LAVAL, QC, ROCKVILLE, MD and CAMBRIDGE, UK – January 13, 2020 – 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, today provided a corporate update and outlined its key corporate and R&D priorities for 2020.
“During 2019, Liminal BioSciences undertook the initial steps towards simplifying and transforming our business to focus our efforts on developing important new medicines for patients and building value for our shareholders”, stated Kenneth Galbraith, Chief Executive Officer of Liminal BioSciences.
Key Achievements for 2019
- USD $85 million in common equity raised from existing and new investors in the second quarter
- Secondary listing of common shares on the Nasdaq Global Market completed in November
- Divestiture of Prometic Bioseparations Limited, our affinity chromatography resins business, to KKR for potential gross proceeds of up to GBP 45 million
- Strengthening of the Board of Directors and leadership team, including the addition of Ms. Moira Daniels as Head of Regulatory Affairs and Quality Assurance
Kenneth Galbraith said, “2020 has the potential to be a transformative year for Liminal BioSciences as we look forward to the filing of an amended Biological License Application (“BLA”) with the United States Food and Drug Administration (“FDA”) seeking approval of RyplazimTM (plasminogen) (“RyplazimTM”) for the treatment of patients with congenital plasminogen deficiency. If approved, RyplazimTM could address the serious unmet needs of patients with this disease and could be Liminal BioSciences’ first approved product.”
“We have also prioritized the R&D programs in our small molecule therapeutics portfolio in order to focus our resources on both existing and new R&D programs that we believe represent the highest potential commercial and scientific merit,” added Mr. Galbraith.
Key Corporate and R&D Priorities for 2020
- Anticipated filing of an amended BLA with FDA for RyplazimTM for the treatment of congenital plasminogen deficiency in the first half of the year
- Expected completion of a global marketing partnership for Ryplazim, and preparation for commercial launch of RyplazimTM in the United States, if approval is received
- Expected initiation of additional Phase 2 and 3 clinical studies for PBI-4050 (fezagepras) in the second half of the year, subject to regulatory approval and further clinical and preclinical studies to determine the appropriate doses of fezagepras for use in such studies
- Anticipated addition of three new preclinical research programs to the R&D portfolio in 2020, including the development of a selective GPR84 antagonist for the treatment of fibrosis
- Key additions to the Board of Directors and leadership team
A corporate presentation describing these corporate priorities, research and development goals and other information will be available on the investors page of the Company’s website at https://resources.liminalbiosciences.com/latest-content on Monday January 13, 2020.
The Company’s estimated cash, cash equivalents and marketable securities balance as of December 31, 2019 was approximately CAD$61 million (unaudited), compared to CAD$7 million as of December 31, 2018. Liminal BioSciences will provide further information in connection with reporting 2019 fourth quarter and annual financial results together with the Company’s progress on the key priorities in late March 2020.
About Liminal BioSciences Inc.
Liminal BioSciences is an innovative biopharmaceutical company with a broad pipeline of small molecule therapeutics under development to address unmet needs in patients with liver, respiratory and kidney disease, with a focus on rare and orphan diseases. Liminal BioSciences’ research involves the study of several G-protein-coupled-receptors, known as free fatty acid receptors (FFAR’s). Our lead small molecule therapeutic product, fezagepras, is expected to enter Phase 3 clinical studies for the treatment of Alström Syndrome and two separate Phase 2 clinical studies for the treatment of respiratory diseases, all subject to further consultation and approval by the FDA and European Medicines Agency.
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 RyplazimTM (plasminogen) for which the Company expects to file an amended BLA with the 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 and unaudited financial information 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, development of R&D programs and the timing of initiation of 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 approvals 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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