Good morning, welcome to the Eiger BioPharmaceuticals Prioritization Strategy and Business Update conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note, this event is being recorded. I would now like to turn the conference over to Wheelhouse Life Science Advisors. Please go ahead. Thank you. Good morning, everyone, and thank you for joining us today. Welcome to Eiger's Prioritization Strategy and Business Update conference call. We issued a press release earlier today, which is also available on our website at eigerbio.com. For today's call, we will have prepared remarks from management, followed by Q&A. We will use slides for the webcast, and a replay will be available on the investors section of our website. Joining me on the call with prepared remarks are Dr. David Apelian, CEO, and Dr. Ingrid Choong, Senior Vice President, Clinical Development, Dr. Colin Hislop, Senior Vice President of Clinical and Development Operations, Dr. Colleen Craig, Vice President of Metabolic Diseases, and Bill Kachioff, CFO, will join for Q&A. Before we begin, I would like to remind investors that this call will include forward-looking statements, including expectations concerning financial performance, commercial products, and potential future products in different stages of development. The forward-looking statements rely on certain assumptions, involve risks and uncertainties beyond Eiger's control, which could cause our actual results to differ materially from those described. A description of our risk factors is contained in Eiger's filings with the SEC, including our latest 10-K and 10-Q reports available on the Eiger website. All forward-looking statements are based on information currently available to Eiger. We assume no obligation to update these statements. I will now turn the call over to David. Thanks, Heather, and thank you for joining us today as we discuss the output from our robust portfolio prioritization analysis. Before we dive into our chart path, I want to highlight the opportunities within our diverse pipeline of innovative therapies. This prioritization process was critical in discerning a compelling path forward to realize the potential of our pipeline. Today's market environment necessitates prudent planning on how best to develop a potential breakthrough medicine for patients and to drive stockholder value, while positioning our innovative programs for success and greater access to patients. With support from our board and a global strategy consulting firm, we conducted a comprehensive process to assess our assets in virology and metabolic disease. As a result of this rigorous process, we bifurcated the pipeline between those programs that we believe will be best developed by Eiger, given our current resources more suitable for large, concentrated markets, and those programs that we believe could be better served by larger, well-resourced partners. Based on this rigorous assessment, we will primarily focus on internal development in metabolic diseases, particularly toward advancing avexitide in hyperinsulinemic hypoglycemia indications. We will also continue to commercialize Zokinvy for the treatment of Hutchinson-Gilford progeria syndrome and processing-deficient progeroid laminopathies. For the HDV and virology programs, we have engaged in strategic partnering discussions for lonafarnib and for peginterferon lambda. Let's dig into those decisions. Avexitide, our first-in-class GLP-1 receptor antagonist, represents a strong opportunity to build long-term value for Eiger shareholders. Avexitide provides an attractive path for value creation, given, one, its broad applicability in hyperinsulinemic metabolic indications. Two, it is a de-risked asset with strong phase II clinical activity. Three, it addresses high unmet needs where no approved therapies exist. Four, in particular, post-bariatric hypoglycemia, or PBH, represents a potential multi-billion dollar market and will be the lead indication in Eiger's pipeline. Importantly, an approximate 25% reduction in workforce, a removal of out-of-pocket spending related to our HDV development program, and our existing long-term loan are expected to extend our cash runway into the fourth quarter of 2024, not including any capital we could realize from a partnership. As for our late-stage virology assets, lonafarnib and peginterferon lambda, we believe the strength of our recent data and alignment on a regulatory path with the FDA make these assets attractive to potential partners, where we are engaged in active discussions. Avexitide offers tremendous potential as a pipeline and a product, allowing us to focus and streamline development while seeking to increase value. As I just mentioned, our initial focus will be on PBH, where we see the highest revenue potential, have demonstrated statistically significant improvement in the reduction of severe hypoglycemic events in phase II studies, and have FDA alignment on phase III study endpoints, sample size, and design. Beyond PBH, upon additional funding, we also plan to develop avexitide for congenital hyperinsulinism, or HI, an ultra-rare, life-threatening pediatric disorder of persistent hypoglycemia that results in irreversible brain damage in up to 50% of