Q1 2023 INmune Bio Inc. Earnings Call
Speaker 1: I.
Speaker 1: I address areaso.
Speaker 2: Good day and welcome to the Immune Bio first quarter 2023 earnings conference call.
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Speaker 2: Please note today's event is being recorded.
Speaker 2: I would now like to turn the conference over to David Moss, Chief Financial Officer. Please go ahead, sir.
Speaker 3: Thank you and good afternoon everybody. We thank you for joining us for the call for inMubios first quarter 2023 financial results.
Speaker 3: With me on the call is Dr. R.J. Tessie, CEO of Immune Bio, and Dr. Mark Lodell, Chief Scientific Officer of Immune Bio, who will provide an update on Immune, our memory-like natural killer cell oncology platform.
Speaker 3: 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.
Speaker 3: These statements involve risks and uncertainties that can cause actual results to differ materially from those forward-looking statements.
Speaker 3: 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.
Speaker 3: There's no assurance of any specific outcome.
Speaker 3: 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.
Speaker 3: Except is required by law, immune biodeclaims, any obligation to update these forward looking any statements to reflect future information, events or circumstances.
Speaker 3: With that behind us, now I'd like to turn the call over to Dr. RJ Tessie, CEO of Immune of the Ohio Healthyaneous Dial. RJ. WHEN DOTAIM?
Speaker 4: 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. Thank you.
Speaker 4: in EXPRO with EXPRO, the DNF program, and then hand the call to Mark Lodell, R-C-S-O, who will speak about the developments in InkMium before I pass it back to David to discuss financial results and provide an update on upcoming milestones.
Speaker 4: Then we will move to Q&A.
Speaker 4: During the first quarter, our primary focus has been to accelerate recruitment into our international-blinded, randomized Phase II trial and patients with early Alzheimer's disease.
Speaker 4: 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.
Speaker 4: In Australia, we continue to see patients opting to continue treatment after the Phase 2 program and joining the Phase 2 Open Label Extension program.
Speaker 4: Although frustrated by the clinical hold, we remain, we continue to move forward with the blinded randomized phase 2 trial and patients with early ADI.
Speaker 4: And we have reached an understanding with the FDA regarding what is needed to list the clinical hold and 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.
Speaker 4: There have been tangible financial benefits. David Moss, our CFO , will provide more detail shortly.
Speaker 4: 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 can continue to invest there.
Speaker 4: These rebates significantly lowered our cash burn in the first quarter to roughly $1.2 million US dollars.
Speaker 4: On our last call, we announced a change in the scope of the Phase II program in patients with ADI.
Speaker 4: As a reminder, ADI is Alzheimer's disease in patients with biomarkers of inflammation, our target population that is about 50 percent at least of patients with Alzheimer's disease.
Speaker 4: Based on new data and a desired stream line,
Speaker 4: the clinical operations of the trial.
Speaker 4: We combined the two blinded randomized phase two trials into a single program.
Speaker 4: Originally, there was a trial in mild ADI patients and a trial in MCI patients.
Speaker 4: MCI is mild cognitive impairment, the pro-dromal Alzheimer's disease syndrome.
Speaker 4: These are now combined.
Speaker 4: into a single trial of early ADI that includes both mild ADI and MCI patients.
Speaker 4: This format has not compromised.
Speaker 4: the trials, but is a benefit.
Speaker 4: Consolidation of the mild ADI and MCI patients into a single trial improves the probability of success, comes with significant cost savings.
Speaker 4: conforms with the industry standard and aligns the program with the expected design of a pivotal phase 3 trial.
Speaker 4: 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.
Speaker 4: Currently, the Phase II is a blinded randomized placebo controlled study in early AD patients with biomarkers of information that uses a validated measure of cognitive function as the primary endpoint.
Speaker 4: 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.
Speaker 4: That is, we don't want to just decrease the rate of cognitive decline. We want to stop cognitive decline in patients that receive expro. Patients who are treated with expro in this trial are treated for six months.
Speaker 4: After that six month period, the patients are offered the opportunity to enroll in a 12 month open label extension trial.
Speaker 4: The Open Label Extension Trial is a 12-month study where safety and efficacy of the X-Pro treatment in patients with early ADI will continue to be evaluated.
