Full Press Release Details
Hello, this is Jon Foster, CFO of Moleculin Biotech, Inc. and
I would like to welcome you to our conference call. Before we begin, I'd like to provide some important disclosures:
Some of the statements in this conference call will be forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934
and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements that
we will discuss in this conference call include, without limitation, our ability to timely file and have allowed an IND for Annamycin
and to commence clinical trials, the ability to get WP1066 into a DIPG clinical trial, the occurrence of a physician-sponsored
IND for testing WP1066 in adult brain tumors this year, the ability to get WP1234 into a pancreatic clinical trial, the ability
to get WP1220 into a CTCL clinical trial and the ability of any of our drugs to show activity in these respective diseases. These
statements relate to future events, future expectations, plans and prospects. Although Moleculin Biotech believes that the expectations
reflected in the forward-looking statements we will discuss today are reasonable as of the date made, expectations may prove to
have been materially different from the results expressed or implied by such forward-looking statements. Moleculin Biotech has
attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,''
''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or
other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements
are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item
1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC")
and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements
discussed on this call speak only as of today. We undertake no obligation to update any forward-looking statements discussed today
to reflect events or circumstances occurring after today or to reflect the occurrence of unanticipated events.
Now, let me hand the call over to Wally Klemp, Chairman and
Wally - Greeting and Comments
Thanks, Jon. Hello and thanks to everyone for joining our conference
call. Again, I'm Wally Klemp, Chairman and CEO of Moleculin Biotech, Inc. and the purpose of this call is to provide a little
better understanding of the important events of the past few weeks and to update you on current business activities. A lot has
happened in just this last month, so we wanted to use this call to put it all into perspective and review what may be coming next.
Before we do, however, I should also acknowledge that there has been a lot of recent activity in our stock. So much so, that it
would be reasonable to assume that a lot of you on this call are new to Moleculin. For that reason, I'd like to also briefly
recap the Moleculin story along the way.
From a big picture perspective, we have a portfolio of three
fundamentally different technologies, each of which is based in part on discoveries made at MD Anderson Cancer Center, the world's
largest cancer research center. One of those technologies is a named drug called Annamycin that we are studying for the treatment
of relapsed or refractory acute myeloid leukemia or AML. I'll cover Annamycin in more detail in a moment, but first let me
summarize the other two technologies.
Our WP1066 portfolio is a collection of molecules focused on
cell signaling. The 1066 molecule has been the subject of nearly 50 peer-reviewed journal articles and has been studied by several
respected institutions, independent from MD Anderson. Based on this extensive research, 1066 and some of its analogs are considered
promising candidates for the treatment of brain tumors, pancreatic and stomach cancers, as well as metastatic melanoma. One of
the important things it appears 1066 can do is to inhibit the activated form of a protein called STAT3. This cell signaling protein
is highly activated in a number of tumors and preclinical testing has shown that 1066 has the potential to kill tumor cells, as
well as prevent tumor growth in a range of animal models.
We announced earlier this week a collaboration with the prestigious
Mayo Clinic to supply them with WP1066 for preclinical testing
for a potential future study in the treatment of pediatric DIPG. Diffuse Intrinsic Pontine Glioma or DIPG is a rare and
untreatable form of brain tumor that appears to have a high correlation with the activated form of STAT3.
The researchers at Mayo undertook their own comparison of a
panel of known STAT3 inhibitors, including WP1066, and concluded that, of all the inhibitors they tested, WP1066 was their preferred
choice to consider for a possible clinical trial. They also shared with us their own testing of WP1066 in live human DIPG tumors
that were transplanted into mice, where the compound showed antitumor activity. Based on their research, the Mayo team asked us
to enter into an agreement to supply WP1066 for further research. Although there are several steps between here and there, the
obvious goal is to try to get 1066 into a DIPG clinical trial as soon as possible.
