Ladies and gentlemen, thank you for standing by, and welcome to the Liminal BioSciences Inc. Third Quarter 2020 Results. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions]. I would now like the hand the conference over to your speaker today, Shrinal Inamdar. Thank you. Please go ahead.

Thank you, operator. My name is Shrinal Inamdar and I’m the Investor Relations and Communications Manager at Liminal BioSciences Inc. Good morning, ladies and gentlemen. This recorded webcast will be accessible from the Investor Resources page on the Liminal BioSciences Web site and will be available for replay later on today. For those of you listening and joining in, you can find a copy of our presentation sides on the webcast section’s Web site or by the conference quarter. Moving on Slide 3, I’d like to remind everyone that we will be making forward-looking statements today during the webcast, including remarks concerning future statements of the pipeline, regulatory plans, our company, the impact of COVID-19 on our business and possible changes in the industry and competitive environment. These forward-looking statements are based on our current expectations and beliefs, unknown information currently available to us. These statements are subject to risks and uncertainties, including those contained in our updated report that we filed with the U.S. Securities and Exchange Commission, or SEC, and Canadian Securities Commissions from time to time, including our Annual Report on Form 20-F and our 6-K containing results for the nine months ended, September 30, 2020, each of which we will have filed with the SEC and on SEDAR that cause actual results to differ materially from those contained in the forward-looking statements. Please note that these forward-looking statements made during this webcast speak only 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 3, joining this morning’s webcast is Murielle Lortie, Liminal’s Chief Financial Officer who will present the financial and operational highlights for the third quarter or nine months ended September 30, 2020. Then, Liminal’s Chief Executive Officer, Mr. Bruce Pritchard; and our President, Mr. Patrick Sartore will provide an update on the business highlights and expected Liminal’s milestones, which we will then follow with a short question-and-answer period for financial analysts only. Murielle, over to you.