Speaker 4: Effort to see will be assessed every three months by MRI and clinical rating scales.
Speaker 4: All the patients that enroll in the open label extension receive expert, regardless of previous treatment assignment.
Speaker 4: 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.
Speaker 4: The Open Label Extension Strategy will provide this critical safety data. Second, the Open Label Extension provides long-term efficacy data.
Speaker 4: Finally, the open label extension is a recruitment tool.
Speaker 4: 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-level extension is high and the clinical teams are enthusiastic.
Speaker 4: We expect to share some data in due time.
Speaker 4: We signaled our interest in the use of DNTNF, our dominant negative TNF platform, for the treatment of the Shane Muscula dystrophy or DMD.
Speaker 4: 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...
Speaker 4: the MD with our dominant negative TNF compounds.
Speaker 4: 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.
Speaker 4: Our confidence in a DMD
Speaker 4: a treatment is based on preclinical data.
Speaker 4: The ticket for entry into DMD as a therapy is that it must decrease inflammation in the muscle and decrease muscle fiber destruction.
Speaker 4: In the animal models, DNT&F does this and more. The most interesting and novel attributes.
Speaker 4: is that DNT and F treatment promotes muscle fiber regeneration. To our knowledge, muscle fiber regenerates, Asian 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.
Speaker 4: 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 therapy may work, but the durability of the therapy.
Speaker 4: and who will benefit is unknown and complicated. Furthermore, we suspect gene therapies may benefit from an anti-inflammatory boost.
Speaker 4: that also has regenerative medicine effects. Today most patients are treated with corticosteroids, a time worn and dangerous standard of care.
Speaker 4: Quarter-Casteroids slow the progression of D&D but at a price.
Speaker 4: Most of the metabolic and cosmetic problems in boys with DMD are related to corticosteroid use.
Speaker 4: If the only benefit of DMTNF 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 DMTNF therapy.
Speaker 4: of corticosteroids to treat the disease. Like the DMD program, we use NBO3, our cancer program using a DMT&F compound, as a partnering program. I don't need to tell dedicated biotech investors, the oncology drug development space is changing.
Speaker 4: Typically, innovation and cancer therapy comes in two forms, development of new therapies, or the better use of existing therapies.
Speaker 4: Inventing new drugs is hard and the number of unclaimed pathways in cancer therapies are few.
Speaker 4: Although MBO3 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 MBO3 to treat muck-for-expression cancers to decrease resistance to existing therapies such as in HER2.
Speaker 4: I mean checkpoint inhibitors, anti-racing kinase inhibitors.
Speaker 4: Adding in BO3 to the therapeutic cocktail treating mutfoward positive, cancer should improve patient survival.
Speaker 4: Our goal is to find a partner, the 4MBO3, to allow this promising asset to benefit patients and allow immune biologists to focus on our core mission.
Speaker 4: the treatment of Alzheimer's disease. I will now move to Inckmune, our memory-like natural killer cell priming program, and pass the call to Mark Ladell, CSO, describe this in more detail. Mark?
Thank you, RJ. And thank you all for joining this call, and I'm looking forward to your questions later. So in early April , we took our first interneclineical expansion step towards the treatment of solid tumors, via the filing of an IND for the use of INMune to treat patients with metastatic castration resistant prostate cancer.
and in the US. The finding was supported by our positive pre-tinital solid tumor data in prostate, renal cell carcinoma, ovarian cancer and indeed nasopharyngeal cancer.
All chimousel lines which are resistant to natural kinestel killing.
The prostate cancer trials are expected to take place at four or more medical centres in the US and it uses a Bayesian optimal interval phase one to trial design. The trials are expected to roll up to 30 patients and along with safety the open labelled trial will evaluate tumour progression using traditional efficacy endpoints of disease burden, PSA and CT scans.
as well as non-traditional measures of disease burden, CTDNA and 18F PSMA PET scans.
So by the end of this open labelled trial, we will understand firstly the safety of ink mun in this new patient population, the dose to be used in a subsequent blinded, randomized pivotal trial and have some indication of the ability of ink mun to control disease in patients with metastatic prostate cancer. We're excited about the potential of ink mun as we expand into treatment
which leaves us to believe it can treat solid tumors.
