Navidea Biopharmaceuticals, Inc. (NAVB) Management on
Q1 2022 Results - Earnings Call Transcript
May 12, 2022 11:30 PM ETNavidea Biopharmaceuticals, Inc. (NAVB)
Navidea Biopharmaceuticals, Inc.
Q1 2022 Results Conference Call May 12, 2022 5:00 PM ET
Michael Rosol - CMO
Erika Eves - VP, Finance &
Conference Call Participants
Michael Okunewitch - Maxim Group
Welcome to the Navidea
Biopharmaceuticals First Quarter 2022 Earnings Call and Business Update.
I will now turn the call over to the
Chief Medical Officer from Navidea, Michael Rosol, you may begin.
Thank you, and thank you all for
joining us for today's earning call. This call is being webcast live on our
website, ir.navidea.com and a replay will be made available. Following prepared
remarks, we will be conducting a live Q&A session. Navidea’s Vice President
of Finance and Administration, Erika Eves will be joining me on the call today.
During the course of this conference
call, we will be making forward-looking statements regarding future events and
the future performance of the company. These events relate to our business
plans to develop Navidea’s molecular diagnostics and immunotherapeutics, which
include clinical and regulatory developments and timing of clinical data readouts,
along with capital resources and strategic matters as well as the impact of the
COVID-19 pandemic on Navidea’s business operations.
All of these statements are based on
the beliefs and expectations of management as of today. These statements involve
certain assumptions, risks and uncertainties and could cause actual results to
differ materially. We assume no obligation to revise or update forward-looking
statements whether as a result of new information, future events or otherwise.
Investors should read carefully the risks and uncertainties described within
the Safe Harbor section of our website as well as the risk factors included in
the company’s most recent quarterly and annual filings with the SEC.
And now, let’s begin with our
update. During the first quarter of 2022 and since, we have continued to work
on financing for the company. We continue our engagement with multiple
investment banks and options are being pursued in terms of capital. Erika will
cover the financials in detail, but we have the bridge loan funds we have
received from the company's largest shareholder and Vice Chair of the Board of
Directors, Mr. Kim Scott, as well as a small milestone payment due and another
potential payment upcoming. This is all I can say at the current time, but be
assured that we are working on this continually, we will provide you with
updates as we are able to do so.
Overall, we've made good progress on
our Phase 2B trial and rheumatoid arthritis, comparing imaging to biopsy. And I
hope you saw our press release several weeks ago, highlighting the promising
results and our ability to distinguish the fibroid pathotype from the
non-fibroid in our first 11 evaluated patients. These strong early results
support our hypotheses and provide great data and support of Tilmanocept
imaging as a biomarker of CD-206 expression in joints of patients with RA.
We also continue to enroll into the
RA Phase 3 and have recently opened up another site.
Additionally, we are advancing our
therapeutics and imaging applications through collaborative relationships with
various well-known institutions and investigators across the globe. And we are
growing in diligently maintaining the company's intellectual property. The team
here works extremely hard and efficiently, and I'm very proud to be associated
with this outstanding group of individuals. Senior management continues to work
closely with the Board of Directors and we are United in moving the company
forward. As we've said in the recent past, there are many things we are working
on behind the scenes and we will
provide you with updates as soon as we are able and as appropriate.
Now, I would like to provide more
detail around the clinical updates. I'll begin with progress in our Rheumatoid
Arthritis or RA program. So we continue to enroll into the Phase III trial on
RA, we've reached double digits now in patient enrollment and have just
recently opened up a third site. We've selected the first sites carefully based
on our experience with them and our previous Phase II B trial. And we're happy
to see that they've hit the ground running. The indications we're going for an
RA are one early prediction of treatment response to a new or first-time anti
TNF alpha therapy, and two, to identify patients with low level of localization
who are less likely to respond to anti TNF alpha therapy.
As we have discussed previously,
there is a large unmet need for reliable early predictor of whether or not a
therapy is working in a patient with RA, because if a drug is not working, the
patient's disease is not being treated and this can lead to long term health
consequences along with unnecessary high drug costs for ineffective therapies
that bring with them possible side effects.
