- Clinical efficacy of PBI-4050 confirmed in multiple phase 2 trials: Idiopathic Pulmonary Fibrosis, metabolic syndrome and Alström syndrome
- Clinical efficacy of plasminogen confirmed in completed pivotal phase 2/3 clinical trial
- Rolling submission of plasminogen BLA initiated
- Significant manufacturing and commercial infrastructure secured to enable plasma derived therapeutics commercial launches accounts for material increase in net loss
- Plasma protein manufacturing investment represents 37% of R&D costs in 2016
- Potential further integration of manufacturing capability and longer term manufacturing capacity expansion provided by Telesta acquisition
- 2016 fourth quarter revenues of $4.1 million and $16.4 million for FY2016
LAVAL, QUEBEC, CANADA – March 30, 2017 – Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“Prometic” or the “Corporation”) today reported its fourth quarter and year ended December 31, 2016 highlights and financial results.
“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.
- The scale 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.
Small Molecule Therapeutics
Metabolic syndrome and type 2 diabetes:
- The Corporation announced its phase 2 clinical trial in patients with metabolic syndrome and type 2 diabetes had met its primary and secondary endpoints. PBI-4050 was demonstrated to be safe and well tolerated without serious drug related adverse events. The pharmacological activity of PBI-4050 was confirmed through the clinically significant reduction in HbA1c. Several biomarkers measured in blood or urine of patients and associated with a high incidence of cardiovascular complications and kidney injury when elevated in metabolic syndrome were also significantly reduced by PBI-4050.
- The Corporation received clearance by Health Canada to commence a placebo-controlled phase 2 clinical trial with its PBI-4050 in patients with metabolic syndrome and type 2 diabetes.
Idiopathic Pulmonary Fibrosis:
- The Corporation announced positive interim results from its phase 2 open-label trial of PBI-4050 in patients with IPF conducted in six centers across Canada. In addition to demonstrating that PBI-4050 is safe and well tolerated in patients suffering from IPF, the objective of this study was to provide early evidence of clinical benefits of PBI-4050 treatment whether used alone or in addition to either nintedanib or pirfenidone. These preliminary results were confirmed later in February, 2017 when the Corporation announced positive results from its completed open label Phase 2 clinical trial in subjects suffering from IPF. The results further confirmed that PBI-4050 is safe and very well tolerated and also confirmed the preliminary results previously announced by Prometic in November, 2016.
- The Corporation disclosed early results from an open-label, single-arm phase 2 study conducted in the UK in patients suffering from Alström syndrome. The objectives of the study are to evaluate the safety and tolerability of PBI-4050, and the effects of PBI-4050 on key organ function, disease progression and inflammatory/fibrotic markers. 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 that it has been cleared by Health Canada to commence a randomized double-blind placebo-controlled clinical trial in patients suffering from Cystic Fibrosis-Related Diabetes (“CFRD”). The objectives of this phase 2 study include the safety and tolerability of PBI-4050 in these patients as well as the evaluation of the effects of PBI-4050 on pancreatic and lung function.
- The Corporation presented new results at the American Heart Association’s annual meeting in New Orleans from preclinical studies performed at the Montreal Heart Institute. Extensive preclinical studies were done to test the potential benefits of PBI-4050 on cardiac and lung fibrosis, respiratory function, and lung structural remodeling following a myocardial infarction (“MI”) induced by coronary artery ligation. The preclinical study demonstrated that PBI-4050 effectively reduced pulmonary hypertension and right ventricular hypertrophy by reducing lung fibrosis and lung remodeling.
2016 Corporate and operational highlights
- The Corporation closed the acquisition of Telesta Therapeutics Inc, by way of a plan of arrangement under the Canada Business Corporations Act.
- The Corporation 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 $30.0 million original issue discount note; and
- The Corporation closed a bought deal public offering of common shares through a syndicate of underwriters led by RBC Capital Markets and Canaccord Genuity Corp. ProMetic issued 19,400,000 common shares of the Corporation in connection with the Offering at a price of $3.10 per share for aggregate gross proceeds of $60.1 million.
- Headcount significantly increased and now exceeds 400 employees with the majority of new employees added in departments of strategic importance to help manage the growing number of clinical trials and expanding product pipeline and clinical indications being pursued.
- The PBP plasma purification facility located in Laval, Quebec, continued to develop and produce, for clinical trial and commercial launch purposes, plasma-derived protein therapeutics
- The Corporation continued to tech-transfer and improve efficiencies at the Emergent Biosolutions plasma purification facility located in Winnipeg, Canada and currently uses this capacity for the development and manufacture of plasma-derived biopharmaceuticals using Prometic’s proprietary plasma purification platform, PPPSTM.
- The plasma collection center located in Winnipeg, Canada commenced to operate under Prometic’s ownership following the grant and receipt of the regulatory licenses by and from the requisite regulatory authorities. PPR is now focused on expanding its plasma donor base, upgrading its plasmapheresis equipment and the automation of certain SOPs.
- The Corporation commenced building its sales and marketing infrastructure strategy ahead of the anticipated commercial launch of its first product, plasminogen.
- The Corporation commenced evaluating the various options concerning Telesta’s manufacturing facilities in Belleville, Ontario and Montreal, Quebec with respect to their possible integration and use in improving efficiencies, and further consolidating plasma-derived therapeutics manufacturing and business activities.
