Liminal BioSciences Joins CoVIg Plasma Alliance to Contribute to Development of Potential New COVID-19 Therapy

Rhea-AI Summary

Liminal BioSciences Inc. (NASDAQ: LMNL) announced on July 2, 2020, that its subsidiary, Prometic Plasma Resources, has joined the CoVIg-19 Plasma Alliance. This collaboration aims to expedite the development of a new therapy for COVID-19 by leveraging the expertise of leading plasma-derived therapeutic companies. The Alliance seeks to collect convalescent plasma for creating a potential treatment for COVID-19. Liminal BioSciences is focused on developing novel therapies for fibrotic diseases and is advancing its lead product candidate, Ryplazim, with a BLA resubmission expected in Q3-2020.

Positive

• Joining the CoVIg-19 Plasma Alliance enhances Liminal BioSciences' position in the biopharmaceutical industry.
• Potential to contribute to the development of a COVID-19 therapy, which can strengthen market reputation.
• Upcoming BLA resubmission for Ryplazim expected in Q3-2020 may lead to regulatory approval and market opportunity.

Negative

• Uncertainty surrounding the actual impact of joining the CoVIg-19 Plasma Alliance on financial performance.
• The success of clinical candidates is contingent on rigorous regulatory approval processes.

LAVAL, QC and CAMBRIDGE, England, July 2, 2020 /PRNewswire/ - Liminal BioSciences Inc. (NASDAQ: LMNL) (TSX: LMNL) ("Liminal BioSciences" or the "Company"), a clinical-stage biopharmaceutical company, today announced that Prometic Plasma Resources, a subsidiary of Liminal BioSciences Inc., has joined the CoVIg-19 Plasma Alliance to contribute to the acceleration of the development of a potential new therapy for COVID-19.

"We are proud to be joining plasma companies Takeda, CSL Behring, ADMA Biologics, Biopharma Plasma, Biotest, BPL, GC Pharma, LFB, Octapharma, Sanquin, and other  contributors and supporters of the CoVIg-19 Plasma Alliance in a unique  partnership of the world's leading plasma-derived therapeutic companies to collaborate and coordinate efforts during the COVID-19 pandemic," stated Kenneth Galbraith, Chief Executive Officer of Liminal BioSciences. "The CoVIg-19 Plasma Alliance aims to put public and patient health first by working together and is combining all efforts to collect convalescent plasma to develop a potential plasma-derived COVID-19 therapy. We hope that our expertise in developing plasma-based therapeutics and our plasma collection centers in the U.S and Canada will go some way to contributing to this important cause."

Individuals interested in donating plasma can visit https://plasma.prometic.com to find the nearest Prometic Plasma Resources plasma collection center to their location.

About Liminal BioSciences Inc.
Liminal BioSciences is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing novel treatments for patients suffering from diseases related to fibrosis, including respiratory, liver and kidney diseases that have high unmet medical need. Liminal BioSciences has a deep understanding of certain biological targets and pathways that have been implicated in the fibrotic process, including fatty acid receptors such as FFAR1, or GPR40, G-protein-coupled receptor 84, or GPR84, and peroxisome proliferator-activated receptors, or PPARs. In preclinical studies, we observed that targeting these receptors promoted normal tissue regeneration and scar resolution, including preventing the progression of and reversing established fibrosis. We also have encouraging clinical data that we believe supports the translatability of our preclinical data observations to the clinic. We have leveraged this understanding, as well as our experience with generating small molecules, to build a pipeline of differentiated product candidates. Our lead small molecule product candidate, fezagepras (PBI-4050), is expected to enter an additional Phase 1 clinical trial in 2H-2020 to evaluate multiple ascending doses of fezagepras in healthy volunteers, at daily dose exposures higher than those previously evaluated in our completed Phase 1 and Phase 2 clinical trials.