Our Phase III trial will establish
the ability of Tilmanocept imaging to serve as an early predictor of treatment
response in RA patients switching to an anti TNF alpha therapy, addressing that
unmet medical need. Once we have funding in place, we can really hit the gas
and open up many more sites that we have been lining up in preparation for that
we have been in our negotiating site contracts with a large number of sites,
and we have conducted literally dozens of site qualification visits to prepare
the sites for opening.
NAV 332 our comparison study of
Tilmanocept imaging to joint biopsy remains in active recruitment. As we've
announced and discussed recently, the preliminary results of this trial were
promising. Our aim is to recruit patients with each of the three pathotypes of
RA to obtain comparative imaging and pathology results. And the trial is
designed so that we enroll a minimum of four subjects in each of the three
pathotypes of RA, the fibroid, the diffuse myeloid, and lympho-myeloid. So
overall trial size has been expected to range between 12 and 24.
To date, we have 11 patients who
have had both their imaging and joint biopsies completed another patient
scheduled for imaging next week, and others in the queue. Out of the completed
11, we have seven fibroid, three diffuse myeloid, and one lympho-myeloid.
Importantly, there is currently no way in advance to know what pathotype of RA
a patient has other than via biopsy. So our enrollment is based on those who
are willing and eligible to enroll.
The primary objective of this study
is to assess the relationship between joint specific Tilmanocept uptake values
and the pathobiology of RA involved joints. Knowledge of an individual RA
patient's pathotype may be clinically important because it may predict to which
RA therapy a patient is likely to respond. There's a growing body of literature
suggesting that those patients with the fibroid subtype of RA are much less
responsive to the anti TNF alpha drugs than the other subtypes. And so a means
of determining whether or not a patient has this particular pathotype is seen
as extremely important to a number of key opinion leaders in Rheumatology. As I
just mentioned, as of this time, there is no reliable way of assessing the
pathotype of a patient's RA other than by doing a biopsy. And we have
hypothesized that Tilmanocept imaging could provide this information.
So preliminary results on those
first 11 patients indicate that Tilmanocept uptake in RA inflamed joints is
able to discreetly differentiate patients with the fibroid pathotype, those who
have low macrophage involvement from those having either the diffuse myeloid or
lympho-myeloid pathotypes of RA, those with higher macrophage involvement. So
seven of the subjects had relatively low levels tilmanocept SPECT imaging. All
seven of those subjects were found of the fibroid pathotype seven out of seven,
out of the remaining four subjects, three of the diffuse myeloid, and one had
the lympho myeloid pathotypes. Those subjects with either the diffuse myeloid
or lympho myeloid pathotypes had on average, more than three times the TNFα
SPECT imaging as the average subject with the fibroid pathotype. So all of
those subjects had higher uptake than the fibroid patients.
To date, we have been able to
clearly classify patients then as either fibroid or non-fibroid based on our
imaging results taken before the biopsy in all 11 cases, these data also
provide support for one of our indications in the Phase 3 trial, namely, the
ability to predict from a baseline scan alone, whether a patient is likely to
receive a meaningful clinical benefit from an anti TNFα therapy. Since, as I
mentioned, there is increasing evidence that if a patient has the fibroid path
type of RA, they are less likely to receive significant clinical benefit from
anti TNFα therapy. You might recall in our previously completed Phase 2B study
that contained a pilot arm looking at the efficacy TNFα SPECT imaging at early
prediction of treatment response. Those patients who exhibited a low level of
TNFα SPECT imaging in their joints on their baseline scan had an almost 90%
non-response rate to anti TNFα therapy using the clinical gold standard
Finally, these biopsy trials are
notoriously slow recruiting, but in fact, our recruitment rate over our number
of sites is several times faster than what our lead principal investigator
indicated -- would've expected as usual. The clinical operations team here has
done a great job at exceeding expectations. We have another patient scheduled,
as I mentioned for imaging next week, several more in screening or in discussions
about screening over the next several weeks. We'll keep you posted on the
We continue to make very good
progress on automating the image quantification as well, which will have
significant benefit for the commercial product. We have the letter of intent
and are working closely with NIM software on the full agreement for them to be
our commercial partner for imaging quantification of tilmanocept SPECT imaging,
an RA. Once again, NIM is a leading medical imaging software company based in
Cleveland with a large footprint in the nuclear medicine space. They completed
a pilot study using data from our trials, demonstrating that they can develop a
fully automated application that can robustly reproduce our quantitative
imaging reads using our proprietary algorithm.