Thank you, Shrinal. If I can ask you now to move to Slide 4 on the deck. As a quick reminder, this part of today's webcast is based on the unaudited consolidated interim financial statements for the quarter and nine months ended September 30, 2020. All the figures are prepared under International Financial Reporting Standards, and the full annual information and important information can be found online at sec.gov and sedar.com. Our financial information is presented in Canadian dollars and all references during the webcast to dollars means Canadian dollars, and all references to U.S. dollars means U.S. dollars. On Slide 6, I'd like to review selected information from our results from continuing operations. Revenues in our plasma-derived therapeutic segment are generated from the sales of specialty plasma from our plasma collection facilities located in Winnipeg, Canada and our latest facility in Amherst, New York, which is awaiting FDA approval. The main purpose of these collection facilities is to secure the supply of normal source plasma needed in the manufacturing of Ryplazim. Revenues were 2.3 million for the nine months ended September 30 compared to 3.9 million for the corresponding period in 2019, representing a decrease of 1.6 million. This decrease is the result in lower plasma collections, as COVID measures were put in place at both collection centers in Q2 2020. There is a corresponding reduction in cost of sales. The manufacturing and purchase cost of product candidates used for R&D purposes for the nine months ended September 30, 2020 was 21.7 million as we invested in the production of Ryplazim to supply patients in connection with expanded access programs, including on a named patient basis and via a compassionate use program until Ryplazim is commercially available, approved and available, if ever. This is an 8.8 million or 29% reduction versus the same period last year, primarily as there were particularly high batch runs produced in Q2 and Q3 of 2019. Additionally, in 2020, we recognized a credit of 2.8 million related to the COVID wage subsidies, which were partially offset by an increase of 1.2 million related to professional fees and operating expenses incurred to prepare for the FDA audit in connection with the resubmission of the BLA. Other R&D expenses during the nine months ended September 30, 2020 was 23.5 million, a 14% decrease from the corresponding period in 2019. The expenses in the small molecule segment were relatively stable versus last year. Other R&D expenses in the plasma-derived segment decreased 3.6 million versus 2019 to 13.4 million, primarily as a result in reduced payroll and related expenses, including as a result of the reduction of our R&D workforce, now that the BLA is submitted. Administration, selling and marketing expenses for the nine months ended September 30 was 29.5 million, a decrease of 5.5 million compared to the corresponding period in 2019. This decrease was mainly attributable to a reduction of 8.6 million in share-based payment expense, a decrease of 3.9 million in payroll and related expenses as a result of workforce reduction, short-term incentive plan estimates and COVID wage subsidies. This decrease was partially offset by an increase of 9.3 million in directors and officers insurance costs as a result of Liminal’s listing on NASDAQ in Q4 2019. Finance costs of 5.7 million for the nine months ended September 30, 2020 decreased by 6.5 million or 53% compared to the corresponding period in 2019. This decrease reflects our lower level of debt during the first nine months of 2020 following a debt restructuring that occurred April 23, 2019. The resulting net loss from continuing operations of 78.9 million was a decrease of 114.5 million versus the corresponding period in 2019. 92.4 million of this was attributed to the loss on extinguishment of liabilities recorded in the second quarter of 2019 in connection with the debt restructuring. Moving to Slide 7, I'd like to walk through the major elements that impacted our cash and cash equivalents throughout the nine months of 2020. We started 2020 with 61.3 million of cash and cash equivalents. 49.2 million was used in operating activities, a decrease of 14.7 million compared to the same period in 2019. The decrease was mainly due to the receipt of 10.6 million of income tax refunds and 3.1 million of COVID wage subsidy grant. Cash flows generated from financing activities was 23.6 million, which includes the drawdown of our entire line of credit of 29.1 million with SALP, 2.4 million issuance of convertible debt concurrent with the acquisition of Fairhaven in August to fund the research program offset by 7 million of payments on lease liabilities, and $1 million of interest on outstanding debt, which bear a 10% interest rate and are due April 2024 and are repayable anytime without penalty. Cash flows in investing activities include the acquisition of Fairhaven in August for 3.8 million, offset by the final adjustments of proceeds from sale of the bioseparation operations that we received in Q1 2020. These uses of cash offset by gains of foreign exchange results in a cash and cash equivalents balance on September 30, 2020 of 36 million. Moving to Slide 8, our net working capital at September 30, 2020 was 28.3 million. In addition to this, we completed an equity financing on November 3 of 37 million of net proceeds. The combination of our net working capital and equity financing will not provide us with sufficient funds to continue maintaining our operating activities at the current spending levels for a period exceeding 12 months. Key priorities for our current resources are preparing for the review by the FDA of the BLA for Ryplazim as well as preparing for the potential commercialization and/or partnering with Ryplazim, pending approval by the FDA of our BLA, along with the fezagepras Phase 1 MAD study. We've been actively managing our cash runway by pacing our investments on new research program and reducing infrastructure and headcount costs wherever possible. We intend to pursue a number of alternative financial initiatives that could potentially extend our current cash runway, if completed. These include a combination of equity offering, debt financing, strategic collaborations with upfront or continuous funding support, monetization of non-core businesses or assets, monetization of any Pediatric Review Voucher or PRV that may be granted by the FDA in the future, and grant funding. I'd now like to welcome Liminal’s Chief Executive Officer, Mr. Bruce Pritchard; and our President, Mr. Patrick Sartore to the call and invite them to talk about Liminal’s key recent developments.