Liminal BioSciences has also leveraged its experience in bioseparation technologies through its subsidiary Prometic Bioproduction Inc. to isolate and purify biopharmaceuticals from human plasma. Our lead plasma-derived product candidate is Ryplazim^® (plasminogen), for which the Company expects to resubmit a BLA in Q3-2020 with the FDA seeking approval to treat patients with congenital plasminogen deficiency.

Prometic Plasma Resources operates two plasma collection centers in North America managed by a team of qualified professionals with decades of experience in the field of plasma collection. Our Canadian center located in Winnipeg, Manitoba is licensed by the FDA and Health Canada, and is certified by the European Union and the Plasma Protein Therapeutics Association (PPTA). Our American center located in Amherst, New York is licensed by the State of New York and its' BLA submission is currently under review by the FDA.

Liminal BioSciences has active business operations in Canada, the United Kingdom and the United States.

About The Alliance
The CoVIg-19 Plasma Alliance is an unprecedented partnership of world-leading plasma companies formed to meet the unprecedented challenge of COVID-19 who are working together to develop a non-branded plasma-derived medicine, called a hyperimmune globulin (H-Ig).  This could be one of the earliest potential treatment options for people at risk for serious complications from COVID-19. To meet its goals, the Alliance urgently need donations of plasma from individuals who have recovered from COVID-19. People who have fully recovered from COVID-19, or know someone who has, can use the Alliance's "plasmabot" to find and be connected to a nearby plasma collection center. Visit www.CoVIg-19PlasmaAlliance.org or www.thefightisinus.org to learn more

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 and our potential contribution to the CoVIg-19 Plasma Alliance, our ability to contribute to the CoVIg-19 Plasma Alliance, our ability to collect and supply convalescent plasma, the CoVIg-19 Plasma Alliance's ability to develop, manufacture and successfully commercialize any product candidates for the treatment of COVID-19 patients, the timing of any planned BLA resubmission, development of R&D programs, the timing of initiation of clinical trials, the exploration of alternatives for the future commercialization of Ryplazim^®, if approved, including through a third-party marketing collaboration, and the potential commercial launch of Ryplazim^®, if approved.

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. At this stage, the product candidates of the Company have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include, but are not limited to, Liminal BioSciences' ability to develop, manufacture, and successfully commercialize product candidates if ever, the impact of the COVID-19 crisis on its business operations, clinical development, regulatory activities and financial and other corporate impacts, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical trials, the ability of Liminal BioSciences to take advantage of business opportunities in the pharmaceutical industry, uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals and general changes in economic conditions. You will find a more detailed assessment of these risks, uncertainties and other risks that could cause actual events or results to materially differ from our current expectations in the Company's U.S. Securities and Exchange Commission and Canadian Securities Commissions filings and reports filings and reports, including in the Annual Report on Form 20-F for the year ended December 31, 2019 and future filings and reports by the Company, from time to time. As a result, we cannot guarantee that any forward-looking statement will materialize. Such risks may be amplified by the COVID-19 pandemic and its potential impact on Liminal BioSciences' business and the global economy. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof.  We assume no obligation to update any forward-looking statement contained in this Press Release 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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SOURCE Liminal BioSciences Inc.

FAQ

What is the significance of Liminal BioSciences joining the CoVIg-19 Plasma Alliance?

By joining the CoVIg-19 Plasma Alliance, Liminal BioSciences can collaborate with other leaders in plasma-derived therapies to accelerate the development of a potential COVID-19 treatment.

What are Liminal BioSciences' expectations regarding Ryplazim?

Liminal BioSciences expects to resubmit a BLA for Ryplazim in Q3-2020, seeking approval for treating congenital plasminogen deficiency.

How could the CoVIg-19 Plasma Alliance impact LMNL's stock?

Participation in the CoVIg-19 Plasma Alliance could positively influence LMNL's stock by enhancing its market reputation and potential revenue from COVID-19 therapies.

What challenges does Liminal BioSciences face with their clinical trials?

Liminal BioSciences faces uncertainties related to the success of clinical trials and potential regulatory hurdles that could impact the commercialization of its product candidates.