Q4 2023 Alpine Immune Sciences Inc Earnings Call
Participants
Temre Johnson; Investor Relations and Corporate Communications; Alpine Immune Sciences Inc
Mitchell Gold; Executive Chairman of the Board, Chief Executive Officer; Alpine Immune Sciences Inc
Stanford Peng; President, Head of Research and Development; Alpine Immune Sciences Inc
Tara Bancroft; Analyst; TD Cowen
Mike Ulz; Analyst; Morgan Stanley
Thomas Smith; Analyst; Leerink Partners
Gregory Renza; Analyst; RBC Capital Markets
Matt Biegler; Analyst; Oppenheimer & Co
Joe Pantginis; Analyst; H.C. Wainwright & Co
Robert Driscoll; Analyst; Wedbush Securities
Andy Chen; Analyst; Wolfe Research
Presentation
Operator
Ladies and gentlemen, and welcome to the Alpine Immune Sciences fourth-quarter 2023 and full-year earnings call. Currently, all participants are in a listen-only mode. As a reminder, this event is being recorded.
I would now like to introduce Temre Johnson, Senior Director of Investor Relations and Corporate Communications at Alpine. Ms. Johnson, please go ahead.
Temre Johnson
Thank you, Abby. Good afternoon, and thank you to everyone for taking the time to join us today. With me on today's call from Alpine are Dr. Mitchell Gold, Executive Chairman and Chief Executive Officer; Dr. Stanford Peng, President and Head of R&D; Paul Rickey, Chief Financial Officer; and Dr. Remy Durand, Chief Business Officer.
Before I turn the call over to Mitch, I'd like to remind you that we'll be making forward-looking statements during today's call. These forward-looking statements represent our views as of today and are based on our current expectations and consequently involve risks and uncertainties.
Actual results could differ materially from those anticipated in such forward-looking statements. As a result of such risks and uncertainties, I encourage you to refer to the most recent SEC filings regarding the risk factors associated with these statements. Mitch, please go ahead.
Mitchell Gold
Thank you, Temre, and thank you all those who are participating in the webcast today. 2023 was a transformational year for Alpine. With initial hygiene and biopsy data presented at the American Society of Nephrology's Kidney Week, suggesting a best-in-class profile for Povetacicept, our wholly own next-generation dual-band able inhibitor with once monthly dosing developed using a directed evolution platform.
We are still only in the early stages of exploring all potential of assets on the back of strong enthusiasm around it and we closed an oversubscribed $150 million equity offering to accelerate multiple development activities. But there are encouraging data set and I again, convenient once monthly dosing regimen, strong balance sheet, we are rapidly advancing development of probably as a potentially meaningful new therapy adoption for patients living with, again, lupus and multiple other autoimmune and inflammatory diseases.
Looking ahead, we are well-positioned for meaningful catalysts 2024 and beyond. In April, we plan to present additional data and publications, except in IgA nephropathy, including the follow-up data from the 80 milligram monthly and initial data from the I. again, 240 milligram monthly dose cohorts at the World Congress in nephrology meeting next month.
In the second half of the year, we plan to initiate Rainier pivotal Phase three study of post-tax except in IT and property and Denali, a Phase two study of Pulmotype SLE. In addition to updates on our clinical studies. We look forward to sharing translational data that further supports the investment, but until post-tax, except in multiple diseases.
I now hand the call over to Stanford to view our progress and provide updates on our development plan, both datasets in more detail standard.
Stanford Peng
Thank you.
Mentioned admitted describe the emerging clinical findings with Open Access continue to inspire us to advance is presently a possible unless continuing meeting. We reported the first clinical observations with Orbotech, except an idea where it was associated with a greater than 50% reduction from baseline in proteinuria at six months as measured by urinary protein and credit ratios are in TCR addition, the majority of patients met remission criteria as defined as reduction in UPCR of less than 0.5 grams per gram, at least a 50% reduction in UPCR from baseline in stable renal function as assessed by estimated glomerular filtration rate or EGFR. Importantly, these findings were associated with significant reduction. HEI., again, biomarker of TDIGA. one, supporting the concept of over time sensitive disease modifying therapy.
