Liminal BioSciences Inc.
Q3 2020 Earnings Call Transcript

Published: 13 Nov 2020

[Operator:]

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. . I would now like the hand the conference over to your speaker today, Shrinal Inamdar. Thank you. Please go ahead.

[Shrinal Inamdar:]

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.

[Murielle Lortie:]

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.

[Bruce Pritchard:]

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.

[Patrick Sartore:]

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 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.

[Bruce Pritchard:]

Great. Thanks, Pat. So wrapping up, key interim 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:]

. Your first question is from Yasmeen Rahimi with Piper Sandler. Your line is open.

[Yasmeen Rahimi:]

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.

[Bruce Pritchard:]

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

[Patrick Sartore:]

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.

[Bruce Pritchard:]

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.

[Yasmeen Rahimi:]

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.

[Bruce Pritchard:]

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.

[Yasmeen Rahimi:]

Thank you so much.

[Bruce Pritchard:]

Perfect. Thank you.

[Operator:]

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

[Bruce Pritchard:]

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.

[Operator:]

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