The microenvironment of solid tumors is hypoxic and contains immunoregulatory cells which inhibit T cells and indeed end-case cell function.
Includes not only primers for patients own nitrochlorous cells to override the immunosuppression of pypoxia and the regulatory cells in the tumor microenvironment. It induces differentiation of the NK cells into a memory-like phenotype.
This memory-like phenotype in K cells are not susceptible to the human or impressive signals from cancer cells, and they express proteins on their surface which protect them for exhaustion and senescence.
Uniquely, these memory-like encase cells secrete a protein which can remove inhibitory signals from tumor cells.
And at the same time increase the strength of the bond between the encase cell and the cancer cell. All of this occurs even in extreme hypoxia. I presented most of these data at the innate killer summit in Europe last year. And a video at the presentation is currently available on the company's website. Under the Therapist tab, inkmune videos or via the company's YouTube channel.
Meanwhile, we continue to treat patients in the MDS AML Phase 1 trial and have recruited the first patient at the second UK clinical site and opened our first site in mainland Europe .
4 UK patients have received complete three dose measurements so far and in therapy has been safe at the dose tested.
Indeed, the fourth patient to be treated receiving unit on an outpatient basis.
which is our planned treatment scenario for the prostate cancer trial in the US. And it's a world away from the days of hospitalisation associations with most current cell therapies.
Through the four patients with hematological cancer, created so far, have shown evidence of encase electivation, and we're analysing the biomarker data to identify those which could best predict outcome.
Of the four patients treated, one remains alive 20 months post-treatment and has enjoyed a much improved quality of life with fewer hospital visits.
Two patients were bridged to transplant, although sadly one died while waiting for a suitable stem cell donor.
So, whilst very early in the clinical trials of incline, and being restricted to using the lowest dose at this stage,
The trial chief investigator who has treated the four patients with hematological disease stated, and I'm quoting him here, all enjoyed an improvement in general fitness with resolution of fevers, stabilized or even improved blood counts, and we were able to give breaks from the low dose chemotherapy they had been receiving.
Definite improvement in subjective parameters of well-being, mood, appetite and clinical performance status.
The clinical experience was presented at the American Society of Hematology in the annual conference in New Orleans last December .
Now in preparation for the increased recruitment into the Laurel NVS trial and the opening of our new trial in metastatic castration resistant prostate cancer, the company has invested in upscaling the manufacturing process of ink immune and the validation of that new process to CGMP is now complete.
This increases capacity and reduces costs substantially. The new manufacturing process forms the basis of the current IND application to the FDA.
This investment pays the way for ambitious plans for trials in other solid tumors, including a very cancer, renal and noza-farran-jule cancer.
as we acquire the relevant supporting data from my R&D team.
Thank you, fellow Indian shareholders, for the trust you've instilled in the company and for the opportunity to provide you with this update on the Indian platform.
I look forward to speaking to you again next quarterly call in three months. RJ, after you.
At this point, I'd like to turn the call over to David Moss, our CFO , to review certain financial terms.
all over the David Moss, I see a photo who reviews certain financial terms. Thank you.
Thank you, RJ and Mark, for the update. I'll provide a brief overview of our financial results and upcoming milestones before we head to our Q&A session.
period in 2022.
Research and development expense totaled approximately 4.1 million for the quarter-ended March 31, 2020-3, compared with approximately 4.3 million for the comparable period in 2022.
General and administrative expense was approximately 2.3 million for the quarter ended March 31st, 2023, compared with approximately 2.3 million for the comparable period in 2022. At March 31st, 2023, the company had cash and cash equivalents of approximately 51 million.
last two quarters. As RJ previously mentioned, we continue to focus on achieving our primary clinical trial objectives while remaining cost-prudent.
To reiterate, a key cash management point highlighted in the Q4 call, the previously announced consolidation of the AD and MCI trials were reduced overall previously forecasted budget outlays for the two combined trials by approximately $8 million.
Further, as we continue to dialogue with the FDA, our budget at Spend in the US is not occurring as forecasted thus resulting in less capital outweighs.
