Clinical efficacy in humans confirmed for PBI-4050
ProMetic’s plasminogen phase 2/3 clinical trial initiated
ProMetic’s IVIG phase 3 clinical trial initiated
Significant expansion of plasma derived therapeutics’ manufacturing capacity
2015 fourth quarter revenues of $14.1 million and $24.5 million for FY2015
2015 fourth quarter product sales of $12.2 million and $21.4 million for FY2015
LAVAL, QUEBEC, CANADA – March 30, 2016 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“ProMetic” or the “Corporation”) today reported revenues of $14.1 million and total revenues of $24.5 million for the fourth quarter and year ended December 31, 2015 respectively. This compares to revenues of $10.5 million and $23.0 million for the fourth quarter and year ended December 31, 2014 respectively.
“2015 has been a year of industrious operational and product development execution. I am very happy to report that ProMetic delivered, as anticipated, on the majority of its ambitious corporate, operational and clinical objectives set for the year”, noted Mr. Pierre Laurin, ProMetic’s President and CEO. “ProMetic has reached a stage where all the necessary components combine to create a fully integrated biopharmaceutical company possessing a rich pipeline of innovative plasma-derived and small molecule therapeutics focused on a multitude of unmet medical needs”, added Mr. Laurin.
Commenting on the fourth quarter and 2015 financial results, Greg Weaver, Chief Financial Officer of ProMetic said: “We are pleased with the strong growth achieved in product sales in 2015, and anticipate this trend to continue in 2016. Following the strengthening of our balance sheet achieved by the equity and debt financings in 2015 and early 2016, we are well positioned to execute on our aggressive plan to advance our therapeutic product pipeline development and continue creating significant value for our shareholders”.
The Corporation closed a bought deal public offering of common shares of the Corporation through a syndicate of underwriters led by Canaccord Genuity Corp., and which included RBC Dominion Securities Inc., Beacon Securities Limited, TD Securities Inc. and Paradigm Capital Inc. ProMetic issued 22,137,500 common shares of the Corporation in connection with the Offering and the exercise of the over-allotment option at a price of $2.60 per share for aggregate gross proceeds of $57.6 million;
The Corporation and Structured Alpha LP (an affiliate of Peter J. Thomson’s investment firm, Thomvest Asset Management Inc.) entered into amended and restated loan agreements in respect of the loan agreements dated September 10, 2013 and July 31, 2014. The Amended and Restated Loan Agreements provided for several amendments in favour of the Corporation, which amongst others included the extension of the maturity date of the Loan Agreements to July 31, 2022, a right of repayment of the Loan Agreements commencing on September 13, 2018 and more flexibility in its affirmative and negative covenants;
ProMetic was added to the S&P/TSX Composite Index and appointed Mr. Gregory Weaver as Chief Financial Officer of the Corporation; and
The Corporation completed an internal corporate reorganization of its subsidiaries owning and exploiting the Small Molecule Therapeutics segment, which involved the centralization of key development and commercialization activities as well as the Small Molecule Intellectual Property (“SMIP”) in a newly created UK subsidiary of the Corporation, ProMetic Pharma SMT Limited (“PSMT”). The Corporation expects this reorganization to enable the Small Molecule Therapeutics business segment to execute its global drug development and commercialization strategy more effectively. The new structure intends to take advantage of the Corporation’s existing operations in the UK, which include R&D and executive management, while leveraging the business, financial, tax and accounting efficiencies therein.
The Corporation used its plasma-derived plasminogen replacement therapy to successfully treat a plasminogen-deficient infant in critical condition in an intensive care unit at the Altona Children’s Hospital located in Hamburg, Germany. ProMetic completed its Phase 1 clinical trial for the treatment of Congenital Plasminogen Deficiency (“CPD”) and presented the clinical results at the American Society of hematology Annual Meeting in Orlando Florida. In addition to confirming that ProMetic’s plasminogen replacement therapy was safe, well tolerated and without any related serious adverse events, an additional case of dramatic multiple lesions reduction was reported in one of the patients in the second cohort of the Phase I trial, providing further evidence of the clinical benefit of the plasminogen therapy in CPD patients. ProMetic’s plasminogen was granted an orphan drug designation for the treatment of plasminogen deficiency by the European Commission and is now in Phase 2/3 clinical trial;
To further expand the clinical use of plasminogen and consolidate its proprietary position, ProMetic entered into a strategic agreement with Swedish-based Omnio AB. The agreements exclusively provide ProMetic with a unique and competitive intellectual property license as well as a comprehensive proprietary understanding of the use of plasminogen in the field of hard-to-treat wounds;
Another strategic agreement was concluded with ProThera Biologics Inc. (“ProThera”) for the development and commercialization of human plasma-derived Inter-alpha Inhibitor Proteins (“IAIP”). The agreements provide ProMetic with global, exclusive intellectual property rights to commercialize products for two clinical indications and both companies have strategic interest in the other’s IAIP-related therapeutic areas through a royalty-bearing cross-license agreement;
The Corporation entered into a strategic manufacturing agreement with Emergent BioSolutions (“Emergent”) which provided ProMetic with access to significant additional cGMP capacity in an FDA-licensed facility, located in Winnipeg, Canada. In addition, The Corporation acquired Emergent’s plasma collection center also located in Winnipeg, Canada. This plasma collection center is an FDA, EMEA and Health Canada licensed plasma collection facility; and
The Corporation received clearance by the US FDA for its Investigational New Drug (“IND”) application for its Intravenous Immunoglobulin (IVIG) biological drug product for the treatment of primary immunodeficiency diseases (“PIDD”) and has initiated its Phase 3 clinical trial.