As a reminder, the approvable efficacy target has historically been 3% reduction in proteinuria at nine months are very encouraging. Findings continue to hold up with additional agents and with longer follow-up. But what next steps could indeed be a particularly compelling therapeutic option for patients with IBS and other autoimmune diseases, Air Force and hit them with amazing area for programming at the Company for the next pivotal phase of development. We look forward to the opportunity to provide a formal clinical data update, overtake perception, I guess next month at the World Congress of Nephrology, which will take place in a late-breaking poster. In the meantime, our primary development goal before we take a test is advancement this year to a pivotal trial of IGM. We are calling me here according to several other autoimmune and inflammatory disease indications remain of great potential interest over time is that first lupus remain the key indication. Second, only to IBM supported by the clinical validation of the pathway in the disease by asset additions and Well Testing hydrogen molecules, they need to plan to initiate a Phase two study in lupus called culpability later this year, and we continue to explore other renal indications at the Ruby Tuesday last year, Kidney Week would be described as single patient with primary member at the property or PNM would achieve and in a lot of coordination of OviTex that such findings suggest that other model antibody related benefit from Open Access. Indeed, we continue to enroll additional subjects with PMN. As a reminder, movie three and also enrolling lupus nephritis and has just recently opened an anchor associated vasculitis cohort. In addition, we continue to have or autoimmune type kit and reinforce a few important future opportunity. The Sheraton flex air Finally, ongoing emerging preclinical and translational data seems to suggest additional therapeutic areas like neurology or allergy, over 10% last year. And indeed, we observed a significant reduction in IgG. And again, patients who received overtaxed step potentially getting potential applicability of ICT related diseases like allergy.
We also presented data on COVID headset that allows all of Mindspeed revenues at the American Association of neuromuscular and electro diagnostic medicine, again will be the next month. We will present data on COVID-19 in a mouse model of encephalitis at the American Academy of Neurology. It might be a model of attacks that occurred superior to clinically relevant comparators, such an FcRn inhibition for B-cell depletion. We mid may in part be related to some beauty biophysical and or other developmental characteristics of OviTex conferring greater tissue penetration and more distribution than well. High-intensity IGBTs disappointed by this statement will be part of a coker feed and speed at the European meeting. Altogether, lead development only reinforced the potential for COVID had a set of broad secular impact and multiple serious diseases for the reminder will be negative with Discovery being helped by our proprietary directed evolution protein engineering platform. We have been quite productive and continued benign novel drug candidates to be agreed future interests. We therefore look forward to opportunities to provide further updates, not only on Pulmotype test, but also our development pipeline in the future. And outside of our R&D, our Chief Financial Officer, Dan Byrne.
And now I'll provide a brief overview of our financials for the year ended December 31st, 2023 for the year ended 2023 collaboration revenue was $58.9 million compared to $13.1 million for the same period in 2022. Increase in collaboration revenue relates primarily to a $24.9 million increase in AMI revenue, of which $20.4 million is due to a cumulative catch-up adjustment resulting from the completion of enrollment in SYNERGY for the amendment with that and a $4.5 million increase in advertising revenue, driven primarily by the expiration of Amgen's option to select a third research program. These increases were partially offset by $0.6 million decrease in Adaptimmune revenue as we completed our final deliverables under the agreement in June 2023.
Research and development expenses for the year ended 2023, inclusive of noncash expenses were $18.9 million and 70.2 million for the same period in 2022, an increase of $10.7 million or $10.7 million was driven by an $8.2 million increase in overtime asset costs, primarily related to higher clinical process development and manufacturing expenses. A $1.3 million increase in cotton costs and closeout costs due primarily to process development and manufacturing and a $7.7 million increase in personnel related costs.
General and administrative expenses for the year ended 2023 or $22.2 million compared to $18 million for the same period in 2022 degrees of $4.3 million was it primarily attributable to increases in personnel costs and professional services. The Company recorded net losses of $13.2 million and $57.8 million for the year ended 2023 and 2022, respectively. As of December 31st, 2023, outlined with cash and investments totaled $368.2 million, which we anticipate should be sufficient to fund our planned operations into 2026.
