Liminal BioSciences Inc.
Q4 2020 Earnings Call Transcript

Published: 25 Mar 2021

[Operator:]

Ladies and gentlemen, thank you for standing by, and welcome to the Liminal BioSciences, Inc. Fourth Quarter and Year-end 2020 Results Conference Call. . I would now like to hand the conference over to Shrinal Inamdar, Investor Relations and Communications Manager. Thank you. Please go ahead, madam.

[Shrinal Inamdar:]

Thank you, operator. 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 Webcasts section of the website or via the conference call portal.

[Murielle Lortie:]

Thank you, Shrinal. If I could ask you now to move to Slide 4 in the deck. As a quick reminder, this part of today's webcast is based on the audited consolidated financial statements for the year ended December 31, 2020. All the figures are prepared under international financial reporting standards, and the full annual information and other 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. For simplicity, some numbers being discussed today have been rounded.

[Bruce Pritchard:]

Thank you, Murielle, and good morning, everyone. If I could ask you now to transition to Slide 10. We have a number of updates to discuss today, including providing some further color on our strategic decision to refocus our resources on the small molecule therapeutics business. Firstly, from a cash perspective, as mentioned on our previous quarterly analyst call, we've been able to strengthen the balance sheet in 2020 with the CAD 29 million long-term loan from our largest shareholder, or Structured Alpha, under an existing loan facility, which is interest-bearing and repayable in full by 2024, and a USD 30 million equity financing gross proceeds of shares and warrants conducted by our private placement agent, Piper Sandler, purchased 50% by Structured Alpha and 50% by a U.S. health care investor. The runway provided by these funds does not extend beyond 12 months. However, we expect that these additional capital inflows will allow us to focus on the important near-term goals, while continuing to consider and evaluate other financing and strategic options for our plasma-derived business, if and when completed. As previously communicated, we've been engaged in the process to find a commercialization partner for Ryplazim, which has to date not resulted in an executable transaction. We, therefore, commenced the process to evaluate potential strategic alternatives for our plasma-derived therapeutics business aimed at minimizing our cash burn. These alternatives may result in a divestment in whole or in part of the plasma-derived therapeutics business and/or other noncore assets or in other courses of action, including, but not limited to, other strategic transactions or the closure of our Ryplazim-related operations. We believe that such a change in our business strategy will allow us to become more streamlined and with a singular focus on our core research capabilities and emerging pipeline. On the small molecule program, we're very pleased to have initiated the Phase I multiple ascending dose clinical trial in healthy volunteers in December for our lead small molecule candidate, fezagepras. This Phase I clinical trial is designed to look at more frequent daily dosing, both twice and 3x daily of fezagepras up to 2,400 milligrams for a total of 14 days. The clinical trial is a standard placebo-controlled Phase I multiple ascending dose design, and the endpoints will include safety, pharmacokinetics and exploratory biomarkers related to the mechanism of action of fezagepras. The data from this clinical trial will be used to guide selection of appropriate dose and dosing frequency of fezagepras for anticipated future clinical trials.

[Patrick Sartore:]

Thank you, Bruce. Good morning, everyone. On the plasma-derived therapeutics business, we will continue to progress our evaluation of strategic alternatives for said business, including a divestment of the Ryplazim business and/or noncore assets related thereto, while continuing to work towards the PDUFA target action date of June 5, 2021 for Ryplazim. Our plasma-derived therapeutics business unit personnel in regulatory affairs, clinical research, manufacturing and quality assurance are continuing preparations for the FDA's review, potential responses to further information requests and a potential pre-approval inspection by the FDA at our facilities. We are 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 new PDUFA target action date. In January, our plasma collection facility in the U.S., Prometic Plasma Resources USA received FDA approval for its plasma collection center located in Amherst, New York, and received a clinical laboratory license from the state of New York. The center commenced operations and initiated source plasma collection in early 2020, and is now FDA-licensed to collect and introduce into interstate commercial farmers, human source plasma for further manufacturing in the U.S. The approval follows the FDA's pre-licensure inspection in September 2020. The FDA approval of our second plasma collection facility, and the first outside of Canada, enables us to continue to internally supply a portion of our raw material or potentially sell on to other customers. Employees in our plasma collection facilities continue to collect normal source plasma used for production of Ryplazim as well as specialty plasma, including from donors who have recovered from COVID-19 for resell purposes. Bruce, perhaps you'd like to wrap up with some comments on the upcoming milestone for our small molecule business?