As highlighted in both the specific press release and the Q4 call, we expect to continue to receive further cash rebates as we spend on international trials.
based particularly in Australia. In some, these events and actions along with longer term strength of the US dollar reduced our base currency costs in foreign jurisdictions such as Australia have significantly reduced our expenses with the first quarter to roughly 1.2 million cash.
We're particularly pleased with our progress during the quarter on all fronts and all of the aforementioned items better position us to manage our cash one way more officially to reach our target goals of recruitment.
Now I'd like to move on to our list of upcoming important milestones. Top line results for our Phase 2 early Alzheimer's disease trial in patients with inflammation and Alzheimer's disease is expected in the second half of 2024.
We will initiate a Phase II trial of EXPROW in patients with treatment resistant depression upon resolution of the FDA manufacturing review.
Additional Open Label Phase 1 trial data, I think being in high-risk NMDS AML in 2023.
Initiation of a Phase I-2 program in metastatic castration-resistant prostate cancer upon the acceptance of the IND by the FDA, which it occurred in the first half of 2023.
Finally, as Arja had mentioned, we are pursuing business development opportunities and it can be no assurance that the company can complete any of the transactions as they are complex and difficult.
We have two platforms and as a small company we will try to expand the applications of these platforms in areas. We do not have the resources or expertise to pursue ourselves in order to benefit shareholders.
Naturally, we will update investors should material business developments occur.
In summary, we are pleased with our progress during the quarter, continue to overcome obstacles, and are grateful for our shareholders' trust and support in our companies. We continue to work hard to bring value from our platforms.
by carefully managing our shareholder resources.
At this point, I'd like to thank you for your time and attention. I'd like to turn the call back to the operator to pull for questions.
Thank you. We will now begin the question and answer session.
To ask a question you may press star then want on your touchdown phone. If you are using the speaker phone we ask that you please pick up your handset before pressing the keys. To a jogger question please press star then two. To a jogger question please press star then two.
Today's first question comes from Tom Schrader with BTIG. Good afternoon. Thanks for taking my questions. I actually have a question first for Mark. One of the biggest surprises in I.O. is that it works with chemo. Do you have any sense of your approach? Do you have pre-plinic?
Okay so
Mark... laughter
All right, I guess that's a bad question. Yeah, let's see if we can fix the things that will come up. There it is. Yeah, hello. Sorry, I was muted. Yeah, it's a great question. It's not something that we can test in VTROPE and the animal models for, I don't really exist outside of us.
the setting of chemotherapy and that prostate cancer is one of those so that's why the risk has gone down that route.
Okay, and then kind of, I think, an obvious one for RJ. You know, it looks like the A-beta antibodies are here to say. How do you think about developing a drug that's quite different in the presence of what is probably going to be a piece of the treatment landscape? Your initial thoughts?
Pivotal trials using anti-M alloyed.
uh... therapies of the gay consistent results and i think the best way to describe it is that if i may paraphrase uh... lilies leadership today is
These drugs may stall progression for six or seven months.
Although we don't know everything about the Lilly trial, we'll learn more in AAC in July . I believe we understand the benefits and liabilities of this class of drugs. But I think there's three main issues and this is where opportunities exist.
I don't think delaying progression is not where we need to be. It's a start, but I believe we need to stop dementia and it's tracks. So I think that we can do better.
for sure.
I personally, and I think many in the field are confused by the safety profile of these drugs. What will happen when Amalegra gets in the hands of community neurologists?
Why does the brain volume continue to shrink? These are answers to questions that are needed. I'm sure we'll get them over time. But the safety issues are real, and this is a fragile population that you're treating.
And then finally, what happens with patients that progress on the anti-aneloid drugs? I mean, the majority of patients continue to progress. I mean, Lily's built its whole program around stopping the drug when you get below a certain threshold of amyloid.
If patients progress, what do you do? And I think this is where combination or sequential therapy will be needed. And that will play very well to X-Pro.
So, you know, I actually believe that there's a lot of opportunity for expro in the space either as...
A therapy alone, we're part of combination of sequential therapy. Five years from now, treatment of amyloid.