I will now hand the call back to Mitch.
Mitchell Gold
As Stanford highlighted, we are highly encouraged by the initial buying it yet for Metaxa and are just beginning to explore the full potential of this unique tangent best in class molecule. We look forward to a catalyst-rich year for data updates in IDS and other indications and the planned initiation of Rainier, our pivotal Phase three study and again and analysis on our Phase two study in SLE. In addition, we continue to evaluate potential potential for public access in additional indications. And as Stanford mentioned, we continue to invest in our immunology discovery efforts, advanced next-generation programs from our directed evolution platform.
With that, I'll turn the call over to the operator for questions.
Question and Answer Session
Operator
Thank you, Dr. Gold. (Operator Instructions)
Tara Bancroft, TD Cowen.
Tara Bancroft
Hi, good afternoon and thanks for hosting this call. So I have a question on ITP. expectations. So first, can you can you provide some potential conferences that the data might be presented? Like how you mentioned for the kidney data? It might be it at two different ones during the second half and now you've leveled it down, but you have just some granularity around potential venues and then what level of efficacy you're looking for to potentially start a Phase three study?
Stanford Peng
Yes.
Mitchell Gold
So really forthrightly our luggage as agency. I mean, we are interested in other.
Yes, yes. No, I agree. So yes, you have ITP. We have we have cold agglutinin disease. And our goal is to be able to, as we mentioned, we'll present that data in the first half of this year. So we haven't yet determined which conference that's going to be ever. There's a couple of that we have run out.
And then you had one other question on ROE, but there was again, no matter who they want to see in 99 and we look at it. And if we look at it since yes, you do have I'll remind you that these are highly refractory patients early in their third or fourth line therapy patients. I think what we saw a meaningful improvement in platelet count is really like a 20% response rate turn. Will that be meaningful?
Tara Bancroft
Okay, great. Thanks.
Stanford Peng
Okay.
Operator
Mike Ulz, Morgan Stanley.
Mike Ulz
Sorry, about that. Hey, guys, thanks for taking the question. Maybe two on Isagen in the update at WCN., can you maybe give us a sense of how many patients we should expect that the 18 to 40 milligram dose and the level of follow-up? And then maybe secondly, just what's your current thinking about selecting the go-forward dose? And what would you need to see at the two 40 milligram dose to bring that one forward? Thanks.
Mitchell Gold
Yes, thanks, Mike. So for WGN, when you say anticipate saying is for the first time, we'll get a look at nine month data at the 80 milligram dose cohort level in the nine month data is very important because that endpoint has the regulators used for accelerated approval I'll remind you that the benchmark there historically has been a 30% reduction in UPCR. And in six months we were seeing over 50% reduction in UPCR. In addition, at WCA and you'll get your first look at the 240 milligram data, and we expect that to be a relatively small number of patients thus far in the Lotus valve. When we look at it versus looking to push as we have added, we look at things now thinks we need to look dramatically better up with to 40 over here at 80 milligrams where we think best in class reductions in proteinuria, and that continues to hold until about nine months, we can greatly impact or the equivalent dose level.
I have 240, where I see that it has to be excellent for the Company and for eight sales.
Mike Ulz
Thanks very helpful.
Operator
Thomas Smith, Leerink Partners.
Thomas Smith
Hey, guys, good afternoon.
Thanks for taking the questions. And looking forward to seeing the data updates at WCR next month, can you just start remind us what your expectations are with respect to the 240 milligram dose relative to the strong 80 milligram dose data that we've already seen out at three and six months. Should we be looking for deeper or perhaps more rapid reductions in proteinuria at these earlier time points? Are you expecting your three similar reductions with the R. 240 milligram dose?