Subsequent highlights to fourth quarter and 2016 year-end:
- On January 5, 2017, the Corporation announced it had amended in December 2016 its licensing agreement originally entered into with Hematech BioTherapeutics Inc. in May 2012 and reacquired the rights initially granted to Hematech in the License Agreement, to a 50% share of the worldwide profits related to plasminogen congenital deficiency sales;
- On January 18, 2017, the Corporation announced that its orally active lead drug candidate, PBI-4050, was granted an orphan drug designation status for the treatment of Alström Syndrome (“AS”) by the European Commission;
- On January 24, 2017, the Corporation announced that its orally active lead drug candidate, PBI-4050, was issued a Promising Innovative Medicine designation by the UK Medicines and Healthcare Products Regulatory Agency for the treatment of Alström Syndrome;
- On February 6, 2017, the Corporation announced that California Capital Equity, LLC, exercised 44,791,488 investment rights at a price of $0.47 per share for total proceeds of $21.1 million to the Corporation; and
- On March 3, 2017, the Corporation announced that an orphan drug designation status was granted, by the FDA, for its orally active, anti-fibrotic, lead drug candidate, PBI-4050, for the treatment of Alstrӧm.
- On March 23, 2017, the Corporation entered into a binding agreement to secure a follow-on investment from Structured Alpha LP, an affiliate of Peter J. Thomson’s investment firm, Thomvest Asset Management Inc., consisting of a $25 million loan.
- On March 30, 2017, the Corporation entered into a binding Memorandum of Terms with Shenzhen Royal Asset Management Co., Ltd. to establish a joint venture for the development, manufacture and commercialization of PBI-4050, PBI-4547 and PBI-4425 in the People’s Republic of China.
2016 Fourth Quarter and Year-End Financial Results
The financial information for the year ended December 31, 2016 should be read in conjunction with the Corporation’s consolidated financial statements as well as the Management’s Discussion and Analysis for the year ended December 31, 2016.
The Corporation incurred a net loss of $110.7 million for the year ended December 31, 2016 compared to a net loss of $56.8 million during the year ended December 31, 2015 while the net loss for the quarter ended December 31, 2016 was $40.1 million compared to a net loss of $12.3 million for the quarter ended December 31, 2015. The increase in net loss is mainly attributable to significantly higher expenses related to the establishment of a significant manufacturing and commercialization infrastructure in anticipation of the plasminogen commercial launch in 2017 and the forthcoming filing of the IVIG BLA
The Corporation incurred total R&D costs of $88.1 million in the year ended December 31 2016 compared to $50.3 million in total R&D costs for the year ended December 31, 2015. Research and Development expenses include the manufacturing of plasma-derived therapeutics used in the clinical trials in Laval and at the Winnipeg CMO and currently represent approximately 37% of the R&D expenses reported during the year ended December 31, 2016. Approximately $11.9 million of this increase is due to the increase in production expenses, excluding employee compensation expenditures, at the Laval and Winnipeg CMO production facilities. The activities at these two locations generate the data required to file the BLAs, provide clinical trial materials and contribute to setting up the commercial infrastructure. The increase in R&D expenses also corresponds to the overall increase in R&D activities with the advancement of several plasma-derived therapeutics, including IVIG and plasminogen progressing in phase 3 clinical trials, and PBI-4050 in multiple phase 2 trials. The overall R&D expense is primarily driven by the plasma protein business, where the company is operating as its own proprietary end-to-end source and supply through commercial product, while the small molecule business is a much smaller contributor to the expense growth.Total revenues for the fourth quarter ended December 31, 2016 were $4.1 million compared to $14.1 million for the fourth quarter ended December 31, 2015. Total revenues for the year ended December 31, 2016 were $16.4 million compared to $24.5 million for the year ended December 31, 2015.
Administrative, selling and marketing expenses amounted to $12.8 million during the fourth quarter of 2016 and $29.3 million during the year ended December 31, 2016 compared to $5.3 million and $16.6 million respectively for the corresponding 2015 periods. The increase is mainly attributable to the increase in salary and benefit expenses of $6.6 million resulting from an increase in headcount of employees over the year and the related increase in operating costs, higher share-based payments expense of $1.9 million, severance expense of $2.1 million in relation to rationalization efforts at Telesta, the recognition of $0.9 million in fees relating to the GE license agreement and a provision for bad debts of $0.8 million.
Revenues from the sale of goods amounted to $3.3 million for the fourth quarter ended December 31, 2016 compared to $12.2 million for the same period in 2015. While the total revenues from the sale of goods amounted to $12.9 million for the year ended December 31, 2016 compared to $21.4 million the previous year with the fulfilment of a very larger order. The Corporation continues to anticipate revenue growth from this business segment based on strong business fundamentals and attributes quarter to quarter revenue variability on the timing and scale of core customer orders.
Conference Call Information
Prometic will host a conference call at 11:00am (EST) on Friday March 31, 2017. 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, 2017 at 2:00 p.m. until April 7, 2017. The numbers to access the replay are 1-416-849-0833 (passcode: 91908544) and 1-855-859-2056 (passcode: 91908544). A live audio webcast of the conference call will be available by clicking here.
Additional Information in Respect to the Fourth Quarter and Year ended December 31, 2016
Prometic’s MD&A and 2016 consolidated financial statements for the quarter and year ended December 31, 2016 will be 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 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. 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. 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, 2016, 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.