Prometic reports on its 2018 annual and special meeting of shareholders highlights

LAVAL, QC, May 10, 2018 /PRNewswire/ - Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("Prometic" or the "Corporation") today reported the highlights from its 2018 annual and special meeting of shareholders and Board of Directors election results.

Prometic continued in 2017 its transition that has transformed the company into a biopharmaceutical company with two drug discovery platforms focusing on rare and orphan diseases targeting significant and unmet medical needs. Prometic demonstrated good performance against its clinical and operational milestones, strengthened its pipeline of products and prioritized its clinical assets for clinical development.

Investment decisions in the two leading drug candidates – PBI-4050 and Ryplazim™ (plasminogen) were prioritized based on their respective clinical successes and data generated as well as their commercialization potential. Both drug candidates produced very encouraging clinical activity data, maintained good safety and tolerability profiles and demonstrated potential to target multiple indications each representing large unmet medical needs where Prometic can assume a leadership role and generate significant value for its shareholders.

Prometic's priority in 2018 is to close the gap between fundamental value created over the last years and the current share price which does not reflect all the corporate, clinical and operational milestones delivered. The road map to accomplishing that is based on the following corporate action plan:

• A financial framework that will enable success by prioritizing projects, spending proportionately and controlling cashflow;
• A robust action plan for the plasminogen BLA review process where a multi-disciplinary, integrated team will review the entire BLA resubmission with the help of an external group of consultants specialized in regulatory affairs support services;
• A human resources strategy that will focus on having the right people, with the right skills and capability to deliver while focusing on managing growth;
• A business development strategy centered around partnership initiatives focused on maximizing value by providing financial resources, participation in upside value creation, providing additional resources to de-risk development programs while increasing Prometic's international reach; and
• The continuing advancement of three late stage clinical assets with the ability for each to fill in significant unmet medical needs.

During the presentation, management focused on the following milestones:

For its lead small molecule PBI-4050 drug candidate, ProMetic plans to:

• Initiate the pivotal placebo controlled phase 3 clinical program in IPF patients in Canada, the U.S. and EU;
• Meet with the U.S. and UK regulatory authorities to determine optimal clinical and regulatory pathways going forward for the pursuit of a pivotal Alström syndrome clinical trial as a stand-alone indication; and
• Enter into a strategic partnership and licensing agreement with a recognized and reputable pharmaceutical corporation for its lead clinical indication, Idiopathic Pulmonary Fibrosis.

For PBI-4547, one of its small molecule follow-on drug candidates , Prometic plans to:

• Complete a phase 1 trial and initiate a phase 2 program in patients suffering from nonalcoholic steatohepatitis (NASH) 

For its lead plasma derived drug candidate Ryplazim^TM (plasminogen), ProMetic anticipates to:

• Complete the implementation and validation of additional analytical assays and "in-process controls" in the manufacturing process of Ryplazim™ (plasminogen);
• Manufacture additional Ryplazim™ (plasminogen) lots to support the implementation and validation of these process changes;
• Provide the FDA with the new Chemistry, Manufacturing and Controls (CMC) data for review as an amendment to the current BLA and submit the long-term (48-week) clinical data at the same time instead;
• File for regulatory approval in Canada; and
• Initiate phase 2 clinical programs in patients suffering from acquired plasminogen deficiencies.

The current auditors, Ernst & Young, were reappointed as auditors of the Corporation, to hold office until the next annual meeting of shareholders.

The following Directors were elected to hold offices until the Corporation's next annual meeting of shareholders or until their successors are elected or appointed:

Dr. Simon Best (Chairman of the Board)
Mr. Stefan Clulow
Mr. Kenneth Galbraith
Mr. David John Jeans
Mr. Charles Kenworthy
Mr. Pierre Laurin
Ms. Louise Ménard
Mr. Paul Mesburis
Ms. Kory Sorenson
Mr. Bruce Wendel

More about Prometic

Prometic Life Sciences Inc. (www.prometic.com) is a biopharmaceutical corporation with two drug discovery platforms focusing on unmet medical needs in the field of fibrosis and orphan diseases. The first platform, small molecule therapeutics, stems from the discovery of two receptors GPR40/GPR84 acting as "dual master switches" which are at the core of the healing process as opposed to fibrosis. The second platform, plasma-derived therapeutics, leverages Prometic's vast experience in bioseparation technologies to address unmet medical needs with therapeutic proteins not currently commercially available, such as Ryplazim™ (plasminogen human). Prometic is also leveraging the second platform higher recovery yield advantage to develop some more established plasma-derived therapeutics with significant growth in demand such as Intravenous Immunoglobulin (IVIG) and provides access to its proprietary bioseparation technologies to enable pharmaceutical companies in their production of non-competing biopharmaceuticals. Globally recognized as a bioseparations expert, the Corporation derives revenue from this activity through sales of affinity chromatography media which contributes to offset the costs of its own R&D investments. 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 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, 2017, 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.

Related Links

http://www.prometic.com