Mitchell Gold
Yes, I'm sure they have to get away at it. But what I would say, Nate, I'll remind you that you go back to our healthy volunteer data at 80 milligrams recovered in April for about three or three weeks. And then we lost coverage of non-covered bath and continue of. So the 80 milligram data so far continues to look best in class, but still early at 240 milligrams is something that we're going to continue to get a quick peek at it at WCN. never would have been no additional files that we could ship to 40 throughout the year as we move throughout the course of the year. As I said, we mentioned head of credit at year end, and we look forward to sharing additional data and augmentation at time of carry different. I'm going to add on that at all in terms of dosing at two 40, I think you've gotten in the US down.
Thomas Smith
Got it. That's helpful.
Yes.
And then just some in terms of continuing to enroll and again, patients in Ruby three at that 200, 40 milligram dose is the young expectation here that you're going to keep enrollment open until you can get the Phase three Rainier trial off the ground later this year?
Or is there their target enrollment that you're looking for?
And I guess some maybe lastly, how much overlap is there between the Ruby three trial sites and the planned sites for Rania?
Mitchell Gold
So what I can tell you that actually, we shared it at any at Kidney Week last year, enrollment and then we again or had been incredibly robust In fact, we have exceeded our enrollment expectations at 240 milligram cohort. So there's been a tremendous amount of investigator interest expense by eight. Interest is building in really three trial. I think that's a testament to the fact that these patients want disease-modifying treatments that are going to alter their disease. So we're pretty excited about the terms of the overlap there will be some overlap there in terms of the sites that are enrolling three and what we're doing and for our pivotal Rainier trial for our asset side, we're kind of we're really a bit of a kind of perfect situation where we expected both on both Phase three studies that are ongoing at IBM right now, we'll be wrapping up enrollment just as we're launching our Phase three to anticipate that we'll be the only Phase three trial they are enrolling during that timeframe, so that hopefully they'll make for a really robust enrollment time line, Kotak Asset Management yesterday.
Thomas Smith
Got it. That makes sense. Super helpful. Thank you, guys. Yes.
Operator
Gregory Renza, RBC Capital Markets.
Gregory Renza
Congrats on the progress. This is support onshore. Great. I have a question on Ruby for and could you remind us the rationale and if you have any preclinical evidence above and April should work synergistically are adequately in this indication and if they are better than the current standard of care. Thank you.
Mitchell Gold
Ever take that ever?
Stanford Peng
Yes, there are several always a very elevated level back in oh eight. It is various cytopenias. It may easily correlated with disease activity or severity of disease severity of the cytopenia, and we actually showed in some of our preclinical publication last year that in some preclinical models, for example, in New Zealand, black white label model, which includes an autoimmunity, can you be a manifestation that treatment with ConvaTec except can be beneficial. And similarly have shown that in certain models that inhibition of both Bethany processes with overtime except for other dual inhibitors, can be superior to either cytokine alone. And so that's why it actually connecting ClickMobile at all. There's a lot of these indications. And then, of course, there's the general rationale that there is a heavy dependence on B-cells, but it has made possible by the those studies also, if you compare against some standard of care, explained T-cell depletion of eight and the translation of preclinical models.
Gregory Renza
Okay. Thank you.
Operator
We will take our next question from Matt Biegler with Oppenheimer. Your line is open.
Matt Biegler
I'm Hamish and team on Good to hear from you. You guys plan to provide any analysis on antidrug antibody development or ideally lack thereof at WC.?
And I guess maybe to address some of the nagging questions on immunogenic immunogenicity.
Mitchell Gold
Yes, we have not seen any clinically significant ADA data on there. Obviously, we're continuing to monitor it as we have remarkably dataset will share that as we update and publish government is it also possible.
Maybe with a further follow-up that ostensibly if the data mature nicely that we can kind of put that idea interest one a unit is different than a lot of other recombinant proteins that are administered subcutaneously in a sense that the mechanism of the drug actually almost designed this EBITDA. So in a certain sense, you know, it's something that probably kind of sets us up well for. But I think if you look at the data that we've seen to date and you'll see the nine month data that we've presented at WCN. We're not seeing anything of clinical significance coming up.
Matt Biegler
Great. Looking forward to it. Thanks. Yes.
Operator
Joe Pantginis, H.C. Wainwright.