This will be important for rollout
of a commercial product, the ability to perform the quantitative reads rapidly
and reproducably, and at large scale through automated means is critical to
large scale use of tilmanocept SPECT for RA. Keep in mind that all of this, the
image analysis methodology, as well as the data upon which it is built,
including the normative database you've heard us discuss before is not only
critical to deriving the most accurate and sensitive objective read of our RA
images, but it also serves as a significant barrier to entry to possible
competitors in this space.
We'll continue to work with NIM to
finalize terms of the partnership and we'll make an announcement when we're
done. There are many factors to consider as we work through the agreement, but
our goal is to have it completed within the next couple of months. We also
recently released the updated primary U.S. market and secondary European market
research valuation for the RA product if it is approved, that report is
available on our website. The results of this analysis validate our assumptions
regarding the great need for, and potential value of our potential product and
RA, and include input from leading rheumatologists across the United States.
The Jubilant MOU, and exclusivity period are still in effect.
As we have mentioned in the past,
the completion of the NAV3-32 biopsy study is an important milestone for both
us and Jubilant. I have been and continue to be in communication with their
leadership and have been involved in these discussions since the beginning. We
are keeping them up to date on the study progress and NAV3-32 results. As we
advance in our clinical program. And as long as our data remains supportive of
our hypotheses, not only are we de-risking the program and asset, but also
increasing our value position. On the cardiovascular disease front, we're
completed on the investigator initiated atherosclerotic plaque imaging study at
mass general hospital in Boston, the data, our promising in terms of
localization of tilmanocept sites of plaque and have been in line with what was
reported in the pilot study. We co -- published with them several years ago.
The group at MGH presented an
abstract at an international conference in February and have submitted a
manuscript based on the full study results. When that manuscript is accepted,
we will let you know. On the preclinical therapeutic assets front, we are
advancing our candidates in the oncology and anti-inflammatory spaces.
Pre-clinical studies and Gallium 68 tilmanocept for PET imaging and related
next-generation Manocept imaging agents have progressed significantly through
internal work at Navidea and through extramural collaboration with researchers
at the University of Alabama at Birmingham or UAB.
We have completed work on our
NIH-funded preclinical studies for evaluating Gallium 68 tilmanocept in various
new imaging agents similar to tilmanocept in a mouse model of atherosclerosis.
Work on another important set of pre-clinical imaging studies was completed and
an abstract has been accepted at an international meeting and a manuscript has
been submitted as well. This work looked at a new technology designed to
increase the localization of our imaging agent to target tissues, while a second
technology was designed to block off target imaging agent localization to the
liver, which is a major site of localization when to tilmanocept administered
by intravenous injection.
These studies were very successful
showing that we can dramatically increase localization of a new tilmanocept
like imaging agent to tumors, while simultaneously and significantly blocking
off target localization to the liver. Additional work on new drug delivery
constructs and new targeted payloads has also progressed. These new constructs
carry new drug payloads that may be more effective than doxorubicin for
beneficially altering the immune status of tumor macrophages for example,
results and mouse models have demonstrated that when administered alone or in
combination with another cancer drug, these therapeutic constructs
significantly reduce the rate of tumor growth.
Some of these results should soon be
presented at a cancer therapeutics meeting as well. When we are allowed to
reach release details we will. We also announced recently that we have received
a notice of allowance from the U.S. PTO for our patent application covering a
man based therapeutic for Leashman ISIS. Leashman ISIS is a vector borne
chronic disease caused by a protozoan parasite that replicates in CD-206
positive macrophages. It is transmitted to humans through the bite of infected
sandfly found in parts of the tropics, subtropics and Southern Europe. It's
rare in the US, but in more tropical countries where the sandfly vectors are
found, Leishmaniasis is a common serious, and potentially life-threatening
disease. Because of this situation it's classified as a neglected tropical
disease. It is on the FDA's list of tropical diseases eligible to receive a
priority review voucher. These are vouchers issued by the FDA that allow the
recipient to expedite review of a new drug product. These vouchers can be sold
to other companies and dollar figures have ranged from as low as 67 million to
hundreds of millions of dollars. The goal is to spur the development of new
treatments for diseases that would otherwise not be developed.
