INmune Bio Inc.

Good day, and welcome to the ImmuneBio first quarter 2023 earnings conference call. All participants will be in a 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 a touch-tone phone. To withdraw your question, please press star then two. Please note today's event is being recorded. I would now like to turn the conference over to David Moss, Chief Financial Officer. Please go ahead, sir.

Thank you, and good afternoon, everybody. We thank you for joining us for the call for MUBio's first quarter 2023 financial results. With me on the call is Dr. RJ Tessie, CEO of Immune Bio, and Dr. Mark Lodell, Chief Scientific Officer of Immune Bio, who will provide an update on IncBio, our memory-like natural killer cell oncology platform. Before we begin, I remind everyone that except for statements of historical facts, the statements made by management and responses to questions on this conference call are forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that can cause actual results to differ materially from those forward-looking statements. Please see the forward-looking statements disclaimer on the company's earnings press release as well as risk factors in the company's SEC filings, including our most recent quarterly filing with the SEC. There's no assurance of any specific outcomes. Undue reliance should not be placed on forward-looking statements which speak only as of the date they are made as the facts and circumstances underlying these forward-looking statements may change. Except as required by law, Immune Bio disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances. With that behind us, now I'd like to turn the call over to Dr. RJ Tessie, CEO of Immune Bio. RJ.

