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 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
Jonathan Aschoff, Ph.D., ROTH Capital
Mikhail Keyserman, BTIG
Mayank Mamtani, B. Riley Securities
Daniel Carlson, TW Research
P R E S E N T A T I O N
Greetings and welcome to the INmune Bio Second
Quarter 2021 Earnings Call.
As a reminder, this conference is being recorded.
A transcript will follow within 24 hours of this conference call, and the replay is available per the instructions on the press release
announcing the second quarter 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 Rachel, and good afternoon everybody.
We thank you for joining us for the call for INmune Bio's second quarter of 2021 financial results.
With me on the call is Dr. 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 and responses to questions on the 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 earning 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 obligation to update these forward-looking statements to reflect future
information, events or circumstances.
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an accurate transcription. There may be material errors, omissions, or inaccuracies in the reporting of the substance of the conference
call. This transcript is being made available for information purposes only.
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We had a busy quarter, as we continue to make
progress on our INKmune and DN-TNF platforms. Now I'd like to turn the call over to Dr. RJ Tesi, cofounder, CEO of INmune Bio, to
discuss these developments. RJ.
Raymond J. Tesi, M.D.
Thank you David, and thank you everyone for joining
the call. As is our practice, I will arrange my remarks to highlight the key take-aways for the second quarter and subsequent period,
and provide updates to our platform programs before I pass it back to David to discuss our financial results and upcoming new milestones.
Then we'll move to Q&A.
In a little bit of a change, I'll begin
with INKmune, our proprietary natural killer cell priming platform, which we have termed a pseudokine. What is a pseudokine? In vitro,
INKmune gives NK cells increased tumor binding, that's also called avidity; increased proliferative capacity, and increased tumor-killing
capacity. This combination of features has previously been seen in NK cells cultured with a cocktail of cytokines IL-12, -15 and -18.
The NK cells produced with INKmune are termed
memory-like NK cells. It is a phenotype that has been shown to be most effective in killing cancer cells.
So INKmune, certainly in vitro, improves antitumor
NK responses, and we believe in patients it will do this in a simple cost-effective manner; there are no cytokines anywhere involved in
either the manufacture of the cells or of INKmune or the treatment of the patients. We believe this product will have therapeutic potential
in both solid and liquid tumors.
INKmune is manufactured in bulk, and available
A month ago we announced the first patient had
been treated in the Phase 1 trial evaluating INKmune in patients with high-risk myelodysplastic syndrome or MDS. High-risk MDS is a preleukemia;
patients often what is called blast off, develop a very severe form of AML.
This patient has received three doses of INKmune
by intravenous infusion, with absolutely no problems. Biomarker data shows the presence of activated NK cells in the patient's blood
that were not there before INKmune therapy, and there is evidence of NK cell proliferation, which is exactly what you want in patients
that have bone marrow dysfunction.
We expect to provide more detailed biomarker response
data in the near future. This is the first of three patients in the lowest dose cohort. We expect to enroll the second patient soon.
Why did we start with MDS, a serious hemopoietic
stem cell disorder, as our first indication? MDS patients have functionally defective NK cells that do not have strong avidity to their
cancer cells, and I remind you low avidity means low tumor killing. This level of dysfunction is actually predictive of overall survival:
the worse the avidity, the shorter the survival.
In vitro study of their NK cells shows
that they respond to INKmune priming with increased avidity and increased killing of tumor blasts in vitro, a response that may predict
improved tumor killing in the patient.
ViaVid has made considerable efforts to provide
an accurate transcription. There may be material errors, omissions, or inaccuracies in the reporting of the substance of the conference
call. This transcript is being made available for information purposes only.
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The biomarker panel used to monitor these patients
will provide detailed data on the patients' immune response to therapy.
The patients eligible for enrolment in this Phase
1 trial are not eligible for high-dose chemotherapy or stem cell transplant, often based on frailty or age, and we believe a safe effective
well-tolerated immunotherapy may be their only option. We hope that INKmune may be a solution to a difficult problem.
We plan to enroll nine patients with high-risk
MDS in the dose escalation protocol. The primary endpoint is the safety and tolerability of the intravenously-administered INKmune; secondary
endpoints are biomarkers of NK function in the peripheral blood, overall response rate using the WHO criteria for MDS, and duration of
I remind you this is a typical open label Phase
1 dose escalation trial in patient with cancer, there is no placebo group.
We will release data periodically as we have done
with the Xpro Alzheimer's disease trial.
Based on extensive preclinical data, we believe
INKmune may have utility in solid tumors as well. We hope to initiate a Phase 1 trial in ovarian cancer in the coming months.
We understand the mechanism of action of INKmune
is unique and different than existing NK cell therapies. INKmune acts like a cytokine cocktail even though there are no cytokines, hence
the "pseudokine" name. INKmune makes the patient's own NK cells better; we are not giving the patient NK cells from
We understand that INKmune's mechanism of
action may be confusing. We have created a short video that explains how INKmune works. The video can be found on our website under Therapies,
INKmune Videos, or on our YouTube channel. We hope you will view it and contact us if you have any questions.
On to Xpro as part of our DN-TNF platform. To
our knowledge, this is the only selective TNF inhibitor targeting inflammation without causing demyelination or immunosuppression.
Xpro is completely different from the currently
approved TNF inhibitors. By neutralizing the bad form of TNF, called soluble TNF, we eliminate inflammation everywhere, including the
brain. By protecting the function of the good TNF, called transmembrane TNF, Xpro improves the immune response to tumors and infection,
promotes remyelination, nerve cell survival, and signaling. These differences are why DNF can be used to treat neurologic diseases while
currently approved non-selective TNF inhibitors are contraindicated inpatients with neurologic disease.
We repeat this message frequently in an effort