Small Molecule Therapeutics:
The Corporation closed patient enrollment in its phase 2 open label study in patients suffering from type 2 diabetes and metabolic syndrome and transitioned to a pivotal placebo-controlled phase 2 study in patients suffering from type 2 diabetes as a result of the statistically and clinically significant decrease in HbA1C observed in the first 11 patients enrolled that had completed 12 weeks in the study. Ten of the 11 patients experienced improved blood glucose control as measured by HbA1C (average decrease of -0.6 p=0.03). In patients with HbA1c values greater than 8% at screening, this decrease in HbA1c exceeded 1%, a performance that compares very favorably to drugs already approved for the treatment of diabetes. These results clearly indicate that the drug’s unique mode of action and related efficacy observed in diabetic animal models translates to humans. There were no drug-related serious adverse events and PBI-4050 was very well tolerated by patients;
Moreover, on March 22, 2016, 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 2, metabolic syndrome and Type 2 diabetes clinical trial provides 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);
Following the CTA clearance from Health Canada to commence the clinical trials in patients suffering from idiopathic pulmonary fibrosis (“IPF”), the Corporation started to enroll patients in a trial design to confirm safety, tolerability and the pharmacokinetic profile of PBI-4050 in this patient population. This Phase 2 open label trial in patients with IPF is underway in six centers across Canada. A pre-IND meeting with the FDA has provided the opportunity for the Corporation to pursue a pivotal study in IPF in the USA and Canada with a clinical trial design adding PBI-4050 to the current standard of care. The Corporation expects to file the IND in the second quarter of 2016 and for such clinical program to commence during the second half of 2016;
The US FDA and the European Commission each granted an orphan drug designation to PBI-4050 drug for the treatment of Idiopathic Pulmonary Fibrosis for the USA and for Europe, respectively;
The Corporation also announced its plans to initiate a double-blind placebo controlled phase II clinical trial in patients suffering from cystic fibrosis (CF) and related diabetes and liver steatosis. CF is a condition which affects approximately 70,000 individuals in North America and compromises their pulmonary, pancreatic and hepatic functions. The CTA for the CF trial should be filed during the second quarter of 2016 with the clinical trial to commence during the second half of 2016.
The Corporation received clearance for its clinical trial application (“CTA”) for its anti-fibrotic lead drug candidate PBI-4050 in patients suffering from a condition associated with severe multi-organ fibrosis and type 2 diabetes (“Alstrӧm Syndrome”) by the Medicines and Healthcare Products Regulatory Agency (“MHRA”) in the United Kingdom.
Bioseparation Technologies highlights:
In 2015, the Corporation recorded its highest ever total yearly revenue from the sale of bioseparation products at $21.4 million, a growth of 98% compared to the sale of bioseparation products in 2014; and
The Corporation renewed its supply agreement with GlaxoSmithKline LLC. The renewed agreement followed the original supply agreement entered into between the parties in 2009.