Thanks, Murielle. And if I could ask the audience listening to turn to Slide 10 in the deck. So we've got a number of updates to discuss today, including providing some further color on announcements made in the past week. During the last quarter, we were pleased to have Mr. Alek Krstajic and Mr. Eugene Siklos join our Board of Directors in September, bringing new levels of expertise in critical areas to support our future operations, including finance, commercialization and global strategic planning. On the corporate front, we announced yesterday that our CEO, Mr. Ken Galbraith tendered his resignation for personal reasons effective today, Friday 13th of November. From today, the Board has asked my colleague Patrick Sartore and I to step up from our present roles as Chief Operating Officers of our plasma and small molecule divisions, respectively, and I am assuming the role of Chief Executive Officer and Patrick that of President. Pat and I are very familiar with the business having each served with the company in leadership roles for over 14 years. And we're delighted that we'll be able to lead the organization with the support of our existing team of colleagues over the coming months as we continue to work on delivery of the strategy that was previously outlined by Ken. We'd like to thank Ken for his leadership of the business over the past 18 months and we wish him very well for his future endeavors. From a cash perspective, we've been able to strengthen our balance sheet considerably over the past few months with a C$29.1 million long-term loan from SALP under an existing credit facility. That's interest bearing in June and repayable in full by 2024. And in addition, a $30 million equity financing with gross proceeds of shares and warrants conducted by our private placement agent Piper Sandler purchased 50% by SALP and 50% by a new U.S. healthcare investor. As Murielle has just stated, the runway provided by these funds does not extend beyond 12 months. However, these additional capital inflows will allow us to focus on the important near-term goals for both Ryplazim and fezagepras, while continuing to consider and evaluate other financing and collaboration initiatives that will extend our cash runway further if and when completed. On the small molecule program, we completed the acquisition of a selective OXER1 antagonist research program. Investigational therapies developed in this program target a key chemo-attractant and activator of eosinophils, which play a role in Type 2 inflammation-driven diseases through tissue repair and resolution of inflammation. This acquisition is a continuation and expansion of our strategy to build a diverse portfolio of early stage R&D programs that complement our established research focus and our lead development opportunities with Ryplazim and fezagepras. This acquisition was also accompanied with an initial investment of C$2.4 million from VC investors to fund the first phase of research and potential funding for further development. So we look forward to advancing the promising OXER1 program in our laboratories at Liminal BioSciences, utilizing our extensive GPCR experience and we hope to nominate a preclinical candidate before the end of 2021. Our Phase 1 MAD study in fezagepras is on track to initiate prior to the end of this calendar year and we expect also to make further progress toward nominating a preclinical candidate for our GPR84 antagonist program in that same timeframe. So in summary, our small molecule business remains firmly on track. At this time, I'd like to pass over to my colleague Patrick to talk a little about the plasma division and the recent changes in the PDUFA date. Pat?