children with the disease, for which we also have Breakthrough Therapy designation from the FDA. Our focus on avexitide will leverage our expertise in orphan drug development, our internal scientific expertise in these indications, and our strengths in patient advocacy, an important element to penetrating rare disease markets. On the commercial front, we will continue to bring revenue for Zolgensma, our life-extending therapy for children and young adults with progeria, which has marketing authorization in the U.S., E.U., and U.K. The approval of Zolgensma demonstrates Eiger's ability to navigate complex global regulatory requirements and successfully commercialize medicines for patients in need. First quarter 2023, Zolgensma net product revenue was $4.1 million. Full year 2022 net product revenue was $12.7 million. On a personal note, I'm honored to be named CEO of Eiger. I've worked closely with Eiger for more than six years, having held various roles, including Chief Operating Officer and Executive Medical Officer, being a member of the Board of Directors, as well as a senior clinical advisor to the company, and most recently, serving as interim CEO. I look forward to leading the company through this pivotal time as we transition our focus to metabolics franchise. I'll now turn the call over to Dr. Ingrid Choong, Senior Vice President, Clinical Development, to provide a program overview. Thanks, David. I'll first provide a brief overview of our avexitide program, followed by our lonafarnib and peginterferon lambda programs. We believe avexitide, our first-in-class GLP-1 receptor antagonist, has the potential to confer meaningful therapeutic benefit across a broad spectrum of hyperinsulinemic hypoglycemia conditions. In patients with PBH, exaggerated secretion of GLP-1 with inappropriately high insulin secretion after oral ingestion of nutrients, has been well established, pointing to the critical role of GLP-1 in mediating PBH. As a GLP-1 receptor antagonist, avexitide targets this underlying mechanism and works upstream of beta cell insulin secretion. In clinical trials conducted to date, avexitide has been shown to reduce dysregulated insulin secretion and the occurrence of hypoglycemia. Similarly, reductions in hypoglycemia have been observed in trials conducted in patients with congenital hyperinsulinism. As David mentioned earlier, our initial focus will be on PBH, where we see the highest revenue potential. Beyond PBH, in the future, with additional capital, we also intend to develop avexitide for congenital hyperinsulinism. Greater than 1,000 individuals, including over 170 patients with PBH and HI, have received avexitide in clinical investigations conducted to date. PBH is a growing complication of bariatric surgery. As obesity continues to grow year after year worldwide, so has the need for weight loss procedures. For the majority of patients, bariatric surgeries have proven successful for weight loss. However, approximately 10% of gastric bypasses and 4% of sleeve gastrectomies result in post-bariatric hypoglycemia, characterized by frequent postprandial episodes of severe hypoglycemia, with blood glucose concentrations low enough to cause neuroglycopenic signs and symptoms, and often leads to devastating outcomes. These outcomes include altered mental status, visual changes, motor incoordination, loss of consciousness, and seizures, putting patients at risk for falls, motor vehicle accidents, and prolonged hypoglycemia. Many PBH patients are unable to drive, work, live alone, or care for dependents. Prevalence of PBH is estimated to be approximately 180,000 in the U.S. and approximately half of that in the EU. Proof of concept of avexitide was shown in more than 170 patients with hyperinsulinemic hypoglycemia in seven completed phase II clinical studies, the results of which demonstrated its ability to prevent hypoglycemic events in patients with hyperinsulinemic hypoglycemia. Notably, results from the 28-day phase II PREVENT study of 18 patients with severe PBH achieved both its primary and secondary endpoints of increased glucose nadir and decreased insulin peak during mixed meal provocation, respectively. Statistically significant reduction in rates of hypoglycemia, regardless of severity, were observed. Importantly, avexitide was shown to be well-tolerated. Adverse events were typically mild to moderate in severity and most commonly included injection site bruising, headaches, diarrhea, nausea, and dizziness. More recently, in a phase IIb trial in 16 patients with hypoglycemia after bariatric and other gastrointestinal surgeries, avexitide demonstrated statistically significant reductions in hypoglycemia and met the primary and secondary endpoints. Avexitide led to a significant reduction in the occurrence and extent of hypoglycemia, confirming results previously observed in gastric bypass patients in the PREVENT study, and demonstrated comparable or greater responses among patients with severe hypoglycemia after sleeve gastrectomy, total gastrectomy, or Nissen fundoplication. These new data support the broader potential of avexitide in patients with hyperinsulinemic hypoglycemia after bariatric and other upper gastrointestinal surgeries. Looking