Liminal BioSciences Inc.

Good morning, ladies and gentlemen, and welcome to Liminal Biosciences, Inc. fourth quarter and year ended December 31st, 2021 results. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question and answer session for analysts. If at any time during this call you require immediate assistance, please press star zero for the operator. Note that this call is being recorded on Friday, March 18th, 2022. And I would like to turn the conference over to Shranel Inandar, Investor Relations and Communications Manager. Please go ahead.

Thank you, Apoita. And good morning, ladies and gentlemen. This recorded webcast will be accessible from the Investor Resources page on the Liminal Biosciences website and will be available for replay later on today. For those of you dialing in, you can find a copy of our presentation slides on the webcast section of the website or via the conference call portal. Moving on to slide two, I'd like to remind everyone that we'll be making forward-looking statements today during the webcast, including remarks or current expectations concerning future developments of the pipeline, the properties of our product candidates, the timing of initiation or nature of preclinical and clinical trials, and potential therapeutic areas, regulatory plans, financing plans, our ability to resolve the NASDAQ listing deficiency and regain compliance with the NASDAQ listing rules, our company, its financial position, the impact of COVID-19 on our business, and possible changes in the industry and competitive environment. The forward-looking statements are based on our common expectations and beliefs and on information currently available to us. These statements are subject to risks and uncertainties, including those contained in our updated reports that we file with the U.S. Securities and Exchange Commission, or SEC, and Canadian Securities Commissions from time to time, including our annual report on Form 20F, and our 6K, containing our press release of the results for the fourth quarter and fiscal year ended December 31st, 2021, each of which we have filed with the SEC and on CDAR. That could cause actual results to differ materially from those contained in the forward-licking statements. Please note that these forward-licking statements made during this webcast speak only of our expectations as of today's date, and Liminal Biosciences undertakes no obligation to update these statements to reflect subsequent events or circumstances except to the extent required by law. As stated on slide three during this morning's webcast, Liminal's Chief Executive Officer, Mr. Bruce Pritchard, will provide an update on the business highlights. Then, Ms. Nicole Russell, Interim Chief Financial Officer, will present the financial and operational highlights for the fourth quarter and year ended December 31st, 2021. We will then follow with the closing comments on the expected near-term milestones and a short question and answer period for financial analysts only. Mr. Patrick Sartori, Luminal Biosciences President, will also be joining us for the Q&A session. I'd just like to note here that unfortunately, as Bruce is suffering from a sore throat, please do bear with us for the conference call today. I'd now like to welcome Luminal's Chief Executive Officer, Mr. Pritchard, who will discuss Luminal's key recent developments. Bruce, over to you.