So back to Leishmaniasis, we have
earlier work published in 2017, demonstrating that high CD206 expressing
macrophages play a role in the dominant form of the disease. And more recently
we have renewed preclinical studies with one of the world leaders in this area
and have promising early results. A follow-on preclinical study is currently
underway. As these studies progress, we will keep you updated. If further
research supports the efficacy of our therapeutic constructs for treating
Leishmaniasis, the awarding of a priority review voucher could have significant
economic value for Navidea. This is extremely important and reveals more of the
potential of our platform technology as well as our strategy. And so our
therapeutic pipeline is robust and moving forward.
That brings me to our overall
intellectual property front. We continue to submit new provisional applications
and work on our pending applications. In the last six months, since November
1st, we have conceived and submitted several new provisionals. Two in the last
quarter up till now and have another two in the works that should go out in the
coming days and weeks. The first of those recently filed is related to new
methods of attaching chemotherapeutics to the man step platform. And the second
relates to maximizing target tissue uptake and off target competitive blocking.
These have important implications for pipeline indications.
As you can see on today's earnings
call update press release, we have also had claims allowed on different patent
applications in various countries. We have an active IP protection strategy
that we believe will provide needed protections and rights to both our current
diagnostic and therapeutic agents, as well as to our next generation molecules
and disease indications.
We also recently press release the
regulatory approval of lymphocy as lympho aim in India. As mentioned in that
release, our partner in India, Sayre Therapeutics will lead the
commercialization efforts there. We're delighted that lympho aim has received
regulatory approval in India and will be available to patients in need. There
is a small milestone payment due for completion of the regulatory application
inquiry process, as well as another due upon receipt of the import license.
We'd expect that first payment by the end of this quarter.
So these are just some of the
highlights of the last quarter that we wanted to touch on for this update. We
remain largely focused on the RA pipeline, specifically the Phase II B imaging
to biopsy trial and the Phase III, while we continue to support and push for
progress on our other diagnostic and therapeutic indications.
As always, I want to thank the team
here for their tireless efforts to keep things moving and our network of
clinical trial sites and academic research collaborators for all of their hard
work. Thank you. And now, let's move on to the financial updates.
And with that, I'll introduce Erika
Thanks, Mike. So total net revenues
for the first quarter of 2022 were zero compared to $124,000 for the same
period in 2021. The decrease was primarily due to the 2021 partial recovery of
debts previously written off in 2015, coupled with recognition of license
revenue related to transitional sales in Europe in 2021.
Research and development expenses
for the first quarters of both 2022 and 2021 were approximately 1.2 million.
Decreases in Manocept diagnostic and to Manocept development costs and decrease
regulatory consulting expenses were offset by increased Manocept therapeutic
development costs, employee compensation, including fringe benefits and
incentive-based awards and recruiting expenses.
Selling, general and administrative
expenses for the first quarter of 2022 were 1.8 million compared to 2.2 million
in the same period in 2021. Decreases in employee compensation, including
fringe benefits and incentive-based awards, legal and professional services,
general office expenses, travel, franchise taxes and investor relations costs were
offset by increased director fees, some losses on the abandonment of certain
intellectual property, and increased insurance costs.
Navidea’s net loss of attributable
to common stockholders for the first quarter of 2022 was 3 million or $0.10 per
share compared to $3 billion or $0.11 per share for the same period in 2021.
And finally, Navidea ended the first quarter of 2022 with 1.2 million in cash
and cash equivalents, with the receipt of the $1.5 million bridge loan from Mr.
Scott, we believe we currently have enough cash on hand to continue operations,
at least through the end of the second quarter.
And turn it back over to Mike.
Thank you. And now let's open up the
[Operator Instructions] Our first
question is going to come from Michael Okunewitch with Maxim Group.
So I guess my first question I'd
like to ask regarding the 32 study, is there a chance that just, if you know,
the probabilities don't work out and you're unable to enroll enough patients of
a given path type since you can't test this before they actually enroll? Is
there a possibility of needing to expand enrollment to capture enough patients
to actually get a meaningful result? What do you mean by expand enrollment? Do
you mean sites or just -- add in additional patients, like, let's say you don't
get enough lymph myeloid patient.
Yes. The 12 to 24. Thanks, Michael.