The treatment of Alzheimer's disease is going to look a lot like the treatment of cancer. Therapy will be personalized where drugs are used to fit the needs of an individual patient.
We believe this is good for us, as you know, we focus on biomarkers and those biomarkers dictate who can benefit from X-Pro and who...
What that benefit looks like. But let's be real. Well done to Lily Kudos. They had a great result. Today's news is great for patients. It's great for Alzheimer's and it's great news for immune bio. Thanks for the question, Tom. Cheers.
benefit looks like. But let's be real. Well done to Lily. Kudos. They had a great result. Today's news is great for patients. It's great for Alzheimer's. And it's great news for immune bio. So thanks for the question, Tom. Sure. Thank you.
Thank you and ladies and gentlemen as a reminder if you'd like to ask a question please press star card 10
All right, next question comes from Daniel Carlson with Tailwinds Research. Thanks for taking my question. Can you talk a little bit about the timing of the IND for prostate?
Yeah, so, you know, I say I'm sitting here, I'm Pinten Needle. I mean, if you guys do the math, we're supposed to hear this week. I can honestly say, as of two seconds ago when I checked my email, we have not heard, but it will be this week. And so you will learn probably early next week where we stand on that. I will say that we had...
Very, what's the right word, very vibrant dialogue between the FDA and the manufacturing team led by Mark, the clinical team led by me on the I&D, which is a sign that at least they're reading it.
So, you know, all I can say is you're going to hear one way or the other next week for sure.
Awesome. And then about the patients on the extension trial, I know you're going to come out with data at some point to be determined. But I'm wondering if there's anything you can sort of say, can generally about what you're seeing from the patients there.
So the problem with the extension trial is we don't know what they were on coming into the trial.
And we're kind of struggling, we haven't yet figured out what this looks like because you've got, you know, two out of three patients come in having had six months of expro, one out of three come in having had placebo.
So what happens in the first three months or so, you know, based on the phase one trial, is going to be meaningful. So we're trying to figure out how to unravel this in a way that we can provide meaningful data to you guys so we can understand it, also not compromise the blinding of the trial. So it's a little bit...
Obviously, it's a little bit complicated until we unblind it, but we'll get you something when the time's right and we make sure one, one, we're not compromising the blind of randomized phase two and two, we can make accurate statements that aren't going to confuse things down the line. Gotcha. And then last question from me, just the...
and business development. So I will let him answer this question. Please David.
Thanks, RJ, and thanks, Dan, for the question. You know, the best thing I can do is tell you exactly what I've shown the call to Ann, unfortunately, and it's that we'll update you on it. I think that the industry right now is on pins and needles to see what happens with Sirepda, which is going to happen this month. And then based on whatever direction happens, I think it'll be a very good time for in-mune to have a number of conversations with all of the key players in the industry.
Appreciate it, Dan. Thanks for your patience.
Thank you. And our next question today comes from Jason McCarthy with Maxon Group. Please go ahead. This is a chat on for Jason. I was sooner you could expand a little bit on the importance of the biomark directed imaging as it relates to the prostate program.
Yeah, thank you. I mean, we actually, and this is really Matt Redding talking. I mean, you'll get a chance to hear from him directly. He's our PI. He's the head of G.O. oncology at the UCLA.
Thank you, and ladies and gentlemen, this concludes our question and answer session. I would like to turn the conference back over to Dr. Tessie, Franny Closing remarks. Yeah, so thank you for listening to the call. I mean, we grow more excited about our lead platforms every day. As you know, Alzheimer's and Inc. Mune are both novel strategies that have risk and reward. But the bottom line is that we are targeting neuroimplamation, which is now recognized as an important part of CNS pathology and NK cells, at least the way Mark goes after them, is novel.
And in fact, if you listen to what he said closely, you know that he has been hard at work on the R&D front, and he has hinted at new findings on how Inkmoon works, and he will explain these once we get the IP in place.
And finally today, I think we really want to emphasize that we really have a two-pronged approach in Mumbai. One is that we focus like a laser on our core missions and expro and CNS and Inc. Mutant Solid Tommers. And secondly, we have this business development effort or partnering effort ongoing because we have valuable assets that we don't want to waste, so to speak.