Thank you, Bruce. On Friday, November 6, we received our correspondence from the FDA that the review period for our Ryplazim BLA was being extended by three months from March 5, 2021 to June 5, 2021. The company recently submitted a response to an information request from the FDA related to the BLA resubmission. On November 6, the FDA notified us that the submission of this information by the company constituted a major amendment in the opinion of the FDA, because the submission can take substantial new manufacturing or facility information not previously submitted to or used by the FDA, which entitles the FDA to extend the review process by three months. The new PDUFA target date is now June 5, 2021. While we're disappointed by this extension, we will continue to work collaboratively with the FDA staff on the review of the BLA filing and concurrently working with our one-off [ph] commercial strategy to provide access to Ryplazim to U.S. patients with congenital plasminogen deficiency, if approval is received from the FDA. With the PDUFA target action date of June 5, 2021, we expect a very busy period of time for our plasma-derived therapeutics business, unit personnel in regulatory affairs, clinical research, manufacturing and quality assurance as we prepare for the FDA review, respond to further information requests and prepare all of our facilities involved in the supply chain of Ryplazim for potential preapproval inspection by the FDA. With the BLA submission behind us, we are mindful of the PDUFA target action date. We continue to have discussions with potential third parties who have an interest in being involved with the potential launch of Ryplazim in the U.S. and more broadly. We also continue our own efforts to build awareness of congenital plasminogen deficiency and the potential for the first approved therapy for patients in the U.S. that may become available commercially in 2021, subject to the FDA’s review and approval of our BLA. We're also mindful of the potential impact of the continuing COVID-19 pandemic on FDA staff and are working cooperatively with them to enable their review to be conducted in a timely manner consistent with the new PDUFA target action date. As an industry, we appreciate their efforts in these difficult circumstances. If we move to Slide 11, the key expected near-term milestones in the plasma-based therapeutics business includes the acceptance of two abstracts for presentation related to the company's clinical development activities for Ryplazim at the 62nd American Society of Hematology Annual Meeting and Exposition that's scheduled to take place in virtual format on December 5 to December 8 2020. We also will be publishing both poster publications in November 2020 in the supplemental issue of Blood. We are looking forward to submission. Following the submission of our BLA for Ryplazim, we look forward to the PDUFA target action date June 5 provided by the FDA. Our regulatory manufacturing quality teams continue to prepare for the FDA’s review and our resubmission, and potential inspection of our production facility and supply chain during the course of the FDA’s review of our BLA. Subject to a FDA approval for Ryplazim, we will be in a position to consider expanding the clinical study for Ryplazim in patients with congenital plasminogen deficiency as well as looking to evaluate other potential applications of the plasminogen in patient populations outside of congenital plasminogen deficiency. Also, we will be working with potential partners in other countries where approval may be possible with an FDA approval for Ryplazim as well as those countries where additional local clinical studies may be necessary to be completed in order to file for regulatory approval, including in Europe. We continue to explore alternatives to provide access to patients for Ryplazim in the U.S. if approval is granted by the FDA, including third party strategic partnerships and marketing collaborations. Employees in our plasma collection facility continue to collect plasma that we will need for future production of Ryplazim as well as from recovered COVID-19 patients. We are making good progress on our pending BLA with the FDA on our newest blood collection center in Amherst, New York in the U.S. Finally, we continue to look for opportunities to help with our industry's efforts to find effective solutions to COVID-19 virus, including by collecting plasma from recovered COVID-19 patients. We continue to participate as a member of the CoVIg-19 Plasma Alliance and to explore opportunities to utilize our assets, products and infrastructure in those activities. Bruce, perhaps you'd like to wrap up with comments on the upcoming milestones for the small molecule business.

Great. Thanks, Pat. So wrapping up, key interim [ph] expected milestones in the small molecule therapeutics business include the clinical stage products as fezagepras moving into a Phase 1 multiple ascending dose, or MAD, trial in the UK before the end of this year. Based on our expertise on the biology of idiopathic pulmonary fibrosis, preclinical signals of activity in our own open label clinical trial experience, we're interested in exploring the safety and tolerability of fezagepras for the potential treatment of the progressive and fibrosing disease of IPF. We’re, therefore, pleased to announce that we hope to further evaluate fezagepras in a global Phase 2b clinical trial in patients with IPF to be initiated in the second half of 2021. And in addition, we expect to be able to initiate a Phase 1b/2a clinical trial of fezagepras for patients with high triglyceride levels, or hypertriglyceridemia in the second half of 2021. Fezagepras has previously been granted Orphan Drug Designation by the FDA and the EMA, or the European Medical Agency, for the treatment of IPF. The treatment has also received a promising medical initiative or PIM designation by the Medicines and Healthcare products Regulatory Authority, MHRA, for IPF. As material events occur with our development programs for Ryplazim and fezagepras as well as our earlier stage preclinical programs in GPR84 and OXER1, we will make appropriate announcements in the weeks and months ahead, indicating our progress. However, given the unpredictability of COVID-19 for our future operational objectives, we may need to amend guidance on the expected progress or nature of our business going forward with an improved understanding of how COVID-19 may impact our future operations, including future clinical studies. Given our cash runway and the unpredictability around the COVID-19 pandemic, we do continue to review our operating plans and where necessary, we'll provide updates as required. We continue to consider and evaluate opportunities for collaborations and partnerships, dispositions of non-core assets and potential issuances of equity or debt instruments and grant funding to provide additional funding for our ongoing operations and programs beyond 2020. We'll continue to look at opportunities over time to broaden our shareholder base, which was the primary purpose of our NASDAQ listing last year, as we started to do in our recent Piper financing completed in November. We're fully committed to continuing work of developing product candidates for patients and focused on delivering our highest priorities for 2020 and 2021, and we look forward to reporting on our progress in the weeks and months ahead. We'd now like to take the opportunity to address any questions that any financial analysts may have. Thank you very much, operator, and thanks for everyone on the phone and I look forward to updating our progress. If we can now move to the Q&A section.

