- PBI-4050 clinical efficacy further evidenced in metabolic syndrome and type 2 diabetes patients
- Plasminogen FDA fast track designation secured, clinical efficacy further evidenced in plasminogen deficient patients
- Strengthened balance sheet with closing of $60.1 million bought deal equity financing
- H1 2016 revenues of $8.5 million vs. $4.8 million for H1 2015
LAVAL, QUEBEC, CANADA – August 11, 2016 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“ProMetic” or the “Corporation”) today reported revenues of $3.3 million for the second quarter ended June 30, 2016 compared to $2.9 million for the second quarter ended June 30, 2015 and total revenues of $8.5 million for the first half of 2016 compared to $4.8 million for the first half of 2015.
“I am pleased to see our drug candidates continue to perform as expected in our ongoing clinical trials. The efficacy, safety and tolerability data generated until now demonstrate their clinical and commercial potential”, indicated Mr. Pierre Laurin, President and CEO of ProMetic Life Sciences Inc. “We look forward to a productive second half of 2016 on all fronts with the expected delivery of numerous corporate and clinical milestones”, added Mr. Laurin.
“A strong balance sheet is of key importance in our strategy to be well positioned to deliver on the growing number of clinical opportunities related to our deep therapeutic pipeline. We now have the resources to advance as needed the most promising drug candidates and clinical indications”, stated Mr. Greg Weaver, Chief Financial Officer of ProMetic.
Second Quarter 2016 Highlights
- The Corporation completed a financing transaction with a syndicate of underwriters whereby the underwriters purchased, on a bought deal basis, 19,400,000 common shares at a price of $3.10 per share for gross proceeds of $60,140,000
- The Corporation also entered into a private placement agreement with Structured Alpha for 1,921,776 common shares at $3.10
Plasma Derived Therapeutics:
- The Corporation announced the successful treatment of another plasminogen deficient patient, in the USA, under a compassionate use IND. A progressive and systematic healing of all the wounds on the patient’s hand over a period of 2 weeks from his first plasminogen infusion was observed. Within 3 hours after that first infusion, minor bleeding from the wounds stopped spontaneously and was followed by the formation of scabs on the wounds which started to fall off after 12 days, just as in the normal healing process.
- The Corporation announced that the treatment of the plasminogen deficient patient treated under a compassionate use IND in the USA showed an additional significant positive response to the treatment; in this case, in his kidney and urinary tract.
- The Corporation received from the U.S. Food and Drug Administration (FDA) a Fast Track designation for its plasminogen drug candidate, currently in a phase 2/3 clinical trial in patients suffering from congenital Plasminogen deficiency.
Small Molecule Therapeutics:
- The Corporation presented new data at the 2016 European Association for the Study of the Liver (EASL)’s 51st Annual Meeting in Spain confirming that PBI-4050’s anti-fibrotic effect demonstrated in the livers of different animal models has been successfully reproduced in human hepatic stellate cells (“HHSC”) during in vitro preclinical experiments designed to simulate fibrogenesis in the liver. PBI-4050 was found to down-regulate key pro-fibrotic biomarkers considered to be driving the fibrotic process in NASH;
- The Corporation announced new data including an additional nine patients enrolled in its PBI-4050 phase 2 open label study in patients suffering from type 2 diabetes and metabolic syndrome confirming the efficacy initially reported in the first 11 patients that had completed the treatment period in December, 2015. In these additional nine patients, administration of PBI-4050 resulted in similar pharmacological activity on the diabetic and metabolic parameters, including the decrease in HbA1c as was shown in the original 11 patients;
- The Corporation reported that it had been approved to commence the clinical trial of its orally active anti-fibrotic lead drug candidate, PBI-4050, in patients suffering from cystic fibrosis following the CTA clearance by Health Canada. The objectives of this 24 week randomized, double-blind, and placebo-controlled Phase 2 study include the evaluation of the effects of PBI-4050 on pancreatic and lung function in 90 CF patients.