Joe Pantginis
Thanks for taking the question.
Good afternoon on. So I was curious, the extent of the translational data that's also coming up that you alluded to earlier.
And then also now that you're going to be going Pivotal, if you could just remind all of us sort of your capacity to address the manufacturing needs for the pivotal programs and early potential commercialization.
Thanks. And take those by maybe deal with the translational data. As we've said it and as we navigate that well, manufacturing and clinical spend?
Stanford Peng
Yes, we have some data at the European meeting later this week or filing or the translational data expanding on some of these studies we showed at AACR last year showing the rationale people invest in the business, but also preclinical studies looking at the distribution of the drug in different organs, demonstrating that ConvaTec, except actually has produced have quite good penetration and distribution ended in August compared to well attacking, which we think is part of why the drug release frequently appears to look better than bomb attack.
Joe Pantginis
Great.
Mitchell Gold
And then just on the manufacturing question is related with the trials. We've been fortunate that we had a very straightforward manufacturing process, but we and we have a lot of plans planning. We need industrial trucks.
Joe Pantginis
Fantastic. Thanks for the info. Yes.
Operator
Robert Driscoll, Wedbush Securities.
Robert Driscoll
Hey, good afternoon, guys, and thanks for taking the questions and maybe a little premature at this point, but how are you guys thinking about the ultimate kind of length of treatment in, again, difficult data sets.
Some of these we've mentioned nine months is kind of the important endpoint here for regulatory and how are you looking at really three patients funds follow-up?
Thanks.
Stanford Peng
Well, I think like most other therapies in this pathway. I think we're looking right now as a treatment for these initial treatment since we don't know yet what the optimal duration and the drug appeared to be quite and so there's not necessarily a need to live an agreement, a duty of potential side effects. That being said, of course, we're very interested in the mechanism of disease modifying therapy that may induce long-term remission. So perhaps as a subsequent live investigation, we wouldn't then think about exploring different lengths of treatment that it may result in long-term responses or hopefully cure Got it.
Robert Driscoll
Thanks, guys.
Operator
Andy Chen, Wolfe Research.
Andy Chen
Hey, thank you for taking the question. So regarding Ruby three enrollment. Can you remind us if enrollment is staggered by indication?
So we've seen a few patients and again, we've seen one patient in them and we haven't seen LN. data are we going to see progressively higher and the newer indications are we going to see more patients in them and a few a few months later, we're going to see another wave of data in LN and then and then Anke vasculitis, how does that work?
Stanford Peng
Yes.
I mean, it was not per protocol by the waiving of response study. We felt the pain of exclusively on IGA nephropathy initially, given part of the prior rationale of the pathway in that in that disease announce your name and actually win business even formally added to this study as well as the only meeting protocol related restriction and timing. But it would after we saw the encouraging initial data here and everybody sort of pushing on other indications and of course, that essentially adding back income estimated spending. So that's up like it did not so much a protocol, restricted timing, but more operational focused in terms of the different indications.
Mitchell Gold
And if there's a view, you will see a continuous flow of updates coming out about Ruby to re-enroll before. And I think that's one of the benefits we get out of the basket that you will get a longer-term follow-up for Mike and I both AT&T and 40 dose levels by the Army will continue to get yet NTM and an outline we'll see the additional intravascular data come out. It will be a trial that continues for a robust data flow coming out of those studies.
Stanford Peng
And then I noticed we did that we did grow at 80 milligrams. It is a multiple ascending dose study. So 80 milligrams were off per that slide. That was the first data center we announced last fall and then to 40 is lagging behind the scenes at the ascending dose design. And that's per indication.
Andy Chen
Thank you. That's helpful. Thank you.
Operator
There are no further questions. So this brings us to the end of our time for questions. Dr. Gold, I'll turn the call back over to you for closing remarks.
Mitchell Gold
I look forward to seeing many of you at upcoming investor and veterinary medical meetings and providing updates in the months ahead. Thank you again.
Operator
And ladies and gentlemen, this concludes today's call and we thank you for your participation. You may now disconnect.