ahead, we have alignment with FDA on phase III endpoints, sample size, and study design for PBH, with endpoints for reduction in the rate of severe hypoglycemia. Of note, avexitide is the only drug in development with Breakthrough Therapy designation from the FDA for reducing the risk of hypoglycemia events in patients with PBH. We believe avexitide's competitive advantage is its targeted and preventative therapeutic approach, which is upstream of insulin secretion. Moving on to our virology programs focused on hepatitis, for which we are in active discussions with potential partners. Lonafarnib is a first-in-class oral prenylation inhibitor, where we recently completed the single pivotal phase III D-LIVR study in patients with chronic HDV. In December of last year, we announced that the end of treatment week 48 data showed that both lonafarnib-based regimens achieved statistical significance over placebo for the composite primary endpoint, as well as the component virologic and biochemical responses. Importantly, the improvement we observed in histology with a combination regimen represents the first time that a treatment of chronic HDV has resulted in a statistically significant improvement in liver histology. This result further strengthens assessment of the potential benefit of lonafarnib-based regimens and could be predictive of improved long-term clinical outcomes. In addition, last week at EASL in Vienna, we were pleased to report end of study week 72, 24 week post-treatment data, which demonstrated a clinically meaningful durability of response. The combined results demonstrated a statistically significant difference in composite response compared to placebo, with 14.2% and 26.4% in the oral and combination arms, respectively. Importantly, 22.7% of patients in the combination arm achieved below the limit of quantitation in HDV RNA at 24 weeks post-treatment with statistical significance. The durability of response at 24-week post-treatment is encouraging, as it suggests that finite therapy may be possible in a subset of patients with chronic HDV. This combined data set was shared with FDA last month in a productive pre-NDA meeting. FDA agreed that both lonafarnib arms achieved statistical significance on the composite primary endpoint versus placebo and indicated that the data may be supportive of a finite 48-week treatment of patients with chronic HDV infection. There was also agreement with the use of response-guided therapy to identify patients who are likely to achieve a clinical response with continued treatment for 48 weeks, while discontinuing therapy for those unlikely to benefit. The agency did indicate that additional virology experiments are needed before submission of an NDA and reminded us that a confirmatory clinical trial would be required to be underway prior to approval. We believe the strength of our data and alignment on regulatory path with the FDA makes this an asset attractive to potential partners. Peginterferon lambda is a potential first-in-class, well-tolerated interferon that has the potential to be the interferon of choice in antiviral combination therapies. Our phase III randomized LIMT-2 study of peginterferon lambda monotherapy is nearly fully enrolled in dosing in 144 patients. The primary endpoint was previously demonstrated in phase II, where 36% of patients achieved HDV RNA below the limit of quantitation at 24 weeks post-treatment, a durable virologic response or DVR. The DVR endpoint is meaningful for both regulatory agencies and physicians as it demonstrates durability of response to a finite therapy and the potential for a functional cure for hepatitis delta virus. As David mentioned, we see great potential of peginterferon lambda as a broad-acting antiviral and are in active discussions with strategic partners on this program and will look for a partner to support the continuation and completion of the phase III LIMT-2 trial. With that summary of our current pipeline, I'll now turn the call back over to David. David? Thanks, Ingrid. Before closing, I want to share my excitement for our future and the path forward in our strategy to focus on metabolics with avexitide and PBH as our lead development program. The good news for Eiger is that we have optionality in our pipeline and our priorities around the programs are set. We look forward to initiating our phase III clinical trial of avexitide for the treatment of PBH as funding permits. With this lead indication, we look forward to expand further in the avexitide development program in general hyperinsulinemia. For lonafarnib and peginterferon lambda, we are in active discussions with partners who would be able to advance these programs and realize their full potential. We believe the strength of our data, the innovation and complementary nature of these products relative to other therapies make them attractive for partnering. We appreciate the meaningful outcome from the recent D-LIVR data and factor that into our prioritization assessment, along with many other considerations. To that end, we determined that PBH provides a substantially better path to value creation for our shareholders. The virology programs of lonafarnib and peginterferon lambda can be