This is Mike Rosol. So the expectation originally was 12 to 24, but indeed we
could increase that. What we could also do is, and we're monitoring this
closely of course is if we feel we have enough data to tell a compelling story,
we can also stop the trial based on our fibroid versus non fibroid
differentiation, I would like, and we would like to give it a little bit of a
greater shake here to see if we could accumulate some patients in those other
two pathotypes, specifically the lympho myeloid. So we can get a better idea of
whether or not we could distinguish between those two. So yes, if we keep
hitting mostly fibroids, we could increase it beyond the 24 or we could look at
the data and say, we've learned enough for now. And we we'll take what we have
because these data are important already, so we can do a number of things.
Thank you. And then I'd also like to
just touch on the kind of on the marketing side of the product, since these are
complex sales where you need buy in from both the nuclear medicine and
rheumatologists. So who are -- who's the primary group that something like this
would be marketed to or would you expect that payers could also help drive
adoption given the efficacy issues with TNS and the fibroid phenotype?
Absolutely. Great question. So we
think the rheumatologists are going to be the primary people we need to market
too, because they'll drive this the new med folks as well. I'm not leaving them
out. They're very excited about having another a possible radiopharmaceutical
in their armamentarium that they can then use to have their machines being busy
and their doctor's reading. So they're very interested as well, but I think
it's really the rheumatologists who are going to be driving this, and indeed
the payers should have a great interest in addition. We have not met with
payers yet, but it's on our upcoming roadmap to meet with payers and start
these kinds of discussions.
All right. Thank you very much. And
just one more for me, and I'll hop back in the queue, but I wanted to ask regarding
the automation or result interpretation. Is this something that you would need
to run an additional study to demonstrate the effectiveness of MIMs software
solution? And if so, could you use your existing imaging results to run it as a
Yes. Great question. So indeed, what
we're doing are our conversations with MIM are that our expectation is we will
be running the -- we'll be validating their software readout on the Phase 3
data, as well as the normative database data. So the plan is and we're working
through the details of this, but the plan is likely to go for 5-K, 10-K
approval of the automated readout in parallel with the Phase 3 and the end of
the Phase 3. And I've been involved in those kinds of submissions before that
have been successful with other companies. And MIM of course, does this for a
living. They've started training their automated algorithm on our earlier
obtained data from the Phase 2 studies. And we're going to be using the Phase 3
data as well as the normative database data to really validate this. And we'll
be comparing it to the plan is currently is to compare it to the nuclear med
doc imaging reads, that'll be part of the Phase 3.
Our next question is going to come
from Mike Shelly, a private investor. Mike, your line is open.
Erika, does keystone converted any
of their common share rights that they held at the end of December?
No, they have not.
And can we assume then that Julin is
because the contract is still or the due diligence still in place? The Julin is
still holding their shares. Can we assume that also?
Well we -- I suppose we might make
an assumption, but it would be just that. We really only get reports on the ultimate
shareholders, especially for those that hold in street name generally only once
a year in preparation for the annual meeting. So, I can tell you as of July of
2021, yes. Julan still was holding those shares. But I haven't seen an update
since then, so I can't tell you for sure right now.
Dr. Rosol couple questions.
Appreciate the update and the emphasis on the 332, that hundred percent image
matching that you did on particularly on the fibroid. I don't think the market
understands how critical or important that was. That's pretty significant,
Yes, I think you're absolutely
right. I mean, that was you don't, I've been around for a while and maybe I
started when I was super young, like Erika did here in any event. You don't
often see a hundred percent results. Now, again, this isn't the end of the
study. It's preliminary report, preliminary progress, but so far we're batting
a thousand as they say, and we've been able to bucket patients into the fibroid
or non-fibroid completely accurately at least with the gold standard of the
So indeed, I guess the market hasn't
recognized that yet. I can tell you, there are players in this field who have
recognized it. So we've had groups reach out to us that are involved in this
field who are pretty excited about those, at least to the level of wanting to
And some of this is on us as well,
right? So we'll need to get these results out there. And so the plan will be to
submit these results to the upcoming large rheumatology conferences as well as
imaging conferences as well. But in following on with the previous question
from Michael from Maxim, really getting the -- getting this news out there to
the rheumatologist is important, starting making a splash in that domain will
help. And then of course we do to get word out to the wider market as well.