[Bruce Pritchard:]

Yes. Thanks, Patrick. So just wrapping up then, based on our experiences on the biology of IPF, preclinical signals of activity and 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 fibrosis disease of IPF. And we hope to further evaluate fezagepras in a global Phase IIb clinical trial in patients with IPF to be initiated in the first half of 2022. In addition, we expect to initiate the proprietary work for the anticipated Phase Ib/IIa clinical trial of feza in the U.S. for patients with high triglyceride levels in 2022, and that clinical trial is expected to enable the definition of future development of fezagepras and other indications. Fezagepras has previously been granted Orphan Drug Designation by the FDA and the EMA for the treatment of IPF. The treatment has also received a Promising Innovative Medicine or PIM designation by the MHRA or Medicines and Healthcare products Regulatory Agency. Pending the outcome of our preclinical research and successful identification of preclinical drug candidate, we plan to initiate an IND-enabling program to support a first-in-human Phase I single ascending dose study for our GPR84 drug candidate in healthy volunteers for safety and tolerability. As always, at the moment, 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 ongoing and future clinical studies. Given our cash runway and the unpredictability around COVID-19, we continue to review our operating plans. So on Slide 12, we continue to consider and evaluate opportunities for collaborations and partnerships, disposition of noncore assets and potential issuances of equity instruments to provide additional funding for ongoing operations and programs beyond 2021. And we continue to work on developing product candidates for patients, and are focused on delivering our highest priorities for 2021 and 2022. At this point, we'd now like to address any questions that any of our financial analysts may have. Operator?

[Operator:]

. Your first question comes from Yasmeen Rahimi of Piper Sandler.

[Yasmeen Rahimi:]

I have a few questions for you. The first question is directed to Bruce. Can you kindly provide us a little bit color on how enrollment is progressing into the Phase I study of fezagepras? If you could just give a little bit color around that? And when we should expect data? And then also kind of remind us on the key biomarkers, proof-of-concept biomarkers that you're hoping to see in the study. And then, I have like one more follow-up.

[Bruce Pritchard:]

Sure. Well, thanks. Yes, thanks for the questions. In terms of the enrollment, that's progressing as planned. We're making our way through the cohorts as predicted and nothing of any note to report there with any challenges enrolling for that study. So everything is progressing as planned there. In terms of the specific biomarkers, we haven't disclosed those at this point in time. It's primarily a safety study. We will be obviously looking at biomarkers that are of interest to us in guiding us towards understanding the mechanism of action, but we've not been specific about those yet, but we'll clearly talk about those when we get to the end of the study. I think you asked about the timing. The study continues as planned, and we would expect to see results from that study in the sort of early part of the second half of this year.

[Yasmeen Rahimi:]

And then maybe in regards to anticipation of starting our global Phase IIb study for IPF have you had -- have you started interacting with the agency in preparation for the study, or is the idea to wait on the help of the MAD study results, then really kick off the meetings with the regulatory agencies? So if you could just kind of help us understand where you are in that preparation for the Phase IIb?

[Bruce Pritchard:]

Sure. Well, I mean, you're absolutely right that we're working on preparing for that study right now. The reality is that we have an ongoing MAD study. We need to make sure that we take into consideration the data that we get from that study before commencing the Phase II study in IPF. We're working right now with our team on the design of that study with input from key opinion leaders and so on. Don't forget that because we've already had previous interaction with the pulmonary division over the FDA, we do actually have an open IND for -- with the FDA, of course, that will have to be modified to take into consideration all of our latest preclinical and clinical information, which we will do. So I think that's probably as much as we can say right now on the status of that, but more to come on that in the coming months.

[Yasmeen Rahimi:]

And then maybe one last question on the GPR84 antagonist that is currently expected to start preclinical IND process and start Phase I. Have you given some more thought on maybe what are the indications and areas for which you believe GPR84 would be ideal? And if you could comment on that, that would be really helpful.

[Bruce Pritchard:]

Yes. I mean, again, I think we've not been sort of specific yet about which indication we would choose to go after. As you're aware, GPR84 antagonist program has potential benefit in a number of fibrotic conditions. You'll be aware, obviously, of the Galapagos and 1205 study in IPF. So we're keeping that under advisement right now. And I guess, and a little too early to say, but again, we'll update the market on our chosen indication as we make a little more progress with that particular assay.

[Operator:]

Your next question comes from Edwin Zhang of H.C. Wainwright.

[Edwin Zhang:]

First one, can you provide us more color on your strategic business trips? What assets are under consideration for divestment from a timeline perspective, a bit more likely to happen in the second half of the year after the Ryplazim PDUFA date? And then I have a follow-up.