Great. Thank you very much for now, and good morning, everyone. If I could ask everyone listening now to move to slide four in the presentation. I'd like to talk about some of our business highlights for the fiscal year ended December 31st and the first quarter of 2022. I'm very pleased with the progress that we have made in the past 12 months to refocus the company into a streamlined small molecule business. Today, we have a focused pipeline of promising small molecule therapeutic candidates with a cash runway positioned to support our immediate clinical development plans. We're delighted to have completed the divestment of our plasma-derived therapeutics business in 2021 which resulted in total proceeds net of payments that were made to third parties, including PVP, of $100.2 million. Consequently, the previous plasma-derived therapeutic subsidiaries are presented as discontinued operations in our financial statements. As a result of these divestments, the leadership team and I are pleased to have successfully delivered on our objective of simplifying our business structure over the past 12 months as part of our evolution in becoming a streamlined small molecules business. Today, Liminal Biosciences is a simplified and debt-free company, and we believe that our pipeline is positioned to deliver multiple anticipated data points throughout 2022 with unencumbered intellectual property and a data-driven clinical and preclinical development plan. In February 2022, the company also announced the early repayment of secured debt with Structured Alpha LP, or SALP, which eliminated the total debt of $39.1 million. The early repayment of this debt continues our strategy to simplify our business, deleveraging our balance sheet and eliminating the associated interest expense. As a result of the early repayment of all of SALP's secured interest against the company's assets was released and will be discharged, resulting in no one having security over our intellectual property. This streamlines the path forward for our operations and grants us additional flexibility for the future, including in relation to potential deal-making around our pipeline assets. The early repayment also results in total interest savings of $9.1 million Canadian dollars, termination of the royalty stream agreement, and cancellation of all warrants issued pursuant to the restructuring agreement. So if we transition to slide five, in summary, the company is focused now on value creation for patients or shareholders and employees. Over the last year, we've worked to improve the financial position, simplify our business operations, refine our business strategy, and focus on our core assets. We believe the steps that we've taken to diverse certain non-core assets have set the stage for future value-cating events and advancing multiple assets into clinical development for the treatment of inflammatory, metabolic, and fibrotic diseases. Following the divestment of the plasma-derived therapeutics business in 2021 and the more recent repayment of debt to Structured Alpha LP this year, we've consequently reduced our cash burn and associated interest payments, meaning that our cash on hand can be better utilised by funding our research and development activity. The continuing operations line in our financial statements now gives a clear picture of the scale of our more focused operations. To repaying our loan with Saab, we consequently ended our creditor relationship. However, we welcome Saab's ongoing support as our major investor. Our pipeline is now made up of three development programs. Our lead asset is Agipras, also known as PGI 4050. clinical stage product candidate which we now intend to pursue as a potential nitrogen scavenger and our gpr 84 antagonist and officer one antagonist programs which are pre-clinical all of which i'll talk about more next at this point though i'd like to take the opportunity to announce an addition to the leadership team nicole riso who recently was appointed as our interim chief financial officer Nicole brings with her over 20 years of financial management experience in the biotech and pharmaceutical industries and 17 years experience in publicly traded companies. Nicole's skills and experience complement those of the existing team and will add additional management bandwidth to allow us to continue delivering on our business objectives. As Trinal mentioned, Nicole will be taking us through the financial and operating results of the fourth quarter and year ended December 31st, 2021, later on in the call, and we look forward to having her presenting on these calls going forward. But for now, let's move forward to slide seven in the deck, and I'd like to highlight some key takeaways from the completed phase one multiple ascending dose clinical trial. In March of this year, we announced that we had completed our analysis of the safety and pharmacokinetic data for our phase one MAD clinical trial of physagiopras and healthy volunteers. The completed phase one MAD randomized double-blind placebo-controlled study was designed to evaluate the safety, tolerability, and PK of multiple ascending doses of Fasagipraz in healthy subjects. While we remain pleased that there were no significant drug-related safety findings in the study, indeed, our analysis of the data from this trial continues to indicate that Fasagipraz well tolerated all doses tested during the Phase I MAD clinical trial. However, based on our observations, the PK profile resulting from the Phase I MAD clinical trial showed lower-than-anticipated plasma concentrations of FasagiPras, which, combined with disproportionate levels of metabolite, lead us, unfortunately, to conclude that FasagiPras is not a suitable candidate to advance for the treatment of fibrotic diseases. Essentially, the data observed showed that the plasma concentrations of the product candidate previously observed in animals did not translate to similar plasma concentrations in humans and led us to conclude that insufficient amounts of the product candidate were activating the fibrosis-related receptors. This data confirmed our previous disclosure that the company would not be progressing the development of FasagiPras for the treatment of idiopathic pulmonary fibrosis nor hypertriglyceridemia. At this stage, we don't believe that any of the potential new indications to be evaluated in the development of FasagiPras are expected to be for the treatment of fibrosis. The pharmacokinetics observed following administration of FasagiPras at all doses in the study up to 2,400 milligrams daily in single and divided doses, demonstrated that the major metabolite of FasagiPras was the glutamine conjugate. What this does mean is that our analysis of the metabolite data from the Phase I MAD clinical trial provided evidence to support the hypothesis that FasagiPras had nitrogen scavenging properties. And this provides an opportunity for FasagiPras' potential development and diseases associated with high plasma ammonia concentrations. Therefore, based on our observations that FasagiPRAS has demonstrated nitrogen scavenging capabilities, we intend now to conduct further research, including a Phase Ia single ascending dose clinical trial designed as a head-to-head comparison with sodium phenylbutyrate to provide us with the further data to determine if FasagiPRAS is worth developing for one of the many potential indications where nitrogen scavenging is beneficial. We've initiated work to conduct the trial and expect, subject to receiving the usual approvals, to commence the phase 1 SAD clinical trial in the second quarter of 2022. Thereafter, if the anticipated phase 1A clinical trial shows satisfactory results, we expect to move physagiopras into an interleaved phase 1 SAD-MAD study in the second quarter of 2022. with potentially higher doses than used before in disease subjects. If we move on to slide eight, and to our earlier stage assets, the companies made significant progress in the identification of high-potency small molecule antagonists of GPR84, including potential selective candidates for development from different structural classes to those GPR84 antagonists for which data has already been published. GPR84 expression is not restricted to the cells in the immune system. It's also expressed in tissues such as the lung, brain, heart, muscle, colon, kidney, liver, intestine, and adipose. We believe that the GPR84 receptor could be an important biological target in a number of therapeutic areas of interest. GPR84 is broadly expressed and may play an interesting role in the relationship between inflammation, obesity, and diabetes. Our preclinical research indicates a potential role for antagonism of GPR84 in the reduction of fibrosis in several diseases, including kidney disease and non-alcoholic steatohepatitis, or NASH. Work on selecting a lead product candidate to progress to the clinic is ongoing from the company's current lead compounds. with plans to finalize candidate selection later on in 2022. Similar to the GPR84 antagonist program, the company is also making good progress on developing potential OXR1 antagonist candidates, as seen on slide 9. OXR1 is a G-protein coupled receptor that is highly selective for 5-OXO8, believed to be one of the most potent human eosinophil chemoattractants. Migration of eosinophils to body sites, including the lungs and intestines, is mediated by eosinophil chemoattractants, such as 5-oxoate. These eosinophils play a key role in type 2 inflammation-driven diseases, including respiratory disease and gastrointestinal diseases. Eosinophils are major effector cells in the immune system. They're part of the innate immune system, traditionally recognized as the first plane of defense against parasitic infections. When activated, they release a cocktail of toxic proteins to damage the parasite, along with cytokines to attract other immune cells. And these toxic proteins can also damage normal tissue and promote inflammation. Eosinophils are also recruited from the blood into the tissues at the sites of inflammation, and they play a role in tissue repair and the resolution of that inflammation. So the development of our pipeline now provides several potential opportunities for the company's growth in the year ahead. At this point, I'll pause and I'll hand over to Nicole Rousseau, who will talk us through the financial and operating results for the fourth quarter and year ended December 31st, 2021. So, Nicole, over to you.