Can you elaborate for us what the
importance is of differentiate -- differentiating between those two non-fibroid
pathotypes? How critical is that to differentiate between those two? Is it just
It might depend on who you ask, but
there, as it, as there is a growing body of research suggesting or
demonstrating that the fibroid versus non-fibroid broadly speaking have
different response rates to the biologics and other drugs that holds true as well
for the diffuse myeloid versus the lymphoid pathotypes. There are data out
there that suggest one of those pathotypes may be more or less responsive to
one or other biologic. So kind of a long term goal would really be able do
imaging and direct the -- give the physician, the rheumatologist information
that could really help them tailor in a fine-tuned fashion the treatment that
they then prescribe for their patient, but already it is a significant win. If
you could say this whole class of drugs, the most commonly used class, anti
TNFα have a very reduced chance of working on your patient, you should look
elsewhere that already in and of itself is a big win and already there's
information that -- looking at those other two classes, the non-fibroid, other drugs,
broadly speaking biologics will have a chance on those as well as the anti TNFs
and the fibroids are much less likely respond to the anti TNF. So moving a
large group of patients, maybe a third of patients around the globe, being able
to tell from a baseline skin that they're unlikely to receive a benefit from
the anti TNFs is a big win. And the rheumatologists are very excited about
But again, to reiterate, being able
to tease out the one versus the other of those two other pathotypes will be good
additive information that can help them really narrow in on the kind of -- the
drug class, for those patients that has a better chance of working. So it's
important, but really the indeed the kind of most important thing I think is
the fibroid versus non fibroid. And all of this is evolving in the literature
and in the understanding of rheumatologist. So we're really at the forefront of
rheumatology and RA medicine, which is a good place to be.
It would seem to me that some of the
big drug firms in this area would be very, very interested in this outcome.
Have you reached out to them or have they reached out to you or can you share
Yes, on both counts. So it's been a
two-way street, so they're yes. So indeed, there are drug companies who are --
they may or may not already have a certain class of therapy for RA already in
the market. But realizing that any one of those has a depending on the
milestones, you use the clinical assessments less than a 50, 50 chance of working
in any patient. They realize that there's opportunity and need in other -- in
developing other drugs and these other classes. And so many of these drug
companies are working on these new therapies. And it could be very beneficial
to them to be able to determine in advance what pathotype of RA a particular
patient has, not just for the responsiveness or non-responsiveness to the drug,
but maybe even to enter the trial. So they could use this to enrich their
trials, for example, or also as a biomarker of efficacy, right? So there are a
number of uses that this that we believe, and we're starting to demonstrate
that -- could provide that would be beneficial for them as they develop new
So getting back to the first part,
yes, we've been in touch and it's been through us and through them contacting
One question that, because these 332
ties closely to the jut deal, under the jut deal. Can you share --- are you
allowed to visit with other potential -- because we're talking here about other
people reaching out to you, are you allowed to talk to other people about
potentially doing something with the RA or are we restric under the --
Yeah, so it's an exclusive --
thanks, Michael. It's an exclusive agreement for the rights and certain domains
for the RA possible product and the indications that I gave. So that does not
cover some of these other possibilities and territories. Does that make sense?
Q – Unidentified Analyst
Okay. So right now you'd be
restricted in I'll call the North America, U.S. territory, but not in others.
Is that right?
Q – Unidentified Analyst
Okay. On the, I know others are
probably in the queues, so I'll make this last question and go back in. This IP
that Navidea has a significantly higher fair market value than it's on the
balance sheet. No doubt about that, because you’ve just got your costs on the
balance sheet. Eric, I think would verify that and you created such a higher,
fair market value. Does the company have any strategy how to go out, how to
tell the world about this ring fence that you've done around this
fast-developing mano CD-206 -- have you guys entering into any kind of strategy
on how to tell the world about this?
Yes. Good, good question, Mike. We
do in all of our discussions with possible investors and partners. These are
critical points that we bring up in those discussions. So in the one on ones,
with all of the above, we certainly bring this up as something of great value.
And I think it's been universally recognized as that or broadly at least. And
in terms of the greater world in general of course when we do any academic
presentations or press releases they're about how we're advancing the science.
