LAVAL, QC, ROCKVILLE, MD and CAMBRIDGE, UK – November 28, 2019 – Liminal BioSciences Inc. (NASDAQ & TSX:LMNL) ( “Liminal BioSciences” or the “Company” ), a clinical-stage biopharmaceutical company focused on developing novel therapeutics to treat unmet needs in patients with liver, respiratory and kidney disease, acknowledges the press release issued today by the Autorité des Marchés Financiers (“AMF”) in which the AMF announced that after a thorough investigation, the AMF has determined that no violation or breach of securities regulation occurred in connection with the refinancing transactions completed by the Company in April 2019. The AMF is the regulatory and oversight body for Québec’s financial sector.
“We are pleased that the AMF has completed its review and concluded that it did not identify any violation or breach of securities regulation in the context of our refinancing transactions”, stated Kenneth Galbraith, the Chief Executive Officer of Liminal BioSciences. “We have been cooperative and transparent with AMF throughout the review and look forward to focusing our efforts on developing and commercializing new medicines that may address serious unmet healthcare needs of patients around the world.”
In April 2019, the Company completed a series of refinancing transactions, which were subject to the prior review and approval of the Toronto Stock Exchange. On November 18, 2019, the common shares of Liminal BioSciences commenced trading on the NASDAQ Global Market.
About Liminal BioSciences Inc.
Liminal BioSciences is an innovative biopharmaceutical company with a broad pipeline of small molecule therapeutics under development to treat unmet needs in patients with liver, respiratory and kidney disease, with a focus on rare or orphan diseases. Liminal BioSciences’ research involves the study of several G-protein-coupled-receptors, GPR40, GPR84 and GPR120, known as free fatty acid receptors (FFAR’s). These drug candidates have a novel mechanism of action as agonist ("stimulator") of GPR40 and GPR 120, and antagonist ("inhibitor") of GPR84. Our lead drug candidate, PBI-4050, is expected to enter Phase 3 clinical studies for the treatment of Alström Syndrome after further consultation and approval by the FDA and EMA. A second drug candidate, PBI-4547, is currently in a Phase 1 clinical study.
Liminal BioSciences has also leveraged its experience in bioseparation technologies through its wholly-owned subsidiary Prometic Bioproduction Inc. to isolate and purify biopharmaceuticals from human plasma. Our lead plasma-derived therapeutic product is Ryplazim(TM) (plasminogen) for which the Company expects to file a BLA with the US FDA in the first half of 2020 seeking approval to treat patients with congenital plasminogen deficiency.
Liminal BioSciences has active business operations in Canada, the United Kingdom and the United States.
Forward Looking Statement
This press release contains forward-looking statements about Liminal BioSciences’ objectives, strategies and businesses that involve risks and uncertainties. Forward‐looking information includes statements concerning, among other things, statements with respect to the timing of any planned Biologics License Application filing and the timing of initiation of Liminal BioSciences' planned clinical trials.
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, Liminal BioSciences’ 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 Liminal BioSciences’ 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 the Annual Information Form for the year ended December 31, 2018, under the heading "Risks and Uncertainties related to Liminal BioSciences’ 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.
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