- The Corporation presented data at the American Diabetic Association’s annual meeting on PBI-4050’s effect on keeping insulin-producing pancreatic beta cells alive explaining how PBI-4050’s unique mechanism of action enables the pancreatic cells to self-regenerate, a natural mechanism that is otherwise downregulated in diabetic patients.
Subsequent highlights to second quarter 2016:
- The Corporation completed the enrolment of the adult patient population (50 adult patients) in its pivotal IVIG phase III clinical trial for the treatment of primary immunodeficiency diseases (“PIDD”).
- The Corporation completed 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”).
More on Second Quarter 2016 Financial Results
The financial information for the second quarter ended June 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 June 30, 2016.
Total revenues for the quarter ended June 30, 2016 were $3.3 million compared to $2.9 million for the quarter ended June 30, 2015. Year-to-date revenues totaled $8.5 million for the first 6 months of 2016 compared to $4.8 million for the first 6 months of 2015. Total year-to-date sale of goods totaled $7.2 million compared to $4.1 million for the first six months of 2015.
Research and development expenses were $19.4 million for the quarter ended June 30, 2016 compared to $10.7 million for the quarter ended June 30, 2015 and $35.8 million year-to date in 2016 compared to $20.4 million for the first six months of 2015. The increase is due to 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.
Administration, selling and marketing expenses totaled $5.2 million for the quarter ended June 30, 2016 compared to $3.8 million for the quarter ended June 30, 2015 and $10.0 million year-to date in 2016 compared to $7.1 million for the first six 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 $24.6 million during the quarter ended June 30, 2016 compared to a net loss of $13.5 million for the corresponding period of 2015 and $42.6 million year-to date in 2016 compared to $34.0 million for the first six months of 2015. The net loss for the second quarter and first six months of 2016 are higher due to the significant increase in research and development activities in the protein technologies and the small molecules therapeutics segments associated with the numerous ongoing and upcoming clinical trials, and the continuing development of additional therapeutic candidates.
Finally, ProMetic closed the quarter ended June 30, 2016 with a cash position of $64.3 million.
Change to Board of Directors
ProMetic is pleased to announce that Mr. Ken Galbraith has joined its Board of Directors effective August 10, 2016.
Ken Galbraith joined Ventures West as a General Partner in 2007 and led the firm’s biotech practice prior to founding Five Corners Capital in 2013 to continue management of the Ventures West investment portfolio. Ken is a well-known and active member of the North American life sciences community with over 25 years of experience acting as an executive, director, investor and advisor to companies in the biotechnology, medical device, pharmaceutical and healthcare sectors.
Previously, Mr. Galbraith served as the Chairman and Interim CEO of AnorMED, a biopharmaceutical company focused on new therapeutic products in hematology, HIV and oncology, until its sale to Genzyme Corp. in a cash transaction worth almost US$600 million. Starting in the biotech sector in 1987, Mr. Galbraith spent 13 years in senior management with QLT Inc., a global biopharmaceutical company specializing in developing treatments for eye diseases and oncology, retiring in 2000 from his position as Executive VP and CFO when QLT’s market capitalization exceeded US$5 billion. He has served on the Board of Directors of several public and private biotechnology companies, including Angiotech Pharmaceuticals (ANPI), Tekmira (TKMR) and Cardiome Pharma (CRME). He currently serves on the Board of Directors of Macrogenics (MGNX), Zymeworks, Augurex and AudienceView Ticketing Software.
Ken earned a Bachelor of Commerce (Honors) degree from the University of British Columbia in 1985 and appointed a Fellow of the Chartered Accountants of BC in 2013.
Conference Call Information
ProMetic will host a conference call at 11:00am (EST) on Friday August 12, 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 August 12, 2016 at 2:00 p.m. until August 19, 2016. The numbers to access the replay are 1-416-849-0833 (passcode: 56333260) and 1-855-859-2056 (passcode: 56333260). A live audio webcast of the conference call will be available by clicking here.
Additional Information in Respect to the Second Quarter ended June 30, 2016
ProMetic’s MD&A and condensed interim consolidated financial statements for the quarter ended June 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 Statements
This 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.