[Bruce Pritchard:]

Okay. I'll maybe start off on that, and then I can ask Patrick to step in as well. But as we said in our press release, we're -- we've made the strategic decision that we'd like to focus the business on our small molecule operations going forward. So we're looking to divest our plasma business in its entirety, whether that's in 1 or multiple transactions. So we're looking to divest the plasma centers, the manufacturing operations and the Ryplazim asset. So that's the nature of what we're looking for. I think it's without giving anything away on what we're doing with negotiations and discussions that would be commercially sensitive. The reality is that we are looking at all opportunities here, whether we do this before or after Ryplazim approval. Pat, I don't know if there's anything that you might want to add to that?

[Patrick Sartore:]

No. I think, Bruce, you've answered the question, and I don't have anything to add on that regarding timing or the scope of assets that are going to be divested.

[Edwin Zhang:]

All right. Because of this shift of business focus, how should we think about the operation expense this year?

[Bruce Pritchard:]

Thanks, Edwin. Again, no specific guidance because I think, as you can understand, a lot of that will really depend upon the timing of the of any transaction, should we be able to conclude one. But the focus really is very much to shift the expenditure profile of the business to become a smaller and more focused business looking ultimately at small molecule R&D. So over time, we will be able to significantly reduce the scale of the operation that we have and ultimately become more capital efficient. But at this stage, no specific guidance to give until we understand the timing and shape of a particular transaction.

[Operator:]

Your next question comes from Doug Loe of Leede Jones Gable.

[Doug Loe:]

Just returning to PBI-4050. So I'll never be able to pronounce it, but then I get pressed, so I won't try and accept them. Just with regard to the potential to target Alström syndrome with the drug, we are mindful, but I mean, you have several competing priorities with the 4050 that might have fallen away for business reasons. But I was just wondering if there were any sort of medical or for scientific evidence that might have caused that indication to fall away through our pipeline.

[Bruce Pritchard:]

Okay. So Doug, I'll try and paraphrase this because I'm afraid, your line wasn't particularly clear, but I think I heard you asking whether there were particular medical or scientific reasons for why we deprioritized Alström. So I think the simple answer to that is that as we've identified in the -- what we now believe to be the mechanism of action for the drug, what we want to do is make sure that we are undertaking our first placebo-controlled clinical study in a very clear indication. The IPF study has been chosen so that we can look at the impact of the drug on fibrosis. And generally speaking, the IPF indication offers us a kind of cleaner route from a sort of biologic and regulatory perspective to doing that. So all I would say is, at the moment, Alström has been deprioritized, and it's not for any other medical or scientific reason other than IPF gives us a kind of clearer reach to assessing whether our drug is effective in fibrosis.

[Doug Loe:]

Got it. Okay, that's helpful. And apologies, I just came to headset, so a little bit clear here now. Maybe you don't want to get too far ahead of your Phase II IPF thinking. But may I recall that you had some interesting data on combining 4050 with the Boehringer Ingelheim's OFEV. I'm just wondering if sort of some combination with pre-existing approved IPF drugs was maybe something that you might be contemplating in Phase II.

[Bruce Pritchard:]

I think, again, it's probably a little early for us to be sort of so specific about the design of the Phase II study. There are a number of things that we want to take into consideration when we finalize the design of that. I think, your point is a valid one when you come to thinking about any marketed treatment for IPF and ultimately, somewhere along the line in a clinical program, it's likely that we'd have to do some sort of study alongside one of the current standard of care products. I think at this stage in where we're at with our drug development process so far, it's probably a little early to pass comment on that at this point in time. But obviously, that will become clearer when we announced the start of that study and the protocol design for that.

[Doug Loe:]

Great. No, that's great feedback. And then just lastly, addressed in your convalescent plasma collection activity, as you probably know, the medical literature is kind of all over the place on the utility of convalescent plasma. And I'm kind of leading myself toward its utility in acute cases more than its lack of utility. But just wondering what your key opinion leaders and what some -- the hospitals who might be using convalescent plasma might be telling you about where it belongs from the continuum of care in COVID-19. And I'll leave it there.

[Bruce Pritchard:]

Great. thanks. And Pat, is there anything you want to comment on the convalescent plasma?

[Patrick Sartore:]

Well, no. All I would say, Bruce, is that on the convalescent plasma side, again, we're collecting convalescent plasma and basically selling it to entities that are currently investigating its use for hyperimmune drugs. So it's not really with the treatment. They don't really use the actual convalescent plasma to treat, but more as a raw material source to extract the anti-COVID-19 protein. So it's more of a hyperimmune play. And we're not really ready to comment or in a good place to comment on the on the medical benefits. We're acting really as a plasma collection center, and reselling that plasma on to others that are part of these trials.

[Operator:]

There are no further questions at this time. And this concludes today's conference call. Thank you for participating. You may now disconnect.