I mean, this is embedded within that, right? So we do make announcements about
our IP and patents being allowed, claims being allowed, and patents being
granted. I don't know that during our presentations, we specifically call that
Maybe it's implied most companies
don't, but in general, we are. And in specific, when we speak with any possible
investors or partners, these are key points of those discussions. So the
message is always getting there to the players that we're speaking to or trying
to speak to whether we've reached out to them in the hopes of having something
happen or whether discussions are actually happening. And then more broadly if
you do presentations and press releases, you can mention it or it's assumed in
the progress you're making in your science, and maybe we can do a better job of
getting the message out there to the broader world.
Q – Unidentified Analyst
I appreciate that. I'll go, I'll go
back the queue, but I think on your presentations, you highlight it, because I
don't think people are so engrossed in their own world and their own little,
cubicle. I don't think they understand this. I just don't think you're
capturing of this CD-206 times is really appreciated. So I’ll go back in the
[Operator Instructions] And our next
question is going to come from Edward English, a Private Investor.
Q – Unidentified Analyst
I would like first to ask, when do
you expect the Royal free hospital in London to begin recruiting for the 332?
Thanks Eddie. So we've been trying
to schedule what's called the site initiation visit with them. And last I
heard, this morning, it's either next week or the week after. So once you've
had the full site initiation visit, which follows upon all sorts of contractual
stuff and a site qualification visit, then they're officially open to enroll.
So that should happen in the next one or two weeks unless somebody cancels. But
that's my understanding from speaking to the clinical team. So it's coming up.
Okay. I hoping that that would,
might help us get to the four full forward objective that we talk about. Okay.
Next question has the request for a drug import license been filed in India for
Timanocept. And would you agree that the estimated time for processing a
request there is approximately three months?
Yes. So that's about the right
timeline. We spoke to the Sayre folks recently in terms of once they filed it,
it can be a little bit longer. And as they've said your miles may vary
depending on what's happening, but in this case, what we're also doing remember
is we are developing we're bringing up to speed a new drug product
manufacturer. And so that needs to happen. And all of the paperwork for that
also needs to be sent over to the Indian regulatory authorities. So that will
take some lead time to do that. And then the Sayre folks will be applying for
the import license as well. And we'll keep you up to date on that, but so
there's some added time on top of that before that three months, so that will
take a bit of time, but we're in a good place with those folks and we're trying
to streamline things. So they get what they need as soon as we can provide it
and they are ready to go to the regulatory authorities.
Speaking of Sayre, I've noticed
their website is still indicating that lympho aim is awaiting DCGI approval.
And I haven't seen a press release from them on the approval in India for
lympho aim. And so with that, why do you think the results they will achieve in
India will be different from Norgen results in the EU?
Yeah. So in the -- on the first part
that's interesting, I've seen that as well. They were involved in our press
release and they were very responsive and excited about getting the press
release out. And they asked us to send us -- send them the link. So I don't
know why they haven't updated their website. I have a feeling their website
hasn't been updated a lot recently in general. But the folks we spoke to were
very enthused the leadership and they were going to go back to their Board of
Directors with a plan. I think - I wasn't around for the Norgen experience. I
think these folks have a good understanding of the market and how to, what kind
of price point they need to set. They have an understanding of the competitive
landscape in India. I can say this because I've spoken to them. So I don't
think they're going to make the same kind of mistakes and hopefully no new
ones, that Norgen made in the past in terms of overpricing and maybe not
getting the word out as well as they should have in Europe. I don't think
they're going to be doing that. And remember that was [Norgen] first and only
radiopharmaceutical and so Sayre has a little more experience in this domain
My last question is something I as,
and I we've talked about for years now that's --. There's a seemingly
open-ended due diligence agreement with them and it's frustrating for many
shareholders and some believe maybe it's even the prolonged analysis is having
a significant negative impact on the stock price. Can you explain why you can't
divulge more detail about the due diligence process for them specifically. Is
the due diligence interval timebound? Is it milestone bound or do you have some
other expiration criteria and what information they need to complete their
assessment? Because two years is a long time.