Subsequent highlights to fourth quarter and 2015 year-end:
On February 29, 2015, the Corporation announced that it had secured a follow-on investment from Structured Alpha LP, an affiliate of Peter J. Thomson’s investment firm, Thomvest Asset Management Inc., consisting of a $30 million original issue discount note (“Note”). As partial consideration for the Note, ProMetic granted Structured Alpha LP 11,793,380 warrants with an exercise price of $4.70 per common share, a premium of 80% to the previous day’s closing share price;
On March 15, 2016, the Corporation announced it was adding scleroderma to PBI-4050’s target indications following evidence that in mice genetically programmed to develop scleroderma, PBI-4050 prevented the over production of collagen and the formation of fibrotic scarring. There is no cure for scleroderma, a chronic disorder characterized by an overproduction of collagen and abnormal growth of connective tissue, which causes scarring (fibrosis) of the skin, and in the case of systemic scleroderma and also affects internal organs such as the lungs, the kidneys and gastrointestinal system. Even though the cause of scleroderma is not fully understood, PBI-4050 addresses the underlying pathological process leading to the scarring of tissues and organs. The Corporation announced its intent to initiate a double-blind, placebo-controlled phase 2 clinical trial to investigate whether PBI-4050 can prevent or even reverse fibrosis in the skin and key target organs such as the lungs
The Corporation disclosed on March 22, 2016, new clinical data (as described above under Small Molecule Therapeutics) providing further evidence of PBI-4050’s efficacy in humans.
2015 Fourth Quarter And Year-End Financial Results
Total revenues for the fourth quarter ended December 31, 2015 were $14.1 million compared to $10.5 million for the fourth quarter ended December 31, 2014. Total revenues for the year ended December 31, 2015 were $24.5 million compared to $23.0 million for the year ended December 31, 2014.
Revenues from the sale of goods amounted to $12.2 million for the fourth quarter ended December 31, 2015 compared to $3.5 million for the same period in 2014. Total revenues from the sale of goods amounted to $21.4 million for the year ended December 31, 2015 compared to $10.8 million for the year ended December 31, 2014. The increase is mainly attributable to an increase in the number of clients and by the quantity of our proprietary bioseparation products required by our existing clients that have reached commercial stages.
The Corporation incurred a net loss of ($56.8) million for the year ended December 31, 2015 compared to a net profit was $2.6 million during the year ended December 31, 2014 while the net loss for the quarter ended December 31, 2015 was ($12.3) million compared to a net profit of $8.5 million for the quarter ended December 31, 2014. The main reasons for this variation include the gain on revaluation of equity investment and the purchase gain on business combination totaling $49.2 million recognized in relation to the NantPro acquisition which occurred in 2014, the overall increase in R&D and administrative expenses in 2015 compared to 2014, and the loss on extinguishment of liabilities of $9.6 million recorded during the year ended December 31, 2015. The Corporation incurred total R&D costs of $17.9 million in the fourth quarter of 2015 compared to $13.0 million in total R&D costs in the fourth quarter of 2014.
The Corporation incurred total R&D costs of $50.3 million in the year ended December 31 2015 compared to $36.0 million in total R&D costs for the year ended December 31, 2014. The increase is mainly due to the overall increase in development activities pursued by the Corporation, including several clinical trials and related costs for PBI-4050, plasminogen and IVIG.
Administrative, selling and marketing expenses amounted to $5.3 million during the fourth quarter of 2015 and $16.6 million during the year ended December 31, 2015 compared to $3.8 million and $12.1 million respectively for the corresponding 2014 periods. The increase is primarily attributable to the organizational growth to support the research and development and pre-commercialization activities of the Corporation.
Conference Call Information
ProMetic will host a conference call at 11:00am (EST) on Thursday March 31, 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 March 31, 2016 at 2:00 p.m. until April 7, 2016. The numbers to access the replay are 1-416-849-0833 (passcode: 71371347) and 1-855-859-2056 (passcode: 71371347). A live audio webcast of the conference call will be available through the following:
Additional Information in Respect to the Fourth Quarter and Year ended December 31, 2015
ProMetic’s MD&A and 2015 consolidated financial statements for the quarter and year ended December 31, 2015 will be filed on SEDAR (http://www.sedar.com) and available on the Corporation’s website at www.prometic.com.
Advance Notice By-Laws:
The Corporation’s board of directors has adopted, on March 23, 2016, By-Law No. 3 relating to advance notice requirements for director elections (the “Advance Notice By-Law”) to provide shareholders, directors and management of the Corporation with a clear framework for nominating directors of the Corporation in connection with any annual or special meeting of the shareholders called for any purpose at which the election of directors is a matter specified in the notice of meeting.
The Advance Notice By-law is effective since its adoption and will be placed before the shareholders of the Corporation for approval, confirmation and ratification at the next annual and special meeting of shareholders of the Corporation scheduled to be held on May 11, 2016 (the “Meeting”). Pursuant to the provisions of the Canada Business Corporations Act, the Advance Notice By-Law will cease to be effective unless it is approved, ratified and confirmed by a resolution adopted by a majority of the votes cast by the shareholders of the Corporation at the Meeting. The full text of the Advance Notice By-law is described in the Corporation’s Management Information Circular dated March 23, 2016, which is available under the Corporation’s profile at www.sedar.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, Australia and Asia.
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.