Thank you, David, and thank you, everyone, for joining the call. I will arrange my remarks to highlight the key takeaways for the first quarter and the subsequent period and also provide updates on our platform programs. I will start by reviewing developments in EXPRO with EXPRO, the DNF program, and then hand the call to Mark Liddell, our CSO, who will speak about the developments in INCME before I pass it back to David to discuss financial results and provide an update on upcoming milestones. Then we will move to Q&A. During the first quarter, our primary focus has been to accelerate recruitment into our international blinded randomized phase two trial in patients with early Alzheimer's disease. We are working to develop the infrastructure needed to expand the number of clinical trial sites in Canada engage in enrolling patients, along with adding regulatory jurisdictions beyond North America. In Australia, we continue to see patients opting to continue treatment after the Phase II program and joining the Phase II open-label extension program. Although frustrated by the clinical hold, we continue to move forward with the blinded randomized Phase II trial in patients with early ADI And we have reached an understanding with the FDA regarding what is needed to lift the clinical hold and are on track to meet those commitments before the end of the year. Although the FDA hold has affected the pace of enrollment of patients into the clinical trial, there have been tangible financial benefits. David Moss, our CFO, will provide more detail shortly. But because a meaningful portion of the trial thus far has occurred in Australia, We have received a sizable research and development rebate in February and expect to continue to receive additional rebates as we continue to invest there. These rebates significantly lowered our cash burn in the first quarter to roughly $1.2 million. On our last call, we announced a change in the scope of the Phase II program in patients with ADI. As a reminder, ADI is Alzheimer's disease in patients with biomarkers of inflammation, our target population that is about 50%, at least, of patients with Alzheimer's disease. Based on new data and a desire to streamline the clinical operations of the trial, we combined the two blinded randomized phase two trials into a single program. Originally there was a trial in mild ADI patients and a trial in MCI patients. MCI is mild cognitive impairment, the prodromal Alzheimer's disease syndrome. These are now combined into a single trial of early ADI that includes both mild ADI and MCI patients. This format has not compromised the trials, but is a benefit. Consolidation of the mild ADI and MCI patients into a single trial improves the probability of success, comes with significant cost savings, conforms with the industry standard, and aligns the program with the expected design of a pivotal phase three trial. This change is not easy, but the complex regulatory process is beginning to bear fruit. Once fully implemented, the pace of enrollment should increase in Australia and Canada and should energize enrollment in newly added regulatory jurisdictions. Currently, the phase two is a blinded randomized placebo-controlled study in early AD patients with biomarkers of inflammation. that uses a validated measure of cognitive function as the primary endpoint. The phase two is a test run for a pivotal trial, and based on data from the phase one trial, our goal is to stop cognitive decline. That is, we don't want to just decrease the rate of cognitive decline, we want to stop cognitive decline in patients that received Expro. Patients who are treated with Expro in this trial are treated for six months. After that six-month period, the patients are offered the opportunity to enroll in a 12-month open-label extension trial. The open-label extension trial is a 12-month study where safety and efficacy of the ex pro treatment in patients with early ADI will continue to be evaluated. Efficacy will be assessed every three months by MRI and clinical rating scales. All the patients that enroll in the open label extension receive Expo regardless of previous treatment assignment. The open label extension serves multiple purposes. First, it provides long-term safety data. We believe the regulatory authorities expect 18 months of safety data for marketing authorization. The open label extension strategy will provide this critical safety data. Second, the open label extension provides long-term efficacy data. Finally, the open label extension is a recruitment tool. Guaranteed access to 18 months of treatment following a six-month study provides significant advantages to patients and their clinical teams. So far, participation in the open label extension is high, and the clinical teams are enthusiastic. We expect to share some data in due time. We signaled our interest in the use of DNTNF, our dominant negative TNF platform, for the treatment of Duchenne muscular dystrophy, or DMV. As highlighted in the January 25th press release, we established DNO2, Inc., a separate wholly-owned subsidiary that will hold the intellectual property needed to facilitate partnering and business development activities for treating DNO2. DMD with our dominant negative TNF compounds. This structure allows us to focus on our core mission, which is the treatment of Alzheimer's disease, without leaving a valuable asset on the shelf, so to speak. Our confidence in a DMD treatment is based on preclinical data. The ticket for entry into DMD as a therapy is is that it must decrease inflammation in the muscle and decrease muscle fiber destruction. In the animal models, DNTNF does this and more. The most interesting and novel attribute is that DNTNF treatment promotes muscle fiber regeneration. To our knowledge, muscle fiber regeneration has not been seen in any small molecule, biologic, or gene therapies being tested to date. A therapy that promotes muscle fiber regeneration may change the course of the disease in these boys. Some of you are wondering why we are promoting a biologic therapy at the dawn of the gene therapy era in DMD. The answer is simple. Gene therapies may work, but the durability of the therapy and who will benefit is unknown and complicated. Furthermore, we suspect gene therapies may benefit from an anti-inflammatory boost, but also has regenerative medicine effects. Today, most patients are treated with corticosteroids, a time-worn and dangerous standard of care. Corticosteroids slow the progression of DMD, but at a price. Most of the metabolic and cosmetic problems and boys with DMD are related to corticosteroid use. If the only benefit of DNTNF therapy is to replace corticosteroids, it is a big win for patients who currently suffer from insulin-resistant diabetes, obesity, cardiovascular disease, short stature, hirsutism, and muscle weakness due to the promiscuous use of corticosteroids to treat the disease. Like the DMD program, we use MbO3. our cancer program using a DNTNF compound as a partnering program. I don't need to tell dedicated biotech investors the oncology drug development space is changing. Typically, innovation in cancer therapy comes in two forms, development of new therapies or the better use of existing therapies. Inventing new drugs is hard, and the number of unclaimed pathways in cancer therapies are few. Although NbO3 acts as an innate immune checkpoint inhibitor, it is ideally used as part of combination therapy to make existing drugs better. We are focused on using NbO3 to treat MUC4-expressing cancers to decrease resistance to existing therapies such as Nher2, immune checkpoint inhibitors, and tyrosine kinase inhibitors. Adding NbO3 to the therapeutic cocktail treating MUC4-positive cancers cancer should improve patient survival. Our goal is to find a partner for MbO3 to allow this promising asset to benefit patients and allow ImmuneBio to focus on our core mission, the treatment of Alzheimer's disease. I will now move to IncMune, our memory-like natural killer cell priming program, and pass the call to Mark Liddell, CSO, to describe this in more detail. Mark.