Yeah, it is, I appreciate the
question. So what I can say is they remain interested we've -- I discussed with
their leadership, uh, regularly I'm in discussions with them. I've known them
for the entire time I've been involved in those discussions. The MOU has had
revisions over time. And I can tell you, it is milestone based. And we haven't
come right out and said it, but you've understood at this point that a
significant milestone, there is the NAV33 32 trial. So I think that much, I can
say, it's not open-ended, it's not forever, and it has been amended over time
for various reasons. And so, again, they remain interested and we are in good
discussion with them and we do have milestones that are out there.
And our next question is coming from
I'll try to finish up with these
two. Erika, we had zero revenue on license sales in the first quarter, as you
noted. Dr. Rosel or Erika, have they been able to get any more product to the
EU to start reselling that if they were out to stock or was that just
coincidental or how is that working then restocking the EU?
So it has never been out of stock.
There was a logistics transition from stock supply from Norgen to our
distributor. And so that caused some lag, you'll see those sales pick up in the
coming quarters now that that's been kind of worked through. And so we're --
we've done all that we can do to make sure that there's a continuing supply of
lymphoseek in Europe. And without going too far out on the ledge here, we've
seen some interest in utilizing this in Europe. And I think there's very good
potential for the product in Europe despite where it's been before.
Well, that's a good piece of news.
And let me try to finish up because I'm just so, astounded by those results in
that 332, that a 100% match. And I think I remember right AbbVie -- and their drug, rinvoq?
The way they're the way they're developing their trials, this would seem to be
very, very important to somebody like them, or am I misunderstanding their
No, you're right. So that's AbbVie and that's rinvoq and you're right. And rinvoq is a Jack inhibitor. So it's a different kind of NextGen or
second line therapy for rheumatoid arthritis. And you may have seen back by the
way in September the FDA, put a put out a notice with kind a warning that
because of side effects from using rinvoq,
they reiterated the FDA that as that the anti TNFα therapies should be utilized
first before patients are put on rinvoq.
And so -- and others, I think are natural possible partners here in various
ways. One as I mentioned is maybe for us to be -- using tilmanocept or them to
be using tilmanocept as a biomarker, predictive of efficacy of their drugs,
potentially enriching their trials or stratifying, looking at the fibroid
versus the non-fibroid and seeing if their drugs work on one or both classes of
And so I think we're a natural
partner for many of these -- for any of these pharmaceutical companies, making
these next generation rheumatoid arthritis drugs. And I'm not promising
anything, but as I said, we've kind of progressed in those results were released
the preliminary results. We've seen some interest related to everything that I
just said based on those NAV3-32 results. So you're right to keep looking at
those Mike, and we hope that as that trial continues and that these great
results will also continue. And we'll keep you posted on these discussions
we're having related to that whenever something significant happens.
Q – Unidentified Analyst
Well, I hope I count. We're all
counting on those potential funders to be listening in to these phone calls,
and listening to these excellent feedback we're hearing, because whoever funds
this is really going to fund a something for humankind, not just for the
shareholders. So I hope people really appreciate that. So thanks for taking my
Next question is coming from Edward
English a Private Investor.
Q – Unidentified Analyst
This is Eddie again. I did have a
question about the financing for Erika, if I could. In the last one of the last
calls Erika, the chairman elaborated on his preference to have a larger
financing deal. That would be multi-year. I'm assuming you're involved in
what's going on with the larger financing plans and activities. Is it still the
preference and likelihood that this financing deal would be a multi-year thing
that would provide the video for long- funding as opposed to short range?
Yes. I would say that that would
still be the preferred route was, would be to kind of do one large funding, and
then not have to worry about it for a couple more years. However, that being
said, we are open to many different potential opportunities and we're
evaluating many different possibilities. Not all of which may be that one large
Q – Unidentified Analyst
And you mentioned that the deal
could involve -- I believe you used the word day one money followed by
milestones that provide additional funding and so forth. Is that still the
framework that's being actively pursued?
Yes. I mean that is one potential
framework. Yes. But as I said, we are looking at and evaluating a number of
different possible scenarios.
Okay. Unfortunately, that is all
over the time that we've had for questions. So now turn it back to Michael
Rosol for closing statements.
Thank you. And thanks everyone for your
attention today for dialing in and for remaining interested in our progress.
We'll keep our noses to the grindstone and we will speak to you again next time
we have some news to announce, and see you then. Thank you.
Okay. This concludes your call. You
may now disconnect.