Full Press Release Details
C O R P O R A T E P A R
David J. Moss, Chief Financial Officer
Raymond J. Tesi, M.D., Chief Executive
C O N F E R E N C E C A
L L P A R T I C I P A N T S
Jonathan Aschoff, Roth Capital Partners
Naureen Quibria, Maxim Group
Arthur He, H.C. Wainwright
P R E S E N T A T I O N
Greetings, and welcome to the INmune Bio Second
Quarter 2020 Earnings Call.
At this time, all lines have been placed on
a listen-only mode, and the floor will open for questions and comments following the presentation. If you have a question please
press the one, followed by the four on your telephone.
As a reminder, this conference is being recorded.
A transcript will follow within 24 hours of this conference call.
At this time, it is my pleasure to introduce
Mr. David Moss, cofounder and CFO of INmune Bio. David, the floor is yours.
Thank you Malika, and good afternoon everybody.
We thank you for joining us for the call for INmune Bio's second quarter 2020 financial results. With me on the call is RJ
Tesi, CEO and cofounder of INmune Bio, who will provide a business update.
Before we begin, I remind everyone that, except
for statements of historical facts, the statements made by management in 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 in such 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 is 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 obligations to update
these forward-looking statements to reflect future information, events or circumstances.
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With the forward-looking statements behind
us, now I'd like to turn the call over to RJ Tesi, cofounder, CEO of INmune Bio. RJ?
Thank you David, and thank everyone for joining
I will arrange my marks to highlight key take-aways
for the second quarter, year to date, and provide updates for the programs using our two platforms before I pass it back to David
to discuss our financial results and upcoming milestones. Then we will move to the Q&A.
We'll start with the DNTNF platform that
targets soluble TNF without affecting transmembrane TNF. This unique biology opens vast therapeutic areas that are not accessed
by the currently approved TNF inhibitors, due to safety concerns.
INmune Bio has four therapeutic programs in
development using the DNTNF platform. These include INB03 for cancer, LIVNate for NASH, Queller, a new program to treat the complications
of cytokine storm related to C19, and XPro1595 for Alzheimer's disease. I'll remind you that these are all the same
drug repurposed for each indication.
XPro1595 for the treatment of Alzheimer's
disease is the obvious place to start. Although not a second quarter event, on July 13 we reported interim results from our Phase
1b clinical trial. We have been clear in describing the goal of this trial, which is to decrease neuroinflammation in patients
with Alzheimer's disease. Preliminary data reported in six patients demonstrated that XPro decreases white matter free water,
a biomarker of neuroinflammation that is measured by MRI, in patients with Alzheimer's disease. The preceding statement understates
the real power of this biomarker. In all patients, neuroinflammation, as measured by this validated biomarker, decrease in the
arcuate fasciculus. Why is this important? The arcuate fasciculus is a white matter tract critical in language.
While these data are preliminary and must be
confirmed with additional study subjects, we believe they provide an important-they are important for three reasons. First,
they show that XPro, when given as a subcutaneous peripheral injection, can decrease neuroinflammations in patients with Alzheimer's
disease. Second, the decrease is in a well defined anatomical structure that plays a crucial role in arguably the most sensitive
clinical symptoms of Alzheimer's disease, and that is language or language dysfunction. Finally, these data provide a distinctive
measurable biomarker that we can use to inform this and future trials, and points to clinical endpoints that will allow us to design
an efficient Phase 2 program while optimizing the dose of the drug to be used in what will be a blinded randomized placebo-controlled
If you did not participate in the KOL webinar
on the morning of the 13th, I suggest you use the link on our website to listen to the clinical vignettes presented by Dr. Rosalyn
Lai, the PI at the KaRa site in Sydney Australia. You can also hear the commentary by our expert team of consultants, and you can
see the data in the slides.
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Like our consultants, we are extremely encouraged
by these findings at such an early stage in our clinical trial. Not only do we see a clear reduction in neuroinflammation, but
we also know where in the brain this reduction is occurring, and which may allow us to predict domains of cognition that might
be affected by the disease and the therapy. We look forward to results in additional patients in the Phase 1b trial, and in the
patients who have been enrolled over into the extension trial. If there are no surprises, we are confident in our goal to initiate
a Phase 2 trial in 2021.
The C19 pandemic continues to rage across the
U.S. The Queller program targets soluble TNF, arguably the most important element of the cytokine storm that is a common feature
in patients requiring hospitalization for COVID-19 infection. We have previously detailed our decision process and strategy as
it relates to this fascinating but complicated public health problem.
Several things have changed. We signaled we
were applying for nondilutive financing from BARDA. On the eve of our application submission, BARDA refocused its mission to supporting
vaccines and diagnostics exclusively. They indicated a submission for a therapeutic would be a low priority. Disappointed but not
deterred, we are working towards treating the first patient. The exact timing for this depends on both the regulatory agencies
and the complex startup activities at the clinical sites. Honestly, two months ago I was concerned that there may not be enough
cases in the United States; obviously that has changed dramatically. This disease is going to be with us for a while. We think
we have a therapy that should be tested and may benefit these patients.
We have two additional DNTNF programs that
are delayed due to the pandemic: INB03 for cancer and LIVNate for NASH. We believe it will not be possible to initiate enrolment
in these programs until 2021. As the pandemic winds down and clinical sites begin to return to normal, we will seek to reengage
the clinical teams that we have identified for these programs. I do not want to predict when patient enrolment will start.
For those of you seeped in the world of biotech,
an obvious question is what about drug supply. We are working with KBI Biopharma, a U.S.-based CDMO, on the production of new drug
for our burgeoning clinical programs. Making biologics is complicated; there are many twists and turns. The best way to describe
the process so far is that it is so far so good. If things remain on track, we expect to have the first batch of drug produced
Before I conclude my comments on the DNTNF
platform, I want to highlight some surprising findings reported by Dr. Roxana Schillaci at the AACR this year. Dr. Schillaci has
demonstrated that the combination of INB03 with the TKI inhibitor lapatinib overcomes resistance to trastuzumab in HER2-positive
breast cancer. Actually in any HER2-positive cancer; she has data in gastric carcinoma also. This body of work continues to expand,
and we hope to present additional preclinical data to support our efforts in oncology.
On to INKmune. This is our NK cell priming
platform. We have two therapeutic programs in the queue. INKmune will be studied in a solid tumor and a hematologic malignancy:
ovarian cancer and high-risk MDS respectively. The latter is a form of pre-leukemia.
In June, we announced the MHRA, the U.K. equivalent
of the FDA, has given approval to initiate the Phase 1 clinical trial with INKmune in high-risk MDS patients. This single-center