- PBI-4050’s positive effects on novel biomarkers confirmed in metabolic syndrome and type 2 diabetes patients
- Strengthened balance sheet with $30 million follow-on debt financing from Structured Alpha LP, and $60 million bought deal equity financing
- 2016 first quarter revenues of $5.2 million vs. $1.9 million for the 2015 first quarter
LAVAL, QUEBEC, CANADA – May 12, 2016 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“ProMetic” or the “Corporation”) today reported revenues of $5.2 million for the first quarter ended March 31, 2016 compared to $1.9 million for the first quarter ended March 31, 2015.
“We are pleased to see our total revenues and product sales off to a good start for the year”, said Mr. Greg Weaver, Chief Financial Officer of ProMetic. “The combination of the Structured Alpha follow-on financing and $60 million bought deal recently announced puts the Corporation in a great position to continue building a strong pipeline of therapeutics”, added Mr. Weaver.
“The clinical data generated so far in both our small molecule and plasma derived therapeutic programs has validated our selection of lead compounds and clinical indications to be first pursued”, stated Mr. Pierre Laurin, President and CEO of ProMetic Life Sciences Inc. “It also provides us with very valuable clinical information and confidence in our ability to continue delivering positive clinical efficacy data going forward in additional related clinical programs”, added Mr. Laurin.
First Quarter 2016 Highlights
The Corporation entered into an agreement with Structured Alpha whereby the Corporation received $30 million in cash in consideration for the issuance of 11,793,380 warrants with an exercise price of $4.70 per warrant and expiring July 31, 2022, and increasing the face value of one of the OID loans maturing on July 31, 2022, from $11.3 million to $61.7 million.
Small Molecule Therapeutics:
The Corporation announced it was adding scleroderma to PBI-4050’s target indications following evidence that even in mice genetically programmed to develop scleroderma, PBI 4050 prevented the over production of collagen and the formation of fibrotic scarring.
The Corporation reported that the preliminary analysis of new pro-inflammatory biomarkers in blood and urine samples from the patients in the on-going, open label, Phase II, metabolic syndrome and Type 2 diabetes clinical trial provided additional evidence of PBI-4050’s pharmacological and clinical activity in humans. Such analysis of novel biomarkers in all 11 patients that completed 12 weeks of treatment with PBI-4050 has revealed that elevated levels of specific biomarkers known to be associated with a higher risk of cardiovascular events were significantly reduced by PBI-4050. Blood levels of resistin and pentraxin-3, two biomarkers known to be associated with higher risk of cardiovascular complications in patients with metabolic syndrome, were significantly reduced by PBI-4050 (p = 0.01). Furthermore, IL 18, a biomarker known to be associated with renal as well as cardiovascular complications in patients with the metabolic syndrome, also showed a statistically significant reduction (p = 0.05).
Other significant developments after the quarter
The Corporation entered into an agreement with a syndicate of underwriters whereby the underwriters have agreed to buy, 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 Offering”). ProMetic has also granted to the underwriters an option to purchase an additional 2,910,000 common shares at the same offering price for a period of 30 days following the closing of the offering (“the over-allotment option”). If the over-allotment option is exercised in full, this will represent additional gross proceeds of $9,021,000, for total gross proceeds of $69,161,000. The underwriters will received a 5% cash commission on the proceeds of the bought deal.
In connection with the Offering, ProMetic filed a preliminary short form prospectus in all Canadian provinces on May 10, 2016. Closing of the Offering is subject to certain conditions including, but not limited to, receipt of all necessary regulatory and stock exchange approvals, including the receipt of listing approval by the Toronto Stock Exchange (“TSX”) for the Common Shares. The Offering is expected to close on or about May 25, 2016.
The Corporation has also entered into a private placement agreement with Structured Alpha for 1,921,776 common shares at the same price and up to a further 288,266 common shares if the underwriters’ over-allotment option is exercised.
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 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 presented new data at the 2016 European Association for the Study of the Liver (EASL)’s 51st Annual Meeting 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.
More on First Quarter 2016 Financial Results
The financial information for the first quarter ended March 31, 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 March 31, 2016.
Total revenues for the quarter ended March 31, 2016 were $5.2 million compared to $1.9 million for the quarter ended March 31, 2015. The revenues from the sale of goods amounted to $4.7 million for the first quarter of 2016 compared to $1.4 million for the first quarter of 2015.
Research and development expenses were $16.5 million for the quarter ended March 31, 2016 compared to $9.8 million for the quarter ended March 31, 2015. The increase is mainly due to the overall increase in research and development activities both in the protein technologies and the small molecules therapeutics segments reflecting the increase in the number of trials in progress, the continuing development of additional therapeutics and the continued efforts towards the filing of future IND.
Administration, selling and marketing expenses totaled $4.8 million for the quarter ended March 31, 2016 compared to $3.3 million for the quarter ended March 31, 2015. The increase is mainly attributable to the increase in compensation expense resulting from an increase in headcount over the one year period and the related increase in operating costs.
The Corporation incurred a net loss of $18.0 million during the quarter ended March 31, 2016 compared to a net loss of $20.4 million for the corresponding period of 2015. The net loss in 2015 was higher since it was affected by a loss on the fair value of the warrant liability of $3.4 million and a loss on extinguishment of liabilities of $6.1 million which were not repeated in 2016. However during the first quarter of 2016, the operating expenses were significantly higher than those in the first quarter of 2015, namely in R&D. Finally, ProMetic closed the quarter ended March 31, 2016 with a cash position of $34.5 million.
Additional Information in Respect to the First Quarter ended March 31, 2016
ProMetic’s MD&A and condensed interim consolidated financial statements for the quarter ended March 31, 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.