better advanced to patients and bring value to Eiger in the form of collaborations with well-resourced partners. We are well positioned with our internal capabilities and expertise to recognize the value of avexitide. We are pleased to share our strategic vision for Eiger, which we believe will provide patients and physicians timely access to our drugs and potentially maximize value for shareholders, while also being prudent and judicious stewards of our capital. We plan to provide further guidance next quarter on the progress of our business development efforts for our virology assets, as well as definitive plans for the PBH phase III study initiation and key study milestones. We will now open the call for Q&A. Operator, please provide instructions for the Q&A portion of the call. We will now begin the question and answer session. To ask a question, you may press star, then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. Once again, that was star then one to ask a question. At this time, we will pause momentarily to assemble the roster. Our first question will come from Maury Raycroft of Jefferies. Please go ahead. Hi, good morning. Thanks for taking my questions. A lot of updates today. I wanted to start off with the HDV update. Maybe if you can talk more about what are the additional virology experiments required before submission of the NDA for lonafarnib for HDV that FDA wants to see. Can you talk about what FDA wants to see for the confirmatory study and also about how we should think about strategic partnering options and scenarios there? Sure. Thanks, Maury. Appreciate the question. In terms of the FDA, and the pre-NDA meeting, they indicated we would need to be doing some additional virology work prior to submission of the application on the D-LIVR data. They also informed us that a confirmatory trial would need to be initiated prior to approval, and that's a bit of a shift in the regulations that was fairly recent. In the past, companies have been able to share plans for confirmatory trials in the setting of an accelerated approval, and initiate them after approval. That has shifted in recent months in terms of the regulations being more rigorous. So those were two of the main feedbacks on the requirements, you know, that came out of the pre-NDA meeting. Thank you. Hey, Maury, and I just wanted to add also, as you know, the endpoints that are in the D-LIVR study are surrogate endpoints, so that two-log decline in HDV RNA and ALT normalization are surrogate endpoints. We knew from our end-of-phase II meeting that those were sufficient for accelerated approval and then for a full traditional approval, a second study for a long-term follow-up study to look at the clinical meaningfulness and outcomes would be required. From that perspective, it was expected. The second part of your question, Maury, is in terms of the partnering opportunities, we view the portfolio as having a virology franchise. Not only lonafarnib but lambda, of course, we believe lonafarnib, you know, based on the D-LIVR data, has complementary features that could be used with other agents such as pegalpha and others. We think it could be a really valuable partnering asset as part of that virology franchise. Lambda, of course, is a really nice all-purpose kind of a utility antiviral that can be used not only in hepatitis B, but HBV, and as we saw in our COVID study, for respiratory diseases such as COVID and flu. We believe there's a broader palette of indications that lambda could be very attractive to partners. Got it. Maybe one follow-up there. For the virology experiments, are you saying whether those would require additional clinical studies? Would you want those done before you get the NDA submission complete or the NDA package completed? Would you want that in place in order to get the most out of a partnership, most value out of a partnership? Yeah, good question. The virology work that was requested was fairly standard, part of a resistance, you know, package that you'd have to submit for any antiviral. We didn't see that as an extraordinary request, and it's certainly part of the package that a partner would have to use in the setting of filing the D-LIVR data for an approval. It's something we're considering, but it wasn't an unusual request, and for this type of submission, virology work is often asked for by the FDA. Got it. Okay, I'll stop there and hop back into you. Thank you. Thank you. The next question comes from Michael Higgins of Ladenburg. Please go ahead. Hi, good morning. This is Farhana on behalf of Michael. David, firstly, congratulations on the new position. Thank you. We have a few questions this morning. I wanted to start with the HCV-related questions first. Can we assume you have talked with potential licensors of your HCV assets and found they probably lost interest since the D-LIVR results? The next question is: Do you still plan to conduct a phase II, LIFT-2 study? On the first question, I don't really follow the question exactly. Could you rephrase it in terms of the licensors or? Yeah, we're trying to understand what has the interest been from licensors, you know, given the D-LIVR results? What I would say is I won't comment on specific feedback from