[Operator Instructions]. Your first question is from Yasmeen Rahimi with Piper Sandler. Your line is open.

Thank you so much for the granular updates that you provided for us. Two questions for you. Maybe the first one would be on Ryplazim? Can you maybe shed light for us between now and the PDUFA date? What plans in regards to the commercial rollout you're taking? And then the second question is on fezagepras. If you could just shed light on to the single ascending and multi-ascending study that's going to get kicked off shortly? What doses will be tested? What is the size of the population? What are the key proof-of-concept biomarkers? And thank you so much for taking my questions.

Great. Thanks very much. Pat, do you want to kick off with the Ryplazim question?

Sure. Thanks for the question. On the Ryplazim side, we're preparing everything we need to prepare for distribution and commercialization, assuming an approval by the FDA prior – by the PDUFA date. We are preparing our infrastructure. We can't really get into details now, but we're working with partners also to distribute, as we said, in the U.S. as well as potentially in other countries where FDA approval suffices to market the drug. At the same time, we are also working with potential partnerships for marketing the drug and strategic partnerships to licensing, et cetera. So again, I think our goal here is to really make sure that we're prepared on all fronts, on commercialization, on our own or with a partner by the end of 2021.

That's great. Thank you, Pat. And maybe if I can just touch on the question about the multiple ascending dose study for fezagepras. So what we've said so far, Yas, is that we are intending to study different dosing regimens to evaluate multiple ascending doses up to 2,400 milligrams looking at QD, BID and TID. We've not been more specific than that in our disclosure about the design. But the purpose of that is to evaluate the multiple ascending dose of fezagepras in healthy volunteers and lead us hopefully to a clear picture on the correct dosing regimen for that drug going forward. At this point in time, we've not disclosed any other biomarkers we'll be looking at in that study. That’s principally just a dose finding study. We will – I mentioned in my talk earlier, that we'll be looking at patients with high triglycerides in the second half of 2021. And then that study will probably go on to look at additional biomarkers at that time.

Thank you. And I apologize that I had one more question maybe, if I may. And this is just in regards to – thank you for letting us know that you're planning to do what needs to be studied in IPF. Can you maybe help us understand what was the pointing evidence that made you to really pursue that as sort of the key indication in the second half of next year just for our listeners, that would be wonderful? And thank you again for taking my questions.

No problem. We'll be elucidating more on this over the coming days as we move forward and issue – have further updates on some upcoming investor conferences. But I think it's fair to say that we have done some early stage work in IPF. We have done a Phase 2 open label study in IPF historically, albeit at a dose that we probably now think is lower than the one that we will move forward with, when we get into the clinical trial with the Phase 2b study. But that study gave us some indicators that we may have an effect on IPF. And we think that IPF is the right initial indication for us to move forward with, the initial fibrotic indication for us to move forward with on the basis that there are some very clear end points for that condition. So, we hope that that is a very clear and manageable study for us to be able to undertake.

Thank you so much.

Perfect. Thank you.

We have no further questions. I’ll turn the call back to Bruce Pritchard for closing remarks.

Thank you, operator, and thank you ladies and gentlemen for tuning in to our Q3 results call. As we mentioned earlier, as we move forward from here, we look forward to providing further update and guidance on the business as we make progress and look forward to talking to you all again on our next update call. Thank you very much.

This concludes today’s conference. You may now disconnect.