Full Press Release Details
C O R P O R A T E P A R T I C I P A N T S
David Moss, Chief Financial Officer
RJ Tesi, Chief Executive Officer
CJ Barnum, Head of Neuroscience
Mark Lowdell, Chief Scientific Officer
C O N F E R E N C E C A L L P A R T I C I P
Mayank Mamtani, B. Riley Securities
Daniel Carlson, Tailwinds Research
P R E S E N T A T I O N
Greetings, and welcome to the INmune Bio Third
Quarter 2022 Earnings Call.
As a reminder, this conference is being recorded.
At this time, it is my pleasure to introduce Mr.
David Moss, CFO at INmune Bio.
David, thank you the floor is now yours.
Good afternoon, everybody. We thank you for joining
us for the call for INmune Bio's third quarter 2022 financial results.
With me on the call is Dr. RJ Tesi, CEO of INmune
Bio, and Dr. CJ Barnum, Head of Neuroscience, who together will provide a business update on our dominant negative TNF platform, or DN-TNF
for short. Also on the call is Dr. Mark Lowdell, Chief Scientific Officer of INmune Bio, who will provide an update on INKmune, our memory-like
Natural Killer cell oncology platform.
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call. This transcript is being made available for information purposes only.
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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 provision of the Private Securities Litigation Reform Act of 1995. These statements involve risks and
uncertainties that could cause actual results to differ materially from those in such forward-looking statements. Please see the forward-looking
statements disclaimers 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 outcome.
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 INmune Bio disclaims any obligation to update these
forward-looking statements to reflect future information, events, or circumstances.
With the forward-looking statements behind us,
now I'd like to turn the call over to Dr. RJ Tesi, CEO of INmune Bio.
Yes, thank you, David.
Today's call is organized a little bit differently.
We have both Mark Lowdell and CJ Barnum on the call, and I believe going forward you will see this larger cast on the calls, because we
are complicated company with a lot of programs going on. We believe that Investors learn the most when they hear directly from the people
that are responsible for those programs.
I will begin with XPro, with some just top line
comments. Obviously the most important issue is the clinical hold that we are under from the FDA. As we've stated previously, the
clinical hold was placed on XPro1595 due to manufacturing issues. These issues are technical in nature, and they are related to the fact
that manufacturing batches were separated by many years and by geography, i.e., different manufacturing plants. This has caused some problems
related to the manufacturing controls and release testing.
We have been working very closely with the FDA
and our manufacturing teams to resolve these problems. We continue to look forward to clearing these hurdles.
Despite this delay, we continue to make progress
with the AD02 trial in mild Alzheimer's disease patients in Australia. We are exploring other regulatory venues that we will hopefully
be able to open the trial and continue to enroll patients or begin to enroll patients. The XPro program is like a coiled spring. Once
the clinical hold is lifted, we will work to have both AD02 in mild AD, and AD03 and MCI, or mild cognitive impairment, enrolling in all
regulatory jurisdictions.
Soon after those two programs are enrolling, we
plan to launch the treatment-resistant depression program in the U.S. Importantly, we will update guidance on the timing of top line readouts
in the Alzheimer's trials at the end of the year. Obviously the timing of those readouts depends on our discussions with the FDA.
I will now pass it back to Dr. CJ Barnum, the
VP of Neurosciences, to speak about the Alzheimer Phase 2 programs.
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As RJ mentioned, we continue to enroll patients
in Australia for the AD02 study. AD02 is a blinded randomized placebo controlled study evaluating cognition in patients treated with XPro
for six months. We are pleased to announce that the first patient has completed the six month Phase 2 study. Notably, this patient has
elected to enroll in our open-label extension study. This open-label extension is a 12 month study where safety and efficacy are evaluated
in an unblinded fashion. All patients that enroll in the open-label extension study receive XPro.
The open-label extension has three purposes. First,
it is a recruiting tool. Patients are offered a year of therapy after participation in the trial. Second, this helps in our product approval
strategy. The FDA and other regulatory authorities focus on both efficacy and safety. The open-label extension provides the expanded and
extended safety database required for approval. Finally, the open-label extension provides long-term efficacy data.
In the Phase 1 trial, MRI biomarker showed continuous
improvement through 12 months. While the data from the open-label extension are not placebo-controlled, nor blinded, they do provide additional
information that will inform the clinical development strategy. We expect to report data from the open-label extension in 2023.
Finally, we remain as confident as ever that we
have the right drug for the right target. Two recent developments reinforced this belief. The first comes from the literature that continues
to provide evidence for targeting TNS. Yet another nationwide study has reported that TNF inhibitors reduce the risk of dementia. There
are now five epidemiological studies examining more than 16 million records that show anti-TNF therapies reduce the risk of AD and/or
dementia by up to 75%.
The second comes from patients treated in the
Phase 1 study. We have been extremely encouraged by their desire to remain on therapy. As a result of their persistence, we have opened
a special access program in Australia, like compassionate use in the United States. As a result, patients now have another avenue to get
access to XPro in Australia, and we have another means of collecting long-term safety information.
Now I'd like to pass the call back to RJ.
I'll now move to INKmune, our Natural Killer
cell priming program. The MDS/AML program, Phase 1 clinical trial program in the U.K. continues to progress. The oncology landscape for
cell therapies is mainly focused on liquid tumors. This is only 10% of cancers. We have generated compelling human preclinical data in
solid tumors that suggests that INKmune may be an ideal therapy for the treatment of solid tumors. That is 90% of cancers are solid tumors.
Historically or even-not even historically, currently, this group of cancers is not well served by cell therapies. We believe refocusing
INKmune towards solid tumors meets an unmet medical need, with great potential.
I'll pass it to Dr. Mark Lowdell, the Chief
Scientific Officer of INmune Bio, to describe this in more detail.
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Thank you, RJ, and thank you, everyone, for joining
A couple of weeks ago, we shared with the investment
community, our recent positive efficacy data in multiple solid tumor cancer cell lines, with INKmune, as RJ just alluded to. As we highlighted