224C83066BCC2731CA436D2B6
Additional Information in Respect to the Third Quarter ended September 30, 2016
ProMetic's MD&A and condensed interim consolidated financial statements for the quarter ended September 30, 2016 have been filed on SEDAR (http://www.sedar.com/) and will be available on the Corporation's website at www.prometic.com.
About ProMetic Life Sciences Inc. ProMetic Life Sciences Inc. (www.prometic.com) is a long established biopharmaceutical company with globally recognized expertise in bioseparations, plasma-derived therapeutics and small-molecule drug development. ProMetic offers its state of the art technologies for large-scale purification of biologics, drug development, proteomics and the elimination of pathogens to a growing base of industry leaders and uses its own affinity technology that provides for highly efficient extraction and purification of therapeutic proteins from human plasma in order to develop best-in-class therapeutics and orphan drugs. ProMetic is also active in developing its own novel small-molecule therapeutic products targeting unmet medical needs in the field of fibrosis, cancer and autoimmune diseases/inflammation. A number of plasma-derived and small molecule products are under development for orphan drug indications. Headquartered in Laval (Canada), ProMetic has R&D facilities in the UK, the U.S. and Canada, manufacturing facilities in the UK and commercial activities in the U.S., Canada, Europe, Russia, Asia and Australia.
Forward Looking StatementsThis press release contains forward-looking statements about ProMetic's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward -looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, ProMetic's ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of ProMetic to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations in ProMetic's Annual Information Form for the year ended December 31, 2015, under the heading "Risk and Uncertainties related to ProMetic's business". As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations. All amounts are in Canadian dollars unless indicated otherwise.
SOURCE ProMetic Life Sciences Inc.