This effort at Mayo Clinic, by the way, is separate from the
efforts of Dr. Amy Heimberger at MD Anderson. Dr. Heimberger continues to make progress toward providing requested information
to the FDA, that is of course the Food & Drug Administration, in order to move forward with her physician-sponsored clinical
trial to study 1066 in adult brain tumors. Now, for those of you who are not familiar with physician-sponsored clinical trials,
these are studies that take place when an individual doctor or institution, in this case MD Anderson, plans, conducts and pays
for a clinical trial from its own funding sources. We view this to be an important validation of the potential of 1066 and we are
optimistic these clinical trials may begin later this year.
We announced a few weeks ago that we had begun preparation of
an IND to allow us to study WP1220, a close analog to 1066, for the treatment of Cutaneous T-Cell Lymphoma or CTCL. CTCL is a potentially
deadly form of skin cancer for which there are very limited treatment options. As you may know, IND stands for Investigational
New Drug application and it is the submission you make to FDA in advance of conducting human trials with a drug. It generally contains
information about the safety of the product you intend to study, the composition, manufacture and control of the drug substance
and drug product, and proposed study protocols, among other things.
In this case, we already have a data package that FDA previously
found sufficient for an IND to study WP1220 for a different indication, and we think that gives us a bit of a leg up here. We believe
developing WP1220 for indications like CTCL may provide opportunities for strategic collaboration and out-licensing while maintaining
our ability to develop other molecules to their highest and best potential. For some added perspective here, CTCL is a rare disease
with less than 50,000 cases per year in the US and EU and for which there are limited treatment options. The most recent advancement
in topical therapies for CTCL was a topical nitrogen mustard called Valchlor. This technology, by the way, is comparable to the
mustard gas used in World War I. Valchlor was purchased by Actelion in 2013 for $250 million plus future milestone payments, so
any opportunity we may have to improve upon Valchlor for the treatment of CTCL may have significant market value.
The other technology we have for development is what we call
the WP1122 Portfolio. We believe this group of molecules has the potential to target the metabolism of cancer. Specifically, it
is well documented that many tumors are highly dependent on glucose to survive. As an example, a human brain tumor cell will consume
up to 35 times as much glucose as a normal healthy brain cell in order to survive. There is a theory that, if we could supply sufficient
glucose decoys that is molecules that look like glucose, but won't convert into energy, we might be able to
starve a tumor to death. The problem with this approach until now has been that the available glucose decoys did not have enough
circulation time for adequate tumor uptake. Our bodies simply metabolize the decoys too rapidly.
WP1122 was designed to increase that circulation time and to
improve tumor uptake of a glucose decoy and it has received a lot of attention from the scientific community because of these improved
characteristics when compared with existing decoys. Through our continued sponsored research at MD Anderson, we announced last
week that we have now identified that WP1234, a close analog to 1122, has even better circulation time and a very high rate of
uptake to the pancreas in animal models.
Even though this is very preliminary information, we believe
these findings are big news. We anticipate formally presenting the findings to the scientific community in the near future, but
given the importance of showing even the early potential of any progress in an area like pancreatic cancer, we wanted to get this
news out to the public as quickly as possible. Pancreatic cancer is considered largely untreatable, so the prospect of a drug that
could slow or stop pancreatic tumor growth has potentially far reaching implications for Moleculin. Clearly, there is a long road
from this initial information to testing products against cancer in humans - let alone demonstrating safety and efficacy.
But we have to start somewhere, and we're excited about these prospects and are already in discussions with clinicians who
are focused on pancreatic cancer to evaluate the best approach for getting WP1234 into an initial clinical trial.
Although the 1066 and 1122 portfolios represent distinctly different
possibilities for important new cancer treatments, Annamycin is considered our most important opportunity, primarily because it
is farther along the development path and already has human data suggesting activity against acute leukemia.
In order to understand just how important Annamycin could be,
let me provide some background on the treatment of AML. The good news for AML patients currently is that bone marrow transplants
are successful in curing AML about 80% of the time. The bad news, however, is that patients must first completely clear their bone
marrow blasts (or tumor cells) before qualifying for a transplant and the "induction therapy" used to do so only succeeds
about 20% of the time. So, that leaves about 80% of AML patients without hope, because there is no approved second-line therapy