potential partners, but I will say that we are in active discussions around the virology franchise, which would include both Lambda and lonafarnib. Based on that interest, we believe we can have a path forward for a value-added partnership that could provide additional resources for the company to invest in PBH. Beyond that, I won't be giving specifics about any of those particular discussions. Okay. do you also... Yeah, do you plan to conduct the phase two? Yeah. Yep. For your second question regarding the LIFT-2 study, yes, our plan is still to conduct that study. Just as a reminder for the audience LIFT-2 is an investigator-sponsored study being conducted at the NIH and funded by the NIH and is evaluating lonafarnib boosted with ritonavir in combination with peginterferon lambda in 30 patients. The plan is for that study to start later this year. We believe that this is a valuable study to be conducted as it does look at the combination of I guess two proprietary assets, where we have seen in prior studies the most robust results to date. Okay, great. I have two questions related to avexitide. Can you tell us a little bit more about the impurity issue that you guys had with the avexitide formulation? Has the phase III trial started enrolling yet? First, on the degradant issue that we had disclosed in the past, we don't see that as a significant issue. We believe it will be resolved before year-end, and it's not something that we see on the critical path to initiating the phase III. We have not yet initiated the phase III trial. We're in the process of planning that, and we look forward to providing more definitive guidance on the PBH phase III next quarter in terms of initiation and key study milestones. Okay, great. Just one last question: Does the cash guidance include, the phase III in PBH, and how much do you believe that trial will cost? The runway guidance to Q4 2024 does not include that. We believe the virology assets that we have in our discussions could very well provide enough resources to conduct the phase III. Importantly, the runway to Q4 2024 would allow us to also explore other funding options. It gives us more time to find the optimal way of funding the program. Okay, great. Thank you so much for taking our questions. Sure. Thank you. The next question comes from Yigal Nochomovitz of Citi. Please go ahead. Hi, team, this is Ashiq Mubarack on for Yigal. Thanks for taking my questions. I guess just following up on the last couple of questions on avexitide. It seems like you have made the choice to switch your indication priority to PBH, but I think previously you had been pretty close to initiating the phase III ASCEND trial in congenital hyperinsulinism. Can you give us a little color on why you made the choice to switch, and maybe what the long-term plan is for the ASCEND study? Thanks. Sure. We have decided to focus on PBH as our lead indication for avexitide, and that was largely driven by its much larger value opportunity in terms of the commercial market opportunity. There are also some other, you know, reasons that made it attractive, namely that a single phase III trial would be sufficient for an approval. We do have FDA buy-in on the key endpoints that we actually demonstrated in phase II already, the sample size and the major elements of the study design. In that sense, we viewed the avexitide PBH program as a more attractive lead indication. That being said, we're still very interested in CHI and intend to, when funding permits, to advance that program as well. We have confidence that avexitide could be a quite a good approach in CHI. We even factored in the potential for the PRV as part of that assessment, and still, even with the PRV factored in, the PBH opportunity for avexitide was substantially greater and made more sense for us to advance as the lead indication. Okay, got it. That's very helpful. Maybe I'll ask one more. I guess, what's the plan with the LIMT-2 study? It sounds like since that trial is nearly fully enrolled or fully enrolled, the plan is to just run that and have follow-up and see what the data looks like next year. Are there any other factors to consider as related to LIMT-2? We agree. LIMT-2 is a fully enrolled phase III program, and we think that's highly valuable for lambda and HCV. We're factoring that into our partnering discussions. We, you know, our expectation is that a partner would continue to fund that program through completion as it represents a really, we think, could be a very significant advance in the treatment of HCV. Got it. Thanks for taking my questions. Sure. Thank you. This concludes our question and answer session. I would like to turn the conference back over to David Apelian for any closing remarks. In closing, we're excited about the potential of avexitide on our own, as well as finding the right strategic partners to advance our hepatitis portfolio. We look forward to executing on our forward-looking strategy and keeping you apprised of our progress. Lastly, I want to thank our team of dedicated employees, and I also want to thank all of you for joining us on the call today. The conference has now concluded. Thank you for attending today's presentation, and you may now disconnect.